The International Conference on Harmonisation has agreed upon the structure and content of the Medical Dictionary for Regulatory Activities (MedDRA) version 2.0 which should become available in the early part of 1999. This medical terminology is intended for use in the pre- and postmarketing phases of the medicines regulatory process, covering diagnoses, symptoms and signs, adverse drug reactions and therapeutic indications, the names and qualitative results of investigations, surgical and medical procedures, and medical/social history. It can be used for recording adverse events and medical history in clinical trials, in the analysis and tabulations of data from these trials and in the expedited submission of safety data to government regulatory authorities, as well as in constructing standard product information and documentation for applications for marketing authorisation. After licensing of a medicine, it may be used in pharmacovigilance and is expected to be the preferred terminology for international electronic regulatory communication. MedDRA is a hierarchical terminology with 5 levels and is multiaxial: terms may exist in more than 1 vertical axis, providing specificity of terms for data entry and flexibility in data retrieval. Terms in MedDRA were derived from several sources including the WHO's adverse reaction terminology (WHO-ART), Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART), International Classification of Diseases (ICD) 9 and ICD9-CM. It will be maintained, further developed and distributed by a Maintenance Support Services Organisation (MSSO). It is anticipated that using MedDRA will improve the quality of data captured on databases, support effective analysis by providing clinically relevant groupings of terms and facilitate electronic communication of data, although as a new tool, users will need to invest time in gaining expertise in its use.
The study offers an insight into a New Zealand hospital environment and suggests the importance of good relationships with physicians and other departments for the health of nurses.
Personnel Officer, East Northamptonshire Cooperative Society and Senior Lecturer, Sheffield Polytechnic, England THIS is the story of the strike at the Grosvenor Hotel, Sheffield. The strike began on I5 December 1976 and ended over six months later on 2 June SOME PERSPECTIVES O N THE STRIKE PHENOMENONThis is not the place to make an exhaustive study of strikes. The purpose here is to illustrate the different ways in which researchers have examined the strike phenomenon and to sketch out their frames of reference, as a background to our study of the Grosvenor dispute.The word "strike" is seldom mentioned dispassionately. The strong feelings which strikes engender on all sides are paralleled by the interest of researchers from a number of disciplines. Studies tend to fall into two major classesmacrostudies concerned with the analysis of strikes within an economy or industry, and micro-studies which are typically detailed case studies of particular organisations. The perspectives of economics, statistics and politics are brought to bear particularly at the macro level, and of sociology, psychology and 3 Ibid. p 18 INOUSTRIAL RELATIONS JOURNAL, Val 9 No 2 0 1 9 7 8 Business Publications Ltd , London I5 4 Whmingham. T G and Towers. 8 , "Strikes and the konomy" in lndusrnal Canflrcr ,n Brtram. eds Evans. E W . and Creigh. S W , Frank 5 Clack. G , "HOW unoffrml strikes help industry ', Burmess. July 6 Johnston. E , InduimaIAcrron. Arrow Bmks. 1975. p 6 0 1 6 1 7 Hyman. R , Srnkes. Fontana. 197 7. p 26 Cass. 1977. p 82 1965. pp 42-4J.qwt+d~nEvsnrandCreighop cnt.p 8 16 8 Goodman. J F B , Strikes in the UK Racsnt Statistcs and Trenh. in Evansand Cntgh. OP cit . P 59 9 Ross. A M. and Hartman. P , Wangmg Parremr of Indusrnal Confllcr. Wtley. 1 9 6 0 1 0 Ksrr. C , and Siegsl. A,, "The enter-industry propensity 10 strike. an ~ntemattonal cornpatison '. m lndusrr,al Confltcr. Edr , Komhaussr. A , Oubm R . and ROSS. A M . MCC~~W.HIII. 1954 11 Turner. t i A ,quoted m MrCsrthy. W. E, J . , "The Nstursof Bfitan's Strike Problem' , in Evans and Crelgh. op ctt p 2 7 2 1 2 Hvman
Summary This study reviews publications to describe the signs, symptoms and impact of tumour-induced osteomalacia (TIO) on patients’ burden of disease. TIO is associated with a spectrum of signs and symptoms imposing a significant clinical burden, but the psychosocial impact of this rare disease has been poorly researched so far. Introduction To describe the signs, symptoms and impacts of tumour-induced osteomalacia (TIO) and summarise the state of research on the burden of disease of this ultra-rare condition. Methods A targeted literature review was conducted in PubMed using pre-defined search terms. Relevant articles published between 1980 and 2021 were screened for inclusion. Seventy records were selected for analysis. Data were extracted and grouped into categories and sub-categories to identify recurrent signs, symptoms and impacts of TIO and describe the burden on patients. Chord diagrams were created to analyse the relationships between different TIO outcomes and characterise the presentation of TIO. Results Although the number of articles on TIO published have been increasing over the past 20 years, most studies were case reports and case series ( n = 65/70) and only few were studies with higher quality of evidence ( n = 5/70). Most articles were based on data reported by clinicians ( n = 67/70). Patients with TIO experienced a combination of outcomes including chronic pain, weakness, skeletal-related manifestations and limitations in mobility. Only a few studies ( n = 2/70) analysed the burden of TIO on the emotional wellbeing and on the work life of the patient. Conclusion Patients with TIO present with a spectrum of signs and symptoms that impose a significant burden. The impact on the psychosocial wellbeing of patients should be further investigated, as this has been poorly researched so far. Studies with high quality of evidence should be designed to further the understanding of the burden of disease of TIO from the patient’s perspective.
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