SQUIRE-SIM (Standards for Quality Improvement Reporting Excellence for SIMulation): Publication Guidelines for Simulation-Based Quality Improvement Projects.

INTRODUCTION: With increased incorporation of simulation-based methodologies into quality improvement activities, standards for reporting on simulation-specific elements in healthcare improvement research are needed. METHODS: We followed established consensus process methodology to iteratively create simulation-based extensions for SQUIRE 2.0 reporting guidelines. Initial steps involved forming a steering committee, defining the scope, and conducting premeeting activities with an expert panel of simulation and quality improvement researchers. Recommendations from the expert panel were brought to a consensus meeting where existing guidelines were reviewed and recommendations made. Steering Committee members reviewed all recommendations, reconciled differences, and made final recommendations, which were piloted by experienced simulation and quality improvement researchers. RESULTS: Fifteen Steering Committee members, 59 experts in simulation and quality improvement research, and 86 consensus meeting attendees reviewed SQUIRE 2.0 reporting guidelines and ultimately recommended simulation-based reporting guidelines for 22 of the 41 (54%) SQUIRE 2.0 guidelines. Those items for which simulation-based extensions were identified were: Notes to Authors, 1 (Title), 2a (Abstract), 2b (Abstract), 4 (Introduction: Available knowledge), 5 (Introduction: Rationale), 7 and 8a & b (Methods: Context and intervention), 9a (Methods - Study of the intervention), 9b (Methods - Study of the intervention), 10a (Methods - Measures), 10b (Methods-Measures), 10c (Methods-Measures), 11b (Methods- Analysis), 12 (Methods - Ethical considerations), 13a (Results), 13e (Results), 14b (Discussion - Summary), 15a-e (Discussion - Interpretation), 16a (Discussion - Limitations), 16b (Discussion - Limitations), 17c (Discussion - Conclusions), and 17d (Discussion - Conclusions). CONCLUSIONS: We created simulation-based extensions to SQUIRE 2.0 reporting guidelines to improve the quality and standardization of reporting on simulation-specific elements of healthcare improvement research.

Longitudinal quality of life after sublobar resection and stereotactic body radiation therapy for early-stage non-small cell lung cancer.

BACKGROUND: Many patients with early-stage lung cancer are not candidates for lobectomy because of various factors, with treatment options including sublobar resection or stereotactic body radiation therapy (SBRT). Limited information exists regarding patient-centered outcomes after these treatments. METHODS: Subjects with stage I-IIA non-small cell lung cancer (NSCLC) at high risk for lobectomy who underwent treatment with sublobar resection or SBRT were recruited from five medical centers. Quality of life (QOL) was compared with the Short Form 8 (SF-8) for physical and mental health and Functional Assessment of Cancer Therapy-Lung (FACT-L) surveys at baseline (pretreatment) and 7 days, 30 days, 6 months, and 12 months after treatment. Propensity score methods were used to control for confounders. RESULTS: Of 337 subjects enrolled before treatment, 63% received SBRT. Among patients undergoing resection, 89% underwent minimally invasive video-assisted thoracic surgery or robot-assisted resection. Adjusted analyses showed that SBRT-treated patients had both higher physical health SF-8 scores (difference in differences [DID], 6.42; p = .0008) and FACT-L scores (DID, 2.47; p = .004) at 7 days posttreatment. Mental health SF-8 scores were not different at 7 days (p = .06). There were no significant differences in QOL at other time points, and all QOL scores returned to baseline by 12 months for both groups. CONCLUSIONS: SBRT is associated with better QOL immediately posttreatment compared with sublobar resection. However, both treatment groups reported similar QOL at later time points, with a return to baseline QOL. These findings suggest that sublobar resection and SBRT have a similar impact on the QOL of patients with early-stage lung cancer deemed ineligible for lobectomy.

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery.

BACKGROUND: Although lumpectomy and mastectomy provide equivalent survival for patients with breast cancer, local recurrence after lumpectomy increases breast cancer mortality. Positive lumpectomy margins, which imply incomplete tumor removal, are the strongest predictor of local recurrence and are identified days after surgery, necessitating a second surgery. METHODS: In this prospective trial, we assessed margin status with or without pegulicianine fluorescence-guided surgery (pFGS) for stages 0 to 3 breast cancers. To prevent surgeons from performing smaller than standard lumpectomies in anticipation of pFGS assistance, patients were randomly assigned 10:1 to pFGS or control groups, thus randomization was not designed to provide a control group for evaluating device performance. In patients undergoing pFGS, additional pFGS-guided cavity margins were excised at sites of pegulicianine signal. We evaluated three coprimary end points: the percentage of patients for whom pFGS-guided margins contained cancer, sensitivity, and specificity. RESULTS: Overall, 406 patients received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Among 392 patients randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. In 27 of 357 patients undergoing pFGS, pFGS-guided margins removed tumor left behind after standard lumpectomy, 22 from cavity orientations deemed negative on standard margin evaluation. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins. On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. Pegulicianine administration was stopped for adverse events in six patients. Two patients had grade 3 serious adverse events related to pegulicianine. CONCLUSIONS: The use of pFGS in breast cancer surgery met prespecified thresholds for removal of residual tumor and specificity but did not meet the prespecified threshold for sensitivity. (Funded by Lumicell, Inc. and the National Institutes of Health; Clinicaltrials.gov number, NCT03686215.)