Showing papers by "Seyyed Mohammad Taghi Ayatollahi published in 1994"

Ethical issues in medical statistics

Abstract: Medical statistics (biostatistics), as a vital essential part of modem life, does raise some fundamental ethical issues. Surprisingly, this aspect seems to have been totally ignored by books on medical ethics. This paper discusses how the statistical aspects affect the ethics. The relation between biostatistics and medical research is explored. All stages of a medical research exercise are vulnerable to statistical mismanagement which might lead to misuse of patients by exposing them to unjustified risk and inconvenience; the misuse of resources incl uding the researchers' time, which could be better employed on more valuable activities; and the consequences of publishing misleading results, which may include carrying out unnecessary further work. These are specific and highly undesirable outcomes. Failure to guard against these is surely as unethical as using experimental methods that offend against moral principles, such as failing to obtain full informed consent from subjects. Raising statistical standards of medical researches and publications serves as a safeguard to observe the element of ethics. This can be achieved by widespread teaching of medical statistics at all levels, involvement of biostatisticians as active participants of any medical researches and ethical committees. Ethical issues in medical statistics require wider and more open debate. Those involved in medical research need to involve the whole medical profession. lndeed, moral philosophers, theologians, and other professional groups have an important contribution to make. M.lIRI, Vol. 8, No.2, 121-125, 1994 .. INTRODUCTION Volume 8 Number 2 Sununer 1373 August 1994 Statistics is the science of collecting. summarizing, presenting, and analyzing data. 111 is analysis may lead to conclusions l:Uld subsequent decisions. The science of medical statistics (biostatistics) embraces those techniques pertaining to the medical field. Although the methodology of statistics is quite general, specific problems arise in medicine, often because the unit of interest is a living person rather Ulan some abstract phenomenon, object, or financial consideration. The following questions, some of which are faced nearly every day by the practising physician, are to a great extent statistical in nature: Is this new drug or procedure better than that commonly in use? How much better? What, if any, are the risks or side effects associated with its use? In testing a new drug how many patients must be treated, and in what manner, in order to demonstrate its worth? What is the nonnal variation in some clinical measurements? How reliable and valid is the measurement? Whatis the magnitude and effect of laboratory and technical error? How does one interpret abnormal values? 121 In fact, the two simple questions a patient can ask his physician-namely: \"What's the diagnosis?\" \"What are my chances, Doctor?\" -are very frequenUy statistical in nature. In order to seek a sound answer one often relies on theresults of statistical analysis. This is why Francis Galton' speaks of statistics as follows: D ow nl oa de d fr om m jir i.i um s. ac .ir a t 2 0: 38 IR S T o n W ed ne sd ay S ep te m be r 23 rd 2 02 0 Ethical Issues in Medical Statistics \"Some people hate the very name of statistics but I find them full of beauty and interests. Wheneverthey are not brutalized, but delicately handled by the higher metllods. and are warily interpreted, their power of dealing witll complicated phenomena is extraordinary. They arc the only tools by which an opening can be cut through tlle fonnidable thicket of difficulties tl,at bars the patll of tllOse who pursue the Science of man\" Such problems and questions, which arc linked to issues merit special attention. Underscoring the need or greater understanding of statistics in medicine is the fact that much of statistical material in tlle medical literature is improperly conceived. executed, or interpreted. which is obviously unethical. Surprisingly. this aspect seems to have been totally ignored by books on medic,� ethics. Thus. the purpose of tllis paper is to discuss briefly a much neglected aspect of medial ethics-how tlle statistic,� aspects affect the etllics. To do so. we follow the structure of a research exercise. outlined in the following figure: