Although current electronic methods of scientific publishing offer increased opportunities for publishing all research studies and describing them in sufficient detail, health research literature still suffers from many shortcomings. These shortcomings seriously undermine the value and utility of the literature and waste scarce resources invested in the research. In recent years there have been several positive steps aimed at improving this situation, such as a strengthening of journals' policies on research publication and the wide requirement to register clinical trials.The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative set up to advance high quality reporting of health research studies; it promotes good reporting practices including the wider implementation of reporting guidelines. EQUATOR provides free online resources http://www.equator-network.org supported by education and training activities and assists in the development of robust reporting guidelines. This paper outlines EQUATOR's goals and activities and offers suggestions for organizations and individuals involved in health research on how to strengthen research reporting.
High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal Art Sedrakyan professor 1 , Bruce Campbell professor 2 , Jose G Merino clinical research editor 3 , Richard Kuntz chief scientific, clinical, and regulatory officer 4 , Allison Hirst researcher 5 , Peter McCulloch professor 5
Objective To assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines. Design Systematic review.Data sources Reporting guidelines from a published systematic review and the EQUATOR Network (October 2011). Studies assessing the completeness of reporting by using an included reporting guideline (termed "evaluations") (1990 to October 2011; addendum searches in January 2012) from searches of either Medline, Embase, and the Cochrane Methodology Register or Scopus, depending on reporting guideline name.Study selection English language reporting guidelines that provided explicit guidance for reporting, described the guidance development process, and indicated use of a consensus development process were included. The CONSORT statement was excluded, as evaluations of adherence to CONSORT had previously been reviewed. English or French language evaluations of included reporting guidelines were eligible if they assessed the completeness of reporting of studies as a primary intent and those included studies enabled the comparisons of interest (that is, after versus before journal endorsement and/or endorsing versus non-endorsing journals).Data extraction Potentially eligible evaluations of included guidelines were screened initially by title and abstract and then as full text reports. If eligibility was unclear, authors of evaluations were contacted; journals' websites were consulted for endorsement information where needed. The completeness of reporting of reporting guidelines was analyzed in relation to endorsement by item and, where consistent with the authors' analysis, a mean summed score.Results 101 reporting guidelines were included. Of 15 249 records retrieved from the search for evaluations, 26 evaluations that assessed completeness of reporting in relation to endorsement for nine reporting guidelines were identified. Of those, 13 evaluations assessing seven reporting guidelines (BMJ economic checklist, CONSORT for harms, PRISMA, QUOROM, STARD, STRICTA, and STROBE) could be analyzed. Reporting guideline items were assessed by few evaluations. ConclusionsThe completeness of reporting of only nine of 101 health research reporting guidelines (excluding CONSORT) has been evaluated in relation to journals' endorsement. Items from seven reporting guidelines were quantitatively analyzed, by few evaluations each. Insufficient evidence exists to determine the relation between journals' endorsement of reporting guidelines and the completeness of reporting of published health research reports. Journal editors and researchers should consider collaborative prospectively designed, controlled studies to provide more robust evidence.Systematic review registration Not registered; no known register currently accepts protocols for methodology systematic reviews.
BackgroundPre-publication peer review of manuscripts should enhance the value of research publications to readers who may wish to utilize findings in clinical care or health policy-making. Much published research across all medical specialties is not useful, may be misleading, wasteful and even harmful. Reporting guidelines are tools that in addition to helping authors prepare better manuscripts may help peer reviewers in assessing them. We examined journals' instructions to peer reviewers to see if and how reviewers are encouraged to use them.MethodsWe surveyed websites of 116 journals from the McMaster list. Main outcomes were 1) identification of online instructions to peer reviewers and 2) presence or absence of key domains within instructions: on journal logistics, reviewer etiquette and addressing manuscript content (11 domains).FindingsOnly 41/116 journals (35%) provided online instructions. All 41 guided reviewers about the logistics of their review processes, 38 (93%) outlined standards of behaviour expected and 39 (95%) contained instruction about evaluating the manuscript content. There was great variation in explicit instruction for reviewers about how to evaluate manuscript content. Almost half of the online instructions 19/41 (46%) mentioned reporting guidelines usually as general statements suggesting they may be useful or asking whether authors had followed them rather than clear instructions about how to use them. All 19 named CONSORT for reporting randomized trials but there was little mention of CONSORT extensions. PRISMA, QUOROM (forerunner of PRISMA), STARD, STROBE and MOOSE were mentioned by several journals. No other reporting guideline was mentioned by more than two journals.ConclusionsAlthough almost half of instructions mentioned reporting guidelines, their value in improving research publications is not being fully realised. Journals have a responsibility to support peer reviewers. We make several recommendations including wider reference to the EQUATOR Network online library (www.equator-network.org/).
Objectives Comparison of medium-term safety and efficacy of hysterectomy and uterine artery embolisation (UAE) for symptomatic uterine fibroids.Design Multicentre retrospective cohort.Setting 18 UK NHS hospital trusts.Participants Four hundred and fifty nine women who had hysterectomy within a national audit during 12 months from October 1994 (VALUE study) (average follow up of 8.6 years) and 649 women receiving UAE from 1996 to 2002 (average follow up of 4.6 years).Methods Clinical data from existing hospital records and patient completed postal questionnaires.Main outcome measures Complication rates, side effects of embolisation, satisfaction with treatment, relief from symptoms and requirement for further fibroid treatment.Results Fewer complications were experienced by women receiving UAE (19 versus 26% hysterectomy, P = 0.001), the adjusted odds ratio for UAE versus hysterectomy was 0.48 (95% CI 0.26-0.89).One-third of women undergoing UAE experienced anticipated general side effects associated with the procedure. More women in the hysterectomy cohort reported relief from fibroid symptoms (95 versus 85%, P < 0.0001) and feeling better (96 versus 84%, P < 0.0001), but only 85% would recommend the treatment to a friend compared with 91% in the UAE arm (P = 0.007). There was a 23% (95% CI 19-27%) chance of requiring further treatment for fibroids after UAE. Twenty-seven women who had had UAE reported 37 pregnancies after treatment resulting in 19 live births.Conclusions UAE results in fewer complications than hysterectomy. Side effects after embolisation should be anticipated, and almost one-quarter of women having UAE were likely to require further treatment for fibroid symptoms. Both treatments appear to be safe and effective over the medium term, and the choice of treatment may be a matter of personal preference for each individual woman.Keywords Complications, embolisation, hysterectomy, uterine fibroids.Please cite this paper as: Dutton S, Hirst A, McPherson K, Nicholson T, Maresh M. A UK multicentre retrospective cohort study comparing hysterectomy and uterine artery embolisation for the treatment of symptomatic uterine fibroids (HOPEFUL study): main results on medium-term safety and efficacy. BJOG
The study results suggest that both UAE and hysterectomy are safe. No unexpected problems were detected following UAE after a long follow-up period (average 5 years). Complications are less common for UAE than hysterectomy. The cost-effectiveness analysis favours embolisation even after taking account of complications, expected side-effects associated with the procedure and subsequent re-treatments for women with a preference for uterus preservation. It is important to improve the management of expectations following UAE, particularly regarding fertility. The data suggested that fertility and miscarriage rate are consistent with those of age-matched women with fibroids. UAE is an effective treatment for some women with fibroids and our trial supports the National Institute for Health and Clinical Excellence guidance that it should be made available as one of the options for treatment, with a possible reduction in the need for hysterectomy as the first-line treatment. Further research is needed into which women will be treated most successfully by UAE, the best method of achieving effective embolisation, advice for women who desire future fertility, the role of prophylactic antibiotics in UAE, and the effects of HRT use after UAE on recurrence of fibroid symptoms.
The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.
The guide helps readers and researchers to understand and implement the IDEAL Framework and Recommendations to improve the quality of evidence supporting surgical innovation.
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