bluuebunny/crossref_metadata_2025_split huggingface dataset:
Systematic review protocol for assessing central auditory functions of Alzheimer’s disease and its preclinical stages
Authors: Jayakody Dona M P , Tarawneh Hadeel Y , Menegola Holly K , Yiannos Jessica M , Friedland Peter L , Wilson Wayne J , Martins Ralph N , Sohrabi Hamid R 
Published: June 2020

IntroductionA number of studies have reported an association between peripheral hearing impairment, central auditory processing and Alzheimer’s disease (AD) and its preclinical stages. Both peripheral hearing impairment and central auditory processing disorders are observed many years prior to the clinical manifestation of AD symptoms, hence, providing a long window of opportunity to investigate potential interventions against neurodegenerative processes. This paper outlines the protocol for a systematic review of studies examining the central auditory processing functions in AD and its preclinical stages, investigated through behavioural (clinical assessments that require active participation) central auditory processing tests.Methods and analysisWe will use the keywords and Medical Subject Heading terms to search the following electronic databases: MEDLINE, PsychINFO, PubMed, Scopus, EMBASE and CINAHL Plus. Studies including assessments of central auditory function in adults diagnosed with dementia, AD and its preclinical stages that were published before 8 May 2019 will be reviewed. This review protocol will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. Data analysis and search results will be reported in the full review. This manuscript has designed the protocols for a systematic review that will identify the behavioural clinical central auditory processing measures that are sensitive to the changes in auditory function in adults with AD and its preclinical stages. Such assessments may subsequently help to design studies to examine the potential impact of hearing and communication rehabilitation of individuals at risk of AD.Ethics and disseminationEthical approval is not required as this manuscript only reports the protocols for conducting a systematic review as primary data will only be reviewed and not be collected. The results of this systematic review will be disseminated through publication and in scientific conferences.PROSPERO registration numberCRD42017078272.
Acupuncture combined with medication for opioid use disorder in adults: a protocol for systematic review and meta-analysis
Authors: Chen Zhihan , Wang Rui , Zhang Min , Wang Yitong , Ren Yulan 
Published: June 2020

IntroductionOpioid use disorder (OUD) is a worldwide health problem. Clinical trials indicated that acupuncture combined with medication is effective in OUD, however, there are different conclusions presented by previous trials. This study is designed to evaluate the efficacy and safety of acupuncture combined with medication in OUD.Methods and analysisPubMed, CENTRAL, Embase, Web of Science, CINAHL, PsycINFO, ProQuest Dissertation and Theses, AMED, OpenGrey, Clinicaltrials.gov and who.int/trialsearch will be searched in September 2019 without a language restriction. Randomised controlled trials (RCTs) and quasi-RCTs which included participants with OUD receiving acupuncture therapy combined with medication versus control group will be included in this study. Two reviewers will independently screen studies, extract data, assess risk of bias by the Cochrane risk of bias assessment tool and assess quality of evidence by Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Any disagreements will be arbitrated by the third reviewer. Data synthesis and analysis will be conducted by using RevMan V.5.3. Subgroup analyses, sensitivity analysis, meta-regression and reporting bias assessment will be conducted if necessary and appropriate.Ethics and disseminationOn account of the nature of this systematic review and meta-analysis, ethical approval is not required. The results will be published in a peer-reviewed journal.PROSPERO registration numberCRD42019123436.
Psychometric properties of an Arabic-language health literacy assessment scale for adolescents (HAS-A-AR) in Palestine
Authors: Sarhan Mohammed B A , Shannon Harry S , Fujiya Rika , Jimba Masamine , Giacaman Rita 
Published: June 2020

ObjectivesHealth literacy research in Palestine is limited, and a locally validated tool for use among adolescents has been unavailable until now. Therefore, this study aimed to adapt health literacy assessment scale for adolescents (HAS-A) into Arabic language (HAS-A-AR) and Palestinian context and to investigate its psychometric properties.DesignWe conducted a cross-sectional household survey using a stratified random sample and household face-to-face interviews.Setting and participantsWe conducted 1200 interviews with sixth to ninth graders in the Ramallah and al-Bireh district of the West Bank, Palestine in 2017.MethodsWe translated and adapted HAS-A to be sensitive to the Palestinian context and tested its psychometric properties. We evaluated face and content validity during the back-translation process and checked for construct validity through exploratory factor analysis (EFA). We tested for internal consistency using Cronbach’s alpha, MacDonald’s omega test and the greatest lower bound (GLB). Furthermore, we calculated the scale’s average inter-item correlation.ResultsEFA revealed that HAS-A-AR has a similar structure to the original HAS-A. It extracted three factors (communication, confusion and functional health literacy) whose eigenvalues were >1. Together they explained 57% of the total variance. The proportions of adolescents with high levels of communication, confusion and functional health literacy were 45%, 68% and 80%, respectively. Cronbach’s alpha, MacDonald’s omega and the GLB values for communication subscale were 0.87, 0.88 and 0.90, and they were 0.78, 0.77 and 0.79 for confusion subscale, while they were 0.77, 0.77 and 0.80, respectively, for functional healthy literacy subscale. The average inter-item correlation for the subscales ranged between 0.36 and 0.59.ConclusionHAS-A-AR is a valid and reliable health literacy measuring instrument with appropriate psychometric properties. HAS-A-AR is currently available for use among adolescents in Palestine and the surrounding Arab countries with similar characteristics as Palestine, including language, culture and political instability.
Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol
Authors: Khan Mohammed I , Holek Matthew , Bdair Faris , Mbuagbaw Lawrence , Eldridge Sandra M , Chan Claire L , Campbell Michael J , Bond Christine M , Hopewell Sally , Lancaster Gillian A , Thabane Lehana 
Published: June 2020

IntroductionPilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting.The primary objective of this study is to assess whether pilot/feasibility studies submitted for ethics approval to a research ethics board transparently communicate the purpose of the study to participants through their informed consent practice. A highly transparent consent practice entails the consent documents communicate: (1) the term ‘pilot’ or ‘feasibility’ in the title; (2) the definition of a pilot/feasibility study; (3) the primary objectives of the study are to assess feasibility; (4) the specific feasibility objectives; and (5) the criteria for the study to successfully lead to the main study. The secondary objectives are to assess whether there is a difference between submitted and revised versions of the consent documents (revisions are made to obtain research ethics approval), to determine factors associated with transparent consent practices and to assess the consistency with which pilot and feasibility studies assess feasibility outcomes as their primary objectives.Methods and analysisThis is a retrospective review of informed consent information for pilot/feasibility studies submitted to the Hamilton integrated Research Ethics Board, Canada. We will look at submitted and revised consent documents for pilot/feasibility studies submitted over a 14-year period. We will use descriptive statistics to summarise data, reporting results as percentages with 95% CIs, and conduct logistic regression to determine characteristics associated with transparent consent practices.Ethics and disseminationThe study protocol was approved by the Hamilton integrated Research Ethics Board, and the results of this study will be submitted for publication in a peer-reviewed journal.
Pulse oximeter with integrated management of childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia: results from a cluster-randomised controlled trial
Authors: Tesfaye Solomon H , Gebeyehu Yabibal , Loha Eskindir , Johansson Kjell Arne , Lindtjørn Bernt 
Published: June 2020

ObjectiveTo assess whether pulse oximetry improves health workers’ performance in diagnosing severe childhood pneumonia at health centres in Southern Ethiopia.DesignParallel cluster-randomised trial.SettingGovernment primary health centres.ParticipantsTwenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia. Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019.Intervention armUse of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter.Control armUse of the IMCI algorithm only.Primary and secondary outcome measuresThe primary outcome was the proportion of children diagnosed with severe pneumonia. Secondary outcomes included referred cases of severe pneumonia and treatment failure on day 14 after enrolment.ResultTwenty-four health centres were randomised into intervention (928 children) and control arms (876 children). The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm. After adjusting for differences in baseline variables children in the intervention arm were more likely to be diagnosed as severe pneumonia cases as compared with those in the control arm (adjusted OR: 5.4, 95% CI 2.0 to 14.3, p=0.001).ConclusionThe combined use of IMCI and pulse oximetry in health centres increased the number of diagnosed severe childhood pneumonia.Trial registration numberPACTR201807164196402.
Is virtual reality effective to teach prevention of surgical site infections in the operating room? study protocol for a randomised controlled multicentre trial entitled VIP Room study
Authors: Masson Claire , Birgand Gabriel , Castro-Sánchez Enrique , Eichel Vanessa Maria , Comte Alexa , Terrisse Hugo , Rubens-Duval Brice , Gillois Pierre , Albaladejo Pierre , Picard Julien , Bosson Jean Luc , Mutters Nico Tom , Landelle Caroline 
Published: June 2020

IntroductionSome surgical site infections (SSI) could be prevented by following adequate infection prevention and control (IPC) measures. Poor compliance with IPC measures often occurs due to knowledge gaps and insufficient education of healthcare professionals. The education and training of SSI preventive measures does not usually take place in the operating room (OR), due to safety, and organisational and logistic issues. The proposed study aims to compare virtual reality (VR) as a tool for medical students to learn the SSI prevention measures and adequate behaviours (eg, limit movements…) in the OR, to conventional teaching.Methods and analysisThis protocol describes a randomised controlled multicentre trial comparing an educational intervention based on VR simulation to routine education. This multicentre study will be performed in three universities: Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany). Third-year medical students of each university will be randomised in two groups. The students randomised in the intervention group will follow VR teaching. The students randomised in the control group will follow a conventional education programme. Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups. The written exam will be the same in the three countries. Secondary outcomes will be satisfaction and students’ progression for the VR group. The data will be analysed with intention-to-treat and per protocol.Ethics and disseminationThis study has been approved by the Medical Education Ethics Committee of the London Imperial College (MEEC1920-172), by the Ethical Committee for the Research of Grenoble Alpes University (CER Grenoble Alpes-Avis-2019-099-24-2) and by the Ethics Committee of the Medical Faculty of Heidelberg University (S-765/2019). Results will be published in peer-reviewed medical journals, communicated to participants, general public and all relevant stakeholders.
A novel patient-reported outcome monitoring with clinical feedback system in bariatric surgery care: study protocol, design and plan for evaluation
Authors: Hegland Pål André , Aasprang Anny , Kolotkin Ronette L , Moltu Christian , Tell Grethe S , Andersen John Roger 
Published: June 2020

BackgroundConsultations before and after bariatric surgery should include structured assessments of patients’ health-related quality of life (HRQOL) and mental health. One way to conduct this assessment is to implement patient-reported outcome monitoring with a clinical feedback system (PRO/CFS).AimWe will explore patients’ and healthcare professionals’ experiences when a PRO/CFS is an integrated part of bariatric surgery care.Methods and analysesThis is a design paper in which a PRO/CFS will be implemented in two bariatric outpatient clinics. All patients who have an appointment with a healthcare professional prior to, and 3 and 12 months after surgery, will be asked to complete six digital questionnaires measuring HRQOL, mental health, bowel symptoms and eating self-efficacy prior to each consultation. A digital summary report generated from the patient’s responses will form the basis for the clinical consultation. A team of patient representatives, healthcare professionals and researchers will be involved in all phases of designing the PRO/CFS to ensure its relevance for clinical consultations. The patients’ experiences will be explored with a generic 12-item questionnaire, developed for use in outpatient clinics, prior to and 12 months after bariatric surgery. We will conduct focus-group interviews with patients and healthcare professionals to explore their experiences when PRO/CFS is integrated into the consultations.Ethics and disseminationWritten informed consent will be obtained for all participants in the study. The project is approved by the Norwegian Centre for Research Data, Department of Data Protection Services (ref. no. 282738). The project has also undergone Data Protection Impact Assessments, both at Førde Hospital Trust and at St. Olav Hospital (registration no. 2016/3912). Data from the qualitative and quantitative studies will be kept in de-identified form in a secured research database, and the findings will be published in international peer-reviewed journals and presented at scientific conferences.
Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial
Authors: Tommiska Pihla , Raj Rahul , Schwartz Christoph , Kivisaari Riku , Luostarinen T , Satopää Jarno , Taimela Simo , Järvinen Teppo , Ranstam Jonas , Frantzen Janek , Posti Jussi , Luoto Teemu M , Leinonen Ville , Tetri Sami , Koivisto Timo , Lönnrot Kimmo 
Published: June 2020

IntroductionChronic subdural haematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimise the risk of symptomatic recurrences. In the past, reoperation rates as high as 20%–30% were described for CSDH recurrences. However, following the introduction of subdural drainage, reoperation rates dropped to approximately 10%. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural drainage. Yet, the role of intraoperative irrigation has not been established. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery could be carried out faster and more safely by omitting the step of irrigation. The aim of this multicentre randomised controlled trial is to study whether no intraoperative irrigation and subdural drainage results in non-inferior outcome compared with intraoperative irrigation and subdural drainage following burr-hole craniostomy of CSDH.Methods and analysisThis is a prospective, randomised, controlled, parallel group, non-inferiority multicentre trial comparing single burr-hole evacuation of CSDH with intraoperative irrigation and evacuation of CSDH without irrigation. In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. The predefined non-inferiority margin for the primary outcome is 7.5%. To achieve a 2.5% level of significance and 80% power, we will randomise 270 patients per group. Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.Ethics and disseminationThe study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District (HUS/3035/2019 §238) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.Trial registration numberNCT04203550
Comparison of antibiotic prescribing records in two UK primary care electronic health record systems: cohort study using CPRD GOLD and CPRD Aurum databases
Authors: Gulliford Martin C , Sun Xiaohui , Anjuman Thamina , Yelland Eleanor , Murray-Thomas Tarita 
Published: June 2020

ObjectivesWe aimed to evaluate recording of antibiotic prescribing from two primary care electronic health record systems.DesignCohort study.SettingUK general practices contributing to the Clinical Practice Research Datalink (CPRD) databases: CPRD GOLD (Vision data) and CPRD Aurum (EMIS data). English CPRD GOLD general practices were analysed as a subgroup, as all CPRD Aurum practices were located in England.Participants158 305 patients were randomly sampled from CPRD Aurum and 160 394 from CPRD GOLD.Outcome measuresAntibiotic prescriptions in 2017 were identified. Age-standardised and sex-standardised antibiotic prescribing rates per 1000 person years were calculated. Prescribing of individual antibiotic products and associated medical diagnoses was evaluated.ResultsThere were 101 360 antibiotic prescriptions at 883 CPRD Aurum practices and 112 931 prescriptions at 290 CPRD GOLD practices, including 112 general practices in England. The age-standardised and sex-standardised antibiotic prescribing rate in 2017 was 512.6 (95% CI 510.4 to 514.9) per 1000 person years in CPRD Aurum and 584.3 (582.1 to 586.5) per 1000 person years in CPRD GOLD (505.2 (501.6 to 508.9) per 1000 person years if restricted to practices in England). The 25 most frequently prescribed antibiotic products were similar in both databases. One or more medical codes were recorded on the same date as an antibiotic prescription for 72 989 (74%) prescriptions in CPRD Aurum, 84 756 (78%) in CPRD GOLD and 28 471 (78%) for CPRD GOLD in England. Skin, respiratory and genitourinary tract infections were recorded for 39 035 (40%) prescriptions in CPRD Aurum, 41 326 (38%) in CPRD GOLD, with 15 481 (42%) in English CPRD GOLD practices only.ConclusionEstimates for antibiotic prescribing and infection recording were broadly similar in both databases suggesting similar recording across EMIS and Vision systems. Future research on antimicrobial stewardship can also be conducted using primary care data in CPRD Aurum.
Accessing emergency contraception pills from pharmacies: the experience of young women in London
Authors: Turnbull Gillian , Scott Rachel H , Mann Sue , Wellings Kaye 
Published: June 2020

IntroductionOver-the-counter provision of emergency contraception pills (ECP) has increased since deregulation of progestogen-only formulations and is now the most common public health service provided by UK pharmacists. Important questions relate to women’s perceptions of their experience of receiving ECPs from pharmacists.MethodsQualitative study: in-depth interviews with young women reporting ECP use, recruited from clinic (10); pharmacy (6) and community settings (5) in London.ResultsKey advantages of pharmacy provision were ease and speed of access and convenience. Disadvantages included a less personal service, inadequate attention to information needs and to prevention of recurrence of ECP need, and unsupportive attitudes of pharmacy staff. Suggested service improvements included increasing privacy, providing more contraceptive advice, adopting a more empathetic approach and signposting follow-up services.ConclusionPharmacies are important in the choice of settings from which ECPs can be obtained and many aspects of pharmacy provision are appreciated by young women. There is scope to further enhance pharmacists’ role.
Investigating mechanical damage mechanisms of tapestries displayed at different angles using 2D DIC
Authors: Costantini Rosa , Lennard Frances , Alsayednoor Jafar , Harrison Philip 
Published: June 2020

AbstractTapestries represent a key but fragile component of many historic collections, as well as a complex challenge for textile conservators who aim to ensure their preservation. Indeed, the heterogeneity of materials, weaving features and conservation history make it difficult to predict the mechanical and physical behaviour of these objects, especially when hung for their display. The reported research postulates and investigates the role of different factors, namely relative humidity related strains and creep, in promoting the mechanical deterioration of tapestries. To track strain, the contactless full-field optical technique digital image correlation (DIC) was used. In particular, 2D DIC was successfully employed to monitor strains across large areas of a tapestry, demonstrating the occurrence of fatigue and creep damage mechanisms. While the former had the most influence on overall expansions and contractions, creep affected damaged areas. In addition, DIC was used for a preliminary evaluation of the efficacy of sloping boards, a non-traditional display method chosen by an increasing number of European museums in an attempt to reduce strain across tapestries. Both theoretical analysis and experimental work showed that, when minimal friction is present, small angles, like 5° from the vertical, do not appear to promote noticeable reductions in strain.