The most important potential limitation of guidelines is that the recommendations made may not only be wrong but may lead to potentially negative health outcomes. Unless guidelines are frequently reviewed and updated, through the use of current, valid research, and EBP principles applied, guidelines may be promoting the use of treatments that are wrong and possibly harmful. According to Hoolf et al ‘recommendations that do not take due account of the evidence can result in sub-optimal, ineffective or harmful practice’ (1999, p.3).
Guidelines that are inflexible may cause harm by leaving insufficient ability for clinicians to adapt guidelines to the medical need of their patients, based on the evidence acquired from the clinical examination, medical history, and events leading up to the illness of injury (Shapiro et al1993, p. 219.
Even if the clinical guideline is excellent for a specific patient, incorrect diagnosis on the clinicians part, or ambiguity either the presenting patient or guideline, may lead to the use of the wrong guideline, and subsequent intervention; ultimately leading to a potentially negative health outcome.
Some clinical guidelines are created without sufficient scientific evidence and research. There are many clinical conditions in which there just hasn’t been enough good medical evidence to support the most appropriate and beneficial treatment. Therefore, what to recommend is often lacking, misleading, or misinterpreted. Only a small subset of what is done in medicine has been tested in appropriate, well-designed studies. Where studies do exist, the findings may be misleading because of design flaws that contribute to bias or poor generalisability. Guideline development groups often lack the time, resources, and skills to gather and scrutinise every last piece of evidence. Even when the data are certain, recommendations for or against interventions will involve subjective value judgments when the benefits are weighed against the harms. The value judgment made by a guideline development group may be the wrong choice for individual patients (Hoolf et al 1999, p.2).
For example the use of lignocaine versus amiodarone in VF arrest. Based on the ethical implications of developing good evidence, such as a randomly controlled double blind study, as to the benefit of using lignocaine or amiodarone in a patient with ventricular fibrillation (VF) in cardiac arrest, very little research has been conducted. As a result, many clinical guidelines on the subject continue to produce guidelines based on what has always been done, as opposed what has the best evidence or potential health benefits. According to Kudenchuck, Cobb and Copass who conducted a comparative study, within the UK, of intravenous amiodarone and intravenous lignocaine in ongoing shock-resistant VF in a small, randomized preliminary study (n=20 patients), which showed statistically significant improvement in resuscitation rates with amiodarone versus lignocaine (Kudenchuck et al1999, p. 871-2). However, further study, with larger cohorts were considered ethically inappropriate. Because such little study has been done conducted to suggest that amiodarone has some clinical benefits and better patient health outcomes than lignocaine, many clinical practice guidelines still recommend the use of lignocaine in VF. For example, NSW Ambulance Service still utilise the clinical intervention of lignocaine in VF cardiac arrest as opposed to amiodarone, based on the concept that it what we have always used (Adelstein and O’Connell 2001, protocol 15).
Furthermore, recommendations within clinical practice guidelines are often influenced by the opinions, clinical experience and composition of the guideline development group. Tests and treatments that experts believe are good for patients may in practice be inferior to other options, ineffective, or even harmful. The beliefs, to which experts subscribe, often in the face of conflicting data, can be based on misconceptions and personal recollections that misrepresent population norms (Woolf 1997, p. 205-8). This, in turn, may cause outdated practices and recommendations to perpetuate outmoded practices and technologies.
When developing clinical practice guidelines the patients’ needs may not be the only priority in making recommendations. Practices that are suboptimal from the patient’s perspective may be recommended to help control costs, serve societal needs, or protect special interests (those of doctors, risk managers, or politicians, for example).
The promotion of flawed guidelines by practices, payers, or healthcare systems can encourage, if not institutionalise, the delivery of ineffective, harmful, or wasteful interventions; while the same parties that stand to benefit from guidelines, such as the patients, healthcare professionals and the healthcare system may all be harmed (Field and Lohr 1990, p.4).
Flawed clinical guidelines harm practitioners by providing inaccurate scientific information and clinical advice, thereby compromising the quality of care. They may encourage ineffective, harmful, or wasteful interventions. Even when guidelines are correct, clinicians often find them inconvenient and time consuming to use. According to Feder ‘conflicting guidelines from different professional bodies can also confuse and frustrate practitioners’ (1994, p. 2-3).
Clinical practice guidelines can also hurt clinicians professionally. Auditors and managers may unfairly judge the quality of care based on criteria from invalid guidelines. The well-intentioned effort to make guidelines explicit and practical encourages the injudicious use of certain words such as ‘should’ instead of ‘may,’ and arbitrary numbers such as months of treatment and time intervals between tests, and simplistic algorithms when supporting evidence may be lacking. Algorithms that reduce patient care into a sequence of binary (yes/no) decisions often do injustice to the complexity of medicine and the parallel and iterative thought processes inherent in clinical judgment (Hurwitz and Eccles 1992, 1-2). Words, numbers, and simplistic algorithms can be used by those who judge clinicians to repudiate unfairly those who, for legitimate reasons, follow different practice policies. Guidelines are also potentially harmful to doctors as citable evidence for malpractice litigation and because of their economic implications (Hurwitz and Eccles 1992, 1-2).
Healthcare systems and payers may be harmed by guidelines if following them escalates utilisation, compromises operating efficiency, or wastes limited resources. Some clinical guidelines, especially those developed by medical and other professional groups unconcerned about financing, may advocate costly interventions that are unaffordable or that cut into resources needed for more effective services within the organisation (Delamothe and Smith 1998, p.1111-12).
Clinicians may seek secular (and even self serving) benefits from guidelines. In some healthcare systems, guidelines prompt government or private payers to provide coverage or to reimburse doctors for services. According to Feder, ‘specialties engaged in ‘turf wars’ to gain ownership over specific procedures or treatments may publish a guideline to affirm their role’ (1994, p. 2-3). Clinicians may turn to guidelines for medicolegal protection or to reinforce their position in dealing with administrators who disagree with their practice policies.