Stats: Effective communication about randomized clinical trials (February 22, 2005, Evidence, Overview)

Effective communication about randomized clinical trials (February 22, 2005). Category: Critical appraisal

The most recent issue of BMJ has a nice article evaluating a training program for health care professionals. This is an unusual thing to do; most of the time, training programs are just put together with the assumption that because intelligent people are designing the program, it must be effective. I'm just as guilty of this as anyone else, of course.

The particular training class is of great interest to me, because it works on how health care professionals communicate to patients about randomized clinical trials. Here is a description of the course:

Our course lasted eight hours, split over two days. The course comprised interactive exercises, didactic presentations, and facilitated discussion about the videotaped scenarios in the modules. During the course, we encouraged participants to consider how they structured trial discussions with patients and how they described treatments available on and off trial and the process of randomisation, and to compare these with those depicted in the modules. At the end of the course participants generated a list of key points about trial discussion.

We developed the training materials in close collaboration with experienced doctors, research nurses, trial managers, and patient groups. We had to conduct original research in several subjects such as patient preferences for different descriptions of randomisation as evidence based recommendations did not exist.10 The training materials comprised four video modules (see fig 1), a CD Rom, and a comprehensive facilitator's handbook.

Module 1 provides a generic introduction to randomised clinical trials and includes comments by six patients, eight clinicians, a research nurse, and a trial manager exploring the difficulties associated with discussing trials.

Module 2 deals with the discussion of adjuvant treatment trials and contains two scenarios—VICTOR, a placebo controlled colorectal cancer trial, and the intergroup exemestane study (IES), a breast cancer trial. This module also looks at handling uncertainty and dealing with uninformed and suspicious patients.

Module 3 includes two scenarios of palliative trials—Myeloma VII, a multiple myeloma trial, and the big lung trial (BLT) for non-small cell lung cancer. This module promotes discussion about handling deferential patients and their more questioning relatives and giving distressed patients complex information about highly toxic treatment.

Module 4 depicts patients who may have a strong preference for a particular treatment arm and explores how to handle patients with high information needs who have collected many internet articles and newspaper cuttings—in the MRC CLASICC trial, a surgical trial for bowel cancer, and MRC PRO7, a prostate cancer trial.

All four modules have a linking commentary and statements by clinicians and nurses.

Before and after the training class, the researchers videotaped course participants discussing clinical trials with actors playing various roles (internet guru, patient with a strong treatment preference, a deferential patient, or a suspicious patient). These videotapes were scored for the presence or absence of key information being conveyed to the actor/patient.

They also asked participants before and after the training class to rate their self-confidence with various difficult situations. They also had the actors rate the health care professionals.

After the training class, the health care professionals were more likely to check the patients understanding of randomization, talk about side effects, and encourage the patient to discuss options with family members. Other issues did not change after the training (e.g., encouraging the patients to read the trial information sheet and reminding them that they could withdraw at any time). The actor ratings were generally higher after the training, though a few of the items did not achieve statistical significance because they were already quite high at the videoptape prior to training. After the training, the participants also rated their self confidence as higher on most items.

Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. Jenkins V, Fallowfield L, Solis-Trapala I, Langridge C, Farewell V. Bmj 2005: 330(7488); 400. [Medline] [Abstract] [Full text] [PDF]

In the same issue of BMJ, a summary of an article,

A controlled trial of active versus passive learning strategies in a large group setting. Haidet P, Morgan RO, O'Malley K, Moran BJ, Richards BF. Adv Health Sci Educ 2004;9: 15-27.

showed that cutting a one hour didactic lecture in half and adding 30 minutes of interactive training did not result in less knowledge, but did improve the feeling of engagement. Students still, however, feel that the one hour didactic session offered greater educational value.

Another summary, of the article

Assessing the evidence--filling the glass. Rhodes RS. Surgery. 2004 Sep;136(3):647-9.

demonstrated that surgeons who attended journal clubs showed better appraisal skills than a comparison group who only received the articles.

A summary of

Laparoscopic virtual reality training: are 30 repetitions enough? Brunner WC, Korndorffer JR Jr, Sierra R, Massarweh NN, Dunne JB, Yau CL, Scott DJ. J Surg Res. 2004 Dec;122(2):150-6. [Medline]

emphasized a commonly stated concern about randomized trials in surgery. Many review articles have argued that these trials are more difficult to run, because there is a difficult learning curve for new procedures (I commented on one such article in my Febraury 14, 2005 weblog entry). The summary of the Brunner et al article points out that surgeons practicing laproascopic procedures on a simulator reached several plateaus as they repeated the task, but did not achieve the maximal efficiency until 22-29 repetitions.

A letter to the editor,

Selective serotonin reuptake inhibitors: placebo washouts inflate antidepressant effects in general practice. van Marwijk HW, Ader HJ. Bmj 2005: 330(7488); 420. [Medline]

criticizes the use of a placebo washout period in randomized trials and the exclusion of placebo responders from the full trial. This is similar to the criticism in Senn 1997. Another problem is when the placebo run-in period is used to exclude non-compliant patients.

Finally, James Penston, author of the book

Fiction and Fantasy in Medical Research: The Large Scale Randomised Trial. Penston J, / FPJ (2003) London, England: London Press. ISBN: 0954463617. [BookFinder4U link]

has a letter to the editor,

Trial protocols: time for more than tinkering. Penston J. BMJ. 2005 Feb 19;330(7488):421. [Medline]

criticizing a proposal

Trial protocols at the BMJ. Jones G, Abbasi K. BMJ. 2004 Dec 11;329(7479):1360. [Medline]

to require submission of trial protocols for reviewers to look at when they are examining manuscripts submitted to BMJ. The proposal sounds quite good to me, because it would allow the reviewers to see if any changes in the protocol had occurred that might limit the validity of the research. Dr. Penston argues, much in the same vein as in his book, that randomized trials are so flawed that "a complete reappraisal" is needed. Interestingly enough, Dr. Penston cites two of my favorite articles in his bibliography:

User's Guide to Detecting Misleading Claims in Clinical Research Reports. Montori VM, Jaeschke R, Schunemann H, Bhandari M, Brozek JL, Devereaux PJ, Guyatt G. British Medical Journal 2004: 329; 1093-1096. [Medline] [Full text] [PDF]

Content and quality of 2000 controlled trials in schizophrenia over 50 years. Thornley B, Adams C. British Medical Journal 1998: 317(7167); 1181-1184. [Medline] [Abstract] [Full text] [PDF]

as well as two articles that I have not read until just now:

Quality of reporting of randomized trials as a measure of methodologic quality. Huwiler-Muntener K, Juni P, Junker C, Egger M. Jama 2002: 287(21); 2801-4. [Medline] [Abstract] [Full text] [PDF]

The PROGRESS trial three years later: time for a balanced report of effectiveness. Wennberg R, Zimmermann C. Bmj 2004: 329(7472); 968-70. [Medline] [Full text] [PDF]

While I appreciate Dr. Penston's criticisms of randomized trials, I fear that he is far too pessimistic.

This webpage was written by Steve Simon and was last modified on 07/08/2008.