REPORT ON THE SCIENTIFIC EFFECTIVENESS AND ECONOMIC ADVANTAGES OF TOPICAL/LOCAL NORMOBARIC OXYGEN THERAPY FOR THERAPY ON TROPHIC ULCERS OF THE LOWER LIMBS
The pathology: what we are speaking about
Vascular problems connected with arterial deficit and venous insufficiency at the expense of the lower limbs constitute the main cause of trophic injuries of the lower limbs.
The causes of these injuries are in order of frequency:
- Venous insufficiency
- Arterial deficit
- Diabetes, trauma
- Iatrogenic and neoplastic
Epidemiology: statistical frequency and numbers
This pathology represents a great problem both medical and socio-medical. It is estimated that in Italy this pathology affects 1.5% of the population and 5% of the population over 65 years old, with an approximate calculation of about two million individuals connected with the problem (P.D.L. N4409/2003). The distribution of this illness is strictly correlated as much to the ageing of the population as to the living conditions and the basic cultural level of the individuals potentially concerned.
An ill person with these injuries, which by definition are chronic, is often incapable, suffering, depressed since this pathology makes his existence problematic, causes a reduction in the quality of life and weighs heavily on the family environment for the continuous need for assistance, accompanied by a slow and not well defined deterioration
The problem for society: the costs
Ulcers of the lower limbs are among the pathologies that most greatly affect the health cost since:
- they are difficult to take care of as often their cause cannot be eliminated;
- their improvement depends on individual responses, age and the associated pathologies apart from the causes and contributory causes;
Costs can be :
- direct (cures and materials used, departments and public services or those within the National Health Service, basic medicine, integrated domestic assistance and homes for the elderly, costs of diagnoses.
- Indirect with working days lost both by the patient and family members concerned and possible insurance costs.
And such costs apart from being chronic are increasing and will continue so given the ageing population
Current therapies available
- primary therapies aimed at resolving or improving the causes and the contributory causes (vasoactive medicines, diabetics, medicines that act on the viscosity of the blood, vasodilators etc …) medicines and aids for the medication (creams, gauzes, bandaging, medicating aids etc ..) and medicines for complications (anticoagulants, antibiotics)
- surgical therapies aimed at cleansing injuries or repairing them (plastic surgery)
- oxygen therapy carried out in the hyperbaric chambers which give good results but are difficult to perform for their scarce availability and the general side-effects (organic and psychological) which limit use.
Socio-medical consequences of unsuitable treatment
The potentially negative outcome of insufficient treatment can have grave implications for the patient (infections, gangrene, amputations and in any case sanitary and relational complications) but also for the family (the life of the family, psychological effects and costs for assistance and help) and for the National Health System (greater costs for complications).
Current possible alternative therapy
In the last few years we have experimented with normobaric oxygen therapy applied locally, which as a traditional therapy of proven effectiveness but of empirical use is affirming itself as a therapy without any side effects, modest in cost, easy to use and within reach of everybody, with advantages both for the patient (excellent results) and for the National Health System (minimal costs as it can also be effected at home by non-medical people).
Difference in costs between oxygen therapy with a hyperbaric chamber and oxygen therapy with a normobaric chamber
Costs are calculated both for the patient and family and for the National Health System.
- For the patient and family this means costs tied to the transport of the patient to the Hyperbaric Chamber which on average takes half a day between journey and therapy time; it means transport of a live person and social costs for the work of one person for half a day.
- As regards the National Health System we must consider that the patient can be transported by public means (hospital or council) to the Hyperbaric Chamber and this transport implies the costs of the means of transport, the driver and paramedical personnel who by law must accompany them.
In any case the cost for the NHS is that tied to the use of the structure accommodating the Hyperbaric Chamber; the Hyperbaric Chambers, except in a few cases, are the property of private structures operating within the National Health Service.
Normally the structure running the Hyperbaric Chamber is paid €90 a sitting and a cycle of 60 sittings is normally foreseen; these sittings are carried out for reasons contingent to the structure 5 days out of 7 (from Monday to Friday). The cost of €90 includes the use of the Hyperbaric Chamber, the medical and paramedical staff who must by law be present; to this must be added the cost of transport of the patient which may be at the expense of the National Health Service or the family.
The cost of the Normobaric Chamber if treatment is carried out at home means resetting or cancelling the cost of transporting the patient.
Thus only the costs of the use of the Normobaric Chamber and the oxygen remain. The costs of medication and medical checks are in theory not varied but in practice it will be shown that the type and modality of treatment can also reduce the costs of medication and of medical and paramedical staff.
The cost to the patient of the Normobaric Chamber currently used by us is €160 monthly + VAT (with 30 days use out of 30 per month) to which is added €90 of oxygen: to sum up €250 a month or a total of €8 per day.
The pro/therapy cost for the National Health Service is €90 per sitting with the Hyperbaric Chamber and would be just €8 with the Normobaric Chamber, which works out at a saving application/patient of €82 with further advantages such as:
- The saving of health service transport costs;
- Therapeutic continuity without interruption for 30 days per month in the tranquility of one’s own living environment and without trauma;
- The facility of widespread use with the possibility to reach all those eligible patients (200,000 calculated in Italy), who at present cannot be treated with oxygen because of the scarce availability of Hyperbaric Chambers in the country, (the latter used for about 80% to treat chronic ulcers).
It should be noted that at present the number of patients receiving therapy in the Hyperbaric Chamber for these pathologies varies between 20,000 and 30,000 per year in our country, this reduced number with respect to the 200,000 eligible cases is determined by limitations for medical side effects and for economic-social problems (availability of the Hyperbaric Chambers, distances, costs of transfers).
However the saving that can be made is even greater. In fact it can be seen (see Progetto di Legge N4409) that the greater costs are absorbed by the expense of the medical and paramedical personnel followed by the various costs of medication. In the case of topical/local* therapy with oxygen, the protocols reduce to the minimum the use of medical and paramedical personnel and the use of various medical aids (like medicated gauzes, antibiotics, creams etc…) since it has been scientifically shown that:
Oxygen by topical/local* means:
- dries the injury, stimulates granulation of the tissues and incentivates vascularization
- the therapy can also be administered by a family member.
COST OF PERSONNEL
- As regards the paramedic personnel (currently the greatest cost) assistance is reduced in collaboration with the doctor during the single surgery or domestic check-up which is recommended once every 15 days.
- The same applies for the medical or specialist personnel who check every 15 days how the pathology is going and judge its course.
COST OF MEDICATION
As regards medication this can be divided into simple medication, that which reduces the exudate and active medication which does not just protect the injury controlling the exudate but which contributes to the process of tissue regeneration.
The costs are variable and one is often induced to use medication with lower costs without considering that improvement or healing of an injury foresees further cost to the National Health Service.
The guidelines of the Royal College of General Practitioners of April 2000 in the U.K. suggest that health operators, even if there is not sufficient proof to recommend one medication rather than another, have to use medication which satisfies clinical demands, the costs and needs of the patient and the location of the injury.
In the same United Kingdom treatment is usually at home to reduce the expense to the National Health institutions.
Thus in the protocol of topical oxygen-therapy all this advice found in the guidelines for the treatment of these injuries is summarized, so that:
- The cost of the hospital and medical and paramedical personnel is reduced.
- Effective treatment in compliance with the patient and family is used with not just objective advantages (progress of the injury) but subjective (clear reduction of symptoms and so the well-being of the patient, at costs which are clearly lower than other treatment.
- Medication is simplified since no passive or active medication is used to reduce exudation and over-infection or to stimulate the tissue of granulation; in fact only simple medication is used physiologically with the advantage of cleansing the injury for better use of topical oxygen, leaving the same oxygen the task of reducing infection, exudation and stimulating the tissue of granulation.
In substance considerable savings are achieved on the health costs of medical and paramedical personnel and on the cost of medication.
Both these parameters and savings are difficult to calculate since at present there are no standardized protocols of diagnosis, therapy and assistance.
However it is easy to calculate a saving from 30 to 50% on the cost of medical and paramedical personnel and a greater saving of 50% as regards the cost of medicines.
To these savings should be added the saving calculated for the patient who uses the normobaric chamber with respect to the hyperbaric chamber.
Madeyski Dr Paolo