ASCO, Author Interviews, Breast Cancer, Cancer Research, NEJM, Surgical Research, Yale / 31.05.2015

Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACSAssociate Professor, Department of Surgery Director, The Breast Center -- Smilow Cancer Hospital at Yale-New Haven Assistant Director -- Global Oncology, Yale Comprehensive Cancer Center Program Director, Yale Interdisciplinary Breast Fellowship Yale University School of Medicine Breast Centerm New Haven, CT 06510MedicalResearch.com Interview with: Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS, Associate Professor, Department of Surgery Director, The Breast Center -- Smilow Cancer Hospital at Yale-New Haven, Assistant Director -- Global Oncology, Yale Comprehensive Cancer Center Program Director, Yale Interdisciplinary Breast Fellowship Yale University School of Medicine Breast Centerm New Haven, CT, Medical Research: What is the background for this study? What are the main findings? Response: Every year in the US, nearly 300,000 women are diagnosed with breast cancer -- the majority of these will have early stage breast cancer, and will opt for breast conserving surgery to remove their disease.  The goal of this operation is to remove the cancer with a rim of normal tissue all the way around it (i.e., a margin), but sadly, 20-40% of women will have cancer cells at the edge of the tissue that is removed, often mandating a return trip to the operating room to remove more tissue to ensure that no further disease is left behind.  No one likes to go back to the operating room -- so we asked the question, "How can we do better?".  Surgeons have debated various means of obtaining clear margins.  Some have advocated taking routine cavity shave margins -- a little bit more tissue all the way around the cavity after the tumor is removed at the first operation.  Others have argued that this may not be necessary; that one could use intraoperative imaging of the specimen and gross evaluation to define where more tissue may need to be removed (if at all) -- i.e., selective margins.  We conducted a randomized controlled trial to answer this question.  We told surgeons to do their best operation, using intraoperative imaging and gross evaluation, and removing selective margins as they saw fit.  After they were happy with the procedure they had performed and were ready to close, we opened a randomization envelope intraoperatively, and surgeons were either instructed to close as they normally would ("NO SHAVE"), or take a bit more tissue all the way around the cavity ("SHAVE"). Patients in both groups were evenly matched in terms of baseline characteristics.  The key finding was that patients who were randomized to the "SHAVE" group half as likely to have positive final margins and require a re-operation than patients in the "NO SHAVE" group.  On their postoperative visit, we asked patients, before they knew which group they had been randomized to, what they thought of their cosmetic results.  While the volume of tissue excised in the "SHAVE" group was higher than in the "NO SHAVE" group, the distribution of patient-perceived cosmetic outcomes were identical in both groups.  Complication rate was also no different between the two groups.  We will be following patients for five years for long-term cosmetic and recurrence outcomes. (more…)
Anesthesiology, Author Interviews, Blood Pressure - Hypertension, Surgical Research / 31.05.2015

Prof. Dr. Robert Sanders MD Assistant Professor, Anesthesiology & Critical Care Trials & Interdisciplinary Outcomes Network (ACTION) Department of Anesthesiology University of Wisconsin, Madison, WIMedicalResearch.com Interview with: Prof. Dr. Robert Sanders MD Assistant Professor, Anesthesiology & Critical Care Trials & Interdisciplinary Outcomes Network (ACTION) Department of Anesthesiology University of Wisconsin, Madison, WI Medical Research: What is the background for this study? What are the main findings? Dr. Sanders: While it is known that chronic raised blood pressure exerts important effects on long term health outcomes, it is unclear how pre-operative blood pressure levels effect risk from surgery. In this study we show that after adjustment for other diseases, high blood pressure does not increase perioperative risk. Rather low blood pressure is associated with an increase in risk of death following surgery and anesthesia. (more…)
Author Interviews, Lancet, Ovarian Cancer, Surgical Research / 22.05.2015

MedicalResearch.com Interview with: Mr Matthew Nankivell MRC Clinical Trials Unit at University College London Institute of Clinical Trials and Methodology Aviation House, London UK Medical Research: What is the background for this study? What are the main findings? Response: Ovarian cancer is diagnosed in over 7000 women each year in the UK. Over 75% of these already have advanced disease, for which the standard treatment is surgery followed by platinum based chemotherapy. The prognosis for these patients remains poor however, with less than 25% surviving for 5 years. There is consistent evidence that achieving optimal debulking (meaning less than 1cm of residual tumour after surgery) is key to increasing survival. The theory tested in Chorus is that giving the chemotherapy before surgery (neo-adjuvantly) would be as least as effective as giving it post-operatively, and may in fact increase the chance of achieving optimal debulking, and subsequently living for longer. In Chorus we randomised 552 women to receiving either the current standard of immediate surgery followed by chemotherapy, or chemotherapy followed by surgery. The trial met its primary aim of showing that neo-adjuvant chemotherapy was no worse than post-operative chemotherapy, with median survival times of 24.1 and 22.6 months respectively. The proportion of women achieving optimal debulking increased from 41% in the post-operative chemotherapy group to 73% in the neo-adjuvant chemotherapy group. Additionally we saw that fewer women experienced serious post-operative complications having had neo-adjuvant chemotherapy (14% vs 24%), and fewer women died within 28 days of surgery (<1% vs 6%). There is a planned meta-analysis, to combine the data from Chorus with those from a similar European trial, which will allow further investigations to take place, and may allow the identification of groups of women who are more likely to benefit from one or other of the approaches. (more…)
Author Interviews, JAMA, OBGYNE, Surgical Research / 14.05.2015

Robert A. Meguid, MD MPH FACS Assistant Professor Section of General Thoracic Surgery Division of Cardiothoracic Surgery Department of Surgery University of Colorado Denver | Anschutz Medical Campus Aurora, CO 80045MedicalResearch.com Interview with: Robert A. Meguid, MD MPH FACS Assistant Professor Section of General Thoracic Surgery Division of Cardiothoracic Surgery Department of Surgery University of Colorado Denver | Anschutz Medical Campus Aurora, CO 80045 Medical Research: What is the background for this study? What are the main findings? Dr. Meguid: The surgical literature on adverse outcomes after surgery on pregnant patients is conflicting.  We know that the majority of surgery performed on pregnant patients is not elective (and just over 50% of it in the database studied was emergency surgery).  We expected to find an increased rate of adverse outcomes in those pregnant patients.  However, when we matched the pregnant and non-pregnant women who underwent surgery in the database, with excellent matching on all available preoperative characteristics and on the actual operation performed, we found similar, low rates of 30-day postoperative death and complication.  In this study, pregnant patients had undergone a broad spectrum of different types of operations, including general, vascular, thoracic, head and neck, non-obstetric gynecologic and urologic, orthopedic, reconstructive, and neuro-surgery.  Given the concern that we as surgeons have over operating on pregnant patients, both for the well-being of the patient and her child, our findings are reassuring.  This suggests that we as a medical profession are diligent in minimizing risk to pregnant women who need surgery that cannot be delayed until after the child's birth.  Again, this study faces the limitations of being unable to assess any short term harm done to the fetus and the subsequent long term outcome of the child. (more…)
Author Interviews, Breast Cancer, JNCI, Surgical Research / 11.05.2015

Bernadette A.M. Heemskerk-Gerritsen, Ph.D. Department of Medical Oncology Erasmus MC Cancer Institute Roterdam, the NetherlandsMedicalResearch.com Interview with: Bernadette A.M. Heemskerk-Gerritsen, Ph.D. Department of Medical Oncology Erasmus MC Cancer Institute Roterdam, the Netherlands Medical Research: What is the background for this study? What are the main findings? Dr. Heemskerk-Gerritsen: Women with a BRCA1 or BRCA2 mutation have substantially higher risks of developing both primary and contralateral breast cancer (BC) and ovarian cancer than women from the general population. Options to reduce these increased cancer risks include risk-reducing mastectomy (RRM) and/or risk-reducing salpingo-oophorectomy (RRSO). The latter intervention obviously reduces the risk of developing ovarian cancer, but has been reported also to reduce the risk of developing a subsequent breast cancer with approximately 50%. However, studies on the efficacy of risk-reducing surgery in BRCA1/2 mutation carriers are confined to observational studies, thus challenging several methodological issues. Consequently, previous studies on breast cancer risk-reduction after RRSO may have been influenced by bias associated with selection of study subjects, bias associated with start of follow-up, or by confounding, and breast cancer risk-reduction may have been overestimated. In the current study, we revisited the association between risk-reducing salpingo-oophorectomy and breast cancer risk in BRCA1/2 mutation carriers, focusing on the impact of different analytical methods and potential types of bias. First, we replicated the analyses of four previously performed studies, to examine if our Dutch cohort was comparable with the cohorts used in the previous studies. We replicated the approximately 50% breast cancer risk reduction after RRSO in the Dutch cohort. Second, we estimated the effect of RRSO on breast cancer risk in the Dutch cohort using a revised analytical approach for observational studies in BRCA1/2 mutation carriers in order to minimize bias as much as possible. Using this method of analysis, we found no evidence of first BC risk-reduction after RRSO in BRCA1/2 mutation carriers. (more…)
Author Interviews, Cancer Research, End of Life Care, Surgical Research, UC Davis / 04.05.2015

Robert J Canter MD Associate Professor of Clinical Surgery Division of Surgical Oncology University of California at DavisMedicalResearch.com Interview with: Robert J Canter MD Associate Professor of Clinical Surgery Division of Surgical Oncology University of California at Davis Medical Research: What is the background for this study? Dr. Canter: Our data suggest that surgeons are improving in their ability to select patients for surgical intervention in cancer patients near their end of life. Our research suggests that surgeons may be operating on healthier patients who are anticipated to have a better recover from a palliative operation. These are patients who can perform activities of daily living without assistance, for example. Our interest in the appropriate surgical care of people with late-stage cancer grew from observing terminally ill patients whose acute problems were addressed through surgery, and who then suffered complications resulting in lengthy stays in intensive care units, and even in death. Unfortunately, it is quite common that this group of disseminated malignancy patients end up dying in the intensive care unit instead of being managed with less invasive interventions with hopes of returning home with their families, including with hospice care. (more…)
Author Interviews, JAMA, Surgical Research, UCSF / 07.04.2015

Emily Finlayson, MD, MS Department of Surgery, Division of General Surgery Department of Medicine, Division of Geriatrics Philip R Lee Institute for Health Policy University of California, San Francisco Director, UCSF Center for Surgery in Older AdultsMedicalResearch.com Interview with: Emily Finlayson, MD, MS Department of Surgery, Division of General Surgery Department of Medicine, Division of Geriatrics Philip R Lee Institute for Health Policy University of California, San Francisco Director, UCSF Center for Surgery in Older Adults Medical Research: What is the background for this study? What are the main findings? Dr. Finlayson: In general, the goal of lower extremity revascularization is to preserve the leg so that patients can maintain the ability to ambulate and maintain functional independence.  We evaluated the results of this operation in older nursing home residents in the United States.  We found that over the 3 year study period, over 10,000 nursing home residents underwent this procedure.  Most of them were functionally dependent before surgery, 3/4 were unable to walk, and over half had dementia. After 1 year, half of the residents had died.  Among residents who could not walk before surgery, 89% were dead or non ambulatory 1 year after surgery. (more…)
Annals Internal Medicine, Author Interviews, Surgical Research, University of Pittsburgh / 06.04.2015

Anthony Delitto, PT, Ph.D, FAPTA Professor and Chair Department of Physical Therapy Associate Dean for Research, SHRS School of Health and Rehabilitation Sciences Pittsburgh,MedicalResearch.com Interview with: Anthony Delitto, PT, Ph.D, FAPTA Professor and Chair Department of Physical Therapy Associate Dean for Research, SHRS School of Health and Rehabilitation Sciences University of Pittsburgh Medical Research: What is the background for this study? What are the main findings? Dr. Delitto: I work with a team, many of whom were authors on the paper, and we see a lot of patients with lumbar spinal stenosis. Some of them did very well with Physical Therapy and avoided surgery. Some people didn’t do well and we ended up having surgery. We really wanted to do a study that compared, in a randomized format, doing surgery vs. a non-surgical approach to lumbar spinal stenosis. The idea we had was to really put the two approaches head to head – a randomized trial of surgery vs. physical therapy for people with lumbar spinal stenosis. We decided only to recruit patients after they had consented to surgery in order to avoid the pitfalls of previous studies where people crossed over after being assigned to a group, for example, being assigned to surgery and then deciding against having surgery. Medical Research: What should clinicians and patients take away from your report? Dr. Delitto: Probably the biggest point to put across to physicians, patients and practitioners, one of the things we realized was: patients don’t exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of the non-surgical options. The obvious finding is, when you compare the two groups, they seem to do the same. The results were equivalent at two years. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in Physical Therapy, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same. So it tells us that for the most part there were equivalent outcomes at two years. (more…)
Author Interviews, Brigham & Women's - Harvard, Melanoma, Surgical Research / 02.04.2015

MedicalResearch.com Interview with: Lyn McDivitt Duncan, MD Professor of Pathology, Harvard Medical School Chief, Dermatopathology Unit and Su Luo, MD Dermatology Resident Massachusetts General Hospital Boston, MA 02114 Medical Research: What is the background for this study? What are the main findings? Response: We studied 475 patients with cutaneous melanoma diagnosed at the Massachusetts General Hospital (MGH) who also had a sentinel lymph node biopsy procedure performed.  There is a practice gap in the sentinel lymph node biopsy procedure ranging from removal of one “sentinel” lymph node to removing the hottest lymph node and any lymph nodes with radioactive tracer of 10% or more of the hottest lymph node’s counts (with an average of three lymph nodes removed).  At the MGH we use this latter method.  We examined the sentinel lymph nodes in each case to determine whether the positive cases with microscopic melanoma metastases had metastases only in the most radioactive, or "hottest", node or whether tumor was also present in the less hot nodes. We found that in 19% of positive cases there were metastases present only in the less hot nodes. We also performed survival analysis and showed that the less hot nodal positive cases are of equivalent prognostic significance.  We found that removal of only the hottest lymph node would have led to under-staging of 19% of patients with melanoma. (more…)
Aging, Author Interviews, Education, NYU, Surgical Research / 21.03.2015

Uzma Samadani, MD, PhD Chief of Neurosurgery, New York Harbor Health Care System Assistant Professor, Departments of Neurosurgery, Psychiatry, Neuroscience and Physiology Co-Director, Steven and Alexandra Cohen Veterans Center NYU Langone Medical CenterMedicalResearch.com Interview with: Uzma Samadani, MD, PhD Chief of Neurosurgery, New York Harbor Health Care System Assistant Professor, Departments of Neurosurgery, Psychiatry, Neuroscience and Physiology Co-Director, Steven and Alexandra Cohen Veterans Center NYU Langone Medical Center Medical Research: What is the background for this study? What are the main findings? Response: The purpose of this study was to determine the current and future incidence of chronic subdural hemorrhage in the United States civilian and Veterans' Administration populations.  It's main findings are that, as the population ages, the incidence of subdural hemorrhage is increasing. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Race/Ethnic Diversity, Surgical Research / 18.03.2015

Dr. Adil Haider, MD, MPH Kessler Director of the Center for Surgery and Public Health (CSPH) at Brigham and Women’s HospitalMedicalResearch.com Interview with: Dr. Adil Haider, MD, MPH Kessler Director of the Center for Surgery and Public Health (CSPH) at Brigham and Women’s Hospital Medical Research: What is the background for this study? Response: Disparities in the quality of care received by minority and low-income patients have been reported for years across multiple medical conditions, types of care, and institutions.  To determine whether clinicians’ unconscious race and/or social class biases correlated with a lower quality of care for minority patients and those of lower socioeconomic status, my colleagues and I conducted a web-based survey among 215 physicians at an academic, level one trauma center. Participants were asked to review eight clinical vignettes, and then respond to three questions about management of care after each. Following their response, a test known as an Implicit Association Test (IAT Test) was used to assess any unconscious preferences. Medical Research: What are the main findings? Response: We found that race and class biases, as measured by response time to a standardized Implicit Association Test, had no relationship to the way that patients were clinically treated. Whether the lack of association found between implicit bias and decision making in this study represents a true lack of association or the failure of clinical vignettes to capture the nuances of how implicit biases translate into management decisions remains unclear. Existing biases might influence the quality of care received by minority patients and those of lower socioeconomic status in real-life clinical encounters. (more…)
Author Interviews, Heart Disease, Surgical Research / 17.03.2015

Marco Valgimigli, MD, PhD Erasmus MC, Thoraxcenter, Rotterdam The NetherlandMedicalResearch.com Interview with: Marco Valgimigli, MD, PhD Erasmus MC, Thoraxcenter, Rotterdam  The Netherlands MedicalResearch: What is the background for this study? What are the main findings? Dr. Valgimigli: Interventional cardiologists can choose between two entry sites in order to perform a diagnostic coronary angiography and or a percutaneous coronary intervention, namely an artery which is in the groin called femoral artery or an artery which is located in the wrist which is called radial artery. The latter is more superficial and has small calibre as compared to the former. Femoral artery is the entry site which is most frequently used in the world especially in US where the use of radial artery is relatively limited. Our study randomly allocated 8,404 patients to undergo diagnostic coronary angiography and PCI, if clinically indicated, either vie the femoral or the radial artery. The main results of our study are that radial access reduced the composite of net adverse clinical events driven by a reduction of mortality and of major bleeding, including transfusions and need for surgical repair or the entry site. (more…)
Author Interviews, Cleveland Clinic, Heart Disease, Lancet, Surgical Research / 15.03.2015

Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories Cleveland Clinic Cleveland, OH For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105). In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment. According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement. “This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says. Superior survival benefit with TAVR PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater. The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83. The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status. (more…)
Author Interviews, Heart Disease, NEJM, Surgical Research / 15.03.2015

Barnaby C. Reeves, D.Phil. Professor of Health Services Research, Clinical Trials & Evaluation Unit School of Clinical Sciences, University of Bristol Bristol Royal Infirmary BristolMedicalResearch.com Interview with: Barnaby C. Reeves, D.Phil. Professor of Health Services Research, Clinical Trials & Evaluation Unit School of Clinical Sciences, University of Bristol Bristol Royal Infirmary Bristol Medical Research: What is the background for this study? Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion. Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).* Medical Research: What are the main findings? Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion. The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant. We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups. We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome. (more…)
Author Interviews, JAMA, Orthopedics, Surgical Research / 11.03.2015

Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital MiddlesbroughMedicalResearch.com Interview with: Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital Middlesbrough Medical Research: What is the background for this study? What are the main findings? Prof. Rangan: The majority of fractures of the proximal humerus (broken shoulders) occur in people older than 65 years. Although surgical treatment is being increasingly used for the more serious (displaced) fractures, it has been unclear whether surgical intervention (fracture fixation or humeral head replacement) produces consistently better outcomes than non-surgical treatment (arm-sling); both followed by physiotherapy. Our multicentre randomized controlled trial (ProFHER), funded by the UK National Institute for Health Research’s Health Technology Assessment Programme, recruited 250 patients aged 16 years or older (mean age, 66 years) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 after sustaining the most common types of acute displaced fracture of the proximal humerus. Data for 231 patients (92.4% of 250) included in the primary analysis showed that there was no significant difference between the two treatment groups over two years or at 6, 12 and 24 months follow-up in self-reported pain and function scores. Nor were there significant differences on measures of health-related quality of life, complications related to surgery or shoulder fracture, later surgery or treatment for these complications, and death. (more…)
Author Interviews, Outcomes & Safety, Surgical Research / 05.03.2015

E. Patchen Dellinger, M.D. Professor of Surgery University of Washington, Box 356410 Seattle, Washington MedicalResearch.com Interview with: E. Patchen Dellinger, M.D. Professor of Surgery University of Washington Seattle, Washington Medical Research: What is the background for this study? What are the main findings? Dr. Dellinger: We know from previous large studies that use of checklists is associated with improvements in patient morbidity and mortality. However, recent large studies have also shown that mandating teams to use the checklist without providing the support required for adequate implementation does not result in better outcomes. This report reviews findings from studies examining checklist compliance and use. We found that when compliance with the checklist is poor it is not as effective as when the checklist is carried out as it is intended. Checklist use appears to be a marker for institutional culture of safety, and organizations with a more robust safety culture may be more likely to use the checklist in an effective manner with resulting improvements in patient safety. (more…)
Author Interviews, JAMA, Outcomes & Safety, Surgical Research / 03.03.2015

MedicalResearch.com Interview with: Dr. Stephen Duquette MD Indiana University Department of Surgery, Division of Plastic Surgery R.L Roudebush VA  Indianapolis, IN Medical Research: What is the background for this study? What are the main findings? Dr. Duquette: Carpal tunnel syndrome is the most common compressive peripheral neuropathy, causing pain, numbness and weakness.  Conservative treatment options include splinting, NSAID pain medications, and steroid injections.  Most often the definitive therapy is carpal tunnel release (CTR).  Over 500,000 procedures are performed in the US yearly, making it one of the most commonly performed hand surgery procedures.  In the United States it is most common to perform this operation in the operating room, under sedation and locoregional anesthesia.  Because it is a very common disease that is treated surgically, process improvement can have a major impact in time to OR, patient recovery, patient satisfaction, and overall throughput.  This is especially valuable in the Veterans Administration (VA) system, where recent problems have arisen due to lack of adequate resources to care for all veterans. This study examined the impact of opening an office-based procedure room in a VA to perform awake hand surgery under local anesthesia only.   This was compared to the prior practice of operating room carpal tunnel release though a number of performance metrics, including time to OR and complications.  Although office carpal tunnel releases are performed routinely in Canada, some surgeons still believe that the complications would increase outside the very sterile environment of the operating room. The current study showed that wait times from initial consultation and initial visit to surgical intervention were significantly decreased in the procedure room group compared to the operating room.  The complication rate was the same for both groups, showing that the procedure room and the operating room were both equally safe and efficacious in providing an environment that was ideal for the performance of carpal tunnel releases. (more…)
Author Interviews, Emory, Frailty, Surgical Research / 02.03.2015

MedicalResearch.com Interview with: Louis M. Revenig, MD and Kenneth Ogan MD, Department of Urology Emory University School of Medicine Atlanta, Georgia 30322 MedicalResearch: What is the background for this study? What are the main findings? Response: Numerous groups from a variety of institutions have investigated different methods of quantifying frailty in surgical populations. All have shown that frailty not only can be measured, but more importantly, reliably identifies the patients who are at higher risk for poor postoperative outcomes compared to their peers.  One obstacle to more widespread use of frailty assessments is the extra burden it places on an already busy clinical setting. In our study we chose what we thought was the already simplest and most clinically applicable frailty assessment, the 5-component Fried Frailty Criteria, and prospectively enrolled a large cohort of surgical patients and followed their outcomes. We critically analyzed the data to assess which components of the frailty assessment were most important. Our results showed that of the 5 components (weight loss, grip strength, gait speed, exhaustion, and activity level), weight loss and grip strength alone carried the same prognostic information for post-operative outcomes as the full assessment. Additionally, when combined with two already routinely collected pre-operative variables (serum hemoglobin and ASA score) we created a novel, simple, and easy to use risk stratification system that is more amenable to a busy clinical setting. (more…)
Author Interviews, Lancet, Surgical Research, Technology / 26.02.2015

MedicalResearch.com Interview with: Aidan Roche MBBS, PhD, BEng and Prof Oskar C Aszmann MD Director of the Christian Doppler Laboratory for Restoration of Extremity Function Division of Plastic and Reconstructive Surgery Department of Surgery Medical University of Vienna, Vienna, Austria Medical Research: What is the background for this study? What are the main findings? Response: The study was prompted by lack of techniques to restore hand function in patients with global plexopathies with avulsion of the lower roots. In simple terms, this is a tearing injury to parts of the brachial plexus. The brachial plexus is a complex junction of nerves that leaves the spinal cord and supplies the arm. If this junction of nerves is severely damaged, information cannot reach the hand to control it or to receive sensation from it.  In some of these cases, traditional reconstructive surgical techniques are only able to restore shoulder and elbow function, not the hand itself. In severe cases, this might leave the patient with a useless hand.  In previous clinical studies with existing amputees, advancing research has shown that good prosthetic control can be achieved by selectively transferring nerves. However, our study differs as our patients had intact, but functionless hands. The innovation here was to selectively transfer nerves and muscles to create useable signals for prosthetic control. Together with a comprehensive rehabilitation regime, followed by elective amputation, this formed the bionic reconstruction process. The main finding is that all three patients had excellent hand function restored through bionic reconstruction (as measured by the uniform improvement in all patients in the clinical outcome scores of the Action Research Arm Test, the Disability of Arm, Shoulder and Hand Questionairre, and the Southampton Hand Assessment Procedure and reported in detail in The Lancet). (more…)
Author Interviews, Education, Outcomes & Safety, Surgical Research, University of Pennsylvania / 25.02.2015

Samuel D. Pimentel Doctoral student Statistics Department Wharton School of the University of PennsylvaniaMedicalResearch.com Interview with: Samuel D. Pimentel Doctoral student Statistics Department Wharton School of the University of Pennsylvania   MedicalResearch: What is the background for this study? What are the main findings? Response: Surgical training has undergone major changes in recent years – including a reduction of six to twelve months of training time – and there is controversy about whether these changes have been good or bad for patient outcomes.   Our work partially addresses the issue by asking whether newly-trained surgeons perform better or worse than experienced surgeons.  We compared surgical patients treated by new surgeons to a similar group of patients treated by experienced surgeons using a new statistical technique called large, sparse optimal matching.  Our analysis found no significant differences in mortality rates between the two groups. (more…)
Author Interviews, Surgical Research / 22.02.2015

Dr. Y. Eltahir University Medical Centre Groningen Department of Plastic Surgery Groningen, The NetherlandsMedicalResearch.com Interview with: Dr. Y. Eltahir University Medical Centre Groningen Department of Plastic Surgery Groningen, The Netherlands Medical Research: What is the background for this study? What are the main findings? Dr. Eltahir: There are different options for breast reconstruction. They are divided into two main groups; autologous or implant breast reconstructions. all may have their effect on the quality of life and might have surgical complications. We were interested to know which breast reconstruction method may provide a better quality of life. However, we wanted to know this information from the patients point of view, that’s why we used the Breast-Q which is a case specific instrument, to compare the two groups. We found out that women with autologous breast reconstruction were more satisfied their breast than the implant group. However, this group has more secondary corrections than the control group. Further were no differences between the two groups. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 09.02.2015

MedicalResearch.com Interview with: Torsten Olbers MD, PhD Assistant Professor of Surgery Sahlgrenska University Hospital Gothenburg, Sweden Medical Research: What is the background for this study? What are the main findings? Dr. Olbers: Until now there has been no consensus regarding preferred bariatric procedure for patients with a body mass index (BMI) above 50 kg/m2. We report on the 5-year outcomes from a randomized clinical trial of gastric bypass and duodenal switch published online by JAMA Surgery on February 4th. (more…)
Author Interviews, Hospital Readmissions, JAMA, Surgical Research / 03.02.2015

Dr. Ryan Merkow, M.D. M.S. American College of Surgeons Chicago, IllinoisMedicalResearch.com Interview with: Dr. Ryan Merkow, M.D. M.S. American College of Surgeons Chicago, Illinois     MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Merkow: The measurement of hospital readmissions has become an important quality and cost-containment metric. Hospitals, policy makers, and individual practitioners are closely tracking readmissions. For the past decade the focus has been primarily on three medical conditions (pneumonia, heart failure and myocardial infarction) and although controversial, many thought leaders and policy makers believed that readmissions were preventable, and stemmed from poor transition of care, outpatient follow up or simply a failure of the medical system to appropriately care for these patients. Recently, the Center for Medicare and Medicaid Services has become increasingly interested in using readmissions as a quality measure and is now mandated by the Hospital Readmission Reduction Program to track hospital-wide readmissions (including all surgical patients), and for the first time, after individual surgical procedures (i.e., total hip and knee replacement). Future inclusion of additional surgical procedures is anticipated. However, despite the growing focus on readmissions after surgery, there have been few studies comprehensively evaluating the underlying reasons and factors associated with readmissions after surgical hospitalizations. Furthermore, the relationship between readmissions and complications that occur during the initial hospitalization after surgery is not clearly established. Importantly, unlike medical conditions, surgical patients undergo a discrete invasive event with known risks of complications. By studying this topic, initiatives to decrease readmissions can be more precisely determined, and national policy decisions that are now targeting readmissions can be appropriately formulated. The primary findings of our study identified surgical site infections as the most frequent reason that patients are readmitted after surgery, Importantly, in >95% of patients this complication was new, occurring after they left the hospital. The other common reason for readmission was obstruction or ileus, which was the second most frequent reason for readmission, particularly after abdominal surgery. Overall, the vast majority of readmissions were the result of new postdischarge, postoperative complications. With respect to factors associated with readmissions, most of the variation was due to differences in patient factors, such as ASA class, renal failure, ascites and/or steroid use. (more…)
Author Interviews, Brigham & Women's - Harvard, Surgical Research / 01.02.2015

Timothy R. Smith, M.D., Ph.D., M.P.H. Pituitary/Neuroendoscopy Fellow Department of Neurosurgery Brigham & Womens Hospital Harvard University Boston, MA 02115MedicalResearch.com Interview with: Timothy R. Smith, M.D., Ph.D., M.P.H. Pituitary/Neuroendoscopy Fellow Department of Neurosurgery Brigham & Womens Hospital Harvard University Boston, MA 0211 Medical Research: What is the background for this study? What are the main findings? Dr. Smith: Defensive medicine is the practice of prescribing unnecessary medical treatment for fear of being sued – it is widely practiced in the United States and contributes to our rising healthcare costs. In high-risk specialties such as neurosurgery, the fear of litigation leads to defensive practices that actually impact clinical decisions. A 2009 American College of Emergency Physicians report created malpractice risk profiles for each state based on its legal atmosphere, tort reform, and insurance availability. Based on these profiles, each state was ranked from 1 to 50 and sorted into separate categories, ranging from A, for the best liability environment, to F, for the worst. We sent a 51-question, anonymous online survey, which covered topics ranging from patient characteristics to surgeon liability profiles, to board-certified US neurosurgeons in the American Association of Neurological Surgeons. The purpose was to determine how neurosurgeons’ perceptions of their medico-legal environments correlated with these established state risk profiles, as well as whether each state’s liability risk environment was a predictor of defensive medical practices. We found that though the average malpractice insurance premium was $103,000 per year, neurosurgeons from high-risk states paid significantly more ($128,000) than those from low-risk states did ($75,000). Even with these amounts, almost 70% of respondents felt that their insurance coverage was inadequate, and 90% felt that the insurance premium was a financial burden. Neurosurgeons from high-risk states were also twice as likely to have been sued as those from low-risk states were. More than 80% of respondents ordered additional imaging for defensive medical purposes, and more than 75% said they ordered additional laboratory tests and made unnecessary referrals for defensive purposes; this behavior was more prevalent in high-risk states. After controlling for important confounders, we found that for every letter-grade change from “A” to “F”, neurosurgeons are 1.5 times more likely to engage in defensive behaviors. For example, moving from a “D” state to an “A” state represents 4.5 fold difference in defensive behaviors. (more…)
Author Interviews, Colon Cancer, Journal Clinical Oncology, Race/Ethnic Diversity, Stanford, Surgical Research / 30.01.2015

Kim F. Rhoads, MD, MS, MPH, FACS Assistant Professor of Surgery Director, Community Partnership Program Stanford Cancer Institute Unit Based Medical Director, E3 Surgery and Surgical Subspecialties Stanford University Stanford, Ca 94305MedicalResearch.com Interview with: Kim F. Rhoads, MD, MS, MPH, FACS Assistant Professor of Surgery Director, Community Partnership Program Stanford Cancer Institute Unit Based Medical Director, E3 Surgery and Surgical Subspecialties Stanford University Stanford, Ca 94305 Medical Research: What is the background for this study? What are the main findings? Dr. Rhoads: Colon cancer is the 3rd most common cancer in US men and women and is the 2nd most common cause of cancer death. For at least 2 decades, minorities with colon cancer have suffered a 15-20% additional risk of death when compared with non-minority patients. Our study set out to understand the influence of the location where treatment was delivered and the quality of care received, on overall survival and racial disparities. We examined more than 30,000 patients who were diagnosed and treated for colon cancer in California from 2001 through 2006.  Using cancer registry data linked to state level inpatient data and hospital information, we compared the rates of National Comprehensive Cancer Network (NCCN) guideline adherence and mortality by location of care and by race. We found that patients treated within an integrated health system (IHS) received NCCN guideline based care at higher rates than those treated outside the system—about 3% higher rates of surgery; and more than 20% higher rates of stage appropriate chemotherapy. The rates of guideline based care were nearly equal between the racial groups treated inside the IHS.  Propensity score matched comparisons revealed a lower risk of death for all patients and no racial disparities associated with treatment within the Integrated system.  For patients treated outside IHS, the disparity in mortality was explained by accounting for differences in receipt of evidence based care by race. (more…)
Author Interviews, Heart Disease, Outcomes & Safety, Surgical Research / 23.01.2015

MedicalResearch.com Interview with: Keita Morikane, Director Division of Clinical Laboratory and Infection Control Yamagata University Hospital Medical Research: What is the background for this study? What are the main findings? Response: The risk factors for surgical site infection following cardiac surgery is extensively investigated, but those specifically of open heart surgery or coronary artery bypass remains unknown. The main findings were that the risk factors between the two types of cardiac surgery were considerably different. (more…)
Author Interviews, Brigham & Women's - Harvard, Geriatrics, Hospital Readmissions, JAMA, Surgical Research / 21.01.2015

Thomas C. Tsai, MD, MPH Departments of Surgery and Health Policy and Management Harvard School of Public Health, Boston, Massachusetts MedicalResearch.com Interview with: Thomas C. Tsai, MD, MPH Departments of Surgery and Health Policy and Management Harvard School of Public Health, Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Dr. Tsai: Emerging evidence is suggesting that fragmented care is associated with higher costs and lower quality. For elderly patients undergoing major surgical procedures, fragmentation of care in the post-discharge period may be especially problematic. We therefore hypothesized that elderly patients receiving fragmented post-discharge care would have worse outcomes. We found that among Medicare patients who are readmitted after a major surgical operation, one in four are readmitted to a different hospital than the one where the original operation was performed. Even taking distance traveled into account, we find that this type of postsurgical care fragmentation is associated with a substantially higher risk of death. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Surgical Research / 18.01.2015

Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s HospitalMedicalResearch.com Interview with: Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting (CAS) vs Carotid endarterectomy (CEA) in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with a mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations. (more…)