| Clinical
Quality Improvement |
| Strite
S, Stuart M
The EBM Organization: Three-part series by Delfini
published in The Physician Executive, Journal of Medical
Management
http://www.delfini.org/Showcase_Publication_PhysicianExecutive.htm
Rosser WW, Davis D,
Gilbart E.
Assessing Guidelines for Use in Family Practice.
Journal of Family Practice 2001; 50: 969-973.
http://www.jfponline.com/Pages.asp?AID=2392&UID=
Hayward RSA et al.
User’s Guides to the Medical Literature, VIII:
How to Use Clinical Practice Guidelines, A: Are the recommendations
valid?
JAMA. 1995; 274: 570-574.
http://www.jamaevidence.com/resource/520
Wilson MC et al.
User’s Guides to the Medical Literature, VIII:
How to Use Clinical Practice Guidelines, B: What are the recommendations
and will they help you in caring for your patients?
JAMA. 1995; 274: 1630-1632.
http://www.cche.net/usersguides/guideline.asp
Bero LA et al. for
the Cochrane Effective Practice and Organization of Care Review
Group.
Closing the gap between research and practice: an overview
of systematic reviews of interventions to promote the implementation
of research findings.
BMJ.1998;317:465-468
http://bmj.com/cgi/content/full/317/7156/465
NHS Centre for Review
and Dissemination.
Effective Health Care. Getting Evidence into Practice.
London, England: Royal Society of Medicine Press;1999. http://www.york.ac.uk/inst/crd/EHC/ehc51.pdf
Oxman AD et al.
No magic bullets: a systematic review of 102 trials of interventions
to improve professional practice.
CMAJ 1995;153:1423-1431.
http://www.jamaevidence.com/resource/520
Click here
to go to the Delfini
Approach to Quality Improvement & Value.
Also see Delfini
Health
Care System Tool Set.
|
| Formulary
Management |
Strite
SA, Stuart ME, Urban S.
Process steps and suggestions for creating drug monographs
and drug class reviews in an evidence-based formulary system.
Formulary. April 2008;43:135–145.
http://www.delfini.org/Showcase_Publication_Formulary.htm
Strite SA, Stuart ME.
An Introduction to Systematic Reviews: The Lifeblood of
Medical Decision-making.
California Pharmacist 2008. Vol LV, No. 3. Summer 2008: 52-56.
http://www.delfini.org/Showcase_Publication_CPhA.htm
Chiquette E, Posey
LM.
Evidence-based Pharmacotherapy.
American Pharmacists Association. APhA Publications; 1 edition (January
15, 2007).
Contributing Authors Include —
Strite SA, Stuart ME, contributing authors. Chapter 7. Applying
Evidence-Based Pharmacotherapy to Formulary Decisions
http://www.delfini.org/Showcase_Publication_EBPharmacotherapy.htm
|
| Balance
Sheets |
| Braddick
M, Stuart M, Hrachovec J.
The use of balance sheets in developing clinical guidelines.
J Am Board Fam Pract. 1999 Jan-Feb;12(1):48-54. Erratum in: J Am
Board Fam Pract 1999 Mar-Apr;12(2):187.
PMID: 10050643 |
| Implementation |
|
Solberg
L et al.
Lessons from Experienced Guideline Implementers: Attend
to Many Factors and Use Multiple Strategies.
Journal of Quality Improvement. 2000; 26: 171-188.
PubMed Abstract:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=10749003&dopt=Abstract%20
Grol R et al.
Evidence-based Implementation of Evidence-based Medicine.
Journal of Quality Improvement. 1999; 25: 10; 503-513.
PubMed Abstract:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=10522231&dopt=Abstract
Grol R et al.
Attributes of clinical guidelines that influence use of
guidelines in general practice: observational study.
BMJ 1998; 317:858-861.
Full Text:
http://bmj.bmjjournals.com/cgi/content/abstract/317/7162/858
Wensing, M et al.
Implementing guidelines and innovations in general practice:
which interventions are effective?
British Journal of General Practice. Feb 1998; 48:991-997.
PubMed Abstract:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=9624774&dopt=Abstract
|
Rogers EM.
Diffusion of Innovations. 3rd Edition. The
Free Press. New York; 1983.
|
 |
Lomas J, Haynes RB.
A taxonomy and critical review of tested strategies for
the application of clinical practice recommendations from “official”
to “individual” clinical policy.
AM J Prevent Med. 1988;4:77-94
PubMed Reference:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=3079143&dopt=Abstract
|
| Performance
Measurement |
| Stuart
M, Strite S
Pitfalls to Performance Measurement: Article by Delfini
published in Modern Healthcare
http://www.delfini.org/Showcase_Publication_PerformanceMeasures.htm
Physician Consortium
for Performance Improvement: Documents from Website: http://www.ama-assn.org/go/quality
- Principles for Performance
Measurement in Health Care
- Introduction to
Physician Performance Measurement Sets, Oct 2001
- Clinical Performance
Measures for various conditions, e.g., Adult Diabetes
National Quality
Measures Clearinghouse (NQMC): Includes many educational
documents and an archive of quality and performance measures
http://www.qualitymeasures.ahrq.gov/
Bagley B.
How does your practice measure up?
Fam Pract Manag. 2006 Jul-Aug;13(7):59-64.
PMID: 16909830
http://www.aafp.org/fpm/20060700/59howd.html
Nerenz DR, Neil N
Performance Measures for Health Care Systems
To access, copy the following into an internet search engine:
www.hret.org/hret/programs/chmr/content/cp19a.pdf
Vijan, Sandeep
Are We Overvaluing Performance Measures?
Effective Clinical Practice ACP site: http://www.acponline.org/journals/ecp/sepoct00/overvalue.htm
Landon BE, Normand
ST, Blumenthal D, Daley J.
Physician clinical performance assessment: prospects and
barriers.
JAMA. 2003;290:1183-1189.
Walter LC, Davidowitz
NP, Heineken PA et al.
Pitfalls of Converting Practice Guidelines into Quality
Measures: Lessons Learned from a VA Performance Measure.
JAMA. 2004;2901:2466-2470. Abstract.
Hofer TP, Hayward RA,
Greenfield S, Wagner EH, Kaplan SH, Manning WG.
The unreliability of individual physician "report cards"
for assessing the costs and quality of care of a chronic disease.
JAMA. 1999 Jun 9;281(22):2098-105.
PMID: 10367820 Abstract.
|
| Evidence-based
Medicine |
| Here
is a nice, short general write up on what evidence-based medicine
is. NOTE: We do have
a couple of issues. 1. We would amend to say "best available
valid and clinically useful evidence." 2. And we are often
asked about industry research. We say that everyone has a potential
bias — critically appraise every study, every secondary source,
for validity and clinical usefulness. Read a recent Bandolier commentary
here.
And yet, we also think overall this is a nice intro to EBM.
Dickersin K, Straus
SE, Bero LA.
Evidence based medicine: increasing, not dictating, choice.
BMJ. 2007 Jan 6;334 Suppl 1:s10. PMID: 17204750.
|
General Books on Evidence-based Medicine Topics
& Clinical Epidemiology |
|
Eddy,
David
Clinical Decision Making: From Theory to Practice: A Collection
of Essays From the Journal of the American Medical Association
Jones & Bartlett Pub; 1st edition (January 15, 1996)
Fletcher, Robert H,
Suzanne W. Fletcher and Edward H. Wagner
Clinical Epidemiology: The Essentials.
Philadelphia PA. Lippincott Williams & Wilkins, 1996.
Geyman, John P., Richard
A. Deyo, Scott D. Ramsey
Evidence-based Clinical Practice — Concepts and Approaches
Butterworth Heinemann, 2000.
Guyatt, Gordon and
Rennie Drummond, ed. The Evidence-Based Medicine Working Group
Users' Guides to the Medical Literature: Essentials
of Evidence-Based Clinical Practice.
AMA Press, 2002.
Jekel, James F., Joann
G. Elmore, David L. Katz
Epidemiology, Biostatistics and Preventive Medicine
WB Saunders Company, 1996
Riegelman, Richard
Studying a Study and Testing a Test.
Philadelphia PA. Lippincott Williams & Wilkins, 2000.
Click here
to go to Delfini
critical appraisal tools in our Evidence Tool Set.
Click here
for Delfini
Primers. |
| Critical
Appraisal — General |
| Delfini
Primers &
Evidence Tools
The Consort
Statement: Consolidated Standards of Reporting Trials —CONSORT
"The CONSORT statement is an
important research tool that takes an evidence-based approach to
improve the quality of reports of randomized trials. The statement
is available in six languages and has been endorsed by prominent
medical journals such as The Lancet, Annals of Internal Medicine,
and the Journal of the American Medical Association. Its critical
value to researchers, health care providers, peer reviewers, and
journal editors, and health policy makers is the guarantee of integrity
in the reported results of research.
CONSORT comprises a checklist and flow diagram to help improve the
quality of reports of randomized controlled trials. It offers a
standard way for researchers to report trials. The checklist includes
items, based on evidence, that need to be addressed in the report;
the flow diagram provides readers with a clear picture of the progress
of all participants in the trial, from the time they are randomized
until the end of their involvement. The intent is to make the experimental
process more clear, flawed or not, so that users of the data can
more appropriately evaluate its validity for their purposes. "
http://www.consort-statement.org/
Gluud LL.
Bias in Clinical Intervention Research.
Am J Epidemiol 2006;163:493–501
PMID: 17119141
Ioannidis JPA (2005)
Why most published research findings are false.
PLoS Med 2(8): e124
PMID: 16060722
Direct access here.
Juni P, Altman DG,
Egger M.
Systematic reviews in health care: Assessing the quality
of controlled clinical trials.
BMJ. 2001 Jul 7;323(7303):42-6.
PMID: 11440947 |
| Randomization |
Schulz
KF, Grimes DA.
Generation of allocation sequences in randomised trials: chance,
not choice.
Lancet 2002; 359: 515–19.
PMID: 11853818 |
| Concealment
of Allocation |
Viera
AJ, Bangdiwala SI.
Eliminating bias in randomized controlled trials: importance
of allocation concealment and masking.
Fam Med. 2007 Feb;39(2):132-8.
PMID: 17273956
Direct access
here. |
| Blinding |
| Boutron
I, Estellat C, Guittet L, Dechartres A, Sackett DL, et al. (2006)
Methods of blinding in reports of randomized controlled
trials assessing pharmacologic treatments: A systematic review.
PLoS Med 3(10): e425. DOI: 10.1371/ journal.
PMID: 17076559
Direct access here.
Flum DR.
Interpreting Surgical Trials With Subjective Outcomes Avoiding
UnSPORTsmanlike Conduct.
JAMA, November 22/29, 2006—Vol 296, No. 20: 2483-1484.
PMID: 17119146
See Delfini commentary in related DelfiniClick™
»
Schulz KF, Chalmers
I, Hayes RJ, Altman DG.
Empirical evidence of bias. Dimensions of methodological
quality associated with estimates of of treatment effects in controlled
trials.
JAMA 1995;273:40812.
PMID: 7823387
See Delfini commentary in related DelfiniClick™
»
Viera AJ, Bangdiwala
SI.
Eliminating bias in randomized controlled trials: importance
of allocation concealment and masking.
Fam Med. 2007 Feb;39(2):132-8.
PMID: 17273956
Direct access
here.
|
| Analysis
(see Intention-to-Treat Analysis also) |
| Kaplan
Meier curves explained:
http://cancerguide.org/scurve_km.html |
| Intention-to-Treat
Analysis |
|
Schulz
KF, Grimes DA
Sample size slippages in randomised trials: exclusions and
the lost and wayward.
The Lancet. Vol 359. March 2, 2002: 781-785 Online
abstract and opportunity for purchasing article copy
PMID: 11888606
NOTE: Delfini stresses
that the approach taken for missing values should not give an advantage
to the intervention.
Hollis S, Campbell
F
What is meant by intention to treat analysis? Survey of
published randomised controlled trials.
BMJ. Vol 319. Sept 1999: 670-674
http://bmj.com/cgi/content/full/319/7211/670?maxtoshow=?eaf
NOTE: Delfini agrees
that differential loss is important to note, but even equivalent
loss of greater than five percent could be a threat to validity.
More reading: Intention-to-Treat
Analysis — The Biased Case of Migraine at our
Evidence Essentials Page.
Click here
to go to Delfini
critical appraisal tools in our Evidence Tool Set and
here for Delfini
White Paper on Missing Data.
Advanced Reading
Lachin JM.
Statistical considerations in the intent-to-treat principle.
Control Clin Trials 2000;21:167–189. PMID: 11018568
|
| Systematic
Reviews & Meta-analyses |
|
Strite SA, Stuart ME.
An Introduction to Systematic Reviews: The Lifeblood of
Medical Decision-making.
California Pharmacist 2008. Vol LV, No. 3. Summer 2008: 52-56.
http://www.delfini.org/Showcase_Publication_Formulary.htm
Oxman
AD, Cook DJ, Guyatt GH. How to use an Overview.
User’s Guides to Evidence-based Medicine.
JAMA. 1994 Nov 2; 272 (17): 1367-71
http://www.cche.net/usersguides/overview.asp
Egger
M, Smith GD, Phillips AN
Meta-analysis: principles and procedures.
BMJ. 1997: 315:1533-1537.
(BMJ has a great site in their collections: http://bmj.com/collections/ma.htm.)
Miser
WF
Applying a Meta-Analysis to Daily Clinical Practice.
J Am Board Fam Pract 13(3) : 201-210, 2000.
This tool is currently unavailable online.
| Delfini
suggestions and commentary on the Miser article and evaluation
tool: |
•
Under “Was the method for selecting articles…”
Question 3. Was selection done blindly and in random order
– means “Were the articles presented in random
order to reviewers and were reviewers blinded [communication
from author]. All relevant studies should be reviewed.
•
Often it is recommended
that all studies selected should go in the same direction
of treatment effect. The issue is trying to ensure that the
studies were similar enough to combine — if the results
are very different, that may point to a dissimilarity in studies.
All relevant studies should be sought using selection criteria,
including those in grey literature to address potential for
publication bias of lack of reporting of negative finding
studies. Doing systematic reviews is complicated. Sensitivity
analyses should be done and reported, along with a robust
discussion by the authors of potential differences in studies. |
Also, we've included
on our site our own Delfini
Systematic Review Validity Tool. Click here
to go to Delfini
critical appraisal tools in our Evidence Tool Set.
|
|
Diagnostic Testing |
| Jaeschke
R et al.
How to Use an Article About a Diagnostic Test. Users’
Guides to Evidence-based Medicine
JAMA.
http://www.jamaevidence.com/resource/520
Greenhalgh T.
How to read a paper: Papers that report diagnostic or screening
tests.
BMJ 1997; 315:540-3
http://bmj.bmjjournals.com/cgi/content/full/315/7107/540
| Fletcher, Robert
H, Suzanne W. Fletcher and Edward H. Wagner Clinical Epidemiology:
The Essentials. Philadelphia PA. Lippincott Williams & Wilkins,
1996. |
 |
Bandolier at http://www.jr2.ox.ac.uk/bandolier/
• Delfini
Diagnostic Testing Calculator Online
[Excel]
Features:
—» Natural
language explanations for results. Can use with patients.
—» Provides
information in percents, probabilities and odds.
—» Likelihood
ratio results computed for you so you don't have to guess what is
“insignificant” and what is “large.” The
calculator does the interpretive work for you.
—» Bandolier
number-needed-to-diagnose (NND) calculated as well.
Calculates on the basis of —
• pre-test likelihood, sensitivity and specificity
• raw data from a 2x2 table
Links to confidence interval calculator
• Delfini
Primer: "Evaluating Diagnostic Tests:
Challenges with Measures of Test Function" online at Evidence
Essentials
Download helpful one-pager that helps you better understand complexities
of diagnostic testing measures »
STARD
for Standards in Reporting of Diagnostic Accuracy
Click here
to go to the Delfini
Diagnostic Testing Tool Set.
|
| Equivalence
Trials |
|
Jones
B et al.
Trials to assess equivalence: the importance of rigorous
methods.
BMJ 1996; 313:36-39 (6 July)
Full Text: http://bmj.bmjjournals.com/cgi/content/full/313/7048/36
Kirshner B
Methodological standards for assessing therapeutic equivalence.
J Clin Epidemiol 1991. Vol. 44, No 8: 839-849
To view the abstract, go to PubMed and enter this PMID number in
the search box -» PMID: 1941037 |
| Cost-analysis
and Cost-effectiveness Analysis |
Gold
MR, Siegel JE, et al., Eds. (1996)
Cost-Effectiveness in Health and Medicine. New
York, Oxford University Press. |
|
Ganiats TG
Cost-effective analysis.
Primary Care. 22(2): 307-318, 1995.
Deyo R
Cost-effectiveness of Primary Care.
J Am Board Fam Pract 13(1):47-54, 2000. PMID: 10682885
Ramsey S et al
Weighing the Economic Evidence: Guidelines for Critical
Assessment of Cost-Effectiveness Analyses.
J Am Board Fam Pract 12(6): 477-485, 1999.
PubMed PMID: 10612366
Click here
to see our Examples of Cost Analysis Tools. |
| Visual
Display of Information |
|
Everything
by Edward Tufte! www.edwardtufte.com.
Click
here to go to our online newsletter of examples of information and
decision aids for practitioners and patients — On
the Same Page ™. |
|