Clark, Clancy J.

Objective: To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER). Background: In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity. Methods: CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the “Methods.” Results: Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = −0.30, P = 0.038). Conclusions: In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.

Anaplastic pancreatic cancer (APC) is a rare undifferentiated variant of pancreatic ductal adenocarcinoma with poor overall survival (OS). The aim of this study was to evaluate the clinical outcomes of APC compared with differentiated pancreatic ductal adenocarcinoma. We conducted a retrospective review of all patients treated at the Mayo Clinic with pathologically confirmed APC from 1987 to 2011. After matching with control subjects with pancreatic ductal adenocarcinoma, OS was evaluated using Kaplan-Meier estimates and log-rank test. Sixteen patients were identified with APC (56.3% male, median age 57 years). Ten patients underwent exploration of whom eight underwent pancreatectomy. Perioperative morbidity was 60 per cent with no mortality. The median OS was 12.8 months. However, patients with APC who underwent resection had longer OS compared with those who were not resected, 34.1 versus 3.3 months ( P = 0.001). After matching age, sex, tumor stage, and year of operation, the median OS was similar between patients with APC and those with ductal adenocarcinoma treated with pancreatic resection, 44.1 versus 39.9 months, ( P = 0.763). Overall survival for APC is poor; however, when resected, survival is similar to differentiated pancreatic ductal adenocarcinoma.

AbstractBackgroundBloating, flatulence, early satiety, and dysphagia resolve in more than 90% of patients early after fundoplication. Gastric dysfunction can persist, however, and a small number of patients develop severe gastric dysfunction (gastroparesis). Management of gastroparesis after antireflux procedures is generally conservative, but gastroparesis can become refractory to medical therapy. The aim of this study was to assess the role of gastric resection in the management of the unusual patient with severe postfundoplication gastric dysfunction.MethodsFrom January 1990 to October 2010, a total of 5,129 gastric resections were performed at our institution. From this cohort, we identified nine patients with postfundoplication gastric dysfunction managed with gastric resection. Clinical records were reviewed retrospectively for preoperative evaluation, perioperative course, and long‐term outcomes.ResultsOver 20 years, nine patients were treated with gastric resection for debilitating gastric dysfunction after antireflux surgery. Seven of the nine patients were female; the median preoperative body mass index was 25 kg/m2 (18–31 kg/m2). Median follow‐up was 23 months (1–97 months). Preoperatively, five patients required enteral feeding. Postoperatively, although there were no deaths, one patient required operative drainage of a subphrenic abscess, one developed temporary respiratory failure, and one was readmitted for partial small bowel obstruction. Six of the nine patients maintain their nutrition orally, but three are maintained with enteral nutrition. Only two patients are subjectively asymptomatic.ConclusionsOutcomes after gastric resection for postfundoplication gastric dysfunction are poor, with three of the nine patients requiring supplemental nutrition and seven of the nine having persistent symptoms.