Author Interviews, Blood Pressure - Hypertension, JAMA, Surgical Research, UCSF / 10.06.2015

MedicalResearch.com Interview with: Susan Ming Lee, MD, FRCPC, MAS (Clinical Research) Clinical Instructor, Dept. of Anesthesia and Perioperative Care University of California, San Francisco Medical Research: What are the main findings? Dr. Lee: Angiotensin receptor blockers (often referred to as ARBs) are common medications used to treat high blood pressure, heart disease, and kidney disease.  Doctors sometimes stop these medications briefly around the time of surgery, since they are known to cause low blood pressure under general anesthesia.  Doctors may hesitate to restart ARBs after surgery because they are worried about low blood pressure or kidney function.  Prior to our research, there was little information to guide the optimal timing of restarting ARBs after surgery. Medical Research: What are the main findings? Dr. Lee: Our study of over 30,000 veterans shows that nearly one third of veterans admitted to hospital for non-cardiac surgery are not restarted on their usual ARBs within two days of their operation.  This delay in resuming ARBs is associated with increased death rates in the first month after surgery.  In fact, even accounting for factors that might contribute to why doctors would withhold ARB (such as low blood pressure, kidney dysfunction, or other comorbidities), 30-day postoperative mortality was increased approximately 50% in those without resumption of ARBs, and this effect was even greater in younger patients under age 60.  Our findings of reduced rates of infections, pneumonia, heart failure, and kidney failure in those that resumed ARBs soon after surgery suggest that early resumption may also reduce complications after surgery. (more…)
Author Interviews, Outcomes & Safety, Surgical Research / 06.06.2015

Dr. Janet Martin PharmD, PhD Director, Medical Evidence, Decision Integrity & Clinical Impact (MEDICI) Assistant Professor, Department of Anesthesia & Perioperative Medicine and Department of Epidemiology & Biostatistics Schulich School of Medicine & Dentistry, Western University London, ON Canada MedicalResearch.com Interview with: Dr. Janet Martin PharmD, PhD Director, Medical Evidence, Decision Integrity & Clinical Impact (MEDICI) Assistant Professor, Department of Anesthesia & Perioperative Medicine and Department of Epidemiology & Biostatistics Schulich School of Medicine & Dentistry, Western University London, ON Canada Medical Research: What is the background for this study? What are the main findings? Response: There remains some scepticism regarding the effectiveness of the safe surgery checklist (SSCL) to tangibly improve patient safety in the real world setting, especially with respect to relative benefits in high-income versus lower-income settings. In general, push-back has been related to surgical teams doubting the power of a simple checklist to make significant impact for surgical settings. Despite their deceptive simplicity, checklists can be powerful tools to deal with the sheer volume of information that must be addressed in sequence in order to support safe surgery. The objective of our study was to determine, through meta-analysis, whether clinically-relevant outcomes after implementation of the WHO Safe Surgery Checklist (SSCL) in the clinical trial setting and in the real world setting are improved, and whether greater benefit occurs in low-middle income countries (LMICs) than in high income countries (HICs). A total of 13 studies (262,970 patients) met the inclusion criteria, including 12 cohort studies and 1 randomized trial. For SSCL versus control, the odds of death was significantly reduced by 21% (OR 0.79, 95%CI 0.67-0.93; p=0.003). The odds of surgical site infection was reduced by 28% (OR 0.72, 95%CI 0.62-0.84; p=0.001). Similarly, overall postoperative complications were significantly reduced by 30% (OR 0.70, 95%CI 0.59-0.82; p=0.009). While HIC and LMICs both experienced reductions in death, surgical site infections, and overall complications, the magnitude of reduction was generally greater for LMICs than in HICs. Sub-analysis by study design demonstrated generalizability between the clinical trial setting and the real world setting. (more…)
Author Interviews, Cancer Research, JAMA, NYU, Surgical Research / 03.06.2015

Wiliam C. Huang, MD FACSAssociate Professor of Urology Division of Urologic Oncology NYU Langone Medical Center/Perlmutter Cancer InstituteMedicalResearch.com Interview with: Wiliam C. Huang, MD FACS Associate Professor of Urology Division of Urologic Oncology NYU Langone Medical Center/Perlmutter Cancer Center Medical Research: What is the background for this study? What are the main findings? Dr. Huang: The presentation of kidney cancers has dramatically evolved over the past two decades with most kidney cancers being incidentally diagnosed at an early stage. We have begun to recognize that at this small size (< 4 cm), the tumors are frequently indolent in nature and some are completely benign. Consequently, the management options for these small cancers have expanded and evolved.  Whereas the entire removal of the kidney was the treatment of choice in the past, alternative options including removal or ablation of the tumor-bearing portion of the kidney has become increasingly utilized. Similar to other early stage cancers, watchful waiting or observation is also becoming a reasonable treatment option. We used the most recent SEER-Medicare Data (2001 – 2009) to evaluate the management trends and outcomes of small kidney cancers in the new millennium.  We believe that this is an important study as it provides important and practical findings, which are useful to both clinical researches as well as practicing physicians. (more…)
Author Interviews, Diabetes, Surgical Research / 03.06.2015

MedicalResearch.com Interview with: Tom E. Robinson School of Population Health University of Auckland, New Zealand Medical Research: What is the background for this study? What are the main findings? Response: Diabetic foot disease affects up to 50% of people with diabetes and lower limb amputation is a serious complication that has a great impact both on patient quality of life and healthcare costs.  Foot complications are however potentially preventable with good diabetes and foot care and early intervention. There is international evidence of unexplained ethnic variations in the incidence of lower limb amputation.  This study found that ethnicity was strongly associated with risk of lower limb amputation. For example, New Zealand Maori people with diabetes have 63% higher rates of lower limb amputations and this increased risk is not altered by controlling for a range of demographic and clinical risk factors.  Asian New Zealander's have much lower risks of amputation but this may, at least in part, be explained by the 'healthy migrant effect'. (more…)
Author Interviews, Heart Disease, JAMA, Surgical Research / 02.06.2015

Mark L. Friedell, MD, FACS Chairman Department of Surgery University of Missouri Kansas City School of Medicine Kansas City, MO 64108MedicalResearch.com Interview with: Mark L. Friedell, MD, FACS Chairman Department of Surgery University of Missouri Kansas City School of Medicine Kansas City, MO 64108 Medical Research: What is the background for this study? What are the main findings? Response: The controversial practice of administering pre-surgery beta-blockers to patients having noncardiac surgery was associated with an increased risk of death in patients with no cardiac risk factors but it was beneficial for patients with three to four risk factors, according to a report published online by JAMA Surgery. Pre-surgery β-blockade is a widely accepted practice in patients having cardiac surgery. But its use in patients at low risk of heart-related events having noncardiac surgery is controversial because of the increased risk of stroke and hypotension (low blood pressure). Because of the persistent controversy, researcher Mark L. Friedell, M.D., of the University of Missouri-Kansas City School of Medicine, and coauthors analyzed data from the Veterans Health Administration to examine the effect of perioperative β-blockade on patients having noncardiac surgery by measuring 30-day surgical mortality. The analysis included 326,489 patients: 314,114 (96.2 percent) had noncardiac surgery and 12,375 (3.8 percent) had cardiac surgery. Overall, 141,185 patients (43.2 percent) received a β-blocker. Of the patients having cardiac surgery, 8,571 (69.3 percent) received a β-blocker and 132,614 (42.2 percent) of the patients having noncardiac surgery got one. The unadjusted 30-day mortality rates among patients having noncardiac surgery for those not receiving β-blockers were 0.5 percent for patients with no cardiac risk factors, 1.4 percent for patients with one to two risk factors and 6.7 percent for patients with three to four risk factors. For those patients having noncardiac surgery who did receive β-blockers, the unadjusted 30-day mortality rates for patients with no cardiac risk factors, one to two risk factors and three to four risk factors were 1 percent, 1.7 percent and 3.5 percent, respectively, according to the results. The results suggest that among patients with no cardiac risk factors having noncardiac surgery, those patients receiving β-blockers were 1.2 times more likely to die than those not receiving β-blockers. The risk of death decreased for those patients with one to two risk factors but the reduction was not significant. However, for patients having noncardiac surgery with three to four cardiac risk factors, those receiving β-blockers were significantly less likely to die than those not receiving β-blockers, the authors found. The authors did not observe similar results in patients having cardiac surgery. “β-blockade is beneficial perioperatively for patients with three to four cardiac risk factors undergoing NCS [noncardiac surgery] but not in patients with one to two cardiac risk factors. Most important, the use of β-blockers in patients with no cardiac risk factors appears to be associated with a higher risk of death, which has, to our knowledge, not been previously reported,” the study concludes. (more…)
Author Interviews, Opiods, Orthopedics, Pain Research, Surgical Research / 02.06.2015

MedicalResearch.com Interview with: Winfried Meissner, M.D. Dep. of Anesthesiology and Intensive Care Jena University Hospital University Hospital Jena, Germany Medical Research: What is the background for this study? Dr. Meissner: Post-operative pain is managed inadequately worldwide. There are probably many reasons for this, one of which may be lack of evidence about outcomes of treatment in the clinical routine. PAIN OUT was established  as a  multi-national research network and quality improvement project offering healthcare providers  validated tools to collect data about pain-related patient reported outcomes and management after surgery. Patients fill in a questionnaire asking for pain intensity, pain interference and side effects of pain management. The questionnaire has now been translated into 20 languages. Data are collected electronically and clinicians are provided with feedback about management of their own patients, compared to similar patients in other hospitals.  Furthermore, the findings are used for outcomes and comparative effectiveness research. PAIN OUT is unique in that  outcomes of postoperative pain management can be examined internationally. PAIN OUT was created in 2009 with funds from the European Commission, within the FP7 framework and  has now been implemented in hospitals in Europe, USA, Africa and SE Asia. The findings allow us to gain insights as to how pain in managed in different settings and countries. For this particular study, we compared management of pain in the US to other countries. We assessed a large group of patients who underwent different types of orthopedic surgery and compared their patient reported outcomes and management regimens. We included 1011 patients from 4 hospitals in the USA  and 28,510 patients from  45  hospitals in 14 countries (“INTERNATIONAL”). Medical Research: What are the main findings? Dr. Meissner: Postoperative pain intensity of US patients was higher than in INTERNATIONAL patients; they felt more often negatively affected by pain-associated anxiety and helplessness, and more US patients stated they wished to have received more pain treatment. However, other patient-reported outcomes like time in severe pain or the level of pain relief did not differ. We found that treatment regiments of American patients differed compared to INTERNATIONAL patients. More US patients received opioids, and their opioid doses were higher compared to INTERNATIONAL patients. In contrast, INTERNATIONAL countries use more nonopioid medications intraoperatively and postoperatively. Thus, under-supply with opioids cannot explain our findings. Mean BMI of US patients was 30.3 while for INTERNATIONAL it was 27.4. However, insufficient evidence exists that this finding might account for differences in pain intensity. Routine pain assessment was performed in almost all US patients, in contrast to about 75% in the INTERNATIONAL group. Obviously, routine pain assessment, as practiced in the United States, fails to result in lower postoperative pain. Perhaps it has the opposite effect by directing patients’ attention to the pain. (more…)
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, 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, 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, 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, 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, Cancer Research, MD Anderson, Nature, Personalized Medicine / 28.02.2015

Dr. Anil Sood MD Professor of Gynecologic Oncology and Reproductive Medicine The University of Texas MD Anderson Cancer CenterMedicalResearch.com Interview with: Dr. Anil Sood MD Professor of Gynecologic Oncology and Reproductive Medicine The University of Texas MD Anderson Cancer Center Medical Research: What is the background for this study? What are the main findings? MedicalResearch: What is the background for this approach? What are the main findings? Dr. Sood: The background involves several different issues: management approaches have varied quite a bit across the US; definition of “optimal” surgery and rates of complete surgical removal of tumor (R0) have also varied. It is quite apparent that patients who benefit the most from surgery upfront are those who have removal of tumor resection. To address these issues, we have implanted a much more personalized approach whereby patients with suspected advanced ovarian cancer undergo laparoscopic assessment using a validated scoring system (based on the pattern and extent of disease noted during laparoscopic assessment); patients with a score <8 undergo upfront debulking surgery and those with a score ≥8 receive neoadjuvant chemotherapy followed by surgery after 3-4 cycles. To date, this program has been fully implemented as part of the Moonshot Program at M.D. Anderson. This program has already resulted in several benefits – for example, prior to this algorithm being put into place among all patients with suspected advanced ovarian cancer, around 20% would have removal of tumor resection; after the implementation of the algorithm, of those going to upfront debulking surgery (after laparoscopic assessment), almost 85% of times removal of tumor resection can be achieved. Also, this method of treatment is allowing for new and innovative clinical trial designs. (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, 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, 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…)
Annals Thoracic Surgery, Author Interviews, Heart Disease, Surgical Research, Yale / 02.01.2015

Karthik Murugiah MBBS Fellow in Cardiovascular Medicine Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510MedicalResearch.com Interview with: Karthik Murugiah MBBS Fellow in Cardiovascular Medicine Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510 Medical Research: What is the background for this study? What are the main findings? Response: Aortic valve disease is common among older people and frequently requires valve replacement. 1-year survival after open surgical aortic valve replacement is high (9 in 10 survive the year after surgery). Our study focuses on the experience of these survivors in terms of the need for hospitalization during the year after surgery. Among patients >65 years of age enrolled in Medicare who underwent surgical replacement of their aortic valve and survived at least one year, 3 in 5 were free from hospitalization during that year. Both, the rates of hospitalization and the average total number of days spent in the hospital in the year following surgery have been decreasing all through the last decade (1999 to 2010). (more…)
Author Interviews, Surgical Research, University Texas, Weight Research / 27.12.2014

Taylor S. Riall, MD, PhD Professor, John Sealy Distinguished Chair in Clinical Research Department of Surgery, University of Texas Medical Branch, Galveston, TXMedicalResearch.com Interview with: Taylor S. Riall, MD, PhD Professor, John Sealy Distinguished Chair in Clinical Research Department of Surgery, University of Texas Medical Branch, Galveston, TX Medical Research: What is the background for this study? What are the main findings? Dr. Riall: In patients who have symptoms related their gallstones – most commonly sharp right upper quadrant abdominal pain (often associated with fatty meals), nausea, and vomiting - the current recommendation is to remove the gallbladder (perform cholecystectomy). However, in older patients there are multiple factors that make this decision difficult. Older patients have more associated medical problems (like diabetes, heart disease, etc.) making elective surgery higher risk. On the flip side, older patients are at higher risk of developing complications from their gallstones, and once they do, their mortality (death from gallbladder disease) and complications increase substantially. In recent study of Medicare beneficiaries with symptomatic gallstones, we found that fewer than 25% underwent elective removal of the gallbladder after an initial episode of pain or symptoms related to their gallbladder. We then developed a model that predicted the likelihood of these same patients requiring emergent gallstone-related complications if they did not have their gallbladder removed electively. This information prompted the current study. We sought to determine if the patients getting their gallbladders removed were the ones at highest risk for complications. Similar to the previous study, we found that only 22% of Medicare beneficiaries in this study (a different population) underwent elective gallbladder removal. We divided patients into three groups based on our risk prediction model – those with <30% risk, 30-60% risk, and >60% risk of requiring acute gallstone-related hospitalization. Please note that while we call the <30% risk group “low” risk, a 17% chance of hospitalization is actually a significant risk – much higher than seen in other medical conditions for which surgery or other interventions may be considered.
  • First, our model worked well – the ACTUAL hospitalization rate was 17%, 45%, and 69% in the two years after the first symptoms.
  • Second, whether patients had their gallbladder removed seemed unrelated to risk. 22% of patients in the lowest risk group, 21% in the middle risk group, and 23% in highest risk group had their gallbladder removed. Even more striking, in the healthiest patients – those with no medical problems and no reason not to perform elective surgery - cholecystectomy rates actually decreased with increasing risk of emergent admission. Cholecystectomy was performed in 34% of patients in the low risk group, 25% of patients in the moderate risk group, and 26% of patients in the highest risk group.
  • In addition, fewer than 10% of patients who didn’t have their gallbladder removed were ever seen by a surgeon, suggesting that this decision is being made at the level of the primary care or emergency physician and not necessarily patient choice.
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Author Interviews, JACC, Surgical Research / 26.12.2014

Dr. Mary T. Hawn Center for Surgical, Medical Acute Care Research, and Transitions, Birmingham Veterans Affairs Medical Center University of Alabama at Birmingham, BirminghamMedicalResearch.com Interview with: Dr. Mary T. Hawn MD, MPH Center for Surgical, Medical Acute Care Research, and Transitions, Birmingham Veterans Affairs Medical Center Section of Gastrointestinal Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama Medical Research: What is the background for this study? What are the main findings? Dr. Hawn: Cardiac risk factors and surgical risk factors contribute to the development of postoperative adverse cardiac events, but the relative contribution of each has not been quantified. In this study, we sought to determine the incremental risk of surgery following coronary stent placement on adverse cardiac events. To answer this question we used a retrospective cohort study of VA patients with coronary stents placed during 2000-2010 undergoing non-cardiac surgery within two years of stent placement matched to patients with coronary stents not undergoing surgery.  The patients were matched on stent type (drug-eluting versus bare metal) and cardiac risk factors at the time of stent placement.  Our outcome of interest was a composite variable of myocardial infarction and coronary revascularization occurring within 30 days of surgery.  We calculated adjusted risk differences over time from stent placement using generalized estimating equations. When comparing the two cohorts, we found a higher rate of composite cardiac events in the surgical cohort compared to the cohort not undergoing surgery. The main findings in the study were that the incremental risk of surgery was greatest when the surgery occurred in the first 6 weeks following stent placement and decreased to approximately 1% after 6 months, where it remained stable out to 24 months. Surgical characteristics associated with a significant reduction in the incremental risk after 6 months following stent placement included elective, inpatient procedures, and in the setting of a drug eluting stent. (more…)
Author Interviews, NYU, Surgical Research / 12.12.2014

Ganesh Sivarajan, MD Department of Urology New York University Langone Medical CenterMedicalResearch.com Interview with: Ganesh Sivarajan, MD Department of Urology New York University Langone Medical Center

  Medical Research: What is the background for this study? What are the main findings? Dr. Sivarajan: The surgical robot was designed to facilitate laparoscopic surgery. The surgeon sits at a console several feet away from the patient and is linked to a multi-armed robot which translates the surgeon’s movements from the console to surgical instruments inside the patient’s insufflated abdomen. The robot is equipped with a high resolution three dimensional camera which improves visualization over traditional open surgery and allows the manipulation of instruments in directions and angles which are difficult in traditional open surgery. In light of these apparent advancements, the robot was rapidly adopted for use during radical prostatectomy. The outcomes data for men undergoing robotic versus open prostatectomy, however, have not demonstrated any clear advantage of robotic surgery, with some studies demonstrating benefit and other demonstrating harm. This fact coupled with the relatively high cost of the robot and its disposable equipment have led many to criticize robotic surgery and its rapid adoption. Partial nephrectomy is a procedure performed for renal cancer in which just the malignant tumor is excised while the remaining healthy kidney is saved. It is increasingly considered to be preferable to the previous gold standard operation – radical nephrectomy or removal of the entire kidney largely secondary to the benefits accrued from preserving renal function. Despite actual changes in the treatment guideline recommending increased use of partial nephrectomy it remains vastly underutilized nationwide likely because of the technical challenges associated with its performance. It has been suggested that the surgical robot facilitates the performance of partial nephrectomy, but this has not been definitively demonstrated in a model which controls for important variables as the effects of changing guidelines, secular trends supporting increased utilization over time and a variety of other hospital-level characteristics. We sought to determine whether acquisition of the surgical robot was independently associated with increased utilization of partial nephrectomy – a guideline-supported procedure. If true, it would suggest that the acquisition of the surgical robot may have improved the quality of care of renal cell carcinoma patients. (more…)
Author Interviews, Case Western, Education, JAMA, Surgical Research / 10.12.2014

Ravi Rajaram MD Division of Research and Optimal Patient Care, American College of Surgeons Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies in the Institute for Public Health and Medicine Feinberg School of Medicine, Northwestern University, Chicago, IllinoisMedicalResearch.com Interview with: Ravi Rajaram MD Division of Research and Optimal Patient Care, American College of Surgeons Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies in the Institute for Public Health and Medicine Feinberg School of Medicine, Northwestern University, Chicago, Illinois Medical Research: What is the background for this study? What are the main findings? Dr. Rajaram: The Accreditation Council for Graduate Medication Education (ACGME) first implemented restrictions to resident duty hours in 2003. In surgical populations, these reforms have not been associated with a change in patient outcomes. However, in 2011, the ACGME further restricted resident duty hours to include: a maximum of 16 hours of continuous duty for first-year residents (interns), direct supervision of interns at all times, a maximum of 4 hours for transitions in care activities for residents in-house for 24 hours, and that these residents be given 14 hours off prior to returning to work. The association between the 2011 ACGME resident duty hour reform with surgical patient outcomes and resident education has not previously been reported. The 2011 resident duty hour reform was not associated with a change in death or serious morbidity in the two years after the reform was implemented. Additionally, the 2011 duty hour reform was not associated with a change in any of the secondary outcomes examined, including any morbidity, failure to rescue, surgical site infection, and sepsis. Furthermore, common measures of surgical resident education, such as in-training examination scores and board certification pass rates, were unchanged after the implementation of the 2011 duty hour reform when compared to scores prior to the reform. (more…)