bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association of smoking reduction and mortality: protocol for a systematic review and meta-analysis of longitudinal observational studies
Authors: Aubin Henri-Jean , Ali Oicheih Laetitia , Gabriel Sonia , Berlin Ivan 
Published: January 2021

IntroductionStrong evidence shows that smoking cessation decreases mortality. Much less is known regarding the association between reduction in cigarettes per day (CPD) and mortality. The primary aim of this systematic review is to compare the mortality risk between smokers achieving a sustained reduction of CPD and smokers maintaining their smoking rate. The secondary aims are to compare the mortality risk between smokers achieving complete, sustained smoking cessation and (1) smokers maintaining their smoking rate and (2) smokers who achieved a sustained reduction in smoking rate.Methods and analysisMEDLINE, Web of Sciences and Embase will be searched using a prespecified search strategy, up to 23 November 2020, and will be limited to studies published in English and in French. Longitudinal observational studies using individual data including smokers with at least two distant CPD assessments and a follow-up period of systematic mortality data recording will be included. The main outcome will be the all-cause mortality. The secondary outcome will be specific mortality. The Newcastle-Ottawa Scale will be used to assess the risk of bias of individual studies. Outcomes will be analysed using HRs. All other outcomes’ effect size reported in included studies will be converted in HRs using validated methods.Ethics and disseminationWe intend to publish the results of our review in a peer-reviewed journal and to present the findings at national and international meetings and conferences.PROSPERO registration numberCRD42019138354.
Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care
Authors: Morris Rebecca L , Gallacher Kay , Hann Mark , Rolfe Carly , Small Nicola , Giles Sally J , Sanders Caroline , Campbell Stephen M 
Published: January 2021

IntroductionPatients and carers should be active partners in patient safety with healthcare professionals and be empowered to use personalised approaches to identify safety concerns and work together to prevent them. This protocol paper details a study to examine the feasibility of a multicomponent intervention to involve patients and/or carers in patient safety in primary care in the UK.Methods and analysisThis is a two-phase, non-randomised feasibility mixed methods pragmatic study of a patient safety guide for primary care (PSG-PC). 8 general practices will recruit 120 patient and/or carer participants. All patient and/or carer participants will receive the PSG-PC. It will examine the feasibility and acceptability of the PSG-PC in primary care settings in patients aged 18 years or older who attend appointments at general practice with health professionals four or more times per year as either patients or carers. It will identify secondary outcomes for improving patient safety, health status and patient empowerment, and reducing health service utilisation over 6 months between baseline and 6-month follow-ups. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients and practices will be needed. The study will be undertaken between January 2020 and September 2021.Ethics and disseminationEthical approval was obtained from the National Health Service London-West London and Gene Therapy Advisory Committee Research Ethics Committee (reference: 19/LO/1289). Research findings will be disseminated with participating general practices and shared in a range of different ways to engage different audiences, including presenting at international and national conferences, publishing in open-access, peer-reviewed journals and facilitating dissemination workshops within local communities with patients, carers and healthcare professionals.Trial registration numberISRCTN90222092.
Medication adherence, self-efficacy and health literacy among patients with glaucoma: a mixed-methods study protocol
Authors: Achilleos Maria , Merkouris Anastasios , Charalambous Andreas , Papastavrou Evridiki 
Published: January 2021

Introduction
As the world population ages, glaucoma is becoming an increasingly significant cause of blindness. A key component in the management of glaucoma is the use of prescribed medications and the adherence to treatment. However, there is evidence of low adherence to prescribed medication in chronic diseases, such as glaucoma. This study aims to explore the level of medication adherence, self-efficacy, social support and health literacy among the patients with glaucoma and to determine if there are any correlations between them. The ultimate aim is to use the information to develop an educational programme for patients with glaucoma at a later stage.

Methods and analysis
This is a mixed-methods study which includes two stages: a descriptive study (stage 1) and focus group discussions (stage 2). Sample: Patients with glaucoma or ocular hypertension, using at least one kind of drops, from two ophthalmology clinics. Selected measures include: The Glaucoma Treatment Compliance Assessment Tool, The European Health Literacy Survey Questionnaire, The Glaucoma Medication Self-Efficacy Questionnaire and The Multidimensional Scale of Perceived Social Support. Two focus groups will be used for the collection of qualitative data, aiming to enrich the study with the patients’ experiences. The data will be analysed with SPSS, using descriptive and inferential statistics for stage 1 whereas content analysis will be used for the data from the focus group discussions (stage 2).

Ethics and dissemination
Permission to conduct the study was received from the National Bioethics Committee and the board of management of the two ophthalmology clinics. All participants will be informed fully on the purpose and methods of the study. Consent forms will be signed and at any time participants will have the right to withdraw. Confidentiality and the protection of data will be respected at all times.
“I just wear it and I become normal”: a qualitative study of Tanzanian women’s experiences with long-term vaginal pessary use for stress urinary incontinence
Authors: Nissen Karina Holm , Shayo Benjamin C , Rasch Vibeke , Masenga Gileard G , Linde Ditte Søndergaard 
Published: January 2021

IntroductionPrevious research has shown that vaginal pessaries are a cost-effective treatment for women worldwide suffering from stress urinary incontinence. However, little is known about African women’s experiences with vaginal pessary use. The aim of this study was to understand the experiences of vaginal pessary use among Tanzanian women who had received long-term pessary treatment for stress urinary incontinence.Methods15 semi-structured, individual interviews were conducted over a 2-month period in 2019 with Tanzanian women living in the Kilimanjaro Region who suffered from stress urinary incontinence and who had been using a pessary for at least 18 months. The interview transcripts were analysed using qualitative content analysis.ResultsThe primary motivation for seeking treatment were discomfort from symptoms, social consequences and low quality of life. Perceived benefits from pessary use included improved quality of life with reacquired abilities to perform daily activities, participate in social gatherings, feeling symptom relief and improved sexual relations. Further, some women saw pessary treatment as superior to other locally available treatment options. Perceived barriers for pessary use included shame, husband’s disapproval, limited access to treatment and lack of knowledge among the women as well as healthcare personnel.ConclusionVaginal pessaries are well-perceived as a long-term treatment method among Tanzanian women suffering from stress urinary incontinence. This method may have potential to be implemented large scale in Tanzania if combined with basic health education.
Diagnostic and predictive accuracy of the Clinical Frailty Scale among hospitalised older medical patients: a systematic review and meta-analysis protocol
Authors: Leahy Aoife , O’Connor Margaret , Condon Jennifer , Heywood Sarah , Shanahan Elaine , Peters Catherine , Galvin Rose 
Published: January 2021

IntroductionFrailty is a common condition affecting older adults and is associated with increased mortality and adverse outcomes. Identification of older adults at risk of adverse outcomes is central to subsequent resource planning and targeted interventions. This systematic review and meta-analysis will examine the: (1) diagnostic accuracy of the Clinical Frailty Scale (CFS) in identifying hospitalised adults ≥65 years with frailty and a medical diagnosis compared with the reference standard Frailty Index or Frailty Phenotype and (2) predictive value of the CFS in determining those at increased risk of subsequent adverse outcomes.Methods and analysisWe will include cross-sectional, retrospective and prospective cohort studies, and randomised controlled trials that assess either the diagnostic accuracy of the CFS when compared with the reference standard Frailty Index/Frailty Phenotype or the predictive validity of the CFS to predict subsequent adverse outcomes in hospitalised adults over 65 years with medical complaints. Adverse outcomes include falls, functional decline, unplanned Emergency Department attendance, emergency rehospitalisation, nursing home admission or death. A systematic search will be conducted in Embase, AMED, MEDLINE (Ebsco, Ovid, Pubmed), CINAHL, PsycINFO, Cochrane Library. Studies will be limited to those published from 2005 to 30 October 2019. Two independent reviewers will screen all titles and abstracts to identify relevant studies. The methodological quality of studies will be independently assessed using the Quality Assessment of Diagnostic Accuracy Studies-2. A CFS score of >4 will be used to identify frailty. We will construct 2×2 tables and determine true positives, true negatives, false positives and false negatives for each study when compared with the reference standard and for each adverse outcome. A bivariate random effects model will be applied to generate pooled summary estimates of sensitivity and specificity.Ethics and disseminationEthical approval is not required for this systematic review. We will disseminate our findings through a peer-reviewed journal.
Investigating the use of a two-stage attention-aware convolutional neural network for the automated diagnosis of otitis media from tympanic membrane images: a prediction model development and validation study
Authors: Cai Yuexin , Yu Jin-Gang , Chen Yuebo , Liu Chu , Xiao Lichao , M Grais Emad , Zhao Fei , Lan Liping , Zeng Shengxin , Zeng Junbo , Wu Minjian , Su Yuejia , Li Yuanqing , Zheng Yiqing 
Published: January 2021

ObjectivesThis study investigated the usefulness and performance of a two-stage attention-aware convolutional neural network (CNN) for the automated diagnosis of otitis media from tympanic membrane (TM) images.DesignA classification model development and validation study in ears with otitis media based on otoscopic TM images. Two commonly used CNNs were trained and evaluated on the dataset. On the basis of a Class Activation Map (CAM), a two-stage classification pipeline was developed to improve accuracy and reliability, and simulate an expert reading the TM images.Setting and participantsThis is a retrospective study using otoendoscopic images obtained from the Department of Otorhinolaryngology in China. A dataset was generated with 6066 otoscopic images from 2022 participants comprising four kinds of TM images, that is, normal eardrum, otitis media with effusion (OME) and two stages of chronic suppurative otitis media (CSOM).ResultsThe proposed method achieved an overall accuracy of 93.4% using ResNet50 as the backbone network in a threefold cross-validation. The F1 Score of classification for normal images was 94.3%, and 96.8% for OME. There was a small difference between the active and inactive status of CSOM, achieving 91.7% and 82.4% F1 scores, respectively. The results demonstrate a classification performance equivalent to the diagnosis level of an associate professor in otolaryngology.ConclusionsCNNs provide a useful and effective tool for the automated classification of TM images. In addition, having a weakly supervised method such as CAM can help the network focus on discriminative parts of the image and improve performance with a relatively small database. This two-stage method is beneficial to improve the accuracy of diagnosis of otitis media for junior otolaryngologists and physicians in other disciplines.
Which Exercise for Low Back Pain? (WELBack) trial predicting response to exercise treatments for patients with low back pain: a validation randomised controlled trial protocol
Authors: Macedo Luciana G , Hodges Paul W. , Bostick Geoff , Hancock Mark , Laberge Maude , Hanna Steven , Spadoni Greg , Gross Anita , Schneider Julia 
Published: January 2021

IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.
Knowledge of symptoms, time to presentation and barriers to medical help-seeking among Omani women diagnosed with breast cancer: a cross-sectional study
Authors: Al-Azri Mohammed , Al-Baimani Khalid , Al-Awaisi Huda , Al-Mandhari Zahid , Al-Khamayasi Jasem , Al-Lawati Yaseen , Panchatcharam Sathiya Murthi 
Published: January 2021

ObjectiveTo identify knowledge of breast cancer (BC) symptoms, time taken to consult a doctor and factors contributing to delays in medical help-seeking.DesignA cross-sectional study of Omani women diagnosed with BC.SettingThe two main teaching hospitals in Oman: Royal Hospital and Sultan Qaboos University Hospital.ParticipantsAdult Omani women recently diagnosed with BC.ToolsThe Breast Module of the Cancer Awareness Measure and the International Cancer Benchmarking Partnership questionnaire were used to collect data.ResultsA total of 300 women with BC participated (response rate: 91.0%). The mean age at diagnosis was 43.0±12.50 years and 33.5% were diagnosed at stage III or IV. Although most women (74.4%) recognised breast/armpit lumps to be a symptom of BC, less than half identified other symptoms, including breast/armpit pain (44.0%), changes in the position of the nipple (36.2%), redness (31.7%), fatigue (26.3%), weight loss (23.4%) and loss of appetite (20.8%). While most (91.6%) were aware that BC could be cured if detected early, only 66.4% sought medical help within a month of developing symptoms. Initial responses to symptoms included informing husbands (40.2%) or family members (36.5%). Barriers to seeking medical help included feeling scared (68.9%) and worried about what the doctor might find (62.8%). Highly educated women were more likely to recognise the following as BC symptoms: changes in nipple position (OR: 0.16, 95% CI 0.03 to 0.81), breast pain (OR: 0.10, 95% CI 0.01 to 0.86) and unexplained weight loss (OR: 0.18, 95% CI 0.04 to 0.88) (all p<0.05).ConclusionsAlthough many Omani women with BC were aware of the importance of early diagnosis, most demonstrated inadequate knowledge of symptoms, did not prioritise seeking medical help and reported emotional barriers to help-seeking. More educational measures are needed to improve symptom recognition and address help-seeking barriers to minimise delays in diagnosis.
358 The relationship between serum biomarkers of traumatic brain injury (TBI) and magnetic resonance imaging (MRI) in patients discharged from the emergency department (ED) with a normal acute CT
Authors: Whitehouse Daniel , Richter Sophie , Czeiter Endre , Winzeck Stefan , Kornaropoulos Evgenios N , Das Tilak , Vyvere Thijs Vande , Verheyden Jan , Williams Guy B , Correia Marta M , Wang Kevin , Menon David K , Büki András , Newcombe Virginia FJ ,   CENTER-TBI MRI Sub-Study Participants and Investigators
Published: January 2021

Aims/Objectives/BackgroundCT remains the neuroimaging of choice in patients with TBI, however the relative lack of sensitivity as compared to MRI for certain traumatic lesion types, including diffuse axonal injury (DAI), could lead to missing important intracranial findings.1 Serum biomarkers may allow screening of ED patients, highlighting those who will benefit from MRI and offer a pathway for further imaging in mild TBI patients.Methods/DesignPatients discharged from ED with a panel of 6 biomarkers (GFAP, NFL, NSE, S100B, t-tau and UCH-L1), acute CT < 24 hrs of injury and acute MRI, were extracted from the CENTER-TBI core dataset.2 Mann Whitney U test to compare median biomarker levels in relation to +ve or –ve MRI. Unadjusted Area Under ROC (AUC) calculated for detection of MRI abnormality.Results/Conclusions80 patients met inclusion criteria, 45 (56%) male, median age 36.5 yr [IQR 24.5–51.3], median GCS 15 [IQR 15–15]. 17/80 (21.25%) had MRI abnormalities. 1 intraventricular haemorrhage, 2 traumatic subarachnoid haemorrhages, 3 intraparenchymal haemorrhages and 13 DAI. Of the biomarkers (median): GFAP (0.28 vs 1.88 ng/ml, p = 0.002), NSE (13.08 vs 15.19 ng/ml, p= 0.013), S100B (0.06 vs 0.12 µg/L, p=0.002), t-tau (0.82 vs 1.58 pg/ml, p=0.002), UCH-L1 (22.33 vs 57.68 pg/ml p<0.001) were significantly raised in patients with MRI abnormality. Serum NFL concentration was not significant (5.80 vs 8.18 pg/ml, p=0.096). AUC [95% CI] for detection of MRI abnormality: GFAP (0.75 [0.61–0.89]), NFL (0.63 [0.48–0.79]), NSE (0.70 [0.55–0.85]), S100B (0.75 [0.61–0.90]), tau (0.75 [0.61–0.89]), UCH-L1 (0.82 [0.69–0.95])The results demonstrate potential utility in several acute serum biomarkers for screening of patients with a negative CT. Fair discrimination for detection of MRI pathology in this cohort was demonstrated by GFAP, NSE, S100B, total tau and UCH-L1. Further prospective analysis is required to assess the utility for biomarkers to determine MRI requirement in an ED population.ReferencesMetting Z, Rödiger LA, De Keyser J, et al. Structural and functional neuroimaging in mild-to-moderate head injury. Lancet Neurol 2007;6:699–710. doi:10.1016/S1474-4422(07)70191-6Maas AIR, Menon DK, Steyerberg EW, et al. Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI): A prospective longitudinal observational study. Neurosurgery 2015;76:67–80. doi:10.1227/NEU.0000000000000575
122 Penthrox: a service evaluation for methoxyflurane use in an emergency department setting
Authors: Ingham Jack , Roberts Gareth 
Published: January 2021

Aims/Objectives/BackgroundIn Manchester Royal Infirmary, a major trauma centre, there are many patient presentations which require fast acting analgesia. Often these presentations, such as shoulder dislocations, require conscious sedation in order to be safely, effectively and humanely treated.Penthrox was introduced to the emergency department in December 2019. It was hoped that it would be used as an alternative to conscious sedation in patients requiring procedures. It was postulated that by having another analgesic method available, patients would have a greater likelihood of being discharged without the requirement for conscious sedation. This would therefore not require waiting for a Resus bed and therefore reduce length of stay in the department.Methods/DesignData was prospectively gathered for patients who received Penthrox in the months of December 2019 to July 2020 using a questionnaire that was filled in by clinicians.Audit forms were collated as well as attendance data (including length of stay) for shoulder dislocations Dec 19 - Feb 19.Pain scores were subjectively scored out of 10 and, using t-tests, compared for significance.Length of stay, checklist completion, progression to concious sedation, further pain relief requirements and indications were also analysed.Results/ConclusionsSubjectively reported pain scores were significantly reduced when comparing before and during procedure (<0.001, 95% CI of a reduction of 1.959 to 5.113) and also before and 10 mins after procedure (p= <0.001, 95% CI 3.96 to 6.33). The distributions of pain scores are demonstrated in the violin plot below.There was no significant association between checklist completion and progression to concious sedation.Difference between length of stay did not quite meet statistical significance (mean = 163.62 using penthrox, mean = 225 without penthrox. p = 0.06).There were no significant adverse events.In conclusion Penthrox is a safe and welcome addition to the ED formulary.