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EDITORIAL |
| Katholieke Universiteit Leuven, Belgium |
Industrial processes, as healthcare delivery, can be described in quality of organisation of the process and in quality of the created product.
It is precisely in the organisation of the process of care that supra-regional organisations can and should play an active advisory and supervisory role. The supra-regional organisations have the professional expertise; they should suggest to the medical practitioners to describe every fragment of their activity, starting with the acceptance of the patient on the waiting list, continuing for example with the treatment of atrial fibrillation day three after CABG and ending with the follow up methodology late after the procedure. The Industry has called these descriptions standard operating procedures or SOP. Essential descriptive elements of e.g. the waiting list are the accepting process, the maintenance of the waiting list, the waiting list priorities and the reporting of waiting list morbidity and mortality. Only few cardio-vascular units have their processes registered. Registering the process of care is the optimal pathway to a continuous upgrade and certainly not a final immobilisation of these processes. Cardiac surgery is the leader in quality control in the medical world, and the industrial world has been promoting process registration as the essential step towards quality of organisation. Supra-regional organisations, willing to accredit units should stress this process registration. It is the more appropriate since this registration is unrelated to the socio-economic environment.
Cardio-surgical units deliver their care with large differences in human and non-human resources: surgeons, assistants, nurses, intensive care beds ... . Some institutions and regions have resources but do not allocate them appropriately, while other institutions and regions have no available resources. This is once more a domain of interest for the supra-regional organisations, but the socio-economic variability forces a more subtle approach. This variability induces two different resource requirements: the optimal ones and the essential ones. Essential requirements are those critical for the practice of cardio-thoracic surgery in a country with normal health care standards. It is clear that no unit can be accredited by the supra-regional organisation if these requirements are not available. A surgeon-on call on a 24/7 basis is clearly essential. To have congenital cardiac surgery done by a congenital cardiac surgeon (activity limited to congenital surgery), have him perform at least two hundred procedures a year and having two of these surgeons on staff is definitely an ideal set-up. The availability of the essential resources and the registration of the processes are clearly pre-requisites for accreditation. They can be easily audited by the supra-regional organisations.
The industry has identified that such a process-accreditation system would dramatically improve the delivery of care and would help the health authorities in planning their resource utilisation and attribution.
For some obscure reason, supra-regional organisations have not focused on these two previous pathways but have been more interested in the actual evaluation of the quality of the created product. Their enthusiasm for this evaluation is inversely related to their experience with the complexity of time-related and multivariate analysis. This complexity starts with the determination of the correct study interval. The hospital stay interval, used by some large organisations, misses every scientific substance. Many studies have identified that the peri-procedural interval for mortality and morbidity extends for three months in CABG patients, for six months in valve patients and up to one year for congenital surgery. An appropriate interval seems therefore at least one year after surgery, but no patient would accept the damage of his physical integrity for a one-year benefit. It would also be very unfair for surgical teams focusing their care on long term results. A more realistic interval would be ten years, balancing early risk versus intermediate benefit.
The second problem is the identification of the variables describing the variability in patients. This variability is the biggest problem in studying the quality of the cardiac surgery product. It is probably not so active in cardiological or other medical domains. It must be said that these domains have not been explored as cardiac surgery. In addition, the variables will differ for every studied event. In fact it is even more complex since many events are structured around different phases, active simultaneously with different strengths. Every phase of every event can be structured around different variables, sometimes the same variables with different transformations and different coefficients. It is clearly easier to forget the science of outcome analysis, as preached by Kirklin and Blackstone, than to practice it. Nearly no research has been made about the impact of the socio-economic environment on the selection of these variables.
Let us dream together and believe that a 10-year model has been created for every event and every procedure of every domain of cardiac surgery. Should supra-regional organisations propose these models as quality standards, require these models to be balanced versus the obtained results and rank units according to the observations? The only observation after comparing predicted versus observed results is an observation of variance. No inference but this variance is valid. The next step is the retro-analysis of every negative observation in the studied dataset, exploring unidentified or abnormal variability, not available for model creation or without stable coefficient. This labour-intensive exploration precedes any inference building about the studied dataset. No supra-regional models have yet been able to include variability in resource availability. It is therefore excluded to impose them on these under-privileged environments!
Ranking is an absurd technology in quality control because it neutralises an essential element of science: the uncertainty of the observation expressed as confidence limit or standard deviation. In addition, the strategy of quality analysis is not the identification of the best unit, but the improvement of the lesser performing units.
Supra-regional organisations should therefore be extremely cautious in requiring participation into these projects before accrediting units. This last statement does not exclude supra-regional organisations from creating simple models for predefined simple intervals. These models are unrelated to science but create languages of care. The STS equation and the EuroSCORE equation are examples of languages of care. Medical professionals can now interrelate about risk and outcome. The impact on improvement of care is made when the unit starts collecting prospectively data describing the patient variability and collecting data about early and late outcome. It is well known that the confrontation with data within the unit has a larger impact on improving care versus any policing activity from an outside body. The supra-regional organisations can even proceed with the refinements of their languages, involving pilot cardiovascular units, willing to submit themselves to in depth explorations of risk and benefits.
The supra-regional organisations have an unprecedented obligation in the improvement of the quality of care; understanding the opportunities and the limitations becomes of prime importance!
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