Investigating SSH Research and Publication Practices in Disciplinary and Institutional Contexts. A Survey-Based Comparative Approach in Two Universities

In this paper, we comparatively analyze, present and discuss the results from a survey on increasing the visibility of research achievements in the social sciences and humanities (SSH) that was carried out at the University of Vienna (Austria) and the University of Navarra (Spain) in 2016 and 2017. Covering four major topics—searching and finding literature, publishing, the visibility of research, and the assessment of research outputs—we ask the following questions: are there disciplinary differences to be identified, and how do they present themselves in the two institutional contexts? Discussing the results, we showcase how disciplinary and institutional traditions and contexts are important factors that influence research and publication practices in the SSH. Our results indicate that the practices of searching and finding literature as well as publication practices and behavior are shaped by disciplinary traditions and epistemic cultures. On the contrary, assessment and valuation of research outputs are influenced by institutional and national contexts in which SSH research is organized and carried out

CONservative TReatment of Appendicitis in Children – a randomised controlled feasibility Trial (CONTRACT)

Objective To establish the feasibility of a multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy in children with uncomplicated acute appendicitis.Design Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.Setting Three specialist paediatric surgery centres in the UK.Patients Children (aged 4–15 years) with a clinical diagnosis of uncomplicated acute appendicitis.Interventions Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).Main outcome measures Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course.Results Fifty per cent of eligible participants (95% CI 40 to 59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.Conclusion Recruitment to a randomised controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.Trial registration number ISRCTN15830435

Conservative treatment for uncomplicated appendicitis in children:the CONTRACT feasibility study, including feasibility RCT

Background Whilst non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, comparative randomised trial data reporting important outcomes compared to appendicectomy are lacking.ObjectivesTo ascertain the feasibility of conducting a multi-centre randomised controlled trial (RCT) testing the effectiveness and cost-effectiveness of a non-operative treatment pathway compared to appendicectomy for the treatment of uncomplicated acute appendicitis in children.•DesignMixed methods study including: a feasibility RCT; embedded and parallel qualitative and survey studies; parallel health economic feasibility study; development of a core outcome set.Setting Three specialist NHS Paediatric Surgical Units in EnglandParticipants Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility RCT. Children, their families, recruiting clinicians and other healthcare professionals involved in caring for children with appendicitis took part in the qualitative study. UK Specialist Paediatric Surgeons took part in the survey. Specialist Paediatric Surgeons, Adult General Surgeons who treat children, and children and young people who previously had appendicitis along with their families took part in the core outcomes set development.Interventions Participants in the feasibility RCT were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy.Main outcome measures Primary outcome measure was the proportion of eligible patients recruited to the feasibility trial.Data sourcesNHS casenotes, questionnaire responses, transcribed audio recordings of recruitment discussions and qualitative interviewsResults Overall, 50% (95%CI 40-59) of 115 eligible participants approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow rates of 89%, 85% and 85% at six weeks, three months and six months respectively). More participants had perforated appendicitis than had been anticipated.Qualitative work enabled us to: communicate about the trial effectively with patients and families; design and deliver bespoke training to optimise recruitment; and understand how to optimise design and delivery of a future trial.The health economic study, indicated that the main cost drivers are the ward stay cost and the cost of the operation, and has informed quality of life assessment methods for future work.A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes.There is adequate surgeon interest to justify proceeding to an effectiveness trial with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol.LimitationsSince the feasibility RCT was only performed in three centres we cannot guarantee successful recruitment across a larger number of sites. However, our qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have moved over time.Conclusions A future effectiveness trial is feasible following limited additional preparation to establish appropriate outcome measures and case identification. We recommend a limited package of qualitative work be included to optimise recruitment at new centres in particular.Future work Prior to proceeding to an effectiveness trial we need to: develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis; reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved.Study registration ISRCTN15830435.Funding detailsNIHR HTA programm

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility):study protocol for a randomised controlled Trial

BackgroundCurrently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial.Methods/designThe study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4–15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery.DiscussionIn this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design.Trial registrationISRCTN15830435. Registered on 8 February 2017

Prevention of Morbidity in Sickle Cell Disease (POMS2a)-overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children.

DESIGN: This randomised crossover trial compared nocturnal auto-adjusting continuous positive airway pressure (APAP) and nocturnal oxygen therapy (NOT) in adults and children with sickle cell anaemia, with patient acceptability as the primary outcome. Secondary outcomes included pulmonary physiology (adults), safety, and daily pain during interventions and washout documented using tablet technology. METHODS: Inclusion criteria were age > 8 years and the ability to use an iPad to collect daily pain data. Trial participation was 4 weeks; week 1 involved baseline data collection and week 3 was a washout between interventions, which were administered for 7 days each during weeks 2 and 4 in a randomised order. Qualitative interviews were transcribed verbatim and analysed for content using a funnelling technique, starting generally and then gaining more detailed information on the experience of both interventions. Safety data included routine haematology and median pain days between each period. Missing pain day values were replaced using multiple imputation. RESULTS: Ten adults (three female, median age 30.2 years, range 18-51.5 years) and eleven children (five female, median age 12 years, range 8.7-16.9 years) enrolled. Nine adults and seven children completed interviews. Qualitative data revealed that the APAP machine was smaller, easier to handle, and less noisy. Of 16 participants, 10 preferred APAP (62.5%, 95% confidence interval (CI) 38.6-81.5%). Haemoglobin decreased from baseline on APAP and NOT (mean difference -3.2 g/L (95% CI -6.0 to -0.2 g/L) and -2.5 g/L (95% CI -4.6 to 0.3 g/L), respectively), but there was no significant difference between interventions (NOT versus APAP, 1.1 (-1.2 to 3.6)). Pulmonary function changed little. Compared with baseline, there were significant decreases in the median number of pain days (1.58 for APAP and 1.71 for NOT) but no significant difference comparing washout with baseline. After adjustment for carry-over and period effects, there was a non-significant median difference of 0.143 (95% CI -0.116 to 0.401) days additional pain with APAP compared with NOT. CONCLUSION: In view of the point estimate of patient preference for APAP, and no difference in haematology or pulmonary function or evidence that pain was worse during or in washout after APAP, it was decided to proceed with a Phase II trial of 6 months APAP versus standard care with further safety monitoring for bone marrow suppression and pain. TRIAL REGISTRATION: ISRCTN46078697 . Registered on 18 July 2014

Failed Pavlik harness treatment for DDH as a risk factor for avascular necrosis

BACKGROUND: Avascular necrosis (AVN) of the femoral head is an irreversible complication seen in the treatment of developmental dysplasia of hip (DDH) with the Pavlik harness. Its incidence is reported to be low after successful reduction of the hip but high if the hip is not concentrically relocated. We aim to investigate its incidence after failed Pavlik harness treatment.METHODS: We prospectively followed up a group of children who failed Pavlik harness treatment for DDH treated at our institution by the senior author between 1988 and 2001 and compared their rates of AVN with a group of children who presented late and hence were treated surgically. AVN was graded as described by Kalamchi and MacEwen and only grade 2 to 4 AVN was considered significant and included in the analysis.RESULTS: Thirty-seven hips were included in the failed Pavlik group (group 1) and 86 hips in the no Pavlik group (group 2). Ten hips in group 1 developed AVN (27%), whereas only 7 hips in group 2 (8%) developed AVN; the odds of developing AVN after failed Pavlik treatment was 4.7 (95% confidence interval, 1.3-14.1) (P=0.009) with a relative risk of 3.32 (range, 1.37 to 8.05).CONCLUSIONS: There was no statistically significant association observed with duration of splintage and severity of AVN (Spearman's correlation, -0.46; P=0.18). However, there was a positive correlation noted with age at presentation and severity of AVN. Therefore, we advise close monitoring of hips in the Pavlik harness and discontinue its use if the hips are not reduced within 3 weeks.LEVEL OF EVIDENCE: Level III.</p

Twenty years experience of selective secondary ultrasound screening for congenital dislocation of the hip

Objectives: the authors report the results of a selective ultrasound screening programme for congenital dislocation of the hip (CDH) over a period of 20 years, with the aim of defining the rate of screening, conservative treatment and late presentation requiring surgery.Methods: all neonates born from June 1988 to December 2008 (inclusive) were included in the prospective cohort, with a minimum follow-up of 12 months. All underwent an early clinical examination of the hips and those with clinical instability were referred for ultrasound at 2 weeks; those with risk factors were sonographically examined at 6 weeks. Risk factors were defined as breech presentation, family history or foot deformity.Results: 107 440 live births were clinically examined, 20 344 (18.9%) were referred for ultrasound assessment at either 2 weeks (due to clinical signs) or 6 weeks (due to risk factors). 774 (3.8%) were diagnosed with dysplasia with a crude overall treatment rate of 7.2 per 1000 live births. 37 (0.34 per 1000) presented late, that is, after 12 weeks of age; none had detectable clinical signs or risk factors. There were no false negatives.Conclusion: elective screening for developmental dysplasia of the hip in association with one stop treatment and monitoring is an effective programme. The number of infants referred increased statistically significantly year on year over the study period and generated more activity. Pavlik harness treatment rates remained acceptable and steady over the period, despite the increase in referrals. The incidence of late presenting cases ranged from 0 to 4 per year, with no secular trend and there were no ultrasound false negatives

Does late hip dysplasia occur after normal ultrasound screening in breech babies?

BACKGROUND: Recent literature has raised concern regarding the occurrence of late dysplasia after normal screening in breech babies. One paper states a late dysplasia incidence of 29%. This finding is in contrast with other published work, which suggests breech presentation is predictive of spontaneous stabilization of the unstable neonatal hip. We decided to identify the rate of late dysplasia after normal screening in our patient cohort and also to investigate the use of a prophylactic abduction diaper.METHODS: During the study period of December 2012 to June 2014, breech babies referred to the screening program at our institution were identified. Ninety babies were prospectively enrolled into the study and randomized to either the observational arm or prophylactic treatment with the Healthy Hip Diaper (HALO, Minnetonka, MN). All babies had a normal initial clinical examination and ultrasound. Regular follow-up including clinical and ultrasound examination was undertaken culminating in pelvic x-rays performed at 13±1 months. A total of 63% of patients elected against their randomization to prophylactic treatment, 28% opted for prophylactic treatment against their randomization to observation only, meaning a total of 40% of babies proceeded against their initial randomization. In total, 75% of recruited babies completed follow-up. Dysplasia was defined as an acetabular index &gt;2 SD from the mean sex, age, and side-specific values.RESULTS: The overall rate of radiographic dysplasia at 13 months was 7.4%. The rate was 5% in those using a Healthy Hip Diaper and 8.3% in those under observation only. This was not a statistically significant difference. Two patients required operative intervention, one requiring capsulorraphy with acetabuloplasty, the other requiring an arthrogram. Overall compliance with the abduction diaper was low.CONCLUSIONS: We conclude that late radiographic dysplasia does occur after normal clinical and ultrasound screening in breech babies, although not to the same extent as recently published data. We cannot recommend prophylactic abduction devices for breech babies who have a normal hip ultrasound at 6 weeks of age. Consideration must be given to further clinical and radiographic follow-up for hip dysplasia when the risk factor of breech presentation is present.LEVEL OF EVIDENCE: Level II-prospective comparative trial.</p

Investigating SSH Research and Publication Practices in Disciplinary and Institutional Contexts. A Survey-Based Comparative Approach in Two Universities

In this paper, we comparatively analyze, present and discuss the results from a survey on increasing the visibility of research achievements in the social sciences and humanities (SSH) that was carried out at the University of Vienna (Austria) and the University of Navarra (Spain) in 2016 and 2017. Covering four major topics—searching and finding literature, publishing, the visibility of research, and the assessment of research outputs—we ask the following questions: are there disciplinary differences to be identified, and how do they present themselves in the two institutional contexts? Discussing the results, we showcase how disciplinary and institutional traditions and contexts are important factors that influence research and publication practices in the SSH. Our results indicate that the practices of searching and finding literature as well as publication practices and behavior are shaped by disciplinary traditions and epistemic cultures. On the contrary, assessment and valuation of research outputs are influenced by institutional and national contexts in which SSH research is organized and carried out

FOXO3 expression during colorectal cancer progression: Biomarker potential reflects a tumour suppressor role.

Background: In previous studies, the Forkhead/winged-helix-box-class-O3 (FOXO3) transcription factor has displayed both tumour suppressive and metastasis-promoting properties.To clarify its role in human colorectal cancer (CRC) progression, we examined in vivo FOXO3 expression at key points of the metastatic cascade.Methods: Formalin-fixed paraffin-embedded resection specimens from normal colon, adenomas, primary CRC specimens of different pathological stage and CRC specimens with matched liver metastases were used to generate three separate custom-designed tissue microarray (TMA) representations of metastatic progression. Triplicate cores, immunostained for FOXO3 were scored semiquantitatively by two investigators.Results: The FOXO3 expression is significantly reduced in CRC specimens compared with normal tissue, and progressive FOXO3 downregulation is associated with advancing pathological stage. In addition, recurrent stage I/II primary tumours show a significantly lower FOXO3 expression compared with stage-matched non-recurrent tumours. When stratified according to high and low FOXO3 expression, mean disease-free survival in the low-expressing group was 28 months (95% CI 15.8–50.6) compared with 64 months (95% CI 52.9–75.4) in the high-expressing group.Conclusion: We have demonstrated an association between low FOXO3 expression and CRC progression in vivo using purpose-designed TMAs. Forkhead/winged-helix-box-class-O3 may represent a novel biomarker of nodal and distant disease spread with clinical utility in CRC.<br/