EDITORIAL

Taking Action on the Volume–Quality Relationship: How Long Can We Hide Our Heads in the Colostomy Bag?

Thomas J. Smith, Bruce E. Hillner, Harry D. Bear

Affiliation of authors: T. J. Smith, B. E. Hillner, H. D. Bear, Massey Cancer Center of the Virginia Commonwealth University Health System, Richmond, VA.

Correspondence to: Thomas J. Smith, M.D., F.A.C.P., Virginia Commonwealth University, Division of Hematology/Oncology and Palliative Care, Massey Cancer Center of Virginia Commonwealth University, MCV Box 980230, Richmond, VA 23298–0230 (e-mail: tsmith{at}hsc.vcu.edu).

WHAT DOES THE STUDY SHOW?

There is remarkably consistent evidence that the more experience doctors or health care systems have with a procedure, the better the results. At last count, 123 of 128 published studies showed some evidence of a "volume–quality" relationship (1,2). For oncology, the evidence is mostly consistent and often provides striking examples of markedly better outcomes with higher volume (3). There is even some evidence that outcomes can be improved with standardized care and clinical practice guidelines, among other things (4).

In this issue of the Journal, Hodgson et al. (5) identified 7257 patients with stage I–III rectal cancer from 1994 through 1997 in the California Cancer Registry to study the relationship of hospital volume with colostomy rates, 30-day mortality, and 2-year survival. The results look like a dose–response curve in chemotherapy: the higher the volume, the better the results, as shown in Table 1Go. The high-volume hurdle is not very high here—just 20 surgeries or more per year compared with less than seven per year. High volume is about two surgeries per month, and the lowest volume is one every 2 months. Of the 7257 patients treated during this time period, 1621 (22%) had their surgery done at centers (221 different hospitals) that did fewer than seven surgeries per year.


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Table 1. Relationship between hospital volume and outcomes
 
There were important differences in processes of care that may explain some of these outcomes. Fewer lymph nodes were evaluated in the lower volume hospitals (six vs. eight lymph nodes, P<.001), which some have suggested is a surrogate for the adequacy of resection, and could lead to under use of adjuvant treatment. There were some minor differences in socioeconomic status among patients at different hospitals, but these were carefully controlled in multivariable analysis, and the conclusions were still valid.

Not all differences were attributable to volume alone. The differences in colostomy rates among individual hospitals near the study’s average were actually greater than the differences among the volume categories. As the authors point out, small hospitals (or nonacademic hospitals or whatever category one chooses) may provide optimal care and have superior outcomes. But most do not.

The results are the most up-to-date, current reflection of contemporary surgical practice in a large state. They are consistent with the wide and deep body of knowledge that shows a strong relationship between volume and quality, long recognized in other industries. How we react to this convincing body of knowledge is up to us. We have listed some of the possible actions in Table 2Go. Those who have followed this debate will recognize the uses of all of these options. These important issues do not arise in a vacuum, and the actions taken will have important consequences for patient outcomes, physician livelihoods and incomes, hospital service capabilities, and the communities that support or are supported by these hospitals. It is unlikely that anyone will mount large randomized clinical trials shortly, and there is not likely to be any more or better evidence that that which is in our hands already.


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Table 2. Options in response to another convincing example of a higher volume/better outcome in U.S. health care
 
That said, what is the appropriate action to take for patients, health care professionals, and payers (i.e., health insurance companies)? Of the options, asking doctors and health care systems to submit data now seems the most logical.

WHAT ACTION SHOULD PATIENTS TAKE, BASED ON THE STUDY?

Observe physicians choosing a physician for their family member or for themselves to get the most practical answer. Although we may be content to go to a "doc in a box" for antibiotics for sinusitis, all of us seek the most experienced provider with the best results for serious illness. Patients should have access to this type of data, so that they may choose whether to use it. Studies of coronary artery disease procedures show that many patients will continue to use their neighborhood hospital even if the mortality rates are not the best. The largest insurer in Virginia has just begun releasing all available hospital performance data to members of its health plans; although such data may not be perfect, some data are almost certainly preferable to none.

Cancer is not an emergency like childbirth or acute myocardial infarction. One has time to plan, get second opinions, and seek out the best care available.

WHAT ACTION SHOULD HEALTH CARE PROFESSIONALS TAKE, AS A RESULT OF THE STUDY?

The most logical action would be to collect data on common procedures and their subsequent outcomes. We have been able to collect important "target" data for breast cancer management from important breast cancer processes and our actual performance from available hospital and provider databases, as shown in Table 3Go. To date we have not been able to use that data for anything other than a performance-monitoring tool, but perhaps there will come a time when insurers will pay more for proven quality. In the meantime, such report cards have given us an important internal measure of quality, and we have expanded their use to palliative care and other parts of the oncology service line.


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Table 3. Important, collectible processes and outcomes in breast cancer management*
 
We think that having a uniform expectation of care and standard algorithms for care makes care more equal. In our own system at the Massey Cancer Center of Virginia Commonwealth University, the use of breast-conserving therapy is approximately 65% across the board, with no differences in socioeconomic status or race. Similarly, the percentage of patients who use palliative care services does not differ by race or socioeconomic status (6). In both instances, our results are substantially different from what would be expected on the basis of national data.

We should study the best outcome systems to learn the reasons for their outcomes, but we should not let that slow down the action now. After all, these differences in survival are larger than those observed with adjuvant therapy.

WHAT ACTION SHOULD PAYERS OR POLICY MAKERS TAKE, BASED ON THE STUDY?

Again, the most logical step may not be the easiest. The most logical step would be for payers to demand a certain level of volume (in this disease, just 20 surgeries a year, or at least more than 7) for reimbursement or permission to perform surgery. The suggested rate of seven per year is lower than the proposed number of 11 or more per year for pancreatic resection and 13 or more per year for esophagectomy (Evidence-Based Hospital Referral. The LEAPFROG Group for Patient Safety Rewarding Higher Standards. April 16, 2003). It is not clear from the current data whether the results are due to the number of surgeons, the number of operations, or the skill of the surgeon; this is an area of much needed research.

On the surface, this study supports a conclusion drawn from evidence of other directed surgical cancer care—that, for cancer surgery, patients or payers should stop doing business with two-thirds of the hospitals in most large U.S. states. This response, of course, would lead to difficulties in patient access to nearby care, disruptions of service menus, disruptions of individual and institutional income, loss or gain of prestige, etc. Alternatively, payers could demand the colostomy rates and 30-day mortality figures by surgeon, by hospital, and by health care system, and then direct patients to only those centers that could provide acceptable results.

The better long-term solution would be to disseminate the components of practice that lead to better outcomes. Whether these solutions are better or worse than allowing an additional seven of every 100 patients to die needlessly is certainly important to the debate.

TAKE HOME MESSAGE

It is time for us to take our heads out of the colostomy bag, and take some action. The data for much of surgical oncology care and some other types of oncology care are compelling enough to demand changes in practice, referral patterns, or both. Colostomy rates or mortality rates that are unexplainably high for similar patients are simply not acceptable. If these decisions did not involve livelihood, prestige, and power, we would have demanded action long ago. It is, however, time now to ask providers to provide data on their outcomes, so that patients and payers can make an informed choice that is based on outcomes rather than on reputation or convenience. It should be noted that such improvements, whether done by concentration of care at certain hospitals or by required reporting of results, may not save costs—just lives (7). That is a good start.

REFERENCES

1 Dudley RA, Johansen KL, Brand R, Rennie DJ, Milstein A. Selective referral to high-volume hospitals: estimating potentially avoidable deaths. JAMA 2000;283:1159–66.[Abstract/Free Full Text]

2 Birkmeyer JD, Siewers AE, Finlayson EV, Stukel TA, Lucas FL, Batista I, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002;346:1128–37.[Abstract/Free Full Text]

3 Hillner BE, Smith TJ, Desch CE. Hospital and physician volume or specialization and outcome in cancer treatment. J Clin Oncol 2000;18:2327–40.[Abstract/Free Full Text]

4 Smith TJ, Hillner BE. Ensuring quality cancer care by the use of clinical practice guidelines and critical pathways. J Clin Oncol 2001;19:2886–97.[Abstract/Free Full Text]

5 Hodgson DC, Zhang W, Zaslavsky AM, Fuchs CS, Wright WE, Ayanian JZ. Relation of hospital volume to colostomy rates and survival for patients with rectal cancer. J Natl Cancer Inst 2003;95:708–16.[Abstract/Free Full Text]

6 Smith TJ, Coyne P, Cassel JB, Hager MA, Penberthy L, Hobson A. A high volume specialist palliative care unit and team may reduce in-hospital end of life care cost. J Pall Med. In press 2003.

7 Birkmeyer JD, Skinner JS, Wennberg DE. Will volume-based referral strategies reduce costs or just save lives? Health Aff (Millwood) 2002;21:234–41.[Abstract/Free Full Text]


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