bluuebunny/crossref_metadata_2025 huggingface dataset:
Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study
Authors: McGillion Michael H , Henry Shaunattonie , Busse Jason W , Ouellette Carley , Katz Joel , Choinière Manon , Lamy Andre , Whitlock Richard , Pettit Shirley , Hare Jacqueline , Gregus Krysten , Brady Katheryn , Dvirnik Nazari , Yang Stephen Su , Parlow Joel , Dumerton-Shore Deborah , Gilron Ian , Buckley D Norman , Shanthanna Harsha , Carroll Sandra L , Coyte Peter C , Ebrahim Shanil , Isaranuwatchai Wanrudee , Guerriere Denise N , Hoch Jeffrey , Khan James , MacDermid Joy , Martorella Geraldine , Victor J Charles , Watt-Watson Judy , Howard-Quijano Kimberly , Mahajan Aman , Chan Matthew T V , Clarke Hance , Devereaux P J
Published: March 2019

Introduction

Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not.

Methods and analyses

In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score.

Ethics and dissemination

This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals.

Trial registration number

NCT01842568.
Healthy Eating and Active Lifestyles for Diabetes (HEAL-D): study protocol for the design and feasibility trial, with process evaluation, of a culturally tailored diabetes self-management programme for African-Caribbean communities
Authors: Goff Louise M , Moore Amanda P , Rivas Carol , Harding Seeromanie
Published: March 2019

Introduction

Black British communities are disproportionately burdened by type 2 diabetes (T2D) and its complications. Tackling these inequalities is a priority for healthcare providers and patients. Culturally tailored diabetes education provides long-term benefits superior to standard care, but to date, such programmes have only been developed in the USA. The current programme of research aims to develop the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) culturally tailored T2D self-management programme for black British communities and to evaluate its delivery, acceptability and the feasibility of conducting a future effectiveness trial of HEAL-D.

Methods and analysis

Informed by Medical Research Council Complex Interventions guidance, this research will rigorously develop and evaluate the implementation of the HEAL-D intervention to understand the feasibility of conducting a full-scale effectiveness trial. In phase 1, the intervention will be developed. The intervention curriculum will be based on existing evidence-based T2D guidelines for diet and lifestyle management; codesign methods will be used to foster community engagement, identify the intervention’s underpinning theory, identify the optimal structure, format and delivery methods, ascertain adaptations that are needed to ensure cultural sensitivity and understand issues of implementation. In phase 2, the intervention will be delivered and compared with usual care in a feasibility trial. Process evaluation methods will evaluate the delivery and acceptability of HEAL-D. The effect size of potential primary outcomes, such as HbA1c and body weight, will be estimated. The feasibility of conducting a future effectiveness trial will also be evaluated, particularly feasibility of randomisation, recruitment, retention and contamination.

Ethics and dissemination

This study is funded by a National Institute of Health Research Fellowship (CDF-2015-08-006) and approved by National Health Service Research Ethics Committee (17-LO-1954). Dissemination will be through national and international conferences, peer-reviewed publications and local and national clinical diabetes networks.

Trial registrationnumber

NCT03531177; Pre-results.
ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial
Authors: Redfern Julie , Hyun Karice , Singleton Anna , Hafiz Nashid , Raeside Rebecca , Spencer Lissa , Carr Bridie , Caterson Ian , Cullen John , Ferry Cate , Santo Karla , Hayes Alison , Leung Regina W M , Raadsma Simon , Swinbourne Jessica , Cho Jin G , King Meredith , Roberts Mary , Kok Cindy , Jenkins Christine , Chow Clara
Published: March 2019

Introduction

Simple and scalable strategies are needed to improve ‘out-of-hospital’ support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.

Methods and analysis

Pragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation.

Ethics and dissemination

Primary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease.

Trial registration number

ACTRN12616001167459
Effect of the public disclosure of industry payments information on patients: results from a population-based natural experiment
Authors: Kanter Genevieve P , Carpenter Daniel , Lehmann Lisa , Mello Michelle M
Published: March 2019

Objective

To determine the effect of the public disclosure of industry payments to physicians on patients’ awareness of industry payments and knowledge about whether their physicians had accepted industry payments.

Design

Interrupted time series with comparison group (difference-in-difference analyses of longitudinal survey).

Setting

Nationally representative US population-based surveys. Surveys were conducted in September 2014, shortly prior to the public release of Open Payments information, and again in September 2016.

Participants

Adults aged 18 and older (n=2180).

Main outcome measures

Awareness of industry payments as an issue; awareness that industry payments information was publicly available; knowledge of whether own physician had received industry payments.

Results

Public disclosure of industry payments information through Open Payments did not significantly increase the proportion of respondents who knew whether their physician had received industry payments (p=0.918). It also did not change the proportion of respondents who became aware of the issue of industry payments (p=0.470) but did increase the proportion who knew that payments information was publicly available (9.6% points, p=0.011).

Conclusions

Two years after the public disclosure of industry payments information, Open Payments does not appear to have achieved its goal of increasing patient knowledge of whether their physicians have received money from pharmaceutical and medical device firms. Additional efforts will be required to improve the use and effectiveness of Open Payments for consumers.
Do data from child protective services and the police enhance modelling of perinatal risk for paediatric abusive head trauma? A retrospective case-control study
Authors: Kelly Patrick , Thompson John M D , Rungan Santuri , Ameratunga Shanthi , Jelleyman Timothy , Percival Teuila , Elder Hinemoa , Mitchell Edwin A
Published: March 2019

Objectives

First, to investigate whether there is a relationship between a family being known to child protective services or police at the time of birth and the risk of abusive head trauma (AHT, formerly known as shaken baby syndrome). Second, to investigate whether data from child protective services or police improve a predictive risk model derived from health records.

Design

Retrospective case control study of child protective service and police records.

Setting

Nine maternity hospitals.

Participants

142 consecutive cases of AHT admitted to a tertiary children’s hospital from 1991 to 2010 and born in one of the nine participating maternity hospitals. 550 controls matched by the date and hospital of birth.

Outcome measure

Abusive head trauma.

Results

There is a relationship between families known to child protective services or police and the risk of AHT. Notification to child protective services: univariable OR 7.24 (95% CI 4.70 to 11.14). Involvement with youth justice: univariable OR 8.94 (95% CI 4.71 to 16.95). Police call-out for partner violence: univariable OR 3.85 (95% CI 2.51 to 5.91). Other violence offence: univariable OR 2.73 (95% CI 1.69 to 4.40). Drug offence: univariable OR 2.82 (95% CI 1.63 to 4.89). However, in multi-variable analysis with data from perinatal health records, notification to child protective services was the only one of these variables to remain in the final model (OR 4.84; 95% CI 2.61 to 8.97) and had little effect on overall predictive power. The area under the receiver operating characteristic curve was 89.5% (95% CI 86.6 to 92.5) using variables from health data alone and 90.9% (95% CI 88.0 to 93.7) when notification was added.

Conclusions

Family involvement with child protective services or police is associated with increased risk of AHT. However, accessing such data at the time of birth would add little predictive power to a risk model derived from routine health information.
Evaluation of metformin in combination with rifampicin containing antituberculosis therapy in patients with new, smear-positive pulmonary tuberculosis (METRIF): study protocol for a randomised clinical trial
Authors: Padmapriyadarsini Chandrasekaran , Bhavani Perumal K , Natrajan Mohan , Ponnuraja Chinnayan , Kumar Hemanth , Gomathy Sivaramakrishnan N , Guleria Randeep , Jawahar Shaheed M , Singh Manjula , Balganesh Tanjore , Swaminathan Soumya
Published: March 2019

Introduction

Shorter duration of treatment for the management of drug-susceptible pulmonary tuberculosis (TB) would be a significant improvement in the care of patients suffering from the disease. Besides newer drugs and regimens, other modalities like host-directed therapy are also being suggested to reach this goal. This study’s objective is to assess the efficacy and safety of metformin-containing anti-TB treatment (ATT) regimen in comparison to the standard 6-month ATT regimen in the treatment of patients with newly diagnosed sputum smear-positive drug-sensitive pulmonary TB.

Methods and analysis

We are conducting a multicentric, randomised open-label controlled clinical trial to achieve the study objective. The intervention group will receive isoniazid (H), rifampicin (R), ethambutol (E) and pyrazinamide (Z) along with 1000 mg of daily metformin (Met) for the first 2 months while the control group will receive only HRZE. After 2 months, both the groups will receive HRE daily for 4 months. The primary endpoint is time to sputum culture conversion. Secondary endpoints will include time to detection ofMycobacterium tuberculosisin sputum, pharmacokinetics and pharmacogenomics of study drugs, drug–drug interactions, safety and tolerability of the various combinations and measurement of autophagy and immune responses in the study participants.

Ethics and dissemination

The ethics committee of the participating institutes have approved the study. Results from this trial will contribute to evidence towards constructing a shorter, effective and safe regimen for patients with TB. The results will be shared widely with the National Programme managers, policymakers and stakeholders through open access publications, dissemination meetings, conference abstracts and policy briefs. This is expected to provide a new standard of care for drug-sensitive patients with pulmonary TB who will not only reduce the number of clinic visits and lost to follow-up of patients from treatment but also reduce the burden on the healthcare system.

Trial registration number

CTRI/2018/01/011176; Pre-results.
Local prevalence of extended-spectrum beta-lactamase (ESBL) producingEnterobacteriaceaeintestinal carriers at admission and co-expression of ESBL and OXA-48 carbapenemase inKlebsiella pneumoniae: a prevalence survey in a Spanish University Hospital
Authors: Díaz-Agero Pérez Cristina , López-Fresneña Nieves , Rincon Carlavilla Angela L , Hernandez Garcia Marta , Ruiz-Garbajosa Patricia , Aranaz-Andrés Jesús María , Maechler Friederike , Gastmeier Petra , Bonten Marc J M , Canton Rafael
Published: March 2019

Objective

To assess the prevalence of extended-spectrum beta-lactamase (ESBL)-producingEnterobacteriaceae(ESBL-E) faecal carriers at admission in a University Hospital in Spain.

Design

Prevalence survey.

Setting

Pneumology, gastroenterology, urology and neurosurgery units at a university tertiary hospital in Madrid (Spain).

Participants

A total of 10 643 patients aged 18 and older admitted from March 2014 to April 2016 with a rectal swab taken at admission or as soon as possible within the first 48 hours.

Primary and secondary outcome measures

Prevalence of ESBL-E faecal carriers and prevalence of ESBL-E infections at admission.

Results

The prevalance of ESBL-E carriers at admission was 7.69% (CI 95% 7.18 to 8.19). Most of the isolates wereEscherichia coli(77.51%), followed byKlebsiella pneumoniae(20.71%). Eighty-eight (10.41%) of ESBL-E were simultaneous ESBL and carbapenemase (CP) producers, 1.83% in the case ofE. coliand 42.86% amongK. pneumoniaeisolates. Of the ESBL typed, 52.15% belonged to the cefotaximases (CTX-M-15) type and 91.38% of the CP were oxacillinase (OXA-48) type. Only 0.43% patients presented an active infection by ESBL-E at admission.

Conclusions

The prevalence found in our study is very similar to that found in literature. However, we found a high percentage of simultaneous ESBL and CP producers, particularly inK. pneumoniae. Despite the high prevalence of colonised patients, the ESBL-infection rate at admission was very low.
Uppsala Longitudinal Adolescent Depression Study (ULADS)
Authors: Alaie Iman , Philipson Anna , Ssegonja Richard , Hagberg Lars , Feldman Inna , Sampaio Filipa , Möller Margareta , Arinell Hans , Ramklint Mia , Päären Aivar , von Knorring Lars , Olsson Gunilla , von Knorring Anne-Liis , Bohman Hannes , Jonsson Ulf
Published: March 2019

Purpose

To present the Uppsala Longitudinal Adolescent Depression Study, initiated in Uppsala, Sweden, in the early 1990s. The initial aim of this epidemiological investigation was to study the prevalence, characteristics and correlates of adolescent depression, and has subsequently expanded to include a broad range of social, economic and health-related long-term outcomes and cost-of-illness analyses.

Participants

The source population was first-year students (aged 16–17) in upper-secondary schools in Uppsala during 1991–1992, of which 2300 (93%) were screened for depression. Adolescents with positive screening and sex/age-matched peers were invited to a comprehensive assessment. A total of 631 adolescents (78% females) completed this assessment, and 409 subsequently completed a 15-year follow-up assessment. At both occasions, extensive information was collected on mental disorders, personality and psychosocial situation. Detailed social, economic and health-related data from 1993 onwards have recently been obtained from the Swedish national registries for 576 of the original participants and an age-matched reference population (N≥200 000).

Findings to date

The adolescent lifetime prevalence of a major depressive episode was estimated to be 11.4%. Recurrence in young adulthood was reported by the majority, with a particularly poor prognosis for those with a persistent depressive disorder or multiple somatic symptoms. Adolescent depression was also associated with an increased risk of other adversities in adulthood, including additional mental health conditions, low educational attainment and problems related to intimate relationships.

Future plans

Longitudinal studies of adolescent depression are rare and must be responsibly managed and utilised. We therefore intend to follow the cohort continuously by means of registries. Currently, the participants are approaching mid-adulthood. At this stage, we are focusing on the overall long-term burden of adolescent depression. For this purpose, the research group has incorporated expertise in health economics. We would also welcome extended collaboration with researchers managing similar datasets.
Human amnion cells for the prevention of bronchopulmonary dysplasia: a protocol for a phase I dose escalation study
Authors: Baker Elizabeth Kate , Malhotra Atul , Lim Rebecca , Jacobs Susan E , Hooper Stuart B , Davis Peter G , Wallace Euan M
Published: March 2019

Introduction

Bronchopulmonary dysplasia (BPD), an important sequela of preterm birth, is associated with long-term abnormalities of lung function and adverse neurodevelopmental outcomes. Inflammation, inhibition of secondary septation and vascular maldevelopment play key roles in the pathogenesis of BPD. Human amnion epithelial cells (hAECs), stem-like cells, derived from placental tissues are able to modulate the inflammatory milieu and, in preclinical studies of BPD-like injury, restore lung architecture and function. Allogeneic hAECs may present a new preventative and reparative therapy for BPD.

Methods and analysis

In this two centre, phase I cell dose escalation study we will evaluate the safety of intravenous hAEC infusions in preterm infants at high risk of severe BPD. Twenty-four infants born at less than 29 weeks’ gestation will each receive intravenous hAECs beginning day 14 of life. We will escalate the dose of cells contained in a single intravenous hAEC infusion in increments from 2 million cells/kg to 10 million cells/kg. Further dose escalation will be achieved with repeat infusions given at 5 day intervals to a maximum total dose of 30 million cells/kg (three infusions). Safety is the primary outcome. Infants will be followed-up until 2 years corrected age. Additional outcome measures include a description of infants’ cytokine profile following hAEC infusion, respiratory outcomes including BPD and pulmonary hypertension and other neonatal morbidities including neurodevelopmental assessment at 2 years.

Ethics and dissemination

This study was approved on the June12th, 2018 by the Human Research Ethics Committee of Monash Health and Monash University. Recruitment commenced in August 2018 and is expected to take 18 months. Accordingly, follow-up will be completed mid-2022. The findings of this study will be disseminated via peer-reviewed journals and at conferences.

Protocol version

5, 21 May 2018.

Trial registration number

ACTRN12618000920291; Pre-results.
Motor activity across delirium motor subtypes in geriatric patients assessed using body-worn sensors: a Norwegian cross-sectional study
Authors: Evensen Sigurd , Bourke Alan Kevin , Lydersen Stian , Sletvold Olav , Saltvedt Ingvild , Wyller Torgeir Bruun , Taraldsen Kristin
Published: March 2019

Objectives

It remains unclear if geriatric patients with different delirium motor subtypes express different levels of motor activity. Thus, we used two accelerometer-based devices to simultaneously measure upright activity and wrist activity across delirium motor subtypes in geriatric patients.

Design

Cross-sectional study.

Settings

Geriatric ward in a university hospital in Norway.

Participants

Sixty acutely admitted patients, ≥75 years, with DSM-5-delirium.

Outcome measures

Upright activity measured as upright time (minutes) and sit-to-stand transitions (numbers), total wrist activity (counts) and wrist activity in a sedentary position (WAS, per cent of the sedentary time) during 24 hours ongoing Delirium Motor Subtype Scalesubtyped delirium.

Results

Mean age was 86.7 years. 15 had hyperactive, 20 hypoactive, 17 mixed and 8 had no-subtype delirium. We found more upright time in the no-subtype group than in the hypoactive group (119.3 vs 37.8 min, p=0.042), but no differences between the hyperactive, the hypoactive and the mixed groups (79.1 vs 37.8 vs 50.1 min, all p>0.28). The no-subtype group had a higher number of transitions than the hypoactive (54.3 vs 17.4, p=0.005) and the mixed groups (54.3 vs 17.5, p=0.013). The hyperactive group had more total wrist activity than the hypoactive group (1.238×104vs 586×104counts, p=0.009). The hyperactive and the mixed groups had more WAS than the hypoactive group (20% vs 11%, p=0.032 and 19% vs 11%, p=0.049).

Conclusions

Geriatric patients with delirium demonstrated a low level of upright activity, with no differences between the hyperactive, hypoactive and mixed groups, possibly due to poor gait function. The hyperactive and mixed groups had more WAS than the hypoactive group, indicating true differences in motor activity across delirium motor subtypes, also in geriatric patients. Wrist activity appears more suitable than an upright activity for both diagnostic purposes and activity monitoring in geriatric delirium.
Adherence to antibiotic guidelines and reported penicillin allergy: pooled cohort data on prescribing and allergy documentation from two English National Health Service (NHS) trusts
Authors: Phillips Cameron J , Gilchrist Mark , Cooke Fiona J , Franklin Bryony D , Enoch David A , Murphy Michael E , Santos Reem , Brannigan Eimear T , Holmes Alison H
Published: March 2019

Objective

To investigate documentation of antimicrobial allergy and to determine prescribing adherence to local antibiotic guidelines for inpatients with and without reported penicillin allergy treated for infection in a National Health Service (NHS) context.

Setting

Data were collected at two English hospital NHS trusts over two time-periods: June 2016 and February 2017.

Design

Cohort study. Trust 1 data were sourced from prospective point prevalence surveys. Trust 2 data were extracted retrospectively from an electronic report.

Participants

Inpatients treated for urinary tract infection (UTI), community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP) and skin and soft tissue infection (SSTI). Data on allergy were collected, and antibiotic selection assessed for adherence to trust guidelines with differences between groups presented as adjusted ORs.

Results

A total of 1497 patients were included, with 2645 antibiotics orders. Patients were treated for CAP (n=495; 33.1%), UTI (407; 27.2%), HAP (330; 22%) and SSTI (265; 17.7%). There were 240 (16%) patients with penicillin allergy. Penicillin allergy was recorded as allergy (n=52; 21.7%), side effect (27; 11.3%) and no documentation (161; 67.1%). Overall, 2184 (82.6%) antibiotic orders were guideline-adherent. Adherence was greatest for those labelled penicillin allergy (453 of 517; 87.6%) versus no allergy (1731 of 2128; 81.3%) (OR 0.52 (95% CI 0.37 to 0.73) p<0.001). Guideline-adherence for CAP was higher if penicillin allergy (151 of 163; 92.6%) versus no allergy (582 of 810; 71.9%) (OR 0.20 (95% CI 0.10 to 0.37) p<0.001). There was no difference in adherence between those with and without penicillin allergy for UTI, HAP or SSTI treatment.

Conclusions

A relatively high proportion of patients had a penicillin allergy and two thirds of these had no description of their allergy, which has important implications for patient safety. Patients with penicillin allergy treated for CAP, received more guideline adherent antibiotics than those without allergy. Future studies investigating the clinical impact of penicillin allergy should include data on adherence to antibiotic guidelines.
Comparison of refractive predictability and endothelial cell loss in femtosecond laser-assisted cataract surgery and conventional phaco surgery: prospective randomised trial with 6 months of follow-up
Authors: Krarup Therese , Ejstrup Rasmus , Mortensen Anouck , la Cour Morten , Holm Lars Morten
Published: March 2019

Objective

Femtosecond laser-assisted cataract surgery (FLACS) decreases the use of energy and provides a more precise capsulorhexis compared with conventional phaco surgery (CPS). The purpose of this study was to examine if the lower energy use in FLACS caused less endothelial cell loss compared with CPS and if there was a difference in refractive predictability between CPS and FLACS.

Methods and analysis

This was a randomised controlled study of 96 patients with a 6-month follow-up comparing one eye surgery by FLACS and the contralateral eye operated by CPS (divide and conquer technique). Both eyes had intraocular aspheric lenses implanted. Uncorrected distance visual acuity, corrected distance visual acuity (CDVA), central corneal endothelial cell count and hexagonality (non-contact endothelial cell microscope) were assessed preoperatively at 40 and at 180 days postoperatively.

Results

The mean phaco energies were 6.55 (95% CI 5.43 to 7.66) and 9.77 (95% CI 8.55 to 10.95) U/S (p<0.0001) by FLACS and CPS, respectively. At day 40, the mean endothelial cell loss (ECL) was 344 cells/mm2(95% CI 245 to 443) by FLACS (12.89%) and 497 cells/mm2(95% CI 380 to 614) by CPS (18.19%) (p=0.027). At day 180, ECL was 362 cells/mm2(95% CI 275 to 450) in FLACS (13.56%) and 465 cells/mm2(95% CI 377 to 554) in CPS (17.03%) (p=0.036).

The mean absolute difference from the attempted refraction was 0.43 (95% CI 0.36 to 0.51) dioptres (D) at day 40 and 0.46 D (95% CI 0.39 to 0.53) at day 180 by FLACS compared with 0.43 D (95% CI 0.36 to 0.51) at day 40 (p=0.95) and 0.46 D (95% CI 0.37 to 0.52) at day 180 (p=0.91) with CPS.

Conclusion

ECL was significantly lower in FLACS compared with CPS at both day 40 and day 180. ECL was correlated to the energy used. We found no difference in refractive predictability or CDVA between the groups.
Is virtual clinic follow-up of hip and knee joint replacement acceptable to patients and clinicians? A sequential mixed methods evaluation
Authors: Parkes Rebekah J , Palmer Joanne , Wingham Jennifer , Williams Dan H
Published: March 2019

Objective

To evaluate the acceptability to key stake holders of a newly introduced virtual clinic follow-up pathway for hip and knee joint replacement.

Design

A service evaluation comprising a questionnaire sent electronically to 115 patients and interviews with 10 individuals.

Setting

A newly introduced virtual clinic follow-up pathway for hip and knee replacement patients in a district general hospital.

Participants

The electronic questionnaire was distributed to all patients treated under the virtual clinic service over a 5-month period (n=115). Purposive sampling from volunteers among respondents, leading to semi-structured interviews with eight patients. Two orthopaedic consultants were also interviewed.

Intervention

Consultant review of web-based patient reported outcome measures and digital radiographs, with feedback to patients via letter, replacing face-to-face outpatient appointments for the follow-up of hip and knee joint replacement.

Results

The response rate to the questionnaire was 40%. 44% indicated they would prefer a virtual appointment over a face-to-face consultation in future. The most common word in the free text comments was ‘good’ (n=107).

Seven main themes were identified from the patient interviews: patient understanding and expectations, patient confidence, patient voice, managing deterioration of condition, patient benefit, patient satisfaction using technology and navigating the website.

Two main themes were identified from the staff interviews: the adapting patient pathway and project management.

Combined analysis elucidated that patients who were doing well liked the ‘click and go’ approach but those with problems were concerned about how to report these and were therefore less satisfied.

Conclusion

The virtual clinic process appears to be well accepted by both patients and clinicians. However, appropriate patient selection and clear pathways of communication to address patient concerns are pivotal to success.
Using Always Events to derive patient-centred quality improvement priorities in a specialist primary care service providing care to a homeless population
Authors: McCallum Marianne , McNab Duncan , Mckay John
Published: March 2019

Background

‘Always Events’ (AE) is a validated quality improvement (QI) method where patients, and/or carers, are asked what is so important that it should ‘always’ happen when they interact with healthcare services. Answers that meet defined criteria can be used to direct patient-centred QI activities. This method has never, to our knowledge, been applied in the care of a UK homeless population. We aimed to test the aspects of the acceptability and feasibility of the AE method to inform on its potential application to improve care for this vulnerable group of patients.

Methods

All patients attending three consecutive drop-in clinics at a specialist homeless general practitioner service in Glasgow, who agreed to participate, were interviewed. Anonymised responses were transcribed and coded and a thematic analysis performed. Themes were summarised to generate candidate AE using the patient’s own words. The authors then determined if they met the AE criteria.

Results

Twenty out of 22 eligible patients were interviewed. Oral transcribing was found to be an acceptable way to gather data in this group. Nine candidate AEs were generated, of which five fitted the criteria to be used as metrics for future QI projects. This project generated AEs and QI targets, and highlighted issues of importance to patients that could be easily addressed.

Conclusion

In the homeless context, obtaining high engagement and useful patient feedback, in a convenient way, is difficult. The AE method is an acceptable and feasible tool for generating QI targets that can lead to improvements in care for this vulnerable group.
What do families want to improve in the management of paediatric febrile neutropenia during anti-cancer treatment? Report of a patient/public involvement group
Authors: Phillips Bob , Depani Sarita , Morgan Jess
Published: March 2019

Background

This study reports how parents and young people who had an experience of

febrile neutropenia (FN) improved the design of a trial to inform the management of this condition. Five parents, a young person who had completed treatment and three clinician-researchers contributed.

Methods

The group was formed after an invitation on social media and met via video conference. Many participants were from an existing childhood-cancer parent-involvement group. The initial questions asked during discussion were about the importance of the topic, the views on the need for a trial, which important outcomes should be measured and the practical aspects which would make it easier or more difficult for people to take part in it. The conversation occurred for an entire afternoon, was audio and video recorded, transcribed, analysed and checked by those involved. The fifth parent added to this via email.

Results

The group altered the trial structure by proposing randomising of each child to one of the two management methods through the whole of their anti-cancer treatment, rather than randomising the study sites or the child at each visit. They felt that even if people declined taking part in the study in the first weeks of diagnosis, their views might change and they should be allowed to consent later. They also proposed methods of collecting important patient and family data, enriching the medical information gained in the study. Active follow-up, negotiated for each individual family, was also suggested.

Conclusion

Trials for improving the management of FN in children and young people who are undergoing anti-cancer treatments should consider individual-patient randomisation, collection of ‘quality of life’ and ‘experience of care’ aspects using digital and paper-based methods, engage families in shared decision-making about management options and ensure adequate supportive information is available and accessible to all patients regardless of background, geographical location or age.
From the safety net to the injury prevention web: applying systems thinking to unravel injury prevention challenges and opportunities in Cirque du Soleil
Authors: Bolling Caroline , Mellette Jay , Pasman H Roeline , van Mechelen Willem , Verhagen Evert
Published: March 2019

Objective

We undertook this qualitative study within an international circus company—Cirque du Soleil—to explore the narrative of artists and the artistic team in regards to injuries and their prevention and to describe the prevention of injuries from a systems thinking lens.

Methods

Focus groups (FG) with artists and semistructured individual interviews with the artistic team were conducted in six selected shows. The structure of the interviews and FGs concerned the themes: ‘injury’, ‘injury-related factors’ and ‘injury prevention’. Data were analysed through comparative data analysis based on Grounded Theory. Concept mapping and systems thinking approaches were used to design a map of participants’ views on how to prevent injuries.

Results

Injury was mainly described based on performance limitation. The factors mostly mentioned to be related to injury occurrence were physical load factors. Many of these factors were said to be connected and to influence each other. Injury prevention was mapped as a multilevel system, composed by artist-related factors (eg, technique and life style) and extrinsic factors (eg, touring conditions and equipment) that integrate different strategies and stakeholders.

Conclusion

Our study reinforces the importance of multilevel injury prevention approaches with shared responsibility and open communication among stakeholders.
Risk perceptions for exertional heat illnesses in junior cricket in Sri Lanka
Authors: Gamage Prasanna Janaka , Fortington Lauren Victoria , Finch Caroline F
Published: March 2019

Objectives

Exertional heat illnesses (EHI) can occur when sport is played in hot and humid environments, such as those common across Asia. Measures to reduce the risk of EHI are important; however, causal data on EHI occurrence are limited and challenging to capture. To gain an initial understanding of EHI risks, we aimed to assess the risk perceptions of EHI of youth cricketers.

Methods

A descriptive cross-sectional survey, comprised of 14 questions on EHI risks, was conducted with 365 Sri Lankan junior male cricketers (age=12.9±0.9 years) who typically play in hot and humid conditions.

Results

For climate related risks, relative humidity was perceived as having a low risk of EHI compared with ambient temperature. The EHI risk associated with wearing protective gear, as commonly used in cricket, was perceived as low. Most junior cricketers perceived a low level of risk associated with recommended preventive measures such as body cooling and heat-acclimatisation.

Conclusion

This is the first study to explore EHI risk perceptions in any sporting context. Young players may not be mindful of all risks. Therefore, leadership and initiative from competition organisers and parents is required to promote countermeasures.
GABRP regulates chemokine signalling, macrophage recruitment and tumour progression in pancreatic cancer through tuning KCNN4-mediated Ca2+ signalling in a GABA-independent manner
Authors: Jiang Shu-Heng , Zhu Li-Li , Zhang Man , Li Rong-Kun , Yang Qin , Yan Jiang-Yu , Zhang Ce , Yang Jian-Yu , Dong Fang-Yuan , Dai Miao , Hu Li-Peng , Li Jun , Li Qing , Wang Ya-Hui , Yang Xiao-Mei , Zhang Yan-Li , Nie Hui-Zhen , Zhu Lei , Zhang Xue-Li , Tian Guang-Ang , Zhang Xiao-Xin , Cao Xiao-Yan , Tao Ling-Ye , Huang Shan , Jiang Yong-Sheng , Hua Rong , Qian Luo Kathy , Gu Jian-Ren , Sun Yong-Wei , Hou Shangwei , Zhang Zhi-Gang
Published: March 2019

Background and aims

Pancreatic ductal adenocarcinoma (PDAC) is a leading cause of cancer-related death worldwide. Neurotransmitter-initiated signalling pathway is profoundly implicated in tumour initiation and progression. Here, we investigated whether dysregulated neurotransmitter receptors play a role during pancreatic tumourigenesis.

Methods

The Cancer Genome Atlas and Gene Expression Omnibus datasets were used to identify differentially expressed neurotransmitter receptors. The expression pattern of gamma-aminobutyric acid type A receptor pi subunit (GABRP) in human and mouse PDAC tissues and cells was studied by immunohistochemistry and western blot analysis. The in vivo implications of GABRP in PDAC were tested by subcutaneous xenograft model and lung metastasis model. Bioinformatics analysis, transwell experiment and orthotopic xenograft model were used to identify the in vitro and in vivo effects of GABRP on macrophages in PDAC. ELISA, co-immunoprecipitation, proximity ligation assay, electrophysiology, promoter luciferase activity and quantitative real-time PCR analyses were used to identify molecular mechanism.

Results

GABRP expression was remarkably increased in PDAC tissues and associated with poor prognosis, contributed to tumour growth and metastasis. GABRP was correlated with macrophage infiltration in PDAC and pharmacological deletion of macrophages largely abrogated the oncogenic functions of GABRP in PDAC. Mechanistically, GABRP interacted with KCNN4 to induce Ca2+ entry, which leads to activation of nuclear factor κB signalling and ultimately facilitates macrophage infiltration by inducing CXCL5 and CCL20 expression.

Conclusions

Overexpressed GABRP exhibits an immunomodulatory role in PDAC in a neurotransmitter-independent manner. Targeting GABRP or its interaction partner KCNN4 may be an effective therapeutic strategy for PDAC.
Fenestration in the Fontan circulation as a strategy for chronic cardioprotection
Authors: Saiki Hirofumi , Kuwata Seiko , Iwamoto Yoichi , Ishido Hirotaka , Taketazu Mio , Masutani Satoshi , Nishida Takashi , Senzaki Hideaki
Published: March 2019

Background

Fenestration in the Fontan circulation potentially liberates patients from factors leading to cardiovascular remodelling, through stable haemodynamics with attenuated venous congestion. We hypothesised that a fenestrated Fontan procedure would possess chronic haemodynamic advantages beyond the preload preservation.

Methods

We enrolled 35 patients with fenestrated Fontan with a constructed pressure–volume relationship under dobutamine (DOB) infusion and/or transient fenestration occlusion (TFO). Despite the use of antiplatelets and anticoagulants, natural closure of fenestration was confirmed in 11 patients. Cardiovascular properties in patients with patent fenestration (P-F) were compared with those in patients with naturally closed fenestration (NC-F). To further delineate the roles of fenestration, paired analysis in patients with P-F was performed under DOB or rapid atrial pacing with/without TFO.

Results

As compared with P-F, patients with NC-F had a higher heart rate (HR), smaller ventricular end-diastolic area, better ejection fraction and higher central venous pressure, with higher pulmonary resistance. While this was similarly observed after DOB infusion, DOB markedly augmented diastolic and systolic ventricular stiffness in patients with NC-F compared with patients with P-F. As a mirror image of the relationship between patients with P-F and NC-F, TFO markedly reduced preload, suppressed cardiac output, and augmented afterload and diastolic stiffness. Importantly, rapid atrial pacing compromised these haemodynamic advantages of fenestration.

Conclusions

As compared with patients with NC-F, patients with P-F had robust haemodynamics with secured preload reserve, reduced afterload and a suppressed beta-adrenergic response, along with a lower HR at baseline, although these advantages had been overshadowed, or worsened, by an increased HR.
Low Serum Magnesium is associated with Faster Decline in Kidney Function: The Dallas Heart Study Experience
Authors: Ferrè Silvia , Li Xilong , Adams-Huet Beverley , Maalouf Naim M , Sakhaee Khashayar , Toto Robert D , Moe Orson W , Neyra Javier A
Published: March 2019

Hypomagnesemia associates with inflammation and risk of diabetes and hypertension, which may contribute to kidney function decline. We hypothesized that low serum magnesium (SMg) levels independently associate with a significant decline in estimated glomerular filtration rate (eGFR). We analyzed SMg levels in 2056 participants from the Dallas Heart Study, a longitudinal, population‐based, multiethnic, cohort study involving residents of Dallas County, Texas, USA. The primary study outcome was the change in eGFR using multivariable linear regression models adjusted for demographics, anthropometric and biochemical parameters, medications, C reactive protein levels, prevalent hypertension and diabetes. During a median follow-up of 7.0 years (25th, 75th percentile: 6.5, 7.6), the median decrease in eGFR was −0.71 (25th, 75th percentile: −2.43, +0.68) mL/min/1.73 m2 per year in the entire cohort. In a fully adjusted model, the lowest SMg quintile (≤1.9 mg/dL or ≤0.8 mM) was associated with a −0.50 mL/min/1.73 m2 per year drop in eGFR (95% CI −0.95 to –0.05; p=0.028) compared with the highest SMg quintile (≥2.3 mg/dL or ≥1.0 mM). Every 0.2 mg/dL (0.08 mM) decrease in SMg was associated with an eGFR decline of −0.23 mL/min/1.73 m2 per year (95% CI −0.38 to –0.08; p=0.003), a decline that was more pronounced in participants with prevalent diabetes compared with patients without diabetes (−0.51 vs −0.18 mL/min/1.73 m2 per year, respectively). In conclusion, low SMg was independently associated with eGFR decline. Further studies are needed to determine whether Mg repletion can ameliorate inflammation, lower blood pressure and serum glucose and ultimately prevent or retard kidney function decline.
Cannabis use is both independently associated with and mediates worse psychosocial health in patients with epilepsy
Authors: Wahby Sandra , Karnik Vikram , Brobbey Anita , Wiebe Samuel , Sajobi Tolulope , Josephson Colin Bruce
Published: March 2019

Objective

To examine whether cannabis use is associated with or mediates psychosocial health in people with epilepsy.

Methods

Consecutive adult epilepsy patients visiting the Calgary Comprehensive Epilepsy Programme clinic were administered validated patient-reported outcome measures (PROMs) including the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), Quality of Life in Epilepsy (QOLIE-10-P), EuroQOL five dimensions five level scale (EQ-5D-5L), Global Assessment of Severity of Epilepsy Scale, Global Assessment of Disability Associated with Seizures Scale and the Treatment Satisfaction Questionnaire for Medication scale. We used multiple regression analyses to investigate associations between cannabis use and PROMs. Mediation analyses were performed to determine the degree to which cannabis modulated the associations between current or past psychiatric disorders, monthly seizure frequency, and 1-year seizure freedom on psychosocial health.

Results

Of 337 consecutive patients, 71 (21%) reported cannabis use. Cannabis use was independently associated with depression (NDDI-E score≥14; OR 3.90; 95% CI 2.01 to 7.59; p<0.001), lower quality of life (β=−16.73, 95% CI − 26.26 to − 7.20; p=0.001), worse epilepsy-related disability (OR 2.23, 95% CI 1.19 to 4.17; p=0.01) and lower satisfaction with antiepileptic medication (OR 0.41, 95% CI 0.23 to 0.72; p=0.002). Cannabis use mediates 7%–12% of the effect of a psychiatric history on depression, worse quality of life and worse health valuation.

Conclusions

There is a strong and independent association between cannabis use and poor psychosocial health, and it partially mediates the deleterious effect of a psychiatric history on these same outcomes. Inclusion of PROMs in future cannabis trials is warranted.
Understanding foreign accent syndrome
Authors: McWhirter Laura , Miller Nick , Campbell Catriona , Hoeritzauer Ingrid , Lawton Andrew , Carson Alan , Stone Jon
Published: March 2019

Objective

Foreign accent syndrome (FAS) is widely understood as an unusual consequence of structural neurological damage, but may sometimes represent a functional neurological disorder. This observational study aimed to assess the prevalence and utility of positive features of functional FAS in a large group of individuals reporting FAS.

Methods

Participants self-reporting FAS recruited from informal unmoderated online support forums and via professional networks completed an online survey. Speech samples were analysed in a subgroup.

Results

Forty-nine respondents (24 UK, 23 North America, 2 Australia) reported FAS of mean duration 3 years (range 2 months to 18 years). Common triggers were: migraine/severe headache (15), stroke (12), surgery or injury to mouth or face (6) and seizure (5, including 3 non-epileptic). High levels of comorbidity included migraine (33), irritable bowel syndrome (17), functional neurological disorder (12) and chronic pain (12). Five reported structural lesions on imaging. Author consensus on aetiology divided into, ‘probably functional (n=35.71%), ‘possibly structural’ (n=4.8%) and ‘probably structural’ (n=10.20%), but positive features of functional FAS were present in all groups. Blinded analysis of speech recordings supplied by 13 respondents correctly categorised 11 (85%) on the basis of probable aetiology (functional vs structural) in agreement with case history assignment.

Conclusions

This largest case series to date details the experience of individuals with self-reported FAS. Although conclusions are limited by the recruitment methods, high levels of functional disorder comorbidity, symptom variability and additional linguistic and behavioural features suggest that chronic FAS may in some cases represent a functional neurological disorder, even when a structural lesion is present.