Inclusion of quasi-experimental studies in systematic reviews of health systems research. Digital Education in Health Professions: The Need for Overarching Evidence Synthesis An international registry of systematic-review protocols Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report. Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology. Interventions to reduce dependency in personal activities of daily living in community-dwelling adults who use homecare services: protocol for a systematic review Interventions aimed at increasing research use in nursing: a systematic review Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: Methods of a decision-maker-researcher partnership systematic review The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials Evidence-based behavioral medicine: What is it and how do we achieve it? Getting to grips with Archie Cochrane's agenda. Systematic review of effectiveness of universal self-regulation-based interventions and their effects on distal health and social outcomes in children and adolescents: review protocol Comparative Effectiveness Research: A Report From the Institute of Medicine
Systematic review s of health systems research commonly limit studies for evidence synthesis to r and omized controlled trials . However , well-conducted quasi-experimental studies can provide strong evidence for causal inference . With this article , we aim to stimulate and inform discussion s on including quasi-experiments in systematic review s of health systems research . We define quasi-experimental studies as those that estimate causal effect sizes using exogenous variation in the exposure of interest that is not directly controlled by the research er . We incorporate this definition into a non-hierarchical three-class taxonomy of study design s - experiments , quasi-experiments , and non-experiments . Based on a review of practice in three disciplines related to health systems research ( epidemiology , economics , and political science ) , we discuss five commonly used study design s that fit our definition of quasi-experiments : natural experiments , instrumental variable analyses , regression discontinuity analyses , interrupted times series studies , and difference studies including controlled before- and -after design s , difference-in-difference design s and fixed effects analyses of panel data . We further review current practice s regarding quasi-experimental studies in three non-health fields that utilize systematic review s ( education , development , and environment studies ) to inform the design of approaches for synthesizing quasi-experimental evidence in health systems research . Ultimately , the aim of any review is practical : to provide useful information for policymakers , practitioners , and research ers . Future work should focus on building a consensus among users and producers of systematic review s regarding the inclusion of quasi-experiments Synthesizing evidence from r and omized controlled trials of  digital health education  poses some challenges . These include a lack of clear categorization of digital health education in the literature ; constantly evolving concepts , pedagogies , or theories ; and a multitude of methods , features , technologies , or delivery setting s. The Digital Health Education Collaboration was established to evaluate the evidence on digital education in health professions ; inform policymakers , educators , and students ; and ultimately , change the way in which these professionals learn and are taught . The aim of this paper is to present the overarching methodology that we use to synthesize evidence across our digital health education review s and to discuss challenges related to the process . For our research , we followed Cochrane recommendations for the conduct of systematic review s ; all review s are reported according to the PRISMA ( Preferred Reporting Items for Systematic Review s and Meta-Analyses ) guidance . This included assembling experts in various digital health education fields ; identifying gaps in the evidence base ; formulating focused research questions , aims , and outcome measures ; choosing appropriate search terms and data bases ; defining inclusion and exclusion criteria ; running the search es jointly with librarians and information specialists ; managing abstract s ; retrieving full-text versions of papers ; extracting and storing large data sets , critically appraising the quality of studies ; analyzing data ; discussing findings ; drawing meaningful conclusions ; and drafting research papers . The approach used for synthesizing evidence from digital health education trials is commonly regarded as the most rigorous benchmark for conducting systematic review s. Although we acknowledge the presence of certain biases ingrained in the process , we have clearly highlighted and minimized those biases by strictly adhering to scientific rigor , method ological integrity , and st and ard operating procedures . This paper will be a valuable asset for research ers and method ologists undertaking systematic review s in digital health education Support for prospect i ve registration of protocol s for systematic review s has been gathering momentum . The PRISMA statement , a guideline for reporting systematic review s and meta-analyses of studies that evaluate health-care interventions , advocates registration . Well-conducted systematic review s are accepted as the best- quality evidence to inform policy and practice , and the dramatic upward trend in the number of systematic review s published annually ( fi gure ) is set to continue . However , there is currently no single facility for identifying this type of research in advance of the appearance of the results of the review . There is concern about and evidence of publication and selective outcome -reporting biases associated with systematic review s. An open registry of review s captured at the protocol stage would facilitate good practice in systematic review s by providing transparency of the review process and outcomes . Discrepancies between the methods of the published review and those planned in the registered protocol could be more readily identifi ed . Registration might also encourage full publication of the review ’s fi ndings and transparency in changes to methods that could bias fi ndings . In both the prevention and revelation of potential bias , registration should improve quality and increase confi dence that policy or practice informed by the fi ndings of systematic review s are indeed drawing on best- quality evidence . A registry of protocol s of systematic review s could assist those planning new review s and updating existing ones . Easy access to information about ongoing review s should help to optimise the use of fi nite re sources by enabling funding and commissioning agencies to avoid unnecessary duplication and encourage collaboration . A comprehensive registry could also create opportunities for method ological and other research , both within and across disciplines . Existing access to systematic - review protocol s is limited to the outputs of individual organisations , such as the Cochrane and Campbell Collaborations and the Joanna Briggs Institute . The National Public Health Service for Wales is piloting an All Wales Systematic Review s Register , but , up to now , there has been no central ised comprehensive registry of systematic - review protocol s. We are developing an international facility to register the details of ongoing systematic review s in health and social care . Our registry is being established with the existing platform and infrastructure that supports the Data base of Abstract s of Review s of Eff ects ( DARE ) , the NHS Economic Evaluations Data base ( NHS EED ) and the Health Technology Assessment ( HTA ) data base produced by the Centre for Review s and Dissemination . The initial scope of the registry will be limited to systematic review s of the eff ectiveness of health interventions . However , the longterm aim is for the registry to include details of all ongoing systematic review s with a health-related outcome in the broadest sense . Ultimately , inclusion will encompass systematic review s of health-care interventions , and review s of the social determinants of health , of service delivery , and of risk factors and genetic associations . Our web-based registry will off er free public access , be electronically search able , and open to all prospect i ve registrants . Registration will require the provision of a minimum data set , the completeness of which will be checked automatically before registration . After acceptance , the registry ’s entry and protocol for the review , if available , will be loaded on the data base as a permanent entry and a unique identifi cation number issued . An audit trail for any amendments to the information will be available within the record . Links to result ing publications will be added . These provisions ensure that the registry will match the relevant criteria required of clinical trials registries OBJECTIVE Scientific and ethical justification for new clinical trials requires them to have been design ed in the light of scientifically defensible assessment s of relevant previous research . Reliable interpretation of the results of new clinical trials entails setting them in the context of up date s of the review s upon which they were deemed scientifically and ethically justifiable . We have shown previously that most reports of r and omized trials published in five general medical journals in May 1997 and in May 2001 failed to set their results in the context of the findings from similar research . In the current study , we assess whether there had been progress in this respect in 2005 and also investigate the extent to which reports begin by referring to systematic review s providing the justification for the new research reported . DESIGN Assessment of the Introduction and Discussion sections in all reports of r and omized trials published during May 2005 in five general medical journals . SETTING Reports of r and omized trials in five general medical journals . PARTICIPANTS Annals of Internal Medicine , BMJ , JAMA , Lancet and New Engl and Journal of Medicine . INTERVENTIONS None . MAIN OUTCOME MEASURES The inclusion or mention of one or more systematic review s in the Introduction or Discussion section of each report assessed . RESULTS We found 18 reports of r and omized trials . The Introduction sections referred to systematic review s in five ( 27 % ) of these reports . None of the discussion sections of the 15 reports of trials that were not the first published trials to address the question studied placed the results of the new trial in the context of an up date d systematic review of other research . Although reference was made to relevant systematic review s in five of these 15 reports , there was no integration - quantitative or qualitative - of the results of the new trials in an up date of these review s. In the remaining ten reports there was no evidence that any systematic attempt had been made to set the new results in the context of previous trials . CONCLUSIONS There is no evidence of progress between 1997 and 2005 in the proportion of reports of trials published in general medical journals which discussed new results within the context of up-to- date systematic review s of relevant evidence from other controlled trials . Although the proportion of trials referring to systematic review s in Discussion sections has increased , the majority of reports continued to fail even to do this . Similarly , most research ers appear not to have considered a systematic review when design ing their trial . Research ers and journal editors do a disservice to the interests of the public and others involved in healthcare decision-making by acquiescing in this situation AIMS The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes . MATERIAL AND METHODS Discussion s were informed by three systematic review s on quality of reporting of observational studies ( case series , case-control and cohort ) and experimental research ( r and omized clinical trials ) . An additional systematic review provided information on choice of outcomes and analytical methods . In addition , an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems . RESULTS The Workshop attempted to clarify the characteristics and the value in dental implant research of different study design s. In most areas , measurable quality improvements over time were identified . The Workshop recognized important aspects that require continued attention by clinical research ers , funding agencies and peer review ers to decrease potential bias . With regard to choice of outcomes , the limitations of currently used systems were recognized . Three broad outcome domains that need to be captured by future research were identified : ( i ) patient reported outcome measures , ( ii ) peri-implant tissue health and ( iii ) performance of implant supported restorations . Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses . CONCLUSIONS The Workshop recommended that collaboration between clinicians and epidemiologists/ clinical trials specialists should be encouraged . Aspects of design aim ed at limitation of potential bias should receive attention by clinical research ers , funding agencies and journal editors . Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary st and ards . Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research Background There is a growing dem and for services whereby individuals receive assistance from care workers for personal care within the home . This has led to the development of re-ablement or restorative homecare services that provide time-limited input aim ed at reducing dependency in personal activities of daily living , and preventing or delaying the need for further homecare support . However , little is currently known about how such interventions are configured , or how they may affect individuals ’ ability to carry out personal care independently . Methods / Design We will seek to identify studies that compare an intervention design ed to reduce dependency in personal activities of daily living with routine input or usual care as the control . We will include r and omised controlled trials , nonr and omised controlled trials , and controlled before and after studies . We will also include interrupted time series studies .We shall search electronic data bases in addition to search ing for ongoing and unpublished studies , and where appropriate will contact key authors . Two review ers will independently screen articles for inclusion ; will assess risk of bias using quality assessment tools ; and will carry out data extraction using pre-prepared forms . Any disagreements , at any stage , will be resolved by discussion and the involvement of a third review er if needed . We will produce a narrative summary of the results . A meta- analysis will be conducted if sufficient data are available of appropriate quality and comparability . Discussion The findings from this review will inform future practice within homecare re-ablement services ; will inform policy decisions about the structure , organisation and content of such services ; and will identify areas where further research is warranted . Systematic review registration This review protocol has been registered on the PROSPERO data base ( CRD42013004163 ) Background There has been considerable interest recently in developing and evaluating interventions to increase research use by clinicians . However , most work has focused on medical practice s ; and nursing is not well represented in existing systematic review s. The purpose of this article is to report findings from a systematic review of interventions aim ed at increasing research use in nursing . Objective To assess the evidence on interventions aim ed at increasing research use in nursing . Methods A systematic review of research use in nursing was conducted using data bases ( Medline , CINAHL , Healthstar , ERIC , Cochrane Central Register of Controlled Trials , and Psychinfo ) , grey literature , ancestry search ing ( Cochrane Data base of Systematic Review s ) , key informants , and manual search ing of journals . R and omized controlled trials and controlled before- and after- studies were included if they included nurses , if the intervention was explicitly aim ed at increasing research use or evidence -based practice , and if there was an explicit outcome to research use . Method ological quality was assessed using pre-existing tools . Data on interventions and outcomes were extracted and categorized using a pre-established taxonomy . Results Over 8,000 titles were screened . Three r and omized controlled trials and one controlled before- and after- study met the inclusion criteria . The method ological quality of included studies was generally low . Three investigators evaluated single interventions . The most common intervention was education . Investigators measured research use using a combination of surveys ( three studies ) and compliance with guidelines ( one study ) . Research er-led educational meetings were ineffective in two studies . Educational meetings led by a local opinion leader ( one study ) and the formation of multidisciplinary committees ( one study ) were both effective at increasing research use . Conclusion Little is known about how to increase research use in nursing , and the evidence to support or refute specific interventions is inconclusive . To advance the field , we recommend that investigators : ( 1 ) use theoretically informed interventions to increase research use , ( 2 ) measure research use longitudinally using theoretically informed and psychometrically sound measures of research use , as well as , measuring patient outcomes relevant to the intervention , and ( 3 ) use more robust and method ologically sound study design s to evaluate interventions . If investigators aim to establish a link between using research and improved patient outcomes they must first identify those interventions that are effective at increasing research use Background Computerized clinical decision support systems are information technology-based systems design ed to improve clinical decision-making . As with any healthcare intervention with cl aims to improve process of care or patient outcomes , decision support systems should be rigorously evaluated before widespread dissemination into clinical practice . Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake . The objective of this research was to form a partnership of healthcare providers , managers , and research ers to review r and omized controlled trials assessing the effects of computerized decision support for six clinical application areas : primary preventive care , therapeutic drug monitoring and dosing , drug prescribing , chronic disease management , diagnostic test ordering and interpretation , and acute care management ; and to identify study characteristics that predict benefit . Methods The review was undertaken by the Health Information Research Unit , McMaster University , in partnership with Hamilton Health Sciences , the Hamilton , Niagara , Haldim and , and Brant Local Health Integration Network , and pertinent healthcare service teams . Following agreement on information needs and interests with decision-makers , our earlier systematic review was up date d by search ing Medline , EMBASE , EBM Review data bases , and Inspec , and review ing reference lists through 6 January 2010 . Data extraction items were exp and ed according to input from decision-makers . Authors of primary studies were contacted to confirm data and to provide additional information . Eligible trials were organized according to clinical area of application . We included r and omized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a  computerized clinical decision support system compared with patient care without such a system . Results Data will be summarized using descriptive summary measures , including proportions for categorical variables and means for continuous variables . Univariable and multivariable logistic regression models will be used to investigate associations between outcomes of interest and study specific covariates . When reporting results from individual studies , we will cite the measures of association and p-values reported in the studies . If appropriate for groups of studies with similar features , we will conduct meta-analyses . Conclusion A decision-maker- research er partnership provides a model for systematic review s that may foster knowledge translation and uptake Background A systematic review , with or without a meta- analysis , should be undertaken to determine if the research question of interest has already been answered before a new trial begins . There has been limited research on how systematic review s are used within the design of new trials , the aims of this study were to investigate how systematic review s of earlier trials are used in the planning and design of new r and omised trials . Methods Documentation from the application process for all r and omised trials funded by the National Institute for Health Research Health Technology Assessment ( NIHR HTA ) between 2006 and 2008 were obtained . This included the : commissioning brief ( if appropriate ) , outline application , minutes of the Board meeting in which the outline application was discussed , full application , detailed project description , referee comments , investigator response to referee comments , Board minutes on the full application and the trial protocol . Data were extracted on references to systematic review s and how any such review s had been used in the planning and design of the trial . Results 50 r and omised trials were funded by NIHR HTA during this period and documentation was available for 48 of these . The cohort was predominately individually r and omised parallel trials aim ing to detect superiority between two treatments for a single primary outcome . 37 trials ( 77.1 % ) referenced a systematic review within the application and 20 of these ( i.e. 41.7 % of the total ) used information contained in the systematic review in the design or planning of the new trial . The main areas in which systematic review s were used were in the selection or definition of an outcome to be measured in the trial ( 7 of 37 , 18.9 % ) , the sample size calculation ( 7 , 18.9 % ) , the duration of follow up ( 8 , 21.6 % ) and the approach to describing adverse events ( 9 , 24.3 % ) . Boards did not comment on the presence/absence or use of systematic review s in any application . Conclusions Systematic review s were referenced in most funded applications but just over half of these used the review to inform the design . There is an expectation from funders that applicants will use a systematic review to justify the need for a new trial but no expectation regarding further use of a systematic review to aid planning and design of the trial . Guidelines for applicants and funders should be developed to promote the use of systematic review s in the design and planning of r and omised trials , to optimise delivery of new studies informed by the most up-to- date evidence base and to minimise waste in research The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care .  Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice s is likely to be particularly useful . 8 The problem of unpublished or incompletely published trials remains difficult . A prerequisite for any solution is that the widespread practice of underreporting the results of well conducted trials should be seen for what it is-namely , scientific misconduct.'9 Clearly , the resolution of the problem ofunderreporting lies mainly in the h and s ofinvestigators and those who fund and enable their research . 12 - 14 20 If research ers , funding bodies , and research ethics committees are to take properly informed decisions about proposals for new research they need both the results of systematic review s and information about trials that are currently recruiting patients . In this way , inadvertent and unnecessary duplication of research ( as distinct from planned and appropriate replication ) can be reduced . Reasonably complete ascertainment of all trials seems likely only through some form of m and atory registration of studies at the time they are started.2'22 Although several registries exist,2425 most remain incomplete because they depend on voluntary notification . Funding agencies and ethics committees should require the registration and publication of trials that they have supported and approved . Encouraging signs exist in several countries ofan interest in establishing systems for registering r and omised controlled trials at their inception , and there is certainly scope for collaboration.25 Within Britain the information systems strategy being developed by the NHS 's research and development programme , the registration of cancer trials fostered by the United Kingdom Coordinating Committee for Cancer Research , and the Medical Research Council 's inventory of controlled trials together provide a useful basis for developing systems to ensure that information about current r and omised controlled trials is assembled more efficiently . As Archie Cochrane pointed out many years ago , failing to conduct systematic , up to date review s of controlled trials of health care may result in substantial adverse consequencesfor patients , practitioners , the health services , research ers , and research funding bodies . Reliable and informative review s depend on identifying as many relevant studies as possible . Achieving this should be possible by registering trials at their inception , minimising underreporting of trials , improving descriptions of research methods in reports of trials , and better indexing in data bases of completed and current research . IAIN Background Growing evidence suggests that childhood and adolescence self-regulation contributes to multiple health , educational and social outcomes . Considering the potential impact of self-regulation skills on improved life chances in conjunction with evidence suggesting that self-regulation can be modified by interventions , there is a need to identify interventions which are most effective in improving childhood and adolescence self-regulation . The present systematic review was design ed to determine the effectiveness of universal interventions focused on enhancing the  self-regulation of children and adolescents . As secondary outcomes , we will also examine the effectiveness of such interventions on distal health and social outcomes . Methods Eligible studies include r and omised controlled trials ( including cluster r and omised trials ) reporting on universal interventions design ed to improve self-regulation in childhood and adolescence ( age 0–19 years ) . The following data bases will be search ed for peer- review ed publications using an iterative search strategy : Medline , PsycINFO , EMBASE , ERIC , CINAHL Plus , British Education Index , Child Development & Adolescent Studies and CENTRAL without applying language or date filters . Additionally , reference lists and citations of included studies will be search ed for eligible studies . A 10 % proportion of the total titles and abstract s will be r and omly selected and screened independently by two review ers ( AP and DH ) . Results will be compared to ensure less than 5 % discrepancy , followed by screening of all results by one review er ( AP ) . Full-text review and data collection will be independently performed by two review ers . Any discrepancies will be solved by mutual discussion , and if unresolved , a third review er ( RV ) will be consulted . Meta- analysis will be conducted to quantify trial effects , if the data is sufficiently homogenous to allow quantitative synthesis . Otherwise , results will be described narratively . Discussion The evidence derived from the systematic review will strengthen the evidence base to inform planning of effective interventions targeting self-regulation skills in childhood and adolescence . This will benefit policy makers , academicians , research ers , health professionals , and also , young people who will benefit from policy and interventions informed by this review . Systematic review registration CRD42016047661 Join the dialogue on health care reform . Comment on the perspectives published in Annals and offer ideas of your own . All thoughtful voices should be heard . On 30 June 2009 , another milestone was achieved in progress toward a national system to promote medical research that focuses on decision making by physicians and patients . The first steps occurred in late 2007 and early 2008 with a seminal article ( 1 ) and an Institute of Medicine ( IOM ) report that called for a national initiative of research that would support better decision making about interventions in health care ( 2 ) . One of us was a coeditor of the IOM report . A third milestone was reached when both presidential c and i date s endorsed this concept . A fourth milestone came when the president signed into law the American Recovery and Reinvestment Act of 2009 ( ARRA ) ; this act allotted $ 1.1 billion to support this form of research , which had become known as comparative effectiveness research ( CER ) . The legislation created a federal council on CER and asked the IOM to elicit input from a broad array of stakeholders on which research topics should have the highest-priority for funding through the ARRA and to then develop a list of the highest-priority topics for the Secretary of Health and Human Services to consider . By law , the Federal Coordinating Council and the IOM committee to set priorities for comparative effectiveness research reported to the Secretary on 30 June 2009 . This issue contains both this article , which is a commentary on the IOM committee report ( 3 ) by the committee 's cochairs , and a perspective on better research methods for CER ( 4 ) . Definition of CER The IOM committee quickly settled on a working definition of CER , which consisted of the elements of earlier definitions reduced to 2 sentences : CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent , diagnose , treat and monitor a clinical condition , or to improve the delivery of care . The purpose of CER is to assist consumers , clinicians , purchasers , and policy makers to make informed decisions that will improve health care at both the individual and population levels . Two key elements that are embedded in this definition are the direct comparison of effective interventions and their study in patients who are typical of day-to-day clinical care . These features would ensure that the research would provide information that decision makers need to know , as would a third feature , research design ed to identify the clinical characteristics that predict which intervention would be most successful in an individual patient . The same research design would also help policymakers by identifying sub population s of patients that are more likely to benefit from one intervention than the other . High-Priority Research Topics The IOM committee sought advice from a broad range of stakeholders and received it in 3 forms : approximately 90 letters ; 54 oral presentations at a day-long hearing in Washington , DC ; and a Web-based nomination form . Overall , the committee received more than 2606 nominations from 1758 individual responders within 3 weeks . In a 3-step voting process , the committee identified 100 high-priority topics , which it ranked in quartiles . At each stage , the committee sought to have a balanced portfolio of topics . Table 5 - 1 in the report ( available at www.iom.edu/cerpriorities ) lists the 100 highest-ranked topics . Establishing a Sustainable National Program of CER The U.S. Congress is currently debating legislation that would guarantee health insurance to more Americans while reforming the U.S. health system . A key aim of the legislation is to moderate the rate at which the cost of health care increases while improving the quality of care . Many leaders believe that reaching this goal will require a sustained effort to produce better evidence to inform decision making . Government officials have characterized the $ 1.1 billion allocated to CER as a down payment on a national program of CER . As of this writing , the House of Representatives bill proposes a national program of CER , and the Senate Finance Committee white paper does likewise . Accordingly , the IOM committee made several recommendations aim ed at a sustainable , trustworthy national CER initiative . The Appendix provides the full text of these recommendations . Governance The 2008 IOM committee recommended establishing a national program with authority , overarching responsibility , sustained re sources , and adequate capacity to ensure production of credible , unbiased information about what is known and what is not known about clinical effectiveness ( 2 ) . The current committee exp and ed this recommendation by calling upon the secretary of the Department of Health and Human Services to establish a mechanismsuch as a coordinating advisory bodywith the authority to strategize , organize , monitor , evaluate , and report on the implementation and impact of the CER Program . The committee recognized that many agencies of the federal government are engaged in research that fits some or all of the key elements of CER . To make the best use of the funds allocated for CER , these agencies should be jointly accountable for spending CER funds on research that reflects the same conceptualization of CER . Therefore , these disparate efforts should use a single definition of CER and the same definitions of outcomes and measures of function and illness . This form of cross-agency coordination is compatible with each agency focusing on the form of research with which it has the greatest experience . Active Involvement of Consumers in CER The 2009 ARRA created a means for coordinating federal CER efforts : the Federal Coordinating Council . Seeking to complement the functions of the Council , the IOM committee focused on the potential contribution of consumers of health care to CER and recommended involving them at all levels of the national CER initiative . The recommendation is as follows : The CER Program should fully involve consumers , patients and their caregivers in key aspects of CER , including strategic planning , priority setting , research proposal development , peer review , and dissemination . The concept that animates this recommendation is a radical but logical departure from past practice : When a principal aim of research is to inform decision makers , listen to the decision makers . Meaningful participation will require consumers to learn more about research , just as they will teach research ers about how to frame their investigations to satisfy the needs of consumers who are also decision makers . This approach has precedent . For example , the National Institute for Health and Clinical Effectiveness in the United Kingdom teaches decision making to consumers who participate in the institute 's program . Methodology of CER Remembering that the purpose of CER is to inform decision making , consider the principal forms of clinical research . Systematic review s of the literature summarize a body of evidence . Over the past 2 decades , they have become indispensable to expert panels that formulate practice guidelines or policymakers who make insurance coverage decisions . These macro decision makers are starting to use decision models for the same purpose s ( 5 ) . Two broad categories of research are the starting point for systematic review s : observational research and r and omized trials . Large established data bases provide an opportunity to link current health care practice s to the outcome of care . These data bases are representative of critical groups often omitted from r and omized trials , but they contain limited data ; of note , they seldom specify the rationale for medical decisions . These observational research methods have many advantagesspeed , real-world decisions , large numbers of decisions and outcomes , and low costbut they can not escape a key limitation : Characteristics of the patient that drive real-life clinical decisions may also influence clinical outcomes , leading to uncertainty about whether they or the intervention itself causes the outcomes . Overcoming the limitations of observational research is the most important frontier of research on study methods . To overcome these limitations , research ers often r and omly assign patients to different interventions . This simple action eliminates much of the uncertainty that plagues the interpretation of observational research . However , we have too often used the conceptual elegance of r and omization to answer the wrong questions . We ask , Does this work ? when our readers want to know , Is this better than that ? Thus , too often , r and omized trials are so-called efficacy studies : They are design ed to create near-ideal circumstances to see whether the intervention can possibly work . To this end , research ers exclude many types of patients from efficacy trials and often compare the intervention with a placebo . In these respects , efficacy trials are unlike the conditions that physicians and patients face in daily practice . Another article in this issue ( 4 ) describes several exciting new methods for making r and omized trials more suitable for CER . The examples of observational research and new r and omized trial methods are the basis for the IOM committee 's strong recommendation that a national CER program should support research in the methods of clinical research . The Infrastructure for Observational Research The committee believes that very large collection s of the electronic records of patients can be a valuable re source for CER . Using these data sets , it is possible to compare the outcomes of using several effective interventions in a population that is representative of daily care , 2 features that are aligned with the goals of CER . The great numbers of patients in these data sets also makes it possible to study subgroups with precision and perhaps identify key predictors of response to an intervention , both of which would facilitate decision making at the individual and population
No single vali date d outcome measure encompassed all potential patient benefits from using a CGS .
A variety of different domains were identified , including anxiety and depression , coping , decision-making , distress , family environment , health status , knowledge , mood , perception of risk , perceived personal control , psychological impact , quality of life , satisfaction and expectations , self-esteem , spiritual well-being , and worry .
Some important aspects of patient benefit from CGS are not covered by existing outcome measures .
OBJECTIVE This systematic review aim ed to inform research ers and policymakers about what vali date d outcome measures are available to evaluate clinical genetics services ( CGS ) and the need for new measures .