Effectiveness and safety of the PlasmaJet® Device in advanced stage ovarian carcinoma: a systematic review.

About 80 % of all women affected by ovarian cancer present with advanced stage disease at the time of diagnosis. Achieving complete cytoreduction is complicated when many small tumor spots are found. Yet, complete cytoreduction is the most important determinant of survival.Application of a thermal plasma energy device to standard surgical instruments may help achieve complete cytoreduction. The 'PlasmaJet® Device' (Plasma Surgical, Inc., Roswell, GA, USA) is an electrically neutral device which emits a high-energy jet of argon plasma for direct tissue effects. We performed a literature review to investigate whether the use of the 'PlasmaJet® Device' in surgery of advanced stage ovarian carcinoma (FIGO IIIB-IV) is effective and safe.The primary outcome was the proportion of complete cytoreductions. The secondary outcomes were: complication rate, proportion of colostomies applied, histological findings, disease-free survival and overall survival.Five case series or reports were found, including a total of 77 patients with FIGO stage IIIC-IV ovarian cancer in whom the PlasmaJet® device was used for primary or interval debulking. Complete cytoreduction was obtained in 79% of the patients. Apart from one pneumothorax after extensive surgery, but no harm or additional complications related to the use of the PlasmaJet® Device were reported. Data on disease-free survival or overall survival were not reported.These findings suggest that the PlasmaJet® Device is an efficient and safe innovative surgical device for debulking surgery with encouraging results. We have proposed an RCT in which we will compare feasibility, safety and effectiveness aspects of the use of the PlasmaJet® versus conventional electrosurgery in advanced stage epithelial ovarian cancer (FIGO IIIB-IV).

[Planned location for delivery; no relationship with maternal or neonatal morbidity]. / Geplande locatie van bevalling.

OBJECTIVE: To compare maternal and neonatal outcomes of planned primary-care birth-centre deliveries with those of planned home deliveries and planned outpatient deliveries. DESIGN: Retrospective cohort study. METHOD: We used data collected in the period February 2009 to November 2013 from 4 community midwife practices attached to the Sophia birth centre (GCS), which is attached to the Erasmus MC academic hospital in Rotterdam, The Netherlands. We included women with low-risk pregnancies for whom primary-care midwives were responsible at the start of the delivery. Pregnant women were stratified according to planned location of delivery (home, outpatient or GCS). The most important outcome measures were: medical intervention during the delivery, and maternal or neonatal morbidity. We used 'propensity score matching' to correct for confounding factors. RESULTS: We included a total of 6185 pregnant women in our study. After propensity score matching, no statistically significant difference was seen in the total number of medical interventions during pregnancy, total maternal morbidity and total neonatal morbidity between pregnant women with planned home deliveries and those with planned GCS deliveries. (Medical interventions 13.6% and 12.4%, respectively; p-value 0.56. Maternal morbidity 4.9% and 5.7%, respectively; p-value 0.53. Neonatal morbidity 6.8% and 5.4%, respectively; p-value 0.31.) Similar results were seen when we compared pregnant women with planned outpatient deliveries with pregnant women with planned deliveries in the GCS. CONCLUSION: In women with low-risk pregnancies the planned location for delivery does not seem to be related to either the number of medical interventions during pregnancy or to maternal or neonatal morbidity. The GCS seems, therefore, to be an appropriate location for these women to deliver, but this should be confirmed by further studies.

Quality of perinatal care services from the user's perspective: a Dutch study applies the World Health Organization's responsiveness concept.

BACKGROUND: The concept of responsiveness was introduced by the World Health Organization (WHO) to address non-clinical aspects of service quality in an internationally comparable way. Responsiveness is defined as aspects of the way individuals are treated and the environment in which they are treated during health system interactions. The aim of this study is to assess responsiveness outcomes, their importance and factors influencing responsiveness outcomes during the antenatal and delivery phases of perinatal care. METHOD: The Responsiveness in Perinatal and Obstetric Health Care Questionnaire was developed in 2009/10 based on the eight-domain WHO concept and the World Health Survey questionnaire. After ethical approval, a total of 171 women, who were 2 weeks postpartum, were recruited from three primary care midwifery practices in Rotterdam, the Netherlands, using face-to-face interviews. We dichotomized the original five ordinal response categories for responsiveness attainment as 'poor' and good responsiveness and analyzed the ranking of the domain performance and importance according to frequency scores. We used a series of independent variables related to health services and users' personal background characteristics in multiple logistic regression analyses to explain responsiveness. RESULTS: Poor responsiveness outcomes ranged from 5.9% to 31.7% for the antenatal phase and from 9.7% to 27.1% for the delivery phase. Overall for both phases, 'respect for persons' (Autonomy, Dignity, Communication and Confidentiality) domains performed better and were judged to be more important than 'client orientation' domains (Choice and Continuity, Prompt Attention, Quality of Basic Amenities, Social Consideration). On the whole, responsiveness was explained more by health-care and health related issues than personal characteristics. CONCLUSION: To improve responsiveness outcomes caregivers should focus on domains in the category 'client orientation'.

Planned home compared with planned hospital births: mode of delivery and Perinatal mortality rates, an observational study.

BACKGROUND: To compare the mode of delivery between planned home versus planned hospital births and to determine if differences in intervention rates could be interpreted as over- or undertreatment. METHODS: Intervention and perinatal mortality rates were obtained for 679,952 low-risk women from the Dutch Perinatal Registry (2000-2007). Intervention was defined as operative vaginal delivery and/or caesarean section. Perinatal mortality was defined as the intrapartum and early neonatal mortality rate up to 7 days postpartum. Besides adjustment for maternal and care factors, we included for additional casemix adjustment: presence of congenital abnormality, small for gestational age, preterm birth, or low Apgar score. The techniques used were nested multiple stepwise logistic regression, and stratified analysis for separate risk groups. An intention-to-treat like analysis was performed. RESULTS: The intervention rate was lower in planned home compared to planned hospital births (10.9% 95% CI 10.8-11.0 vs. 13.8% 95% CI 13.6-13.9). Intended place of birth had significant impact on the likelihood to intervene after adjustment (planned homebirth (OR 0.77 95% CI. 0.75-0.78)). The mortality rate was lower in planned home births (0.15% vs. 0.18%). After adjustment, the interaction term home- intervention was significant (OR1.51 95% CI 1.25-1.84). In risk groups, a higher perinatal mortality rate was observed in planned home births. CONCLUSIONS: The potential presence of over- or under treatment as expressed by adjusted perinatal mortality differs per risk group. In planned home births especially multiparous women showed universally lower intervention rates. However, the benefit of substantially fewer interventions in the planned home group seems to be counterbalanced by substantially increased mortality if intervention occurs.

Different settings of place of midwife-led birth: evaluation of a midwife-led birth centre.

OBJECTIVES: The claimed advantages of home deliveries, including fewer medical interventions, are potentially counter balanced by the small additional risk on perinatal adverse outcome compared to hospital deliveries in low risk women. Homelike birth centres have been proposed a new setting for low risk women combining the advantages of home and hospital, resulting in lower intervention rates with equal safety. This paper addresses whether the introduction of a midwife-led birth centre adjacent to the hospital combines the advantages of home and hospital deliveries. Additionally, we investigate whether the introduction of a midwife-led birth centre leads to a different risk selection of women planning their delivery either at home, at the hospital or at the birth centre. METHODS: Anonymized data, between January 2007 and June 2012, was collected from the four participating midwife practices. Women (n = 5558) were categorized according to intended place of birth. Women's characteristics and pregnancy outcomes were compared between the period before and after its introduction using Chi square and Fisher's Exact tests. Direct and indirect standardized rates were calculated for different outcomes [(1) intrapartum and neonatal mortality (<24 h), (2) composite outcome of neonatal morbidities, (3) composite outcome of maternal morbidities, and (4) medical intervention], taking the period before introduction as reference. RESULTS: After the introduction of the birth centre a different risk selection was observed. Women's characteristics were most unfavourable for intended birth centre births. Additionally, an higher neonatal risk load was seen within these women. After its introduction neonatal morbidities decreased (5.0 vs. 3.8 %) and maternal morbidities decreased (8.3 vs. 7.3 %). Interventions were about equal. Direct and indirect standardization provided similar results. CONCLUSION: Neonatal morbidity and maternal morbidity tended to decrease, while overall intervention rates were unaffected. The introduction of the midwife-led birth centre seems to benefit the outcome of midwife-led deliveries. We interpret this change by the redistribution of the higher risk women among the low risk population intending birth at the birth centre instead of home.

Validity of a questionnaire measuring the world health organization concept of health system responsiveness with respect to perinatal services in the Dutch obstetric care system.

BACKGROUND: The concept of responsiveness, introduced by the World Health Organization (WHO), addresses non-clinical aspects of health service quality that are relevant regardless of provider, country, health system or health condition. Responsiveness refers to "aspects related to the way individuals are treated and the environment in which they are treated" during health system interactions. This paper assesses the psychometric properties of a newly developed responsiveness questionnaire dedicated to evaluating maternal experiences of perinatal care services, called the Responsiveness in Perinatal and Obstetric Health Care Questionnaire (ReproQ), using the eight-domain WHO concept. METHODS: The ReproQ was developed between October 2009 and February 2010 by adapting the WHO Responsiveness Questionnaire items to the perinatal care context. The psychometric properties of feasibility, construct validity, and discriminative validity were empirically assessed in a sample of Dutch women two weeks post partum. RESULTS: A total of 171 women consented to participation. Feasibility: the interviews lasted between 20 and 40 minutes and the overall missing rate was 8%. Construct validity: mean Cronbach's alphas for the antenatal, birth and postpartum phase were: 0.73 (range 0.57-0.82), 0.84 (range 0.66-0.92), and 0.87 (range 0.62-0.95) respectively. The item-own scale correlations within all phases were considerably higher than most of the item-other scale correlations. Within the antenatal care, birth care and post partum phases, the eight factors explained 69%, 69%, and 76% of variance respectively. Discriminative validity: overall responsiveness mean sum scores were higher for women whose children were not admitted. This confirmed the hypothesis that dissatisfaction with health outcomes is transferred to their judgement on responsiveness of the perinatal services. CONCLUSIONS: The ReproQ interview-based questionnaire demonstrated satisfactory psychometric properties to describe the quality of perinatal care in the Netherlands, with the potential to discriminate between different levels of quality of care. In view of the relatively small sample, further testing and research is recommended.

Planned home compared with planned hospital births in the Netherlands: intrapartum and early neonatal death in low-risk pregnancies.

OBJECTIVE: The purpose of our study was to compare the intrapartum and early neonatal mortality rate of planned home birth with planned hospital birth in community midwife-led deliveries after case mix adjustment. METHODS: The perinatal outcome of 679,952 low-risk women was obtained from the Netherlands Perinatal Registry (2000-2007). This group represents all women who had a choice between home and hospital birth. Two different analyses were performed: natural prospective approach (intention-to-treat-like analysis) and perfect guideline approach (per-protocol-like analysis). Unadjusted and adjusted odds ratios (ORs) were calculated. Case mix was based on the presence of at least one of the following: congenital abnormalities, small for gestational age, preterm birth, or low Apgar score. We also investigated the potential risk role of intended place of birth. Multivariate stepwise logistic regression was used to investigate the potential risk role of intended place of birth. RESULTS: Intrapartum and neonatal death at 0-7 days was observed in 0.15% of planned home compared with 0.18% in planned hospital births (crude relative risk 0.80, 95% confidence interval [CI] 0.71-0.91). After case mix adjustment, the relation is reversed, showing nonsignificant increased mortality risk of home birth (OR 1.05, 95% CI 0.91-1.21). In certain subgroups, additional mortality may arise at home if risk conditions emerge at birth (up to 20% increase). CONCLUSION: Home birth, under routine conditions, is generally not associated with increased intrapartum and early neonatal death, yet in subgroups, additional risk cannot be excluded.