Cheah, J (2000). "Development and implementation of a clinical pathway programme in an acute care general hospital in Singapore." International Journal for Quality in Health Care 12(5): 403-12.

A critical or clinical pathway defines the optimal care process, sequencing and timing of interventions by doctors, nurses and other health care professionals for a particular diagnosis or procedure. Clinical pathways are developed through collaborative efforts of clinicians, case managers, nurses, pharmacists, physiotherapists and other allied health care professionals with the aim of improving the quality of patient care, while minimizing cost to the patient. The use of clinical pathways has increased over the past decade in the USA, the UK, Australia, and many other developed countries. However, its use in the developing nations and Asia has been sporadic. To the author's knowledge, there is to date, no published literature on the use and impact of clinical pathways on the quality and cost of patient care in the Asian health care setting. This paper provides a qualitative account of the development and implementation of a clinical pathway programme (using the example of patients with uncomplicated acute myocardial infarction) in an acute care general hospital in Singapore. The paper concludes that clinical pathways, when implemented in the context of an acute care hospital, can result in improvements in the care delivery process.

Hospital Demand Management Group (2001). ED Critical Pathways Project Final Report. Melbourne, Department of Human Services: 1-28.

A recent study, commissioned by the Victorian Department of Human Services, explored the use of Short Stay Units in Victorian Hospitals. This study confirmed that few critical pathways and/or guidelines were used in Victorian Emergency Departments. Aim: To develop a pathway for an ED condition, building on previous work undertaken in this area, with a focus on high volume ED presentations that do not require inpatient admission. Outcomes: 17 Victorian Emergency Departments participated in the project and developed a total of 25 pathways for conditions including asthma (adult & paediatric), cellulitis, DVT, chest pain, and renal colic. Additional outcomes for this project include: pathway development resource manual, educational presentation, evidence based literature review for four commonly selcted conditions, and an ED pathway networking opportunity.

Silagy, C, Stead, L, et al. (2001). "Use of systematic reviews in clinical practice guidelines: case study of smoking cessation." British Medical Journal 323(7317): 833-836.

Objective: To examine the extent to which recommendations in the national guidelines for the cessation of smoking are based on evidence from systematic reviews of controlled trials.
Design: Retrospective analysis of recommendations for the national guidelines for the cessation of smoking.
Materials: National guidelines in clinical practice on smoking cessation published in English.
Main outcome measures: The type of evidence (systematic review of controlled trials, individual trials, other studies, expert opinion) used to support each recommendation. We also assessed whether a Cochrane systematic review was available and could have been used in formulating the recommendation.
Results: Four national smoking cessation guidelines (from Canada, New Zealand, the United Kingdom, and the United States) covering 105 recommendations were identified. An explicit evidence base for 100%, 89%, 68%, and 98% of recommendations, respectively, was detected, of which 60%, 56%, 59%, and 47% were based on systematic reviews of controlled studies. Cochrane systematic reviews could have been used to develop between 39% and 73% of recommendations but were actually used in 0% to 36% of recommendations. The UK guidelines had the highest proportion of recommendations based on Cochrane systematic reviews.
Conclusions: Use of systematic reviews in guidelines is a measure of the "payback" on investment in research synthesis. Systematic reviews commonly underpinned recommendations in guidelines on smoking cessation. The extent to which they were used varied by country and there was evidence of duplication of effort in some areas. Greater international collaboration in developing and maintaining an evidence base of systematic reviews can improve the efficiency of use of research resources.

Clarke, J (1984). "A concise model for the management of possible appendicitis." Medical Decision Making 4(3): 331-8.

A conventional decision tree model for the management of patients with possible appendicitis requires at least 15 pieces of information. It makes three assumptions. A more concise decision tree model of the problem is presented here. It requires six pieces of information and prevents unintended mathematical shifts between disease states. It makes an additional five assumptions. The concise decision tree model was compared with the larger original model. Expert surgeons gave opinions on the management of a theoretical patient with possible appendicitis and the information necessary to solve the problem by decision analysis. Information from 25 surgeons whose opinions were consistent with analyses of their information using the original large decision tree was used to reanalyze the problem using the concise decision tree. The concise decision tree agreed with the original analysis in 24 of 25 cases (96%), despite violation of the five additional assumptions in 103 of 125 possible instances. The surgeon's decision can be shown by this model to be a function of the probability of appendicitis, the probability of perforation during observation, and the relative differences in outcomes between avoidable perforation and unnecessary operation.

Cowell, V, Ciraulo, D, et al. (1998). "Trauma 24-hour observation critical path." Journal of Trauma-Injury Infection and Critical Care 45(1): 147-50.

Background: The 24-hour observation critical pathway for trauma is a clinical tool developed to expedite health care delivery to minimally injured patients. The use of patient care, BS, guidelines and physician-approved standing orders was implemented in a Level I trauma center.
Methods: A retrospective chart review was performed of 122 patients admitted via the emergency department between December 1, 1993, and May 31, 1994. All patients were evaluated in the emergency department by emergency medicine and trauma physicians and deemed appropriate for 24-hour observation. The information collected included patient demographics, hospital charges, injuries, length of stay, diagnostic tests, consultations, and variances from the critical pathway.
Results: During the 6-month study period, there were 600 trauma admissions. Of those admissions, 122 patients (20%) were evaluated in the emergency department and deemed appropriate for enrollment in the 24-hour observation pathway. The charts of these patients were reviewed. Fourteen admissions were determined inappropriate for the critical pathway because of the severity of injuries or discharge against medical advice. One hundred eight charts were evaluated further. Eighty-nine patients (80%) completed the critical pathway with a length of stay of 24 hours.
Conclusion: The 24-hour observation critical pathway was designed and used appropriately as exemplified by an overall 80% completion rate. The critical pathway offers a mechanism to streamline care of the minimally injured trauma patient. It also serves as a quality-improvement tool for increasing efficiency, decreasing utilization of resources, and decreasing length of stay.

Dalton, P, Macintosh, D, et al. (2001). "Variance analysis in clinical pathways for total hip and knee joint arthroplasty." Journal of Quality in Clinical Practice 20(4): 145-9.

Clinical pathways are being increasingly used for daily patient care. The pathways consist of a sequence of critical treatment events matched to the patient's recovery. Variance analysis identifies deviations from the pathway and can be used for quality improvement and clinical audit. The aim of this study is to analyse the variances from clinical pathways in two common elective orthopaedic operations. A prospective variance analysis was performed from the clinical pathways of all patients undergoing total hip and total knee arthroplasty over a 12 month period. Variances were categorised according to their source and then further divided into serious and non-serious variances. A total of 65 patients underwent total knee replacement during the study. Eleven serious variances were recorded in eight of these patients (12.3%) with a surprisingly high number of cardiac events. A total of 52 patients underwent total hip replacement with nine serious variances recorded in seven of these patients (13.5%). Clinical pathways can be used as a means of incorporating evidence-based medicine into clinical practice. Variance analysis of the pathways can be utilised as a process of quality control and to improve patient outcomes. Serious variances within this study were higher than anticipated.

Department of Veterans' Affairs (2001). Community Nursing. Clinical Pathways Manual. DVA Website.

In June 2000, a set of nine community nursing clinical pathways was published to assist providers in the delivery of quality home nursing services to veterans and war widows. The clinical pathways were developed by the Bendigo Health Care Group for the Department of Veterans' Affairs and reflect the top nine categories of client types as identified by contracted community nursing providers across Australia.
The Department wants to protect the validity of the pathways; any agency who changes the content of the current pathways to meet their specific requirements should do so under their own name and logo but should ensure the Commonwealth Department of Veterans' Affairs is acknowledged for its initiative in sponsoring this developmental work.

Halm, E, Atlas, S, et al. (2000). "Understanding physician adherence with a pneumonia practice guideline." Archives of Internal Medicine 160: 98-104.

Background: Adherence with clinical practice guidelines is highly variable. Reasons for their inconsistent performance have not been well studied.
Objective: To determine the patient, system, and physician factors that may explain why physicians may not follow guidelines.
Methods: We used chart review and physician surveys to measure adherence with an actively implemented guideline to reduce hospitalizations for patients coming to the emergency department with community-acquired pneumonia. Logistic regression analyses were used to identify factors associated with guideline nonadherence.
Results: Overall nonadherence with the guideline was 43.6%, with 71 of 163 low-risk patients with pneumonia being hospitalized despite the recommendation for outpatient therapy. In univariate analyses, nonadherence to the guideline was more likely for patients who were aged 65 years or older, were male, were employed, and had multilobar disease or other comorbid conditions (P<.05). Active involvement of a primary care physician in the admission decision also increased nonadherence (odds ratio, 4.9; 95% confidence interval, 2.2-11.0). Physicians with more pneumonia experience were more likely not to follow the guideline (P<.001). In multivariate models, the odds of nonadherence were 2 to 3 times greater when patients were 65 years or older, were male, or had multilobar disease, or the primary care physician was involved in the triage decision (P<.05). Physicians' reasons for admission were the presence of active comorbidities (55%), the primary care physician's wish for hospitalization (41%), the presence of worse pneumonia than the guideline indicated (36%), patient preference (17%), and inadequate home support (16%).
Conclusions: Nonadherence to a pneumonia guideline was associated with a variety of patient, system, and physician factors. Guideline implementation strategies should take into account the heterogeneous forces that can influence physician decision making.

Jankowski, R (2001). "Implementing national guidelines at local level." British Medical Journal 322: 1258-9.

FULL TEXT
Both internationally and nationally, the introduction of clinical guidelines is seen as a means of improving healthcare outcomes and reducing costs.1 In the NHS primary care professionals, hospital trusts, and health authorities are becoming increasingly involved in disseminating, implementing, and evaluating local clinical guidelines. 2 3 Though evaluations of the most effective strategies by which to implement guidelines have been undertaken, 4 5 few studies have evaluated the impact of such guidelines on both patient outcomes and health service costs.
Two evaluations of similar sets of clinical guidelines on the management of infertile couples (one of them in this week's BMJ) have now shown improvement in general practitioners' performance. Following the use of the guidelines their performance in obtaining the clinical history and performing appropriate examination and investigations before referring patients to hospital had improved (p 1282). 6 7 Compared with the earlier study in Aberdeen,7 the Glasgow study reported this week showed a more modest improvement in the proportion of referrals that had been appropriately managed.6 This difference in findings between the two studies seems to reinforce the importance of taking local factors into account when developing and implementing guidelines. Local factors suggested in the Glasgow study include the larger number of referral centres and a greater number of couples where partners were registered with different general practitioners, thereby making investigations more problematic.
Also, in the Glasgow study effective implementation strategies, such as educational interactive meetings and practice visits, 8 were taken up by only a minority of general practitioners in the intervention group. The use of such strategies was not mentioned in the Aberdeen study, though there was a strong history of research collaboration across the primary-secondary interface.
The novel message of the comparison between the two studies, however, is that a more comprehensive evaluation of the guidelines questions the underlying assumptions about improvements in terms of patient outcomes and reduced costs. Unlike the Aberdeen study, the Glasgow study also measured clinical behaviour in the secondary sector. Despite the increase in the rate of appropriate investigations carried out by the intervention practices, a high proportion of tests were repeated in hospital, even though the results were normal before referral.6 There was also no demonstrable difference between control and intervention practices in the number of hospital outpatient appointments needed before the management plan was agreed in secondary care for couples. This lack of the expected changes in clinicians' behaviour in secondary care may also explain the lack of reduction in direct NHS costs.
This disappointing finding might have been avoided if the secondary care professionals had taken part in developing the guidelines. Common clinical problems require shared management between primary care and the hospital teams. The importance of identifying all groups of professionals who may be affected by or who may influence the desired changes in practice cannot be overemphasised.5 These groups and individuals must be actively engaged, and specific individual and organisational barriers must be identified and addressed. The Glasgow authors suggest that hospital clinicians may repeat investigations with normal results because they mistrust results from unfamiliar laboratories. This problem could be eased by computerised access to the results of laboratory investigations and the use of high quality standardised laboratory procedures.
More studies are needed that evaluate guidelines in terms of changes in the behaviour of both primary and secondary care professionals. If guidelines on common problems are to deliver cost effective care, appropriate clinical management in primary care needs to substitute for and not to be in addition to traditional hospital management. The Glasgow study suggests that, perversely, implementing guidelines may lead to a higher overall direct NHS costs per patient referred. Increased venesection and requests for specimens are also likely to have psychological costs for the patients. If the authors had not invested in evaluating these guidelines wider dissemination of the guidelines could have increased NHS costs. Clearly it cannot be assumed that well formulated and implemented guidelines will lead to lower expenditure in the NHS.
The national service frameworks and organisations such as the National Institute of Clinical Excellence (NICE) are leading an increasing tendency to formulate and disseminate national guidance throughout the NHS. If these national initiatives are to lead to improved patient care and more cost effective use of resources, then local implementation and evaluation are required. For common clinical conditions this requires the collaboration of both primary and secondary care health professionals. Increasingly these professionals will include not only doctors but also nurses, physiotherapists, occupational therapists, dieticians, laboratory technicians, and others. Local research expertise should be harnessed to demonstrate changes in practice, and NHS managers need to ensure that these initiatives are properly resourced to ensure rigorous implementation and evaluation of the impact.
REFERENCES
1. Woolf SH, Grol R, Hutchinson A, Eccles MP, Grimshaw JM. Clinical practice guidelines: the potential benefits, limitations and harms of recommending how to care for patients. BMJ 1999; 318: 527-530
2. Secretary of State for Health. The NHS plan. London: Stationery Office, 2000.
3. Secretary of State for Health. A first class service: quality in the new NHS. London: Stationery Office, 1997.
4. Effective Health Care. Implementing clinical guidelines: can guidelines be used to improve clinical practice? Leeds: University of Leeds, 1994.
5. Effective Health Care. Getting evidence into practice. York: University of York, 1999.
6. Morrison J, Carroll L, Twaddle S, Cameron I, Grimshaw J, Leyland A, et al. Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary-secondary care interface. BMJ 2001; 322: 1282-1284
7. Emslie C, Grimshaw J, Templeton A. Do clinical guidelines improve general practice management and referral of infertile couples? BMJ 1993; 306: 1728-1731
8. Bero LA, Grilli R, Grimshaw J, Harvey E, Oxman A, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. BMJ 1998; 317: 465-468

Katz, D, Griffith, J, et al. (1996). "The use of empiric clinical data in the evaluation of practice guidelines for unstable angina." Journal of the American Medical Association 276(19): 1568-74.

Objective: To determine the applicability to emergency department (ED) clinical practice of a nationally disseminated practice guideline on the disposition of patients with a diagnosis of unstable angina, and to determine the potential impact of the guideline on hospital admissions and demand for intensive care beds.
Design: Application of guideline criteria for ED disposition decisions to a validation sample derived from a prospective clinical trial.
Setting: Five hospitals, including 2 urban general teaching hospitals, 2 urban tertiary care university hospitals, and 1 suburban university-affiliated community hospital.
Patients: A consecutive sample of 457 patients who presented with symptoms suggestive of acute cardiac ischemia and who had "unstable angina" or "rule out unstable angina" diagnosed by ED physicians. Greater than 90% of eligible patients were enrolled in the clinical trial; follow-up data sufficient for assignment of a definitive diagnosis were obtained for 99% of subjects.
Main Outcome Measures: Acute myocardial infarction and unstable angina, based on blind review of initial and follow-up clinical data, including cardiac enzyme levels and electrocardiograms. After completion of the trial, without knowledge of final diagnosis or outcome, the investigators classified patients into risk groups specified by the unstable angina guideline.
Results: Of subjects with an ED diagnosis of unstable angina, only 6% (n=28) met the guideline's criteria corresponding to low risk for adverse events and were therefore suitable for discharge directly to home. Fifty-four percent (n=247) met the intermediate-risk criteria; 40% (n=182) met the high-risk criteria and were identified as requiring admission to an intensive care unit. Actual ED disposition differed from guideline recommendations in 2 major areas: only 4% (1/28) of low-risk patients were discharged to home with outpatient follow-up, and only 40% (72/182) of high-risk patients were admitted to an intensive care unit.
Conclusions: Although the guideline was intended to reduce hospitalization by identifying a low-risk group, the small size of this group among ED patients suggests that little reduction in hospitalization can be expected. Indeed, the guideline may increase demand for the limited number of intensive care beds to accommodate patients with unstable angina considered high-risk but currently placed elsewhere. These results emphasize the need to use empiric data from target clinical settings to assess the likely actual impact of guidelines on clinical care prior to national dissemination.

Long, M (2001). "Clinical practice guidelines: When the tool becomes the rule." Journal of Evaluation in Clinical Practice 7(2): 191-9.

This work provides a critical examination of the use of clinical practice guidelines to measure individual performance. The problems inherent in using a measure of central tendency derived from a distribution of individual performances are addressed, as is the translation of the collectively determined guidelines into a measurement instrument. It is suggested that every process on the distribution of processes used to determine the guideline must be considered equally legitimate representations of the process in question. It is further suggested that to accept as a standard of quality, a particular process simply because there is a minimum of variation between providers, is to ignore the importance of the linkage between process and outcome. The importance of an independent measure of quality based on outcomes is further emphasized by highlighting the tautological nature of analyses that include an input measure, such as nursing hours, in both the dependent variable and the list of independent variables. It is recommended that individual performance be evaluated within the tolerances of the distribution from which they were derived and not be held to some measure of central tendency of that distribution. The alternative is to use the measure of central tendency with plus or minus limits such as one, or more, standard deviations.

Morrison, J, Carroll, L, et al. (2001). "Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface." British Medical Journal 322: 1-5.

Objective: To investigate the effect of clinical guidelines on the management of infertility across the primary care secondary care interface.
Design: Cluster randomised controlled trial.
Setting: General practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area.
Participants: All 221 general practices in Glasgow; 214 completed the trial.
Intervention: General practices in the intervention arm received clinical guidelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings.
Main outcome measures: The time from presentation to referral, investigations completed in general practice, the number and content of visits as a hospital outpatient, the time to reach a management plan, and costs for referrals from the two groups.
Results: Data on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were referred inappropriately early. Referrals from intervention practices were significantly more likely to have all relevant investigations carried out (odds ratio 1.32, 95% confidence interval 1.00 to 1.75, P = 0.025). 70% of measurements of serum progesterone concentrations during the midluteal phase and 34% of semen analyses were repeated at least once in hospital, despite having been recorded as normal when checked in general practice. No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan. NHS costs were not significantly affected.
Conclusions: Dissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice, but there are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care tended to fail to respond to changes in referral practice by as to lead to changes in both primary care and secondary care.

National Health and Medical Research Council (1999). A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines. Canberra, Commonwealth of Australia: 1-79.

The National Health and Medical Research Council (NHMRC) has developed a guidelines methodology specifically for the Australian setting which can be applied to a variety of health care procedures and interventions, and is aimed at improving health outcomes.
The publication is a revised edition of the NHMRC's 1995 publication, Guidelines for the development and implementation of clinical practice guidelines.
The 1999 Guide to the development implementation and evaluation of clinical practice guidelines, draws on the latest research in guideline development and implementation, and addresses the need for a widely accessible, comprehensive tool for people interested in developing best practice guidelines. The publication is of particular relevance to health professionals, researchers, and policy makers.
Its development was prompted by concern over unjustifiable variations in clinical practice for the same condition, the increasing availability of new treatments and technology, an uncertainty as to the effectiveness of many interventions in improving people's health and a desire to make the best use of available health resources.
The guidelines provide a methodology designed to improve the quality of health care in particular clinical settings and circumstances by fostering:
* Reduction in the number of unnecessary or harmful interventions;
* Provision of treatment options with maximum benefit; and
* Provision of treatments/interventions with minimum risk,
All within a framework of acceptable financial costs.
The document details a definition and covers a brief history of guidelines development, including an approach to credentialing others guidelines. Key principles are articulated, and the stages of development, dissemination, implementation are covered, as are legal implications.
The document emphasises the importance of basing guideline recommendations on the systematic identification and synthesis of the best available scientific evidence. Levels of evidence, quality of evidence, relevance of evidence and strength of evidence are outlined. Discussion of the need for guidelines to encourage health professionals to improve their treatment practices and improve patient and community access to information about treatment options is a salient feature of the guidelines.

National Health and Medical Research Council (2001). NHMRC Standards and Procedures for Externally Developed Clinical Practice Guidelines. Canberra, Commonwealth of Australia: 1-5.

The National Health and Medical Research Council (NHMRC) encourages the development of evidence-based clinical practice guidelines by expert bodies, and the National Health and Medical Research Council Act 1992 ('the Act') allows for externally developed guidelines to be approved by the Council.
This paper aims to inform external persons and bodies of the procedures to be followed in developing guidelines which are intended for submission to the NHMRC for approval.
Externally developed guidelines must meet certain requirements and standards in order to be approved by Council. These requirements and standards are set out both in legislation and in NHMRC publications on the development, implementation and evaluation of clinical practice guidelines.
Not all externally developed guidelines will be appropriate for consideration by Council. Organisations planning to develop guidelines are encouraged to contact the NHMRC at an early stage to obtain Council's agreement in principle to consider guidelines for approval once they are completed.
Completed guidelines submitted for Council approval will be considered in the first instance by the Health Advisory Committee, which may commission an independent review of the guidelines.
Strategies for open review and updating of the guidelines must form part of the development and guidelines themselves.
Note: This publication is available free from The NHMRC Publication's Officer. For further details see the following page: www.health.gov.au/nhmrc/publicat/order.htm

National Institute for Clinical Excellence (2001). Frequently asked questions about clinical guidelines. NICE Website.

Answers the questions:
1) What are Clinical Guidelines?
2) How are guidelines developed?
3) What's wrong with existing guidelines?
4) What are Referral Cues or Referral Protocols?
5) Who selects the topics for guidelines?

National Pathway Association (2001). National Pathway Association Strategic Direction 2001 to 2003. NPA Website.

The following information describes the strategic direction 2001 to 2003. It discusses the rationale for the strategy and briefly sets out the strategic actions the NPA will take over the next two years. More detail on how this will be achieved is contained within the NPA Business Plan 2001 to 2002.

National Pathway Association (2001). Frequently asked questions. NPA Website.

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What is a Care Pathway?
An integrated care pathway determines locally agreed, multidisciplinary health practice, based on guidelines and evidence where available, for a specific user group.
Can you only write Care Pathways for acute conditions?
No, they can be developed for medical and chronic conditions, as well as acute surgical ones.
Can you individualise Care Pathways?
Yes, the Care Pathway should be designed so that there is scope for the individualisation of the pathway based on user circumstances.
How long does it take to develop a Care Pathway?
The first Pathway to be developed by a team may involve 8-10 meetings spread over several months.
Can you 'import' a Care Pathway from somewhere else?
If you do, you must ensure the relevant team reviews the contents, makes it locally applicable and takes ownership of the Pathway.
Is it 'cookbook medicine'?
No, Care Pathways should be seen as a set of proposed activities and interventions that are not rigidly prescriptive, but are based on national guidelines that need to be assessed and applied locally.
Are Care Pathways simply introduced to save money?
No, the primary aim of Care Pathways is to improve the quality of care.

Nichol, G, Walls, R, et al. (1997). "A critical pathway for management of patients with acute chest pain who are at low risk for myocardial ischaemia: Recommendations and potential impact." Annals of Internal Medicine 127: 996-1005.

Background: Use of resources for patients with acute chest pain may be improved with clinical strategies that integrate research, Bayesian analysis, and expert opinion.
Objectives: To 1) develop a critical pathway for management of patients with acute chest pain who are at low risk for complications of ischemic heart disease and 2) assess the potential effects of implementation of the pathway on patient safety and resource use.
Design: Evidence-based consensus and prospective cohort study.
Setting: Urban teaching hospital.
Patients: Patients at least 30 years of age who were seen in the emergency department for chest pain and who did not have a history of trauma or abnormalities on radiologic study.
Intervention: Physician-opinion leaders defined criteria for patient inclusion in the pathway and for remaining on the pathway after 6 or 12 hours of observation. Criteria were defined for appropriateness of direct admission, direct discharge, or 6 hours of observation followed by exercise treadmill testing.
Measurements: Number of patients admitted to the hospital, number of days that patients were hospitalized, and clinical outcome.
Results: 2898 of 4585 patients (63%) were admitted to the hospital; of the 2898, 1152 (40%) were classified as potentially eligible for the pathway and 1068 (93%) had a benign clinical course during the initial observation period. The 1068 patients had a mean length of stay of 2.8 +/- 4.8 days. If 47% of these patients had been discharged after observation and exercise testing, implementation of the pathway would have reduced the number of admissions by 505 (17%) and days of hospitalization by 1407 (11%).
Conclusions: Retrospective analysis suggests that a critical pathway for patients with acute chest pain may substantially reduce resource use. Prospective study is needed to ensure increased efficiency without increased adverse outcomes.

Psaty, B, Furberg, C, et al. (2000). "National guidelines, clinical trials, and quality of evidence." Archives of Internal Medicine 160(17): 2577-80.

The results of clinical trials provide the best evidence for clinical decision making and public policy. Since the publication of a meta-analysis showing the benefits of low-dose diuretic therapy for the treatment of hypertension, several new clinical trials have been published, and their results are being incorporated into the new guidelines for hypertension. Both the British and American hypertension guidelines recommend not only low-dose diuretics but also dihydropyridine calcium channel blockers for older adults with isolated systolic hypertension on the basis of the results of the Systolic Hypertension in Europe Trial (Syst-Eur Trial). In the new British Hypertension Society guidelines for hypertension management, the authors rely on evidence from the Hypertension Optimal Treatment randomized trial (HOT) to define treatment goals. Moser's review of the national recommendations for the pharmacologic treatment of hypertension considers the recently published Captopril Prevention Project (CAPPP) randomized trial.
Confidence in the findings of randomized clinical trials is directly related to their quality. Among the most important elements of well-conducted trials are adequate randomization, blinding, and complete follow-up for ascertainment of primary events. Generalization of results is appropriate to populations that are similar to those under study. Herein, we review these principles with reference to several recent trials that appear to be shaping national guidelines and recommendations regarding the treatment of hypertension.

Roberts, R, Zalenski, R, et al. (1997). "Costs of an emergency department-based accelerated diagnostic protocol vs hospitalization in patients with chest pain: A randomized controlled trial." Journal of the American Medical Association 278(20): 1670-6.

Context: More than 3 million patients are hospitalised yearly in the United States for chest pain. The cost is over $3 billion just for those found to be free of acute disease. New rapid diagnostic tests for acute myocardial infarction (AMI) have resulted in the proliferation of accelerated diagnostic protocols (ADPs) and chest pain observation units.
Objective: To determine whether use of an emergency department (ED)-based ADP can reduce hospital admission rate, total cost, and length of stay (LOS) for patients needing admission for evaluation of chest pain.
Design: Prospective randomised controlled trial comparing admission rate, total cost, and LOS for patients treated using ADP vs inpatient controls. Total costs were determined using empirically measured resource utilization and microcosting techniques.
Setting: A large urban public teaching hospital serving a predominantly African American and Hispanic population.
Patients: A sample of 165 patients was randomly selected from a larger consecutive sample of 429 patients with chest pain concurrently enrolled in an ADP diagnostic cohort trial. Eligible patients presented to the ED with clinical findings suggestive of AMI or acute cardiac ischemia (ACI) but at low risk using a validated predictive algorithm.
Main Outcome Measures: Primary outcomes measured for each subject were LOS and total cost of treatment.
Results: The hospital admission rate for ADP vs control patients was 45.2% vs 100% (P<.001). The mean total cost per patient for ADP vs control patients was $1528 vs $2095 (P<.001). The mean LOS measured in hours for ADP vs control patients was 33.1 hours vs 44.8 hours (P<.01).
Conclusions: In this trial, ADP saved $567 in total hospital costs per patient treated. Use of ED-based ADPs can reduce hospitalisation rates, LOS, and total cost for low-risk patients with chest pain needing evaluation for possible AMI or ACI.

Roberts, R, Schaider, J, et al. (2001). "Developing clinical decision rules to determine the need for chest radiographs in emergency department patients with chest pain." Academic Emergency Medicine 8(5): 504.

Objectives: Patients presenting to the emergency department with chest pain (CP) often have a chest radiograph (CXR), but the yield is low. The goals of this study are to identify clinical factors that could lead to the development of clinical decision rules that could decrease the number of CXRs in patients with CP and to develop criteria for predicting both negative and positive CXRs.
Methods: All patients having CXRs ordered in the emergency department for CP during the month of June 1999 were enrolled. Using an Excel program, a data collection chart was set up based on 51 historical symptoms and 24 physical exam signs. Thirteen possible abnormal positive CXR findings were correlated with these factors. The radiology reports and ED physicians' dictation were reviewed to determine the relative frequencies of these symptoms and signs in patients with normal versus abnormal CXRs. From this preliminary data, a sample size will be determined that will be large enough to positively or negatively predict a normal versus abnormal CXR. A p-value less than 0.2 was used and a prevalence of symptom/sign greater than 0.2 was considered statistically significant.
Results: From June 1999, we reviewed 202 patients' charts. Only 7 of the 13 abnormal findings on the CXR were considered clinically important findings. Of the 51 symptoms, 16 were found to be significant, while only 8 of the 24 signs were significant (p-value <0.2 and prevalence >0.2). Fischer's exact test was used to determine the p-value.
Conclusions: Of the 51 symptoms and 24 signs considered, 16 symptoms and 8 signs were found to correlate with an abnormal CXR. Further studies using these clinical factors are needed to develop clinical criteria to predict which CP patients should have CXRs.

Schaider, J, Evans, A, et al. (2001). "Impact of a decision aid on triage of chest pain admissions." Academic Emergency Medicine 8(5): 505.

Objectives: An interdepartmental committee developed a chest pain decision aid that delineated the ideal unit to admit patients with suspected cardiac ischemia based on established complication risk strata. The goal was to change the emergency physician admission pattern with an expected increase of very-low-risk chest pain patients admitted to the emergency department chest pain observation (ED CP OBS) unit and a corresponding decrease of very-low-risk chest pain patients admitted to the telemetry units.
Methods: Consecutive admissions for one month in 1997 were risk-stratified into high (>16%), low/moderate (4-8%), and very low (<1%) based on the Goldman complication prediction rule for major cardiac complications served as the pre-intervention group. From August 1999 through November 1999, the completion of a chest pain triage aid was required for admission of patients suspected of having cardiac ischemia. The risk strata distributions of the admission of patients with suspected cardiac ischemia to the CCU, telemetry, and CP OBS unit were compared between the pre- and post-intervention.
Results: The pre- and post-intervention groups consisted of 207 and 1,008 consecutive patients, respectively. There were no significant differences between the groups. For very-low-risk patients, 27% (95% CI: 21, 33) of the pre-intervention group were admitted to the ED CP OBS unit vs. 58% (95% CI: 55, 61) in the post-intervention group (p < 0.001). For low/moderate-risk patients, there was a trend toward larger percentage of CCU admissions (68/ 406, 17% vs. 6/83, 7%, p = 0.04). For high-risk patients, 10/16, 63% (95% CI: 39, 87) of the pre-intervention group were admitted to the CCU vs. 23/92, 25% (95% CI: 16, 34) of the post-intervention group (p = 0.007).
Conclusions: Use of a chest pain decision aid increased the proportion of very-low-risk patients admitted to the ED CP OBS unit and decreased the proportion of highrisk patients admitted to the CCU.

Scottish Intercollegiate Guidelines Network (2001). New SIGN website launched with 50th SIGN publication - "A Guideline Developers' Handbook". SIGN Website: 1-3.

FULL TEXT (Press Release)
In response to growing demand from guideline users and developers throughout the U.K., and internationally, SIGN [1] has today launched its 50th guideline in the form of a handbook which will enable guideline users and developers alike to use the experience gained by SIGN, in guideline development methodology, when embarking upon new clinical guideline projects.
'SIGN 50: A Guideline Developers' Handbook' was developed in order to support the development of national guidelines for the NHS in Scotland and their local adaptation and implementation. SIGN has been increasingly requested by guideline developers in other parts of the U.K., and abroad, to assist with guideline development and it was realised that a handbook of this nature would be of wider value than just to clinicians working within the NHS in Scotland.
The Handbook is primarily available, free of charge [2], to users of the SIGN website at www.sign.ac.uk, which has simultaneously been re-launched in order to offer SIGN guideline users more information and to make the website more user-friendly [3]. The Handbook contains information on -
* The medico-legal implications of guidelines;
* The criteria for selection of guideline topics;
* Guideline development groups (the importance of multi-disciplinary groups, patient participation, and critical appraisal skills training for group members);
* Systematic literature review (identifying, selecting and evaluating the evidence) · Forming guideline recommendations (synthesising and interpreting the evidence, and levels of evidence and grades of recommendations);
* Consultation and peer review;
* Presentation and dissemination;
* Implementation;
* Audit and review
Speaking after the launch, Prof Jim Petrie, Chairman of SIGN, said, "We are delighted to be able to share our experience of guideline development with both users and developers. As the number of guidelines grows guideline developers have a responsibility to be transparent about the methods used, so that users can see with confidence that potential biases have been addressed adequately, that the recommendations are valid and that they are feasible for practice.
"By making this resource available, as an electronic publication on our new website, this will complement the wealth of evidence and clinical information that SIGN can offer to all clinicians involved in the patient's journey of care, be they Consultants, GPs, surgeons, nurses or PAMs, due to the multi-disciplinary involvement in our development process."

Scottish Intercollegiate Guidelines Network (2001). A Guideline Developers' Handbook. Scotland, SIGN.

This report, SIGN's 50th publication, updates and expands the description of SIGN methodology which was published in July 1999.6 Since then, there have been significant developments in many aspects of SIGN methodology, particularly in the procedures for selecting topics, grading recommendations, and disseminating guidelines. This description of the guideline development methodology used by SIGN is intended to support both the development of national guidelines for the NHS in Scotland and their local adaptation and implementation. It provides guideline users with information on the methodology by which SIGN guidelines are developed, and resources for groups embarking on new guideline development projects. It has therefore been produced in a loose-leaf format to allow photocopying of the various templates and forms which are provided in the Annexes.
As the number of guidelines available to practitioners grows, guideline developers have an increasing obligation to be transparent about the methods they have used to develop their guideline. Users can then see with confidence that the potential biases of guideline development have been addressed adequately and that the recommendations are both internally and externally valid, and feasible for practice. However, guidelines are also intended as tools for busy practitioners, therefore it is important not to overload every guideline with repetition of the same methodological detail. SIGN 50 is therefore an essential companion document to SIGN's published guidelines and those in development, outlining the key elements of the development process common to all SIGN guidelines. Only details specific to the topic under consideration or any variations from the standard processes described here are reported in individual SIGN guidelines.

Sesperez, J, Wilson, S, et al. (2001). "Trauma case management and clinical pathways: Prospective evaluation of their effect on selected patient outcomes in five key trauma conditions." Journal of Trauma-Injury Infection and Critical Care 50(4): 643-9.

Background: This study evaluated the implementation of clinical pathways and case management between July 1998 and July 1999 in five key trauma conditions: severe head injury, fractured ribs, fractured pelvis, blunt abdominal trauma, and fractured femurs presenting to a single trauma service.
Methods: Thirteen key elements of care with expected outcomes were defined for each key trauma condition. Deviations from expected outcome were defined as variances. Attainment of the expected outcomes was measured before (stage 1) and after introduction (stages 2 and 3) of clinical pathways and case management. Nonattained outcomes were quantified and categorized into time of occurrence, and relationship to staff, patient, or system.
Results: Two hundred thirty-five patients were studied, with a mean age of 41.8 (SD, 20.6) years and mean Injury Severity Score (ISS) of 11.7 (SD, 11.0). The mean number of observed variances per patient for stage 1 was 51.7 (SD, 43.5); stage 2, 42.3 (SD, 32.9); and stage 3, 23.2 (SD, 21.7) (p = 0.0001 for both stage 1 and stage 2 compared with stage 3). There was a significant improvement in outcomes achieved from stage 1 (92.7%; 95% confidence interval, 92.5-92.9%), to stage 3 (96.7%; 95% confidence interval, 96.5-96.9%). Of the total number of variances seen, 0.2% related to system errors, 25% related to patient factors, and 75.8% related to staff. The proportion of staff-related variances was significantly reduced in stage 3.
Conclusion: Clinical pathways and case management identified areas in need of remedial action and improved the delivery of patient care to our trauma population. It has set a template for the future management of our trauma service.

Shekelle, P, Eccles, M, et al. (2001). "When should clinical guidelines be updated?" British Medical Journal 323(7305): 155-7.

Considerable resources are being expended internationally on the development of clinical practice guidelines.1 Although consensus is increasing about methods for developing evidence based guidelines,2 less attention has been paid to the process for assessing when guidelines should be updated. The most common advice is for guidelines to include a scheduled review date. This could result in wasted resources, however, if a full update is undertaken prematurely in a slowly evolving field, or in guidelines in a rapidly evolving field becoming out of date before the scheduled review. Some guidelines state that they should be updated when new information becomes available. It is unclear, however, how this should be done, and we are unaware of any systematic attempts to devise a method. In this paper we propose a set of principles and a pragmatic model for assessing whether guidelines need to be updated.

Victorian Centre for Ambulatory Care Innovation (2000). Critical Pathways in the Australian Health Care System. Melbourne, VCACI: 18.

This project was undertaken in order to establish an understanding of the existence and utilisation of critical pathways across Australian health care settings, including acute home care (eg. Hospital in the Home) and the experiences and issues surrounding pathway development, use and evaluation. The specific objectives of the survey were to:
1. examine what critical pathways are currently used, and expected to be used in the future,
2. develop a national critical pathways information database, in order to provide further resource and support for health care organisations involved in pathway development and utilisation,
3. examine variance management strategies and the issues surrounding variance management,
4. establish the existence of, and analyse the use of, critical pathways related software, and
5. determine and analyse any further issues surrounding the development of critical pathways in the Australian Healthcare system.

Vinson, D and Berman, D (2001). "Outpatient treatment of deep venous thrombosis: a clinical care pathway managed by the emergency department." Annals of Emergency Medicine 37(3): 251-8.

Study Objective: We evaluate the effectiveness and safety of an outpatient clinical care pathway for the initial treatment of acute proximal lower-extremity deep venous thrombosis (DVT) with low molecular weight heparin (LMWH) managed by the emergency department of 2 affiliated community hospitals.
Methods: This observational, retrospectively defined, population-based study with 39(1/2) months of preintervention analysis and 32(1/2) months of postintervention analysis was conducted in 2 suburban EDs of a large group model health maintenance organization. Our outpatient DVT clinical care pathway used careful patient selection and multidisciplinary follow-up. Ninety-six patients before the intervention and 178 patients after the intervention met eligibility criteria for the pathway. Adverse events during the first 2 weeks of treatment included symptomatic pulmonary embolism (PE), progressive DVT, minor and major bleeding, and death.
Results: Demographic and baseline clinical characteristics of the 2 groups were similar. Five (5.2%) of 96 preintervention subjects (95% confidence interval [CI] 2.4 to 8.1) developed adverse events compared with 5 (2.8%) of 178 postintervention subjects (95% CI 1.5 to 4.1; difference between groups 2.4%; P =.50). In each group, 1 (1.0% versus 0.6%) subject developed a PE, 2 (2.1% versus 1.1%) developed progressive symptoms of progressive DVT, and 2 (2.1% versus 1.1%) developed minor bleeding. Major bleeding occurred in 1 (1.0%) preintervention subject and no postintervention subjects. No patient in either cohort died.
Conclusion: Managed by the ED, an outpatient DVT clinical care pathway using careful patient selection and an integrated multidisciplinary approach can provide a similar degree of effectiveness and safety as customary inpatient therapy.