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Listening effort and downstream effects due to hearing loss in children and young people: an online quantitative questionnaire-based observational study

Por: Shields · C. A. · Sladen · M. · Rajai · A. · Guest · H. · Bruce · I. · Kluk · K. · Nichani · J.
Introduction

The clinical application of listening effort (LE) is challenging due to the lack of consensus regarding measuring the concept. Correlational analysis between different measuring instruments shows conditional and weak relationships, indicating they capture different dimensions of LE. Current research has suggested possible links between LE and downstream consequences such as fatigue, stress and confidence. One way to clinically measure LE would be to focus on its corollaries. Further research is needed to explore whether tools used to measure these downstream effects can be applied to capture LE. This study explores using existing questionnaire-based outcome instruments to evaluate LE and its associated consequences in children and young people (CYP), with and without hearing loss.

Methods and analysis

One hundred CYP aged 12–17 years with normal hearing and a range of hearing loss levels will be invited to complete a series of online questionnaires (Speech, Spatial and Qualities, Vanderbilt Fatigue Scale–Child, Perceived Stress Scale and Rosenberg Self-Esteem Scale) and a hearing test (Digits in Noise). They will complete the questionnaires at two time points (1) at the end of a rest day and (2) at the end of a workday. Standard demographic and hearing health information will be collected. The sample size was determined pragmatically due to a lack of comparable published data to power the study. Tests are exploratory and for generating hypotheses; therefore, the standard criterion of p

Ethics and dissemination

This study has been reviewed within the funding organisation (Cochlear Research and Development Limited) by an independent and relevant peer reviewer/committee. This study has had a favourable ethics committee review by both NHS ethics and University of Manchester ethics. The study will be disseminated through newsletters, publication and presentations at conferences. The results will be made available to participants on request.

Management and outcomes of intracranial fungal infections in children and adults in Africa: a scoping review protocol

Por: Takoutsing · B. D. · Ooi · S. Z. Y. · Egu · C. B. · Gillespie · C. S. · Bandyopadhyay · S. · Dada · O. E. · Dokponou · Y. C. H. · Dalle · D. U. · Ciuculete · A. C. · Awad · A. K. · Khan · M. · Erhabor · J. · Ikwuegbuenyi · C. A. · Kesici · O. · Bankole · N. D. A.
Introduction

The protocol presents the methodology of a scoping review that aims to synthesise contemporary evidence on the management and outcomes of intracranial fungal infections in Africa.

Methods and analysis

The scoping review will be conducted in accordance with the Arksey and O’Malley’s framework. The research question, inclusion and exclusion criteria and search strategy were developed based on the Population, Intervention, Comparator, Outcome framework. A search will be conducted in electronic bibliographic databases (Medline (OVID), Embase, African Journals Online, Cochrane Library and African Index Medicus). No restrictions on language or date of publication will be made. Quantitative and qualitative data extracted from included articles will be presented through descriptive statistics and a narrative description.

Ethics and dissemination

This study protocol does not require ethical approval. Findings will be reported in a peer-reviewed medical journal and presented at local, regional, national and international conferences.

Current state of management and outcomes of facial nerve palsy in low-income and middle-income countries: a scoping review protocol

Por: Ikwuegbuenyi · C. A. · Ooi · S. Z. Y. · Takoutsing · B. D. · Jesuyajolu · D. A. · Nwanmah · C. · Olobatoke · T. · Ogunfolaji · O. · David · S. · Ojo · T. · Umutoni · A.
Introduction

The aim of the protocol is to present the methodology of a scoping review that aims to synthesise up-to-date evidence on the management and outcomes of facial nerve palsy in low-income and middle-income countries (LMICs).

Methods and analysis

The scoping review will be conducted per the Arksey and O’Malley’s framework and the Joanna Briggs Institute Reviewers’ Manual. The scoping review question, eligibility criteria and search strategy will be developed in accordance to the Population, Concept, and Context strategy. The search will be conducted in electronic bibliographic databases (Medline (OVID), Embase, WHO Global Index Medicus, Cochrane Library, Global Health, African Journals Online). The review will synthesise and report the findings with descriptive statistics and a narrative description of both quantitative and qualitative evidence.

Ethics and dissemination

This scoping review does not require ethical approval. This protocol will describe the proposed scoping review that will map the evidence on the management and outcomes of facial nerve palsies in LMICs. The proposed review aims to collate and summarise published literature to inform policy-makers and healthcare organisations and governments and to identify knowledge gaps that will translate into future research priorities in LMICs.

Prevalence of fluoroquinolone resistance-associated mutations in Mycoplasma genitalium among clients of two sexual health centres in the Netherlands: a cross-sectional study

Por: Braam · J. F. · Zondag · H. C. A. · van Dam · A. P. · de Vries · H. J. C. · Vergunst · C. · Hetem · D. · Schim van der Loeff · M. F. · Bruisten · S. M.
Objective

This study aimed to determine the prevalence of fluoroquinolone resistance-associated mutations (QRAMs) in Mycoplasma genitalium (MG) among clients of two sexual health centres (SHCs) in the Netherlands.

Design

A cross-sectional study.

Setting and participants

Between 2018 and 2019, 669 clients with MG were included from two previous studies: 375 male clients with urethritis from the SHC in Amsterdam; and 294 clients (male and female) from the SHC in Amsterdam and The Hague. Urogenital and anal samples (705 in total) that tested positive for MG by nucleic acid amplification tests were selected.

Outcome measures

The presence of QRAM was detected by an MG-QRAM PCR targeting four mutations in the parC gene and investigated by sequence analysis of relevant regions of the gyrA and parC genes. Possible risk factors for the presence of QRAM were investigated.

Results

We found QRAM in 58 of 669 (9%) clients with an MG infection: 36 of 375 (10%) in the study population of men with urethritis and 22 of 294 (7%) in the study population of other clients (including both men and women; p=0.334). Most prevalent mutations in the parC gene were S83I and D87N, occurring in 31 of 60 (52%) and 20 of 60 (33%) samples, respectively. Factors associated with the presence of QRAM were: men who have sex with men (adjusted OR (aOR) 3.4, 95% CI 1.7 to 6.9) and Asian origin (aOR 2.5, 95% CI 1.2 to 5.6). Multidrug resistance (QRAM plus macrolide resistance-associated mutations) was found in 46 of 669 (7%) clients.

Conclusions

Nine per cent of MG-positive clients from two Dutch SHCs had QRAM. New treatment strategies and antibiotics are needed to treat symptomatic patients with multidrug-resistant MG.

Prevalence of long COVID-19 among healthcare workers: a systematic review and meta-analysis protocol

Por: Al-Oraibi · A. · Naidu · J. S. · Chaka · A. · Woolf · K. · B Nellums · L. · Tarrant · C. · Pan · D. · Sze · S. · Martin · C. A. · Gogoi · M. · Nazareth · J. · Pareek · M.
Introduction

A proportion of those who survive the acute phase of COVID-19 experience prolonged symptoms, commonly known as long COVID-19. Given that healthcare workers (HCWs) face an elevated risk of acute COVID-19 compared with the general population, the global burden of long COVID-19 in HCWs is likely to be large; however, there is limited understanding of the prevalence of long COVID-19 in HCWs, or its symptoms and their clustering. This review will aim to estimate the pooled prevalence and the symptoms of long COVID-19 among HCWs infected with SARS-CoV-2 globally, and investigate differences by country, age, sex, ethnicity, vaccination status and occupation.

Methods and analysis

A systematic review and meta-analysis will be conducted. Medline (via Ovid), CINAHL (via EBSCO), Embase (via Ovid), PsycINFO (via EBSCO), OpenGrey (grey literature) and medRxiv (preprint server) will be searched from the 31 December 2019 onward. All research studies and preprint articles reporting any primary data on the prevalence and/or the symptoms of long COVID-19 among adult HCWs will be included. Methodological quality will be assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data. Outcomes are anticipated to be the prevalence of long COVID-19 among HCWs around the world and trajectory of symptoms. Data synthesis will include random-effect meta-analysis for studies reporting prevalence data of long COVID-19 following SARS-CoV-2 infection among HCWs. The results will be presented with a 95% CI as an estimated effect across studies. Heterogeneity will be assessed using I² statistic. Where meta-analysis is inappropriate, a narrative synthesis of the evidence will be conducted.

Ethics and dissemination

Ethical approval is not needed as data will be obtained from published articles. We will publish our findings in a peer-reviewed journal and disseminate the results of our review at conferences.

PROSPERO registration number

CRD42022312781.

Challenges and ways of coping of parturient women with chronic hepatitis B in Ghana during COVID-19 pandemic: a qualitative inquiry

Por: Lanyo · T. N. · Ani-Amponsah · M. · Adjei · C. A.
Objective

To explore the psychosocial concerns and ways of coping of pregnant women with chronic hepatitis B infection in Ghana.

Setting

Participants were selected from public health facilities in the Tema Metropolis.

Design

Exploratory descriptive qualitative design was employed.

Participants

Fourteen pregnant women were purposively selected to participate in face-to-face interviews. The data were analysed using the content analysis procedure.

Results

The participants' psychosocial concerns and coping strategies were diverse. A significant number of the participants were concerned about the impact their hepatitis B seropositivity would have on their relationships, finances, and general well-being. Specifically, they feared that their social network, especially their spouses, would perceive them as having led a promiscuous lifestyle in the past to acquire hepatitis B infection. Also, fear of transmitting the infection to their infants and the effects of the infection on their infants later in life were identified as major concerns by nearly all participants. The participants further reported feelings of distress and diminished self-esteem. These psychosocial afflictions reported were attributed to lack of pre-test counselling during the antenatal care period. However, the participants coped using different strategies, including avoidance/denial, spirituality, and alternative treatment use.

Conclusion

To achieve optimal psychological and social well-being of pregnant women with chronic hepatitis B, it is important that their unique challenges are considered in their care and treatment cascade. Explicitly, protocols for supportive care addressing the specific needs of pregnant women with chronic hepatitis B should be implemented in the study setting

Tayside Screening For Cardiac Events (TASCFORCE) study: a prospective cardiovascular risk screening study

Por: Lambert · M. A. · Houston · J. G. · Littleford · R. · Fitton · C. A. · Struthers · A. · Sullivan · F. · Gandy · S. · Belch · J. J. F.
Purpose

Risk factor-based models struggle to accurately predict the development of cardiovascular disease (CVD) at the level of the individual. Ways of identifying people with low predicted risk who will develop CVD would allow stratified advice and support informed treatment decisions about the initiation or adjustment of preventive medication, and this is the aim of this prospective cohort study.

Participants

The Tayside Screening for Cardiac Events (TASCFORCE) study recruited men and women aged≥40 years, free from known CVD, with a predicted 10-year risk of coronary heart disease

Findings to date

4423 (1740, 39.3% men) were recruited. Mean age was 52.3 years with a median BNP of 7.50 ng/L and 15.30 ng/L for men and women, respectively. 602 had a predicted 10-year risk of 10%–19.9%, with the remainder

Future plans

The TASCFORCE study is investigating the ability of a screening programme, using BNP and WBCE-MRI, at the time of enrolment, to evaluate prediction of CVD in a population at low/intermediate risk. Blood stored for future biomarker analyses will allow testing/development of novel biomarkers. We believe this could be a new UK Framingham study allowing study for many years to come.

Clinical trial registration

ISRCTN38976321.

Development and validation of a prediction rule for patients suspected of acute coronary syndrome in primary care: a cross-sectional study

Por: Wouters · L. T. C. M. · Zwart · D. L. M. · Erkelens · D. C. A. · Adriaansen · E. J. M. · den Ruijter · H. M. · De Groot · E. · Damoiseaux · R. A. M. J. · Hoes · A. W. · van Smeden · M. · Rutten · F. H.
Objective

To develop and validate a symptom-based prediction rule for early recognition of acute coronary syndrome (ACS) in patients with acute chest discomfort who call out-of-hours services for primary care (OHS-PC).

Design

Cross-sectional study. A diagnostic prediction rule was developed with multivariable regression analyses. All models were validated with internal-external cross validation within seven OHS-PC locations. Both age and sex were analysed as statistical interaction terms, applying for age non-linear effects.

Setting

Seven OHS-PC in the Netherlands.

Participants

2192 patients who called OHS-PC for acute chest discomfort (pain, pressure, tightness or discomfort) between 2014 and 2017. Backed up recordings of telephone triage conversations were analysed.

Primary and secondary outcomes measures

Diagnosis of ACS retrieved from the patient’s medical records in general practice, including hospital specialists discharge letters. Performance of the prediction rules was calculated with the c-statistic and the final model was chosen based on net benefit analyses.

Results

Among the 2192 patients who called the OHS-PC with acute chest discomfort, 8.3% females and 15.3% males had an ACS. The final diagnostic model included seven predictors (sex, age, acute onset of chest pain lasting less than 12 hours, a pressing/heavy character of the pain, radiation of the pain, sweating and calling at night). It had an adjusted c-statistic of 0.77 (95% CI 0.74 to 0.79) with good calibration.

Conclusion

The final prediction model for ACS has good discrimination and calibration and shows promise for replacing the existing telephone triage rules for patients with acute chest discomfort in general practice and OHS-PC.

Trial registration number

NTR7331.

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations policies in England and Wales

Por: Ochieng · C. A. · Richards · H. · Zahra · J. · Cousins · S. · Elliott · D. · Wilson · N. · Paramasivan · S. · Avery · K. N. L. · Mathews · J. · Main · B. G. · Hinchliffe · R. · Blencowe · N. S. · Blazeby · J. M.
Objective

To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).

Design

A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.

Setting

NHS trusts in England and health boards in Wales, UK.

Participants

Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review.

Results

From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included.

Conclusions

Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address variability around information provision/consent for innovative procedures.

Epidemiology of uterine fibroid in black African women: a systematic scoping review

Objective

Studies, mainly from high-income countries, suggest that there are ethnic and racial variations in prevalence of uterine fibroids (UF). However, there have been few studies of the epidemiology of UF in sub-Saharan Africa (SSA). We reviewed published articles on the epidemiology of UF in SSA.

Design

This was a scoping review of literature.

Settings

We searched three databases (PubMed, African Wide Information (EBSCO) and African Journals OnLine (AJOL)). The search for eligible articles was conducted between December 2019 and January 2021.

Primary and secondary outcome measures

To describe the reported prevalence/incidence of, and risk factors for UF in SSA.

Results

Of the 1052 articles retrieved, 9 met the inclusion criteria for review. The articles were from Nigeria (4/9), Ghana (2/9), Cameroon (1/9), Kenya (1/9) and South Africa (1/9). Two studies from pathology departments and three studies from radiology departments reported prevalence of UF. We did not find any study on the incidence or genomics of UF in SSA. Of the three studies that reported on the risk factors of UF, only one case–control study that was conducted using retrospective data of attendees at a gynaecological clinic conducted multivariable analysis.

Conclusion

There is lack of robust epidemiological studies of the prevalence, incidence and risk factors of UF in SSA. There is urgent need to study epidemiological and genomics risk factors of UF in SSA because UF is the most common gynaecological neoplasm in this population where it is associated with significant morbidity and occasional, usually perioperative, mortality.

I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations

Por: Files · D. C. · Matthay · M. A. · Calfee · C. S. · Aggarwal · N. R. · Asare · A. L. · Beitler · J. R. · Berger · P. A. · Burnham · E. L. · Cimino · G. · Coleman · M. H. · Crippa · A. · Discacciati · A. · Gandotra · S. · Gibbs · K. W. · Henderson · P. T. · Ittner · C. A. G. · Jauregui
Introduction

The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.

Methods and analysis

The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.

Ethics and dissemination

ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.

Trial registration number

NCT04488081.

Dutch injection versus surgery trial in patients with carpal tunnel syndrome (DISTRICTS): protocol of a randomised controlled trial comparing two treatment strategies

Por: Palmbergen · W. A. C. · de Bie · R. M. A. · Alleman · T. W. H. · Verstraete · E. · Jellema · K. · Verhagen · W. I. M. · Brekelmans · G. J. F. · de Ruiter · G. C. W. · van de Beek · D. · de Borgie · C. A. J. M. · de Haan · R. · Beekman · R. · Verhamme · C.
Introduction

Carpal 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 analysis

The 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 dissemination

The 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 number

ISRCTN Registry: 13164336.

Time-limited trials in the ICU: a mixed-methods sequential explanatory study of intensivists at two academic centres

Por: Viglianti · E. M. · Ervin · J. N. · Newton · C. A. · Kruser · J. M. · Iwashyna · T. J. · Valley · T. S.
Objective

To understand intensivist perceptions of the appropriateness of time-limited trials (TLTs)—a strategy to align life-sustaining care with patient goals and values in the midst of clinical uncertainty.

Design

We conducted a mixed-methods sequential explanatory study of intensive care unit (ICU) intensivists regarding appropriateness of utilising TLTs in three vignettes centred on invasive mechanical ventilation (IMV); continuous renal replacement therapy (CRRT); and heated high-flow nasal cannula (HHFNC). Semistructured interviews were conducted using the Tailored Implementation of Chronic Diseases framework. Data were analysed using thematic and matrix analysis.

Setting

Two academic medical centres in the USA participated in the randomised surveys and one centre participated in the semistructured interviews.

Participants

Pulmonary and critical care intensivists and fellows.

Primary and secondary outcomes

To understand intensivists perceptions of the appropriateness in using TLTs.

Results

Of 115 physicians surveyed, 71 initiated the survey and 44 completed the entire survey with a response rate of 38% (N=44/115) and a completion rate of 62% (N=44/71). While 35% (N=23/66) of intensivists had never heard of a TLT, of the intensivists who had heard of a TLT, 77% (N=33/43) had participated in one. In response to the vignettes, appropriateness of using a TLT varied (IMV: 74% (N=46/62); CRRT 78% (N=49/63); HHFNC 92% (N=56/61) as did the durations of the TLT. Semistructured interviews with 11 intensivists revealed having clarity about patient goals and clinical endpoints facilitated successful TLTs while lack of an evidenced-based framework was a barrier.

Conclusion

More than half of the physicians who responded had conducted or participated in a TLT. To increase the use of TLTs in the ICU, clinicians desire a more robust, evidence-based framework on how to conduct TLTs.

Could the perioperative use of opioids influence cancer outcomes after surgery? A scoping review protocol

Por: Cascella · M. · Cuomo · A. · Bifulco · F. · Perri · F. · Carbone · F. · Aprea · M. · Forte · C. A. · Fiore · M.
Background

During and after general anaesthesia, opioids are commonly used for pain treatment. Since preclinical studies underlined the potential immunosuppressive activity of these drugs, it was postulated that their perioperative administration could influence cancer outcomes after surgery. Nevertheless, clinical data have been extrapolated mainly from retrospective analyses. Consequently, the precise link between perioperative opioid use and cancer recurrence/metastasis or cancer-related mortality/morbidity is still an unsolved issue.

Methods and analysis

This scoping review is planned to follow the Joanna Briggs Institute recommendations. The authors will conduct a literature review through the PRISMA statement using PubMed and EMBASE databases; the Grey literature will be explored using Google Scholar and Conference Proceedings Citation Index (via Web of Science). The search strategy will be limited to articles published in the English language and to human studies. The database searches are planned from the inception to January 2022. Two reviewers will independently screen titles and abstracts, followed by a full-text screening of potentially relevant articles with standardised data extraction. Any disagreement for the inclusion between the two reviewers will be discussed with a third reviewer.

Ethics and dissemination

The review aims to map the available literature, focusing on a possible association between perioperative opioid use and cancer outcomes in patients undergoing surgery. The proposed approach will be useful to identify and analyse the knowledge gap in the field and serve as a prerequisite for future research.

Scoping review registration

Open Science Framework https://osf.io/vfhw6/ DOI 10.17605/OSF.IO/VFHW6

Development of type 2 diabetes in women with comorbid gestational diabetes and common mental disorders in the Born in Bradford cohort

Por: Wilson · C. A. · Santorelli · G. · Reynolds · R. M. · Simonoff · E. · Howard · L. M. · Ismail · K.
Objectives

To compare, in a population of women with gestational diabetes mellitus (GDM), the time to diagnosis of Type 2 diabetes in those with and without common mental disorder (CMD) (depression and/or anxiety) during pregnancy.

Design and setting

prospective study of the Born in Bradford cohort in Bradford, UK.

Participants

909 women diagnosed with GDM between 2007 and 2010, with linkage to their primary care records until 2017. The exposed population were women with an indicator of CMD during pregnancy in primary care records. The unexposed were those without an indicator.

Outcome measures

Time to diagnosis of type 2 diabetes as indicated by a diagnosis in primary care records.

Analysis

time to event analysis using Cox regression was employed. Multiple imputation by chained equations was implemented to handle missing data. Models were adjusted for maternal age, ethnicity, education, preconception CMD and tobacco smoking during pregnancy.

Results

165 women (18%) were diagnosed with type 2 diabetes over a follow-up period of around 10 years. There was no evidence of an effect of antenatal CMD on the development of type 2 diabetes following GDM (adjusted HR 0.95; 95% CI 0.57 to 1.57).

Conclusions

Women with CMD were not at an increased risk of type 2 diabetes following GDM. This is reassuring for women with these co-morbidities but requires replication in other study populations.

Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol

Introduction

More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%–0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications.

Methods and analysis

Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7–2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board.

Ethics and dissemination

The Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants.

Trial registration

NCT02810704.

Effectiveness of educational interventions to develop patient safety knowledge, skills, behaviours and attitudes in undergraduate nursing students: a systematic review protocol

Por: De Rezende · H. · Vitorio · A. M. F. · Morais · A. S. · Garzin · A. C. A. · Nicole · A. G. · Quadrado · E. R. S. · Lourencao · D. C. d. A. · Martins · M. S.
Introduction

Patient safety is a healthcare discipline that aims to prevent and reduce patient harm, risks and errors during the provision of healthcare. Given the size of the nursing workforce in the healthcare system the inclusion of patient safety in the undergraduate nursing curriculum is necessary to enhance a safe culture in the daily work of their future careers. To this end, it is essential to apply effective teaching strategies to develop patient safety competencies. This review will aim to evaluate the effectiveness of educational interventions in developing patient safety knowledge, skills, behaviours and attitudes in undergraduate nursing students within the existing topic areas of the WHO Multi-professional Patient Safety Curriculum Guide.

Methods and analysis

The databases Medline, CINAHL, Scopus, Education Research Complete, The Cochrane Central Register of Controlled Trials, LILACS, Medes and Grey literature such as ClinicalTrials.gov, Google Scholar, DART-Europe, ProQuest Dissertations, CAPES thesis and dissertations, The Virginia Henderson Global e-Repository, Mednar and Thesis Canada will be searched from July 2011 to January 2022. Two independent reviewers will conduct the search, extract the data and assess the risk of bias for the included studies, using standardised critical appraisal instruments from the Joanna Briggs Institute. The quality of the evidence will be assessed using the Grading of Recommendations, Assessment Development and Evaluation methodology. Studies will be pooled in the meta-analysis. Alternatively, the findings will be presented in narrative form, including tables and figures, to aid in data presentation.

Ethics and dissemination

This study raises no ethical issues. The findings will be disseminated through presentations at professional conferences and publications in a peer-reviewed journal.

PROSPERO registration number

CRD42021254965.

KETOgenic diet therapy in patients with HEPatocellular adenoma: study protocol of a matched interventional cohort study

Por: Oudmaijer · C. A. J. · Berk · K. A. · van der Louw · E. J. T. M. · de Man · R. · van der Lelij · A.-J. · Hoeijmakers · J. H. J. · IJzermans · J.
Introduction

Hepatocellular adenoma (HCA) is an uncommon, solid and benign liver lesion, mainly occurring in women using oral contraceptives. Patients are advised to stop using oral contraceptives (OC) and, as overweight is frequently observed, dietary restrictions. Metabolic changes are assumed to play a role and it has been suggested that diet may help to reduce tumour size. A low-calorie ketogenic diet (LCKD) has been shown to induce weight loss and multiple metabolic changes, including the reduction of portal insulin concentrations, which downregulates hepatic growth hormone receptors. Weight reduction and an LCKD can potentially reduce the size of HCAs.

Methods and analysis

We designed a matched, interventional cohort study to determine the effect of an LCKD on the regression of HCA. The study population consists of female subjects with an HCA, 18–50 years of age, body mass index>25 kg/m2, who are entering a surveillance period including cessation of OC. A historical control group will be matched. The intervention consists of an LCKD (approximately 35 g carbohydrate/1500 kcal/day) for 3 months, followed by a less strict LCKD for 3 months (approximately 60 g carbohydrate/1500 kcal/day). Main study endpoint is the diameter of the HCA after 6 months, as compared with the historic control group. Secondary endpoints include adherence, quality of life, change in physical activity, liver fat content, body weight, body composition and resting energy expenditure.

Ethics and dissemination

The medical ethical committee has approved the study protocol, patient information files and consent procedure and other study-related documents and procedures.

Trial registration number

NL75014.078.20; Pre-results. https://www.trialregister.nl/trial/9092

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study)

Por: Johnson · M. I. · Paley · C. A. · Jones · G. · Mulvey · M. R. · Wittkopf · P. G.
Objective

To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults.

Design

Systematic review and meta-analysis.

Data sources

Medline, Cochrane Central, Embase (and others) from inception to July 2019 and updated on 17 May 2020.

Eligibility criteria for study selection

Randomised controlled trials (RCTs) comparing strong non-painful TENS at or close to the site of pain versus placebo or other treatments in adults with pain, irrespective of diagnosis.

Data extraction and synthesis

Reviewers independently screened, extracted data and assessed risk of bias (RoB, Cochrane tool) and certainty of evidence (Grading and Recommendations, Assessment, Development and Evaluation). Mean pain intensity and proportions of participants achieving reductions of pain intensity (≥30% or >50%) during or immediately after TENS. Random effect models were used to calculate standardised mean differences (SMD) and risk ratios. Subgroup analyses were related to trial methodology and characteristics of pain.

Results

The review included 381 RCTs (24 532 participants). Pain intensity was lower during or immediately after TENS compared with placebo (91 RCTs, 92 samples, n=4841, SMD=–0·96 (95% CI –1·14 to –0·78), moderate-certainty evidence). Methodological (eg, RoB, sample size) and pain characteristics (eg, acute vs chronic, diagnosis) did not modify the effect. Pain intensity was lower during or immediately after TENS compared with pharmacological and non-pharmacological treatments used as part of standard of care (61 RCTs, 61 samples, n=3155, SMD = –0·72 (95% CI –0·95 to –0·50], low-certainty evidence). Levels of evidence were downgraded because of small-sized trials contributing to imprecision in magnitude estimates. Data were limited for other outcomes including adverse events which were poorly reported, generally mild and not different to comparators.

Conclusion

There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

PROSPERO registration number

CRD42019125054.

Assessing tobacco smoke exposure in pregnancy from self-report, urinary cotinine and NNAL: a validation study using the New Hampshire Birth Cohort Study

Por: Peacock · J. L. · Palys · T. J. · Halchenko · Y. · Sayarath · V. · Takigawa · C. A. · Murphy · S. E. · Peterson · L. A. · Baker · E. R. · Karagas · M. R.
Objectives

Accurate assessment of tobacco smoke exposure is key to evaluate its effects. We sought to validate and establish cut-offs for self-reported smoking and secondhand smoke (SHS) exposure during pregnancy using urinary cotinine and 4-(methylnitrosamino)-1-(-3-pyridyl)-1-butanol (NNAL) in a large contemporary prospective study from the USA, with lower smoking prevalence than has previously been evaluated.

Design

Prospective birth cohort.

Setting

Pregnancy clinics in New Hampshire and Vermont, USA.

Participants

1396 women enrolled in the New Hampshire Birth Cohort Study with self-reported smoking, urinary cotinine, NNAL and pregnancy outcomes.

Primary and secondary outcome measures

Cut-offs for urinary cotinine and NNAL concentrations were estimated from logistic regression models using Youden’s method to predict SHS and active smoking. Cotinine and NNAL were each used as the exposure in separate multifactorial models for pregnancy outcomes.

Results

Self-reported maternal smoking was: 72% non-smokers, 5.7% ex-smokers, 6.4% SHS exposure, 6.2% currently smoked, 10% unreported. Cotinine and NNAL levels were low and highly intercorrelated (r=0.91). Geometric mean cotinine, NNAL were 0.99 ng/mL, 0.05 pmol/mL, respectively. Cotinine cut-offs for SHS, current smoking were 1.2 ng/mL and 1.8 ng/mL (area under curve (AUC) 95% CI: 0.52 (0.47 to 0.57), 0.90 (0.85 to 0.94)). NNAL cut-off for current smoking was 0.09 pmol/mL (AUC=0.82 (95% CI 0.77 to 0.87)). Using cotinine and NNAL cut-offs combined gave similar AUC to cotinine alone, 0.87 (95% CI 0.82 to 0.91). Cotinine and NNAL gave almost identical effect estimates when modelling pregnancy outcomes.

Conclusions

In this population, we observed high concordance between self-complete questionnaire smoking data and urinary cotinine and NNAL. With respect to biomarkers, either cotinine or NNAL can be used as a measure of tobacco smoke exposure overall but only cotinine can be used to detect SHS.

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