The quality of reporting of randomized controlled trials in pelvic organ prolapse

Introduction and hypothesis  

Randomized controlled trials (RCTs) must comply with the strict rules of design and conduct and their reporting should reflect it. Our aim was to evaluate how the quality of RCT reporting in pelvic organ prolapse (POP) has evolved.     

The quality of reporting of randomized controlled trials in solid organ transplantation

Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 ( n  = 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs.     

A brief history of the Journal of Bone and Joint Surgery

The Journal of Bone and Joint Surgery had its origins in the Transactions of the American Orthopedic Association, which first were published in 1889. In 1903, the Transactions of the American Orthopedic Association, Volume 16, became the first volume of the American Journal of Orthopedic Surgery, still under the sponsorship of the American Orthopedic Association. In 1919, the word American was dropped from the title and the Journal of Orthopaedic Surgery became the official publication of the newly formed British Orthopaedic Association and the American Orthopedic Association. The name was changed to The Journal of Bone and Joint Surgery in 1921. Shortly after the founding of the American Academy of Orthopaedic Surgeons in 1933, The Journal became the official organ of the academy; however, ownership of The Journal remained with the American Orthopaedic Association. The British volume appeared in 1948. The Journal of Bone and Joint Surgery became an independent, not-for-profit corporation in 1954. The Journal, which continues to be a leader in the area of orthopaedic publication, began publishing the full text on compact disk in January 1992, the full text in electronic form through BRS/Saunders in 1995, and the full text on The Journal's website in December 1999.     

A history of osteomyelitis from the Journal of Bone and Joint Surgery: 1948 TO 2006

Osteomyelitis is one of the oldest diseases known. It took many years before the acute infection could be brought under control with antibiotics and chronic osteomyelitis remains difficult to manage. The modern history of the disease is reflected in the pages of the Journal of Bone and Joint Surgery.     

The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies

BACKGROUND: The Consolidated Standards of Reporting Trials statement for the reporting of randomized controlled trials has been limited by its applicability to surgical trials. In response, a Checklist to Evaluate a Report of a Nonpharmacological Trial was recently developed by the Consolidated Standards of Reporting Trials group to address reporting issues in surgical trials. We aimed (1) to apply the checklist for nonpharmacological therapies to orthopaedic randomized controlled trials across multiple journals from 2004 through 2005, and (2) to survey authors when methodological safeguards itemized in the checklist were not reported to determine whether they actually had been performed. We hypothesized that lack of reporting of a methodological safeguard did not necessarily mean it had not been conducted. METHODS: We searched for relevant orthopaedic randomized controlled trials across eight journals in the period from January 2004 through December 2005. We applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to all eligible studies. We contacted authors to determine what methodological safeguards were actually used, especially when details remained unclear from the publication. RESULTS: We included eighty-seven randomized controlled trials from eighty-five scientific reports. In assessing the randomized controlled trials with the checklist for nonpharmacological therapies, seventy-three studies (84%) had unclear reporting of treatment allocation concealment. Only seventeen studies (20%) mentioned surgeon skill or experience. The blinding of patients, ward staff, rehabilitation staff, clinical outcome assessors, and nonclinical outcome assessors was unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%), and thirty-three studies (38%), respectively. Authors from forty-three randomized controlled trials responded to our survey. The results of the survey showed that 41% (95% confidence interval, 25% to 58%) of the trials had adequate allocation concealment when this had been unclear from the report. Although the surgical experience of the investigators was rarely reported, most authors (70%) acknowledged that they had defined "surgical expertise criteria" such as minimum case criteria, specialized training, and clinical performance. The survey also showed that 28% to 40% of the trials had blinding of relevant groups despite the fact that the reporting of such blinding had been unclear in the publications. CONCLUSIONS: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias-reducing safeguards that were not reported in a randomized controlled trial did not occur. Our study reinforces the need for the consistent use of a tool like the Checklist to Evaluate a Report of a Nonpharmacological Trial to assess the methodology of surgical trials.