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Is sarcopenia a risk factor for reduced diaphragm function following hepatic resection? A study protocol for a prospective observational study

Por: van der Kroft · G. · Fritsch · S. J. J. · Rensen · S. S. · Wigger · S. · Stoppe · C. · Lambertz · A. · Neumann · U. P. · Damink · S. W. M. O. · Bruells · C. S.
Introduction

Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising postoperative pulmonary function. We hypothesise that both major hepatic resection and sarcopenia have a measurable impact on diaphragm function. Furthermore, we hypothesise that sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection. The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared with non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared with non-sarcopenic patients.

Methods and analysis

Transcostal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in 33 sarcopenic and 33 non-sarcopenic patients undergoing right-sided hemihepatectomy starting 1 day prior to surgery and up to 30 days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery . A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.

Ethics and dissemination

This trial is open for recruitment. The protocol was approved by the official Independent Medical Ethical Committee at Uniklinik (Rheinish Westphälische Technische Hochschule (RWTH) Aachen (reference EK309-18) in July 2019. Results will be published via international peer-reviewed journals and the findings of the study will be communicated using a comprehensive dissemination strategy aimed at healthcare professionals and patients.

Trial registration number

ClinicalTrials. gov (EK309-18); Pre-results.

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM)

Por: Park · K. U. · Lee · S. · Sarna · A. · Chetta · M. · Schulz · S. · Agnese · D. · Grignol · V. · Carson · W. · Skoracki · R. J.
Introduction

Nipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA.

Methods and analysis

This is a single-arm prospective pilot study to determine the safety, efficacy and potential risks of RNSM. Up to 12 RNSM will be performed to assess the safety and feasibility of the procedure. Routine follow-up visits and study assessments will occur at 14 days, 30 days, 6 weeks, 6 months and 12 months. The primary outcome is to assess the feasibility of removing the breast gland en bloc using the RNSM technique. To assess safety, postoperative complication information will be collected. Secondary outcomes include defining benefits and challenges of RNSM for both surgeons and patients using surveys, as well as defining the breast and nipple-areolar complex sensation recovery following RNSM. Mainly, descriptive analysis will be used to report the findings.

Ethics and dissemination

The RNSM protocol was reviewed and approved by the US Food and Drug Administration using the Investigational Device Exemption mechanism (reference number G200096). In addition, the protocol was registered with ClinicalTrials.gov (NCT04537312) and approved by The Ohio State University Institutional Review Board, reference number 2020C0094 (18 August 2020). The results of this study will be distributed through peer-reviewed journals and presented at surgical conferences.

Trial registration number

NCT04537312.

Nurse staffing and patient-perceived quality of nursing care: a cross-sectional analysis of survey and administrative data in German hospitals

Por: Winter · V. · Dietermann · K. · Schneider · U. · Schreyögg · J.
Objective

To examine the impact of nurse staffing on patient-perceived quality of nursing care. We differentiate nurse staffing levels and nursing skill mix as two facets of nurse staffing and use a multidimensional instrument for patient-perceived quality of nursing care. We investigate non-linear and interaction effects.

Setting

The study setting was 3458 hospital units in 1017 hospitals in Germany.

Participants

We contacted 212 554 patients discharged from non-paediatric, non-intensive and non-psychiatric hospital units who stayed at least two nights in the hospital between January and October 2019. Of those, 30 174 responded, yielding a response rate of 14.2%. Our sample included only those patients. After excluding extreme values for our nurse staffing variables and removing observations with missing values, our final sample comprised 28 136 patients ranging from 18 to 97 years of age (average: 61.12 years) who had been discharged from 3458 distinct hospital units in 1017 hospitals.

Primary and secondary outcome measures

Patient-perceived quality of nursing care (general nursing care, guidance provided by nurses, and patient loyalty to the hospital).

Results

For all three dimensions of patient-perceived quality of nursing care, we found that they significantly decreased as (1) nurse staffing levels decreased (with decreasing marginal effects) and (2) the proportion of assistant nurses in a hospital unit increased. The association between nurse staffing levels and quality of nursing care was more pronounced among patients who were less clinically complex, were admitted to smaller hospitals or were admitted to medical units.

Conclusions

Our results indicate that, in addition to nurse staffing levels, nursing skill mix is crucial for providing the best possible quality of nursing care from the patient perspective and both should be considered when designing policies such as minimum staffing regulations to improve the quality of nursing care in hospitals.

Machine learning techniques for mortality prediction in emergency departments: a systematic review

Por: Naemi · A. · Schmidt · T. · Mansourvar · M. · Naghavi-Behzad · M. · Ebrahimi · A. · Wiil · U. K.
Objectives

This systematic review aimed to assess the performance and clinical feasibility of machine learning (ML) algorithms in prediction of in-hospital mortality for medical patients using vital signs at emergency departments (EDs).

Design

A systematic review was performed.

Setting

The databases including Medline (PubMed), Scopus and Embase (Ovid) were searched between 2010 and 2021, to extract published articles in English, describing ML-based models utilising vital sign variables to predict in-hospital mortality for patients admitted at EDs. Critical appraisal and data extraction for systematic reviews of prediction modelling studies checklist was used for study planning and data extraction. The risk of bias for included papers was assessed using the prediction risk of bias assessment tool.

Participants

Admitted patients to the ED.

Main outcome measure

In-hospital mortality.

Results

Fifteen articles were included in the final review. We found that eight models including logistic regression, decision tree, K-nearest neighbours, support vector machine, gradient boosting, random forest, artificial neural networks and deep neural networks have been applied in this domain. Most studies failed to report essential main analysis steps such as data preprocessing and handling missing values. Fourteen included studies had a high risk of bias in the statistical analysis part, which could lead to poor performance in practice. Although the main aim of all studies was developing a predictive model for mortality, nine articles did not provide a time horizon for the prediction.

Conclusion

This review provided an updated overview of the state-of-the-art and revealed research gaps; based on these, we provide eight recommendations for future studies to make the use of ML more feasible in practice. By following these recommendations, we expect to see more robust ML models applied in the future to help clinicians identify patient deterioration earlier.

Longitudinal humoral antibody response to SARS-CoV-2 infection among healthcare workers in a New York City hospital

Por: Menon · V. · Shariff · M. A. · Perez Gutierrez · V. · Carreno · J. M. · Yu · B. · Jawed · M. · Gossai · M. · Valdez · E. · Pillai · A. · Venugopal · U. · Kasubhai · M. · Dimitrov · V. · Krammer · F.
Objective

Dynamics of humoral immune responses to SARS-CoV-2 antigens following infection suggest an initial decay of antibody followed by subsequent stabilisation. We aim to understand the longitudinal humoral responses to SARS-CoV-2 nucleocapsid (N) protein and spike (S) protein and to evaluate their correlation to clinical symptoms among healthcare workers (HCWs).

Design

A prospective longitudinal study.

Setting

This study was conducted in a New York City public hospital in the South Bronx, New York.

Participants

HCWs participated in phase 1 (N=500) and were followed up 4 months later in phase 2 (N=178) of the study. They underwent SARS-CoV-2 PCR and serology testing for N and S protein antibodies, in addition to completion of an online survey in both phases. Analysis was performed on the 178 participants who participated in both phases of the study.

Primary outcome measure

Evaluate longitudinal humoral responses to viral N (qualitative serology testing) and S protein (quantitative Mount Sinai Health System ELISA to detect receptor-binding domain and full-length S reactive antibodies) by measuring rate of decay.

Results

Anti-N antibody positivity was 27% and anti-S positivity was 28% in phase 1. In phase 1, anti-S titres were higher in symptomatic (6754 (5177–8812)) than in asymptomatic positive subjects (5803 (2825–11 920)). Marginally higher titres (2382 (1494–3797)) were seen in asymptomatic compared with the symptomatic positive subgroup (2198 (1753–2755)) in phase 2. A positive correlation was noted between age (R=0.269, p

Conclusions

Higher initial anti-S antibody titres were associated with larger number and longer duration of symptoms as well as a faster decay between the two time points.

Potential effects on cardiometabolic risk factors and body composition by short message service (SMS)-guided training after recent minor stroke or transient ischaemic attack: post hoc analyses of the STROKEWALK randomised controlled trial

Por: Vahlberg · B. M. · Lundström · E. · Eriksson · S. · Holmback · U. · Cederholm · T.
Objectives

To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke.

Design

Randomised controlled intervention study with per-protocol analyses.

Setting

University Hospital in Sweden.

Participants

Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) ≥18 years with good motor function (modified Rankin Scale ≤2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations.

Interventions

The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care.

Main outcome measures

Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months.

Results

Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (–1.30 kg, 95% CI –2.45 to –0.14; p=0.029, ES=0.41 vs –0.76 kg, 95% CI –1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol –0.65 mmol/L, 95% CI –1.10 to –0.2; p=0.06, ES: 0.5 vs –1.1 mmol/L, 95% CI –1.47 to –0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups.

Conclusions

No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived health. Further research is needed to evaluate secondary prevention efforts in larger populations after recent stroke.

Trial registration number

NCT02902367.

Efficacy of a Low-threshold, Culturally-Sensitive Group Psychoeducation Programme for Asylum Seekers (LoPe): study protocol for a multicentre randomised controlled trial

Por: Weise · C. · Grupp · F. · Reese · J.-P. · Schade-Brittinger · C. · Ehring · T. · Morina · N. · Stangier · U. · Steil · R. · Johow · J. · Mewes · R.
Introduction

Despite high levels of mental distress, accessing psychological treatment is difficult for asylum seekers in Western host countries due to a lack of knowledge about mental disorders, and the health system, as well as due to cultural and language barriers. This study aims to investigate whether brief culturally sensitive and transdiagnostic psychoeducation is effective in increasing mental health literacy.

Methods and analysis

The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either culturally sensitive, low-threshold psychoeducation (‘Tea Garden’ (TG)) or a waitlist (WL) control group. It takes place at four study sites in Germany. A total of 166 adult asylum seekers who report at least mild mental distress will be randomly assigned. The TG consists of two 90 min group sessions and provides information about mental distress, resources and mental health services in a culturally sensitive manner. The primary outcome is the percentage of participants in the TG, as compared with the WL, achieving an increase in knowledge concerning symptoms of mental disorders, individual resources and mental healthcare from preintervention to postintervention. The further trajectory will be assessed 2 and 6 months after the end of the intervention. Secondary outcomes include changes in mental distress, openness towards psychotherapy and resilience. Furthermore, healthcare utilisation and economics will be assessed at all assessment points.

Ethics and dissemination

The study has been approved by the Ethics Commission of the German Psychological Society (ref: WeiseCornelia2019-10-18VA). Results will be disseminated via presentations, publication in international journals and national outlets for clinicians. Furthermore, intervention materials will be available, and the existing network will be used to disseminate and implement the interventions into routine healthcare.

Trial registration number

DRKS00020564; Pre-results.

Protocol version

2020-10-06, version number: VO2F.

Infant feeding, appetite and satiety regulation, and adiposity during infancy: a study design and protocol of the 'MAS-Lactancia birth cohort

Por: Ramirez-Silva · I. · Perez Ferrer · C. · Ariza · A. C. · Tamayo-Ortiz · M. · Barragan · S. · Batis · C. · Cantoral · A. · Sanchez · M. · Zambrano · E. · Burguete-Garcia · A. I. · Avila-Jimenez · L. · Ramakrishnan · U. · Stein · A. D. · Martorell · R. · Rivera · J. A.
Introduction

The prevalence of childhood obesity has risen dramatically in recent years. A proportion of this burden has been attributed to factors that occur during the first 1000 days of life such as genetic predisposition, breast feeding and complementary feeding. Although the mechanisms by which these factors affect weight and adiposity are less well understood, appetite and satiety regulation may be a key to understanding them. This cohort study aims to investigate the role of appetite and satiety regulation as a mediator in the association between infant feeding practices and genetic polymorphisms with children’s growth, adiposity and metabolic risk factors.

Methods and analysis

‘MAS-Lactancia’ (the first word means ‘more’ and is also an acronym in Spanish for ‘Appetite and Satiety Mechanisms’, the second word is ‘breastfeeding’) is an open, ongoing, prospective birth cohort that began the enrolment in 2016 of mother–child pairs affiliated to the Mexican Social Security Institute and that live in the city of Cuernavaca, Mexico. Pregnant women between 16-week and 22-week gestation are followed during the second half of their pregnancies, at birth and throughout their infant’s first 48 months of life (at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months and 48 months) at the clinic and at-home visits that include questionnaires, anthropometric measurements and biospecimen collection. The main exposure variables are infant feeding (breast feeding and complementary feeding) and genetic polymorphisms (fat mass and obesity-associated, leptin and adiponectin genes). Outcome variables include infant’s growth, adiposity and metabolic risk factors. We will conduct longitudinal models and path analyses to identify the potential mediating role of satiety and appetite indicators (leptin, adiponectin, insulin concentrations, appetite and satiety perception).

Ethics and dissemination

The study protocol, data collection instruments, consent forms and procedures were approved by the institutional review boards of the National Institute of Public Health and the Mexican Social Security Institute in Mexico. Findings will be disseminated through conferences, peer-reviewed publications and meetings with stakeholders.

Study protocol: the ear-nose-throat (ENT) prospective international cohort of patients with primary ciliary dyskinesia (EPIC-PCD)

Por: Goutaki · M. · Lam · Y. T. · Alexandru · M. · Anagiotos · A. · Armengot · M. · Bequignon · E. · Boon · M. · Burgess · A. · Coste · A. · Emiralioglu · N. · Erdem · E. · Haarman · E. G. · Harris · A. · Hool · S.-L. · Karadag · B. · Kim · S. · Latzin · P. · Lorent · N. · Ozcelik · U. · Reula · A
Introduction

Primary ciliary dyskinesia (PCD) is a rare, genetic, multiorgan disease with an estimated prevalence of 1 in 10 000. It affects mainly the upper and lower airways due to impaired mucociliary clearance. Almost all patients have sinonasal or otologic (ear–nose–throat, ENT) problems, although the ENT clinical phenotype may present great variability. Despite that, data on PCD ENT manifestations are scarce and based on small single-centre studies. To date, we know little about the spectrum and severity of PCD ENT disease, its association with lung disease, its course over life and its determinants of prognosis.

This study protocol describes the aims and methods of the first prospective, observational, multinational cohort study focusing on ENT disease in patients with PCD.

Methods and analysis

The ENT prospective international cohort of patients with PCD (EPIC-PCD) is a prospective standardised observational clinical cohort set up as a multinational multicentre study, embedded into routine patient care. It aims to longitudinally characterise ENT disease in patients with PCD and its association with lung disease, and to identify determinants of its prognosis. Patients of all ages, diagnosed with PCD who undergo an ENT clinical assessment at least once a year at one of the participating centres will be invited to participate. Collected data include diagnostic test results, results of ENT examinations, lung function measurements, information on management of ENT disease and patient-reported data on clinical symptoms and health-related quality of life (QoL). Data are collected using the standardised PCD-specific FOLLOW-PCD form and the validated QoL-PCD questionnaire.

Ethics and dissemination

The study has been reviewed and approved by the Human Research Ethics Committees at all participating centres, based on local legislation. The results of the study will be published in scientific journals, presented at scientific conferences and disseminated to participants and national patient organisations.

Trial registration

NCT04611516.

Observational cohort study of the triggers, diagnoses and outcomes of the medical emergency team (MET) response in adult psychiatry inpatients colocated with acute medical services in Australia

Por: Azraai · M. · Pham · J. H. · Looi · W. F. · Wirth · D. · Ng · A. S. L. · Babu · U. · Saluja · B. · Lim · A. K. H.
Objectives

Medical emergencies in psychiatric inpatients are challenging due to the model of care and limited medical resources. The study aims were to determine the triggers and outcomes of a medical emergency team (MET) call in psychiatric wards, and the risk factors for MET activation and mortality.

Design

Retrospective multisite cohort study.

Setting

Psychiatry units colocated with acute medical services at three major metropolitan hospitals in Melbourne, Australia.

Participants

We studied 487 adult inpatients who experienced a total of 721 MET calls between January 2015 and January 2020. Patients were relatively young (mean age, 45 years) and had few medical comorbidities, but a high prevalence of smoking, excessive alcohol intake and illicit drug use.

Outcome measures

We performed a descriptive analysis of the triggers and outcomes (transfer rates, investigations, final diagnosis) of MET calls. We used logistic regression to determine the factors associated with the primary outcome of inpatient mortality, and the secondary outcome of the need for specific medical treatment compared with simple observation.

Results

The most common MET triggers were a reduced Glasgow Coma Scale, tachycardia and hypotension, and 49% of patients required transfer. The most frequent diagnosis was a drug adverse effect or toxidrome, followed by infection and dehydration. There was a strong association between a leave of absence and MET calls, tachycardia and the final diagnosis of drug adverse effects. Mortality occurred in 3% after MET calls. Several baseline and MET clinical variables were associated with mortality but a model with age (per 10 years, OR 1.61, 95% CI 1.29 to 2.01) and hypoxia (OR 3.59, 95% CI 1.43 to 9.04) independently predicted mortality.

Conclusion

Vigilance is required in patients returning from day leave, and drug adverse effects remain a challenging problem in psychiatric units. Hypoxic older patients with cardiovascular comorbidity have a higher risk of death.

Effects of chronic ethnic discrimination in the daily life of Turkish immigrants living in Austria: study protocol of a 30-day ambulatory assessment study

Por: Goreis · A. · Nater · U. M. · Mewes · R.
Introduction

Chronic ethnic discrimination is associated with negative mental and physical health outcomes in ethnic minority groups. It is assumed that suffering from repeated discriminatory events leads, over time, to psychological consequences such as higher perceived stress, higher negative affect and lower positive affect. Higher stress reactivity to non-discriminatory stressors, such as daily hassles, as well as anticipation and avoidance behaviour regarding discriminatory events, may further contribute to the overall burden for affected individuals. Studies investigating chronic ethnic discrimination and its psychological consequences in the daily lives of affected persons are lacking. Here, we present a study protocol to investigate the impact of chronic ethnic discrimination and acute discriminatory events in the daily lives of Turkish immigrants living in Austria, using an ambulatory assessment design. The feasibility of our study design was tested and confirmed in a pilot study (n=10).

Methods and analysis

Ninety male Turkish immigrants will complete daily questionnaires for 30 days. Participants will indicate stress, perceived discrimination, negative and positive affect, daily hassles, anticipation and avoidance behaviour, as well as rumination with regard to discriminatory events on a daily basis. Furthermore, they will use preprogrammed iPods to assess acute discriminatory events in real time. Our hypotheses will be tested using multilevel analyses.

Ethics and dissemination

This study has been approved by the institutional review board of the University of Vienna (reference number 00358). Results will be presented at conferences and submitted for publication in a peer-reviewed journal.

Perinatal factors and hospitalisations for severe childhood infections: a population-based cohort study in Sweden

Por: Videholm · S. · Kostenniemi · U. · Lind · T. · Silfverdal · S.-A.
Objective

To examine the association between perinatal factors and hospitalisations for sepsis and bacterial meningitis in early childhood (from 28 days to 2 years of age).

Design

A population-based cohort study. The Swedish Medical Birth Register was combined with the National Inpatient Register, the Cause of Death Register, the Total Population Register and the Longitudinal integration database for health insurance and labour market studies. Associations between perinatal factors and hospitalisations were examined using negative binomial regression models.

Setting

Sweden.

Participants

1 406 547 children born in Sweden between 1997 and 2013.

Main outcome measures

Hospital admissions for sepsis and bacterial meningitis recorded between 28 days and 2 years of life.

Results

Gestational age was inversely associated with severe infections, that is, extreme prematurity was strongly associated with an increased risk of sepsis, adjusted incidence rate ratio (aIRR) 10.37 (95% CI 6.78 to 15.86) and meningitis aIRR 6.22 (95% CI 2.28 to 16.94). The presence of congenital malformation was associated with sepsis aIRR 3.89 (95% CI 3.17 to 4.77) and meningitis aIRR 1.69 (95% CI 1.09 to 2.62). Moreover, children born small or large for gestational age were more likely to be hospitalised for sepsis and children exposed to maternal smoking were more likely to be hospitalised for meningitis.

Conclusions

Prematurity and several other perinatal factors were associated with an increased risk of severe infections in young children. Therefore, clinical guidelines for risk assessment of infections in young children should consider perinatal factors.

Sustainability of a school-based health intervention for prevention of non-communicable diseases in marginalised communities: protocol for a mixed-methods cohort study

Por: Arnaiz · P. · Adams · L. · Müller · I. · Gerber · M. · Walter · C. · du Randt · R. · Steinmann · P. · Bergman · M. M. · Seelig · H. · van Greunen · D. · Utzinger · J. · Pühse · U.
Introduction

The prevalence of chronic, lifestyle-related diseases is increasing among adults and children from low-income and middle-income countries. Despite the effectiveness of community-based interventions to address this situation, the benefits thereof may disappear in the long term, due to a lack of maintenance, especially among disadvantaged and high-risk populations. The KaziBantu randomised controlled trial conducted in 2019 consisted of two school-based health interventions, KaziKidz and KaziHealth. This study will evaluate the long-term effectiveness and sustainability of these interventions in promoting positive lifestyle changes among children and educators in disadvantaged schools in Nelson Mandela Bay, South Africa, in the context of the COVID-19 pandemic.

Methods and analysis

This study has an observational, longitudinal, mixed-methods design. It will follow up educators and children from the KaziBantu study. All 160 educators enrolled in KaziHealth will be invited to participate, while the study will focus on 361 KaziKidz children (aged 10–16 years) identified as having an increased risk for non-communicable diseases. Data collection will take place 1.5 and 2 years postintervention and includes quantitative and qualitative methods, such as anthropometric measurements, clinical assessments, questionnaires, interviews and focus group discussions. Analyses will encompass: prevalence of health parameters; descriptive frequencies of self-reported health behaviours and quality of life; the longitudinal association of these; extent of implementation; personal experiences with the programmes and an impact analysis based on the Reach, Efficacy, Adoption, Implementation, Maintenance framework.

Discussion

In settings where resources are scarce, sustainable and effective prevention programmes are needed. The purpose of this protocol is to outline the design of a study to evaluate KaziKidz and KaziHealth under real-world conditions in terms of effectiveness, being long-lasting and becoming institutionalised. We hypothesise that a mixed-methods approach will increase understanding of the interventions’ capacity to lead to sustainable favourable health outcomes amid challenging environments, thereby generating evidence for policy.

Trial registration number

ISRCTN15648510

Registered nurses require increased time allocation and improved placement support measures to enhance student nurse placement learning experiences

Por: Kerin · U.

Commentary on: Cusack L, Thornton K, Drioli-Phillips PG, et al. Are nurses recognised, prepared and supported to teach nursing students: mixed methods study. Nurse Educ Today 2020; 90:104434. doi: 10.1016/j.nedt.2020.104434.

Implications for practice and research

  • Registered nurses require time to deliver high-quality experiential learning and where possible; this should be reflected in clinical practice workload allocation.

  • Future research should develop enhanced strategies to improve support provision for registered nurses involved in teaching, supervising, mentoring and assessing nursing students in practice.

  • Context

    Clinical placements provide nursing students with experiential learning opportunities to practice professional values, socialise into the clinical context, enhance clinical skills competence and integrate theory into practice.1 2 While on placement, students are assigned to one or more registered nurses (RNs). Mentors, preceptors, assessors and practice supervisors are just some of the titles assigned to RNs who teach, supervise,...

    BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial

    Por: Schop · S. S. J. · Hommes · J. E. · Krastev · T. K. · Derks · D. · Larsen · M. · Rakhorst · H. · Schmidbauer · U. · Smit · J. M. · Tan · T. · Wehrens · K. · de Wit · T. · van der Hulst · R. R. W. J. · Piatkowski de Grzymala · A. A.
    Introduction

    Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed).

    Methods and analysis

    This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire.

    Ethics and dissemination

    Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals.

    Trial status

    Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021.

    Trial registration number

    NCT02339779.

    COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study

    Por: Carlsson · Y. · Bergman · L. · Zaigham · M. · Linden · K. · Andersson · O. · Veje · M. · Sandström · A. · Wikström · A.-K. · Östling · H. · Fadl · H. · Domellöf · M. · Blomberg · M. · Brismar Wendel · S. · Aden · U. · Sengpiel · V. · For the COPE study group · Elfvin · Hagman
    Introduction

    There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.

    The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic.

    Methods and analysis

    This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents’ experiences will be studied by performing qualitative interviews.

    Ethics and dissemination

    Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals.

    Trial registration number

    NCT04433364.

    Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial

    Por: Klein · J. P. · Hauer-von Mauschwitz · A. · Berger · T. · Fassbinder · E. · Mayer · J. · Borgwardt · S. · Wellhöfer · B. · Schweiger · U. · Jacob · G.
    Importance

    Borderline personality disorder (BPD) is a severe mental disorder that is often inadequately treated.

    Objective

    To determine if adding a self-management intervention to care as usual (CAU) is effective and safe.

    Design

    Randomised, controlled, rater-blind trial. Duration of treatment and assessments: 12 months.

    Setting

    Secondary care, recruited mainly via the internet.

    Participants

    Patients with BPD and BPD Severity Index (BPDSI) of at least 15.

    Interventions

    CAU by treating psychiatrist and/or psychotherapist alone or adjunctive use of an internet-based self-management intervention that is based on schema therapy (priovi).

    Main outcome measure

    Outcomes were assessed by trained raters. The primary outcome was change in BPDSI. The safety outcome was the number of serious adverse events (SAEs). The primary outcome time point was 12 months after randomisation.

    Results

    Of 383 participants assessed for eligibility, 204 were included (91.7% female, mean age: 32.4 years; 74% were in psychotherapy and 26% were in psychiatric treatment). The slope of BPDSI change did not differ significantly between groups from baseline to 12 months (F3,248= 1.857, p=0.14). At 12 months, the within-group effect sizes were d=1.38 (95% CI 1.07 to 1.68) for the intervention group and d=1.02 (95% CI 0.73 to 1.31) for the control group. The between-group effect size was d=0.27 (95% CI 0.00 to 0.55) in the intention-to-treat sample and d=0.39 (95% CI 0.09 to 0.68) for those who used the intervention for at least 3 hours (per-protocol sample). We found no significant differences in SAEs.

    Conclusions

    We have not found a significant effect in favour of the intervention. This might be due to the unexpectedly large effect in the group receiving CAU by a psychiatrist and/or psychotherapist alone.

    Trial registration

    NCT03418142.

    Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)

    Por: Pal · A. · Stapleton · S. · Yap · C. · Lai-Kwon · J. · Daly · R. · Magkos · D. · Baikady · B. R. · Minchom · A. · Banerji · U. · De Bono · J. · Karikios · D. · Boyle · F. · Lopez · J.
    Introduction

    Early phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures—this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.

    Methods and analysis

    This is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).

    Ethics and dissemination

    Ethics approval was granted by the National Health Service Health Research Authority on 15 June 2020—IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.

    Trial registration number

    NCT04407676; Pre-results.

    Life or limb: an international qualitative study on decision making in sarcoma surgery during the COVID-19 pandemic

    Por: Bunzli · S. · O'Brien · P. · Aston · W. · Ayerza · M. A. · Chan · L. · Cherix · S. · de las Heras · J. · Donati · D. · Eyesan · U. · Fabbri · N. · Ghert · M. · Hilton · T. · Idowu · O. K. · Imanishi · J. · Puri · A. · Rose · P. · Sabah · D. · Turcotte · R. · Weber · K. · Dowsey · M. M. · Choon
    Objectives

    The COVID-19 pandemic is unprecedented as a global crisis over the last century. How do specialist surgeons make decisions about patient care in these unprecedent times?

    Design

    Between April and May 2020, we conducted an international qualitative study. Sarcoma surgeons from diverse global settings participated in 60 min interviews exploring surgical decision making during COVID-19. Interview data were analysed using an inductive thematic analysis approach.

    Setting

    Participants represented public and private hospitals in 14 countries, in different phases of the first wave of the pandemic: Australia, Argentina, Canada, India, Italy, Japan, Nigeria, Singapore, Spain, South Africa, Switzerland, Turkey, UK and USA.

    Participants

    From 22 invited sarcoma surgeons, 18 surgeons participated. Participants had an average of 19 years experience as a sarcoma surgeon.

    Results

    17/18 participants described a decision they had made about patient care since the start of the pandemic that was unique to them, that is, without precedence. Common to ‘unique’ decisions about patient care was uncertainty about what was going on and what would happen in the future (theme 1: the context of uncertainty), the impact of the pandemic on resources or threat of the pandemic to overwhelm resources (theme 2: limited resources), perceived increased risk to self (theme 3: duty of care) and least-worst decision making, in which none of the options were perceived as ideal and participants settled on the least-worst option at that point in time (theme 4: least-worst decision making).

    Conclusions

    In the context of rapidly changing standards of justice and beneficence in patient care, traditional decision-making frameworks may no longer apply. Based on the experiences of surgeons in this study, we describe a framework of least-worst decision making. This framework gives rise to actionable strategies that can support decision making in sarcoma and other specialised fields of surgery, both during the current crisis and beyond.

    Protection levels of N95-level respirator substitutes proposed during the COVID-19 pandemic: safety concerns and quantitative evaluation procedures

    Por: Ballard · D. H. · Dang · A. J. · Kumfer · B. M. · Weisensee · P. B. · Meacham · J. M. · Scott · A. R. · Ruppert-Stroescu · M. · Burke · B. A. · Morris · J. · Gan · C. · Hu · J. · King · B. · Jammalamadaka · U. · Sayood · S. · Liang · S. · Choudhary · S. · Dhanraj · D. · Maranhao · B. · Mil
    Objective

    The COVID-19 pandemic has precipitated widespread shortages of filtering facepiece respirators (FFRs) and the creation and sharing of proposed substitutes (novel designs, repurposed materials) with limited testing against regulatory standards. We aimed to categorically test the efficacy and fit of potential N95 respirator substitutes using protocols that can be replicated in university laboratories.

    Setting

    Academic medical centre with occupational health-supervised fit testing along with laboratory studies.

    Participants

    Seven adult volunteers who passed quantitative fit testing for small-sized (n=2) and regular-sized (n=5) commercial N95 respirators.

    Methods

    Five open-source potential N95 respirator substitutes were evaluated and compared with commercial National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators as controls. Fit testing using the 7-minute standardised Occupational Safety and Health Administration fit test was performed. In addition, protocols that can be performed in university laboratories for materials testing (filtration efficiency, air resistance and fluid resistance) were developed to evaluate alternate filtration materials.

    Results

    Among five open-source, improvised substitutes evaluated in this study, only one (which included a commercial elastomeric mask and commercial HEPA filter) passed a standard quantitative fit test. The four alternative materials evaluated for filtration efficiency (67%–89%) failed to meet the 95% threshold at a face velocity (7.6 cm/s) equivalent to that of a NIOSH particle filtration test for the control N95 FFR. In addition, for all but one material, the small surface area of two 3D-printed substitutes resulted in air resistance that was above the maximum in the NIOSH standard.

    Conclusions

    Testing protocols such as those described here are essential to evaluate proposed improvised respiratory protection substitutes, and our testing platform could be replicated by teams with similar cross-disciplinary research capacity. Healthcare professionals should be cautious of claims associated with improvised respirators when suggested as FFR substitutes.

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