1. HDA Writers Workshop
Concise Answers to Clinical Questions Written for Physicians by Physicians

2. FPIN Staff Host Introduction
Name: Position: FPIN Mission: "FPIN supports a collaborative learning community for primary care clinicians, learners, and faculty to promote and disseminate evidence-based scholarship. We improve patient care by translating research into practice.“ What is so valuable about the FPIN Network?
STAFF SLIDE
Notes:
Not a medical expert, but instead an expert on FPIN processes and systems
Here to support the faculty presenters and ensure the program knows what they need to after the workshop
Assist with meeting your program’s goal for today
What is so valuable about the FPIN Network? Highlight what YOU think is the best thing about FPIN as an organization for our members in your own words. Build credibility. Build enthusiasm.

3. Train faculty and new residents with the HDA process
Objectives for Today
Walk through the steps of writing an HDA
Get 40-60% complete with your first draft
Answer questions you have about the process
Prepare your leaders to write and mentor future authors
AND…
Achieve your program’s goal for today:
Train faculty and new residents with the HDA process
STAFF SLIDE
Include the program’s specific goal

4. Today’s Schedule and Materials
Introduction
Dissect the Question
Conduct a Smart Search
Synthesize the Evidence
10 min Break
Write it Right
Strength of Recommendation
Next Steps
Evaluations
Materials
1 Folder per group
Left Side: Group exercises
Right Side: Reference materials
1 USB per group
Electronic copies of materials
Blank writing template
Question Card
Question assignment
PICO exercise
Evidence-Based Practice
STAFF SLIDE
Be sure to use a folder as an example and point out each material as you verbally go through the list so both the audio and visual learners get the information

5. Follow FPIN on Facebook
Sharing Photos
Like Us!
Evaluations
STAFF SLIDE
-Ask if anyone is uncomfortable if you take a few photos and put them on Facebook as a promotion. Explain that it is our tradition to share photos and post whenever we are on location at a member program or at a conference.
-Ask if anyone has a smartphone on them right now if they would be so kind as to look us up Facebook and “like” us
-Pull out the evaluations bookmark and explain that they will be asked to take this at the conclusion the workshop before they leave. Let them know if they have to leave early that they can find the information for accessing the evaluation on this bookmark. Tell them the types of questions on the evaluation so they can be thinking about it during the workshop.

6. FPIN Faculty Presenter Introduction
Name: Corey Lyon, DO Program: University of Colorado FMR Title: Associate Program Director FPIN Leadership Positions: EIC PURLs; HDA Deputy editor and editor trainer; Board President Elect
STAFF SLIDE
Each staff host should plan out the introduction piece. It should be an acknowledgement and a explanation of their expertise. It should contain a balance of their experience outside of FPIN, FPIN experience, leadership skills, and any other positive qualities that you would like to include.

7. What are HDAs?
HDAs are brief, concise, structured responses to clinical questions of practicing family clinicians drawing on:
Systematic reviews of the best available evidence
Meta-analyses
Original research studies
Evidence-based guidelines OR
Authoritative guidelines (if none of the above are available)
STAFF SLIDE

8. Critical Components of an HDA
Clinical Question
Evidence Based Answer (35-75 words, with SORT grade)
Evidence Summary ( words)
References ( words, with LOEs)
STAFF SLIDE
Handouts: Direct participants to EBP, point out the sections of an actual HDA
* Let them know that the question they work on today will more than likely be published in a future issue of EBP unless it is lucky enough to be hand-selected by one of the journal editors to be published in American Family Physician or The Journal of Family Practice
The ideal word count is 500, including references. HDAs should run no more than 600 words – a small table counts for approximately 100 words.

9. Tools for Writing an Excellent HDA
Dissect the Clinical Question
Conduct a Smart Search
Synthesize the Evidence
Write It Right
Presenter starts here.
OPTION: Faculty can have everyone go around the room and share their scholarly activity experience, what they hope to get out of today. 9

10. DISSECT THE CLINICAL QUESTION
TOOL #1
DISSECT THE CLINICAL QUESTION

11. Distill the Clinical Question to P.I.C.O.
Key Elements
Define Search Terms
Patient / Problem
Patient cohort, age, sex
Problem, disease, or co-existing conditions.
Intervention
Proposed drug, therapy, test, intervention etc. Possible prognostic factor, or exposure.
Comparison
Alternative course of action/inaction?
Outcome
Goal i.e., relieve or eliminate the symptoms? reduce the number of adverse events? improve function or test scores?
HANDOUT #5: EXAMPLE SEARCH TABLE
Patient / Problem Atrial Fibrillation, elderly
Intervention heparin, warfarin
Comparison, if any none, placebo
Outcome primary: reduce need for hospitalization; secondary: reduce mortality
HANDOUT #6: SEARCH RESULTS FOR QUESTION
Search results – possible references
GROUP EXERCISE – WINNOW DOWN TO THE BEST 3 and explain why your group chose those

12. PICO Question 1
You have a patient with COPD with frequent exacerbations and ED visits. You wonder if starting daily prophylactic antibiotics will help.
P: Adults with COPD and frequent exacerbations
I: Daily prophylactic antibiotics (or daily azithormycin)
C: No treatment, or placebo
O: Reduction of ER visits; reduction in exacerbations
Search terms

13. PICO Question 2
You have a 48 y/o female with a history of a DVT in the past. She is having vaginal symptoms since becoming menopausal 2 years ago. You wonder if vaginal estrogen is safe to use for her symptoms
P: Adult menopausal females with h/o DVT
I: Vaginal estrogen
C: No treatment, placebo, oral HRT
O: Development of DVT
Search terms

14. Group Exercise #1-PICO
Take your clinical question and rewrite it into a PICO format

15. TOOL #2
CONDUCT A SMART SEARCH

16. Search for the BEST CURRENT Evidence . . .
The HDA search aims to produce the references that would be uncovered by the average tech-savvy physician in 1-2 of hours at the computer.
Characteristics:
Highly Focused.
Most Recent Evidence (last 3-5 years).
Outcomes-Based Studies.
Not Long and Drawn Out.

17. . .Let the Evidence Pyramid Be Your Guide
As you move up the pyramid, the amount of available literature decreases, but increases in relevance to the clinical setting.
Meta-Analysis
Systematic Reviews
Randomized Control Trials
Cohort Studies
Case-Control Studies
Case Series
Expert Opinion

18. Use These Search Tips* for Best Results
Begin with PICO!
Truncate words to pick up variant endings.
Type in all variations of a word.
Limit to Publication Types: Meta-analysis, Practice Guideline, RCT, etc.
Use ‘specificity’ as a text word in diagnosis searches. Limit using MeSH terms including: Treatment Outcome, Prognosis; or Sensitivity and Specificity .
Less is more.
*Full version in HDA Resources.
To save time and ensure quality:
Ask the co-author to save the search terms and the search engines that were used. Save this in an electronic folder so it can be available to peer reviewers.
When the co-authors have agreed on the references, ask the resident to send the pdf of each reference to the faculty co-author. Save these in an electronic folder so these are available to you and the peer reviewer. Eventually we can upload them along with the manuscript.

19. Search Resources Recommended Search Tools
TRIP Database
FPIN search
PURLs
Clinical Inquiries
HDAs
Note: The Trip Database will more than likely direct you to fee-based databases that will require passwords (Example-Cochrane Database) so you will want to make sure that you are aware of the resources available through your institution and have the proper login credentials. You will be able to search Medline/PubMed directly from Trip as well. If you have difficulty finding accessible articles, try setting the limits in PubMed to search for “free articles”. If you have questions, please don’t hesitate to contact anytime.
WHY THESE DATABASES?
Outcomes oriented evidence-based articles, guidelines textbooks, and peer-reviewed journals.
TRIP database:
Scottish Intercollegiate Guidelines Network (SIGN)
National Institute for Clinical Excellence (NICE)
USPSTF Evidence Reports AHRQ Evidence Reports
REFER TO HANDBOOK PAGE#
#106 Search sources and strategies
#107 EBM Search tips
If necessary you may also want to move on to a PubMed or an Ovid search. Before doing so, read HDdocument #107 EBM Search tips, prepared by the FPIN Librarians
BOTTOM LINE: 3-5 MOST RECENT. SEARCH 1 HOUR! If the search takes longer, STOP, rethink your strategy.

20. SYNTHESIZE THE EVIDENCE
TOOL #3
SYNTHESIZE THE EVIDENCE

21. Synthesis Part 1: Grading the Evidence
Most HDAs deal with questions of diagnosis or therapy.
Diagnosis:
How to select and interpret diagnostic tests.
Therapy:
How to select treatments that do more good than harm and that are worth the efforts and costs
involved.
Prognosis:
How to estimate the clinical course of the condition
and anticipate likely related complications.
Harm/Etiology:
How to identify causes for disease (including
iatrogenic forms.)
Prevention:
Differential diagnosis / symptom prevalence study.
Cost:
Economic and decision analyses. What is the most cost effective alternative.
DEFINITION: SYNTHESIS: Bring together the underlying ideas and influences within each study to create a new whole (clearer understanding) . Simplify to the essential core elements

22. Refer Back to the Pyramid, if in Doubt
Go back to the Evidence Pyramid and identify the TYPE of study reported in each article.
Meta-Analysis
Systematic Reviews
Randomized Control Trials
Cohort Studies
Case-Control Studies
Case Series
Expert Opinion

23. Evidence Pyramid Definitions
Meta-analysis is a systematic review which uses quantitative methods to summarize the results. The analysis will thoroughly examine a number of valid studies on a topic and combine the results using accepted statistical methodology as if they were from one large study. Some clinicians put meta-analysis at the top of the pyramid because part of the methodology includes critical appraisal of the selected RCTs for analysis.
Systematic reviews are articles in which the authors have systematically searched for, appraised, and summarized 'all of the medical literature' for a specific topic. Systematic reviews usually focus on a clinical topic and answer a specific question. An extensive literature search is conducted to identify all studies with sound methodology. The studies are reviewed, assessed, and the results summarized according to the predetermined criteria of the review question. The Cochrane Collaboration has done a lot of work in the area of systematic reviews.

24. Definitions Continued
Randomized controlled clinical trials are carefully planned studies, testing the effect of a therapy on real patients. The group of patients is randomized into an experimental group and a control group. These groups are followed up for the variables/outcomes of interest. RCTs include methodologies that reduce the potential for bias (randomization and blinding) and that allow for comparison between intervention groups and control groups (no intervention).
Cohort studies involve the identification of two groups (cohorts) of patients, one which received the exposure of interest, and one which did not, and following these cohorts forward over time for the outcome of interest. A cohort study involves a large population and follows these patients who have a specific condition or receive a particular treatment over time and compares them with another group that has not been affected by the condition or treatment being studied. Cohort studies are observational and not as reliable as randomized controlled studies, since the two groups may differ in ways other than in the variable under study.

25. Definitions Continued
Case control studies are studies in which patients who already have a specific condition are compared with people who do not. They often rely on medical records and patient recall for data collection. These types of studies are often less reliable than randomized controlled trials and cohort studies because showing a statistical relationship does not mean than one factor necessarily caused the other.
Case series report on a series of patients with an outcome of interest. No control group is involved. These studies consist of collections of reports on the treatment of individual patients or a report on a single patient. Because they are reports of cases and use no control groups with which to compare outcomes, they have no statistical validity.

26. It’s Time to Grade the Evidence!
Levels of Evidence (STEPs) are assigned to each reference using the CEBM tables.
The type of QUESTION directs you to the COLUMN.
The type of STUDY guides you to the ROW and STEP.
The CEBM table is online, in the HDA Resources at FPIN.org, and in the Author Handbook.
CEBM TABLE - HANDOUT AND IN AUTHOR HANDBOOK
NOTE THE TWO COLUMNS THAT ARE MOST FREQUENTLY USED IN HDAS.

27. 2011 CEBM Table: Levels of Evidence (STEP)

28. STEP 2

29. STEP 1

30. STEP 3

31. Activity #2-LOEs (STEPs)
Instructions and time allowed:
Using the CEBM Table assign STEPs to your article(s)
Share with the group how you derived at your answer
20 minutes

32. Synthesis Part 2 – Statistics
Cause the most fear among faculty new to writing
You do not need to learn how to DO the statistics
You just need to understand the statistics
Keep it simple

33. Statistical Evidence
Convert study results into user-friendly statistics:
Confidence Intervals
Likelihood Ratios
Number Needed to Treat/Harm
Use tables to summarize or compare studies.
Statistics ARE the ‘heart’ of the evidence. If the author is unsure, the reader will be unsure. If in doubt, seek experts.

34. EBM Glossary 95 percent confidence interval Odds Ratio
An estimate of certainty. It is 95% certain that the true value lies within the given range. A narrow CI is good. A CI that spans 1.0 calls into question the validity of the result.
Odds Ratio
Compares whether the probability of a certain event is the same for two groups.
An odds ratio of 1 implies that the event is equally likely in both groups. OR >1 implies that the event is more likely in the first group. OR <1 implies that the event is less likely in the first group.
Example - ASA supplementation and prevention of pre-eclampsia in pregnant patients at risk
OR 0.76; 95% CI,

35. EBM Glossary (cont) Relative Risk (RR)
direct measure comparing the probabilities in two group
also known as the risk ratio
RR equal to 1 implies that the event is equally probable in both groups. A RR >1 implies that the event is more likely in the first group. A RR <1 implies that the event is less likely in the first group
Example – Rate of COPD exacerbations with daily azithroymcin compared to placebo
(RR 0.58; 95% CI, )

36. EBM Glossary (cont) Mean Difference (Mean Difference)
Measure of continuous data – data before or after an intervention; or difference between 2 groups (ie blood pressure, weight, pain scales, etc)
Compared to dichotomous data – only 2 points (ie improve or not improve; die or not die; etc)
Weighted Mean Difference – weighted average of studies (or groups)
A mean difference of 0 implies that the data is equal in both groups. MD >0 implies that the data is increased in the first group. MD <0 implies that the data is less in the first group.
Weight gain in patients with GDM teated with metformin vs insulin
(MD -2.1 kgs; 95% CI -2.9 to -1.3)

37. EBM Glossary (cont) Number needed to treat – NNT
The number of patients who need to receive an intervention instead of the alternative in order for one additional patient to benefit.
Number needed to harm – NNH
The number of patients who need to receive an intervention instead of the alternative in order for one additional patient to experience an adverse event.

38. EBM Glossary - Diagnosis
Sensitivity – SnOut
the proportion of truly diseased persons who are identified as diseased by the test
In other words, a sensitive test has very few false negatives; SnOut (Sensitivity rules Out dz)
Specificity - SpIn
the proportion of truly non-diseased persons who are identified as being non-diseased by the test; SpIn (Specificity rules In disease)
In other words, a specific test has very few false positives

39. EBM Glossary – Diagnosis (cont)
Likelihood ratio LR
LR >1 indicates an increased likelihood of disease, LR <1 indicates a decreased likelihood of disease. The most helpful tests generally have a ratio of less than 0.2 or greater than 5
LR+ = sensitivity / (1-specificity) LR- = (1-sensitivity) / specificity

40. Confidence Intervals Provides a measure of the study results
Places a clear quantification of the effect
Contrast to a P value – arise from significance testing
Tells nothing of the size or direction of the difference
CI’s reveal the treatment benefit/harm and strength of evidence
CI’s – “a range of values within which we can be 95% sure that the true values lie”

41. Example: Confidence Ratio

42. Confidence Interval (cont)
Can measure multiple clinical measures of interest
Odds Ratio- ER use for asthma exacerbation in prednisone group vs placebo;
OR 0.54; 95% CI
NNT – ER use for asthma; Prednisone vs placebo;
NNT 7; 95% CI
Specificity – Family Physicians in diagnosing depression
81%; 95% CI 74 – 87
RR – Return to Care in pts receiving Zofran vs placebo
RR 1.3; 95% CI 0.77 – 2.3
Mean Difference – LBP pain score with back brace (1-10 scale)
MD -2.3; 95% CI -5.3 to 1.3

43. 2X2 Table for Outcome of Interest
User-Friendly Stats
2X2 Table for Outcome of Interest
Experimental Treatment
Placebo/ Comparison + - a b c d
a. Control Event Rate: Cer = c / c + d
b. Experimental Event Rate: Eer = a / a + b
c. Absolute Risk Reduction: ARR = Cer – Eer
d. Relative Risk Reduction: RRR = ARR / Cer
e. Relative Risk Ratio = Eer / Cer
Number Needed to Treat: NNT = 1 / ARR

44. Example: User-Friendly Stats

45. Example: User-Friendly Stats Recurrence of cellulitis+ - 30
106 51 87
Experimental treatment
Placebo/
Comparison
Control Event Rate: Cer = c / c + d = 51/51+87= 0.37
Experimental Event Rate: Eer = a / a + b = 30/30+106= 0.22
Absolute Risk Reduction: ARR = Cer – Eer = 0.37 – 0.22 = 0.15
Relative Risk Reduction: RRR = ARR / Cer = 0.15/0.37 = 0.40
Number Needed to Treat: NNT = 1 / ARR = 1/0.15 = 7

47. TOOL #4
WRITE IT RIGHT

48. Get Ready: Revisit the HDA Anatomy.
Clinical Question
Evidence Based Answer (35-75 words, with SORT grade)
Evidence Summary ( words)
References ( words, with LOEs)
The ideal word count is 500, including references. HDAs should run no more than 600 words – a small table counts for approximately 100 words.

49. Get Set: Re-Read HDA Author Instructions.
Identify the question. Translate to PICO.
Conduct literature search using PICO terms.
Grade the available evidence using STEPs.
Synthesize the evidence. Refine statistics so they are ‘user friendly’.
Organize the flow of information (begin with the best evidence, then supporting evidence.)
Now it is time to write!

50. G.O. – Get Organized. Choose the tool that works for you:
Evidence Table
Brief Paragraph Summarizing Each Study
Critical Appraisal Worksheet
Formal Outline

51. Example: Treatment Question
Study 1
Study 2
Study 3
Citation
Population
Study Design
Intervention
(N in the Group)
Comparison
Follow-Up Period
Outcomes Measure
Effect Estimate
(CI or p)
Study Quality
Reviewer Comments
EVIDENCE TABLE
What:
Tabular description of the studies.
Compare studies by characteristics.
Why:
Prevent errors of interpretation.
Increase clarity of analysis.
Plan a statistical analysis.

53. Example: Treatment Question
Study 1
Citation
Population
Study Design
Intervention
(N in the Group)
Comparison
Follow-Up Period
Outcomes Measure
Effect Estimate
(CI or p)
Study Quality
Reviewer Comments
Local corticosteroid injections for carpal tunnel syndrome
Adults with carpal tunnel syndrome that have failed conservative therapy
Meta-analysis of 12 RCTs (N=671)
Corticosteroids injections CTS
1. Placebo; 2. systemic corticosteroids; 3. anti-inflammatory med with neutral angle wrist splints
1 month
8 weeks
1. Clinical improvement (50% reduction in pain); 2. Global symptom score (0-50 w/ 50=severe pain); 3. Symptoms severity scale (1-5; 5=severe)
1.Clinical (2 trials; N=141; RR 2.6; 95% CI, )
2. Global Symptom trial; N=70; MD -7.16; 95% CI, -12 to -2.9)
3. Symptom Severity Scale (1 trial; N=23; MD 0.1; 95% CI, to 0.53)
Good

55. Azithromycin maintenance therapy in COPD
Citation
Population
Study Design
Intervention
(N in the Group)
Comparison
Follow-Up Period
Outcomes Measure
Effect Estimate
(CI or p)
Study Quality
Reviewer Comments
Azithromycin maintenance treatment in patients with frequent exacerbations of chronic obstructive pulmonary disease; a randomized, double-blind, placebo-controlled trial
92 adult COPD patients who had at least three exacerbations in the year preceding the study
RCT
Pulsed azithromycin prophylaxis (500mg three times weekly for 12 months)
Placebo
12 months
Rate of COPD exacerbations
Median time to first exacerbation
Rate of COPD exacerbations less in the azithroymcin groups vs placebo (RR 0.58; 95% CI )
Median time to first exacerbation longer in azithroymcin groups compared to the placebo group (130 days vs. 59 days, P=.001) 55

56. Activity #3-Evidence Table
Instructions and time allowed:
Part A
Fill-out the Evidence Table for your article
Part B
Compare your findings with the rest of the group to determine the strength of each source and which studies will be included in the final HAD
20 minutes

57. Writing with Transparency
“The voice” of HDAs are unique
The writing is very concise and descriptive
Write with enough detail that your readers could practically reproduce the study
Do not describe a study by lead author
“As educated consumers of the best evidence, if our readers need to read a sentence twice in order to understand it, there is something wrong with the writing, not with their ability to understand it.”
 - Dr. Goutham Rao, University of Chicago NorthShore, FMRP 57

58. Descriptive writing Descriptive writing includes
Study design (RCT, cohort study, etc)
Including the question the study was trying to answer
Number of patients
Number of studies included if discussing a systematic review
Names, dose, frequency of any drugs
Description of experimental and control groups
Tell your readers what is being compared to what
Define the outcomes
Be specific; define what is “better” (ie how many days,
how many point on a pain scale, what is the definition
of cure…) 58

59. Presenting the Evidence
It is not enough to tell your readers the results
You need to “show them the evidence”
Show statistical significance
But don’t over rely on “P values” – that doesn’t show the “magnitude of effect”, ie How much better.
Use Confidence Intervals
When possible, convert data into user friendly statistics
NNT, likelihood ratios, confidence intervals, etc 59

60. P value – how to use it P value show statistical significance
But not magnitude or direction of effect
A P value by itself is not helpful………need data
Not acceptable use of P value
Less patients had a MI in the treatment group compared to the control group (P=.001)
Acceptable use of P value
Less patients had a MI in the treatment group compared to the control group (23% vs 36%; P=.001)
This shows a magnitude of effect.

61. Examples of Descriptive Writing
A 2006 randomized placebo-controlled trial examined the effectiveness of a one-time dose of 160mg of IV methylprednisolone compared to placebo for the treatment of back pain in 87 adult patients presenting to the ER with acute non-radicular back pain.2 All patients were provided with a “back pack” which included 14 naprosyn 500mg and 12 oxycodone PRN with discharge instructions, and then followed up by phone in one week and one month. There was no difference in the improvement from baseline at one week (mean difference [MD] 0.6; 95% CI -0.9 to 2.2) and one month (MD 0.6; 95% CI -1.0 to 2.2) on an 11-point numerical pain score between the treatment and placebo groups.

62. Examples of Descriptive Writing
A 2013 retrospective cohort study evaluated the incidence of VTE and bleeding in 392 hospitalized patients with chronic liver disease who received pharmacologic prophylaxis compared with 1189 patients who did not.3 There was no statistical difference in INR between groups at baseline. Incidence of VTE was lower in those who received prophylaxis versus those who did not (0.5% vs. 1.8%; P=.05). Pharmacologic prophylaxis was protective against VTE with those who received prophylaxis (odds ratio 0.34; 95% CI, ).

63. Example: Treatment Question
Study 1
Citation
Population
Study Design
Intervention
(N in the Group)
Comparison
Follow-Up Period
Outcomes Measure
Effect Estimate
(CI or p)
Study Quality
Reviewer Comments
Local corticosteroid injections for carpal tunnel syndrome
Adults with carpal tunnel syndrome that have failed conservative therapy
Meta-analysis of 12 RCTs (N=671)
Corticosteroids injections CTS
1. Placebo; 2. systemic corticosteroids; 3. anti-inflammatory med with neutral angle wrist splints
1 month
8 weeks
1. Clinical improvement (50% reduction in pain); 2. Global symptom score (0-50 w/ 50=severe pain); 3. Symptoms severity scale (1-5; 5=severe)
1.Clinical (2 trials; N=141; RR 2.6; 95% CI, )
2. Global Symptom trial; N=70; MD -7.16; 95% CI, -12 to -2.9)
3. Symptom Severity Scale (1 trial; N=23; MD 0.1; 95% CI, to 0.53)
Good

64. From the table, make a summary paragraph
A meta-analysis included 12 RCTs (n=671) to examine the efficacy of corticosteroid injection for carpal tunnel syndrome (CTS) in comparison to placebo or other non-surgical interventions.1 Corticosteroid injections showed clinical improvement at one month or less compared to placebo injection (2 trials; N=141; 73% vs 28%; relative risk [RR] 2.6; 95% CI, 1.7 – 3.9; NNT 2). Compared to systemic corticosteroids, corticosteroid injections improved symptoms on a Global Symptom Score (scored on a scale of 0 – 50, with 50 indicating the most severe symptoms) at 8 weeks (1 trial; N=60; MD -7.2; 95% CI, -12 to -2.9). However, there was no difference in the Symptom Severity Scale (scored on a scale of 1 – 5, with 5 indicating the most severe symptoms) between corticosteroid injections and oral anti-inflammatory medications with neutral angle wrist splints at eight weeks (1 trial; N=23; MD 0.1; 95% CI, to 0.53). 64

65. Azithromycin maintenance therapy in COPD
Citation
Population
Study Design
Intervention
(N in the Group)
Comparison
Follow-Up Period
Outcomes Measure
Effect Estimate
(CI or p)
Study Quality
Reviewer Comments
Azithromycin maintenance treatment in patients with frequent exacerbations of chronic obstructive pulmonary disease; a randomized, double-blind, placebo-controlled trial
92 adult COPD patients who had at least three exacerbations in the year preceding the study
RCT
Pulsed azithromycin prophylaxis (500mg three times weekly for 12 months)
Placebo
12 months
Rate of COPD exacerbations
Median time to first exacerbation
Rate of COPD exacerbations less in the azithroymcin groups vs placebo (RR 0.58; 95% CI )
Median time to first exacerbation longer in azithroymcin groups compared to the placebo group (130 days vs. 59 days, P=.001) 65

66. From the table, make a summary paragraph
An RCT compared pulsed azithromycin prophylaxis (500mg three times weekly for 12 months) with placebo in 92 adult COPD patients who had at least three exacerbations in the year preceding the study. The rate of COPD exacerbations among patients over the 12-month follow-up period was significantly lower for patients receiving pulsed azithromycin compared to placebo (RR 0.58; 95% CI, ). Patients in the azithromycin group also had a longer median time to first exacerbation during the study period compared to the placebo group (130 days vs. 59 days, P=.001). 66

67. Group Activity #4-Write EBS
Instructions and time allowed:
Using the Evidence Table, begin to write the Evidence Based Summary as a group.
40 minutes

68. Strength of Recommendation

69. Add the Strength of Recommendation - SOR
The Evidence-based Answer is assigned a Strength of Recommendation (SORT) grade, followed by an explanatory phrase.
HDAs use AAFP’s patient centered method of grading the answer.
Instruct attendees to turn to the SOR chart in the author handbook

70. Example – Using the SORT Flowchart

71. EXAMPLE – USING THE SORT FLOW CHART

72. SOR Example 1 – Answer
Recommendation: Mechanical intervention with a back brace is effective for LBP
Based on a Cochrane review of 7 clinical trials that are consistent in their support of a mechanical intervention for low back pain, but the trials were poorly designed (ie, unblinded, nonrandomized, or with allocation to groups unconcealed).
SOR A
b)SOR B
c)SOR C
ASK GROUP TO TURN TO THE SORT DIAGRAM IN THE AUTHOR’S HANDBOOK 72

73. SOR Example 1 – Answer
Recommendation: Mechanical intervention with a back brace is effective for LBP
Based on a Cochrane review of 7 clinical trials that are consistent in their support of a mechanical intervention for low back pain, but the trials were poorly designed (ie, unblinded, nonrandomized, or with allocation to groups unconcealed).
SOR A
b)SOR B – Consistent, lower quality trials
c)SOR C
ASK GROUP TO TURN TO THE SORT DIAGRAM IN THE AUTHOR’S HANDBOOK 73

74. SOR Example 2 – Assign the SOR
“Recommendation: Corticosteroids reduce the duration and decrease residual symptoms from Bells Palsy.”
This recommendation is based on a systematic review of 5 good quality RCTs, and all the results were consistent in their support of corticosteroids.
SOR A
SOR B
SOR C
ASK GROUP TO TURN TO THE SORT DIAGRAM IN THE AUTHOR’S HANDBOOK 74

75. SOR Example 2 – Assign the SOR
“Recommendation: Corticosteroids reduce the duration and decrease residual symptoms from Bells Palsy.”
This recommendation is based on a systematic review of 5 good quality RCTs, and all the results were consistent in their support of corticosteroids.
SOR A - based on SR of consistent RCTs
SOR B
SOR C
ASK GROUP TO TURN TO THE SORT DIAGRAM IN THE AUTHOR’S HANDBOOK 75

76. SOR Example 3 – Assign the SOR
Recommendation: Breathease, a new drug, increases the forced expiratory volume in 1 second (FEV1) and peak flow rate in patients with an acute asthma exacerbation.
Based on a systematic review on consistent RCTs
SOR A
SOR B
SOR C 76

77. SOR Example 3 – Answer Based on a systematic review on consistent RCTs
Recommendation: Breathease, a new drug, increases the forced expiratory volume in 1 second (FEV1) and peak flow rate in patients with an acute asthma exacerbation.
Based on a systematic review on consistent RCTs
SOR A
SOR B
SOR C – Disease oriented evidence 77

78. Write EBA & Assign SORs Example Evidence-Based Answer:
Thickened infant formulas marginally reduce the
episodes of vomiting and regurgitation symptoms
compared with nonthickened formula (SOR: A,
consistent RCTs). A 2- to 4-week trial of a thickened
formula or an extensively hydrolyzed protein formula
(hypoallergenic formula) is a reasonable first step for
such symptoms (SOR: B, evidence-based guideline).

79. Group Activity #5-Write EBA & Assign SORs
Instructions and time allowed:
Once your summary is complete, begin to write the Evidence Based Answer
Using the SORT Flow Chart, assign SOR to each recommendation in your EBA
20 minutes

80. All HDAs are Peer Reviewed
Reviewers are experienced HDA faculty authors from another FPIN program.
Objective: to help improve the manuscript.
Comments on the peer review form in the EMS.
Drafts are submitted for the first round of editorial review before returning to the author.
Draft should be returned 4-6 weeks after your first submission.

81. Peer Review Structure HDA Peer Review Form
Is the manuscript clear and well written?
Does the Evidence-Based Answer directly address the question?
Does the Summary directly support the recommendation given in the Evidence-Based Answer?
Is this article based on an up-to-date complete literature search?
Do you feel this article reflects the best evidence available on patient-oriented outcomes?
Is this article fair and balanced?
Is this an article you would read (i.e. is this relevant to your practice)?
Peer Review Structure
Submit manuscript through the EMS.
Peer Reviewer is assigned.
Review is then submitted directly for editorial review.
Local Editor meets with authors to discuss review comments.

82. All HDAs Go To Editorial Review
Editor’s Dirty Dozen
Poor sentence/paragraph structure.
Fuzzy logic.
Too many comparisons for text (needs a table.)
Footnotes numbered incorrectly.
SOR does not have explanatory phrase.
Studies not described in enough detail.
Studies referred to by the lead author’s name.
No STEPs in references.
SOR does not match quality of evidence presented.
Outcome data does not include measure of magnitude of effect.
Confidence intervals missing (over-reliance on P values.)
STEPs noticeable incorrect (i.e. STEP 1 for an RCT)
All HDAs Go To Editorial Review
The EIC has the final word.
The EIC uses Track Changes (the redline tool).
The EIC is focused on publication quality.

83. To: HDA Author
From: Editorial Management System
Publication Venues
RE: CONGRATULATIONS! HDA 5868 READY FOR PUBLICATION
Congratulations!  HDA has been approved for publication! Please review the attached file and let me know if you agree with the final edits.  You can expect to see your manuscript published in Evidence-Based Practice (EBP). 
Below is a sample citation of an HDA to help you update your CV:
Lateef H., Patel D. Is kyphoplasty or vertebroplasty better for vertebral body compression fractures in an osteoporotic woman?  Evidence-Based Practice. 2007; 10(7):7. 
If you would like a print copy of the EBP with your article for your files, please send me your address for US mail once your receive the electronic copy.
Just as a reminder, faculty authors will be asked to peer review manuscripts from other FPIN programs.
Thank you for your contribution to EBP and FPIN.  We look forward to your continued participation!
Best regards,
Evidence-Based Practice
American Family Physician
The Journal of Family Practice
MO Family Physician
and more!

84. Next Steps 2 – 90 minute follow-up sessions
Meet as a writing group to complete your drafts
Review modules, author instructions
Format your draft according to the HDA style
Invitation from Editorial Management System (EMS)
Due 45 days after invitation is accepted by your group’s faculty corresponding author (draft and pdfs of references)
Drafts will go through peer review and 2-4 rounds of editorial review
Read your publication and other articles in EBP via our website:
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85. Evaluations
We are always looking to improve our workshop process and value any suggestions for improvements or comments on what went well.
Confidential
Individual evaluations slips
Link:
THANK YOU!!
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86. HelpDesk Answers Team
Interim Executive Editor: Dr. Bernard Ewigman, U of Chicago
Editor-in-Chief Evidence-Based Practice: Dr. Jon O. Neher, U of Washington
Editor-in-Chief HelpDesk Answers: Dr. Tom Satre, University of Minnesota
Executive Director: LuShawna Romeo, FPIN
EBP Managing Editor: Adelina Colbert, FPIN
Membership Manager: Taylor Gericke, FPIN
Our FPIN Author Community!

87. (phone hours M-F 8:30-4:00 PM, Central Time)
FPIN Contact Information
Specific questions regarding your HelpDesk Answers assigned project:
Any additional membership, education, or miscellaneous questions:
Or, contact us by phone for any inquiries and we will get you to the right point person:
(phone hours M-F 8:30-4:00 PM, Central Time)