Risk management and the identification and analysis of risk
Risk management is the identification and analysis of risk. This leads to planning and implementation of control measures which may be physical, clinical, financial or cultural. The intended objective or aim being to eliminate, reduce or transfer risk. (Wilson.J. and Tingle.J. ed (1999)). Risk is defined as the possibility of incurring misfortune or loss and may be associated with patients, visitors and staff. It may also be associated with buildings and estate, equipment and consumables, systems and management. (Dobos C (1992)). Alaszewski et al (1998) a social scientist defines risk as the possibility that a given course of action will not achieve its desired and intended outcome and that some undesired and undesirable situation will develop instead.
In the case of pressure ulcers, the nurses’ objective is to prevent them or stopping them from deteriorating any further. To do this there is need to identify the best assessment tool that can identify those that are at risk. With several assessment tools out there, there is need to identify a tool that is able to measure what it is supposed to measure and more accurately. (Dougherty et al 2008)
Importance of risk management
All organizations, public or private, large or small, do regularly face internal and external uncertainties that affect their ability to achieve their objectives. Effective implementation of risk management can help Organizations improve their chances of survival and success. Risk management encourages organizations to rely on proactive management to promote high quality care; deal effectively with opportunities and threats; comply with regulatory requirements. It also encourages them to improve on mandatory and voluntary reporting; improve on governance; encourage stakeholder confidence and trust; enhance strategic planning; minimize financial, environmental and safety losses; and improve on organizational resilience and performance. (Shortreed ,2010:p 8 ).There is little evidence though which testifies that risk management reduces litigation, controls or reduces the incidence of adverse events or produces improvements in quality of care (Walshe and Deneen 1998.p 12-3).
Risk managementis a fundamental element of the nurse’s role which is expected to lead to health and safety promotion of the members of the team and the patients with whom they come into contact. Pieces of legislation like the Health and Safety at Work Act 1974, The Management of Health and Safety at Work Regulations 1999 and Mental Health Act 1983. Also Human Rights Act 1998, Data protection Act 1998 and Mental Capacity Act 2005 do support the need for risk management. Patient safety in particular has been placed high on the Government’s agenda, the focus of guideline documents including ‘Organization with a memory’ (DH, 2000), ‘Building a safer NHS for patients’ (DH, 2001) and ‘Doing less harm’ (DOH and NPSA 2001). Also ‘Learning from Bristol’ (DOH 2002), ‘Design for Patient Safety’ DOH 2005, ‘Safety First’ (DH, 2006) and in ‘The operating framework for the NHS in England 2009/10’ (DH 2008), do give patient safety top priority. The NHS Plan reiterates the need for risk management by mentioning that all health organizations now have a statutory duty of quality and a responsibility to reduce the number of mistakes. (Department of Health, 2000). In the case of pressure ulcers it is the duty of the nurses to make sure that they are prevented and research shows that it is possible in 95% of the time (Waterlow 2005).
Causes of pressure ulcer
Pressure ulcers, are commonly referred to as pressure sores, bed sores, pressure damage, and pressure injuries. They are areas of localised damage to the skin, which can extend to underlying structures such as muscle and bone. Damage is believed to be caused by a combination of factors including pressure, shear forces, friction and moisture .EPUAP (2009)
Pressure ulcers can develop in any area of the body. In adults damage usually occurs over bony prominences, such as the sacrum. (Dougherty et al 2008). People who are more prone to ulcers are those in most cases with the following intrinsic risk factors namely reduced mobility
increasing age, incontinence, poor nutritional intake/dehydration, acute, terminal or chronic illness, neurological deficit, poor oxygen supply to the tissues, diabetes ,obesity/reduced body weight, sepsis/pyrexia, mental state/depression, medication .(NICE 2003). In community the changes in health environment and demographic set up have further compounded the problem of pressure ulcers as the health service changes have led to more patients being discharged earlier from acute care into the community. This, together with demographic changes, has given rise to increasing numbers of immobile elderly patients being cared for by the already short staffed community nursing staff. (Chaloner et al 1999.p 1142)
Pressure ulcer grading
EPUAP (2009) came up with four Category/Stages in grading pressure ulcers. Stage I pressure sore is a Non-blanchable erythema intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area. The area may be painful, firm, soft, warmer or cooler as compared to the rest of the tissue. Category I may be difficult to detect in
Individuals with dark skin tones. In risk management this category is usually a sign that the patient is at risk of pressure sores. Category/Stage 2 presents clinically as an abrasion or blister. It is a partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled or sero-sanginous filled blister. This category is sometimes confused with tape burns, incontinence associated dermatitis, maceration or excoriation. Category Stage 3 is superficial lesions. Subcutaneous fat may be visible but bone, tendon or muscle is not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunnelling. The depth of the pressure sore depends on the location of the ulcer. Category/Stage 4 results in full thickness tissue loss with exposed bone, tendon or muscle. Slough or escharmay be present. Often includes undermining and tunneling. The depth of a Category/Stage 4 pressure ulcer just like stage three varies by anatomical location. They can extend into muscle and/or supporting structures. Bone and muscle is left exposed.
Prevalence and Incidence
It is estimated that approximate pressure ulcer prevalence is 6.7% of the UK patient population (DH 1992). Kaltenthaler, E et al (2001) reviewed sixty research papers that were written between 1980 and 1997 and a few before 1980. In the review they were able to establish that Prevalence reported for hospitals in the UK ranged from 5.1to 32.1%.The range for community settings was 4.4 to 6.8% and that for nursing homes was 4.6 to 7.5%.The highest reported prevalence was 37% for a palliative care unit. Incidence reported for hospitals in the UK ranged from 2.2% per annum to 29% over a maximum period of six weeks. Only one study, which included patients who were bedfast and chair fast, was reported for community settings giving an estimate of 20% over a maximum period of six weeks. No incidence studies were found for nursing homes. The highest reported incidence was for older patients with hip fractures which was 66% over an 18-month period. There were discrepancies in measuring prevalence and incidence which can affect the findings, namely, substitution of incidence for prevalence in analysis, use of different classification systems, under-reporting of pressure ulcers on transfer from different care facilities, overestimation of prevalence data by not taking case-mix into account, use of pressure ulcers as a measurement of quality, causing under-reporting, use of different study designs (prospective versus retrospective, observation versus chart review). (Sternberg, J. (1989.p 50). Moffatt, and Franks (1997:p.96-105) came to the conclusion that prevalence in community may be higher than stated since it is difficult to gain all information about patients in community.
Cost of pressure ulcers
The total cost of pressure ulcer care in the UK is said to be between ?1.4 billion–?2.1 billion which constitute four percent of total NHS expenditure. More than ninety percent of the cost of treatment is the cost of nurse time. (Bennett et al 2004). Modern dressings accounted for eighty million pounds worth of sales and traditional (dry, gauze based) dressings accounted for twenty one million pounds in the UK in 1999 (Russell, 2000). This can be divided into hospital (fourteen million pounds, six million pounds) and community (sixty four million pounds, fifteen million pounds for the modern and traditional respectively (Dealey, 1994). Patients in the UK are increasingly aware of their political clout and litigation against the NHS when it delivers below expectation is becoming a common occurrence (Walshe and Deneen 1998.p 9-10). The NHS receives around ten thousand new claims for clinical negligence annually, and this number is rising (National Audit Office 2001). The total annual charge to NHS accounts for settling claims has risen seven-fold since 1995–1996. Relatively few of the current claims relate to pressure damage and in the UK the mean value of settlements in these cases is relatively low compared to other countries like the United States of America (typically less than ten thousand pounds). (Tingle J. 1997.p 757-8). The emotional costs of living with a pressure ulcer are difficult to quantify. What is known is that patients experience pain, dependency, fear of the odor from the ulcer as well as feeling unclean. In a nutshell, negative effects on quality of life are real but impossible to quantify. (Bush 2002.p 34) (Reed et al 2001). All this according to Walshe and Dineen (1998.p 1-37) justifies the case for risk management.
Identification and Assessment of risk
Part of risk management requires that patients be screened on initial contact and if identified to be at risk of developing pressure ulcers should receive a full assessment of that risk. This is considered best practice. It is also best practice to use evidence based tools and scales in the process. (DH 2010). The rationale for trying to identify those that are at risk of pressure ulcers is that it is cost effective to prevent pressure ulcers than to cure them. This can be achieved considering that up to 95% of the pressure sores are said to be preventable (Waterlow 2005). Also it is cost effective to catch them early than later ((Touche Ross, 1994). There are a number of tools and scales that have been devised over a long period of time. The most widely used are the Norton (Norton et al, 1962) and Waterlow (Waterlow, 1985.) scales in the UK and the Braden Scale (Braden and Bergstrom, 1988.) in the USA. Although precise figures on the use of these scales is unknown, it is acknowledged that the Waterlow scale is the most frequently used risk assessment score in the UK ,especially in secondary care and some community setting. In communityin the UK ,The Walsall Community Risk Score Calculator has been in use for about twenty years but further research on validity of the tool is needed .( Chaloner.D.M, and Franks .P .J. (1999.p 11 42-1156)).
The predictive validity of these assessment tools and scales in predicting which patients go on to develop pressure ulcers has shown that there are clear variation in sensitivity, which means some tools are more effective in identifying and predicting those who are at elevated risk, and thus may go on to develop a pressure ulcer. (NICE 2005.).Some researchers like Edwards (1996.) do doubt the rationale of applying measures of sensitivity and specificity to the scales when mathematical models were not used in designing them. There is an also ethical issue that arises in testing because it is not possible to have a sample of patients who are at risk who are not receiving intervention, which may have an effect on specificity (Deeks, 1996). Using the development of pressure ulcers as the only criteria for measuring the tools has its own weakness in that it misses those that were at risk but were rescued by good nursing and medical care .Waterlow (1996.) argues that there is bound to be statistical fallacy in the use of sensitivity and specificity because conditions never in most cases remain static especially in the face of good or bad preventive nursing and medical interventions.
The Norton scale was the first tool used for pressure sore risk prediction, although it was originally intended for use as a research tool for studies in geriatric populations and not as a risk predictor (Norton et al, 1975). The scale contains assessments of general physical condition, mental status, activity, mobility and incontinence. The Norton Scale is designed to identify the need for preventive pressure care in older hospital patients and aged care home residents. Each of the five items is scored from 1 to 4, with a maximum total score of 20. Scores of 14 or less rate the patient as ‘at risk’ of developing pressure sores, the lower the score, the greater the risk. The cut off point for at risk patients was later raised to 15 or 16 by Norton (Norton et al 1985).
Strengths and Limitations of Norton Scale
The tool has received wide spread criticism. Its simplicity which is supposed to be it strength has been identified as a weakness. The weakness identified is the assessor subjectivity (Dougherty et al 2008). It has been accused of both over predicting and under predicting patients who are at risk of developing pressure ulcers especially in patients undergoing surgery or recovering from myocardial infarction (Flanagan, M., 1993.),(Pritchard 1986). According to Bergstrom et al 1987 the Norton scale in his test over predicts by 64% while the Braden scale over predicts by 36%. This over and under predicting can have an effect on the resources that are to be utilized in dealing with the risk. The result may be wastage or use of less than adequate resources. The Norton is said to acknowledge that the tool was not intended as a universal tool, otherwise age and nutrition would have formed part of the criteria (Waterlow 2005).
Deeks (1996.) used five separate studies to assess the predictive abilities of the Norton scale. Three studies reported sensitivities of between 60% and 90% (Norton et al, 1975; Goldstone and Goldstone, 1982; Smith, 1989), one reported a sensitivity of less than 20% (Stotts, 1988), and one only had five patients developing pressure sores (Lincoln et al, 1986) and hence provided a very inaccurate zero estimate. The low sensitivity in this study may be attributed to the fact that it was based on patients who were admitted for an elective surgery and the Norton scores were taken on admission to predict pressure ulcers and the post operative data was not sufficient to come up with a sensible conclusion. On specificity the verdict was that it did vary a lot and variation was between 30% and 95%. All this shows massive inconsistence when it comes to sensitivity and specificity.
The waterlow scale is a popular scale in United Kingdom. It is seen as an improvement on the Norton scale (Heath (1995.p 625).Waterlow (1985) believed that many of the intrinsic factors, such as pain, nutrition, reduced cardiac output and anesthesia, had been omitted from the Norton scale which had been developed for an elderly population. Consequently, the Waterlow risk-assessment scale was developed in 1984 (Waterlow, 1985) as a comprehensive tool to be used in conjunction with the nursing process. The tool was supposed to help nurses in the medical and surgical setting but not to replace clinical judgment. Unlike other tools which are based on an under taking of data collection, the aim of the tool is to provide guidelines on the selection of preventive aids and equipment as well as on management of established pressure sores. It is also to promote awareness of causes of pressure sores and provide a means to determine risk of pressure ulcer development. (Simpson et al (1997).The waterlow has six main areas of risks namely build/weight, continence, skin type, mobility, sex/age and appetite. It also alerts the user to tissue malnutrition, neurological deficit, trauma and specific medication. The risk score threshold is 10, with 10-15 being ‘at risk’, 15-20 ‘high risk’, and above 20 being ‘very high risk’. (Dougherty 2008).
Strength and limitations of the Waterlow
On validity, Thompson (2005.p 455-459) cited Dealey (1989) comparative study of the Waterlow and Norton score. In the assessment of 175 elderly patients the waterlow had ninety eight percent sensitivity, and fourteen percent specificity. The Norton on the hand had had eighty eight percent sensitivity and twenty six percent specificity. The Waterlow was better on sensitivity but no so good on specificity. In another study by Wallard (2000), the waterlow scale was better than the Braden and Norton scale in terms of pressure sore predictive power in a study of 60 patients with spinal cord injuries. The Waterlow scored sixty four percent at high rate and thirty four percent at very high rate. Norton tool scored eighty six percent at no risk, eight percent at risk and two percent at high risk while the Braden scored four percent at no risk, twenty nine percent at low risk, forty six percent at moderate risk and twenty one percent at high risk. This shows that the Waterlow performs well in this group of patients.
Although the waterlow scale is popular in UK, Edwards (1996) is skeptical on it’s inter reliability stating that Waterlow herself performed most of the observations during its development. Dealey (1989) in her research in which Student nurses from four wards assessed the same five patients using the Waterlow tool and the Norton tool. The results of that research showed 60% agreement on the Waterlow score and a 70% agreement using the Norton score .Despite this weakness on the part of the Waterlow it still is the most popular scale in UK. Edwards (1995) also assessed its inter-rater reliability using a cross-sectional observational survey of 40 community elderly patients with and without pressure ulcers. To minimize the risk of error, a research assistant with the same level of knowledge and experience participated with the researcher. 25% total agreement was reached and the specific low agreement categories were, mobility, build/weight for height and skin condition, suggesting that the tool is subjective. This means that patients may have received expensive equipment unnecessarily based on such unreliable scores.
Waterlow (2005.) is the one to admit that it is a simplistic tool which needs the support of good clinical judgment and advice from the tissue viability nurses for it to be effective. This is true when choosing preventative aids. Also Waterlow (2005) is not confident that it will be effective in other areas other than in hospital and nursing homes were it was designed. This leaves the community and residential home settings with a tool that needs modification.
The Braden Scale was developed in the 1980sin the USA for usein medical and surgical acute units. It was developed following a prospective investigation of risk factors in the development of pressure sores (Moffatt, and Frank, (1997). The Braden scale has been widely utilized in United States of America. It does get backing from the Agency for Health and Research which recommended it for use in predicting pressure sore development in hospital and nursing homes in the United States of America. (Simpson et al (1996.)).Unlike the Norton and the Waterlow scales which assess risk it is a pressure ulcer predictor (Dougherty (2008.)).The Braden scale is a twenty three point instrument composed of six subscales namely sensory perception, moisture, activity, mobility, nutrition, friction, and shear (Heath (1995)) .They are scored from 1 to 4 depending on the severity of the condition except for friction and shear which is scored 1 to 3. The total score is then added up with a range which can go from 6 to 23.The lower the score, the higher the risk of developing a pressure ulcer. (Dougherty et al (2008).
Strengths and limitations
Unlike other tools the internal ratings of the six categories are supported by assessment guidelines. These guidelines seek to clearly describe the behavior and experience of the patient. The Braden Score has been validated in a number of patient populations (Bergstrom et al 1987 cited by Moffatt, and Frank, (1997)).For example, 99 medical and surgical patients assessed by registered nurses had an agreement between staff 88 per cent of the time. A sensitivity of 100 per cent, a specificity of 90 per cent and a negative predictive value of 100 per cent. A licensed practical nurses study had an agreement in only 19 per cent of 100 patients; sensitivity and negative predictive value were 100 per cent and a specificity of 64 per cent. These shows a poor inter rater reliability even though the prediction value is high. Bergstrom et al (1987) in a further study of 60 adults in intensive care showed a sensitivity of 83 per cent, a specificity of 64 per cent and a negative predictive value of 85 percent. This shows that the Braden scale has very good sensitivity and reasonable specificity levels in patients in hospital if not better than all the above mentioned tools. In negative specificity it proved that it can identify those that will not end up with pressure sores in medical, surgical and intensive care. (Moffatt, and Frank, (1997). It has been criticized for being difficult to use in a working environment and that it is still to prove itself in different settings in UK especially in community. (Dougherty (2008) (Simpson et al (1997).
The Walsall score
The Walsall Community Health Trust undertook to develop a tool for use in patients within the community .The development came about as a result of examining the existing risk scores and evaluating factors which they felt were likely to be important in the development of pressure sores. Each factor was then ascribed a score based on the influence it was felt it had on increasing the risk of pressure ulcer development. The development was based on clinical opinion and not epidemiological evidence to determine risk factors and scoring methods. (Chaloner.D.M and Frank’s .P .J. (1999)
The Walsall tool looks at the following, predisposing disease, level of consciousness, mobility,
skin condition, nutritional status ,bladder incontinence ,bowel incontinence .These are factors which other tools look at with one exception which makes it more relevant in community where the benefit of the 24 hour nursing care which is provided in hospital does not exist. The exception is the carer input which is particularly relevant to patients being treated in the community where care is intermittent, and often provided by informal carers who may be relatives or friends. Nursing intervention is expected in the following mobility, skin condition, nutritional status, bladder incontinence, bowel incontinence, and carer input categories. (Chaloner.D.M, and Franks .P .J. (1999).The “Total Risk Scores” determine the category as less than 4 (not at risk), 4 – 9 (low risk), 10 – 14 (medium risk), and 15 and over (high risk).
Strengths and limitations
All the mentioned tools were developed in hospital in some cases specifically for inpatients and the Walsall is meant specifically for patients in community and residential homes.
To assess validity, a cross sectional study of 720 patients in Walsall, was under taken looking at the incidence of pressure damage, despite intervention, over a 12-week period. The study was in two phases. The first phase looked at nine categories which included pain and in the second phase they decided that pain was not relevant in determining pressure sores and left it out. Using ROC curve analysis highest sensitivity after adjustment was 80% with a corresponding specificity of 54%.The original weightings which included pain and predisposing diseases with an equivalent specificity could only achieve a sensitivity of 64 %.( Chaloner.D.M, and Frank’s .P .J. (1999). Although not better than other tools in terms of sensitivity and specificity, this modified tool is the first risk tool, developed specifically for the community environment to be scientifically tested. It is also yet to be subjected to rigorous tests .Like all risk tools it is not supposed to replace clinical judgment.
From the critical analysis of the above mentioned tools the only conclusion is that no single tool is considered reliable for universal use. Also some tools even in their intended areas of use do not always produce consistent result. The only way forward is for areas of care to produce their own hybrid risk assessment tool tailored to specific patient needs. This tool would be used as an ‘aide memoire’ to be used in conjunction with clinical judgment (RCN 2001). The hybrid risk assessment tool creation to be effective should involve all health professionals, patients and carers. This makes sense because there is need to involve all the professionals and non professionals involved in the care of the patient in identifying risk. These professionals and non professionals should have the full knowledge that failure of one link in the chain of prevention will result in the development of a pressure ulcer. (Simpson et al 1997).
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