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PubMed1997

American Academy of Dermatology guidelines of care. Development and process.

Medical practice guidelines are being developed at an accelerating pace, in all areas of medicine, for a wide range of uses. The field of practice guideline development is not new, but a number of important economic and health care issues have renewed interest in their creation. In 1987, in response to many of these issues, the American Academy of Dermatology took a leadership role and began a process designed to develop guidelines for disease entities treated by dermatologists. The result was a set of clinical practice guidelines and the most comprehensive dermatology guideline development processes to date. Herein we describe the guideline development process in its current, refined form and discuss some of its unique and important characteristics. New applications of guidelines, outside of clinical practice improvement, have made their development controversial. Nevertheless, it is important for the medical profession to lead in this effort, and the American Academy of Dermatology continues to explore ways to refine and update its guidelines to reflect the latest medical science and technology.

Humans↗

PubMed2004

Implementing guidelines for smoking cessation: comparing the efforts of nurses and medical assistants.

BACKGROUND: It is unclear how different types of intake clinicians (registered nurses [RNs], and less costly licensed practical nurses [LPNs] and medical assistants [MAs]) compare in the performance of smoking-cessation activities recommended in the Agency for Healthcare Research and Quality (AHRQ) smoking-cessation clinical practice guideline. METHODS: A secondary analysis of data from a randomized controlled trial of guideline implementation was performed. Exit interviews of consecutive adult smokers who presented to nine primary care clinics for routine, non-emergency care were conducted during the period February 2000 to May 2001; a total of 1221 patients with adequate data were analyzed. Intake clinicians were surveyed prior to guideline training. Hierarchical logistic regression models were used to determine the association between type of intake clinician and performance of cessation counseling at the clinic visit, after adjustment for patient-level covariates, intake clinicians' characteristics, and study site. RESULTS: Performance of all guideline-recommended counseling activities were significantly greater for all intake clinicians at test versus control sites. MAs were significantly less likely to assess willingness to quit (adjusted odds ratio [AOR]=0.4, 95% confidence interval [CI]=0.2-0.8, p =0.005) and tended to offer advice and assistance in quitting less often than RNs. Similar findings were observed for LPNs (AOR=0.5, 95% CI=0.3-1.0, p =0.03, for assessing willingness to quit). Subset analysis in subjects with complete survey data revealed that being seen by a MA was no longer associated with statistically significant differences in performance, after accounting for personal beliefs, self-efficacy, and role satisfaction in cessation counseling. CONCLUSIONS: Although both MAs and LPNs showed marked improvements in performance in response to the guideline intervention, patients seen by these intake clinicians were less likely to receive guideline-recommended counseling, compared to those patients seen by RNs. Given their important role in the delivery of preventive care, MAs and LPNs should receive proper training in cessation counseling, should have strong physician and administrative support, and should be included in efforts to implement smoking-cessation guidelines in primary care.

Adolescent↗

PubMed1998

Elderly patients receive less aggressive medical and invasive management of unstable angina: potential impact of practice guidelines.

BACKGROUND: The Agency for Health Care Policy and Research (AHCPR) released a practice guideline on the diagnosis and management of unstable angina in 1994. OBJECTIVE: To examine practice variation across the age spectrum in the management of patients hospitalized with unstable angina 2 years before release of the AHCPR guideline. DESIGN: Retrospective cohort. SETTING: Urban academic hospital. PATIENTS: All nonreferral patients diagnosed as having unstable angina who were hospitalized directly from the emergency department to the intensive care or telemetry unit between October 1, 1991, and September 30, 1992. MEASUREMENTS: Percentage of eligible patients receiving medical treatment concordant with 8 important AHCPR guideline recommendations. RESULTS: Half of the 280 patients were older than 66 years; women were older than men on average (70 vs 64 years; P<.001). After excluding those with contraindications to therapy, patients in the oldest quartile (age, 75.20-93.37 years) were less likely than younger patients to receive aspirin (P<.009), beta-blockers (P<.04), and referral for cardiac catheterization (P<.001). Overall guideline concordance weighted for the number of eligible patients declined with increasing age (87.4%, 87.4%, 84.0%, and 74.9% for age quartiles 1 to 4, respectively; chi2, P<.001). Increasing age, the presence of congestive heart failure at presentation, a history of congestive heart failure, previous myocardial infarction, increasing comorbidity, and elevated creatinine concentration were associated with care that was less concordant with AHCPR guideline recommendations; only age and congestive heart failure at presentation remained significant in the multivariate analysis (odds ratios, 1.28 per decade [95% confidence interval, 1.02-1.61] and 3.16 [95% confidence interval, 1.57-6.36], respectively). CONCLUSIONS: Older patients were less likely to receive standard therapies for unstable angina before release of the 1994 AHCPR guideline. Patients presenting with congestive heart failure also received care that was more discordant with guideline recommendations. The AHCPR guideline allows identification of patients who receive nonstandard care and, if applied to those patients with the greatest likelihood to benefit, could lead to improved health care delivery.

Age Factors↗

PubMed2000

Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicology testing.

Atthe International Workshop on Genotoxicity Test Procedures (IWGTP) held in Washington, DC, March 25-26, 1999, an expert panel met to develop guidelines for the use of the single-cell gel (SCG)/Comet assay in genetic toxicology. The expert panel reached a consensus that the optimal version of the Comet assay for identifying agents with genotoxic activity was the alkaline (pH > 13) version of the assay developed by Singh et al. [1988]. The pH > 13 version is capable of detecting DNA single-strand breaks (SSB), alkali-labile sites (ALS), DNA-DNA/DNA-protein cross-linking, and SSB associated with incomplete excision repair sites. Relative to other genotoxicity tests, the advantages of the SCG assay include its demonstrated sensitivity for detecting low levels of DNA damage, the requirement for small numbers of cells per sample, its flexibility, its low costs, its ease of application, and the short time needed to complete a study. The expert panel decided that no single version of the alkaline (pH > 13) Comet assay was clearly superior. However, critical technical steps within the assay were discussed and guidelines developed for preparing slides with agarose gels, lysing cells to liberate DNA, exposing the liberated DNA to alkali to produce single-stranded DNA and to express ALS as SSB, electrophoresing the DNA using pH > 13 alkaline conditions, alkali neutralization, DNA staining, comet visualization, and data collection. Based on the current state of knowledge, the expert panel developed guidelines for conducting in vitro or in vivo Comet assays. The goal of the expert panel was to identify minimal standards for obtaining reproducible and reliable Comet data deemed suitable for regulatory submission. The expert panel used the current Organization for Economic Co-operation and Development (OECD) guidelines for in vitro and in vivo genetic toxicological studies as guides during the development of the corresponding in vitro and in vivo SCG assay guidelines. Guideline topics considered included initial considerations, principles of the test method, description of the test method, procedure, results, data analysis and reporting. Special consideration was given by the expert panel to the potential adverse effect of DNA degradation associated with cytotoxicity on the interpretation of Comet assay results. The expert panel also discussed related SCG methodologies that might be useful in the interpretation of positive Comet data. The related methodologies discussed included: (1) the use of different pH conditions during electrophoreses to discriminate between DNA strand breaks and ALS; (2) the use of repair enzymes or antibodies to detect specific classes of DNA damage; (3) the use of a neutral diffusion assay to identify apoptotic/necrotic cells; and (4) the use of the acellular SCG assay to evaluate the ability of a test substance to interact directly with DNA. The alkaline (pH > 13) Comet assay guidelines developed by the expert panel represent a work in progress. Additional information is needed before the assay can be critically evaluated for its utility in genetic toxicology. The information needed includes comprehensive data on the different sources of variability (e.g., cell to cell, gel to gel, run to run, culture to culture, animal to animal, experiment to experiment) intrinsic to the alkaline (pH > 3) SCG assay, the generation of a large database based on in vitro and in vivo testing using these guidelines, and the results of appropriately designed multilaboratory international validation studies.

Animals↗

PubMed1999

A review and commentary on a sample of 15 UK guidelines for the drug treatment of Alzheimer's disease.

BACKGROUND: There has been widespread development of clinical guidelines for the treatment of Alzheimer's disease since the introduction of donepezil in the UK in 1997. These have been developed nationally, regionally, locally and by independent groups. An independent review of guidelines available in the public domain was commissioned to provide an overview of the range and variability in the recommendations being made. METHODS: Fifteen sets of guidelines obtained from a variety of sources were reviewed in a standardized way to extract the recommendations being made in the following areas: diagnosis; investigations; the evidence base of the recommendations: initiation of drug treatment; monitoring and dose adjustment; and decision-making on maintenance or discontinuation of treatment. RESULTS: None of the documents fulfilled criteria for high-quality evidence-based guidelines. Substantial variability was evident in all areas of recommendation. All of the guidelines appeared to be based upon consensus opinion. Only one incorporated a statement of potential conflicts of interest affecting the working group who developed the guideline. CONCLUSIONS: The lack of consistency found in this sample of guidelines would inevitably lead to inequalities in the health care delivered in different areas. A national initiative is needed to encourage true evidence-based guideline development, not only on drug treatment but also on the wider issues raised such as diagnosis, investigations and the best treatment setting for delivering drug and other therapies.

Aged↗

PubMed2002

Industry perspectives on ICH guidelines.

In 1990 the International Conference on Harmonization (ICH) effort was begun with the intent of standardizing the drug registration and approval process. The need to rationalize and harmonize regulation was driven by concerns over rising costs of health care, escalation of the cost of research and development and the need to meet the public expectation that there should be a minimum delay in making safe and efficacious new treatments available to patients in need. Since most regulatory agencies have limited resources to interact with sponsor companies, standardized guidelines would help expedite communications with companies at the programme design stage. The ICH is a joint initiative involving both regulators and industry as partners in scientific and technical discussions of the testing procedures which are required to ensure the safety and efficacy of medicines. While all regions of the world have some input to the process, the primary development of the guidelines is derived from industry and regulatory representatives from Europe, Japan and the United States. Much progress has been made in the ten years since the initiation of the ICH, but the implementation and maintenance of the guidelines are in the early stages for most if not all of the published guidelines. If the guidelines do not gain a solid foothold early on, then drift between the regions in use of the guidelines will defeat the goals of the ICH. While the ICH covers the entire drug development process, this paper will review the guidelines that pertain most closely to clinical trials and their use in the drug registration process. Some of the guidelines have been approved and some are still in the development stage.

Drug Approval↗

PubMed1997

EPA's neurotoxicity risk assessment guidelines.

The proposed Neurotoxicity Risk Assessment Guidelines (U.S. EPA, 1995c Fed. Reg. 60(192), 52032-52056) of the U.S. Environmental Protection Agency (EPA) were the subject of a workshop at the 1997 Meeting of the Society of Toxicology. The workshop considered the role of guidelines in the risk assessment process, the primary features, scientific basis, and implications of the guidelines for EPA program offices, as well as for industrial neurotoxicologists from the perspectives of both pesticides and toxic substances regulation. The U.S. National Academy of Sciences (NAS, 1983, Risk Assessment in the Federal Government: Managing the Process) established a framework for distinguishing risk management from risk assessment, the latter being the result of integrating hazard identification, hazard characterization, and exposure assessment data. The guidelines are intended to establish operating principles that will be used when examining data in a risk assessment context. The proposed neurotoxicity risk assessment guidelines provide a conceptual framework for deciding whether or not a chemically induced effect can be considered to be evidence of neurotoxicity. Topics in the proposed guidelines include structural and functional effects, dose-response and -duration considerations, and relationships between effects. Among the issues that must be considered are the multiplicity of chemical effects, the levels of biological organization in the nervous system, and the tests, measurements, and protocols used. Judgment of the adversity of an effect depends heavily on the amount and types of data available. The attribution of a chemically induced effect to an action on the nervous system depends on several factors such as the quality of the study, the nature of the outcome, dose-response and time-response relationships, and the possible involvement of nonneural factors. The guidelines will also serve as a reference for those conducting neurotoxicity testing, as well as establish a consistent approach to neurotoxicity risk assessment by regulators. Extending this approach through international harmonization would be advantageous to the development of products for a worldwide market. Thus, both risk assessors and regulated industries have a large stake in the guidelines to provide a framework that will lead to accurate risk assessment decisions.

Data Collection↗

PubMed2006

An evaluation of Australian sediment quality guidelines.

Interim sediment quality guidelines (ISQGs) adapted recently to Australia from North American effects-based guidelines were evaluated with matching chemical and toxicological data collected for sediments (n = 103) from Sydney Harbour and south coast estuaries of New South Wales. The incidence of toxicity for the test battery was low (7%) among samples with all chemical concentrations below ISQG-Low values, indicating these guidelines are accurate and protective of non-toxic conditions. The incidence of toxicity increased greatly (to 73%) when one or more ISQG-Low values were exceeded, suggesting that ISQG-Low guidelines are appropriate for compliance. Frequent toxic effects (in >75% of samples) were associated with chemical concentrations exceeding ISQG-High guidelines. As expected, the high guideline values were more predictive of adverse effects than the low guidelines. Predictive abilities of ISQGs were not markedly affected by normalization of organic compounds to organic carbon or the use of dilute acid extractions for metals, suggesting that the guidelines are applicable to a wide range of conditions.

Amphipoda↗

PubMed2006

Developing evidence-based guidelines for management of alimentary mucositis: process and pitfalls.

INTRODUCTION: It is important yet difficult to maintain currency in clinical oncology practice. The emergence of new diagnostic technologies and new paradigms for cancer treatment combine to produce a rapidly changing clinical approach to patients aided by the increasing use of multidisciplinary care teams and development of evidence-based protocols. METHODS: Teams of experts review the literature in a given area and produce management guidelines and protocols for use by practicing clinicians. Traditionally within Hematology/Oncology, these guidelines have been directed to management of a given tumor type. However, in recent years, attention has increasingly turned to supportive oncology; for example, there are now management guidelines for conditions such as neutropenic fever [Hughes et al. Clinical Infectious Diseases 34(6):730-751, 2002], antiemetic (The Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer Annals of Oncology 17:20-28, 2006) and most recently, mucositis [Rubenstein et al. Cancer 100(9 Suppl):2026-2046, 2004]. It is critical that any guideline process should include education, evaluation, and timely update in its remit, because guidelines become highly compromised if their existence is not widely known, if they do not facilitate clinical practice, or if they are not reflective of contemporary medical literature. RESULTS: The Mucositis Study Group (MSG) of the Multinational Association for Supportive Care in Cancer/International Society for Oral Oncology was created in 1998 to specifically address the multiprofessional approach to clinical care, research, and education associated with mucosal injury in cancer patients. A specific outcome has been the development of evidence-based guidelines for the management of mucositis [Rubenstein et al. Cancer 100(9 Suppl):2026-2046, 2004; The Mucositis Study Group of MASCC/ISSO 2005]. The original guidelines [Rubenstein et al. Cancer 100(9 Suppl):2026-2046, 2004] and a companion paper discussing the science behind mucositis [Sonis et al. Cancer 100(9):1995-2025, 2004], were published in 2004. The MSG has recently updated the guidelines [The Mucositis Study Group of MASCC/ISSO 2005]. DISCUSSION: This paper discusses the process involved and the lessons learned that might help other groups planning to undertake a similar project.

Effect Modifier, Epidemiologic↗

PubMed2006

JPN Guidelines for the management of acute pancreatitis: cutting-edge information.

The JPN Guidelines for the Management of Acute Pancreatitis are organized under the subject headings: epidemiology, diagnosis, management strategy, severity assessment and transfer criteria, management of gallstone pancreatitis, nonsurgical management, and surgical management. The Guidelines contain cutting-edge information on each of these subjects, as well as a section on the Japanese medical insurance system which provides information that should prove useful to physicians in other countries. The quality of the evidence was evaluated by the evidence-based classification method used at the Cochrane Library. The levels of recommendation of the individual management methods contained in the Guidelines were determined on the basis of the evaluation of evidence by the consensus of the members of the Working Group (see below). The Japanese Society for Abdominal Emergency Medicine, the Japan Pancreas Society, and the Research Group for Intractable Diseases and Refractory Pancreatic Diseases (which is sponsored by the Japanese Ministry of Health, Labour, and Welfare) were commissioned to produce the JPN Guidelines for the Management of Acute Pancreatitis. A Working Group of 20 physicians specializing in pancreatic diseases and emergency medicine investigated and analyzed 14821 cases retrieved by means of a Medline (1960-2004) search and discussed the available literature on acute pancreatitis (limited to human pancreatitis). The Working Group held many general discussions in order to reach a consensus on the content of the Guidelines. After producing a draft, the Publishing Committee of the JPN Guidelines for the Management of Acute Pancreatitis posted it on a website and asked for comments and criticisms. Subsequently, a final version of the Guidelines was published in Japanese in 2003. The Publishing Committee is now making the Guidelines available to a much wider readership by bringing out an English version.

Acute Disease↗

PubMed2005

Inguinal hernia surgery in The Netherlands: a baseline study before the introduction of the Dutch Guidelines.

BACKGROUND: In 2003 the Dutch Guidelines for treatment of inguinal hernia (IH) were published. For treatment of IH in adults, the evidence-based guidelines recommend the use of a mesh repair technique. In order to be able to evaluate the effects of these guidelines, a baseline analysis of inguinal hernia surgery before the introduction of these guidelines had to be performed. The second analysis will be performed two years (January-March 2005) after the publication of the Guidelines. OBJECTIVE: To make an inventory of IH surgery in the Netherlands, before the introduction of guidelines for IH treatment, to serve as a baseline for future evaluation of the impact of the implementation of these guidelines. METHODS: A retrospective descriptive study was performed in 2003 using patient and operation charts including IH repairs performed in The Netherlands over a three-month period (January-March 2001). RESULTS: 97/133 (73%) hospitals cooperated with the study, generating data from a total of 4386 IH in 3979 patients (3284 adults, 695 children). Mesh techniques were used in 2839 (78%) adult inguinal hernias while 800 (22%) patients were treated with non-mesh techniques. 484 (14.7%) adult patients were operated on during the study period for a recurrent hernia from previous years. Early recurrence (<1 year) occurred in 2.2% of all patients. Wound infection was documented in 0.8% of all IH. The mortality rate was 0.1%. 1257 of the 3284 (38.3%) adults, and 566 of the 695 children (81.4%), were operated on in ambulatory care. CONCLUSIONS: In the episode prior to implementation of the Dutch evidence-based Guidelines for treatment of inguinal hernia, 2839 (78%) adult patients were treated with mesh repair and 484 (13.3%) patients were treated for a recurrent hernia.

Adolescent↗

PubMed2006

Models for guideline representation.

Despite the great emphasis that the medical community has dedicated to clinical practice guidelines in the last few decades, it has become clear that it is difficult to adequately distribute texts (paper-based guidelines) and for them to be used by final users. The reasons for this are manifold: the large number of guidelines delivered each year, their necessary updates on the face of new scientific evidence, the text is not always free from ambiguities, etc. When these problems became evident, the medical informatics community hypothesised that more formal electronic versions would increase the probability of the effective diffusion of guidelines and also physicians' compliance to them. This claim was based on a few hypotheses: one is that formal models, such as flowcharts or other graphical metaphors, provide a more friendly and immediate way of reading a guideline, thus improving learning and absorbing of the guideline content (e. g. using formal models as educational/simulation tools); another hypothesis is that formal models allow easier guideline integration with the daily clinical workflow, raising the possibility of building real-time decision support systems, which again should improve physicians' compliance. This paper focuses on the issues that must be taken into account when modelling guidelines to ensure their effective implementation in real-world computerised environments.

Computer Simulation↗

PubMed1992

Poland-US collaborative study on cardiovascular epidemiology: classification agreement between US National Cholesterol Education Program and European Atherosclerosis Society hyperlipidemia guidelines in selected Polish and US populations.

Data from two epidemiological studies are used to measure the degree to which two well-known guidelines agree in measuring hyperlipidemia in population samples in the US and Poland. The epidemiological studies are the US Lipid Research Clinics Program Prevalence Study and the Pol-MONICA project in Poland and the guidelines are those adopted by the US National Cholesterol Program (USNCEP) and by the European Atherosclerosis Society (EAS). EAS guidelines were analyzed in two ways: Method 1 used triglycerides and total cholesterol only in classifying persons as hyperlipidemics or non-hyperlipidemics; Method 2 used triglycerides, total cholesterol and nine additional risk factors in the classification process. USNCEP guidelines used total cholesterol, low density lipoprotein cholesterol and the same additional nine risk factors used in EAS Method 2 in classifying hyperlipidemics. Classification differences between the two sets of guidelines were high when EAS Method 1 guidelines were compared with USNCEP guidelines. However, EAS Method 2 which included risk factors, compared favorably with USNCEP guidelines in all three populations under study.

Adult↗

PubMed1991

Chromosome analysis guidelines preliminary report.

These guidelines have been developed by the Association of Cytogenetic Technologists (ACT) for chromosome analysis. In formulating its recommendations, the task force reviewed guidelines established by several states and regional genetics groups. Draft guidelines prepared by the task force were reviewed by a panel of expert consultants, all of whom are laboratory directors and well known in their respective fields of expertise. The intention of the task force was to reflect procedures that are believed to be generally accepted by cytogenetic laboratories as basic criteria for effective chromosome analysis and that are consistent with existing cytogenetic quality assurance guidelines. It is important to stress that the primary purpose of the task force at this time is to establish guidelines for chromosome analysis. While the present guidelines address issues other than chromosome analysis, they do so incidentally and only in general terms. A more comprehensive discussion of other technical aspects of cytogenetics can be found in the forthcoming second edition of the ACT Cytogenetics Laboratory Manual. It is important to note that these guidelines are not intended to prescribe appropriate analyses for all individual circumstances. That determination is appropriately a matter for the judgment of the laboratories concerned. ACT, its members, and the task force that assisted in preparation of these guidelines make no warranty and assume no liability with respect to the information contained herein.

Amniotic Fluid↗

PubMed1990

Practice guidelines and professional autonomy in a universal health insurance system: the case of tissue plasminogen activator in Ontario.

Ontario's universal health insurance system has placed few constraints on the clinical and economic autonomy of medical doctors. Although fees are standardized, most physicians remain in private fee-for-service practice and thereby retain control of the mix and volume of services. Utilization review is minimal. While organized medicine has argued that health care is 'under-funded', the government is pressing for better use of extant resources through firmer management of the medical services sector. The Ontario Medical Association (OMA), the major bargaining agent for doctors in the province, has accordingly sought to protect professional autonomy by developing voluntary self-regulatory approaches that obviate the need for external controls over physician practice patterns. Part of this strategy is promulgation of practice guidelines. Tissue plasminogen activator (t-PA), a clot-lysing drug for myocardial infarction, was released in late 1987, and, at C$2950 per treatment, constituted an unforeseen add-on cost for hospitals. The OMA subsequently convened an expert panel to develop guidelines for thrombolysis in myocardial infarction. Among the unanticipated results was the conclusion that insufficient evidence had accumulated to recommend routine use of t-PA instead of streptokinase, an older drug costing C$290. The OMA panel's guidelines were approved by the OMA executive, and led the government to reject special add-on funding for hospitals purchasing t-PA. The OMA's position and government decision provoked negative reactions from the OMA's own cardiology section. Indicative of clinicians' feelings, a follow-up survey of cardiologists and internists showed that only 28% of respondents were indifferent between t-PA and streptokinase, while 64% preferred t-PA. On the other hand, 74% supported clinical policy development by the OMA, while 94% opposed direct government involvement in guideline-setting. The case of the OMA thrombolysis guidelines illustrates a strategic conundrum facing Canadian organized medicine. Professional activism in guideline-setting may in theory protect the individual practitioner's autonomy by offering a voluntary alternative to utilization management by government, and is likely to strengthen the collective influence of organized medicine. However, among the risks are alienation of practitioners who see professional guidelines and government control as two sides of the same regulatory coin, and the transmogrification of voluntary guidelines into parameters for cost control and utilization management by government or hospitals. Future initiatives will depend on how these benefits and risks are weighed.

Cost Control↗

PubMed2006

Proposed program guidelines for pregnant radiology residents: a project supported by the American Association for Women Radiologists and the Association of Program Directors in Radiology.

RATIONALE AND OBJECTIVES: Written institutional policies governing radiation exposure and work responsibilities for pregnant radiology residents are not uniform and often are nonexistent. Standardized program guidelines would allow residents and program directors alike to prepare for a resident pregnancy with objectivity and consistency. MATERIALS AND METHODS: The American Association for Women Radiologists (AAWR) launched a task force to revisit guidelines for the protection of pregnant residents from radiation exposure during training. We conducted two surveys of the Association of Program Directors in Radiology (APDR) membership. Survey 1 was designed to learn about existing program and institutional policies and to assess the need for and interest in standardized guidelines that would address radiation exposure and work responsibilities for pregnant radiology residents. Based on those responses, we drafted a set of program guidelines incorporating policies contributed by responding program directors. Our follow-up APDR survey, survey 2, was conducted to determine opinions and acceptance of the drafted program guidelines. Each survey was analyzed by using a proportion of means test. RESULTS: Fifty-five of 156 program director APDR members (35%) responded to survey 1. Only half the respondents had formal written policies at their respective institutions. Review of submitted policies showed widely divergent opinions about appropriate policies for pregnant radiology residents. Most (34/52; 75%) supported the development of standardized guidelines. In survey 2, 38/73 responding APDR members (53%) offered their opinions and comments on our drafted guidelines. Approximately 90% agreement was catalogued on 13 of 18 items (72%); a majority (>60%) agreed on all points, even the most controversial points concerning fluoroscopy. CONCLUSION: A minority of radiology residency programs have written policies addressing pregnancy during training. With expressed support from a majority of responding program directors, we have developed and present here proposed program guidelines for pregnant radiology residents to serve as a framework for radiology residents and program directors alike.

Data Collection↗

PubMed2006

Improving compliance with postpolypectomy surveillance guidelines: an interventional study using a continuous quality improvement initiative.

BACKGROUND: Despite guidelines, physicians tend to perform postpolypectomy surveillance colonoscopies too frequently. OBJECTIVE: The objective of the study was to determine the baseline compliance rate with postpolypectomy guidelines in our unit and to determine the influence of a continuous quality improvement (CQI) intervention on improving the compliance rate and on decreasing the potential additional costs because of the scheduling of postpolypectomy surveillance colonoscopies earlier than indicated. DESIGN: This was a single-arm, pretest-posttest design. SETTING: This study took place at a tertiary care, academic medical center. PATIENTS: The medical records of all patients who underwent colonoscopy with polypectomy in our unit retrospectively during 6 months preceding (baseline period) and prospectively for 6 months after an intervention (postintervention period) were reviewed for patient demographics, colonoscopy findings, and scheduling of repeat colonoscopies. INTERVENTION: We used 3 components: (1) distribution of a wallet-size card with a summary of postpolypectomy guidelines to all endoscopists, (2) placement of guideline charts near computers used for typing endoscopy reports, and (3) distribution and reinforcement of the guidelines in a monthly continuous quality improvement meeting. MAIN OUTCOME MEASURES: The main outcome measures were compliance rates, mean times to repeat colonoscopy, and additional costs from surveillance colonoscopies being scheduled earlier than indicated were compared between the two periods. RESULTS: There were 278 patients in the baseline period and 242 in the postintervention period, with similar patient and polyp characteristics. After the intervention, the compliance rate with guidelines improved from 57.2% to 81% (p < 0.001). The mean time to a repeat colonoscopy increased from 4.5 to 5.2 years (p = 0.003) (i.e., a 14% reduction in the number of postpolypectomy surveillance colonoscopies performed per year). This would result in a reduction of a total of 73 surveillance colonoscopies per year in our unit, with a projected cost savings of 171,331 dollars per year (cost of a colonoscopy assumed at 2347 dollars). LIMITATIONS: The limitation of the study was possible enhanced performance secondary to being observed (Hawthorne effect). Because more than 1 intervention was used, we do not know which one is more effective. CONCLUSIONS: Relatively simple and easy-to-implement quality improvement initiatives can significantly enhance compliance with postpolypectomy guidelines and result in cost savings because of a reduction in the number of postpolypectomy surveillance colonoscopies being scheduled earlier than recommended guidelines.

Colonoscopy↗

PubMed2005

Treatment guidelines for bipolar disorder: a critical review.

INTRODUCTION: The development of treatment guidelines emerged as an important element so as to standardize treatment and to provide clinicians with algorithms, which would be able to carry research findings to the everyday clinical practice. MATERIAL AND METHOD: The MEDLINE was searched with the combination of each one of the key words 'mania', 'manic', 'bipolar', 'manic-depression', 'manic-depressive' with 'treatment guidelines'. RESULTS: The search was updated until March 1st, 2004 and returned 224 articles. Twenty-seven papers concerning the publication of treatment algorithms were traced. DISCUSSION: Despite supposedly being evidence-based, guidelines for the treatment of bipolar disorder vary significantly across committees or working groups. Overall, however, at the first stage of the mania/hypomania algorithm, monotherapy with lithium, divalproex sodium or olanzapine is generally recommended. At latter stages combination therapy is strongly recommended. It is clearly stated that in bipolar depression antidepressants should be used only in combination with antimanic agents in order to avoid switching of phases. During the maintenance phase all patients should receive antimanic agents, while some may need the addition of antidepressants. The most recent guidelines emphasize the use of atypical antipsychotics for mania and lamotrigine for depression. The main problem with guidelines is that they are rapidly outdated and that the evidence base relies mainly on registration monotherapy trials that hardly reflect treatment in routine clinical conditions. CONCLUSION: Treatment guidelines may be useful to avoid non-evidence-based treatment decisions, but they are quickly out-of-date and may not fully apply to the clinical setting. The more recent guidelines point the value of atypical antipsychotics, lithium, and valproate in the treatment of mania; the role of lithium, lamotrigine, and olanzapine as options for maintenance therapy; and the scarcity of options for the treatment of bipolar depression. Psychoeducation is also supported by most guidelines as an adjunctive treatment.

Algorithms↗