|Year : 2001 | Volume
| Issue : 2 | Page : 201-206
Clinical practice guidelines in patient management
Department of Urology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
Department of Urology, JIPMER, Pondicherry - 605 006
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Efforts have always been made to evolve certain principles to reduce the variability in the management of patients and make medical care more appropriate. These efforts have become almost a movement since 1980s as evidenced in the development of clinical practice guidelines in all medical disciplines. This article describes the need for clinical practice guidelines and their development methods and qualities. Advantages and limitations of clinical practice guidelines are enumerated. The salient features of various available clinical practice guidelines in urology are also described.
Keywords: Clinical Practice Guidelines; Patient Management; Urology
|How to cite this article:|
Kumar S. Clinical practice guidelines in patient management. Indian J Urol 2001;17:201-6
| Introduction|| |
The management of patients is both an objective science and a subjective art. It is a science because various basic scientific principles are used. It is an art because patients are human beings with their built-in variability in health as well as in disease and thus individual patient management requires clinical judgement of doctors. Efforts have always been made to evolve certain principles to reduce the variability in the management of patients and make medical care more appropriate. However, these efforts have become almost a movement since 1980s. This is evidenced in the development of clinical practice guidelines,  group recommendations, , consensus conferences  and international consultations. ,
This article focusses on clinical practice guidelines. It describes the need for clinical practice guidelines and their development methods and qualities. It also discusses the advantages and limitations of clinical practice guidelines. The salient features of various available clinical practice guidelines in urology are also described.
| Terminology|| |
Clinical practice guidelines or clinical guidelines or practice guidelines is the most commonly used term to describe the recommended principles for patient management. The word "guideline" means a directing principle.  Clinical practice guidelines are defined as the official statements or policies of major organisations and agencies on the proper indications for performing a procedure or treatment or the proper management for specific clinical problems.  According to another definition, clinical guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. 
Other terms which have been used include standard. recommendation and option. The word `standard' is a measure of the degree of excellence required for a particular purpose.  Clinical standards are minimum mandated levels of performance.  Thus, requirements of the Occupational Safety and Health Administration (OSHA) for protection from transmission of infection to health care workers in the endoscopy suite are standards that must be universally followed.  In contrast, deviations from clinical practice guidelines may be acceptable under certain circumstances. A recommendation is an advice about a course of action' and an option is something that can be chosen.  Application of these terms will be explained later in the article. The words protocols and policies are not usually preferred. 
| The Need for Clinical Practice Guidelines|| |
The need for the development of clinical practice guidelines was felt in the United States for three reasons: 
(1) rising health care costs,
(2) practice variations, and
(3) reports of inappropriate care.
By 1990, health care costs in the United States had increased to more than $660 billion per year which was about 12% of the gross national product.  A need was felt to examine whether some health care services were unnecessary and thus could be eliminated.
Studies had documented variable rates of various procedures in different geographical areas. , Some variations could be explained by differences in patient populations, available resources and patient preferences.  However other variations could have been due to inadequate or excessive use of procedures perhaps resulting from uncertainty about their indications.
A study of medical records to measure the appropriateness of coronary angiography, carotid endarterectomy and upper gastrointestinal tract endoscopy showed that a substantial proportion of these procedures were inappropriate. 
An effectiveness initiative was launched by the US Department of Health and Human Services to obtain information on the effectiveness of clinical practices.  In 1990, the Agency for Health Care Policy and Research (AHCPR) was established in the United States to supervise the development and dissemination of clinical practice guidelines.  Initial topics for guideline development included benign prostatic hyperplasia, pain management, pressure sores, cataracts, urinary incontinence, sickle cell disease and depression.  American Urological Association was one of the Specialist Societies which started developing clinical practice guidelines. Independent research centres, hospitals, insurers and private enterprises also started taking part in the development of clinical guidelines.
| Development of Clinical Practice Guidelines|| |
Four methods of clinical practice guideline development have been described. 
1. Informal Consensus Method
In this method, guidelines are developed almost entirely on the basis of expert opinion. Groups of experts meeet and reach consensus by open discussion. Guidelines developed by informal consensus method include only recommendations and no information is provided about the process of their development. This conventional method of guideline development suffers from several weaknesses. The opinion of experts may lack validity and during an unstructured open discussion dominant persons may prevent the participation of other persons.
2. Formal Consensus Method
This approach also mainly depends on expert opinion but a planned systematic procedure is used for achieving consensus. Several procedures have been used for achieving consensus. In one procedure a structured, 2½ day conference including open discussion, plenary session, closed session and press conference was used for developing guidelines.  In another procedure, a two-step Delphi technique was used for developing guidelines. 
3. Evidence-Based Method
In evidence-based method of guideline development recommendations are linked to the quality of the underlying evidence.  Canadian Task Force on the Periodic Health Examination has classified recommendations into five categories based on different qualities of evidences.  Recommendation category A means that there is a good evidence (a randomised controlled trial) to support it. Recommendation category B implies that there is fair evidence (non-randomised controlled trials) to support it. Recommendation category C denotes that there is poor evidence (cohort or case control studies) to include it. Recommendation category D means that there is fair evidence (only uncontrolled comparisons) to exclude it. Recommendation category E implies that there is good evidence (only expert opinion) to exclude it.
The main limitation of pure evidence-based method is that often acceptable evidence may not be available and it is especially true for recent interventions.
4. Explicit Method
In this method the benefits, harms and costs of potential interventions are specified and estimates of the probability of each outcome are derived by using scientific evidence and formal analytic methods, whenever possible, and expert opinion, if necessary. ,, These estimates are presented as a balance sheet which allows patients, clinicians and policy-makers to review the potential benefits, harms and costs of each choice. The judgements about the desirability of the outcomes can be made by individual patients according to their perferences by using the balance sheet.
| Steps in Guideline Development|| |
The development of clinical practice guidelines involves the following steps:  selection of topic, selection of panel members, clarification of purpose, assessment of clinical benefits and harms, assessment of scientific evidence, assessment of expert opinion, summary of benefits and harms and determinations of appropriateness.
| Desirable Qualities of Clinical Practice Guidelines|| |
Several desirable qualities of clinical practice guidelines have been identified.  Guidelines are valid if they lead to health gains and costs predicted for them. Guidelines are reproducible if another group produces the same recommendations using the same evidence and methods. Guidelines are reliable if another health professional interprets and applies them in the same way. Guidelines should be developed by a process in which key affected groups participate. Guidelines should be clinically applicable and clinically flexible. They should be clear and should include the record of participants, assumptions, evidence and methods. Guidelines must state when and how they are to be reviewed in future.
Guidelines are highly valid if evidence is synthesised by formal meta-analysis or graded systematic review, all key disciplines take part in their development and they are developed using evidence-based methods.  Guidelines are. moderately valid if evidence is synthesised by ungraded systematic review or unsystematic review, only some key disciplines take part in their development and they are developed using formal consensus method.  The validity of guidelines is low if expert opinion is used,, only one key discipline takes part in their development'and they are developed using informal consensus method. 
| Dissemination and Implementation Methods|| |
Dissemination of guidelines can be done using specific educational intervention, continuing medical education, mailing targeted groups and publication in professional journals.  Various guideline implementation strategies include patient specific reminder at the time of consultation, patient specific feedback, general feedback and general reminders about the guidelines. 
| Advantages of Clinical Practice Guidelines|| |
Guidelines provide the busy clinician with current information and consensus opinion of professional experts. Guidelines have the potential for improving medical care and reducing health-care costs.
| Limitations of Clinical Practice Guidelines|| |
Guidelines may not be applicable to all patients because of individual social, psychological and economic differences.  Guidelines may become outdated unless they are periodically reviewed and revised in view of rapid scientific and technological advances.
| Clinical Practice Guidelines in Urology|| |
Several clinical practice guidelines are available in urology which have been developed by the Agency for Health Care Policy and Research (AHCPR), USA  and American Urological Association ,,,, [Table - 1]. These guidelines have been developed using explicit method. 
Treatment recommendations are graded by 3 levels of flexibility  based primarily on the strength of the scientific evidence for estimating outcomes of interventions. A standard is the least flexible of the 3 levels, a guideline is more flexible and an option is most flexible [Table - 2]. 
A treatment recommendation is considered a standard if the health and economic outcomes of the alternative interventions are sufficiently well-known to permit meaningful decisions and there is virtual unanimity about which intervention is preferred.
A treatment recommendation is considered a guideline if the health and economic outcomes of the interventions are sufficiently well-known to permit meaningful decisions and an appreciable but not unanimous majority agree on which intervention is preferred.
A treatment recommendation is considered an option if the health and economic outcomes of the interventions are not sufficiently well-known to permit meaningful decisions, preferences among the outcomes are not known, patient preferences are divided among alternative interventions and/or patients are indifferent about the alternative interventions. 
| Salient Features of Clinical Practice Guidelines in Urology|| |
1. Benign Prostatic Hyperplasia: Diagnosis and Management
The terms recommended, optional and not recommended indicate degree of desirability for specific diagnostic interventions. Recommended initial evaluation includes history, physical examination, digital rectal examination, urinalysis and creatinine and PSA is optional. Watchful waiting, surgery, balloon dilatation and medical therapy are 4 treatment alternatives. Only treatment recommendation of standard grade is that patients with mild symptoms need watchful waiting.
2. Management of Staghorn Calculi
Treatment recommendations of standard grade are that a newly diagnosed struvite staghorn calculus is an indication for active intervention and that a patient with newly diagnosed struvite staghorn calculus must be informed about the 4 accepted active treatment methods (open surgery, percutaneous nephrolithotomy, ESWL and a combination of percutaneous nephrolithotomy and ESWL) and their estimates for benefits and harms.
3. Management of Clinically Localised Prostate Cancer
Treatment recommendations of standard grade are that an assessment of life expectancy, overall health status and tumour characteristics is necessary before any treatment decisions can be made, that the patient must be informed about the accepted initial interventions (radical prostatectomy, radiation therapy and surveillance) and their estimates of benefits and harms and that patient preference should be considered in determining the treatment.
4. Treatment of Organic Erectile Dysfunction
Treatment recommendations of standard grade are that the patient and, if possible, his partner should be fully informed about treatment options (vacuum constriction device, intracavernous vasoactive drug injection therapy and penile prosthesis implantation), that the patient should be informed that a prolonged erection can occur after vasoactive drug injection and that penile prosthesis implantation should not be performed in men with psychogenic erectile dysfunction unless a psychiatrist or psychologist agrees with its necessity.
5. Management of Primary Vesicoureteral Reflux in Children 
There was no treatment recommendation of standard ,grade. Treatment recommendations were classified as guidelines, preferred options and reasonable alternatives. Treatment options selected by 8 or 9 of the 9 panel members were classified as guidelines. Treatment options selected by 5 to 7 members were called preferred options and treatment options that received 3 to 4 votes were called reasonable alternatives. Treatments that received 1 or 2 votes were termed as having no consensus.
6. Surgical Management of Female Stress Urinary Incontinence 
Treatment recommendations of standard grade are that the pre-operative evaluation of women with symptoms of stress, urinary incontinence should comprise history (impact of symptoms on life style), physical examination (objective demonstration of stress incontinence), urinalysis and diagnostic studies to assess symptom causes, frequency and severity of incontinent episodes and patient expectations from treatment and that the patient should be informed of the available surgical alternatives (retropubic suspensions, transvaginal suspensions, anterior repairs and sling procedures) and their estimated benefits and risks.
| End Note|| |
Clinical decision making has a subjective art component and an objective science component [Figure - 1]. Totally subjective (art) clinical decision making is undesirable because it is ineffective. Totally objective (science) clinical decision making is an unattainable ideal due to variability in patients and variability in diseases. Clinical practice guidelines endeavour to make clinical decision making more objective but clinical judgement is always needed on the part of clinicians for individual patient management to take care of individual variations.
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[Figure - 1]
[Table - 1], [Table - 2]