RESPIRATORY MEDICINE (1997) 91, 89-93

The importance of process variables analysis in the

assessment of long-term oxygen therapy by
concentrator

A. GRANADO~, J. ESCARRABILL~,
J. M. BORR&~ AND R. RODRIGUEZ-ROIS~N*

“Agkncia d’Avaluaci6 de Tecnologia Mt?dica (CAHTA), Deparfamenf de Sanifat i Segwefat Social,

Genevalifat de Cafalunya, Barcelona, Spain
tUFISS-Respimt~uia, Sevveide Pneunzologia, Ciufat Sanifciria i Univevsithia de Bellvitge,
l’Hospifalef, Spain
*Servei de Pneumologia i Al~lhgia Respivatbvia, Hospital Clinic, Deparfamenf de Medicina,
Universifat de Barcelona, Spain

The aim of the present study was to evaluate process variables and intermediate outcomes involved in
long-term oxygen therapy (LTOT) by concentrator with the purpose of identifying which of those factors
would be the most influential in the final health outcome of the therapy. A cross-sectional survey was
carried out on a random sample of 111 patients receiving LTOT by concentrator in Catalonia (Spain).
Patients were interviewed and assessed at home by a trained physician, and the variables collected were
arterial oxygen saturation, performance of the concentrators, and patient compliance. Sixty-two patients
participated in the study. Overall, LTOT was appropriately prescribed in 36 patients, of whom only 29
were able to correct their level of hypoxaemia. Patient compliance with treatment was considered
adequate in 19 of those 29 patients. Thus, only 19 of 62 patients (31%) fulfilled those criteria needed to
achieve the expected clinical benefits. Strategies for improving the effectiveness of medical interventions
or technologies ought to consider those factors of the therapeutic process which might influence the
expected health outcomes in a specific health-care context.

RESPIR. MED. (1997) 91, 89-93

Introduction is dependent, in averageclinical practice, on the

achievement of the different intermediate out-
Technology assessment activities include the comes implied in the therapeutic process, along
evaluation of the efficacy, safety, effectiveness with its appropriate indication and use. In
and appropriatenessof emerging and established LTOT, those process variables are the diagnosis
health technologies (1,2). Randomized control of chronic hypoxaemia, the correction of the
trials have proved the efficacy of long-term oxy- hypoxaemia which depends on correct prescrip-
gen therapy (LTOT) as survival rates of patients tion of oxygen flow rate and proper functioning
with chronic obstructive pulmonary disease of the device, and patient compliance with the
(COPD) and chronic respiratory failure were treatment. All those intermediate factors should
shown to increase due to the effect of therapy be met simultaneously in each treated patient in
(3,4). However, the effectivenessof any therapy order to get the expected health benefit of the
therapy. Therefore, the effectiveness of LTOT
Received 25 December 1995 and accepted in revised form depends initially on the appropriateness of the
20 May 1996. therapeutic process.
Correspondence should be addressed to: A. Granados,
The aim of the present study was to evaluate
Agkncia d’Avaluaci6 de Tecnologia Mkdica (CAHTA),
Travessera de les Corts, 13 l-1 59, Pave116 Ave Maria, 08028 process variables and intermediate outcomes
Barcelona, Spain. involved in LTOT by concentrator with the
0954-6111/97/020089+05 $12.00/O 0 1997 W. B. SAUNDERS COMPANY LTD
90 A. GRANADOS ET AL.

purpose of identifying which of those factors (1) Diagnosis of chronic hypoxaemia at the
would be the most influential in the final out- time of” the survey (SaO, I 88% at rest while
come of the therapy. The questions include: are breathing room air) (5);
the patients, enrolled in a public financed pro- (2) Oxygen flow rate capable of raising
gramme, being prescribed oxygen correctly?, arterial oxygen tension (PaO,) at rest (SaO,
are they complying with its use?, are they >90% at rest whilst breathing oxygen) (6);
reporting compliance accurately? and, finally, is (3) Proper functioning of the concentrator
the equipment functioning well? (percent of oxygen delivered >90% at a flow rate
of 2 1min - ‘) (7); and
(4) Adequate patient compliance.
Patients and Methods The latter was measured by a clock fitted to
every device in order to record hours of electric-
In Catalonia (Spain), the total number of ity used for a period of at least 7 days. Adequate
patients included in the public financed LTOT compliance was defined as concentrator utiliza-
programme was 3910 in 1991 (prevalence rate tion for at least 80% (2 12 h day - ‘) of the
65/100000). Overall, 534 patients (14%) of those previously defined appropriate utilization time
patients were receiving LTOT by concentrator. A (215 hday-l).
random sample of 111 patients was selectedfrom Data are expressedas mean f SD. Differences
the census of all patients who had received this between self-reported and measured compliance
therapy via concentrator during 1991. A cross- were examined using the McNemar test. A P
sectional survey of the 111 patients was carried value ~0.05 was considered to be significant.
out from March to April 1992.Patients who died
during the time interval from the census to the Results
survey (n=21) or were no longer receiving treat-
ment (n= 14) were excluded from the study. All Overall, 76 patients were considered eligible,
patients were assessedat home by the same although only 62 participated in the study (82%).
trained physician, who was not a member of the Reasons for non-participation were change of
research team. Each patient provided informed address (nine patients) and hospitalization at
consent before participating in the study. the time the survey took place (five patients).
Data regarding gender and place of residence The average age of the participant patients was
of members of the programme were collected 68 f 9 years, 76% were male, 11% of the sur-
from the Catalan Health Service information veyed patients were active smokers at the time of
system. A questionnaire was also specifically the study, 60% were ex-smokers, and 29% had
designed to obtain the following information: never smoked. The most frequent diagnosis
age, smoking habits, main diagnosis, and type reported was chronic obstructive pulmonary dis-
and hours of concentrator utilization. Level of ease (70%). In 87% of cases, the therapy had
percentagesaturation of haemoglobin with oxy- been prescribed by chest physicians.
gen in arterial blood (,SaO,)at rest was measured Inclusion in the LTOT programme was
using a pulse oxymeter (Ohmeda Biox IVA, considered to be appropriate for only 36 of the
U.K.), firstly whilst breathing room air for 62 patients assessedat the time of the survey
30 min and, secondly, whilst breathing oxygen at (SaO,, 81.0 f 5.8%), while this therapy was
the prescribed flow rate for more than 30 min. considered to be inappropriate in the remaining
The percentage of oxygen delivered by concen- 26 patients (SaO,, 92.1 + 2.1%). The latter group
trator was measured at a flow rate of 2 1min - ’ of patients was, therefore, excluded from the
when the device was working for more than therapeutic process analysis. In addition, 12 of
1.5min using an Ohmeda 5120. Oxygen Monitor the 62 devices (19O/,)were found not to work
(U.K.) indicated oxygen concentrations from 0 properly. Defective devices were observed
to 100% (drift range f 1%; monitor linearity mainly in the group in which the therapy was
f 1% of full scale). inappropriately prescribed (10 of 12 devices).
The criteria established to define the ap- Table 1 includes the list of concentrator models
propriateness of the therapeutic process were: used.
 PROCESS VARIABLES ANALYSIS IN THE ASSESSMENT 0~ LT~T 91

TABLE 1. Concentrator models indication and use of LTOT by concentrator in

the present series.Key factors of the therapeutic
Model Number process which might modify the effectiveness
of the therapy were identified and analysed.
Companion 208 (U.S.A.) 17 Overall, 29 of the 36 patients in whom LTOT
Bunn 3001 (U.S.A.) 16 had been appropriately prescribed were able
DeVilbis (U.S.A.) 13 to correct their level of hypoxaemia (SaO,
Bunn Rx02 (U.S.A.) 9 94.0 ic 2.0%) using the device at the prescribed
Forlip (U.S.A.) 4 flow rate. Of those 29 patients, 19 received
Bunn Lite (U.S.A.) 3 oxygen for more than 12 h day - t as measured
Total 62 by the device’s clock. Therefore, the therapy was
prescribed and used appropriately in only 19 of
the 62 patients.
1 Patients participating in study (n = 62) /

Discussion

The results of this study indicate that LTOT via

oxygen concentrator was prescribed and used
appropriately in only 31% of the patients who
were enrolled in the programme. Therefore, the
overall effectivenessof the therapy might have
been affected by a non-appropriate prescription,
an incorrectly prescribed flow rate, an improper
performance of the device, and/or a low patient
compliance. Some studies have analysed the
influence of all these factors independently
(X-11). However, this is the first time that these
factors have been considered simultaneously in a
Satisfactory Unsatisfactory
19/29 10/29
single sample of patients. The first therapeutic
factor to be considered in the assessmentof the
Appropriate process therapeutic process was the appropriateness of
of LTOT by concentrator
the prescription. Pulse oxymetry does not
19162
replace arterial blood gas measurements in the
FIG. 1. Process variables analysis of long-term indication of LTOT; however, since the error in
oxygen therapy (LTOT) via oxygen concentrator, the accuracy and the precision in most pulse
oxymeters is smaller than 3% (12), it is accept-
with the therapy was reported
Compliance able to consider that patients with a SaO, of
as adequate by 54 patients (87%), although 81.0 i 5.8% have a sufficient level of hypoxaemia
measured compliance was found to be adequate to justify home oxygen therapy. One of the
in only 38 of those patients (67%). The latter indications for home oxygen therapy accepted
group were patients who had used the concen- by Medicare is &‘aO, I 88% (13). The results of
trator for an average of 18.1i 4.0 h day ~ ‘. The the present study showed that LTOT by concen-
group who misreported their compliance (12116) trator were not prescribed in accordance with
had used the therapy for an average of well-established prescription criteria (14) in 42%
8+4&3.4hday-‘. The difference between self- of the study patients.
reported and measured compliance with the A secondfactor that might have influenced the
therapy was significant (P~0.05). appropriatenessof the processwas the capability
Figure 1 summarizes the results of the global of the device to correct the baseline level of
assessmentof the process associated with the hypoxaemia. Only 29 of 36 patients who fulfilled
92 A. GRANADOS ET AL

established criteria for the appropriate prescrip- The objective of this work was not to decide
tion of the therapy were able to correct their whether LTOT was to be maintained or not; this
hypoxaemia levels. Failure to raise PaO, to should be made by the physician in charge. The
therapeutic levels may have been a consequence authors’ aim was to generateobjective informa-
of either an incorrectly prescribed oxygen flow tion, regarding the environment, to be used
rate (n= 5) or a poor device performance (n=2). to elaborate recommendations for clinicians,
Overall, concentrators did not work properly in health-care providers and administrators.
19% of the entire sample, a figure which is In patients with underlying chronic condi-
similar to that observed in France (15). Concen- tions, factors related to the therapeutic process
trators have beenused in Catalonia as an oxygen must be re-assessedperiodically if the effective-
source since 1984 (16). At the time of the present ness of the therapy is to be guaranteed (21).
study, there was a regulation from the local This study showed how therapeutic process
health authorities which aimed to ensure the variables, which might be more easily con-
periodical control of home oxygen therapy com- trolled in a randomized control trial but not in
pliance (by checking the concentrator timer), but average clinical practice, might distort the true
it did not explicitly oblige the providers to make effect of the therapy and, therefore, modify its
periodical inspections of the device functioning. expected effectiveness.The present results indi-
The fact that almost 20% of all devices did not cate that, in the context of the Catalan Health
work properly can be used to support the notion Service, efforts directed towards improving
that oxygen concentrators should be equipped adherence to well-designed clinical practice
with alarms to detect failures in the delivery of guidelines for the appropriate prescription of
oxygen concentration. Also, quality control the therapy might have more effect on the
strategiesto detect these failures must be imple- overall effectiveness than efforts directed to
mented. The number of patients using concen- improve patient compliance alone. The latter
trators in Catalonia has progressively increased. might be the implementation of quality control
One year after the present study was undertaken, measuresto detect faulty devices.
23% of the patients on LTOT used this oxygen This type of technology assessmentstudy can
source, and the percentage of patients using provide the objective information needed to
concentrators fulfilling the indication for LTOT design strategiesto improve the therapeutic pro-
was higher than the population of patients with cess and, thereby, the effectivenessof LTOT in
LTOT supplied by cylinders (17). COPD patients.
The last factor related to the therapeutic
process that should be considered is patient
compliance with therapy. According to differ- Acknowledgements
ent published studies, the percentage of non-
complaints can range from 36 to 62% (l&19). The authors thank J. M. Anto, A. Jovell, and
In the present study, measured compliance F. Manresa for their critical comments, C. Vila
(61%) was lower than self-reported compliance for data collection, and A. Boland for edi-
(87%). torial help. This study was supported by the
The results of the present study showed that Departament de Sanitat i Seguretat Social,
only one out of three patients who were enrolled Generalitat de Catalunya, Spain and the
in the LTOT programme via concentrator might Comissionat per Universitats i Recerca.
have received its expected clinical benefits. In-
appropriate prescription appears to be a key
factor on the inappropriateness of the therapeu-
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