Frederick H. Millham

The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery

INTRODUCTION The development of reporting guidelines over the past 20 years represents a major advance in scholarly publishing with recent evidence showing positive impacts. Whilst over 350 reporting guidelines exist, there are few that are specific to surgery. Here we describe the development of the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS We published our protocol apriori. Current guidelines for case series (PROCESS), cohort studies (STROBE) and randomised controlled trials (CONSORT) were analysed to compile a list of items which were used as baseline material for developing a suitable checklist for surgical cohort guidelines. These were then put forward in a Delphi consensus exercise to an expert panel of 74 surgeons and academics via Google Forms. RESULTS The Delphi exercise was completed by 62% (46/74) of the participants. All the items were passed in a single round to create a STROCSS guideline consisting of 17 items. CONCLUSION We present the STROCSS guideline for surgical cohort, cross-sectional and case-control studies consisting of a 17-item checklist. We hope its use will increase the transparency and reporting quality of such studies. This guideline is also suitable for cross-sectional and case control studies. We encourage authors, reviewers, journal editors and publishers to adopt these guidelines.

Preferred reporting of case series in surgery; the PROCESS guidelines

INTRODUCTION Case series have been a long held tradition within the surgical literature and are still frequently published. Reporting guidelines can improve transparency and reporting quality. No guideline exists for reporting case series, and our recent systematic review highlights the fact that key data are being missed from such reports. Our objective was to develop reporting guidelines for surgical case series. METHODS A Delphi consensus exercise was conducted to determine items to include in the reporting guideline. Items included those identified from a previous systematic review on case series and those included in the SCARE Guidelines for case reports. The Delphi questionnaire was administered via Google Forms and conducted using standard Delphi methodology. Surgeons and others with expertise in the reporting of case series were invited to participate. In round one, participants voted to define case series and also what elements should be included in them. In round two, participants voted on what items to include in the PROCESS guideline using a nine-point Likert scale to assess agreement as proposed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group. RESULTS In round one, there was a 49% (29/59) response rate. Following adjustment of the guideline with incorporation of recommended changes, round two commenced and there was an 81% (48/59) response rate. All but one of the items were approved by the participants and Likert scores 7-9 were awarded by >70% of respondents. The final guideline consists of an eight item checklist. CONCLUSION We present the PROCESS Guideline, consisting of an eight item checklist that will improve the reporting quality of surgical case series. We encourage authors, reviewers, editors, journals, publishers and the wider surgical and scholarly community to adopt these.

Fracture locations influence the likelihood of rectal and lower urinary tract injuries in patients sustaining pelvic fractures.

BACKGROUND Rectal and lower urinary tract injuries in pelvic fractures can lead to significant complications. We sought to determine whether fracture locations could serve as markers for injury. METHODS In our retrospective review of patients with blunt pelvic fractures, the association of fracture locations with injury to the rectum, bladder, and urethra was explored with Fishers exact test and subsequently analyzed with multiple logistic regression. RESULTS Of the 362 patients reviewed, 8 had rectal injury and 24 had lower urinary tract injury. The following locations were found to be significant. Rectum: symphysis pubis (relative risk [RR] = 3.3, p < 0.001) and sacroiliac (SI) joint (RR = 2.1, p = 0.014). Bladder: symphysis pubis (RR = 2.1, p < 0.001), SI joint (RR = 2.0, p < 0.001), and sacrum (RR = 1.6, p = 0.002). Urethra: symphysis pubis (RR = 2.9, p = 0.003), SI joint (RR = 1.8, p = 0.04), and inferior ramus (RR = 4.6, p = 0.008). After multivariate analysis, the primary and independent predictors for each of the injuries were as follows: rectal injury, widened symphysis; bladder injury, widened symphysis and SI joint; and urethral injury, widened symphysis and fracture of the inferior pubic ramus. Although these associations were significant, the overall prevalence of associated rectal and urologic injuries was low. Consequently, the predictive values of these radiologic findings were also low, ranging from 5% to 9% for urethral and rectal injuries to 20% for bladder injuries. CONCLUSION Certain fracture locations are associated with increased risk for rectal, bladder, or urethral injury. Fractures involving these locations should prompt further work-up for assessment.

Relationship between weather and seasonal factors and Trauma admission volume at a Level I Trauma center

BACKGROUND We sought to determine whether trauma patient admission volume to our Level I trauma center was correlated with observable weather or seasonal phenomena. METHODS Trauma registry data and national weather service data for the period between September 1, 1992, and August 31, 1998, were combined into a common data set containing trauma admission data and weather data for each day. Sequential linear regression models were constructed to determine relationships between variables in the data set. RESULTS There is a highly significant relationship (p < 0.00001) between maximum daily temperature and trauma admissions (R = 0.22). Rain is associated with a decrease in overall trauma volume. Rain had no effect on the number of admissions because of motor vehicle crash, however. Neither humidity nor snowfall affects trauma admission volume. Trauma admissions are significantly more frequent in July and August, and on Saturdays and Sundays (p < 0.05). Linear regression analysis identified maximum temperature, precipitation, day of week, and month as independent predictors of trauma admission volume (p < 0.001, R = 0.328). CONCLUSION There is a significant relationship between weather and trauma center activity; temperature and precipitation are independently associated with trauma admission volume at our institution. Statistical models of trauma incidence should consider these phenomena. Evaluation of a larger, population-based data set is needed to confirm these relationships.

Increased Risk of Postoperative Deep Vein Thrombosis and Pulmonary Embolism in Patients With Inflammatory Bowel Disease: A Study of National Surgical Quality Improvement Program Patients

HYPOTHESIS Patients with inflammatory bowel disease (IBD) undergoing surgery are at increased risk for postoperative thromboembolism, including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke. DESIGN Retrospective cohort study. SETTING Two hundred eleven hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program. PATIENTS All 271,368 patients from the National Surgical Quality Improvement Program 2008 Participant Use Data File were examined, and 2249 patients with IBD were compared with 269,119 patients without IBD. MAIN OUTCOME MEASURES Occurrence of DVT, PE, myocardial infarction, or stroke within 30 days of surgery. RESULTS Of 268,703 National Surgical Quality Improvement Program patients, 2249 (0.8%) had IBD. There were 2665 cases of DVT or PE (1.0%). Occurrence of DVT or PE was more common in patients with IBD (2.5%) overall (P < .001). Nonintestinal surgical cases had a higher rate of DVT or PE (5.0%; P = .002). Regression analysis, controlling for confounders, confirmed that IBD was associated with increased risk for DVT or PE (odds ratio = 2.03; 95% CI, 1.52-2.70). For nonintestinal surgery, risk of DVT or PE for patients with IBD was increased (odds ratio = 4.45; 95% CI, 1.72-11.49). Inflammatory bowel disease had no effect on risk of postoperative myocardial infarction or stroke. CONCLUSIONS Patients with IBD are at increased risk for developing postoperative DVT or PE. This risk persists when potential confounding variables are controlled for. Risk of DVT or PE appears to be even higher for patients with IBD who are having nonintestinal surgery. Cardiac and stroke risks do not appear to be increased by IBD. Perhaps standards for DVT and PE prophylaxis in these cases should be reconsidered.

How many sunsets? Timing of surgery in adhesive small bowel obstruction: A study of the Nationwide Inpatient Sample

BACKGROUND Best practices promulgated by the Eastern Association for the Surgery of Trauma suggest that delay in surgery for adhesive small bowel obstruction (ASBO) should not exceed 5 days. This study aimed to probe the relationship between operative delay and adverse outcomes, defined as occurrence of a complication, requirement for bowel resection, prolonged postoperative stay, or death in ASBO using the Nationwide Inpatient Sample. METHODS We used the Nationwide Inpatient Sample for 2009. The relationship among days to surgery (preoperative days) and defined as occurrence of a defined set of complications, death during hospitalization, resection, and postoperative length of stay greater than 7 days (postoperative days > 7) was assessed, taking into account potential confounding factors using regression analysis. RESULTS A total of 27,046 patients were identified with small bowel obstruction; 4,826 (18%) of these required surgery, and the remainder did not, staying a mean of 4 days (median, 3 days). Of the surgical group, 1,208 patients (25.0%) had Rsx, 1,527 (32%) had postoperative days of greater than 7, 138 (2.86%) died, 3,216 (66.7%) were female. Mean age was 62.2 years, mean total length of stay was 8.51 days, mean preoperative days was 1.94 days. Odds ratio (OR) of death for operated patients was 1.64 (95% confidence interval [CI], 1.11–2.19) when preoperative days was 4 or more. Postoperative days of greater than 7 was more likely if surgery preoperative days were 4 or more (OR, 1.26; 95% CIs, 1.07–1.48). No relationship between complication and preoperative days was observed. CONCLUSION Delay in management of small bowel obstruction is associated with death and longer postoperative stays. Delay was not associated with complication or bowel resection. These data lend support to a policy encouraging observation of ASBO for no more than 5 days. LEVEL OF EVIDENCE Epidemiologic study, level III; therapeutic study, level IV.

Survival determinants in patients undergoing emergency room thoracotomy for penetrating chest injury

Survival determinants were examined in patients undergoing ERT-PCI who were admitted to the Surgical Intensive Care Unit (SICU) between January 1, 1982 and August 1, 1991. Twenty-one of 290 patients undergoing ERT-PCI (aged 14-36 years) were admitted to the SICU. Of the 21, nine survived to discharge with normal neurologic function. Four survived with neurologic impairment. Eight expired 1 to 12 days after admission. The ERT was done immediately upon hospital arrival or subsequently in the Emergency Department for impending arrest despite resuscitation. All survivors had a pulse or blood pressure either in the field or upon arrival in the ER. Seven of nine who survived neurologically intact were awake on arrival in the ER, the other two were moving their extremities. One of four who survived with neurologic impairment was awake on arrival; three were comatose. Five of the eight who died were in full arrest in the field and upon arrival in the ER. Two of these patients were brain dead shortly after SICU arrival. All survivors had vital signs either in the field or on ER arrival. Patients with penetrating chest wounds without vital signs in the field who do not recover vital signs by hospital arrival do not benefit from emergency room thoracotomy. Evidence of mentation in the field or on arrival may predict ultimate neurologic outcome of survivors.

Emergency room thoracotomy for penetrating chest injury: effect of an institutional protocol.

BACKGROUND Emergency room thoracotomy (ERT) can be life saving in patients with penetrating chest injury. A protocol was established at our institution stating that ERT be performed for cases of cardiac tamponade secondary to penetrating chest trauma on patients with vital signs/mentation in the field or on arrival to the emergency room. To validate our protocol, we reevaluated patients undergoing ERT at our institution. METHODS In our retrospective review, there were 49 patients undergoing ERT over a 6-year period. RESULTS Survival in patients with vital signs was approximately 50%. Survival in those without was 0%. Compared with the preprotocol data, the number of ERTs declined from 32.2 cases per year to 8.1 cases per year. Overall survival increased from 4% to 20%. Neurologic outcome remained unchanged. CONCLUSION We believe that the data validate our protocol, and the establishment of a guideline has enabled us to maximize patient survival and minimize exposure risks to our staff.

Women’s Preferences for Minimally Invasive Incisions

STUDY OBJECTIVE To determine whether traditional, robotic, or single-site laparoscopic incisions are more appealing to women. DESIGN Descriptive study using a survey (Canadian Task Force classification III). SETTING Single-specialty referral-based gynecology practice. PATIENTS All patients older than 18 years who came for care to the Newton-Wellesley Hospital Minimally Invasive Gynecological Surgery Center from April 2, 2010, to June 30, 2010. INTERVENTIONS Three identical photos of an unscarred female abdomen were each marked with a black pen to indicate typical incision lengths and locations for robotic, single-site, and traditional laparoscopic surgery. Subjects were then asked to rank these incisions in order of preference. Additional demographic and surgical history questions were included in the survey. MEASUREMENTS AND MAIN RESULTS Two-hundred fifty of 427 patients (58.5%) returned surveys, and of these, 241 completed critical survey elements. Preference for traditional laparoscopic incisions was 56.4% (95% confidence interval [CI], 50.1%-62.7%), for a single incision was 41.1% (95% CI, 34.8%-47.3%), and for robotic surgery was 2.5% (95% CI, 0.5%-4.5%). Two-sample test of proportion (Z test) showed the difference in preference for traditional over the other methods to be significant: p = .007 for a single incision and p <.001 for robotic surgery. Multivariatble analysis for factors influencing choice of single-site incision demonstrated that Latina/Hispanic ethnicity was the only significant factor (p = .02). CONCLUSION Women prefer both single-site and traditional laparoscopic incisions over robotic procedures. Inasmuch as aesthetics are an important consideration for many women and clinical outcomes are similar, during the informed-consent procedure, location and length of incisions should be included in the discussion of risks, benefits, and alternatives.

Which risk model to use? Clinical implications of the ACS MRI screening guidelines.

The American Cancer Society (ACS) guidelines define the appropriate use of MRI as an adjunct to mammography for breast cancer screening. Three risk assessment models are recommended to determine if women are at sufficient risk to warrant the use of this expensive screening tool, however, the real-world application of these models has not been explored. We sought to understand how these models behave in a community setting for women undergoing mammography screening. We conducted a retrospective analysis of 5,894 women, who received mammography screening at a community hospital and assessed their eligibility for MRI according to the ACS guidelines. Of the 5,894 women, 342 (5.8%) were eligible for MRI, but we found significant differences in the number of eligible women identified by each model. Our results indicate that these models identify very different populations, implying that the ACS guidelines deserve further development and consideration. Cancer Epidemiol Biomarkers Prev; 22(1); 146–9. ©2012 AACR.