Guidelines for Perioperative Care for Pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS®) Society Recommendations

Background

Protocols for enhanced recovery provide comprehensive and evidence-based guidelines for best perioperative care. Protocol implementation may reduce complication rates and enhance functional recovery and, as a result of this, also reduce length-of-stay in hospital. There is no comprehensive framework available for pancreaticoduodenectomy.

Methods

An international working group constructed within the Enhanced Recovery After Surgery (ERAS^®) Society constructed a comprehensive and evidence-based framework for best perioperative care for pancreaticoduodenectomy patients. Data were retrieved from standard databases and personal archives. Evidence and recommendations were classified according to the GRADE system and reached through consensus in the group. The quality of evidence was rated “high”, “moderate”, “low” or “very low”. Recommendations were graded as “strong” or “weak”.

Results

Comprehensive guidelines are presented. Available evidence is summarised and recommendations given for 27 care items. The quality of evidence varies substantially and further research is needed for many issues to improve the strength of evidence and grade of recommendations.

Conclusions

The present evidence-based guidelines provide the necessary platform upon which to base a unified protocol for perioperative care for pancreaticoduodenectomy. A unified protocol allows for comparison between centres and across national borders. It facilitates multi-institutional prospective cohort registries and adequately powered randomised trials.     

Entscheidend ist, was ankommt

Background

Guidelines are developed to improve the quality of patient care. The effect of German urologic guidelines has not been evaluated so far. Therefore, we aimed to systematically investigate the acceptance, use, and quality of the published guidelines from a user’s perspective.

Methods

A link to an online questionnaire concerning use and barriers to the application of guidelines was distributed via e-mail by the German Society of Urology (DGU). German urologists’ opinions on differences in national guideline quality were evaluated regarding prostate cancer (PCA), bladder cancer, germ cell tumors (GCT), renal cell carcinomas, and erectile dysfunction.

Results

Four hundred sixty-seven German urologists participated. More than 90% of the participants considered guidelines to be helpful. The Internet as the main tool for guideline distribution was favored by 28.4%, followed by publication in Urologe A. The main barrier to guideline usage was attributed to the lack of up-to date clinical data. Guidelines for GCT scored best in all quality categories and reached the highest level of use (65.8%), and 40.5% of participating urologists considered the additional establishment of comprehensive care centers for GCT as more effective for quality improvement than guideline development alone. For the other urologic tumors, especially PCA, guideline development was favored as a tool for quality improvement.

Conclusion

More than 90% of participating urologists accept clinical guidelines as useful instruments in clinical practice and for therapeutic decisions. Our results should be integrated into guideline dissemination and implementation strategies in order to achieve a higher degree of treatment conformation to guidelines.     

What is the utilization of the SAGES guidelines by its members?

Background

The development and implementation of evidence-based clinical practice guidelines involves many challenges. The Society of the American Gastrointestinal and Endoscopic Surgeons (SAGES) has been at the forefront of guideline development for laparoscopic surgery since 1991, providing its membership with guidelines on the clinical application of procedures and the granting of privileges. The objective of this study was to assess the use of SAGES guidelines by its members.

Methods

An electronic survey of SAGES members was conducted via e-mail in August 2007. Members were asked if they used the guidelines, how often, for what purposes and when, and to rank the frequency of use and the usefulness of each of the 26 guidelines. They also were asked to suggest topics for new guideline development and to provide comments.

Results

Two hundred thirty-nine SAGES members (4.1%) responded to the survey; 121 (50%) responders used the guidelines. Of these, 95% accessed the guidelines monthly or less often, 58% after hours, 52% during work hours, and 9% while on call. Reasons for guideline use included developing practice protocols (56%) and patient treatment paradigms (51%), creating education and training guidelines for staff privileges (35%), and credentialing new medical staff (25%). The most often used and most useful guidelines included clinical application guidelines on laparoscopic bariatric, antireflux, biliary, and colorectal surgery, laparoscopic appendectomy, and deep vein thrombosis prophylaxis. Some respondents indicated no knowledge of guideline existence and made requests for new guidelines.

Conclusions

The results of this survey provided valuable information about current use of SAGES guidelines by its members. The pattern of use highlights the need for interventions that increase member awareness and adoption of these guidelines. Such efforts are currently underway.     

Schmerz, Agitation und Delirium

Background

Intensive care patients regularly feel pain, not only during intensive care therapeutic measures but also when resting. The associated negative physiological and psychological sequelae can be serious and protracted in intensive care patients. Acute pain is predestined for the development of persistant neuropathic pain.

Aim

This study informs the readership on the contents of the amended 2013 guidelines of the American College of Critical Care Medicine (ACCCM) on pain, agitation and delirium and presents strategies for implementation of the guidelines.

Material and methods

The focus of the amended recommendations is to give recommendations for treatment, in particular with respect to practical implementation of evidence-based scientific knowledge in the daily routine of intensive care wards.

Results

The fundamental principles which are summarized in these guidelines are: the regular collation of pain, measurement of depth of sedation and delirium with valid and reliable measurement instruments, an adequate and preemptive analgesia, administration of sedatives only when necessary and titration of sedatives so that patients remain responsive and are able to react.

Conclusion

The amended version of the guidelines is intended to achieve a high acceptance and clinical implementation in intensive care medical teams and therefore to improve the outcome of intensive care patients by optimized therapy.     

How do SAGES members rate its guidelines?

Background

The development of practice guidelines should take into consideration the opinions of end users. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has implemented several changes in its guideline development and dissemination process based on previous end-user input.

Methods

An anonymous electronic survey was conducted via e-mail solicitation in September 2011. Respondents were asked to submit their feedback on the 26 guidelines produced by our society using a 32-item questionnaire and to suggest topics for new guideline development and areas of improvement.

Results

Responses from the survey were received by 494 people, of whom 474 (96 %) were clinicians; 373 (75 %) were general, laparoscopic, or bariatric surgeons; and 324 (65 %) held leadership roles within their institution. Most respondents were 35–44 years old (36 %), male (83 %), and had been in practice for over 10 years (54 %). A total of 383 (81 %) had used our guidelines, and, of those, 96 % agreed with their content. Guideline quality was rated 4.34; value 4.27; and ease of access 3.97 on a five-point Likert scale. The most commonly referenced guideline in the survey regarded surgical treatment of reflux (67 %), followed by laparoscopy during pregnancy (51 %). The three most common reasons guidelines were accessed were to update knowledge (68 %), to maximize patient care through evidence-based treatment (51 %), and to obtain a critical literature review.

Conclusions

The majority of respondents indicated they greatly value and agree with our guidelines. These results indicate that recent efforts to improve our guidelines have succeeded.     

Evidence-based clinical management and utilization of new technology in European neurosurgery

Background

Evidence-based medicine (EBM) has become one of the pillars of modern patient care. However, neurosurgery has always been an experience-based and technology-driven discipline, and it remains unknown to which extent European neurosurgeons follow high-level evidence-based recommendations.

Methods

We conducted a Web-based survey with a 15-item questionnaire about evidence-based clinical management and utilization of new technology among European neurosurgeons. Two different sum scores were calculated from the questions concerning clinical practice; evidence-based treatment score and new technology score. A high evidence-based treatment score means that more clinical conditions (i.e., study questions) were managed in compliance with the available highest levels of evidence from published clinical trials. A high new technology score reflects the use of a high number of modern tools in neurosurgical practice.

Results

A total of 239 neurosurgeons from 30 different European countries answered the questionnaire. There were large variations among European neurosurgeons in providing evidence-based care and in utilization of various modern tools. There were significant regional differences in evidence-based treatment scores and modern technology scores with higher scores in northern and western Europe. High-volume institutions were not associated with better evidence-based treatment scores, but had significantly higher new technology scores. There were significantly higher new technology scores at university hospitals and a trend towards higher evidence-based treatment scores compared to other hospitals.

Conclusions

Clinical management in neurosurgery does not always comply with the best available evidence and there are large regional differences in clinical management and in utilization of various modern tools. The position of evidence-based medicine in European neurosurgery seems weak and this may be a threat to the quality of care.     

Adherence to a femoral neck fracture treatment guideline

Purpose

In 2007 the Dutch Surgical Society published a clinical practice guideline for the treatment of hip fracture patients, based on the best available international evidence at that time. We investigated to what extent treatment of femoral neck fracture patients in the Netherlands corresponded with these guidelines, and determined differences in patient characteristics between the treatment groups.

Methods

All femoral neck fracture patients treated in 14 hospitals between February 2008 and August 2009 were included. Patient characteristics, X-rays, and treatment data were collected retrospectively.

Results

From a total of 1,250 patients 59 % had been treated with arthroplasty, 39 % with internal fixation, and 2 % with a non-operative treatment. While 74 % of the treatment choices complied with the guideline, 12 % did not. In 14 % adherence could not be determined from the available data. Arthroplasty was preferred over internal fixation in elderly patients with severe comorbidity, pre-fracture osteoporosis and a displaced fracture, who were ambulatory with aids pre-fracture (odds ratio, OR 2.2–58.1). Sliding hip screws were preferred over cancellous screws in displaced fractures (OR 1.9).

Conclusions

Overall guideline adherence was good. Most deviations concerned treatment of elderly patients with a displaced fracture and implant use in internal fixation. Additional data on these issues, preferably at a higher scientific level of evidence, is needed in order to improve the guideline and to reinforce a more uniform treatment of these patients.     

An overview of clinical guidelines for the management of vertebral compression fracture: a systematic review

Background Context

Vertebral compression fractures (VCFs) are the most common type of osteoporotic fracture comprising approximately 1.4 million cases worldwide. Clinical practice guidelines can be powerful tools for promoting evidence-based practice as they integrate research findings to support decision making. However, currently available clinical guidelines and recommendations, established by different medical societies, are sometimes contradictory.

Gibt es eine Evidenz für medizinische Aussichtslosigkeit?

Background

In the age of evidence-based medicine, therapeutic decisions should invariably be based on the best available evidence.

Aim

Are there defined clinical scenarios with sufficient evidence for futility of an otherwise successful treatment?

Materials and methods

Literature-based meta-analysis of studies claiming or rejecting futility in cardiac arrest or otherwise critically ill patients.

Results

The studies differ substantially in their definition of futility and in their statistical methodology. The studies are generally too small, there are large grey zones with ambiguous results, and the quality of the predictions is poor. The methodological problems resulting from framing and context effects, timing, and self-fulfilling prophecies are insufficiently addressed and possibly intrinsic. These can, however, be overcome with substantial methodological efforts.

Conclusion

There is no reliable evidence for or against the futility of medical interventions in end-of-life care. Instead of relying on scientific results, the time to abandon life-saving care has to be chosen following a patient’s will according to humanitarian considerations.     

Nichtinvasive Beatmung als Therapie der akuten respiratorischen Insuffizienz

Background

Scientific evidence is accumulating that non-invasive ventilation (NIV) may be beneficial for different patient groups with acute respiratory insufficiency (ARI). The aim of the new S3 guidelines is to propagate evidence-based knowledge about the indications and limitations of NIV in clinical practice.

Methods

A total of 28 experts from 12 German medical societies were involved in the process of development of the present guidelines. These experts systematically analyzed approximately 2,900 publications. Finally, the recommendations were discussed and approved in two consensus conferences.

Results

In hypercapnic ARI, NIV reduces the length of stay and mortality during intensive care treatment [grade A recommendation (A)]. Patients with cardiopulmonary edema should be treated with continuous positive airway pressure (CPAP) or NIV (A). For immunocompromized patients with ARI, NIV reduces the mortality (A). In patients with postextubation respiratory failure and during weaning from mechanical ventilation, NIV reduces the risk of reintubation (A). For patients who decline to be ventilated invasively, NIV may be an acceptable alternative (B). Non-invasive ventilation can also successfully be used in pediatric patients with ARI caused by different reasons (C). In acute respiratory distress syndrome (ARDS) NIV cannot generally be recommended because the failure rate is relatively high.

Conclusion

Non-invasive ventilation is still not as widely implemented in clinical medicine as would be expected on the basis of the scientific literature. The aim of the present guidelines is to further propagate NIV for the treatment of ARI.     

Nutrition therapy for critically ill and injured patients

Background

Nutrition support has undergone significant advances in recent decades, revolutionizing the care of critically ill and injured patients. However, providing adequate and optimal nutrition therapy for such patients is very challenging: it requires careful attention and an understanding of the biology of the individual patient’s disease or injury process, including insight into the consequent changes in nutrients needed.

Objective

The objective of this article is to review the current principles and practices of providing nutrition therapy for critically ill and injured patients.

Methods

Review of the literature and evidence-based guidelines.

Results

The evidence demonstrates the need to understand the biology of nutrition therapy for critically ill and injured patients, tailored to their individual disease or injury, age, and comorbidities.

Conclusion

Nutrition therapy for critically ill and injured patients has become an important part of their overall care. No longer should we consider nutrition for critically ill and injured patients just as “support” but, rather, as “therapy”, because it is, indeed, a key therapeutic modality.     

Does Evidence Permeate All Surgical Areas Equally? Publication Trends in Wound Care Compared to Breast Cancer Care: A Longitudinal Trend Analysis

Background

Evidence-based decision making has permeated the daily practice of healthcare professionals. However, in wound care this seems more difficult than in other medical areas, such as breast cancer, which has a similar incidence, variety of etiologies, financial burden, and diversity of treatment options. This incongruence could be due to a lack in quantity and quality of available evidence. We therefore compared worldwide publication trends to answer whether research in wound care lags behind that in breast cancer.

Methods

In order to assess the trends in quantity and methodological quality of publications as to wound care and breast cancer treatments, we examined relevant publications over the last five decades. Publications in MEDLINE were classified into seven study design categories: (1) guidelines, (2) systematic reviews (SR), (3) randomized (RCT), and controlled clinical trials (CCT), (4) cohort studies, (5) case-control studies, (6) case series and case reports, and (7) other publications.

Results

We found a 30-fold rise in publications on wound care, versus a 70-fold increase in those on breast cancer. High-quality study designs like SR, RCT, or CCT were less frequent in wound care (difference 1.9, 95?% CI 1.8–2.0?%) as were guidelines; 76 on wound care versus 231 for breast cancer.

Conclusions

Publications on wound care fall behind in quantity and quality as compared to breast cancer. Nevertheless, SR, RCT, and CCT in wound care are becoming more numerous. These high-quality study designs could motivate clinicians to make evidence-based decisions and researchers to perform proper research in wound care.     

Leitlinie zur chirurgischen Therapie bei Erkrankungen der Nierenarterien

Background

These guidelines are the current publication of the German guidelines for surgical revascularization of renal artery disease, focusing on atherosclerotic renal artery stenosis. These guidelines update a previous version: Allenberg JR (1998) Guidelines for renovascular disease. In: German College of Vascular Surgery (DGG) Guidelines for diagnostic and therapy in vascular surgery. Deutscher Ärzteverlag, Köln

Purpose

The aim was to evaluate the effect of surgical revascularization on clinical outcomes in adults with atherosclerotic renal artery stenosis in comparison to endovascular therapy or best medical treatment.

Data Sources

The appropriate criteria were reviewed by a literature search (MEDLINE database) and updated in order to evaluate the results of previous studies and obtain new and highly significant scientific evidence on the surgical therapy of renovascular diseases.

Data interpretation

Using the evidence-based criteria there were only two randomized trials with an evidence level type Ib, one comparing surgical revascularization with best medical treatment and another comparing surgical revascularization with percutaneous transluminal angioplasty (PTA). In both studies there were no significant differences in the outcome. However, the statistical power of these trials with a total of 110 randomized patients was poor. Many trials with evidence level II and III have been carried out. Available evidence is not sufficient to predict which intervention would result in better outcomes. There have been no randomized prospective trials comparing the three therapeutic options, surgical revascularization, PTA/stent and best medical treatment.

Conclusion

An advantage for a specific type of therapy has not yet been demonstrated. The decision for any kind of treatment approach depends on the individual renal artery lesion, the therapeutic options, skills and the necessary interdisciplinary infrastructure of the treating medical unit.     

Multidisciplinary Management of Rectal Cancer: the OSTRICH

Background

Disparity exists in outcomes for rectal cancer patients in the US. Similar problems in several European countries have been addressed by the creation of national networks of rectal cancer centers of excellence (CoEs) that follow evidence-based care pathways and specified protocols of care and process and are certified by regular external validation.

Aim

This paper reviews the current status of rectal cancer care in the US and examines the evidence for multidisciplinary rectal cancer management. A US rectal cancer CoE system based on the existing UK model is proposed.

Methods

A literature search was performed for publications related to US rectal cancer outcomes, multidisciplinary management of rectal cancer, and European rectal cancer programs.

Results

US rectal cancer outcomes are highly variable. The majority of US rectal cancer patients are treated by generalists in low-volume hospitals. Current evidence supports five main principles of rectal cancer care that have been incorporated into European rectal cancer CoE programs. These programs have dramatically improved rectal cancer outcomes in Scandanavian countries and the UK.

Conclusions

A similar CoE program should be established in the US to improve the outcomes of rectal cancer patients.     

Dutch guidelines for physiotherapy in patients with stress urinary incontinence: an update

Introduction and hypothesis

Stress urinary incontinence (SUI) is the most common form of incontinence impacting on quality of life (QOL) and is associated with high financial, social, and emotional costs. The purpose of this study was to provide an update existing Dutch evidence-based clinical practice guidelines (CPGs) for physiotherapy management of patients with stress urinary incontinence (SUI) in order to support physiotherapists in decision making and improving efficacy and uniformity of care.

Materials and methods

A computerized literature search of relevant databases was performed to search for information regarding etiology, prognosis, and physiotherapy assessment and management in patients with SUI. Where no evidence was available, recommendations were based on consensus. Clinical application of CPGs and feasibility were reviewed. The diagnostic process consists of systematic history taking and physical examination supported by reliable and valid assessment tools to determine physiological potential for recovery. Therapy is related to different problem categories. SUI treatment is generally based on pelvic floor muscle exercises combined with patient education and counseling. An important strategy is to reduce prevalent SUI by reducing influencing risk factors.

Results

Scientific evidence supporting assessment and management of SUI is strong.

Conclusions

The CPGs reflect the current state of knowledge of effective and tailor-made intervention in SUI patients.     

Urological cancer care pathways: development and use in the context of systematic reviews and clinical practice guidelines

Background

Making healthcare treatment decisions is a complex process involving a broad stakeholder base including patients, their families, health professionals, clinical practice guideline developers and funders of healthcare.

Methods

This paper presents a review of a methodology for the development of urological cancer care pathways (UCAN care pathways), which reflects an appreciation of this broad stakeholder base. The methods section includes an overview of the steps in the development of the UCAN care pathways and engagement with clinical content experts and patient groups.

Results

The development process is outlined, the uses of the urological cancer care pathways discussed and the implications for clinical practice highlighted. The full set of UCAN care pathways is published in this paper. These include care pathways on localised prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, hormone-resistant prostate cancer, localised renal cell cancer, advanced renal cell cancer, testicular cancer, penile cancer, muscle invasive and metastatic bladder cancer and non-muscle invasive bladder cancer.

Conclusion

The process provides a useful framework for improving urological cancer care through evidence synthesis, research prioritisation, stakeholder involvement and international collaboration. Although the focus of this work is urological cancers, the methodology can be applied to all aspects of urology and is transferable to other clinical specialties.     

Evidence-Based Surgery: Barriers, Solutions, and the Role of Evidence Synthesis

Background

Surgery is a rapidly evolving field, making the rigorous testing of emerging innovations vital. However, most surgical research fails to employ randomized controlled trials (RCTs) and has particularly been based on low-quality study designs. Subsequently, the analysis of data through meta-analysis and evidence synthesis is particularly difficult.

Methods

Through a systematic review of the literature, this article explores the barriers to achieving a strong evidence base in surgery and offers potential solutions to overcome the barriers.

Results

Many barriers exist to evidence-based surgical research. They include enabling factors, such as funding, time, infrastructure, patient preference, ethical issues, and additionally barriers associated with specific attributes related to researchers, methodologies, or interventions. Novel evidence synthesis techniques in surgery are discussed, including graphics synthesis, treatment networks, and network meta-analyses that help overcome many of the limitations associated with existing techniques. They offer the opportunity to assess gaps and quantitatively present inconsistencies within the existing evidence of RCTs.

Conclusions

Poorly or inadequately performed RCTs and meta-analyses can give rise to incorrect results and thus fail to inform clinical practice or revise policy. The above barriers can be overcome by providing academic leadership and good organizational support to ensure that adequate personnel, resources, and funding are allocated to the researcher. Training in research methodology and data interpretation can ensure that trials are conducted correctly and evidence is adequately synthesized and disseminated. The ultimate goal of overcoming the barriers to evidence-based surgery includes the improved quality of patient care in addition to enhanced patient outcomes.     

Quality of Care Indicators for the Surgical Treatment of Gastric Cancer: A Systematic Review

Background

Quality assurance is increasingly acknowledged as a crucial factor for the (surgical) treatment of gastric cancer. The purpose of the current study was to define a minimum set of evidence-based quality of care indicators for the surgical treatment of locally advanced gastric cancer.

Methods

A systematic review of the literature published between January 1990 and May 2011 was performed, using search terms on gastric cancer, treatment, and quality of care. Studies were selected based on predefined selection criteria. Potential quality of care indicators were assessed based on their level of evidence and were grouped into structure, process, and outcome indicators.

Results

A total of 173 articles were included in the current study. For structural measures, evidence was found for the inverse relationship between hospital volume and postoperative mortality as well as overall survival. Regarding process measures, the most common indicators concerned surgical technique, perioperative care, and multimodality treatment. The only outcome indicator with supporting evidence was a microscopically radical resection.

Conclusions

Although specific literature on quality of care indicators for the surgical treatment of locally advanced gastric cancer is limited, several quality of care indicators could be identified. These indicators can be used in clinical audits and other quality assurance programs.     

Endovenöse Lasertherapie der Varikose – Evidenz und Perspektiven

Background

Endovenous laser therapy (ELT) has been used to treat patients suffering from saphenous vein insufficiency for approximately 15 years. Characteristic for EVT is a plethora of treatment protocols describing numerous different laser systems and application techniques. Efficacy and safety of this method was shown by many controlled studies and meta-analyses and several evidence-based treatment guidelines recommend ELT for treating saphenous vein insufficiency.

Objectives

This article investigates the value of ELT compared to other forms of treatment and whether the method can be improved.

Material and methods

An evaluation of numerous controlled studies and meta-analyses and several evidence-based treatment guidelines was carried out.

Results and conclusion

Experimental studies as well as clinical data indicate that ELT may be further improved by specific measures, including (1) the use of laser generators with longer wavelengths, (2) the application of radially emitting fibers and (3) implementation of appropriate dose monitoring taking the size of treated veins into account. Nevertheless, more clinical studies are necessary to prove the efficacy of ELT and to compare it with other open surgical (e.g. crossectomy and saphenous vein stripping) and endovenous methods including mechanical, chemical, mechano-chemical and thermal techniques. This would serve to determine the optimal range of indications for each method.