bluuebunny/crossref_metadata_2025 huggingface dataset:
Topographic development of a compressional mountain range, the western Transverse Ranges of California, USA, resulted from localized uplift along individual structures and regional uplift from deeper shortening
Authors: Onderdonk N. , Garcia A.F. , Kelty C. , Farris A. , Tyler E.
Published: November 2022

The western Transverse Ranges are a tectonically active mountain belt in southern California (USA) characterized by fast rates of shortening and rock uplift. Large drainages at the western end of this mountain belt, including the Santa Ynez River and its tributaries, transect regional west–northwest-striking reverse faults and folds. We used fluvial strath terraces within the Santa Ynez River watershed as geomorphic markers for measuring Quaternary rock uplift and deformation across these structures. Mapping, surveying, and numerical dating of these strath terraces in both hanging-wall and footwall blocks of the major reverse faults allow us to separate regional uplift from localized uplift along individual structures.

Luminescence dates from 18 sites within the Santa Ynez River watershed show that the three prominent terrace levels present throughout the area formed between ca. 85 ka and 95 ka, 55 ka and 75 ka, and 30 ka and 45 ka. All three fluvial terrace straths grade into marine paleo-shore platforms along the coast that formed during sea-level highstands. The fluvial straths were formed as a result of lateral erosion during warm, dry climate intervals when vertical incision was temporarily arrested. Incision of the terraces followed during intervening periods of wet climate.

Mapping and valley-long profiles of the terraces document deformation by faults and folds, and we infer minimum rock-uplift rates from the amount of incision below the terrace strath surfaces. Rock-uplift rates range from 0.3 mm/yr to 4.9 mm/yr, with faster rates in the hanging-wall blocks of the major reverse faults and slower rates in the footwall blocks. Rock-uplift rates calculated from strath terraces in the footwall blocks range from 0.3 mm/yr to 1.6 mm/yr, which indicates a regional component of uplift that results from deeper deformation. Higher rates of rock uplift in the hanging-wall blocks (0.5–4.9 mm/yr) are superposed on this regional component. Incremental rock-uplift rates calculated over three time intervals and differences in terrace deformation with age suggest that deformation rates across some structures have decreased over the past 85 k.y.

We conclude that topographic growth of the western Transverse Ranges results from a combination of localized uplift along individual structures that varies both spatially and temporally and a more constant regional uplift that likely results from deeper ductile deformation or slip along detachment faults that have been inferred to underlie the area.
Foreland basin response to middle Cretaceous thrust belt evolution, southwestern Montana, USA
Authors: Gardner Cole T. , Finzel Emily S. , Rosenblume Justin A. , Pearson David M.
Published: November 2022

The middle Cretaceous Blackleaf Formation records the first major transgressionregression of the Western Interior Seaway into the southwestern Montana retroforeland basin. Although Blackleaf sedimentology is well documented, sediment provenance and potential linkages with regional tectonics are not. Recent characterization of hinterland tectonics, fold-thrust belt detrital zircon signatures, and advances in high-n detrital zircon analysis allow for significant provenance refinement. We present new detrital zircon ages (n = 5468) from ten samples from the upper Blackleaf Formation (Intervals C and D) in southwestern Montana. Based on maximum depositional ages, sedimentation spanned from 106 to 92 Ma. Jurassic and Cretaceous grains were primarily derived from the older portion of the Cordilleran magmatic arc in western Idaho. Triassic and older grains were recycled from older central Idaho sedimentary strata inboard of the arc. Three depositional stages are identified based on statistical modeling of detrital age distributions. Stage 1 (106–104 Ma) records sourcing from lower Paleozoic strata in central Idaho. Stage 2 (105–101 Ma) records initial unroofing of upper Paleozoic–Triassic strata via propagation of the fold-thrust belt into eastern Idaho, accommodating shortening of Mississippian and younger rocks above the Lemhi Arch. Stage 3 (102–100 Ma) records continued unroofing in central Idaho down to Cambrian stratigraphic levels and distal mixing of sources in the eastern part of the basin. Exhumation in the fold-thrust belt beginning at ca. 105 Ma is coincident with marginwide fault slip-rate increases. We infer that increased sedimentation rates and lowmagnitude flexural loading from shallow thrusting in eastern Idaho drove clastic wedge progradation across the basin.
Pyroclastic deposits of Ubehebe Crater, Death Valley, California, USA: Ballistics, pyroclastic surges, and dry granular flows
Authors: Valentine Greg A. , Fierstein Judy , White James D.L.
Published: November 2022

We describe and interpret deposits associated with the final Ubehebe Crater-forming, phreatomagmatic explosive phase of the multivent, monogenetic Ubehebe volcanic center. Ubehebe volcano is located in Death Valley, California, USA. Pyroclastic deposits occur in four main facies: (1) lapilli- and blockdominated beds, (2) thinly bedded lapilli tuff, (3) laminated and cross-laminated ash, and (4) massive lapilli ash/tuff. Lapilli- and block-dominated beds are found mostly within several hundred meters of the crater and transition outward into discontinuous lenses of lapilli and blocks; they are interpreted to have been deposited by ballistic processes associated with crater-forming explosions. Thinly bedded lapilli tuff is found mainly within several hundred meters, and laminated and cross-laminated ash extends at least 9 km from the crater center. Dune forms are common within ~2 km of the crater center, while finer-grained, distal deposits tend to exhibit planar lamination. These two facies (thinly bedded lapilli tuff and laminated and cross-laminated ash) are interpreted to record multiple pyroclastic surges (dilute pyroclastic currents). Repeated couplets of coarse layers overlain by finer-grained, laminated horizons suggest that many or most of the surges were transient, likely recording individual explosions, and they traveled over complex topography in some areas. These two factors complicate the application of classical sediment-transport theory to quantify surge properties. However, dune-form data provide possible constraints on the relationships between suspended load sedimentation and bed-load transport that are consistent using two independent approaches. Massive lapilli ash/tuff beds occur in drainages below steep slopes and can extend up to ~1 km onto adjacent valley floors beneath large catchments. Although they are massive in texture, their grain-size characteristics are shared with laminated and cross-laminated ash facies, with which they are locally interbedded. These are interpreted to record concentrated granular flows sourced by remobilized pyroclastic surge deposits, either during surge transport or shortly after, while the surge deposits retained their elevated initial pore-gas pressures. Although similar surge-derived concentrated flows have been described elsewhere (e.g., Mount St. Helens, Washington, USA, and Soufriére Hills, Montserrat, West Indies), to our knowledge Ubehebe is the first case where such processes have been identified at a maar volcano. These concentrated flows followed paths that were independent of the pyroclastic surges and represent a potential hazard at similar maar volcanoes in areas with complex terrain.
Diagnosis of systemic lupus erythematosus with early manifestation of an eosinophilic pleural effusion
Authors: Cho Gene , Matti Moreen , Ghassemzadeh Saeed , Nobari Matthew
Published: November 2022

A woman in her 70s with a history of Crohn’s disease presented to the emergency department with dyspnoea, cough and intermittent fevers. Evaluation revealed a pleural effusion with neutrophil predominance, and initial suspicion of infection prompted a short course of antibiotic therapy. However, the patient subsequently developed recurrent pleural effusion with eosinophilic predominance. Serological data confirmed a diagnosis of systemic lupus erythematosus (SLE) and the patient was started on appropriate treatment.

This case presents an initial manifestation of eosinophilic-dominant pleural effusion in SLE. Current guidelines in treating pleural effusions do not explore rheumatological causes. However, we believe that our case demonstrates the value of a prompt investigation for rheumatological aetiologies in an otherwise unclassified eosinophilic-predominant pleural effusion. Such an investigation should include serological data as an important confirmatory marker for the diagnosis of SLE.
ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE): research protocol of a multicentric prospective study
Authors: Legué Sylvie , Marchand-Adam Sylvain , Plantier Laurent , Bayeh Betsega Assefa , Morel Hugues , Mangiapan Gilles , Flament Thomas
Published: November 2022

Introduction

Idiopathic pulmonary fibrosis (IPF) is the most common and severe interstitial lung disease (ILD). It is a progressive disease that requires a regular follow-up: clinical examination, pulmonary function testing (PFT) and CT scan, which is performed yearly in France. These exams have two major disadvantages: patients with severe dyspnoea have difficulties to perform PFT and repeated CT scans expose to high dose of radiations. Considering these limits, it would be relevant to develop new tools to monitor the progression of IPF lesions. Three main signs have been described in ILD with lung ultrasound (LUS): the number of B lines, the irregularity and the thickening of the pleural line. Cross-sectional studies already correlated the intensity of these signs with the severity of fibrosis lesions on CT scan in patients with IPF, but no prospective study described the evolution of the three main LUS signs, nor the correlation between clinical evaluation, PFT and CT scan. Our hypothesis is that LUS is a relevant tool to highlight the evolution of pulmonary lesions in IPF. The main objective of our study is to show an increase in one or more of the three main LUS signs (total number of B lines, pleural line irregularity score and pleural line thickness) during the follow-up.

Methods

ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution is a French prospective, multicentric and non-interventional study. Every 3 months, patients with IPF will have a clinical examination, PFT and LUS. CT data will be collected if the CT scan is performed within 3 months before the inclusion; the second CT scan will be performed from 9 to 12 months after the inclusion. The presence, location and severity of LUS signs will be recorded for each patient, and their correlation with clinical, functional and CT scan evolution will be evaluated. 30 patients will be enrolled.

Ethics and dissemination

The protocol was approved by the French Research Ethics Committee (Comité de Protection des Personnes SUD OUEST ET OUTRE MER II, reference RIPH3-RNI19-TOUPIE) on 11 April 2019. Results will be disseminated via peer-reviewed publication and presentation at international conferences.

Trial registration number

NCT03944928;Pre-results
.
Impact of BCG revaccination on the response to unrelated vaccines in a
Ugandan adolescent birth cohort: randomised controlled trial protocol C for
the ‘POPulation differences in VACcine responses’ (POPVAC) programme
Authors: Zirimenya Ludoviko , Nkurunungi Gyaviira , Nassuuna Jacent , Natukunda Agnes , Mutebe Alex , Oduru Gloria , Kabami Grace , Akurut Hellen , Onen Caroline , Namutebi Milly , Serubanja Joel , Nakazibwe Esther , Akello Florence , Tumusiime Josephine , Sewankambo Moses , Kiwanuka Samuel , Kiwudhu Fred , Kizindo Robert , Kizza Moses , Wajja Anne , Cose Stephen , Muwanga Moses , Webb Emily , Elliott Alison M
Published: November 2022

Introduction

There is evidence that BCG immunisation may protect against
unrelated infectious illnesses. This has led to the postulation that
administering BCG before unrelated vaccines may enhance responses to
these vaccines. This might also model effects of BCG on unrelated
infections.

Methods and analysis

To test this hypothesis, we have designed a randomised controlled
trial of BCG versus no BCG immunisation to determine the effect of BCG
on subsequent unrelated vaccines, among 300 adolescents (aged 13–17
years) from a Ugandan birth cohort. Our schedule will comprise three
main immunisation days (week 0, week 4 and week 28): BCG (or no BCG)
revaccination at week 0; yellow fever (YF-17D), oral typhoid (Ty21a) and
human papillomavirus (HPV) prime at week 4; and HPV boost and
tetanus/diphtheria (Td) boost at week 28. Primary outcomes are
anti-YF-17D neutralising antibody titres,Salmonella
typhilipopolysaccharide-specific IgG concentration,
IgG specific for L1-proteins of HPV-16/HPV-18 and tetanus and diphtheria
toxoid-specific IgG concentration, all assessed at 4 weeks after
immunisation with YF, Ty21a, HPV and Td, respectively. Secondary
analyses will determine effects on correlates of protective immunity
(where recognised correlates exist), on vaccine response waning and on
whether there are differential effects on priming versus boosting
immunisations. We will also conduct exploratory immunology assays among
subsets of participants to further characterise effects of BCG
revaccination on vaccine responses. Further analyses will assess which
life course exposures influence vaccine responses in
adolescence.

Ethics and dissemination

Ethics approval has been obtained from relevant Ugandan and UK
ethics committees. Results will be shared with Uganda Ministry of
Health, relevant district councils, community leaders and study
participants. Further dissemination will be done through conference
proceedings and publications.

Trial registration number

NCT10482904.
TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE):
protocol for a cluster-randomised clinical trial on adult general ICUs in
Brazil
Authors: Noritomi Danilo Teixeira , Ranzani Otavio T , Ferraz Leonardo Jose Rolim , dos Santos Maura C , Cordioli Eduardo , Albaladejo Renata , Serpa Neto Ary , Correa Thiago D , Berwanger Otávio , de Morais Lubia Caus , Schettino Guilherme , Cavalcanti Alexandre Biasi , Rosa Regis Goulart , Biondi Rodrigo Santos , Salluh Jorge IF , Azevedo Luciano Cesar Pontes , Pereira Adriano Jose
Published: November 2022

Introduction

Daily multidisciplinary rounds (DMRs) consist of systematic
patient-centred discussions aiming to establish joint therapeutic goals
for the next 24 hours of intensive care unit (ICU) care. The aim of the
present study protocol is to evaluate whether an intervention consisting
of guided DMRs, supported by a remote specialist and audit/feedback on
care performance will reduce ICU length of stay compared with a control
group.

Methods and analysis

A multicentre, controlled, cluster-randomised superiority trial
including 30 ICUs in Brazil (15 intervention and 15 control), from
August 2019 to June 2021. In a parallel assignment, ICUs are randomised
to a complex-intervention composed by daily rounds carried out through
Tele-ICU by a remote ICU physician; development of local quality
indicators dashboards coupled with monthly meetings with local
leadership; and dissemination of evidence-based clinical protocols
versus usual care. Primary outcome is ICU length of stay. Secondary
outcomes include classification of the unit according to the profiles
defined by the standardised resource use and the standardised mortality
rate, hospital mortality, incidence of healthcare-associated infections,
ventilator-free days at 28 days, patient-days receiving oral or enteral
feeding, patient-days under light sedation or alert and calm, rate of
patients under normoxaemia. All adult patients admitted after the
beginning of the study in each participant ICU will be enrolled.
Inclusion criteria (clusters): public Brazilian ICUs with a minimum of 8
ICU beds interested/committed to participating in the study. Exclusion
criteria (clusters): units with fully established DMRs by an
intensivist, specialised or step-down units.

Ethics and dissemination

The study protocol was approved by the institutional review board
(IRB) of the coordinator centre, and by IRBs of each enrolled
hospital/ICU. Statistical analysis protocol is being prepared for
submission before the end of patient’s enrolment. Results will be
disseminated through conferences, peer-reviewed journals and to each
participating unit.

Trial registration number

NCT03920501; Pre-results.
Transforming primary care for older Canadians living with frailty: mixed
methods study protocol for a complex primary care intervention
Authors: Stolee Paul , Elliott Jacobi , Giguere Anik MC , Mallinson Sara , Rockwood Kenneth , Sims Gould Joanie , Baker Ross , Boscart Veronique , Burns Catherine , Byrne Kerry , Carson Judith , Cook Richard J , Costa Andrew P , Giosa Justine , Grindrod Kelly , Hajizadeh Mohammad , Hanson Heather M , Hastings Stephanie , Heckman George , Holroyd-Leduc Jayna , Isaranuwatchai Wanrudee , Kuspinar Ayse , Meyer Samantha , McMurray Josephine , Puchyr Phyllis , Puchyr Peter , Theou Olga , Witteman Holly
Published: November 2022

Introduction

Older Canadians living with frailty are high users of healthcare
services; however, the healthcare system is not well designed to meet
the complex needs of many older adults. Older persons look to their
primary care practitioners to assess their needs and coordinate their
care. They may need care from a variety of providers and services, but
often this care is not well coordinated. Older adults and their family
caregivers are the experts in their own needs and preferences, but often
do not have a chance to participate fully in treatment decisions or care
planning. As a result, older adults may have health problems that are
not properly assessed, managed or treated, resulting in poorer health
outcomes and higher economic and social costs. We will be implementing
enhanced primary healthcare approaches for older patients, including
risk screening, patient engagement and shared decision making and care
coordination. These interventions will be tailored to the needs and
circumstances of the primary care study sites. In this article, we
describe our study protocol for implementing and testing these
approaches.

Methods and analysis

Nine primary care sites in three Canadian provinces will participate
in a multi-phase mixed methods study. In phase 1, baseline information
will be collected through questionnaires and interviews with patients
and healthcare providers (HCPs). In phase 2, HCPs and patients will be
consulted to tailor the evidence-based interventions to site-specific
needs and circumstances. In phase 3, sites will implement the tailored
care model. Evaluation of the care model will include measures of
patient and provider experience, a quality of life measure, qualitative
interviews and economic evaluation.

Ethics and dissemination

This study has received ethics clearance from the host academic
institutions: University of Calgary (REB17-0617), University of Waterloo
(ORE#22446) and Université Laval (#MP-13-2019-1500 and 2017-2018-12-MP).
Results will be disseminated through traditional means, including
peer-reviewed publications and conferences and through an extensive
network of knowledge user partners.

Trial registration number

NCT03442426; Pre-results.
Effect of occupational therapy home visit discharge planning on
participation after stroke: protocol for the HOME Rehab trial
Authors: Lannin Natasha A , Clemson Lindy , Drummond Avril , Stanley Mandy , Churilov Leonid , Laver Kate , O'Keefe Sophie , Cameron Ian , Crotty Maria , Usherwood Tim , Andrew Nadine E , Jolliffe Laura , Cadilhac Dominique A
Published: November 2022

Introduction

After first stroke, the transition from rehabilitation to home can
be confronting and fraught with challenges. Although stroke clinical
practice guidelines recommend predischarge occupational therapy home
visits to ensure safe discharge and provision of appropriate equipment,
there is currently limited evidence to support this
recommendation.

Methods and analysis

The HOME Rehab trial is a national, multicentre, phase III
randomised controlled trial with concealed allocation, blinded
assessment and intention-to-treat analysis being conducted in Australia.
The trial aim is to determine the effect and potential
cost-effectiveness of an enhanced occupational therapy discharge
planning intervention that involves pre and postdischarge home visits,
goal setting and occupational therapy in the home (the HOME programme)
in comparison to an in-hospital predischarge planning intervention.
Stroke survivors aged ≥45 years, admitted to a rehabilitation ward,
expected to return to a community (private) dwelling after discharge,
with no significant prestroke disability will be randomly allocated 1:1
to receive a standardised discharge planning intervention and the HOME
programme or the standardised discharge planning intervention alone. The
primary outcome is participation measured using the Nottingham Extended
Activities of Daily Living. Secondary outcome areas include hospital
readmission, disability, performance of instrumental activities of daily
living, health-related quality of life, quality of care transition and
carer burden. Resources used/costs will be collected for the
cost-effectiveness analysis and hospital readmission. Recruitment
commenced in 2019. Allowing for potential attrition, 360 participants
will be recruited to detect a clinically important treatment difference
with 80% power at a two-tailed significance level of 0.05.

Ethics and dissemination

This study is approved by the Alfred Health Human Research Ethics
Committee and site-specific ethics approval has been obtained at all
participating sites. Results of the main trial and the secondary
endpoint of cost-effectiveness will be submitted for publication in
peer-reviewed journals

Trial registration number

NCT12618001360202
Protocol of controlled odorant stimulation for reducing apnoeic episodes
in premature newborns: a randomised open-label Latin-square study with
independent evaluation of the main endpoint (PREMODEUR)
Authors: Duchamp-Viret Patricia , Nguyen Huu Kim , Maucort-Boulch Delphine , Remontet Laurent , Guyon Aurore , Franco Patricia , Cividjian Andrei , Thevenet Marc , Iwaz Jean , Galletti Sonia , Kassai Behrouz , Cornaton Elise , Plaisant Franck , Claris Olivier , Gauthier-Moulinier Hélène
Published: November 2022

Introduction

Apnoea affects 85% of premature infants under 34 weeks of age and
would be an important risk factor for subsequent neuropsychological
disorders. Currently, premature children with life-threatening apnoeas
receive stimulants such as methylxanthines (mainly, caffeine) or
doxapram (an analeptic unlicensed in children under 15). However, these
products have undesirable effects (hyperarousal, irritability, sleep
disorders, tachycardia) and are not always effective because apnoea does
persist in some premature newborns. Previous studies have indicated that
odorant stimulation, a non-invasive intervention, may stimulate the
respiratory rhythm. The objective of the present protocol is to reduce
the occurrence of apnoeic episodes in premature newborns by controlled
odorant stimulation added to current pharmacological
treatments.

Methods and analysis

The project is a randomised open-label Latin-square trial with
independent evaluation of the main endpoint. It will include 60 preterm
neonates from two university hospital neonatal intensive care units over
2 years (2021–2023). Each newborn will receive no (S0), sham (S1) or
real olfactory stimulation (S2) in random order. During S2, three
distinct odorants (mint, grapefruit and vanilla) will be delivered
successively, in puffs, over 24 hours. Mint and grapefruit odours
stimulate the main and the trigeminal olfactory pathways, whereas
vanilla odour stimulates only the main olfactory pathway. A statistical
analysis will compare the incidence of apnoeic episodes during S1 versus
S2 using a mixed effects Poisson model.

Ethics and dissemination

Ethical approval was obtained from the Comité de Protection des
Personnes Île-de-France XI (# 2017-AO13-50-53). The results will be
disseminated through various scientific meetings, specialised
peer-reviewed journals and, whenever possible, posted on appropriate
public websites.

Trial registration number

NCT02851979; Pre-results.
PediAppRREST: effectiveness of an interactive cognitive support tablet
app in reducing deviations from guidelines in the management of paediatric
cardiac arrest: protocol for a simulation-based randomised controlled
trial
Authors: Corazza Francesco , Arpone Marta , Snijders Deborah , Cheng Adam , Stritoni Valentina , Ingrassia Pier Luigi , De Luca Marco , Tortorolo Luca , Frigo Anna Chiara , Da Dalt Liviana , Bressan Silvia
Published: November 2022

Introduction

Paediatric cardiac arrest (PCA), despite its low incidence, has a
high mortality. Its management is complex and deviations from guideline
recommendations occur frequently. We developed a new interactive tablet
app, named PediAppRREST, to support the management of PCA. The app
received a good usability evaluation in a previous pilot trial. The aim
of the study is to evaluate the effectiveness of the PediAppRREST app in
reducing deviations from guideline recommendations in PCA
management.

Methods and analysis

This is a multicentre, simulation-based, randomised controlled,
three-parallel-arm study. Participants are residents in Paediatric,
Emergency Medicine, and Anaesthesiology programmes in Italy. All 105
teams (315 participants) manage the same scenario of in-hospital PCA.
Teams are randomised by the study statistician into one of three study
arms for the management of the PCA scenario: (1) an intervention group
using the PediAppRREST app or (2) a control group Paediatric Advanced
Life Support (CtrlPALS+) using the PALS pocket reference card; or (3) a
control group (CtrlPALS-) not allowed to use any PALS-related cognitive
aid. The primary outcome of the study is the number of deviations
(delays and errors) in PCA management from PALS guideline
recommendations, according to a novel checklist, named c-DEV15plus. The
c-DEV15plus scores will be compared between groups with a one-way
analysis of variance model, followed by the Tukey-Kramer multiple
comparisons adjustment procedure in case of statistical
significance.

Ethics and dissemination

The Ethics Committee of the University Hospital of Padova,
coordinating centre of the trial, deemed the project to be a negligible
risk study and approved it through an expedited review process. The
results of the study will be disseminated in peer-reviewed journals, and
at national and international scientific conferences. Based on the study
results, the PediAppRREST app will be further refined and will be
available for download by institutions/healthcare
professionals.

Trial registration number

NCT04619498; Pre-results.
Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study
Authors: Bruhn Simon Majormoen , Ingelsrud Lina Holm , Bandholm Thomas , Skou Søren Thorgaard , Schroder Henrik M , Reventlow Susanne , Møller Anne , Kjellberg Jakob , Kallemose Thomas , Troelsen Anders
Published: November 2022

Introduction

Knee osteoarthritis (OA) is associated with chronic knee pain and functional disability that negatively affect the ability to carry out normal daily activities. Patients are offered a large variety of non-surgical treatments, often not in accordance with clinical guidelines. This observational study will provide a comprehensive overview of treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon, including timing and order of treatment modalities, predictors of treatment outcomes, cost-effectiveness of treatment pathways and patients’ views on different treatment pathways.

Methods and analysis

Patients with primary referrals to an orthopaedic surgeon due to knee OA are consecutively invited to participate and fill out a questionnaire prior to their consultation with an orthopaedic surgeon. Follow-up questionnaires will be obtained at 6 and 24 months after inclusion. Based on a prospective cohort study design, including questionnaires and register data, we will (1) describe treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon; (2) describe the characteristics of patients choosing different treatment pathways; (3) develop predictive models for patient-self-determined classifications of good and poor treatment outcomes; (4) evaluate the cost-effectiveness of treatment pathways that live up to clinical guidelines versus pathways that do not; based on a qualitative study design using semistructured individual interviews, we will (5) describe the patients’ perspectives on treatment pathways for knee OA.

Ethics and dissemination

The study is approved by the Danish regional ethical committee (journal number H-17017295) and the Danish Data Protection Agency (journal number AHH-2017–072). Data will be anonymised and handled in line with the General Data Protection Regulation and the Danish Data Protection Act. The study results will be submitted to international open-access peer-reviewed journals and disseminated at conferences.

Trial registration number

NCT03746184, pre-results.
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS):
protocol of a prospective, randomised, adaptive, multicentre clinical
trial
Authors: Kanjo Anna , Molnar Zsolt , Zádori Noémi , Gede Noémi , Erőss Bálint , Szakó Lajos , Kiss Tamás , Márton Zsolt , Malbrain Manu L N G , Szuldrzynski Konstanty , Szrama Jakub , Kusza Krzysztof , Kogelmann Klaus , Hegyi Péter
Published: November 2022

Introduction

Sepsis and septic shock have mortality rates between 20% and 50%. In
sepsis, the immune response becomes dysregulated, which leads to an
imbalance between proinflammatory and anti-inflammatory mediators. When
standard therapeutic measures fail to improve patients’ condition,
additional therapeutic alternatives are applied to reduce morbidity and
mortality. One of the most recent alternatives is extracorporeal
cytokine adsorption with a device called CytoSorb. This study aims to
compare the efficacy of standard medical therapy and continuous
extracorporeal cytokine removal with CytoSorb therapy in patients with
early refractory septic shock. Furthermore, we compare the dosing of
CytoSorb adsorber device changed every 12 or 24 hours.

Methods and analysis

It is a prospective, randomised, controlled, open-label,
international, multicentre, phase III study. Patients fulfilling the
inclusion criteria will be randomly assigned to receive standard medical
therapy (group A) or—in addition to standard treatment—CytoSorb therapy.
CytoSorb treatment will be continuous and last for at least 24 hours,
CytoSorb adsorber device will be changed every 12 (group B) or 24 hours
(group C). Our primary outcome is shock reversal (no further need or a
reduced (≤10% of the maximum dose) vasopressor requirement for 3 hours)
and time to shock reversal (number of hours elapsed from the start of
the treatment to shock reversal).

Based on sample size calculation, 135 patients (1:1:1) will need to
be enrolled in the study. A predefined interim analysis will be
performed after reaching 50% of the planned sample size, therefore, the
corrected level of significance (p value) will be 0.0294.

Ethics and dissemination

Ethics approval was obtained from the Scientific and Research Ethics
Committee of the Hungarian Medical Research Council (OGYÉI/65049/2020).
Results will be submitted for publication in a peer-reviewed
journal.

Trial registration number

NCT04742764; Pre-results.
SHAPER-PND trial: clinical effectiveness protocol of a community singing
intervention for postnatal depression
Authors: Estevao Carolina , Bind Rebecca , Fancourt Daisy , Sawyer Kristi , Dazzan Paola , Sevdalis Nick , Woods Anthony , Crane Nikki , Rebecchini Lavinia , Hazelgrove Katie , Manoharan Manonmani , Burton Alexandra , Dye Hannah , Osborn Tim , Greenwood Lorna , Davis Rachel E , Soukup Tayana , Arias de la Torre Jorge , Bakolis Ioannis , Healey Andy , Perkins Rosie , Pariante Carmine
Published: November 2022

Introduction

Postnatal depression (PND) affects approximately 13% of new mothers.
Community-based activities are sought after by many mothers, especially
mothers that prefer not to access pharmacological or psychological
interventions. Singing has shown positive effects in maternal mood and
mother–child bonding. The Scaling-Up Health-Arts Programmes:
Implementation and Effectiveness Research-Postnatal Depression study
will analyse the clinical and implementation effectiveness of 10-week
singing sessions for PND in new mothers. This protocol paper will focus
on the clinical effectiveness of this trial.

Methods and analysis

A total of 400 mothers with PND (with a score of at least 10 on the
Edinburgh Postnatal Depression Scale) and their babies will be recruited
for this hybrid type II randomised controlled trial. The intervention
group will attend 10 weekly singing sessions held at community venues or
online, facilitated by the arts organisation, Breathe Arts Health
Research (Breathe). A control group will be encouraged to attend
non-singing sessions in the community or online for 10 weeks. A package
of assessments will be collected from participants for clinical,
mechanistic and implementation outcomes, at different stages of the
trial. Clinical assessments will include questionnaires and interviews
for demographics, mental health and social measures, together with
biological samples for measurement of stress markers; the study visits
are at baseline, week 6 (mid-trial) and week 10 (end of trial), with
follow ups at weeks 20 and 36. Multiple imputation will be used to deal
with possible missing data and multivariable models will be fitted to
assess differences between groups in the outcomes of the study.

Ethics and dissemination

Ethical approval has been granted by the London-West London and GTAC
Research Ethics Committee, REC reference: 20/PR/0813.

Trial registration number

NCT04834622; Pre-results.
Implementation of medicinal cannabis in Australia: innovation or
upheaval? Perspectives from physicians as key informants, a qualitative
analysis
Authors: Hallinan Christine Mary , Gunn Jane Maree , Bonomo Yvonne Ann
Published: November 2022

Objective

We sought to explore physician perspectives on the prescribing of
cannabinoids to patients to gain a deeper understanding of the issues
faced by prescriber and public health advisors in the rollout of
medicinal cannabis.

Design

A thematic qualitative analysis of 21 in-depth interviews was
undertaken to explore the narrative on the policy and practice of
medicinal cannabis prescribing. The analysis used the Diffusion of
Innovations (DoI) theoretical framework to model the conceptualisation
of the rollout of medicinal cannabis in the Australian context.

Setting

Informants from the states and territories of Victoria, New South
Wales, Tasmania, Australian Capital Territory, and Queensland in
Australia were invited to participate in interviews to explore the
policy and practice of medicinal cannabis prescribing.

Participants

Participants included 21 prescribing and non-prescribing key
informants working in the area of neurology, rheumatology, oncology,
pain medicine, psychiatry, public health, and general practice.

Results

There was an agreement among many informants that medicinal cannabis
is, indeed, a pharmaceutical innovation. From the analysis of the
informant interviews, the factors that facilitate the diffusion of
medicinal cannabis into clincal practice include the adoption of
appropriate regulation, the use of data to evaluate safety and efficacy,
improved prescriber education, and the continuous monitoring of product
quality and cost. Most informants asserted the widespread assimilation
of medicinal cannabis into practice is impeded by a lack of health
system antecedents that are required to facilitate safe, effective, and
equitable access to medicinal cannabis as a therapeutic.

Conclusions

This research highlights the tensions that arise and the factors
that influence the rollout of cannabis as an unregistered medicine.
Addressing these factors is essential for the safe and effective
prescribing in contemporary medical practice. The findings from this
research provides important evidence on medicinal cannabis as a
therapeutic, and also informs the rollout of potential novel
therapeutics in the future.
Effects of mindfulness-based stress reduction on adults with sleep disturbance: an updated systematic review and meta-analysis
Authors: Kim Seong Min , Park Jeong Min , Seo Hyun-Ju , Kim Jinhee , Noh Jin-Won , Kim Hyun Lye
Published: November 2022

Objective

Mindfulness-based stress reduction (MBSR) is a meditation-based therapy originally recommended for stress management. However, it is currently used to alleviate sleep disturbances. Therefore, this contemporary systematic review aimed to elucidate the clinical effects of MBSR on sleep quality and sleep-related daytime impairment in adults with sleep disturbances, including chronic insomnia disorders.

Design

Systematic review and meta-analysis of randomised controlled trials (RCTs).

Methods

A comprehensive search was conducted using the following databases: Ovid MEDLINE, AMED, Ovidembase, PsycINFO, Cochrane Library, CINAHL, and four domestic databases: KoreaMed, KISS, KMbase and NDSL. The final search update was performed in June 2022. Two researchers independently selected relevant studies, assessed the risk of bias and extracted the data.

Results

Of the 7516 records searched, 20 RCTs and 21 reports were included. In the subgroup analysis, MBSR did not improve objective or subjective sleep quality in chronic insomnia and cancers. However, MBSR versus waitlist control might have been effective in improving subjective sleep quality, but with substantial heterogeneity (standardised mean difference=−0.32; 95% CI: −0.56 to –0.08; I2=71%). In addition, MBSR compared with active control did not improve the sleep-related daytime impairments including depression, anxiety, stress, fatigue and quality of life. The overall risk of bias included in this review was a concern because of performance and detection bias.

Conclusions

MBSR might be ineffective for improving sleep quality in patients with chronic insomnia and cancers. In addition, more than half of the RCTs included in this review had small sample sizes and were vulnerable to performance and detection biases. Therefore, well-designed RCTs with larger sample sizes are required to confirm the clinical effects of MBSR in adults with sleep disturbances.

PROSPERO registration number

CRD42015027963.
Common mental disorders and associated factors among high school students in Debre Markos Town, Northwest Ethiopia: an institutional-based cross-sectional study
Authors: Melkam Mamaru , Nenko Goshu , Demilew Demeke
Published: November 2022

Background

Common mental disorders include anxiety, depression and somatic symptoms. These pose significant public health problems because of their serious effects on personal well-being, social and occupational functions. They also can affect the health and quality of life of people in adolescence, because this age group has been vulnerable to different factors. According to the American Psychiatry Association, more than 60% of adolescents fulfil the criteria for at least one common mental disorder. Despite the high burden of the disorders, there are limited studies in Ethiopia; therefore, this study provided the prevalence of common mental disorders among students in Ethiopia.

Methods

From 5 May to 30 May 2021, an institutional-based cross-sectional study was undertaken. Simple random sampling was used to select study participants from each class level across all high schools. A self-administered survey was used that included Self-Reporting Questionnaire 20, Oslo Social Support Scale-3 and other semistructured instruments for the screening of common mental disorders. Data were checked, coded and entered into Epi-Data V.4.6.0, then exported to SPSS V.20 for analysis. Bivariable and multivariable logistic regression analyses were done to identify factors associated with common mental disorders. Adjusted ORs with 95% CIs were calculated and variables with a p value of <0.05 were considered as significantly associated with common mental disorders.

Results

A total of 600 high school students were recruited with a response rate of 93.2%. The overall prevalence of common mental disorders among the participants was 181 (32.4%). Being female (adjusted OR (AOR)=1.93; 95% CI: 1.27 to 2.99), a family history of mental illness (AOR=2.23; 95% CI: 1.15 to 4.35), poor social support (AOR=3.14; 95% CI: 1.51 to 6.54), a history of non-physical sexual abuse (AOR=2.09; 95% CI: 1.21 to 3.62) and a history of physical sexual abuse (AOR=2.43; 95% CI: 1.29 to 4.59) were significantly associated with common mental disorders.

Conclusion and recommendation

The prevalence of common mental disorders was 32.4% among students; therefore, it is recommended facilitating institutional-based intervention services in the school to decrease the contributing factors for the common mental disorders.
‘It’s a Dance Between Managing Both’: a qualitative study exploring perspectives of persons with knee osteoarthritis and type 2 diabetes mellitus on the impact of osteoarthritis on diabetes management and daily life
Authors: King Lauren K , Waugh Esther , MacKay Crystal , Stanaitis Ian , Stretton Jane , Weisman Alanna , Ivers Noah M , Lipscombe Lorraine L , Hawker Gillian , Parsons Janet A
Published: November 2022

Objectives

Type 2 diabetes (T2DM) and knee osteoarthritis (OA) commonly co-occur and epidemiologic studies suggest concomitant symptomatic knee OA increases the risk of T2DM complications. We sought to explore the experiences and perspectives of individuals’ living with both symptomatic knee OA and T2DM, with a focus on the impact of OA on T2DM management and daily life.

Design

We conducted qualitative semistructured telephone interviews with persons living with T2DM and knee OA. We inductively coded and analysed interview transcripts, informed by interpretative description.

Setting

We recruited participants from a community arthritis self-management programme and an academic hospital’s family medicine clinic in Ontario, Canada.

Participants

We included 18 participants who had a physician diagnosis of both T2DM and knee OA, with variation age, gender, and duration of T2DM and knee OA.

Results

Participants with T2DM described how concomitant painful and disabling knee OA made it difficult to engage in physical activity, negatively impacting blood glucose control. Joint pain itself, associated sleep disturbance and emotional distress were also seen to affect blood glucose control. Beyond diabetes management, the impact of OA-related pain and functional limitations on nearly all aspects of daily life led participants to view their OA as important. Despite this, many participants described that their health professionals paid little attention to their OA, which left them to self-manage. Balancing both conditions also required navigating a medical system that provided piecemeal care.

Conclusions

Individuals with T2DM view symptomatic knee OA as an important barrier to both T2DM management and overall well-being, yet are frequently met with insufficient support from health professionals. Greater recognition and management of knee OA in persons with T2DM could help improve patient-centred care and potentially disease outcomes.
Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
Authors: Sánchez-Velázquez Patricia , Pueyo-Périz Eva , Álamo J M , Suarez Artacho Gonzalo , Gómez Bravo Miguel Ángel , Marcello Manuel , Vicente Emilio , Quijano Yolanda , Ferri Valentina , Caruso Riccardo , Dorcaratto Dimitri , Sabater Luis , González Chávez Pilarena , Noguera Jose , Navarro Gonzalo Ana , Bellido-Luque Juan , Téllez-Marques Clara , Ielpo Benedetto , Burdio Fernando
Published: November 2022

Introduction

To date, no pancreatic stump closure technique has been shown to be superior to any other in distal pancreatectomy. Although several studies have shown a trend towards better results in transection using a radiofrequency device (radiofrequency-assisted transection (RFT)), no randomised trial for this purpose has been performed to date. Therefore, we designed a randomised clinical trial, with the hypothesis that this technique used in distal pancreatectomies is superior in reducing clinically relevant postoperative pancreatic fistula (CR-POPF) than mechanical closures.

Methods and analysis

TRANSPAIRE is a multicentre randomised controlled trial conducted in seven Spanish pancreatic centres that includes 112 patients undergoing elective distal pancreatectomy for any indication who will be randomly assigned to RFT or classic stapler transections (control group) in a ratio of 1:1. The primary outcome is the CR-POPF percentage. Sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1−β), expected POPF in control group of 32%, expected POPF in RFT group of 10% and a clinically relevant difference of 22%. Secondary outcomes include postoperative results, complications, radiological evaluation of the pancreatic stump, metabolomic profile of postoperative peritoneal fluid, survival and quality of life. Follow-ups will be carried out in the external consultation at 1, 6 and 12 months postoperatively.

Ethics and dissemination

TRANSPAIRE has been approved by the CEIM-PSMAR Ethics Committee. This project is being carried out in accordance with national and international guidelines, the basic principles of protection of human rights and dignity established in the Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013), and in accordance with regulations in studies with biological samples, Law 14/2007 on Biomedical Research will be followed. We have defined a dissemination strategy, whose main objective is the participation of stakeholders and the transfer of knowledge to support the exploitation of activities.

Registration details

ClinicalTrials.gov Registry (NCT04402346).