Guidelines @ MindSay 
rules
"Dr. W. Edwards Deming taught that by adopting appropriate principles of management, organizations can increase quality and simultaneously reduce costs (by reducing waste, rework, staff attrition and litigation while increasing customer loyalty). The key is to practice continual improvement and think of manufacturing as a system, not as bits and pieces."
Why and how could such a paradigm be a curse? The answer is simple. Take the paradigm and turn it exactly on its head by applying it in "bits and pieces" to complex human endeavors where no consensus for a workable, measureable definiton of quality exists. Deming, after all, was addressing manufacturing.
How would Picasso and Monet have incorporated Deming's paradigm into their work? Alarming to contemplate is the question of how their immediate supervisors would have used the paradigm. Then consider the other extreme of human endeavor: precision manufacuring of a product designed for a specific purpose. The engineering inmates portrayed in "Shindler's List" furtively discussed their manufacture of artillery shells. Their "customers" were their captors. The inmates' goal was to increase customer waste and rework while still maintaining "customer loyalty" so they could reduce "staff attrition." This required ingenuity not contemplated by Deming.
A local hospital informs us via a media campaign that should all hospitals adopt their policies and procedures, 100,000 fewer people would be killed by medical errors each year. The evidence for this claim flows from an analysis performed by a consultant hired by the hospital. The 100,000 figure comes from a widely promulgated report by the Institute of Medicine. The lives saved claim flows form the Institute for Health Care Improvement, who suggested in the Journal of the American Medical Association "six highly feasible interventions for which efficacy is documented in the peer-reviewed literature and is reflected in standards set by relevant specialty societies and government agencies."
The claim that "efficacy is documented" is a little strong. The claim is accompanied by references to non-randomized surveys conducted by enthusiasts for the interventions being examined. The list of refereneces does not include any studies that fail to show benefit. For example, the "rapid response teams" intervention that is the first listed was studied in a randomized prospective trial in Australia. That more robustly scientific (though far from perfect or definitive) trial did not show any benefit to the intervention.
The definition of a death from a medical mistake is not easily crafted. As always, there are anecdotal examples where a cause and effect relationship is inescapable. However, many mistakes occur in a complex mosaic. Often, in the case of death, the underlying disease state is advanced and unstable. What in retrospect appears to be an error can really be a reasonable judgement examined retrospectively.
Equally uncertain is that the interventions being implemented will actually improve the net outcomes when taken in the aggregate. For example, taking a group of caregivers from their assigned clinical duties in order for them to rapidly respond to a perceived emergency elsewhere (there is no easily reproducible definition of the threshold that requires that the team be summoned) cannot improve their level of attention to their regularly assigned duties. Taking a nurse from the ICU, where patieints are by definition seriously ill, must entail some risk for errors of omission or comission for the ICU patient. Who is measuring this?
Next is a discussion of the "bits and pieces" strategy that the current "100,000 lives campaign" depends upon.
I thank you for calling out my name in times that I have wondered a little too far and my sight became blurry, there were no other guidelines or indications to point me back to my destiny.
I am appreciative for the countless moments I was forced to stand still and listen to lectures and speeches never completely hearing what your heart was saying until now. I was still a child then and as a child I thought I knew everything.
There are no words to describe the feelings as you held me when everything appeared to be at its worse.
A simple rub on my back or a smile in my direction or the words I love you.
I thank you Father, both here and there.
I thank you for being the ultimate father that will love me more than anyone else can imagine so much so that you gave me my own father
I
A serious question for women with breast cancer and their physicians is whether chemotherapy should be employed after the initial breast surgery. This decision is particularly vexing for situations where the prognosis is relatively good, but not good enough. Patients whose cancers have estrogen receptors and who do not have any spread to the lymph nodes comprise such a group. And the group is large, perhaps half the women with breast cancer.
A decade or so ago the results from the National Surgical Adjuvant Breast Project chemotherapy trial B-20 were reported. This trial suggested chemotherapy was of benefit before the menopause with a step down in usefulness with menopause and then a continuing decline with age. Thus tamoxifen plus chemotherapy seemed wise up until roughly the age of 60 (the trial did not include women over 70). The chemotherapy employed in B-20 were regimens that date to the 1970's. Many experts believe that newer regimens are more effective.
B-20 revealed that the degree of estrogen positivity was possibly important, with women with lower levels benefiting more from the chemotherapy and tamoxifen combination. The advent of gene profiling, like the proprietary “Oncotype Dx”, seems to have resolved the chemotherapy issue for many patients and physicians. Is this rational or simply another example of the technological imperative?
“The RS [Oncotype Recurrence Score] assay not only quantifies the likelihood of breast cancer recurrence in women with node-negative, estrogen receptor-positive breast cancer, but also predicts the magnitude of chemotherapy benefit” is the conclusion in a paper in the Journal of Clinical Oncology in 2006. Based largely on this study, Oncotype Dx appears with favorable mention in the American Society of Clinical Oncologists and National Comprehensive Cancer Network guidelines. Genomic Health, the company that sells the Oncotype Dx test, uses these guidelines and the JCO paper in its marketing.
The 12 page JCO report is chock full of sophisticated analysis, such as “linear fit of the likelihood of distant recurrence as a continuous function of recurrence score” analyses and various multivariate models. But what is the basis for the statement that Oncotype “predicts the magnitude of chemotherapy benefit”?
A glance at “Fig. A2” on page 11 tells the story. Figure A2 gives 12 year “overall survival” comparisons for four groups: tamoxifen versus combined tamoxifen/chemo for all patients lumped together, and the corresponding comparisons for good, intermediate, and poor Oncotype Dx score groups. Seven of the eight groups have 12 year survival ranging from about 92% for the low score tamoxifen alone group to about 82% for both intermediate groups, and the tamoxifen/chemotherapy high risk group.
Only the high Oncotype risk score tamoxifen alone group jumps off the page. This group has a 12 year survival of only 60%. But the tamoxifen alone group with high risk Oncotype scores consists of only 47 patients. Where did these 47 patients come from? They came from a study (B-20) done by the NSABP and reported in 1997 and included 2363 patients with breast cancer, negative lymph nodes and positive estrogen receptors. The 47 unlucky patients were about 2% of the total enrolled patients in NSABP B-20.
Are the 47 patients representative of all the Oncotype high risk patients in B-20? It is hard to say. Samples of the original breast tumors were available for only 670 patients and testing was successful in 651. So, only about ¼ of the B-20 patients are included in the Oncotype study. If this sample were random, probabilistic analysis might be intact. But the absence of material to test was not random. Some of the tumor samples were “used up” in other studies, and not saved in others. Presumably these other studies were focused on something specific and not random.
And what about the “overall survival” of 60%? Is that real? Again, it is hard to say. “Deaths before distant recurrence [was] considered [a] censoring event”. This means that a patient who was killed in an auto crash would be counted as alive but lost to follow up rather than counted as a death. But what if the crash was caused by a blood clot caused by the tamoxifen? And, since both chemotherapy and tamoxifen are thought to increase clots, what if several more patients in the combined group than in the tamoxifen died of strokes or heart attacks?
Oncotype is being used by patients and physicians all over the country to decide upon chemotherapy based on the 47 patients. Perhaps by a coincidence, the 12 year survival for both the Oncotype intermediate and high risk combined tamoxifen/chemotherapy groups was nearly identical at 82%. There were 212 such patients.
However, the 47 high risk tamoxifen alone group had survival 22% less than any other group. What are the possible explanations for the remarkably bad outcome for the 47 patients? Perhaps it is as it seems – tamoxifen alone is inadequate for high risk patients. Still it seems odd that the worst prognosis group had almost exactly the same survival experience as the intermediate group when the treatment was both chemotherapy and tamoxifen. If the understanding is that tamoxifen is good for estrogen receptor positive patients and chemotherapy adds something for some patients, how is it that the combination gives the same results for both intermediate and high risk patients?
Maybe the 47 were just very unlucky and the 117 high risk patients who got the combination therapy were astonishingly lucky to get the same results as the intermediate group. To account for this possibility, tests of statistical significance are performed. Using one of these (Cox proportional hazard test), there is less than one chance in a thousand that the 22% difference in survival is “random”, according to the analysis done by the authors. The tests for statistical significance assume random allocation of treatment. The original B-20 trial was randomized but the Oncotype study was not based on a random sample from that trial and was retrospective.
In addition, the “significance testing” was not said to have been corrected for the fact that many comparisons were made. The degree of confidence one takes away from a retrospective study full of potentially confounding variables and assumptions that violate basic probabilistic underpinnings is not as high as the statistical significance level might otherwise imply.
The authors of the JCO paper claim that their test “predicts the magnitude of chemotherapy benefit.” This seems not quite right. The magnitude of benefit from tamoxifen/chemo was identical in the intermediate and high risk score groups. What the test may have predicted in those 47 patients with high scores was a poor outcome with tamoxifen alone. One would think that the suggestion that Oncotype should serve as the basis for treatment selection for 100,000 women should not be based on the experience of an undefined 47 patient “chunk sample”.
The test costs about $3650. About 100,000 women may have er positive, node negative cancer diagnosed this year. That’s $365 mil for just one test in a complicated setting where many other images and tests will be required. Oncotype Dx should be verified by a prospective randomized trial that is appropriately stratified. Such a trial is underway.
Most of you know I am a single mom, and have been for several years. Some of you might even remember my "fling" as seeresvelvet , although that blog disappeared a while back. On this New Year's Day, I'd like to open a discussion on sex. For some, it may be an old and tired topic, but for me, as a single mom of teens/young adults, it is an ever-present issue.
I have 2 girls, ages 23 & 17, and one boy who is 20. They have been raised on the foundational belief that sex is a wonderful & beautiful gift to give your spouse within a committed marriage. Outside of that, problems arise. As small children, they were taught that dating, by definition, is the search for a mate, and therefore, they would not be permitted to "date" until they were at least 18. Prior to that, group ventures are encouraged.
Now I see your head shaking in disbelief, but it has actually worked! To my mind, it's not that sex is dirty or bad, just the opposite, in fact. It is too special to just throw around at any Tom or Henrietta that comes along and shows some interest. What goes on in the bedrooms of committe, consenting adults, for the most part, is their business. I know some beautifully Christian people who practice a form of BDSM. I have believing friends who teach a course in healthy sexuality from a Biblical perspective. The fact that sex is not discussed, in my opinion, allows distortions and abuses to continue unchecked.
Since my divorce in 2001, my kids have had ample opportunity to witness this practice in my own life. When I was first seperated, I wanted to date anything that moved, to validate my femininity. I was afraid of being alone ... of growing old alone. THANK GOD, that is no longer the case. I still date on occasion and there remains a small glimmer of hope that perhaps one day I still may find a male companion with whom to spend my remaining years. If that does not happen, it will NOT break my heart.
Our society puts tremendous pressure on us to couple. I think this is even more true to females than males, but it applies to all of us. There is an unwritten, undefined stigma attached to singleness like we are somehow less than whole. Just look at how young our children now become aware of those that attract them. Elementary age children are "going steady"! To which I reply, for what purpose???????? It makes no sense to me AND puts an unhealthy strain on our young people to be more concerned with their attractiveness to the opposite sex than with their studies.
My point? hmmm ... well, I love sex ... in the proper arrangement, and hope to have that opportunity again before my time passes. I am thrilled that my kids took my words and instruction to heart, and value themselves enough to exercise self-control until they are ready to marry. I wish believers were not so stuffy about sex and sexual issues. Open discussions, in themselves, help to answer questions and keep things in perspective.
So, I'm opening this up ... What about Christians and sex?
~ B
 | My Peculiar Aristocratic Title is: Honourable Lady Velvet the Liminal of Fishkill St Wednesday Get your Peculiar Aristocratic Title |
Neil's Stringent Set of Prescriptions for the Proper Use of Sunglasses
1: Never wear sunglasses indoors; it's pretentious.
Qualification: Anticipate entering, do not anticipate exiting.*
2: Remove your sunglasses when sharing a meal; it's polite.
Qualification: The term "meal" is admittedly vague. Generally, if you are sitting down for the purpose of eating whatever it is you are eating, it is a meal. However, this does not exclude the possibility of meals standing up. A bag of chips, drinks, hors d'oeuvres... These things are not a meal. All in all, this stipulation requires use of judgment the most.
3: Sunglasses may be worn any time of the day.
4: Never wear sunglasses in the rain; it makes you look amazingly desperate.
5: Once you put a pair of sunglasses on, you are committed to that pair for the rest of the day.
Qualification: You are not required to wear the pair for the rest of the day, you are merely not allowed to wear a different pair.**
6: Never be the only one wearing a pair of sunglasses.
Qualification: There does not have to be another person in your company wearing sunglasses, there must merely be another person wearing sunglasses within the general vicinity, whether it be school, park, block party, etc.*By this I mean, take your sunglasses off before going indoors but do not put them back on until you are already outdoors. No exceptions.
Qualification: You may disregard this rule at night, night meaning "after sunset".
**Regardless of whether you change your outfit, cut your hair or get a sex change, you must not change the pair of sunglasses you wear over the course of day. No exceptions.
There you have it. By following this set of guidelines, your the qaulity of your life will greatly soar and your happiness will be increased ten-fold.
-Neil
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