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.
Introduction: Strengthening The Reporting Of Cohort Studies in Surgery (STROCSS) guidelines were developed in 2017 in order to improve the reporting quality of observational studies in surgery and updated in 2019. In order to maintain relevance and continue upholding good reporting quality among observational studies in surgery, we aimed to update STROCSS 2019 guidelines. Methods: A STROCSS 2021 steering group was formed to come up with proposals to update STROCSS 2019 guidelines. An expert panel of researchers assessed these proposals and judged whether they should become part of STROCSS 2021 guidelines or not, through a Delphi consensus exercise. Results: 42 people (89%) completed the DELPHI survey and hence participated in the development of STROCSS 2021 guidelines. All items received a score between 7 and 9 by greater than 70% of the participants, indicating a high level of agreement among the DELPHI group members with the proposed changes to all the items. Conclusion: We present updated STROCSS 2021 guidelines to ensure ongoing good reporting quality among observational studies in surgery.
The development of nonviral methods for efficient gene transfer to the lung is highly desired for the treatment of several pulmonary diseases. We have developed a noninvasive procedure using electroporation to transfer genes to the lungs of rats. Purified plasmid (100-600 microg) was delivered to the lungs of anesthetized rats through an endotracheal tube, and a series of square-wave pulses were delivered via electrodes placed on the chest. Relatively uniform gene expression was observed in multiple cell types and layers throughout the lung, including airway and alveolar epithelial cells, airway smooth muscle cells, and vascular endothelial cells, and this finding was dose- and pulse length-dependent. Most important, no inflammatory response was detected. To demonstrate efficacy of this approach, the beta1 subunit of the Na(+),K(+)-ATPase was transferred to the lungs of rats with or without electroporation, and 3 days later, alveolar fluid clearance was measured. Animals electroporated with the beta1 subunit plasmid showed a twofold increase in alveolar fluid clearance and Na(+),K(+)-ATPase activity as compared with animals receiving all other plasmids, with or without electroporation. These results demonstrate that electroporation is an effective method to increase clearance by introducing therapeutic genes (Na(+),K(+)-ATPase) into the rat lung.
Background: Surgery is a major physiologic stress comparable to intense exercise. Diminished cardiopulmonary reserve is a major predictor of poor outcomes. Current preoperative workup focuses mainly on identifying risk factors, however little attention is devoted to improving cardiopulmonary reserve beyond counseling. We propose that patients could be optimized for a “surgical marathon” similar to the preparation of an athlete. Study Design: The Michigan Surgical and Health Optimization Program (MSHOP) is a formal prehabilitation program that engages patients in four activities before surgery: physical activity, pulmonary rehabilitation, nutritional optimization, and stress reduction. We prospectively collected demographic, intraoperative (first hour), and postoperative data for patients enrolled in MSHOP undergoing major abdominal surgery. Statistical analysis was performed using 2:1 propensity score matching to compare the MSHOP group (N=40) to emergency (N=40) and elective, non-MSHOP (N=76) patients. Results: Overall, 70% of MSHOP patients complied with the program. Age, gender, ASA classification, and BMI did not differ significantly between groups. One hour intraoperatively, MSHOP patients showed improved systolic and diastolic blood pressures and lower heart rate (Figure). There was a significant reduction in Clavien-Dindo class 3–4 complications in the MSHOP group (30%) compared to the non-prehabilitation (38%) and emergency (48%) groups (p=0.05). This translated to total hospital charges averaging $75,494 for the MSHOP group, $97,440 for the non-prehabilitation group, and $166,085 for the emergency group (p < 0.001). Conclusion: Patients undergoing prehabilitation prior to colectomy showed positive physiologic effects and experienced fewer complications. The average savings of $21,946 per patient represents a significant cost offset for a prehabilitation program, and should be considered for all patients undergoing surgery.
Rationale: Acute lung injury and acute respiratory distress syndrome are common clinical syndromes resulting largely from the accumulation of and inability to clear pulmonary edema, due to injury to the alveolar epithelium. Gene therapy may represent an important alternative for the treatment and prevention of these diseases by restoring alveolar epithelial function. We have recently developed an electroporation strategy to transfer genes to the lungs of mice, with high efficiency and low inflammation. Objectives: We asked whether electroporation-mediated transfer of genes encoding subunits of the Na 1 ,K 1 -ATPase could protect from LPS-induced lung injury or be used to treat already injured lungs by up-regulating mechanisms of pulmonary edema clearance. Methods: Plasmids were delivered to the lungs of mice using transthoracic electroporation. Lung injury was induced by intratracheal administration of LPS (4 mg/kg body weight). Biochemical, cellular, and physiologic measurements were taken to assess gene transfer and lung injury. Measurements and Main Results: Improvements in wet-to-dry ratios, pulmonary effusions, bronchoalveolar lavage protein levels and cellularity, alveolar fluid clearance, and respiratory mechanics were seen after delivery of plasmids expressing Na 1 ,K 1 -ATPase subunits, but not control plasmids, in LPS-injured lungs. Delivery of plasmids expressing Na 1 ,K 1 -ATPase subunits both protected from subsequent lung injury and partially reversed existing lung injury by these measures.Conclusions: These results demonstrate that electroporation can be used effectively in healthy and injured lungs to facilitate gene delivery and expression. To our knowledge, this is the first successful use of gene delivery to treat existing lung injury, and may have future clinical potential.
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