In addition, they place a significant socioeconomic burden on the patient, the healthcare system, as well as the community. Chronic venous disease is the underlying cause of between 40% and 80% of leg ulcers and is listed as the seventh most common chronic disease worldwide. Inappropriate care contributes to unfavourable outcomes and could be ascribed to the lack of knowledge and skills of the practitioner delivering the care.
Clinical guidelines seem to be one of the most effective ways to apply evidence to practice and to improve quality of care. Access to high-quality, effective care inevitably contributes to the timely healing of venous leg ulcers.
What are chronic venous leg ulcers?
Chronic venous leg ulcers are defined as full-thickness skin lesions around the gaiter area and are a result of chronic venous insufficiency. Chronic wounds fail to progress through a normal timely sequence of tissue repair, thus resulting in protracted healing trajectories. Inaccurate diagnosis and not managing the underlying cause have been shown to contribute to chronicity as well as recurrence of the problem.
Several best practice guidelines advocate a holistic assessment of the patient suffering from a lower leg ulcer to identify and treat underlying causes. Assessment would include diagnostic tests, such as an ankle brachial pressure index (ABPI) to exclude peripheral arterial disease and developing a patient-centred care plan, which could include the application of compression. Implementation and application of standardised protocols could improve the outcomes for patients with venous lower-leg ulcers.
Andrews and Langley point out that there are no standards for wound care in South Africa. Thus, with no standards in place, quality of care cannot be measured. There is a need for standardisation of care within the South African context. Donabedian developed the structure-process outcome model to measure quality of care. In this model, ‘structure’, focuses on the qualifications of the care providers, their tools and resources, as well as the physical/organisational setting of the facility.
The second concept, ‘process’, refers to the interpersonal and technical aspects of the treatment process, best practice guidelines (BPGs) and how these are implemented. The third concept, ‘outcomes’, measures the change in patient symptoms and functioning. Implementing standardised care would improve not only the quality of care but also patient outcomes.
The current survey comprised an assessment of the current level of care patients suffering from lower leg ulcers are receiving by utilising the Donabedian framework to evaluate the structure of the facility, processes implemented or not, and outcomes reached about the treatment of venous lower-leg ulcers. This assessment could guide practitioners in addressing gaps in their application of evidence-based care into practice. Improved application of evidence-based care into practice will result in improved outcomes.
A descriptive quantitative design was used to evaluate venous leg ulcer care in wound care practices in Gauteng.
Two trained fieldworkers used structured interviews to collect data on the first Donabedian concept of structure and extracted data from patient files about the process and outcome. The initial questionnaire and checklist were designed by the first author to evaluate practice against standards that are based on international guidelines about the structure of the facility that delivers a wound care service using available BPGs and consensus documents.
Published guidelines from the Wound Healing Society (United Kingdom), the Society of Vascular Surgeons (United States), the European Wound Management Association and the Wound Healing Association of Southern Africa were consulted, as well as the Dutch Venous Ulcer Guidelines and Australian and New Zealand clinical practice guidelines. A panel consisting of wound care experts and a biostatistician evaluated both the initial drafts of the questionnaire and the checklist.
These experts determined content and face validity. Studies conducted by Herberger et al on the quality of care for leg ulcers supported the use of the newly developed, guideline-based, quality indicator index measurement tools, which contributed to validity and reliability of the newly developed measuring tool.
The questionnaire contained the following components indicated as being able to provide an evaluation of the structure of the facility, eg biographical data, access to the facility, equipment available in the facility, level of education of the staff at the facility as well as policies and protocols in place at the facility, and treatment modalities available. In addition to the questionnaire, the first author developed a checklist that was based on international guidelines to evaluate the second concept of the Donabedian model, namely processes implemented in the care of patients with venous lower-leg ulcers as well as the outcomes reached.
Trained fieldworkers extracted the information from the patient files and recorded it on the checklist. The checklist comprised aspects such as assessment tools utilised, which had to include patient assessment, history taking, diagnostic test performed, wound bed assessments as well as assessing patient-centred concerns to evaluate processes followed. The checklist included the assessment of oedema and infection, how infection was diagnosed and treated, what was utilised to clean the wounds, and the type of compression therapy that was used.
Finally, the outcome measures indicated any changes in health status according to the following criteria: reduction in devitalised tissue, reduction in oedema, reduction in pain, reduction in wound size, advancement of wound edges, reduction in malodour, reduction in exudate level, increase in daily activities, and improvement in the surrounding skin condition. Components relating to process implemented and outcomes reached were assessed on initial assessment, after a three-week interval and on completion of treatment to assist in identifying possible correlations between processes implemented and outcomes reached.
Based on the experience of the wound care experts, an interval of three weeks was used because this is the period during which most patients present with an infection after commencing treatment. A small number of facilities (five) were included in a pilot study using convenient sampling to validate the checklist and determine the feasibility of the study. Both the checklist and the questionnaire were adapted due to information obtained from the pilot study.
Questions had to be streamlined and the checklist was expanded to include different intervals of assessment. The pilot study tested inter alia the ease with which the tools could be administered, understanding of each item in the tools, and consistency in recording the results. The researcher incorporated the results from the training sessions and pilot study into the measurement tools, but none of the pilot data was included for analysis.
Study population and sampling
The study population comprised 82 facilities that offer wound care within a 75km radius from the researcher’s base in the following strata: private wound clinics, pharmacies that deliver a wound care service, general practitioners, private nursing practitioners who provide home-based care, and outpatient wound clinics within the public sector (state) facilities. Forty-eight facilities were randomly selected to be representative of each stratum.
The researcher listed facilities alphabetically per stratum and numbered them. The initial population consisted of 20 private wound clinics (hospital-based or not), seven public sector (state-owned) clinics, 30 pharmacies, 18 general practitioner (GP) practices, and 30 homebased care nurses.
First contact was made through an introductory phone call to establish willingness to participate and confirm contact details. Another list was compiled and every third number on the list was selected to compile a 50% sample that resulted in 48 facilities, which comprised 17 private wound clinics, four public sector wound clinics, six general practitioner practices, five pharmacy clinics and 16 home-based care nurses.
Challenges were experienced with the sampling as initial lists were incomplete, some of the practices withdrew and could not be replaced, and the large pharmacy groups declined participation. Gaining access to public sector clinics was challenging and required registration with the Department of Health as well as obtaining consent from each of the department heads as well as the chief executive officer of each of the facilities, which had to be done in person.
An appointment was scheduled for the structured interview with the participants who indicated that they were willing to participate. It was also arranged that the fieldworkers could extract the information from the patients’ files. On arrival at the facility, the fieldworker introduced herself, and obtained written informed consent from the participant.
The fieldworker then proceeded with the structured interview. Clinical efficacy emphasises the process of care, while an outcome-based measure focuses on outcomes reached and the patient’s response to the care provided. In this study, process and outcomes were measured using a checklist to extract data from files of patients who presented with lower-leg ulcers. Files were pre-selected by the unit manager, and then supplied to the fieldworker.
Inclusion criteria were files of patients with confirmed venous lower-leg ulcers and who had completed care in the last six months prior to the audit. From the files supplied to the fieldworker, a random selection was made by choosing every second file from the pile. The number of files extracted was calculated to provide at least a 20% sample of the total number of files supplied by the clinician. One hundred and sixty files representing each of the five strata were audited utilising a checklist.
Data coding, capturing and analysis
The data collected was coded by the first author, and numerical values assigned to aid analysis. An independent data capturer loaded the data in an MS Excel spreadsheet. A biostatistician checked all captured data and calculated descriptive statistics to describe the numerical data and frequency distributions used to summarise the distribution of a variable.
Approval for the research was obtained from the Health Sciences Research Ethics Committee of the University of the Free State. Ethics principles were adhered to throughout the study. The study was also registered with the Department of Health (GP2017RP16560), and permission was obtained from each of the facilities.
Newly developed, guideline-based, quality indicator index measurement tools were supported by evidence from studies conducted by Herberger et al on the quality of care for leg ulcers. The fieldworkers always had a copy of the research protocol with them to refer to the procedures if necessary. The primary author checked every completed data sheet for accuracy and comprehensiveness. Data clearance was done under the supervision of the biostatistician, who also performed the data analysis. The data interpretation and recommendations were verified by the biostatistician, based on the study results.
In general, record-keeping in the files was very poor and data recorded was incomplete. We applied the maxim that if something was not recorded it had not been done. The discussion of the results below will follow the structure-process-outcome sequence.
Figure 1 shows that many of the clinicians (61%, n=48) attending to patients with lower-leg ulcers had no formal wound care training, and that registered nurses were the main wound care providers.
Clinicians who are certified in wound care have a better understanding of wound care and deliver more consistent evidence-based care with improved outcomes, eg reduced healing times and a smaller number of wound care rounds, which ultimately has a cost implication. Evaluating the structure of the facility also included assessing the clinical wound care experience of the clinicians attending to the patients within the facility. Figure 2 shows the distribution of years of clinical wound care experience of the clinicians attending to the patients.
Within the 48 facilities, 11% of the practitioners had no clinical wound care experience. Experience aids in clinical decision-making and application of best practice. Improving healthcare delivery focuses on and involves the development and implementation of standards, guidelines and protocols as part of evidence-based practice. However, only 37% (n=48) of the clinicians indicated that they used guidelines in their practice.
Compression therapy is seen as the gold standard for treatment of lower-leg ulcers of venous origin, when the ABPI value is between 0.9 and 1.3.16 An external pressure of 30mmHg-40mmHg is required to counteract effects of venous insufficiency, yet, 45% (n=48) of the facilities did not have any form of compression available to treat patients presenting with venous lower-leg ulcers.
When assessing processes, which included history taking, it seemed that aspects such as smoking, body mass index and anaemia, which all play a role in wound healing, were recorded in less than 30% (n=160) of the files. A lack of baseline information could influence the quality of care delivered. Although the majority of files (92%, n=160) indicated that an assessment tool was used, many of the elements thereof were not comprehensively assessed according to best available evidence.
Pain, presence of varicose veins, previous treatment, and functioning of the calf muscle were assessed and recorded in more than 70% of the files. Processes also included a physical examination, and as mentioned, in only 30% (n=160) of the patients an ABPI was recorded. Compression therapy also seemed either underutilised or not helpful in treating the underlying cause, or applied when the ABPI was not known, which is a medico-legal risk. According to the files, the required follow-up 24 hours after application of compression was not done routinely. Table 1 presents a summary of the data regarding the application of compression.
In 114 files, the use of compression was indicated, and only 48 files indicated that an ABPI was assessed during the physical examination. Of the 48 patients assessed, only 44 fitted the criteria for the utilisation of compression bandaging, eg ABPI between 0.9 and 1.2. Thus, in 66 files, compression was applied without measuring the ABPI, or was applied when the patient’s ABPI reading did not fit the criteria.
Assessing patient-centred concerns, such as pain, malodour, exudate and social functioning was recorded in 70% or more of the files, but general hygiene, religion, fear, anxiety, and financial issues were not addressed. Although the descriptive clinical, etiological, anatomical and pathophysiological (CEAP) classification of chronic venous insufficiency is a valuable communication and a standardisation tool, none of the clinicians reported using it. Clinicians who participated in this study seemed unable to distinguish between superficial and deep infection, as well as the correct treatment of it.
There was evidence of a general tendency of between 40% and 60% overuse of antimicrobial and systemic antibiotics. Forty per cent of the files indicated the use of wound swabs at assessment, but only 31% (n=160) of the files indicated signs and symptoms that could have been indicative of infection. Only in 18% (n=160) of the files, the dressing applied adhered to the guidelines advocating the use of a basic non-adherent absorbent dressing in conjunction with compression.
Record-keeping regarding outcomes reached was insufficient, and approximately one third of the wounds did not heal. In 27 cases, an amputation was performed. This number of amputations is high and could be linked to inadequate assessment and suboptimal or incorrect treatment due to a lack of knowledge.
Guidelines, protocols and algorithms are developed and designed to aid evidence-based practice. Weller states that evidence-based practice promotes a high quality of care, but that the lack of guideline implementation results in practice variation and suboptimal care. Woo further points out that adequately trained clinicians are more likely to provide evidence-based care, and that there is a direct correlation between improved quality of care and clinicians who possess adequate knowledge.
The application of evidence-based care not only contributes to improved outcomes, but also aids in more cost-effective care. Thus, with clinicians who are adequately trained and applying evidence to practice, it is not only the patient who benefits, but also the funders and the community at large. Clinical experience is fundamental in acquiring the skills to apply theory to practice; therefore, continuous, self-directed learning regarding wound management could aid in improving clinical decision-making as well as the quality of care delivered.
Within the 48 facilities, 11% of the practitioners had no clinical wound care experience. Comprehensive holistic assessment of the patient suffering from a lower-leg ulcer is essential not only to identify the problem, but also to consider barriers to healing, patient preferences and to develop an appropriate care plan that is also accepted by the patient. Incomplete data collection influences the quality of the care delivered. Thus, the outcomes reached.
Although more than 90% of the files reflected utilising assessment tools, the information on the tools was incomplete and lacked vital data that could correlate with the suboptimal care in some instances. Thorough documentation is a legislative requirement as it helps prevent litigation and aids better communication.
International guidelines dictate that peripheral arterial disease should be excluded in the treatment of lower-leg ulcers. A lack of availability of equipment and a lack of training could contribute to the fact that in only 30% (n=160) of files it had been recorded that the ABPI was assessed even though 66% (n=48) of the facilities had hand-held Dopplers available.
Hanefeld et al state that the availability of equipment does not guarantee that high-quality care is being delivered, and it was clear from this survey that this was indeed the case at the facilities under study. Weller indicates a lack of confidence as a reason why practitioners do not routinely use Doppler assessments. There is a general underutilisation of ABPI measurement, over-reliance on dressings and a lack of understanding of compression therapy amongst practitioners.
Time constraints and remuneration issues also contribute to the underutilisation of ABPI measurements. Currently, medical funders in South Africa do not reimburse practitioners for ABPI measurements. When compression is applied without measuring ABPI, the risk of complications, such as amputation and pressure damage increases and this is a medical-legal risk.
The inability of clinicians to distinguish between superficial and deep infection is concerning as the over-utilisation of antimicrobials and antibiotics (40–60%) (n=160), could contribute to an increase in antibiotic resistance and cost of treatment. Infection is the most important contributor to delayed wound healing and, if diagnosed or treated insufficiently, also contributes to cost increase and poor outcomes for the patients. Infection is also a contra-indication for the application of compression; consequently, infection that is poorly assessed could have unfavourable outcomes.
Compression bandaging is the cornerstone of treatment in venous lower-leg ulcers and should be applied when indicated. From this survey, it was clear that compression was being under-utilised or utilised inappropriately at the facilities under study. Once again, a lack of skill and knowledge among the clinicians could prevent evidence-based care and result in suboptimal care with detrimental outcomes. Partsch also concluded that there is a lack of knowledge regarding the use of compression and that training is needed, as the application of compression requires a practical approach. In the current study, the outcomes showed that 27 cases resulted in amputations, which calculates to almost 17% of cases.
The detrimental effect of an amputation results in an increase in cost, reduction in quality of life and an increase in mortality rates. Improved quality of care results in better treatment strategies, better outcomes and improved quality of life for patients suffering from lower-leg ulcers.
Limitations of the study
Limitations of the study included the lack of accurate and comprehensive record-keeping in the audited files, which influenced the quality of the data collected. The physical clinic setting was also not inspected, and availability of standard operating procedures and equipment was only assessed through an interview. Outcome measures were not quantified and could have contributed to more comprehensive data collection.
AUTHOR: Febe Bruwer, Yvonne Botma and Magda Mulder, School of Nursing, University of the Free State, Bloemfontein
Utilising the Donabedian model, quality of care could be assessed by evaluating structures within a facility, processes implemented, and outcomes reached. Accurate record keeping is vital to obtain a view of the processes being implemented and the outcomes being reached. Consensus dictates that clinicians rendering wound care should be trained appropriately and that the application of best practice could contribute to improved outcomes.
Wound care as a specialty has evolved over the last 10 to 15 years and requires clinicians who can effectively apply evidence-based care in practice, make effective clinical decisions and are committed to delivering a high standard of care through continuous self-directed, lifelong learning. From this survey, it was evident that not all clinicians providing wound care are trained adequately in wound care, that best practice guidelines are not being implemented fully during processes, and that the consequences or outcomes may be detrimental to the patients, as a high number of amputations were reported. This highlights the need for improved legislation and regulation for practitioners who deliver wound care services.
A few main findings from the study revealed that, at the time of this study, guidelines were not being followed, equipment was not readily available at the facilities, and clinicians attending to patients with lower-leg ulcers lacked basic wound care training. The study further revealed a need for training and continuous professional development regarding aspects of wound care. It is recommended that medical funders consider remuneration actions based on best practice guidelines.
Future research could include the development of a model to improve the application of evidence-based care to practice or a model to identify and address barriers that might influence the application of evidence-based care. The hippopotamus is a large semi-aquatic mammal found in African countries. Hippos can weigh up to 3 200 kg, and they spend most of their time in rivers and lakes with only the eyes, nose and ears sticking out of the water. They seem harmless but are one of the most dangerous animals in Africa.
They lurk under the water but can swim very fast and their jaws are said to be able to snap a canoe in half, hence, the metaphor ‘the ears of the hippo’, used in Afrikaans, one of South Africa’s languages. This survey can be compared to the ‘ears of the hippo’ as the bulk of the problem is yet to be addressed. Lower-leg ulcer care is only one component of specialised wound care, and if guidelines are not being adhered to in one area, one could perhaps hypothesise that it is also not adhered to in other aspects of wound management.