MEDLINE-listed Journals Research Articles

Controllable Factors to Reduce the Rate of Complications in Primary Breast Augmentation: A Review of the Literature.

Aesthetic augmentation mammoplasties are one of the most demanded procedures performed in the aesthetic surgical sector. Because of the high epidemiological impact, the evaluation of measures to reduce the risk of complications is highly needed. The goal of this review is to evaluate the current literature for successful actions to reduce the risk of complications in aesthetic breast augmentation. We searched Medline-listed journals for "complications primary breast augmentation" and defined surgeon-dependent and patient-dependent factors within those. Most of the strategies to reduce the risk of any complication are based on meticulous hygienic precautions and adequate training of the surgeon. The current literature suggests complications such as capsular contracture, infection and BIA-ALCL are closely linked with bacterial contamination and therefore can be avoided with different hygienic measures. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The incidence of implant fractures after knee arthroplasty.

This study aimed to evaluate the incidence of "implant" fractures after knee arthroplasty using clinical literature and worldwide arthroplasty registers. The hypothesis was that register datasets report higher rates of these rare complications than clinical studies. Calculations were based on the pooled incidence of revision operations after fractures of knee arthroplasties, comparing clinical studies published in MEDLINE-listed journals and annual reports from worldwide arthroplasty registers in a structured literature analysis based on a standardized methodology. Twelve clinical studies and datasets from six worldwide registers were included. Rates of fractures of knee arthroplasties were reported from 0.2 to 2.5% in clinical studies versus 0.02-0.17% in worldwide arthroplasty registers. Fractures of knee arthroplasty systems are rare complications, with clinical studies showing higher incidence rates than worldwide arthroplasty registries. Unicompartmental knee arthroplasty (UKA) implanted before 2000, constrained primary or revision constrained total knee arthroplasties, and patellar replacements showed the highest incidence of implant fracture. The results of this analysis can help clinicians to counsel patients on potential complications following knee arthroplasty. III.

Revision rate of Birmingham Hip Resurfacing arthroplasty: comparison of published literature and arthroplasty register data

Hip resurfacing arthroplasty has gained popularity for treating young and active patients who have arthritis. There are two major data sources for assessing outcome and revision rate after total joint arthroplasty: sample-based clinical trials and national arthroplasty registers. The purpose of this study was to evaluate the outcome of the Birmingham Hip Resurfacing (BHR) arthroplasty in terms of revision rate as reported in clinical studies and recorded by national arthroplasty registers. A comprehensive literature research was performed from English-language, peer-reviewed journals and annual reports from national joint arthroplasty registers worldwide. Only publications from MEDLINE-listed journals were included. The revision rate was used as the primary outcome parameter. In order to allow for direct comparison of different data sets, calculation was based on revisions per 100 observed component years. For statistical analysis, confidence intervals (CI) were calculated. A total of 18,708 implants, equivalent to 106,565 observed component years, were analysed in the follow-up studies. The register reports contained 9,806 primary cases corresponding to 44,294 observed component years. Statistical analysis revealed a significant difference in revisions per 100 observed component years between the development team (0.27; CI: 0.14-0.40) and register data (0.74; CI: 0.72-0.76). The BHR arthroplasty device shows good results in terms of revision rate in register data as well as in clinical studies. However, the excellent results reported by the development team are not reproducible by other surgeons. Based on the results of our study, we believe that comprehensive national arthroplasty registers are the most suitable tool for assessing hip arthroplasty revision rate.

Impact of Implant Developers on Published Outcome and Reproducibility of Cohort-Based Clinical Studies in Arthroplasty

The reproducibility of the results of cohort-based clinical studies of arthroplasty procedures by the average orthopaedic surgeon is a major issue involving the quality of the scientific literature. We compared the results of a comprehensive literature analysis with data from national arthroplasty registries to examine the influence of arthroplasty implant inventors on the outcomes published in peer-reviewed journals. A structured review of the literature published in MEDLINE-listed journals was performed. A comparison of the average revision rates in the identified studies (adjusted for the number of arthroplasty cases and the duration of follow-up) with the registry data was then conducted. Seventeen of the analyzed arthroplasty implants were developed in the United States. Studies by the developers of these implants often had a substantial influence on the published outcome. For approximately 50% of the implant systems analyzed, the average revision rate derived by combining all published studies showed a statistically significant and clinically relevant deviation from the revision rate derived from the arthroplasty registry data, which reflected the outcome in the average patient. For the majority of implants for which the revision rate calculated from the published clinical studies was very low compared with the rate calculated from the registry data, the developing institution accounted for 39% to 100% of the published outcome data for the implant. In contrast, the published results were usually reproducible in clinical practice if <25% of the published data were reported by the developers. Three of the nine arthroplasty implants developed in Europe showed a significant and clinically relevant difference between the revision rate derived from only the studies published by the developers and the rate calculated from the registry data. However, because of the considerably greater amount of data from independent studies that was typically available for the European implants than for the American implants, studies by the developer that deviated significantly from the registry data could usually also be identified as outliers by a meta-analysis of all published studies. A high proportion of the published data involving three of the European implants was reported by the inventors, but comparison with the registry data revealed that the average published revision rates for two of these three implants were reproducible in clinical practice. The published results of the clinical studies involving many of the arthroplasty implants, especially implants developed in the United States, were highly influenced by reports from the center that developed the implant. This often had a substantial effect on the reproducibility of the outcome data. There appeared to be relevant differences between the medical research systems in Europe and the United States that also affected the reproducibility and applicability of the results for the average surgeon. Registry data can contribute substantial added value to an informed discussion of arthroplasty outcomes.

Outcome of the cementless Taperloc stem: a comprehensive literature review including arthroplasty register data

Background and purpose The validity of various data sources for the assessment of the outcome quality of medical devices was investigated by comparative analysis of the published data sources available for a sample of implants. It was the aim of the study to determine the performance of this implant and to identify potential bias factors inherent to the various datasets.Methods A comprehensive literature search was carried out from English-language, peer-reviewed journals and worldwide reports from national arthroplasty registers. Publications from Medline-listed journals were included. The main parameter was revision rate, calculated as “revisions per 100 observed component years” to allow adjusted direct comparison of different datasets.Results Of 16 clinical studies that met the inclusion criteria, 9 originated from the implant developer's hospital. In the clinical studies category, publications from the developer's hospital suggested considerably lower revision rates than the other datasets. In fact, the values quoted were 5.5 times below the average of all other studies, and 9.51 times lower than in the Australian arthroplasty register. These differences are statistically significant.Interpretation The cementless Taperloc stem is an implant that shows good performance regarding revision rates in registry data and in clinical studies. However, the excellent results published by the developer's clinic are generally not reproducible by other surgeons. In terms of reference data, registry data are able to make an important contribution to the assessment of clinical sample-based studies, particularly regarding evaluation of the extent to which published results are reproducible in daily routine.

Are presentations of abstracts at EGPRN meetings followed by publication?

Background: Research presented at scientific meetings is inaccessible to clinicians, unless the findings are subsequently published in a journal. Aims: To assess the publication rate of studies presented at 10 European General Practice Research Network (EGPRN) meetings between 1999 and 2006. Methods: Survey by e-mail or postal questionnaire among all presenters. Results: Information was obtained on 251 presentations (response rate 60%). In total, 113 out of these 251 (45%) presentations had been published. However, only 60% of the research findings were published in English Medline-listed journals, whereas 20% were not Medline-listed. The most frequently cited reason for non-publication was that the paper had not been submitted yet at time of follow up (103 responses). The main reason for non-submission was that the research presented had not been completed yet.Conclusion: Presentations at EGPRN meetings commonly concern research ideas or ongoing research. In this light, the ratio of published work to presented work compares well with the corresponding ratios found for international meetings in other specialist fields. This survey was also meant as an audit of the EGPRN meetings and gives better insight in needs for future strategy.

Homeopathy in the paediatric population

Homeopathy in the paediatric population

On the effectiveness of the homeopathic remedy Arnica montana

Arnica montana is a homeopathic remedy often prescribed after traumata and injuries. To assess whether Arnica is effective beyond placebo and to identify factors which support or contradict this effectiveness. All prospective, controlled trials on the effectiveness of homeopathic Arnica were included. Overall effectiveness was assessed by meta-analysis and meta-regression techniques. 68 comparisons from 49 clinical trials show a significant effectiveness of Arnica in traumatic injuries in random effects meta-analysis (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.24-0.55), but not in meta-regression models (OR, 0.37; CI, 0.11-1.24). We found no evidence for publication bias. Studies from Medline-listed journals and high-quality studies are less likely to report positive results (p = 0.0006 and p = 0.0167). The hypothesis that homeopathic Arnica is effective could neither be proved nor rejected. All trials were highly heterogeneous, meta-regression does not help to explain this heterogeneity substantially.

Minimal Reporting Requirements for Weight Loss: Current Methods Not Ideal

There is variety in the reporting of weight loss outcomes within the bariatric literature. Our aim is to compare methods of reporting weight loss in surgical and medical studies, and in addition look for a minimal reporting requirement that allows meaningful comparison. A review of methods of reporting weight loss in studies published during 2004 was conducted. Bariatric surgical studies included all reports from MEDLINE-listed journals, and medical studies included reports of non-surgical weight loss from 9 leading journals. 65 surgical and 36 non-surgical reports were retrieved. There were 3 common (>20% of reports) methods of reporting in the surgical literature; mean weight, percentage of excess weight loss (%EWL) and body mass index (BMI), and 4 in the medical literature; mean weight loss, weight, percentage weight loss and BMI. %EWL was reported in 2/3 of surgical reports and in none of the non-surgical. The origin of ideal weight for %EWL calculations was reported in 10 (23%) of these studies and included 5 differing definitions. All methods of reporting other than those using "ideal weight" can be calculated from mean weight and BMI at all time-points. There is complexity and confusion in the reporting of bariatric surgery weight outcomes when calculations are based on ideal weight. Providing weight (kg) and BMI (kg/m2) at all time-points allows the reader to interpret and compare the results in the context of the population of interest. These two measures should be provided as a minimum by all journals reporting on intentional weight loss.