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Leon G Fine, Bruce E Keogh, Shan Cretin, Maria Orlando, and Mairi M Gould
How to evaluate and improve the quality and credibility of an outcomes database: validation and feedback study on the UK Cardiac Surgery Experience
BMJ 2003; 326: 25-28 [Abstract] [Full text]
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[Read Rapid Response] It may take a culture change to achieve optimal standards
Richard G Fiddian-Green   (30 July 2003)

It may take a culture change to achieve optimal standards 30 July 2003
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Richard G Fiddian-Green,
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Re: It may take a culture change to achieve optimal standards

Outcome auditing is essential if one is to improve quality (1)but outcome auditing alone may not be enough to improve quality and quality improvement programs may even be an impediment to achieving an optimal standard of care.

During my three month tenure as Chief of the Surgical Services at the Brooklyn VA hospital in 1995 I quickly found the quality of care unacceptably bad. Everything was wrong and, since the quality of surgery being delivered in the institution was in the middle of the bell-shaped curve for all 144 VAs, everything was wrong with surgical care in the majority of VAs. My recommendations, the most basic of which were to have a consultant held responsible for the care of each patient and to have his/her name placed on the patients records so everyone would know who was responsible ["But residents choose this training program because they are given independent responsibility for patient care at the VA"] and having the patients X-rays with them when seen in the clinic ["you mean you do not accept the radiologist's written reports?"] were not followed. In fact these initiatives were actively disrupted by political parties protecting their turf and a long established pecking order within the institution. Here is an organisation in which the residents, porters, electricians and janitors really do have power.

As in the NHS the hospital director had the same fixation with the time taken for patients to be seen in the clinics, follow-up of patients found to have cancers, and the back-log of patients waiting for herniorrhaphies [the false assumption being that repair is mandatory in all]. I was fired after imforming the chief of staff it was dangerous taking care of patients in the institution and recommending that the operating rooms be closed until these basic issues had been resolved. It was said that I was fired for "upsetting too many people". A cardiac surgeon and chief of the surgical srvices at the Harvard affilliated VA and the new chairman of surgery at Cornell were put in charge of a politically and managerially correct quality improvement initiative in all VA hospitals which began shortly after my departure in 1995.

The VA National Surgical Quality Improvement Program (NSQIP) data collection process had been established in 1994 , just before my arrival at the VA, to document the improvements. [I had been privy to the raw data available in 1995, hence my knowledge of the ranking of the Brooklyn VA]. The initial results of the improvements implemented were published in a paper in January 2002, seven years after I had left the VA (2). The 30-day postoperative mortality for major surgery had decreased 27%, and the 30- day morbidity 45%. Whilst hailed as a success by the VA directors and politicians alike [as Milburn hailed his improvements] these seemingly impressive figures are a measure of how bad the care was not of how good it has become.

After a feasibility study (3) the Department of Veterans Affairs conducted the National VA Surgical Risk Study between October 1, 1991, and December 31, 1993, in 144 VA medical centers. An army of nurses combed the records each day and questioned staff in order to document the changes. The study developed and validated from some 1,000,000 patients models for risk adjustment of 30-day morbidity and 30-day mortality after major surgery in 8 noncardiac surgical specialties. Based on the results of the National VA Surgical Risk Study and the Continuous Improvement in Cardiac Surgery Program, the VA had established in 1994 the VA National Surgical Quality Improvement Program (NSQIP) in which all the medical centers performing major surgery participated beginning in 1995 (2).

In a paper published in January 2003 some 7/8 years after introducing the NSQIP the thirty-day mortality for oesophageal surgery had fallen to 9.8% (174/1,777) and the incidence of one or more of 20 predefined complications to 49.5% (880/1,777) (4). In a paper published in May 2003 the overall mortality was reported to have fallen to 10.0% (56/562) for transthoracic esophagectomy and 9.9% (38/383) for transhiatal esophagectomy (P =.983). Morbidity occurred in 47% (266/562) of patients after transthoracic esophagectomy and in 49% (188/383) of patients after transhiatal esophagectomy (P =.596). Wound dehiscence [usually a a midline incision] occurred in an astonishing 5% (18/383) of patients undergoing transhiatal esophagectomy and 2% (12/562) of patients undergoing transthoracic esophagectomy, the difference not being statistically significant (5). In another paper published in May 2003 the 30-day postoperative mortality rate for pancreaticoduodenectomy had fallen to 9.3% (43/462) (6). In a paper published a year earlier the 30-day morbidity rate for gastrectomy had fallen to 33.3% (236 of 708). The overall 30-day mortality rate had fallen to 7.6% (54 of 708) (7).

Whilst apparently comparing favourably with published results obtained in non-governmental institutions in the US and in the NHS and, in the case of oesophageal surgery, even some of the best known surgeons in the US these results fall far short of the standard, 0% mortality and low morbidity, some gastrointestinal surgeons have been achieving with regularity for decades and others have made huge progress towards achieving in recent years (8). It would be fair to say that most of these surgeons would regard the results obtained in the VA hospitals, reported 7/8 years after implementation of NSQIP, to be unacceptably bad. Extrapolating backwards from the 27% reduction in 30-day postoperative mortality and 45% 30-day morbidity 45% after major surgery the results before the implementation of the improvement program was simply horrendous as indeed the raw data I saw showed. So the improvement has been from horrendous to bad in 7/8 years.

It takes more than a politically and managerially correct quality improvement initiative of 7/8 years duration to achieve a 0% mortality and 0% morbidity certainly for elective surgery in a large organisation such as the Veterans Administration hospitals and by extrapolation the NHS. Proper training is clearly of paramount importance (9) but can be worthless in the absence of the appropriate culture and support sytems. Might there be insumountable impediments to ever achieving these goals within the VA and NHS cultures? Possibly. I believe the goal of 0% mortality and 0% morbidity is far more likely to be achieved by a major culture change directed by a leader with established clinical credentials. This presupposes that he/she is given the authority and administrative appropriate support.

It is not possible to get many surgeons with the necessary clinical skills to make the sacrifices necessary to work fulltime in a VA or even to do cardiac surgery in the NHS as Professor Sir Magdo Yacoub found in widely publicised attempt to fulfill Blair's charter. Even if they could be recruited I have serious doubts whether many would be able to achieve in the VA/NHS the standards they had achieved before they worked for the VA/NHS. There is just too much mediocrity, inertia, red tape and political baggage in these massive state organisations. There are better ways of accomplishing these objectives.

1. How to evaluate and improve the quality and credibility of an outcomes database: validation and feedback study on the UK Cardiac Surgery Experience Leon G Fine, Bruce E Keogh, Shan Cretin, Maria Orlando, and Mairi M Gould BMJ 2003; 326: 25-28 2. Khuri SF, Daley J, Henderson WG. The comparative assessment and improvement of quality of surgical care in the Department of Veterans Affairs. Arch Surg. 2002 Jan;137(1):20-7.

3. Bailey SH, Bull DA, Harpole DH, Rentz JJ, Neumayer LA, Pappas TN, Daley J, Henderson WG, Krasnicka B, Khuri SF. Outcomes after esophagectomy: a ten-year prospective cohort. Ann Thorac Surg. 2003 Jan;75(1):217-22; discussion 222.

4. Rentz J, Bull D, Harpole D, Bailey S, Neumayer L, Pappas T, Krasnicka B, Henderson W, Daley J, Khuri S. Transthoracic versus transhiatal esophagectomy: a prospective study of 945 patients. J Thorac Cardiovasc Surg. 2003 May;125(5):1114-20.

5 .Billingsley 3. KG, Hur K, Henderson WG, Daley J, Khuri SF, Bell RH Jr. Outcome after pancreaticoduodenectomy for periampullary cancer: an analysis from the veterans affairs national surgical quality improvement program. J Gastrointest Surg. 2003 May-Jun;7(4):484-91.

6. Grossmann EM, Longo WE, Virgo KS, Johnson FE, Oprian CA, Henderson W, Daley J, Khuri SF. Morbidity and mortality of gastrectomy for cancer in Department of Veterans Affairs Medical Centers. Surgery. 2002 May;131(5):484-90.

7. Only one standard: 0% morbidity and mortality Richard G Fiddian-Green bmj.com/cgi/eletters/326/7393/786#31254, 16 Apr 2003

8. Destructive influence of medical politcs Richard G Fiddian-Green bmj.com/cgi/eletters/325/7368/787#26371, 18 Oct 2002

9. Training is more important than volume Richard G Fiddian-Green bmj.com/cgi/eletters/325/7368/787#26226, 12 Oct 2002

Competing interests:   None declared