Wartolowska K.,Oxford NIHR Musculoskeletal Biomedical Research Unit |
Wartolowska K.,University of Oxford |
Collins G.S.,University of Oxford |
Collins G.S.,Center for Statistics in Medicine |
And 15 more authors.
BMJ Open | Year: 2016
Objectives: To find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding. Design: Systematic review. Data sources and study selection: The analysis involved studies published between 1959 and 2014 that were identified during an earlier systematic review of benefits and harms of placebo-controlled surgical trials published in 2014. Results: 63 trials were included in the review. The main problem reported in many trials was a very slow recruitment rate, mainly due to the difficulty in finding eligible patients. Existing placebo trials were funded equally often from commercial and non-commercial sources. General anaesthesia or sedation was used in 41% of studies. Among the reviewed trials, 81% were double-blinded, and 19% were single-blinded. Across the reviewed trials, 96% (range 50-100%) of randomised patients completed the study. The withdrawal rate during the study was similar in the surgical and in the placebo groups. Conclusions: This review demonstrated that placebo-controlled surgical trials are feasible, at least for procedures with a lower level of invasiveness, but also that recruitment is difficult. Many of the presumed challenges to undertaking such trials, for example, funding, anaesthesia or blinding of patients and assessors, were not reported as obstacles to completion in any of the reviewed trials.
Guerri-Fernandez R.,Hospital Universitari Del Mar Parc Of Salut Mar Imim |
Villar-Garcia J.,Hospital Universitari Del Mar Parc Of Salut Mar Imim |
Diez-Perez A.,Hospital Universitari Del Mar Parc Of Salut Mar Imim |
Prieto-Alhambra D.,Oxford NIHR Musculoskeletal Biomedical Research Unit
Arquivos Brasileiros de Endocrinologia e Metabologia | Year: 2014
With the advent of high active antiretroviral therapy there was a significant improvement on HIV subjects survival. Thus, bone changes related to HIV became an important aspect of these individuals. HIV affects bone remodeling causing bone fragility. In addition, antiretroviral therapy may also negatively affect bone metabolism. Several studies describe an increased incidence of fractures in these patients when compared with controls without the disease. The European Society of AIDS (EACS), and other societies, have included guidance on management of osteoporosis in HIV-infected patients emphasizing the identification of patients with low bone mass. Supplementation of calcium and vitamin D and the use of alendronate in these individuals should be recommended on a case base. © ABE&M todos os direitos reservados.
PubMed | Oxford NIHR Musculoskeletal Biomedical Research Unit and University of Oxford
Type: Journal Article | Journal: BMC surgery | Year: 2016
The aim of this study was to investigate the beliefs and attitudes of trainee surgeons regarding placebo interventions, in surgical practice and in research, and to compare them to those of senior orthopaedic surgeons.An invitation to participate in an online survey was sent to all the email addresses in the members database of the British Orthopaedic Trainees Association (BOTA).All 987 members of BOTA were invited to participate in the survey and 189 responded (19%). The majority of trainees think that the placebo effect is real (88%), has therapeutic benefits (88%) and that placebo manipulations are permissible (98%). Sixty per cent of respondents agree that placebo can be used outside of research, most commonly, to distinguish between organic and non-organic symptoms (36%). Trainees are more likely than senior surgeons to use placebo for pain management (34% vs. 12%). They are mainly concerned about the risk of side effects associated with the use of placebo (80%) and prefer placebo interventions with minimal invasiveness. Seventy-three per cent respondents would recruit patients into the proposed randomised controlled surgical trial.The views regarding efficacy, permissibility and indications for placebo among trainees are similar to those of orthopaedic consultants. Orthopaedic trainees regard placebo as permissible and show willingness to recruit into placebo-controlled trials. However, they seem to have limited understanding of mechanisms of placebo effect and underestimate its ubiquity.