Evidence-Based Medicine Working Group Research Articles

FIGO recommendations: Use of midurethral slings for the treatment of stress urinary incontinence.

Stress urinary incontinence (SUI) is a global problem. It can significantly adversely impact a woman's quality of life. The use of synthetic mesh in vaginal surgery is controversial, especially when used for pelvic organ prolapse surgery. Although negative effects have been reported, the synthetic mesh midurethral sling (MUS) is considered to be safe and effective in the surgical treatment of SUI. To provide evidence-based data and recommendations for the obstetrician/gynecologist who treats women with SUI and performs or plans to perform MUS procedures. Academic searches of MEDLINE, the Cochrane Library, Embase, and Google Scholar articles published between 1987 and March 2020 were performed by a subgroup of the Urogynecology and Pelvic Floor Committee, International Federation of Gynecology and Obstetrics (FIGO). The obtained scientific data were associated with a level of evidence according to the Oxford University Centre for Evidence-Based Medicine and GRADE Working Group system. In the absence of concrete scientific evidence, the recommendations were made via professional consensus. The FIGO Urogynecology and Pelvic Floor Committee reviewed the literature and prepared this evidence-based recommendations document for the use of MUS for women with SUI. Despite the extensive literature, there is a lack of consensus in the optimal surgical treatment of SUI. These recommendations provide a direction for surgeons to make appropriate decisions regarding management of SUI. The MUS is considered safe and effective in the treatment of SUI, based on many high-quality scientific publications and professional society recommendations. Comprehensive long-term data and systemic reviews are still needed, and these data will become increasingly important as women live longer. These recommendations will be continuously updated through future literature reviews.

Interpretation of clinical trial results: a committee opinion

This document provides guidance, background, and tips on how to recognize quality trials and focuses on evaluating the validity, importance, and relevance of clinical trial results. This document replaces the document of the same name, last published in 2008 (Fertil Steril® 2008;90:S114-20).

Multiplicity in oncology randomised controlled trials: a threat to medical evidence?

Randomised controlled trials offer several advantages over observational studies in establishing whether cancer treatments improve patient outcomes. First, randomised controlled trials minimise bias and confounding. Observational studies judge treatments that were chosen not at random but deliberately by physicians, and the decision to treat or not treat an individual might be affected by patient characteristics, a type of bias called confounding by indication. Randomised controlled trials prescribe therapy and avoid this limitation. Second, randomised controlled trials restrict multiple hypothesis testing. Randomised controlled trials typically address a specific research question with a prespecified primary outcome and a predefined statistical analysis plan. This approach reduces the ability of investigators to assess multiple outcomes, which in turn minimises the risk of a spurious (eg, false positive) finding. For these reasons, David Sackett placed randomised controlled trials at the apex of the hierarchy of evidence. 1 Guyatt GH Sackett DL Sinclair JC Hayward R Cook DJ Cook RJ Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA. 1995; 274: 1800-1804 Crossref PubMed Scopus (739) Google Scholar Yet in the past 10 years, one of these assumptions is increasingly being questioned. Randomised controlled trials have proliferated in number, often test similar compounds with similar molecular targets, and are often run in redundant and duplicative trial portfolios or agendas. For this reason, multiplicity has emerged as a new threat to the validity of conclusions drawn from randomised controlled trials. In this Comment, we explore this issue. Statistical significance and clinical evidence – Authors' replyWe thank Simon Gates for his reply. In our Comment,1 we highlight an emerging challenge in cancer trials; large portfolios of trials that test a single drug (or very similar drugs) in many different tumour types, even in some settings with limited clinical rationale. By chance alone, some will be positive. This issue must be accounted for. Full-Text PDF Statistical significance and clinical evidenceIn their Comment,1 Vinay Prasad and Christopher M Booth raised an important issue about the interpretation of trial results. However, their proposal of applying Bonferroni-type corrections to p values is likely to be seriously misleading and lead to non-sensical conclusions. For example, if we run a trial and find a result with a p-value of 0·03, and that trial is replicated by another group who get the same result, a reasonable conclusion would be that support for a moderately significant effect is enhanced. Full-Text PDF

Risk Factors for Elbow and Shoulder Injuries in Adolescent Baseball Players: A Systematic Review

Background: The incidence of shoulder and elbow injuries among adolescent baseball players is on the rise. These injuries may lead to surgery or retirement at a young age. Purpose: To identify independent risk factors for elbow and shoulder injuries in adolescent baseball players. A secondary aim was to determine whether the literature supports the Major League Baseball and USA Baseball Pitch Smart guidelines. Study Design: Systematic review. Methods: A systematic review was performed in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines utilizing MEDLINE, SPORTDiscus, and Web of Science. Because of study heterogeneity, a quantitative synthesis was not performed. A qualitative review was performed on 19 independent risk factors for elbow and shoulder injuries in adolescent baseball players. Level of evidence was assigned per the Oxford Centre for Evidence-Based Medicine Working Group, and risk of bias was graded per the Newcastle-Ottawa Scale. Results: Twenty-two articles met criteria for inclusion. Of the 19 independent variables that were analyzed, age, height, playing for multiple teams, pitch velocity, and arm fatigue were found to be independent risk factors for throwing arm injuries. Pitches per game appears to be a risk factor for shoulder injuries. Seven independent variables (innings pitched per game, showcase participation, games per year, training days per week, pitch type, shoulder external rotation, and shoulder total range of motion) do not appear to be significant risk factors. The data were inconclusive for the remaining 6 variables (weight, months of pitching per year, innings or pitches per year, catching, shoulder horizontal adduction, and glenohumeral internal rotation deficit). Conclusion: The results from this study demonstrate that age, height, playing for multiple teams, pitch velocity, and arm fatigue are clear risk factors for throwing arm injuries in adolescent baseball players. Pitches per game appears to be a risk factor for shoulder injuries. Other variables are either inconclusive or do not appear to be specific risk factors for injuries.

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial

BackgroundCancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer.The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy.Methods/designThis trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected).DiscussionThe randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.Trial registrationClinicalTrials.gov, NCT02829762. Registered on 29 June 2016.

A fixed inhaled nitrous oxide/oxygen mixture as an analgesic for adult cancer patients with breakthrough pain: study protocol for a randomized controlled trial

BackgroundThe management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient’s and caregiver’s quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain.Methods/designThis is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University. The target study subjects are at least 18 years old, and are hospitalized cancer patients who are receiving routine opioids to control cancer-related pain but still experience breakthrough pain. A total of 240 patients will be recruited and randomly allocated between three treatment groups (A, B, C) and a control group (group D) in a ratio of 3:1. All treatment groups (A, B, C) will receive standard pain treatment (oral immediate-release morphine) plus a pre-prepared nitrous oxide/oxygen mixture, and the control group (D) will receive the standard pain treatment plus oxygen. Patients, doctors, nurses, and data collectors are all blind to the experiment. Assessments will be taken before treatment (T0), at 5 min (T1) and 15 min (T2) during treatment, and at 5 min after treatment (T3). The primary endpoint measures will be the percentage of patients whose pain is relieved at T1, T2, and T3. Secondary outcome measures will include the safety of treatment, adverse events, and satisfaction from both health professionals and patients.DiscussionThis study aims to provide an effective and practical intervention for a fast breakthrough pain relief and to improve cancer patients’ quality of life significantly. The Evidence-Based Medicine Working Group claim that a randomized, double-blind, placebo-controlled experimental intervention is the most appropriate design to demonstrate its efficacy, so this study could give a new approach to controlling breakthrough pain episodes.Trial registrationChiCTR-INC-16008075. Registered on 8 March 2016.

Evidence-Based Medicine

Descriptions of “evidence-based” approaches to medical care are now ubiquitous in both the popular press and medical journals. The term evidence-based medicine (EBM) was first coined in 1992, and over the last two decades, the field has experienced rapid growth, and its principles now permeate both graduate medical education and clinical practice. The field of EBM has been in constant evolution since its introduction and continues to undergo refinements as its principles are tested and applied in a wide variety of clinical circumstances. This review presents a brief history of EBM, EBM: fundamental tenets, a critical appraisal of a single study, reporting guidelines for single studies, a critical appraisal of a body of evidence, evidence-based surgery, and limitations in EBM. Tables list strength of evidence for treatment decisions (EBM working group), Oxford Centre for Evidence-Based Medicine revised levels of evidence for treatment benefits , “4S” approach to finding resources for EBM, critical appraisal of individual studies examining therapeutic decisions, reporting guidelines by study design, and key resources for evidence-based surgery. This review contains 6 tables and 85 references

Evidence-Based Medicine

Descriptions of “evidence-based” approaches to medical care are now ubiquitous in both the popular press and medical journals. The term evidence-based medicine (EBM) was first coined in 1992, and over the last two decades, the field has experienced rapid growth, and its principles now permeate both graduate medical education and clinical practice. The field of EBM has been in constant evolution since its introduction and continues to undergo refinements as its principles are tested and applied in a wide variety of clinical circumstances. This review presents a brief history of EBM, EBM: fundamental tenets, a critical appraisal of a single study, reporting guidelines for single studies, a critical appraisal of a body of evidence, evidence-based surgery, and limitations in EBM. Tables list strength of evidence for treatment decisions (EBM working group), Oxford Centre for Evidence-Based Medicine revised levels of evidence for treatment benefits , “4S” approach to finding resources for EBM, critical appraisal of individual studies examining therapeutic decisions, reporting guidelines by study design, and key resources for evidence-based surgery. This review contains 6 tables and 85 references

CON-COUR study: Interferential therapy in the treatment of chronic constipation in adults: study protocol for a randomized controlled trial.

BackgroundThe prevalence of chronic constipation is about 15 % in Western countries with a significant impact on quality of life and health care costs. The first-line therapy, based on medical treatment combined with laxatives and dietary rules, is often disappointing. Interferential therapy is a new treatment that has demonstrated its efficiency in the treatment of chronic constipation in children and encouraging results in adults. The primary objective of this study is to assess the efficacy of interferential therapy during 8 weeks in adult patients. The secondary objectives are to assess this new and noninvasive therapy in terms of persistence of the clinical efficacy, colonic transit time, ano-rectal manometry, patient satisfaction and quality of life (QoL), and tolerance.Methods/DesignDesign: multicenter, prospective, randomized, placebo-controlled, double blind, two-parallel groups study. Setting: nine French adult gastroenterology centers. Inclusion criteria: adult patients with a history of chronic constipation refractory to medical treatment for at least 3 months. Treatment groups: (1) interferential-experimental group (effective stimulation); (2) placebo-control group (sham stimulation). Randomization: 1:1 allocation ratio. Evaluation times: inclusion (T0, randomization), baseline assessment (T1), start of stimulation (T2), intermediary assessment (T3, 4 weeks), end of stimulation (T4, 8 weeks), follow-up (T5 and T6, 1- and 6-month). Endpoints: (1) primary: short-term efficacy at T4 (treatment response defined as three or more spontaneous, complete bowel movements per week); (2) secondary: efficacy at T5 and T6, symptoms (Patient Assessment of Constipation Symptoms questionnaire), colonic transit time, anorectal manometry, patient satisfaction (analogical visual scale), patient QoL (Patient Assessment of Constipation Quality of Life Questionnaire), side/unexpected effects. Sample size: 200 individuals to obtain 80 % power to detect a 20 % difference in treatment response at T4 between the two groups (15 % of lost to follow-up patients expected).DiscussionThe randomized, double-blind, placebo-controlled design is the most appropriate to demonstrate the efficacy of a new experimental therapeutic (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.Trial registrationCurrent controlled trials NCT02381665 (registration date: February 13, 2015).

PS-089 Which Decision Rules Meet Methodological Standards In Children With Febrile Neutropenia? Results Of A Systematic Review And Analysis

Background and aim Clinical decision rules (CDRs) have sought to identify the few children with chemotherapy-induced febrile neutropenia (FN) really at risk of severe infection to reduce the invasive procedures and costs for those at low risk. Several reports have shown that most rules do not perform well enough to be clinically useful. Our objective was to analyse the derivation methods and validation procedures of these CDRs. Methods A systematic review using Medline, Ovid, Refdoc, and the Cochrane Library through December 2012 searched for all CDRs predicting the risk of severe infection and/or complications in children with chemotherapy-induced FN. Their methodological quality was analysed by 17 criteria for deriving and validating a CDR identified in the literature. The criteria published by the Evidence Based Medicine Working Group were applied to the published validations of each CDR to assess their level of evidence. Results The systematic research identified 612 articles and retained 12 that derived CDRs. Overall the CDRs met a median of 65% of the methodological criteria. The criteria met least often were that the rule made clinical sense, or described the course of action, or that the variables and the CDR were reproducible. Only one CDR, developed in South America, met all methodological criteria and provided the highest level of evidence; unfortunately it was not reproducible in Europe. Conclusion Only one CDR developed for children with FN met all methodological standards and reached the highest level of evidence.

From the Guest Editors: Change the World: Teach Evidence-Based Practice!

From the Guest Editors: Change the World: Teach Evidence-Based Practice!

Efficacy of lidocaine in patients receiving palliative care with opioid-refractory cancer pain with a neuropathic component: study protocol for a randomized controlled study.

BackgroundThe management of patients suffering from opioid-refractory cancer pain with a neuropathic component remains an important challenge for healthcare workers. Only one retrospective study specifically reported the use of intravenous (IV) lidocaine amongst the palliative care unit population, the study found that there was a positive response to this therapy. These preliminary uncontrolled results need to be confirmed by randomized controlled trials. The primary objective of this study is to assess the analgesic efficacy of IV lidocaine in patients in palliative care suffering from opioid-refractory cancer pain with a neuropathic component. The secondary objectives are to assess the tolerance of, symptomatology, and patient satisfaction with the therapeutic approach.Methods/DesignThis will be a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel group study. It will take place in eight adult palliative care units across France. The main inclusion criteria are as follows: adult patients suffering from opioid-refractory cancer pain with a neuropathic component, and those receiving palliative care as defined by French Society of Palliative and Support Care. Participants will be randomized (1:1 allocation ratio) to one of two treatment groups: a) lidocaine-experimental group (intravenous lidocaine), or b) placebo-control group (intravenous saline solution). Evaluation assessments will be taken at baseline (T0 randomization), 40 minutes (T1), 120 minutes (T2), 12 hours (T3), 24 hours (T4), 48 hours (T5), and 14 days (T6) after baseline. The primary endpoint is change in the pain level between T0 and T1. The secondary endpoints are: changes in the pain level between T0 and other times, intensity of the neuropathic pain component, daily opioid consumption, symptoms (as classified by the MD Anderson Symptom Inventory), adverse events, and patient’s satisfaction (measured using the Pain Treatment Satisfaction Scale). A sample size of 200 individuals will be needed to obtain 90% power to detect a 25% difference in pain success at T1 between the two groups; pain success is classified as a 30% decrease in the pain level between T0 and T1 (10% of patients lost to follow-up expected).DiscussionThe randomized, double-blind, placebo-controlled design is the most appropriate design to demonstrate the efficacy of a new experimental intervention (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.Trial registrationCurrent controlled trials NCT02137954 (registration date: 7 May 2014).

In Search of the Highest Quality: Levels of Evidence in Oral and Maxillofacial Surgery

Evidence-based medicine is defined as delivery of care supported by clinical studies reflecting the highest level of evidence available. Surgeon experience and preference of the patient also must enter into clinical decision making. 1 Sackett D.L. Rosenberg W.M. Gray J.A. et al. Evidence based medicine: What it is and what it isn’t. BMJ. 1996; 312: 71 Crossref PubMed Google Scholar , 2 Montori V.M. Guyatt G.H. Progress in evidence-based medicine. JAMA. 2008; 300: 1814 Crossref PubMed Scopus (203) Google Scholar , 3 Urschel J.D. Goldsmith G.H. Tandan V.R. et al. Users’ guide to evidence-based surgery: How to use an article evaluating surgical interventions. Evidence-Based Surgery Working Group. Can J Surg. 2001; 44: 95 PubMed Google Scholar , 4 Evidence-Based Medicine Working Group Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA. 1992; 268: 2420 Crossref PubMed Scopus (3479) Google Scholar The principal goal is to use all available source data to provide the best possible patient care. Levels of evidence are ranked with the randomized controlled trial (RCT) and meta-analyses of high-quality RCT studies at the pinnacle. Cohort or case-control studies, case series, case reports, expert opinion, and animal (preclinical) studies, in descending order, constitute the remainder of the hierarchy (Centre for Evidence-based Medicine; http://www.cebm.net; Fig 1).

Which decision rules meet methodological standards in children with febrile neutropenia? Results of a systematic review and analysis.

Clinical decision rules (CDRs) have sought to identify the few children with chemotherapy-induced febrile neutropenia (FN) really at risk of severe infection to reduce the invasive procedures and costs for those at low risk. Several reports have shown that most rules do not perform well enough to be clinically useful. Our objective was to analyze the derivation methods and validation procedures of these CDRs. A systematic review using Medline, Ovid, Refdoc, and the Cochrane Library through December 2012 searched for all CDRs predicting the risk of severe infection and/or complications in children with chemotherapy-induced FN. Their methodological quality was analyzed by 17 criteria for deriving and validating a CDR identified in the literature. The criteria published by the Evidence Based Medicine Working Group were applied to the published validations of each CDR to assess their level of evidence. The systematic research identified 612 articles and retained 12 that derived CDRs. Overall, the CDRs met a median of 65% of the methodological criteria. The criteria met least often were that the rule made clinical sense, or described the course of action, or that the variables and the CDR were reproducible. Only one CDR, developed in South America, met all methodological criteria and provided the highest level of evidence; unfortunately it was not reproducible in Europe. Only one CDR developed for children with FN met all methodological standards and reached the highest level of evidence.

Teaching Evidence-Based Practice: Lessons From the Pioneers

Academy of Management Learning & EducationVol. 13, No. 3 Essays, Dialogues, & InterviewsTeaching Evidence-Based Practice: Lessons From the PioneersAn Interview With Amanda Burls and Gordon GuyattEric G. R. Barends and Rob B. BrinerEric G. R. BarendsCenter for Evidence-Based ManagementUniversity of Bath and Rob B. BrinerCenter for Evidence-Based ManagementUniversity of BathPublished Online:25 Apr 2014https://doi.org/10.5465/amle.2014.0136AboutSectionsView articleView Full TextPDF/EPUB ToolsDownload CitationsAdd to favoritesTrack Citations ShareShare onFacebookTwitterLinkedInRedditEmail View articleREFERENCES Briner R. , Denyer D. , Rousseau D, 2009. Evidence-based management: Concept cleanup time. Academy of Management Perspectives, 23(4): 19–32.Link , Google Scholar Charlier S. , Brown K. G. , Rynes S. L. 2011. Teaching evidence-based management in MBA programs: What evidence is there?. Academy of Management Learning and Education, 10(2): 222–236.Link , Google Scholar Daly J. 2005. Evidence-based medicine and the search for a science of clinical care. Berkeley: University of California Press. Google Scholar Dawes M. , Summerskill W. , Glasziou P. , Cartabellotta A. , Martin J. , Hopayian K. , Porzsolt F. , Burls A. , Osborne J. 2005. Second International Conference of Evidence-Based Health Care Teachers and Developers. Sicily statement on evidence-based practice. BMC Medical Education, 5: 1. Google Scholar Evidence-Based Medicine Working Group. 1992. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA: The Journal of the American Medical Association, 268(17): 2420–2425. Google Scholar Guyatt G. H. 1991. Evidence-based medicine. ACP Journal Club (Annals of Internal Medicine), (Supplement 12), A-16. Google Scholar Mezirow J. 1997. Transformative learning: Theory to practice. New Directions for Adult and Continuing Education, 74: 5–12. Google Scholar Petrosino A. , Turpin-Petrosino C. , Hollis-Peel M. E. , Lavenberg J. G. 2013. Scared Straight and other juvenile awareness programs for preventing juvenile delinquency. Cochrane Database of Systematic Reviews, 4: CD002796. Google Scholar Pfeffer J. , Sutton R. 2006. Hard facts, dangerous half-truths, and total nonsense. Boston, MA: Harvard Business School Press. Google Scholar Rose S. , Bisson J. , Churchill R. , Wessely S. 2001. Psychological debriefing for preventing post-traumatic stress disorder. Cochrane Database of Systematic Reviews, 2(CD000560.). Google Scholar Sacket D. L. , Haynes R. B. , Tugwell P. 1991. Clinical epidemiology, A basic science for clinical medicine. Boston, MA: Little, Brown. Google Scholar Sackett D. L. , Rosenberg W. M. C. , Gray J. A. M. , Haynes R. B. , Richardson W. S. 1996. Evidence-based medicine: What it is and what it isn't. BMJ, 312: 71–72. Google ScholarFiguresReferencesRelatedDetailsCited byThe Realist Rationality of Evidence-Based ManagementDenise M. Rousseau26 October 2020 | Academy of Management Learning & Education, Vol. 19, No. 3Student Understandings of Evidence-Based Management: Ways of Doing and BeingApril L. Wright, Gemma Irving, Paul Hibbert and Geoff Greenfield17 December 2018 | Academy of Management Learning & Education, Vol. 17, No. 4 Vol. 13, No. 3 Permissions Metrics in the past 12 months History Published online 25 April 2014 Published in print 1 September 2014 Information© Academy of Management Learning & EducationDownload PDF

Communication Commentary: Psychotherapy: Separate Worlds: Bridging the Divide Between Evidence-Based and Patient-Centered Care

Communication Commentary: Psychotherapy: Separate Worlds: Bridging the Divide Between Evidence-Based and Patient-Centered Care

Transparent Guideline Methodology Needed

As part of learning at the Nordic Workshop of Evidence-based Medicine, we have read with interest the practice guidelines for central venous access, published in your Journal in 2012.1 We appraised the quality of this guideline using the checklist developed by The Evidence-Based Medicine Working Group.2 Similar criteria for guideline quality have been suggested elsewhere.3 Our conclusion was that this much needed guideline is currently unclear about several aspects of the methodology used in developing the recommendations. This means potential users cannot be certain that the recommendations are based on best currently available evidence.Our concerns are in two main categories: the rigor of development, including methodology of searching, evaluating, and combining the evidence; and editorial independence, including funding and possible conflicts of interest. The methodological issues that we would like to see clarified in the guideline are:The searches may have missed relevant information. The authors report their searches covered a period from 1968 to 2011, identifying over 2,000 citations. When we made a PubMed search until the end of 2011 using “central venous catheter” as the search term, we found 12,453 references; adding “infection” retained 4,729 of these; and adding “coated” resulted in 128 studies, including a cohort study of catheters coated with antibiotics published in 2011.4 This study shows such catheters significantly decreased infections “in a manner that was independent and complementary to the infection control precautions.” In the paragraph on Recommendations for Use of Catheters Containing Antimicrobial Agents, the guideline has no references. A clear description of the search strategies could explain such a discrepancy.The concept of “evidence linkage” is rather central for the methodology but not quite fully explained in the methods. Does it mean “a statement regarding potential relationships between clinical interventions and outcomes” (as in appendix 5)?In reporting the results, we would appreciate separating the recommendations based on published scientific evidence and opinion-based evidence. Reading the guideline, it was first unclear to us whether the letters (e.g., Category B2 evidence) referred to scientific evidence or opinion-based evidence. Getting to the footnote of appendix 5, it seems the categories refer to scientific evidence only. It would be interesting to learn whether the guideline group for the next version could consider using a more widely used grading system, such as the GRADE (The Grading of Recommendations Assessment, Development and Evaluation).5It may be that we have missed where the authors have referred to the methods used, although we did our best to study the publication and the Supplemental Digital Content carefully. We also searched the website of this Journal† to make sure we did not miss any information on guideline methodology. In many guidelines, for example in a recent one on the prevention of intravascular catheter-related infections,6 the methodology is provided on an external site.‡Finally, we would have appreciated seeing the conflict of interest statements for all authors, and a declaration of how this undoubtedly work-intensive process has been funded.Making the evidence more transparent would be helpful to guideline users. Our suggestions are anchored in principles of evidence-based medicine. Our aim with this letter is to encourage the authors to provide information which could increase our confidence in the guideline and thus promote its application in practice.We hope that this important guideline will be updated within a couple of years, and that the American Society of Anesthesiologists Task Force on Central Venous Access will consider adding the necessary methodological information in their guideline.

If the cap fits…

Journal of Wound CareVol. 22, No. 8 EditorialIf the cap fits…Daniel ShanahanDaniel ShanahanSearch for more papers by this authorDaniel ShanahanPublished Online:29 Sep 2013https://doi.org/10.12968/jowc.2013.22.8.387AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View articleReferences1 Cochrane, A.L. Effectivenes: and Efficiency: Random Reflections on Health Services. Nuffield Provincial Hospitals Trust, 1972. Google Scholar2 Evidence-Based Medicine Working Group. Evidence-based medicine: a new approach to teaching the practice of medicine. JAMA. 1992; 268: 2420–2425. Crossref, Medline, Google Scholar3 Sonnad, S.S., Goldsack, J.C., Mohr, P., Tunis, S. Methodological recommendations for comparative effectiveness research on the treatment of chronic wounds. J Wound Care. 2013; 22: 9: In press. Link, Google Scholar FiguresReferencesRelatedDetails 1 August 2013Volume 22Issue 8ISSN (print): 0969-0700ISSN (online): 2052-2916 Metrics History Published online 29 September 2013 Published in print 1 August 2013 Information© MA Healthcare LimitedPDF download

Music-Based Intervention Reporting for Children with Autism: Implications for Music Therapy Publication Guidelines

The concept first appeared in the early 1990s and has since been applied in medical, behavioral, and alternative therapeutic treatment and research (Eddy, 1990; Evidence Based Medicine Working Group, 1992; Robb & Carpenter, 2009). Evidence-based practice combines practitioner wisdom with knowledge from rigorous clinical research to address the needs and desires of a client through effective treatment interventions (Detrich, 2008). It is currently considered a powerful force in today's health environment and has grown ... to prominence in the development of clinical standards and guidelines to improve quality of care (Davidson et al., 2003, p. 162).Researchers in both music therapy and in other fields have evaluated the level of evidence supporting music therapy practice for children with autism. Although some have suggested that music therapy is an appropriate treatment option for children with autism (e.g., Gold, Wigram, & Elefant, 2006; National Autism Center, 2009; Reschke-Hernandez, 2011b; Whipple, 2004), all have exposed a need to validate the efficacy of music therapy with this clinical population (Accordino, Comer, & Heller, 2007; Gold et al., 2006; National Autism Center, 2009; New York State Department of Health Early Intervention Program, 1999; Reschke-Hemandez, 2011b; Romanczyk & Gillis, 2005; Whipple, 2004; Wigram & Gold, 2006). A recent historical review of music therapy treatment interventions for children with autism has indicated that intervention techniques used in the past continue to be utilized despite an absence of sufficient research evidence (Reschke-Hernandez, 2011b). One of the potential causes of this continued recycling of interventions without sufficient supporting evidence could be the result of general insufficient reporting of music-based treatment interventions for children with autism in the literature.Intervention reporting provides a detailed account of the rationale for why an intervention was chosen, how it was executed and by whom, and how others can replicate the intervention for application in practice. Published clinical research provides a venue for explaining the details of these intervention techniques through qualitative and quantitative methods and thus informs music therapy clinical practice and future research. Without detailed intervention reporting in clinical literature, music therapy clinicians cannot adequately determine the quality of a treatment intervention or the research supporting it. It is also difficult to derive accurate and complete information to replicate the study, conduct systematic reviews, or apply the intervention in practice (Des Jariais, Lyles, Crepaz, & the TREND Group, 2004; Robb & Carpenter, 2009). Inadequate intervention reporting leaves music therapists unable to validate music therapy as an evidence-based treatment option for children with autism to other professionals, clients and their families, and third party providers. Guidelines for reporting the wide variety oi music-based intervention techniques for this population in the literature are needed.Guidelines for transparently reporting randomized controlled trials (RCTs) have been presented in the medical literature. The Consolidated Standards for Reporting Trials (CONSORT) Statement (CONSORT, 2010) is a free 25-item checklist to guide authors in supplying the detailed information that is necessary in a study in order for readers to adequately understand and evaluate the research. It specifies how authors should report information in all aspects of published research. Since its first publication in 1996, the CONSORT statement has had a significant positive impact on transparent research reporting, particularly in journals that have adopted the guidelines (Moher, Jones, & Lepage, 2001). Adherence to reporting guidelines . . . decreases honest reporting errors, helps to uncover bad research practice, and improves the reliability and usefulness of publications (Altman & Simera, 2010, p. …

Evidence-Based Medicine: Its Roots and Its Fruits

The Roots of EBM The practice of evidence-based medicine (EBM) in the United States dates back to at least the 1980s. Some would argue, however, that the concept of “burden of proof” has undergirded medical decision-making since the days of Hippocrates. The basic premise of the Hippocratic oath, “primum non nocere,” or “first, do no harm,” challenges practitioners to evaluate the benefit of a therapeutic decision for a patient prior to implementation. In the modern era, the basis for analytical medical research includes inference testing that begins with a null hypothesis — a statement declaring the lack of effectiveness of the treatment in question — that must be rejected with a high degree of certainty to support the implementation of the treatment.1 The widespread acceptance of randomized clinical trials as the gold standard research design for generating the best evidence regarding treatment decisions was championed in the early 1970s by Archie Cochrane, an epidemiologist from Great Britain.2 Today the Cochrane Collaboration is an international group of physicians and researchers that offers health care providers carefully researched systematic review articles covering thousands of clinical questions, enabling busy practitioners to make evidence-based decisions without spending the time needed to appraise the evidence individually.3 The term EBM was introduced to US health care providers in an article published in the Journal of the American Medical Association in 1992 by Gordon Guyatt of McMaster University in Ontario, Canada. In the article, Guyatt and colleagues from the Evidence-Based Medicine Working Group discussed the importance of a shift in medical practice from relying on personal expertise and experience to a more objective, data-driven approach to medical practice.4 In the two decades since then, EBM has come to be defined as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”5 EBM is now taught in medical schools, residency programs, and physician assistant (PA) programs around the country. Students and medical practitioners are learning to develop a clinical question based on a specific patient problem, search the medical literature for articles that address the issue, critically review the quality of the evidence in the articles, apply the findings to their specific patient as appropriate,6 and then evaluate the clinical results and the effectiveness of the process.2 While the introduction and application of EBM principles have substantially changed the practice of western medicine, wholesale adoption of evidencebased practice is not without its challenges. Despite increased access to just-in-time evidence available at the bedside, a lack of consistent and reliable evidence for all encounters, time and resource constraints, barriers to the practice of high-quality medicine, and the misperception that it is an “ivory-tower concept”7 challenge implementation. One opponent to Feature Editors’ Note: