Healthcare decision makers face challenges when using guidelines, including understanding the quality of the evidence or the values and preferences upon which recommendations are made, which are often not clear.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 randomized trials, refined, and assessed during the development of real guidelines.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 (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 settings, and it will support the transfer of research into practice in healthcare systems globally. Clinical practice guidelines and health technology assessments have emerged as a source of support. Clinical practice guidelines are becoming increasingly popular, i.e., statements that include recommendations intended to optimize patient care that should be informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options [Health professionals, patients, policymakers, and the public aspire to making healthcare decisions on the basis of the best available research evidence -6. Howev options ,14.Guidelines are considered a convenient way of packaging evidence and present recommendations to healthcare decision makers. Nevertheless, decisions should be influenced not only by the best estimates of the expected benefits and harms of a therapy or intervention but also by other factors. These include the confidence in these estimates , patient values, preferences, and for policy makers in particular, resource use, feasibility, and equity might also be relevant. Guideline developers have been inconsistent in how they rate quality of evidence and grade strength of recommendations, despite the critical role of these processes in guideline production . As a rehttp://www.gradeworkinggroup.org). The GRADE approach is now well-established and is widely used internationally [The GRADE Working Group—a widely representative international group of guideline developers, health professionals, epidemiologists and statisticians—has spent over a decade developing an approach towards assessing and communicating the quality of evidence and the strength of recommendations  to health professionals, and has contributed to ways of presenting this information to guideline developers, policymakers and patients -28. The DECIDE’s objectives are to develop and evaluate strategies for the targeted communication of evidence-based recommendations to the key stakeholders who determine what happens in healthcare. We will develop and evaluate strategies for effectively and efficiently communicating and supporting the uptake of evidence-based recommendations to: healthcare professionals; policymakers and managers; and patients and the general public.In addition to addressing recommendations about prevention, treatment, and rehabilitation, we will develop strategies for recommendations about diagnostic tests  and health system policies (targeted mainly at policymakers).To ensure wide communication of DECIDE’s results we will: develop a tool kit for preparing and effectively communicating evidence-based recommendations; develop a database of evidence profiles (see ‘Development of a database of evidence profiles’ below); and host a European conference on promoting the optimal development and communication of evidence based recommendations.DECIDE as originally envisaged has not been placed in a particular knowledge transfer or implementation framework. Instead, it aims to provide empirical support for a range of communication strategies, particularly how research evidence is presented to users to optimize access and use of the information contained within guidelines. A recent framework for guideline implementability  does, hohttp://www.decide-collaboration.eu/).DECIDE started on 1 January 2011 and will run for five years , each aimed at a different stakeholder group or type of recommendation: health professionals (WP1); policymakers and managers (WP2); public, patients and carers (WP3); diagnostic tests (WP4); and health system policies (WP5).There are three other work packages in DECIDE: WP6 will develop a toolkit for preparing and disseminating evidence-based recommendations (see below); WP7 will support communication; and WP8 is project management.All work packages involve work in all DECIDE partner countries, namely Finland, Germany, Italy, the Netherlands, Norway, Spain, and the United Kingdom (UK)  through user testing, plus feedback from key stakeholders, for example, people who author guidelines. We will analyse feedback, define problem areas, and revise the strategies in brainstorming workshops. Additionally, we will survey user perceptions of a variety of current guidelines and their preferences regarding guideline content and presentation.This work will collect user feedback from people in each of the targeted groups  and the different types of interventions .The strategies coming from phase one will be evaluated, generally in randomized trials. The evaluations will be tailored to the different groups being targeted ’ below).A simplified flow diagram of how the three phases of DECIDE will work in practice is given in Figure Finally, ethics approval will be sought for each of DECIDE’s studies separately according to national regulations.http://www.support-collaboration.org/) [Our initial development of communication strategies to effectively communicate evidence-based recommendations to stakeholders will be based on the work of the GRADE Working Group, Cochrane Collaboration Summary of Findings ,22,31,32on.org/) ,24, and on.org/) -27. Frome.g., with DECIDE partners) to generate ideas and solutions to problems uncovered through feedback and testing.1. Brainstorming workshops  to inform development and revisions from diverse perspectives.3. Stakeholder feedback . To inform revisions from a user perspective.4. User testing  present recommendations and evidence summaries, and a second looking for what has been studied about the different aspects around presentation of recommendations and evidence summaries. The results of all these reviews will inform DECIDE’s work, as well as advance knowledge around presenting guideline information to a wide range of stakeholders.If relevant reviews do not already exist, then work packages will do one or more reviews to collate what is known about guideline dissemination methods for particular target groups. WP3, for example, will review the literature covering the evidence around patient  beliefs, feelings, awareness, understanding and knowledge, expectation and perception of healthcare guidelines, and to collate knowledge on methods of communicating guideline recommendations to this audience. WP4 will review the grading systems used to grade evidence on diagnostic tests, which will inform work on how this might be improved and how the results of the grading might best be presented. WP1 will do two rapid systematic reviews, one looking at how guidelines and secondary resources . Less frequently, topics might be of interest to a single or just some participant countries. The summaries and recommendations we prepare will be used as the basis for gathering feedback on the format, content and delivery method of GRADE evidence-based recommendations and supporting materials in all of the participating countries. It is hard to predict what issues stakeholders will raise, but feedback could, for example, relate to the merits of quantitative versus qualitative presentation of information, the quality of information presented, or information missing from presentations.We will prepare summaries and recommendations for selected clinical topics using the strategies that are agreed on at the first brainstorming workshop. We will include topics that could be relevant to all partners  and the stage of the work . We will guide test participants through a series of questions to explore which parts of the recommendations and supporting materials cause them problems, probing to better understand the nature of these problems.Participants from each partner country will take part in the user tests. The type of participant will vary depending on the work package ; medium (causes much frustration or unnecessarily slow use); or low (minor or cosmetic problems). We will also register nice-to-haves (things users explicitly liked) and suggestions for improvement.e.g., the public or policymakers) regarding their understanding of guidelines, or their perceptions of a variety of current guidelines on the same topic  and their preferences regarding guideline content, presentation of recommendations and current strategies used to disseminate research evidence. The surveys may also be used to evaluate alternative potential presentations formats. For example, we might ask health professionals about which icons they prefer in electronic guideline presentations.We will survey representative samples of our targeted users .e.g., common explanations of terminology). The objectives of the evaluations are to assess the impact of the various DECIDE strategies on intended behaviour and attitudes, as well as correct comprehension of key information and general satisfaction.The various DECIDE strategies coming from phase one will be rigorously evaluated in partner countries, generally through a randomized trial. These strategies are likely to include the way documents are worded, how numerical information is summarized, graphical presentations, layering of information and electronic versus paper presentations. The strategies may differ between work packages although common elements are likely , or another DECIDE strategy. Discussions with stakeholder groups will provide us with estimates of the minimal important difference in outcomes upon which to base sample size calculations. The trial questionnaires will include multiple-choice questions measuring correct comprehension of the specific recommendation and supporting material, attitudes, hypothetical or intended behaviour, and satisfaction. The measurement of attitude and intention will be informed by appropriate behavioural theory. Participants’ responses will be anonymous. Where the trial is run as a face-to-face meeting, structured discussions will be carried out at the end of the meeting, and we will interview selected participants to explore strengths and weaknesses of the strategies, reasons for their success or failure, and ways of improving them.In each trial, we will randomize participants to receive information and clinical recommendations using one of the proposed DECIDE strategies for that work package or an alternative, which might be a conventional strategy . For example, we may find that one DECIDE communication strategy allows participants to both find and understand the balance of benefits and harms much better than a second DECIDE strategy and the existing guideline presentation. Another trial might have clinicians reviewing a number of clinical scenarios after first having been presented with guideline recommendations presented in one of two formats. For example, measurement of intention to refer patients in the scenarios to screening may be more closely aligned with the guideline recommendations with one format than another. If participants are not too heterogeneous it may be possible to pool results from several trials. Interview data will help to explain and interpret the results of the quantitative analysis. The trials will allow us to sift out the least promising strategies prior to moving to phase three.These trials will tell us if one or more of the DECIDE strategies supports increased understanding, user satisfaction, and/or behaviours (http://www.gradeworkinggroup.org/society/index.htm). These guideline developers will use the strategies for communicating evidence-based recommendations and the supporting material generated during phases one and two with their new or updated guidelines. We will test our strategies for optimal dissemination of recommendations through different designs such as interrupted time series, surveys and randomized trials of alternative presentation formats.The most promising DECIDE strategies for each work package will be revised as needed based on the results of phase two. The revised strategies will then be tested by using them with real clinical practice guidelines prepared by DECIDE partners and other collaborators. Other developers linked to the GRADE Working Group will also be involved  before and after the DECIDE strategies are used to present recommendations supplemented by interviews (after communication of the recommendations).We will develop a toolkit for preparing and communicating evidence-based recommendations. Development of the toolkit will be based on the GRADE profiler (GRADEpro) software developed by members of the GRADE Working Group and used by a wide variety of organisations, including the DECIDE partners. GRADEpro is an application for developing, managing, and sharing evidence profiles and Summary Of Findings Tables and making recommendations. This tool is intended for authors of systematic reviews, guideline developers, and those requiring summaries of the best available evidence for recommendations about particular courses of action in healthcare. An evidence table is a key tool in the presentation of evidence and the corresponding results, and it displays the information about all outcomes for a given healthcare question in tabular format, information that should include a systematic review of the best available evidence. Health professionals, patients and the public, guideline developers, and policymakers should be able to access succinct, explicit, and structured evidence summaries to inform their decisions. While an unambiguous healthcare question is key to evidence summaries, the requirements for specific users may differ in content and detail. The Decision Table, another table developed by GRADEpro, includes the rationale for making recommendations based on the underlying quality of evidence, the balance between benefits and harms, values and preferences, and resource considerations. This table is used to lay out judgments that guideline developers make when they develop recommendations .i.e., WPs 1 to 5) to support communication to health professionals, policymakers, and members of the public, as appropriate. The software will support materials in several languages including Dutch, English, French, German, Italian and Spanish. We will encourage GRADE members from other European countries to provide a translation for their country’s language. The revised and expanded software will be tested by all of the DECIDE partners and by other members of the GRADE Working Group and users, including Cochrane Collaboration review authors. The final product will be an interactive, browser-based guideline development tool.As part of the DECIDE project, we will further develop GRADEpro to incorporate presentations  developed in the five empirical work packages described above (http://www.gradeprofiles.org/). We will establish an advisory group with representatives from producers of guidelines and systematic reviews to obtain input into key decisions, including quality control, inclusion of metadata, and access to the database. In addition to organisations that are partners in DECIDE, we will invite representatives from the Cochrane Collaboration, the G-I-N, and the International Network of Agencies for Health Technology Assessment (INAHTA) to join the advisory group. The role of the advisory group will be to help ensure that the database is optimally designed to minimize unnecessary duplication of efforts and maximize access to evidence profiles by guideline developers and HTA agencies in Europe.To facilitate collaboration across European guideline developers, we will develop a database of evidence profiles prepared using GRADEpro and the strategies developed by DECIDE. An evidence profile consists of two components: an assessment of the quality of evidence and a summary of the findings . This woe.g., effect sizes, and the evidence profile will be re-created on demand. This allows for flexibility in providing different profile presentations that can be utilized for targeted user testing in randomized trials and allows creating different output formats, such as pdf files, rich text formats, or in graphical form. In addition, the original data set can be downloaded at any time for reuse and for easy updating at a later time point or by other authors. GRADE profiles will be conceptually stored in three separate components: the profile identifiers , patient or population-important outcomes , as well as annotations .The profile database will accommodate the changing and evolving nature of the grading methodology over time . This makes storing static documents (such as pdf files of finished evidence profiles) less appealing. Instead, the database will store the individual data points, Other tools and resources may also be developed. For example, documents providing guidance to guideline developers about how best to present information to the public or policymakers.http://www.decide-collaboration.eu/work-packages-strategies). WP1’ user-testing of presentation formats has so far resulted in an electronic multilayered guideline format to be made available in outputs for multiple platforms . Figure Table WP1 has through this research identified the need to develop the presentation formats in parallel with development of the Guideline Development Tool to facilitate the authoring of guideline content and creation of the various electronic outputs. This will require specific functionality in the Guideline Development Tool to be developed in WP6. Work packages 1, 3, 4, and 5 are developing frameworks for going from evidence to recommendations as a means of supporting recommendations that are well informed by evidence. These frameworks build on the previous work of the Decision Table. WP2 (policymakers) will focus specifically on coverage decisions, for which recommendations are uncommon. WP1 is also developing an Evidence To Recommendation Table for healthcare professionals. This table aims to be a friendlier Summary of Findings Table that includes other features as values and preferences and resource use.The Evidence to Recommendation Frameworks . The explanations will include brief explanations of concepts such as ‘quality of evidence’ or ‘confidence intervals’ that can, for example, be used as cursor-over help in guidelines, or Summary of Findings Tables. In addition, we will develop longer explanations using videos, interactive applications, or other presentations to facilitate understanding. These can be provided as help using hypertext links in, for example, online guidelines, as resources or a help file on guideline producers’ websites or in resources, such as the Cochrane Library, as an open access online resource, or as an introduction to a group making recommendations or decisions. The objective of this interactive work is to improve understanding and use of evidence of the effects of healthcare interventions by developing products  that allows producers to tailor a presentation to different target audiences and for users to interact with the presentation.We are additionally developing and testing explanations of key concepts and interactive Summary of Findings Tables that will be adapted for use across all five work packages and their final strategies (http://www.guidelinedevelopment.org) will build on the features of GRADEpro and include:The Guideline Development Tool .3. Support for communication, polling, managing conflict of interest, voting, and other forms of interaction among multiple stakeholders providing input , which develops methodology and technology to integrate guidelines in the electronic medical record  and to facilitate local adaptation and dynamic updating of healthcare recommendations.Based on this work DECIDE will develop and evaluate ways of effectively communicating and supporting the uptake of evidence-based recommendations (and the basis for such recommendations). This work will advance the state-of-the-art by taking the successful GRADE system and providing new research data on the most effective ways of using GRADE to develop and disseminate research evidence to key clinical practice stakeholders across different countries, health systems, and settings in Europe. It will provide new information on how to tailor global research evidence to local needs. Moreover, DECIDE is also a partner in a research programme called MAGIC , Spain: Pablo Alonso-Coello, Laura Martinez-García, David Rigau, Ivan Solà, Andrea Juliana Sanabria. Lazio Regional Health Service, Italy: Laura Amato, Massimo Brunetti, Marina Davoli, Nicola Magrini, Elena Parmelli, Francesco Nonino, Rossana De Palma, Donato Papini, Silvia Pregno, Carlo Saitto; University of Amsterdam, the Netherlands: Patrick Bossuyt, Gowri Gopalakrishna, Miranda Langendam, Mariska Leeflang, Rob Scholten; World Health Organisation: Metin Gülmezoglu, Govin Permanand, Krisantha Weerasuriyak; University Hospital Freiburg, Germany: Gerd Antes, Jörg Meerpohl, Holger Schünemann; National Institute for Health and Clinical Excellence, UK: Phil Alderson, Emma McFarlane, Judith Thornton; Scottish Intercollegiate Guidelines Network, UK: Margaret Callaghan, Karen Graham, Robin Harbour, Karen Ritchie, Duncan Service; Finnish Medical Society Duodecim, Finland: Ilkka Kunnamo, Helena Liira; McMaster University, Canada: Gordon Guyatt, Reem Mustafa, Ignacio Neumann, Nancy Santesso, Fred Spencer; Case Western Reserve University, USA: Yngve Falck-Ytter; University of Chile, Chile: Romina Brignardello-Petersen, Alonso Carrasco-Labra; University Hospital Basel, Switzerland: Regina Kunz; University of Buffalo, USA: Elie Akl.Example framework from WP1.Click here for fileExample framework from WP2.Click here for fileExample framework from WP5.Click here for fileThe Guideline Development Tool.Click here for file


In 2007, the World Health Organization (WHO) received a criticism for a lack of transparency and systematic methods in the development of guidelines, which were at that time perceived as substantially driven by expert opinion. In this paper we assessed the quality of maternal and perinatal health guidelines developed since then. We used the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool to evaluate the quality of methodological rigour and transparency of four different WHO guidelines published between 2007 and 2011. Our findings showed high scores among the most recent guidelines on maternal and perinatal health suggesting higher quality. However, there is still potential for improvement, especially in including different stakeholder views, transparency of guidelines regarding the role of the funding body and presentation of the guideline document. The World Health Organization (WHO) has an important role in the provision of global guidance on health interventions and health care In 2007, Oxman, Lavis and Fretheim examined the use of evidence in WHO guidelines by interviewing senior staff. They found infrequent use of systematic reviews, an absence of a systematic guideline development methodology and a tendency to rely on expert opinion The WHO Guideline Review Committee (GRC) was subsequently established “to ensure that WHO guidelines are of a high methodological quality and are developed through a transparent, evidence-based decision-making process” The WHO Department of Reproductive Health and Research (RHR) hosts the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). This programme is the main body within the United Nations system for research in sexual and reproductive health. RHR is responsible for normative guidance on sexual and reproductive health and rights This analysis aimed to assess the quality of maternal and perinatal health guideline development by examining the four guidelines described above. We used the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool to evaluate each guideline Four appraisers who had not previously participated in the development of WHO guidelines conducted the assessment . The appraisers used the online training tools recommended by the AGREE collaboration before conducting appraisals. Each of the four guidelines was rated independently with the AGREE II tool online by each appraiser. Appraisers did not communicate or confer with each other during the appraisal process.scope and purpose assesses whether the guideline describes its overall objective and target population clearly. A guideline should entail a clear definition of the target users, as well as demonstrate that the views and preferences of the target population  have been sought and that the guideline development group includes all relevant professional groups which is assessed in stakeholder improvement. The next domain assesses the rigour of guideline development, encompassing systematic literature searching methodology, transparency of evidence-gathering process and whether evidence is explicitly linked to the recommendations. It also asks if the guideline has been externally reviewed prior to publication and if an updating strategy has been documented. The fourth domain examines clarity of guideline presentation. Recommendations must be specific, unambiguous and easily identifiable. Different options for management of the condition or health issue should be clearly presented. Applicability examines whether guidelines describe facilitators and barriers to application and if they provide advice and/or tools on how the recommendations can be put into practice. It also assesses resource implications for guideline application and monitoring and/or auditing criteria editorial independenceThe AGREE II tool encompasses 23 items in six domains: scope and purpose (3 items), stakeholder involvement (3 items), rigour of development (8 items), clarity of presentation (3 items), applicability (4 items), and editorial independence (2 items). The domain Each item is rated from 1 (strongly disagree) to 7 (strongly agree). Detailed criteria for each item are available within the AGREE II tool to assist the appraiser Average appraisal scores were calculated for each appraiser by taking the average rating (1–7) for all items of a single guideline. From this, overall average appraisal scores and standard deviations were calculated for all four appraisers for a single guideline. Scaled percentages for each domain were then calculated for inter-domain comparison. This was done by adding all four appraiser ratings (1–7) of items within a single domain (obtained score) and scaling by maximum and minimum possible domain scores and converting to a percentage.E.g.:Average appraisal scores and average overall assessments for each guideline are shown in scope and purpose of the guidelines, the recent guidelines scored highest, though since 2007 the scores were relatively high (79%). Stakeholder involvement was rated higher over time - P-PPH (2007) scored 32%, M-PPH (2009) 51%, IOL (2011) 69% and PE/E (2011) 86%. Rigour of Development scores tended to be higher in the recent guidelines, although scores were relatively high in all four guidelines. Clarity of Presentation scored over 90% in the IOL and PE/E guidelines. The appraisers gave relatively low scores on applicability throughout all four guidelines, although the P-PPH from 2007 scored the lowest with 22%, followed by M-PPH, scoring 29% and IOL and PE/E scoring 61% and 58%, respectively. Editorial independence has the most variation in scores as presented in the table. The complete assessments of all four appraisers are presented in We used the AGREE II online guideline assessment tool to evaluate the quality of four WHO reproductive health guidelines issued between 2007 and 2011 It should be noted that among the six domains evaluated by the AGREE II tool, three of them  had received scores in the higher end of the spectrum of quality in all four guidelines. This may be due to the fact that the WHO Department of Reproductive Health and Research is recognized as having a very strong methodological component and a large experience in randomized trials and systematic reviews.“views and preferences of the target population”, remains a challenge. RHL commentators conducting independent assessments of these guidelines have also identified this as a weakness of some of these guidelines However, the involvement of stakeholders, particularly the integration of the The appraisers identified clarity and visibility of key recommendations as strengths of the IOL and PE/E guidelines. However, appraisers suggested that presenting the guideline in two versions would be of benefit: one containing a detailed description of methodology and evidence, and a simpler version with key messages only. This would allow target users to capture the key recommendations easily, improving compliance with best practice.Applicability and editorial independence were the lowest scoring domains in the two most recent guidelines. The low scores in the applicability domain (61% and 58% for IOL and PE/E respectively) reflect poor scoring in items on resource implications and cost effectiveness. However, WHO guidelines target a wide variety of countries, making specific and detailed information about resources and financial costs problematic. The RHL commentators drew similar conclusions for the IOL guideline, remarking that while no cost analysis was conducted, the recommendations are “feasible in under-resourced settings” and “likely to be cost–effective and acceptable to the pregnant women, their obstetricians and policy-makers in under-resourced settings” funding bodies in the content of the guideline would be of benefit. Disclosure of funding sources and influence contributes to a more transparent process and is in line with existing WHO policy.In spite of the fact that the funding bodies of these four guidelines are essentially governmental agencies and academic institutions , appraisers noted that additional details on the role of the rigour of development and scope and purpose had higher scores in the most recent guidelines. This may suggest possible improvements in defining objectives and target populations as well as in systematic literature searching methodologies and transparency of the evidence-gathering process. Oxman et al. (2007) also identified a lack of timelines for updating and plans for dissemination and implementation rigour of development domain. The implementation and dissemination aspects of guidelines received also higher scores in the most recent guidelines.Oxman et al. (2007) pointed out several specific weaknesses of the WHO guideline development process. They highlighted an absence of systematic, transparent methods of synthesizing and presenting evidence, as well as infrequent use of systematic reviews and over-reliance on expert opinion There are limitations within our analysis that should be noted. The AGREE II tool has been tested for reliability and validity, and is applicable to a wide variety of health professionals, geographical areas and guideline development processes Appraisers also remarked that if a guideline is presented in a more structured way (without improvements in content), this would lead to a more positive evaluation overall. Another limitation is that the appraisers were health professionals relatively inexperienced in guideline development and evaluation and not blinded to the publication year of the guidelines they appraised. At the time of appraisal they were on temporary, voluntary assignment in RHR, which may constitute a potential conflict of interest that needs to be considered. These factors may have affected the quality of results and may have been a potential source of bias. However, we tried to minimize bias ensuring adequate training on the use of the AGREE II tool before the actual guideline appraisal. It is worthwhile noting that the same four appraisers assessed all four guidelines using the AGREE II tool. Anonymisation of results and instructions to not communicate during the appraisal process may also have contributed to reducing the potential bias. With these actions, conditions for effective use of the evaluating tool and a meaningful inter-appraiser comparison were fostered. In addition, notwithstanding having no participation in the guideline assessment, three of the authors  are WHO employees and have been involved in the development of the guidelines under assessment.In conclusion, the appraisals suggest that the process of guideline development and quality of reporting are robust in maternal and perinatal health guidelines produced by WHO. Among the remaining challenges, the involvement of stakeholders and the applicability aspects should be highlighted. Considering the large number of guidelines produced by WHO, findings of this assessment may be indicative of change, but a more comprehensive assessment is needed in order to demonstrate or not a change in the process of guideline development and the quality of reporting in WHO.Table S1Assessment of the Guidelines on Prevention of PPH.(XLSX)Click here for additional data file.Table S2Assessment of the Guidelines on Management PPH and retained placenta.(XLSX)Click here for additional data file.Table S3Assessment of the Guidelines on Induction of labour.(XLSX)Click here for additional data file.Table S4Assessment of the Guidelines on Eclampsia.(XLSX)Click here for additional data file.Table S5Total score averages and overall assessment averages for all four guidelines.(XLSX)Click here for additional data file.Table S6Sums and Percentages.(XLSX)Click here for additional data file.Table S7Scaled domain percentages for all appraisers for each guideline.(XLSX)Click here for additional data file.Table S8Appraiser recommendations for use of guidelines.(XLSX)Click here for additional data file.


Recent terrorist attacks and natural disasters have led to an increased awareness of the importance of emergency planning. However, the extent to which emergency planners can access or use evidence remains unclear. The aim of this study was to identify, analyse and assess the location, source and quality of emergency planning publications in the academic and UK grey literature.We conducted a scoping review, using as data sources for academic literature Embase, Medline, Medline in Process, Psychinfo, Biosis, Science Citation Index, Cinahl, Cochrane library and Clinicaltrials.gov. For grey literature identification we used databases at the Health Protection Agency, NHS Evidence, British Association of Immediate Care Schemes, Emergency Planning College and the Health and Safety Executive, and the websites of UK Department of Health Emergency Planning Division and UK Resilience.Aggregative synthesis was used to analyse papers and documents against a framework based on a modified FEMA Emergency Planning cycle.Of 2736 titles identified from the academic literature, 1603 were relevant. 45% were from North America, 27% were commentaries or editorials and 22% were event reports.Of 192 documents from the grey literature, 97 were relevant. 76% of these were event reports.The majority of documents addressed emergency planning and response. Very few documents related to hazard analysis, mitigation or capability assessment.Although a large body of literature exists, its validity and generalisability is unclear There is little evidence that this potential evidence base has been exploited through synthesis to inform policy and practice. The type and structure of evidence that would be of most value of emergency planners and policymakers has yet to be identified. Numberous guidance documents have been issued since the Civil Contingencies Act placed a legal responsibility for emergency planning with NHS organisations -3. FolloThe process for developing policy and guidance documents is variable with the strength and quality of the underlying evidence base often proving unclear. For example the UK Emergency Preparedness document gives no information on the provenance of its evidence base. The revFollowing compilation by the authors of themes and topics considered relevant to the field, pilot searching was carried out in the subarea of health services business continuity. This is an accepted stage for all scoping reviews as it seeks to establish an optimal balance between sensitivity and specificity. This is important conceptually, to finalise the scope of the review, and pragmatically, to ensure that the review is feasible within the available time and resources . A finalExtracted titles and abstracts were screened by KC, AL, PG and AB. Each title or abstract was reviewed and deemed to be relevant, equivocal (subject matter suggestive of relevance to emergency planning and/or management), not relevant or containing inadequate information for coding . Based on this, we searched databases at the Health Protection Agency, NHS Evidence, British Association of Immediate Care Schemes, Emergency Planning College and the Health and Safety Executive, and the websites of UK Department of Health Emergency Planning Division and UK Resilience. We also conducted an internet search using Google and Internet Archive for publicly accessible reports (public enquiries and coroner’s reports) into the following previously identified major incidents:Aberfan slag heap slipHillsborough stadium disasterIbrox stadium incidentJuly 7 bombingsKegworth (M1) aircraft crashLadbroke Grove railLockerbie bombingManchester airport take-off crashMarchioness pleasure boat sinkingPiper Alpha oil rig explosionPotters Bar railSummerland fire disasterUfton Nervet rail crashZeebrugge ferry sinkingWhere the title and abstract were considered to be relevant or equivocal we extracted further information relating to country of origin, type of publication and type of event discussed. Publications were coded on an Microsoft Excel spreadsheet using aggregative synthesis, a technique appropriate for exploring qualitative data where the concepts are secure, predefined and not contested. We usedWe reviewed 2940 titles and abstracts. Of these, 625 were coded by a pair of reviewers and with kappa values of 0.578 (AL/AB) and 0.740 (KC/PG). 1545 publications were felt to be relevant or equivocal. The country, type of publication and type of event are shown in Tables Themes addressed in each publication are shown in Table 192 documents were initially identified, of which 97 were relevant. Of these, 52 were published by the Health Protection Agency. Table This scoping review demonstrates that the published literature relating to health emergency planning is disproportionately centred on North America; Australasia and Europe have produced surprisingly little academic literature given the number of reported incidents in these areas, although non-English publications from Europe were excluded from the scope of this review. The proliferation of emergency planning research in the US may represent the effect of widespread federal funding following the 9/11 attacks.To our knowledge this represents the first attempt to scope the emergency planning literature relevant to a UK setting. This scoping review used a deliberately inclusive strategy and therefore our findings may over-estimate the extent of useable evidence. Equally, we did not assess the methodological quality of individual publications beyond their stated design. It is unclear whether the traditional hierarchy of evidence applied to clinical research  is approWe have identified a substantial amount of literature relating to emergency response. However, the validity and generalisability of the data is unclear, as is its amenability to synthesis and how this should inform policy and practice. We have also exposed the limited evidence base available to assist emergency planners and policymakers in the areas of mitigation and recovery. The development of an evidence base for emergency planning needs to take into account practical considerations regarding what type of evidence is most likely to be influential, as well as theoretical considerations of what constitutes valid evidence. The type and structure of evidence that would be of most value of emergency planners and policymakers has yet to be identified. Further research into stakeholder perceptions will be required to determine this.A significant body of emergency planning literature exists. Nevertheless its usefulness to UK planners is constrained because it is dominated geographically by the US, thematically by emergency response topics and methodologically by event reports.The authors declare that they have no competing interests.SG, AL, KC and AB conceived the study. AB and HBW developed and carried out the academic literature search. AB, AL, KC and PG coded the academic literature. PG carried out the grey literature search which was coded by KC and AL. All authors had full access to the data and have approved the final manuscript. KC is the guarantor.Ethical approval was not required.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/12/542/prepub


Globally, emerging zoonotic diseases are increasing. Existing surveillance systems for zoonoses have substantial gaps, especially in developing countries, and the systems in place in the developed world require improvements. Resources and updates on evidence-based practice (EBP) for zoonoses are sparser in the veterinary literature as compared to the medical literature. Evidence updates for emerging zoonoses are either absent or rudimentary in both human and veterinary medicine. A ‘one-health’ concept, including a global signaling surveillance system for emerging zoonoses, will be essential for correct diagnoses, interventions, and public health strategies. An open access EBP platform supported by builders of EBP resources is urgently needed to counter emerging zoonoses. The World Health Organization (WHO) defines emerging zoonosis as ‘a zoonosis that is newly recognized or newly evolved, or that has occurred previously but shows an increase in incidence or expansion in geographical, host or vector range’ . The emeThere is a large and complex interdependence between different species on our planet. Therefore, it is essential to combine disciplines in biology, veterinary medicine, and human medicine in order to understand and control emerging diseases . The manThere are two general surveillance systems for early warning and preparedness: (A) ‘Syndromic surveillance’ that focuses on disease trends by analyzing data on a cluster of clinical symptoms potentially associated with a disease or a phenomenon (in the absence of pathogen identification); and (B) ‘Risk surveillance’ that focuses on detecting risk factors for disease transmission without estimating the prevalence of pathogens, or identifying clinical features. Even in developed countries, syndromic surveillance for animal diseases, including zoonoses, are rudimentary. To overcome this deficiency, the Triple-S project, co-funded by the European Commission, is forging synergies between the human and animal health sectors by providing scientific and technical guidance on syndromic surveillance in real-time or near real-time which encompasses emerging zoonoses . ExampleMorbidity and Mortality Weekly Report (MMWR) of CDCGlobal Public Health Information Network (GPHIN) of Health CanadaUK public health network for zoonosesEuropean Centre for Disease Prevention and Control (ECDCMedVetNet and PACNET in the Pacific region)Sentiweb in FranceMekong Basin Disease Surveillance Network (MBDS) – China, Cambodia, Vietnam, Thailand, Myanmar, and Lao PDRMiddle East Consortium on Infectious Disease Surveillance (MECIDS) – Israel, Jordan, and the Palestinian TerritorySouth-eastern European Health Network (SEEHN) – Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, the Republic of Moldova, Romania, Serbia, and the former Yugoslav Republic of Macedonia (FYROM)Asian Partnership on Emerging Infectious Disease Research (APIER) – Cambodia, China, Lao PDR, Indonesia, Thailand, and VietnamSouth African Centre for Infectious Disease Surveillance (SACIDS) – DR Congo, Mozambique, South Africa, Zambia, and TanzaniaEast African Integrated Disease Surveillance Network (EAIDSNet) – Kenya, Tanzania, and UgandaNon-governmental organizations, including the Red Cross, Red Crescent, and so onOther than the country-specific surveillance systems, certain global, region-specific, and non-governmental organizations which provide information related to zoonoses in general are:Although there are early warning and surveillance systems in the developed world for timely recognition of emerging zoonotic diseases in humans and farm animals, improvements are needed. However, detection and surveillance systems for emerging zoonoses in the developing world are much less functional. In that regard, surveillance systems for wildlife, exotic animals, and companion animals have not been established. Wildlife represents a significantly large and often unknown reservoir for emerging zoonoses, in addition to being a reservoir for re-emergence of zoonoses previously controlled. Factors for emergence of zoonoses from wildlife include a burgeoning human population leading to exploitation of forest areas for agriculture and dwelling, ecotourism, outdoor activities, and live animal trade .Evidence-based practice (EBP) – an interdisciplinary approach to clinical practice – in human medicine has evolved over the past two decades due to a parallel progressive transformation in the following core domains: clinical trial registries, research reporting standards, systematic reviews, collaborations that produce and archive systematic reviews, MEDLINE indexing, and evidence update resources for point-of-care decision support. In contrast, the information and infrastructure supporting evidence-based veterinary medical practice in all of the above elements are less developed due to less public funding being made available to the veterinary side as compared to human health care .The EBP resources include websites that provide processed information on best available research evidence which are critically appraised, integrated, concisely summarized, and regularly updated as new research evidence becomes available. Distilling and disseminating evidence, a process of knowledge translation, which evaluates relevance and applicability in various scenarios, is made accessible to health providers and those making policy decisions. These EBP resources are either freely accessible or via subscription. Access to such resources addresses several barriers identified by health care decision makers regarding access to evidence-based information, including limitations of time and lack of knowledge regarding resources that synthesize, summarize, and assess evidence for quality. Some of the available resources that provide ready access to high-quality, pre-processed research evidence include Cochrane database, National Guideline Clearinghouse (NGC-USA), American College of Physicians–American Society of Internal Medicine , National Institute for Health and Clinical Evidence (NICE – UK), Bandolier, Clinical Evidence, Database of Abstracts of Reviews of Effectiveness (DARE). Meta search sources include the Turning Research Into Practice (TRIP) Database, The British Medical Journal (BMJ) evidence centre, SUM Search, and other noteworthy resources, including OVID, Clinical Queries in PubMed, NHS Centre for Reviews and Dissemination (CRD) Databases, and Public Health plus. Some of these have been assessed using quality, relevance, and newsworthiness filters and are regularly updated.The above listed EBP resources provide evidence updates on etiology, diagnosis, treatment, prognosis, and economics but are restricted to medical conditions only. Unfortunately, there are apparently no corresponding open, related guideline repositories or registries in veterinary medical practice, although the Evidence-Based Clinical Practice Guidelines of agency for health research and quality (AHRQ) has a short index for zoonoses-related guidelines .The focus of this commentary is on resources for evidence updates to counter emerging zoonoses, for example, Severe Acquired Respiratory Syndrome (SARS), West Nile, Avian Influenza, new variant Creutzfeldt – Jakob Disease, Nipah, and the most recent Middle East Respiratory Syndrome. There is no certainty when and where the next zoonosis will emerge. Miscalculating an emerging zoonosis and poor risk communication between veterinary and medical sectors could have dire consequences for public health and cause considerable economic loss.Guided by the American Veterinary Medical Association (AVMA) and Council on public health and regulatory veterinary medicine, numerous articles have been published on zoonoses from the year 2000 onwards under ‘Zoonosis Updates’ in the Journal of American Veterinary Medical Association (JAVMA). This section does not provide evidence updates. On a regular basis, solicited scientific opinions are published in the European Food Safety Authority (EFSA) journal on zoonotic diseases, outbreaks, trends and on diagnostic tests . New edidiagnostic tests to accurately classify the health status of individualsthe most effective preventative and therapeutic interventionsany emerging antimicrobial resistance and counter measurespublic health strategies for population-based interventionsAccording to NICE , evidence updates highlight new evidence and provide a commentary describing its strengths and weaknesses relating to published accredited guidance . SimilarIn order to strengthen the health care system , knowledge translation, exchange, and action are required by synthesis, dissemination, transfer, and uptake of knowledge in practice and decision making. This should begin with an unbridled global joint signaling structure which encompasses syndromic surveillance and risk surveillance for emerging zoonoses. The signaling structure should foster a regular rapid flow of information between veterinary and medical health sectors, give early warning of pathogen emergence, and focus on determinants of disease emergence. Parallel systems of processing evidence regarding the proposed diagnosis, interventions, medical measures, and other public health strategies to assist decision making, emergency preparedness, and response should evolve in the lines of the existing evidence updates resources.Emerging zoonoses causes serious health threats and global economical losses. Countering them mandates the adoption of a one-health approach involving various stake holders, including ecologists, to understand the host–parasite interaction in the natural reservoir and to understand the ecological constraints, often limiting adaptation to other hosts. Providing early warning of zoonotic pathogen emergence requires a one-health surveillance system at local, regional, and global levels. Evidence updates on diagnostic, preventative, and therapeutic interventions; antimicrobial resistance; and public health policies would support clinicians, public health practitioners, scientists, and policy makers to prevent and control emerging zoonoses. To accomplish this, a multi-disciplinary evidence-based strategy integrating with the existing EBP resources would provide a useful tool. Such a coordinated strategy should be essentially translated and disseminated in an open access performing platform to be of utility in real-time emergency preparedness and response.


Prognosis research aims to identify factors associated with the course of health conditions. It is often challenging to judge the overall quality of research evidence in systematic reviews about prognosis due to the nature of the primary studies. Standards aimed at improving the quality of primary studies on the prognosis of health conditions have been created, but these standards are often not adequately followed causing confusion about how to judge the evidence.This article presents a proposed adaptation of Grading of Recommendations Assessment, Development and Evaluation (GRADE), which was developed to rate the quality of evidence in intervention research, to judge the quality of prognostic evidence.We propose modifications to the GRADE framework for use in prognosis research along with illustrative examples from an ongoing systematic review in the pediatric pain literature. We propose six factors that can decrease the quality of evidence  and two factors that can increase it .We describe criteria for evaluating the potential impact of each of these factors on the quality of evidence when conducting a review including a narrative synthesis or a meta-analysis. These recommendations require further investigation and testing. Prognosis research examines the progression of a health condition over time in order to identify risk and protective factors that can alter the likelihood of a future event during the course of such a condition . The eviGRADE was first developed to provide methodological guidance in reviewing intervention research; specifically, how to rate the quality associated with estimated effects of an intervention on a specific outcome, and how to grade the strength of recommendations regarding the intervention as part of a guideline development process . When maConsistent with the GRADE principles, when synthesizing the evidence from prognosis research it is important to estimate the effect of a factor on an outcome and also to report the level of confidence in these findings. Therefore, in a systematic review of prognostic factors it is recommended to assess the quality of evidence for each outcome of interest across studies. Our team has applied the GRADE framework and concepts to assess the quality of a body of evidence from prognosis studies into four quality categories  according to the traditional GRADE framework Table . Along wWe think most of the factors taken into consideration by the GRADE framework to rate the quality of evidence from intervention research are conceptually applicable when applying the GRADE to judge the quality of evidence from prognostic research. However, our proposed assessment approach to determine how much each of these factors influence the quality of evidence is different from the approach originally suggested for intervention research. Table Next we describe the assessment approach for considering the potential effect of each of these factors on the quality of evidence.When evaluating the overall quality of evidence, we suggest that researchers consider the phase of investigation. A high level of evidence for prognosis is derived from a cohort study design that seeks to generate understanding of the underlying processes for the prognosis of a health condition, called a phase 3 explanatory study, or a cohort study design that seeks to confirm independent associations between the prognostic factor and the outcome, called phase 2 explanatory studies ,7. ProspFollowing phase of investigation considerations, the evidence can be upgraded or downgraded according to the following additional criteria.The findings derived from individual prognostic studies are often limited for their methodological shortcomings. There are several tools available for assessing methodological limitations -20. We rWe suggest that, when assessing the risk of bias of a prognostic factor across studies for a specific outcome, reviewers should rate the evidence as having: (1) no serious limitations when most evidence is from studies at low risk of bias for most of the bias domains; (2) serious limitations when most evidence is from studies at moderate or unclear risk of bias for most of the bias domains; or (3) very serious limitations when most information is from studies at high risk of bias with respect to almost all of the domains.Table Inconsistency occurs when there is unexplained heterogeneity or variability in results across studies. When this happens, the quality of evidence decreases. Different approaches to assess inconsistency can be applied if the systematic review incorporates narrative synthesis or meta-analysis.P value; and (3) the I2, which quantifies the proportion of the variation in point estimates due to true study variations in effect size from one study to the next, is substantial  estimates of the effect of the prognostic factor on the outcome vary across studies with the points of effect on either side of the line of no effect and their confidence intervals show minimal or no overlap; (2) the statistical test for heterogeneity, which tests the null hypothesis that all studies in a meta-analysis have the same underlying magnitude effect, shows a low  greater ).a priori defined subgroup analyses. Differences in the population, the duration of follow-up, the outcome, the prognostic factor, or study methods across studies may explain differences. In this case, we propose to estimate separate effects accordingly. If, after running separate subgroup meta-analyses, this hypothesis is supported by the data, we suggest that reviewers consider presenting separate pooled estimates instead of estimating an overall combined effect.Potential inconsistency related to differences in the magnitude of effects, as described above, should ideally be explored with If a meta-analysis is not conducted, we recommend that reviewers consider downgrading for inconsistency when estimates of the prognostic factor association with the outcome vary in direction  and the confidence intervals show no, or minimal overlap. See an example in Table Inconsistency cannot be assessed when only a single study within the existing body of literature has estimated the effect. In these cases, this criterion may be considered as 'not applicable’. However, we still recommend the reviewers to downgrade the quality of evidence since this is an indicator that the literature is not well established in the area. If observed inconsistency is unexplained, reviewers should decide whether the inconsistency is serious or very serious and justify why they have made this decision with a footnote.Indirectness exists when the participant population, prognostic factor(s) and/or outcomes considered by researchers in the primary studies do not fully represent the review question defined in the systematic review. The judged quality of evidence decreases because the results derived from the primary studies are less generalizable for the purpose of the systematic review.Regardless of whether reviewers perform a meta-analysis or not, downgrading the quality of evidence for indirectness is appropriate when: (1) the final sample only represents a subset of the population of interest  lead to a larger effect size over lower levels of the factor. The presence of such a gradient increases confidence in the findings that the factor is associated with an increased risk or protective value and therefore raises our rating of the quality of evidence.When conducting systematic reviews with meta-analysis, the reviewers should observe whether an exposure-response gradient is present between subgroup analyses for factors measured at different doses.If a meta-analysis or subgroup analyses are not conducted, or only one meta-analysis is conducted for the relationship between a prognostic factor and outcome, reviewers should observe whether a possible exposure-response gradient consistently exists within and between primary studies. The use of the same measures to evaluate prognostic factors and outcomes across studies is a required condition to appropriately evaluate the possible existence of this gradient between studies. Table The findings derived from the GRADE framework to judge the evidence derived from prognostic studies can be presented in the proposed summary of findings tables (see Tables This article is a first attempt to outline how GRADE may be adapted to assess the quality of evidence for prognostic research studies for a systematic review of the literature. To date, a formal system to guide researchers in assessing the evidence for prognostic studies has been lacking. Our adaptation is a first step in developing a systematic approach to evaluate the quality of evidence for prognostic research. We encourage these recommendations to be further developed and tested for GRADEing the quality of evidence when synthesizing findings from prognostic research studies. For instance, further guidance for reviewers is needed to decide when each of these GRADE factors causes the evidence to be down- or upgraded one versus two levels. At this stage, we leave this decision up to the judgment of the review teams to decide how much these factors impact the overall quality of evidence. Empirical research is also needed to explore our hypothesis that risk of bias detrimentally affects the factor-outcome relationship and what the strength of this relationship is.GRADE: Grading of recommendations assessment, development and evaluation.The authors declare that they have no competing interests.AH is the lead researcher of this project and wrote the first draft of the manuscript. AH, JAH, and MET formulated an initial proposal for the adaptation of the GRADE framework to prognosis research. JS, PJM, and CTC helped to reformulate this first proposal. AH, JAH, JS, PJM, CTC, MET and LW contributed significantly to the methodology, writing and revision of the manuscript. All authors read and approved the final manuscript.


Drug and health literacy is a key determinant of health outcomes. There are several tools to assess drug and health literacy. The objective of this article is to determine drug literacy level and its relationships with other factors using a single item screening tool. A cross-sectional survey was conducted among 1104 people in Qazvin province, Iran. Based on the proportional-to-size method, participants over 15 years old with ability to read were recruited randomly from 6 counties in Qazvin province and were interviewed directly. To determine drug literacy relationship with other variables, Chi-Square and t-test were used. Also, logistic regression model was used to adjust the relationship between drug literacy and other relevant variables. Response rate in clusters was 100%. Findings showed that inadequate drug literacy in Qazvin province is 30.3% and it was in association with (1) age (p = .000), (2) marital status (p = .000), (3) educational attainment (p = .000), (4) home county (p = .000), (5) residing area (p = .000), (6) type of basic health insurance (p = .000), (7) complementary health insurance status (p = .000), and (8) family socioeconomic status (p = .000). After adjusting for these variables using logistic regression model, the association between (1), (3), (4), (5) and (8) with drug literacy level was confirmed. The analysis also showed that this method can also be used in other health care settings in Iran for drug and health literacy rapid assessment.  The “health literacy” term was first used in the 1970s . According to The Patient Protection and Affordable Care Act, health literacy is defined as “the degree of capacity of individuals to obtain, process, and understand basic health information and services needed to make appropriate health decisions”,3. ObvioThere are some disagreements between researchers about the differences between literacy and health literacy and scope of each of them. Some researchers believe that health literacy is literacy in the health area, while some others think that health literacy and literacy are separate .Many studies have shown the prevalence of limited health literacy in countries . A studyEvidences have shown the relationships between health literacy and health status; amount and pattern of use of health services; knowledge and ability to manage chronic diseases and adherence to treatment and medication use . It is iMoreover, evidence has shown the relationship between inadequate health literacy and utilization pattern of health care services such as higher use of emergency health care services, lower use of preventive services, difficulties with medication dosages and understanding health messages ,14, repoIn medication field, 20- 50% of patients do not take their medication as their physicians have prescribed, which might lead to medication nonadherence. Inadequate health literacy had been considered as one of the most important key factors for medication nonadherence . More thOn the other hand, individuals with adequate health literacy can use their skills of reading, numeracy, and writing, for health-related subjects within the health-care settings . Strong link between education and health has led researchers to focus on reading skills and health related outcomes like health knowledge, medication adherence, and hospitalization rates , 20.There are many tools to assess health literacy  and 31 T1- Word recognition tests: Wide Range Achievement Test–Revised (WRAT-R), Rapid Estimate of Adult Literacy in Medicine–Short Form (REALM-SF), Short Assessment of Health Literacy for Spanish Adults (SAHLSA-50), and the Medical Terminology Achievement Reading Test (MART);2- Reading comprehension tests, which are mostly used in educational settings;3- Functional health literacy tests: Test of Functional Health Literacy in Adults (TOFHLA), and the Newest Vital Sign (NVS); and,4- Informal methods . Time is a very important component in assessing health literacy in the health care setting. Informal methods are the most common methods to assess health literacy. Usually, they consist of some questions to estimate health literacy level. In comparison with other methods, they need less time to be utilized . Chew anThe 3 Questions were:- “How confident are you in filling out medical forms by yourself?”,- “How often do you have someone help you read hospital materials?”, and- “How often do you have problems in learning about your medical condition because of difficulty in understanding written information?” Patients select 1 of 5 responses ranging from 1- Never to 5- Always , 32, 35.Wallace and colleagues suggested that 1 question of these 3 questions might be sufficient for detecting limited and marginal health literacy .Morris and colleagues designed a single question,“How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?”, to assess poor literacy level. They found that this method can assess limited health literacy moderately well in comparison with TOFHLA as gold standard . JeppsenMost studies in assessing health literacy are conducted in English speaking countries and it is essential to assess this subject in non- English countries as well. The purpose of this study is to assess drug literacy level in Qazvin province in Iran. The Single Item Literacy Screener (SILS) method was used to do this study.Materials and methodset al., method  of 1104 participants from both rural and urban areas in 6 counties  in Qazvin province during April 7 to June8, 2013. A questionnaire was designed to collect demographic data  as well a single question for assessing health literacy according to Morris, , method ;, and lack of any disability that can prevent reading. Data was collected in subsequent interviews with households (up to 5 times) by trained interviewers. If the interview attempts were unsuccessful, substituted random sample was used. Data collection method led to a response rate of 100%.Response choices of SILS were: 1-Never, 2-Rarely, 3- Sometimes, 4-Often, and 5-Always. Cutoff > 2 was used to identify limited drug literacy screening sensitivity. Scores greater than 2 were considered positive, which meant participant had inadequate drug literacy. To assess socioeconomic status of participants, a questionnaire with 30 items, was used. The data was analyzed using Principle Component Analysis (PCA) method  and 39 TThe results were analyzed using SPSS.V.16.0. Descriptive analyses were used to calculate frequencies and Chi-square test was used to examine the relationship between qualitative variables while t-test was used for quantitative variables. To determine the final associations between drug literacy level and effective variables, logistic regression model was used.1104 individuals participated in this survey who lived in 6 counties in Qazvin province: (Qazvin (584),Takestan(114), Boeen-Zahra (85), Alborz(217), Abyek(86), and Avaj(18). 47.7% of participants were female.20.7% lived in rural areas. Married participants were 72.6%. 85.6 % had basic health insurance. In addition, 37.3% had complementary health insurance. Job status showed that 43.7% of participants were employed. The maximum family size was 7. The mean age of participants was 34.7 years (SD 12.95). The mean of years of education was 9.8 years (SD 4.02), and participants with education less than high school diploma were 80.4%. 27.8% of participants were in weak socioeconomic status. Overall, 30.3% of participants had inadequate health literacy. Characteristics of the participants and their relationship with drug literacy (using Chi-Square and t-test) are shown in To adjust the relationships between relevant variables  in relationship with age, formal education level, and economic status, using logistic regression model analysis . Improvmc status . Gazmarac status . et al., stated the relationship between health literacy and age, education, gender, and language  were 5.7 times more probable to have inadequate drug literacy. Moreover, living in Avaj County is correlated with higher level of inadequate drug literacy in comparison with other counties in Qazvin province. As a result, drug literacy has a positive correlation with living in Abyek, Qazvin, Alborz, Boeen Zahra, and Takestan counties. It seems that living in a rural area increases the chance to have inadequate drug literacy nearly 2.3 times in comparison with living in urban areas. Finally, low socioeconomic status may increase inadequate drug literacy level nearly 3 times more compared to good socioeconomic status.drug literacy level is an important characteristic which can help people evaluate their own health situation properly. It can improve patients’ medical adherence, decrease their misunderstanding of pharmaceutical dosages, and prevent self-administration of medications.The authors recommend that the government supports drug literacy promotional programs in all educational levels and other fields of intervention such as primary health care settings, clinics, pharmacies, and hospitals, using all kinds of media.


Evidence-based medicine is an evolving new paradigm. With the advent of numerous new diagnostic techniques and therapeutic interventions, one needs to critically evaluate and validate them by appropriate methods before adopting them into day-to-day patient care. The concepts involved in the evaluation of diagnostic tests and therapy are discussed. For delivering the highest level of clinical care, evidence alone is not sufficient. Integrating individual clinical experience and patients’ perspectives with the best available external evidence is essential. Glaucoma is the second leading cause of blindness worldwide. As clini23An accurate perspective on the utility of the advances in the diagnosis and management of glaucoma necessitates that the published literature is critically appraised before accepting the recommendations and practicing them. The skills involved in performing an efficient literature search and applying formal rules of evaluation to the literature are new skills that a clinician requires.13The aim of this article is neither to elaborate on the principles of critical appraisal, nor present a summary of the existing literature on the diagnosis and management of glaucoma. We shall try and summarize the need for the skills for the practice of Evidence-Based Medicine (EBM) in glaucoma diagnosis and management with a few examples. Understandably, this will reflect our own perspective and biases in glaucoma management. As Sweeney said, “it is almost impossible for doctors to be clinically dispassionate or completely neutral about a topic.”et al. defined EBM as “integrating individual clinical expertise with the best available external clinical evidence.”[Sackett vidence.” The evidvidence.” The Cochvidence.” thus reiImaging of the optic nerve head and retinal nerve fiber layer are widely reported to be useful in glaucoma diagnosis. One coulGarway-Heath appropriately stated that “devices cannot diagnose our patients’ conditions, but the findings they provide frequently alter the probability that a subject has a particular condition.” Thus devThe principle behind the use of the LRs is the calculation of the increase in the probability for a given diagnosis given the prior probability of the disease  and the result of the diagnostic test with its LRs. This principle is applicable not only for the diagnosis of a disease but also for any event. This principle in mathematical terms is called the Bayesian theorem. Keeping the mathematics aside, the concept is very intuitive and we keep using this in our daily lives extensively, albeit without the mathematical calculations or the complex terminologies.For example, on a cloudy day during the rainy season, if it rains we say “it is bound to happen” and if it did not rain, one might say “that was very unlikely” or some such thing. If a 25-year-old, healthy, prospective army recruit ends up with an ST segment change on electrocardiogram (ECG), one would suspect the test or the machine, as the likelihood of this young, healthy man having ischemic heart disease (IHD) is very low. The same result in a 60-year-old gentleman with diabetes and hypertension with precordial discomfort on exertion would be a diagnostic sign of IHD. The prior probability of IHD is very high in the latter and very low in the former. This explains why the same test result is interpreted differently in different situations. The clinical use of the LR is exemplified in Figs. et al. They studied the reporting of 11 key methodological items in RCTs published in American Journal of Ophthalmology, Archives of Ophthalmology, British Journal of Ophthalmology, and Ophthalmology in the year 2005. Among the 67 eligible RCTs assessed, the mean number of items reported was 6.3 per RCT. Details on sequence generation, randomization restriction, allocation concealment, allocation implementation, patient-flow diagrams, and sample size calculation were reported in < 50% of the RCTs assessed. The authors concluded that similar to other specialties, room for improvement exists in the reporting of key methodological items of RCTs in clinical ophthalmic journals. A stricter adoption of the CONSORT statements might enhance the reporting quality of RCTs in ophthalmic journals.[RCTs are the best form of evaluating a therapy. To ensure that the methodological rigor required is followed, there are guidelines for reporting of RCTs called the CONSORT guidelines. How the Ophthalmic literature adheres to these guidelines was evaluated by Lai journals.et al. on the role of primary trans-scleral cyclophotocoagulation in the management of primary open angle glaucoma (POAG).[The possible bias in reporting the study results is exemplified in a study by Egbert a (POAG). The autha (POAG). A carefua (POAG). from theIn understanding and putting into perspective the results of a therapeutic trial, we need to understand the following terms: relative risk reduction (RRR), absolute risk reduction (ARR), and the number needed to treat (NNT). In the ocular hypertension treatment study (OHTS), the risk of conversion of ocular hypertension (OHT) to glaucoma after a 4-year follow-up was 9.5% in the untreated group and 4.4% in the treated group. The benehomogeneity describes the goal of randomization in a clinical trial, then the word heterogeneity describes the patient population we see in our practices.[In the practice of EBM, we should not lose sight of the fact that all these efforts in creating evidence and practicing EBM are for the benefit of the patient. While the best evidence comes from an RCT or a meta-analysis of RCTs, we need to remind ourselves that an RCT is about the intervention and not the patient. If the word ractices. We need ractices. A succesractices.It is important that evidence is not the sole criterion; one needs to compare the risks and benefits, consider the inconvenience and costs as well as patients’ values, and finally the hierarchy of evidence. The importance of EBM should not result in diluting the time-honored craft of caring for the sick. The tools of evidence-based practice are essential but they alone cannot ensure the ability to deliver the highest quality patient care. The highest level of care also requires compassion and an understanding of the patient’s personality, socioeconomic limitations, and cultural values and not just the clinical and surgical skills or the tools of evidence-based practice. Glaucoma is a chronic asymptomatic condition, wherein our understanding of the role of the only treatable parameter  in preventing visual disability is limited. Further,In conclusion, EBM is a great path to enhance the care of our patients. If we understand the nuances of EBM, we will decide what is best for the individual patient in our care rather than extrapolate the recommendations for the average patient from the most recent RCT as taught by the expert or packaged by the industry.


In the third paper in a three-part series on health systems guidance, Simon Lewin and colleagues explore the challenge of assessing how much confidence to place in evidence on health systems interventions. Assessing how much confidence to place in different types of research evidence is key to informing judgements regarding policy options to address health systems problems.Systematic and transparent approaches to such assessments are particularly important given the complexity of many health systems interventions.Useful tools are available to assess how much confidence to place in the different types of research evidence needed to support different steps in the policy-making process; those for assessing evidence of effectiveness are most developed.Tools need to be developed to assist judgements regarding evidence from systematic reviews on other key factors such as the acceptability of policy options to stakeholders, implementation feasibility, and equity.Research is also needed on ways to develop, structure, and present policy options within global health systems guidance.PLoS Medicine on health systems guidance.This is the third paper in a three-part series in This is one paper in a three-part series that sets out how evidence should be translated into guidance to inform policies on health systems and improve the delivery of clinical and public health interventions.Health systems interventions establish or modify governance , financial  and delivery  arrangements, and implementation strategies  within health systems  approach to assessing confidence in estimates of effects  and to grading the strength of recommendations on policy options for health systems interventions;Discuss factors that are important when developing recommendations on policy options regarding health systems interventions.Users of such evidence almost always draw implicit or explicit conclusions regarding how much confidence to place in evidenceSuch evidence may inform judgements regarding recommendations, including the strength of such recommendationsfacilitating critical appraisal of evidenceprotecting against biasclarifying implementation issuesresolving disagreements among stakeholderscommunicating information regarding the evidence, the judgements made, and recommendations drawn from itSystematic and explicit approaches can be useful in: Systematic and explicit approaches are particularly important given the complexity of many health systems interventions. These interventions may be complex in terms of the number of discrete, active components and the interactions between them; the number of behaviours to which the intervention is directed; the number of organisational levels targeted by the intervention; the degree of flexibility or tailoring permitted in intervention implementation; the level of skill required by those delivering the intervention; and the extent of context dependency Source: adapted from The first paper in this series makes a case for developing guidance to inform decisions on health systems questions and explores challenges in producing such guidance and how these might be addressed In this paper, which like the other two papers is based on discussions of the Task Force on Developing Health Systems Guidance , we focuThe Task Force on Developing Health Systems Guidance was established in 2009 by the World Health Organization (WHO) to improve its response to requests for guidance on health systems.The Task Force consisted of 20 members selected by WHO for their expertise in the field of health systems research and implementation.Handbook for Developing Health Systems Guidance and to the identification of broader issues that warranted further dialogue and debate Through a series of face-to-face and virtual meetings, the Task Force provided input to and oversight of the development of a As part of this process, the Task Force and the Handbook developers reviewed approaches to developing clinical guidelines and the instruments used for clinical guideline development.The Task Force suggested ways in which some of these approaches and instruments could be adapted for use in the development of health systems guidance and indicated where there were important differences between these approaches.The writing group for this paper further considered the issues raised in these discussions and produced a first draft of the manuscript for comment by the Task Force.This paper, and the other two in the series Well-conducted systematic reviews Many tools are available to assess the risk of bias in individual studies of the effects of interventions http://www.gradeworkinggroup.org.) We will discuss the application of the GRADE approach to assess the quality of evidence and the strength of recommendations for health systems interventions later.Tools to assess how much confidence to place in review findings are most developed for systematic reviews of evidence on effectiveness. The GRADE approach is one such tool, but many others are available Tools to assist judgements on how much confidence to place in the findings of reviews of questions other than effects that are relevant to the policy-making process are at an early stage of development. Such questions include stakeholders' values and preferences and the feasibility of interventions . For somReviews exploring factors affecting the implementation of options might employ mixed methods syntheses  such as realist synthesis Resource use is another key issue, and tools are available to assess the reliability of reviews of economic studies The GRADE approach clearly separates two issues: the quality of the evidence and the strength of recommendations. Quality of evidence is only one of several factors considered when assessing the strength of recommendations.Within the context of a systematic review, GRADE defines the quality of evidence as the extent to which one can be confident in the estimate of effect. Within the context of guidelines or guidance, GRADE defines the quality of evidence as the confidence that the effect estimate supports a particular recommendation. The degree of confidence is a continuum but, for practical purposes, it is categorised into high, moderate, low, and very low quality .Evidence on the effectiveness of health systems interventions raises a number of challenges that may, in turn, influence assessments of the quality of this evidence and the development of recommendations using the GRADE approach. Firstly, while experimental studies :Whether there is uncertainty about the balance of benefits versus harms and burdensThe quality of the evidence from the systematic review Whether there is uncertainty or variability in values and preferences among stakeholdersWhether there is uncertainty about whether the net benefits are worth the costs or about resource useWhether there is uncertainty about the feasibility of the intervention Additional factors that it may be useful to consider for health systems interventions:Ease of implementation at the systems level, including governance arrangements , financial arrangements , and implementation strategies Socio-political considerations, e.g., how the proposed options relate to existing policies, values within the political system in relation to issues such as equity or privatisation, and economic changesWithin the GRADE approach, recommendations reflect the degree of confidence that the desirable effects of applying a recommendation outweigh the undesirable effects. Specifically, a strong recommendation implies confidence that the desirable effects of applying a recommendation outweigh the undesirable effects, whereas a conditional/qualified/weak recommendation suggests that the desirable effects of applying a recommendation probably outweigh the undesirable effects, but there is uncertainty.GRADE attempts to make all judgments regarding the factors that are considered in developing recommendations transparent (by documenting these judgments) and systematic . The move from an assessment of the quality of evidence to making recommendations on policy options involves a number of challenges. Firstly, assessments of the strength of a recommendation may require a detailed understanding of the evidence creation and evaluation process that is not always available. Secondly, categorising recommendations as “strong” and “weak” can raise difficulties. Panels developing global guidance may, for example, be reluctant to make “weak” recommendations in case policy makers fail to respond to such recommendations because they assume they are equivalent to “no recommendation”. Thirdly, the quality of evidence is typically assessed for two alternative policy options in tools such as GRADE, while many health system  involve multiple interventions, which adds to the complexity of interpretation and decision-making and makes it even more important to be transparent.http://www.decide-collaboration.eu) collaboration on ways of presenting information on GRADE assessments and policy options to policy makers.How might some of these challenges be addressed? Methodological expertise is needed to conduct and interpret systematic reviews and perform assessments using tools such as GRADE. Health systems guidance panels therefore need to be supported by methodology experts. Moreover, the outputs of these tools need to be “translated” into appropriate language and formats to ensure that they can be interpreted and used correctly by the panel. Research is under way within initiatives such as the DECIDE  that are needed to develop recommendations regarding health systems interventions Finally, international standard-setting organisations, such as WHO, have to formulate recommendations that are applicable at a global level. However, as noted earlier, creating global recommendations on health systems questions can be difficult because of important variations in context-specific factors that influence the applicability of interventions at national and sub-national levels http://www.decide-collaboration.eu/work-packages-strategies). Importantly, global guidance should always indicate the factors that should be considered to assess the implications of variations in intervention, context, and other conditions. Decision models may be useful in exploring the effects of these variations  for presenting the available evidence to such groups. In addition, efforts are needed to build the capacity of policy makers to use evidence to inform their decisions Useful tools are available for grading quality of evidence and strength of recommendations on policy options regarding health systems interventions, but several challenges need to be addressed. Firstly, these tools involve judgements, and these need to be made systematically and transparently. Secondly, for many health systems questions, evidence is still likely to be of low quality. Better quality research in these areas is needed and would allow guidance panels to have more confidence in the evidence and to issue stronger recommendations. Thirdly, research is needed on ways to develop, structure, and present policy options for consideration within global health systems guidance. These options need to include evidence on health and political system factors and implementation considerations, and tools to assess such evidence need to be refined. Finally, greater attention needs to be given to how guidance on health systems interventions may be implemented at the local level.Alternative Language Summary Points S1Translation of the Summary Points into Spanish by Xavier Bosch-Capblanch(DOC)Click here for additional data file.Alternative Language Summary Points S2Translation of the Summary Points into French by Bruno Clary, William Lenoir, and Lise Beck(DOC)Click here for additional data file.Alternative Language Summary Points S3Translation of the Summary Points into Portuguese by Bruno Viana(DOC)Click here for additional data file.Alternative Language Summary Points S4Translation of the Summary Points into Arabic by Fadi El-Jardali(DOC)Click here for additional data file.Box S1Definitions of terms used in this paper(PDF)Click here for additional data file.Table S1Types of systematic reviews needed for different steps in the policy-making process and the availability of tools to assess how much confidence can be placed in the evidence presented in these reviews(PDF)Click here for additional data file.Table S2GRADE criteria for assessing the quality of evidence for each important outcome assessed in a systematic review of effects(PDF)Click here for additional data file.Table S3Strengths of the GRADE approach(PDF)Click here for additional data file.Table S4Assessing how much confidence can be placed in the findings of systematic reviews of qualitative studies(PDF)Click here for additional data file.Table S5Definitions of the quality of evidence categories within GRADE(PDF)Click here for additional data file.Table S6Example of factors affecting decisions about strength of recommendations—Changes in user fees in low- and middle-income countries(PDF)Click here for additional data file.Table S7Example of factors affecting decisions about strength of recommendations—Continuing education programmes for rural health workers to support their retention(PDF)Click here for additional data file.