Thursday, August 16, 2007

Mortality & quality; Whole brain radiation; PEG pedantry; The Academy

(Monday August 20, 2007: somehow sections #2 & #3 of this post became merged and some of the text was lost - I have tried to restore it by filling in the text as best as I can remember it. This post as it now stands is different that my original version but unless anyone can supply that to me this is how it's going to remain. Sorry about any confusion - Drew.)

JAMA has a commentary on the use of mortality as a measure of hospital quality. The context of the commentary is the increased reporting of hospital mortality rates as supposed measures of quality, etc. The authors examine this, point out some problems, and suggest some solutions. I certainly can't say anything about this better than the authors themselves, so I'll quote them:

"Absent from these discussions is a more fundamental question: what is the quality of care for the 1.16 million individuals who die each year in US hospitals (over 40% of all US deaths)? Deaths from errors and deaths after deliberate decisions not to pursue unwanted life-prolonging treatments are polar opposite outcomes. Conflating the 2 may have unintended consequences of undermining expert palliation of dying patients and rewarding overly aggressive treatment when it is not desired or beneficial."

"Taken alone, short-term mortality measures essentially treat death as a medical failure and reinforce avoiding death at all costs. As a result, short-term mortality measures do not acknowledge the naturalness of death, disproportionately reinforce treatments that prolong life, and potentially discourage palliative care. In addition, the absence of cancer-related mortality measures and the increasing number of mortality measures for noncancer conditions reinforces the erroneous assumption that patients with cancer are expected to die and patients with non-cancer diagnoses are expected to live."

"A major challenge will be to better distinguish patients who are not supposed to die from those dying of advanced chronic illness. This distinction will be best informed not by studying decedents, but by following seriously ill patients over time and determining patient, physician, and system factors contributing to how and when individuals die, including the circumstances that the improved coordination, communication, and symptom control may improve quality of care, but have mixed effects on mortality. This is particularly relevant given the findings that more frequent use of acute care services during the last 6 months of life may be associated with overall worse health outcomes."

Somewhat consonant with the above mortality<-?->quality quandary....

The New England Journal of Medicine has an article about prophylactic whole brain irradiation for patients with extensive stage small-cell lung cancer. The context here is that prophylactic WBI is generally accepted as a good thing for people with limited stage small cell lung cancer but it's less clearly helpful for those with extensive small-cell. This was a randomized, international, multicenter trial of WBI for people with extensive stage small cell lung cancer who had 'responded' (this was poorly defined in the trial) to initial chemotherapy, had good performance statuses, and did not have known brain metastases. They were randomized to receive WBI (various protocols were used) or not. There was no standardization of imaging before randomization or even at baseline staging after diagnosis; nor were people imaged in any standard way after treatment - only if they developed symptoms.

Findings: mortality outcomes, as expected for small cell cancer, were dismal but better in the WBI group. Median survival difference was a little over a month (6.7 months vs. 5.4 months) and 1-year survivals were 27 vs. 13% in the WBI and control groups, respectively. Symptoms were worse in the WBI groups (fatigue, hair loss, appetite loss, nausea/vomiting, leg weakness) but overall quality of life/global health status scores were similar between groups, as measured by the EORTC QLQ-C30. (These were all secondary outcomes in the study and so it's unknown if the study was adequately powered to show QOL differences.) So WBI seems to improve survival by a little over a month but doesn't improve QOL (and worsens some symptoms). The authors conclude that prophylactic WBI should become the standard of care for all extensive stage small cell patients who respond to chemo but given the lack of standardization in this trial (of protocols, of scanning, and even of defining 'response to chemotherapy'), and lack of improvement in QOL, I'm not convinced.

American Journal of Gastroenterology has a controlled trial of long-term polyethylene glycol (PEG 3350 or 'MiraLAX') laxative use for constipation. The 600+ patients were healthy adults who had chronic idiopathic constipation (2 or fewer BM's a week plus either straining, hard stools, or sensation of incomplete evacuation at least 25% of the time, and not caused by drugs or a medical condition). They were randomized to either 17gm daily of PEG or placebo and followed for 6 months. The primary outcome was defined as >50% of weeks patients had 3 or more BM's, no use of rescue meds (bisacodyl), and no more than one of the associated straining/hard stools/incomplete evacuation symptoms). So, basically, the outcome was did PEG increase people from 2 or fewer tough stools a week to 3 or more decent stools a week at least half the time? We're not exactly talking catharsis here.

They found that PEG was much more effective than placebo (with minimal side effects including electrolyte abnormalities) - 52% of the PEG subjects achieved the primary endpoint as compared to 11% of the placebo patients.

Why am I mentioning this article at all? To be honest it's because I'm having a rare moment of pedantry because, at least where I practice, PEG seems to be the most widely misused laxatives. Notably, I see the above dosing scheme (17gm daily) frequently used as monotherapy for severely medically ill patients who do not have chronic/idiopathic constipation: it's drug induced (opioids, anticholinergics, chemo, etc.), or from general debility (bedbound, sick patients), or multifactorial. Nevertheless patients receive this drug/dose which was designed to get PEG 3350 a FDA indication so that it can be marketed to healthy adults who poop twice weekly to get them to poop thrice weekly. My sense is that because it's PEG which at higher (hundreds of grams at a time) can cause catharsis and is used for bowel preps for colonoscopy etc. that some people assume it's a 'big gun' and don't realize 17gm is 'gentle.' Certainly PEG has a role along with other osmotic laxatives in treating constipation in the medically ill (I've not seen it studied in this population - however I've yet to look) but it's role is not as a monotherapy and not at 17gm a day. Despite this I have seen it used more and more as monotherapy for even opioid-induced constipation and I've been devoting more time to 'discussing' this with housestaff, etc.

I desperately try to avoid coming off as pedantic on this blog, so I apologize, but I hope many of Pallimed's readers can appreciate the passion that is sometimes needed to prevent and ameliorate one of our patients' most frequent and troublesome symptoms.

And finally - the AAHPM's new CEO, Steve Smith, has started on the job, per this announcement. The same announcement also notes candidates for the AAHPM board election - all around a very strong list - that includes my friend, collaborator, and all around good guy Dr. Christian Sinclair who's running for for a Director-at-Large spot. Good luck Christian. If anyone wants to talk with Christian as to why he's running leave a comment or email him at ctsinclair at gmail dot com and I'm sure he'll get back to you.

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