A Methodology for Successfully Producing Global Translations of Patient Reported Outcome Measures for Use in Multiple Countries

The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire—Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.     

New approaches to the diagnosis of functional upper gut disease

Abstract Functional upper gut symptoms, such as nausea, vomiting and abdominal pain, are a continuing challenge in gastroenterological practice. This article considers the approaches applied in recent years to evaluate motor function in the upper gut including manometry and radio-nuclide transit studies, and symptom-provocation tests such as balloon distension and pharmacologic stimulation.
An approach is proposed that is based on positive symptomatic diagnosis of the disturbed pathophysiologic state, followed by treatment of this disturbance of function after a minimum of confirmatory investigations.     

Immediate Obturator Stabilization Using Mini Dental Implants

Edentulous patients with maxillary defects face a more challenging oral rehabilitation process than dentate patients. With the use of mini dental implants (MDIs), it is now possible to immediately increase obturator retention and stability. Implant patients can have a retentive obturator that enhances the overall efficacy of the prosthesis both in comfort and function.     

Estrogen and Progesterone Receptors

BACKGROUND: Postsclerotherapy neoangiogenesis telangiectatic matting (TM) occurs in up to 24% of individuals treated by sclerotherapy. Although the etiology is unknown, obstructive flow factors, angiogenic factors, estrogen, inflammatory, and endogenous factors have all been postulated to play a role in its pathogenesis. OBJECTIVE: The aim of the study was to ascertain the presence or absence of estrogen and progesterone receptors in postsclerotherapy TM lesions and thus substantiate their possible role in the pathogenesis of TM. METHODS: Ten women, median age 37.7 years, were included in the study population who developed TM following a single sclerotherapy treatment session employing Sotradecol 0.25% for class I-II telangiectasia/venulectasia. Four of 10 patients had a history of previous hormonal therapy or pregnancy in the previous 12 months prior to entering into the study. Three millimeter punch biopsies were taken at 12 weeks posttreatment and assayed for estrogen and progesterone receptors by the ERICA and PRICA (estrogen/progesterone immune cytochemical assay) techniques. RESULTS: Zero of 10 patients were positive for estrogen/progesterone receptors as assayed by the ERICA/PRICA technique in biopsied sites of postsclerotherapy TM. CONCLUSION: Although estrogen and progesterone may play an indirect role in the development of postsclerotherapy TM via vasodilatory or secondary angiogenic or cytokine release mechanisms, they do not appear to play a primary role in promoting postsclerotherapy neoangiogenesis as demonstrated in this study.     

d-penicillamine: Chemistry and clinical use in rheumatic disease

The discovery of d-penicillamine and its uses in medicine are reviewed. Chemical-physical properties are discussed, and the molecular structure of d-penicillamine and several of its reaction products are illustrated. Examples of its three main types of biochemical reactions—sulfhydryl-disulfide exchange, thiazolidine formation, and metal chelation are included. Trials of d-penicillamine in RA patients are reviewed critically. The administration of the drug is discussed in detail, including dosages, clinical and laboratory responses, patterns of adverse side effects or toxicity, drug-induced autoimmune diseases, indications and contraindications, and the monitoring and management of patients.     

Role of the physician in the prehospital setting

Despite the initial successes achieved in early emergency medical services (EMS) systems, many prehospital care services have developed without the intense involvement of physicians whose interest fueled the first experimental medical programs of prehospital care. Among a myriad of variables affecting EMS is the important element of intense, authoritative physician involvement in education, field supervision, and research. Recognizing this problem, many states now have legislated that EMS systems be closely supervised by medical directors. Political and financial constraints often have diluted medical influence and authority, and intense, direct field supervision is the exception rather than the rule. successful EMS systems can demonstrate their influence on morbidity and mortality through appropriate data collection and quality assurance programs. Such programs appear to have in common the element of direct involvement of competent physicians in initial training, field supervision, and policy decisions. Until recently, full-time compensated physician involvement in EMS has been regarded as unnecessary or impractical. Certainly in large urban centers such full-time involvement is mandatory. While in smaller municipalities full-time commitments may be unnecessary, partial compensation for time dedicated to EMS pursuits should be part of the EMS budget. It has been the experience of major urban EMS systems that field participation by physicians has lent irrefutable credibility to the authority of medical directors. Beyond the obvious benefits of quality assurance and supervision, the in-field EMS physician provides the impetus and leadership for EMS research conducted at the street level. Because EMS is the practice of medicine through physician surrogates in a prehospital setting, it sets the stage and tone for subsequent patient care and outcome.(ABSTRACT TRUNCATED AT 250 WORDS)