Risk of Major Complications From Coronary Angioplasty Performed Immediately After Diagnostic Coronary Angiography: Results From the Registry of the Society for Cardiac Angiography and Interventions

AbstractObjectives. This study was designed to determine the risk of performing percutaneous transluminal coronary angioplasty (PTCA) at the time of diagnostic catheterization (“combined procedures”).Background. Health care providers are under increasing pressure to combine diagnostic and interventional coronary procedures to reduce costs. However, the risk associated with combined procedures has not been rigorously assessed.Methods. A multicenter cohort study of 35,700 patients undergoing elective PTCA from 1992 through 1995 was performed to determine the risk of major complications (myocardial infarction, emergency coronary artery bypass graft surgery or death) from combined relative to staged procedures (i.e., performing PTCA at a session subsequent to diagnostic catheterization).Results. The risks of major complications from combined and staged procedures were 2.0% and 1.6%, respectively (unadjusted odds ratio [OR] 1.28, 95% confidence interval [CI] 1.05 to 1.57). After adjusting for clinical and angiographic differences and clustering by laboratory, the risk from combined procedures was not significantly elevated (multivariable OR 1.18, 95% CI 0.89 to 1.55). However, several subgroups of patients did have an increased risk from combined procedures: patients with multivessel disease (multivariable OR 1.64, 95% CI 1.13 to 2.39); women (multivariable OR 1.64, 95% CI 1.05 to 2.55); patients >65 years old (multivariable OR 1.40, 95% CI 1.02 to 1.93); and patients undergoing multilesion PTCA (multivariable OR 1.53, 95% CI 1.06 to 2.21). The risk of combined relative to staged procedures decreased over the 4-year period (multivariable p = 0.029).Conclusions. Combining PTCA with diagnostic catheterization appears to be safe in many patients. However, several subgroups of patients may be at increased risk. Careful patient selection will most likely remain critical to ensuring the safety of combined procedures.(J Am Coll Cardiol 1997;30:193–200

Diabetic neuropathic foot ulcers. The association of wound size, wound duration, and wound grade on healing

WSTĘP. Celem badań była ocena, czy możliwe jest określenie prostych (niezłożonych) czynników ryzyka, na podstawie których można stwierdzić, czy u chorych z owrzodzeniami stopy na tle neuropatii cukrzycowej standardowa terapia będzie skuteczna. MATERIAŁ I METODY. Było to badanie kohortowe, w którym oceniano grupę ponad 31 000 pacjentów z owrzodzeniem stopy w przebiegu neuropatii cukrzycowej, będących pod opieką Curative Health Services System (CHS). Stosując wieloczynnikową logistyczną regresję, oceniano związki pomiędzy wielkością rany, okresem jej trwania, stopniem zaawansowania rany oraz innych zmiennych (i ich wpływu) a wyleczeniem w ciągu 20 tygodni opieki. WYNIKI. Wykazano, że wielkość rany, okres jej trwania i stopień jej zaawansowania istotnie wpływały na prawdopodobieństwo wygojenia się rany w ciągu 20 tygodni leczenia. Dodatkowo zauważono, że leczenie w specjalistycznym ośrodku leczenia ran, niezależnie od tego, czy jednostką analizy była jedna rana pacjenta, czy wszystkie, oraz bez względu na stosowane dodatkowe terapie, nie zmieniało istotnie tej zależności. WNIOSKI. Wykazano, że trzy łatwe do oceny czynniki ryzyka są związane z gojeniem się ran. Uzyskane wyniki powinny pomóc klinicystom w ustaleniu, jakie jest prawdopodobieństwo wyleczenia rany, jak również pomóc w projektowaniu dalszych badań klinicznych.INTRODUCTION. The goal of this study was to evaluate whether simple risk factors can be identified that successfully characterize who will heal and who will not heal among patients who have received standard therapy for diabetic neuropathic foot ulcers. MATERIAL AND METHODS. For this cohort study, we evaluated > 31,000 individuals with a diabetic neuropathic foot ulcer seen in the Curative Health Services System. Using multivariate logistic regression, we evaluated the association between wound size, wound duration, wound grade, and other variables and their effect on whether a patient would heal by the 20th week of care. RESULTS. We demonstrated that wound size, wound duration, and wound grade are all significantly associated with the likelihood of a wound healing by the 20th week of care. In addition, we noted that these associations were not significantly affected by the treating wound care center, whether the unit of analysis was one wound on a patient or all of their wounds, or current adjuvant therapies. CONCLUSIONS. We have shown that three easy-to- -measure risk factors are associated with a wound healing. These results should help clinicians understand the likelihood that a wound will heal and help those conducting clinical investigations to design better trials

Meta-analysis of the effect of an essential oil–containing mouthrinse on gingivitis and plaque

AbstractBackgroundStandard recommendations for oral hygiene practices have focused on mechanical methods (toothbrushing and interdental cleaning). Published evidence indicates antimicrobial mouthrinses provide oral health benefits beyond mechanical methods alone. The purpose of this meta-analysis was to evaluate the combined effectiveness of mechanical methods with essential oil–containing mouthrinses (MMEO) versus mechanical methods (MM) alone in achieving site-specific, healthy gingival tissue and reducing plaque and gingivitis.Types of Studies ReviewedAll industry-sponsored clinical trials investigating the antigingivitis and antiplaque effects of essential oil (EO)–containing mouthrinses conducted from 1980 to 2012 were reviewed; 29 of 32 studies met the inclusion criteria of 6 months or longer duration, randomized, observer-masked, placebo-controlled, and with individual-level site-specific data. By-study treatment effects were estimated through generalized linear models for binary data and analysis of covariance for continuous data, and then combined using standard meta-analysis techniques; heterogeneity was also assessed.ResultsSummary odds ratios for a healthy gingival site and for a plaque-free site were, respectively, 5.0 (95% confidence interval [CI], 3.3-7.5) and 7.8 (95% CI, 5.4-11.2) for MMEO participants versus MM participants at 6 months. The summary percentage reductions in whole-mouth mean gingivitis and plaque at 6 months were 16.0 (95% CI, 11.3-20.7) and 27.7 (95% CI, 22.4-32.9), respectively. Responder analyses using aggregate individual-level data showed 44.8% of MMEO participants and 14.4% of MM participants achieved at least 50% healthy sites in their mouths at 6 months. Similarly, 36.9% of MMEO participants and 5.5% of MM participants achieved at least 50% plaque-free sites in their mouths at 6 months.Conclusions and Practical ImplicationsThis is the first meta-analysis to demonstrate the clinically significant, site-specific benefit of adjunctive EO treatment in people within a 6-month period (that is, between dental visits)

Choosing the target difference ('effect size') for a randomised controlled trial - DELTA(2) guidance protocol

BACKGROUND: A key step in the design of a randomised controlled trial (RCT) is the estimation of the number of participants needed. By far the most common approach is to specify a target difference and then estimate the corresponding sample size; this sample size is chosen to provide reassurance that the trial will have high statistical power to detect such a difference between the randomised groups (at the planned statistical significance level). The sample size has many implications for the conduct of the study, as well as carrying scientific and ethical aspects to its choice. Despite the critical role of the target difference for the primary outcome in the design of an RCT, the manner in which it is determined has received little attention. This article reports the protocol of the Difference ELicitation in TriAls (DELTA(2)) project, which will produce guidance on the specification and reporting of the target difference for the primary outcome in a sample size calculation for RCTs. METHODS/DESIGN: The DELTA(2) project has five components: systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2); a Delphi study (stage 3); a 2-day consensus meeting bringing together researchers, funders and patient representatives, as well as one-off engagement sessions at relevant stakeholder meetings (stage 4); and the preparation and dissemination of a guidance document (stage 5). DISCUSSION: Specification of the target difference for the primary outcome is a key component of the design of an RCT. There is a need for better guidance for researchers and funders regarding specification and reporting of this aspect of trial design. The aim of this project is to produce consensus based guidance for researchers and funders

Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA2 five-stage study, including a workshop

BACKGROUND: The randomised controlled trial is widely considered to be the gold standard study for comparing the effectiveness of health interventions. Central to its design is a calculation of the number of participants needed (the sample size) for the trial. The sample size is typically calculated by specifying the magnitude of the difference in the primary outcome between the intervention effects for the population of interest. This difference is called the 'target difference' and should be appropriate for the principal estimand of interest and determined by the primary aim of the study. The target difference between treatments should be considered realistic and/or important by one or more key stakeholder groups. OBJECTIVE: The objective of the report is to provide practical help on the choice of target difference used in the sample size calculation for a randomised controlled trial for researchers and funder representatives. METHODS: The Difference ELicitation in TriAls2 (DELTA2) recommendations and advice were developed through a five-stage process, which included two literature reviews of existing funder guidance and recent methodological literature; a Delphi process to engage with a wider group of stakeholders; a 2-day workshop; and finalising the core document. RESULTS: Advice is provided for definitive trials (Phase III/IV studies). Methods for choosing the target difference are reviewed. To aid those new to the topic, and to encourage better practice, 10 recommendations are made regarding choosing the target difference and undertaking a sample size calculation. Recommended reporting items for trial proposal, protocols and results papers under the conventional approach are also provided. Case studies reflecting different trial designs and covering different conditions are provided. Alternative trial designs and methods for choosing the sample size are also briefly considered. CONCLUSIONS: Choosing an appropriate sample size is crucial if a study is to inform clinical practice. The number of patients recruited into the trial needs to be sufficient to answer the objectives; however, the number should not be higher than necessary to avoid unnecessary burden on patients and wasting precious resources. The choice of the target difference is a key part of this process under the conventional approach to sample size calculations. This document provides advice and recommendations to improve practice and reporting regarding this aspect of trial design. Future work could extend the work to address other less common approaches to the sample size calculations, particularly in terms of appropriate reporting items. FUNDING: Funded by the Medical Research Council (MRC) UK and the National Institute for Health Research as part of the MRC-National Institute for Health Research Methodology Research programme

A randomized trial provided new evidence on the accuracy and efficiency of traditional vs. electronically annotated abstraction approaches in systematic reviews

Abstract Objectives Data Abstraction Assistant (DAA) is a software for linking items abstracted into a data collection form for a systematic review to their locations in a study report. We conducted a randomized cross-over trial that compared DAA-facilitated single-data abstraction plus verification ("DAA verification"), single data abstraction plus verification ("regular verification"), and independent dual data abstraction plus adjudication ("independent abstraction"). Study Design and Setting This study is an online randomized cross-over trial with 26 pairs of data abstractors. Each pair abstracted data from six articles, two per approach. Outcomes were the proportion of errors and time taken. Results Overall proportion of errors was 17% for DAA verification, 16% for regular verification, and 15% for independent abstraction. DAA verification was associated with higher odds of errors when compared with regular verification (adjusted odds ratio [OR] = 1.08; 95% confidence interval [CI]: 0.99–1.17) or independent abstraction (adjusted OR = 1.12; 95% CI: 1.03–1.22). For each article, DAA verification took 20 minutes (95% CI: 1–40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction. Conclusion Independent abstraction may only be necessary for complex data items. DAA provides an audit trail that is crucial for reproducible research

Character, Incidence, and Predictors of Knee Pain and Activity after Infrapatellar Intramedullary Nailing of an Isolated Tibia Fracture

© Copyright 2015 Wolters Kluwer Health, Inc. All rights reserved. Objective: To study the activity and incidence of knee pain after sustaining an isolated tibia fracture treated with an infrapatellar intramedullary nail at 1 year. Design: Retrospective review of prospective cohort. Setting: Multicenter Academic and Community hospitals. Patients: Four hundred thirty-seven patients with an isolated tibia fracture completed a 12-month assessment on pain and self-reported activity. Intervention: Infrapatellar intramedullary nail. Outcomes: Demographic information, comorbid conditions, injury characteristics, and surgical technique were recorded. Knee pain was defined on a 1-7 scale with 1 being no pain and 7 being a very great deal of pain. Knee pain \u3e4 was considered clinically significant. Patients reported if they were able, able with difficulty, or unable to perform the following activities: kneel, run, climb stairs, and walk prolonged. Variables were tested in multilevel multivariable regression analyses. Results: In knee pain, 11% of patients reported a good deal to a very great deal of pain (\u3e4), and 52% of patients reported no or very little pain at 12 months. In activity at 12 months, 26% and 29% of patients were unable to kneel or run, respectively, and 31% and 35% of patients, respectively, stated they were able with difficulty or unable to use stairs or walk. Conclusions: Clinically significant knee pain (\u3e4/7) was present in 11% of patients 1 year after a tibia fracture. Of note, 31%-71% of patients had difficulty performing or were unable to perform routine daily activities of kneeling, running, and stair climbing, or walking prolonged distances