The purpose of this study was to better understand the authorship publishing trends in the field of hand surgery. To accomplish this, a comparative analysis was completed between the European and American volumes of the Journal of Hand Surgery (JHSE and JHSA) over the past three decades. Well-established bibliometric methods were used to examine one representative year from each of the past three decades. The focus of the study was to examine changes in author gender over time as well as to compare authorship trends across the two volumes. All JHSA and JHSE publications from 1985, 1995, 2005, and 2015 were placed into a Microsoft Excel spreadsheet. Data was collected for each publication including the gender of first and corresponding authors, corresponding author position, corresponding author country of origin, number of credited institutions, authors, printed pages, and references. Countries were grouped by regions. A total of 450 and 763 manuscripts from JHSE and JHSA, respectively, met inclusion criteria. JHSE and JHSA both showed increases in most variables analyzed over time. Both journals showed an increase in female first and corresponding authors. JHSE and JHSA displayed a rise in collaboration between institutions and countries. Both JHSE and JHSA display increasing female inclusion in the hand surgery literature, which has traditionally been a male dominated field. The observed increase in collaboration between institutions and countries is likely linked to advances in technology that allow sharing of information more conveniently and reliably than was previously possible. As further advances are made socially and technologically, hopefully these trends will continue, leading to faster and higher quality research being generated in the field of hand surgery.
Unambiguous description of anatomical structures is essential to communicate information either in the clinical or research context. In view of this and following recommendations by the Nomenclature Committee of the International Societies for Surgery of the Hand (IFSSH), the booklet "Terminology for Hand Surgery" was published in 2001. The aim of this study was to identify whether the nomenclature used in the papers published in the Journal of Hand Surgery (British and European volume) followed its recommendations. The study showed that we still continue to use traditional terminology. The most common "mistake" is numbering of the metacarpals instead of naming them. Usage of newer terms would improve the clarity of information distributed.
This study evaluates the extent of duplicate publication in the Hand Surgery literature. A retrospective review of original articles published in the American and the British & European editions of Journal of Hand Surgery during the years 1999 and 2000 was performed using MEDLINE (PUBMED) search engine. Index articles suspected of dual publication were identified by using key words in the title and the names of the first, second and last authors. The full initial text was carefully studied and suspected duplicate articles were classified as dual, potentially dual or fragmented. Six hundred articles were evaluated, of which 25 (4%) index articles were identified with 33 "suspects". Eleven "index" and 15 "suspected" articles were cleared on closer scrutiny. Thus 14 "index" articles (2%) were found to be associated with 18 duplicated articles. Of these, four were classified as dual, five as potentially dual and nine as fragmented. We conclude that although duplicate publication of articles in the Journals of Hand Surgery (American and British/European Volumes) does occur, the incidence in the sample studied is lower than some other surgical journals.
To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of reported clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.
Purpose: (JHS). We aimed to test the null hypothesis that there would be no difference among these 3 groups with respect to gender, geographic location, academic productivity, and financial relationships with industry. Methods: Editors, reviewers, and physician authors were identified for 2018 JHS. Gender and geographic location were recorded for each person. We used the Scopus database to determine the Hirsch index (h-index) as well as the number of publications and citations for members of each group. Industry payment information was obtained using the Open Payments Web site. Results: The editor group contained 20% women compared with the author group (17% women). Authors (59%) were less likely to be from the United States compared with editors (91%) and reviewers (88%). Editors were found to have a higher h-index (16) compared with reviewers (14) and authors (12). Authors demonstrated significantly higher mean total payments from industry ($41,738) compared with editors ($13,712) and reviewers ($20,457). Conclusions: In 2018, there appeared to be an even distribution with respect to gender among editors, authors and reviewers in the JHS. International editors and reviewers are relatively under-represented compared to authors. Whereas editors and reviewers demonstrated higher h-indices compared with authors, JHS authors had significantly higher mean total payments in the Open Payments database. Clinical relevance: Defining demographics, academic productivity, and conflicts of interest for journal editors, reviewers, and authors may aid in identifying potential sources of both author and peer review bias.
As the name suggests, evidence-based medicine is about finding evidence and using that evidence to make clinical decisions. A cornerstone of evidence-based medicine is the hierarchical system of classifying evidence. This hierarchy is known as the levels of evidence. Physicians are encouraged to find the highest level of evidence to answer clinical questions. Several articles published in plastic surgery journals concerning evidence-based medicine topics have touched on this subject.1–6 Specifically, previous articles have discussed the lack of higher level evidence in Plastic and Reconstructive Surgery and the need to improve the evidence published in the Journal. Before that can be accomplished, it is important to understand the history behind the levels and how they should be interpreted. This article focuses on the origin of levels of evidence, their relevance to the evidence-based medicine movement, and the implications for the field of plastic surgery and the everyday practice of plastic surgery. HISTORY OF LEVELS OF EVIDENCE The levels of evidence were originally described in a report by the Canadian Task Force on the Periodic Health Examination in 1979.7 The report's purpose was to develop recommendations on the periodic health examination and base those recommendations on evidence in the medical literature. The authors developed a system of rating evidence (Table 1) when determining the effectiveness of a particular intervention. The evidence was taken into account when grading recommendations. For example, a grade A recommendation was given if there was good evidence to support a recommendation that a condition be included in the periodic health examination. The levels of evidence were further described and expanded by Sackett8 in an article on levels of evidence for antithrombotic agents in 1989 (Table 2). Both systems place randomized controlled trials at the highest level and case series or expert opinions at the lowest level. The hierarchies rank studies according to the probability of bias. Randomized controlled trials are given the highest level because they are designed to be unbiased and have less risk of systematic errors. For example, by randomly allocating subjects to two or more treatment groups, these types of studies also randomize confounding factors that may bias results. A case series or expert opinion is often biased by the author's experience or opinions, and there is no control of confounding factors.Table 1: Canadian Task Force on the Periodic Health Examination's Levels of EvidenceTable 2: Levels of Evidence from SackettMODIFICATION OF LEVELS Since the introduction of levels of evidence, several other organizations and journals have adopted variations of the classification system. Diverse specialties are often asking different questions, and it was recognized that the type and level of evidence needed to be modified accordingly. Research questions are divided into the following categories: treatment, prognosis, diagnosis, and economic/decision analysis. For example, Table 3 shows the levels of evidence developed by the American Society of Plastic Surgeons for prognosis9 and Table 4 shows the levels developed by the Centre for Evidence-Based Medicine for treatment.10 The two tables highlight the types of studies that are appropriate for the question (prognosis versus treatment) and how quality of data is taken into account when assigning a level. For example, randomized controlled trials are not appropriate when looking at the prognosis of a disease. The question in this instance is, “What will happen if we do nothing at all?” Because a prognosis question does not involve comparing treatments, the highest evidence would come from a cohort study or a systematic review of cohort studies. The levels of evidence also take into account the quality of the data. For example, in the chart from the Centre for Evidence-Based Medicine, a poorly designed randomized controlled trial has the same level of evidence as a cohort study.Table 3: Levels of Evidence for Prognostic StudiesTable 4: Levels of Evidence for Therapeutic StudiesA grading system that provides strength of recommendations based on evidence has also changed over time. Table 5 shows the Grade Practice Recommendations developed by the American Society of Plastic Surgeons. The grading system provides an important component in evidence-based medicine and assists in clinical decision making. For example, a strong recommendation is given when there is level I evidence and consistent evidence from level II, III, and IV studies available. The grading system does not degrade lower level evidence when deciding recommendations if the results are consistent.Table 5: Grade Practice RecommendationsINTERPRETATION OF LEVELS Many journals assign a level to the articles they publish, and authors often assign a level when submitting an abstract to conference proceedings. This allows the reader to know the level of evidence of the research, but the designated level of evidence does always guarantee the quality of the research. It is important that readers not assume that level I evidence is always the best choice or appropriate for the research question. This concept will be very important for all of us to understand as we evolve into the field of evidence-based medicine in plastic surgery. By design, our designated surgical specialty will always have important articles that may have a lower level of evidence because of the level of innovation and technique articles that are needed to move our surgical specialty forward. Although randomized controlled trials are often assigned the highest level of evidence, not all randomized controlled trials are conducted properly, and the results should be scrutinized carefully. Sackett8 stressed the importance of estimating types of errors and the power of studies when interpreting results from randomized controlled trials. For example, a poorly conducted randomized controlled trial may report a negative result because of low power when in fact a real difference exists between treatment groups. Scales such as the Jadad scale have been developed to judge the quality of randomized controlled trials.11 Although physicians may not have the time or inclination to use a scale to assess quality, there are some basic items that should be taken into account. Items used for assessing randomized controlled trials include randomization, blinding, a description of the randomization and blinding process, a description of the number of subjects who withdrew or dropped out of the study, the confidence intervals around study estimates, and a description of the power analysis. For example, Bhandari et al.12 published an article assessing the quality of surgical randomized controlled trials. The authors evaluated the quality of randomized controlled trials reported in the Journal of Bone and Joint Surgery from 1988 to 2000. Articles with a score of greater than 75 percent were deemed high quality, and 60 percent of the articles had a score less than 75 percent. The authors identified 72 randomized controlled trials during this time period, and the mean score was 68 percent. The main reason for the low-quality score was lack of appropriate randomization, blinding, and a description of patient exclusion criteria. Another article found the same quality score of articles in the Journal of Bone and Joint Surgery with a level 1 rating compared with level 2.13 Therefore, one should not assume that level 1 studies are of higher quality than level 2 studies. A resource for surgeons to use when appraising levels of evidence are the users' guides published in the Canadian Journal of Surgery14,15 and the Journal of Bone and Joint Surgery.16 Similar articles that are not specific to surgery have been published in the Journal of the American Medical Association.17,18 PLASTIC SURGERY AND EVIDENCE-BASED MEDICINE The field of plastic surgery has been slow to adopt evidence-based medicine. This was demonstrated in an article examining the level of evidence of articles published in Plastic and Reconstructive Surgery.19 The authors assigned levels of evidence to articles published in Plastic and Reconstructive Surgery over a 20-year period. The majority of studies (93 percent in 1983) were level IV or V, which denotes case series and case reports. Although the results were disappointing, there was some improvement over time. By 2003, there were more level I studies (1.5 percent) and fewer level IV and V studies (87 percent). A recent analysis looked at the number of level I studies in five different plastic surgery journals from 1978 to 2009. The authors defined level I studies as randomized controlled trials and meta-analyses and restricted their search to these studies. The number of level I studies increased from one in 1978 to 32 by 2009.20 From these results, we see that the field of plastic surgery is improving the level of evidence but still has a long way to go, especially in improving the quality of studies published. For example, approximately one-third of the studies involved double blinding, but the majority did not randomize subjects, describe the randomization process, or perform a power analysis. Power analysis is another area of concern in plastic surgery. A review of the plastic surgery literature found that the majority of published studies have inadequate power to detect moderate to large differences between treatment groups.21 Regardless of the level of evidence for a study, if the study is underpowered, the interpretation of results is questionable. Although the goal is to improve the overall level of evidence in plastic surgery, this does not mean that all lower level evidence should be discarded. Case series and case reports are important for hypothesis generation and can lead to more controlled studies. In addition, in the face of overwhelming evidence to support a treatment, such as the use of antibiotics for wound infections, there is no need for a randomized controlled trial. CLINICAL EXAMPLES USING LEVELS OF EVIDENCE To understand how the levels of evidence work and aid the reader in interpreting levels, we provide some examples from the plastic surgery literature. The examples also show the peril of medical decisions based on results from case reports. An association was hypothesized between lymphoma and silicone breast implants based on case reports.22–27 The level of evidence for case reports, depending on the scale used, is IV or V. These case reports were used to generate the hypothesis that a possible association existed. Because of these results, several large retrospective cohort studies from the United States, Canada, Denmark, Sweden, and Finland were conducted.28–32 The level of evidence for a retrospective cohort study is II. All of these studies had many years of follow-up for a large number of patients. Some of the studies found an elevated risk and others found no risk for lymphoma. None of the studies reached statistical significance. Therefore, higher level evidence from cohort studies does not provide evidence of any risk of lymphoma. Finally, a systematic review was performed that combined the evidence from the retrospective cohorts.27 The results found an overall standardized incidence ratio of 0.89 (95 percent confidence interval, 0.67 to 1.18). Because the confidence interval includes 1, the results indicate there is no increased incidence. The level of evidence for the systematic review is I. Based on the best available evidence, there is no association between lymphoma and silicone implants. This example shows how studies with a low level of evidence were used to generate a hypothesis, which then led to higher level evidence that disproved the hypothesis. This example also demonstrates that randomized controlled trials are not feasible for rare events such as cancer and emphasizes the importance of observational studies for a specific study question. A case-control study is a better option and provides higher level evidence for testing the prognosis of the long-term effect of silicone breast implants. Another example is the injection of epinephrine in fingers. Based on case reports before 1950, physicians were advised that epinephrine injection can result in finger ischemia.33 We see in this example that level IV or V evidence was accepted as fact and incorporated into medical textbooks and teaching. However, not all physicians accepted this evidence and were performing injections of epinephrine into the fingers, with no adverse effects on the hand. Obviously, it was time for higher level evidence to resolve this issue. An in-depth review of the literature from 1880 to 2000 by Denkler33 identified 48 cases of digital infarction, of which 21 had been injected with epinephrine. Further analysis found that the addition of procaine to the epinephrine injection was the cause of the ischemia.34 The procaine used in these injections included toxic acidic batches that were recalled in 1948. In addition, several cohort studies found no complications from the use of epinephrine in the fingers and hand.35–37 The results from these cohort studies increased the level of evidence. Based on the best available evidence from these studies, the hypothesis that epinephrine injection will harm fingers was rejected. This example highlights the biases inherent in case reports. It also shows the risk when spurious evidence is handed down and integrated into medical teaching. OBTAINING THE BEST EVIDENCE We have established the need for randomized controlled trials to improve evidence in plastic surgery but have also acknowledged the difficulties, particularly with randomization and blinding. Although randomized controlled trials may not be appropriate for many surgical questions, well-designed and well-conducted cohort or case-control studies could boost the level of evidence. Many of the current studies tend to be descriptive and lack a control group. The way forward seems clear. Plastic surgery researchers need to consider using a cohort or case-control design whenever a randomized controlled trial is not possible. If designed properly, the level of evidence for observational studies can approach or surpass those from a randomized controlled trial. In some instances, observational studies and randomized controlled trials have yielded similar results.38 If enough cohort or case-control studies become available, the prospect of systematic reviews of these studies will increase, which will increase overall evidence levels in plastic surgery. CONCLUSIONS The levels of evidence are an important component of evidence-based medicine. Understanding the levels and why they are assigned to publications and abstracts helps the reader to prioritize information. This is not to say that all level IV evidence should be ignored and all level I evidence accepted as fact. The levels of evidence provide a guide, and the reader needs to be cautious when interpreting these results. ACKNOWLEDGMENTS This work was supported in part by a Midcareer Investigator Award in Patient-Oriented Research (K24 AR053120) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (to K.C.C.).
The purpose of the study was to evaluate the trend in documentation of surgeon level of expertise among the Journal of Hand Surgery (American Volume) and the Journal of Hand Surgery (European Volume) publications. A review of Journal of Hand Surgery (American Volume) and Journal of Hand Surgery (European Volume) databases for level of expertise between January 2015 and October 2019 was performed. Of 1042 articles identified, all 115 (20%) reporting level of expertise were published in Journal of Hand Surgery (European Volume). Since 2015, there has been an increase in reported level of expertise in Journal of Hand Surgery (European Volume) (2015: 8 (7%); 2016: 15 (13%); 2017: 22 (19%); 2018: 28 (24%); 2019: 42 (37%)). In the same period, no publications have reported level of expertise in Journal of Hand Surgery (American Volume). Documenting level of expertise may provide readers with additional information for incorporation of novel techniques into their practices. It may identify procedures that require a baseline level of expertise for effective performance. Further evaluation of level of expertise criteria may improve the reliability of the numeric scale, while widespread adoption of this scale will allow future outcome analysis by level of expertise.
BACKGROUND: Citation of published articles by peers provides an indication of the relevance of the scientific work. Still, it is unknown what kinds of plastic surgery articles are cited most often. The authors set out to identify the characteristics of the 50 top-cited articles as published in four international, peer-reviewed, PubMed-indexed general plastic surgery journals. METHODS: The 50 most-cited articles were identified in each of the following journals: Plastic and Reconstructive Surgery, the British Journal of Plastic Surgery, the Annals of Plastic Surgery, and the Scandinavian Journal of Plastic and Reconstructive Surgery and Hand Surgery. These 200 articles were ranked after their citation index, defined as the mean number of times they were cited per year during the first 16 years after publication. The top-50 articles thus ranked were analyzed for citation and journal distribution, geographic and institutional origin, surgical and anatomical subject, and level of evidence. RESULTS: Forty-one of the 50 top-cited articles (82 percent) were published in Plastic and Reconstructive Surgery and 35 articles (70 percent) originated from institutions within the United States. Most of the articles dealt with the reconstruction of acquired defects (45 percent) and with basic or experimental research (41 percent). Research that offered means for clinical improvement, rather than a high level of evidence or the results of multi-institutional collaboration, was most often cited. CONCLUSION: An article featuring a clinical or nonclinical innovation, observation, or discovery that leads to clinical improvement has the best potential to become a "classic."
BACKGROUND: The purpose of this study was threefold: (1) to determine the scientific quality of published randomized trials in the American Volume of The Journal of Bone and Joint Surgery from 1988 through 2000, (2) to identify predictors of study quality, and (3) to evaluate inter-rater agreement in the scoring of study quality with use of a simple scale. METHODS: Hand searches of The Journal of Bone and Joint Surgery were conducted in duplicate to identify randomized clinical trials. Of 2468 studies identified, seventy-two (2.9%) met all eligibility criteria. Two investigators each assessed the quality of the study under blinded conditions and abstracted relevant data. RESULTS: The mean score (and standard error) for the quality of the seventy-two randomized trials was 68.1% plus minus 1.6%; 60% (forty-three) scored <75%. Drug trials had a significantly higher mean quality score than did surgical trials (72.8% compared with 63.9%, p < 0.05). Regression analysis revealed that cited affiliation with an epidemiology department and cited funding were associated with higher quality scores. Failure to conceal randomization, to blind outcome assessors, and to describe why patients were excluded resulted in significantly lower quality scores (p < 0.05), more than the 5% decrease expected by removal of each item. A priori calculations of sample size were rarely performed in the reviewed studies, and only 2% of the studies with negative results included a post hoc power analysis. The Detsky quality scale met accepted standards of interobserver reliability (kappa, 0.87; 95% confidence interval, 0.70 to 0.95). CONCLUSIONS: Few studies published in The Journal of Bone and Joint Surgery were randomized trials. More than half of the trials were limited by a lack of concealed randomization, lack of blinding of outcome assessors, or failure to report reasons for excluding patients. Application of standardized guidelines for the reporting of clinical trials in orthopaedics should improve quality.
The number of citations that a published article has received reflects the importance that paper has on that area of practice. In hand surgery, it is unknown which journal articles are cited most frequently. The purpose of this study was to identify and analyze the characteristics of the top 100 papers in the field of hand surgery. The 100 most cited papers were identified in the following journals; the Journal of Hand Surgery (American volume), the Journal of Hand Surgery (European volume), the Journal of Hand Surgery (British and European volume), The Scandinavian Journal of Plastic and Reconstructive and Hand Surgery, Hand Clinics, and the Journal of Plastic Surgery and Hand Surgery. The articles were ranked in order of the number of citations received. These classic 100 papers were analyzed for article type, their journal distribution, as well as geographic and institutional origin.
OBJECTIVE: To update the American College of Rheumatology (ACR) 2000 recommendations for hip and knee osteoarthritis (OA) and develop new recommendations for hand OA. METHODS: A list of pharmacologic and nonpharmacologic modalities commonly used to manage knee, hip, and hand OA as well as clinical scenarios representing patients with symptomatic hand, hip, and knee OA were generated. Systematic evidence-based literature reviews were conducted by a working group at the Institute of Population Health, University of Ottawa, and updated by ACR staff to include additions to bibliographic databases through December 31, 2010. The Grading of Recommendations Assessment, Development and Evaluation approach, a formal process to rate scientific evidence and to develop recommendations that are as evidence based as possible, was used by a Technical Expert Panel comprised of various stakeholders to formulate the recommendations for the use of nonpharmacologic and pharmacologic modalities for OA of the hand, hip, and knee. RESULTS: Both “strong” and “conditional” recommendations were made for OA management. Modalities conditionally recommended for the management of hand OA include instruction in joint protection techniques, provision of assistive devices, use of thermal modalities and trapeziometacarpal joint splints, and use of oral and topical nonsteroidal antiinflammatory drugs (NSAIDs), tramadol, and topical capsaicin. Nonpharmacologic modalities strongly recommended for the management of knee OA were aerobic, aquatic, and/or resistance exercises as well as weight loss for overweight patients. Nonpharmacologic modalities conditionally recommended for knee OA included medial wedge insoles for valgus knee OA, subtalar strapped lateral insoles for varus knee OA, medially directed patellar taping, manual therapy, walking aids, thermal agents, tai chi, self management programs, and psychosocial interventions. Pharmacologic modalities conditionally recommended for the initial management of patients with knee OA included acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid injections; intraarticular hyaluronate injections, duloxetine, and opioids were conditionally recommended in patients who had an inadequate response to initial therapy. Opioid analgesics were strongly recommended in patients who were either not willing to undergo or had contraindications for total joint arthroplasty after having failed medical therapy. Recommendations for hip OA were similar to those for the management of knee OA. CONCLUSION: These recommendations are based on the consensus judgment of clinical experts from a wide range of disciplines, informed by available evidence, balancing the benefits and harms of both nonpharmacologic and pharmacologic modalities, and incorporating their preferences and values. It is hoped that these recommendations will be utilized by health care providers involved in the management of patients with OA.
CONTEXT AND OBJECTIVE: There is no systematic assessment of the quality of scientific production in the specialty of hand surgery in our setting. This study aimed to systematically assess the status of evidence generation relating to hand surgery and to evaluate the reproducibility of the classification method based on an evidence pyramid. DESIGN AND SETTING: Secondary study conducted at Universidade Federal de São Paulo (Unifesp) and Faculdade Estadual de Medicina de Marília (Famema). METHODS: Two researchers independently conducted an electronic database search for hand surgery studies published between 2000 and 2009 in the two main Brazilian orthopedic journals (Acta Ortopédica Brasileira and Revista Brasileira de Ortopedia). The studies identified were subsequently classified according to methodological design (systematic review of the literature, randomized clinical trial, cohort study, case-control study, case series and other studies) and evidence level (I to V). RESULTS: A total of 1,150 articles were evaluated, and 83 (7.2%) were included in the final analysis. Studies with evidence level IV (case series) accounted for 41 (49%) of the published papers. Studies with evidence level V (other studies) accounted for 12 (14.5%) of the papers. Only two studies (2.4%) were ranked as level I or II. The inter-rater reproducibility was excellent (k = 0.94). CONCLUSIONS: Hand surgery articles corresponded to less than one tenth of Brazilian orthopedic production. Studies with evidence level IV were the commonest type. The reproducibility of the classification stratified by evidence level was almost perfect.
AIM: To review current applications of the laparoscopic surgery while highlighting the standard procedures across different fields. METHODS: A comprehensive search was undertaken using the PubMed Advanced Search Builder. A total of 321 articles were found in this search. The following criteria had to be met for the publication to be selected: Review article, randomized controlled trials, or meta-analyses discussing the subject of laparoscopic surgery. In addition, publications were hand-searched in the Cochrane database and the high-impact journals. A total of 82 of the findings were included according to matching the inclusion criteria. Overall, 403 full-text articles were reviewed. Of these, 218 were excluded due to not matching the inclusion criteria. RESULTS: A total of 185 relevant articles were identified matching the search criteria for an overview of the current literature on the laparoscopic surgery. Articles covered the period from the first laparoscopic application through its tremendous advancement over the last several years. Overall, the biggest advantage of the procedure has been minimizing trauma to the abdominal wall compared with open surgery. In the case of cholecystectomy, fundoplication, and adrenalectomy, the procedure has become the gold standard without being proven as a superior technique over the open surgery in randomized controlled trials. Faster recovery, reduced hospital stay, and a quicker return to normal activities are the most evident advantages of the laparoscopic surgery. Positive outcomes, efficiency, a lower rate of wound infections, and reduction in the perioperative morbidity of minimally invasive procedures have been shown in most indications. CONCLUSION: Improvements in surgical training and developments in instruments, imaging, and surgical techniques have greatly increased safety and feasibility of the laparoscopic surgical procedures.
BACKGROUND: Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee. METHODS: A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial. RESULTS: At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference. CONCLUSIONS: In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.
The disclosure forms of all experts involved in the development of these guidelines are available on the ESC website http://www.escardio.org/guidelines. The Addenda and Questions and Answers companion documents of these guidelines are available at: www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Peripheral-Artery-Diseases-Diagnosis-and-Treatment-of For the Web Addenda which include background information and detailed discussion of the data that have provided the basis for the recommendations see https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehx095#supplementary-data Current background information and detailed discussion of the data for these Guidelines can be found in ESC CardioMed - Section 49 Peripheral arterial diseases ... ... Guidelines summarize and evaluate available evidence with the aim of assisting health professionals in selecting the best management strategies for an individual patient with a given condition. Guidelines and their recommendations should facilitate decision making of health professionals in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible health professional(s) in consultation with the patient and caregiver as appropriate.
BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. METHODS: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. RESULTS: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). CONCLUSIONS: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.).
BACKGROUND AND METHODS: In the United States, most patients with primary hyperparathyroidism have few or no symptoms. The need for parathyroidectomy to treat all patients with this disorder has therefore been questioned. We studied the clinical course and development of complications for periods of up to 10 years in 121 patients with primary hyperparathyroidism, 101 (83 percent) of whom were asymptomatic. There were 30 men and 91 women (age range, 20 to 79 years). During the study, 61 patients (50 percent) underwent parathyroidectomy, and 60 patients were followed without surgery. RESULTS: Parathyroidectomy in patients with or without symptoms led to normalization of serum calcium concentrations and a mean (+/-SE) increase in lumbar-spine bone mineral density of 8+/-2 percent after 1 year (P=0.005) and 12+/-3 percent after 10 years (P=0.03). Bone mineral density of the femoral neck increased 6+/-1 percent after 1 year (P=0.002) and 14+/-4 percent after 10 years (P=0.002). Bone mineral density of the radius did not change significantly. The 52 asymptomatic patients who did not undergo surgery had no change in serum calcium concentration, urinary calcium excretion, or bone mineral density. However, 14 of these 52 patients (27 percent) had progression of disease, defined as the development of at least one new indication for parathyroidectomy. All 20 patients with symptoms had kidney stones. None of the 12 who underwent parathyroidectomy had recurrent kidney stones, whereas 6 of the 8 patients who did not undergo surgery did have a recurrence. CONCLUSIONS: In patients with primary hyperparathyroidism, parathyroidectomy results in the normalization of biochemical values and increased bone mineral density. Most asymptomatic patients who did not undergo surgery did not have progression of disease, but approximately one quarter of them did have some progression.
BACKGROUND: Obesity is associated with increased morbidity and mortality. Surgery for morbid obesity is considered when other treatments have failed. A number of procedures are available, but the effects of these surgical procedures compared with medical management and with each other are uncertain. OBJECTIVES: To assess the effects of surgery for morbid obesity. SEARCH STRATEGY: Studies were obtained from computerized searches of multiple electronic bibliographic databases, supplemented with hand searches of selected journals and consultation with experts in obesity research. Date of the most recent searches: December 2004. SELECTION CRITERIA: Randomised controlled trials comparing different surgical procedures, and randomised controlled trials and prospective cohort studies comparing surgery with non-surgical management for morbid obesity. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked independently by two reviewers. Two reviewers independently assessed trial quality. MAIN RESULTS: Twenty-six trials were included. Two randomised controlled trials and three prospective cohort studies compared surgery with non-surgical management, and 21 randomised controlled trials compared different surgical procedures. The quality of most of the trials was poor; just three trials had adequate allocation concealment. A meta-analysis was not possible due to differences in the surgical procedures performed, measures of weight change and length of follow-up. Compared with conventional management, surgery resulted in greater weight loss (21 kg weight loss at eight years versus weight gain), with improvements in quality of life and comorbidities. Some complications of surgery occurred, such as wound infection. Gastric bypass was associated with greater weight loss, better quality of life and fewer revisions, reoperations and/or conversions than gastroplasty, but had more side-effects. Greater weight loss and fewer side-effects and reoperations occurred with adjustable gastric banding than vertical banded gastroplasty, but laparoscopic vertical banded gastroplasty produced more patients with an excellent or good result and fewer late complications than laparoscopic adjustable silicone gastric banding. Vertical banded gastroplasty was associated with greater weight loss but more vomiting than horizontal gastroplasty. Some postoperative deaths occurred in the studies. Weight loss was similar between open and laparoscopic procedures. Fewer serious complications occurred with laparoscopic surgery, although conversion to open surgery was sometimes required. Most studies found that laparoscopic surgery had a longer operative time. But, it resulted in reduced blood loss and quicker recovery. AUTHORS' CONCLUSIONS: The limited evidence suggests that surgery is more effective than conventional management for weight loss in morbid obesity. The comparative safety and effectiveness of different surgical procedures is unclear.
Three hundred randomly selected references collected from the Journal of Hand Surgery (American Volume), the Journal of Hand Surgery (British and European Volume), and the British Journal of Plastic Surgery, spanning the years 1998 to 2002, were evaluated for citation errors. Forty-four citations across all journals contained errors (14.6 per cent). None of the errors made the cited article impossible to retrieve. Ten of the forty-four inaccuracies were incorrect final page numbers.
BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes. RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes. CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).