Access, use, and challenges of claims data analyses in Germany The American Heart Association's recommendations for expanding the applications of existing and future clinical registries: a policy statement from the American Heart Association. False Dichotomies and Health Policy Research Designs: Randomized Trials Are Not Always the Answer National policy development for cotrimoxazole prophylaxis in Malawi, Uganda and Zambia: the relationship between Context, Evidence and Links Does health insurance improve health?: Evidence from a randomized community-based insurance rollout in rural Burkina Faso. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research Rationale and methods of a multicentre randomised controlled trial of the effectiveness of a Community Health Assessment Programme with Emergency Medical Services (CHAP-EMS) implemented on residents aged 55 years and older in subsidised seniors’ housing buildings in Ontario, Canada Perceived stigma and help-seeking behavior: longitudinal evidence from the healthy minds study. A randomized controlled trial evaluating the impact of knowledge translation and exchange strategies Measuring improved targeting of health interventions to the poor in the context of a community-randomised trial in rural India. Public views on determinants of health, interventions to improve health, and priorities for government. Registration of systematic reviews: PROSPERO The Tanzania Connect Project: a cluster-randomized trial of the child survival impact of adding paid community health workers to an existing facility-focused health system The effects of expanded mental health benefits on treatment costs. Clinical Trial Registration Looking Back and Moving Ahead Expanding the evidence within evidence-based healthcare: thinking about the context, acceptability and feasibility of interventions A conversation with Joseph Lau. Health insurance and health-seeking behavior: evidence from a randomized community-based insurance rollout in rural Burkina Faso. Cancer treatment at home or in the hospital: what are the costs for French public health insurance? Findings of a comprehensive-cancer centre. Using randomized controlled trials to evaluate socially complex services: problems, challenges and recommendations. The impact of population-based disease management services for selected chronic conditions: the Costs to Australian Private Insurance - Coaching Health (CAPICHe) study protocol Learning from a cluster randomized controlled trial to improve healthcare workers' access to prevention and care for tuberculosis and HIV in Free State, South Africa: the pivotal role of information systems.
Worldwide , information infrastructures have developed rapidly towards big data over the past few years . The evolution of powerful computers has made it possible to improve the data exchange process within the healthcare system [ 1 ] . This technological trend has also triggered new and powerful possibilities in health service-related research ( e.g. , cl aims data analyses ) , because it now allows the analysis of more complex and larger data sets . In this editorial , we focus on cl aims data analyses , because they are an important and powerful source of information to support the decision-making processes of healthcare stakeholders , research ers , and policy-makers regarding various aspects of the healthcare system . A few years ago , the statutory health insurance ( SHI ) companies in Germany made their data available for research purpose s , because they realized the comprehensive potential of these data for both rational allocation of re sources and for health services research to optimize healthcare provisions . The German government increasingly supports and funds cl aims data research , thus confirming the growing relevance of such research . Furthermore , recently , this research field developed a sophisticated method ological framework for comprehensively analyzing and interpreting the data in the context of various research questions . The significant increase in the number of cl aims data studies ( and frequency of policy-relevant research ) confirms this trend [ 2 , 3 ] ( see Fig. 1 ) . Cl aims data studies mainly use the information stored in data warehouses of the SHI . As a form of administrative data , primarily collected for billing and reimbursement purpose s , cl aims data belong to the category of secondary data . These data are transmitted directly from healthcare providers to SHI funds , which include information on ( all ) cross-sector contacts between the insured and the healthcare system in their data base . Compared with clinical trials , cl aims data analyses could reflect real-life healthcare provisions . Further advantages of this data source are the costefficient generation of data and a typically large study population compared with r and omized controlled trials , which research ers often view as the gold st and ard for providing information on treatment efficacy and safety in a clinical setting . These data also help include groups that are typically more difficult to observe through primary data collection ( e.g. , children , severely ill individuals , dementia patients , or residents of nursing homes ) . Over the last 15 years , almost one-third of the published cl aims data studies have focused on health economics [ 2 ] . Furthermore , due to its advantages , research ers have previously used this data source for health services research on treatment patterns , under and overtreatment of specific diseases , epidemiology studies , and as an input factor for modeling studies [ 4 ] . The aim of all these studies was to increase transparency and efficiency of the healthcare system by analyzing real-world evidence . Moreover , the latest national call for proposals confirms that there is both an increase in the importance of and positive development in cl aims data research . The German government and the Federal Joint Committee ( Gemeinsamer Bundesausschuss , G-BA ) established the ‘ Innovation Fund ’ , which will provide funding of 75 million euros per year for projects dealing with health service research over a period of 4 years . In such projects , it is & Sarah Neubauer Clinical registries play an important role in measuring healthcare delivery and supporting quality improvement for individuals with cardiovascular disease and stroke . Well- design ed clinical registry programs provide important mechanisms to monitor patterns of care , evaluate healthcare effectiveness and safety , and improve clinical outcomes . The use of clinical registries is likely to grow given the increasing focus on measuring and improving healthcare delivery and patient outcomes by stakeholders in both the private and public sectors . The American Heart Association ( AHA ) has a longst and ing commitment to promoting the innovative and effective use of clinical registries . The importance of clinical registries was highlighted recently in an AHA Scientific Statement on “ Essential Features of a Surveillance System to Support the Prevention and Management of Heart Disease and Stroke ” in the United States.1 This policy statement exp and s on the previous scientific statement by providing recommendations to policy makers and the healthcare community for expansion of the applications of existing and future clinical registries . The term “ clinical registry ” is defined here as an observational data base of a clinical condition , procedure , therapy , or population in which there are often no registry-m and ated approaches to therapy and relatively few inclusion or exclusion criteria . The focus of clinical registries is to capture data that reflect “ real-world ” clinical practice in large patient population s. The data from clinical registries do not replace the need for traditional r and omized controlled trials . Rather , registries and trials are complementary approaches , each with unique advantages and imperfections.2 Such clinical registries do not solely contain cl aims or administrative data yet may be linked to such data sources . There are at least 3 classifications of clinical registries based on the patient population , including procedure/therapy/encounter-based , disease-based , and population -based registries . Registries also can be classified from a functional perspective , such as whether the registry is used to conduct clinical research , Some medical scientists argue that only data from r and omized controlled trials ( RCTs ) are trustworthy . They cl aim data from natural experiments and administrative data sets are always spurious and can not be used to evaluate health policies and other population -wide phenomena in the real world . While many acknowledge biases caused by poor study design s , in this article we argue that several valid design s using administrative data can produce strong findings , particularly the interrupted time series ( ITS ) design . Many policy studies neither permit nor require an RCT for cause- and -effect inference . Framing our arguments using Campbell and Stanley ’s classic research design monograph , we show that several “ quasi-experimental ” design s , especially interrupted time series ( ITS ) , can estimate valid effects ( or non-effects ) of health interventions and policies as diverse as public insurance coverage , speed limits , hospital safety programs , drug abuse regulation and withdrawal of drugs from the market . We further note the recent rapid uptake of ITS and argue for exp and ed training in quasi-experimental design s in medical and graduate schools and in post-doctoral curricula Background Several frameworks have been constructed to analyse the factors which influence and shape the uptake of evidence into policy processes in re source poor setting s , yet empirical analyses of health policy making in these setting s are relatively rare . National policy making for cotrimoxazole ( trimethoprim-sulfamethoxazole ) preventive therapy in developing countries offers a pertinent case for the application of a policy analysis lens . The provision of cotrimoxazole as a prophylaxis is an inexpensive and highly efficacious preventative intervention in HIV infected individuals , reducing both morbidity and mortality among adults and children with HIV/AIDS , yet evidence suggests that it has not been quickly or evenly scaled-up in re source poor setting s. Methods Comparative analysis was conducted in Malawi , Ug and a and Zambia , using the case study approach . We applied the ‘ RAPID ’ framework developed by the Overseas Development Institute ( ODI ) , and conducted a total of 47 in-depth interviews  across the three countries to examine the influence of context ( including the influence of donor agencies ) , evidence ( both local and international ) , and the links between research er , policy makers and those seeking to influence the policy process . Results Each area of analysis was found to have an influence on the creation of national policy on cotrimoxazole preventive therapy ( CPT ) in all three countries . In relation to context , the following were found to be influential : government structures and their focus , donor interest and involvement , healthcare infrastructure and other uses of cotrimoxazole and related drugs in the country . In terms of the nature of the evidence , we found that how policy makers perceived the strength of evidence behind international recommendations was crucial ( if evidence was considered weak then the recommendations were rejected ) . Further , local operational research results seem to have been taken up more quickly , while r and omised controlled trials ( the gold st and ard of clinical research ) was not necessarily translated into policy so swiftly . Finally the links between different research and policy actors were of critical importance , with overlaps between research er and policy maker networks crucial to facilitate knowledge transfer . Within these networks , in each country the policy development process relied on a powerful policy entrepreneur who helped get cotrimoxazole preventive therapy onto the policy agenda . Conclusions This analysis underscores the importance of considering national level variables in the explanation of the uptake of evidence into national policy setting s , and recognising how local policy makers interpret international evidence . Local priorities , the ways in which evidence was interpreted , and the nature of the links between policy makers and research ers could either drive or stall the policy process . Developing the underst and ing of these processes enables the explanation of the use ( or non-use ) of evidence in policy making , and potentially may help to shape future strategies to bridge the research -policy gaps and ultimately improve the uptake of evidence in decision making From 2004 to 2006 , a  community-based health insurance ( CBI ) scheme was rolled out in Nouna District , Burkina Faso , with the objective of improving access to health services and population health . We explore the r and om timing of the insurance rollout generated by the stepped wedge cluster-r and omized design to evaluate the welfare and health impact of the insurance program . Our results suggest that the insurance had limited effects on average out-of-pocket expenditures in the target areas , but substantially reduced the likelihood of catastrophic health expenditure . The introduction of the insurance scheme did not have any effect on health outcomes for children and young adults , but appears to have increased mortality among individuals aged 65 and older . The negative health effects of the program appear to be primarily driven by the adverse provider incentives generated by the scheme and the result ing decline in the quality of care received by patients OBJECTIVES Health decision-makers involved with coverage and payment policies are increasingly developing policies that seek information on " real-world " ( RW ) outcomes . Motivated by these initiatives , the International Society for Pharmacoeconomics and Outcomes Research ( ISPOR ) created a Task Force on Real-World Data to develop a framework to assist health-care decision-makers in dealing with RW data , especially related to coverage and payment decisions . METHODS Task Force cochairs were selected by the ISPOR Board of Directors . Cochairs selected chairs for four working groups on : clinical outcomes , economic outcomes , patient-reported outcomes , and evidence hierarchies . Task Force members included representatives from academia , the pharmaceutical industry , and health insurers . The Task Force met on several occasions , conducted frequent correspondence and exchanges of drafts , and solicited comments on three drafts from a core group of external review ers and from the ISPOR membership . RESULTS We defined RW data as data used for decision-making that are not collected in conventional r and omized controlled trials ( RCTs ) . We considered several characterizations : by type of outcome ( clinical , economic , and patient-reported ) , by hierarchies of evidence ( which rank evidence according to the strength of research design ) , and by type of data source ( supplementary data collection alongside RCTs , large simple trials , patient registries , administrative cl aims data base , surveys , and medical records ) . Our report discusses eight key issues : 1 ) the importance of RW data ; 2 ) limitations of RW data ; 3 ) the fact that the level of evidence required depends on the circumstance ; 4 ) the need for good research practice s for collecting and reporting RW data ; 5 ) the need for good process in using RW data in coverage and reimbursement decisions ; 6 ) the need to consider costs and benefits of data collection ; 7 ) the ongoing need for modeling ; and 8) the need for continued stakeholder dialogue on these topics . CONCLUSIONS Real-world data are essential for sound coverage and reimbursement decisions . The types and applications of such data are varied , and context matters greatly in determining the value of a particular type in any circumstance . It is critical that policymakers recognize the benefits , limitations , and method ological challenges in using RW data , and the need to consider carefully the costs and benefits of different forms of data collection in different situations There is a growing appreciation that our current approach to clinical research leaves important gaps in evidence from the perspective of patients , clinicians , and payers wishing to make evidence -based clinical and health policy decisions . This has been a major driver in the rapid increase in interest in comparative effectiveness research ( CER ) , which aims to compare the benefits , risks , and sometimes costs of alternative health-care interventions in ‘ the real world ’ . While a broad range of experimental and nonexperimental methods will be used in conducting CER studies , many important questions are likely to require experimental approaches – that is , r and omized controlled trials ( RCTs ) . Concerns about the generalizability , feasibility , and cost of RCTs have been frequently articulated in CER method discussion s. Pragmatic RCTs ( or ‘ p RCTs ’ ) are intended to maintain the internal validity of RCTs while being design ed and implemented in ways that would better address the dem and for evidence about real-world risks and benefits for informing clinical and health policy decisions . While the level of interest and activity in conducting p RCTs is increasing , many challenges remain for their routine use . This article discusses those challenges and offers some potential ways forward Introduction Chronic diseases and falls substantially contribute to morbidity/mortality among seniors , causing this population to frequently seek emergency medical care . Research suggests the paramedic role can be successfully exp and ed to include community-based health promotion and prevention . This study implements a community paramedicine programme targeting seniors in subsidised housing , a high-risk population and frequent users of emergency medical services ( EMS ) . The aims are to reduce EMS calls , improve health outcomes and healthcare utilisation . Methods / analysis This is a pragmatic clustered r and omised control trial in four communities across Ontario , Canada . Within each , four to eight seniors ’ apartment buildings will be paired and within each pair one building will be r and omly assigned to receive the Community Health Assessment Programme through EMS ( CHAP-EMS ) intervention , while the other building receives no intervention . During the 1-year intervention , paramedics will run weekly sessions in a common area of the building , assessing risk factors for cardiovascular disease , diabetes and falls ; providing health education and referrals to community programmes ; and communicating results to the participant 's primary physician . The primary outcomes are rate of emergency calls per 100 residents , change in blood pressure and change in Canadian Diabetes Risk ( CANRISK ) score , as collected by the local EMS and study data bases . The secondary outcomes are change in health behaviours , measured using a preintervention and postintervention survey and healthcare utilisation , available through administrative data bases . Analysis will mainly consist of descriptive statistics and generalised estimating equations , including subgroup cluster analysis . Ethics/dissemination This study is approved by the Hamilton Integrated Research Ethics Board and will follow the Tri-Council Policy Statement . Findings will be disseminated through reports to local stakeholders , publication in peer- review ed journals and conference presentations . Trial registration number NCT02152891 OBJECTIVE Despite considerable policy interest in the association between perceived public stigmatization of mental illness and use of mental health services , limited empirical evidence , particularly from longitudinal data , documents this relationship . This study used longitudinal data to estimate the association between perceived public stigmatization and subsequent mental health care seeking . METHODS A Web-based survey was used to collect data from a r and om sample of undergraduate and graduate students at a university at baseline and two years later ( N=732 ) .  Logistic regression models assessed the association between students ' perceived public stigma at baseline and measures of subsequent help seeking for mental health problems ( perceived need for help and use of mental health services ) at follow-up . RESULTS No significant associations were found between perceived public stigma and help-seeking behavior over the two-year period . CONCLUSIONS In this population of college students , perceived stigma did not appear to pose a substantial barrier to mental health care Context Significant re sources and time are invested in the production of research knowledge . The primary objective of this r and omized controlled trial was to evaluate the effectiveness of three knowledge translation and exchange strategies in the incorporation of research evidence into public health policies and programs . Methods This trial was conducted with a national sample of public health departments in Canada from 2004 to 2006 . The three interventions , implemented over one year in 2005 , included access to an online registry of research evidence ; tailored messaging ; and a knowledge broker . The primary outcome assessed the extent to which research evidence was used in a recent program decision , and the secondary outcome measured the change in the sum of evidence -informed healthy body weight promotion policies or programs being delivered at health departments . Mixed-effects models were used to test the hypotheses . Findings One hundred and eight of 141 ( 77 % ) health departments participated in this study . No significant effect of the intervention was observed for primary outcome ( p < 0.45 ) . However , for public health policies and programs ( HPPs ) , a significant effect of the intervention was observed only for tailored , targeted messages ( p < 0.01 ) . The treatment effect was moderated by organizational research culture ( e.g. , value placed on research evidence in decision making ) . Conclusion The results of this study suggest that under certain conditions tailored , targeted messages are more effective than knowledge brokering and access to an online registry of research evidence . Greater emphasis on the identification of organizational factors is needed in order to implement strategies that best meet the needs of individual organizations . Trial Registration The trial registration number and title are as follows : IS RCT N35240937 -- Is a knowledge broker more effective than other strategies in promoting evidence -based physical activity and healthy body weight programming In spite of growing interest in socioeconomic differentials in health outcomes and access to health services , little has been written about method ologies for assessing the impact of equity-enhancing policies or programs . This paper describes three method ological challenges involved in design ing a r and omised trial with an equity outcome , and how these were met in a trial of alternative strategies to improving the uptake of benefits of a health insurance scheme among its poorest members . The Vimo SEWA trial is nested within a community-based insurance scheme in rural India . While conducting this trial , three method ological problems were encountered : ( i ) measuring poverty ( or " wealth " , or " socioeconomic status " ) ( ii ) assessing beneficiaries against an appropriate reference st and ard population and ( iii ) settling on an appropriate equity measure as an outcome indicator . These problems are likely to arise in any policy or program assessment that has an equity outcome . In the Vimo SEWA trial , the socioeconomic status of beneficiaries ( cl aim ants ) is assessed relative to that of all scheme members living in same sub-district by applying a rapid assessment question naire -- which reduces to an integrated index of socioeconomic status -- to both a r and om sample of members in each sub-district , and to all cl aim ants . The results are used to estimate the full distribution of socioeconomic status of members in each sub-district , with each member given a rank score between 0 and 100 . Interpolation is used to estimate the rank scores of cl aim ants relative to the membership base . The primary outcome measure for the trial is the mean socioeconomic rank score of cl aim ants . In developing country setting s , using an index of socioeconomic status is simpler than assessing household income or the value of household consumption . It is also relatively straightforward to compare the socioeconomic status of health program beneficiaries with a relevant reference population , although two independent surveys are required . Expressing relative wealth on a scale from zero to 100 is conceptually appealing , and the mean value of this rank score provides an equity-specific outcome measure readily integrated into the usual analytic framework for cluster-r and omised trials OBJECTIVE There is increasing evidence about the importance of factors that impact health beyond health care and individual behavior , yet there is little public and policy discourse about these things in the United States . We surveyed Wisconsin adults to see what they think are the most important factors that affect health . We also examined which interventions they believe would improve health , and whether government should prioritize such interventions . METHODS A phone survey of a r and om sample of 1459 Wisconsin adults was conducted between September 2006 and February 2007 . RESULTS The Wisconsin public believes that health practice s , access to health care , and health insurance are the most important factors affecting health , and that health insurance is a high government priority . Other broader social and economic determinants of health , such as employment , social support , income , housing , and neighborhood factors are seen as less important to health . Although respondents believe that health practice s are important to health , they are less likely to suggest that government prioritize improving individual health practice s. Although the public believes the government should prioritize access to health care and health insurance , they are not as likely to support government implementing social or economic policies in order to improve health . CONCLUSION In light of research demonstrating the importance of social and economic determinants of health , and of ongoing public forums meant to raise awareness of these determinants of health , it will be important to track whether public opinion of Wisconsin adults changes over time to increase attention to the social and economic determinants of health and related policy initiatives Since July 2005 , the International Committee of Medical Journal Editors ( ICMJE ) has recommended that all journals subscribing to their guidelines should require clinical trials to be registered with a public registry ( e.g. http:// clinical trials.gov ) prior to commencing the study ( www.icmje.org/publish ing_10register.html ) . Moreover , BJOG also supports the WHO recommendation that from July 2008 , any research study that prospect ively assigns human participants or groups of humans to one or more healthrelated interventions , to evaluate the effects on health outcomes , must have been registered prospect ively ( this includes phase-I and phase-II trials and non-r and omised studies of interventions ) ( www.bjog.org/ view/0/authorInformation.html ) . The arguments for this editorial policy are compelling . It results in greater transparency in the execution and reporting of such studies , because it allows first the editorial staff , and then the journal readership , to check whether there has been any deviation between the study protocol reported in a su bmi tted paper and the study design when the trial began . It also safeguards against selective reporting of outcomes that just happen to be statistically significant . Irrespective of the results of the study and its publication fate , a copy of the details of the study design is kept as a public record , allowing clinicians , patients and healthcare policy makers open access . Finally , it also allows grant funding bodies and research ers to identify whether a similar study on the same topic has already been conducted or is in progress , thereby avoiding any unnecessary duplication of research work . Following the implementation of this policy for prospect i ve studies , a similar initiative has been launched for the conduct and reporting of systematic review s. The International Prospect i ve Register of Systematic Review s ( PROSPERO ) is an open access data base of systematic review s administered at the Centre of Review s and Dissemination , University of York , UK ( www.crd.york.ac.uk/ prospero ) . Registration is conducted online , is free , and is anticipated to take less than an hour to complete . Within the first few months of opening , there have been over 260 systematic review s registered . Registration involves the su bmi ssion of the following information about the review , derived from a Delphic approach ( iterative consultation ) between international experts : the review question ( s ) ; the search strategy ; the type of studies included ; the study inclusion criteria for the review ; a brief description of study participants , interventions , comparator(s ) and control ; the primary and secondary clinical outcomes ; the method of data extraction from the primary studies ; the assessment of study quality ; the strategy for data synthesis ; the dissemination plans ; the anticipated commencement and completion date s of the review ; the source of funding ; and the contact details of the primary review er . There are a total of 22 m and atory fields and 18 optional fields to be completed before a review can be accepted for publication in the registry . The review will then be allocated a unique registration number to simplify the retrieval of the record as well as to link it with any subsequent report(s ) . The data base is intended to include any systematic review s of healthcare interventions and preventive or diagnostic strategies with a clinical outcome , but not scoping review s or review s of review s. Review s on method ological issues and review s on animal studies are also currently not eligible . However , the long-term aim is for the registry to include details of all continuing systematic review s with a health-related outcome in the broadest sense . The reasons why BJOG should support a public register on systematic review s are similar to those outlined above for r and omised controlled trials . In addition , registration with PROSPERO will encourage research ers to comply with the PRISMA statement ( www . prisma -statement.org ) when reporting their findings in a peer review publication . Similar to the registration of r and omised controlled trials , the registration of systematic review s with PROSPERO is intended to be undertaken when the review protocol has been completed , but before the commencement of screening of primary studies for inclusion into the review . Unlike the situation with trials , however , it is not currently suggested that all systematic review s must be prospect ively registered before they can be considered for publication in a peer review journal . Nonetheless , a m and atory policy remains a future possibility . The BJOG editorial policy is to encourage registration . We would like systematic review s to be registered as soon as the review protocol has been completed and before the literature search begins . However , review s su bmi tted to BJOG that have not been prospect ively registered will still be considered for publication . The rationale for this decision is as follows . Firstly , there is no universal agreement amongst biomedical journals that m and atory prospect i ve registration for systematic review s should be implemented at this stage . Secondly , the issue of reporting biases with deviation from the original protocol might appear to be less relevant with systematic review s as compared with r and omised controlled trials . However , large studies of systematic review s have indicated that there is still a real risk of selective reporting bias . In one study , over a fifth of protocol – review pairings were found to contain a discrepancy in at least one outcome measure , mainly the primary outcome measure . There was potential bias in a third of these review s , with changes being made after knowledge of the results . Outcomes that were promoted in the review were more likely to be significant than if there was no discrepancy ( relative risk 1.66 ; 95 % CI 1.10–2.49 ; P = 0.02 ) . We acknowledge that it might often be necessary and desirable to modify the original review protocol , including the questions a review addresses , in light of the evidence accumulated in the process of conducting the review . For example , new relevant clinical outcomes might need to Background Tanzania has been a pioneer in establishing community-level services , yet challenges remain in sustaining these systems and ensuring adequate human re source strategies . In particular , the added value of a cadre of professional community health workers is under debate . While Tanzania has the highest density of primary health care facilities in Africa , equitable access and quality of care remain a challenge . Utilization for many services proven to reduce child and maternal mortality is unacceptably low . Tanzanian policy initiatives have sought to address these problems by proposing expansion of community-based providers , but the Ministry of Health and Social Welfare ( MoHSW ) lacks evidence that this merits national implementation . The Tanzania Connect Project is a r and omized cluster trial located in three rural districts with a population of roughly 360,000 ( Kilombero , Rufiji , and Ulanga).Description of interventionConnect aims to test whether introducing a community health worker into a general program of health systems strengthening and referral improvement will reduce child mortality , improve access to services , exp and utilization , and alter reproductive , maternal , newborn and child health seeking behavior ; thereby accelerating progress towards Millennium Development Goals 4 and 5 . Connect has introduced a new cadre — Community Health Agents ( CHA ) — who were recruited from and work in their communities . To support the CHA , Connect developed supervisory systems , launched information and monitoring operations , and implemented logistics support for integration with existing district and village operations . In addition , Connect ’s district-wide emergency referral strengthening intervention includes clinical and operational improvements . Evaluation design Design ed as a community-based cluster-r and omized trial , CHA were r and omly assigned to 50 of the 101 villages within the Health and Demographic Surveillance System ( HDSS ) in the three study districts . To garner detailed information on household characteristics , behaviors , and service exposure , a r and om sub- sample survey of 3,300 women of reproductive age will be conducted at the baseline and endline . The referral system intervention will use baseline , midline , and endline facility-based data to assess systemic changes . Implementation and impact research of Connect will assess whether and how the presence of the CHA at village level provides added life-saving value to the health system . Discussion Global commitment to launching community-based primary health care has accelerated in recent years , with much of the implementation focused on Africa . Despite extensive investment , no program has been guided by a truly experimental study . Connect will not only address Tanzania ’s need for policy and operational research , it will bridge a critical international knowledge gap concerning the added value of salaried professional community health workers  in the context of a high density of fixed facilities . Trial registration : IS RCT BACKGROUND Mental health disorders represent one of the most common problems facing adults in the labor force . It is estimated that within a 12-month period nearly 30 % of the US population experiences some diagnosable mental health or addictive disorder . This study examines the impact that corporate benefit policies can have on mental health treatment costs . AIMS To measure the effects of a change in mental health benefit design on treatment expenditures for employees of a large US-based company . METHODS Data came from mental health treatment administrative cl aims and eligibility information provided by the company and a comparable set of cl aims for a r and omly selected control group for the years 1995 - 1998 . We measure the effect of a change in mental health benefits consisting of three major elements : a company-wide effort to destigmatize mental illness ; reduced cost-sharing for mental health treatment ; and the implementation of a provider network that emphasized access to non-physician mental health specialists . We use a two-part regression model within a difference in differences framework to examine outpatient , pharmaceutical , and combined outpatient and pharmaceutical expenditures between the treatment company and the control group . RESULTS We find that the program led to a statistically significant dollar 17 increase in outpatient costs ( excluding pharmaceutical costs ) per employee . Similar to outpatient care we find that the benefit change was associated with a statistically significant increase in pharmaceutical costs of about dollar 15 . DISCUSSION The results reveal that the mental health benefit expansion at the company led to a significant increase in aggregate mental health expenditures among employees . However , the aggregate increase in cost masks a number of interesting underlying trends in mental health utilization . First , conditional upon any mental health treatment , mental health costs were virtually unchanged before and after the benefit change . Conditional on any use , outpatient and pharmaceutical expenditures went in opposite directions , with outpatient expenditures falling and pharmaceutical expenditures increasing . IMPLICATION S FOR HEALTH CARE PROVISION AND USE Private sector initiatives can increase use of mental health care treatment through decreased cost-sharing , improved access to specialty providers , and destigmatization of mental disorders . IMPLICATION S FOR HEALTH CARE POLICY FORMULATION : Given that the vast majority of people in the US get their health insurance through employer-sponsored health insurance , efforts on the part of the private sector to recognize and treat serious chronic illnesses such as mental disorder in a proactive manner should be encouraged . IMPLICATION S FOR FUTURE RESEARCH While the aggregate cost of corporate initiatives to improve access to quality mental health care is frequently examined , it is also important to decompose the aggregate cost changes into effects from a change in the rate of initiation and changes in utilization conditional upon initiation Key Summary Points In addition to accepting registration in any of the 5 existing registries , the ICMJE will accept registration of clinical trials in any of the primary registers that participate in the WHO ICTRP . Registration in a partner register only is insufficient . The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrollment on or after 1 July 2008 . This definition states that a clinical trial is any research study that prospect ively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes . The ICMJE will not consider results posted in the same clinical trials registry in which the primary registration resides to be previous publication if the results are presented in the form of a brief , structured ( < 500 words ) abstract or table . In 2005 , the International Committee of Medical Journal Editors ( ICMJE ) initiated a policy requiring investigators to deposit information about trial design into an accepted clinical trials registry before the onset of patient enrollment ( 1 ) . This policy aim ed to ensure that information about the existence and design of clinical ly directive trials was publicly available , an ideal that leaders in evidence -based medicine have advocated for decades ( 2 ) . The policy precipitated much angst among research investigators and sponsors , who feared that registration would be burdensome and would stifle competition . Yet , the response to this policy has been overwhelming . The ICMJE promised to reevaluate the policy in 2 years after implementation . Here , we summarize that reevaluation , specifically commenting on registries that meet the policy requirements , the types of studies that require registration , and the registration of trial results . As is always the case , the ICMJE establishes policy only for the 12 member journals ( a detailed description of the ICMJE and its purpose is available at www.icmje.org ) , but many other journals have adopted our initial trial registration recommendations , and we hope that they will also adopt the modifications discussed in this up date . The research community has embraced trial registration . Before the ICMJE policy , Clinical Trials.gov , the largest trial registry at the time , contained 13153 trials ; this number climbed to 22714 one month after the policy went into effect ( 3 ) . In April 2007 , the registry contained over 40000 trials , with more than 200 new trial registration s occurring weekly ( Zarin D. Personal communication ) . The 4 other registries that meet the ICMJE criteria have also grown as scores of journals have adopted the ICMJE clinical trials registration policy . In response to burgeoning registration , many investigators , sponsors , and government agencies have asked the ICMJE to recognize their local registries as data bases that meet the policy . Fortunately , the World Health Organization 's ( WHO ) International Clinical Trial Registry Platform ( ICTRP ) , which was nascent when the ICMJE began to require trial registration , has matured rapidly and provides options for those that desire a wider array of registries . The ICTRP has taken the first steps toward developing a network of primary and partner registers that meet WHO-specified criteria ( 4 ) . Primary registers are WHO-selected registers managed by not-for-profit entities that will accept registration s for any interventional trials , delete duplicate entries from their own register , and provide data directly to the WHO . Partner registers , which will be more numerous , will include registers that su bmi t data to primary registers but limit their own register to trials in a restricted area ( such as a specific disease , company , academic institution , or geographic region ) . The ICMJE strongly supports the WHO 's efforts , through the ICTRP , to develop a coordinated process for identifying , gathering , deduplicating , and search ing trials from registries around the world , thus eventually providing a 1-stop search portal for those seeking information about clinical trials . In addition to the 5 existing registries , the ICMJE will now also accept registration in any of the primary registers that participate in the WHO ICTRP . Because it is critical that trial registries are independent of for-profit interests , the ICMJE policy requires registration in a WHO primary register rather than solely in a partner register , since for-profit entities manage some partner registers . As previously , trial registration with missing or uninformative fields for the minimum data elements is inadequate ( 1 ) . Initially , the ICMJE required registration of all clinical ly directive trials , which it defined as any research project that prospect ively assigns human subjects to intervention or comparison groups to study the cause- and -effect relationship between a medical intervention and a health outcome ( 1 ) . In May 2005 , the ICMJE clarified this definition to exclude preliminary trials design ed to study pharmacokinetics or major unknown toxicity ( phase I trials ) ( 5 ) . However , the ICMJE recognizes the potential benefit of having information about preliminary trials in the public domain , because these studies can guide future research or signal safety concerns . Consequently , the ICMJE is exp and ing the definition of the types of trials that must be registered to include these preliminary trials and adopts the WHO 's definition of clinical trial : any research study that prospect ively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes ( 4 ) . Health-related interventions include any intervention used to modify a biomedical or health-related outcome ( for example , drugs , surgical procedures , devices , behavioral treatments , dietary interventions , and process-of-care changes ) . Health outcomes include any biomedical or health-related measures obtained in patients or participants , including pharmacokinetic measures and adverse events . As previously , purely observational studies ( those in which the assignment of the medical intervention is not at the discretion of the investigator ) will not require registration . The ICMJE member journals will start to implement the exp and ed definition of clinical ly directive trials for all trials that begin enrollment on or after 1 July 2008 . Those who are uncertain whether their trial meets the exp and ed ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal . Over the time during which registration of trial methods has become common practice , several forces have begun advocating for registration of trial results . We recognize that the climate for results registration will probably change dramatically and unpredictably over coming years . For the present , the ICMJE will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief , structured ( < 500 words ) abstract or table . The ICMJE favors a st and ard abstract format for results reporting , and the CONSORT ( Consoli date d St and ards for the Reporting of Trials ) group 's forthcoming guidelines for abstract s related to trials may be one such option . The ICMJE believes that parties interested in results registration should consider requiring the deposition of such an abstract in the registry 24 months after closure of data collection if results are not published in a peer- review ed venue by that time . The registered abstract should either cite any related full , peer- review ed publications or include a statement that indicates that the report has not yet been published in a peer- review ed journal . Research ers should be aware that editors may consider more detailed deposition of trial results in publicly available registries to be prior publication . When su bmi tting a paper , authors should fully disclose to editors all posting in registries of results of the same or closely related work . Three years ago , trials registration was the exception ; now it is the rule . Registration facilitates the dissemination of information among clinicians , research ers , and patients , and it helps to assure trial participants that the information that accrues as a result of their altruism will become part of the public record . The WHO 's global efforts towards comprehensive trials registration and the ICMJE 's requirements for registration aim to increase public trust in medical science . Christine Laine , MD , MPH , Senior Deputy Editor , Annals of Internal Medicine Richard Horton , FMedSci , Editor , The Lancet Catherine D. DeAngelis , MD , MPH , Editor-in-Chief , JAMA Jeffrey M. Drazen , MD , Editor-in-Chief , New Engl and Journal of Medicine Frank A. Frizelle , MBChB , MMedSc , Editor-in-Chief , The New Zeal and Medical Journal Fiona Godlee , MBBChir , BSc , Editor-in-Chief , BMJ Charlotte Haug , MD , PhD , MSc , Editor-in-Chief , Norwegian Medical Journal Paul C. Hbert , MD , MHSc , Editor-in-Chief , Canadian Medical Association Journal Sheldon Kotzin , MLS , Executive Editor , MEDLINE , National Library of Medicine Ana Marusic , MD , PhD , Editor , Croatian Medical Journal Peush Sahni , MS , PhD , Representative and Past President , World Association of Medical Editors Torben V. Schroeder , MD , DMSc , Editor , Journal of the Danish Medical Association Harold C. Sox , MD , Editor , Annals of Internal Medicine Martin B. Van Der Weyden , MD , Editor , The Medical Journal of Australia Freek W.A. Verheugt , MD , Deputy Editor , Nederl and s Tijdschrift voor Geneeskunde ( Dutch Journal of Medicine Evidence -based medicine is crucial to contemporary healthcare . It is dependent on systematic review methodology modelled on an arguably inadequate hierarchy of evidence . There has been a significant increase in medical and health research using qualitative and mixed method design s. The perspective taken in this article is that we need to broaden our evidence base if we are to fully take account of issues of context , acceptability and feasibility in the development and implementation of healthcare interventions . One way of doing this is to use a range of methods that better fit the different aspects of intervention development and implementation . Methods for the systematic review of evidence , other than r and omised-controlled trials , are available and there is a readiness to incorporate these other types of evidence into good- practice guidance , but we need a clear methodology to translate these advances in research into the world of policy Dr. Joseph Lau is a world-leading expert in meta- analysis and systematic review s. Currently a professor in the Department of Health Services , Policy and Practice and co-director of the Center for Evidence -based Medicine at Brown University , Professor Lau has applied evidence -based methods to a variety of clinical , biomedical and healthcare topics ; has developed reliable and efficient methods and tools to conduct systematic review s and meta-analyses ; and has advanced an underst and ing on the impact of factors that may contribute to differences of results in scientific studies . His past research includes cumulative meta- analysis of r and omized controlled trials , comparison of results from large trials and meta-analyses of small trials , effect of baseline risk in the interpretation of clinical trial results , and empirical evaluation of existing methods of combining data . His current focus is on a Web-based repository of systematic review data , review s of diagnostic tests , nutrition , clinical practice guidelines , and dissemination of evidence -based methods to varied health-care disciplines . This report is a conversation from an adapted version of an interview , more or less chronologically arranged , between Joseph C. Cappelleri as interviewer and Joseph Lau as interviewee , with Meghan Ingerick recording and transcribing the interview In 2004 , a community-based health insurance ( CBI ) scheme was introduced in Nouna district , Burkina Faso , with the primary objective of improving access to facility-based health services . In order to overcome self- selection issues in the analysis of the behavioral effects of insurance , we combine four waves of the Nouna Health District Household Survey into a panel data set , and use the r and omized timing of insurance rollout to estimate the causal effect of insurance coverage on health-seeking behavior . While we find a generally positive association between CBI affiliation and treatment seeking , we can not reject the null that the introduction of health insurance does not have any effect on treatment seeking in general , and utilization of facility-based professional care , in particular . Low levels of health care provider satisfaction , poor perceived quality of care by enrollees , and ambiguity in the coverage level of the CBI benefit package appear to have contributed to these weak results . Our findings imply that the basic notion of insurance mechanically increasing facility-based professional care is not necessarily true empirically , and likely contingent on a large number of context ual factors affecting health-seeking behavior within households and communities OBJECTIVE The objective of this study was to evaluate the cost of home-cancer-healthcare programs and their potential interest for public health insurance as compared to inpatient cancer care . PATIENTS AND METHODS The study was conducted at the Centre Leon Berard ( CLB ) , a comprehensive cancer centre in Lyon , France . Hospitals at home patients were monitored by nurses and oncologists from the CLB . All patients , who received home treatment over a 15-day period in 2001 , were included in the study . Patients were broken down into groups according to the type of healthcare required and the corresponding impact on health insurance expenditure . For each of these patients , a fictive-hospital stay was then reconstructed , which corresponded to the inpatient hospital care that would have been required during the observation period , had hospital at home not been available . RESULTS The average cost of hospital at home was significantly lower than the corresponding estimated cost for treatment at the hospital ( 776.6 versus 2012.5 , P < 0.001 ) . This difference was particularly high for patients in the  " palliative care " group ( N = 33 ) ( 1201.7 versus 3489.7 , P < 0.001 ) , whereas in the " chemotherapy "  group , results were not significantly different ( N = 34 ) ( 225.5 versus 318 ) . CONCLUSION Our study suggests that hospitalisation alternatives can generate substantial savings for public health insurance in France BACKGROUND : Following the lead of evidence -based medicine , practice based on effectiveness research has become the new gold st and ard of contemporary public policy . Studies of this sort are increasingly dem and ed to evaluate services provided by mental health , social services and criminal justice systems . AIMS : The paper questions whether the simple r and omized controlled trial ( RCT ) paradigm as applied in clinical trials can be used " off the rack " to evaluate socially complex service ( SCS ) interventions . These are services that are characterized by complex , diverse and non-st and ardized staffing arrangements ; ambiguous protocol s ; hard-to-define study sample s and unevenly motivated subjects and dependence on broader social environments . The difficulty of ensuring precise protocol s , equivalent groups ( tied to a meaningful target population ) and neutral and equivalent trial environments under real world conditions are explored , as are the implication s of not achieving st and ardization and equivalence . METHODS : Limitations of effectiveness research as a research tool and information source are examined by comparing the assumptions underpinning the simple RCT to the characteristics of SCS interventions , as illustrated by programs targeted to mentally disordered offenders in Britain . RESULTS : SCSs violate the assumptions underpinning the simple RCT model in ways that draw into sharp question the validity , reliability and generalizability of inferences of SCS trials . DISCUSSION : The RCT is not a panacea . Effectiveness research of SCS interventions that is based on the RCT model is unlikely to yield valid , reliable and generalizable inferences without becoming more complex in design and more sensitive to issues of selection bias , unmeasured variables and endogeneity . Ten recommendations are offered for stylizing the RCT design to the characteristics of socially complex services . IMPLICATION S : It remains an empirical issue whether RCT -based services effectiveness research can inform mental health policy . Without major design innovations , it is more likely that the information generated by this research will have limited practical use , especially if the RCT model is unable to control for the effect of social complexity and the interaction between social complexity and dynamic systemic change . Scientific evaluations of services make clinical and economic sense so long as they are design ed to meet the challenges of the services of which they promise greater knowledge Background Recent evidence from a large scale trial conducted in the United States indicates that enhancing shared decision-making and improving knowledge , self-management , and provider communication skills to at-risk patients can reduce health costs and utilisation of healthcare re sources . Although this trial has provided a significant advancement in the evidence base for disease management programs it is still left for such results to be replicated and /or generalised for population s in other countries and other healthcare environments . This trial responds to the limited analyses on the effectiveness of providing chronic disease management services through telephone health coaching in Australia . The size of this trial and it 's assessment of cost utility with respect to potentially preventable hospitalisations adds significantly to the body of knowledge to support policy and investment decisions in Australia as well as to the international debate regarding the effect of disease management programs on financial outcomes . Methods Intention to treat study applying a prospect i ve r and omised design comparing usual care with extensive outreach to encourage use of telephone health coaching for those people identified from a risk scoring algorithm as having a higher likelihood of future health costs . The trial population has been limited to people with one or more of the following selected chronic conditions : namely , low back pain , diabetes , coronary artery disease , heart failure , and chronic obstructive pulmonary disease . This trial will enrol at least 64,835 source d from the approximately 3 million Bupa Australia private health insured members located across Australia . The primary outcome will be the total ( non-maternity ) cost per member as reported to the private health insurer ( i.e. charged to the insurer ) 12 months following entry into the trial for each person . Study recruitment will be completed in early 2012 and the results will be available in late 2013 . Discussion If positive , CAPICHe will represent a potentially cost-effective strategy to improve health outcomes in higher risk individuals with a chronic condition , in a private health insurance setting .Trial Registration Australian New Zeal and Clinical Trials Registry reference : Background Occupational tuberculosis ( TB ) continues to plague the healthcare workforce in South Africa . A 2-year cluster r and omized controlled trial was therefore launched in 27 public hospitals in Free State province , to better underst and how a combined workforce and workplace program can improve health of the healthcare workforce . Objective This mid-term evaluation aim ed to analyze how well the intervention was being implemented , seek evidence of impact or harm , and draw lessons . Methods Both intervention and comparison sites had been instructed to conduct bi-annual and issue-based infection control assessment s ( when healthcare workers [ HCW ] are diagnosed with TB ) and offer HCWs confidential TB and HIV counseling and testing , TB treatment and prophylaxis for HIV-positive HCWs . Intervention sites were additionally instructed to conduct quarterly workplace assessment s , and also offer HCWs HIV treatment at their occupational health units ( OHUs ) . Trends in HCW mortality , sick-time , and turnover rates ( 2005 - 2014 ) were analyzed from the personnel salary data base ( ' PERSAL ' ) . Data su bmi tted by the OHUs were also analyzed . Open-ended question naires were then distributed to OHU HCWs and in-depth interviews conducted at 17 of the sites to investigate challenges encountered . Results OHUs reported identifying and treating 23 new HCW cases of TB amongst the 1,372 workers who used the OHU for HIV and /or TB services ; 39 new cases of HIV were also identified and 108 known-HIV-positive HCWs serviced . Although intervention-site workforces used these services significantly more than comparison-site healthcare staff ( p<0.001 ) , the data recorded were incomplete for both the intervention and comparison OHUs . An overall significant decline in mortality and turnover rates was documented over this period , but no significant differences between intervention and comparison sites ; sick-time data proved unreliable . Severe OHU workload as well as residual confidentiality concerns prevented the proper implementation of protocol s , especially workplace assessment s and data recording . Particularly , the failure to implement computerized data collection required OHU staff to duplicate their operational data collection duties by also entering research paper forms . The study was therefore halted pending the implementation of a computerized system . Conclusions The significant differences in OHU use documented can not be attributable to the intervention due to incomplete data reporting ; unreliable sick-time data further precluded ascertaining the benefit potentially attributable to the intervention . Computerized data collection is essential to facilitate operational monitoring while conducting real-world intervention research . The digital divide still requires the attention of research ers along with overall infrastructural constraints
INTERPRETATION Increased health insurance coverage generally appears to increase access to health care facilities , improve financial protection and improve health status , although findings are not totally consistent .
BACKGROUND Exp and ing public health insurance seeks to attain several desirable objectives , including increasing access to healthcare services , reducing the risk of catastrophic healthcare expenditures , and improving health outcomes .
The extent to which these objectives are met in a real-world policy context remains an empirical question of increasing research and policy interest in recent years .