Which of the Following Is the Pro Not Responsible for Reviewing

• Journal List
• BMJ
• v.318(7182); 1999 February xx
• PMC1114973

BMJ. 1999 Feb twenty; 318(7182): 527–530.

Clinical guidelines

Potential benefits, limitations, and harms of clinical guidelines

Steven H Woolf

^a Department of Family Do, Virginia Commonwealth University, Fairfax, Virginia 22033, United states of america, ^b Center for Quality of Care Research, University of Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, ^c School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, ^d Middle for Wellness Services Enquiry, Academy of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, ^e Health Services Research Unit, University of Aberdeen, Aberdeen AB9 2ZD

Richard Grol

^a Department of Family unit Do, Virginia Republic University, Fairfax, Virginia 22033, USA, ^b Centre for Quality of Care Research, Academy of Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, ^c Schoolhouse of Health and Related Enquiry, University of Sheffield, Sheffield S1 4DA, ^d Middle for Wellness Services Enquiry, Academy of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, ^e Wellness Services Enquiry Unit, University of Aberdeen, Aberdeen AB9 2ZD

Allen Hutchinson

^a Department of Family Practice, Virginia Commonwealth University, Fairfax, Virginia 22033, USA, ^b Center for Quality of Care Research, University of Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, ^c School of Wellness and Related Enquiry, University of Sheffield, Sheffield S1 4DA, ^d Center for Wellness Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, ^e Health Services Research Unit of measurement, University of Aberdeen, Aberdeen AB9 2ZD

Martin Eccles

^a Department of Family unit Exercise, Virginia Republic University, Fairfax, Virginia 22033, The states, ^b Center for Quality of Care Research, Academy of Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, ^c School of Health and Related Research, Academy of Sheffield, Sheffield S1 4DA, ^d Center for Health Services Research, Academy of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, ^eastward Health Services Enquiry Unit, University of Aberdeen, Aberdeen AB9 2ZD

Jeremy Grimshaw

^a Department of Family Practice, Virginia Commonwealth University, Fairfax, Virginia 22033, USA, ^b Center for Quality of Care Research, University of Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, ^c School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, ^d Center for Health Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, ^east Health Services Inquiry Unit, University of Aberdeen, Aberdeen AB9 2ZD

Over the past decade, clinical guidelines have increasingly get a familiar office of clinical practice. Every twenty-four hour period, clinical decisions at the bedside, rules of performance at hospitals and clinics, and health spending by governments and insurers are being influenced by guidelines. Equally defined by the Found of Medicine, clinical guidelines are "systematically developed statements to aid practitioner and patient decisions about appropriate health treat specific clinical circumstances."¹ They may offering concise instructions on which diagnostic or screening tests to order, how to provide medical or surgical services, how long patients should stay in hospital, or other details of clinical practice.

The broad interest in clinical guidelines that is stretching across Europe, N America, Commonwealth of australia, New Zealand, and Africa (box) has its origin in issues that about healthcare systems face: rising healthcare costs, fueled by increased demand for care, more expensive technologies, and an ageing population; variations in service delivery among providers, hospitals, and geographical regions and the presumption that at least some of this variation stems from inappropriate care, either overuse or underuse of services; and the intrinsic want of healthcare professionals to offer, and of patients to receive, the best intendance possible. Clinicians, policy makers, and payers run into guidelines equally a tool for making care more consistent and efficient and for closing the gap between what clinicians practise and what scientific evidence supports.

As guidelines diffuse into medicine, there are important lessons to learn from the firsthand experience of those who develop, evaluate, and employ them.³ This commodity, the offset of a iv part series to reflect on these lessons, examines the potential benefits, limitations, and harms of clinical guidelines. Futurity articles will review lessons learned well-nigh their development,⁴ legal and emotional ramifications,⁵ and finally their implementation.^half-dozen

Summary points

• Clinical guidelines are an increasingly familiar function of clinical practice

• They have potential benefits and harms

• Rigorously adult evidence based guidelines minimise the potential harms

• Clinical guidelines are only 1 pick for improving the quality of care

Potential benefits of clinical practice guidelines

The chief benefit of guidelines is to improve the quality of care received by patients. Although it has been shown in rigorous evaluations that clinical do guidelines can improve the quality of care,^{7 ,8} whether they achieve this in daily practice is less articulate. This is partly considering patients, doctors, payers, and managers define quality differently and considering electric current testify well-nigh the effectiveness of guidelines is incomplete.

Potential benefits for patients

For patients (and almost everyone else in health care), the greatest benefit that could be accomplished past guidelines is to meliorate wellness outcomes. Guidelines that promote interventions of proved benefit and discourage ineffective ones have the potential to reduce morbidity and mortality and meliorate quality of life, at least for some conditions. Guidelines can also amend the consistency of care; studies around the world bear witness that the frequency with which procedures are performed varies dramatically among doctors, specialties, and geographical regions, even after case mix is controlled for.^ix Patients with identical clinical problems receive different care depending on their clinician, hospital, or location. Guidelines offer a remedy, making it more than likely that patients will be cared for in the aforementioned fashion regardless of where or by whom they are treated.

Overview of international action on guidelines

More details in the grade of a full paper are available on the BMJ'south website.	Federal republic of germany, Italy, and Spain—Guidelines are on the rise in Germany and Italy, where a guidelines database is existence adult to support national healthcare reform. In Espana, the Catalan Bureau for Health Engineering Assessment has begun preparing guidelines and teaches methods of guideline development. Consensus guidelines figure prominently in Catalonian healthcare reform.
Europe	North America
Great britain—Guidelines have existed in England for decades; contempo years take heightened involvement in guidelines as a tool for implementing health intendance based on proof of effectiveness. Professional person bodies, encouraged by the NHS, are producing guidelines for use past providers to amend care and by purchasers to guide contracting and commissioning decisions. The NHS is now using a critical appraisement instrument to determine which guidelines to commend to wellness government. Although historically virtually British guidelines take derived from consensus conferences or good opinion, there is growing interest in using explicit methods to develop prove based guidelines. The Scottish Intercollegiate Guideline Network uses a systematic multidisciplinary arroyo to set testify based guidelines. National guidelines are converted at the local level into formats that encourage adoption in practice.	Guidelines, protocols, and care pathways adult by professional societies and other groups are common in American hospitals and health plans, where they are used for quality improvement and price control. Although some evidence based guidelines produced past government panels and medical societies have received prominent attention, many healthcare organisations purchase commercially produced guidelines that emphasise shortened lengths of stay and other resource savings. Canadian wellness intendance is largely land funded, but a similar proportion of organisations as in the United States use guidelines. The massive guideline industry in America has created special problems such as information overload. Directories and newsletters have become necessary to monitor the hundreds of guideline topics and sponsoring organisations. Americans have articulated evidence based methods in manuals and other reports. This expertise has not always plant its mode into actual guidelines—most of which remain rooted in consensus or stance.
The Netherlands—In the Netherlands, the Dutch College of Full general Practitioners has produced guidelines since 1987, issuing more than 70 guidelines at a rate of 8-x topics per year. A rigorous procedure involves an assay of the scientific literature, combined with consensus discussions among ordinary general practitioners and content experts. A systematic implementation programme follows guideline evolution. Updating of the guidelines has recently begun. Guidelines effigy prominently in Dutch wellness policy.	Commonwealth of australia and New Zealand
Finland and Sweden—In Finland, national and local bodies have issued more than 700 guidelines since 1989. A programme for evidence based guideline development has been started recently. Guidelines in Sweden announced in reports past the Swedish Quango on Technology Assessment in Health Care, an internationally consulted technology assessment agency, and in recommendations from other regime bodies.	Guidelines in Australia date to the belatedly 1970s, when the state health authority began endorsing guideline booklets,two and they continue on a large calibration today. There is an increasing emphasis on the need for evidence based methods.
France—In France, the Agence Nationale de l'Accréditation et d'Évaluation en Santé has published over 100 guidelines based on consensus conferences or modified guidelines from other countries. It has likewise adult more 140 références médicales, guidelines on procedural indications for utilize in setting coverage policy. The guidelines are disseminated through networks of full general practitioners, and their effectiveness is evaluated through local audits.	Guidelines in New Zealand emanate directly from national health policy. New Zealand's choosing to restrict services at the signal of service through guidelines received international attending in debates most rationing. One guideline on hypertension and a subsequent cholesterol guideline from the New Zealand National Heart Foundation broke new basis methodologically past linking recommendations to patients' accented chance probabilities rather than to generic handling criteria .

Clinical guidelines offering patients other benefits. Those accompanied by "consumer" versions (leaflets, audiotapes, or videos in lay linguistic communication) or publicised in magazines, news reports, and internet sites inform patients and the public about what their clinicians should exist doing. Increasingly, lay guidelines summarise the benefits and harms of available options, along with estimates of the probability or magnitude of potential outcomes.¹⁰ Such guidelines empower patients to make more informed healthcare choices and to consider their personal needs and preferences in selecting the best option. Indeed, clinicians may first larn near new guidelines (or be reminded of oversights) when patients ask virtually recommendations or treatment options.

Finally, clinical guidelines tin help patients by influencing public policy. Guidelines telephone call attention to underrecognised health problems, clinical services, and preventive interventions and to neglected patient populations and loftier risk groups. Services that were not previously offered to patients may be fabricated available as a response to newly released guidelines. Clinical guidelines adult with attending to the public good tin promote distributive justice, advocating better delivery of services to those in need. In a cash limited healthcare system, guidelines that improve the efficiency of health care free up resource needed for other (more equitably distributed) healthcare services.

Potential benefits for healthcare professionals

Clinical guidelines can improve the quality of clinical decisions. They offering explicit recommendations for clinicians who are uncertain almost how to proceed, overturn the beliefs of doctors accepted to outdated practices, amend the consistency of care, and provide authoritative recommendations that reassure practitioners about the ceremoniousness of their handling policies. Guidelines based on a critical appraisal of scientific evidence (evidence based guidelines) clarify which interventions are of proved benefit and document the quality of the supporting data. They alert clinicians to interventions unsupported by good science, reinforce the importance and methods of critical appraisal, and call attention to ineffective, dangerous, and wasteful practices.

Clinical guidelines can back up quality improvement activities. The beginning step in designing quality assessment tools (standing orders, reminder systems, critical intendance pathways, algorithms, audits, etc) is to reach agreement on how patients should be treated, frequently by developing a guideline. Guidelines are a common point of reference for prospective and retrospective audits of clinicians' or hospitals' practices: the tests, treatments, and treatment goals recommended in guidelines provide ready process measures (review criteria) for rating compliance with all-time intendance practices.¹¹

Medical researchers benefit from the spotlight that evidence based guidelines shine on gaps in the bear witness. The methods of guideline development that emphasise systematic reviews focus attention on fundamental research questions that must be answered to establish the effectiveness of an intervention¹² and highlight gaps in the known literature. Critical appraisal of the evidence identifies design flaws in existing studies. Recognising the presence and absenteeism of testify can redirect the piece of work of investigators and encourage funding agencies to support studies that fulfill this effectiveness based agenda.

Finally, some uses of clinical guidelines straddle the purlieus betwixt benefits and harms. Clinicians may seek secular (and even self serving) benefits from guidelines. In some healthcare systems, guidelines prompt government or individual payers to provide coverage or to reimburse doctors for services. Specialties engaged in "turf wars" to gain buying over specific procedures or treatments may publish a guideline to affirm their function. Clinicians may plough to guidelines for medicolegal protection or to reinforce their position in dealing with administrators who disagree with their practise policies.

Potential benefits for healthcare systems

Healthcare systems that provide services, and regime bodies and individual insurers that pay for them, have found that clinical guidelines may be effective in improving efficiency (often by standardising care) and optimising value for money.¹³ Implementation of certain guidelines reduces outlays for hospitalisation, prescription drugs, surgery, and other procedures. Publicising adherence to guidelines may also amend public image, sending messages of commitment to excellence and quality. Such letters tin promote adept will, political support, and (in some healthcare systems) revenue. Many believe that the economic motive backside clinical guidelines is the principal reason for their popularity.

Potential limitations and harms of guidelines

The about important limitation of guidelines is that the recommendations may be incorrect (or at to the lowest degree wrong for individual patients). Apart from human considerations such as inadvertent oversights by busy or weary members of the guideline group, guideline developers may err in determining what is all-time for patients for three important reasons.

Firstly, scientific bear witness well-nigh what to recommend is frequently lacking, misleading, or misinterpreted. Only a small subset of what is done in medicine has been tested in advisable, well designed studies. Where studies do exist, the findings may be misleading because of design flaws which contribute to bias or poor generalisability. Guideline development groups often lack the fourth dimension, resources, and skills to get together and scrutinise every last piece of evidence. Even when the data are certain, recommendations for or against interventions volition involve subjective value judgments when the benefits are weighed against the harms. The value judgment made by a guideline development group may be the incorrect choice for individual patients.

Secondly, recommendations are influenced by the opinions and clinical feel and composition of the guideline evolution group. Tests and treatments that experts believe are skilful for patients may in practice exist inferior to other options, ineffective, or even harmful. The beliefs to which experts subscribe, frequently in the face of conflicting data, can be based on misconceptions and personal recollections that misrepresent population norms.¹⁴

Thirdly, patients' needs may not be the merely priority in making recommendations. Practices that are suboptimal from the patient's perspective may be recommended to assist control costs, serve societal needs, or protect special interests (those of doctors, chance managers, or politicians, for example).

The promotion of flawed guidelines past practices, payers, or healthcare systems can encourage, if not institutionalise, the delivery of ineffective, harmful, or wasteful interventions. The aforementioned parties that stand to benefit from guidelines—patients, healthcare professionals, the healthcare organisation—may all be harmed.

Potential harms to patients

The greatest danger of flawed clinical guidelines is to patients. Recommendations that do not take due account of the evidence can outcome in suboptimal, ineffective, or harmful practices. Guidelines that are inflexible can harm past leaving insufficient room for clinicians to tailor care to patients' personal circumstances and medical history. What is best for patients overall, as recommended in guidelines, may be inappropriate for individuals; blanket recommendations, rather than a menu of options or recommendations for shared decision making, ignore patients' preferences.¹⁵ Thus the ofttimes touted benefit of clinical guidelines—more consequent exercise patterns and reduced variation—may come at the expense of reducing individualised care for patients with special needs. Lay versions of guidelines, if improperly constructed and worded, may mislead or confuse patients and disrupt the doctor-patient human relationship.

Clinical guidelines can adversely affect public policy for patients. Recommendations against an intervention may pb providers to drop admission to or coverage for services. Imprudent recommendations for plush interventions may displace limited resource that are needed for other services of greater value to patients. The tendency of guidelines to focus attention on specific health bug is subject to misuse past proponents and advocacy groups, giving the public (and health professionals) the wrong impression about the relative importance of diseases and the effectiveness of interventions.

Potential harms to healthcare professionals

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 ofttimes find them inconvenient and fourth dimension consuming to utilize. Alien guidelines from different professional bodies can besides confuse and frustrate practitioners.^xvi Outdated recommendations may perpetuate outmoded practices and technologies.

Clinical guidelines can besides 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 sure words ("should" instead of "may," for example), arbitrary numbers (such every bit months of treatment, intervals betwixt screening tests), and simplistic algorithms when supporting evidence may exist lacking. Algorithms that reduce patient care into a sequence of binary (yes/no) decisions often practise injustice to the complexity of medicine and the parallel and iterative thought processes inherent in clinical judgment. Words, numbers, and simplistic algorithms can exist used by those who gauge clinicians to repudiate unfairly those who, for legitimate reasons, follow different do policies. Guidelines are as well potentially harmful to doctors as citable show for malpractice litigation and considering of their economic implications. Referral guidelines tin can shift patients from one specialty to another. A negative (or neutral) recommendation may prompt providers to withdraw availability or coverage. A theoretical business concern is that clinicians may exist sued for not adhering to guidelines although, as discussed in the tertiary paper in this series,⁵ this has not however get an important reality.

Guidelines can damage medical investigators and scientific progress if further research is inappropriately discouraged. Guidelines that conclude that a procedure or treatment lacks evidence of benefit may exist misinterpreted by funding bodies as grounds for not investing in further research and for not supporting efforts to refine previously ineffective technologies.

Potential harms to healthcare systems

Healthcare systems and payers may be harmed by guidelines if post-obit them escalates utilisation, compromises operating efficiency, or wastes limited resource. Some clinical guidelines, especially those adult by medical and other groups unconcerned almost financing, may abet plush interventions that are unaffordable or that cut into resources needed for more effective services.

Conclusion

In the face of these mixed consequences, attitudes about whether clinical guidelines are good or bad for medicine vary from 1 group to another. Guidelines produced by governments or payers to control spiraling costs may constitute responsible public policy but may be resented by clinicians and patients as an invasion of personal autonomy. Guidelines developed past specialists may seem cocky serving, biased, and threatening to generalists. To specialists, guidelines adult without their input exercise not contain adequate expertise. Inflexible guidelines with rigid rules near what is appropriate are popular with managers, quality auditors, and lawyers just are decried as "cookbook medicine" past doctors faced with not-uniform clinical problems and as invalid by those who cite the lack of supporting data.

These disparate sentiments and the growing sensation of their limitations and harms have done petty to stem the rapid promulgation of guidelines around the earth (see box). The unbridled enthusiasm for guidelines, and the unrealistic expectations well-nigh what they will accomplish, frequently betrays inexperience and unfamiliarity with their limitations and potential hazards. Naive consumers of guidelines accept official recommendations on face value, especially when they carry the imprimatur of prominent professional groups or regime bodies.

More discerning users of clinical guidelines scrutinise the methods by which they have been developed.^four Moreover, a more key problem is that guidelines may exercise little to alter practice behaviour.^vi

Clinical guidelines are merely one option for improving the quality of care. Besides oft, advocates view guidelines as a "magic bullet" for healthcare issues and ignore more constructive solutions. Clinical guidelines make sense when practitioners are unclear most appropriate practice and when scientific evidence can provide an reply. They are a poor remedy in other settings. When clinicians already know the data contained in guidelines, those concerned with improving quality should redirect their efforts to identify the specific barriers, beyond knowledge, that stand in the style of behaviour change.

Supplementary Cloth

[extra: Clinical guidelines]

Footnotes

Series editors: Martin Eccles, Jeremy Grimshaw

Funding: The Health Services Research Unit is funded by the Principal Scientist Function of the Scottish Office Section of Health. However, the views expressed are those of the authors and not the funding body.

website extra: An boosted article—an international overview—is available on our website, as is a longer version of this article world wide web.bmj.com

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1114973/