2021 Evidence Foundation Scholar Receives Health Equity Travel Scholarship

The Evidence Foundation is proud to announce that spring 2021 GRADE Workshop Scholar Ifeoluwa Babatunde, Pharm.D, MS, received the 2025 Encoding Health Equity Summit Travel Scholarship for Patients and Emerging Leaders, an opportunity made possible by Doris Duke Foundation and the Council of Medical Specialty Societies (CMSS). 

About her experience at the summit, Babatunde shared,

"The Encoding Equity conference was an enriching experience for me. I found it quite inspiring to hear about the diverse initiatives and research projects geared towards achieving health equity. Hearing from biomedical researchers, clinicians, public health providers, guideline developers, and medical societies truly showcased the depth of work in this field.

"My personal takeaway from the conference was on the power of collaboration. Successfully achieving the central goal of health equity integration would require all stakeholders, from providers & researchers to members of the very communities we aim to impact, actively sharing their perspectives. By engaging in consistent mutual learning, we can inspire innovation and translate our findings to actionable change across the entire medical ecosystem.

"As someone in guideline development, I particularly resonated with the work being done on pioneering a 'Population Conscious Analysis' approach to handling race and ethnicity as a variable in biomedical research. This innovation has me very optimistic about the positive impact it will have on new and existing quality appraisal tools being used in evidence synthesis.

"Lastly, I enjoyed engaging in discussions with poster presenters working on projects closely aligned with that of my team. Specifically, those focused on creating a race-conscious framework for for guideline development. These discussions reinforced the significant impact of the work we are engaged in."

Open the doors to opportunity:

Interested in contributing to the future of evidence-based medicine? Become an Evidence Foundation Scholar and attend our upcoming virtual fall workshop (October 29-31, 2025) for free. Application close August 31, 2025. See evidencefoundation.org/scholarships.html 

for application details.

GRADE Guideline Development Workshop - now with INGUIDE!

We at the U.S. GRADE Network are excited to announce that, for the first time ever, we have partnered with INGUIDE, a credentialing system for guideline developers, to offer free access to their Level 1 online training to participants of our Guideline Development Workshop and Guideline Fundamentals for Panel Members and Organization Staff pre-workshop course. 

This announcement comes just in time for our next workshop, held in Austin, Texas May 17-19, for which there are still spots available at our workshop website.

The INGUIDE program, the result of a collaboration between the Guidelines International Network (G-I-N) and McMaster University, provides certification of individuals involved in guideline development on four successive levels, from a Guideline Panel Member to becoming a Guideline Development Credentialing Instructor themselves. 

To obtain access to the INGUIDE Level 1 course, simply register for and attend our 3-day GRADE guideline development workshop in addition to the pre-workshop course on Guideline Fundamentals for Panel Members and Organization Staff. This 3-hour pre-workshop course will cover all of the necessary information about the practical aspects of guideline development, including:

• the importance of trustworthy guidelines
• checklists for the development of guidelines
• the structure and roles of a guideline panel
• the process of grading evidence and formulating recommendations

The main 3-day workshop will cover important aspects of assessing risk of bias, rating the certainty of evidence, and considering other important factors when using GRADE to develop a guideline.

Our pre-workshop course combined with our main three-day in-person course will provide all of the training required for a breeze-through experience online. You will receive free access to the ~2-3 hour online course, comprising four modules, that you can complete at your convenience after the workshop. Upon completion, you will be officially certified as an INGUIDE Level 1 Guideline Panel Member.

Why We Can't Wait for Our Austin Workshop

The U.S. GRADE Network's 18th workshop is just five weeks away! With a focus on assessing certainty of evidence informed by non-randomized studies, this workshop will take place in Austin, Texas - the home of Austin City Limits, the famous Bat Bridge, and some next-level barbecue joints.

We asked some of the workshop facilitators about what they're looking forward to about the trip (besides the chance to talk about GRADE and evidence-based medicine for three days straight!) Here's what they said...

Limited space remains for the workshop. Learn more and register and www.gradeconf.org. 

2022 Recap and What's Next for the U.S. GRADE Network

Thanks to you, 2022 was one of our best years yet.

We were relieved to see you in person, our first time since 2020, at our spring workshop in Chicago last June! Then, we reconvened online for a virtual workshop in November. Overall, we hosted over 100 participants from around the world, stretching from Canada and Spain to Colombia and Sweden. 

Facilitators and participants at the spring 2022 GRADE guideline development workshop in Chicago, IL - the first in-person USGN workshop since March 2020.

We also launched our new two-day virtual Systematic Review workshop offering and welcomed another 48 learners, including a record 13 scholars from across the globe!

We published our takeaways from our early experiences moving our workshop online in response to the Covid-19 pandemic in BMJ Evidence-Based Medicine, which you can read about here.

Finally, we launched the USGN Webinar Series and will host regular free webinars on all things GRADE. For our inaugural session, we were joined by Drs. Gordon Guyatt and Reem Mustafa. You can watch the recording and subscribe to our new YouTube channel here. 

We look forward to seeing you at our 18th Guideline Development Workshop, in person in sunny Austin, Texas, May 17-19, 2023! The workshop will have a special focus on assessing the certainty of evidence informed by non-randomized studies. Registration is now open.

From Risk of Bias to Living Evidence, Fall 2022 EF Scholars Present on Cutting-Edge EBM Projects

During our 17th GRADE Guideline Development Workshop, held virtually, the U.S. GRADE Network had the honor of introducing the three latest recipients of the Evidence Foundation scholarship to the virtual stage. On the third and final morning of the workshop, each scholar presented on their current projects to reduce bias in healthcare and move the field of evidence-based medicine methodology forward. 

Abrar Alshorman, MBBS, presented on her work to examine the tools used to assess risk of bias across various types of evidence. As choosing the wrong risk of bias tool at the start of an evidence synthesis effort might waste time and disrupt workflow, her project aims to guide systematic reviewers in choosing the best tool to use. The resulting list includes risk of bias tools for use in primary studies that were identified in a search of the evidence, including those with applications in randomized, non-randomized, diagnostic test accuracy, prognosis, and qualitative bodies of evidence. 

"The workshop struck the perfect balance between informative and interactive," said Alshorman. "[A]ll sessions have been extremely informative and provided by very knowledgeable presenters. This opportunity offered me insight into the key concepts of the GRADE approach for guideline development. I look forward to incorporating the information I've learned into practice."

Next, Brett Norling, a third-year medical student, discussed his project examining the use of the GRADE framework in systematic reviews in urology. The project reviewed literature published in the top 5 urology journals since 2000, using Perl programming code to identify articles using GRADE. The team then applied a 37-item checklist developed de novo from the "Criteria for Applying or Using GRADE." The results demonstrated that while most (95.8%) of the included reviews correctly applied GRADE on an outcome-level basis, nearly one-third (31.4%) of the 70 reviews summary of findings, evidence profile, or other from of table to present their findings.

"I came to the GRADE Workshop having performed a systematic review and a few other research projects regarding systematic review methodology," said Norling. "I felt that my understanding of GRADE was in the developing stages, though it felt a bit abstract prior to the workshop. Key GRADE principles of evidence assessment came to life as I worked with a small group to assess a body of evidence and arrive at a recommendation. I now feel well equipped to confidently assess evidence and perform systematic reviews with a greater level of autonomy than prior to this workshop."

Finally, Ariadna Alaudell-Rispau, a PhD candidate in the Biomedical Research Methodology and Public Health Doctoral Program at the Autonomous University of Barcelona, presented her proposal for the development of Living Evidence Structures Summaries (LESS). Auladell-Rispau described her project to lead a multi-design, iterative study that allows for a systematic and rigorous development of a "Living Evidence updates reporting model" that "accounts for the periodic and/or constant updates of the evidence syntheses developed under the Living Evidence model, permits the development of valid, reliable, and updated health information to health decision makers, including guideline or [health technology assessment] developers..., [and is] friendly and accessible." The project will include a systematic review, brainstorming meetings, a Delphi consensus process, and finally, testing and assessment of the newly developed model.

We look forward to updating the blog about these projects as they move forward!

ANNOUNCEMENT: Applications for the Spring 2023 GRADE Guideline Development Workshop, held in Austin, Texas, May 17-19, 2023, are due February 28th! Learn more about the application requirements here and read about the workshop details here.

U.S. GRADE Network Describes Experience Moving to All-Virtual Workshop Format

On March 4-6, 2020, the U.S. GRADE Network held an in-person workshop in Phoenix, Arizona, much like any of the 11 workshops to have come before it. Participants and facilitators enjoyed a taco buffet bar together at the first night's reception, sat together in small and large rooms to learn and collaborate, and mingled over coffee and pastry refreshments during breaks.

One week later, the World Health Organization announced that COVID-19 had reached pandemic proportions. 

Over that summer, the USGN took our workshops online, hosting three consecutive fully virtual workshops in October 2020, May 2021, and October 2021. While some changes were made (the addition of multiple, 45-60 minute breaks, for instance, to accommodate eating times in multiple time zones), much of what lay at the heart of a GRADE workshop remained: a three-day format  including plenary lectures from PICOs to recommendations, presentations by Evidence Foundation scholars, and small-group, hands-on experiential learning opportunities.

The USGN's shift to an all-virtual setting, and its challenges as well as opportunities for growth, are presented in a new paper by Siedler and colleagues published online in the BMJ Evidence-Based Medicine journal. Using routine feedback survey data collected both before and after the pandemic, the authors (all GRADE workshop facilitators) found that...

• Perceived understanding of GRADE improved to the same extent in virtual and in-person formats,
• At least half of attendees (54-62%) indicated that the virtual format was important for their ability to attend, and
• Participants indicated a high degree of workshop satisfaction and perceived educational value. Similar results were observed for the level of knowledgeability of speakers, value of plenary sessions, and helpfulness of small-group sessions.

The major takeaway from the USGN's experience in an all-virtual format is that, based upon positive feedback and the ability to reach a global audience of learners, it will continue to offer learning opportunities in a virtual setting this year and beyond.

In fact, the next all-virtual workshop will take place November 30-December 2, 2022, and registration is now open at www.gradeconf.org.

Siedler MR, Murad MH, Morgan RL, et al. (2022). Proof of concept: All-virtual guideline development workshops using GRADE during the COVID-19 pandemic. BMJ Evidence-Based Medicine (online before print). Manuscript available from publisher's website here.

Spring 2022 Scholars Discuss Developments in Diagnostic and Environmental Health Evidence

The USGN's 16th GRADE Guideline Development Workshop, held in Chicago, was the first to be held in-person since March of 2020. In classic USGN style, participants enjoyed vibrant conversation, hours of learning, and delicious yogurt parfaits and strong coffee during morning breaks.

Two participants joined the fun and learning as part of the Evidence Foundation scholarship program, presenting to fellow attendees about their current projects related to evidence synthesis and guideline development. 

Spring 2022 Evidence Foundation scholars Kapeena Sivakumaran and Ibrahim El Mikati, center, pose for a photo between sessions in Chicago with the U.S. GRADE Network faculty (from left to right: Reem Mustafa, Philipp Dahm, Shahnaz Sultan, Yngve Falck-Ytter, Rebecca Morgan, and Hassan Murad).

Ibrahim El Mikati, a post-doctoral research fellow in the Outcomes and Implementation Research Unit at the University of Kansas Medical center, discussed his project helping to develop guidance for judging imprecision in diagnostic evidence. This approach will utilize thresholds for confidence intervals and will also introduce the concept of optimal information sizes for assessing imprecision in the context of diagnostic guidelines.

One thing that the GRADE workshop has helped me appreciate is transparency," said Ibrahim. "Having a transparent explanation of judgments provides users with trustworthy guidelines."

Kapeena Sivakumaran is currently leading two systematic reviews for Health Canada related to the impact of noise exposure and sleep disturbance on health outcomes. Challenges of these projects include a focus on short-term outcomes in the relevant literature as well as the need to incorporate multiple evidence streams, such as mechanistic data that can be interpreted in conjunction with observational evidence. 

“The workshop provided me with valuable insight into guideline development and using the GRADE approach to assess the evidence," said Kapeena. "One new thing I learned from the workshop was how automation and [artificial intelligence] can be integrated into the process of living systematic reviews to support guideline development.”

Note: applications for scholarships to attend our upcoming systematic review and guideline development workshops, held virtually, close August 12th and September 30th, 2022, respectively. See application details here.

2021 Reflections Before a Big Year Ahead

 From all of us at the U.S. GRADE Network, thanks for making 2021 a year to remember.

• We hosted our 14th and 15th workshops virtually - meaning we had the joy of talking GRADE with 95 attendees from many corners of the world, including Spain, Argentina, Pakistan, and Peru.
• We co-published an international needs assessment of guideline-producing organizations in collaboration with the Guidelines International Network.
• We announced our first ever two-day comprehensive systematic review workshop scheduled to be held virtually this coming February 1-2. Learn more and register here.
• And we continue to look forward to hosting our 16th guideline development workshop, once again live and in person, from June 29-July 1, 2022, in Chicago, Illinois. Registration now open.

GRADE faculty take a moment to pose for a picture with some attendees of the fall 2021 virtual guideline development workshop.

Stay tuned for more.

To stay up-to-date on all future news, events, and research round-ups from us, make sure to follow us on Facebook, twitter, and LinkedIn.

Thanks again for an excellent year, and our best and brightest wishes for a brilliant 2022.

Evidence Foundation Welcomes Four Scholars in First Virtual Workshop

In late October, the U.S. Grade Network held its thirteenth GRADE Guideline Development Workshop. Like any of the twelve workshops before it, there was much learning, discussion, and networking to be shared. However, unlike any workshop in the past, it was fully online.

Among the 45 attendees who participated in offices and living rooms from Brazil to Cyprus were four participants who attended the workshop free of charge as recipients of the Evidence Foundation scholarship. During a virtual Evening with the Fall 2020 Evidence Foundation Scholars, these four bright minds presented briefly on a proposal or current project designed to reduce bias in healthcare.

Dr. Stavros Antoniou, Chair of the European Association for Endoscopic Surgery Guidelines Subcommittee, discussed the tripartite Guideline Assessment Project (GAP) aimed at developing an extension of the AGREE II tool for surgical guidelines. In an exploratory analysis published earlier in 2018 (GAP I), Antoniou and colleagues assessed 67 surgical guidelines and reported that development of more than one guideline per year, the presence of a guideline committee, and the use of GRADE was associated with higher scores in AGREE II. Second, the group explored the reliability, internal consistency, and unidimensionality of the AGREE II tool when applied to surgical guidelines (GAP II). The group is now in the process of using the Delphi process to identify and finalize items for the surgical extension based on stakeholder input, pilot-testing the instrument, and assessing its validity (GAP III). Of the workshop. Dr. Antoniou noted, "participating in the GRADE Guideline Workshop as a scholar was an inspirational experience. It was fascinating to be trained by world-renowned experts, who have embraced us with true interest and conveyed their passion with quality in guideline development."

Jung Min Han, PharmD, MS, manages the development of guidelines for the American Academy of Dermatology. Her presentation reviewed her current project to update the organization's 2016 guidelines on the management of acne vulgaris using the GRADE framework. Ms. Han discussed the plan to organize two working groups, one to review and update the nine clinical questions from the previous guidelines, and the other to add additional new questions as needed. An updated search would then be run for the first set of questions to identify any newly published evidence since the original guidelines were developed; simultaneously, a novel systematic search would be conducted for the second group of questions. New recommendations would then be drafted following the GRADE methodology. Ms. Han stated, "The GRADE Workshop has trained me to confidently use GRADE in different scenarios where head-to-head data from randomized controlled trials are not available. The workshop was very well-structured with a concrete theme and a mix of lectures, small and large group discussions, meet the experts Q&A sessions, and real-world examples that challenged trainees in many ways."

Dr. Georgios Schoretsanitis of Zucker Hillside Hospital in Glen Oaks, New York presented on his work developing guidelines for therapeutic drug monitoring to optimize and tailor treatment for psychotherapeutic medications. Beginning in 2017, a series of recommendations for reference ranges for two commonly prescribed antipsychotic medications was developed, followed this year by an international joint consensus statement on blood levels to optimize antipsychotic treatment in clinical practice. "For long I have been interested in conducting systematic reviews and meta-analyses," said Dr. Schoretsanitis. "Attending the GRADE Guideline Workshop organized by the US GRADE Network gave me exactly what I was looking for: a unique chance to essentially deepen my knowledge on major methodological aspects during stimulating lectures by experts that have set the tone in the field. It was an intense experience far beyond acquiring knowledge, which I highly suggest to every methodologist."

Dr. Zeinab Hosseini, a Saskatchewan Health Research post-doctoral fellow at the University of Saskatchewan, discussed her work examining the impact of exercise interventions on osteoporosis. Because gender and sex affect the prognosis and management of the disease, guidelines that consider these differences are needed, she said. As part of her research under the advisement of Dr. Phil Chilibeck, she hopes to contribute further understanding in the field related to gender- and sex-specific considerations for exercise recommendations in patients with osteoporosis, and to help inform future guideline recommendations on this topic. "The US GRADE Network Workshop was an amazing opportunity for me as a post-doctoral fellow in health proving insight on how to think as a health researcher from early stages of research up to knowledge translation and dissemination and how to provide evidence-based recommendations to inform the public considering situations where the literature is scarce," said Dr. Hosseini. "There are top women and men scientists on the training panel who respond to questions using their experiences as member on different panels, which I think is unique."

The USGN facilitators pose for a virtual group photo with the four fall 2020 Evidence Foundation scholars. Click to enlarge.

The Evidence Foundation thanks all four scholars for attending and contributing their engagement and expertise to our 2020 fall workshop.

If interested in applying for a scholarship to future GRADE workshops, more details can be found here: https://evidencefoundation.org/scholarships.html. Please note the deadline for applications to our next workshop in Chicago, Illinois will be February 28, 2021.

Spring 2020 - Scholarship Recipients

Earlier this month, the U.S. GRADE Network welcomed 51 participants to the Twelfth GRADE Guideline Workshop in sunny Phoenix, Arizona. Two participants, Giulia Lane and Hayley Dunnack, were awarded a scholarship from the Evidence Foundation that covered their workshop registration fee. As the two latest additions in a line of over 40 Foundation scholars since 2014, Lane and Dunnack presented to their fellow participants about their projects related to improving the use of evidence-based decision-making in healthcare.

Hayley Dunnack, left, and Giulia Lane, right, were the recipients of the Evidence Foundation scholarship for the spring 2020 GRADE workshop held in Phoenix, AZ

Hayley Dunnack: Opportunities and Challenges in Guidelines for Nursing Practice

Hayley Dunnack, BSN, CMS-RN, OCN is a PhD candidate at the University of Connecticut School of Nursing. Dunnack presented on her work with the Oncology Nursing Society (ONS) to develop guidelines on symptom management for patients with cancer. Currently, ONS has several projects underway to develop guidelines on symptom management based on systematic reviews of the evidence and using GRADE guideline methodology. A current challenge in the ONS’ guideline development relates to the development of guidelines on topics for which randomized studies are sparse or difficult to conduct, such as the management of hypersensitivity reactions or the use of vascular access devices.  Dunnack’s project aims to examine the use of non-randomized and “real-world” evidence to inform the development of rigorous guidelines based on systematic reviews and using the GRADE process.

“I had an incredible experience at the GRADE Guideline Development Workshop,” said Dunnack. “From the didactic material to the small group sessions, there was so much to learn. The ability to network with other professionals and hear their viewpoints added immensely to the experience."

Dunnack and Lane pose with Dr. Shahnaz Sultan of the U.S. GRADE Network

Giulia Lane: Shared Decision-Making in Urology Guidelines

Dr. Giulia Lane is a urology fellow at the University of Michigan. Lane’s project examines the current uptake and opportunities for improvement in the use of shared decision-making aids in the field of urology. Although shared decision-making aids are a critical step of assessing patients’ values and preferences, Lane explained, they are not commonly used in the field of urology. While almost everyone completes the initial step of informing patients about treatment options, exploring individual preferences is less frequent, and of the 29 American Urological Association (AUA) guidelines reviewed by Dr. Lane, only 12 mention shared decision-making at all. Of those guidelines that mentioned shared decision-making by name, only seven (58%) further described the process. Clinicians in urology, Dr. Lane concluded, are not provided support or encouragement to use shared decision-making in their practice. However, this appears to be changing: shared decision-making was mentioned in 2019 guidelines nearly eight times as often as those published in 2010.

In contrast to what is commonly believed, shared decision-making does not take more time once clinicians are trained. Clinicians should consider providing ready-made online modules to patients to review ahead of their visit, further reducing the time required to improve patient engagement and understanding of their treatment options. Dr. Lane’s work provides a baseline assessment of the use of shared decision-making in urology and will help inform the direction of future research in this area.

“I felt that the best part of the GRADE workshop was the small-group setting with intimate access to experts in the field,” said Dr. Lane. “The networking opportunities were exceptional and I met several people with whom I plan to collaborate. The people I met at the GRADE workshop and the transfer of ideas were the most important take away point for me.”

If interested in applying for a scholarship to future GRADE workshops, more details can be found here: https://evidencefoundation.org/scholarships.html. Please note the deadline for applications to our next workshop in Chicago, Illinois will be July 31, 2020.

Evidence Foundation Scholar Update

Contributed by Janice Tufte, 2019 Evidence Foundation Scholar & Madelin Siedler, 2019/2020 U.S. GRADE Network Research Fellow

Janice Tufte, an independent consultant and a leader in patient-public partnership initiatives, received a scholarship to attend the tenth GRADE guideline development workshop held in Denver, Colorado in February 2019 (blog post here). As part of her scholarship, Tufte presented to the larger workshop group on the unique opportunities of using patient partners during the development of GRADE guidelines.

Spring 2019 scholarship recipients: Dr. Irbaz bin Riaz (L) and Ms. Janice Tufte (R)

Tufte has worked with the American College of Physicians as a public panel member on multiple guidelines in addition to serving as a panel member of their Clinical Guidelines Committee. In these roles, she has provided input on outcomes of importance and on future topics for guideline development and is listed as a co-author on recent guidelines and guidance statements. She has also presented to groups on the basics of guideline development including fellow ambassadors of the Patient-Centers Outcomes Research Institute (PCORI).

Recently, Tufte co-published a protocol for the development of guidance for multi-stakeholder engagement (MuSE) in health and healthcare guideline development and implementation. The forthcoming guidance will be based on four different systematic reviews, including an examination of the current barriers and opportunities for stakeholder involvement in the guideline development process and the effect of stakeholder engagement on resulting guidelines and their implementation. The project will ultimately provide recommendations for ways to improve stakeholder engagement.

Here, Tufte provides an update on her work to continue to promote patient involvement in guideline development, including the use of GRADEpro software for these purposes.

My first exposure to the GRADE process and subsequent utilization of the GRADEpro platform genuinely captured and kept my attention. I quickly realized how beneficial both the Evidence to Decision and Summary Tables could be to public patients involved with systematic reviews, guideline development, and recommendations. I could view the overall landscape and better comprehend the pertinent information and findings in the EtD and Summary table that I needed as a non-scientist, allowing me to contribute more effectively in a meaningful manner in a panel conversation on evidence, recommendations or judgements.

GRADEpro is a versatile and modifiable online format. We are able to create a foundation based on the specificities and needs unique to our individual question that will then display the evidence and quality syntheses in a neat table as well as a reliable summary. Having diverse stakeholders at the table is important. Encouraging all to bring in the public and patient perspective is my particular favorite niche, and I will continue to promote this no matter the topic area.

I have recently enjoyed working with the new GRADEpro extensions while serving on a guidelines panel, where we have incorporated GRADE infographics. One challenge I have discovered is synthesizing the information down to an easy understandable one-pager for both clinicians and public reading.

I am looking forward to working with GRADE in the future, with a goal to better deliver reliable, understandable evidence to all who could benefit.

Stay tuned for future updates regarding Janice’s continued work in promoting patient engagement in guideline development.

If you are interested in learning more about GRADE and attending the workshop as a scholarship recipient, applications for our upcoming workshop in Chicago this October are open. The deadline to apply is July 31, 2020. Details can be found here.

Don’t Sell Your Guideline Short – Remember to Report! (Part 1)

Contributed by Madelin Siedler, 2019/2020 U.S. GRADE Network Research Fellow

The development of a high-quality, evidence-based clinical guideline is no small feat. It requires significant time and effort from content experts, methodologists, and organizational staff and typically takes more than 1-2 years from start to finish.

Given the effort and hours that go into guideline development, it’s all too easy - and all too common - for the reporting of the development process of these guidelines to significantly undersell their quality. This is important, because published analyses assessing the quality of guidelines will likely only use what is reported or referenced in the text of the guideline. In other words, guidelines that do not adequately report on the methods they used to develop their recommendations will be under-appraised in the published literature – and this could lead to a gross underestimation of a guideline-developing organization’s work as a whole.

Quality and Reporting Standards: A Brief Review

Over the past decade, a number of standard sets, reporting checklists, and appraisal tools have been published to assist guideline developers in the reporting of their methods and to provide ways for researchers to assess the quality of these guidelines. These standards and methods of appraisal include but are not limited to:

• The Appraisal of Guidelines for Research and Evaluation (AGREE) II tool (2010)
• the National Academy of Medicine (formerly the Institute of Medicine [IOM]) Standards for Trustworthy Clinical Practice Guidelines (2011)
• the Guideline International Network (G-I-N) Key Components of High-Quality and Trustworthy Guidelines (2012)
• World Health Organization (WHO) Handbook for Guideline Development (2nd ed., 2014)
• Reporting Items for practice Guidelines in HealThcare (RIGHT) Statement (2017)

Report, or it didn’t happen.

A guideline may be developed using the most water-tight, rigorous methods, but if these methods are not adequately described either in the text of the guideline or in a referenced external text, then an assessor will likely under-appraise the quality of a guideline. To ensure the most accurate appraisal of a guideline possible, guideline developers should consider the following helpful tips:

• Create a guideline template including boilerplate text that meets as much reporting criteria as possible, such as a general description of the systematic review and recommendations development processes; competing interest statements for all involved authors and guideline panel members; a description of the method used to assess certainty of evidence and grade the strength of recommendations; and a clear table at the beginning of the document listing all clinical questions and resulting recommendations.
• Maintain an up-to-date, in-depth description of the guideline development process on the website of the guideline-producing organization. Refer to this page specifically in the text of the guideline. This allows both guideline end-users and potential assessors to view the development process in depth without requiring too much space in the guideline document itself. 
• When in doubt, refer it out. If there are supplemental texts to the guideline that include information related to the development process – such as an underlying systematic review or a list of authors’ conflict of interest disclosures – make sure these documents are clearly referenced in the guideline text and made easily accessible in the online version via hyperlinks. 
• Don’t make assumptions. Even aspects of the development process that seem obvious, such as whether the guideline is externally reviewed, will likely not be included in a published quality assessment if it is not explicitly mentioned. 
• Always be specific. Do not make the end-user of a guideline have to guess who the guideline is for, the clinical questions driving the guideline, or the appropriate scenarios in which to employ the recommendations. Utilizing the PICO (Population, Intervention, Comparison, Outcome) format to explicitly describe the clinical questions and resulting recommendations is a failsafe way to ensure your guideline is specific enough to be useful. 

Stay tuned for Part II where we provide a list of commonly overlooked items in published guidelines and discuss how to instantly improve the quality assessment of a guideline.

Fall 2019 - Scholarship recipients

Contributed by Madelin Siedler, 2019/2020 U.S. GRADE Network Research Fellow

The Eleventh GRADE Guideline Development Workshop was held in Orlando, Florida, this past September. This workshop welcomed 52 participants, including several international attendees from Canada and Brazil. Among these participants were three recipients of a scholarship provided by the Evidence Foundation, which covers the cost of registration. Coming from diverse backgrounds ranging from organizational work to evidence synthesis to policymaking, scholars Faduma Gure, Eric Linskens, and Christian Kershaw presented their proposals for new innovations or opportunities for improving the application and implementation of evidence-based medicine.

Faduma Gure, MSc, a knowledge translation and research specialist for the Association of Ontario Midwives, discussed the challenges of incorporating client perspectives to midwifery guidelines for the organization, which utilizes the GRADE approach. Pregnancy through the post-partum period is often a tumultuous time filled with decision-making, Gure explained, and more can be done to better understand the values and preferences of midwifery clients and to employ an equity lens when formulating recommendations. Gure proposed a solution that includes the development of an equity advisory group consisting of key stakeholders representative of Ontario’s population of midwifery clients. The organization could then involve these stakeholders through the entire guideline development process - from the initial setting of research priorities to the ultimate formulation of recommendations - and elicit important feedback about patient values and preferences as well as the potential impacts of a guideline on various communities.

Eric Linskens, BSc, serves the Minneapolis Veterans Affairs Evidence Synthesis Program and the Minnesota Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center. Linskens presented his current work applying the GRADE approach to existing systematic reviews which did not originally use GRADE. Linskens discussed some of the challenges that his team has faced as part of the initiative, as well as innovative solutions to these issues. For instance, a systematic review conducted by AHRQ may automatically rate down for inconsistency due simply to the inclusion of a sole study, whereas in the GRADE approach, this would not be the case. Additionally, an existing review may break down one clinical question into multiple smaller analyses of comparators or sub-populations, whereas it would be more clinically relevant to use these data to create one larger recommendation. To best solve these issues, Linskens noted, it is important to consider the end-user of any given review or guideline so that their needs can be best met. Additionally, transparently reporting all judgments around the analyses is key. Regarding his time at the workshop, Linskens said, “[i]t was very helpful to work through examples with the GRADE workshop facilitators in small group sessions. They answered our questions as they came up.”

Christian Kershaw, PhD, is a molecular neuroscientist who now works as a health policy analyst for CGS, a Medicare fee-for-service contractor. Dr. Kershaw used her personal experience transitioning from bench science to policymaking to inspire her presentation on the utility of cross-functional teams in medicine and healthcare policy. To develop a cross-functional team, Dr. Kershaw explained, it is best to identify a problem that would best be solved by a group of individuals with heterogeneous skills and backgrounds that would each uniquely serve a common goal or purpose. As an example, Kershaw discussed the development of a team to standardize the way information is used to form coverage decisions as part of the 21st Century Cures Act. The team is comprised of a medical doctor to understand the need for and content of the policies; an outreach and education specialist to understand their legal implications; and a basic research scientist to compile and assess the information. Leveraging individual team members’ strengths and encouraging innovation are keys to success when working in a cross-functional team. “I was impressed with the versatility of the GRADE framework,” Kershaw noted. “It was very informative to learn all of the different ways that the conference attendees were using GRADE to suit their projects.”

If interested in applying for a scholarship to future GRADE workshops, more details can be found here: https://evidencefoundation.org/scholarships.html. Please note the deadline for applications to our next workshop in Phoenix, AZ will be December 4, 2019.

Spring 2019 - Scholarship Recipients

Contributed by Madelin Siedler, 2018/2019 U.S. GRADE Network Research Fellow

Recently, we held the Tenth GRADE Guideline Development Workshop in Denver, Colorado. This workshop was one of the largest groups to date, with 51 participants traveling to the Mile-High City from as far away as Poland and Korea. During the workshop, participants focused on learning and applying the GRADE approach for diagnostic test accuracy. 

Two participants attended as recipients of the scholarship program funded by the U.S. GRADE Network and Evidence Foundation. This scholarship covers the cost of registration for workshop attendees who are newer to GRADE and have never attended a formal GRADE workshop. Scholars Janice Tufte and Dr. Irbaz bin Riaz presented on their innovative ideas for improving the development, implementation, or dissemination of guidelines with the aim of reducing bias in healthcare recommendations.

Scholarship recipients: Dr. Irbaz bin Riaz (L) and Ms. Janice Tufte (R), 

with scholarship coordinator, Dr. Shahnaz Sultan

Tufte, an independent consultant who leads patient-public partnership initiatives, presented on the unique opportunities of using patient partners during the development of GRADE guidelines. Patient partners are representatives of the patient population whom the guideline aims to serve. As part of a guideline panel, they offer fresh perspectives, ground the guideline development process with lived experience, and help the panel to identify and address differences in priorities among stakeholders.

Throughout her presentation, Tufte provided ways to improve how patient partners are involved in the guideline process, such as creating one-pagers and glossaries that cover the basics of GRADE methodology and inquiring beforehand about specific accommodations that might be needed in order to enhance the patient’s participation in the panel. “It was an honor to attend the GRADE Workshop in Denver as a Patient Partner Scholar,” said Tufte. “I felt like I was treated like a colleague where we were all learning together how to use GRADE tools to share best evidence within our individual systems and guidelines work.”

Dr. bin Riaz, an oncologist at Mayo Clinic, presented on a framework for developing living systematic reviews and guidelines to inform clinical decision-making, especially in topic areas undergoing rapid change. It can take several years for a systematic review and resulting clinical recommendations to be developed, Dr. bin Riaz explained. In the meantime, new drug approvals or indications, changes in drug labeling, or new information about potential risks and benefits of a treatment option can arise. As opposed to traditional, static documents, living systematic reviews and guidelines are continually updated as new evidence or important decision-making information comes to light. The ultimate goal of such an approach is to facilitate a more timely translation of medical knowledge into clinical practice, allowing patients and their providers to come to decisions informed by the totality of current evidence.

If interested in applying for a scholarship to future GRADE workshops, more details can be found here: https://evidencefoundation.org/scholarships.html. Please note the deadline for applications to our next workshop in Orlando, Florida will be July 1, 2019.

Stating the “Obvious”: A Primer on Good Practice Statements in GRADE Guidelines

Contributed by Madelin Siedler, 2018/2019 U.S. GRADE Network Research Fellow

Stating the “Obvious”: A Primer on Good Practice Statements in GRADE Guidelines

One of the benefits of the GRADE approach is that it provides a framework for the development of evidence-based recommendations that are clear and actionable for practicing clinicians even when only lower-quality evidence is available. However, in some particular instances, caution is warranted when developing a recommendation based on low-quality evidence or inference. “Good practice statements” are one such instance. 

The term “good practice statement” is sometimes interchanged for “motherhood statement”.” In either case, the practice being recommended is usually something that is already commonly accepted as beneficial or practical advice. It could even be seen as irrefutably “good” as motherhood and apple pie (hence the term). The nature of these types of statements is such that the action is seen as so obviously beneficial that it would be unduly onerous to conduct a review to demonstrate its efficacy.

An example of a good practice statement is the first recommendation from the American Gastroenterological Association (AGA)’s 2015 guideline on the management of asymptomatic pancreatic cysts, which reads, “The AGA recommends that before starting any pancreatic cyst surveillance program, patients should have a clear understanding of programmatic risks and benefits” (Vege et al., 2015).

How to Spot a Good Practice Statement
An easy way to identify a good practice statement is to restate the recommendation as its inverse: for instance, “patients should not have a clear understanding of programmatic risks and benefits.” If this “unstated alternative” is absurd or clearly does not conform to ethical norms, the original statement is likely a good practice statement (Guyatt et al., 2016).

The Problem with Good Practice Statements
The GRADE Working Group recommends that good practice statements be used sparingly, if at all. Because good practice guidance is typically based on several linked sources of indirect evidence, there is no way to tell whether the benefits of the proposed recommended action are as truly obvious or incontestable as they seem. And if they are (if the inverse of the proposed recommendation would be absurd or unethical) then they are likely unwarranted and can dilute the strength of the guideline as a whole. 

Sometimes, good practice statements may even appear as graded recommendations in a guideline (a decision that’s not recommended by the GRADE working group for the reasons above). In this case, the guideline authors may be tempted to make a strong recommendation based on low-quality evidence, which should ideally be a rare occurrence and based on well-defined criteria (Guyatt et al., 2015). 

Practical Advice for Dealing with Good Practice Statements
The GRADE Working Group recommends using the following checklist to determine whether a good practice statement is warranted:

1. Is the statement clear and actionable? 
2. Is the message really necessary in regards to actual health practice? 
3. After consideration of all relevant health outcomes and potential downstream consequences, will implementing the good practice statement result in large net positive consequences? 
4. Is collecting and summarizing the evidence a poor use of a guideline panel’s limited time and energy? 
5. Is there a well-documented clear and explicit rationale connecting the indirect evidence?

If the answer is 'yes' to all five questions, a good practice statement may be warranted for inclusion in a guideline document. When done correctly, good practice advice statements should appear as ungraded recommendations, meaning no formal rating of quality of evidence or strength of recommendation should be given (Guyatt et al., 2015).

However, many potential good practice statements will be eliminated through the use of this checklist. For instance, careful consideration of Question #3 could lead the panel to realize that the assumed net positive of a specific action may not be so obvious after all. In this case, the guideline panel should consider whether a thorough review of the evidence should be conducted and formal grading methods applied.

Fall 2018 Scholarship Recipients

Contributed by Madelin Siedler, 2018/2019 U.S GRADE Network Research Fellow

We were pleased to support the participation of three research scholars at our recent GRADE guideline development workshop held in Silver Spring, Maryland, October 17-19, 2018. By providing complementary registration, we hope that these scholars increased their understanding and application of the GRADE approach. As part of the U.S. GRADE Network/Evidence Foundation scholarship, recipients presented to fellow workshop participants about their interests and current endeavors in the field of guideline development.

Scholarship recipients: Oilvia Magwood, Mohamad Kalot, and Mohammed Alkhatib

A few details about our Fall 2018 scholarship recipients:

Mohamad Kalot, MD, a postdoctoral research fellow at University of Kansas Medical Center, Kansas City, Kansas, applied for the scholarship due to his interest in improving quality and decreasing disparities in healthcare through the development of evidence-based guidelines. Dr. Kalot presented on his current work in the development of guidelines for the management of rare diseases. Dr. Kalot explained how the development of such guidelines presents a unique challenge in that there is often a dearth of research on these populations, which can affect the directness of evidence among other factors.

“Since an important part of my conducted reviews and research deals with developing guidelines for rare diseases, I would ultimately face specific challenges in the process of assessing the certainty of evidence in my work, and I’m interested in exploring innovative methods to deal with these challenges,” said Kalot. “The GRADE workshop in Silver Spring didn’t only help me find solutions for my challenges, it made me see the research methodology world from a different, deeper and more practical perspective - especially with the very helpful tools [RevMan and GRADEpro Guideline Development Tool] that we learned about in the small groups sessions and the discussions about rating up and rating down the quality of evidence.”

Olivia Magwood, MPH, attended from the Buyere Research Institute in Ottawa, Ontario, where she has participated in the development of three national and international guidelines. Ms. Magwood presented on the development of the FACE (Feasibility, Acceptability, Cost, and Equity) Framework Stakeholder Survey. The FACE Stakeholder Survey aims to identify cognitive bias that may influence guideline development as well as inform the quality and impact and improve the uptake of evidence-based recommendations in various stakeholder groups.

“For me, the GRADE workshop highlighted the importance of building my network and having the right people on your team throughout the guideline development process,” explained Magwood. “This includes involving methodologists early and throughout guideline development, as well as emphasizing patient perspectives, especially while deciding on patient-important outcomes. Guideline development is truly a collaborative process that benefits from multi-stakeholder engagement.”

Mohammed Alkhatib, MD, a postdoctoral research fellow at University of Kansas Medical Center, Kansas City, Kansas, applied for the scholarship due to his interest in examining and refining the adoption, adaptation and de novo development (or “adolopment,” for short) of guidelines to be used in lower-resource settings. Dr. Alkhatib presented on the importance of this approach, as well as the unique challenges of tailoring the development of clinical recommendations to settings with limited resources, such as developing nations and areas of conflict.

“It was an exceptional experience for me to present my proposal in front of high-level scholars of guideline development and to listen to their positive feedback,” said Alkhatib. “[The] GRADE workshop was very helpful for me at the level of interpretation of [systematic reviews] and how to judge strengths and weaknesses using GRADEpro.”

**If interested in applying for a scholarship to future GRADE workshops, more details can be found here: https://evidencefoundation.org/scholarships.html. Please note the deadline for applications to our next workshop in Denver, Colorado will be January 1, 2019.

Drug Value Symposium

The first Drug Value Symposium was held in Cleveland, Ohio on May 5th, 2018 in conjunction with the 8th Guideline Development Workshop using the GRADE approach.

Attendees found the inaugural Drug Value Symposium to be engaging, appreciating the opportunity to share ideas on how to systematically approach making evidence-based drug-coverage decisions at their institutions.

Attendees from all over the world with various backgrounds and expertise attended. The symposium opened with a thought-provoking presentation from Yngve Falck-Ytter, one of the founding U.S. GRADE Network members. His presentation highlighted why healthcare costs are becoming an increasing challenge and how incorporating a methodologically rigorous framework, such as GRADE, to formulary decision making can facilitate sensible decisions. 

Dr. Falck-Ytter opens the symposium with an overview of how GRADE includes both cost and cost-effectiveness when making health-care decisions.

Representatives from local healthcare systems then offered varying perspectives on the institutional successes and challenges of managing high cost drugs. Presenters included Mandy Leonard from Cleveland Clinic, Indrani Kar from University Hospitals, Christina Wadsworth and Jan Kover from MetroHealth, and Candice Wenzell from the Northeast Ohio VA Healthcare System. 

       Lessons learned from managing costly drugs within the Cleveland, OH 

Veteran's Administration, as presented by Ms. Wenzell.

The symposium concluded with an interactive session facilitated by Yngve Falck-Ytter, Candice Wenzell, and Kelsey Rife that allowed attendees to apply the GRADE methodology to evaluate a drug for a specific indication and then make a decision on whether or not they would recommend the use of the drug. 

Join us in Cleveland, OH!

Our next Guideline Development Workshop using the GRADE approach will be held in Cleveland, OH from May 2nd through 4th, 2018. More information, including a proposed agenda, registration, and hotel information can be found at http://gradeconf.org/. As with every workshop, we encourage you to bring examples of your work and questions to discuss with participants at the workshop and the faculty.



We hope to see you there!

It's been a DTA kind of year

We started 2016 in Minneapolis by hosting our regular Guideline Development Workshop focused on making recommendations about diagnostic tests and test strategies. In 2016, the GRADE Working Group released guidance on decision making about diagnostic tests. That paper can be found here. Our Spring workshop featured three days of guideline development materials tailored for tests and test strategies, including a pre-course systematic review workshop on how to meta-analyzing this material. Dr. Holger Schünemann provided guest lectures and support during the small group exercises.



Earlier this week, in collaboration with the Dutch GRADE Network and Barcelona GRADE Center, Dr. Reem Mustafa kicked off a similar workshop on diagnostic test accuracy (DTA).



Many resources have been released detailing the advancements in DTA decision making. A few are listed below:

• Decision-making about healthcare-related tests and diagnostic strategies series. Paper 1: testing to improve people's health: a new series
• Decision-Making about Healthcare Related Tests and Diagnostic Strategies: User Testing of GRADE Evidence Tables