• 1

    Medical Research Council: Streptomycin treatment of pulmonary tuberculosis: a report of the Streptomycin in Tuberculosis Trials Committee. .BMJ 2::769. ,1948. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2

    Sackett DL, Hoey J: Why randomized controlled trials fail but needn’t: a new series is launched. .CMAJ 162::1301. ,2000. .

  • 3

    Freiman JA, Chalmers TC, Smith H Jr, et al: The importance of beta, the type II error and sample size in the design and interpretation of the randomized controlled trial: a survey of 71 “negative” trials. .N Engl J Med 299::690. ,1978. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4

    Moher D, Dulberg CS, Wells GA: Statistical power, sample size, and their reporting in randomized controlled trials. .JAMA 272::122. ,1994. .

  • 5

    Begg CB, Cho MK, Eastwood S, et al: Improving the quality of reporting of randomized controlled trials: the CONSORT statement. .JAMA 276::637. ,1996. .

  • 6

    CONSORT Statement. Available at: http://www.consort-statement.org. Accessed August 29. ,2002. .

  • 7

    Landorf KB: Ensuring adequate reporting of randomized controlled trials: the CONSORT statement [commentary]. .JAPMA 91::435. ,2001. .

  • 8

    Joseph WS: Introduction to Landorf KB: Ensuring adequate reporting of randomized controlled trials: the CONSORT statement [commentary]. .JAPMA 91::435. ,2001. .

    • Search Google Scholar
    • Export Citation
  • 9

    Turlik MA, Kushner D: Levels of evidence in articles in podiatric medical journals. .JAPMA 90::300. ,2000. .

  • 10

    Crawford F, Atkins D, Edwards J: Interventions for treating plantar heel pain. .Cochrane Database Syst Rev 3::CD000416. ,2000. .

  • 11

    Bell-Syer SE, Hart R, Crawford F, et al: A systematic review of oral treatments for fungal infections of the skin of the feet. .J Dermatolog Treat 12::69. ,2001. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12

    Ferrari J, Higgins JPT, Williams RL: Interventions for treating hallux valgus (abductovalgus) and bunions. .Cochrane Database Syst Rev 2::CD000964. ,2000. .

    • Search Google Scholar
    • Export Citation
  • 13

    Gibbs S, Harvey I, Sterling JC, et al: Local treatments for cutaneous warts. .BMJ 325::461. ,2002. .

  • 14

    Bryant A, Mahoney B, Tinley P: Lateral intermetatarsal angle: a useful measurement of metatarsus primus el-evatus?. JAPMA 91::251. ,2001. .

    • Search Google Scholar
    • Export Citation
  • 15

    Gupta AK, Joseph WS: Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States. .JAPMA 90::495. ,2000. .

    • Search Google Scholar
    • Export Citation
  • 16

    Head J, Bryant B, Ebeling P: Short term use of ibuprofen or paracetamol affects bone resorption in healthy males: a double blind, placebo controlled study. .Australas J Podiatric Med 32: (suppl):1. ,1998. .

    • Search Google Scholar
    • Export Citation
  • 17

    McCabe CJ, Stevenson RC, Dolan AM: Evaluation of a diabetic foot screening and protection programme. .Diabet Med 15::80. ,1998. .

  • 18

    Miller SL, Wertheimer SJ: A comparison of the efficacy of injectable dexamethasone sodium phosphate versus placebo in postoperative podiatric analgesia. .J Foot Ankle Surg 37::223. ,1998. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Piette JD, Weinberger M, Kraemer FB, et al: Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial. .Diabetes Care 24::202. ,2001. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    Plotkin S: Clinical comparison of preinjection anesthetics. .JAPMA 88::73. ,1998. .

  • 21

    Ronnemaa T, Hamalainen H, Toikka T, et al: Evaluation of the impact of podiatrist care in the primary prevention of foot problems in diabetic subjects. .Diabetes Care 20::1833. ,1997. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22

    van Schie CH, Whalley A, Vileikyte L, et al: Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial. .Diabetes Care 23::634. ,2000. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    Dovison R, Keenan AM: Wound healing and infection in nail matrix phenolization wounds: does topical medication make a difference?. JAPMA 91::230. ,2001. .

    • Search Google Scholar
    • Export Citation
  • 24

    Hamalainen H, Ronnemaa T, Toikka T, et al: Long-term effects of one year of intensified podiatric activities on foot care knowledge and self-care habits in patients with diabetes. .Diabetes Educ 24::734. ,1998. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25

    Lagan KM, Clements BA, McDonough S, et al: Low intensity laser therapy (830nm) in the management of minor postsurgical wounds: a controlled clinical study. .Lasers Surg Med 28::27. ,2001. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 26

    Thomson CE, Morrow LJ, Martin DJ: A randomised double blind trial to compare pain on digital injection of warm and cold anaesthetic. .The Foot 8::89. ,1998. .

    • Search Google Scholar
    • Export Citation
  • 27

    van Gils CC, Roeder B, Chesler SM, et al: Improved healing with a collagen-alginate dressing in the chemical matricectomy. .JAPMA 88::452. ,1998. .

    • Search Google Scholar
    • Export Citation
  • 28

    Schulz KF, Chalmers I, Grimes DA, et al: Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. .JAMA 272::125. ,1994. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29

    Schulz KF: Subverting randomization in controlled trials. .JAMA 274::1456. ,1995. .

  • 30

    Kennedy A, Grant A: Subversion of allocation in a randomised controlled trial. .Control Clin Trials 18::35. ,1997. .

  • 31

    Silverman W: “Risks and Benefits of Medical Innovations,” in Non-Random Reflections on Health Services Research, ed by A Maynard, I Chalmers, BMJ Publications, London. ,1997. .

The Need for Randomized Controlled Trials in Podiatric Medical Research

Jill Porthouse York Trials Unit, Department of Health Sciences, University of York, York, England.

Search for other papers by Jill Porthouse in
Current site
Google Scholar
PubMed
Close
 MSc
and
David J. Torgerson York Trials Unit, Department of Health Sciences, University of York, York, England.

Search for other papers by David J. Torgerson in
Current site
Google Scholar
PubMed
Close
 PhD
View More View Less

The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These studies were of variable quality. We also discuss the key features of a rigorous trial design. To date, the clinical practice of podiatric medicine is not adequately informed by the best available evidence. We call for more high-quality randomized controlled trials to be undertaken in podiatric medical research. (J Am Podiatr Med Assoc 94(3): 221–228, 2004)

Corresponding author: Jill Porthouse, MSc, York Trials Unit, Department of Health Sciences, University of York, York YO10 5DD, England.
Save