Design of post project analysis and risk management processes for r&d projects

This study has been performed as a project management process improvement project in the R&D Department of a leading white goods manufacturer in Turkey. Data related to 93 projects executed and finished during 1994-2001 in the R&D Department is compiled. These projects are analyzed to determine the factors that affect the project performance and to identify the risks encountered in the past and to compile a Risk Checklist as an input to the proposed risk management process. Then, a risk management process and a post project analysis process are designed for introducing risk management and organizational learning practice to the R&D Center. The risk management and project analysis processes are tested on a project close to its initiation and on two recently completed projects, respectively. It is observed that learning points are identified upon analyzing risk issues and the risk management process outcomes may provide insights into the weaknesses in the project management process. Thus, both processes are intertwined and evolve around each other

Prognostic Importance of Lymph-Vascular Space Involvement in Stage I Endometrioid Type Endometrial Cancer

Objective:The study aimed to investigate the prognostic significance of lymph-vascular space invasion (LVSI) in patients with stage I endometrioid-type endometrial carcinoma (EC) and to determine its impact on overall survival (OS) and disease-free survival (DFS).Methods:Medical records of 611 patients with stage I endometrioid-type EC who underwent surgery at our Ankara Dr. Zekai Tahir Burak Women's Health Training and Research Hospital Gynecology Clinic were retrospectively analyzed. The patients were divided into two groups based on the presence or absence of LVSI. The primary outcome measures were DFS and OS, and the prognostic significance of LVSI was assessed using univariate and multivariate analyses.Results:We identified 52 LVSI-positive patients among 611 patients with stage I endometrioid EC during the study period; 489 (80%) were classified as stage IA and 122 (20%) as stage IB. The total number of recurrences was 26 (4.3%). LVSI was observed in only 4 patients with recurrence (15.3%). For the LVSI positive patients, the 5-year DFS was 88.7%, whereas the 5-year OS rate was 91.6%. Age >60 years [hazard ratio (HR) 4.08, 95% confidence interval (CI) 1.57-10.59; p=0.004] and tumor size >2.8 cm (HR 2.48, 95%, CI 1.001-6.148; p=0.05) were found to be independent prognostic factors of decreased OS.Conclusion:We found that LVSI in stage I endometrioid-type EC was not a significant predictor of DFS and OS. Patient’s age and tumor size were independent prognostic factors of crude survival. These results suggest that LVSI may not be a useful prognostic marker in this patient population and that further studies are needed to identify more reliable predictors of survival in EC

Abscess in Adenomyosis Mimicking a Malignancy in a 54-Year-Old Woman

Background: Although there are a few reports describing abscess formation in endometriotic foci no report of abscess formation arising de novo within adenomyosis appears in the literature. Preoperative diagnosis of adenomyosis is frequently difficult because of non-specific signs and symptoms. Synchronous pelvic pathologies such as leiomyoma, endometrial polyp, endometrial hyperplasia, as well as endometrial cancer may cause differential diagnostic problems. Case: A 54-year-old postmenopausal woman complaining of inguinal pain, nightsweats and hot flashes is presented. Radiologic examinations of the pelvis revealed a 95 × 85 mm leiomyoma-like lesion including a 53 × 43 mmcystic space and 9 × 6 mmpapillary formation within the uterus raising clinical suspicion of malignancy. A total abdominal hysterectomy and bilateral salpingo-oophorectomy were performed accompanied by a frozen section diagnosis. The frozen section revealed an abscess formation arising in a focus of adenomyosis. The postoperative period of the patient was uneventful. Conclusion : The present case, to our knowledge, is the first report representing abscess formation in adenomyosis. Abscess arising within adenomyosis can strongly raise the suspicion of endometrial cancer, particularly if the patient is postmenopausal. If endometrial cancer cannot be ruled out with definitive histopathological diagnosis in the preoperative period, a frozen section becomes mandatory during surgical intervention

Ar-ge projeleri için proje sonrası analiz ve risk yönetimi süreçleri

Bu çalışma, dayanıklı tüketim eşyası üreten bir firmanın Araştırma – Geliştirme (Ar-Ge) biriminde proje yönetiminde süreç iyileştirmesi projesi olarak yürütülmüştür. Sekiz yıllık bir dönem içinde Ar-Ge biriminde yönetilmiş ve sonlandırılmış 160 projeden arşivlenmis verilerinde hiçbir eksik olmayan 93 projeye ait veriler derlenmiştir. Bu projeler, proje yönetimi performansını etkileyen faktörlerin belirlenmesi, geçmişte karşılaşılan risklerin saptanması ve bir Risk Listesi hazırlamak için analiz edilmiştir. Oluşturulan Risk Listesi bu araştırma kapsamında önerilen risk yönetimi sürecinde bir girdi olarak kullanılmıştır. Bu makalede Ar-Ge projeleri için proje sonrası analiz ve risk yönetimi süreçlerine odaklanılmaktadır. Önerilen sistemle proje yaşamı boyunca edinilen bilgi ve tecrübenin belgelendirilmesinin sağlanmasını amaçlamaktadır. Özellikle bir proje organizasyonu için böyle değerli bilgi ve deneyimin biriktirilmesi elzemdir. Sistemik bir proje sonrası analiz bu gereksinimi yerine getirmekte olduğu gibi aynı zamanda kurumsal öğrenme sürecinin önemli bir parçası olarak düşünülmelidir. Proje sonrası analiz bir projenin kendisi ile beraber iki temel çıktısından biri olarak düşünülmelidir

The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Purpose: Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods: Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results: Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion: The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Which method is best for the induction of labour?: A systematic review, network meta-analysis and cost-effectiveness analysis

Background: More than 150,000 pregnant women in England and Wales have their labour induced each year. Multiple pharmacological, mechanical and complementary methods are available to induce labour. Objective: To assess the relative effectiveness, safety and cost-effectiveness of labour induction methods and, data permitting, effects in different clinical subgroups. Methods: We carried out a systematic review using Cochrane methods. The Cochrane Pregnancy and Childbirth Group’s Trials Register was searched (March 2014). This contains over 22,000 reports of controlled trials (published from 1923 onwards) retrieved from weekly searches of OVID MEDLINE (1966 to current); Cochrane Central Register of Controlled Trials (The Cochrane Library); EMBASE (1982 to current); Cumulative Index to Nursing and Allied Health Literature (1984 to current); ClinicalTrials.gov; the World Health Organization International Clinical Trials Registry Portal; and hand-searching of relevant conference proceedings and journals. We included randomised controlled trials examining interventions to induce labour compared with placebo, no treatment or other interventions in women eligible for third-trimester induction. We included outcomes relating to efficacy, safety and acceptability to women. In addition, for the economic analysis we searched the Database of Abstracts of Reviews of Effects, and Economic Evaluations Databases, NHS Economic Evaluation Database and the Health Technology Assessment database. We carried out a network meta-analysis (NMA) using all of the available evidence, both direct and indirect, to produce estimates of the relative effects of each treatment compared with others in a network. We developed a de novo decision tree model to estimate the cost-effectiveness of various methods. The costs included were the intervention and other hospital costs incurred (price year 2012–13). We reviewed the literature to identify preference-based utilities for the health-related outcomes in the model. We calculated incremental cost-effectiveness ratios, expected costs, utilities and net benefit. We represent uncertainty in the optimal intervention using cost-effectiveness acceptability curves. Results: We identified 1190 studies; 611 were eligible for inclusion. The interventions most likely to achieve vaginal delivery (VD) within 24 hours were intravenous oxytocin with amniotomy [posterior rank 2; 95% credible intervals (CrIs) 1 to 9] and higher-dose (≥ 50 μg) vaginal misoprostol (rank 3; 95% CrI 1 to 6). Compared with placebo, several treatments reduced the odds of caesarean section, but we observed considerable uncertainty in treatment rankings. For uterine hyperstimulation, double-balloon catheter had the highest probability of being among the best three treatments, whereas vaginal misoprostol (≥ 50 μg) was most likely to increase the odds of excessive uterine activity. For other safety outcomes there were insufficient data or there was too much uncertainty to identify which treatments performed ‘best’. Few studies collected information on women’s views. Owing to incomplete reporting of the VD within 24 hours outcome, the cost-effectiveness analysis could compare only 20 interventions. The analysis suggested that most interventions have similar utility and differ mainly in cost. With a caveat of considerable uncertainty, titrated (low-dose) misoprostol solution and buccal/sublingual misoprostol had the highest likelihood of being cost-effective. Limitations: There was considerable uncertainty in findings and there were insufficient data for some planned subgroup analyses. Conclusions: Overall, misoprostol and oxytocin with amniotomy (for women with favourable cervix) is more successful than other agents in achieving VD within 24 hours. The ranking according to safety of different methods was less clear. The cost-effectiveness analysis suggested that titrated (low-dose) oral misoprostol solution resulted in the highest utility, whereas buccal/sublingual misoprostol had the lowest cost. There was a high degree of uncertainty as to the most cost-effective intervention