Of Mice and Cheese: Research with Non-equivalent Groups

Last week’s blog focused on the strongest types of evidence that you might find when trying to solve a clinical problem. These are: #1 Systematic reviews, Meta-analyses, or Evidence-based clinical practice guidelines based on systematic review of RCTs; & #2 Randomized controlled trials. (For levels of evidence from strongest to weakest, see blog “I like my coffee (and my evidence) strong!”)

So after the two strongest levels of evidence what is the next strongest? #3 level is controlled trials without randomization. (Sometimes called quasi-experimental studies.)

Here’s an example of a controlled trial without randomization: I take two groups of mice and test two types of cheese to find out which one mice like best. I do NOT randomly assign the mice to groups. The experimental group #1 loved Swiss cheese, & the control group #2 refused to eat the cheddar. I assume confidently that mice LOVE Swiss cheese & do NOT like cheddar. What’s the problem with my conclusion? If you want to know, then read on!swiss cheese

In my mouse Controlled Trial Without Randomization, the groups were formed by convenience and Not randomly assigned. Thus, any difference in outcomes between groups might be related to some pre-existing difference between groups. My outcome of mice loving Swiss & hating Cheddar might have nothing to do with the experimental treatment.   In fact, I did not know that all my mice in the Swiss cheese group #1 hadn’t eaten in 2 days, and my mice in the cheddar group #2 had just had a full lunch. Ooops.

On the other hand if I had randomly assigned all the mice to two groups, then I could be relatively confident that all little differences between group members were evenly distributed to both groups, so that the groups were equivalent. My two mouse-groups would have probably ended up with a pretty even distribution of both hungry and not-so-hungry mice.   Then if my Swiss cheese group devoured the Swiss and my cheddar group rejected the cheddar, I could be more certain that mice love Swiss and dislike cheddar.

Happy evidence hunting!

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“I like my coffee (and my evidence) strong!”

Let’s say you are still working to solve the issue of whether gum chewing reduces post-operative ileus. You identified titles of all relevant articles using PubMed database (http://www.ncbi.nlm.nih.gov/pubmed), and had the librarian pull the full articles for you.

Now you find yourself looking at a formidable stack of articles on the topic. You are sure that some are probably better quality than coffee2others, but how can you tell?

Professionals have agreed on which types of evidence are strongest. Here’s one well-accepted hierarchy form strongest #1 to weakest #6 (Melnyk & Fineout-Overholt, 2005).

  1. Systematic reviews, Meta-analyses, or Evidence-based clinical practice guidelines based on systematic review of RCTs
  2. Randomized controlled trial
  3. Controlled trials without randomization
  4. Case controlled or cohort studies
  5. Systematic review of descriptive studies
  6. Single descriptive or qualitative study
  7. Expert opinion of individuals or committees

Number 1= Strongest.   Number 6=Weakest

When you are trying to solve a problem, FIRST look for the three (3) types of evidence that are the very strongest (#1). These are:

  1. Systematic reviews that are summaries of research findings from many studies;
  2. Meta-analyses that are summaries of research findings in which the data from those other studies are combined into one big study;
  3. Evidence-based clinical practice guidelines that are clinical recommendations based on a summary of research and other evidence. An expert panel has often agreed on the summary and recommendations.

Your next strongest option, #2, is at least one randomized controlled trial (RCT). In an RCT a group of subjects is randomly separated into at least two groups. One group gets the experimental treatment—whether it is a drug or teaching plan or something else—and the other group usually gets standard treatment or a placebo. Then the group outcomes are compared statistically to see which did better.

Usually the title or first few lines of the article will tell you that the article is a systematic review, a meta-analysis, an evidence-based clinical practice guideline, or an RCT. Rarely is this left a mystery! (Never assume that a research study article is strong just because you LIKE the findings, or that it is weak because you DON’T like the findings.)

I’ll comment on other levels of evidence soon, but let’s focus on the strongest types first. Try the critical thinking for practicing the ideas above.

Critical Thinking:  Using the article titles below, rank these three (3) research studies in order from Strongest evidence to Weakest evidence:

Want to read more?  A good summary of one hierarchy is and why it’s important is at this 5 minute youtube video: https://www.youtube.com/watch?v=5H8w68sr0u8 . While that hierarchy does not precisely match the one above, the video still has lots of good information.

 

 

How to Re-Invent the Wheel (NOT!!)

You can avoid re-inventing the wheel by checking in with top notch wheelexperts who have already examined the practice problem that you face.

In other words, it’s time to head to the library. After all that’s what the library is: the experiences and research written down by experts, who have spent a lot of time thinking about the same problem that you are facing. Really it’s pretty amazing that we have access to health professionals all over the world who are eager to help you avoid re-inventing the wheel.imagesCAGYW6WB

The best experts in the field are talking directly to you through their publications!

Of course it’s important to ask your colleagues in your own and other institutions about their ideas on the problem, but that’s not enough. You will be limited by what they happen to know; or worse you will be limited by what they don’t happen to know! Nurses on your floor can provide practical, site-specific insights, but it’s easy to see why you would want to add newest information from the top experts. That is BEST evidence.

Remember: EBP = Best evidence + Clinical judgment + Patient/family preferences/values

HOW do you find the experts in the library?

  1. The first step is to identify KEY WORDS from your PICO.
  2. Use single words or put phrases in parenthesis in your list of words (e.g., “postoperative ileus”). A librarian can help with key words, too.
  3. Google the site PubMed (PubMed is a complete database of healthcare publications)
  4. In the search box at the top of the PubMed page, type in your key words
  5. You will get a list of articles on your topic (and some related articles on the right side)
  6. Click on the box beside the ones that you want & email that list tocomputers shaking hands your facility librarian with a request to pull the complete articles for you! (Of course if you are a student with some direct access to full-text articles in a school library, then it may be quicker to get them on your own. It’s up to you, but part of your “village that it takes” might be the librarian.) [See “Take five!” if you want more on to why PubMed beats Google Scholar.]

EXAMPLE: Let’s get specific….

  • Take this problem that we have discussed before:
    • P = Postoperative patients with ileus (Population or Problem)
    • I = Gum chewing postop (Intervention to try out)
    • C = NPO with gradual diet progression when bowel sounds start returning (Comparison intervention)
    • O = Reduce time of postop ileus with sooner return to nutritious eating (Outcome that you want)
  • What are some key words from the above PICO stated problem? “Postoperative ileus” adults “gum chewing”
  • Go ahead. Pull up PubMed. Paste in the key words You should get 11 articles about gum chewing & postoperative ileus. Check the boxes of the ones you want, then…
  • Click on the “SEND TO” link near the upper right corner of the screen and email the list to the librarian with a request for full-text of the articles. (You can send to yourself, too)
  • Congratulate yourself on an EBP literature search well-started!

CRITICAL THINKING: Why wouldn’t you simply use google.com to find expert opinions?  [If you want more “data”  related to this question.  Check out“Take five!”]

FOR MORE INFO: Check out this tutorial on how PubMed works & what’s in it http://www.nlm.nih.gov/bsd/disted/pubmedtutorial/020_010.html You pay for PubMed through your taxes—get your $$ worth!

 

 

It Takes a “Village”

BEST patient care results from using the best evidence in practice using your clinical judgment and the preferences and values of patients & families. In shorthand this is called evidence-based practice (EBP).

Most of the time it takes more than one person to bring evidence into practice.   Maybe not really a whole village,….but definitely anyone  who will be affected by the change OR whose cooperation you need to make the change!

team

In the last blog, we considered how to identify a problem clearly by using the acronym PICO.   Here was our example:

  • P = Postoperative patients with ileus (Patient population & Problem)
  • I = Gum chewing postop (Intervention to try out)
  • C = NPO with gradual diet progression when bowel sounds start returning (Comparison intervention—maybe the current protocol or highly varied individual RN expertise)
  • O = Reduce time of postop ileus with sooner return to nutritious eating (Outcome—what you want to happen!)  (For more on PICO check out last week’s post: “You Got a Problem with That? Try PICO)

The next BIG question: “Is the problem you have identified a PRIORITY?”

priority

  • Some priorities are triggered by problems—for example, your observation that something is not working, or poor PI outcome data, or below benchmark HCAHPS scores.
  • Others are triggered by new knowledge—for example, you read an   article, new research has come out, or your professional organization has new standards.

Now what? You need to gather your “village,” even if it’s only 2 people!!   Let’s say postoperative ileus is a BIG, PRIORITY problem on your unit, and you saw a research article on how gum chewing reduces time of postop ileus. Your next question is, “Who do I need to help reduce ileus by trying out gum chewing?” Well…your manager would certainly want to know, and the surgeon. Other patient-care RNs on the unit are critical to its success, too. And maybe you could use some help in finding and critiquing articles/evidence.

team

NO need to go it alone in solving the issue! Find others who care about the problem. Invite them & anyone (stakeholders) who would need to know about the postop gum chewing. The team can be 2 people if you like; or a lot more.

  • If you have a unit-based council, then you already have a pre-made team!
  • If you need to find some teammates, consider some of these people: a respected clinician with lots of respect; a new graduate with lots of energy; someone who loves to read research; & others.

Critical Thinking: Think of a clinical problem on your unit. Write it out in PICO format and list the names of those who would be on your problem-solving “village” team.  Whose cooperation do you need?

Want to read more? Melnyk, B.M., Fineout-Overholt, E., Stillwell, S.B., Williamson, & K. (2009). Evidence-Based Practice: Step by Step: Igniting a Spirit of Inquiry, American Journal of Nursing, 109(11), 49-52, doi: 10.1097/01.NAJ.0000363354.53883.58

You Got A Problem With That? Try PICO*

IF….

  • The Purpose of evidence-based practice (EBP) =  BEST PATIENT CARE, &
  • The Definition of EBP = Best evidence + Clinical judgment + Patient/Family preferences & values

THEN…How do I get started with EBP to improve patient care?

One of the 1st steps is to identify clearly the clinical issue that needs solving.   One way to do that is by using PICO.*

WHAT IS PICO?   PICO is an acronym to help you clarify the clinical problem & to help you prepare to search the literature for evidence

  • P = Patient population or problem
  • I = Intervention or treatment that you want to try out & is based in best evidence
  • C = Comparison intervention or treatment (This might be some standardized care on your unit; or un-standardized care given by individual nurses based on their individual expertise)
  • O = Outcome you want to achieve.

EXAMPLE:  Let’s say you work with post-op patients and want to speed up patients’ return of normal GI function.  Right now on your unit, patients are NPO post-op progressing to ice chips and so on as their bowel sounds start returning.  But you have 2 concerns: a) some patients’ GI function seems quite slow to return; & b) quicker return to a nutritious diet may speed healing.  You read an article that gum chewing can reduce the time of postoperative ileus.  With that information, here is how your PICO problem would look:

  • P = Postoperative patients with ileus
  • I = Gum chewing postop
  • C = NPO with gradual diet progression when bowel sounds start returning
  • O = Reduce time of postop ileus with sooner return to nutritious eating

CRITICAL THINKING: Now you try it.  What is problem for patients (or nurses) on your unit? Try writing it out in a sentence or two and then put it into PICO format.  You are now on your way with beginning an EBP project that will promote the very BEST PATIENT CARE.

Want to read more on PICO?  Try out

*Note: Some use PICOT that includes “T”.  The “T” stands for the time it will take to show an outcome.  Because the timing does not seem to me relevant to all questions I typically omit it, but you may find it helpful.  If so, use it!

 

EBP: What’s the point? & What is it anyway?*

The next few blogs will focus on how to improve your nursing practice by finding & using the best evidence.

  • 1st– What is the point or goal of evidence-based practice (EBP)? Best patient care.
  • 2nd– What is the definition of Evidence based Practice (EBP)?

Evidence-based Practice (EBP) =

Best evidence(research &/or nonresearch) +

Clinical Expertise +

Patient/family preferences & values

(See http://guides.mclibrary.duke.edu/c.php?g=158201&p=1036021 for more.)

  • 3rd– What should I do step-by-step to use the best evidence in order to give BEST patient care? At Dignity NHMC we use the Iowa model as a step-by-step guide (Titler et al, 2001). (Other readers should check to see if their hospital has adopted a model that they should follow.)   NHMC employees can find a copy of the Iowa model reprinted with permission and other information at S:\Everyone\everyone\EVIDENCE BASED PRACTICE-RN Scientist Role.  Additionally NHMC employees can contact the nursing EBP/research facilitator at martha.highfield@dignityhealth.org or extension 3339 for questions or one-to-one help.
  • What is the general process of EBP?Most models include the following elements:
  1. Identify clearly the clinical issue that needs solving.Maybe this is a problem that you’ve encountered in your practice, or maybe it is something you heard about from a colleague or journal. For example, what is the best way to manage injection pain in children?
  2. Find the best evidence. Research is typically regarded as best evidence.  When no research has been done on the topic we can still use expert opinions, case studies, and scientific principles.
  3. Critique the strength of the evidence. This is figuring out how much confidence you have that the research studies are coming to the right conclusions.  If you’re not sure, an NP or CNS could help or point you to another mentor.
  4. Combine (synthesize) all evidence.When research study outcomes contradict each other, then we have to look at which studies are most carefully done.  Again an APN can help.
  5. Write clinical recommendations for your settingbased on best evidence+clinical expertise+patient/family values & preferences.
  6. Try out (or pilot) the clinical recommendationsin your setting using clinical judgment and patient/family preferences and values.
  7. Evaluate the outcomes.
  8. PRN “tweak” your recommendations to improve outcomes& roll out the project to other units if appropriate.
  9. Reinforce the “new & improved” evidence-based practiceso that it is sustained.
  10. Monitor outcomes.

CRITICAL THINKING:  What is one patient-care issue that you think can be improved on your unit?  For example: Reducing post-op ileus? Cutting down on nighttime noise on the unit? Dealing with nurses’ potential alarm fatigue?  Other?   Write the problem out.  Writing it out makes you think it through more clearly so don’t just think it—write it.  Then, STAY TUNED next blog for more on clarifying the problem.

Reference: Titler, M.G., Kleiber, C., Steelman, V.J., Rakel, B.A., Budreau, G., Everett, L.Q., Buckwalter, K.C., Tripp-Reimer, T., Goode, C.J. (2001) The Iowa Model of Evidence-Based Practice to Promote Quality Care. Critical Care Nursing Clinics of North America, 13(4), 497-509.

*The next few blogs will focus more on how to use research in practice (commonly known as Evidence-based Practice)

What’s an RCT anyway?

  • Question: What is a randomized controlled trial (RCT)? And why should I care?
  • Answer: An RCT is one of the strongest types of studies in showing that a drug or a treatment actually improves a symptom or disease. If I have strep throat, I want to know what antibiotic works best in killing the bacteria, & RCTs are one of the best ways to find that answer.

In the simplest kind of RCT, subjects are randomly assigned to 2 groups.  One group gets the treatment in which we are interested, & it is called the experimental group.   The other group gets either no treatment or standard treatment, & it is called the control group.  

Here’s an example from a study to determine whether chewing gum prevents postoperative ileus after laparotomy for benign gynecologic surgery:  A total of 109 patients were randomly assigned to receive chewing gum (n=51) or routine postoperative care (n=58).  Fewer participants assigned to receive chewing gum … experienced postoperative nausea (16 [31.4%] versus 29 [50.0%]; P=0.049) and postoperative ileus (0 vs. 5 [8.6%]; P=0.032).* There were no differences in the need for postoperative antiemetics, episodes of postoperative vomiting, readmissions, repeat surgeries, time to first hunger, time to toleration of clear liquids, time to regular diet, time to first flatus, or time to discharge. Conclusion?  Postop gum chewing is safe & lowers the incidence of nausea and ileus! (Jernigan, Chen, & Sewell, 2014. Retrieve from PubMed abstract)

Do you see the elements of an RCT in above?

Let’s break it down.

  • Randomized means that 109 subjects were randomly divided into 2 or more groups. In above case, 51 subjects ended up in a gum chewing group & 58 were assigned to a routine care, no gum group.  Randomization increases the chance that the groups will be similar in characteristics such as age, gender, etc.   This allows us to assume that different outcomes between groups are caused by gum-chewing, not by differences in group characteristics.
  • Controlled means that 1 of the groups is used as a control group. It is a comparison group, like the no-gum , standard care group above
  • Trial means that it was a study. The researchers were testing (trying) an intervention and measuring the outcomes to see if it worked.  In this case the intervention was gum chewing and the measure outcomes were nausea and ileus.

Why should you care about RCTs?  Because RCTs are strong evidence that an intervention works (or doesn’t) for your patients

Critical Thinking Exercise:   Go to http://www.ncbi.nlm.nih.gov/pubmed   In the blank box at the very top enter a few key words about the problem in which you are interested + RCT.  For example:  music pain + RCT.   Then read 1 or more of the abstracts looking for random assignment (randomized), control group, and whether it was a study (trial).   You’re on your way!    -Dr.H

*Note: You may remember from other blogs that p<.05 means the difference between groups is probably cause by the intervention—in this case gum chewing.

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