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| Journal of the New Zealand Medical Association,
22-May-2009, Vol 122 No 1295
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|
Venous ulcer management in New Zealand: usual care
versus guideline recommendations
Andrew Jull, Natalie Walker, Varsha Parag, Peter Molan,
Anthony Rodgers; on behalf of the Honey as Adjuvant Leg Ulcer Therapy
(HALT) trial collaborators
Leg ulcers are defects in the epidermis, below the knee,
which are present for more than 4 to 6 weeks.1
Typically, leg ulceration is a chronic, relapsing, and remitting condition that
is associated with impaired circulation. The main causal conditions are venous
disease, arterial disease, diabetes, or unrelieved pressure over a bony
prominence.
Venous insufficiency is the most common cause of leg
ulceration, accounting for more than half of all ulcers on the lower limb and
67–70% of ulcers above the foot.2,3 The
period prevalence of leg ulcers in New Zealand has been estimated at 79 per
100,000 per year,4 although capture-recapture
analysis suggests a more accurate estimation is between 393 and 839 per 100,000
per year.5
In both New Zealand and overseas there is wide variation in
treatments used in ulcer management, with large numbers of products
employed.1,6 Research in the United Kingdom
indicates that such variation remains the case even after protocol-guided care
has been implemented, although the variation in product use may be
reduced.7
In 2000 the first New Zealand guidelines for leg ulcer
management were disseminated.8 The extent to
which community-based management of venous ulcers mirrors the guideline
recommendations has not been assessed. Data from the control arm of
community-based clinical trial on venous ulcers offers such an opportunity.
MethodClinical
trial—The Honey as Adjuvant Leg Ulcer Therapy (HALT) trial
(ISRCTN 06161544) was a New Zealand-based pragmatic, open-label, randomised
controlled trial to evaluate the effectiveness of manuka honey-impregnated
calcium alginate dressings in addition to compression bandaging on venous ulcer
healing compared to usual care.9 Usual care
consisted of the normal range of compression systems and dressings available to
the district nurses at the study centre. Participants could also receive
additional treatment for their venous ulcers as clinically indicated, either
from the district nurse or from other providers, such as general practitioners
or hospital-based practitioners.
Participants were recruited through four district
nursing services (Auckland, Counties Manukau, Waikato, and the Nurse Maude
Association in Christchurch). These services were selected because they had
organised leg ulcer services and provided ulcer care that was likely to be
consistent with that recommended in the New Zealand Guideline for Care of People
with Chronic Leg Ulcers.8
Participants were recruited between May 2004 and
September 2005 and were included if they were: aged 18 years or over; able to
provide informed consent; had a venous leg ulcer; had an ankle-brachial index of
0.7 or greater; were able to be treated with compression at one of the study
centres; did not have diabetes, rheumatoid arthritis, or peripheral arterial
disease; and were not using honey on the ulcer.
Participants had face-to-face assessments at
randomisation and at 12 weeks after randomisation. During the 12-week treatment
period, district nurses provided data after each visit on healing status and the
resources used during the visit. Costs were calculated using the resource data
and the retail cost of the products. Participants were also contacted by
telephone at 6 months after randomisation to assess ulcer recurrence and
stocking use. Treatment duration was until healing or for 12 weeks, whichever
occurred sooner.
Guideline recommendations—Four
treatments from the guideline were selected to compare practice with guideline
recommendations.
These treatments represent interventions that can be
reasonably assured to have an effect on cost and/or effectiveness during an
episode of care (Box 1).
The treatments were:
Results181 participants received to usual care. The baseline
characteristics of the participants by study centre are presented in Table 1.
Compression171 (96%) participants were in multilayer compression, with
59% in four-layer compression and 36% in three-layer compression. Only 6% of
participants were in single-layer systems (short-stretch or long-stretch
compression). There was regional variation in preference for bandaging systems
with 80% of participants in Auckland being in three-layer compression whereas
83% of Waikato participants were in four-layer compression (Table 2). Counties
Manukau and Christchurch participants had compression split approximately 60:40
between four-layer and other systems.
Overall, compliance with compression bandaging (defined as
being in compression for more than 75% of the district nursing visits over the
12-week treatment period) was 89%. Compliance was highest in Christchurch (98%),
but similar in the remaining centres (84–85%).
Dressing selectionThe frequency of dressings used is described in Table 3. The
total number of dressings used (1823) was lower than the total number of
district nursing visits (2196). This difference was in the main accounted for by
the fact a dressing would not be used on the final district nursing visit when a
patient’s ulcer had healed.
Overall simple, moist, and medicated dressings each
accounted for about one-third of dressings used. Across study centres, simple
dressing use was broadly similar, but the frequency of moist and medicated
dressing use varied by centre. For example, district nurses at Auckland DHB
mostly used moist wound products for their patients, whereas Counties Manukau
district nurses used mostly medicated products.
Within the product categories, there were also clear
regional preferences with 99% of medicated dressings used in Counties Manukau
being silver-impregnated, compared to 7% in Waikato and 36% in Christchurch.
The total spend on dressings was $17,191 in 2005 dollar
terms. Expenditure on simple dressings was $832 (5%), on moist dressings was
$6009 (35%) and on medicated dressings was $10,287 (60%).
Table 1. Characteristics of 181 participants in
usual care arm by study centre*
* Values are N (%) unless otherwise stated. SD is
standard deviation. ADHB is Auckland District Health Board, CMDHB is Counties
Manukau District Health Board, WDHB is Waikato District Health Board and ChCh is
Nurse Maude Association, Christchurch. ABI is ankle:brachial index.
Table 2. Compression use by study
centre*
*Values are N (%). SD is standard deviation. ADHB is
Auckland District Health Board, CMDHB is Counties Manukau District Health Board,
WDHB is Waikato District Health Board and ChCh is Nurse Maude Association,
Christchurch.
Pentoxifylline—Only one participant
from Christchurch was receiving pentoxifylline at randomisation and no other
participants were prescribed pentoxifylline during the 12-week follow-up.
Compression hosiery after
healing—Overall 70% of the 90 participants who had healed at 12
weeks were using compression hosiery at 6 months after randomisation (Table 4).
However, only 50% were wearing compression every day. There was considerable
variation (17–50%) between the centres in the proportion of participants
not wearing hosiery after healing.
Table 3. Dressings used by study
centre*
* Values are N (%). Simple=non-adherent + absorbent;
Moist = hydrogel + hydrocolloid + alginate + hydrofibre + foam; Medicated =
silver-impregnated + iodophor. ADHB is Auckland District Health Board, CMDHB is
Counties Manukau District Health Board, WDHB is Waikato District Health Board
and ChCh is Nurse Maude Association, Christchurch.
Table 4. Use of compression hosiery after
healing*
* Values in parentheses are percentages unless
otherwise stated. SD is standard deviation. ADHB is Auckland District Health
Board, CMDHB is Counties Manukau District Health Board, WDHB is Waikato District
Health Board and ChCh is Nurse Maude Association, Christchurch. ABI is
ankle:brachial index.
DiscussionThe four elements of a treatment regimen reported here are
the first occasion that usual care of patients with venous leg ulcers in New
Zealand has been compared to guideline recommendations in centres with organised
services for leg ulcer management. As such, this study demonstrates that
adherence to guideline recommendations can serve as quality measures that
indicate opportunities for improvement.
Use of multilayer bandaging systems in the HALT trial was
consistent with guideline recommendations, as were regional preferences for
different bandaging systems. The preference for multilayer systems may reflect
current knowledge as four layer elastic systems have been shown to deliver
better healing rates than short stretch
systems.11 However, there are two areas of
incongruence with guideline recommendations, namely dressing selection and use
of pentoxifylline. These inconsistencies offer clear opportunity for improvement
and cost saving. Furthermore, although compression hosiery use after healing was
generally congruent with guideline recommendations, compliance varied by region
and may also represent an opportunity for improving outcomes.
Dressing selectionThere are no published New Zealand data specifically on the
number of different types of dressings used in community-based management of
venous ulcers. Internationally, audits reveal a variety of dressing products
being used. A Swedish study found 51 dressings products being used in 294
patients,6 while an English study found 36
different dressings used in the treatment of patients with venous
ulcers.7 With respect to dressings the central
issue must be whether any dressing provides added benefit in terms of healing.
Three systematic reviews have found little evidence to
support the view that any dressing, whether a simple dressing or a moist
dressing, gives any benefit over compression
alone.12–14 Moist wounds have been found
to heal faster than dry wounds. 15 Moist wound
dressings are designed to ensure that the wound surface is kept modestly moist,
either through the donation of moisture in the case of hydrogels, the retention
of moisture in the case of hydrocolloids, or through absorption of excess
moisture in the case of alginates, hydrofibres and polyurethane foam dressings.
However, venous ulcers under compression tend to be moist and a simple
non-adherent dressing will prevent adhesion of bandages to the ulcer surface.
Absorbent dressings may also be required on occasion to prevent
maceration.
A recent addition to the range of available dressings is the
silver impregnated dressing. Silver dressings in contact with wound fluid have
antimicrobial activity against a variety of bacteria and
fungi.16 However, these dressings tend to be
the most expensive dressing option with the retail price for a 10 x 10 cm
dressing being up to twice that of a similarly sized moist dressing and 19 times
more expensive than a non-adherent dressing.
The most recent systematic review on this topic found a lack
of evidence to support the routine use of silver dressings in ulcer
care.17 Despite this finding, silver
impregnated dressings are in regular use in New Zealand, accounting for 19% of
the dressings used and 38% of the total spend on dressings in the HALT trial.
The other group of medicated dressings are iodophor dressings, which contain
cadexomer iodine and have antibacterial
properties.18
A systematic review has found some evidence suggesting
cadexomer iodine dressings may improve healing rates when used in conjunction
with compression (RR 6.7, 95%CI 1.6 to 29.0), but the trials were small and of
short duration (4 weeks).19 The implication of
the review is that the evidence supporting the use of iodophor dressings is of
limited reliability and such dressings should be used cautiously. Indeed,
anything other than simple dressings should only be used when there is clear
empirical need and all other evidence-based options have failed.
The New Zealand guideline recommendation for use of simple
dressings needs to be considered in the light of the relative cost of such
dressings. Although simple dressings accounted for about 29% of all usual care
dressings in the HALT trial, expenditure on these dressings was 5% of the total
spend. Using simple dressings, such as silicon-impregnated vicryl, presents a
real opportunity for cost saving in the treatment of venous ulcers.
PentoxifyllineThe almost complete absence of pentoxifylline as an adjuvant
treatment among the participants in the HALT trial was a striking finding. The
median period of ulcer duration prior to entry in the trial was 16 weeks,
suggesting at least 50% of participants may have been candidates for treatment
on the basis of the guideline recommendation.
Pentoxifylline has been shown to increase healing when used
as an adjuvant to compression (RR 1.6, 95%CI 1.1 to 2.1) and to be the dominant
economic strategy.20 Pentoxifylline appears to
be particularly effective with slow to heal ulcers (RR 2.4, 95%CI 1.7 to
3.2),21 and such ulcers can be easily
identified using a simple prognostic index. Thus candidate patients need not
await treatment failure before being prescribed pentoxifylline. They can be
prospectively identified using the Margolis
index.22 Using this prognostic index, up to 97
(54%) participants in the usual care arm would have been candidates for
treatment with pentoxifylline.
The main reasons for the low use of pentoxifylline are
likely to be organisational and economic. Full subsidy of the drug was removed
in 2003 and patients are now required to make a co-payment of approximately nine
dollars per script. For a patient willing to pay, the district nurse needs to
liaise with the general practitioner to make a case for prescription, the
general practitioner has to apply to HealthPAC for special authority to
prescribe and the drug has to be obtained from a hospital pharmacy in some
areas, or approved retail pharmacy in other areas.
Another barrier to use is that the PHARMAC schedule only
lists the drug as oxpentifylline. If the general practitioner searches for
pentoxifylline, no hits are returned. Without amelioration of the above
barriers, an opportunity to accelerate healing in a large group of patients may
be missed.
Compression hosieryThere is an opportunity to improve on the use of compression
hosiery and reduce ulcer recurrence. Thirty percent of the 90 participants in
usual care who had healed at 12 weeks were not wearing any compression hosiery
at six months. An additional 14% were not wearing compression hosiery every day.
Ulcer recurrence can be more than halved over five years by use of compression
hosiery after healing.23
The guidelines currently recommend class 3 hosiery as being
more effective than class 2 hose, a recommendation based on 3-year follow up
data from the only trial that has compared the two
systems.24 A more recent publication of the
five year follow up data from this trial found no significant difference between
the two systems.25 It is probably preferable to
recommend patients start on class 3 hose and drop down to a lower level of
compression in order to maintain compliance than the reverse strategy, although
any level of compression is preferable to none. Use of compression hosiery
appears to be influenced by belief in the worth of the
stockings,26 and practitioners may be able to
influence this perception.
This secondary analysis of the HALT trial usual care arm is
subject to limitations. The major limitation is that the trial participants may
not reflect the typical experience of venous ulcer patients in New Zealand. It
was not possible to determine how many patients were approached by district
nurses to participate in the trial and thus how representative the sample may
be. However, the HALT trial was a pragmatic trial with broad inclusion criteria
and of the 392 potential participants notified to the researchers, 368 (94%)
were randomised. There were no significant differences between participants
registered and those randomised and it seems unlikely that patients outside of
the HALT trial would have treatment regimens that more closely follow the New
Zealand guidelines than those within the trial, especially in regions where
there are no organised models of care for venous ulceration. Organised care has
been shown to improve leg ulcer healing rates, better manage resource use and
reduce costs compared to more naturalistically developed
services.7 Therefore regions without organised
models of care for venous ulcer management may be presented with greater
opportunities to improve outcomes.
A lesser limitation of this study is that random variation
may account for some of the regional differences observed, particularly where
the numbers were small, such as with variation in the use of compression hosiery
after healing.
ConclusionUse of compression, both during an episode of venous
ulceration and after healing, was generally consistent with recommendations in
the New Guideline for Care of People with Chronic Leg Ulcers. However, simple
dressings were used less frequently than more complex, expensive options and
pentoxifylline was almost entirely absent from the armamentarium of care.
Increasing use of simple dressings and prescribing pentoxifylline in appropriate
patients represent opportunities for cost saving and improving rates of healing
in patients with venous ulcers. Compliance with use of compression hosiery after
healing may also benefit from attention.
Competing interests: None. (The study
sponsors had no role in study design, data collection, analysis or
interpretation, writing of the report, or in the decision to submit for
publication. The corresponding author had full access to all data in the study
and had final responsibility for the decision to submit for publication.)
Author
information: Andrew Jull, Associate Professor at the School of Nursing
and Senior Research Fellow at the Clinical Trials Research Unit, University of
Auckland; Natalie Walker, Programme Director, Clinical Trials Research Unit,
University of Auckland; Varsha Parag, Biostatistician, Clinical Trials Research
Unit, University of Auckland; Anthony Rodgers, Professorial Fellow, George
Institute for International Health, University of Sydney; Peter Molan, Professor
of Biochemistry, University of Waikato and Director of the Waikato Honey
Research Unit, Hamilton
Acknowledgements: The HALT trial was
principally funded by a project grant from the Health Research Council of New
Zealand. Comvita New Zealand Ltd provided an additional unconditional
operational grant and supplied the manuka honey dressings. USL Medical Ltd
provided the wound tracing grids.
This trial was designed and conducted with the support of
the HALT collaborative group, consisting of the study authors, Professor Bruce
Arroll (Department of General Practice and Primary Care, Auckland University,
Auckland), Julie Betts (Waikato District Health Board, Hamilton), Cathy Hammond
(Nurse Maude Association, Christchurch), Anita Latta (Auckland District Health
Board, Auckland), Susan McAuley (Counties Manukau District Health Board,
Otahuhu), and Dr Jill Waters (Auckland District Health Board, Auckland). The
following people are thanked; the participants and their whānau; the trial
research nurses: Sue Callender, Mary Cleland, Trish Johns, Anna Reid, Rachel
White; Dr Young Mee Yoon (Comvita Ltd); Lucy Sanders (USL Medical Ltd).
Correspondence:
Dr Andrew Jull, Associate Professor, School of Nursing, University of Auckland,
Private Bag 92019, Auckland Mail Centre, New Zealand. Fax: +64 (0)9 367-7158;
email: a.jull@auckland.ac.nz
References:
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