Developing a study: initial strategy

In this article the preparation of a scientific paper and its project are described. The possible reasons that lead to rejection of an article such as the proper focus of the chosen journal, its writing and mistakes in the grammar are considered. The initial steps of a scientific paper such as the choice of an idea, literature search, and the selection of related articles are described. After a group discussion about the purpose of the paper and its methods (brainstorm), the project is described and its items (Introduction, Objective, Methods, Protocol, References and Chronogram) are analyzed.     

An unusual variation of a malignant fibrous histiocytoma: a case report

This case study was written to acquaint the reader with the etiology, incidence, pathology, clinical course, and treatment of a variation of the malignant fibrous histiocytoma. In review of the literature, only three cases of malignant fibrous histiocytoma (myxoid variant) were found in the foot. The authors want to impress on the reader the necessity of the pathologic study of any lesion in the foot regardless of its gross appearance.     

JOA Back Pain Evaluation Questionnaire: initial report

Background There is no widely accepted objective evaluation for lumbar spine disorders. New outcome measures should be patient-oriented and should measure symptoms and self-reported functional status in multiple dimensions. The aim of this study was to identify items to be included in the disease-specific quality of life (QOL) questionnaire for the assessments of patients with lumbar spine disorders. Methods The draft of the QOL questionnaire that consisted of a total of 60 items, including 24 items derived from the Japanese version of the Roland Morris Disability Questionnaire (RDQ) and 36 items derived from the Japanese version of Short Form 36 (SF-36), were administered to patients and controls. After obtaining written informed consent, the following data were collected from the patient group (n = 328) and the control group (n = 213): (1) background characteristics, including age, diagnosis, Japanese Orthopaedic Association (JOA) score, and finger to floor distance; (2) responses to the questionnaire; (3) the identification rate by discrimination analysis to select the candidates for adoption and by adopting explanatory variables. The items to be excluded were determined by examining the explanatory variables, which were selected after the discrimination analysis, by setting the candidate to-be-excluded items as an objective variable. Results Based on the distribution of the responses, two items, RDQ-15 and RDQ-19, were excluded. From the results of the correlation coefficient calculation for each question in the patient group, 33 items were excluded and 27 candidate items were adopted. Based on the adoption explanatory variable used in the discrimination analysis, 25 of the 27 candidate items for adoption were accepted. Conclusions This study identified the 25 specific questionnaire items that should be included in the questionnaire to evaluate QOL of patients with various lumbar spine disorders.     

Photography in medical research

Medical photography is an adequate scientific document when performed on a standard fashion. A proper photography is an important issue on a scientific publication. Plastic surgeons are experts in clinical photography and, frequently, an image is a more significant data than the written part of a paper. The purpose of this article is to describe the principles developed in this specialty. Basic photographic equipment used for clinical pictures is described. Standardized pictures determined by patient position and framing using anatomical references are reported. Using these rules it is possible to compare pre and post operative pictures. Topics such as intra operative pictures in endoscopic surgery, computer fotogrametry and in Experimental Surgery are also analyzed.     

Evaluation indicators of biomedical research

The evaluation of R + D activities and the politics that promote them is essential to justify the investment done as well as to optimize their results. In this context, the evaluation should be understood as the group of techniques and procedures that allow obtaining useful information to take decisions in the field of R + D. This article has two main objectives: (i) to present the basic concepts associated with the evaluation of research, and (ii) to offer a general and updated panoramic view of which are the most frequently used methods to evaluate research. For that, in addition to considering the most conventional evaluation, focused on scientific results, we also think about the need of evaluating the impacts that scientific results generate on the social-economic context, and that in the case of biomedical research, these may be presented in terms of quality and life expectancy, improvements in patient care, etc. Therefore, the motivation of present article is to give a modern and updated perspective that allows the reader who is interested to study in-depth this emerging field of Science, if he/she wants.     

Development of the Qualeffo–31, an osteoporosis-specific quality-of-life questionnaire

Introduction Vertebral deformities are a common consequence of osteoporosis and are known to decrease quality of life. The Qualeffo–41 is a quality-of-life questionnaire especially developed for measuring quality of life in patients with vertebral deformities. It consists of 41 questions arranged in five domains: pain, physical function, social function, general health perception, and mental function. The objectives of this study were: (1) to develop a shorter version of the Qualeffo–41 by removing redundant questions; and (2) to investigate the scale characteristics, reliability, and validity of this shorter version. Methods The study was performed using data from the Qualeffo validation study and the Multiple Outcomes of Raloxifene Evaluation (MORE) study. The analyses were performed in patients with vertebral deformities (n=579). Factor analysis on polychoric correlations and an item response theory (IRT) model, i.e., the generalized partial credit model (GPCM), were used to create a shorter version of Qualeffo–41. Using GPCM, scoring weights were computed for all items. Results Three items were removed from the data set because of too many missing values. Factor analysis identified three instead of five domains: (1) pain, (2) physical function, and (3) mental function. Five items had factor loadings <0.4 and were not included in the GPCM. After excluding several items, the domains pain (four items), physical function (18 items), and mental function (nine items) showed a good, reasonable, and excellent fit, respectively. This indicates that the mental function domain and the pain domain are more unidimensional than the physical function domain. All three domains showed a very high correlation (r ≥0.95) with the corresponding domains of the Qualeffo–41. Conclusions Qualeffo–31 was developed, consisting of three domains with a reasonable to excellent fit to the GPCM. Although the fit to the GPCM supports the construct validity of the Qualeffo–31, validation in a new study should be performed before using it in practice.     

骨质疏松实验室诊断及影响因素专家共识2022

骨质疏松实验室诊断是通过对血液、组织液、细胞、蛋白、活体组织等进行实验分析,科学评价和判断全身骨代谢的动态变化及骨代谢的活性,对骨质疏松临床诊断与鉴别诊断、疗效观察,以及骨代谢疾病的调控机制研究具有重要意义。课题组以《原发性骨质疏松症诊疗指南(2017)》为依据,研讨骨质疏松实验室诊断的基本检查项目、骨转换指标、鉴别诊断检查项目,旨在促进骨质疏松实验室诊断技术的推广应用。骨质疏松实验室诊断,应做好室内质量控制,减少批间误差。在进行连续监测和疗效判定时,应使用同一检测系统进行,以保证测定结果的可比性,严格规范检测流程,建立科学参考范围,减少影响因素的产生,更好应用于临床诊断、疗效评价和科学研究工作。     

A concept for the validation of fracture classifications

The fracture classification systems currently used most frequently were not developed or validated by rigorous scientific evaluation methods. This paper discusses the classification of fractures from an epidemiological and clinical decision-making perspective and proposes a standardized methodological concept for their development and scientific validation. Classification categories are clinically relevant entities that surgeons should be able to use for diagnosis with sufficient confidence to limit misclassification and associated treatment errors. The process of validation should assess the value of specific clinical information (eg, the use of radiographs or computed tomography scans) in increasing the probability of a correct diagnosis. A 3-phase validation concept is proposed where: 1) classification categories are defined and the classification process using specific diagnostic images is evaluated by experts in a series of agreement studies (reliability, accuracy, likelihood ratios); 2) a multicenter agreement study is conducted among a representative group of future users of the classification; and 3) the classification proposal is applied in the context of a prospective clinical study to assess its clinical usefulness.     

Cómo poner en marcha y desarrollar un estudio multicéntrico prospectivo,controlado y aleatorizado

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial.The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years.In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended.When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines.Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately.And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.     

Research designs

The purpose of this study is to analyze the classifications and concepts found in the literature regarding the research models on scientific studies commonly used in medical articles. This paper provides elements to facilitate the creation of a research model. It also helps the researcher to identify which is the research model of an article. This article will enable the reader of a scientific paper to have a more accurate sense of criticism of the Methods of a study.     

我国护理用具研究文献分析

目的 了解我国护理用具的研究状况。方法 采用文献分析法对我国1996～2002年发表的护理用具研究论文进行分析。结果 护理用具研究论文发表量近两年明显增加，但护理用具研究完成合作度较低、资金资助项目较少．护理用具的研究相对集中于护士操作最多的护理技术方面；发表论文最多的是《护理学杂志)和《中华护理杂志》；在研制过程中仅21．0％使用随机实验验证新产品的效果；24．1％的研究中使用了高新技术；只有25项研究成果申请专利；成果获得奖励和产品推广情况不理想。结论 需加强时护理用具研究的科研指导；加强科研基金的投入；协调护理研究者与相关专业人员的合作；指导护理人员加快成果转化。护理人员自身也应加强科研能力的学习。     

Concept and Realization of a Multimedia Program for Veterinary Physiology

A multimedia program, a non‐linear system which supplements the traditional, linear way of learning (e.g. with a text book), was developed. Non‐linear systems allow the direct use of information in a free sequence. A problem of these systems is the danger that the reader becomes lost in detail. Therefore, a program was constructed which tries to combine the properties of linear and non‐linear teaching systems. Student groups were continuously involved during all stages of the project. The program is organized in several levels. These are: (1) choice of chapters; (2) table of contents of one chapter; (3) summary; (4) text and (5) pictures, animations, simulations and video sequences. The program can be used in different ways. In the linear mode, the reader selects via action words different levels of the program. The user can read either only on the level of the summaries or on detailed information (text, pictures, simulations and videos). In the non‐linear mode the user jumps via menu items or buttons to selected pictures, simulations or a searched term. In this way, more than 3500 screen pages are integrated into a multimedia program for veterinary physiology. The program is written in toolbook ^®, and can be used on a personal computer with Windows 95^® or higher.     

Use of non-invasive esophageal echo-Doppler system in the ICU: a practical experience

In a recent issue of the Journal of Trauma, Kim et al. described their experience with the esophageal Doppler monitor (EDM) in major burn patients. Other authors have reported the historical development of the EDM, reviewed the technical and scientific aspects of this modality, and compared the EDM with the pulmonary arterial catheter (PAC). However, most studies exclude the bedside, practical aspects of EDM placement and use. We retrospectively reviewed our EDM utilization over the past 27 months, with emphasis on the practical aspects of its use, potential indications, and contraindications. The purpose of this paper is to share our EDM experience with the reader.     

Treinta años del Grupo de Trabajo de Urología Oncológica de la Asociación Española de Urología (1978-2008)

Introduction and objectivesJune 2008 marked the thirtieth anniversary of the creation of the Oncological Urology Work Group of the AEU in June 1978. A historical review is thus made of the circumstances leading to its creation, with a special focus on the role played by coordinators and the activities carried out.Materials and methodsA review is made of the Group's rules, the agendas of its annual meetings, and AEU publications since 1968. Any news about and references to the Group included are analyzed, and direct information from coordinators, as well as personal experiences, are provided.ResultsThe Board of Directors of the AEU created this first Work Group in response to the requests by urologists who wanted to work together to achieve a deeper understanding of urological cancer. Twenty-five meetings directed by seven coordinators who have strived for updating oncological pathology and consolidating the group have been held over these 30 years.ConclusionsThe Board of Directors initially suggested the Group's activities, but the personality and scientific quality of the coordinators soon caused them to mark the pace of the work, in which review of all urological tumors, with special emphasis on those of most interest and most controversial at each given point in time, is the primary objective. The most outstanding achievements of the Group have been the publishing of a diagnostic protocol and several books on cancer of the urinary tract, joint work with oncologists, and opening of new research and study lines.     

On how to analyze the credibility of a clinical trial or meta-analysis whose main result is expressed in odds ratio, relative risk or hazard ratio

Beyond the type of design or the statistical analysis applied, the credibility of a research study lies in the compatibility of its results with the intensity that the reader could accept that the phenomenon studied might have from a biological point of view. Ultimately this requires a value judgment. The present article describes a procedure that can be used to objectively approach the limits of intensity that that a biological phenomenon could have, according to the data presented, so that, based on the reader's judgment derived from the available knowledge of the problem, the study can be deemed credible. The procedure is valid when the results of the study are expressed in odds ratio, relative risk or hazard ratio. Although these statistics are difficult to interpret, they are probably the most widely used in clinical trials and meta-analyses, that is, in studies whose methodological designs provide the highest level of evidence.