More Informative Abstracts of Articles Describing Clinical Practice Guidelines Methods for Development of the European Commission Initiative on Breast Cancer Guidelines Management of Depression in Patients With Cancer: A Clinical Practice Guideline. Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Vitamin D World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Prebiotics World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Probiotics American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003. The Melbourne Family Support Program: evidence-based strategies that prepare family caregivers for supporting palliative care patients Consensus guidelines for the promotion and management of continence by primary health care teams: development, implementation and evaluation. NHS Executive Nursing Directorate. Developing and evaluating communication strategies to support informed decisions and practice based on evidence (DECIDE): protocol and preliminary results Evidence-based clinical practice guideline for the evaluation of potentially malignant disorders in the oral cavity: A report of the American Dental Association. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians Protocol for CONSORT-SPI: an extension for social and psychological interventions Developing guided self-help for depression using the Medical Research Council complex interventions framework: a description of the modelling phase and results of an exploratory randomised controlled trial Developing ‘high impact’ guideline-based quality indicators for UK primary care: a multi-stage consensus process Improving Adherence to Dementia Guidelines through Education and Opinion Leaders
Patients hope that their doctors will correctly identify health problems , clearly articulate sensible options for managing each problem , wisely interpret the best available evidence about probable outcomes associated with each option , sensitively solicit patient preferences for each outcome , and thereby implement practice s that are likely to achieve the results patients care about . Groups of patients hope that doctors will work to prevent , detect , and treat health problems in a way that maximizes the public good achieved with available health care re sources . To meet these dual expectations , doctors face forbidding tasks of clinical decision making . Improved methods for preparing , appraising , and abstract ing overviews of available evidence about a clinical topic can bring a broader range of high- quality information within the busy practitioner 's grasp [ 1 - 4 ] . However , even well- design ed overviews often do not synthesize information about benefits , harms , and costs of medical practice s in a way that facilitates clinical decision making . Clinical practice guidelines have been defined as systematic ally developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances [ 5 ] . Guidelines that are based on sound scientific evidence , and a trustworthy process for judging the value of alternative practice s , could help physicians deal with the information overload they face . Existing practice guidelines , however , vary widely in their quality , and clinicians should carefully consider the validity and applicability of each guideline they read . We propose a structured format for abstract s of articles describing practice guidelines that is based on emerging principles of guideline development and evaluation [ 6 - 13 ] . The proposal is design ed to help readers obtain the key information needed to assess the applicability , importance , and validity of any guideline . The proposed structure for more informative abstract s of articles describing clinical practice guidelines has been review ed and pilot-tested by guideline developers , evaluators , and implementors and by groups of practicing clinicians . Early versions of the proposal were sent to consultants at the National Library of Medicine , the Institute of Medicine , the American College of Physicians ( ACP ) , and the Agency for Health Care Policy and Research . Subsequent versions of the proposal were pilot tested on various published guidelines and were assessed by selected health care organizations for applicability to guidelines under development . An improved proposal was sent to 82 persons active in guideline development , evaluation , and implementation . The Internal Medicine Center to Advance Research and Education circulated the proposal to volunteer practitioners , and the authors solicited feedback from physician and health administrator participants at three national workshops about practice guidelines . The proposal that follows represents an integration of the collective wisdom of our external review ers . ( A glossary of terms used in articles on clinical practice guidelines is supplied in the Appendix . ) Proposed Structure and Content for Abstract s of Articles Describing Clinical Practice Guidelines The proposed structure for abstract s of papers describing clinical practice guidelines is summarized in Table 1 . Key elements of the guideline development process are captured with statements about the principal objective and target of the guideline , the main practice options and outcomes that were considered , the nature of the evidence and values that were analyzed , the main benefits and harms expected from guideline implementation , the key recommendations , and a statement of whether the recommendations have been tested and by whom they have been endorsed . If details about guideline development methods or supporting evidence are published separately , then the abstract should indicate the existence of supporting documents and the most relevant parts of those should be summarized in the abstract . To be included in their entirety in the online bibliographic data bases of the National Library of Medicine , structured abstract s of clinical practice guidelines should not exceed 4096 characters ( approximately 500 words ) in length . Individual journals may have different requirements . Table 1 . Proposed Format for Structured Abstract s of Clinical Practice Guidelines Objective The abstract should state the objective of the guideline by identifying the targeted health problem , the targeted patients and physicians , and the main reason or reasons for developing new recommendations concerning this problem for this population . For guidelines primarily concerned with the management of health conditions , the stage of illness and intent to prevent , diagnose , treat , or palliate the disorder should be specified . For guidelines primarily concerned with health procedures , an intervention and its role in patient management should be defined . Targeted providers , setting s , and patients should be specified so that readers can tell who should do what , where it should be done , and to whom . A statement of objective also may specify why a new guideline is needed and how it should be used . Practice guidelines may be written to clarify or resolve clinical controversies , to communicate important new findings from clinical studies , or to promote more effective , efficient , or consistent physician practice s at less cost or risk to patients . Guidelines may be used concurrently to help physicians and patients make choices ( for example , clinical algorithms ) , retrospectively to compare physician choices to pre-established criteria ( for example , utilization review ) , or prospect ively to set limits on physician choices ( for example , preprocedure approval ) . Options Clinical practice guidelines pertain to clinical decisions . The nature of those decisions should be made explicit by disclosing the main management options considered . The abstract should list principal alternative preventive , diagnostic , or therapeutic strategies available to targeted clinicians and patients . Outcomes The abstract also should specify which health outcomes , such as death , morbidity , quality of life , economic costs , or changes in the process of health care were considered . Evidence To estimate the probable effect of a health intervention on an outcome , relevant data must be defined , gathered , and appraised . Readers need to know what kind of evidence was considered and what methods were used to select and combine evidence from different sources . Potential sources of evidence about clinical outcomes include the results of clinical studies ( published or unpublished ) , expert opinion , information contained in public or private health data bases , and direct input from patients or providers . Potential sources of evidence about economic outcomes include the results of cost-effectiveness studies , various fee schedules , and information contained in public or private health cl aims data bases . Potential methods of gathering evidence include computerized search es for articles that satisfy predetermined criteria , review s of bibliographies of relevant articles , and surveys of relevant persons or organizations [ 1 ] . The abstract should state whether explicit methods were used to combine results from scientific studies ( for example , meta- analysis ) or opinions of experts ( for example , Delphi technique ) [ 14 , 15 ] . The abstract may also indicate whether specific criteria were used to gauge the quality of information from different sources [ 16 , 17 ] . Scientific evidence regarding the likelihood of certain outcomes is often missing or conflicting . It is desirable for the strength of evidence supporting a guideline to be gauged in some way [ 16 ] . If gaps in the evidence were bridged formally ( for example , through use of decision- analysis models ) or informally ( for example , best guess of clinical experts ) , then major assumptions or areas of uncertainty should be acknowledged [ 11 ] . Because of the extraordinary time required to properly assemble and review evidence and then to achieve consensus about practice recommendations , the abstract of a practice guideline should specify the publication date s of the most recent evidence considered . If a sensitivity analysis was performed , then any major vulnerability of the guideline to weaknesses in the evidence should be acknowledged . These considerations may be summarized by qualifying a guideline as provisional by specifying date s for expiration or review , by listing studies in progress that could affect the guideline , or by identifying key research priorities . Values The declaration of a recommended practice presumes an implicit or explicit process for judging the relative desirability of the health , economic , and process outcomes associated with alternative practice s. These are matters of opinion and value . For example , in developing guidelines for breast cancer screening , it is necessary to weigh the value of preventing a death from breast cancer against the value of avoiding unnecessary harm or anxiety in women who do not have breast cancer . A high value placed on maximizing detection of asymptomatic malignancy may motivate an organization to recommend teaching self-examination of breasts to young women [ 18 ] . A relatively greater value placed on avoiding false-positive results may motivate others to not promote such programs [ 19 ] . Consequently , the principal sources of such values and the method by which judgments were made should be reported in guideline abstract s. At a minimum , the abstract should identify the major groups that participated in the process of assigning values to outcomes ( for example , generalist or specialist physicians , other health care providers , insurers , representatives of health organizations , and special-interest groups ) and whether patient preferences were represented . The abstract may also indicate the method used to synthesize opinions from In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from PURPOSE This report up date s the Cancer Care Ontario Program in Evidence -Based Care guideline for the management of  depression in adult patients with cancer . This guideline covers pharmacologic , psychological , and collaborative care interventions , with a focus on integrating practical management tools to assist clinicians in delivering appropriate treatments for depression in patients with cancer . METHODS Recommendations were developed by synthesizing information from extant guidelines and review s and search ing for r and omized controlled trials from the date of data base inception ( 1964 for MEDLINE and 1974 for EMBASE ) to January 2015 . Quality assessment of guidelines and systematic review s were conducted by using the Appraisal of Guidelines for Research and Evaluation II ( AGREE II ) , Assessment of Multiple Systematic Review s ( AMSTAR ) , and Cochrane Risk of Bias tools . Final recommendations were developed through a st and ardized Program in Evidence -Based Care multidisciplinary expert and knowledge user review process . RESULTS Two high- quality relevant clinical practice guidelines , eight pharmacologic trials , nine psychological trials , and eight collaborative care intervention trials composed the evidence base upon which the recommendations were developed . Eight specific recommendations were made to establish a st and ard of care for the management of depression in patients with cancer . The recommendations and practical management tools were review ed as being well organized and helpful , although systemic barriers to implementation were identified . CONCLUSION This up date d guideline supports the previous general recommendation that patients with cancer who have depression may benefit from psychological and /or pharmacologic interventions , without evidence for the superiority of any specific treatment over another . New recommendations for a collaborative care model that incorporates a stepped care approach suggest that multidisciplinary mental health care restructuring may be required for optimal management of depression Diabetes is the leading cause of major complications , such as end-stage renal disease and lower extremity amputations , and is a significant contributor to ischemic heart disease , stroke , peripheral vascular disease , and vision loss ( 1 ) . There has been increasing acceptance of the importance of individualizing glycemic management and assessment of risk for adverse events , especially hypoglycemia ( 26 ) . This is of great importance for all patients , especially older adults ( aged 65 years ) with comorbid conditions . In 2013 , 12.0 million older adults in the United States had diabetes , comprising 40 % of the 30.2 million persons with the disease ( 7 ) . Older adults account for an estimated 60 % to 70 % of the U.S. Department of Veterans Affairs ( VA ) and U.S. Department of Defense ( DoD ) diabetic population ( largely retirees ) ( VA/DoD. Unpublished data ) . These considerations make safe and effective diabetes management a policy priority for health care providers ( physicians , nurses , dietitians , and pharmacists ) and policymakers in both the VA and the DoD. The 2017 VA/DoD Clinical Practice Guideline ( CPG ) for the Management of Type 2 Diabetes Mellitus in Primary Care offers health care providers an evidence -based framework to evaluate , treat , and manage persons with type 2 diabetes  mellitus in the context of their individual needs and preferences ( 8) . The current article is a summary of key CPG recommendations , which was developed with multiple stakeholders to ensure representation by a broad spectrum of clinicians . It provides practice recommendations for the care of patients with diabetes , with an emphasis on shared decision making . Guideline Development and Review Process These recommendations were developed using methods established by the VA/DoD Evidence -Based Practice Work Group ( EBPWG ) ( 9 ) , which are aligned with st and ards for trustworthy guidelines ( 10 ) . The EBPWG and the U.S. Army Medical Comm and selected guideline panel cochairs ( 1 each from the VA and the DoD ) . The cochairs then selected a multidisciplinary panel of practicing clinician stakeholders , including primary care physicians ( family and internal medicine ) , endocrinologists , medical nutritionists , pharmacists , diabetes educators , and nurse practitioners . At the start of the CPG development process and at other key points throughout , all members were required to su bmi t disclosure statements for potential conflicts of interest in the previous 24 months . Verbal affirmations of no conflicts were used during meetings throughout the development process . The project team was also subject to r and om Web-based surveillance ( for example , ProPublica ) . The VA/DoD contracted with The Lewin Group , a third party with expertise in clinical practice guideline development , to facilitate meetings . The guideline panel , in collaboration with the ECRI Institute , developed 9 key questions using the PICOTS ( population , intervention , comparator , outcomes , timing of outcomes measurement , and setting ) format . A systematic search of the peer- review ed literature from January 2009 through March 2016 was conducted to find evidence relevant to the key questions that focused on r and omized trials , systematic review s , and meta-analyses of fair or better quality . One key question was up date d through 14 June 2016 . The search methods and results are detailed in the full guideline ( 8) . The guideline panel rated recommendations by using the GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) method ( 11 ) . The guideline panel focused on developing new and up date d recommendations using the evidence review for the key questions . The panel also considered , without a complete review of the relevant evidence , the current applicability of recommendations that were included in the 2010 CPG . As part of the development process , a patient focus group was also convened to better underst and the perspectives of patients receiving diabetes treatment in the VA and the DoD. Five patients were included , consistent with the requirements of the federal Paperwork Reduction Act . All patients had type 2 diabetes and were veterans receiving care in the VA . The focus group explored knowledge of treatment options , views on the delivery of care , patients ' needs and preferences , and the effect of diabetes on their lives . Important concepts that emerged from the focus group were shared with the panel and informed guideline development . It was acknowledged that this convenience sample may not be representative of all VA and DoD patients receiving treatment for type 2 diabetes . The draft guideline was sent to more than 15 expert review ers inside and outside the federal sector . Comments were review ed and , where appropriate , were incorporated into the final guideline based on panel consensus . The VA/DoD EBPWG approved the final document on 3 April 2017 and released it on 17 April 2017 . Recommendations are presented in the Table , and an algorithm for establishing a personalized glycemic goal and treatment plan is presented in the Figure . Key recommendations are review ed in this article . Table . Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus Figure . Algorithmic approach to evaluating glycemic control risk factors , setting a personalized glycemic control target range , providing self-management ( including lifestyle and nutrition ) education , and initiating or reevaluating medication therapy . Recommendations Provide Patient-Centered Care and Incorporate Shared Decision Making The CPG strongly encourages clinicians to incorporate shared decision making and partner with their patients . Shared decision making is the process by which the patient and family , in conjunction with the care provider , reach an agreement about a plan of care and treatment . Key principles include readiness of the patient and family , tools with underst and able information about the benefits and harms of all options , and strategies to identify and incorporate patient preferences . Patients can not effectively participate in care and shared decision making unless they underst and diabetes and how they can be involved in planning and carrying out the jointly developed care plan . Shared decision making reinforces a trusted therapeutic relationship and increases patient satisfaction and treatment buy-in with regard to the methods used to reach a particular goal or treatment plan ( 1214 ) . It should be used not only for patients with stable glycemic control but also to assist those who are not able or willing to make lifestyle changes and decisions that affect their diabetes at any time during the course of treatment . At a minimum , shared decision making should be included at the time of diagnosis , during difficulties with management , and at times of transition or development of complications ( 14 ) . Benefits include greater knowledge of medications ( 13 ) and underst and ing of risks ( 14 ) . In addition , patient-centered care and shared decision making together may decrease patient anxiety , increase trust in clinicians ( 15 ) , and improve treatment adherence ( 16 ) . Family involvement should be considered if appropriate , especially in older adults ( 17 ) . Patient information should be culturally appropriate ; underst and able and actionable by people with limited literacy skills ; and accessible to those with physical , sensory , or learning needs ( 18 ) . As part of the patient-centered care approach to diabetes management , clinicians should explore with the patient the outcomes of previous opportunities for shared decision making , their ability to self-manage , prior efforts to change health behaviors , past treatment experiences ( including reasons for discontinuing treatment ) , and relevant clinical outcomes . In actively sharing decisions , they should involve the patient in prioritizing problems to be addressed and setting specific goals regardless of the setting or level of care . Assess Patient Characteristics and Nonglycemic Factors When Interpreting Results of Hemoglobin A1c , Fructosamine , and Other Glycemic Biomarker Testing Many factors affect measurement of hemoglobin A1c ( HbA1c ) besides the level of glycemia ( 19 ) . Because HbA1c level depends on the duration of erythrocyte exposure to glucose , conditions that alter erythrocyte life span affect the measured level of HbA1c ( 20 , 21 ) . Iron deficiency anemia , which prolongs erythrocyte life span and exposes the cell to glucose for a longer period , is associated with falsely elevated HbA1c levels ( 22 ) . In contrast , conditions that shorten erythrocyte life span ( such as hemolytic anemia ) may result in falsely low HbA1c levels . Various other conditions , such as chronic kidney disease , may alter HbA1c measurement . Hemoglobin variants can result in falsely elevated or falsely lowered HbA1c levels , depending on the assay used ( 2325 ) . In addition , oral hypoglycemic agents ( metformin or sulfonylureas ) may alter the relationship between blood glucose and HbA1c levels , although the clinical significance is unclear ( 26 ) . There are also racial/ethnic differences in HbA1c levels for a given level of glycemia . A previous study found that African Americans with prediabetes ( 27 ) had HbA1c values that were 0.4 % higher than among white persons ; those who were within 3 years of diagnosis ( 28 ) also had higher HbA1c values than white persons for any measure of glycemia . This difference can not be explained by measured differences in glycemia , clinical factors known to affect HbA1c measurement , or sociodemographic factors ( 27 , 28 ) . Therefore , it is recommended that a new diagnosis of diabetes be based on a confirmatory fasting blood glucose level of at least 7.0 mmol/L ( 126 mg/dL ) if the initial HbA1c value is 6.5 % to 6.9 % . How and where the HbA1c level is measured can also affect results because of intralaboratory variation ( variation in test accuracy and precision ) and interlaboratory variation ( variation related to use of different test methods ) . A single HbA1c measurement , even from a OBJECTIVES To review UK guidelines regarding the use of financial incentives for healthcare professionals to become involved in clinical trials , and to survey perceptions and current practice . DATA SOURCES Electronic data bases were search ed from inception to June 2006 . Interviews were held with NHS healthcare professionals , research managers from the pharmaceutical industry and members of the public . REVIEW METHODS From the search es , 634 identified studies were assessed for inclusion in the systematic review , but only three met the criteria for data extraction . Fifty-eight individuals were interviewed : 38 chief investigators , six non- research active clinicians , eight public and six pharmaceutical managers . Investigators were selected from those funded by the HTA Programme , the other by ' snowballing ' and personal contact . RESULTS The evidence from the literature was limited and inconclusive . In UK guidelines , the issues around payments to clinicians or patients were implied rather than stated , usually linked to discussion of conflict of interest and disclosure of any such conflicts . Developments in NHS research governance had led to increased transparency in all payments for research participation and for payments to be made to NHS Trusts rather than individual clinicians . While reimbursement of costs incurred by research was strongly supported by the interviewees , payments to incentivise recruitment were not . A code of practice was suggested for payments in publicly funded trials , which was closely linked to the principles of Good Clinical Practice in research . Factors such as interest in the topic , scope for patient benefit and good communication were considered more important than payment . Interviews with the general public indicated low levels of awareness of the existence of payments to clinicians linked to patient recruitment in trials , and unanimous support for full disclosure . Interviews with managers in the pharmaceutical industry showed greater familiarity with payments for research involvement . GPs were seen as the only group for whom scope existed for individual payments . Concerns were expressed by the pharmaceutical company interviewees at the rising cost of research and unnecessary bureaucracy . CONCLUSIONS The ethical stances outlined in Good Clinical Practice in research were widely endorsed by the three groups interviewed . These allow reasonable payments to clinicians , subject to disclosure of any possible conflicts of interest . The potential for incentivising clinicians to recruit was limited as any payments should be based on the cost of inputs and should not be made to individuals but to their host organisation . NHS professionals were concerned that payments could damage the quality of research and also considered full disclosure to patients as challenging . Patients and members of the public favoured full disclosure and payment of expenses to patients involved in research . Pharmaceutical company interviewees viewed payment to the NHS for all research activities as normal and highly regulated . They complained that the prices charged were high and so variable that they required benchmarking . Considerable scope exists for compiling data on the factors that help and hinder the progress of clinical trials and also for experimenting with different incentives to encourage involvement in clinical research . Further research should focus on improved reporting of those organisational aspects of trials that are known to affect recruitment ; retrospective analysis of the factors associated with different levels of recruitment to RCTs ; prospect i ve comparative research on trial recruitment ; qualitative research on participants ' experiences of being involved in different kinds of trials , and proposals to include within trials experiments with payments methods Breast cancer is the most common cancer type in women and the fourth leading cause of cancer death in the United States ( 1 ) . The goal of screening is to reduce morbidity and mortality , both specific to breast cancer and overall , with acceptable tradeoffs ( 2 , 3 ) . The most commonly used screening test is mammography . Recommended strategies vary for breast cancer screening in average-risk women . Ages to start and discontinue mammography , screening intervals , the role of imaging methods other than mammography , and the role of clinical breast examination ( CBE ) have been points of disagreement among guideline developers . Purpose and Target Population The goal of this American College of Physicians ( ACP ) guidance statement is to critically review selected guidelines from around the world and their included evidence to assist clinicians in making decisions about breast cancer screening in asymptomatic women with average risk for breast cancer . Included screening methods are CBE and breast imaging ( that is , mammography , ultrasonography , magnetic resonance imaging [ MRI ] , and digital breast tomo synthesis [ DBT ] ) . This guidance statement does not address breast self-examination because no evaluated guideline recommends it for screening . The target population for this guidance statement is women with average risk for breast cancer . The target audience is all clinicians . Age is the single most important risk factor for breast cancer . Included guidelines generally define average-risk women as those who do not have a personal history of breast cancer or a previous diagnosis of a high-risk breast lesion , are not at high risk for breast cancer due to genetic mutations known to increase that risk ( such as BRCA1/2 gene mutation or another familial breast cancer syndrome ) , and were not exposed to radiation therapy to the chest in childhood ( 4 , 5 ) . However , definitions of average risk vary among guidelines . In addition , although risk factors ( including early menarche , late menopausal onset , oral contraceptive or menopausal hormone therapy , increased breast density on mammography , and a family member with a history of postmenopausal breast cancer ) may put a woman at greater risk for breast cancer than women without these factors , the evaluated guidelines generally include women with these factors under the umbrella of average risk . Therefore , our guidance statement applies to these women . Guidelines vary somewhat in target population s and screening methods addressed ( Table [ 411 ] and Appendix ) . Both the U.S. Preventive Services Task Force ( USPSTF ) and the World Health Organization ( WHO ) include women with dense breasts and those with a single family member with breast cancer in their guideline 's target population ( 5 , 6 ) . The Canadian Task Force on Preventive Health Care ( CTFPHC ) guideline also includes women with dense breasts ; however , it explicitly mentions that women with a first-degree relative with breast cancer are considered to be at increased risk and are thus excluded from the guideline ( 7 ) . Table . Summary of Included Recommendations in Assessed Guidelines for Breast Cancer Screening of Average-Risk Women Methods The ACP Clinical Guidelines Committee develops guidance statements on topics where several conflicting guidelines are available . Guidance statements rely on evidence presented or referenced in selected guidelines and accompanying evidence reports ; they do not include de novo review s or search es of the literature outside the body of evidence referenced by the guidelines . The goal of ACP guidance statements is to provide clinicians with a rigorous review of the available guidelines and their included evidence and to develop subsequent guidance based on an assessment of the benefits and harms reported by each guideline and its evidence . Unlike ACP guidelines , guidance statements are not derived from a systematic evidence review and hence do not use GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) ( 12 ) to assess the quality of evidence or strength of recommendations . Data Sources and Guideline Selection We search ed the National Guideline Clearinghouse and the Guidelines International Network library for breast cancer screening guidelines from national organizations that addressed breast imaging ( that is , mammography , ultrasonography , MRI , or DBT ) and CBE in women and were published in English between 1 January 2013 and 15 November 2017 . We search ed Web sites housing the selected guidelines for up date s on 10 December 2018 . We excluded guidelines that addressed specific population s ( such as pregnant women and women at increased risk for breast cancer ) or were more than 5 years old ( thus considered inactive ) . We also excluded guidelines that directly endorsed another guideline , such as that of the American Academy of Family Physicians , which endorsed the USPSTF guideline . Our search yielded 3 guidelines , from the American College of Radiology ( published in 2017 ; literature search end date , February 2016 ) ( 9 ) , American Cancer Society ( ACS ) ( published in 2015 ; literature search end date , March 2014 ) ( 4 ) , and USPSTF ( published in 2016 ; literature search end date , June 2015 ) ( 5 ) . We also selected 3 guidelines not identified in either data base but commonly used in clinical practice , from the National Comprehensive Cancer Network ( NCCN ) ( published in 2018 ; literature search end date not reported ) ( 10 ) , WHO ( published in 2014 ; literature search end date , December 2012 ) ( 6 ) , and American College of Obstetricians and Gynecologists ( published in 2017 ; literature search end date not applicable ) ( 8) . In addition , we selected the CTFPHC guideline , which was up date d after our initial search ( published in 2018 ; literature search end date , January 2017 ) ( 7 ) . The American College of Obstetricians and Gynecologists guideline was based on guidelines from the ACS , NCCN , and USPSTF and supporting evidence review s. Critical Appraisal Five co authors independently review ed , assessed , and scored each guideline using the AGREE II ( Appraisal of Guidelines for Research and Evaluation II ) instrument ( 13 , 14 ) ( Appendix Table 1 ) . Appendix Table 1 . Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment Clinician Peer Review The guidance statement was peer- review ed through Annals of Internal Medicine and by ACP Regents and Governors , who represent ACP members at the regional and international level . Public Member Review The development process for the guidance statement included participation by public members ( 2 of the Clinical Guidelines Committee and 7 of ACP 's Public Panel ) to share their perspectives , values , and preferences . Critical Appraisal of Evaluated Guidelines The major difference between high- and low-scoring guidelines ( Appendix Table 1 ) was methodology . Guidelines from ACS ( 4 ) , CTFPHC ( 7 ) , USPSTF ( 5 ) , and WHO ( 6 ) scored highest on the AGREE II instrument , whereas those from the American College of Obstetricians and Gynecologists ( 8) , American College of Radiology ( 9 ) , and NCCN ( 10 ) scored lowest . In addition to our review of each guideline , we examined the evidence supporting the 4 that scored highest ( ACS , CTFPHC , USPSTF , and WHO ) . We also considered recommendations for adoption or adaptation from these 4 guidelines when developing our own guidance . Several factors were important in considering guideline quality . The ACS , CTFPHC , USPSTF , and WHO guidelines best articulated benefits , harms , and strength of the evidence and how these link to recommendations . The lower-scoring guidelines often inadequately described how they considered these factors in developing the recommendations , or they relied on lower- quality evidence . The guidelines varied in the studies they reported , weighting of observational or modeling studies relative to r and omized controlled trials ( RCTs ) , and emphasis on relative versus absolute effects . The guidelines rarely addressed the small absolute effect on breast cancer mortality ; the long lead time to any reduction in this mortality , especially in women with estimated life expectancy less than 15 to 20 years ; and the low incidence of breast cancer for women younger than 60 years . Mammography Depending on the guideline , the recommended age to discuss initiating screening is 40 years ( 4 , 5 , 8) and the recommended age to start screening ranges from 40 ( 9 , 10 ) to 45 ( 4 ) to 50 ( 58 ) years . Most guidelines agree to screen average-risk women with  mammography  between ages 50 and 74 years . However , WHO and CTFPHC recommend that screening in women aged 50 to 69 years should include shared decision making because screening is conditional on a woman 's values and preferences . For women aged 70 to 75 years , WHO recommends screening only in the context of both rigorous research and shared decision making . Other areas of disagreement include screening in women aged 40 to 49 years , screening in women aged 75 years or older , and recommended screening intervals ( Table ) . Intervals range from annual ( particularly in women aged 40 to 49 years ) to biennial or triennial . Guidelines from ACS , USPSTF , and WHO conclude that a close balance exists between screening benefits and harms for women in their 40s ( for ACS , 40 to 44 years ) and that decisions are influenced by patient preferences . The WHO guideline suggests population -based screening programs in women aged 40 to 49 years only in the context of rigorous research , monitoring , and evaluation and if shared decision-making strategies are implemented . The CTFPHC conditionally recommends against screening in women aged 40 to 49 years ( without a first-degree family history of breast cancer ) ; however , it states that some women in this age group may wish to be screened and that clinicians should engage in shared decision making with women who express interest ( Appendix ) . Appendix Table 2 summarizes the available data from the 4 guidelines with the highest AGREE II scores ( ACS , CTFPHC , USPSTF , and WHO ) . Appendix Table 2 . Summary of Evidence on Screening Background The prevalence of allergic diseases is approximately 10 % in infants whose parents and siblings do not have allergic diseases and 20–30 % in those with an allergic first-degree relative .  Vitamin D is involved in the regulation of the immune system and it may play a role in the development , severity and course of asthma and other allergic diseases . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations addressing the use of vitamin D in primary prevention of allergic diseases . Methods Our WAO guideline panel identified the most relevant clinical questions and performed a systematic review of r and omized controlled trials and non-r and omized studies ( NRS ) , specifically cohort and case-control studies , of vitamin D supplementation for the prevention of allergic diseases . We also review ed the evidence about values and preferences , and re source requirements ( up to January 2015 , with an up date on January 30 , 2016 ) . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . Results Having review ed the currently available evidence , the WAO guideline panel found no support for the hypothesis that vitamin D supplementation reduces the risk of developing allergic diseases in children . The WAO guideline panel suggest not using vitamin D in pregnant women , breastfeeding mothers , or healthy term infants as a means of preventing the development of allergic diseases . This recommendation does not apply to those mothers and infants who have other indications for prophylactic or therapeutic use of vitamin D. The panel ’s recommendations are conditional and supported by very low certainty evidence . Conclusions WAO recommendations about vitamin D supplementation for the prevention of allergic diseases support parents , clinicians and other health care professionals in their decisions whether or not to use vitamin D in preventing allergic diseases in healthy , term infants Background The prevalence of allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Prebiotics – non-digestible oligosaccharides that stimulate growth of probiotic bacteria – have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of prebiotics in the prevention of allergy . Methods The WAO guideline panel identified the most relevant clinical questions about the use of prebiotics for the prevention of allergy . We performed a systematic review of r and omized controlled trials of prebiotics , and review ed the evidence about patient values and preferences , and re source requirements ( up to January 2015 , with an up date on July 29 , 2015 ) . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . Results Based on GRADE evidence to decision frameworks , the WAO guideline panel suggests using prebiotic supplementation in not-exclusively breastfed infants and not using prebiotic supplementation in exclusively breastfed infants . Both recommendations are conditional and based on very low certainty of the evidence . We found no experimental or observational study of prebiotic supplementation  in pregnant women or in breastfeeding mothers . Thus , the WAO guideline panel chose not to provide a recommendation about prebiotic supplementation in pregnancy or during breastfeeding , at this time . Conclusions WAO recommendations about prebiotic supplementation for the prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether or not to use prebiotics for the purpose of preventing allergies in healthy , term infants Background Prevalence of  allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Probiotics have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of probiotics in the prevention of allergy . Methods We identified the most relevant clinical questions and performed a systematic review of r and omized controlled trials of probiotics for the prevention of allergy . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . We search ed for and review ed the evidence about health effects , patient values and preferences , and re source use ( up to November 2014 ) . We followed the GRADE evidence -to-decision framework to develop recommendations . Results Currently available evidence does not indicate that probiotic supplementation  reduces the risk of developing allergy in children . However , considering all critical outcomes in this context , the WAO guideline panel determined that there is a likely net benefit from using probiotics result ing primarily from prevention of eczema . The WAO guideline panel suggests : a ) using probiotics in pregnant women at high risk for having an allergic child ; b ) using probiotics in women who breastfeed infants at high risk of developing allergy ; and c ) using probiotics in infants at high risk of developing allergy . All recommendations are conditional and supported by very low quality evidence . Conclusions WAO recommendations about probiotic supplementation for prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether to use probiotics in pregnancy and during breastfeeding , and whether to give them to infants * The up date s are underlined for quick reference . INTRODUCTION A critical need exists for efficient , measurable systems of disease management that reconcile conflicts between socioeconomic responsibility and patient welfare . Clinical guidelines have become an important component of these systems because they address elements of care that are effective and that reduce the variability in our approach to patient management . The American Association of Clinical Endo-crinologists ( AACE ) 2001 Medical Guidelines for Clinical Practice for the Prevention and Management of Postmenopausal Osteoporosis address the prevention , diagnosis , and management of postmenopausal osteoporo-sis , a disorder that is recognized as a major public health problem because of its physical and socioeconomic consequences . They are intended to simplify medical decision making and to help physicians and their patients make good decisions about skeletal health and postmenopausal osteoporosis . The specific goals of these guidelines are to reduce the incidence of fractures related to osteoporosis and to achieve the highest quality of life for individual patients by using the most effective and efficient methods of diagnosis and management . In the preparation of this 2001 edition , reports in the peer- review ed literature dealing with prevention , diagnosis , and treatment of postmenopausal osteoporosis , which were published and indexed between 1996 ( the publication date of the previous edition of these guidelines ) and January 2001 , were identified by computer search , review ed , and grade d for clinical relevance and scientific merit . Although cost-effectiveness was carefully considered , variabilities in actual costs could not be accurately determined . Therefore , cost-effectiveness modeling was not undertaken . Whenever possible , recommendations were based on r and omized , prospect i ve , double-blind studies of well-defined patient population s. Studies that used the most relevant clinical endpoint , fracturing , were considered " level 1 " evidence . When level 1 evidence was not available , recommendations were based on cross-sectional studies , investigations that tested smaller or nonr and omized patient population s , or studies that tested secondary or surrogate clinical endpoints for fracture , such as bone mineral density ( BMD ) or bone turnover markers , in treated population s ( level 2 evidence ) . When stronger evidence was not available , review s , editorials , and expert opinions were used ( level 3 evidence ) . We recognize that the process of developing clinical guidelines necessarily results in a narrowing and codifica-tion of clinical choices , which can be inappropriate in some clinical situations . Because the application of objective information to the specific needs of patients is the ultimate responsibility of the practicing physician , clinical practice guidelines are not intended to be rigid or restrictive , nor Background A key component of palliative care is support for family caregivers . Although some family caregivers identify positive aspects , the impact is typically burdensome ; they are prone to physical and psychological morbidity , financial disadvantage and social isolation . Outcomes of systematic review s have highlighted the importance of investment in  family caregiver intervention research . Purpose To provide an overview of the development , evaluation and outcomes arising from of a programme of research ( The Melbourne Family Support Program ( FSP ) ) , which focused on reducing the psychosocial burden of family caregivers . Methods Developmental work involved a systematic literature review ; focus groups with family caregivers and health professionals ; and identification of a conceptual framework . Following a pilot r and omised controlled trial ( RCT ) , a programme of psychoeducational intervention studies was developed and tested ; one via RCT , the others via prepost test . Results Four psychoeducational interventions , incorporating one-to-one and group format delivery , conducted in both the home and inpatient hospital/hospice were evaluated . Statistically significant outcomes included improvements in family caregivers ’ preparedness , competence , positive emotions , more favourable levels of psychological wellbeing and a reduction in unmet needs . Internationally endorsed guidelines for the psychosocial support of family caregivers were produced and several re sources were constructed . Fifteen publications in international peer- review ed journals have arisen from this programme . Conclusions The interventions and re sources from the Melbourne FSP provide several evidence d-based and clinical ly relevant approaches that focus on reducing the psychosocial burden of the caregiving role . In several instances , however , more rigorous method ological testing is advocated A project was undertaken as part of the NHS Executive Strategy for Major Clinical Guidelines , involving the development of national clinical guidelines for the promotion and management of continence by primary health care teams , through the process of managed consensus based on scientific review . The guidelines were then implemented at one urban general practice . This article outlines the development and implementation of the guidelines and describes the study undertaken to evaluate the impact of implementation on clinical outcomes . The study involved a pre- and post-implementation postal survey of a r and om sample of 17 % of patients aged 18 years and over from the practice ( n = 1503 ) . The pre-implementation survey determined the period prevalence of incontinence , related biological data and data on the pre-implementation management of incontinence . Incontinence sufferers were invited to have their condition assessed or review ed . All sufferers who agreed to be followed-up were sent the post-implementation survey , which identified those patients who had sought help , and ascertained reasons for not seeking help . Data on the management of incontinence post-implementation were also obtained . Clinical outcomes measured pre- and post-implementation were a vali date d severity index for urinary incontinence , ( also adapted for faecal incontinence ) and perception of the incontinence as a problem . A 3-month period was allowed between pre- and post-implementation surveys . The study confirmed previous research which showed that few incontinence sufferers respond to invitations to seek help , and that help-seeking behaviour was significantly related to severity of incontinence . The guidelines did not have any positive impact on the clinical outcomes measured , although slight improvements in approaches taken by the primary health care team to the promotion and management of continence were recorded . However , the study was limited by the small sample size and short time scale . Further evaluation of the impact of the guidelines on these outcomes is therefore recommended Background Healthcare decision makers face challenges when using guidelines , including underst and ing the quality of the evidence or the values and preferences upon which recommendations are made , which are often not clear . Methods GRADE is a systematic approach towards assessing the quality of evidence and the strength of recommendations in healthcare . GRADE also gives advice on how to go from evidence to decisions . It has been developed to address the weaknesses of other grading systems and is now widely used internationally . The Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence ( DECIDE ) consortium ( http://www.decide-collaboration.eu/ ) , which includes members of the GRADE Working Group and other partners , will explore methods to ensure effective communication of evidence -based recommendations targeted at key stakeholders : healthcare professionals , policymakers , and managers , as well as patients and the general public . Surveys and interviews with guideline producers and other stakeholders will explore how presentation of the evidence could be improved to better meet their information needs . We will collect further stakeholder input from advisory groups , via consultations and user testing ; this will be done across a wide range of healthcare systems in Europe , North America , and other countries . Targeted communication strategies will be developed , evaluated in r and omized trials , refined , and assessed during the development of real guidelines . Discussion Results of the DECIDE project will improve the communication of evidence -based healthcare recommendations . Building on the work of the GRADE Working Group , DECIDE will develop and evaluate methods that address communication needs of guideline users . The project will produce strategies for communicating recommendations that have been rigorously evaluated in diverse setting s , and it will support the transfer of research into practice in healthcare systems globally BACKGROUND An expert panel convened by the American Dental Association ( ADA ) Council on Scientific Affairs and the Center for Evidence -Based Dentistry conducted a systematic review and formulated clinical recommendations to inform primary care clinicians about the potential use of adjuncts as triage tools for the evaluation of lesions , including potentially malignant disorders ( PMDs ) , in the oral cavity . TYPES OF STUDIES REVIEW ED This is an up date of the ADA 's 2010 recommendations on the early diagnosis of PMDs and oral squamous cell carcinoma . The authors conducted a systematic search of the literature in MEDLINE and Embase via Ovid and the Cochrane Central Register of Controlled Trials to identify r and omized controlled trials and diagnostic test accuracy studies . The authors used the Grading of Recommendations Assessment , Development and Evaluation approach to assess the certainty in the evidence and to move from the evidence to the decisions . RESULTS The panel formulated 1 good practice statement and 6 clinical recommendations that concluded that no available adjuncts demonstrated sufficient diagnostic test accuracy to support their routine use as triage tools during the evaluation of lesions in the oral cavity . For patients seeking care for suspicious lesions , immediate performance of a biopsy or referral to a specialist remains the single most important recommendation for clinical practice . In exceptional cases , when patients decline a biopsy or live in rural areas with limited access to care , the panel suggested that cytologic testing may be used to initiate the diagnostic process until a biopsy can be performed ( conditional recommendation , low- quality evidence ) . CONCLUSIONS AND PRACTICAL IMPLICATION S The authors urge clinicians to remain alert and take diligent action when they identify a PMD . The authors emphasize the need for counseling because patients may delay diagnosis because of anxiety and denial Diabetes mellitus is a leading cause of death in the United States and is associated with microvascular and macrovascular complications . Approximately 29.1 million persons , or 9.3 % of the U.S. population , have type 2 diabetes ( 1 ) . In 2012 , the total direct and indirect costs associated with diabetes in the United States were $ 245 billion ( 1 ) . Markedly elevated glucose levels can result in subacute symptoms , such as polyuria , polydipsia , weight loss , and dehydration . Over time , the metabolic derangements associated with diabetes may lead to vision loss , painful neuropathy or sensory loss , foot ulcers , amputations , myocardial infa rct ions , strokes , and end-stage renal disease . Lowering blood glucose may decrease risk for complications , but lowering strategies come with harms , patient burden , and costs . Blood glucose can be measured in various ways , including the hemoglobin A1c ( HbA1c ; also called glycosylated or glycated hemoglobin ) level , which approximates average blood glucose control over about 3 months . As with all laboratory tests , HbA1c measurements are associated with variability ( 2 ) and can vary further with race and ethnicity ( 35 ) . Guidelines have historically recommended initiation or intensification of pharmacologic therapy to achieve specific HbA1c targets , depending on the population in question . The ideal target that optimally balances benefits and harms remains uncertain . Guidance Statement Focus and Target Population The purpose of this American College of Physicians ( ACP ) guidance statement is to critically review the available guidelines from various organizations and the evidence included therein to assist clinicians in making decisions about targets when using pharmacologic therapy in adults with type 2 diabetes . Recent data suggesting that newer agents reduce cardiovascular morbidity and mortality in high-risk patients with type 2 diabetes have prompted calls for a fundamental shift in diabetes management . Some anticipate that treatment decisions will eventually be based more on cardiovascular risk than achievement of specific HbA1c targets , analogous to recent changes in lipid management . However , for the foreseeable future , glycemic targets will continue to influence management decisions by front-line clinicians ( 6 ) . This statement focuses on the benefits and harms of targeting lower versus higher HbA1c levels and does not cover use of specific medications outside of their use to achieve HbA1c targets . The intended audience is all clinicians , and the target population is nonpregnant adults with type 2 diabetes . Methods The Clinical Guidelines Committee ( CGC ) of ACP develops guidance statements on topics where several conflicting guidelines are available . We provide clinicians with a rigorous review of the guidelines and the evidence they include . We then adopt the clinical recommendations if we agree with their evaluation of benefits and harms or adapt them if changes are needed based on our assessment of the recommendations and evidence . Data Sources and Guideline Selection We search ed the National Guideline Clearinghouse and the Guidelines International Network library ( May 2017 ) for guidelines on recommended HbA1c targets in the treatment of type 2 diabetes in nonpregnant outpatient adults . We included guidelines that were developed by national organizations , were published in English , and targeted the correct population . We review ed titles and abstract s and excluded guidelines that were modified or adapted from other organizations or addressed specific population s ( such as pregnant women or patients with kidney disease ) . Our search yielded guidelines from the National Institute for Health and Care Excellence ( NICE ) ( 7 ) and the Institute for Clinical Systems Improvement ( ICSI ) ( 8) . On the basis of the knowledge and expertise of ACP CGC members , we also selected the following 4 guidelines not identified in either data base at the time of the search but commonly used in clinical practice : the American Association of Clinical Endocrinologists and American College of Endocrinology ( AACE/ACE ) guideline ( 9 ) , the American Diabetes Association ( ADA ) guideline ( 10 ) , the Scottish Intercollegiate Guidelines Network ( SIGN ) guideline ( 11 ) , and the U.S. Department of Veterans Affairs and Department of Defense ( VA/DoD ) guideline ( 12 ) . Quality Assessment Six co authors independently review ed and assessed each guideline using the AGREE II ( Appraisal of Guidelines for Research and Evaluation II ) instrument ( 13 ) . This instrument asks 23 questions in the following 6 domains : scope and purpose , stakeholder involvement , rigor of development , clarity of presentation , applicability , and editorial independence . The authors scored each guideline independently , and the scores were compared ( Appendix Figure and Appendix Table 1 ) . Authors then provided a summary determination of whether they would recommend this guideline for use by recording yes , no , or yes with modifications . Appendix Figure . Mean AGREE II scores for items in each domain across the 6 review ers . Each question was rated on a Likert scale with a minimum of 1 point and a maximum of 7 points . The scores were averaged for each of the 6 review ers . Error bars represent calculated st and ard deviation . AACE/ACE = American Association of Clinical Endocrinologists and American College of Endocrinology ; ADA = American Diabetes Association ; AGREE II = Appraisal of Guidelines for Research and Evaluation II ; GDG = guideline development group ; ICSI = Institute for Clinical Systems Improvement ; NICE = National Institute for Health and Care Excellence ; SIGN = Scottish Intercollegiate Guidelines Network ; VA/DoD = U.S. Department of Veterans Affairs and Department of Defense . Appendix Table 1 . Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment Peer Review The draft guidance statement was peer- review ed through Annals of Internal Medicine and was posted online for comments from ACP Regents and Governors , who represent ACP members at the regional level . The final guidance statement incorporated comments from peer review ers and ACP Regents and Governors . Public Panel Review The development of this guidance statement also included perspectives , values , and preferences of 2 CGC members who represent the public and a 7-member public panel . Summary of Evaluated Guidelines Using the AGREE II Instrument We review ed and rated 6 guidelines ( AACE/ACE [ 9 ] , ADA [ 10 ] , ICSI [ 8 ] , NICE [ 7 ] , SIGN [ 11 ] , and VA/DoD [ 12 ] ) , focusing solely on sections addressing HbA1c targets in patients with type 2 diabetes . Appendix Table 1 shows the detailed scaled domain scores and average quality ratings for each guideline , and the Appendix Figure shows average AGREE II scores for each item in each of the 6 domains . The fundamental difference between high- and low-scoring guidelines was methodology . The 2 lowest-scoring guidelines , AACE/ACE and ADA , scored lowest on stakeholder involvement , applicability , editorial independence , and scientific rigor . A systematic review is the backbone for any trustworthy guideline , but some guidelines might not be based on a systematic review or may not have made the review publicly available ( 14 , 15 ) . Several factors were important in considering guideline quality . For example , although many guidelines described benefits , adverse effects , and the strength and limitations of evidence or linked the evidence to the recommendation , they often inadequately described how they had considered or weighted these factors in developing the final recommendations . The guidelines frequently relied on selective reporting of studies or outcomes and focused on relative versus absolute effects and asymptomatic surrogate measures rather than patient-centered health outcomes . All of the review ed guidelines recommend individualizing HbA1c targets on the basis of patient characteristics , such as comorbid conditions and risk for hypoglycemia ( Appendix ) . The ADA and SIGN guidelines recommend a target of 7 % for the general population , whereas AACE/ACE recommends 6.5 % ( if it can be achieved safely ) . The NICE guideline specifies 6.5 % or 7 % , depending on the patient 's treatment regimen . Both ICSI and VA/DoD recommend target ranges . The ICSI guideline recommends less than 7 % to less than 8 % based on patient factors , whereas the VA/DoD recommends the following target ranges based on life expectancy and comorbid conditions : 6 % to 7 % for patients with a life expectancy greater than 10 to 15 years and no or mild microvascular complications ; 7 % to 8.5 % for those with established microvascular or macrovascular disease , comorbid conditions , or a life expectancy of 5 to 10 years ; and 8 % to 9 % for those with a life expectancy less than 5 years , significant comorbid conditions , advanced complications of diabetes , or difficulties in self-management attributable to mental status , disability , or other factors ( 12 ) . All guidelines recognize that HbA1c targets can be higher in patients with comorbid conditions and limited life expectancy . We looked into the evidence presented in these guidelines , specifically 5 large , long-term r and omized trials with a treat-to-target strategy and corresponding reports on extended follow-up ( 1623 ) . We summarize below the individual studies and result ing benefits and harms . Note that recent studies evaluating the effectiveness and safety of several newer diabetes drugs ( for example , recently approved sodiumglucose cotransporter-2 inhibitors , dipeptidyl peptidase-4 inhibitors , and glucagon-like peptide-1 receptor agonists ) were not considered in guideline sections pertaining to HbA1c targets because these studies were not design ed to evaluate treat-to-target strategies . Therefore , their findings are not described here . Benefits and Harms of Lower HbA1c Targets : Evidence From Clinical Trials Five large , long-term r and omized controlled trials investigated intensive ( achieved HbA1c levels , 6.3 % to 7.4 % ) versus less intensive ( achieved HbA1c levels , 7.3 % to 8.4 % ) Background Determining the effectiveness of social and psychological interventions is important for improving individual and population health . Such interventions are complex and , where possible , are best evaluated by r and omised controlled trials ( RCTs ) . The use of research findings in policy and practice decision making is hindered by poor reporting of RCTs . Poor reporting limits the ability to replicate interventions , synthesis e evidence in systematic review s , and utilise findings for evidence -based policy and practice . The lack of guidance for reporting the specific method ological features of complex intervention RCTs contributes to poor reporting . We aim to develop an extension of the Consoli date d St and ards of Reporting Trials Statement for Social and Psychological Interventions ( CONSORT-SPI ) . Methods / design This research project will be conducted in five phases . The first phase was the project launch , which consisted of the establishment of a Project Executive and International Advisory Group , and recruitment of journal editors and the CONSORT Group . The second phase involves a Delphi process that will generate a list of possible items to include in the CONSORT Extension . Next , there will be a formal consensus meeting to select the reporting items to add to , or modify for , the CONSORT-SPI Extension . Fourth , guideline documents will be written , including an explanation and elaboration ( E&E ) document that will provide detailed advice for each item and examples of good reporting . The final phase will comprise guideline dissemination , with simultaneous publication and endorsement of the guideline in multiple journals , endorsement by funding agencies , presentations at conferences and other meetings , and a dedicated website that will facilitate feedback about the guideline . Conclusion As demonstrated by previous CONSORT guidelines , the development of an evidence -based reporting guideline for social and psychological intervention RCTs should improve the accuracy , comprehensiveness , and transparency of study reports . This , in turn , promises to improve the critical appraisal of research and its use in policy and practice decision making . We invite readers to participate in the project by visiting our website ( http://tinyurl.com/CONSORT- study ) Background Current guidelines for the management of depression suggest the use of guided self-help for patients with mild to moderate disorders . However , there is little consensus concerning the optimal form and delivery of this intervention . To develop acceptable and effective interventions , a phased process has been proposed , using a modelling phase to examine and develop an intervention prior to preliminary testing in an exploratory trial . This paper ( a ) describes the modelling phase used to develop a guided self-help intervention for depression in primary care and ( b ) reports data from an exploratory r and omised trial of the intervention . Methods A guided self-help intervention was developed following a modelling phase which involved a systematic review , meta synthesis and a consensus process . The intervention was then tested in an exploratory r and omised controlled trial by examining ( a ) fidelity using analysis of taped guided self-help sessions ( b ) acceptability to patients and professionals through qualitative interviews ( c ) effectiveness through estimation of the intervention effect size . Results Fifty eight patients were recruited to the exploratory trial . Seven professionals and nine patients were interviewed , and 22 tapes of sessions analysed for fidelity . Generally , fidelity to the intervention protocol was high , and the professionals delivered the majority of the specific components ( with the exception of the use of feedback ) . Acceptability to both professionals and patients was also high . The effect size of the intervention on outcomes was small , and in line with previous analyses showing the modest effect of guided self-help in primary care . However , the sample size was small and confidence intervals around the effectiveness estimate were wide . Conclusion The general principles of the modelling phase adopted in this study are design ed to draw on a range of evidence , potentially providing an intervention that is evidence -based , patient-centred and acceptable to professionals . However , the pilot outcome data did not suggest that the intervention developed was particularly effective . The advantages and disadvantages of the general methods used in the modelling phase are discussed , and possible reasons for the failure to demonstrate a larger effect in this particular case are outlined Background  Quality indicators ( QIs ) are an important tool for improving clinical practice and are increasingly being developed from evidence -based guideline recommendations . We aim ed to identify , select and apply guideline recommendations to develop a set of QIs to measure the implementation of evidence -based practice using routinely recorded clinical data in United Kingdom ( UK ) primary care . Methods We review ed existing national clinical guidelines and QIs and used a four-stage consensus development process to derive a set of ‘ high impact ’ QIs relevant to primary care based upon explicit prioritisation criteria . We then field tested the QIs using remotely extracted , anonymised patient records from 89 r and omly sample d primary care practice s in the Yorkshire region of Engl and . Results Out of 2365 recommendations and QIs originally review ed , we derived a set of 18 QIs ( 5 single , 13 composites – comprising 2–9 individual recommendations ) for field testing . QIs predominantly addressed chronic disease management , in particular diabetes , cardiovascular and renal disease , and included both processes and outcomes of care . Field testing proved to be critical for further refinement and final selection . Conclusions We have demonstrated a rigorous and transparent methodology to develop a set of high impact , evidence -based QIs for primary care from clinical guideline recommendations . While the development process was successful in developing a limited set of QIs , it remains challenging to derive robust new QIs from clinical guidelines in the absence of established systems for routine , structured recording of clinical care Many medical specialty societies devote substantial re sources to the development and dissemination of practice guidelines . Studies suggest that passive dissemination ( such as publication or mailing of guidelines ) is ineffective in increasing adoption of recommendations into clinical practice ( 1 - 5 ) . Educational efforts to increase physicians ' adoption of guidelines are more likely to be effective when they are local , are multifaceted , and incorporate strategies that use a social influence model of change ( 1 , 2 , 4 , 6 - 9 ) . In particular , opinion leadersrespected authorities within a medical communityhave been shown to influence the adoption of guidelines ( 1 , 7 , 10 , 11 ) . However , despite the widespread development and endorsement of guidelines by specialty societies , little research has been done on the effectiveness of guideline implementation efforts ( 3 - 5 , 12 ) . We conducted a r and omized , controlled trial to evaluate a multifaceted , evidence -based educational program to enhance the adoption of practice recommendations for the care of patients with dementia that were endorsed by the American Academy of Neurology ( AAN ) and local opinion leaders . We hypothesized that more neurologists who received the educational intervention  would adhere more to the guideline recommendations than would neurologists who did not receive this intervention . Methods Our methods have been described in detail elsewhere ( 13 ) and are summarized here . The University of Rochester institutional review board approved the study . Study Sample We identified neurologists from six major urban regions in New York State ( Albany , Buffalo , the Upper East Side of Manhattan , Queens , Rochester , and Syracuse ) by using both the AAN membership data base ( n=407 ) and , for neurologists not in the AAN data base , the New York State physician master file ( n=10 ) ( 13 ) . Neurologists were eligible to participate if they were board eligible or board certified in neurology or currently in a neurology residency or fellowship . We excluded neurologists whose primary specialty was child neurology , neuropathology , ophthalmology , nuclear medicine , or pediatrics and those who provided no patient care . Study Group Assignment We r and omly assigned neurologists to the baseline group , control group , or intervention group ( Figure 1 ) . Only neurologists in the intervention group received the educational intervention . We assessed the primary study outcomes in the baseline group 3 months before the intervention and in the control and intervention groups 6 months after the intervention . Neurologists in the same practice could be r and omly assigned to different study groups . Comparison of baseline and control group results enabled assessment of possible temporal effects and potential information transfer between control and intervention groups ( 14 ) . Figure 1 . Participant flow and follow-up . n n n P CME Selection of Practice Recommendations We review ed all available clinical practice guidelines on dementia care that were developed and endorsed by the AAN ( 15 , 16 ) , as well as other published dementia guidelines ( 17 - 26 ) . We selected six recommendations because they were developed or endorsed by a specialty society and because the literature suggested performance gaps and practice variations for the clinical care issues outlined in the recommendations ( 27 - 30 ) . These recommendations included two about the indications for neuroimaging and electroencephalography in patients with dementia , from a previously published , AAN-developed practice parameter on dementia ( 15 ) ; one on the use of apolipoprotein E genotype testing , from a position paper that had been officially endorsed by the AAN and other specialty society organizations ( 16 ) ; and one on detection and treatment of depression , from guidelines developed by a national panel of experts ( 19 , 20 ) . In addition , we developed two recommendations specifically for the project on referring patients and their families to the Alzheimer 's Association and to the Alzheimer 's Association Safe Return Program , a national program design ed to reduce the potential of adverse consequences of w and ering . An AAN Advisory Panelcomposed of four dementia experts nominated by the AAN , neurology opinion leaders from each study region , and persons from the local Alzheimer 's associations representing the study regionsendorsed all six recommendations ( see the Appendix for the wording of each guideline ) . Opinion Leader Selection To identify local opinion leaders , we mailed a survey ( 31 ) to a r and om sample of half of all eligible persons in each region except Albany and Syracuse , where all eligible persons received the survey . This survey was completed before neurologists were r and omly assigned to study groups , and it guided the identification and recruitment of 12 opinion leaders : 1 in Albany ; 2 each in Buffalo , Manhattan , Rochester , and Syracuse ; and 3 in Queens ( 13 ) . Educational Intervention The intervention was an evidence -based educational program consisting of a mailed AAN continuing medical education ( CME ) course ( 32 ) , a re source manual with tools to help implement guidelines , an invitation to an AAN-sponsored evidence -based seminar , and five reminder mailings . The AAN , the local opinion leaders , and other advisory panel members endorsed the program . The individual components of the program were administered in the fall of 1997 to the intervention group only . The mailed CME course was design ed so that readers could quickly review each recommendation and then analyze the rationale and evidence supporting it in more depth ( 32 ) . The course begins with an executive summary highlighting all six practice recommendations , along with a short rationale formatted as a bulleted list . The course continues with four similarly formatted sections . Each section presents one or two recommendations in outline format , along with the endorsing organizations , followed by the rationale and supporting data , a clinical algorithm and a clinical case vignette illustrating and reinforcing each recommendation , and an in-depth discussion that elaborates on the recommendations . We included a list of physician re sources and patient education and information h and outs in two appendices . The re source manual consisted of a three-ring binder containing tools design ed to help neurologists incorporate these recommendations into their practice , including the Cornell Scale for Depression in Dementia ( 33 ) , a fact sheet for patients and caregivers about their local branch of the Alzheimer 's Association ( with the Association 's telephone number ) , and a Safe Return Program application ( 13 ) . All tools were also included in the CME course . We invited all neurologists in the intervention group to attend an AAN-sponsored local seminar on dementia care . The seminars occurred on a weeknight , included dinner , and lasted 3 hours . The local opinion leaders , a representative from the local Alzheimer 's Association , and a study investigator served as faculty . The seminars followed a st and ard format . The study investigator presented each practice recommendation , along with the rationale and supporting evidence . After formal presentation of each recommendation , the opinion leaders endorsed the recommendation and led a 10- to 15-minute interactive discussion with attendees about practical issues of incorporating the recommendation in routine clinical practice . The Alzheimer 's Association representative also actively participated in the discussion . Tools that applied to the recommendations were presented and were distributed to each attendee . Six weeks after the seminar , we sent five mailings ( each approximately 2 to 3 weeks apart ) with cover letters signed by the opinion leaders to all intervention neurologists . The first four mailings highlighted one or two recommendations . The final mailing included a copy of the executive summary of all six recommendations , a business card for the local branch of the Alzheimer 's Association , and a Safe Return Program application . The AAN was the primary sponsoring body for the practice recommendations and evidence -based seminars . We also used the AAN 's continuing education program , CONTINUUM ( 34 ) , as the primary vehicle to disseminate the recommendations in the CME course . In addition , AAN leadership signed introductory letters that accompanied study mailings . Outcome Measures We assessed adherence to the six practice recommendations by evaluating neurologists ' written responses to three clinical scenarios , each depicting a typical patient with dementia presenting for an initial evaluation . After each scenario , participants were asked to provide information on the same four items : 1 ) Write in the most likely diagnosis ; 2 ) from a list of 12 common diagnostic tests , indicate which you would order ; 3 ) write in any additional diagnostic tests you would order ; and 4 ) write in any treatment or management recommendations you would make . The scenarios and questions were developed by study investigators , review ed by dementia experts on the Advisory Panel , and pilot tested with seven neurologists . Scenarios 1 and 3 depicted patients who presented with features typical of Alzheimer 's disease and who did not meet any of the recommended criteria for ordering either a neuroimaging study or electroencephalography .  Scenario 2 depicted a patient with established Alzheimer 's disease who had symptoms consistent with a diagnosis of major depression . Three physician investigators who were masked to the neurologists ' group assignments review ed all written responses to each scenario and determined whether each response adhered to each practice recommendation . Neurologists who did not order a neuroimaging study ( magnetic resonance imaging or computed tomography ) were considered adherent to the neuroimaging recommendation . We analyzed responses to scenarios 1 and 3 separately because the patient in scenario 1 had no previous neuroimaging studies , whereas in scenario 3 , the patient had a normal noncontrast computed
This guideline does not apply to those with other sleep disorders or untreated anxiety , depression , or other physical or mental health conditions that might be causing or aggravating insomnia .
Benzodiazepine receptor agonists are associated with harms , and therapeutic effects might be short term .
Tapering BZRAs improves cessation rates compared with usual care without serious harms .
Patients might be more amenable to deprescribing conversations if they underst and the rationale ( potential for harm ) , are involved in developing the tapering plan , and are offered behavioural advice .
OBJECTIVE To develop an evidence -based guideline to help clinicians make decisions about when and how to safely taper and stop benzodiazepine receptor agonists ( BZRAs ) ; to focus on the highest level of evidence available and seek input from primary care professionals in the guideline development , review , and endorsement processes .