correspondence
Letters We note the recent release of the ‘Prevention and Treatment of Pressure Ulcers: Quick Reference Guide’ developed by the National Pressure Ulcer Advisory Panel, (NPUAP) European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA).1 While much of the information in the Guide is not new, we were intrigued to read the recommendation to screen patients ‘as soon as possible after admission but within a maximum of eight hours’ (p14; strength of evidence C) without any supporting reference. Screening ‘as soon as possible...’ is good advice knowing that pressure ulceration, an ischaemic process leading to tissue death, can begin in as little as one hour.2 But the question is, how did the authors come up with ‘...eight hours’ as the maximum time in which it would be safe to screen for risk? In our experience, given the option of doing a task later, rather than sooner, usually results in the former option. Consequently, the eight hour screening window will not translate into good practice. This is because if staff do not screen patients for risk of pressure ulcer within eight hours, it is more likely than not those ulcers will develop. The key issue is whether eight hours possibly sitting or lying in one position, predisposes to pressure ulcer formation. No assurance is given in the Guide that this will not occur. Furthermore, the strength of evidence denoted ‘C’ is not supported by any citation of supporting evidence. The Guide ‘provides an indication to the health professional of the confidence
one can have that the recommendation will do more good than harm, and can be used to assist in prioritising pressure ulcer related interventions (p1).’ The consequences of leaving any patient in one position for up to eight hours1 before screening for pressure ulcer risk, then intervening, are dire even though the time for onset of a pressure ulcer is not exact but a range of probable times.3 The authors of the Guide claim that ‘an explicit scientific methodology was used to identify and critically appraise all available research. In the absence of definitive evidence, expert opinion (often supported by indirect evidence and other guidelines) was used to make recommendations (p1).1’ There is no disputing their recommendation that screening should be carried out ‘as soon as possible after admission...’ but no references have been provided to support this statement. Of greater concern is that no references have been provided to support the recommendation that screening can be carried out up to ‘...a maximum of eight hours’ (p14). Indeed, there is evidence that inflammatory mediators postulated to be a contributory factor in ulcer development, are released within the first four hours of exposure to pressure.4 Evidence, together with the common sense derived from experience of patient care, strongly suggests that assessment and appropriate intervention be conducted within the first hour. Furthermore, delay will exacerbate the patient’s problem making ulcer development more likely. When patients present with symptoms of stroke, another ischaemic process leading to
J O U R N A L O F WO U N D C A R E V O L 2 4 , N O 5 , M AY 2 0 1 5
tissue death, the ‘golden hour’ concept is applied because hyper-acute therapy is known to be more effective than later intervention.5 Screening patients on admission using rapid clinical judgement, focusing on immobility, the only evidencebased risk factor for pressure ulcer development,6 is the fastest way to determine risk. Interventions could then be provided immediately and pressure ulcers prevented. Accordingly reducing delays in screening for pressure ulcer risk and providing pressure relief within the first ‘golden hour’ must henceforth be considered as the foundation of pressure ulcer prevention. It is unconscionable to delay assessment for up to eight hours Catherine A. Sharp Pressure Injury Prevention/Wound Care/Infection Control Consultant, Australia. Richard J. White Professor of Tissue Viability, University of Worcester, UK.
The International Pressure Ulcer Guideline Development Group response to Pressure ulcer risk assessment: do we need a golden hour? We thank Ms. Sharp and Prof. White for their interest in the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline (2014) developed and published jointly by the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA). The authors’ letter addresses the guideline recommendation: Conduct a structured risk assessment as soon as possible (but within a maximum of eight
References 1 National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014. 2 Kosiak, M. Etiology and pathology of ischemic ulcers Etiology and pathology of ischemic ulcers. Archives of Physical Medicine and Rehabilitation 1959; 40: 2, 62–69. 3 Gefen, A. How Much Time Does it Take to Get a Pressure Ulcer? Integrated Evidence from Human, Animal, and In Vitro Studies Ostomy Wound Manage. 2008; 54: 10, 26–35. 4 Stojadinovic, O., Minkiewicz, J., Sawaya, A. et al. Deep tissue injury in development of pressure ulcers: a decrease of inflammasome activation and changes in human skin morphology in response to aging and mechanical load. PLoS One 2013 8: 8, e69223. 5 Saver, J.L., Smith, E.E., Fonarow, G.C. et al. The “Golden Hour” and Acute Brain Ischemia: Presenting Features and Lytic Therapy in >30 000 Patients Arriving Within 60 Minutes of Stroke Onset. Stroke; a journal of cerebral circulation. 2010; 41: 7, 1431–1439. 6 Sharp, C.A., McLaws, M.L. Estimating the risk of pressure ulcer development: is it truly evidence based? Int Wound J 2006; 3: 4, 344–353.
s
© 2013 MA Healthcare
ltd
Pressure ulcer risk assessment: do we need a golden hour?
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ournal of Wound Care. Downloaded from magonlinelibrary.com by 130.179.016.201 on November 24, 2015. For personal use only. No other uses without permission. . All rights reserved
1 National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 2014. 2 Oomens, C.W., Bader, D.L., Loerakker, S., Baaijens F. Pressure induced deep tissue injury explained. Ann Biomed Eng. 2015;43(2):297-305. 3 Coleman, S., Nixon, J., Keen, J. et al. A new pressure ulcer conceptual framework. J Adv Nurs. 2014; 70: 10, 2222–2234. 4 Moore Z.E., Cowman, S. Risk assessment tools for the prevention of pressure ulcers. Cochrane Database Syst Rev 2014 5; 2: CD006471. 5 Gillespie, B.M., Chaboyer, W.P., McInnes, E. et al. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev 2014 3; 4: CD009958. 6 Moore, Z.E., Cowman, S. Repositioning for treating pressure ulcers. Cochrane Database Syst Rev 2015 Jan 5; 1: CD006898. 7 Jaeschke, R., Guyatt, G., H., Dellinger, P. et al. Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive. BMJ 2008; 337: 7665. 8 National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 2014.
The editor welcomes readers’ letters. These should be emailed to jwc@markallengroup. com 238
hours after admission) to identify individuals at risk of developing pressure ulcers. (Strength of Evidence = C; Strength of Recommendation = CC) (p43).1 Ms Sharp and Prof. White write that “…screening ‘as soon as possible…’ is good…”, but conducting a risk assessment after eight hours is much too late because ‘…pressure ulceration, an ischaemic process…’ occurs much earlier. The authors are concerned that the recommendation is not supported by references and suggest it is contrary to the overall purpose of the Guideline to recommend practice that does more good than harm. Given the complexity of this issue, we briefly present some key points to the discussion: (1) We agree that pressure ulcer risk of all individuals who are potentially at risk must be assessed as soon as possible, as clearly stated in this recommendation. The importance of conducting the risk assessment ‘as soon as possible’ is emphasised in both message and visual appearance in the text accompanying the recommendation in the full version of the guideline (p43).1 The accompanying text also specifies that the risk assessment should be conducted ‘at first contact with the health professional’ (p43).1 (2) The addition in parentheses that a risk assessment must be conducted ‘within a maximum of eight hours’ does not mean that such an important clinical assessment can be postponed. In most acute care settings in which patients are admitted and clinical staff are constantly present, the patient would have early contact with a health professional and the maximum of eight hours probably does not apply. However, the International Guideline recommendations address a wide range of clinical situations and care settings,
including the first contact with a health professional in a community setting. Again, we do not recommend that a risk assessment be delayed. However, if a patient is, for example, transferred from a hospital to a home care service the recommendation states a risk assessment should be conducted within eight hours, providing a feasible benchmark. Additionally, the Risk Factors and Assessment section of the International Guideline includes the concept of ‘structured risk assessment.’ How such an approach might look is carefully outlined. A structured risk assessment requires more than screening the individual, therefore the interpretation by Sharp and White that this recommendation supports an ‘eight hour screening window’ is incorrect. Interestingly, the authors have concluded that pressure redistribution and other preventive interventions are withheld until a structured risk assessment has been performed. There are many clinical settings in which patients are placed on pressure redistribution surfaces immediately after admission, and prior to conducting a structured pressure ulcer risk assessment. Likewise, experienced and competent health professionals often commence additional pressure ulcer prevention interventions immediately as they recognise individual traits and risk patterns. (3) Although only a minor point in the letter from Sharp and White, we must emphasise that pressure ulcer development is not just an ‘ischaemic process’. Direct cell deformation, reperfusion injury and probably other aetiological factors are important contributors to skin and soft tissue damage.1 When discussing possible critical windows, direct deformation
injury appears to be the most important mechanism for early pressure ulceration possibly occurring within minutes.6 (4) Finally, Sharp and White raise the important question regarding ‘supporting evidence.’ When one reviews the full body of pressure ulcer literature it becomes clear that direct evidence from empirical research is lacking in many areas of pressure ulcer prevention and treatment. For example, our understanding of the aetiological and pathophysiological pathway of pressure ulcer development is still incomplete.3 Currently, no clinical trials provide evidence on whether structured pressure ulcer risk assessment tools reduce pressure ulcer incidence;4 nor do they fully address the effectiveness of repositioning in preventing5 and healing6 pressure ulcers. Consequently, the Strength of Evidence of most recommendations in the International Guideline is ‘C’ which is based on internationally reviewed expert opinion and indirect evidence when available and relevant.1 This leads to the very practical question: “how do we address these evidence gaps?” Health professionals around the globe caring for individuals at risk of, or with existing pressure ulcers continue to make clinical decisions on a daily basis. These decisions are often made without consideration to the type of relevant and available evidence. The Guideline Development Group strongly believes that thoughtful guidance should be provided for situations in which direct evidence from clinical research is unavailable. A lack of evidence does not invalidate a proposed causal relationship, nor does it provide evidence that a certain intervention is ineffective. For example, contemporary health professionals would agree that activity and mobility limitations
© 2013 MA Healthcare
References
ltd
correspondence
J O U R N A L O F WO U N D C A R E V O L 2 4 , N O 5 , M AY 2 0 1 5
ournal of Wound Care. Downloaded from magonlinelibrary.com by 130.179.016.201 on November 24, 2015. For personal use only. No other uses without permission. . All rights reserved
correspondence are the most important factor indicating pressure ulcer risk. While highly significant, activity and mobility limitations are not the ‘… only evidence-based risk factor…’, although it is strongly recommended that both characteristics are included in every risk assessment approach. However, there is no single randomised controlled double-blinded trial to ‘prove’ that this approach is effective.1 A lack of high quality evidence does not preclude strong recommendations on ways in which care should be delivered. Interestingly, Sharp and White state: ‘No assurance is given in the Guide that this (pressure ulcer development within eight hours) will not occur.’ From an empirical scientific viewpoint it is important to emphasise that the concepts of ‘assurance’ or ‘proof’ in medicine and health care are misnomers. This field is always dealing with likelihoods and uncertainty. Rejecting the null hypothesis in a randomised controlled confirmatory trial with a negligible risk of bias does not provide ‘proof’ for the alternative hypothesis. In empirical research, rejecting the null hypothesis
never leads to assurance. When reviewing the International Guideline1 it is important to note that the Strength of Recommendation provides more relevant guidance to clinical practice than the Strength of Evidence. After drafting, all recommendations and a summary of supporting evidence were made available for review by members of the sponsoring organisations, guideline working groups and approximately 1,000 interested stakeholders in 63 countries. The recommendations were improved and/or clarified based on stakeholder feedback. Recommendations were then formally evaluated by the full development team using the methodology introduced by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) group.7 Thus, every recommendation has been subjected to a thorough consensus process and its inclusion in the International Guideline is supported, even where direct evidence is elusive. Once again, we thank Sharp and White for their thoughtful
comments. Such discussions are very important and highly welcome. We cordially invite commentators to review the full International Guideline and support material (e.g., Methodology Addendum, lists of identified studies, the methodological appraisals and data extraction tables) at http:// www.internationalguideline. com. As highlighted in its introduction, ‘Users should not rely on excerpts from the Quick Reference Guide alone.’8 Jan Kottner, PhD, CharitéUniversitätsmedizin Berlin, Berlin, Germany. Emily Haesler, BN, PGDipAdvNursing, PhD candidate Canberra, Australia. on behalf of the Guideline Development Group*
* The International Pressure Ulcer Guideline Development Group (GDG) is comprised of representatives from the National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA). The primary purposes of the GDG are to conduct comprehensive reviews and appraisals of available research and develop evidence-based guidelines with the input of international pressure ulcer experts and stakeholders.
Additional Guideline Development Group Members (in alphabetical order): K. Carville, PhD, RN, Australia. M. Clark, PhD, UK; J. Cuddigan, PhD, RN, CWCN, FAAN; D. Langemo, PhD, RN, FAAN; , USA.; S. Law, BScN, MScN, RN, RM-ET, Hong Kong; L. McNichol, MSN, RN, GNP, CWOCN, CWON-AP; USA. P. Mitchell, MN, RN, PGDipWHTR, New Zealand; C Oomens, PhD, Ir, The Netherlands; L. Schoonhoven, PhD, UK; J. Stechmiller, PhD, ACNP-BD, FAAN, USA. A. Tay, BN, CWS, Singapore.
The professionals comprehensive guide todermatology product selection
www.dermatologyhandbook.co.uk s
© 2013 MA Healthcare
ltd
• Need to know what new products are available at your fingertips? • Ever wonder which product is the best for your patient?
J O U R N A L O F WO U N D C A R E V O L 2 4 , N O 5 , M AY 2 0 1 5
239
ournal of Wound Care. Downloaded from magonlinelibrary.com by 130.179.016.201 on November 24, 2015. For personal use only. No other uses without permission. . All rights reserved
Letters We note the recent release of the ‘Prevention and Treatment of Pressure Ulcers: Quick Reference Guide’ developed by the National Pressure Ulcer Advisory Panel, (NPUAP) European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA).1 While much of the information in the Guide is not new, we were intrigued to read the recommendation to screen patients ‘as soon as possible after admission but within a maximum of eight hours’ (p14; strength of evidence C) without any supporting reference. Screening ‘as soon as possible...’ is good advice knowing that pressure ulceration, an ischaemic process leading to tissue death, can begin in as little as one hour.2 But the question is, how did the authors come up with ‘...eight hours’ as the maximum time in which it would be safe to screen for risk? In our experience, given the option of doing a task later, rather than sooner, usually results in the former option. Consequently, the eight hour screening window will not translate into good practice. This is because if staff do not screen patients for risk of pressure ulcer within eight hours, it is more likely than not those ulcers will develop. The key issue is whether eight hours possibly sitting or lying in one position, predisposes to pressure ulcer formation. No assurance is given in the Guide that this will not occur. Furthermore, the strength of evidence denoted ‘C’ is not supported by any citation of supporting evidence. The Guide ‘provides an indication to the health professional of the confidence
one can have that the recommendation will do more good than harm, and can be used to assist in prioritising pressure ulcer related interventions (p1).’ The consequences of leaving any patient in one position for up to eight hours1 before screening for pressure ulcer risk, then intervening, are dire even though the time for onset of a pressure ulcer is not exact but a range of probable times.3 The authors of the Guide claim that ‘an explicit scientific methodology was used to identify and critically appraise all available research. In the absence of definitive evidence, expert opinion (often supported by indirect evidence and other guidelines) was used to make recommendations (p1).1’ There is no disputing their recommendation that screening should be carried out ‘as soon as possible after admission...’ but no references have been provided to support this statement. Of greater concern is that no references have been provided to support the recommendation that screening can be carried out up to ‘...a maximum of eight hours’ (p14). Indeed, there is evidence that inflammatory mediators postulated to be a contributory factor in ulcer development, are released within the first four hours of exposure to pressure.4 Evidence, together with the common sense derived from experience of patient care, strongly suggests that assessment and appropriate intervention be conducted within the first hour. Furthermore, delay will exacerbate the patient’s problem making ulcer development more likely. When patients present with symptoms of stroke, another ischaemic process leading to
J O U R N A L O F WO U N D C A R E V O L 2 4 , N O 5 , M AY 2 0 1 5
tissue death, the ‘golden hour’ concept is applied because hyper-acute therapy is known to be more effective than later intervention.5 Screening patients on admission using rapid clinical judgement, focusing on immobility, the only evidencebased risk factor for pressure ulcer development,6 is the fastest way to determine risk. Interventions could then be provided immediately and pressure ulcers prevented. Accordingly reducing delays in screening for pressure ulcer risk and providing pressure relief within the first ‘golden hour’ must henceforth be considered as the foundation of pressure ulcer prevention. It is unconscionable to delay assessment for up to eight hours Catherine A. Sharp Pressure Injury Prevention/Wound Care/Infection Control Consultant, Australia. Richard J. White Professor of Tissue Viability, University of Worcester, UK.
The International Pressure Ulcer Guideline Development Group response to Pressure ulcer risk assessment: do we need a golden hour? We thank Ms. Sharp and Prof. White for their interest in the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline (2014) developed and published jointly by the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA). The authors’ letter addresses the guideline recommendation: Conduct a structured risk assessment as soon as possible (but within a maximum of eight
References 1 National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014. 2 Kosiak, M. Etiology and pathology of ischemic ulcers Etiology and pathology of ischemic ulcers. Archives of Physical Medicine and Rehabilitation 1959; 40: 2, 62–69. 3 Gefen, A. How Much Time Does it Take to Get a Pressure Ulcer? Integrated Evidence from Human, Animal, and In Vitro Studies Ostomy Wound Manage. 2008; 54: 10, 26–35. 4 Stojadinovic, O., Minkiewicz, J., Sawaya, A. et al. Deep tissue injury in development of pressure ulcers: a decrease of inflammasome activation and changes in human skin morphology in response to aging and mechanical load. PLoS One 2013 8: 8, e69223. 5 Saver, J.L., Smith, E.E., Fonarow, G.C. et al. The “Golden Hour” and Acute Brain Ischemia: Presenting Features and Lytic Therapy in >30 000 Patients Arriving Within 60 Minutes of Stroke Onset. Stroke; a journal of cerebral circulation. 2010; 41: 7, 1431–1439. 6 Sharp, C.A., McLaws, M.L. Estimating the risk of pressure ulcer development: is it truly evidence based? Int Wound J 2006; 3: 4, 344–353.
s
© 2013 MA Healthcare
ltd
Pressure ulcer risk assessment: do we need a golden hour?
237
ournal of Wound Care. Downloaded from magonlinelibrary.com by 130.179.016.201 on November 24, 2015. For personal use only. No other uses without permission. . All rights reserved
1 National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 2014. 2 Oomens, C.W., Bader, D.L., Loerakker, S., Baaijens F. Pressure induced deep tissue injury explained. Ann Biomed Eng. 2015;43(2):297-305. 3 Coleman, S., Nixon, J., Keen, J. et al. A new pressure ulcer conceptual framework. J Adv Nurs. 2014; 70: 10, 2222–2234. 4 Moore Z.E., Cowman, S. Risk assessment tools for the prevention of pressure ulcers. Cochrane Database Syst Rev 2014 5; 2: CD006471. 5 Gillespie, B.M., Chaboyer, W.P., McInnes, E. et al. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev 2014 3; 4: CD009958. 6 Moore, Z.E., Cowman, S. Repositioning for treating pressure ulcers. Cochrane Database Syst Rev 2015 Jan 5; 1: CD006898. 7 Jaeschke, R., Guyatt, G., H., Dellinger, P. et al. Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive. BMJ 2008; 337: 7665. 8 National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 2014.
The editor welcomes readers’ letters. These should be emailed to jwc@markallengroup. com 238
hours after admission) to identify individuals at risk of developing pressure ulcers. (Strength of Evidence = C; Strength of Recommendation = CC) (p43).1 Ms Sharp and Prof. White write that “…screening ‘as soon as possible…’ is good…”, but conducting a risk assessment after eight hours is much too late because ‘…pressure ulceration, an ischaemic process…’ occurs much earlier. The authors are concerned that the recommendation is not supported by references and suggest it is contrary to the overall purpose of the Guideline to recommend practice that does more good than harm. Given the complexity of this issue, we briefly present some key points to the discussion: (1) We agree that pressure ulcer risk of all individuals who are potentially at risk must be assessed as soon as possible, as clearly stated in this recommendation. The importance of conducting the risk assessment ‘as soon as possible’ is emphasised in both message and visual appearance in the text accompanying the recommendation in the full version of the guideline (p43).1 The accompanying text also specifies that the risk assessment should be conducted ‘at first contact with the health professional’ (p43).1 (2) The addition in parentheses that a risk assessment must be conducted ‘within a maximum of eight hours’ does not mean that such an important clinical assessment can be postponed. In most acute care settings in which patients are admitted and clinical staff are constantly present, the patient would have early contact with a health professional and the maximum of eight hours probably does not apply. However, the International Guideline recommendations address a wide range of clinical situations and care settings,
including the first contact with a health professional in a community setting. Again, we do not recommend that a risk assessment be delayed. However, if a patient is, for example, transferred from a hospital to a home care service the recommendation states a risk assessment should be conducted within eight hours, providing a feasible benchmark. Additionally, the Risk Factors and Assessment section of the International Guideline includes the concept of ‘structured risk assessment.’ How such an approach might look is carefully outlined. A structured risk assessment requires more than screening the individual, therefore the interpretation by Sharp and White that this recommendation supports an ‘eight hour screening window’ is incorrect. Interestingly, the authors have concluded that pressure redistribution and other preventive interventions are withheld until a structured risk assessment has been performed. There are many clinical settings in which patients are placed on pressure redistribution surfaces immediately after admission, and prior to conducting a structured pressure ulcer risk assessment. Likewise, experienced and competent health professionals often commence additional pressure ulcer prevention interventions immediately as they recognise individual traits and risk patterns. (3) Although only a minor point in the letter from Sharp and White, we must emphasise that pressure ulcer development is not just an ‘ischaemic process’. Direct cell deformation, reperfusion injury and probably other aetiological factors are important contributors to skin and soft tissue damage.1 When discussing possible critical windows, direct deformation
injury appears to be the most important mechanism for early pressure ulceration possibly occurring within minutes.6 (4) Finally, Sharp and White raise the important question regarding ‘supporting evidence.’ When one reviews the full body of pressure ulcer literature it becomes clear that direct evidence from empirical research is lacking in many areas of pressure ulcer prevention and treatment. For example, our understanding of the aetiological and pathophysiological pathway of pressure ulcer development is still incomplete.3 Currently, no clinical trials provide evidence on whether structured pressure ulcer risk assessment tools reduce pressure ulcer incidence;4 nor do they fully address the effectiveness of repositioning in preventing5 and healing6 pressure ulcers. Consequently, the Strength of Evidence of most recommendations in the International Guideline is ‘C’ which is based on internationally reviewed expert opinion and indirect evidence when available and relevant.1 This leads to the very practical question: “how do we address these evidence gaps?” Health professionals around the globe caring for individuals at risk of, or with existing pressure ulcers continue to make clinical decisions on a daily basis. These decisions are often made without consideration to the type of relevant and available evidence. The Guideline Development Group strongly believes that thoughtful guidance should be provided for situations in which direct evidence from clinical research is unavailable. A lack of evidence does not invalidate a proposed causal relationship, nor does it provide evidence that a certain intervention is ineffective. For example, contemporary health professionals would agree that activity and mobility limitations
© 2013 MA Healthcare
References
ltd
correspondence
J O U R N A L O F WO U N D C A R E V O L 2 4 , N O 5 , M AY 2 0 1 5
ournal of Wound Care. Downloaded from magonlinelibrary.com by 130.179.016.201 on November 24, 2015. For personal use only. No other uses without permission. . All rights reserved
correspondence are the most important factor indicating pressure ulcer risk. While highly significant, activity and mobility limitations are not the ‘… only evidence-based risk factor…’, although it is strongly recommended that both characteristics are included in every risk assessment approach. However, there is no single randomised controlled double-blinded trial to ‘prove’ that this approach is effective.1 A lack of high quality evidence does not preclude strong recommendations on ways in which care should be delivered. Interestingly, Sharp and White state: ‘No assurance is given in the Guide that this (pressure ulcer development within eight hours) will not occur.’ From an empirical scientific viewpoint it is important to emphasise that the concepts of ‘assurance’ or ‘proof’ in medicine and health care are misnomers. This field is always dealing with likelihoods and uncertainty. Rejecting the null hypothesis in a randomised controlled confirmatory trial with a negligible risk of bias does not provide ‘proof’ for the alternative hypothesis. In empirical research, rejecting the null hypothesis
never leads to assurance. When reviewing the International Guideline1 it is important to note that the Strength of Recommendation provides more relevant guidance to clinical practice than the Strength of Evidence. After drafting, all recommendations and a summary of supporting evidence were made available for review by members of the sponsoring organisations, guideline working groups and approximately 1,000 interested stakeholders in 63 countries. The recommendations were improved and/or clarified based on stakeholder feedback. Recommendations were then formally evaluated by the full development team using the methodology introduced by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) group.7 Thus, every recommendation has been subjected to a thorough consensus process and its inclusion in the International Guideline is supported, even where direct evidence is elusive. Once again, we thank Sharp and White for their thoughtful
comments. Such discussions are very important and highly welcome. We cordially invite commentators to review the full International Guideline and support material (e.g., Methodology Addendum, lists of identified studies, the methodological appraisals and data extraction tables) at http:// www.internationalguideline. com. As highlighted in its introduction, ‘Users should not rely on excerpts from the Quick Reference Guide alone.’8 Jan Kottner, PhD, CharitéUniversitätsmedizin Berlin, Berlin, Germany. Emily Haesler, BN, PGDipAdvNursing, PhD candidate Canberra, Australia. on behalf of the Guideline Development Group*
* The International Pressure Ulcer Guideline Development Group (GDG) is comprised of representatives from the National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA). The primary purposes of the GDG are to conduct comprehensive reviews and appraisals of available research and develop evidence-based guidelines with the input of international pressure ulcer experts and stakeholders.
Additional Guideline Development Group Members (in alphabetical order): K. Carville, PhD, RN, Australia. M. Clark, PhD, UK; J. Cuddigan, PhD, RN, CWCN, FAAN; D. Langemo, PhD, RN, FAAN; , USA.; S. Law, BScN, MScN, RN, RM-ET, Hong Kong; L. McNichol, MSN, RN, GNP, CWOCN, CWON-AP; USA. P. Mitchell, MN, RN, PGDipWHTR, New Zealand; C Oomens, PhD, Ir, The Netherlands; L. Schoonhoven, PhD, UK; J. Stechmiller, PhD, ACNP-BD, FAAN, USA. A. Tay, BN, CWS, Singapore.
The professionals comprehensive guide todermatology product selection
www.dermatologyhandbook.co.uk s
© 2013 MA Healthcare
ltd
• Need to know what new products are available at your fingertips? • Ever wonder which product is the best for your patient?
J O U R N A L O F WO U N D C A R E V O L 2 4 , N O 5 , M AY 2 0 1 5
239
ournal of Wound Care. Downloaded from magonlinelibrary.com by 130.179.016.201 on November 24, 2015. For personal use only. No other uses without permission. . All rights reserved
