Effect of Body Mass Index on pregnancy outcomes in nulliparous women delivering singleton babies

Peer reviewedPublisher PD

Causal inference for long-term survival in randomised trials with treatment switching: Should re-censoring be applied when estimating counterfactual survival times?

Treatment switching often has a crucial impact on estimates of effectiveness and cost-effectiveness of new oncology treatments. Rank preserving structural failure time models (RPSFTM) and two-stage estimation (TSE) methods estimate ‘counterfactual’ (i.e. had there been no switching) survival times and incorporate re-censoring to guard against informative censoring in the counterfactual dataset. However, re-censoring causes a loss of longer term survival information which is problematic when estimates of long-term survival effects are required, as is often the case for health technology assessment decision making. We present a simulation study designed to investigate applications of the RPSFTM and TSE with and without re-censoring, to determine whether re-censoring should always be recommended within adjustment analyses. We investigate a context where switching is from the control group onto the experimental treatment in scenarios with varying switch proportions, treatment effect sizes and time-dependencies, disease severity and switcher prognosis. Methods were assessed according to their estimation of control group restricted mean survival (that would be observed in the absence of switching) at the end of the simulated trial follow-up. We found that RPSFTM and TSE analyses which incorporated re-censoring usually produced negative bias (i.e. under-estimating control group restricted mean survival and therefore over-estimating the treatment effect). RPSFTM and TSE analyses that did not incorporate re-censoring consistently produced positive bias (i.e. under-estimating the treatment effect) which was often smaller in magnitude than the bias associated with the re-censored analyses. We believe that analyses should be conducted with and without re-censoring, as this may provide decision makers with useful information on where the true treatment effect is likely to lie. Analyses that incorporate re-censoring should not always represent the default approach when the objective is to estimate long-term survival times and treatment effects on long-term survival

Assessing methods for dealing with treatment switching in clinical trials: A follow-up simulation study

When patients randomised to the control group of a randomised controlled trial are allowed to switch onto the experimental treatment, intention-to-treat analyses of the treatment effect are confounded because the separation of randomised groups is lost. Previous research has investigated statistical methods that aim to estimate the treatment effect that would have been observed had this treatment switching not occurred and has demonstrated their performance in a limited set of scenarios. Here, we investigate these methods in a new range of realistic scenarios, allowing conclusions to be made based upon a broader evidence base. We simulated randomised controlled trials incorporating prognosis-related treatment switching and investigated the impact of sample size, reduced switching proportions, disease severity, and alternative data-generating models on the performance of adjustment methods, assessed through a comparison of bias, mean squared error, and coverage, related to the estimation of true restricted mean survival in the absence of switching in the control group. Rank preserving structural failure time models, inverse probability of censoring weights, and two-stage methods consistently produced less bias than the intentionto-treat analysis. The switching proportion was confirmed to be a key determinant of bias: sample size and censoring proportion were relatively less important. It is critical to determine the size of the treatment effect in terms of an acceleration factor (rather than a hazard ratio) to provide information on the likely bias associated with rank-preserving structural failure time model adjustments. In general, inverse probability of censoring weight methods are more volatile than other adjustment methods

Simulating quantum statistics with entangled photons: a continuous transition from bosons to fermions

In contrast to classical physics, quantum mechanics divides particles into two classes-bosons and fermions-whose exchange statistics dictate the dynamics of systems at a fundamental level. In two dimensions quasi-particles known as 'anyons' exhibit fractional exchange statistics intermediate between these two classes. The ability to simulate and observe behaviour associated to fundamentally different quantum particles is important for simulating complex quantum systems. Here we use the symmetry and quantum correlations of entangled photons subjected to multiple copies of a quantum process to directly simulate quantum interference of fermions, bosons and a continuum of fractional behaviour exhibited by anyons. We observe an average similarity of 93.6\pm0.2% between an ideal model and experimental observation. The approach generalises to an arbitrary number of particles and is independent of the statistics of the particles used, indicating application with other quantum systems and large scale application.Comment: 10 pages, 5 figure

Psychometric Properties of an Arabic Pain Anxiety Symptoms Scale-20 (PASS-20) in Healthy Volunteers and Patients Attending a Physiotherapy Clinic.

PURPOSE: The aim of this study was to cross-culturally adapt the PASS-20 questionnaire for use in Libya. METHODS: Participants were 71 patients (42 women) attending the physiotherapy clinic, Ibn Sina Hospital, Sirt, Libya for management of persistent pain and 137 healthy unpaid undergraduate students (52 women) from the University of Sirt, Libya. The English PASS-20 was translated into Arabic. Patients completed the Arabic PASS-20 and the Arabic Pain Rating Scales on two occasions separated by a 14-day interval. Healthy participants completed the Arabic PASS-20 on one occasion. RESULTS: The internal consistency (ICC) for pain patient and healthy participant samples yielded a good reliability for the total score, cognitive anxiety, fear of pain, and physiological anxiety. The test-retest reliability of the Arabic PASS-20 score showed high reliability for the total score (ICC = 0.93, p < 0.001), escape/avoidance (ICC = 0.93, p < 0.001), fear of pain (ICC = 0.94, p < 0.001), and physiological anxiety subscales (ICC = 0.96, p < 0.001) and good reliability for the cognitive anxiety (ICC = 0.85, p < 0.001). Inspection of the Promax rotation showed that each factor comprised of five items were consistent with the theoretical constructs of the original PASS-20 subscales. CONCLUSION: The Arabic PASS-20 retained internal consistency and reliability with the original English version and can be used to measure pain anxiety symptoms in both pain and healthy individual samples in Libya

Urbanization and Slum Formation

The formation of slums need not be inevitable with rapid urbanization. Such an argument appears to be contradicted by evidence of large slum populations in a large number of developing countries and particularly in rapidly urbanizing regions like Asia. The evidence discussed suggests that city authorities faced with rapid urban development lack the capacity to cope with the diverse demands for infrastructural provision to meet economic and social needs. Not only are strategic planning and intervention major issues in agenda to manage rapid urbanization, but city governments are not effectively linking the economic development trajectory to implications for urban growth and, hence, housing needs. In the following discussion, a case study is presented in support of the argument that city governments have to first recognize and then act to establish the link that is crucial between economic development, urban growth, and housing. This is the agendum that has been largely neglected by city and national governments that have been narrowly focused on economic growth with the consequent proliferation of slum formation as a housing solution

Primary gastric tuberculosis – report of 5 cases

BACKGROUND: Gastric tuberculosis is rare, and usually associated with pulmonary tuberculosis or an immunodeficient state. Here, we report five cases of gastric tuberculosis in immunocompetent patients without evidence of pulmonary involvement. CASE PRESENTATION: Three patients presented with gastric outlet obstruction that required surgery to relieve the obstruction as well as to confirm the diagnosis. The remaining two had involvement of gastroesophageal junction. All of them responded well to standard antitubercular treatment. CONCLUSION: Though gastric tuberculosis is rare, it should be considered a possibility when patients present with gastric outlet obstruction or with endoscopic evidence of diffuse chronic inflammatory activity, particularly in areas endemic for tuberculosis

Drivers of unprofessional behaviour between staff in acute care hospitals: a realist review

Abstract Background Unprofessional behaviours (UB) between healthcare staff are rife in global healthcare systems, negatively impacting staff wellbeing, patient safety and care quality. Drivers of UBs include organisational, situational, team, and leadership issues which interact in complex ways. An improved understanding of these factors and their interactions would enable future interventions to better target these drivers of UB. Methods A realist review following RAMESES guidelines was undertaken with stakeholder input. Initial theories were formulated drawing on reports known to the study team and scoping searches. A systematic search of databases including Embase, CINAHL, MEDLINE and HMIC was performed to identify literature for theory refinement. Data were extracted from these reports, synthesised, and initial theories tested, to produce refined programme theories. Results We included 81 reports (papers) from 2,977 deduplicated records of grey and academic reports, and 28 via Google, stakeholders, and team members, yielding a total of 109 reports. Five categories of contributor were formulated: (1) workplace disempowerment; (2) harmful workplace processes and cultures; (3) inhibited social cohesion; (4) reduced ability to speak up; and (5) lack of manager awareness and urgency. These resulted in direct increases to UB, reduced ability of staff to cope, and reduced ability to report, challenge or address UB. Twenty-three theories were developed to explain how these contributors work and interact, and how their outcomes differ across diverse staff groups. Staff most at risk of UB include women, new staff, staff with disabilities, and staff from minoritised groups. UB negatively impacted patient safety by impairing concentration, communication, ability to learn, confidence, and interpersonal trust. Conclusion Existing research has focused primarily on individual characteristics, but these are inconsistent, difficult to address, and can be used to deflect organisational responsibility. We present a comprehensive programme theory furthering understanding of contributors to UB, how they work and why, how they interact, whom they affect, and how patient safety is impacted. More research is needed to understand how and why minoritised staff are disproportionately affected by UB. Study registration This study was registered on the international database of prospectively registered systematic reviews in health and social care (PROSPERO): https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021255490. </jats:sec

Resection of the liver for colorectal carcinoma metastases - A multi-institutional study of long-term survivors

In this review of a collected series of patients undergoing hepatic resection for colorectal metastases, 100 patients were found to have survived greater than five years from the time of resection. Of these 100 long-term survivors, 71 remain disease-free through the last follow-up, 19 recurred prior to five years, and ten recurred after five years. Patient characteristics that may have contributed to survival were examined. Procedures performed included five trisegmentectomies, 32 lobectomies, 16 left lateral segmentectomies, and 45 wedge resections. The margin of resection was recorded in 27 patients, one of whom had a positive margin, nine of whom had a less than or equal to 1-cm margin, and 17 of whom had a greater than 1-cm margin. Eighty-one patients had a solitary metastasis to the liver, 11 patients had two metastases, one patient had three metastases, and four patients had four metastases. Thirty patients had Stage C primary carcinoma, 40 had Stage B primary carcinoma, and one had Stage A primarycarcinoma. The disease-free interval from the time of colon resection to the time of liver resection was less than one year in 65 patients, and greater than one year in 34 patients. Three patients had bilobar metastases. Four of the patients had extrahepatic disease resected simultaneously with the liver resection. Though several contraindications to hepatic resection have been proposed in the past, five-year survival has been found in patients with extrahepatic disease resected simultaneously, patients with bilobar metastases, patients with multiple metastases, and patients with positive margins. Five-year disease-free survivors are also present in each of these subsets. It is concluded that five-year survival is possible in the presence of reported contraindications to resection, and therefore that the decision to resect the liver must be individualized. © 1988 American Society of Colon and Rectal Surgeons