Clinical Research Oriented Workshop (CROW) Meeting: January 5, 2012

Present: Abby Crocker, Kairn Kelley, Rodger Kessler, Amanda Kennedy, Ben Littenberg, Connie van Eeghen

1. Start Up: Jazz at the Spot on Friday night in Burlington, Shelburne Rd.

2. Journal Club: Bronfort, Spinal Manipulation Ann Intern Med, 2012 – focus: methods review. One guideline available for reporting studies is found on the CTS website: CONSORT, which provides a “gold standard” checklist for reporting, not for running a clinical study. (See Ben’s post below under “Research Reporting Guidelines” for more info on this.) This particular article followed most of the checklist items. The Annals requires this as a standard for publishing.

a. Researchers: DC is a Doctor of Chiropractic. Authors come from the center for clinical studies at NW Health Sciences U in MN, a pain management clinic in MN, an unaffiliated stats/data specialist, health policy and clinical effectiveness division of Cinci Children’s Hospital OH, and a center for outcomes and clinical research in MN

b. Problem stated: treatment of mechanical neck pain (acute and subacute) has little research guidance

c. Objective: measure relative efficacy (ability of an intervention to produce the desired beneficial effect in expert hands and under ideal circumstances) of SMT, Rx, and HEA in short and long term (multiple periods from 2 to 52 weeks)

d. Design: RCT

i. Randomization: what is “permutated blocks of different sizes?” p. 2

1. Block randomization is a method of distributing patients randomly in “blocks” of 3, 6, 9… so that the clinician can’t predict which arm the “next” participant will be in.

2. Participants were not blinded but could have been. The study asks which is the most efficacious treatment, without the participants’ choosing. Informed participants who could choose and were blinded to whether they received their chosen treatment would have answered a different question. Blinded participants would have provided more basis for choosing in the real world.

3. Interventions were not equivalent: SMT brings with it a lot of individual attention.

4. No stratification by sex or age or baseline pain measure.

ii. Goal was 270 participants; 272 entered study; needed 229 for power calc

1. Lost 6 in med arm immediately; wound up with 219 p. 6

2. More women wound up in med group; other differences in distribution

e. Measures: reported pain; secondarily reported disability, global improvement, med use, satisfaction, health status (SF36), adverse events. Evaluation of neck motion blinded (global improvement).

f. Results: SMT>med; HEA>meds but took longer-and not stat sig. p. 5. SMT=HEA for pain.

i. This is an issue of “multiple comparisons.” The study finds an apparent logical contradiction: SMT>med and SMT=HEA but HEA=med?

1. Data will regress to the mean: if the study starts with high pain, pain will go down just because it changes over time and the study starts at “high”

2. This clinical issue self-resolves.

3. Involvement in a study produces a success, by itself.

ii. What is “linear mixed-model analysis with the MIXED procedure in SAS?” p.3

1. It appears to assess the effect of missing data on the overall results by imputing patterns related to those lost to follow-up. Based on Intention-to-treat principle to include all participants in baseline data in the analyses, regardless of loss to follow-up.

iii. Analysis: Fisher (protected) least-significant-difference test

1. Run the ANOVA on the three arms together to determine if one group is more different than the other two

2. If yes, look for all possible correlations using Fisher

3. Currently discredited; better alternatives exist. Therefore, p values are less believable.

iv. Interpretation of the magnitude of group differences was facilitated by “responder analyses” conducted by group “for pain reduction (absolute risk reduction) of 50%, 75%, and 100% (including 95% CIs) at the end of treatment” and two additional times, This analysis helps assure that pain scores are relatively similarl. Good for helping future patients make a decision.

g. Funding: NIH-National Center for Complementary and Alternative Medicine

h. Summary: excellent report. Questionable clinical relevance or use.

3. Workshop Goals for 2012:

a. Journal club: identify UVM guests and articles; invite to CROW ahead of time

b. Research updates: share work-in-process

4. Next Workshop Meeting(s): Thursday, 1:00 p.m. – 2:30 p.m., at Given Courtyard Level 4.

a. Jan 12: Kairn – review of “Development and Evidence of Reliability and Validity” chapter from SCAN-3 (no Ben)

b. Jan 19: Chris Jones and Rodger’s article on QALI’s (no Connie)

c. Jan 26: (no Amanda)

d. Feb 2: Rodger: discuss design for PCBH clinical and cost research

e. Feb 9: (no Ben, Amanda)

f. Feb 16: (no Connie)

g. Feb 23:

h. Mar 1: (no Connie)

i. Mar 8:

j. Mar 15: (no Ben, Connie)

k. Future agenda to consider:

i. Ben: budgeting exercise for grant applications

ii. Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding

iii. Amanda: presentation and interpretation of data in articles

iv. Sharon Henry: article by Cleland, Thoracic Spine Manipulation, Physical Therapy 2007

v. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)

Recorder: C. van Eeghen