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EDUCATION
Year : 2001  |  Volume : 17  |  Issue : 2  |  Page : 201-206
 

Clinical practice guidelines in patient management


Department of Urology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India

Correspondence Address:
Santosh Kumar
Department of Urology, JIPMER, Pondicherry - 605 006
India
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Source of Support: None, Conflict of Interest: None


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   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

How to cite this URL:
Kumar S. Clinical practice guidelines in patient management. Indian J Urol [serial online] 2001 [cited 2019 Jan 22];17:201-6. Available from: http://www.indianjurol.com/text.asp?2001/17/2/201/21071



   Introduction Top


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, [1] group recommendations, [2],[3] consensus conferences [4] and international consultations. [5],[6]

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 Top


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. [7] 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. [8] According to another defini­tion, clinical guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. [9]

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. [7] Clinical standards are minimum mandated levels of perform­ance. [10] 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. [10] 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. [7] Application of these terms will be ex­plained later in the article. The words protocols and policies are not usually preferred. [11]


   The Need for Clinical Practice Guidelines Top


The need for the development of clinical practice guide­lines was felt in the United States for three reasons: [8]

(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. [12] 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. [13],[14] Some variations could be explained by differences in patient populations, available resources and patient preferences. [15] 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. [16]

An effectiveness initiative was launched by the US De­partment of Health and Human Services to obtain informa­tion on the effectiveness of clinical practices. [17] 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. [18] Ini­tial topics for guideline development included benign prostatic hyperplasia, pain management, pressure sores, cataracts, urinary incontinence, sickle cell disease and de­pression. [8] 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 Top


Four methods of clinical practice guideline development have been described. [19]

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. [20] In another procedure, a two-step Delphi tech­nique was used for developing guidelines. [21]

3. Evidence-Based Method

In evidence-based method of guideline development re­commendations are linked to the quality of the underlying evi­dence. [19] Canadian Task Force on the Periodic Health Examination has classified recommendations into five catego­ries based on different qualities of evidences. [22] 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. [23],[24],[25] 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 Top


The development of clinical practice guidelines involves the following steps: [8] 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 Top


Several desirable qualities of clinical practice guide­lines have been identified. [26] 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. [27] 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. [27] 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. [27]


   Dissemination and Implementation Methods Top


Dissemination of guidelines can be done using specific educational intervention, continuing medical education, mailing targeted groups and publication in professional journals. [27] Various guideline implementation strategies include patient specific reminder at the time of consulta­tion, patient specific feedback, general feedback and gen­eral reminders about the guidelines. [27]


   Advantages of Clinical Practice Guidelines Top


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 Top


Guidelines may not be applicable to all patients because of individual social, psychological and economic differ­ences. [28] Guidelines may become outdated unless they are periodically reviewed and revised in view of rapid scien­tific and technological advances.


   Clinical Practice Guidelines in Urology Top


Several clinical practice guidelines are available in urol­ogy which have been developed by the Agency for Health Care Policy and Research (AHCPR), USA [1] and Ameri­can Urological Association [29],[30],[31],[32],[33] [Table - 1]. These guidelines have been developed using explicit method. [34]

Treatment recommendations are graded by 3 levels of flexibility [34] 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]. [34]

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.[34]

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. [34]


   Salient Features of Clinical Practice Guidelines in Urology Top


1. Benign Prostatic Hyperplasia: Diagnosis and Management[1]

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[29]

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[30]

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[31]

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 [32]

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 [33]

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 Top


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.

 
   References Top

1.McConnell J, Barry M. Bruskewitz et al. Benign Prostatic Hyper­plasia: Diagnosis and Treatment. Clinical Practice Guidelines, No. 8. AHCPR Publication No. 94-0582. Rockville, MD, Agency for Health Care Policy and Research, Public Health Service. US De­partment of Health and Human Services, 1994.  Back to cited text no. 1    
2.Strandberg K et al (editors). Treatment of Urinary Tract Infections. Medical Products Agency, Lakemedelsverket, Uppsala, Sweden, 1990.  Back to cited text no. 2    
3.Beermann B et al (editors). Treatment of Benign Prostatic Hyper­plasia. Medical Products Agency, Lakemedelsverket. Uppsala, Swe­den. 1997.  Back to cited text no. 3    
4.Abrams P. Wein AJ (editors). The Overactive Bladder and its Treat­ments: Consensus Conference. BJU International 2000: 85 (Sup­plement 3): 1-66 and 1-84.  Back to cited text no. 4    
5.Abrams P, Khoury S, Wein AJ. Incontinence: 1st International Consulta­tion on Incontinence. Plymouth, UK: Plymbridge Distributors Ltd. 1999.  Back to cited text no. 5    
6.Cockett AT et al (editors). The 3rd International Consultation on BPH Recommendations of the International Consensus Commit­tee. Jersey, UK: Scientific Communication International. 1996.  Back to cited text no. 6    
7.The Concise Oxford Dictionary of Current English. Delhi: Oxford University Press, 1980.  Back to cited text no. 7    
8.Woolf SH. Practice guidelines: A new reality in medicine. I: Recent developments. Arch Intern Med 1990; 150: 1811-1818.  Back to cited text no. 8    
9.Institute of Medicine. Guidelines for clinical practice: from devel­opment to use. Washington DC: National Academic Press, 1992.  Back to cited text no. 9    
10.Zuccaro G Jr. Treatment and referral guidelines in gastroenterology. Gastroenterology Clinics of North America 1997: 26 (4): 845-857.  Back to cited text no. 10    
11.Onion CWR. Walley T. Clinical guidelines: development, imple­mentation and effectiveness. Postgrad Med J 1995: 71: 3-9.  Back to cited text no. 11    
12.Vincenzio JV. Trends in medical care costs: a look at the 1990s. Stat Bull Metrop Insur Co. 1990: January-March: 28-35.  Back to cited text no. 12    
13.Wennberg JE, Gittelsohn A. Small area variation in health care de­livery. Science 1973: 182: 1102-1108.  Back to cited text no. 13    
14.Lewis CE. Variations in the incidence of surgery. N Engl J Med 1969; 281: 880-885.  Back to cited text no. 14    
15.Leape LL, Park RE. Solomon DH, Chassin MR. Kosecoff J. Brook RH. Does inappropriate use explain small area variations in the use of health care services? JAMA 1990; 263: 669-672.  Back to cited text no. 15    
16.Chassin MR. Kosecoff J. Park RE et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA 1987: 258: 2533-2537.  Back to cited text no. 16    
17.Roper WL, Winkenwerder W. Hackbarth GM. Krakauer H. Effec­tiveness in health care: an initiative to evaluate and improve medi­cal practice. N En-1 J Med 1988; 319: 1197-1202.  Back to cited text no. 17    
18.Marwick C. New health care research agency reflects interest in evaluating quality. JAMA 1990; 263: 929-930.  Back to cited text no. 18    
19.Woolf SH. Practice guidelines: A new reality in medicine. II: Meth­ods of Developing Guidelines. Arch Intern Med 1992: 152: 946-952.  Back to cited text no. 19    
20.Institute of Medicine Council on Health Care Technology. Consen­sus Development at the NIH: Improving the Program. Washington DC: National Academic Press, 1990.  Back to cited text no. 20    
21.Park RE, Fink A, Brook RH, et al. Physician ratings of appropriate indications for six medical and surgical procedures. Am J Public Health 1986; 76: 766-772.  Back to cited text no. 21    
22.Canadian Task Force on the Periodic Health Examination. The pe­riodic health examination. Can Med Assoc J 1979: 121: 1193-1254.  Back to cited text no. 22    
23.Eddy DM. Practice policies: guidelines for methods. JAMA 1990: 263: 1839-1841.  Back to cited text no. 23    
24.Eddy DM. Guidelines for policy statements: the explicit approach. JAMA 1990; 263: 2239.  Back to cited text no. 24    
25.Eddy DM. Comparing benefits and harms: The balance sheet. JAMA 1990;263:2493.  Back to cited text no. 25    
26.Institute of Medicine Guidelines for Clinical practice: from devel­opment to use: Washington DC: National Academic Press, 1992.  Back to cited text no. 26    
27.Grimshaw JM, Hutchinson A. Clinical practice guidelines - do they enhance value for money in health care? British Medical Bulletin 1995; 51 (4): 927-940.  Back to cited text no. 27    
28.Woolf SH. Practice guidelines: A new reality in medicine. III: Impact on patient care. Arch Intern Med 1993: 153: 2646-2655.  Back to cited text no. 28    
29.Segura J, Preminger G, Assimos D et al. Nephrolithiasis clinical guidelines panel summary report on the management of staghorn calculi. J Urol 1994; 151: 1648-1651.  Back to cited text no. 29    
30.Middleton R, Thompson I. Austenfeld M et al. Prostate cancer clini­cal guidelines panel summary report on the management of clini­cally localised prostate cancer. J Urol 1995: 154: 2144-2148.  Back to cited text no. 30    
31.Montague D, Baroda J. Belker A et al. Clinical guidelines panel on erectile dysfunction summary report on treatment of organic erec­tile dysfunction. J Urol 1996; 156: 2007-2011.  Back to cited text no. 31    
32.Elder J, Peters C, Aront B et al. Pediatric vesicoureteral reflux guide­lines panel summary report on the management pf primary vesicoureteral reflux in children. J Urol 1997: 157: 1846-1851.  Back to cited text no. 32    
33.Leach G, Dmochowski R, Appel R et al. Female stress urinary in­continence clinical guidelines summary report on surgical manage­ment of female stress urinary incontinence. J. Urol 1997: 158: 875-880.  Back to cited text no. 33    
34.Eddy DM. A Manual for Assessing Health Practices and Design­ing Practice Policies: The Explicit Approach. Philadelphia: Ameri­can College of Physicians, 1992.  Back to cited text no. 34    


    Figures

  [Figure - 1]
 
 
    Tables

  [Table - 1], [Table - 2]



 

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    Abstract
    Introduction
    Terminology
    The Need for Cli...
    Development of C...
    Steps in Guideli...
    Desirable Qualit...
    Dissemination an...
    Advantages of Cl...
    Limitations of C...
    Clinical Practic...
    Salient Features...
    End Note
    References
    Article Figures
    Article Tables

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