Appendix 4: Examples of different formats which can be used to describe and/or provide

study intervention materials [posted as supplied by author]

A TRIAL WEBSITE

Example paper:

White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, et al. Comparison of

adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist

medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011; 377: 823-36.

www.pacetrial.org – This trial website contains trial information, including the treatment manuals.

PHOTOS OF INTERVENTION MATERIALS

Example paper:

Bennell KL, Bowles K, Payne C, Cicuttini F, Williamson E, Forbes A, et al. Lateral wedge insoles

for medial knee osteoarthritis: 12 month randomised controlled trial. BMJ 2011;342:d2912

VIDEO OF INTERVENTION PROCEDURE

Example paper:

Arts MP, Brand R, van den Akker M, et al. Tubular diskectomy vs conventional microdiskectomy

for sciatica: a randomised controlled trial. JAMA 2009;302:149-158.doi:10.1001/jama.2009.972.

“Figure 1; a video showing a tubular diskectomy and a conventional microdiskectomy is available at

http://www.jama.com/cgi/content/full/302/2/149/DC1”

Example journal:

JOVE (Journal of Visualised Experiments)

SMARTPHONE APP

Example paper:

Hupperets MDW, Verhagen EALM, Mechelen

proprioceptive training on recurrences of ankle sprain: randomised controlled trial.

2009;339:b2684.

This app (available through iTunes) demonstrates the exercises involved in the intervention,

including their schedule.

JOVE (Journal of Visualised Experiments) – www.jove.com

Hupperets MDW, Verhagen EALM, Mechelen W V. Effect of unsupervised home based

proprioceptive training on recurrences of ankle sprain: randomised controlled trial.

This app (available through iTunes) demonstrates the exercises involved in the intervention,

W V. Effect of unsupervised home based

proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ

This app (available through iTunes) demonstrates the exercises involved in the intervention,

WEBSITE WITH INTERVENTION MATERIALS USED FOR TRAINING

INTERVENTION PROVIDERS

Example paper:

Butler CC, Simpson SA, Hood K, Cohen D, Pickles T, Spanou C, et al. Training practitioners to

deliver opportunistic multiple behaviour change counselling in primary care: a cluster randomised

trial. BMJ 2013;346:f1191.

This website, along with the username and password to access it, is referred to in the primary paper

and it contains intervention materials used to train the intervention providers.

PROTOCOL (WITH FURTHER INTERVENTION DETAILS) AS A

PUBLISHED PAPER

Example paper:

Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J. Effect of tailored practice

and patient care plans on secondary prevention of heart disease in general practice: cluster

randomised controlled trial. BMJ 2009;339:b4220.

Further intervention details are provided in the published protocol: Murphy AW, Cupples ME,

Smith SM, Byrne M, Leathem C, Byrne MC. The SPHERE Study. Secondary prevention of heart

disease in general practice: protocol of a randomised controlled trial of tailored practice and patient

care plans with parallel qualitative, economic and policy analyses. Trials 2005;16:1–16.

PROTOCOL (AND ALL INTERVENTION DETAILS) AS AN ONLINE

APPENDIX TO THE MAIN PAPER

Example paper:

Bieri F, Gray DJ, Williams GM, Raso G, Li Y-S, Yuan L, et al. Health-education package to

prevent worm infections in Chinese schoolchildren. N Engl J Med 2013;368:1603–12.

“Details of the implementation of the educational package are provided in Table 1. A description of the

development of the cartoon is provided in the Supplementary Appendix, and the front cover is shown in

Figure 2. The cartoon can be accessed at NEJM.org or at www.qimr.edu.au/page/Home/Magic_glasses. A

specific teacher-training workshop was held before commencement of the trial (for details, see the

protocol, available at NEJM.org).”

PAT PLOT

PaT plot is a graphical method of depicting the components of complex interventions. It is

described in: Perera R, Heneghan C, Yudkin P. Graphical method for depicting randomised trials of

complex interventions. BMJ 2007;334:127–9.

Example paper:

Kaner E, Bland M, Cassidy P, Coulton S, Dale V, Deluca P, et al. Effectiveness of screening and

brief alcohol intervention in primary care (SIPS trial): pragmatic cluster randomised controlled trial.

BMJ 2013;346:e8501.

“A graphical summary of the trial procedures has been provided to clarify the sequence and timing of

screening, assessment, brief intervention, and follow-up activity (see supplementary diagram 1, PaT plot).”

INTERVENTION MANUAL AS A SEPARATE PUBLISHED PAPER

Example paper:

Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher ME, et al. Efficacy of brief

behavioral treatment for chronic insomnia in older adults. Arch Intern Med 2011;171:887–95.

The full intervention manual for the intervention reported in this primary paper is published in a

separate paper: Troxel WM, Germain A, Buysse DJ. Clinical management of insomnia with brief

behavioral treatment (BBTI). Behav Sleep Med 2012;10:266–79.