Course Introdução à Medicina School year 2010/2011 BLAND-ALTMAN’S METHOD: Teacher Cristina Maria Nogueira da Costa Santos Class 04 The importance of precise measurement History of Bland-Altman’s method What is the Bland-Altman’s Method Our main question Aims Information collection Methods Our results Discussion Final observations Bland-Altman’s method is used to… What is the importance of precise measurement in medicine ? In medicine, any error can be fatal; The constant development of new measurement methods; How can one guarantee that the values read in the new instrument are compatible with the values from the old one? COULD WE? WHY CAN’T WE USE THE CORRELATION COEFFICIENT ? The use of correlation is misleading; It does not measure the degree of agreement between two methods but only their correlation; By how much the new instrument is likely to differ from the old one? 15 g; 30g; 25g. + 15 -5 5 g; 20g; 15g. + 15 -5 The Bland-altman’s method history In 1980 cardiologists asked for Martin Bland and G. Altman help in assessing the rate of agreement between two methods. After reviewing the different methods available, they found out none of them served this need and decided to create one of their own. 1983 – first publication: The Institute of Statistics 1 1 Bland J M and Altman D G Bland JM, Altman DG. This week's citation classic: Comparing methods of clinical measurement. Current Contents CM20(40) Oct 5, 8, 1992 The Bland-altman’s method history 1986: Lancet magazine published the article: “Statistical methods for assessing agreement between two methods of clinical measurement” Most quoted article from Lancet magazine: > 18 000 citations. What is the Bland-altman’s method 2 ? Alternative method, based on graphical techniques and simple calculations; Created in 1983 by Bland J M & Altman D G; Used to assess agreement between two methods of clinical measurement. By how much the new instrument is likely to differ from the old one? 2 Bland J M & Altman D G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1:307-10, 1986. What is the Bland-altman’s method ? 1st step: build a scatter of the difference between the methods against their mean and make sure that there is no relation between the difference and the mean, and that the sd is constant – 1st ASSUMPTION Example showing relation between averages and differences Example showing good agreement (no relation) Example showing not constant sd (standard deviation) What is the Bland-altman’s method ? 2nd step: determine the limits of agreement (LA) LA = [u – 2sd ; u + 2sd] LA – limits of agreement u – average of differences sd - standard deviation of difference It is expected that most of the differences (95%) lie between the limits of agreement. Such differences are likely to follow a normal distribution – 2nd ASSUMPTION Example showing normal distribution The article that explains the Bland-Altman’s method is the most quoted article from Lancet magazine, which means that the method has been much quoted or/and applied. but… Verify if the journals with the greatest impact factor HAS THE METHOD BEEN publish articles that apply the method in a more correct way CORRECTLY APPLIED ? Find out what if the most recent articles MAIN AIM apply the method in a more correct way Selection of the Population Selection’s Criteria: • Documents indexed on ISI quoting the Bland-Altman’s Method at 19 March 2011, 09:22pm. 18360 documents quoting the method • Among all the documents indexed on ISI quoting the method, we selected the proceeding papers and the articles. Why? •Proceeding papers and articles are the ones which can apply the method. 17289 documents as population (proceeding papers and articles) Selection of the Sample The Selection: 17289 population • Random selection of a sample of 70 documents, using the statistical program SPSS®. • Random distribution of the sample between the two classes in an equal way, using SPSS®. 70 sample 35 Why 70 ? ► With 70 documents we guarantee that all the documents can be read and analyzed, and at the same time we have an amount big enough to enable us to draw valid conclusions. 35 Documents’ analysis And Data collecting • The 35 documents were distributed to the class’ students for analysis and data collecting. • The data were collected using a checklist developed for this purpose. Each document was analyzed twice by two different students in order to verify the inter-observer reproducibility of the checklist. We built a database using the SPSS® program and inserted there the data collected. A third person analysed the items which were differing. Data Analysis •The data analysis was done using the SPSS ® program and the chi-square statistical test was used to analyze the results. •To test the checklist reproducibility a crosstab was done on SPSS. The two analyses’ answers were tested for their concordance. We estimated, with a confidence interval of 95%: • The proportion of documents that apply the method and the proportion of documents that only quote it; • The proportion of documents that apply each of the checklist’s conditions against the ones that don’t, sorted by the impact factor of the journals where they were published, and publication year. applied the method found articles 30 31 1 35 4 quoted the method without applying it First of all, from the 35 articles that we were supposed to analyze, we could only find 31. Out of the articles we found, we have concluded that 30 of these have indeed applied the method and that only 1 made a reference to it without applying it. So, the discussion of the results will be based on the analysis of the articles that we found (31). TABLES OF RESULTS TABLE 1 – “Results Agreement: reproducibility of the answers given to the checklist” TABLE 2 – “Our Results: the answers to the checklist “ • Despite our initial aim was to analyze the results from a sample of 70 articles (35 from each class), we ended up analyzing just the 35 articles selected for our class, due to: lack of information related to the reproducibility of some results; not getting all data on time. • We were expecting that the majority of scientific publications applied correctly the method, but the results were not statistically significant (pvalue superior to 0.05). We could see a tendency pointing to: a generalized lack of comprehension of the method; a major mistakes when it comes to its application. • It was also expected that the journals with the greatest impact factor applied the method in a more correct way, however, we can’t conclude about the relationship between the impact factor and the correct application of the method because we obtained a p-value superior to 0.05. not significant • The most recent articles often present a histogram or tell us about the distribution of the differences. This is what we expected: the more recent the articles were, the better they would have applied the method. Our Work Evolution 1. During this project we came across… ○ We had face some troubles related to data variability (journal, medical area of the documents…) and so we had to eliminate some of our aims reducing the number of the initial ones – because some of them could not get any answer satisfied. ○ The checklist suffered successive changes because there were always new parameters showing up in each article that we were not expecting (for example, the method used for primary and secondary data). Our Work Dificulties 2. During this project we came across… ○ The evaluation of the method application ends up to be associated with some extra difficulties: it involves total comprehension of the method and requires a careful reading of each article analyzed; ○ Some of the articles did not fit clearly into any point of the questions included in the checklist, which raised many doubts and, possibly, some errors; Our Work Dificulties 3. During this project we came across… ○ We recorded a not strong reproducibility of the checklist. Despite the checklist evolution, its adaptation to new variables and the presence of explanations for each question, we think that the checklist still might have induced different interpretations between our class students ; ○ Since the beginning, our goal was to examine 70 articles with the collaboration of the class 13; unfortunately, due to the incompatibility of the methods used to create the different databases we were not allowed to complete this stage. How important was this work? 4. This work developed our capabilities to: elaborate and apply a checklist; analyze and write articles; collect and treat data; do statistical analysis; deal with typical difficulties of a research work. Finally, a major contribution of this work was understanding Bland-Altman’s method, since it is an important statistical method, perhaps important in our academic and medical future. Professora Doutora Cristina da Costa Santos Professor Doutor Altamiro Manuel Rodrigues Costa Pereira Nicola Massy-Westropp B App Sc O.T., PhD. Dr Paul Henderson Ennio Lubrano, MD, PhD Turma 13