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  Delfini Recommended Reading

Topics

  • Clinical Quality Improvement »
  • Balance Sheets »
  • Implementation »
  • Performance Measurement »
  • Evidence-based medicine »
  • General Books on Evidence-based Medicine Topics & Clinical Epidemiology »
  • Critical Appraisal of Primary Studies for Therapies —
    • General »
    • Randomization »
    • Concealment »
    • Blinding »
    • Analysis »
    • Intention-to-Treat Analysis »
  • Systematic Reviews & Meta-analyses »
  • Diagnostic Testing »
  • Equivalence Trials »
  • Cost-analysis and Cost-effectiveness Analysis »
  • Visual Display of Information »
  • Patient-centered Information at On the Same Page »
  • Also see —›

Bulletin Board

About PMID Numbers
We frequently utilize a PMID number in place of a citation. Where PMID numbers are available, enter that number into the PubMed search box to retrieve that citation and listing.

Also see...

  • Surprising facts you should know »
  • About Evidence-based Medicine — for Consumers & their Clinicians »
  • What Matters to Patients »
  • Evidence Essentials: Tips »
  • Delfini Tools & Educational Materials »
  • Delfini Publications & More »
  • DelfiniClick™: Evidence Commentaries & Quality Improvement Nibblets »
  • On the Same Page: Communicating Medical Information to Patients »
Click here periodically for information nibblets...
DelfiniClick
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/page_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/content/2001/11/jfp_1101_09690.asp

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.cche.net/usersguides/guideline.asp

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/ehc51warn.htm

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://mdm.ca/cpgsnew/cpgs/CPGworkshop1994/1423e.html

Click here to go to the Delfini Approach to Quality Improvement & Value.

Also see Delfini Health Care System Tool Set.

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
Online:
http://www.medscape.com/viewarticle/417834

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/page_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
http://depts.washington.edu/chmr/public/p0028/

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. Online.

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/

And glossary: http://www.consort-statement.org/explanation/newene.htm#glosstop

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 co
mmentary 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

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.
You can access the article and tool at
MedScape.

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.cche.net/usersguides/diagnosis.asp

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. http://www.familypractice.com/journal/abfpjournal_frame.htm?
main=/journal/2000/v13.n01/1301.07/art-1301.07.htm

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.
http://www.familypractice.com/journal/abfpjournal_frame.htm?
main=/journal/1999/v12.n06/1206.07/art-1206.07.htm

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 ™.

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