Clinical research

A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a VMP to Competent Authorities at defined time points post-authorisation. At these times, MAHs are expected to provide succinct summary information on all adverse events together with a critical evaluation of the benefit-risk balance of the VMP in the light of any new or changing pharmacovigilance information

Background: Laryngomalacia is the commonest congenital abnormality of the larynx. It the most important cause of stridor in neonates and infants stridor in the main presenting symptoms. In majority of the patient seen especially in peripheral health centers clinical symptoms and signs are relied upon for the diagnosis of the condition. Flexible laryngoscopy is however the mainstay of diagnosis. Objective: The aim of this study is to compare clinical findings and endoscopic findings of laryngomalacia in department of Ear, Nose and Throat of Aminu Kano Teaching Hospital Northern Nigeria. Material and Methods: We undertook a prospective cross-sectional review of all patient with larynomalacia who presented at the department of ENT Aminu Kano Teaching Hospital between June 2012 to May 2014. Biodata and clinical information were obtained and stridor graded. Then flexible fiber optic laryngoscopy was done on the entire patient and the stage of endoscopic grading documented. RESULT: A total of 35 children were seen during the study period and 26 met the inclusion criteria and were enrolled. There were 17 (65.4%) males and 9 (34.6%) females with a male female ratio of 2.1:1. There ages ranged from 1day to1year. The mean age at presentation was 5 ± 2.71 months. Twenty six (100%) of the children presented with different degrees of stridor. Based on, the clinical staging of stridor the degree of stridor found was 21(80.8%) had grade 1 to 2 stridor, and 5 (19.2%) had grade 3 none was found to have grade 4 stridor. Clinical assessment of the severity of the condition by the same investigators, 17 (65.4%) of the patients had mild laryngomalacia, 5 (19.2%) had moderate laryngomalacia and 4 (15.4%) had severe laryngomalacia. Objective endoscopic grading of findings in these patients showed 18 (69.2%) of the patients had grade 1 to 2, 3 (11.5%) had grade 3 and 5 (19.2%) had grade 4 to 5 laryngomalacia. Using the Spearman rho correlation coefficient test, we found a significant strong positive correlation between clinical assessment and endoscopic grading of laryngomalacia (r=0.860, P=0.000).Conclusion: clinical evaluation still has significant reliability in the diagnosis of laryngomalacia. But flexible laryngoscopy remains the mainstay of diagnosis and all patients with laryngomalacia should have flexible laryngoscopy.

Objective: This study was to evaluate the normal ovarian volume amongst normal adults using transvaginal ultrasound. Methods: This was a hospital based prospective descriptive study carried out between May and December 2012 on consecutive patients presenting for ultrasonography at Federal Medical Centre Makurdi. Sonographic examination was done using Sonoscape SS1-1000 machine fitted with a 5.2 MHz transvaginal transducer and incorporated with an electronic calipers. With an empty bladder, the patient lay in a supine position and the transducer was advanced into the vagina. The ovarian volume of each patient was obtained. The sociodemographic data and body mass index of each patient was also recorded. The data was entered into an Excel sheet and analyzed using EPI INFO statistical software version 3.5.4. Results: Two hundred and seven subjects were recorded for this study. The average volumes of the left and right ovaries were 6.5±3.3 ml and 6.4±3.8 ml respectively. Conclusion: These values represent the normal average ovarian volume for healthy women in our environment.

A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials.

ARTICLE INFORMATION Background: Migraine is the second most common primary headache disorder and is the nineteenth most common cause of disability worldwide. One of the ancient medical techniques mentioned in the Unani system of medicine is wet cupping to reduce the use of analgesics in migraine. It is a simple, effective and cost-effective treatment in several diseases. The purpose of this study was to evaluate the effectiveness of wet cupping in the management of migraine. Materials and methods: A Randomized single blinded clinical study was conducted from March 2014 to November 2014 in the outpatient department of Base Ayurveda Hospital, Kappalthurai, Trincomale. 40 patients, aged 20-60 years were selected. Wet cups were applied on 0th day, 15th day and 30th day. The effectiveness of the study was assessed by using Visual Analog Score (VAS) in 3 follow ups. Data were analyzed by repeated measure of ANOVA with paired t-tests. Results: Results suggested that, compared to the baseline, the means for pain intensity at the beginning and the end of the study were significantly decreased (p<0.01). In most patients pain was intolerable before therapy; however, after the first and second sessions of therapy, pain lessened was significant. Conclusion: This study revealed that the wet-cupping leads to clinical relevant benefits for migraine.

A mutual Dilemma for site management organizations continues to be finding experienced clinical research coordinators. The success of clinical trials depends profoundly on clinical research coordinators as they play a key role in the executions of trial procedures. Therefore, the demand for experienced and qualified clinical research coordinators is extremely high. This article will describe the duties of clinical research coordinators, discuss how to stimulate their performance, and explore the training impact on CRCs.

Clinical trials are a key research tool for advancing medical knowledge and patient care. They ultimately gear towards ameliorating and improving diagnosis and treatment of all diseases by introducing novel interventions and therapies. Essential to conducting a clinical trial is randomizing the proper study population through recruiting eligible participants based on inclusion and exclusion criteria, and ensuring study completion and adherence of study patient participation. Although these may seem simplistic, patient recruitment, retention and adherence are the most difficult challenges in clinical trials. While patient recruitment is one of the key elements to study completion, over 80% of clinical trials shockingly do not finish on time. Devising a potential strategy is vital in overcoming recruitment barriers; however, it is very costly and cumbersome. Lambda Health, LLC is in the process of creating a clinical research tool that can interface with EMR, in hopes of increasing patient retention through proper site selection, and setting reminders to patients about medication dosing, diary documentation, study procedures and visits scheduling. Ideally through implementing this tool into clinical trials, less effort and money will be spent on recruitment and the rates of adherence and retention will increase.

Non-English-speaking populations may be excluded from rigorous clinical research because of the lack of reliable and valid instrumentation to measure psychosocial variables. The purpose of this article is to describe the process and challenges when translating a research instrument. The process will be illustrated in the project of translating into Spanish the Short Version of the Perinatal Grief Scale, extensively studied in English-speaking, primarily Caucasian populations. Translation methods, errors, and tips are included. Tools cannot be used in transcultural research and practice without careful and accurate translation and subsequent psychometric evaluation, which are essential to generate credible and valid findings.

Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People’s Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.

A framework for the classification of information on maintaining or improving effectiveness and efficiency in health care systems is proposed. Activities, disciplines and methods that are available to identify, implement and monitor the available evidence in health care are called 'best practice'. We reviewed the literature in order to (1) establish a definition for 'best practice' in the health sector, (2) develop a framework to classify relevant information, and (3) synthesise the literature on activities, disciplines and methods pertinent to the concept. Health care, public health activities and health policy should be advised by the best available evidence. Currently, the concept can be broken down into three activities (Health Technology Assessment (HTA), Evidence-Based Medicine (EBM), Clinical Practice Guidelines (CPGs)) by which evidence is synthesised either as an evidence base (EBM and most HTA) or in the form of recommendations (CPGs and some HTA) for different decision purposes : S 0 1 6 8 -8 5 1 0 ( 0 0 ) 0 0 1 3 8 -X M. Perleth et al. / Health Policy 56 (2001) 235-250 236

In breast cancer clinical research, an important goal is to analyze how factors are seen to affect the disease process. Meanwhile, the disease progression is not fully modelled using standard analysis since transitions between intermediate events such as local-regional recurrences (LRR) or metachronous contralateral breast cancer (MCBC) are not considered. In the present study, the progression of disease was modelled using a multistate model. By this approach, we assessed transitions during the course of the disease and studied prognostic factors for each transition. The model was applied to 6,185 patients with unilateral ductal invasive breast cancer, clinical stage I through III, treated between 1981 and 1988 at the Curie Institute.