Civiale background: http://scholar.google.com/scholar?q=Jean%20Civiale / https://en.wikipedia.org/wiki/Jean_Civiale (1836 reward & publication) Parallèle des divers moyens de traiter les calculeux http://books.google.com/books?id=28ZEAAAAcAAJ&printsec=frontcover&dq=Parall%C3%A8le+des+divers+moyens+de+traiter+les+calculeux&hl=en&sa=X&ei=H5gfVJaYJ5OnyASMloHgAg&redir_esc=y#v=onepage&q=5443&f=false / https://archive.org/stream/parallledesdiver00civi#page/348/mode/2up
Academie report: http://scholar.google.com/scholar?cluster=1883366974866603345&hl=en&as_sdt=0,21
where is Civiale’s data? perhaps in Traité pratique sur les maladies des organes génito-urinaires: Maladies du corps de la vessie, Volume 3 http://books.google.com/books?id=fCEXXapUnsoC&dq=Jean+Civiale&lr=&source=gbs_navlinks_s
1141 of 5715 operated upon patients died; perhaps can trace full data using these numbers: https://www.google.com/search?q=civiale+5715+1141&newwindow=1&gbv=2&sei=I3XuVKWQB-basASZzIHACA http://books.google.com/books?id=ud7EzIBwQBwC&pg=PA229&lpg=PA229&dq=civiale+5715+1141&source=bl&ots=fkITFAbYKY&sig=6K59R1VobsDSTPaerAN8vAaJeUY&hl=en&sa=X&ei=AZYfVL61KMKqyASawIHoBw&redir_esc=y#v=onepage&q=civiale&f=false http://books.google.com/books?id=ysJOAAAAcAAJ&pg=PA242&lpg=PA242&dq=civiale+5715+1141&source=bl&ots=Ra5a2Bq47T&sig=NREEFzon1rbZyDFs9ln6fSBVOVY&hl=en&sa=X&ei=AZYfVL61KMKqyASawIHoBw&redir_esc=y#v=onepage&q=civiale%205715%201141&f=false
“Commentary: ‘Medical art’ versus ‘medical science’: J Civiale’s statistical research on conditions caused by calculi at the Paris Academy of Sciences in 1835” Tröhler http://ije.oxfordjournals.org/content/30/6/1252.full
“Commentary: Treatment of bladder stones and probabilistic reasoning in medicine: an 1835 account and its lessons for the present” http://ije.oxfordjournals.org/content/30/6/1253.full Vandenbroucke 2001 “Commentary: The Paris Academy of Science report on Jean Civiale’s statistical research and the 19th century background to evidence-based medicine” http://ije.oxfordjournals.org/content/30/6/1249.full Matthews 2001
“Civiale, stones and statistics: the dawn of evidence-based medicine” http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2009.08529.x/full Herr 2009
In the period from 1823 to 1827, he operated on 43 patients and claimed 42 successes. He called his new method ‘lithotripsy’ and soon became convinced that it was superior to perineal lithotomy .
- 5: Civiale J. De la Lithotritie, ou brolement de la pierre. Paris, 1827
To prove his point, Civiale began a statistical study to compare the outcomes between lithotomy and lithotripsy. To do that, he compiled all operations done by the prominent lithotomists in Europe at the time and tabulated their crude death rates. Little was known about the results of lithotomy other than rumour, anecdotes, and probably exaggerated good results that amounted to favourable publicity. Surgeons received more patients if they recorded higher success rates. Civiale did not say how he selected the different centres, how he approached his surgical colleagues, how he collected the numbers and verified their accuracy, who paid him to do so, who had the idea, and why. As to the ‘who and why’, the best guess is that he wanted credit as the inventor of the first lithotrite and to establish that his new bloodless procedure for removing bladder stones, lithotripsy, was superior to the widely used but dangerous open method of lithotomy.
…Civiale compiled a total of 5715 operations for bladder stone by perineal lithotomy for which the results were well known. Of these, he found 1141 deaths (20%) and another 100 infirmities beyond repair as a result of the operation. The treatment mortality rate was one in five, although more than half the patients were aged < 14 years and it was known that chances of recovery at that age were doubled. To these results, he compared his total of 257 patients treated by lithotripsy, of whom there were only six deaths (2.3%), and among these there were only a few aged <14 years. This gave less than one death for 42 patients treated by lithotripsy. To complete the demonstration of the superiority of lithotripsy over lithotomy, he added that since the discovery of lithotripsy, among a fairly large number of physicians suffering from calculi, none had resorted to lithotomy; all were operated by lithotripsy. Quite naturally Civiale keenly propagated his innovative method of treatment, which he considered much safer, as evidenced by stone-recovery rates of 98% according to his results, compared to 78% he later calculated after aggregating statistics on thousands of lithotomies .
- 6: Civiale J. Traite de l’affection calculeuse, ou recherches sur la formation, les caracteres physiques et chimiques, les causes, les signes, et les effets pathologiques de la pierre et de la gravelle suives d’un Essai de statistique sur cette malade. Paris: Crochard et Comp, 1838
However, by 1878, it was becoming increasingly apparent that lithotripsy had its own dangers and mortality, probably because more less-skilful surgeons adopted the method. At that time, lithotomy still carried a mortality rate of 20-23%; however, the mortality rate for lithotripsy now had increased from 15 to 23% in patients aged >50 years, and 10% if <50 years. Even the best evidence does, and should, change.
“Big Data in the 1800s in surgical science: A social history of early large data set development in urologic surgery in Paris and Glasgow” http://bds.sagepub.com/content/1/2/2053951714543701.full Mazur 2014
- Gant F (1878) Science and Practice of Surgery, 2nd ed. Vol. 2. Philadelphia, PA: Lindsay & Blackston, pp. 698-700.
In 1862, the British Medical Journal published a report from a hospital gazette showing that Civiale’s data from 1860 to 1861 focused on both survival/mortality and quality of life. In terms of survival, the following was noted about Civiale’s cases:
“Taking all his cases in 1860 and 1861 together, M. Civiale has had 120 calculous patients: 115 males and 5 females. Of these, lithotrity has been performed on 88; of whom, 3 have died, 79 have recovered; and in 6 functional disturbances remain-independent, however, both of the stone and of the operation. Lithotomy has been performed on 17 patients; of whom 8 are cured, 2 have fistulae remaining, and 7 have died. The remaining 15 patients have not been operated on; 6 have died, and 9 are still alive.”
- Anonymous (1862). “Progress of medical science”. British Medical Journal 1862; 1: 439. Taken from Gazette de Hopitaux, 25 Fevrier. - not available? http://scholar.google.com/scholar?q=%22Progress+of+medical+science%22+British+Medical+Journal+1862&btnG=&hl=en&as_sdt=0%2C21
However, not only were Civiale’s own patients included as data points to support his procedure, but his lithotrity procedure had also gained widespread support from urologists over Europe who were collecting data on their patients. Civiale added these sets to his own data in his report to the Academie des sciences. Belinaye (1837) notes that with lithotomy, 1024 of 5443 patients died, and with lithotrity, 5 of 245 patients died.
- Belinaye HG (1837) Compendium of Lithotripsy, London: JB Bailliere, pp. 179
…In terms of Civiale’s patient numbers, 5443 patients underwent surgery for removal of the bladder stone(s), and 245 patients underwent Civiale’s lithotrity procedure. The Académie des sciences commissioned Poisson et al. (1835) to evaluate Civiale’s data. Commentators (Black, 2001; Matthews, 2001; Tröhler, 2001; Vandenbroucke, 2001) note that this type of presentation of data by a surgeon to an august body of experts - Poisson, an expert statistician; Dulong, a physician-chemist; Larrey, a great military surgeon who was Napoleon’s surgeon; and Double, a representative of the medical establishment - was a unique form of peer review for Civiale’s era. These evaluators noted that these numbers were “all supplied by the practice of the greatest surgeons alive.” Physicians in Civiale’s era considered the set of 5443+ patient cases a large number. Even though the reported numbers were large, derived from experts across Europe, and considered even today as “hard data” (survival and mortality data (Boivin, 2014)), the Académie des sciences subjected Civiale’s data to rigorous review.
- Poisson SD, Dulong PL, Larrey DJ, et al. (1835, 2001) “Statistical research on conditions caused by calculi by Doctor Civiale”. International Journal of Epidemiology 30(6): 1246-1249; at p. 1247. Published in Comtes Rendus de l’Académie des Sciences, Paris 1835; 1: 167-177. Translated for the International Journal of Epidemiology by Angela Swaine Verdier.
- Black N (2001), “Commentary: That was then, this is now”. International Journal of Epidemiology 30(6): 1251.
- Matthews JR (2001) “Commentary: The Paris Academy of Science report on Jean Civiale’s statistical research and the 19th century background to evidence-based medicine”. International Journal of Epidemiology 30(6): 1249-1250.
- Tröhler U (2001), “Commentary:”Medical art" versus “medical science”: J. Civiale’s statistical research on conditions caused by calculi at the Paris Academy of Sciences in 1835". International Journal of Epidemiology 30(6): 1252-1253.
- Vandenbroucke JP (2001), “Commentary: Treatment of bladder stones and probabilistic reasoning in medicine: An 1835 account and its lessons for the present”. International Journal of Epidemiology 30(6): 1253-1258.
Poisson et al. (1835) noted that these comparative calculations were not made on very accurate bases (retrospective review of reported cases); therefore, they could not take the place of science. In addition, the expert reports lacked details of how the expert urologists carried out the assessments. Thus, for the Académie des sciences, these reports fell short of the goal of determining the numerical proportions of mortality after incision with any degree of accuracy. Yet, the commission commended Civiale for recognizing both the importance of large numbers and many of the problems interpreting large numbers, especially when those large numbers involved a compilation of data sets from different urologic surgeons. The Académie des sciences concluded that Civiale’s work comparing surgical approaches (surgery versus lithotrity) was moving in the right direction. In the commission’s report on Civiale’s data, Civiale was encouraged “to pursue his statistical research to increase the volume of data, and to provide more circumstantial detail to make it more conclusive…”
As noted by Buchanan, surgeons of Civiale’s day were already interested in both mortality data and other data, such as the demographics of the patient that made a procedure like lithotrity more or less suitable to be undertaken. From a historian’s perspective, Tröhler (2001) argues that Civiale’s report on his lithotrite and lithotrity procedure presented to the Académie des sciences in 1835 was part of a formal evaluation of Civiale’s numbers. This evaluation by urologic surgeons and Poisson, as a participant evaluator, needs to be viewed in “the context of a contest in contemporary French medical literature about the applicability of ‘statistics’ to ‘medicine’” (Tröhler, 2001). However, Civiale’s numbers on the relative mortality of his lithotrity procedure versus lithotomy (cystotomy) were so good from a mortality reduction standpoint that expert urologists throughout Europe adopted the lithotrity procedure in their own practice and continued with the procedure based on their own clinical experience with both lithotomy and lithotrity. Civiale’s data set on bladder stone removal was the most extensive of its day, and his less invasive procedure of lithotrity and his instrument (which other urologists in France and around Europe used quickly and improved upon readily) continued to develop over time. Even Civiale started using Heurteloup’s instruments in his lithotrity practice.