Construction and Use of Wound Care Guidelines: An Overview

Login toDownload PDF version
Index: 
Ostomy Wound Manage. 2012;58(8):37–47.
Sammy Al-Benna, MB, ChB, PhD, MRCS

Abstract

  Patients should receive care based on the best available scientific knowledge. Clinical wound care guidelines have been created using many methodologies, but many remain consensus-based. A consensus-based approach is no longer considered adequate or appropriate. The best guidelines are developed from a systematic examination and appraisal of good evidence from well-conducted trials. The development process must be transparent, utilize an accepted evidence rating system, be supported by appropriate clinical expertise, and lead to unambiguous recommendations. Prospective validation studies are important as part of the development process, especially for areas of care with limited literature-based evidence. Wound care will become a process of applying the best data available to the clinical situation. The ultimate use of guidelines will be the development of evidence-based, validated clinical tools that can be integrated with existing patient data and available to the wound care professional at the consultation.

 Potential Conflicts of Interest: none disclosed

Introduction

  Wound care professionals support high-quality patient care, ready access to healthcare, and patient satisfaction within reasonable cost.1 As developed and developing countries continue to grapple with ways to reach these healthcare goals, numerous strategies have been proposed2; wound care guidelines are among those strategies.3 Unfortunately, a large proportion of guidelines fall short of meeting quality markers, so it is important to prevent poor guidelines from influencing clinical standards.4,5 A systematic review published in 2000 of specialty societies, including wound care organizations, found that only 5% of clinical guidelines published in peer-reviewed journals met minimal methodological criteria for their production.4

  Evidence-based guidelines claim to be authoritative because they presume to embody a combination of best evidence and judgment designed to ensure that recommendations are valid and reliable.6 To ensure clinician commitment to guidelines, clinicians also must find them trustworthy.6,7 Clinical guidelines are designed to assist in the diagnosis and treatment of specific clinical entities6 with the goal to describe optimal delivery of care for patients by minimizing variations in practice.8 Yet health policy leaders and purchasers of healthcare are deeply concerned with rising costs and lack of uniformity in the care process,9,10 and managed care organizations promote guidelines that focus on resource utilization and cost control.11

  The inexorable rise of the guidelines movement has been accelerated by numerous publications in this and other journals that have taken a lead role in summarizing evidence and producing authoritative guidance.12,13 Guidelines offer an opportunity to integrate evidence from clinical research with rational health policy to improve the quality of healthcare at a local level.14   In most cases, wound care societies (eg, the World Union of Wound Healing Societies, the Wound Healing Society, the European Wound Management Association, and the Association for the Advancement of Wound Care [AAWC]) have developed guidelines to establish standards of care for wounds and procedures under their purview and to educate their members and help them improve outcomes and become competitive while providing cost-effective care.15-18 Some hospitals, hospital chains, managed care plans, and large medical practice groups have developed proprietary guidelines in an attempt to control costs and to enhance their competitiveness.19

  Wound care professionals may have concerns that implementing clinical guidelines will diminish their autonomy while they increase clinical risk, liability, and workload.20 In this era of increased accountability, some form of practice guideline is likely a part of the strategy to meet organizational goals. The challenge is to assist wound care professionals in understanding the benefits and pitfalls of guidelines in general, the appropriate analysis and application of specific guidelines, and how to develop, modify, or utilize guidelines in their practice. The aim of this overview is to help wound care professionals understand how wound care guidelines are constructed and used.

What are Guidelines?

  The Institute of Medicine’s21 widely accepted definition of guidelines states they are “systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.” This otherwise useful definition says little about the quality or effectiveness of guidelines. The Institute of Medicine describes literature searching as the key step in developing valid guidelines. Table 1 defines other key terms relating to guidelines.

  Clinical guidelines are a powerful method for standardizing and uniformly improving the quality of medical care, providing a set of schematic plans, at varying levels of abstraction and detail, for managing patients who have a particular clinical entity; guidelines may cover aspects of care from investigation and diagnosis to acute treatment and rehabilitation.4-10 Guidelines may address the management of a particular condition, such as venous ulcers, or they may be restricted to a specific aspect of care — eg, compression bandages and stockings for patients with venous ulcers. They are not intended as a substitute for professional judgment; instead, they support the practitioner in making an informed decision relating to patient management in accordance with individual professional competence. The application of clinical guidelines by healthcare professionals typically involves collecting and interpreting considerable amounts of data over time, applying standard therapeutic or diagnostic plans in an episodic fashion, and revising those plans when necessary.

  Evidence in medicine refers to information derived from observation, reasoning, or experiment linked analytically to conclusions and beliefs.7 The term evidence-based does not refer to a new notion of evidence or even to a new conception of its importance — the key contribution of evidence-based medicine is its ranking the credibility to be accorded to evidence depending on factors such as the likelihood of bias influencing data collection and interpretation.4,5 Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.22 Evidence-based guidelines comprise standardized terms of care that apply to the general condition and not necessarily to the actual clinical situation at hand; therefore, they require extrapolation to an individual patient’s circumstances.4-6,22 Guidelines are constructed from many sources of information and may create a false sense of consensus, may disguise or play down controversy, and can fast become obsolete as a result of novel findings.4,5,8 Thus, once a guideline is published, the process does not stop. Guidelines should be updated if new evidence substantially changes the conclusion. The National Guideline Clearinghouse’s inclusion criteria specifically require that guidelines represented in their database have been developed, reviewed, or revised within the last 5 years or they will be removed.23 Many guidelines face more-or-less well-grounded degrees of dissent much of the time4; recognition of the role of clinical discretion in taking account of particular circumstances underpins the lack of an administrative or legal requirement that physicians should always follow authoritative guidelines.5 A certain amount of acumen lies at the heart of clinical judgment, which has to take competing influences on decision making such as the patient’s choice, healthcare targets, costs, and incentives into account in simultaneous accordance with the patient’s best interests and within professional bounds.23 Due to the logical gap between the generalities of guideline recommendations and the particularities of a patient’s case, a good rule of thumb is that following evidence-based guidelines may generally but not always ensure good medical care, and diverging from guidelines does not always signal poor care, particularly if guideline level of evidence is low.12,13

Guideline Construction

  The method used to synthesize the available evidence should be the most stringent applicable. Although enthusiasm for guidelines and their development at international, national, and local levels of care oversight is increasing, relatively few medical issues have been found to have a sound research evidence base.24-26 Taking the evidence, regardless of level, quality, relevance, or strength, and turning it into a clinically useful recommendation depends on the judgment, experience, and good sense of the group developing the guidelines.24-30 Having evidence from a high-level study does not automatically result in a good clinical recommendation. Best intentions are necessary but, unfortunately, not sufficient for the construction of valid guidelines.25

  One factor in recognizing good guidelines is the way in which they are constructed.26-30 Guidelines based on informal consensus are more likely to be flawed because they 1) fail to use a systematic approach to incorporate evidence, 2) rely upon the potentially restricted knowledge of the individuals involved, and 3) may be distorted by the he-who-makes-the-most-noise phenomenon. A formal consensus method with a structured approach to achieving agreement may avoid some of these problems, particularly if combined with prior preparation presenting a summary of the underlying evidence.29-31 Formal consensus approaches include the Delphi method and adaptation of the RAND method for combining the strength of the evidence and expert opinion.29-31 However, some of the weaknesses of consensus methods remain, hence the need for formal validation.

Guideline Basis and Validity

  Important considerations for users of any wound care guideline are the motivation of the facilitator(s), the methodology used, and the validity of the information contained in the guideline. Wound care guidelines driven by cost containment or reimbursement limitation should be suspect.10,24 Guidelines also may be used as a political move to limit professional power and as a means of reducing the physician intervention as a strategy to save money.7,8,10,24

  Early clinical guidelines often were developed by expert panels using so-called consensus methodology, but scientific principles infrequently were applied.25,26 This is still often the case in wound care: where guidelines are not evidence-based, guideline developers default to consensus methodology, sometimes with alternative consensus statements. With opinion-based or consensus-based guidelines, the likelihood of disagreement is greater depending on who is sitting on a particular panel and who is drafting the guidelines. As the consensus process matured, a number of organizations insisted on a scientific basis for guideline development24-26 using many methodologies, each with particular advantages and disadvantages.26-28

  Optimally, clinical guidelines are evidence-based, supported by randomized clinical trials (RCTs), and validated by focused outcome studies.26,27 However, in many situations, data are insufficient to create evidence-based guidelines. In many of these scenarios, guidelines based on common sense and clinical experience are appropriate.27-31 When a validated evidence-based guideline conflicts with an opinion or consensus guideline, the evidence-based guideline should take precedence.29 The method by which a set of guidelines is developed is important (see Table 2), particularly as it influences the quality of the guideline and its likely effectiveness in achieving the health gains expected.26,29,31 Entities utilizing guidelines should be aware of the differences in methodology used to develop them and the outcome and validity measures, if any, that have been applied.26,29,31-35

  Validity. Validity is the degree to which data and results are accurate reflections of reality. The correct interpretation of clinical research rests largely on understanding the notion of validity. Validity involves the concepts investigated, the people or objects studied, the methods by which data are collected, and the findings produced.7 The accepted criteria for guideline validity have evolved from the “essential elements of good guideline” identified by the US Institute of Medicine in 1990.21 These recommended “attributes of good guidelines” include validity, reliability, clinical applicability, clinical flexibility, clarity, multidisciplinary process, scheduled review, and documentation.

  External validity is the degree to which the results of a study can be generalized beyond the study sample to a population of interest. Internal validity is the extent to which the results of a study are true — ie, the intervention caused the change, not some other extraneous factor such as differences in assessment procedures between intervention and control conditions. Put another way, validity is the extent to which researchers provide compelling evidence that the causal (independent) variable causes changes in the outcome (dependent) variable. To do this, researchers must rule other potential explanations for the changes in the outcome variable. Although much effort has been invested in the study of internal validity, comparatively little progress has been made in defining criteria for external validity.7 The applicability of research data beyond the study population depends on clinical judgment, an inherently slippery art, but an art nonetheless.23

  Instruments for assessing the validity and utility of guidelines already are established.33,34 However, a recent review33 of 626 clinical guidelines (including wound care guidelines) demonstrated that despite some increase in quality of clinical guidelines over time, the quality scores as measured with the Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument have remained moderate to low over the last two decades. This finding urges guideline developers to continue improving the quality of their products. Obtaining reliable and valid assessments of research utilization in healthcare settings is essential for several reasons. First, assessments are necessary to empirically verify the assumption that patient outcomes are sensitive to varying levels of research utilization by healthcare providers. Second, robust measurement of research utilization is needed to better understand the guideline’s latent construct, including its causal predictors and effects. These causal mechanisms inform the development and evaluation of interventions to improve patient care by increasing healthcare provider use of research findings in clinical practice.

  The AAWC’s Guideline of Pressure Ulcer Guidelines is found on the National Guideline Clearinghouse website along with formal content validation results.36 Respondents rated the clinical relevance of each recommendation on a scale of 1 to 4 and added open-ended comments for improving each recommendation with a corresponding rationale. After the inclusive list of recommendations was developed and simplified by the AAWC Guideline Committee, each recommendation was independently content-validated by 31 multidisciplinary wound care professionals (physicians of varying specialties, nurses, physical therapists, and other wound care specialists) from November 2008 through February 2009. The content validity index was calculated as the percent of respondents rating the recommendation as clinically relevant and succinct or clinically relevant with recommended minor change. The criterion for including a recommendation in the final content-validated guideline was a content validity index of at least 75%.

  Level of evidence. Levels of evidence are related to the quality of studies, not to the reported effects.23 Therefore a small amount of evidence efficacy can lead to a strong recommendation. In addition, the external validity of RCTs is limited, and patients who give informed consent for a RCT often differ considerably from real-world patients.23,27 The absence of evidence for older treatment options leads to treatment recommendations for newer, well-examined, and frequently more expensive options without evidence of superiority. In addition, the ethical framework of many clinically relevant objectives cannot be represented fully in RCTs.23,24,27 Only a tiny proportion of guidelines has been shown in rigorous trials to lead to better outcomes.24

Guideline Development

  Approach. The most widely accepted method for the development of guidelines, and the one most generally accepted as valid, uses the evidence-based approach.27,28 This process relies on systematically identifying relevant research, reviewing the evidence using methodologically sound critical appraisal, and summarizing the evidence explicitly.29-31 The strength of the evidence provided by an individual study depends on the ability of the study design to minimize the possibility of bias and to maximize attribution. This does not mean guidelines can be produced only from RCTs or meta-analyses, but it does mean the quality and extent of the research on which recommendations are based are explicitly recognized. For example, a recommendation will be based on consensus where this is the best available means of determining best practice, but it will be clear that it comes from consensus and not from evidence derived from RCTs. This method incorporates the best available evidence, helps identify research priorities, and allows for guidance on issues where evidence from randomized trials is not available. It is also crucial for the subsequent local use of guidelines.

  Contributor expertise. The guideline developers should incorporate a relevant range of expertise.24-26,29-31 A major indicator of clinical guideline quality is a description of the type of professionals involved in developing the guideline, along with the biases or conflicts of interest of the panel members.4 Expertise is a combination of knowledge and experience that manifests as improved performance; expert clinical input is necessary to define the subject clearly and to ensure the guidelines produced are relevant to clinical circumstances.26,27 For example, guidelines for the treatment of diabetic foot ulcers need input from people with expertise in guidelines development, literature searching and appraisal, and health economists, as well as from wound care professionals, cardiologists, endocrinologists, family physicians, pharmacists, and other professionals. The evidence-based method includes clinical input as a necessary component of defining the subject area clearly and ensuring the guidelines produced are clear and appropriate to the relevant clinical circumstances.4,9,10,12,13 Much of the evidence-based method arises in the secondary care sector where specialists manage specific diagnoses and problems. This evidence then may be applied to the general practice setting, raising concerns regarding generalizability and how results of a study may only apply to a particular patient in a particular practice. Furthermore, the emphasis would have been on the quantitative aspects of diagnosis and management and not the qualitative features essential to primary wound care providers.37

  Also, a certain amount of acumen lies at the heart of clinical judgment, which has to take into account competing influences on decision making, such as the patient’s choice, healthcare targets, costs, and incentives.4,5,22 But acumen must be exercised in accordance with the patient’s best interests and within professional bounds. Clinicians need to appreciate that following evidence-based guidelines may generally, but not always, ensure good medical care and that diverging from guidelines does not always signal poor care.5

  Establishing a local fit. Most well-researched and developed guidelines were intended for broad application; therefore, modification at the practice setting is expected.4,5,12,13,22 Most wound care societies have developed clinical guidelines that may be used at the local level without modification; however, reviewing and modifying a guideline to fit local practice has certain advantages.13 This process will achieve a degree of buy-in from guideline users and guard against implementing a national guideline that is not appropriate for local practice conditions and available resources13 — eg, a guideline developed for use in a university or research setting may not be valid in a community hospital or rural setting.2,13 Some groups may decide to develop clinical policies de novo, although doing this well will require substantial commitment and effort.38 People involved in developing guidelines are more likely to use them, but locally developed guidelines are less likely to go through the appropriate development process to ensure their validity; busy wound care professionals in need of guidelines are not usually best placed to develop them.12,13

  Guidelines on the same topic developed by different groups can vary considerably in their content and implications for clinical decisions and patient benefits, even in areas with a strong evidence base.4,5 As an example, the SOLUTIONS® (ConvaTec, Skillman, NJ) wound care algorithm39 on the National Guideline Clearinghouse website offers a wide choice of options for debridement (eg, autolytic [Level A], enzymatic [Level B], surgical [Level C], and other treatment [Level C]) with different strengths of evidence). The AAWC’s Guideline of Pressure Ulcer Guidelines36 adds “choose a debridement method appropriate to pressure ulcer status, individual condition, and goals of care.”

  Finding an appropriate guideline. What is the best way to access and appraise available guidelines? What can be done in the absence of “good” guidelines? In addition to checking with local and national sources of expertise,32 clinicians can consult the web for resources for guidelines and evidence-based practice (see Table 4). An appropriate start is to search for evidence-based guidelines that explicitly grade the evidence base and recommendations. The grading can facilitate decisions about whether to adopt a particular recommendation locally. For example, it would be inappropriate to ignore or significantly alter a Grade A recommendation based upon well-designed RCTs, but reasonable to discuss lower-grade recommendations and adapt them to local circumstances.

Guideline Use

  Guidelines, even if they are valid, have no effect unless they are placed in the hands of intended users and implemented. Guidelines are more likely to be effective if they are disseminated as part of an educational initiative and least likely if they are disseminated through journal publication.32 The former approach allows the guidelines to be discussed, debated, and adapted to local circumstances before implementation.13

  The degree of clinical guideline penetration into the daily practice of wound care is currently undocumented. Barriers to wound care guideline implementation are educational (traditional knowledge/ritualistic practice, appropriate training and support, lack of understanding of research process, poor quality research, lack of critical appraisal skills, negative attitudes toward evidence-based practice, and information overload) and professional/organizational (lack of expert consensus, inconsistent research findings, no standardization of accepted practice, interprofessional rivalry, lack of effective clinical role models, instability of heath services, lack of resources, and lack of focus on wound management). Educational strategies need to be specifically targeted to meet the needs of different wound professional groups and levels of expertise to maximize effectiveness. Guidelines and policy makers in particular should take into account that implementation may be hampered by the fact that professionals often are unaware the guidelines exist or are not familiar with their content.40 Clearly, it is not sufficient to merely disseminate a guideline. Directly and actively involving professionals in guidelines featuring targeted implementation interventions can facilitate awareness. Examples of such targeted interventions combine web-based, written, or face-to-face practical recommendations, educational material, and educational meetings.41 The most common example is appropriately equipping clinical leaders such as specialist nurses with the skills, knowledge, and attitudes necessary to disseminate and implement evidence-based wound care locally. Wound care guideline adoption rates have been shown to increase when guidelines comprise simple, standardized wound care categories and clear definitions of wound dressing efficacies.42 Compliance with these guidelines is generally voluntary; most wound care practitioners are aware of these documents, but attempts to implement guidelines with strict adherence is uncommon.

Integrating Wound Care Guidelines into Clinical Decision-making

  As wound care defines and refines its role in the delivery systems of the future, the concept disease management will become increasingly important. Disease management involves addressing a specific disease over its entire spectrum rather than as isolated episodes of care.43 Integration of prevention (primary and secondary), acute care, chronic care, hospitalization, rehabilitation, and health maintenance are part of this multidisciplinary comprehensive approach.11,35 The National Guideline Clearinghouse36 states that although the evidence supporting recommendations may serve as a legitimate basis for informing clinical decisions, the recommendations are not to be construed as legal requirements or precedents. Guidelines should be considered instruments to guide professionals but should not lead to cookbook medicine.44

  Benchmarks for adherence to recommendations vary; a certain level of interprofessional variation in adherence to clinical practice guidelines is justified by differences in case mix. Professionals are responsible for adjusting their clinical decisions to each individual patient. Relevant arguments (eg, comorbidity, gender, genetic susceptibility, allergies, the private situation) can justify nonadherence to guidelines. Guideline recommendations are more easily aligned with what is good for a specific population than for a given individual. Guideline use should consider patient choices along with individual patient characteristics. First are ethical considerations relevant to patient autonomy; patients increasingly want to be informed by their clinicians and be active in clinical decision-making,45 although the wish to actually participate in treatment decisions is context-dependent.46 Second, valid medical evidence is available only for a subset of the recommendations in clinical guidelines: in preference-sensitive or “grey zone” decisions, the lack of evidence results in high levels of uncertainty about the best course of action.47 Third, even when recommendations are built on rigorous evidence, individuals often vary widely in their choices, despite assurance from population-based research. Fourth, even when high-quality evidence is available, more than one effective treatment option may exist (as has been noted from the AAWC pressure ulcer guideline), with comparable effectiveness of the various options from a medical point of view,36 a situation referred to as equipoise48 — ie, when options may be equal in the sense that scientific evidence points to a balance between harms and benefits within or between options. Finally, there is evidence from musculoskeletal medicine46 that patient preferences and motivation for treatment positively affect treatment outcomes in RCTs. Therefore, one-for-all guidelines designed for a specific population do not account for differences between patient characteristics and preferences, suggesting a need for flexible guidelines that enable and facilitate patient involvement in medical decision making.

Liability Considerations

  A major objection often raised by healthcare professionals regarding clinical guidelines is that their implementation will expose the provider to increased legal risk.5,23,36,49 Guidelines that lack a solid foundation in evidence and/or are poorly drafted may increase clinical and legal risks.24,49 However, guidelines that incorporate sound evidence-based clinical principles are unlikely on their own to increase risk, because plaintiff’s attorneys have access to the original published evidence.49 Subsequent to a suboptimal clinical outcome, an appropriately crafted guideline may provide a measure of protection, provided the guideline was followed.49,50 Guidelines are introduced into British courts by expert witnesses as evidence of accepted and customary standards of care, but cannot, as yet, be introduced as a substitute for expert testimony; they are treated as hearsay evidence. The fact that a guideline exists can neither establish its authority nor support the view that in the circumstances before a court, compliance with the guideline would be reasonable and noncompliance negligent. In contrast, a US study50 has shown that guidelines play a relevant or pivotal part in the proof of negligence in 6% to 7% of malpractice actions.

  Documentation of and familiarity with applicable guidelines are clearly important. Guidelines cannot be applied to all clinical situations, and exceptions to the guidelines are not unusual. The application of clinical guidelines must always be weighed in the context of the wound care professional’s clinical judgment, and that professional needs to have a clear idea when the guideline is appropriate.42,44 Documenting the decision-making process contributes substantially when defending the logic of ultimate conclusions regardless of whether or not guidelines apply. Some clinical situations and problems lack a clearly established, proven basis favoring one type of treatment over another. Where evidence is insufficient to support guidelines, clinical options should be accepted.36,44

Future Guideline Application and Implementation

  Computerization of medical information offers potential opportunities to improve wound care and reduce costs, both of great importance to managed healthcare.51,52 The computerized patient record offers the opportunity to quickly assemble the patient’s past and present medical information for the provider,51,52 data that then can be integrated with evidence-based guidelines to assist the provider in directing the patient’s treatment in the most clinically effective and cost-conscious way.53 Multiple commercial and academic ventures are currently underway to develop the infrastructure necessary to support the computerized record.51-53 Computerized records have supported the implementation of guidelines. Manual reminder systems were effective in many, but not all, studies but computer implementation may prompt a review of the record-keeping system and may initiate developments such as multiprofessional integrated care pathways.54,55 Computerized decision support is being developed, but currently four different categories of health information are available from the computerized record:
    1. Health data such as prior history, medications, allergies, procedures, imaging studies, and consultations;
    2. Administrative data such as demographics and health plan information;
    3. Legal documents such as advance directives, records releases, and the like; and
    4. Knowledge databases with decision support systems and applicable clinical guidelines or pathways.   Where appropriate, guidelines may be integrated with patient information through the computerized record. An intriguing scenario to consider: treating a leg ulcer patient when prior records, prior radiology, prior microbiology, and photographs are available on a tablet computer. The computerized record, linked to a data system, also provides evidence-based guidelines as to treatment choices, risks involved, and outcomes. The computerized record can assist in streamlining administrative functions such as quality assurance, utilization review, risk management, workload allocation, and support for third party claims. Computerized decision support can improve guideline implementation by increasing the knowledge of preferred practice and reducing both inertia to previous practice and guideline complexity.54,55 It can be effective in improving the team’s concordance with guidelines and so also might be able to help increase guideline execution.55

  However, computerized records are in their infancy and not without substantial barriers.51-55 Overcoming the sociobehavioral issues in convincing physicians to move from the traditional paper record to the electronic record is requiring much effort and time.54,55 Also, computerized decision support is not effective when organizational or procedural changes are required that users consider to be beyond their tasks and responsibilities.55 Also, certain decision-making experts have little confidence in the ability of healthcare professionals to overcome practice pattern bias and compulsion; perhaps nonhuman checking mechanisms (eg, tablet computer) can prevent bias.5,56

  The key factor is that the guidelines are brought to the wound care professional’s attention at the time of the consultation and thus are able to influence the clinical decision prospectively.56 Audit of practice policy and guidelines, even if retrospective, seems both a necessary element of appropriate monitoring as well as a stimulus to more effective implementation, if the data are fed back to clinical decision makers.57 Because the evidence on which clinical guidelines are based can change, good guidelines will include a date by which the evidence, and the guidelines, should be reviewed.57

Conclusion

  Guidelines help provide decision-making support to wound care professionals. The best guidelines are developed from a systematic examination and appraisal of good evidence from well-conducted trials and supported by appropriate clinical expertise and critical appraisals/validation studies, leading to unambiguous recommendations. Adapting guidelines may entail taking broad-based guidelines and turning them into locally applicable guidelines or protocols. Although ownership is more readily achieved among those who have participated in development, this needs to be weighed against the benefits in adopting or adapting readily available guidelines. Adapting available guidelines to local circumstances may be sufficient to stimulate ownership. Guidelines are more likely to be effective if they are disseminated as part of an educational initiative and if the healthcare professional is prompted to use them at the time of patient consultation. Most managed care plans are concentrating their efforts on utilization and are using commercially available actuarial or empirically based guidelines to control costs. Evidence-based wound care guidelines are preferable.58 As payors and stakeholders focus on costs, wider application of wound care guidelines will undoubtedly be proposed or mandated. Wound care professionals should respond to this challenge by developing wound care guidelines that are uniquely suited to their practice environment and that can be integrated into the continuum of disease management and programs for managing care.

  Wound care is moving away from an empirically based process that often used isolated data to make clinical decisions. Wound care will become a process of applying the best data available to the clinical situation. The ultimate use of guidelines will be the development of evidence-based validated clinical tools that will be integrated with existing patient data and available to the wound care professional at the consultation. The gap between research and its practical clinical application in everyday practice will close. Clinical guidelines based on actuarial or cost-saving models and/or on opinion will be replaced by evidence-based guidelines adapted to the appropriate clinical situation. Rather than fearing guidelines as a threat imposed by health plans or other outside agencies, wound care professionals should continue leading the development of clinically sound evidence-based clinical guidelines as decision support tools rather than rigid recipes. Hopefully, these tools will help provide more efficient service and better care for patients.

Dr. Al-Benna is an Academic Attending Physician in Plastic and Reconstructive Surgery, Department of Plastic Surgery, BG University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany. Please address correspondence to: Sammy Al-Benna, MB, ChB, PhD, MRCS, Department of Plastic Surgery, BG University Hospital Bergmannsheil, Ruhr University Bochum, Buerkle-de-la Camp-Platz 1, 44789 Bochum, North Rhine-Westphalia, Germany; email: Sammy.Al-Benna@ruhr-uni-bochum.de.

References: 

1. Paine TG, Milne CT, Barr JE, Cordrey R, Dieter S, Harwood J, et al. The AAWC conceptual framework of quality systems for wound care. Ostomy Wound Manage. 2006;52:57–66.

2. Lyder CH, Shannon R, Empleo-Frazier O, McGeHee D, White C. A comprehensive program to prevent pressure ulcers in long-term care: exploring costs and outcomes. Ostomy Wound Manage. 2002;48:52–62.

3. MacLeod FE, Harrison MB, Graham ID. The process of developing best practice guidelines for nurses in Ontario: risk assessment and prevention of pressure ulcers. Ostomy Wound Manage. 2002;48:30–38.

4. Ballini L, Grilli R. Practice guidelines by specialist societies: a jump back into the past? Int J Clin Pract. 2007;61:1075–1076.

5. Mulrow CD, Lohr KN. Proof and policy from medical research evidence. J Health Polit Policy Law. 2001;26:249–266.

6. Al-Benna S. An easy and comfortable way of maintaining dressings in breast surgery: reply. Plast Reconstr Surg. 2008;121:681.

7. Al-Benna S, Alzoubaidi D, Al-Ajam Y. Evidence-based burn care — an assessment of the methodological quality of research published in burn care journals from 1982 to 2008. Burns. 2010 ;36: 1190–1195.

8. Grimshaw J, Eccles M, Thomas R, et al. Toward evidence-based quality improvement. Evidence (and its limitations) of the effectiveness of guideline dissemination and implementation strategies 1966–1998. J Gen Intern Med. 2006;21:14–20.

9. McKee M, Clarke A. Guidelines, enthusiasms, uncertainty, and the limits to purchasing. BMJ. 1995;310:101–104.

10. Moulds RF. Clinical practice guidelines: the need for greater transparency in formulating recommendations. Med J Aust. 2011;195:324–325.

11. Villagra V. Strategies to control costs and quality: a focus on outcomes research for disease management. Med Care. 2004;42(4 suppl):III24–30.

12. Haines T, McKnight L, Duku E, Perry L, Thoma A. The role of systematic reviews in clinical research and practice. Clin Plast Surg. 2008;35:207–214.

13. Honig PK. Systematic reviews and meta-analyses in the new age of transparency. Clin Pharmacol Ther. 2010;88:155–158.

14. Harrison MB, Légaré F, Graham ID, Fervers B. Adapting clinical practice guidelines to local context and assessing barriers to their use. CMAJ. 2010;182:E78–E84.

15. World Union of Wound Healing Societies. General publication. Available at: www.wuwhs.org/general_publications.php. Accessed July 23, 2012.

16. Wound Healing Society. Wound Care Guidelines. Available at: www.woundheal.org/index.php?option=com_content&view=article&id=180&Itemi...). Accessed July 23, 2012.

17. European Wound Management Association. EWMA Publications. Available at: http://ewma.org/english/publications.html. Accessed December 15, 2011.

18. Association for the Advancement of Wound Care. Professional Resource Center. www.aawconline.org/professionalresources.shtml. Accessed July 23, 2012.

19. Chassin MR, Loeb JM. The ongoing quality improvement journey: next stop, high reliability. Health Aff (Millwood). 2011;30(4):559–568.

20. Hutton JL, Eccles MP, Grimshaw JM. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implement Sci. 2008;3:52.

21. Field MJ, Lohr KN (eds). Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academy Press;1990.

22. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312:71–72.

23. National Guideline Clearinghouse. Available at: www.guideline.gov/faq.aspx. Accessed July 23, 2012.

24. Larkin GL, Hamann CJ, Monico EP, et al. Knowledge translation at the macro level: legal and ethical considerations. Acad Emerg Med. 2007;14:1042–1046.

25. Sox HC, Helfand M, Grimshaw J, et al. Comparative effectiveness research: Challenges for medical journals. Cochrane Database Syst Rev. 2010;8:ED000003.

26. Eldredge JD, Harris MR, Ascher MT. Defining the Medical Library Association research agenda: methodology and final results from a consensus process. J Med Libr Assoc. 2009;97:178–185.

27. Crowther M, Lim W, Crowther MA. Systematic review and meta-analysis methodology. Blood. 2010;116:3140–3146.

28. Worrall J. Evidence: philosophy of science meets medicine. J Eval Clin Pract. 2010;16:356–362.

29. Methodology Manual for ACCF/AHA Guideline Writing Committees. Available at: www.acc.org/qualityandscience/clinical/manual/pdfs/methodology.pdf. Accessed December 15, 2011.

30. Gupta S, Wan FT, Newton D, Bhattachary YA, Chignel MH, Strauss SE. WikiBuild: a new online collaboration process for multistakeholder tool development and consensus building. J Med Internet Res. 2011;13:e114.

31. Tan C, Treasure T, Browne J, Utley M, Davies CW, Hemingway H. Seeking consensus by formal methods: a health warning. J R Soc Med. 2007;100:10–14.

32. Fervers B, Carretier J, Bataillard A. Clinical practice guidelines. J Visc Surg. 2010;147: e341–349.

33. Alonso-Coello P, Irfan A, Solà I, Gich I, et al. The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies. Qual Saf Health Care. 2010;19:e58.

34. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. 2009;301:868–869.

35. Epstein RS, Sherwood LM. From outcomes research to disease management: a guide for the perplexed. Ann Intern Med. 1996;124:832–837.

36. Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Available at: www.guideline.gov/content.aspx?id=24361. Accessed December 15, 2011.

37. Lugtenberg M, Burgers JS, Westert GP. Effects of evidence-based clinical practice guidelines on quality of care: a systematic review.. 2009;18:385–392.

38. Pérez B, Porres I. Authoring and verification of clinical guidelines: a model driven approach. J Biomed Inform. 2010;43:520–536.

39. SOLUTIONS wound care algorithm. Available at: http://www.guideline.gov/content.aspx?id=13559. Accessed December 15, 2011.

40. Samanta A, Samanta J, Gunn M. Legal considerations of clinical guidelines: will NICE make a difference? J R Soc Med. 2003;96:133–138.

41. Francke AL, Smit MC, de Veer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak. 2008;8:38.

42. Lloyd-Vossen J. Implementing wound care guidelines: observations and recommendations from the bedside. Ostomy Wound Manage. 2009;55:50–55.

43. Bohmer RMJ. Designing care: aligning the nature and management of health care. Boston: Harvard Business Press; 2009.

44. van der Weijden T, Légaré F, Boivin A, et al. How to integrate individual patient values and preferences in clinical practice guidelines? A research protocol. Implement Sci. 2010;5:10.

45. Say R, Murtagh M, Thomson R. Patients’ preference for involvement in medical decision making: a narrative review. Pat Educ Couns. 2006;60:102–114.

46. Llewellyn-Thomas HA. Measuring patients’ preferences for participating in healthcare decisions: avoiding invalid observations. Health Expect. 2006;4:305–306.

47. O’Connor AM. Using decision aids to help patients navigate the ‘grey zone’ of medical decision making. CAMJ. 2007;176:1597–1598.

48. Preference Collaborative Review Group. Patients’ preferences within randomised trials: systematic review and patient level meta-analysis. BMJ. 2008;337: a1864.

49. Walden RJ. Legal considerations of clinical guidelines. J R Soc Med. 2003;96:472–473.

50. Hyams AL, Brandenburg JA, Lipsitz SR, Shapiro DW, Brennan TA. Practice guidelines and malpractice litigation: a two way street. Ann Intern Med. 1995;122:450–455.

51. Häyrinen K, Saranto K, Nykänen P. Definition, structure, content, use and impacts of electronic health records: a review of the research literature. Int J Med Inform. 2008;77:291–304.

52. Balas A, Al Sanousi A. Interoperable electronic patient records for health care improvement. Stud Health Technol Inform. 2009;150:19–23.

53. Conway PH, Clancy C. Transformation of health care at the front line. JAMA. 2009;301:763–765.

54. Goud R, van Engen-Verheul M, de Keizer NF, Bal R, Hasman A, Hellemans IM, Peek N. The effect of computerized decision support on barriers to guideline implementation: a qualitative study in outpatient cardiac rehabilitation. Int J Med Inform. 2010;79:430–437.

55. Goud R, de Keizer NF, ter Riet G, Wyatt JC, Hasman A, Hellemans IM, Peek N. Effect of guideline based computerised decision support on decision making of multidisciplinary teams: cluster randomised trial in cardiac rehabilitation. BMJ. 2009;338:b1440.

56. Paradis C. Bias in surgical research. Ann Surg. 2008;248:180–188.

57. Salomone M, Canavese C, Bergamo D, et al. Guidelines audit may overcome disparities in health care: experience of an Italian region. J Nephrol. 2006;19:296–302.

58. Al-Benna S. A discourse on the contributions of evidence-based medicine to wound care. Ostomy Wound Manage. 2010;56:48–54. 

Section: