bluuebunny/crossref_metadata_2025_split huggingface dataset:
Optimising colorectal cancer screening in Shanghai, China: a modelling study
Authors: Cenin Dayna , Li Pei , Wang Jie , de Jonge Lucie , Yan Bei , Tao Sha , Lansdorp-Vogelaar Iris 
Published: May 2022

IntroductionTo reduce the burden of colorectal cancer (CRC) in Shanghai, China, a CRC screening programme was commenced in 2013 inviting those aged 50–74 years to triennial screening with a faecal immunochemical test (FIT) and risk assessment. However, it is unknown whether this is the optimal screening strategy for this population. We aimed to determine the optimal CRC screening programme for Shanghai in terms of benefits, burden, harms and cost-effectiveness.MethodsUsing Microsimulation Screening Analysis-Colon (MISCAN-Colon), we estimated the costs and effects of the current screening programme compared with a situation without screening. Subsequently, we estimated the benefits (life years gained (LYG)), burden (number of screening events, colonoscopies and false-positive tests), harms (number of colonoscopy complications) and costs (Renminb (¥)) of screening for 324 alternative screening strategies. We compared several different age ranges, screening modalities, intervals and FIT cut-off levels. An incremental cost-effectiveness analysis determined the optimal strategy assuming a willingness-to-pay of ¥193 931 per LYG.ResultsCompared with no screening, the current screening programme reduced CRC incidence by 40% (19 cases per 1000 screened individuals) and CRC mortality by 67% (7 deaths). This strategy gained 32 additional life years, increased colonoscopy demand to 1434 per 1000 individuals and cost an additional ¥199 652. The optimal screening strategy was annual testing using a validated one-sample FIT, with a cut-off of 10 µg haemoglobin per gram from ages 45 to 80 years (incremental cost-effectiveness ratio, ¥62 107). This strategy increased LY by 0.18% and costs by 27%. Several alternative cost-effective strategies using a validated FIT offered comparable benefits to the current programme but lower burden and costs.ConclusionsAlthough the current screening programme in Shanghai is effective at reducing CRC incidence and mortality, the programme could be optimised using a validated FIT. When implementing CRC screening, jurisdictions with limited health resources should use a validated test.
Drivers of paediatric inpatient experience: retrospective analysis of casemix factors for the Alberta Paediatric Inpatient Experience Survey in Alberta, Canada
Authors: Steele Brian Jacob , Fairie Paul , Kemp Kyle , Santana Maria-Jose 
Published: May 2022

ObjectiveIn Alberta, the Alberta Paediatric Inpatient Experience Survey (APIES) is used as a proxy-reported measure of paediatric experience. To our knowledge, the influence of casemix factors on patient experience as measured by paediatric patient experience surveys have not been reported within Canadian paediatric samples. In this paper, we sought to determine the patient and respondent factors associated with paediatric inpatient experiences in Alberta, Canada.DesignRetrospective analysis of patient experience survey data.SettingInpatiet acute care hospitals in Alberta, Canada.Intervention and main outcome measuresRetrospective analyses were conducted using APIES surveys linked with eligible inpatient records (n=6262). Descriptive statistics were reported. χ2 tests were performed to assess distribution of casemix between general and paediatric hospitals. Logistic regression was performed with overall hospital experience as the dependent variable with casemix and hospital variables as independent variables.ResultsCasemix characteristics were unevenly distributed between general and paediatric hospitals. Compared with reference categories, older respondents, healthier patients and treatment at paediatric facilities had increased odds of providing most-positive ratings. Increased respondent education was associated with decreased odds of providing most-positive ratings. Likelihood-ratio tests showed that most casemix variables improved model fit, except for respondent relationship to the patient.ConclusionsTo improve reports of paediatric inpatient experience, administrators and providers require reliable and comparable measurement. Both the Child Hospital Consumer Assessment of Healthcare Providers and Systems and other measures of patient and family experience need to consider patient and respondent characteristics when interpreting results. Considered with other research from patient experience in Alberta, we discuss future directions and quality improvement implications.
Oral pre-exposure prophylaxis (PrEP) to prevent HIV: a systematic review and meta-analysis of clinical effectiveness, safety, adherence and risk compensation in all populations
Authors: O Murchu Eamon , Marshall Liam , Teljeur Conor , Harrington Patricia , Hayes Catherine , Moran Patrick , Ryan Mairin 
Published: May 2022

ObjectiveTo conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) of the effectiveness and safety of oral pre-exposure prophylaxis (PrEP) to prevent HIV.MethodsDatabases (PubMed, Embase and the Cochrane Register of Controlled Trials) were searched up to 5 July 2020. Search terms for ‘HIV’ were combined with terms for ‘PrEP’ or ‘tenofovir/emtricitabine’. RCTs were included that compared oral tenofovir-containing PrEP to placebo, no treatment or alternative medication/dosing schedule. The primary outcome was the rate ratio (RR) of HIV infection using a modified intention-to-treat analysis. Secondary outcomes included safety, adherence and risk compensation. All analyses were stratified a priori by population: men who have sex with men (MSM), serodiscordant couples, heterosexuals and people who inject drugs (PWIDs). The quality of individual studies was assessed using the Cochrane risk-of-bias tool, and the certainty of evidence was assessed using GRADE.ResultsOf 2803 unique records, 15 RCTs met our inclusion criteria. Over 25 000 participants were included, encompassing 38 289 person-years of follow-up data. PrEP was found to be effective in MSM (RR 0.25, 95% CI 0.1 to 0.61; absolute rate difference (RD) −0.03, 95% CI −0.01 to −0.05), serodiscordant couples (RR 0.25, 95% CI 0.14 to 0.46; RD −0.01, 95% CI −0.01 to −0.02) and PWID (RR 0.51, 95% CI 0.29 to 0.92; RD −0.00, 95% CI −0.00 to −0.01), but not in heterosexuals (RR 0.77, 95% CI 0.46 to 1.29). Efficacy was strongly associated with adherence (p<0.01). PrEP was found to be safe, but unrecognised HIV at enrolment increased the risk of viral drug resistance mutations. Evidence for behaviour change or an increase in sexually transmitted infections was not found.ConclusionsPrEP is safe and effective in MSM, serodiscordant couples and PWIDs. Additional research is needed prior to recommending PrEP in heterosexuals. No RCTs reported effectiveness or safety data for other high-risk groups, such as transgender women and sex workers.PROSPERO registration numberCRD42017065937.
What are the environmental factors that affect implementation of the Manchester Healthy Schools programme? A qualitative exploration of staff perspectives
Authors: Goldthorpe Joanna , Vaughan Matthew , Keyworth Chris , Epton Tracy , Calam Rachel , Armitage Chris 
Published: May 2022

ObjectivesPrimary/elementary schools are crucial settings for early weight management interventions but effects on children’s weight are small. This may be because the environments in which these schools are situated support unhealthy behaviours that lead to weight gain (obesogenic environments). Staff working in schools have a unique insight into the environmental factors that might affect their efforts to support child health and weight management interventions. The aim of this study is to explore the views of staff in relation to the perceived effects of the environmental context in which they deliver a child health promotion intervention.MethodsStaff from five schools involved in delivering the Manchester Healthy Schools programme were interviewed (N=19). These interviews were transcribed verbatim and analysed thematically.ResultsThree themes were produced: opportunities to be healthy; importance of funding, resources and governance; and resources available to households and neighbourhoods.ConclusionThe views of school staff were consistent with themes identified in other relevant literature. Although there were serendipitous opportunities to capitalise on local resources, such as using nearby land and leisure facilities for outdoor physical activities, many barriers relating to local environmental and resource features were reported. Joined up, multi-agency solutions such as place-based approaches might be able to offer schools some resource-based support; however, more research is needed to establish the best way to achieve the best outcomes for children.
Rationale design and efficacy of a smartphone application for improving self-awareness of adherence to edoxaban treatment: study protocol for a randomised controlled trial (adhere app)
Authors: Kim In-Cheol , Lee Ji Hyun , Choi Dong-Ju , Park Sung-Ji , Lee Ju-Hee , Park Sang Min , Kim Mina , Kim Hack-Lyoung , Lee Sunki , Kim In Jai , Choi Seonghoon , Bang Jaehun , Ali Bilal , Hussain Musarrat , Ali Taqdir , Lee Sungyoung 
Published: May 2022

IntroductionHigh adherence to oral anticoagulants is essential for stroke prevention in patients with atrial fibrillation (AF). We developed a smartphone application (app) that pushes alarms for taking medication and measuring blood pressure (BP) and heart rate (HR) at certain times of the day. In addition to drug alarms, the habit of measuring one’s BP and HR may reinforce drug adherence by improving self-awareness of the disease. This pilot study aims to test the feasibility and efficacy of the smartphone app-based intervention for improving drug adherence in patients with AF.Methods and analysisA total of 10 university hospitals in Korea will participate in this randomised control trial. Patients with AF, being treated with edoxaban for stroke prevention will be included in this study. Total of 500 patients will be included and the patients will be randomised to the conventional treatment group (250 patients) and the app conditional feedback group (250 patients). Patients in the app conditional feedback group will use the medication reminder app for medication and BP check alarms. The automatic BP machine will be linked to the smartphone via Bluetooth. The measured BP and HR will be updated automatically on the smartphone app. The primary endpoint is edoxaban adherence by pill count measurement at 3 and 6 months of follow-up. Secondary endpoints are clinical composite endpoints including stroke, systemic embolic event, major bleeding requiring hospitalisation or transfusion, or death during the 6 months. As of 24t November 2021, 80 patients were enrolled.Ethics and disseminationThis study was approved by the Seoul National University Bundang Hospital Institutional Review Board and will be conducted according to the principles of the Declaration of Helsinki. The study results will be published in a reputable journal.Trial registration numberKCT0004754.
Study protocol of the HGCSG1803: a phase II multicentre, non-randomised, single-arm, prospective trial of combination chemotherapy with oxaliplatin, irinotecan and S-1 (OX-IRIS) as first-line treatment for metastatic or relapsed pancreatic cancer
Authors: Nakano Shintaro , Kawamoto Yasuyuki , Yuki Satoshi , Harada Kazuaki , Miyagishima Takuto , Sogabe Susumu , Dazai Masayoshi , Sato Atsushi , Ishiguro Atsushi , Nakamura Michio , Kajiura Shinya , Takahashi Yasuo , Tateyama Miki , Hatanaka Kazuteru , Tsuji Yasushi , Sasaki Takahide , Shindo Yoshiaki , Kobayashi Tomoe , Yokota Isao , Sakamoto Naoya , Sakata Yuh , Komatsu Yoshito 
Published: May 2022

IntroductionCombination chemotherapy with oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) has become one of the standard treatments for metastatic pancreatic cancer. However, the use of FOLFIRINOX requires prolonged infusion. Therefore, we planned to develop a new combination chemotherapy regimen with oxaliplatin, irinotecan and S-1 (OX-IRIS) for advanced pancreatic cancer. In the phase Ⅰ study that was conducted previously, the safety and recommended dose of OX-IRIS were assessed. In this study, we will evaluate the efficacy and safety of OX-IRIS.Methods and analysisThe HGCSG1803 study started as a multicentre, non-randomised, single-arm, prospective, phase II study in December 2019. Eligible subjects were patients with untreated metastatic or relapsed pancreatic cancer. OX-IRIS is administered as follows: 30 min infusion of antiemetic; 2-hour infusion of oxaliplatin (65 mg/m2); 1.5-hour infusion of irinotecan (100 mg/m2) on day 1 and 15 of each 4-week cycle; and oral S-1 (40 mg/m2) twice daily from after dinner on day one to after breakfast on day 15, followed by a 14-day rest, to be repeated every 2 weeks until disease progression, unacceptable toxicity or patient refusal. The primary endpoint is response rate. The secondary endpoints are overall and progression-free survival, safety and dose for each drug. Using a binomial test, a sample size of 40 patients was set with a threshold value of 10% and expected value of 30%. Registration of 40 cases is planned from 18 institutions in Japan.Ethics and disseminationAll the procedures will be conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Declaration of Helsinki of 1964 and its later versions. All the patients will receive written information about the trial and will provide informed consent before enrolment. This trial was approved by the Hokkaido University Certified Review Board (approval No: 018-037).Trial registration numberjRCTs011190008.
Association between work situation and life satisfaction during the COVID-19 pandemic: prospective cohort study in Norway
Authors: Carlsen Ellen Øen , Caspersen Ida H , Ask Helga , Brandlistuen Ragnhild Eek , Trogstad Lill , Magnus Per 
Published: May 2022

ObjectivesTo estimate the impact of being laid off from work, having to work from home or having been diagnosed with COVID-19 on self-reported satisfaction with life.DesignNationwide population-based cohort study.SettingNorway.ParticipantsWe followed more than 80 000 participants in an ongoing cohort study, the Norwegian Mother, Father and Child Cohort Study (MoBa), during the COVID-19 pandemic. We analysed current life satisfaction in April and again in September/October 2020 for subjects whose work situation and infection status had changed.Main outcome measuresSelf-reported satisfaction with life, using a scale from 0 (worst) to 10 (best). We analysed the scale both continuously and as a binary variable (<or ≥6).ResultsTemporary and permanent layoffs, working from a home-based office, and getting a COVID-19 diagnosis were all associated with modestly, but significantly lower concurrent life satisfaction, both in the total on a population level and for subjects experiencing a change in job status between spring and autumn. The associations with change in work situation were stronger for men. For men with permanent job loss, the adjusted odds ratio (OR) for low life satisfaction (<6) was 3.2 (95% CI 2.4 to 4.2) in April and 4.9 (95% CI 3.5 to 6.9) in autumn. Among all, a suspected or confirmed COVID-19 diagnosis was associated with an adjusted OR for low life satisfaction of 1.9 (95% CI 1.6 to 2.3) in spring. The strength of associations between work situation and life satisfaction did not vary much across socio-economic strata, but layoffs were more common among those with low education.ConclusionLayoffs, home office and infection status had clear impact on the quality of life as measured with a global life satisfaction scale. These findings suggest that social differentials in quality of life, are increasing during the pandemic.
Support programmes for parents of children with intellectual disabilities: a scoping review protocol
Authors: Marais Janene Elizabeth , Wegner Lisa , Mthembu Thuli 
Published: May 2022

IntroductionEvidence shows that parents of children with intellectual disabilities experience high levels of stress, emotional challenges and higher levels of depression. Despite these challenges, support for parents has tended to be peripheral in healthcare services of children. There is a lack of research attention given to support programmes for parents of children with intellectual disabilities despite the importance of parenting for the optimal development of children with intellectual disabilities.Methods and analysisThis review will follow the Joanna Briggs Institute scoping review methods manual. The search for relevant studies will be in Medline (EbscoHost), PsychARTICLES, PubMed, CINHAL, Academic Search Complete and SAePublications. Reference mining of full review studies will be conducted. A three-step search strategy will be used, including the use of information management software to manage the search results and to remove duplications. An independent reviewer will extract data using a data extraction tool. Furthermore, another reviewer will screen the included articles in conjunction with the results of the scoping review. The data extracted will be presented in a tabular format with a narrative summary related to the key findings.Ethics and disseminationThis scoping review has received ethical approval (BM20/4/26). A summary of the findings of the study will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding of the support programmes available to parents of children with intellectual disabilities. This could be the first step in highlighting the gaps and future directions for the development and implementation of support programmes for parents of children with intellectual disabilities.Registration detailsMarais JE, Wegner L, Mthembu T. Support programs for parents of children with intellectual disabilities: a scoping review [Internet].OSF; 2021. Available from:https://osf.io/en6cs/.
Rescuing Cancer Immunity by Plasma Exchange in Metastatic Melanoma (ReCIPE-M1): protocol for a single-institution, open-label safety trial of plasma exchange to clear sPD-L1 for immunotherapy
Authors: Davidson Tara M , Foster Nathan , Lucien Fabrice , Markovic Svetomir , Dong Haidong , Winters Jeffrey L , Park Sean S , Orme Jacob J 
Published: May 2022

BackgroundPatients with metastatic melanoma rely on PD-(L)1 immunotherapy, but only one-third of patients experience treatment response and all initial responders eventually develop resistance. Tumour-derived extracellular vesicles expressing Programmed death ligand 1 (evPD-L1) and soluble Programmed death ligand 1 (sPD-L1) in peripheral blood of patients with melanoma limit PD-(L)1 immunotherapy and correlate with poor survival. Therapeutic plasma exchange (TPE) removes immunosuppressive evPD-L1 and sPD-L1. We hypothesise that TPE may rescue and restore antimelanoma immunity.MethodsIn this two-arm study, 60 patients with metastatic melanoma progressing on checkpoint inhibition will be accrued. All patients will undergo radiotherapy on days 1–5 (at least one measurable lesion will not be irradiated) and ongoing checkpoint inhibition on day 8 and every 2–3 weeks per standard of care. Patients with baseline sPD-L1 level of ≥1.7 ng/mL and adequate clinical capacity will be enrolled in the TPE intervention arm and will undergo TPE on days 5–7, in addition to standard of care radiotherapy and immunotherapy. Other patients will remain in the standard of care arm.The primary endpoint of the study is to evaluate safety. Secondary endpoints include kinetics of sPD-L1 and evPD-L1 and clinical response by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Study registered at ClinicalTrials.gov (NCT04581382).Ethics and disseminationThis trial has been approved by the Mayo Clinic Institutional Review Board. It will assess the safety and feasibility of TPE in improving outcomes for PD-(L)1 inhibitor immunotherapy in melanoma. Data will be maintained on a secure database with deidentified patient information. Data will be shared on publication in a peer-reviewed journal without the aid of professional writers. If successful, this trial will lay the ground for phase II studies that will include cancer treated with PD-(L)1 inhibitors which may benefit from TPE such as renal, bladder and lung cancers.Trial registration numberNCT04581382.
Treatment of unresectable locally advanced pancreatic cancer with percutaneous irreversible electroporation (IRE) following initial systemic chemotherapy (LAP-PIE) trial: study protocol for a feasibility randomised controlled trial
Authors: Rai Zainab L , Ranieri Veronica , Palmer Daniel H , Littler Peter , Ghaneh Pauleh , Gurusamy Kurinchi , Manas Derek , Pizzo Elena , Psarelli Eftychia Eirini , Gilmore Roopinder , Peddu Praveen , Bartlett David C , de Liguori Carino Nicola , Davidson Brian R 
Published: May 2022

BackgroundApproximately 30% of patients with pancreas cancer have unresectable locally advanced disease, which is currently treated with systemic chemotherapy. A new treatment option of irreversible electroporation (IRE) has been investigated for these patients since 2005. Cohort studies suggest that IRE confers a survival advantage, but with associated, procedure-related complications. Selection bias may account for improved survival and there have been no prospective randomised trials evaluating the harms and benefits of therapy. The aim of this trial is to evaluate the feasibility of a randomised comparison of IRE therapy with chemotherapy versus chemotherapy alone in patients with locally advanced pancreatic cancer (LAPC).Methods and analysisEligible patients with LAPC who have undergone first-line 5-FluoroUracil, Leucovorin, Irinotecan and Oxaliplatin chemotherapy will be randomised to receive either a single session of IRE followed by (if indicated) further chemotherapy or to chemotherapy alone (standard of care). Fifty patients from up to seven specialist pancreas centres in the UK will be recruited over a period of 15 months. Trial follow-up will be 12 months. The primary outcome measure is ability to recruit. Secondary objectives include practicality and technical success of treatment, acceptability of treatment to patients and clinicians and safety of treatment. A qualitative study has been incorporated to evaluate the patient and clinician perspective of the locally advanced pancreatic cancer with percutaneous irreversible electroporation trial. It is likely that the data obtained will guide the structure, the primary outcome measure, the power and the duration of a subsequent multicentre randomised controlled trial aimed at establishing the clinical efficiency of pancreas IRE therapy. Indicative procedure-related costings will be collected in this feasibility trial, which will inform the cost evaluation in the subsequent study on efficiency.Ethics and disseminationThe protocol has received approval by London-Brent Research Ethics Committee reference number 21/LO/0077.Results will be analysed following completion of trial recruitment and follow-up. Results will be presented to international conferences with an interest in oncology, hepatopancreaticobiliary surgery and interventional radiology and be published in a peer-reviewed journal.Trial registration numberISRCTN14986389.