Guidelines on Chemotherapy in Advanced Stage Gynecological Malignancies: An Evaluation of 224 Professional Societies and Organizations

BACKGROUND: Clinical practice guidelines are important for guiding practice, but it is unclear if they are commensurate with the available evidence. METHODS: We examined guidelines produced by cancer and gynecological societies and organizations and evaluated their coverage of and stance towards chemotherapy for advanced stage disease among 4 gynecological malignancies (breast, ovarian, cervical, endometrial cancer) where the evidence for the use of chemotherapy is very different (substantial and conclusive for breast and ovarian cancer, limited and suggesting no major benefit for cervical and endometrial cancer). Eligible societies and organizations were identified through systematic internet searches (last update June 2009). Pertinent websites were scrutinized for presence of clinical practice guidelines, and relative guidelines were analyzed. RESULTS: Among 224 identified eligible societies and organizations, 69 (31%) provided any sort of guidelines, while recommendations for chemotherapy on advanced stage gynecological malignancies were available in 20 of them. Only 14 had developed their own guideline, and only 5 had developed guidelines for all 4 malignancies. Use of levels of evidence and grades of recommendations, and aspects of the production, implementation, and timeliness of the guidelines did not differ significantly across malignancies. Guidelines on breast and ovarian cancer utilized significantly more randomized trials and meta-analyses. Guidelines differed across malignancies on their coverage of disease-free survival (p = 0.033), response rates (p = 0.024), symptoms relief (p = 0.005), quality of life (p = 0.001) and toxicity (p = 0.039), with breast and ovarian cancer guidelines typically covering more frequently these outcomes. All guidelines explicitly or implicitly endorsed the use of chemotherapy. CONCLUSIONS: Clinical practice guidelines are provided by the minority of professional societies and organizations. Available guidelines tend to recommend chemotherapy even for diseases where the effect of chemotherapy is controversial and recommendations are based on scant evidence

Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study.

BACKGROUND: The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers' claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. METHODS: Electronic searching was undertaken to identify randomized controlled trials (RCTs) published over a 5-year period (1 January 2012 to 31 December 2016). Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. RESULTS: Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO) (23.8%), followed by the European Journal of Orthodontics (EJO) (14.3%), Journal of Orthodontics (JO) (10.7%) and Angle Orthodontist (AO) (10.7%). Overall, 45% (38/84) of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%), with the relative merits of non-surgical adjuncts (14.1%) and other orthodontic auxiliaries (13.1%) also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56) and conflict of interest (p = 0.96) were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44) and conflict of interest (p = 0.28) were found. CONCLUSIONS: Almost half of orthodontic clinical trials over the past 5 years involve analysis of marketed products after their introduction. The results highlight a potential source of waste in orthodontic research emanating from existing approaches to licensing and marketing of orthodontic products