Longitudinal effects of adjuvant chemotherapy and lymph node staging on patient-reported outcomes in endometrial cancer survivors: a prospective cohort study.

BACKGROUND: Most patients with endometrial cancer with localized disease are effectively treated and survive for a long time. The primary treatment is hysterectomy, to which surgical staging procedures may be added to assess the need for adjuvant therapy. Longitudinal data on patient-reported outcomes comparing different levels of primary treatment are lacking, especially when adjuvant radiotherapy is omitted. OBJECTIVE: We assessed the impact of lymphadenectomy and adjuvant chemotherapy on patient-reported symptoms, function, and quality of life. We hypothesized that these treatment modalities would substantially affect patient-reported outcomes at follow-up. STUDY DESIGN: We prospectively included patients with endometrial cancer enrolled in the ongoing MoMaTEC2 study (ClinicalTrials.gov Identifier: NCT02543710). Patients were asked to complete the patient-reported outcome questionnaires European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EN24 preoperatively and at 1 and 2 years of follow-up. Functional domains and symptoms were analyzed for the whole cohort and by treatment received. To assess the effect of the individual treatment modifications, we used mixed regression models. RESULTS: Baseline data were available for 448 patients. Of these patients, 339 and 219 had reached 1-year follow-up and 2-year follow-up, respectively. Treatment included hysterectomy (plus bilateral salpingo-oophorectomy) alone (n=177), hysterectomy and lymph node staging without adjuvant therapy (n=133), or adjuvant chemotherapy irrespective of staging procedure (n=138). Overall, patients reported improved global health status and quality of life (+9 units; P<.001), increased emotional and social functioning, and increased sexual interest and activity (P<.001 for all) from baseline to year 1, and these outcomes remained stable at year 2. Means of functional scales and quality of life were similar to age- and sex-weighted reference cohorts. Mean tingling and numbness and lymphedema increased after treatment. The group who received adjuvant chemotherapy had a larger mean reduction in physical functioning (-6 vs +2; P=.002) at year 1, more neuropathy (+30 vs +5; P<.001; year 1) at years 1 and 2, and more lymphedema at year 1 (+11 vs +2; P=.007) than the group treated with hysterectomy and salpingo-oophorectomy only. In patients not receiving adjuvant chemotherapy, patient-reported outcomes were similar regardless of lymph node staging procedures. Adjuvant chemotherapy independently increased fatigue, lymphedema, and neuropathy in mixed regression models. CONCLUSION: Patients with endometrial cancer receiving adjuvant chemotherapy reported significantly reduced functioning and more symptoms up to 2 years after treatment. For patients treated by surgery alone, surgical staging did not seem to affect the quality of life or symptoms to a measurable degree at follow-up. Therefore, subjecting patients to lymph node removal to tailor adjuvant therapy seems justified from the patient's viewpoint; however, efforts should increase to find alternatives to traditional chemotherapy.

Claims for compensation after alleged birth asphyxia: a nationwide study covering 15 years.

OBJECTIVE: To analyze compensation claims with neurological sequela or death following alleged birth asphyxia. DESIGN: A cohort study. SETTING: A nationwide study in Norway. SAMPLE: All claims made to The Norwegian System of Compensation to Patients (NPE) concerning sequela related to alleged birth asphyxia, between 1994 and 2008. A total of 315 claims of which 161 were awarded compensation. METHODS: Examination of hospital records, experts' assessments and the decisions made by the NPE, the appeal body and courts of law. MAIN OUTCOME MEASURES: Characteristics of deliveries resulting in intrapartum asphyxia and causes of substandard care categorized in eight groups. RESULTS: In the 161 compensated cases, 107 children survived (96 with neurological sequela), and 54 children died. Human error was a frequent reason of substandard care, seen as inadequate fetal monitoring (50%), lack of clinical knowledge and skills (14%), noncompliance with clinical guidelines (11%), failure in referral for senior medical help (10%) and error in drug administration (4%). System errors were registered in only 3%, seen as poor organization of the department, lack of guidelines and time conflicts. The health personnel held responsible for substandard care was an obstetrician in 49% and a midwife in 46%. CONCLUSIONS: Substandard care is common in birth asphyxia, and human error is the cause in most cases. Inadequate fetal monitoring and lack of clinical knowledge and skills are the most frequent reasons for compensation after birth asphyxia.

A nationwide descriptive study of obstetric claims for compensation in Norway.

OBJECTIVE: To describe causes of substandard care in obstetric compensation claims. DESIGN AND SETTING: A nationwide descriptive study in Norway. POPULATION: All obstetric patients who believed themselves inflicted with injuries by the Health Service and applying for compensation. METHODS: Data were collected from 871 claims to The Norwegian System of Compensation to Patients during 1994-2008, of which 278 were awarded compensation. MAIN OUTCOME MEASURES: Type of injury and cause of substandard care. RESULTS: Of 871 cases, 278 (31.9%) resulted in compensation. Of those, asphyxia was the most common type of injury to the child (83.4%). Anal sphincter tear (29.9%) and infection (23.0%) were the most common types of injury to the mother. Human error, both by midwives (37.1% of all cases given compensation) and obstetricians (51.2%), was an important contributing factor in inadequate obstetric care. Neglecting signs of fetal distress (28.1%), more competent health workers not being called when appropriate (26.3%) and inadequate fetal monitoring (17.3%) were often observed. System errors such as time conflicts, neglecting written guidelines and poor organization of the department were infrequent causes of injury (8.3%). CONCLUSIONS: Fetal asphyxia is the most common reason for compensation, resulting in large financial expenses to society. Human error contributes to inadequate health care in 92% of obstetric compensation claims, although underlying system errors may also be present.

[Delivery of a breech presentation]. / Fødselsmetode ved seteleie.

BACKGROUND: Vaginal delivery in breech presentation is controversial, but in Norway vaginal delivery is recommended to certain groups of women. We have examined maternal and neonatal outcome at our hospital by mode of delivery to test whether our results support the recommendation. MATERIAL AND METHODS: We analyzed data from 385 women who delivered singleton breech fetuses after 34 weeks of gestation in the 10-year period 1997 - 2006 in Nordlandssykehuset, Bodø. Data were analyzed according to intended mode of delivery (caesarean section or vaginal delivery). Outcomes measured were neonatal and maternal mortality and morbidity, indication for caesarean section and use of forceps in vaginal delivery. RESULTS: 36 % of women delivered vaginally, and 39 % by planned and 25 % by acute caesarean section. Forceps were used in 16 % of vaginal deliveries. We found a higher incidence of early neonatal morbidity after vaginal delivery than after caesarean section (11/214 vs. 0/134, p < 0.008), but none of the children had any noticeable morbidity after one year. There was a higher risk of bleeding more than 1 000 ml after caesarean section (p = 0.01). INTERPRETATION: We found increased neonatal morbidity after vaginal deliveries of breech presentations, but the increase was about the same as that forming the basis for the national guidelines. We therefore choose to continue our practice with recommended vaginal delivery in breech presentation after careful selection.

Gas Embolism During Hysteroscopic Surgery?: Three Cases and a Literature Review.

During a period of 1 month, 3 episodes of probable or actual venous air embolism occurred during hysteroscopic surgery. All patients developed the same symptoms of ventilatory and hemodynamic decompensation, beginning with a reduction in end-tidal carbon dioxide, arterial desaturation, and cyanosis on the upper trunk, and rapidly progressed to hypotension and 2 cardiac arrests. While entrainment of some air is common during hysteroscopy, life-threatening embolism is a rare but serious complication for which an anesthetist needs to be vigilant and prepared. If even a small drop in end-tidal carbon dioxide occurs, venous air embolism should be suspected and the operation should be discontinued.

Is it possible to detect malposition of the vertex at an early stage in labour? A case-control study.

OBJECTIVES: The aim of this study was to investigate if there are clinical signs which allow detection of malposition of the vertex on admission to the delivery unit, or when crossing the action line on the partogram. STUDY DESIGN: Case-control study from 2007 to 2010 conducted on the delivery unit of Nordland Hospital, Bodø. Labours with malposition of the vertex (n = 171) were compared with a group with normal vertex presentation (n = 165). The positive predictive value was estimated for each sign using Bayes' rule. MAIN OUTCOME MEASURES: Magnitude of positive predictive value for each clinical sign. RESULTS: The positive predictive values for malposition were 9% if the foetus were in a right position, 11% if the labour was induced, 5% if the foetus was above the ischial spines, 4% if the reason for admission was contractions and 6% if cervix was <3 cm. CONCLUSION: The ability of clinical assessment to predict malposition, either on admission or when crossing the action line on the partogram, was poor. Diagnosing malposition of the vertex requires other methods with a higher predictive value.