Research Pearls: How Do We Establish the Level of Evidence?

Evidence-based medicine (EBM) guidelines were first introduced in 1986 and were defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research. Level of evidence (LOE) stratifies publications from Level I to Level V and provides the foundation for EBM. Three questions should be asked when an LOE is assigned to a scientific article: (1) What is the research question? (2) What is the study type? and (3) What is the hierarchy of evidence? In cases in which LOE is not appropriate or relevant (basic science and laboratory-based investigations), a clinical relevance statement should be used. Unfortunately, study quality is not assessed by the assigned hierarchy level. LOE and EBM have increased the number of investigations published with better levels of evidence. As authors, reviewers, editors, and publishers, we desire a system that is consistent, effective, and reliable. Fortunately, the system has proven to have all of those attributes with good interobserver and intra-observer values. The increase in investigations with higher LOEs allows for more frequent use of EBM.     

Optimal surgical care for adolescent idiopathic scoliosis: an international consensus

Purpose

The surgical management of adolescent idiopathic scoliosis (AIS) has seen many developments in the last two decades. Little high-level evidence is available to support these changes and guide treatment. This study aimed to identify optimal operative care for adolescents with AIS curves between 40° and 90° Cobb angle.

Methods

From July 2012 to April 2013, the AOSpine Knowledge Forum Deformity performed a modified Delphi survey where current expert opinion from 48 experienced deformity surgeons, representing 29 diverse countries, was gathered. Four rounds were performed: three web-based surveys and a final face-to-face meeting. Consensus was achieved with ≥70 % agreement. Data were analyzed qualitatively and quantitatively.

Results

Consensus of what constitutes optimal care was reached on greater than 60 aspects including: preoperative radiographs; posterior as opposed to anterior (endoscopic) surgical approaches; use of intraoperative spinal cord monitoring; use of local autologous bone (not iliac crest) for grafts; use of thoracic and lumbar pedicle screws; use of titanium anchor points; implant density of <80 % for 40°–70° curves; and aspects of postoperative care. Variability in practice patterns was found where there was no consensus. In addition, there was consensus on what does not constitute optimal care, including: routine pre- and intraoperative traction; routine anterior release; use of bone morphogenetic proteins; and routine postoperative CT scanning.

Conclusions

International consensus was found on many aspects of what does and does not constitute optimal operative care for adolescents with AIS. In the absence of current high-level evidence, at present, these expert opinion findings will aid health care providers worldwide define appropriate care in their regions. Areas with no consensus provide excellent insight and priorities for future research.     

Utilising the Delphi Process to Develop a Proficiency-based Progression Train-the-trainer Course for Robotic Surgery Training

Context

As the role of robot-assisted surgery continues to expand, development of standardised and validated training programmes is becoming increasingly important.

A modified-delphi study establishing consensus in the therapeutic management of posttrauamtic elbow stiffness

Study Design: Web-based modified Delphi study.Background: Therapy is widely considered the first choice of treatment for posttraumatic stiffness of the elbow since loss of motion is a common sequela following traumatic elbow injuries. There is high variability in practice patterns for the management of the posttraumtic elbow.Purpose: The aim of this study is to identify the current therapeutic management of posttraumatic elbow stiffness using expert consensus.Methods: This study surveyed experts using a web-based 3 round modified Delphi method. Quantitative data and comments were collected during the first round. Questions with Likert scaling were used to identify consensus (defined as 75% agreement) with each statement and comment boxes enabled open-ended responses to gather expert opinion. Lack of consensus and data from comments guided the second-round of the survey. This process was repeated after Round 2 to develop the Round 3 survey. Consensus was achieved at Round 3 and no further rounds were needed.Results: Round 1 included 34 experts (response rate 20%), not all experts were able to continue through all rounds. Round 2 included 18 experts and Round 3 included 15 experts. Survey items were categorized as follows: examination procedures, therapeutic interventions, orthotic intervention considerations, contributing patient factors, and clinical decisions and rehabilitation challenges. Twenty-five percent of items achieved consensus after Round 1, 30% after Round 2 and 52% after Round 3. Although most participants agreed that orthotic intervention is critical to patient outcomes, there were conflicting thoughts about the orthotic design and wearing schedule.Conclusions: The findings of this web-based modified Delphi study helped to establish a current body of knowledge using expert consensus to guide practice and identify specific questions that can be studied in future clinical studies on posttraumatic elbow stiffness.     

A modified Delphi process to establish future research priorities in malignant oesophagogastric surgery

BackgroundWith rapid advancement in the genomics of oesophagogastric (OG) cancer and raised expectations in clinical outcomes from patients and clinicians alike there is a clear need to determine the current research priorities in OG cancer surgery. The aim of our study was to use a modified Delphi process to determine the research priorities among OG cancer surgeons in the United Kingdom.MethodsDelphi methodology may be utilised to develop consensus opinion amongst a group of experts. Members of the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland were invited to submit individual research questions via an online survey (phase I). Two rounds of prioritisation by multidisciplinary expert healthcare professionals (phase II and III) were completed to determine a final list of high priority research questions. All questions submitted and subsequently ranked were analysed on an anonymised basis.ResultsIn total, 427 questions were submitted in phase I and 75 with an OG cancer focus were taken forward for prioritisation in phase II. Phase III produced a final list of 12 high priority questions with an emphasis on tailored or personalised treatment strategies in OG cancer surgery.ConclusionA modified Delphi process produced a list of 12 high priority research questions in OG cancer surgery. Future studies and awards from funding bodies should reflect this consensus list of prioritised questions in the interest of improving patient care and encouraging collaborative research across multiple centres.     

Consensus guidelines for sustained neuromuscular blockade in critically ill children

BACKGROUND: The United Kingdom Paediatric Intensive Care Society Sedation, Analgesia and Neuromuscular Blockade Working Group is a multidisciplinary expert panel created to produce consensus guidelines on sedation, analgesia and neuromuscular blockade in critically ill children and forward knowledge in these areas. Neuromuscular blockade is recognized as an important element in the care of the critically ill and adult clinical practice guidelines in this area have been available for several years. However, similar clinical practice guidelines have not previously been produced for the critically ill pediatric patient. METHODS: A modified Delphi technique was employed to allow the Working Group to anonymously consider draft recommendations in up to three Delphi rounds with predetermined levels of agreement. This process was supported by a total of four consensus conferences and once consensus had been achieved, a systematic review of the available literature was carried out. RESULTS: A set of consensus guidelines was produced including six key recommendations. An evaluation of the existing literature supporting these recommendations is provided. CONCLUSIONS: Multidisciplinary consensus guidelines for maintenance neuromuscular blockade in critically ill children (excluding neonates) have been successfully produced and are supported by levels of evidence. The Working Group has highlighted the paucity of high quality evidence in these important clinical areas and this emphasizes the need for further randomized clinical trials in this area.     

危重患者肠内营养安全实施流程的构建

目的探索危重患者肠内营养安全实施流程,确保肠内营养实施的安全性和有效性。方法在分析现有临床工作及查阅相关文献的基础上,初步拟订危重患者肠内营养安全实施流程;应用Delphi专家咨询法,对10名专家进行2轮问卷咨询。结果经2轮专家咨询,构建了包括10个项目、36个子项目的流程,专家的积极系数分别为100%和88.9%,权威系数为0.81,子项目的协调系数为0.305。结论应用Delphi法所构建的危重患者肠内营养安全实施流程的条目专家意见集中,研究结果可信度高,对肠内营养的实施提供了客观依据。     

Expert Opinion Is Necessary: Delphi Panel Methodology Facilitates a Scientific Approach to Consensus

Our current trend and focus on evidence-based medicine is biased in favor of randomized controlled trials, which are ranked highest in the hierarchy of evidence while devaluing expert opinion, which is ranked lowest in the hierarchy. However, randomized controlled trials have weaknesses as well as strengths, and no research method is flawless. Moreover, stringent application of scientific research techniques, such as the Delphi Panel methodology, allows survey of experts in a high quality and scientific manner. Level V evidence (expert opinion) remains a necessary component in the armamentarium used to determine the answer to a clinical question.     

Evidence: What Is It,Where Do We Find It,and How Do We Use It?

The purpose of this paper is to review the history and rationale for evidence-based medicine (EBM). The development of EBM is briefly described, together with the pros and cons of evidence-based research, review techniques, and resources. The current status of EBM with regard to the treatment of overactive bladder (OAB) is also discussed. In short, EBM can be defined as the conscientious, explicit and judicious use of current best evidence to make decisions about the care of individual patients. The four main steps are: (1) formulate a clear question from a patient’s problem, (2) search the literature for relevant clinical articles, (3) evaluate and critically appraise existing evidence for its validity and usefulness, and (4) implement useful findings in clinical practice. The power of the evidence-based approach can be enhanced by the development of techniques such as systematic review and meta-analysis. However, although EBM allows us to use current best evidence to make decisions about patient care, the evidence gained from systematic review and meta-analysis only applies to an “average patient” and is not readily adaptable to issues such as etiology, diagnosis and prognosis.     

Using a Delphi process to develop an effective train-the-trainers program to train health and social care professionals throughout Europe

Research has shown that developing a Train-the-Trainers (TTT) program is important if agencies are to implement guidelines, but the most effective way to deliver a TTT program remains unanswered. This article presents data from a 3-round Internet-based Delphi process, which was used to help develop consensus-based guidelines for a TTT programme to deliver to health and social care professionals throughout Europe a curriculum on traumatic stress. In Round 1, 74 experts rated the importance of statements relating to the TTT field and then reassessed their scores in the light of others' responses in subsequent rounds. Forty-one (67%) of 61 statements achieved consensus (defined as having a mean score >7 or < 3 on the 0-9 rating scales used and 70% of participants scoring 7 and above or 3 and below) for inclusion. Key TTT components included interactive and practical presentations, delivery to groups of 7-12 people over 2 days, external and local expert facilitation, course manuals, refresher courses, and supervision. The Delphi process allowed a consensus to be achieved in an area in which there are limitations in the current evidence.     

达芬奇机器人手术系统安全使用与维护专家共识

目的 形成达芬奇机器人手术系统安全使用与维护专家共识,为规范其使用提供实践指导。 方法 通过文献检索和小组讨论,确定达芬奇机器人手术系统手术护理操作中的关键环节,制定达芬奇机器人手术系统安全使用与维护专家共识初稿,设计专家函询表,通过2轮德尔菲专家咨询,结合客观证据和专家意见,对共识初稿进行修改完善。 结果 达芬奇机器人手术系统安全使用与维护专家共识从达芬奇机器人手术系统相关定义、安装与使用、维护与保养3方面提出手术护理规范化实施内容。 结论 形成的达芬奇机器人手术系统安全使用与维护专家共识,可为机器人手术配合护士提供临床实践指引,以保障机器人手术患者安全,提高手术室专科护理质量。     

Evidence-based Surgery: A Passing Fad?

Recent years have witnessed the development of a new movement within health care: the promotion of “evidence-based medicine” (EBM). EBM is about integrating individual clinical expertise and the best external evidence derived from scientific research. Advocates claim that much medical practice is based too much on opinion and experience and insufficiently on research evidence. Their approach would increase the quality of care and its efficiency. This paper describes the principal steps in the evidence-based approach—systematic reviews of the literature and meta-analyses—and its shortcomings in surgery. These include the reliance of EBM on randomized trials, the lack of generalizability of scientific evidence to individual patients, the lack of attention to third party interests, the threat to the “art” of medicine, and the dangers of an oversimplistic approach. Although EBM clearly has a place, it does not have all the answers.     

OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines

PURPOSE: To develop concise, patient-focussed, up to date, evidence-based, expert consensus recommendations for the management of hip and knee osteoarthritis (OA), which are adaptable and designed to assist physicians and allied health care professionals in general and specialist practise throughout the world. METHODS: Sixteen experts from four medical disciplines (primary care, rheumatology, orthopaedics and evidence-based medicine), two continents and six countries (USA, UK, France, Netherlands, Sweden and Canada) formed the guidelines development team. A systematic review of existing guidelines for the management of hip and knee OA published between 1945 and January 2006 was undertaken using the validated appraisal of guidelines research and evaluation (AGREE) instrument. A core set of management modalities was generated based on the agreement between guidelines. Evidence before 2002 was based on a systematic review conducted by European League Against Rheumatism and evidence after 2002 was updated using MEDLINE, EMBASE, CINAHL, AMED, the Cochrane Library and HTA reports. The quality of evidence was evaluated, and where possible, effect size (ES), number needed to treat, relative risk or odds ratio and cost per quality-adjusted life years gained were estimated. Consensus recommendations were produced following a Delphi exercise and the strength of recommendation (SOR) for propositions relating to each modality was determined using a visual analogue scale. RESULTS: Twenty-three treatment guidelines for the management of hip and knee OA were identified from the literature search, including six opinion-based, five evidence-based and 12 based on both expert opinion and research evidence. Twenty out of 51 treatment modalities addressed by these guidelines were universally recommended. ES for pain relief varied from treatment to treatment. Overall there was no statistically significant difference between non-pharmacological therapies [0.25, 95% confidence interval (CI) 0.16, 0.34] and pharmacological therapies (ES=0.39, 95% CI 0.31, 0.47). Following feedback from Osteoarthritis Research International members on the draft guidelines and six Delphi rounds consensus was reached on 25 carefully worded recommendations. Optimal management of patients with OA hip or knee requires a combination of non-pharmacological and pharmacological modalities of therapy. Recommendations cover the use of 12 non-pharmacological modalities: education and self-management, regular telephone contact, referral to a physical therapist, aerobic, muscle strengthening and water-based exercises, weight reduction, walking aids, knee braces, footwear and insoles, thermal modalities, transcutaneous electrical nerve stimulation and acupuncture. Eight recommendations cover pharmacological modalities of treatment including acetaminophen, cyclooxygenase-2 (COX-2) non-selective and selective oral non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs and capsaicin, intra-articular injections of corticosteroids and hyaluronates, glucosamine and/or chondroitin sulphate for symptom relief; glucosamine sulphate, chondroitin sulphate and diacerein for possible structure-modifying effects and the use of opioid analgesics for the treatment of refractory pain. There are recommendations covering five surgical modalities: total joint replacements, unicompartmental knee replacement, osteotomy and joint preserving surgical procedures; joint lavage and arthroscopic debridement in knee OA, and joint fusion as a salvage procedure when joint replacement had failed. Strengths of recommendation and 95% CIs are provided. CONCLUSION: Twenty-five carefully worded recommendations have been generated based on a critical appraisal of existing guidelines, a systematic review of research evidence and the consensus opinions of an international, multidisciplinary group of experts. The recommendations may be adapted for use in different countries or regions according to the availability of treatment modalities and SOR for each modality of therapy. These recommendations will be revised regularly following systematic review of new research evidence as this becomes available.     

Management of the injured patient: identification of research topics for systematic review using the delphi technique

BACKGROUND: Systematic reviews of controlled clinical trials in the form of meta-analyses can serve as an important guide to direct clinical practice. This study identifies the most important research questions pertaining to the acute care of the injured patient using a Web-based Delphi technique to achieve consensus of expert opinion. METHODS: Experts in trauma care from the United States and Canada (n = 68) were asked to generate structured research questions and were then required to rank these questions in order of importance and estimate the amount of research currently published. RESULTS: The questions ranking in the highest tertile are presented along with an estimate of their importance and the amount of research published using an ordinal scale. Only 9 of 16 (56%) questions had some or a substantial amount of research available on which to perform a systematic review. CONCLUSION: This study identifies the areas of trauma care in which research efforts might best be directed. In the absence of sufficient data for systematic reviews, these research topics represent important areas for the design and implementation of clinical trials.     

宫颈癌根治术后间歇导尿患者延续护理方案的构建

目的 构建宫颈癌根治术后间歇导尿患者延续护理方案,以规范间歇导尿延续护理实践.方法 结合奥马哈问题分类系统,在检索指南、专家会议基础上,采用Delphi法对20名专家进行2轮函询.结果 2轮函询问卷有效回收率均为100％,专家权威系数分别为0.920、0.926,方案重要性的Kendall's W系数分别为0.140、...     

Duodenal switch: Fully stapled technique

BackgroundDuodenal switch and single anastomosis modifications continue to gain greater interest among bariatric surgeons. Limiting factors to adoption include concerns around the nutritional management, patient compliance and follow-up, and the technical challenge of the operation. The majority of techniques offered currently use a hand-sewn duodenoileostomy. This approach is limited by the steep learning curve as well as longer operating times.ObjectivesWe present a video demonstrating the fully stapled technique for duodenoileostomy and ileileostomy. We offer technical pearls around the technique, specifically focused on maintaining a widely patent anastomosis, open biliopancreatic limb, safe duodenal dissection, and correct loop orientation.MethodsLaparoscopic fully stapled duodenoileostomy for duodenal switch and single anastomosis modification.SettingCommunity hospital, single institution, 3 surgeons.ConclusionTriple staple offers a reproducible and safe technique for the duodenoileostomy and specifically for construction of a Roux or loop anastomosis in duodenal switch.     

International consensus on safe techniques and error definitions in laparoscopic surgery

Background

Definitions of errors and poor technique in laparoscopic surgery are lacking in modern clinical practice. As a result, educators often base their teaching on personal experience and individual preferences. The objective of this study was to achieve expert consensus regarding these definitions in order to provide a framework for a standardized approach to teaching safe technique and avoiding common errors in laparoscopic surgery.

Methods

A Delphi survey was conducted with an international panel of experts in laparoscopic surgery. Survey items for definitions and examples of errors and resulting injuries (events) were derived from literature reviews and procedural observations. An online platform was used to administer the survey. Experts were requested to rate their level of agreement regarding survey items on a 5-point Likert-type scale; additional comments were facilitated through free-text entries. Consensus was defined as Cronbach’s α > 0.70. Items that were rated ≥3 (“somewhat agree”) by 75 % or more of the panel were included in the consensus list. The Delphi process was continued until all subsections of the survey met the defined consensus level.

Results

Two survey rounds were completed with 33 experts from 12 countries (round 1) and 25 experts from nine countries (round 2). Overall consensus was high for both rounds (α = 0.9). Seventeen definitions and 39 examples of errors and events were included in the final consensus list.

Conclusions

Standardized definitions and examples of technical errors in laparoscopic surgery were established using a consensus-based approach. These definitions can serve as uniform nomenclature and can be used by educators as a reference guide to ensure standardization in surgical training and performance assessment.     

气管切开患者围手术期护理质量评价指标体系的构建

目的建立气管切开围手术期护理质量评价指标体系,以提高其护理质量。方法基于文献回顾,初步拟定气管切开围手术期护理质量评价指标体系一套,形成专家咨询问卷,应用德尔菲法对15名重症监护、耳鼻咽喉头颈外科护理等相关专家进行两轮咨询。结果遴选专家积极系数为100%,平均权威系数为0.877,专家对所有指标意见的协调系数Kendall′s W分别为0.483、0.833(均P0.01)。经过两轮咨询,构建了气管切开护理质量的评价指标体系,包括要素质量、环节质量及终末质量3项一级指标、10项二级指标、38项三级指标并设置了不同的权重。结论两轮专家咨询的结果具有一定可靠性,所构建的评价指标能够科学有效地对气管切开围手术期的护理质量予以评价,对提高其护理质量、患者及家属的满意度具有较好作用。