bluuebunny/crossref_metadata_2025_split huggingface dataset:
Image guidance for endoscopic sinus surgery in patients with chronic rhinosinusitis: a systematic review and meta-analysis protocol
Authors: Nobre Maria Luisa , Sarmento Ayane Cristine Alves , Nobre Maria Gabriela , Bedaque Henrique de Paula , Medeiros Kleyton Santos , Cobucci Ricardo Ney , Gonçalves Ana Katherine 
Published: May 2022

IntroductionEndoscopic sinus surgery (ESS) is a current procedure for treating patients with chronic rhinosinusitis (CRS). Image-guided surgery (IGS) for ESS may help reduce complications and improve precision. However, it is uncertain in which cases IGS is beneficial. This work aims to compare ESS with and without IGS in patients with CRS.Methods and analysisPubMed, Embase, Scopus, Web of Science, Scielo, Cochrane Central Register of Controlled Trials, CINAHL, LILACS and Clinicaltrials.gov will be searched for reported clinical trials comparing the quality of life and perioperative outcomes of ESS with and without navigation. The search is planned for 20 April 2022. Three independent authors will select eligible articles and extract their data. The risk of bias will be assessed using the Cochrane Handbook for Systematic Reviews of Interventions. The Grading of Recommendation Assessment, Development and Evaluation method will evaluate the strength of the evidence. Data synthesis will be performed using the Review Manager software V.5.4.1. To assess heterogeneity, I2statistics will be computed. Additionally, meta-analysis will be performed if the included studies are sufficiently homogenous.Ethics and disseminationThis study reviews published data, and thus it is not necessary to obtain ethical approval. The findings of this systematic review will be published in a peer-reviewed journal.PROSPERO registration numberCRD42020214791.
From direct attendance to telephone triage in an emergency primary healthcare service: an observational study
Authors: Midtbø Vivian , Fotland Siri-Linn Schmidt , Johansen Ingrid Hjulstad , Hunskaar Steinar 
Published: May 2022

ObjectivesTo describe how an intervention to limit direct attendance in an emergency primary healthcare service affected the contacts to the clinic and the level of care given, and which factors were associated with a change from direct attendance to telephone contact.DesignObservational study.SettingSeven Norwegian emergency primary healthcare services. The telephone triage operators are primarily registered nurses.ParticipantsRegistered patient contacts to the services during 2007–2019.InterventionsIn 2013, one of the seven services made an intervention to limit direct attendances to the emergency primary healthcare clinic. Through an advertisement in a local newspaper, the public was encouraged to call in advance. Patients who still attended directly, were encouraged to call in advance next time.MeasuresWe compared the proportions of direct attendance and telephone contact, and of consultation by a general practitioner and telephone consultation by an operator, before and after the intervention. We also compared the proportions of direct attendance regarding gender, age group, time of day and urgency level. Descriptive analyses and log binomial regression analyses were applied.ResultsThere were 1 105 019 contacts to the seven services during the study period. The average proportion of direct attendance decreased from 68.7% (95% CI 68.4% to 68.9%) to 23.4% (95% CI 23.2% to 23.6%) in the service that carried out the intervention. Telephone consultation by an operator increased from 11.7% (95% CI 11.5% to 11.8%) to 29.2% (95% CI 28.9% to 29.5%) and medical consultation by a general practitioner decreased from 78.3% (95% CI 78.1% to 78.5%) to 57.0% (95% CI 56.7% to 57.3%). The youngest and the oldest age group and women had the largest decrease in direct attendance, by −81%, −74% and −71%, respectively.ConclusionThe intervention influenced how the public contacted the service. Information campaigns on how to contact healthcare services should be implemented on a regular basis.
Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
Authors: Bajpai Meenu , Maheshwari Ashish , Dogra Vikas , Kumar Suresh , Gupta Ekta , kale Pratibha , Saluja Vandana , Thomas Sherin S , Trehanpati Nirupama , Bihari Chhagan , Agarwal Reshu , Bharti Praveen , Shankar Prabha , Hussain Javid , Chhabra Karan , Gupta Amita , Narayanan Ashad , Agarwal Sarika , Jain Shruti , Bhardwaj Ankit , Kumar Guresh , Yadav Birendra Kumar , Sarin Shiv Kumar 
Published: May 2022

ImportanceNo proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation.ObjectiveTo compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients.Design, setting and participantsA multicentric, open-labelled, phase-III randomised controlled trial conducted at two treatment centres with COPLA collected at the third dedicated centre in North-India, the coordinating centre during trial from June 2020 to December 2020. The study population comprised 400 participants in the ratio of 1:1 in each treatment group.InterventionOne group received COPLA with SMT (n=200), and another group received SMT only (n=200).Main outcome measuresPrimary outcome was time to clinical improvement measured by a two-point reduction in the ordinal scale. Secondary outcomes included duration of O2therapy, the proportion of patients on mechanical ventilation at day-7, mortality, SARS-CoV-2 antibody levels, cytokine levels and incidence of adverse events.ResultsThe median time to a two-point reduction in the ordinal scale in both groups was 9 days (IQR=7–13) (p=0.328). The median duration of O2therapy was 8 days (IQR=6–12) in COPLA and 10 days (IQR=6–12) in SMT group (p=0.64). The PaO2/FiO2ratio showed significant improvement at 7 days in COPLA group(p=0.036). There was no difference in mortality till 28 days in both groups (p=0.62). However, if COPLA was given within 3 days of hospital admission, a significant reduction in ordinal scale was observed (p=0.04). Neutralising antibody titres in COPLA group (80 (IQR 80–80)) were higher than SMT group (0 (IQR 0–80)) at 48 hours (p=0.001). COPLA therapy led to a significant reduction in TNF-α levels at 48 hours (p=0.048) and D-dimer at 7 days (p=0.02). Mild allergic reactions were observed in 3 (1.5%) patients in COPLA group.Conclusion and relevanceConvalescent plasma with adequate antibody titres should be transfused in COVID-19 patients along with SMT in the initial 3 days of hospitalisation for better clinical outcomes.Trial registration numberNCT04425915.
Effect of partial preservation versus complete preservation of Denonvilliers’ fascia on postoperative urogenital function in male patients with low rectal cancer (PREDICTION): protocol of a multicentre, prospective, randomised controlled clinical trial
Authors: Zheng Zhifang , Ye Daoxiong , Wang Xiaojie , Lu Xingrong , Huang Ying , Chi Pan 
Published: May 2022

IntroductionTotal mesorectal excision (TME) has been the gold standard for the surgical treatment of mid-low rectal cancer, but traditional TME removal of Denonvilliers’ fascia (DVF) is too low and is prone to damage the connecting branches of the bilateral neurovascular bundles, which can lead to posturogenital dysfunction. A recently published multicenter randomised controlled trial revealed that TME with complete preservation of DVF (CP-DVF) has protective effects on postoperative urogenital function for male patients with rectal cancer with specific staging and location (preoperative staging T1-4N0-2M0, but T1-2 for anterior rectal wall). Our previous studies have confirmed that TME with partial preservation of DVF (PP-DVF) could also achieve satisfactory results regardless of the circumferential location of the tumour. However, there is a lack of randomised controlled trials to prove that the efficacy of TME with PP-DVF is equivalent to that with CP-DVF with respect to postoperative urogenital function.Methods and analysisThis study is a prospective, multicentre, equivalent design, open-label randomised clinical trial in which 278 male patients with low rectal cancer will be recruited from 11 large-scale gastrointestinal medical centres in China. Patients will be randomly assigned to undergo PP-DVF or CP-DVF. We will test the hypothesis that PP-DVF is similar to CP-DVF with respect to sexual function at postoperative month 12 (5-item version of the International Erectile Function Index Questionnaire and ejaculation function classification). The secondary outcomes include the assessment of urinary function, surgical safety and oncological outcomes.Ethics and disseminationThis trial has been approved by the Institutional Review Board of Fujian Medical University Union Hospital (2020YF016-01) and is filed on record by all other centres. Written informed consent will be obtained from all eligible participants before enrolment. The trial’s results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numberChiCTR2000034892.
Causal explanations for patient engagement with primary care services in Saudi Arabia: a realist review protocol
Authors: Alghamdi Alaa , Abrams Ruth , Bailey Julia V , Alves Paula , Park Sophie 
Published: May 2022

IntroductionSaudi Arabia (SA) has a rapidly developing universal healthcare system which is maturing from its hospital focused origins. However, health service usage suggests that up to 65% of the cases seen in emergency departments were classified as non-urgent and could have been appropriately managed in primary healthcare (PHC) settings. Primary care development in SA has lagged behind secondary care, and evidence suggests that Saudi citizens are currently ambivalent or dissatisfied with their PHC services. Previous research has focused on the quality and patient satisfaction of PHC services in SA. Yet, uncertainty still exists about causal explanations for patient engagement with PHC services and what refinements are needed for PHC. Less attention has been paid to how patient engagement strategies might work differently, which is increasingly recognised as important in PHC services. The aim of this review is to understand the causal explanations for patient engagement with PHC and to generate theory of how the intended outcome of patient engagement with PHC in SA might be achieved through identified contexts and mechanisms.Methods and analysisA realist review approach will be used to synthesise the evidence. Databases including Medline, EMBASE and CINAHL will be searched. Literature will be included if it has relevance to the research question, and is trustworthy in nature. All document types will be screened including peer reviewed articles, relevant grey literature and related media items. All study types will be included. Stakeholders’ feedback will also inform our review. A realist approach is suitable for this review because patient engagement with PHC services is a complex phenomenon. A range of different relevant data will be included in the following stages: developing an initial programme theory, searching the evidence, selecting data, extracting data, synthesising data and refining the programme theory.Ethics and disseminationThis study will use secondary data, and stakeholders are involved only to shape our understanding of the important contexts in patient engagement; hence, a formal ethics review is not required. Findings will be disseminated in a peer-reviewed journal and at relevant conferences.PROSPERO registration numberCRD42020175955.
Patient experience of symptoms and impacts of COVID-19: a qualitative investigation with symptomatic outpatients
Authors: Rofail Diana , McGale Nadine , Podolanczuk Anna J , Rams Alissa , Przydzial Krystian , Sivapalasingam Sumathi , Mastey Vera , Marquis Patrick 
Published: May 2022

ObjectivesThere is little in-depth qualitative evidence of how symptoms manifest themselves in outpatients with COVID-19 and how these in turn impact outpatients’ daily lives. The objective of the study was therefore to explore the experience of outpatients with COVID-19 qualitatively, concerning the symptomatic experience and its subsequent impact on daily life.SettingQualitative research study comprising virtual in-depth, open-ended interviews with outpatients and clinicians.ParticipantsThirty US adult patients with COVID-19 were interviewed within 21 days of diagnosis. Patients were 60% female and 87% white, who had to self-report one of the following: fever, cough, shortness of breath/difficulty breathing, change/loss of taste/smell, vomiting/diarrhoea or body/muscle aches. Five independent clinicians were also interviewed about their experience treating outpatients.Primary and secondary outcome measuresTranscripts were analysed thematically to organise symptoms and impacts of daily life into higher-order overarching categories, and subsequently propose a conceptual model. The adequacy of the sample size was assessed by conceptual saturation analysis.ResultsPatient-reported concepts were organised into six symptom themes (upper respiratory, lower respiratory, systemic, gastrointestinal, smell and taste, and other) and seven impact themes (activities of daily living, broad daily activities, leisure/social activities, and physical, emotional, professional and quarantine-specific impacts). Symptom type, severity, duration and time of onset varied by patient. Clinicians endorsed all patient-reported symptoms.ConclusionsThe manifestation of symptoms in outpatients is heterogeneous and affects all aspects of daily life. Outpatients offered new detailed insights into their symptomatic experiences, including heterogeneous experiences of smell and taste, and the impacts that symptoms had on their daily lives. Findings of this research may be used to supplement existing knowledge of the outpatient experience of mild-to-moderate COVID-19, to further inform treatment guidelines and to provide an evidence base for evaluating potential treatment benefits.
Dutch injection versus surgery trial in patients with carpal tunnel syndrome (DISTRICTS): protocol of a randomised controlled trial comparing two treatment strategies
Authors: Palmbergen Wijnand A C , de Bie Rob M A , Alleman Tim W H , Verstraete Esther , Jellema Korne , Verhagen Wim I M , Brekelmans Geert J F , de Ruiter Godard C W , van de Beek Diederik , de Borgie Corianne A J M , de Haan Rob , Beekman Roy , Verhamme Camiel 
Published: May 2022

IntroductionCarpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. The objective of the Dutch Injection versus Surgery TRIal in patients with CTS (DISTRICTS) is to investigate if initial surgery of CTS results in a better clinical outcome and is more cost-effective when compared with initial treatment with corticosteroid injection.Methods and analysisThe DISTRICTS is an ongoing multicenter, open-label randomised controlled trial. Participants with CTS are randomised to treatment with surgery or with a corticosteroid injection. If needed, any additional treatments after this first treatment are allowed and these are not dictated by the study protocol. The primary outcome is the difference between the groups in the proportion of participants recovered at 18 months. Recovery is defined as having no or mild symptoms as measured with the 6-item carpal tunnel symptoms scale. Secondary outcome measurements are among others: time to recovery, hand function, patient satisfaction, quality of life, additional treatments, adverse events, and use of care and health-related costs.Ethics and disseminationThe study was approved by the Medical Ethical Committee of the Amsterdam University Medical Centers (study number 2017-171). Study results will be disseminated in peer-reviewed journals and conferences.Trial registration numberISRCTN Registry: 13164336.
COVID-19 pandemic in shelters for asylum seekers: a scoping review of preventive measures
Authors: Führer Amand , Özer Erdogdu Ilknur , Kompa Paula , Yilmaz-Aslan Yüce , Brzoska Patrick 
Published: May 2022

ObjectiveTo investigate which measures are recommended by guidelines on prevention and management of infectious disease outbreaks in refugee shelters, how outbreaks have been dealt with in these facilities in the past and how measures taken compare with the recommendations identified in the literature.Design, data sources and eligibility criteriaThe review comprised German and English language literature on refugees residing in shelters located in high-income countries, published between 1990 and 2021. We searched PubMed, CINAHL and Web of Science.Data extraction and synthesisWe extracted information concerning the characteristics of the setting and the study population, measures for outbreak prevention and reported difficulties with implementing these measures. The findings were evaluated using descriptive statistics and were narratively summarised.ResultsOf a total of 1162 publications, 36 were included in the review, of which 19 were original research articles and 17 were guidelines/commentaries. In the guidelines, 37 different measures of infection control were mentioned. Among those, social distancing and isolation or quarantine were mentioned most frequently. In the outbreak reports, 27 different measures were reported, of which testing was reported most often. Different reasons why recommendations are difficult to implement in shelters were described, which are related to space, equipment, staff and financial constraints. Discrepancies between recommendations and actual practice mostly relate to the lack of preparation for outbreaks and the lack of appropriate measures to ensure intersectoral cooperation.ConclusionsRecommendations on infection control and outbreak management and the measures actually taken in refugee shelters differ considerably. Among others, this results from a lack of intersectoral cooperation between state ministries, municipal health offices and the administration of the facilities as well as from guidelines not sufficiently tailored to the characteristics of refugee shelters.
Pulse oximetry and oxygen services for the care of children with pneumonia attending frontline health facilities in Lagos, Nigeria (INSPIRING-Lagos): study protocol for a mixed-methods evaluation
Authors: Graham Hamish R , Olojede Omotayo E , Bakare Ayobami Adebayo A , McCollum Eric D , Iuliano Agnese , Isah Adamu , Osebi Adams , Seriki Ibrahim , Ahmed Tahlil , Ahmar Samy , Cassar Christine , Valentine Paula , Olowookere Temitayo Folorunso , MacCalla Matt , Uchendu Obioma , Burgess Rochelle Ann , Colbourn Timothy , King Carina , Falade Adegoke G 
Published: May 2022

IntroductionThe aim of this evaluation is to understand whether introducing stabilisation rooms equipped with pulse oximetry and oxygen systems to frontline health facilities in Ikorodu, Lagos State, alongside healthcare worker (HCW) training improves the quality of care for children with pneumonia aged 0–59 months. We will explore to what extent, how, for whom and in what contexts the intervention works.Methods and analysisQuasi-experimental time-series impact evaluation with embedded mixed-methods process and economic evaluation. Setting: seven government primary care facilities, seven private health facilities, two government secondary care facilities. Target population: children aged 0–59 months with clinically diagnosed pneumonia and/or suspected or confirmed COVID-19. Intervention: ‘stabilisation rooms’ within participating primary care facilities in Ikorodu local government area, designed to allow for short-term oxygen delivery for children with hypoxaemia prior to transfer to hospital, alongside HCW training on integrated management of childhood illness, pulse oximetry and oxygen therapy, immunisation and nutrition. Secondary facilities will also receive training and equipment for oxygen and pulse oximetry to ensure minimum standard of care is available for referred children. Primary outcome: correct management of hypoxaemic pneumonia including administration of oxygen therapy, referral and presentation to hospital. Secondary outcome: 14-day pneumonia case fatality rate. Evaluation period: August 2020 to September 2022.Ethics and disseminationEthical approval from University of Ibadan, Lagos State and University College London. Ongoing engagement with government and other key stakeholders during the project. Local dissemination events will be held with the State Ministry of Health at the end of the project (December 2022). We will publish the main impact results, process evaluation and economic evaluation results as open-access academic publications in international journals.Trial registration numberACTRN12621001071819; Registered on the Australian and New Zealand Clinical Trials Registry.
Decision-making autonomy in maternal health service use and associated factors among women in Mettu District, Southwest Ethiopia: a community-based cross-sectional study
Authors: Kassahun Asmamaw , Zewdie Asrat 
Published: May 2022

ObjectivesWomen’s autonomy is valued in a range of healthcare settings, from seeking and receiving care to deciding between treatment options. This study aimed to assess the level of decision-making autonomy women have and associated factors when it comes to using maternal healthcare services.DesignA community-based cross-sectional study was conducted.SettingThe study was conducted in Mettu Rural District, Iluababor Zone, Southwest Ethiopia.MethodsData were collected using a pretested interviewer-administered questionnaire from 541 women selected by a multistage sampling technique. The collected data were entered into EpiData V.3.1 and exported to SPSS V.22 for analysis. Bivariable and multivariable binary logistic regression were used to identify factors associated with women’s decision-making autonomy on maternal health service use. Variables with a p value less than 0.05 at 95% CI were declared significant, and the strength of the association was measured by an adjusted OR (AOR).Primary outcomeLevel of women’s decision-making autonomy on maternal health service use.ResultsIt was found that 60.5% of women were autonomous in maternal health service use (95% CI 56.2% to 64.7%). The older age group (AOR=4.27, 95% CI 1.6 to 11.4, p=0.034), higher educational level (AOR=3.8, 95% CI 2.2 to 6.7, p=0.042), small family size (AOR=2.5, 95% CI 1.5 to 4.1, p=0.01) and proximity to health facilities (AOR=5.3, 95% CI 2.5 to 11.3, p=0.004) were all associated factors with healthcare decision-making autonomy.ConclusionTwo-fifths of women have diminished autonomy in decision making on healthcare service use. Age, level of education, family size and accessibility of health services were found to influence women’s autonomy. Special attention should be given to education and access to health services to improve women’s autonomy.