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PubMed2000

Rational pharmacotherapy and clinical practice guidelines. Theories and perspectives on implementing pharmacotherapeutic treatment guidelines.

Several theories behind implementing clinical guidelines have been described within the literature. At first sight, these may seem different. However, there are similarities and eventually they are rather complementary than mutually exclusive. This article integrates several theoretical views on implementation of pharmacotherapeutic treatment guidelines and subsequently addresses some empirical considerations. Furthermore, specific limitations and potential harms of implementing guidelines are addressed. Several checklists are provided in order to make pharmacists, pharmacologists and clinicians aware of perspectives on dissemination, implementation, and subsequent application of pharmacotherapeutic treatment guidelines.

Drug Therapy↗

PubMed2001

[CPR--guidelines 2000. New international guidelines for cardiopulmonary resuscitation].

The "Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. An International Consensus an Science" are the first true international CPR guidelines in the history of resuscitation medicine. Experts from major international resuscitation organizations (International Liaison Committee on Resuscitation, ILCOR) achieved a consensus of recommendations which had to pass a rigorous review procedure applying the tools of evidence-based medicine: all proposed guidelines or guideline changes had to be based on critically appraised pieces of evidence which had to be integrated into a final class of recommendations. The most important changes compared to previous recommendations from either the European Resuscitation Council or the American Heart Association are presented and commented upon.

Advanced Cardiac Life Support↗

PubMed2004

Implementation strategies for a Scottish national epilepsy guideline in primary care: results of the Tayside Implementation of Guidelines in Epilepsy Randomized (TIGER) trial.

PURPOSE: To determine the effectiveness of two dissemination and implementation strategies to implement a national guideline for epilepsy management in primary care settings. METHODS: Three-arm cluster-randomized controlled trial. The participants were general practitioners from 68 practices in Tayside, Scotland, and 1,133 of their patients with self-reported epilepsy treated with antiepileptic medications (AEDs). Practices were randomized blind to a control, intermediate, or intensive intervention. CONTROL: Postal dissemination of a nationally developed clinical guideline. Intermediate intervention: Postal dissemination of the guideline supported by interactive, accredited workshops, and dedicated, structured protocol documents. Intensive intervention: Intermediate intervention plus a nurse specialist who supported and educated practices in the establishment of epilepsy review clinics. The primary outcome was the SF-36 health-related quality-of-life instrument. Secondary measures were a battery of prevalidated epilepsy-specific quality-of-life instruments. These were administered at baseline and after the intervention phase. Process of care was assessed by case-note review on number of review meetings and counseling sessions for epilepsy before and after the interventions. RESULTS: None of the intervention groups showed any change in the primary or secondary outcome measures or process-of-care measures. CONCLUSIONS: None of the intervention strategies led to improvements in patient quality of life or quality of epilepsy care. Further research is needed to discover why the interventions failed, to identify barriers to adoption of guidelines, and to develop strategies that might improve implementation and uptake in the future.

Adult↗

PubMed2003

A review of guidelines on benign prostatic hyperplasia and lower urinary tract symptoms: are all guidelines the same?

OBJECTIVE: To compare overall and methodological quality with content in national and supra-national Clinical Practice Guidelines (CPGs) on benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), as the purpose of CPGs is to reduce unwanted variation in practice and improve patient care by setting agreed standards based on the best available evidence. METHODS: An electronic search was used to identify Internet-based national and supra-national CPGs on BPH and LUTS available in 2001. Two independent assessors analysed the content and appraised the methodological quality of the CPGs using an existing and validated instrument (St. George's Hospital Medical School Health Care Evaluation Unit Appraisal Instrument) comprising 37 items grouped into three broad areas, i.e. rigour of development, context and content, and clinical application. RESULTS: Eight CPGs were suitable for appraisal; there was much variation in overall and methodological quality. There was agreement that a patient history and physical examination (including a digital rectal examination) should be used in all symptomatic men. In addition, patients' symptoms should be assessed using a validated symptom score, e.g. the International Prostate Symptom Score. There was considerable variation in the number and type of diagnostic tests recommended for routine assessment. CPGs scoring low on the appraisal instrument (indicating poor overall and methodological quality) were more likely to recommend more diagnostic tests than those scoring high. There was general agreement between the guidelines on the treatment of BPH/LUTS and the importance of the patient's involvement in making management decisions. Guideline quality was independent of local health resources and publication year. CONCLUSION: The overall and methodological quality of CPGs on BPH/LUTS varies considerably. There appears to be an inverse relationship between guideline quality and the number of diagnostic tests recommended for routine assessment. Using CPGs of high quality may prevent men with BPH/LUTS being exposed to tests of doubtful utility. Although this may reduce both resource use and exposure to potential harm, moving to a more minimalist approach to diagnosis may itself be potentially harmful to patients.

Decision Making↗

PubMed2006

Guidelines abstracted from the Department of Veterans Affairs/Department of Defense clinical practice guideline for the management of stroke rehabilitation.

OBJECTIVES: To assist facilities in identifying those evidence-based processes of poststroke care that enhance measurable patient outcomes. The guideline(s) should be used by facilities (hospitals, subacute-care units and providers of long-term care) to implement a structured approach to improve rehabilitative practices and by clinicians to determine best interventions to achieve improved patient outcomes. OPTIONS: The guideline considers five elements of poststroke rehabilitation care: interdisciplinary teams; use of standardized assessments; intensity, timing, and duration of therapy; involvement of patients' families and caregivers in decision-making; and educational interventions for patients, families, and caregivers. Evidence, benefits, harms, and recommendations for each of the five designated elements and specific annotated recommendations for poststroke managements are presented separately. OUTCOMES: The overall guideline considers improvement in functional status measures as the primary outcome. Achieving community-dwelling status and preventing complications, death, and rehospitalization are also important outcomes. Costs are not specifically addressed. PARTICIPANTS: The Department of Veterans Affairs/Department of Defense (VA/DoD) Stroke Rehabilitation Working Group consisted of 28, largely VA and military hospital, representatives of medical and allied professions concerned with stroke diagnosis, management, and rehabilitation. Nine additional members with similar credentials served as the editorial committee. Technical consultation was contracted from ACS Federal Health Care, Inc., and the Center for Evidence-Based Practice, State University of New York-Upstate Medical University, Department of Family Medicine conducted evidence appraisal. Consensus was achieved over several years of facilitated group discussion and iterative evaluation of draft documents and supporting evidence. SPONSOR: The guideline was prepared under the auspices of the VA/DoD. No other source of support was identified in the document, or supporting documents.

Early Diagnosis↗

PubMed2006

Guidelines for guidelines.

Practice guidelines are proliferating in medicine. In addition to methodological problems that cause guidelines to be outdated rapidly, they are plagued by conflicts of interest. They are largely consensus opinions of panels of experts, most of whom are supported by industry. Professional societies, health insurers, Centers for Medicare and Medicaid Services, and dialysis providers also benefit from guidelines. Little attention is paid to the potential for harm to patients, and to the profession of medicine, from the widespread use of guidelines.

Centers for Medicare and Medicaid Services, U.S.↗

PubMed1998

Getting a validated guideline into local practice: implementation and audit of the SIGN guideline on the prevention of deep vein thrombosis in a district general hospital.

This paper describes the implementation of a specific clinical guideline on venous thromboprophylaxis and outlines the audit design and methods used to achieve this objective. A member of the clinical staff was seconded to oversee this implementation and co-ordinate audit of current in the main clinical specialties within the trust. The Trust Clinical Audit Committee agreed to fund this low cost initiative (approximately 3,800 pounds) from clinical guideline monies. Findings from the initial audit revealed a total of 224 patients identified as 'at risk' of developing deep vein thrombosis or pulmonary embolism. Of this number 72.8%, (n = 163), were prescribed prophylaxis compared with the pre-set standard of 90.0%. Fifty four percent, (n = 122), of all identified patients were prescribed the correct prophylaxis in accordance with SIGN guideline recommendations. As a result of the initial findings local prevention protocols were developed or upgraded as required in line with the national guideline. The repeat audit findings highlighted a significant increase in the number of 'at risk' patients prescribed prophylaxis rising from 72.8% to 97.4% (P < 0.001) and similarly from 54.5% to 95.9% for those prescribed the correct prophylaxis (P < 0.001).

Hospitals, General↗

PubMed2001

From paper-based to electronic guidelines: application to French guidelines.

In order to develop an internet-based decision support system, making available for French general practitioners several prevention guidelines is was necessary to implement paper based guideline. We propose a framework allowing to transform paper based practice guideline into their electronic form. Three different problems were identified: computability (e.g. determinism of the eCPG), logic (e.g. ambiguities when combining Booleans operators) and external validity (i.e. stability of decision for variations around thresholds and proportion of subjects classified in the various terminal nodes). The last problem concerned documentation of evidence: the level of evidence was associated only with the terminal decision node and not with the pathway through the decision tree. We concluded that computerisation of guidelines is not possible without expertise or authors advice. To improve computability it is necessary to provide authors with a framework that checks ambiguities, and logical errors.

Algorithms↗

PubMed2002

[New recommendations in European cardiopulmonary resuscitation guidelines (Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care 2000: an International Consensus on Science].

The article presents most important changes in international guidelines for adult cardiopulmonary resuscitation. In this article guideline changes in basic and advanced life support published in Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care--a Consensus on Science are discussed. Major changes in guidelines presented in this article include: pulse check, ventilation technique for rescue breathing, compression technique, abdominal thrust recommendations, precordial thump, universal algorithm changes.

Cardiology↗

PubMed2003

[Draft ICH guideline S7B: guideline on safety pharmacology studies for assessing the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals].

Nonclinical assessment of potential of QT interval prolongation caused by non-antiarrhythmic drugs has been an issue for drug development because QT interval prolongation increases the risk of ventricular tachyarrhythmia, including torsade de pointes when combined with other risk factors. However, there is no scientific consensus on approaches and no international consensus on regulatory recommendations. This guideline is being developed to provide the general nonclinical testing strategy for evaluating the potential risk of QT prolongation and presents some major principles for in vitro and in vivo electrophysiology studies. The basis of this guideline is the integrated risk assessment that provides overall evaluations based on nonclinical study results and chemical/pharmacological class information to predict the potential of a test substance to prolong QT interval in humans (i.e., evidence of risk) and that contributes clinical study design and interpretation of clinical results. Safety margins are also components of integrated risk assessment. Since this guideline addresses a field of research that is in a state of rapid evolution, the proposed concept for evidence of risk and safety margins needs to be further refined based on the data being collected by international initiatives. In this article, the draft S7B guideline is outlined.

Drug-Related Side Effects and Adverse Reactions↗

PubMed2004

Guidelines for the safe use of wastewater in agriculture: revisiting WHO guidelines.

The use of wastewater in agriculture is occurring more frequently because of water scarcity and population growth. Often the poorest households rely on this resource for their livelihood and food security needs. However, there are negative health implications of this practice that need to be addressed. WHO developed Guidelines for the Safe Use of Wastewater in Agriculture in 1989. The Guidelines are currently being revised based on new data from epidemiological studies, quantitative microbial risk assessments and other relevant information. WHO guidelines must be practical and offer feasible risk management solutions that will minimize health threats and allow for the beneficial use of scarce resources. To achieve the greatest impact on health, guidelines should be implemented with other health measures such as: health education, hygiene promotion, provision of adequate drinking water and sanitation, and other health care measures.

Agriculture↗

PubMed1996

[Guidelines for the diagnosis and management of bronchial asthma--a comparison of the Japanese guidelines for the adult asthma with GINA and ICR].

Although the concept of asthma management of the Japanese Guidelines is basically similar in the other guidelines including GINA, ICR, of British Thoracic Society, and of the other countries, assuming that asthma is a chronic inflammatory disorder of the airway, the program of stepwise pharmacologic therapy is not the same in various points. Therapy suggested in the Japanese Guidelines is different in 1) oral antiallergic drugs are widely used, 2) patients prefer oral bronchodilators to inhaled bronchodilators, 3) sustained released theophylline in the long term management and intravenous infusion of aminophylline for the treatment of acute exacerbation are accepted and frequently used by the physicians. Also the differences in the choice of medication between GINA, which is characterized by concept of cost, and other guidelines are discussed.

Asthma↗

PubMed1998

[Goals, possibilities and limits of quality evaluation of guidelines. A background report on the user manual of the "Methodological Quality of Guidelines" check list].

Recently a German appraisal instrument for clinical guidelines was published that could be used by various parties in formal evaluation of guidelines. An user's guide to the appraisal instrument was designed that contains a detailed explanation for each question to ensure that the instrument is interpreted consistently. This paper describes the purposes, format and contents of the user's guide, and reviews the key factors influencing the validity of guidelines. Taking into account international experiences, the purposes, chances and methodological limitations of a prospective assessment of clinical practice guidelines are discussed.

Germany↗

PubMed1998

[Methodological quality of clinical practice guidelines in Germany: results of a systemic assessment of guidelines presented on the Internet].

Critics claim that most of the German clinical practice guidelines are of poor quality having produced by informal ad hoc methodologies without a rigorous approach. This paper reports on the systematic appraisal of 329 guidelines published online by the Association of the Scientific Medical Societies (AWMF) in Germany. The results of this study suggest that most of the guidelines presented in Internet do not meet internationally recognised criteria for quality. Proposals are offered how to enhance the methodological quality of future guidelines.

Humans↗

PubMed2005

Multicenter survey on the validity of the CD-ROM guideline for antiarrhythmic drug therapy produced by the Japanese Circulation Society and the Japanese Society on Electrocardiology: preliminary report of the survey of the Japanese guideline for Arrhythmia Management By Individual Therapy (J-GAMBIT).

BACKGROUND: A multicenter investigational survey (Japanese Guideline for Arrhythmia Management By Individual Therapy) was conducted to evaluate the validity of using CD-ROM guidelines vs physician choice for the selection of antiarrhythmic drugs. METHODS AND RESULTS: Patients with paroxysmal atrial fibrillation (PAF, n=274) or premature ventricular contractions (PVC, n=216) were enrolled. The rate of concordance for drug selection between the treating physician and the CD-ROM was 216 of 274 patients (78.8%) with PAF. Of these, 168 (61.3%) were concordant for first-line agents and the remaining 48 (17.5%) were concordant for second-line agents. The concordance for the treatment of PVC was 154/216 cases (71.3%). Of these, 106 (49.1%) were concordant for first-line agents and the remaining 48 (22.2%) were concordant for second-line agents. Nonconcordance for PAF therapy was more likely to occur for patients with underlying heart disease (p<0.05), depressed cardiac function (p<0.001), and with more frequent ECG abnormalities and renal dysfunction. These differences were not seen in patients with PVC. CONCLUSION: The CD-ROM guidelines appear to be valid in the selection of antiarrhythmic drugs for both PAF and PVC, but their usefulness is influenced by the patient's clinical characteristics.

Aged↗

PubMed2002

The role of high-dose chemotherapy and stem-cell transplantation in patients with multiple myeloma: a practice guideline of the Cancer Care Ontario Practice Guidelines Initiative.

The Hematology Disease Site Group of the Cancer Care Ontario Practice Guidelines Initiative has systematically reviewed the published literature and, through a consensus process, developed an evidence-based practice guideline assessing the role of stem-cell transplantation in patients with multiple myeloma. The conclusions were validated by solicited feedback from 221 practitioners across Ontario, Canada. The guideline comprises six recommendations: 1) Autologous transplantation is recommended for patients with stage II or III myeloma and good performance status. Evidence of benefit is strongest for patients who are younger than 55 years of age and have a serum creatinine level less than 150 micromol/L (<1.7 mg/dL). Physicians must use clinical judgment in recommending transplantation to other patients. 2) Allogeneic transplantation is not recommended as routine therapy. 3) Patients potentially eligible for transplantation should be referred for assessment early after diagnosis and should not be extensively exposed to alkylating agents before collection of stem cells. 4) Autologous peripheral blood stem cells should be harvested early in the patient's treatment course. The best available data suggest that transplantation is most advantageous when performed as part of initial therapy. 5) The comparative data addressing the specifics of the transplantation process are insufficient to allow definitive recommendations. In the absence of such data, a single transplant with high-dose melphalan, with or without total-body irradiation, is suggested for patients undergoing transplantation outside a clinical trial. 6) At this time, no conclusions can be reached about the role of interferon therapy after transplantation.

Age Factors↗

PubMed2001

Chemoprevention of breast cancer. A joint guideline from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative's Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer.

OBJECTIVE: To assist women and their physicians in making decisions regarding the prevention of breast cancer with tamoxifen and raloxifene. EVIDENCE: Systematic review of English-language literature published from 1966 to August 2000 retrieved from MEDLINE, HealthSTAR, Current Contents and Cochrane Library. VALUES: The strength of evidence was evaluated using the methods of the Canadian Task Force on Preventive Health Care and the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. RECOMMENDATIONS: Women at low or normal risk of breast cancer (Gail risk assessment index < 1.66% at 5 years): There is fair evidence to recommend against the use of tamoxifen to reduce the risk of breast cancer in women at low or normal risk of the disease (grade D recommendation). Women at higher risk of breast cancer (Gail index > or = 1.66% at 5 years): Evidence supports counselling women at high risk on the potential benefits and harms of breast cancer prevention with tamoxifen (grade B recommendation). The cutoff for defining high risk is arbitrary, but the National Surgical Adjuvant Breast and Bowel Project P-1 Study included women with a 5-year projected risk of at least 1.66% according to the Gail index, and the average risk of patients entered in the trial was 3.2%. Examples of high-risk clinical situations are 2 first-degree relatives with breast cancer, a history of lobular carcinoma in situ or a history of atypical hyperplasia. As the risk of breast cancer increases above 5% and the benefits outweigh the harms, a woman may choose to take tamoxifen. The duration of tamoxifen use in such situations is 5 years based on the results from trials of tamoxifen involving women with early breast cancer. If a woman raises concerns or has already been evaluated and is calculated to be at high risk, then individuals experienced and skilled in counselling may discuss the potential benefits and harms of tamoxifen use. Important additional issues: Prevention of breast cancer with raloxifene: Current evidence does not support recommending chemoprevention of breast cancer with raloxifene outside of a clinical trial setting. Screening using the Gail risk assessment index: This index was the main eligibility criterion for enrolling women in the one study that showed potential benefit from chemoprevention. However, it has not been evaluated for use as a routine screening or case-finding instrument; validation of the index is required. Overall, current evidence does not support a shift to its routine use in physicians' offices for screening or case finding. However, when a woman or her physician is concerned about the woman's increased risk of breast cancer, the index can be a useful tool in deciding whether to pursue an in-depth discussion of the potential benefits and harms of chemoprevention. Hence, the approach to identifying women at higher risk who warrant counselling and shared decision-making will vary across practices. (The risk assessment index is available online at http://bcra.nci.nih.gov/brc/). [A patient version of these guidelines appears in Appendix 2.] VALIDATION: The authors' original text was revised by both the Canadian Task Force on Preventive Health Care and the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. The final document reflects a consensus of these contributors. SPONSOR: Health Canada. COMPLETION DATE: February 2001.

Adult↗

PubMed2004

Short version of the Guideline: Early Detection of Breast Cancer in Germany. An evidence-, consensus-, and outcome-based guideline according to the German Association of the Scientific Medical Societies (AWMF) and the German Agency for Quality in Medicine (AeZQ).

The goal of the Guideline "Early Detection of Breast Cancer in Germany" is to assist physicians, healthy women, and patients in the decision-making process in favour of appropriate health care regarding early detection and diagnosis of breast cancer. The principle of early detection of breast cancer embraces the detection of non-invasive stages of breast cancer (UICC stage 0, carcinoma in situ), reducing the frequency of invasive breast cancer development, as well as the identification of breast cancer at an early stage (UICC stage I) having a chance of cure of more than 90%, as shown by a large number of trials. The Guideline summarized in the following paper is a precondition to establishing a nation-wide, comprehensive, quality-assurance program for the early detection and diagnosis of breast cancer. The resulting consequence should be a timely mortality reduction of breast cancer. The cure of early stage disease will additionally be achieved by less intensive treatment methods while largely maintaining the quality of life of breast cancer patients. Implementing the Guideline offers the possibility of a significant improvement in women's health care.

Biopsy↗