Using case vignettes to study the presence of outcome, hindsight, and implicit bias in acute unplanned medical care: a cross-sectional study.

BACKGROUND AND IMPORTANCE: Various biases can impact decision-making and judgment of case quality in the Emergency Department (ED). Outcome and hindsight bias can lead to wrong retrospective judgment of care quality, and implicit bias can result in unjust treatment differences in the ED based on irrelevant patient characteristics. OBJECTIVES: First, to evaluate the extent to which knowledge of an outcome influences physicians' quality of care assessment. Secondly, to examine whether patients with functional disorders receive different treatment compared to patients with a somatic past medical history. DESIGN: A web-based cross-sectional study in which physicians received case vignettes with a case description and care provided. Physicians were informed about vignette outcomes in a randomized way (no, good, or bad outcome). Physicians rated quality of care for four casevignettes with different outcomes. Subsequently, they received two more case vignettes. Physicians were informed about the past medical history of the patient in a randomized way (somatic or functional). Physicians made treatment and diagnostic decisions for both cases. SETTING AND PARTICIPANTS: One hundred ninety-one Dutch emergency physicians (EPs) and general practitioners (GPs) participated. OUTCOME MEASURES AND ANALYSIS: Quality of care was rated on a Likert scale (0-5) and dichotomized as adequate (yes/no). Physicians estimated the likelihood of patients experiencing a bad outcome for hindsight bias. For the second objective, physicians decided on prescribing analgesics and additional diagnostic tests. MAIN RESULTS: Large differences existed in rated quality of care for three out of four vignettes based on different case outcomes. For example, physicians rated the quality of care as adequate in 44% (95% CI 33-57%) for an abdominal pain case with a bad outcome, compared to 88% (95% CI 78-94%) for a good outcome, and 84% (95% CI 73-91%) for no outcome (P < 0.01). The estimated likelihood of a bad outcome was higher if physicians received a vignette with a bad patient outcome. Fewer diagnostic tests were performed and fewer opioids were prescribed for patients with a functional disorder. CONCLUSION: Outcome, hindsight, and implicit bias significantly influence decision-making and care quality assessment by Dutch EPs and GPs.

Improved implementation of aspirin in pregnancy among Dutch gynecologists: Surveys in 2016 and 2021.

OBJECTIVE: To evaluate the implementation of low-dose aspirin in pregnancy for the prevention of utero-placental complications among gynecologists in the Netherlands between 2016 and 2021. In this timeframe, a national guideline about aspirin in pregnancy was introduced by the Dutch Society of Obstetrics and Gynecology. MATERIALS AND METHODS: A national online survey among Dutch gynecologists and residents was performed. An online questionnaire was distributed among the members of the Dutch Society of Obstetrics and Gynecology in April 2016 and April 2021. Main outcome measure was the proportion of gynecologists indicating prescription of aspirin in pregnancy for high and moderate risk indications. RESULTS: In 2016, 133 respondents completed the survey, and in 2021 231. For all indications mentioned in the guideline there was an increase in prescribing aspirin in 2021 in comparison to 2016. More specifically, the percentage of gynecologists prescribing aspirin for a history of preeclampsia before 34 weeks, between 34 and 37 weeks and at term increased from respectively 94% to 100%, 39% to 98%, and 15% to 97%. Consultant obstetricians and respondents working in an university hospital did not more often indicate the prescription of aspirin for tertiary care indications in 2021. Future use of a prediction model was suggested in the narrative comments. CONCLUSION: Implementation of aspirin in pregnancy among Dutch gynecologists substantially improved after a five year timeframe in which the national guideline on aspirin during pregnancy was introduced and trials confirming the effect of aspirin were published.

Evaluation of low-dose aspirin in the prevention of recurrent spontaneous preterm labour (the APRIL study): A multicentre, randomised, double-blinded, placebo-controlled trial.

BACKGROUND: Preterm birth is the leading cause of neonatal morbidity and mortality. The recurrence rate of spontaneous preterm birth is high, and additional preventive measures are required. Our objective was to assess the effectiveness of low-dose aspirin compared to placebo in the prevention of preterm birth in women with a previous spontaneous preterm birth. METHODS AND FINDINGS: We performed a parallel multicentre, randomised, double-blinded, placebo-controlled trial (the APRIL study). The study was performed in 8 tertiary and 26 secondary care hospitals in the Netherlands. We included women with a singleton pregnancy and a history of spontaneous preterm birth of a singleton between 22 and 37 weeks. Participants were randomly assigned to aspirin 80 mg daily or placebo initiated between 8 and 16 weeks of gestation and continued until 36 weeks or delivery. Randomisation was computer generated, with allocation concealment by using sequentially numbered medication containers. Participants, their healthcare providers, and researchers were blinded for treatment allocation. The primary outcome was preterm birth <37 weeks of gestation. Secondary outcomes included a composite of poor neonatal outcome (bronchopulmonary dysplasia, periventricular leukomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotising enterocolitis > stage 1, retinopathy of prematurity, culture proven sepsis, or perinatal death). Analyses were performed by intention to treat. From May 31, 2016 to June 13, 2019, 406 women were randomised to aspirin (n = 204) or placebo (n = 202). A total of 387 women (81.1% of white ethnic origin, mean age 32.5 ± SD 3.8) were included in the final analysis: 194 women were allocated to aspirin and 193 to placebo. Preterm birth <37 weeks occurred in 41 (21.2%) women in the aspirin group and 49 (25.4%) in the placebo group (relative risk (RR) 0.83, 95% confidence interval (CI) 0.58 to 1.20, p = 0.32). In women with ≥80% medication adherence, preterm birth occurred in 24 (19.2%) versus 30 (24.8%) women (RR 0.77, 95% CI 0.48 to 1.25, p = 0.29). The rate of the composite of poor neonatal outcome was 4.6% (n = 9) versus 2.6% (n = 5) (RR 1.79, 95% CI 0.61 to 5.25, p = 0.29). Among all randomised women, serious adverse events occurred in 11 out of 204 (5.4%) women allocated to aspirin and 11 out of 202 (5.4%) women allocated to placebo. None of these serious adverse events was considered to be associated with treatment allocation. The main study limitation is the underpowered sample size due to the lower than expected preterm birth rates. CONCLUSIONS: In this study, we observed that low-dose aspirin did not significantly reduce the preterm birth rate in women with a previous spontaneous preterm birth. However, a modest reduction of preterm birth with aspirin cannot be ruled out. Further research is required to determine a possible beneficial effect of low-dose aspirin for women with a previous spontaneous preterm birth. TRIAL REGISTRATION: Dutch Trial Register (NL5553, NTR5675) https://www.trialregister.nl/trial/5553.

Influence of timing of maternal antibiotic administration during caesarean section on infant microbial colonisation: a randomised controlled trial.

OBJECTIVE: Revised guidelines for caesarean section (CS) advise maternal antibiotic administration prior to skin incision instead of after umbilical cord clamping, unintentionally exposing the infant to antibiotics antenatally. We aimed to investigate if timing of intrapartum antibiotics contributes to the impairment of microbiota colonisation in CS born infants. DESIGN: In this randomised controlled trial, women delivering via CS received antibiotics prior to skin incision (n=20) or after umbilical cord clamping (n=20). A third control group of vaginally delivering women (n=23) was included. Faecal microbiota was determined from all infants at 1, 7 and 28 days after birth and at 3 years by 16S rRNA gene sequencing and whole-metagenome shotgun sequencing. RESULTS: Compared with vaginally born infants, profound differences were found in microbial diversity and composition in both CS groups in the first month of life. A decreased abundance in species belonging to the genera Bacteroides and Bifidobacterium was found with a concurrent increase in members belonging to the phylum Proteobacteria. These differences could not be observed at 3 years of age. No statistically significant differences were observed in taxonomic and functional composition of the microbiome between both CS groups at any of the time points. CONCLUSION: We confirmed that microbiome colonisation is strongly affected by CS delivery. Our findings suggest that maternal antibiotic administration prior to CS does not result in a second hit on the compromised microbiome. Future, larger studies should confirm that antenatal antibiotic exposure in CS born infants does not aggravate colonisation impairment and impact long-term health.

Maternal vascular malperfusion in spontaneous preterm birth placentas related to clinical outcome of subsequent pregnancy.

INTRODUCTION: Spontaneous preterm birth (SPTB) has several causes and its pathophysiology remains unclear. In a significant proportion of SPTB, placental histology shows signs of maternal vascular malperfusion (MVM); commonly associated with hypertensive disorders of pregnancy (HD), fetal growth restriction (FGR) and placental abruption, together referred to as clinical ischemic placental diseases (IPD). We hypothesized that women with SPTB and placental MVM are at elevated risk for IPD in a subsequent pregnancy. METHODS: We included women with SPTB in our cohort and followed the subsequent ongoing pregnancy (n = 110). Histological placental characteristics in the index were reported according to new international guidelines, and related to the clinical outcome of the subsequent pregnancy. RESULTS: In the SPTB placentas, we observed MVM in 61.8% (n = 68). In the subsequent pregnancies in 19.1% (n = 21) at least one clinical sign of IPD was present (HD (12.7%), FGR (5.5%) or placental abruption (0.9%)). There was no significant difference in the prevalence of clinical IPD or recurrence of SPTB in the subsequent pregnancy between women with and without placental MVM in the index pregnancy, although our study was not powered to detect small differences. DISCUSSION: Women with a history of SPTB have an elevated risk of IPD in the subsequent pregnancy. MVM is present in a large proportion of SPTB placentas. The presence of placental MVM in the index pregnancy does not predict clinical IPD or recurrent SPTB in a subsequent pregnancy.

Increased incidence of hypertensive disorders of pregnancy in women with a history of spontaneous preterm birth: A longitudinal linked national cohort study.

OBJECTIVE: Determine the risk of hypertensive disorders of pregnancy (HD) in women with a history of spontaneous preterm birth (SPTB). STUDY DESIGN: Longitudinal linked national cohort study within the Dutch Perinatal Registry (1999-2009) on linked data among 349,291 women with a first and second singleton pregnancy in the Netherlands. MAIN OUTCOME MEASURES: The incidence of HD, small for gestational age (SGA) and placental abruption in the second pregnancy. RESULTS: Out of 349,291 women with a singleton first pregnancy, 19,991 (5.7%) had a SPTB. The incidence of HD in the second pregnancy was 8.1% in women with a previous SPTB, as compared to 5.6% in women with a previous term birth (aOR 1.49 (CI 1.41-1.57)). Also after excluding HD, SGA and/or placental abruption in the first pregnancy, women with a history of SPTB had a higher risk of HD in their second pregnancy compared to women with a previous term birth (4.6% versus 2.7%, aOR 1.77 (CI 1.64-191)). Similarly, the incidence of SGA and placental abruption was higher in the second pregnancy in women with a history of SPTB compared to term birth in the first pregnancy. CONCLUSIONS: Women with a history of SPTB are at elevated risk of HD in the subsequent pregnancy. These results support shared pathophysiology between SPTB and HD.

Analysis of Publication Interest on Preterm Birth Over Two Decades.

INTRODUCTION: Preterm birth (PTB) is one of the greatest challenges in obstetric and children's healthcare. PTB remains the most important cause of perinatal morbidity and mortality worldwide. We studied the number of publications concerning PTB over the last two decades using advanced bibliometric visualization methodology. We put the number of publications in perspective of growing awareness of PTB as a major health problem. METHODS: We analyzed publications over time and performed bibliometric analysis of publications on PTB in the Web of Science from 1997 to 2016. The subjects of publications were visualized using a term map showing the relevant terms occurring in titles and abstracts. RESULTS: We identified 47,811 publications. The annual number of publications on PTB increased significantly by 443% in 2016 (n = 5027) compared to 1997 (n = 1135). Obstetrics & Gynecology is the leading research field (with 10.4% on the subject PTB in 2016) followed closely by Pediatrics (7.6% on the subject PTB in 2016), within the field Public, Environmental & Occupational Health minimal increase was observed (only 1% was published on the subject PTB in 2016). The publications on PTB have increased at higher rates than the overall increase of publications. In recent years we found more publications on PTB describing epidemiology and clinical characteristics/outcomes whereas in earlier years publications focused more on translational, basic research. CONCLUSION: A significant increase in research concerning PTB was observed over the last two decades. This increase of publications is in line with the growing global awareness of the need to reduce PTB by clinical research.

The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial.

BACKGROUND: A disturbance in the early colonisation of the gut by microorganisms is associated with an aberrant innate immune system and a variety of clinical conditions later in life. Several factors are considered to influence this initial colonisation, including maternally administered antibiotics during pregnancy and delivery. Recent revisions to international obstetric guidelines have resulted in the exposure of all infants born by caesarean section (CS) to broad-spectrum antibiotics perinatally. To date, the consequences of these new guidelines on neonatal gut colonisation and the associated short- and long-term health implications have not yet been addressed. The aim of this study is to investigate the influence of the timing of antibiotic administration during CS to the mother on the course of neonatal intestinal colonisation up to 2 years of age. METHODS/DESIGN: This single-centre randomised controlled trial will recruit 40 women scheduled for an elective CS. The subjects will be randomised to receive 1500 mg of cefuroxime intravenously either prior to the skin incision (n = 20) or after clamping of the umbilical cord (n = 20). Levels of cefuroxime in cord blood will be determined for exposed neonates. Faecal samples from the children will be collected on days 1, 7 and 28 days and at 2 years old and analysed by 16S sequencing. Shannon-diversity indices, absolute and relative abundances, and unsupervised and supervised classification methods will be used to evaluate the effect of the timing of intrapartum cefuroxime administration on the composition of the microbiota. The outcomes for both study groups will be compared to the intestinal microbiota of vaginally born infants (n = 20). To detect possible effects on health state, a questionnaire on health-related issues will be taken at the age of 2 years. DISCUSSION: In the proposed study, changes in the intestinal microbiota of 40 children born by CS will be followed until the age of 2 years. Research on this topic is necessary since significant effects relating to the timing of antibiotic administration on microbial colonisation may conflict with the current guidelines, as this may have health consequences later in life. TRIAL REGISTRATION: Netherlands Clinical Trial Registry, NTR6000 . Retrospectively registered on 25 July 2016.

Low dose aspirin in the prevention of recurrent spontaneous preterm labour - the APRIL study: a multicenter randomized placebo controlled trial.

BACKGROUND: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial. METHODS/DESIGN: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) < 37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo. DISCUSSION: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth. TRIAL REGISTRATION: Clinical trial registration number of the Dutch Trial Register: NTR 5675 . EudraCT-registration number: 2015-003220-31.

Do online communities change power processes in healthcare? Using case studies to examine the use of online health communities by patients with Parkinson's disease.

OBJECTIVE: Communication technologies, such as personal online health communities, are increasingly considered as a tool to realise patient empowerment. However, little is known about the actual use of online health communities. Here, we investigated if and how patients' use of online communities supports patient empowerment. SETTING: A network of primary and secondary care providers around individual patients with Parkinson's disease. PARTICIPANTS: We conducted case studies to examine our research question. We interviewed 18 patients with Parkinson's disease and observed the use of online health communities of 14 of them for an average of 1 year. PRIMARY OUTCOME MEASURES: We analysed the interviews and the online conversations between patients and healthcare providers, using Foucault's framework for studying power processes. RESULTS: We observed that patient empowerment is inhibited by implicit norms that exist within these communities around the number and content of postings. First, patients refrained from asking too many questions of their healthcare providers, but felt obliged to offer them regular updates. Second, patients scrutinised the content of their postings, being afraid to come across as complainers. Third, patients were cautious in making knowledge claims about their disease. CONCLUSIONS: Changing implicit norms within online communities and the societal context they exist in seems necessary to achieve greater patient empowerment. Possibilities for changing these norms might lie in open dialogue between patient and healthcare providers about expectations, revising the curriculum of medical education and redesigning personal online health communities to support two-way knowledge exchange.

The value of autopsy and other histological examinations for the safety of tissue transplantation.

Directive 2006/17/EC requires that all available medical information, including autopsy reports, is evaluated before releasing tissues for transplantation. The aim of this study was to investigate whether evaluation of results of autopsy and other histological examinations contributes to the safety of tissue transplantation. From the files of all deceased Dutch donors, from whom tissues were retrieved in a 6-month period, results of autopsy and other histological examinations (remnant heart after valve donation and biopsies obtained during retrieval) were evaluated for contraindications for transplantation. Of 758 donors at least one tissue was considered suitable for transplantation at initial assessment. 637 Donors donated corneas, 256 skin, 177 heart valves and 61 musculoskeletal tissues. On 220 donors (29.0%) autopsy was done. Of seven donors no autopsy results were requested, since a contraindication was detected earlier in the medical screening. In 19 donors with autopsy (8.9%) general or tissue-specific contraindications were detected. There were no differences in distribution of detected contraindications among donors who donated different tissues. For 136 donors (17.9%) results of histological examinations other than autopsy were available; results of examination of remnant hearts for all, brain autopsy for two (0.3%) and retrieval biopsy for four donors (0.5%). Contraindications were detected in nine of these donors with histology results other than autopsy (6.6%). For 402 donors (53%) no histological examinations were done. Evaluation of results of autopsy and other histological examinations improves the safety of tissue transplantation for all types of tissues. In donors without autopsy alternative histological examinations can contribute to enhance the safety of tissue transplantation.

Evaluation of the autopsy report before releasing musculoskeletal tissue donors; what is the benefit? EATB International Conference, October 17-20, Budapest, Hungary.

EU directive 2006/17/EC requires that all available medical information, including the autopsy report, is evaluated before releasing tissues for transplantation. The study objective was to investigate whether evaluation of autopsy results of musculoskeletal tissue donors contributes to safety and availability of transplantable tissues. The files of all donors of whom musculoskeletal tissues were retrieved by BIS in 2006 were reviewed for death cause and autopsy results. Of 84 donors musculoskeletal tissues were retrieved. In 47 donors autopsy was performed (56.0%). The groups with and without autopsy were similar in sex, age, length, and weight. In one donor no autopsy results were evaluated, since the donor was already rejected because of positive blood tests. In 13 donors (28.1%) death causes before autopsy were unknown. In 12 of these donors a death cause could be established after autopsy. In nine of the donors with a clear suspected death cause (27.3%), the death cause after autopsy differed from the suspected death cause. Four donors with autopsy (8.7%) had a general contraindication for donation, a (possible) sepsis in three and a persisting unknown death cause in one. Eight donors (17.4%) had musculoskeletal-specific contraindications, i.e. local infections. In conclusion, in 26.1% of the donors with autopsy, general or musculoskeletal-specific contraindications for donation were found. Furthermore, performance of autopsies enlarges the potential donor pool, since death causes can be established in almost all autopsies done in case of an unknown death cause. Therefore, evaluation of autopsy results improves the safety and quantity of tissues for transplantation.

Toronto hospital reduces sharps injuries by 80%, eliminates blood collection injuries. A case study: Toronto East General Hospital pioneers healthcare worker safety.

Needlestick and other sharps injuries are a key Canadian public health issue, affecting 70,000 people per year and costing some dollar 140 million. A safety program at Toronto East General Hospital--focusing on blood collection and patient injection--achieved an 80% reduction in injuries within one year (from 41 in 2003 to eight in 2004), with blood collection injuries eliminated entirely.