Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study).

BACKGROUND: Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3-4) gastric cancer, fluorodeoxyglucose positron emission tomography with CT (FDG-PET/CT or PET) and staging laparoscopy (SL) may have a role in staging, but evidence is scarce. The aim of this study is to evaluate the impact and cost-effectiveness of PET and SL in addition to initial staging in patients with locally advanced gastric cancer. METHODS: This prospective observational cohort study will include all patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4b, N0-3, M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT. The modalities to be investigated in this study is the addition of PET and SL. The primary outcome of this study is the proportion of patients in whom the PET or SL lead to a change in treatment strategy. Secondary outcome parameters are: diagnostic performance, morbidity and mortality, quality of life, and cost-effectiveness of these additional diagnostic modalities. The study recently started in August 2017 with a duration of 36 months. At least 239 patients need to be included in this study to demonstrate that the diagnostic modalities are break-even. Based on the annual number of gastrectomies in the participating centers, it is estimated that approximately 543 patients are included in this study. DISCUSSION: In this study, it is hypothesized that performing PET and SL for locally advanced gastric adenocarcinomas results in a change of treatment strategy in 27% of patients and an annual cost-reduction in the Netherlands of €916.438 in this patient group by reducing futile treatment. The results of this study may be applicable to all countries with comparable treatment algorithms and health care systems. TRIAL REGISTRATION: NCT03208621 . This trial was registered prospectively on June 30, 2017.

Mapping nurses' activities in surgical hospital wards: A time study.

BACKGROUND: Balancing the number of nursing staff in relation to the number of patients is important for hospitals to remain efficient and optimizing the use of resources. One way to do this is to work with a workload management method. Many workload management methods use a time study to determine how nurses spend their time and to relate this to patient characteristics in order to predict nurse workload. OBJECTIVE: In our study, we aim to determine how nurses spend their working day and we will attempt to explain differences between specialized surgical wards. SETTING: The research took place in an academic hospital in the Netherlands. Six surgical wards were included, capacity 15 to 30 beds. METHOD: We have used a work sampling methodology where trained observers registered activities of nurses and patient details every ten minutes during the day shift for a time period of three weeks. RESULTS: The work sampling showed that nurses spend between 40.1% and 55.8% of their time on direct patient care. In addition to this, nurses spend between 11.0% and 14.1% on collective patient care. In total, between 52.1% and 68% of time spent on tasks is directly patient related. We found significant differences between wards for 10 of the 21 activity groups. We also found that nurses spend on average 31% with the patient (bedside), which is lower than in another study (37%). However, we noticed a difference between departments. For regular surgical departments in our study this was on average 34% and for two departments that have additional responsibilities in training and education of nursing students, this was on average 25%. CONCLUSIONS: We found a relatively low percentage of time spent on direct plus indirect care, and a lower percentage of time spent with the patient. We suspect that this is due to the academic setting of the study; in our hospital, there are more tasks related to education than in hospitals in other study settings. We also found differences between the wards in our study, which are mostly explained by differences in the patient mix, nurse staffing (proportion of nursing students), type of surgery and region of the body where the surgery was performed. However, we could not explain all differences. We made a first attempt in identifying and explaining differences in nurses' activities between wards, however this domain needs more research in order to better explain the differences.

Parental perspectives on the awareness and delivery of preconception care.

BACKGROUND: The attention for Preconception Care (PCC) has grown substantially in recent years, yet the implementation of PCC appears challenging as uptake rates remain low. The objective of this study was to assess parental perspectives on how PCC should be provided. METHODS: Recruitment of participants took place among couples who received antenatal care at a Dutch community midwifery practice. Between June and September 2014, five focus group sessions were held with 29 women and one focus group session with 5 men. Thematic analysis was conducted using NVivo 10 software. RESULTS: Participants were generally unfamiliar with the concept of PCC. It was proposed to raise awareness by means of a promotional campaign, stipulating that PCC is suited for every couple with a (future) child wish. Suggestions were made to display marketing materials in both formal and informal (local community) settings. Addressing existing social networks and raising social dialogue was expected to be most efficient. It was recommended to make PCC more accessible by offering multiple forms and to involve male partners. Opportunistic offering PCC by healthcare providers was considered more acceptable when the subject was deliberately raised, for example while discussing contraceptives, lifestyle risks or drug prescriptions. GP's or midwifes were regarded the most suitable PCC providers, however provider characteristics such as experience, empathy and communication skills were considered more important. CONCLUSIONS: This study showed that from the parental perspective it is recommended to address every couple with a (future) child wish by means of enlarging the awareness and accessibility of PCC. In order to enlarge the awareness, it is recommended to address social networks, to raise the social dialogue and to conduct promotional campaigns regarding PCC. In order to improve the accessibility of PCC, it was suggested to simultaneously offer multiple forms: group sessions, individual consultations, walk-in-hours and online sessions, and to involve male partners.

Healthcare providers' views on the delivery of preconception care in a local community setting in the Netherlands.

BACKGROUND: The attention for preconception care (PCC) has grown substantially in recent years, yet PCC is far from routine in daily practice. One of the major challenges for the implementation of PCC is to identify how it can best be organized and provided within the primary care setting. The aim of this study was to identify bottlenecks and solutions for the delivery of PCC from a healthcare providers' perspective in a local community setting in the Netherlands. METHODS: Health professionals within the region of Zeist, the Netherlands, were invited for a meeting on the local implementation of PCC. Five parallel group sessions were held with 30 participants from different disciplines. The sessions were moderated based on the Nominal Group Technique, in which bottlenecks (step 1) and solutions (step 2) for the delivery of PCC were gathered, categorized and prioritized by the participants. RESULTS: Participants expressed that the provision of PCC is challenging due to lack of awareness, the absence of a costing structure and unclear allocation of responsibilities. The most pragmatic approach considered was to make interdisciplinary arrangements within the local primary care setting. Participants recommended to 1) settle a costing structure by means of third party reimbursement, 2) improve collaboration by means of a local cooperation network and an adequate referral system, 3) invest in education, tools and logistics and 4) increase uptake rates by the routine opportunistic offer of PCC and promotional campaigns. CONCLUSIONS: From a provider's perspective a tailored approach is advocated in which interdisciplinary arrangements for collaboration and referral are set up within the local primary care setting.

Balancing nurses' workload in hospital wards: study protocol of developing a method to manage workload.

INTRODUCTION: Hospitals pursue different goals at the same time: excellent service to their patients, good quality care, operational excellence, retaining employees. This requires a good balance between patient needs and nursing staff. One way to ensure a proper fit between patient needs and nursing staff is to work with a workload management method. In our view, a nursing workload management method needs to have the following characteristics: easy to interpret; limited additional registration; applicable to different types of hospital wards; supported by nurses; covers all activities of nurses and suitable for prospective planning of nursing staff. At present, no such method is available. METHODS/ANALYSIS: The research follows several steps to come to a workload management method for staff nurses. First, a list of patient characteristics relevant to care time will be composed by performing a Delphi study among staff nurses. Next, a time study of nurses' activities will be carried out. The 2 can be combined to estimate care time per patient group and estimate the time nurses spend on non-patient-related activities. These 2 estimates can be combined and compared with available nursing resources: this gives an estimate of nurses' workload. The research will take place in an academic hospital in the Netherlands. 6 surgical wards will be included, capacity 15-30 beds. ETHICAL CONSIDERATIONS: The study protocol was submitted to the Medical Ethical Review Board of the University Medical Center (UMC) Utrecht and received a positive advice, protocol number 14-165/C. DISCUSSION: This method will be developed in close cooperation with staff nurses and ward management. The strong involvement of the end users will contribute to a broader support of the results. The method we will develop may also be useful for planning purposes; this is a strong advantage compared with existing methods, which tend to focus on retrospective analysis.

Internet-based self-management compared with usual care in adolescents with asthma: a randomized controlled trial.

INTRODUCTION: Asthma control often is poor in adolescents and this causes considerable morbidity. Internet-based self-management (IBSM) improves asthma-related quality of life in adults. We hypothesized that IBSM improves asthma-related quality of life in adolescents. METHODS: Adolescents (12-18 years) with persistent and not well-controlled asthma participated in a randomized controlled trial with 1 year follow-up and were allocated to IBSM (n = 46) or usual care (UC, n = 44). IBSM consisted of weekly asthma control monitoring with treatment advice by a web-based algorithm. Outcomes included asthma-related quality of life (Pediatric Asthma Quality of Life Questionnaire, PAQLQ) and asthma control (Asthma Control Questionnaire, ACQ) and were analyzed by a linear mixed-effects model. RESULTS: At 3 months, PAQLQ improved with 0.40 points (95% CI: 0.17-0.62, P < 0.01), by IBSM compared to 0.0 points for UC (P = 0.02 for the difference). At 12 months the between-group difference was -0.05 (95% CI: -0.50 to 0.41, P = 0.85). At 3 months ACQ improved more in IBSM than in UC (difference: -0.32 points; 95% CI: -0.56 to -0.079, P < 0.01). At 12 months the difference was -0.05 (95% CI: -0.35 to 0.25, P = 0.75). CONCLUSION: IBSM improved asthma-related quality of life and asthma control in adolescents with not well-controlled asthma after 3 months, but not after 12 months.

Assessment of parenting and developmental problems in toddlers: development and feasibility of a structured interview.

BACKGROUND: Assessment of (early signs of) parenting and developmental problems in young children by preventive child health care (CHC) workers is recommended, but no validated instruments exist. The aim of this project was to develop and test an instrument for early detection and assessment of problems in toddlers, using the perspectives and experience of both the parent and the professional. METHODS: Using an iterative process, we adapted and expanded a structured interview on need for parenting support into the Structured Problem Analysis of Raising Kids (SPARK). The SPARK consists of 16 subject areas, ranging from somatic health to family issues. The SPARK was tested in daily practice for feasibility and discriminative capacity. The sample consisted of all toddlers aged 18 months living in Zeeland, a province of the Netherlands, during the study period (n= 1140). RESULTS: The response rate was 97.8%. Although the median level of support needed according to the SPARK was low, 4.5% of the toddlers and their parents required intensive help or immediate action. The risk assessment showed 2.9% high, 16.5% increased and 80.6% low risk for parenting and developmental problems. The risk assessment of the CHC professional was associated with known risk factors for child maltreatment. CONCLUSIONS: This study shows that a structured interview, named the SPARK, is feasible in daily practice and clarifies risks and care needs for parenting and developmental problems in toddlers.

Predicting admission and mortality with the Emergency Severity Index and the Manchester Triage System: a retrospective observational study.

OBJECTIVE: To compare the degree to which the Emergency Severity Index (ESI) and the Manchester Triage System (MTS) predict admission and mortality. METHODS: A retrospective observational study of four emergency department (ED) databases was conducted. Patients who presented to the ED between 1 January and 18 July 2006 and were triaged with the ESI or MTS were included in the study. RESULTS: 37 974 patients triaged with the ESI and 34 258 patients triaged with the MTS were included. The likelihood of admission decreased significantly with urgency categories in both populations, and was greater for patients triaged with the ESI than with the MTS. Mortality rates were low in both populations. Most patients who died were triaged in the most urgent triage categories of both systems. CONCLUSION: Both the ESI and MTS predicted admission well. The ESI was a better predictor of admission than the MTS. Mortality is associated with urgency categories of both triage systems.

Patient-reported outcome in total hip replacement. A comparison of five instruments of health status.

Our aim was to define the minimum set of patient-reported outcome measures which are required to assess health status after total hip replacement (THR). In 114 patients, we compared the pre-operative characteristics and sensitivity to change of the Oxford hip score (OHS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), the SF-36, the SF-12 (derived from the SF-36), and the Euroqol questionnaire (EQ-5D). At one year after operation, very large effect sizes were found for the disease-specific measures, the physical domains of the SF-12, SF-36 and the EQ-5Dindex (1.3 to 3.0). Patients in Charnley class A showed more change in the OHS, WOMAC pain and function, the physical domains of the SF-36 and the EQ-5Dvas (p < 0.05) compared with those in the Charnley B and C group. In this group, the effect size for the OHS more than doubled the effect sizes of WOMAC pain and physical function. We found high correlations and correlations of change between the OHS, the WOMAC, the physical domains of the SF-12 and the SF-36 and EQ-5Dindex. The SF-36 and EQ-5D scores at one year after operation approached those of the general population. Furthermore, we found a binomial distribution of the pre-operative EQ-5Dindex score and a pre-operative discrepancy and post-operative agreement between the EQ-5Dvas and EQ-5Dindex. We recommend the use of the OHS and SF-12 in the assessment of THR. The SF-36 may be used in circumstances when smaller changes in health status are investigated, for example in the follow-up of THR. The EQ-5D is useful in situations in which utility values are needed in order to calculate cost-effectiveness or quality-adjusted life years (QALYs), such as in the assessment of new techniques in THR.

Multivariable assessment of the 6-min walking test in patients with chronic obstructive pulmonary disease.

Functional exercise tolerance in patients with chronic obstructive pulmonary disease (COPD) is often assessed by the 6-min walking test (6MWT). To assess if the use of multiple factors adds to walking distance in describing performance in the 6MWT, an exploratory factor analysis was performed on physiological measurements and dyspnea ratings recorded during testing. Eighty-three patients with mild to severe COPD performed repeated 6MWTs before inpatient pulmonary rehabilitation. Factor analysis on 15 variables yielded a stable four-factor structure explaining 78.4% of the total variance. Recorded heart rate variables contributed to factor 1 (heart rate pattern), walking distance, heart rate increase, and decrease contributed to factor 2 (endurance capacity), oxygen desaturation variables contributed to factor 3 (impairment of oxygen transport), and dyspnea and effort variables contributed to factor 4 (perceived symptoms). Walking distance decreased in half of the 53 patients measured posttreatment, but self-perceived change in exercise tolerance improved in 84% and was explained by change in walking distance, by less desaturation, and by less dyspnea (R(2) = 0.55, p = 0.005). Qualitative analysis showed that 29 of 53 patients improved in three or four factors. Performance in the 6MWT can be described with four statistically independent and clinically interpretable factors. Because clinically relevant changes consist of more than only walking distance, assessment of functional exercise tolerance in patients with COPD improves by reporting multiple variables.