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PubMed1998

Findings from the American College of Epidemiology's survey on Ethics guidelines. The American College of Epidemiology Ethics and Standards of Practice Committee.

PURPOSE: A survey to establish both the need and subject areas for a possible new set of ethics guidelines for epidemiologists was conducted among a random sample of 300 North American (Canada, Mexico, and United States) members of three major United States-based professional epidemiology organizations. METHODS: An 88% response rate revealed wide agreement on topics to be included in any new set of guidelines, but uncertainty prevailed about the need for new guidelines; 41% agreed that there was a need to develop a new set, 43% had no opinion, and 16% disagreed. RESULTS: There was almost no difference in preferences between men and women for topics to be included in a new set of guidelines, or between those aware or unaware of extant ethics guidelines in epidemiology. Fifty-four percent were aware of such guidelines and only 29% of these said they could describe the content of the guidelines. CONCLUSION: More needs to be done to evaluate the utility of ethics codes in epidemiology.

Data Collection↗

PubMed1995

A model for practice guideline adaptation and implementation: empowerment of the physician.

The Medical Center model of practice guideline adaptation and implementation uses local clinical leaders to evaluate nationally endorsed guidelines, adapt those guidelines for use in the local setting, work with support staff to develop and apply methods for guideline implementation, and assist the evaluation of clinical practice and outcomes data. The model described here combines the guideline dissemination techniques of clinical leadership, implementation, and data support and feedback. This model overcomes the failures of previous models by incorporating local physician involvement during every step of practice guideline selection, adaptation, implementation, and evaluation, and by supporting the physician leaders with quality data, resources to support guideline implementation, and outcomes assessment and feedback.

Feedback↗

PubMed1995

Collaborating outside the box: when employers and providers take on environmental barriers to guideline implementation.

BACKGROUND: In 1992 15 employers in Minneapolis/St Paul, operating as the Business Health Care Action Group (BHCAG), combined their self-insured plans. To successfully bid for the BHCAG contract, three competing group practices and a health plan cooperated, operating functionally like a fully integrated care system to measure outcomes, develop practice guidelines, and meet other BHCAG requirements. To accomplish this, a new organization, the Institute for Clinical Systems Integration (ICSI), was conceived. PROVIDERS AND EMPLOYERS COLLABORATE: To reduce costs ICSI has implemented 16 of 80 planned guidelines. Teams including members from clinics and BHCAG develop best-practice algorithms. Each guideline is then reviewed and piloted before being implemented in all ICSI clinics. MANAGING EXTERNAL ENVIRONMENT: The guideline on cystitis in healthy women eliminated two costly practices-obtaining a urine culture and visiting the doctor. Yet many physicians and the clinics were afraid of losing significant revenue because they were reimbursed by BHCAG on a fee-for-service basis. In turn, BHCAG's hands were tied. If they changed to a capitated payment system, they would face onerous state insurance requirements. The solution lay in collaborating at a higher level. ICSI and BHCAG leaders persuaded the state legislature to pass a new law that allowed BHCAG to capitate providers without state regulation. As a result, the cystitis guideline is now widely implemented in ICSI clinics. LESSONS LEARNED: The cystitis guideline experience highlights the need to manage the external environment so that it reinforces, rather than inhibits, quality improvement in medical practices. Guidelines will not be implemented unless the macro-environment into which they are introduced is supportive.

Contract Services↗

PubMed1996

Phase II of the AHCPR-sponsored heart failure guideline: translating practice recommendations into review criteria.

BACKGROUND: In 1992, under the sponsorship of the U.S. Agency for Health Care Policy and Research, RAND assembled an expert panel to develop the Heart Failure Clinical Practice Guideline. Phase II of the effort was intended to identify which of the guideline's recommendations the panel felt were suitable for use in retrospective utilization review and quality assessment programs and to develop review criteria, performance measures, and standards of quality for use in monitoring compliance with those recommendations. SELECTION OF RECOMMENDATIONS: Selecting guideline recommendations for translation into review criteria and ultimately into standards of care was a multistep process comprising (1) identification of 34 recommendations from the guideline, (2) rating them on the basis of importance to quality of care and feasibility of monitoring, (3) review by a subcommittee and the full guideline panel, (4) translation into review criteria, and (5) further review and input by panelists and peer and pilot reviewers. Finally, standards of care (the minimum proportion of cases expected to be in accordance with guideline recommendations) were determined to be 90%-95% for six of the final criteria and 75%-80% for the other two. CONCLUSION: Despite some reservations, physicians and other health care professionals agreed to be held accountable for following a core set of guideline recommendations for the treatment of heart failure. Substantial progress was made in identifying recommendations that panelists and reviewers were willing to endorse in utilization review activities, including adoption of improved documentation standards. The review criteria's major impact may be the knowledge that the criteria are in place and that care is being monitored based on those standards.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed1996

Developing evidence-based practice guidelines and pathways: the experience at the local hospital level.

BACKGROUND: Using an evidence-based approach to developing clinical practice guidelines at the local level promotes implementation by clinicians. In 1994 Cedars-Sinai Health System embarked on a joint project with VHA, Inc, to pilot test a software program, Clinical Cost-Reduction System (CCRS), featuring length-of-stay guidelines for low-risk patients with specific conditions. Data currently are being collected on the effect of the software on length-of-stay reductions and other important patient outcomes. THE NEED FOR A MORE COMPREHENSIVE SOFTWARE PROGRAM: To involve clinicians more actively in the development of guidelines, Cedars-Sinai sought to develop a software system for presenting organized medical information to hospitals interested in designing their own evidence-based clinical pathways. DEVELOPING THE CLINICAL PATHWAY CONSTRUCTOR (CPC): The CPC is a computerized grid for writing clinical pathways, backed by a database of information for select clinical conditions and categories of care. Multidisciplinary teams are to review the evidence presented in the database and then determine those guidelines they wish to encode into an actual pathway, which can then be printed out. The decision regarding which guidelines to use and which not to use rests entirely with the team designing a pathway; the program is intended to aid the team in developing appropriate guidelines that are evidence based, not to legislate guidelines. Data on the "portability" of the program are still being collected. SEARCHING AND SUMMARIZING THE LITERATURE: There are many challenges involved in searching, summarizing, and classifying the medical literature.

Cost Control↗

PubMed2001

Conceptual alignment of electronic health record data with guideline and workflow knowledge.

Even though computerized practice guidelines and workflow management (WfM) are proven effective techniques to improving quality of care and reducing costs, they are not widely deployed today. One reason for this is the impedance mismatch between guideline systems and electronic health record (EHR) systems. This paper presents the Unified Service Action Model (USAM) that has been developed for the HL7 Reference Information Model (RIM) and that conceptually integrates guidelines and WfM in the EHR. We argue that the information items recorded in the EHR are logically similar to elements of guideline and WfM definitions. Therefore, the USAM suggests that guidelines and EHR reuse the same information structures. This reuse is possible through a technique borrowed from natural language grammar and modal logic. The conceptual alignment of guidelines, WfM and the EHR could facilitate the sharing and deployment of guidelines in routine health care.

Cost Control↗

PubMed2003

Lying in the bed we've made: reflection on some unintended consequences of clinical practice guidelines in the courts.

Evidence on the use of clinical practice guidelines to aid in the legal determination of negligence is increasing, specifically where they affect determinations of the standard of care and causation. So too is evidence that some clinical practice guidelines are of poor quality. An action alleging the negligent failure to diagnose and treat gestational diabetes in 1988, in which the neonate suffered permanent brachial plexus injury, entered into evidence a 1984 clinical practice guideline authored by the Society of Obstetricians and Gynaecologists of Canada. No "experts" were called to adjudicate the quality of this guideline, which cited no evidence or rationale in support of its recommendations. The standard as laid out in the guideline was judged by the court to reflect a prevailing standard of care, and a finding of negligence was rendered. As the courts pay increased attention to clinical practice guidelines, critical appraisal by the professional organizations developing these documents must occur to assure methodological rigour. Further, the quality of clinical practice guidelines should receive critical scrutiny by the courts if they are to be relied upon, even partially, to assist with legal determinations of the standard of care or issues under causation.

Brachial Plexus↗

PubMed2000

Using practice guidelines to allocate medical technologies. An ethics framework.

Clinical practice guidelines are expanding their scope of authority from clinical decision making to collective policy making, and promise to gain ground as resource allocation tools in coming years. A close examination of how guidelines approach patient selection criteria offers insight into their ethical implications when used as resource allocation or rationing instruments. The purposes of this paper are: a) to examine the structure of allocative reasoning found in clinical guidelines; b) to identify the ethical principles implied and compare how guidelines enact these principles with how explicit systems-level rationing exercises and health policy analyses have approached them; and c) to offer some preliminary suggestions for how these ethical issues might be addressed in the process of guideline development. The resulting framework can be used by guideline developers and users to understand and address some of the ethical issues raised by guidelines for the use of scarce technologies.

Biomedical Technology↗

PubMed2000

A comparison of clinical practice guideline appraisal instruments.

OBJECTIVE: To identify and compare clinical practice guideline appraisal instruments. METHODS: Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966-99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments. RESULTS: Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated. CONCLUSIONS: A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.

Humans↗

PubMed2006

Evidence-based guidelines for anxiety disorders: can they improve clinical outcomes?

Evidence-based medicine (EBM) enables clinicians to justify decision making, enhances the quality of medical practice, identifies unanswered research questions, and ensures the efficient practice of medicine. Implementation of evidence-based mental health programs requires education, time, and improved effort by administration, regulatory, and clinical professionals. Essential to these efforts are consistent incentives for change, effective training materials, and clear clinical guidelines. Guidelines exist within the framework of EBM. Good guidelines are simple, specific, and user friendly, focus on key clinical decisions, are based on research evidence, and present evidence and recommendations in a concise and accessible format. Potential limitations of guidelines to improve clinical outcomes in anxiety disorders are the widespread distribution of anxiety symptoms in primary care, health inequalities across patient groups, persistent misconceptions regarding psychotropic drugs, and low confidence in using simple psychological treatments. Clinical guidelines generally specify therapeutic areas covered and not covered, but often there is no mention of cost or cost effectiveness of treatment. Guidelines can inform clinical decision making, but administrators of drug formularies may regard themselves as being primarily responsible for limiting costs and access to certain medications, even if these decisions are at odds with guideline recommendations.

Anti-Anxiety Agents↗

PubMed2003

Malpractice liability implications of pacemaker and defibrillator guidelines in Canada.

Different guidelines for implantable pacemaker and cardioverter defibrillator therapy pose problems for legal liability in Canada. Medical practices in the United States provide measures for comparative assessment, but the Canadian health care system is operated and publicly funded on West European principles. Provincial governments accept the responsibility to provide their residents with reasonable access to medically necessary services, including devices, on conditions of partial reimbursement by federal government funds. However, some provinces may fund services for which they will not be reimbursed. Practitioners may practise according to governmental funding arrangements. The law recognizes that practitioners in a respected minority in their specialty can depart from generally approved professional guidelines, by retaining earlier practices that are not discredited, or by adopting newer, but non-mainstream practices. They can similarly follow professional guidelines different from those of their colleagues. Practitioners who depart from guidelines they profess to follow risk legal liability, but compliance does not invariably ensure judicial approval. Judges preserve the right to set standards of professional proficiency, since they are a matter of law, but usually endorse professional guidelines. Patients' choices must be adequately informed, according to well-established criteria of disclosure that must be applied to evolving professional views of best and acceptable practice, which are usually influenced by practice guidelines. Inadequate governmental provision of devices or services to ensure patients' care according to practice guidelines can be challenged in legal proceedings. Success may require governments to improve supplies, but judges may decline to give directions with serious budgetary implications. However, unsuccessful litigants against, for instance, governments or physicians, are liable to be required to pay the successful defendants' legal costs, and usually their own.

Canada↗

PubMed2004

The impact of guidelines on long-term asthma care: a study of hospitalised patients in Malta.

OBJECTIVE: To compare actual practice to that recommended in asthma guidelines, published in Malta in February 1998, with respect to the management of asthma. These were the first national clinical guidelines to be published locally. METHOD: A piloted, structured interview was conducted with patients between 14-59 years who were hospitalised with an admission diagnosis of acute asthma. In the case of repeated admissions, only the first interview was considered. All interviews were carried out by either of two clinical pharmacists and lasted about 30 min. The four-year prospective study started in February 1997 (one year before publication of guidelines and aimed at collecting baseline data) and finished in January 2001 (three years after publication of the local guidelines). MAIN OUTCOME MEASURES: Inhaled steroids on admission. Patient partnership: use of a written self-management plan and home peak flow monitoring. Patient compliance with inhaled steroids. RESULTS: 304 patients (68% females; mean population age 33.9 years SD +/- 13.41) were interviewed over the four-year period. The difference in proportions test (Z-test) was used to analyse the data comparing years 2, 3 and 4 with year 1. No statistical differences were found when comparing the groups for inhaled steroid treatment on admission or availability of a home peak flow meter. Similarly, no differences were found between groups when comparing compliance with inhaled steroids. A statistically significant increase in availability of a self-management plan was found over the study period (3% in year 1; 1% in year 2; 11% in year 3; 9% in year 4), but the overall use of such plans remains disappointingly low. CONCLUSION: With the exception of an increased use of self-management plans, there appears to be lack of adherence to guidelines with consequent undertreatment of asthma, despite the fact that guidelines were published three years ago. This indicates a need to ensure better dissemination and implementation strategies to promote adherence. It is suggested that the clinical pharmacist is well-placed to promote adherence to guidelines.

Acute-Phase Reaction↗

PubMed2002

A controlled "before-after" study: impact of a clinical guidelines programme and regional cancer network organization on medical practice.

A regional cancer network has been set up in the Rhône-Alpes region in France. The aim of the project is to improve the quality of care and to rationalize prescriptions in the network. In this network, we assessed the impact of the implementation of a clinical practice guidelines project by assessing the conformity of practice with the guidelines and comparing this with the conformity in an external matched control group from another French region without a regional cancer network. Four hospitals (private and public) accepted to assess the impact of the clinical practice guidelines on the management of breast and colon cancer in the experimental group and three hospitals (private and public) in the control group. In 1994 and 1996, women with non-metastatic breast cancer (282 and 346 patients in the experimental group, 194 and 172 patients in the control group, respectively) and all new patients with colon cancer (95 and 94 patients in the experimental group, and 89 and 118 patients in the control group, respectively) were selected. A controlled "before-after" study, using institutional medical records of patients with breast and colon cancer. The medical decisions concerning the patients were analyzed to assess their compliance with the clinical practice guidelines. When medical decisions were judged to be non-compliant, we verified if they were based on scientific evidence in a published article, if they were not, the medical decision was classified as having "no convincing supporting scientific evidence". The compliance rates were significantly higher in 1996 than in 1994 in the experimental group; 36% (126 out of 346) vs 12% (34 out of 282) and 46% (56 out of 123) vs 14% (14 out of 103) (P<0.001) for breast and colon cancer, respectively. Whereas, in the control group the compliance rates were the same for the two periods; 7% (12 out of 173) vs 6% (12 out of 194) (P=0.46) and 39% (49 out of 126) vs 32% (31 out of 96), P=0.19. In the experimental group, in 1994, 101 of the 282 medical decisions (36%) and 27 of the 103 (26%) for breast and colon cancer, respectively, were classified as having "no convincing supporting scientific evidence" compare with 72 out of 346 in 1996 (21%) for breast cancer, and 21 of the 123 (17%) for colon cancer P<0.05. Whereas in the control group these results were 106 out of 194 in 1994 (55%) and 90 out of 172 in 1996 (52%), P=0.65 for breast cancer and 28 out of 96 in 1994 (29%) and 30 out of 126 in 1996 (24%), P=0.36 for colon cancer. The development and implementation strategy of the clinical practice guidelines programme for cancer management results in significant changes in medical practice in our cancer network. These results would suggest that introducing guidelines with specific implementation strategy might also increase the compliance rate with the guideline and "evidence-based medicine".

Breast Neoplasms↗

PubMed2003

Possible consequences of applying guidelines to healthy women with a family history of breast cancer.

Possible effects of consistently applying published guidelines on healthy women with breast cancer in their family history were analysed. We investigated 1060 unrelated breast cancer patients and calculated the numbers of first-degree relatives that would be referred to a familial cancer clinic if the guidelines were consistently applied. A first-degree relative was considered a candidate for referral if she was female, without breast cancer at the moment of the interview, alive and over the age of 24. The criteria for referral were based on one Dutch and two British guidelines. According to the Dutch guideline, for one affected woman with breast cancer, 0.25 (95% CI 0.22-0.28) healthy first-degree female relatives should be offered a consultation at a familial cancer clinic (FCC). Application of the British guidelines would lead to a similar number of referrals. Of all healthy first-degree female relatives, who should be referred to an FCC, 34-37% had an index case among their family who was already known at a genetic department. If current guidelines are consistently applied, a sharp increase in referrals to FCCs may be expected. These guidelines, however, are arbitrary and only limited data are available on the efficacy of this surveillance for high-risk healthy women.

Aged↗

PubMed1999

Clinical guidelines in nursing, midwifery and the therapies: a systematic review.

BACKGROUND: While nursing, midwifery and professions allied to medicine (PAMs) are increasingly using clinical guidelines to reduce inappropriate variations in practice and ensure higher quality care, there have been no rigorous overviews of their effectiveness in relation to these professions. We identified 18 evaluations of guidelines which met established quality for evaluations of interventions aimed at changing professional practice. This paper describes characteristics of guidelines evaluated and the effectiveness of different dissemination and implementation strategies used. METHODS: Guideline evaluations conducted since 1975 which used a randomized controlled trial, controlled before-and-after, or interrupted time-series design, were identified using a combination of database and hand searching. FINDINGS: It is mostly impossible to tell whether the guidelines evaluated were based on evidence. The most common method of guideline dissemination was the distribution of printed educational materials. Three studies compared different dissemination and/or implementation strategies: findings suggest educational interventions may be of value in the dissemination of guidelines and confer a benefit over passive dissemination.

Allied Health Occupations↗

PubMed2000

Clinical guidelines: promoting clinical effectiveness or a professional minefield?

The development of clinical guidelines as one means of implementing evidence-based practice is currently a topical issue. The recent Government White Paper, The New NHS. Modern. Dependable, proposes the establishment of a National Institute for Clinical Excellence whose expressed aim will be to produce and disseminate guidelines based upon evidence of clinical effectiveness in health care. There will be an expectation that practitioners adapt these national guidelines for local needs and particularize them to individual patients. There has been considerable debate in the medical press between the critics and advocates of evidence-based medicine surrounding the relative usefulness of clinical guidelines. However, there has been limited corresponding debate within the nursing literature, which has largely limited itself to descriptions of the implementation of guidelines. This paper examines some of the advantages and limitations of clinical guidelines as a means of operationalizing research evidence to promote effective health care. Finally, some recommendations surrounding the implementation of guidelines will be made.

Clinical Competence↗

PubMed1999

Impact of new guidelines on physicians' ordering of preoperative tests.

OBJECTIVE: To compare the number of preoperative tests ordered for elective ambulatory surgery patients during the 2 years before and the 2 years after the establishment of new hospital testing guidelines. MEASUREMENTS: The patterns of preoperative testing by surgeons and a medical consultant during the 2 years before and the 2 years after the establishment of new guidelines at one orthopedic hospital were reviewed. All tests ordered preoperatively were determined by review of medical records. Preoperative medical histories, physical examinations, and comorbidities were obtained according to a protocol by the medical consultant (author). Perioperative complications were determined by review of intraoperative and postoperative events, which also were recorded according to a protocol. MAIN RESULTS: A total of 640 patients were enrolled, 361 before and 279 after the new guidelines. The mean number of tests decreased from 8.0 before to 5.6 after the new guidelines ( p =.0001) and the percentage decrease for individual tests varied from 23% to 44%. Except for patients with more comorbidity and patients receiving general anesthesia, there were decreases across all patient groups. In multivariate analyses only time of surgery (before or after new guidelines), age, and type of surgery remained statistically significant ( p =.0001 for all comparisons). Despite decreases in surgeons' ordering of tests, the medical consultant did not order more tests after the new guidelines ( p =.60) The majority of patients had no untoward events intraoperatively and postoperatively throughout the study period, with only 6% overall requiring admission to the hospital after surgery, mainly for reasons not related to abnormal tests. Savings from charges totaled $34,000 for the patients in the study. CONCLUSIONS: Although there was variable compliance among physicians, new hospital guidelines were effective in reducing preoperative testing and did not result in increases in untoward perioperative events or in test ordering by the medical consultant.

Adult↗

PubMed2001

Usefulness of the evidence-based medicine-supported cancer pain management guideline.

The Japanese guidelines for the clinical practice of cancer pain management supported by evidence-based medicine were established by the Japanese Society for Palliative Medicine in 1999 [as their Evidence-based Medicine-supported Cancer Pain Management Guideline ]. To evaluate usefulness of the Guideline for the management of cancer pain, the same questionnaires were addressed to nurses and physicians of enrolled institutions twice. The first survey was conducted before the distribution of the Guideline in July, 1999 and the second was done after the distribution in January, 2000. Usefulness of the Guideline was examined by comparing the results of two surveys. Cancer patients were divided into two groups depending on their stages (conservative or terminal). (1) Morbidity of pain in cancer patients at each stage having some analgesics did not change at each survey period. (2) At the first survey the rate of pain relief in each stage of cancer patients was essentially unchanged from a previous result obtained in 1998. (3) The rate of pain relief shown in the second survey tended to be higher than that shown in the first in both groups of patients. (4) The rate of pain relief with per os morphine was shown to be significantly higher in the second survey than in the first for each group of patients at conservative or terminal stage. (5) The rate of pain relief of patients staying in the ward where the guidance for dosing of morphine had been carried out was 37.5% at the first survey versus 47.9% at the second. (6) The answers from physicians to questions about treatment of cancer pain remained unchanged between the first and the second survey. The usefulness of the Guideline for cancer pain management is partly confirmed by these results. The significance of the Guideline will be totally discussed by comparing its effects on nurses, pharmacists and physicians.

Administration, Oral↗