Improving Medical Research in the United Kingdom

Peer reviewedPublisher PD

AGREE-S: AGREE II extension for surgical interventions - United European Gastroenterology and European Association for Endoscopic Surgery methodological guide

The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument has been developed to inform the methodology, reporting and appraisal of clinical practice guidelines. Evidence suggests that the quality of surgical guidelines can be improved, and the structure and content of AGREE II can be modified to help enhance the quality of guidelines of surgical interventions

Clinical relevance of ErbB-2/HER2 nuclear expression in breast cancer

<p>Abstract</p> <p>Background</p> <p>The biological relevance of nuclear ErbB-2/HER2 (NuclErbB-2) presence in breast tumors remains unexplored. In this study we assessed the clinical significance of ErbB-2 nuclear localization in primary invasive breast cancer. The reporting recommendations for tumor marker prognostic studies (REMARK) guidelines were used as reference.</p> <p>Methods</p> <p>Tissue microarrays from a cohort of 273 primary invasive breast carcinomas from women living in Chile, a Latin American country, were examined for membrane (MembErbB-2) and NuclErbB-2 expression by an immunofluorescence (IF) protocol we developed. ErbB-2 expression was also evaluated by immunohistochemistry (IHC) with a series of antibodies. Correlation between NuclErbB-2 and MembErbB-2, and between NuclErbB-2 and clinicopathological characteristics of tumors was studied. The prognostic value of NuclErbB-2 in overall survival (OS) was evaluated using Kaplan-Meier method, and Cox model was used to explore NuclErbB-2 as independent prognostic factor for OS.</p> <p>Results</p> <p>The IF protocol we developed showed significantly higher sensitivity for detection of NuclErbB-2 than IHC procedures, while its specificity and sensitivity to detect MembErbB-2 were comparable to those of IHC procedures. We found 33.6% NuclErbB-2 positivity, 14.2% MembErbB-2 overexpression by IF, and 13.0% MembErbB-2 prevalence by IHC in our cohort. We identified NuclErbB-2 positivity as a significant independent predictor of worse OS in patients with MembErbB-2 overexpression. NuclErbB-2 was also a biomarker of lower OS in tumors that overexpress MembErbB-2 and lack steroid hormone receptors.</p> <p>Conclusions</p> <p>We revealed a novel role for NuclErbB-2 as an independent prognostic factor of poor clinical outcome in MembErbB-2-positive breast tumors. Our work indicates that patients presenting NuclErbB-2 may need new therapeutic strategies involving specific blockage of ErbB-2 nuclear migration.</p

Factors affecting compliance with the measles vaccination schedule in a Brazilian city

CONTEXT AND OBJECTIVE: The success of vaccination campaigns depends on the degree of adherence to immunization initiatives and schedules. Risk factors associated with children's failure to receive the measles vaccine at the correct age were studied in the city of São Paulo, Brazil. DESIGN AND SETTING: Case-control and exploratory study, in the metropolitan area of São Paulo. METHODS: The caregivers of 122 children were interviewed regarding their perceptions and understanding about the measles vaccination and the disease. RESULTS: The results showed that age, region of residence, marital status and education level were unrelated to taking measles vaccines adequately. Most individuals remembered being informed about the last annual vaccination campaign by television, but no communication channel was significantly associated with vaccination status. The answers to questions about knowledge of the disease or the vaccine, when analyzed alone, were not associated with taking measles vaccinations at the time indicated by health agencies. The results showed that, when parents felt sorry for their children who were going to receive shots, they delayed the vaccination. Most of the children did not take the measles vaccination on the exactly recommended date, but delayed or anticipated the shots. CONCLUSION: It is clear that there is no compliance with the government's recommended measles vaccination schedule (i.e. first dose at nine and second at 15 months of age, as recommended in 1999 and 2000). Feeling sorry for the children receiving shots can delay vaccination taking

The uptake of the core outcome set for non-specific low back pain clinical trials is poor: a meta-epidemiological study of trial registrations

We conducted a meta-epidemiological study on all non-specific low back pain (NSLBP) trial registrations on the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. We aimed to 1) assess the uptake of the core outcome set (COS) for NSLBP in clinical trials; 2) assess the uptake of the core outcome measurement set for NSLBP in clinical trials; and 3) determine whether specific study characteristics are associated with the COS uptake. After applying the relevant filters for the condition, study type, and phase of the trial, 240 registry entries were included in this study. Only 50 (20.8%) entries showed a full COS uptake, and this rate did not increase over time. Most registry entries that planned to measure physical functioning (n = 152) used the Roland-Morris Disability Questionnaire (n = 74; 48.7%); a small percentage used the numeric rating scale (n = 60; 27.3%) or Short Form-12 (n = 5; 8.3%) if they planned to measure pain intensity (n = 220) or health-related quality of life (n = 60), respectively. Only the planned sample size (OR = 1.02; 95% CI = 1.01, 1.03) showed a significant but small association with COS uptake. The uptake of the COS for NSLBP is poor. Only 21% of the randomized controlled trials aimed to measure all COS domains in their study registration and COS uptake is not increased over time. Great heterogeneity in measurement instruments was also observed, revealing poor core outcome measurement set uptake. Perspective: The Core Outcome Set (COS) for non-specific low back pain was published more than 20 years ago. We evaluated whether trial registrations are using this set of outcomes when testing interventions for low back pain. Full uptake was found only in 21% of the sample, and this is not increasing over time. Researchers should use the COS to ensure that trials measure relevant outcomes consistently.</p

Steering Committee members.

BackgroundIn biomedical research, it is often desirable to seek consensus among individuals who have differing perspectives and experience. This is important when evidence is emerging, inconsistent, limited, or absent. Even when research evidence is abundant, clinical recommendations, policy decisions, and priority-setting may still require agreement from multiple, sometimes ideologically opposed parties. Despite their prominence and influence on key decisions, consensus methods are often poorly reported. Our aim was to develop the first reporting guideline dedicated to and applicable to all consensus methods used in biomedical research regardless of the objective of the consensus process, called ACCORD (ACcurate COnsensus Reporting Document).Methods and findingsWe followed methodology recommended by the EQUATOR Network for the development of reporting guidelines: a systematic review was followed by a Delphi process and meetings to finalize the ACCORD checklist. The preliminary checklist was drawn from the systematic review of existing literature on the quality of reporting of consensus methods and suggestions from the Steering Committee. A Delphi panel (n = 72) was recruited with representation from 6 continents and a broad range of experience, including clinical, research, policy, and patient perspectives. The 3 rounds of the Delphi process were completed by 58, 54, and 51 panelists. The preliminary checklist of 56 items was refined to a final checklist of 35 items relating to the article title (n = 1), introduction (n = 3), methods (n = 21), results (n = 5), discussion (n = 2), and other information (n = 3).ConclusionsThe ACCORD checklist is the first reporting guideline applicable to all consensus-based studies. It will support authors in writing accurate, detailed manuscripts, thereby improving the completeness and transparency of reporting and providing readers with clarity regarding the methods used to reach agreement. Furthermore, the checklist will make the rigor of the consensus methods used to guide the recommendations clear for readers. Reporting consensus studies with greater clarity and transparency may enhance trust in the recommendations made by consensus panels.</div