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Clinical guidelines have the potential to increase health gains, but also to cause harm. In this opinion article we state some misgivings about the application of the Portuguese National Health Directorate's guideline type 2 diabetes therapy: metformin in primary care. We seek to highlight guideline wording that may allow for multiple interpretations (alternatives to monotherapy with metformin, hierarchy of drugs to be associated with metformin, and metformin contraindications). Furthermore, we argue that it seems that choosing a glycemic target of 6.5% in a normative document to be applied in the general population may have unforeseen consequences. publishersversion published

Background Clinical guidelines are intended to improve healthcare. However, even if guidelines are excellent, their implementation is not assured. In subfertility care, the European Society of Human Reproduction and Embryology (ESHRE) guidelines have been inventoried, and their methodological quality has been assessed. To improve the impact of the ESHRE guidelines and to improve European subfertility care, it is important to optimise the implementability of guidelines. We therefore investigated the implementation barriers of the ESHRE guideline with the best methodological quality and evaluated the used instrument for usability and feasibility. Methods We reviewed the ESHRE guideline for the diagnosis and treatment of endometriosis to assess its implementability. We used an electronic version of the guideline implementability appraisal (eGLIA) instrument. This eGLIA tool consists of 31 questions grouped into 10 dimensions. Seven items address the guideline as a whole, and 24 items assess the individual recommendations in the guideline. The eGLIA instrument identifies factors that influence the implementability of the guideline recommendations. These factors can be divided into facilitators that promote implementation and barriers that oppose implementation. A panel of 10 experts from three European countries appraised all 36 recommendations of the guideline. They discussed discrepancies in a teleconference and completed a questionnaire to evaluate the ease of use and overall utility of the eGLIA instrument. Results Two of the 36 guideline recommendations were straightforward to implement. Five recommendations were considered simply statements because they contained no actions. The remaining 29 recommendations were implementable with some adjustments. We found facilitators of the guideline implementability in the quality of decidability, presentation and formatting, apparent validity, and novelty or innovation of the recommendations. Vaguely defined actions, lack of facilities, immeasurable outcomes, and inflexibility within the recommendations formed barriers to implementation. The eGLIA instrument was generally useful and easy to use. However, assessment with the eGLIA instrument is very time-consuming. Conclusions The ESHRE guideline for the diagnosis and treatment of endometriosis could be improved to facilitate its implementation in daily practice. The eGLIA instrument is a helpful tool for identifying obstacles to implementation of a guideline. However, we recommend a concise version of this instrument.

Background There is little evidence as to whether or not guideline concordant care in general practice results in better clinical outcomes for people with anxiety and depression. This study aims to determine possible associations between guideline concordant care and clinical outcomes in general practice patients with depression and anxiety, and identify patient and treatment characteristics associated with clinical improvement. Methods This study forms part of the Netherlands Study of Depression and Anxiety (NESDA). Adult patients, recruited in general practice (67 GPs), were interviewed to assess DSM-IV diagnoses during baseline assessment of NESDA, and also completed questionnaires measuring symptom severity, received care, socio-demographic variables and social support both at baseline and 12 months later. The definition of guideline adherence was based on an algorithm on care received. Information on guideline adherence was obtained from GP medical records. Results 721 patients with a current (6-month recency) anxiety or depressive disorder participated. While patients who received guideline concordant care (N = 281) suffered from more severe symptoms than patients who received non-guideline concordant care (N = 440), both groups showed equal improvement in their depressive or anxiety symptoms after 12 months. Patients who (still) had moderate or severe symptoms at follow-up, were more often unemployed, had smaller personal networks and more severe depressive symptoms at baseline than patients with mild symptoms at follow-up. The particular type of treatment followed made no difference to clinical outcomes. Conclusion The added value of guideline concordant care could not be demonstrated in this study. Symptom severity, employment status, social support and comorbidity of anxiety and depression all play a role in poor clinical outcomes.

Background Guidelines on smoking cessation (SC) emphasize healthcare cooperation and community pharmacists' involvement. This study explored the familiarity and implementation of the National SC Guideline in Finnish community pharmacies, factors relating to Guideline familiarity, implementation and provision of SC services. Methods A nationwide mail survey was sent to a systematic, sample of community pharmacy owners and staff pharmacists (total n = 2291). Response rate was 54% (n = 1190). Factors related to the SC Guideline familiarity were assessed by bivariate and multivariate analysis. Results Almost half (47%) of the respondents (n = 1190) were familiar with the SC Guideline and familiarity enhanced Guideline implementation. The familiarity was associated with the respondents' perceptions of their personal SC skills and knowledge (OR 3.8); of customers' value of counseling on nicotine replacement therapy (NRT) (OR 3.3); and regular use of a pocket card supporting SC counseling (OR 3.0). Pharmacists' workplaces' characteristics, such as size and geographical location were not associated with familiarity. In addition to recommending NRT, the pharmacists familiar with the Guideline used more frequently other Guideline-based SC methods, such as recommended non-pharmacological SC aids, compared to unfamiliar respondents. Conclusions SC Guideline familiarity and implementation is crucial for community pharmacists' involvement in SC actions in addition to selling NRT products. Pharmacists can constitute a potential public health resource in SC easily accessible throughout the country.

Despite the typically benign nature of febrile seizures, a large number of children with simple febrile seizures are overinvestigated and overtreated, according to the personal clinical experience of the treating doctors. The study objective was to analyze the effect of implementing an evidence-based medicine guideline on the management of febrile seizures in two European pediatric emergency departments. After introduction of a selected guideline, we analyzed the change in hospitalization rate and in the rate of execution of blood exams in children presenting with febrile seizures. Included in the study were 483 children. Clinical characteristics of seizures were similar both before and after implementation. Clinical management was modified after guideline introduction, because the hospitalization rate significantly decreased (respectively, from 57.3% to 20.5%, and from 16.9% to 3.2%), without any concomitant increase in readmission rate. Readmission cases were never due to severe bacterial infections. The proportion of patients who received blood examinations decreased significantly. We conclude that in both of the Emergency Departments studied, introduction of a guideline on febrile seizure positively modified clinical management. The availability of a guideline contributed to accelerating the process of improving welfare and positively influenced the quality of care.

Aims and Background The status of the axillary lymph nodes at the time of diagnosis has been accepted as one of the most important prognostic factors for the overall and disease-free survival of patients with breast cancer. The aim of our study was to determine which factors influence axillary node involvement in invasive breast cancer. Methods The data presented here were obtained from 344 patients who were treated for invasive breast cancer at the Department of Radiation Oncology, Uludag University Medical College, Bursa, Turkey. Possible prognostic factors were categorized as patient related and tumor related. The Mann-Whitney U test was used for univariate analysis and logistic regression was used for multivariate analysis. Results In univariate analysis, a familial cancer history (P = 0.0042), age Conclusions In conclusion, absence of familial cancer history, presence of lymphatic vessel invasion, higher T stage, and age below 40 years independently increased the risk of axillary node involvement. Presence of perineural invasion and lymphatic vessel invasion, age below 40, and an extensive intraductal component of more than 25% independently affected the risk of having ≥4 nodes involved. Patients characterized by these factors may be classified into a higher risk group for nodal involvement, but more data are needed to define factors that can help in the decision-making regarding the omission of axillary treatment.

Goals of work: Growth factors and cytokines may be useful in preventing chemotherapy (CT)- and radiotherapy (RT)-induced oral and gastrointestinal mucositis. Two systematic reviews of the medical literature on growth factors and cytokines for the amelioration of CT- and RT-induced mucositis throughout the alimentary tract were performed by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology. The aim of these evidence-based scientific reviews was to critically evaluate the literature and create evidence-based guidelines for the use of growth factors and cytokines in the prevention or treatment of CT- and RT-induced mucositis. Method: The two reviews covered articles on clinical trials from January 1966 through May 2002 and preclinical studies from June 2002 through May 2005, respectively. The systematic review process was based on a well-established method for evaluating scientific literature. Main results: The number of articles in the first review was 29. In the second review, 23 articles were evaluated, 14 preclinical and 9 clinical studies. It was concluded from the first review that there was no sufficient evidence to provide any recommendations for clinical practice guidelines regarding growth factors and cytokines. From the second review, a guideline could be presented recommending the use of recombinant human keratinocyte growth factor-1 (palifermin) to prevent oral mucositis in patients receiving high-dose CT and total body irradiation followed by stem cell transplantation for haematological malignancies. A guideline could also be provided suggesting that granulocyte macrophage colony-stimulating factor mouthwash not be used for the prevention of oral mucositis in the transplant setting with high-dose CT and autologous or allogeneic stem cell transplantation. Conclusions: These systematic reviews have provided clarity and shown exciting new results. Further studies will provide new options for this debilitating side-effect of cancer therapy.

Objective: To investigate whether physicians' attitudes towards treatment guidelines for primary and secondary care differ between teaching and nonteaching hospitals shortly before and 4 years after the guidelines' introduction. Methods: Possible barriers and facilitators of joint treatment guidelines were obtained by self-administered questionnaires twice during the study period. Questionnaires were distributed among all internists and cardiologists in the Groningen region of The Netherlands. Results: Physicians from teaching and nonteaching hospitals differed in attitude regarding the content and usefulness of the guidelines. Physicians from nonteaching hospitals more often believed that the guidelines are too restrictive (64% vs. 18%) and too rigid to apply to individual patients (14% vs. 6%) and that they oversimplify medical practice (79% vs. 35%). Physicians from teaching hospitals more often agreed that good recommendations for first-choice drugs had been made (76% vs. 50%) and that these guidelines are a convenient source of advice (94% vs. 57%), can facilitate communication with general practitioners (94% vs. 71%), and can improve the quality of pharmacotherapeutic care (88% vs. 43%). Four years later, a larger proportion of physicians from both hospital settings had a negative attitude towards the usefulness of the guidelines, but the difference in attitude between teaching and nonteaching hospitals remained the same. Conclusion: Physicians from nonteaching hospitals were less positive about the usefulness of joint treatment guidelines than physicians from teaching hospitals were. Results from studies on the implementation of guidelines in teaching hospitals can therefore not be transferred to nonteaching settings.

BACKGROUND: The increasing prevalence of morbid obesity together with the development of laparoscopic approaches has led to a steep rise in the number of bariatric operations. These guidelines intend to define the comparative effectiveness and surrounding circumstances of the various types of obesity surgery. METHODS: A consensus panel representing the fields of general/endoscopic surgery, nutrition and epidemiology convened to agree on specific questions in obesity surgery. Databases were systematically searched for clinical trial results in order to produce evidence-based recommendations. Following two days of discussion by the experts and a plenary discussion, the final statements were issued. RECOMMENDATIONS: After the patient's multidisciplinary evaluation, obesity surgery should be considered in adults with a documented BMI greater than or equal to 35 and related comorbidity, or a BMI of at least 40. In addition to standard laboratory testing, chest radiography, electrocardiography, spirometry, and abdominal ultrasonography, the preoperative evaluation of obesity surgery patients also includes upper gastrointestinal endoscopy or radiologic evaluation with a barium meal. Psychiatric consultation and polysomnography can safely be restricted to patients with clinical symptoms on preoperative screening. Adjustable gastric banding (GB), vertical banded gastroplasty (VBG), Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) are all effective in the treatment of morbid obesity, but differ in degree of weight loss and range of complications. The choice of procedure therefore should be tailored to the individual situation. There is evidence that a laparoscopic approach is advantageous for LAGB, VBG, and GB (and probably also for BPD). Antibiotic and antithromboembolic prophylaxis should be used routinely. Patients should be seen 3 to 8 times during the first postoperative year, 1 to 4 times during the second year and once or twice a year thereafter. Outcome assessment after surgery should include weight loss and maintainance, nutritional status, comorbidities and quality-of-life.

Contains fulltext : 58147.pdf (Publisher’s version ) (Closed access) Clinical practice guidelines are regarded as powerful tools to achieve effective health care. Although many countries have built up experience in the development, appraisal, and implementation of guidelines, until recently there has been no established forum for collaboration at an international level. As a result, in different countries seeking similar goals and using similar strategies, efforts have been unnecessarily duplicated and opportunities for harmonisation lost because of the lack of a supporting organisational framework. This triggered a proposal in 2001 for an international guidelines network built on existing partnerships. A baseline survey confirmed a strong demand for such an entity. A multinational group of guideline experts initiated the development of a non-profit organisation aimed at promotion of systematic guideline development and implementation. The Guidelines International Network (G-I-N) was founded in November 2002. One year later the Network released the International Guideline Library, a searchable database which now contains more than 2000 guideline resources including published guidelines, guidelines under development, "guidelines for guidelines", training materials, and patient information tools. By June 2004, 52 organisations from 27 countries had joined the network including institutions from Oceania, North America, and Europe, and WHO. This paper describes the process that led to the foundation of the G-I-N, its characteristics, prime activities, and ideas on future projects and collaboration.

Objective. To identify factors that may hinder or facilitate specialists' use of joint treatment guidelines for primary and secondary care. Design. Qualitative study using focus group discussions based on a topic guide with open-ended questions. Main outcome measures. Themes identified by two researchers that specify the specialists' views on the use and implementation of treatment guidelines in general, and transmural guidelines in particular. Setting. Departments of Cardiology and Internal Medicine in three Dutch hospitals. Study participants. Ten general internists, 11 cardiologists, and six gastroenterologists participating in seven group discussions. Results. Specialists did not perceive the treatment guidelines as useful for their own field of expertise, but expected that joint guidelines might improve integration between primary and secondary care. Furthermore, the guidelines could be useful for areas outside their expertise, for specialists in training, and for general practitioners. Concerns were expressed regarding their content and development process. In addition, specialists feared negative consequences, such as loss of autonomy, extra administrative workload, and organizational and financial barriers such as loss of industry-sponsored research and conferences. Conclusion. Specialists are not very motivated to use the guidelines themselves. This is a major obstacle that should be addressed in an implementation programme. Furthermore, negative outcomes at the organizational and financial levels must be minimized or compensated for. A joint implementation programme seems worthwhile, making use of the advantage seen by specialists in making agreements with general practitioners.

Decision aids can help shared decision making, but most have been hard to produce, onerous to update, and are not being used widely. Thomas Agoritsas and colleagues explore why and describe a new electronic model that holds promise of being more useful for clinicians and patients to use together at the point of care

Guideline statements may be supported by evidence obtained from various study designs, but randomized trials are usually considered most important for making recommendations about therapeutic and preventive interventions. This study evaluated the extent to which randomized trials are cited in guidelines published in major journals. The references of 191 guidelines of therapeutic and/or preventive interventions published in Annals of Internal Medicine, BMJ, JAMA, Lancet, NEJM and Pediatrics in 1979, 1984, 1989, 1994, and 1999, were analyzed. The percentage of guidelines not citing any randomized controlled trials (RCTs) decreased gradually from 95% in 1979 to 53% in 1999. Among 4,853 references of the guidelines, there were 393 RCTs (8.1% of total), 19 systematic reviews (0.4%), and 23 meta-analyses of RCTs (0.5%). Among 19 guidelines Published in 1999 or 1994 with

Background: Translation of rational drug therapy into practice remains an international problem. Although pharmacotherapeutic treatment guidelines (PTGs) as managerial tools are favoured over hospital drug formularies (HDFs), the latter are still applied in most hospitals. HDF enforcement often leads to time-consuming consultation from the perspective of both pharmacy staff and prescriber. So far, research on HDFs has only been conducted outside Europe. Moreover, this research has only been descriptive. Straightforward indicators qualitatively characterising HDF non-adherence have never been assessed. Methods: A retrospective 1:1 case-control study was conducted across three general teaching hospitals. Non-HDF requests were compared with HDF requests. Data were multivariably analysed, considering patient. prescriber, drug, and HDF characteristics as possible indicators for non-adherence. Results: HDF adherence was almost universal across characteristics. Non-adherence was characterised by newly marketed drugs, drugs that were part of patients' pre-admission drug therapy, drugs with many fellow drugs within the drug group on the market, and drugs originating from a drug group for which the HDF was highly restrictive. Contrary to common perception, nonadherence was independent of medical specialty, therapeutic area, and patient characteristics. Conclusion: This research provides an epidemiological framework for hospitals (drug and therapeutics committees) for evaluating pharmacy data on HDF nonadherence. It can be used for educational tailor-made feedback to prescribers and for drug selection when the inclusion of newly marketed drugs is considered or HDF restrictiveness for certain drug groups is reconsidered. Moreover, it demonstrates the importance of a regional approach involving secondary and primary health care to establish continuity in seamless care of drug therapy.

This article provides a theoretical and methodological framework for the use of cognitive analysis to support the representation of biomedical knowledge and the design of clinical systems, using clinical-practice guidelines (CPGs) as an example. We propose that propositional and semantic analyses, when used as part of the system-development process, can improve the validity, usability, and comprehension of the resulting biomedical applications. The framework we propose is based on a large body of research on the study of how people mentally represent information and subsequently use it for problem solving. This research encompasses many areas of psychology, but the more important ones are the study of memory and the study of comprehension. Of particular relevance is research devoted to investigating the comprehension and memory of language, expressed verbally or in text. In addition, research on how contextual variables affect performance is informative because these psychological processes are influenced by situational variables (e.g., setting, culture). One important factor limiting the acceptance and use of clinical-practice guidelines (CPGs) may be the mismatch between a guideline's recommended actions and the physician-user's mental models of what seems appropriate in a given case. Furthermore, CPGs can be semantically complex, often composed of elaborate collections of prescribed procedures with logical gaps or contradictions that can promote ambiguity and hence frustration on the part of those who attempt to use them. An improved understanding of the semantics and structure of CPGs may help to improve such matching, and ultimately the comprehensibility and usability of CPGs. Cognitive methods of analysis can help guideline designers and system builders throughout the development process, from the conceptual design of a computer-based system to its implementation phases. By studying how guideline creators and developers represent guidelines, both mentally and in text, and how end-users understand and make decisions with such guidelines, we can inform the development of technologies that seek to improve the match between the representations of experts and practitioners. We urge informaticians to recognize the potential relevance of cognitive analysis methods and to begin more extensive experimentation with the their use in biomedical informatics research.

Purpose Patients suffering from gastrointestinal mucositis often receive parenteral nutrition as nutritional support. However, the absence of enteral nutrition might not be beneficial for the intestine. We aimed to determine the feasibility of minimal enteral feeding (MEF) administration in a methotrexate (MTX)-induced mucositis rat model and thereby determine the effect of MEF on recovery. Methods Male Wistar rats were attached to swivel systems from day 1 to 5 after 45 mg/kg MTX IV injection. The MTX group continued ad libitum feeding, and the MTX + MEF group continued ad libitum feeding and received from day 1 to 5 continuously MEF. MEF consisted of 20 % of their normal caloric intake. We measured body weight, intake, and plasma citrulline. At day 10, the rats were terminated and villus and crypt length were measured. Results The administration of MEF caused no increased severity of mucositis phenotype, with comparable caloric intake, body weight, and plasma citrulline during mucositis. The recovery of plasma citrulline levels was not different between both groups. At day 7 and 8, the MTX + MEF group gained significantly more weight (p

Purpose of review Fever in neutropenia is the most frequent potentially life-threatening complication of chemotherapy in children and adolescents with cancer. This review summarizes recent studies that refine our knowledge of how to manage pediatric fever in neutropenia, and their implications for clinical practice and research. Recent findings Many studies have focused on improving risk stratification based on clinical and laboratory characteristics, and on stepping-down treatment in low-risk episodes. New diagnostic strategies are in their infancy, including use of polymerase chain reaction (PCR) methods and cross-sectional imaging. Increasing use of systematic review and meta-analysis has helped to consolidate research and to reduce or identify uncertainties in many areas. Summary Our understanding of the cause of fever in neutropenia has been improved by PCR-based diagnostics, but the clinical implications remain unclear. Many risk-prediction models have been developed, but none is useful for clinical practice as yet. First-day outpatient management, with oral or intravenous antibiotics, is now known to be efficacious and cost-effective for pediatric low-risk fever in neutropenia. Before implementing this regimen as new standard of care, its safety should be assessed. Internationally supported evidence-based guidelines for pediatric fever in neutropenia are being developed. They have the potential to rationalize everyday practice, and stimulate further research.

Background Although practice guidelines are important tools to improve quality of care, implementation remains challenging. To improve adherence to an evidence-based guideline for the management of mental health problems, we developed a tailored implementation strategy targeting barriers perceived by occupational physicians (OPs). Feasibility and impact on OPs’ barriers were evaluated. Methods OPs received 8 training-sessions in small peer-learning groups, aimed at discussing the content of the guideline and their perceived barriers to adhere to guideline recommendations; finding solutions to overcome these barriers; and implementing solutions in practice. The training had a plan-do-check-act (PDCA) structure and was guided by a trainer. Protocol compliance and OPs’ experiences were qualitatively and quantitatively assessed. Using a questionnaire, impact on knowledge, attitude, and external barriers to guideline adherence was investigated before and after the training. Results The training protocol was successfully conducted; guideline recommendations and related barriers were discussed with peers, (innovative) solutions were found and implemented in practice. The participating 32 OPs were divided into 6 groups and all OPs attended 8 sessions. Of the OPs, 90% agreed that the peer-learning groups and the meetings spread over one year were highly effective training components. Significant improvements (p

Contains fulltext : 186499.pdf (Publisher’s version ) (Open Access) BACKGROUND: Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme's effectiveness and the fidelity, acceptability and feasibility of its implementation. METHODS: A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines' main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen's d). RESULTS: Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000