**Monthly Mean newsletter, September/October 2009**

You are viewing an early draft of the Monthly Mean newsletter for September/October 2009.

The monthly mean for September/October is 15.75.

Welcome to the Monthly Mean newsletter for September/October 2009. If you are having trouble reading this newsletter in your email system, please go to www.pmean.com/news/2009-09.html. If you are not yet subscribed to this newsletter, you can sign on at www.pmean.com/news. If you no longer wish to receive this newsletter, there is a link to unsubscribe at the bottom of this email. Here's a list of topics.

Lead article: Can I stop this study early?

2. The third deadly sin of researchers: gluttony.

3. Ban the bar! Pitch the pie!

4. Monthly Mean Article (peer reviewed): Statistics in Medicine -- Reporting of Subgroup Analyses in Clinical Trials

5. Monthly Mean Article (popular press): Don’t Blame Flu Shots for All Ills, Officials Say

6. Monthly Mean Book: Statistical Rules of Thumb

7. Monthly Mean Definition: Normal probability plot

8. Monthly Mean Quote: An undefined problem...

9. Monthly Mean Website: Freakonomics blog

10. Nick News: Nicholas and a very busy week in October

11. Very bad joke: A statistician had twins...

12. Tell me what you think.

13. Upcoming statistics webinars.

**1. Lead article: Can I stop this study early?**

I got an email from a researcher on a project I was peripherally involved with awhile back. Here's what she wrote (with a few details removed to protect anonymity).

As you all are aware, enrollment for the BLANK study has been slower than anticipated. However, due to a high suspicion that patients in the CONTROL arm were having more complications (more rescue therapy) and less improvement, we have decided to look at the data prior to reaching our initial proposed N=140. We had 79 patients enrolled. We found that significantly more patients in the TREATMENT arm reported that their main symptom was better at 24 hours than the CONTROL arm (p=0.02). Also, we had 6 patients need some kind of rescue, 5 of those were in the CONTROL arm (this approached statistical significance, p=0.08). Therefore, I am writing to see if you agree with stopping the study at this point. Please let me know at your earliest convenience.I am always willing to offer an opinion, but first I wanted to confirm that there was no official guidelines for early stopping in the protocol that was submitted to the IRB and that there was no formal data safety and monitoring committee. If that turns out to be the case, then any choice made at this point will be somewhat arbitrary from a statistical perspective. There is no magic number that can be calculated post hoc that will provide definitive guidance here.

First and foremost, you need to acknowledge that the primary investigator has the right (and the duty) to stop a study if he/she a strong gut feeling that continuing the study is bad for the patients enrolling in the study. I would never use a statistical argument to overrule someone's gut feeling, though I would be glad to discuss whether the data tends to support their gut or not. Early stopping often involves a tradeoff between patient safety and scientific integrity, and I would almost always side with patient safety.

I would not let failure to pre-specify stopping rules be a barrier either. It's a bad idea for a researcher to fail to anticipate and document in the protocol reasons for early stopping, but we should not punish future patients because of this oversight. There is an implicit stopping rule that exists for every protocol, whether it is stated or not. Any research protocol can be terminated if, in the opinion of the principle investigator, further continuance of the study would put some or all of the future patients at an unnecessary level of risk. The principal investigator does not need the approval of a statistician, the IRB, or any other party to invoke this rule, though consultation with various people is always reasonable.

If I were asked about post hoc justification for early stopping, I would try first to create a plausible set of stopping rules that was as independent of the current data analysis as possible. This is impossible to do perfectly, but a good standard for post hoc justification is any rule that would have been likely to have been received well if it had been proposed during the protocol development stage.

Finally, stopping a study permanently is a pretty serious decision, but I certainly would suggest that a temporary freeze of the study (no enrollment of new patients) is a safe and judicious action to take while discussions are ongoing.

**2. The third deadly sin of researchers: gluttony**

Researchers will often pile the data analysis high on a plate with limited data. There's only so much data analysis, however, that can be conducted on a given amount of data. When you try to do more than this, your data analysis will have poor replicability.

If you think about it, poor replicability is about the worst thing you can accuse a data analysis of. Research attempts to make generalizations and poor replicability strikes at the heart of generalization.

How can you tell if the data analysis is too complex for a limited data set. One rough rule of thumb is that you should have 10-15 observations for each variable in the data analysis. A variable is "in the data analysis" if it is incorporated into any of the screening steps that are used to hone in on a final data model. Thus if you look at ten independent variables and only two make it into your final data model, then you still need 100 to 150 observations.

For logistic regression, the ratio of 10-15 relates not to the number of observations, but rather to the number of observations with the rarer of the two possible outcomes. It doesn't matter if you have thousands of observations. If one of the two possible outcomes is rarer then it is the number of these outcomes that determines how complex your statistical model can be.

The same general rule holds true for survival data analysis. If you have 500 observations, but 450 of them are censored values, then the number of potential predictor variables is somewhere between 50/10 = 5 and 50/15 = 3.

Another form of gluttony is including many different outcome measures in the same data set. Suppose that you are interested in whether a toxic exposure is associated with cancer. If you liked, you could look at bladder cancer, breast cancer, liver cancer, lung cancer, pancreatic cancer, prostate cancer, skin cancer, and that funny thing dangling down in the back of your throat cancer.

Unless some attempt is made to identify a small number of these outcomes are primary (with the others relegated to a secondary data analysis), then the net effect is to dilute the credibility of your research findings. In the cancer study above, either pick a particular organ that you think is likely to be most affected by your toxic exposure, or just get a count of all cancer types combined.

There's a saying in statistics that if you torture your data long enough, it will confess to something. Don't keep piling on the analyses if the size of your data set doesn't warrant it.

**3. Ban the bar! Pitch the pie!**

This is an outline of a speech that I gave to Bluejacket Toastmasters on June 5, 2003. It was published at my old website (www.childrensmercy.org/stats/model/barpie.asp) and is a fun little article with a bit of useful advice about displaying data.

I work a lot with numbers and I've found that there is usually a good way to display those numbers and a bad way. Here's an example.

It's a pie chart with bright bold colors and a deep 3-D effect. Is this a good way to display the data? WRONG! You should pitch the pie.

Here's another example.

It's a bar chart with big bold purple bars. Is this a good way to display the data? WRONG AGAIN! You should ban the bar.

These charts are useful once in a while, but most of the time all you need is the numbers themselves. You don't have to surround them in a cloak of fancy colors and graphic effects. The numbers by themselves are often all that you need.

But you can't just toss the numbers onto a sheet of paper and hope that it will work out well. You have to plan things. There are two things that can help:

- a little bit of rounding, and
- a little bit of re-ordering.

Shown below is a table loosely adapted from a web page on pet care. I've taken a few liberties with some of the numbers to simplify this discussion, but the numbers are fairly close to the values on that web page.

^{
}

^{1}includes items like cost of the pet, initial shots, litter box,
collar, aquarium, etc.^{
2}yearly cost. This cost will vary based on the size of the pet.

The initial cost would include the cost of the pet, litter box for a cat, collar and leash for a dog, aquarium for fish, and so forth. These are also averages and would not apply to someone who gets diamond studded collars for their pets. Also the average food cost for a small Yorkie is not going to compare the average food cost for a big Siberian Husky.

Look at this table and tell me what patterns you see. A few patterns might appear

- snakes and lizards are more expensive than I would have thought.
- hermit crabs and rodents are fairly inexpensive.
But it takes a lot of squinting and staring to discover these patterns.

This table needs some work. The first thing is to do some rounding. Rounding is important because it reduces the strain on your brain. You don't have to work so hard to uncover patterns in the data.

When you look at a table of numbers, the first thing you often do is to make comparisons. These comparisons often involve an implicit subtraction. For example, you might wonder to yourself "

How much difference is there between the average vet bills for a dog and for a cat?" The respective numbers are317.24

193.08Take some time to subtract here. This would tell you how much you would save on yearly vet bills if you got a cat instead of a dog.

Let's see, four minus eight is ummm, borrow the one, ow, ow, ow, my brain hurts.

You can simplify life by rounding the data to one or two significant figures. Here are the rounded costs

320

190If I asked you to subtract those two numbers, you should be able to tell me the answer quickly and painlessly--130. My wife, an avid dog lover, would tell you that dogs are worth every penny!

When you round, you lose a little bit in precision. In this example, we're off by about six dollars or so. But the small loss in precision is more than made up for by the big gain in comprehension. People I work with often don't like to round their numbers. It took a lot of effort to get that 317.24, by golly, and I don't want to throw any of that away. Sometimes they will round their numbers but not enough. "

Why can't I keep a third digit?" they ask. It turns out that the third digit will give you brain pain.There's a reason for this. Inside your brain is a spot for short term memory storage. It can usually hold about four pieces of information without a problem. Anything more causes an overload and slows things down. A pair of two digit numbers will fit into short term memory very easily, but a pair of three digit numbers will not.

In the vet costs example, rounding to three significant figures means rounding to the nearest dollar rather than to the nearest ten spot. This leads to the following subtraction.

317

193Ow, ow, ow, my brain hurts again.

When you arrange these numbers, try to anticipate the possible comparisons and then place the numbers close to one another. You have a choice here. You can orient the numbers horizontally,

320 190

by placing them within the same row. You could also orient the numbers vertically,

320

190by placing them in the same column.

Which orientation is best for subtracting? The vertical orientation appears far more natural for doing a subtraction. Also be sure to place the larger number above the smaller one. If you had the smaller one on top

190

320it doesn't work as well.

Try to sort your numbers from high to low. If you have more than one column of numbers, use the first column, use the last column, or use the average of all the columns. It doesn't matter too much. A few of your numbers might not be in perfect order, but these deviations are actually interesting, as you will see in the example below. Sorting by one of the columns will do a lot for your data, and if almost always better than the usual approach of alphabetizing by labels.

Have you ever seen a list of numbers for each of the fifty states. It's almost always alphabetical, but most of the time this places states next to one another that have almost nothing in common. Alaska is always between Alabama and Arkansas. Wisconsin is always between West Virginia and Wyoming. There is nothing to recommend this approach. Sure you can find your own state quickly, but then can you find other states that are similar to your state?

A better approach would be to sort the states by some criteria. List the states with the largest square miles at the top (Alaska, Texas, California) and put the states with the smallest square miles at the bottom (Connecticut, Delaware, Rhode Island). Or list the states with the most people at the top (California, Texas, New York) and with the fewest people at the bottom (Alaska, Vermont, Wyoming).

Here is the same table reworked. I rounded each value, and re-oriented the table so that the costs for each type of pet fell into the same column. I also sorted the numbers based on the initial cost.

^{
}

^{1}includes items like cost of the pet, initial shots, litter box,
collar, aquarium, etc.^{
2}yearly cost. This cost will vary based on the size of the pet.

This table is a lot easier to look at. You might notice a few new patterns that weren't so obvious before.

- Birds, dogs, and cats all have about the same initial cost, but cats have far smaller yearly costs.
- Lizards and snakes may not cost a lot at first, but they are expensive to feed.
- Fish don't cost that much to buy and to feed, but have a lot of miscellaneous costs, probably due to aquarium upkeep.
You will probably notice other interesting patterns.

Summary: If you are displaying numbers, pitch the pie and ban the bar. Most of the time you are better off displaying the numbers themselves. Just be sure to do a little bit of rounding and re-ordering first.

References: All of the ideas described above were championed by A.S.C. Ehrenberg three decades ago. You can find more details in his book.

A Primer in Data Reduction.A.S.C. Ehrenberg (1982) New York: John Wiley & Sons.The web site where I got the numbers from is

How Much Does it Cost to Own a Pet?Steph Bairey. Accessed on 2003-06-04. www.practical-pet-care.com/article_view.php?ver=22The numbers on the web page were already rounded, so I had to "unround" them for this example by adding a small random amount to each value. I also replaced some of the zero values by a slightly larger number and made some other minor adjustments. The costs reflected in my tables, however, are very close to the ones on the web.

**4. Monthly Mean Article (peer-reviewed): Statistics in Medicine --
Reporting of Subgroup Analyses in Clinical Trials**

Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM.

Statistics in Medicine -- Reporting of Subgroup Analyses in Clinical Trials. N Engl J Med. 2007;357(21):2189-2194. Excerpt:Medical research relies on clinical trials to assess therapeutic benefits. Because of the effort and cost involved in these studies, investigators frequently use analyses of subgroups of study participants to extract as much information as possible. Such analyses, which assess the heterogeneity of treatment effects in subgroups of patients, may provide useful information for the care of patients and for future research. However, subgroup analyses also introduce analytic challenges and can lead to overstated and misleading results. This report outlines the challenges associated with conducting and reporting subgroup analyses, and it sets forth guidelines for their use in the Journal. Although this report focuses on the reporting of clinical trials, many of the issues discussed also apply to observational studies.Available at: http://content.nejm.org/cgi/content/full/357/21/2189 [Accessed September 3, 2009].

**5. Monthly Mean Article (popular press): Don’t Blame Flu Shots for
All Ills, Officials Say**

McNeil, Jr. DG.

Don’t Blame Flu Shots for All Ills, Officials Say. The New York Times. September 28, 2009. [Accessed October 26, 2009]. Available at: www.nytimes.com/2009/09/28/health/policy/28vaccine.htmlOne of the hardest things to do is to sort out adverse reactions associated with a treatment when those adverse reactions also occur naturally to those who aren't treated. It gets worse with vaccination programs. The large number of people being vaccinated creates an increased tendency for unfortunate but spurious findings to arise. This article talks about some of those unfortunate findings with previous vaccination programs and what the government is trying to do with the current round of flu vaccinations to help sort out the spurious findings from the real findings.

**6. Monthly Mean Book: Statistical Rules of Thumb**

Gerald Van Belle (2008),

Statistical Rules of Thumb, Second Edition, Wiley Interscience: New York NY. ISBN: 0470144483. I wrote a review for this book which was published in the Journal of Biopharmaceutical Statistics, Volume 19, Issue 4 (July 2009), 752-754. It's one of my favorite books, so I was thrilled when I was offered the chance to review this. Here's an excerpt from the review.

Experienced statisticians will see a few surprises among these rules of thumb, but most of the time, you'll just nod your head in agreement. The real value of the book to an experienced statistician is the careful way that Dr. van Belle supports all of these rules. A new statistician would find great benefit in this book because it offers pragmatic advice obtained through the collective experience of many statisticians. Learn these rules, and you will come across as wise beyond your years. Sections on The Basics (Chapter 1); Design, Conduct, and Analysis (Chapter 8); and especially Consulting (Chapter 10) are of particular interest to beginners.

I like this book a lot, and much of the appeal comes from the audacity of the premise. Can the practice of statistics be captured in a few pithy statements that are simple and memorable? Of course not, is the first reaction of those of us proud of the depth and intricacies of statistical practice. But when you read through this book, you see that a lot of what we do has been summarized well. Perhaps the best endorsement of this book that I can offer is that I use these rules of thumb all the time in my consulting practice.www.informaworld.com/smpp/section?content=a912536459&fulltext=713240928

**7. Monthly Mean Definition: Normal probability plot**

The normal probability plot, sometimes called the qq plot, is a graphical way of assessing whether a set of data looks like it might come from a standard bell shaped curve (normal distribution). To compute a normal probability plot, first sort your data, then compute evenly spaced percentiles from a normal distribution. Optionally, you can choose the normal distribution to have the same mean and standard deviation as your data, or you can save some time by using evenly spaced percentiles from a standard normal distribution. Finally, plot the evenly spaced percentiles versus the sorted data. A reasonably straight line indicates a distribution that is close to normal. A markedly curved line indicates a distribution that deviates from normality.

Here's an example. The following data set represents a simulation from a non-normal distribution.

`31 88 23 44 35 26 66 92 32`

Sort the data.

`23 26 31 32 35 44 66 88 92`

Calculate evenly spaced percentiles. There are several formulas that will produce evenly spaced percentiles. I like the formula i/(n+1). With 9 observations, that would produce the 10th, 20th, 30th,...90th percentiles. Another commonly used formula for evenly spaced percentiles is (i-0.5)/10. This would produce the 6th, 17th, 28th, 39th, 50th, 61st, 72, 83rd, and 94th percentiles. Don't worry about the different formulas. In practice, they produce very similar results.

Here are the percentiles from the standard normal distribution.

`-1.28 -0.84 -0.52 -0.25 0.00 0.25 0.52 0.84 1.28`

Here are the percentiles from a normal distribution with the same mean and standard deviation as the data. I line these up with the sorted values

`23 26 31 32 35 44 66 88 92 (sorted values)`

14 26 35 42 49 55 63 71 83 (normal percentiles)Here's how R produces a normal probability plot.

You can also get a normal probability plot in PASW (formerly known as SPSS). On my website, I show how to interpret a normal probability plot, including what particular deviations from a straight line can tell you about the type of non-normality in your data. I also show a real world example of a normal probability plot using PASW.

**8. Monthly Mean Quote: An undefined problem...**

An undefined problem has an infinite number of solutions. - Robert A. Humphrey. As quoted in www.wxpnews.com/archives/wxpnews-401-20091020.htm.

**9. Monthly Mean Website: Freakonomics blog**

I'm not a big fan of the authors of Freakonomics, Steven D. Levitt and Stephen J. Dubner, for a variety of reasons, but they do have an interesting blog on the New York Times. Often the issues they talk about are more statistical than economic, though there is a fuzzy dividing line between the two topics. The best part of the blog is when they highlight interesting research of others. http://freakonomics.blogs.nytimes.com/

**10. Nick News: Nicholas and a very busy week in October**

Nicholas has had a pretty busy October, and it is not over yet. In the span of four days he starred as a bumble bee in a second grade school play, visited the Moon Marble Company, attended the Kansas City Renaissance Festival, took his own pictures at a wedding, and played at the Pumpkin Patch Festival at the Deanna Rose Farmstead. Here is one picture of his adventures. Look for more pictures at www.pmean.com/personal/OctoberFun.html.

**11. Very bad joke: A statistician had twins...**

A statistician had twins. She was delighted. She rang the minister who was also delighted. "Bring them to church on Sunday and we'll baptize them," said the minister. "No," replied the statistician. "Baptize one. We'll keep the other as a control."

Please note that I made a minor editorial change to emphasize that both men and women can be statisticians. Originally published in STATS: The Magazine For Students of Statistics, Winter 1996, Number 15. Quoted at www.workjoke.com/statisticians-jokes.htm.

**12. Tell me what you think.**

How did you like this newsletter? I have three short open ended questions at

You can also provide feedback by responding to this email. My three questions are:

- What was the most important thing that you learned in this newsletter?
- What was the one thing that you found confusing or difficult to follow?
- What other topics would you like to see covered in a future newsletter?
Two people provided feedback to the last newsletter. I got positive comments about my article on weighted means and the JAMA article about changes to the primary outcome measure. Both were confused by the article on Bayesian data analysis. One had difficulty with interpreting conditional probability, especially with the order (A given B versus B given A). In spite of this, I was encouraged to write more about Bayesian statistics.

**13. Upcoming statistics webinars.**

I will be giving three webinars (web seminars) on Statistics in November. These webinars are on three consecutive Wednesdays (November 4, 11, and 18) from 11am to noon Central Standard Time (CST). All of my statistics webinars provide an elementary introduction to the topic with little or no mathematics required. There are no pre-requisites for these webinars and they can be taken in any order.

Free to all! The first three steps in data entry, with examples in PASW/SPSS,Wednesday, November 4, 2009, 11am-noon, CST.Abstract: This one hour training class will give you a general introduction to data management using PASW (formerly known as SPSS) software. This class is useful for anyone who needs to enter or analyze research data. Students should know how to use a mouse and how to open applications within Microsoft Windows. No statistical experience is necessary. There are three steps that will help you get started with data entry for a research project. First, arrange your data in a rectangular format (one and only one number in each intersection of every row and column). Second, create a name for each column of data and provide documentation on this column such as units of measurement. Third, create codes for categorical data and for missing values. This class will show examples of data entry including the tricky issues associated with data entry of a two by two table and entry of dates.

What do all these numbers mean? Odds ratios, relative risks, and number needed to treat,Wednesday, November 11, 2009, 11am-noon, CST.Abstract:This one hour training class will teach you some of the numbers used in studies where the outcome only has two possible values (e.g., dead/alive). The odds ratio and the relative risk are both measures of risk used for binary outcomes, but sometimes they can differ markedly from one another. The relative risk offers a more natural interpretation, but certain research designs preclude its computation. Another measure of risk, the number needed to treat, provides comparisons on an absolute rather than relative scale and allow you to assess the trade-offs between effects and harms.

The first three steps in a descriptive data analysis, with examples in PASW/SPSS,Wednesday, November 18, 2009, 11am-noon, CST.Abstract:This one hour training class will give you a general introduction to descriptive data analysis using PASW (formerly known as SPSS) software. This class is useful for anyone who needs to analyze research data. Students should know how to use a mouse and how to open applications within Microsoft Windows. No statistical experience is necessary. There are three steps that will help you get started with descriptive data analysis. Get a count of available and missing data, compute ranges and frequencies, and examine relationships among variables.There will be a fee for the November 11 and November 18 webinars--only 40 US dollars for a single attendee, 75 US dollars for multiple attendees at the same site.

More details about these webinars are at

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This work is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2010-09-23.