Rational models of evidence-informed policy have historically centred on an assumption that it is possible to identify ‘effective’ interventions, before recommending wider implementation. However, for population health interventions , transferability to new contexts is often uncertain.While definitions are contested, context can be defined as a set of active and unique characteristics and circumstances that interact with, modify, facilitate or constrain intervention delivery and effects. It includes geographical, epidemiological, sociocultural, socioeconomic, ethical, legal and political determinants.There is increased recognition then of the need to consider context when making decisions about the transferability of evidence. Population health interventions are increasingly conceived as ‘events in systems’, which aim to modify aspect(s) of a pre-existing context, altering conditions that sustain suboptimal population health outcomes. Effects therefore may be shaped as much by changes to or displacement of prior features of the context, as by properties of the new intervention. Implementation may differ in a new context due to the complexity of the intervention components or ambiguity over its mechanisms, inhibiting high fidelity. Implementation failure may ensue if an intervention conflicts with entrenched cultural norms or requires resources that are not available. Even where implemented as intended, variation in effects may arise from differences in system starting points, with targeted outcomes driven and sustained by different underlying mechanisms.Assuming that a history of what has worked elsewhere can guarantee future success of similar action in a new time and place is therefore problematic. Equally, assuming effective approaches cannot be transported across contexts is contentious. A systematic understanding of the extant evidence base is important. Large and expensive re-evaluations may not be warranted if an intervention is acceptable and feasible in the new context, and there is robust evidence that the mechanisms targeted by the intervention are relevant. Moreover, there is a need to remain critical about whether purported failures to replicate effects genuinely reflect non-transferability, or are the consequence of the methodologies used in the evaluation in either the original or new context. For example, methods may have become more rigorous as the field develops or the evaluation moves from being conducted by intervention developers to independent investigators.et alAlthough there has been limited conceptual development about what constitutes intervention adaptation, Stirman geographical: interventions transferred across countries sociocultural: interventions replicated within the same geographical context with modifications for population subgroups .There are numerous examples of adapted interventions, which often include but are not limited to (1) In recent years, there has been an emergence of editorials and case studies on how to adapt population health interventions to new contexts. There is, however, no current overarching guidance. As such, current decision-making may be undertaken on an ad-hoc basis. Furthermore, there is a lack of consideration of the importance of describing context, with limited use of frameworks and methods for mapping system-level characteristics.The Medical Research Council (MRC)-National Institute for Health Research (NIHR) Methodology Research Programme in the UK is currently supporting the development of guidance on the adaptation of evidence-informed population health interventions for new contexts. The authors of the present editorial are leading guidance development. Guidance will be developed through inter-related work packages, comprising (1) a systematic review of existing recommendations and a scoping review of interventions implemented and/or re-evaluated in new contexts; (2) qualitative interviews with research, policy and practice stakeholders; and (3) an international Delphi exercise to identify areas of consensus and key theoretical, methodological or substantive uncertainties that can inform the research agenda moving forward. This new guidance will support researchers, policymakers and practitioners in critically evaluating assertions that effects may or may not be contextually contingent, and how to draw on rigorous evidence to establish if adaptation is warranted. It will also support decision-making about the nature and extent of adaptations to be undertaken, how to describe the processes for undertaking adaptations, and the level of re-evaluation required to address uncertainties regarding transferability.Provision of criteria for assessing the appropriateness of adaptations will assist research funders, journal editors and peer reviewers in resourcing and disseminating the highest quality research. Uptake of guidance across stakeholders will help to overcome the current ad-hoc approach to practice within intervention adaptation. The guidance will build on existing MRC guidance, including guidance for developing and evaluating complex interventions


Raisins are a commonly consumed dried fruit and given their nutrient profile may offer nutritional and health benefits.To examine the association between consumption of raisins and raisin‐containing foods with nutrient intake and dietary quality in children.NHANES) data for 2001–2012 in those 2–18 years of age  were used. Consumers of raisins  and raisin‐containing foods  were defined as reporting any consumption of raisins and raisin‐containing foods, respectively, during the first 24‐hr diet recall. Diet quality was assessed using the Healthy Eating Index (HEI)‐2010. Regression analyses were conducted comparing consumers and nonconsumers using appropriate sample weights and adjusted for demographic and lifestyle covariates with significance set at p < 0.01.National Health and Nutrition Examination Survey  than nonconsumers.Regarding “nutrients of public health concern/shortfall nutrients” and “nutrients to limit,” raisin consumers had higher intakes of dietary fiber (23%), potassium (16%), magnesium (12%) with lower intakes of added sugars (−19%) than nonconsumers. Similarly, consumers of raisin‐containing foods also had higher intakes of dietary fiber (15%), potassium (5%), magnesium (11%), iron (6%), vitamin A (10%), and vitamin E (13%) and lower intake of sodium (−5%). Consumers of raisin and raisin‐containing foods had higher intakes of fruits , whole fruits  and whole grains  and had a better diet quality as per higher total In conclusion, consumption of raisins or raisin‐containing foods was associated with better nutrient intake and diet quality in American children. The Dietary Guidelines for Americans 2015–2020 (DGA) recommended adequate consumption of fruits and vegetables as part of healthy eating pattern [DHHS/USDA, Raisins (dried grapes) are a commonly consumed dried fruit [Keast, O'Neil, & Jones, 22.1Data from children age 2–18 years participating in the National Health and Nutrition Examination Survey (NHANES) 2001–2002, 2003–2004, 2005–2006, 2007–2008, 2009–2010, and 2011–2012 CDC,  were use2.2n = 154) were defined as those consuming raisins in any amount during the 24‐hr recall. Consumers of raisin‐containing foods  were defined as those consuming any quantity of foods that contained raisins during the 24‐hr recall. Energy and nutrient intake were determined similar to that of Fulgoni et al., Dietary intake data from the first 24‐hr recall dietary interviews collected using United States Department of Agriculture's (USDA) automated multiple‐pass method were utilized [Centers for Disease Control and Prevention (CDC), 2.3USDA's Healthy Eating Index (HEI)‐2010 was used to estimate diet quality. HEI‐2010 has 12 components, and each component represents a particular aspect of diet quality [Guenther et al., 2.4p < 0.01 was deemed significant.SAS 9.2  and SUDAAN 11  were used for all analysis. The complex sample design of NHANES was considered using primary sampling units and strata with appropriate survey weights (day one dietary sample weights) in all intake analyses. Similar to our approach used previously  were consumers of raisins and 10.3% children  were consumers of raisin‐containing foods. Consumers of raisins as well as of raisin‐containing foods were younger than nonconsumers. Consumers of raisins were less likely to be Mexican American and smokers while the consumers of raisin‐containing foods were more likely to be non‐Hispanic White and less likely to be of other ethnicity  energy adjusted daily intakes of dietary fiber (22.9%), magnesium (11.6%) and potassium (16.0%), and lower intakes of added sugar (‐19.1%), total fat (−5.1%), and monounsaturated fat (−9.2%) compared to nonconsumers. Similarly, consumers of raisin‐containing foods also had significantly higher (p < 0.01) intakes of energy (10.8%), carbohydrate (1.8%), dietary fiber (14.6%), total sugar (3.2%), copper (7.9%), iron (6.6%), magnesium (11.5%), potassium (5.3%), vitamin A (10.0%), vitamin B6 (10.0%), and vitamin E (12.9%) with lower intakes of monounsaturated fat (−3.6%) and sodium (−4.6%) compared to nonconsumers. The intakes of other nutrients were not significantly different among consumers/nonconsumers of raisins as well as of consumers/nonconsumers raisin‐containing foods  in food group intake (Table p < 0.01) among consumers of raisins  and raisin‐containing foods  compared to nonconsumers. Overall diet quality  among consumers was significantly higher (21.5% for consumers of raisins and 7.7% for consumers of raisin‐containing foods) compared to nonconsumers  using NHANES 2003–2008 [McGill et al., The consumers of raisins and also of raisin‐containing foods also had higher intakes of fruits, whole fruit, and whole grain. The higher intake of these food groups is associated with healthier diets. HEI‐2010 is a validated measure of diet quality and is indicative of compliance with dietary recommendations. It has 12 components (nine components address adequacy intake and three address moderation of intake) each of which relate to a specific DGA recommendation [DHHS/USDA, One limitation of this study is the use of cross‐sectional data, which cannot confer casualty. Additionally, given 24‐hr dietary recalls rely on participants’ memory to self‐report dietary intakes, they are subject to misreporting or reporting bias. Data used in this study were based on a single 24‐hr dietary recall and for some participants relied on intakes reported by parents/caregivers. Major strengths of this study included the use of a nationally representative large sample and the use of numerous covariates to adjust data in an attempt to remove potential confounding. However, residual confounding may still exist that could explain some of the results reported.In conclusion, the results from this study suggest that consumption of raisins/raisin‐containing foods is associated with better diet quality and nutrient intake in American children.JP consults with Sun‐Maid Raisin Growers of California, the National Pasteurized Egg Board, Paramount Pistachios, and the National Dairy Council. AC works for Sun‐Maid Raisin Growers of California. VLF provides analyses of NHANES for members of the food/beverage industry.Ethical review: The Research Ethics Review Board at the National Center for Health Statistics of the Center for Disease Control and Prevention approved the survey protocol.Informed Consent: Written informed consent was provided by all participants or proxies .VLF and AC designed of the study. VLF conducted analysis; VLF, JP, and AC reviewed results. VLF developed the first draft of the manuscript; JP and AC provided edits. All authors read the final version.


The existing frameworks for the evaluation of genetic and genomic applications clearly address the technical and clinical value of a test, but are less concerned with the way genetic services are delivered and organized. We therefore aimed to develop a comprehensive new framework that includes an assessment of service delivery.A new framework was built on the evaluation dimensions identified through a systematic review of the existing frameworks and a Delphi survey of Italian experts in public health genomics.Our framework has four sections. The first two sections, respectively, guide the evidence collection process for the genetic test  and its delivery models . The third section guides the formulation of the research priorities to be addressed in future research. Finally, the fourth section suggests three criteria to summarize the collected evidence .We have successfully developed an evaluation framework for the evaluation of genetic tests that includes an assessment of service delivery. It also introduces some neglected evaluation dimensions such as personal utility and patient perspective. The expanding knowledge of the human genome and the consequently growing availability of genetic and genomic applications in recent decades are expected to revolutionize medicine . The mosThe existing frameworks for the evaluation of genetic and genomic applications rely mainly on the technical and clinical assessments described in the well-known ACCE  model , 4. NeveIn Italy, the approval of genetic and genomics applications for funding by the National Healthcare System is largely unregulated. For this reason, the National Plan for Public Health Genomics has proposed, as a key objective, the development of a more comprehensive evaluation framework for genetic and genomic applications, which could support decision-makers in coverage decisions . Our worA new framework was developed by combining a systematic review and a Delphi survey. The systematic review was performed to review the need for a new framework and to provide a basis for its creation. It aimed to identify and compare the existing frameworks, with a particular focus on their evaluation dimensions . The Delphi survey was designed to support the systematic review and aimed to identify additional frameworks and to further explore the importance of their dimensions.Throughout the paper, a genetic/genomic test is defined as an analysis of human chromosomes, DNA, RNA, genes, and/or gene products (e.g. enzymes or other proteins) that is primarily used to detect heritable or somatic mutations, genotypes, or phenotypes related to disease and health .The systematic review is described elsewhere . In brieThe online Delphi survey involved 55 members of the Italian Network of Public Health Genomics (GENISAP)  7]. The. The7]. We developed a two-part survey that includes both open- and closed-ended questions. The questionnaire is shown in Since the threshold of 65% had already been exceeded in the first round for all the proposed evaluation dimensions, we used round II to evaluate one new dimension proposed by some experts in round I. Therefore, after communicating the results of round I to the panelists, we asked them to assign a score from 1 to 5 to the new dimension, which had also been provided with a definition. As in round I, they had three weeks to answer, were given the chance to provide comments and add dimensions and were encouraged by phone and e-mail remainders. At the end of the second round, having reached a satisfactory level of agreement (i.e. ≥65%) among the experts, we terminated the consensus procedure and communicated the results to participants.The framework was built on the evaluation dimensions identified through the systematic review and the Delphi procedure and refined in frequent meetings in the presence of the moderator (P.V.). The analysis of the strengths and weaknesses of the existing frameworks guided the whole process. The final version of the framework was sent to the Delphi panelists, and their feedback was collected via e-mail.The systematic search identified 29 frameworks published between 2000 and 2017, mainly in the USA and Europe . They aroverview of the disease and the test under study, analytic validity, clinical validity, clinical utility and ELSI were all scored 4–5 by at least 95% of respondents, followed by economic evaluation, which 93% of respondents scored 4–5. On the other hand, delivery models, organizational aspects and research priorities were scored 4–5 by less than 90% of experts, respectively 89%, 88% and 82%. Relevant comments were raised about some dimensions  followed by the actual evaluation dimensions. Four dimensions refer to the “genetic test”  and four to its “delivery models” . For each dimension, suggestions on which sources of evidence to consult are provided. The third section deals with evidence gaps unearthed during the collection of evidence. Finally, the fourth section suggests three criteria to summarize the collected evidence into practical points for decision.We created a framework that integrates the two most popular approaches to the evaluation of genetic tests i.e. the ACCE model, which is well-suited to the assessment of the technical and clinical value of genetic tests, and the HTA approach, which analyzes in a more systematic manner the organizational and delivery aspects of genetic services. As a reference tool for the HTA approach we adopted the EUnetHTA core model, well recognized at a European level and supported by the results of the Delphi survey . The finintroduction aimed at defining the clinical condition and the test under examination. The clinical condition should be characterized in terms of clinical presentation, pathophysiology, genetic background, and public health impact. The genetic test should be generally described, reporting the identifiable genes and variants; technically defined, with a focus on the analytic procedure; and clinically contextualized in terms of purpose, target population and actual use. This introduction is the foundation for the study of the related dimensions, i.e. analytic validity, clinical validity, clinical utility and personal utility. Analytic validity assesses the accuracy with which a particular genetic characteristic, such as DNA sequence variants, chromosomal deletions, or biochemical indicators, is identified in a given laboratory test [Clinical validity assesses the ability of the test to accurately and reliably detect or predict a clinical condition [Clinical utility assesses the health impact of the test in terms of risks and benefits; it considers the availability, efficacy, effectiveness and safety of the interventions to be put in place, depending on the test results, compared to the current practice [personal utility considers the full range of personal reasons for testing and the personal effect of testing, both of which are subjective and non-health related , e.g. improving the patient’s understanding of the disease, enabling reproductive and life planning, etc. [Section I starts with an ory test . It is aory test , 15, 16.ondition . It consondition . Clinicapractice , 19. Finng, etc. , 21.introduction aimed at defining the delivery models for the provision of the test under study. A delivery model is the broad context in which genetic tests are offered to individuals and families with or at risk of genetic disorders [organizational aspects leads to an estimate of the expected demand for the genetic test under study and the resources needed to implement the related healthcare program. It should also consider possible barriers to implementation and further requirements such as education and training of staff; information dissemination to professionals, patients and citizens; access to care; cooperation, communication and coordination between and within organizations; quality assurance, monitoring and control systems [economic dimension assesses the quantity and quality of cost-effectiveness and cost-utility evidence for alternative genetic testing programs [ELSI dimension considers an ensemble of heterogeneous concepts, namely the moral value that society confers on the proposed interventions, the specific related norms and the impact on the patient’s and his or her family’s social life [patient perspective dimension collects qualitative and quantitative evidence on the perspective of patients who, as the direct beneficiaries of the genetic program in question, can contribute to an understanding of its value (N.B. the term patient is used to define any user of a genetic service) [Section II starts with an isorders . It shouisorders , 24; theisorders ; and theisorders . The des systems . The ecoprograms . The ELSial life . Some ofial life , 29. Theservice) .Section III was designed to address the evidence gaps that will almost certainly be unearthed during the evaluation process. These gaps, other than in the quantity and quality of the evidence, may also relate to evidence generalizability and relevance to the specific context of evaluation. In this section it should be defined whether the amount of evidence for each dimension is exhaustive, incomplete or missing , ranging in descending order from positive to negative  in descending order from easy to impossible  should be added to each rating class, as appropriate.The approach suggested by Section IV is not mandatory and the three criteria should be used at the discretion of decision makers.We have developed a new framework aimed at producing technology assessments on which decision makers, i.e. the Ministry of Health with the support of the National Agency for Regional Healthcare Services and the National Institute of Health in Italy, can base national provision and coverage decisions regarding genetic and genomic technologies.The framework is distinguished by a dual focus on both the technology and its delivery models. This is consistent with the HTA evolution process theorized by Battista, according to which HTA has evolved through three distinct phases: the “machine phase”, focusing on the technical performance of health technologies; the “clinical outcomes phase”, focusing on outcomes of technology use in clinical settings; and the “delivery modes phase”, focusing on how health services are organized and delivered . While tBRCA1/2 mutations, personal aspects to be considered might be the shift of cancer risk perception, the personal meaning ascribed to the mutation status, and the experience of being a mutation-negative/positive individual, with regard to the role of family dynamics [The first section of the framework, mainly based on the ACCE model, guides the assessment of the genetic test. In particular, by adopting the dimensions of the ACCE model, this section addresses some aspects of genetic tests that are fundamental to an understanding of their clinical suitability, such as analytic and clinical validity, which are not adequately addressed by standard methods of technology assessment. Because analytic validity cannot be defined by a universal set of criteria, applicable to all kinds of test, we suggest looking at the criteria most often addressed in the current literature , 14, 15.dynamics , 35. Fordynamics , 35.The second section of the framework, mainly based on the HTA approach, focuses on the delivery models. When collecting economic, organizational, ELSI and patient perspective evidence, a consideration of delivery models could be very valuable for decision makers. For example, BRCA1/2 genetic tests could be delivered in a population screening program, where healthy women invited for mammography may be advised to take a BRCA1/2 test on the basis of their family history. In this case, local healthcare units would need to coordinate active call of patients, risk assessments, genetic counseling, preventive or treatment pathways, cascade screening etc. A BRCA1/2 genetic test could also be delivered in a specialist care setting, such as an oncology clinic, where women with breast cancer may be advised to take the test on the basis of their personal and family history. In this case, active call to recruit the general population is not needed, and counseling and other interventions will probably take place in a specialist context. These two different delivery models will definitely have different costs, benefits, organizational issues, ethical concerns and impact on patient perspective. Thus, they will prove more or less appealing for decision makers. This is why shifting the focus from the genetic test to its delivery models is fundamental when considering implementation questions. While some existing frameworks include economic or organizational considerations within clinical utility (e.g. the ACCE framework), we believe that treating these dimensions independently could provide clearer guidance to evaluators and a more useful represention of the evidence collected to decision makers. Regarding economic implications, our framework asks that not only are the results of the existing economic analyses reported, but also their methodological details . In this way decision makers can understand the quality of the analysis performed and its relevance to their own context . ContextSection three addresses one of the major difficulties encountered in the evaluation of genetic tests, i.e. the collection of evidence. Finding the answer to some of the evaluation questions, especially those related to the clinical value and to the implementation of a genetic test, is not a simple matter. In fact, while gene discovery studies are carried out relatively rapidly, translation studies  often lag behind , 38. MorSection four of the framework aims to synthesize the collected evidence into practical points for decision. We think that it is critical for decision makers to consider the net benefit, cost-effectiveness and feasibility of a particular test, as well as the quality of scientific evidence supporting it. Nevertheless, defining an appraisal framework is beyond the scope of our work. In this regard, it should be made clear that our framework only covers the process of evidence collection. This is undoubtedly the main focus of technology assessment, but it is only one step of an ideal decision pathway. Evidence collection should be preceded by a priority setting phase, as the number of available genetic tests far outweighs the resource available for their assessment, and followed by an appraisal phase, which provides recommendations on the use of a test by prioritising the various elements of the large body of evidence collected.If the comprehensiveness of the evaluation dimensions is the strength of our framework, it is also the main limitation. In fact, the considerable time needed to complete the evaluation process clashes with the rapid development and dissemination of genetic tests. Moreover, the lack of direct evidence for several dimensions would make it necessary to refer to grey literature, resulting in a higher probability of error and a reduced quality of evidence. Finally, decision makers might be hampered by the large amount of information collected (and therein lies the utility of section four). Another limitation of our work might be the intention to use a single framework to evaluate different types of test, but we do not claim the framework to be a universal guide. It is a wayfinder that can be adapted to the individual test under study, for which particular dimensions and criteria might be appropriate, optional or not applicable. We chose a handbook format to ensure flexibility, it being less restrictive than a questionnaire or checklist. On the other hand, we believe that the adoption of a single framework for the evaluation of different types of test might allow comparison of technologies and the sharing of information. Moreover, our framework could be of benefit for the assessment of other types of technologies and services. In fact, by bringing together the ACCE model with the HTA approach, we have created a framework that adopts genetic test-specific and widely recognized dimensions and terminology, but is conceptually and structurally similar to generic technology assessments. Finally, two main concerns result from the selected Delphi survey sample, i.e. the GENISAP experts. The first one is the representativeness of the sample. In fact, while the primary audience of our framework is represented by Italian national and local government decision makers, the GENISAP sample comprises predominantly academics. Nevertheless, in Italy academics are often consulted for healthcare decision making, and are particularly involved in the evidence collection for decision making. For this reason, we think that the contribution of the GENISAP experts was extremely useful for the development of the framework, given also their specific experience in the field of public health genomics. The second concern is the generalizability of our framework to other countries. In fact, it was developed with the contribution of Italian experts only. Nevertheless, it is also based on information derived from a systematic international literature review, so we believe it may be a suitable model for other health systems.BRCA1/2 genetic test for susceptibility to breast and ovarian cancer. The framework seems to be an efficient tool for collecting and organizing existing evidence, although it takes some time to complete. Moreover, as anticipated in our previous work [Even though the final version of the framework was approved by the GENISAP experts, to gain first-hand experience we are currently validating it by assessing the ous work , the useOur work was financed by the Italian Ministry of Health to implement the 2013 National Plan for Public Health Genomics, one of the few examples of a national policy in Europe aimed at translating genomics into clinical practice at a central level . A furthIn conclusion, our framework aims to broaden the evaluation of genetic and genomic tests to include service delivery. While the context dependence of this analysis reduces its transferability, it is the only way to meet the specific requirements of decision makers. Italian experts gave positive feedback, but the framework will probably require further refinement. Subsequently, regular updates will be needed to keep pace with new innovations in the field.S1 File(PDF)Click here for additional data file.S2 File(PDF)Click here for additional data file.S3 File(XLS)Click here for additional data file.


In the past decade, the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) has introduced two programs: “Horizon Scanning in Oncology” (HSO) and extra medical services (“MELs”), which are to facilitate coverage decisions based on early assessments. This article aims to outline the general process and methods within these two programs.A narrative-descriptive synthesis of the literature was performed to outline the general and LBI-HTA-specific processes and methods of early assessments.In total, 79 HSO assessments (2009–2018) and 95 MELs (2008–2018) have been conducted by the LBI-HTA. Recently, additional methods that contribute to European applicability have been introduced into these programs.Overall, pre-coverage decisions based on early assessment reports are dependent on the existing evidence. However, the organisation of the health care system and the cross-linking between decision-makers and HTA institutions can have an impact. Health technology assessment (HTA) has gained increasing importance in supporting decisions. Over time, not only have specific HTA methodologies been developed, but the specific timing of assessments along the life-cycle of medical technologies has also evolved. Early assessments—before the broad diffusion of such health technologies—bear the advantage of supporting transparent, evidence-based reimbursement decisions on benefit catalogues, as well as of assisting budget allocations for costly medicinal products –3. DepenThe fast implementation of new and often costly technologies into clinical practice and the high number of medicinal products in the pipeline have led to the introduction of early awareness systems, also called horizon scanning systems (HSS) –6. SeverFurthermore, many countries maintain benefit catalogues covering medical services and technologies that can be reimbursed. Some benefit catalogues cover all interventions of the in- and outpatient sectors, or—as in Austria—separate catalogues exist for the inpatient and outpatient sectors. In addition to the flat-rate payments based on a diagnosis-related group (DRG) system, costly interventions are reimbursed via a supplementary tariff in Austria. Within this hospital benefit catalogue, highly specialised services, such as medical devices and some specific oncology drugs, are offset as extra medical services (MELs) , 11. SinThis article aims to outline the general process of pre-coverage decision support and the scientific methods applied for early assessments on the basis of two routine programs implemented in Austria: Horizon Scanning in Oncology (HSO) and extra medical services (“MELs”).To outline the general process of pre-coverage decision support with regard to LBI-HTA-specific methods also on an international level, a narrative-descriptive synthesis of the literature was performed. Therefore, Austrian and international HTA standards of early assessments are incorporated into this article. In addition to a targeted manual search, an internal methods handbook of the LBI-HTA was used as a basis to provide an overview of the methods and processes of early assessments in Austria . Basicalhttp://eprints.hta.lbg.ac.at/view/types/dsd-hso.html). Two to three new therapies are assessed quarterly, resulting in at least eight early assessments annually. The aim of the HSO program is to identify new anti-cancer drugs or already approved drugs with licensing extensions that have a potentially relevant therapeutic and/or financial impact on the Austrian health care system. Thus, it shall not only contribute to a rational and evidence-based decision-making process, but also facilitate estimations of the impact on the health budget [As mentioned, Austria is one of the countries where new anti-cancer treatments are adopted faster and are available earlier after approval by the European Medicines Agency (EMA) compared to many other European countries , 9. Therh budget .Across those countries that have implemented HSS, like the UK, Canada and Sweden, the inherent process basically includes the same steps .The first step in the Austrian HSO process Fig. b is to iSince 2015, the structure of HSO assessments has been based on the HTA Core Model® for Rapid Relative Effectiveness Assessment of Pharmaceuticals developed by the European network for HTA (EUnetHTA) . The HTATo facilitate further European collaboration and to continuously refine scientific methods, additional research tools have been incorporated into the HSO reports in recent years. Therefore, the internal and external validity of clinical trials are assessed by applying tools based on EUnetHTA guidelines. These methods assess the methodological quality of evidence by evaluating the risk of bias (RoB) at study level  and the applicability of study results, specifically the extent to which the results can be generalised to clinical practice  , 17. Morhttp://eprints.hta.lbg.ac.at/view/types/dsd-hso.html), as well as sent out via a mailing list including health stakeholders from different areas including oncologists, hospital pharmacists, medical directors, representatives of the MoH and health insurance providers [To ensure a transparent HSS system, final HSO reports are published on the LBI-HTA website (roviders . Additiohttp://eprints.hta.lbg.ac.at/view/types/dsd.html).As one of the first European countries, Austria began introducing a systematic evaluation of new hospital interventions submitted for reimbursement in 2008. The Federal Health Commission (FHC) of the Austrian MoH maintains a benefit catalogue of medical interventions that are provided in the inpatient sector. As mentioned in the introduction, the hospital benefit catalogue includes a list of MELs for which costs are reimbursed in addition to the DRG flat rates , 12. EveArbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF), other evidence-based guidelines and Open Knowledge Maps [After initial compilation and prioritisation by the MoH, potentially relevant topics are provisionally communicated to the LBI-HTA for scoping. This process includes the scanning of different sources, like the HTA and Planned and Ongoing Projects (POP) Databases, Deximed, UpToDate, S3 guidelines  and patient-relevant Outcomes (PICO). A systematic literature search is then conducted in the following databases: Medline via Ovid (including PubMed), Embase, The Cochrane Library, and the Centre for Reviews and Dissemination (CRD). Furthermore, to identify ongoing and unpublished studies, a search in three clinical trial registries  is carried out. As a final step of the systematic literature search, a PRISMA  flow diagram has to be prepared and implemented in the assessment [After the final selection of the topics, the exact research question is defined by clarifying the target sessment , 21.www.eunethta.eu, see Horizon Scanning in Oncology program—process and method) [Subsequently, the quality of the studies is rated by an RoB assessment. Based on the study design, different methodological tools can be considered for the RoB assessment . The external validity is additionally evaluated, i. e., the extent to which the results can be generalised to the population in clinical practice. In a next step, efficacy and safety data of the included studies are extracted by one author and reviewed by another independent author , 22. Sin method) .Accordingly, a critical appraisal based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework is conducted to evaluate whether the overall strength of evidence supports the conclusions . Therefohttp://eprints.hta.lbg.ac.at/view/types/dsd.html) and a mailing list addressing health care stakeholders.The recommendation can include one of the four following categories: “yes”, “yes—with restrictions”, “no—preliminary” and “no” Table . The catBetween 2008 and 2017, 69 assessments for hospital interventions  that can be followed-up to a political decision were conducted within the MEL program of the LBI-HTA. Twenty-five 36.2%) of those were included into the hospital benefit catalogue, whereby only five (7.2%) were included without any restrictions. On the other hand, 44 (63.8%) were not eligible for inclusion into the catalogue. Regarding the MEL recommendations, 54 (78.3%) interventions were initially not recommended to be included, of which 50 (72.5%) were preliminarily not recommended due to gaps in clinical evidence. Fifteen (21.7%) of the interventions were recommended with restrictions for inclusion into the benefit catalogue and none were recommended without any restrictions (Table 6.2% of tMany countries have implemented HTA concepts to forecast the benefit–risk ratio of costly interventions in order to support transparent, evidence-based health care reimbursement decisions, but also to facilitate budget allocations , 12, 25.There are an increasing number of fast track approval pathways accompanied by the approval of drugs with ambiguous benefit–risk profiles , 26–29. In contrast to pharmaceuticals, recommendations in early assessments of new hospital interventions are even more limited by the quality of available clinical evidence , 30. SinEuropean collaborations regarding HTA reports and HSS have gained importance in the past two decades , 25, 33.Overall, coverage decisions based on early assessment reports not only depend on the available evidence, but are also influenced by the organisation of the health care system and the cross-linking between decision-makers and HTA institutions. Since the early assessments of the MEL program of the LBI-HTA are directly linked to the maintenance and shaping process of the hospital benefit catalogue covering the inclusion or exclusion of new technologies, they have an actual impact on reimbursement decisions and encourage more transparent and evidence-based decisions. Therefore, the use of HTA has become more prospective and proactive rather than solely reactive. In contrast, HSS could facilitate decentralised medical procurement decisions by supporting, for example, drug commissions of hospital owner organisations. Although the HSO program is efficient in identifying new potential indications for cancer drugs, the extent of the actual implication of these assessments on pre-coverage decisions remains unclear. Overall, the article offers a comparison of Austrian early assessments including international methodological standards and a general overview of two different approaches to decision support on costly drugs and medical devices.


The generation of robust evidence has been emphasised as a priority for global health. Evidence generation spans a wide range of activities including clinical trials, surveillance programmes and health system performance measurement. As resources for healthcare and research are limited, the desirability of research expenditure should be assessed on the same basis as other healthcare resources, that is, the health gains from research must be expected to exceed the health opportunity costs imposed as funds are diverted to research rather than service provision.We developed a transmission and costing model to examine the impact of generating additional evidence to reduce uncertainties on the evolution of a generalised HIV epidemic in Zambia.We demonstrate three important points. First, we can quantify the value of additional evidence in terms of the health gain it is expected to generate. Second, we can quantify the health opportunity cost imposed by research expenditure. Third, the value of evidence generation depends on the budgetary policies in place for managing HIV resources under uncertainty. Generating evidence to reduce uncertainty is particularly valuable when decision makers are required to strictly adhere to expenditure plans and when transfers of funds across geographies/programmes are restricted.Better evidence can lead to health improvements in the same way as direct delivery of healthcare. Quantitative appraisals of evidence generation activities are important and should reflect the impact of improved evidence on population health, evidence generation costs and budgetary policies in place. Strategies for HIV investment rely on the availability of relevant evidence but this evidence is subject to uncertainty.The value of additional evidence to resolve uncertainties has typically ignored the impact of budgetary policies when managing programme delivery.The conceptual modelling framework shows how to value evidence generation activities to improve decisions made within a vertical HIV disease programme in the face of uncertainty and realistic budgetary policies and compares this to the health opportunity costs of research expenditure.The value of evidence generation activities vary across settings that use different budgetary policies, which has important implications for research prioritisation decisions.Decision makers charged with prioritising evidence generation activities can maximise population health outcomes in the same way as other healthcare investment by taking account of the health opportunity costs of research expenditure.HIV/AIDS remains one of the leading causes of death and disability in much of eastern and southern Africa.Cost-effectiveness analysis can support the development of a ‘focused’ strategy for HIV investment,The development of a strategy for HIV investments relies on the availability of relevant and reliable evidence. This typically includes evidence relating to the epidemiology and natural history of HIV and how this varies across different populations, the impact of alternative interventions on these processes, the costs of interventions and other healthcare costs. This evidence typically comes from a wide range of sources including clinical trials, surveillance studies, long-term observational studies, costing studies and quality of life surveys. Evidence is often synthesised using decision modelling in order to provide estimates of the costs and outcomes associated with different policy choices over a suitable time frame.The costs and health gains from local HIV services are inherently uncertain as the underlying evidence base and modelling approach are subject to uncertainty. This uncertainty has two implications.First, the HIV investment strategy that was expected to maximise population health from available resources may not turn out to be the optimal course of action. This implies that if we had better information when planning the HIV investment strategy, better health outcomes could be achieved from available funding.The second implication of uncertainty is that budgets allocated to fund specific services in specific populations or geographies may not align with the prevailing situation on the ground. For example, HIV prevalence or costs of care may be higher than expected, so planned levels of population coverage for services may not be attainable with available funds. Where decision makers face hard budget constraints that limit their ability to accommodate cost over-runs, they will require a budgetary policy to be in place in order to manage the cost variances. This implies that if we had better information when planning the HIV investment strategy, the likelihood of deviations from the strategy could be reduced. This represents an important benefit of reducing uncertainty for real-world resource allocation decisionsIn this study, we show the health benefits of evidence generation activities when both of these implications of uncertainty are considered. We show the importance of weighing these health benefits against the opportunity costs associated with allocating resources to research rather than service provision. Finally, we show how the value of evidence generation activities depends on the budgetary policy in place.A conceptual modelling framework is used to explore the population health implications of investing in evidence generation activities. This model is based on features of a generalised HIV epidemic in sub-Saharan Africa and the policy response to this. We use Zambia as a case study to illustrative the principles of the analyses required and the qualitative implications of alternative courses of action. The model is a simplified representation of HIV epidemiology in Zambia, the HIV prevention and treatment investment opportunities available and the available options for policymakers responding to uncertainty. For these reasons, the results should not be interpreted as providing an accurate quantification of different policy options for Zambia but instead are intended to demonstrate qualitative findings in a relevant setting. A simple transmission model is used to quantify health effects. The aim of the national HIV programme is to allocate a fixed budget to different interventions and across Zambian provinces to maximise population health . The interventions considered are (1) antiretroviral therapy (ART) in individuals with HIV who present for care due to ill health and who typically have CD4 counts below 350 ; 2) voluntary medical male circumcision in those without HIV infection (‘circumcision’) and (3) ART in individuals with HIV who are identified via outreach testing and who typically have CD4 counts above 350 (‘early ART’). The first stage of national HIV planning involves determining the optimum coverage level of the interventions in each region in order to maximise the expected (average) health outcomes based on currently available information . This represents the ‘planned’ HIV investment strategy. This is developed under an additional requirement that late ART is considered an imperative voluntarregional policy operates whereby once the HIV investment strategy has been set and budgets disbursed to regions, the regions must adhere to the intervention budgets allocated. This reflects the fact that recent years have seen a move towards budgets being held locally by decentralised levels of government or non-governmental service providers.The second stage involves application of a policy response to uncertainty. Under current information, we initially assume that a To assess the maximum value of investing in evidence generation activities, we assess the health that could be achieved if current uncertainties were completely eliminated and the values of the model parameters were known that is, the health that could be achieved if we had perfect information. Although in reality further data collection will not resolve all uncertainty, the health generated under perfect information can be compared with the health attained with current information to establish the maximum expected health gains associated with evidence generation activities. This provides the starting point to determine whether additional data collection is worthwhile and whether spending should be devoted to data collection or service delivery.We then show the impact of the costs of research on the net health benefits of evidence generation activities. These are quantified by comparing the health achieved under current information with the health achieved with perfect information but with a reduced intervention budget (to reflect the resources that must be spent on research). This comparison can be made using different estimates of the resources that must be spent on research. We also estimate the maximum that can be spent on research before it becomes net health reducing that is, the monetary value of research. This can then be used as a benchmark to compare to the costs of the research to determine whether the research is potentially worthwhile.Finally, we examine how the budgetary policy, by modifying the health attained under current information, impacts on the health benefits of evidence generation. We examine two alternatives to the regional policy response: the national policy and the contingency fund policy, which alongside the regional policy are intended to represent the spectrum of approaches operating in countries in sub-Saharan Africa.A transmission model was used to predict the impact of interventions on the course of the HIV epidemic over a 15-year period 2015–2030. We modelled outcomes in adults aged 15–49 in nine different provinces of Zambia with populations ranging from 400 000 to 1.1 million individuals. Each region represented a locality for which a HIV budget can be administered by a government or non-government organisation. The regions differed in HIV prevalence, which ranged from 5.4% to 18.2%, and the baseline proportion of individuals entering the population who were circumcised, which ranged from 1.6% to 72.6% of men; this resulted in differences across regions in the costs and effects of investments. Individuals entered the population without infection at age 15. A proportion of individuals who do not have HIV faced the risk of infection. Newly infected individuals enter early-stage infection and progress to late-stage infection which worsens their quality of life and prognosis. Full details on study methods are available in 10.1136/bmjgh-2017-000488.supp1Supplementary dataet al.Province-level population data, HIV prevalence and rates of circumcision were obtained from a previous epidemiological model and reflect the parameter values obtained following calibration to a range of key data sources; for further detail, see McGillen Uncertainties in HIV prevalence in each region, the impact of circumcision and ART on the risk of transmission and the costs of ART and circumcision delivery were included in the model. Uncertainties were included in the model by assigning a statistical distribution to each uncertain quantity. Different distributions were assigned to prevalence in each region to reflect prior knowledge regarding HIV epidemiology in each region. The same distributions were used across regions for the other uncertain parameters. The uncertainty reflects the fact that the true values of these quantities are unknown. For example, an estimate of HIV prevalence for a particular geographical area may be available from a household survey. Nonetheless, actual prevalence may differ from this estimate as the survey sample may have been small and therefore by chance have contained more or less individuals with HIV than the target population or the sample may not fully match the characteristics of the target population.Costs per circumcision, per year on ART and of HIV testing were included and reflect comprehensive large scale costing studies conducted in Zambia.All policies involved a first stage in which the planned HIV investment strategy was developed to maximise health given the available resources and based on currently available data . This prregional policy, decision makers spent what they initially planned on each intervention in each region. They did not reallocate resources across interventions or have means by which to extend their total regional funds beyond those allocated. This ensured regional spending did not exceed the budget; however, it did not guarantee that regions were able to achieve the coverage planned. For example, if HIV prevalence was higher than expected, available funds may not be sufficient to deliver on a commitment to universal late ART coverage. If the funding for an intervention within a region exceeded that required to deliver the planned coverage level, then intervention coverage was scaled up to the point at which the allocated funds were exhausted unless this exceeded the maximum feasible coverage level, in which case coverage was capped at this maximum and any further funds that were allocated to that intervention were used ineffectively. This was considered to be a close model of the challenges faced when managing funds under uncertainty. This simulates the situation whereby once funds are committed to a region and intervention programme, it is not possible for those funds to be transferred to another region or intervention.Under current information and a perfect information the values taken by the model parameters are known and the HIV investment strategy can therefore be revised for each realisation of uncertainty. This ensures that the investment strategy delivers the maximum health from available resources, and removes the possibility of cost variances as budgets are always set correctly. The difference between the health achieved with perfect information  and the health achieved under current information  represents the expected maximum health benefits of evidence generation activities .Under national budgetary policy total spending across regions was required to remain within the national HIV budget but funds could be transferred between regions to support implementation of the planned investment strategy. If the total cost of the investment strategy exceeded the national HIV budget then expenditure was scaled down by the same proportion across interventions and regions. If total costs fell below the national budget spending was scaled up until the budget was exhausted or the maximum coverage reached. This simulates the situation where there is central co-ordination that allows the transfer of funds between regions to support the provision of planned local investments.Under current information and a contingency fund policy a proportion of the total HIV budget was set aside prior to development of the investment strategy ,In this work, we estimated the expected maximum value that could be derived from removing all uncertainty relating to a specific set of policy questions. Estimating the value of removing all uncertainty provides the starting point to determine whether additional data collection efforts are worthwhile. If the cost of potential new research activities exceeds the value of removing all uncertainty, then further evidence generation is unlikely to be worthwhile. However, if this is not the case, the next step would be to quantify the value of specific data collection activities which would be expected to reduce some uncertainties rather than completely eliminate all uncertainty. Evaluations of specific evidence generation activities should reflect the degree to which new data will reduce uncertainties, the value of resolving these uncertainties, the timeliness with which data can be collected and reported, whether commissioning research would have any implications for the HIV investment strategy today , uncertain future changes in prices/technologies/the evidence base, decision makers response to new information and to cost over-runs and under-runs, any response by other actors to unfolding events , the full set of constraints in place  and the costs and timing of collecting data .The development of a strategy for HIV investment, and in fact any investment in healthcare, relies on the availability of relevant and reliable evidence. This evidence and the process by which it is synthesised to support decision making are inherently subject to some level of uncertainty. We show that the collection of further information to reduce these uncertainties at the point at which an investment strategy is being developed and budgets assigned has the potential to improve population health. Better evidence can both improve the design of the investment strategy and the likelihood that any planned investment strategy will actually be implemented, thus leading to health improvements in the same way as direct delivery of healthcare. However, as resources for healthcare and research are limited, the desirability of research expenditures should be assessed on the same basis as other healthcare resources, that is, the health gains from research must be expected to exceed the health opportunity costs imposed as funds are diverted to research rather than service provision. Quantitative appraisals of evidence generation activities offer the opportunity to support a more accountable process for allocating health-related funding to evidence generation activities, and further pragmatic guidance on conducting these types of assessments in HIV and global health more generally is required.


Peripheral artery disease (PAD) is often asymptomatic but increases the risk of developing cardiovascular events. Due to the uncertainties regarding the quality of related guidelines and a lack of clear-cut evidence, we performed a systematic review and critical appraisal of these guidelines to evaluate their consistency of the recommendations in asymptomatic PAD population.Guidelines in English between January 1st, 2000 to December 31th, 2017 were screened in databases including Medline via PubMed, EMBASE, the G-I-N International Guideline Library, the National Guidelines Clearinghouse, the Canadian Medication Association Infobase and the National Library for Health. Those guidelines containing recommendations on screening and treatment for asymptomatic PAD were included, and three reviewers evaluated the quality of the guidelines using Appraisal of Guidelines Research and Evaluation (AGREE) II instrument. Related recommendations were then fully extracted and compared by two reviewers.Fourteen guidelines were included finally and the AGREE scores ranged from 39 to 73%. Most of included guidelines scored low in Rigor of development and Editorial independence, and only two guidelines  reached the standard on Conflict of Interest from Institute of Medicine (IOM). Eight guidelines recommended screening at different strength while the others found insufficient evidence or were against screening. Conflicting recommendations on treatment were found in the target value of the lipid lowering and antiplatelet therapy. The treatment policies in three guidelines  appeared more aggressive, but they had low transparency between guideline developer and industry or did not reach the standard of IOM.Current guidelines on asymptomatic PAD varied in the methodological quality and fell short of the standard in the rigor of development and editorial independence. Conflicting recommendations were found both on the screening and treatment. More effort is needed to provide clear-cut evidences with high quality and transparency among guideline developer and industry.The online version of this article (10.1186/s12872-018-0960-8) contains supplementary material, which is available to authorized users. Peripheral arterial disease (PAD) is defined as an atherosclerotic process that leads to stenosis and occlusion in non-cerebral and non-coronary arteries . More thHowever, sufficient attention has not been paid to asymptomatic PAD, though several studies have been conducted to assess the value of screening for PAD patients , 7. But In this study, we aimed to systematically appraise the guidelines on the screening and treatment for asymptomatic PAD and find out the agreements and the differences in the recommendations.The systematic review was performed according to the Cochrane methodology . ClinicaA systematic search was performed to identify relevant guidelines containing the recommendations on management of asymptomatic PAD. We searched the Medline via PubMed and the EMBASE databases. Four guideline-related databases were also searched, including the Guidelines International Network (G-I-N) International Guideline Library, the National Guidelines Clearinghouse (United States), the Canadian Medical Association Infobase (Canada) and the National Library for Health (United Kingdom). The search was limited to guidelines published from January 1st, 2000 to December 31th, 2017. Details on the search strategies was provided in the Additional file Guidelines which met following criteria were selected. (1) The target population of the guideline includes asymptomatic PAD patients; (2) the guideline contains recommendations on the screening for asymptomatic PAD and/or treatment for asymptomatic PAD, including but not limited to exercise, pharmacological treatment, surgical treatment; (3) the guideline is available online; (4) the guideline is written in English; (5) the guideline is developed by related national or international academic organizations. Guidelines were excluded out of following reasons: (1) the guideline was not the latest version on the same topic and population; (2) the topic was only mentioned in the guidelines.Three appraisers  assessed the quality of the selected guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE) II instrument. The AGREE II instrument is a 23-item tool with international certification which serves to evaluate the six domains of methodological quality of a guideline, including scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence  (AdditioThen each guideline was given a recommendation according to its percentage score. If most (4 or more) domains scored over 60%, a guideline would be regarded as “strongly recommended for use in practice”; if scores of most domains (4 or more) ranged 30–60%, the guideline would be regarded as “recommended for use with some modification”; if most of the domains (4 or more) scored less than 30%, the guideline would be regarded as “not recommended for use in practice”.To examine the consistency of specific recommendations, we used a data extraction form  . AlthougCurrent guidelines about asymptomatic PAD varied in the methodological quality and fell short of the standard in the rigor of development and editorial independence. The conflicting recommendations were both on the screening and treatment. Increasing effort is needed to provide the clear-cut evidence with high quality and transparency among guideline developers and industry.Additional file 1:Table S1. Search strategies. (DOCX 17 kb)Additional file 2:Table S2. Structure and content of the AGREE instrument. (DOCX 15 kb)Additional file 3:Table S3. Data extraction template. (DOCX 14 kb)


Inthis report, we presented a case of a bilobed spleen that was misdiagnosed as aleft renal mass during routine abdominal ultrasonography in a 25-year-old femalewho complained of recurrent left hypochondrium pain. The bilobed configurationwas confirmed with MRI and ultrasound examination of the abdomen.There is a wide range of congenital anomalies of the spleen regarding its shape,location, number, and size. Most of these congenital anomalies are commonlydetected on ultrasonography, CT, or MRI and may sometimes represent achallenging diagnosis for radiologists and clinicians. The bilobed spleen is anextremely rare form of congenital anomaly. In most cases, it is accidentallydiscovered during abdominal surgeries. The bilobed spleen is usually large insize when compared with the normal spleen; hence, it is more liable to trauma.Transposition of the inferior vena cava refers to a very rare variant course of the IVC. The most common variations areduplicate IVC, as well as retroaortic left renal vein and circumaortic venousrings. Left-sided IVC occurs in 0.17–0.5% of the general population.Diagnosis of left-sided IVC is important when planning vascular procedures likeportosystemic shunt, the placement of an IVC filter, nephrectomy, and renaltransplant. There should be an awareness of the Riedel lobe, which is a commonanatomical variant of the liver, as it can simulate a mass. Itsmisidentification as a pathological abdominal mass can lead to surgery;pathology can also occur ( The spleen is a large, encapsulated organ that mainly encompasses vascular andlymphoid tissue; it is situated in the upper-left quadrant of the abdominal cavitybetween the diaphragm and fundus of the stomach, and it relates to the tail of thepancreas and the upper pole of the left kidney. It is important to understand thewide variety of splenic shapes, numbers, fissures, and positions to avoid imagingpitfalls and to safeguard against misinterpreting these normal variations aspathological processes.1 in the literature, the left IVC has a prevalence of 0.17–0.5%.2A persistent left inferior vena cava (IVC) is caused by the regression of a rightsupracardinal vein and the persistence of a left supracardinal vein. Typically, theleft IVC meets the left renal vein, which passes anteriorly to the aorta in an“N fashion”, thereby joining the right renal vein to create a normalright-sided prerenal IVC;2 We believe that a left IVC with hemiazygos and azygos continuation is a veryrare variation of IVC.Here, we report an extremely rare case of multiple congenital anomalies including abilobed spleen, where there is medial  and lateral  spleniclobes connected at the splenic hilum. In this case, we present a left IVC that wasdraining into the hemiazygos vein that eventually joined the azygos vein,supradiaphragmatically. The combined hemiazygos and azygos veins were draining intothe superior vena cava (SVC). This pattern is not consistent with the common leftIVC variations reported in the literature. In fact, in the literature, we were notable to find data on the prevalence of left hemiazygos/azygos variations.3 and congenital abnormalities of the liver are considered rare.4 The Riedel lobe of the liver is one such variation; it is a tongue-likeinferior projection of the right lobe of the liver that extends to the right of thegall bladder.5The size of the liver depends on several factors such as age, sex, body size, andshape. The liver can be palpable for anatomical reasons or due to underlyingabnormal conditions,4 Riedel lobes should be included in the differential diagnosis of right-sidedabdominal palpable masses to avoid unnecessary surgery.6A Riedel lobe was reported in seven female patients who had palpable masses in theright hypochondrium, and the diagnosis was confirmed at surgery.7Careful examination of the spleen should be done to differentiate between commonlyencountered congenital anomalies and different pathological entities. The spleen isnormally located in the upper-left quadrant of the body; it does not developdirectly from the gut. Several suspensory ligaments, including gastrosplenic,lienophrenic, lienocolic, and lienorenal ligaments maintain the spleen in its normal position.8The spleen undergoes a number of developmental processes that result in a wide rangeof anatomical differences, which can include variations in shape, as well as thepresence of fissures and notches. The spleen originates from the mesenchyme of thedorsal mesogastrium, which lies over the dorsal pancreatic endoderm as a long stripof cells next to the developing stomach. The spleen loses its hematopoietic functionon embryo development. In late pregnancy, lymphoid precursor cells migrate into thespleen from the central lymph organs. The splenic notch is a remnant of thepreviously lobulated structure of the spleen.9The spleen is usually a single organ, but it is commonly surrounded by smalleramounts of splenic tissue (splenunculi or accessory spleens), which usually lie inproximity to the pancreatic tail.10 It is easy to differentiate splenunculi from enlarged lymph nodes, as theydisplay isodensity, as well as specific intensity and enhancement patterns on pre-and multiphasic post-contrast studies.11Splenunculi are more frequently detected in a number of advanced imaging modalities;thus, they can be differentiated from more sinister pathologies.12 It should be differentiated from splenunculus.The bilobed spleen may mimic enlarged lymph nodes and tumors in the lefthypochondrium organs, which include hypervascular pancreatic tumors, neuroendocrinetumors, metastatic lesions, or enlarged lymph nodes in the splenic hilum.13Accessory spleens are small nodules of splenic tissue found distal from the main bodyof the spleen; this separation is the primary feature that differentiates it fromthe medial  splenic lobe of the bilobed spleen, which is connected to thesplenic hilum.13The medial/internal lobe of the bilobed spleen can extend medially to displace andcompress the pancreatic tail and the upper pole of the left kidney with aconcomitant, non-existent lienorenal ligament. It can indent the posterior aspect ofthe gastric fundus, mimicking an iceberg tumor.T1 and T2 .Ultrasound, CT, and MRI remain the primary imaging modalities used to visualize thesplenic parenchyma. MRI is preferred over CT scans given that there is no need forradiation exposure or contrast injection, and it offers better soft-tissuediscrimination. The characteristics of the spleen visible via MRI are unique; thereis a large amount of fractional heme content characterized by long13Ultrasound is a non-invasive, highly sensitive, and specific imaging technique thatcan be used to evaluate the spleen. Ultrasound evaluation of the spleen should notbe limited to splenic size; rather, it should be used to determine its shape and location.The spleen is the dark male of the abdomen more echogenic than both the liver andkidney; it is best assessed in the supine, left lateral position with the left armplaced behind the head, obliquely in the 9th or 10th intercostal spaces .In the current case, an ultrasound was performed, which revealed a bilobed spleen andsmall spenules ; thelefThe clinician did not concur that the mass was a medial splenic lobe and consideredit a lesion arising from the left kidney; the clinician then compared the currentultrasound scan to a previous ultrasound that was performed by another radiologistwho, unfortunately, misdiagnosed it as a left renal mass (and did not notice theother findings). The clinician asked for a CT scan with contrast, but the patientrefused as she was waiting to get pregnant. The clinician then asked for an MRI scanwithout contrast and the patient consented.T1 and T2 weighted imaging   .2 We believe that the left IVC with hemiazygos and azygos continuation is avery rare variation of IVC.In the current case, a left IVC was draining into the hemiazygos vein that eventuallyjoined the azygos vein supradiaphragmatically; the combined hemiazygos and azygosvein was draining into the SVC . This pa14 Koç et al reported a similar variation, but the drainage promptlyreturned to the continuous azygos vein and progressed thereafter.15Haswell et al reported a left IVC with azygos and accessory hemiazygos thateventually entered the SVC through the brachiocephalic route.16The Riedel lobe was first described by Corbin in 1830; it was subsequently defined byRiedel in 1888 as a “round tumor on the anterior side-of the liver, near thegallbladder, to its right.” It is more common in females. With theadvancements made in several imaging modalities, it has become easier to detect suchrare hepatic morphological variants.17The Riedel lobe is either congenital or acquired. The congenital Riedel lobe resultsfrom an anomaly that occurs in the development of the hepatic bud, which leads tothe formation of an accessory lobe.18 It might also be secondary to tractions exercised by adherential syndrome dueto lithiasic cholecystitis, peritoneal inflammation, and prior surgical intervention.19The acquired form of the Riedel lobe could be secondary to hepatic morphologicalmodifications (which are either age- or sex-related) and to skeletal anomalies, suchas kyphoscoliosis with a wide thorax.20Our case was typical of an accidentally discovered, non-palpable Riedel lobe of theliver, as it was discovered during an examination for a bilobed spleen . General20 Knowledge or suspicion of the possibility of a Riedel lobe is important, asit does not always remain clinically latent in cases of torsion or hepatic tumors,which can include metastasis or hepatocellular carcinoma that may sometimes ariseonly in the lowest part of the Riedel lobe.21A typical Riedel lobe is usually associated with a good prognosis, particularly incases of an early-stage diagnosis, and there is typically a lack of complications.We presented an extremely rare combined morphological congenital anomaly of thespleen, IVC, and liver in one case. The bilobed spleen is composed of medial and lateral  lobes connected at the hilum. The medial lobe isseen compressing and mildly displacing the tail of the pancreas. The left kidney isdisplaced downwards. The rarely encountered bilobed spleen could be confused withsplenomegaly. A bilobed spleen, as reported here, might be misinterpreted as a massoriginating from the tail of the pancreas, left adrenal gland, or the fundus of thestomach. The similar signal intensity to spleen on MRI is a crucial distinguishingfactor.Transposition of the IVC  drained into the hemiazygosvein, that eventually joined the azygos vein supradiaphragmatically; the combinedhemiazygos and azygos veins were draining into the SVC, referring to a very rarevariant course of the IVC. The findings of this report may ultimately be ofimportance to radiologists, surgeons, clinicians, and patients.This type of elongation of the caudate lobe of the liver may cause symptoms likesensations of pressure, pulling, and pain in the epigastrium. Moreover, knowledge ofthis type of liver anomaly will be helpful for surgeons when planning hepatobiliarysurgeries.Knowledge of the possible anomalies and different morphological variants ofthe spleen, IVC, and liver are important in order to avoid pitfalls in theinterpretation of abdominal imaging studies, such as MRI and ultrasound.For this reason, this case report demonstrates an extremely rare variant ofthe spleen that could be confused for splenic or renal mass lesions.No available appreciable data are available regarding the bilobed spleen, itsrelated findings, or symptoms in the imaging literature.This case demonstrates an extremely rare variant of the transposition of theIVC  draining into the hemiazygos vein thateventually joined the azygos vein supradiaphragmatically; the combinedhemiazygos and azygos veins were draining into the SVC.Knowledge or suspicion of the possibility of a Riedel lobe is important, asit does not always remain clinically latent in cases of torsion or hepatictumors, which include metastasis. Further, hepatocellular carcinoma maysometimes arise only in the lowest part of the Riedel lobe.


Research shows that training can improve skills needed for evidence-based decision making, but less is known about instituting organizational supports to build capacity for evidence-based chronic disease prevention.The objectives of this case study were to assess facilitators and challenges of applying management practices to support evidence-based decision making in chronic disease prevention programs in the public health system in Georgia through key informant interviews and quantitatively test for changes in perceived management practices and skills through a pre–post survey.Leadership of the chronic disease prevention section hosted a multiday training, provided regular supplemental training, restructured the section and staff meetings, led and oversaw technical assistance with partners, instituted transparent performance-based contracting, and made other changes. A 65-item online survey measured perceived importance of skills and the availability of skilled staff, organizational supports, and use of research evidence at baseline (2014) and in 2016 (after training). A structured interview guide asked about management practices, context, internal and external facilitators and barriers, and recommendations.Seventy-four staff members and partners completed both surveys (70.5% response). Eleven participants also completed a 1-hour telephone interview. Interview participants deemed leadership support and implementation of multiple concurrent management practices key facilitators to increase capacity. Main challenges included competing priorities, lack of political will, and receipt of requests counter to evidence-based approaches. At posttest, health department staff had significantly reduced gaps in skills overall (10-item sum) and in 4 of 10 individual skills, and increased use of research evidence to justify interventions. Use of research evidence for evaluation, but not skills, increased among partners.The commitment of leaders with authority to establish multiple management practices to help staff members learn and apply evidence-based decision-making processes is key to increased use of evidence-based chronic disease prevention to improve population health. Evidence-based decision making for chronic disease prevention (EBDM) involves complex processes, including applying program planning and quality improvement frameworks; engaging partners in assessment and decision making; adapting and implementing evidence-based policies and programs; conducting sound evaluation; and using evaluation findings to improve implementation and reach ,2. Both The Centers for Disease Control and Prevention (CDC), along with other funders, expect state public health departments to implement or contract for evidence-based approaches . TraininThe Chronic Disease Prevention Section (CDPS) of the Georgia Department of Public Health (GDPH) has about 50 staff members that help communities create policy, systems, and environmental changes to reduce risk factors for cardiovascular diseases, cancers, diabetes, asthma, and other chronic conditions, promote the healthy development of children and adolescents, and provide access to early detection and management of chronic conditions. CDPS also funds part of the cost of district health chronic disease coordinators in each of the 18 public health districts.In fall 2013, a new chronic disease director was hired to move the section toward a coordinated chronic disease approach. To foster collaboration and information sharing to implement evidence-based approaches to reduce risk factors common across disease areas, CDPS was organized into the 4 domains of chronic disease prevention instead of disease area or funding source: epidemiology, environmental approaches, health care systems interventions, and community–clinical linkages . In addiIn 2014, recognizing the importance of EBDM, in addition to structure, in achieving improved organizational effectiveness, CDPS also enrolled in a study to assess the impact of an EBDM training and related intervention activities ,8. The oParticipants and data collection. In August 2014, 30 staff members from CDPS and 1 university partner attended a multiday EBDM training provided by the senior author (R.C.B.) and other faculty members and coordinated by 2 coauthors (R.R.J. and P.A). The content covered 8 modules  and the availability of agency staff members who have that skill , frequency of use of research evidence , work unit and agency expectations and supports for EBDM , and steps taken to enhance EBDM capacity . The measures were developed from a literature review . Skill gaps for each of 10 EBDM competencies were calculated as the score for the perceived importance of the skill minus the score for the perceived availability of resources to apply the skill. The sum of the 10 skill gap scores comprised the overall EBDM skill gap. Inferential analyses included paired t tests and McNemar tests. Two study team members  independently coded each verbatim interview transcript in NVivo version 10  and then met to reach consensus. Coded texts were reviewed to identify themes and illustrative quotes.Participant characteristics. Of the 74 survey participants that completed both baseline and post-training surveys, 30 were from CDPS. The remaining 44 surveys were completed by partners from district, local, and other state governmental agencies (38.6%), coalitions or community-based organizations (34.1%), universities (20.5%), or other organizations (6.8%). Among all participants, most were female (75.7%) and had a master’s or doctoral degree in any field (81.9%). More than one-third (37.5%) had graduate degrees in public health. Nearly half (48.6%) were at least 50 years old. Participant characteristics were similar between CDPS staff members and partners, except partners on average reported more years worked at their agency  and in public health  than CDPS staff members . The 11 participants interviewed (5 CDPS and 6 partners) had worked a median of 15.5 years  in public health and a median of 5.5 years  in their agencies.Capacity-building activities. Initial steps after the August 2014 EBDM training included revising the staff meeting agendas to incorporate EBDM information with sharing of information across program areas; establishment of a webinar training series for staff and partners, called “Chronic Disease University,” to increase the awareness of the evidence-based strategies for chronic diseases; identifying a mechanism for staff members to have access to the scientific literature; a plan to ensure contracts funded evidence-based strategies and practices; the implementation of management support of opportunities for staff members to publish and present their work; and the addition of expectations to use EBDM approaches into CDPS staff performance plans , in prioritization (P = .01), adapting interventions (P = .005), qualitative evaluation (P = .04), and action planning (P = .01). Mean perceived supervisory expectations for use of EBDM increased (P = .006), as did perceived work-unit access to staff resources for EBDM (P = .01). Use of research evidence to justify selection of interventions increased (P = .008). Among the 44 partners, use of research evidence to evaluate interventions increased (P = .03). ormation . Mean peCommonly reported steps to improve capacity for EBDM, as reported by CDPS and partner survey participants, were informally sharing EBDM knowledge (53%), using EBDM knowledge to plan (43%) or evaluate (33%) a program, and building EBDM principles into employee performance expectations (27%).Participant recommendations. CDPS recommendations focused on training, hiring, and educating decision makers about prevention effectiveness. Training recommendations included 1) a standardized EBDM orientation for new staff, 2) more skills-based training, not just informational trainings, and 3) more training in policy change. Staff wanted planned hiring of people experienced in policy change to continue to increase the section’s capacity to guide partners. And because of lack of belief in prevention in some areas, “it’s convincing people that prevention works. I think we have to get better at doing that.”Partners made similar recommendations, and also wanted CDPS to 1) provide summaries of emerging issues such as e-cigarettes, 2) pool and distribute information important to communities, 3) increase interagency collaboration at the state level, 4) give as much notice as possible of upcoming proposals to allow time for local partnering in preparation, and 5) involve district staff in drafting requests for proposals. Partners also recommended hiring more district and local health promotion staff so in-person relationship building can lay the groundwork for increased local capacity to implement evidence-based practice.This case study describes multiple management strategies used to build EBDM capacity in the chronic disease prevention unit of a state health department in the areas of leadership support, workforce development, partnering, and financial practices. After training and institution of management practices, self-reported EBDM skills and availability of resources for EBDM improved among CDPS staff. Use of research evidence increased among CDPS staff and partners.Leadership support and the use of multiple management strategies rather than a single strategy emerged as the key facilitators of EBDM capacity building among interview participants. In qualitative studies in Canada, participants deemed leadership role modeling, expectations of EBDM, and provision of staff time to learn and apply EBDM processes instrumental in building EBDM capacity and use –11. AaroAn additional strategy was the reorganization of CDPS by role instead of chronic condition, with the intent to facilitate cross-program data sharing and collaboration to better plan and implement evidence-based approaches to reduce risk factors such as obesity and tobacco use, which are common to multiple chronic diseases. In a case study of structure, chronic disease prevention staff found that collaboration was enhanced by having specialist groups meet across program areas . A publiWorkforce development was multifaceted, as recommended by Roche and colleagues , with onManaging change with communication is critical to building EBDM capacity. Health department staff and public health leaders emphasize the importance of clear communication of EBDM principles, expectations, and processes, and sharing of information across programs –11,14–17The efforts to have transparent budget processes, requests for proposals, and timelines were appreciated in partner interviews. Partners wanted more lead time for requests for proposals to work through local partnerships in time to apply competitively, but they also expressed understanding of timeline constraints. Performance-based contracts ensure that resources support evidence-based planning, implementation, evaluation, and enhanced transparency in the contracting process .Challenges to EBDM expressed by participants reflected barriers noted in earlier studies ,19, wherIn addition to recommendations from interview participants, we recommend the following: 1) ongoing development among leadership teams and staff members in skills not only in EBDM but also in technical assistance, communication, strategic planning, policy development, and coalition building; 2) replication of EBDM training with nonuniversity chronic disease prevention partners; 3) long-term commitment to EBDM communication and change management; 4) enhanced engagement in participatory decision making as staff and partner skills in EBDM and communication grow; and 5) addressing health equity challenges. Health departments are directing resources to areas with poor health outcomes but lack of political will for EBDM persists in some corners. Skepticism about the effectiveness of prevention, racism and social inequality, and reluctance in some communities to partner across racial, economic, and rural/urban strata are common challenges requiring nontraditional transdisciplinary work  made it difficult to detect significant change. The self-reported Likert items on organizational supports may not fully measure actual management practices.Leadership support is critical for EBDM capacity building and dissemination. Commitment of leaders within agencies with authority and skills to institute multiple management practices and help staff learn and apply EBDM processes is important for the spread of evidence-based chronic disease prevention and improved population health.