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Unexplained mortality during the US COVID-19 pandemic: retrospective analysis of death certificate data and critical assessment of excess death calculations

Por: Fairman · K. A. · Goodlet · K. J. · Rucker · J. D. · Zawadzki · R. S.
Objectives

Cause-of-death discrepancies are common in respiratory illness-related mortality. A standard epidemiological metric, excess all-cause death, is unaffected by these discrepancies but provides no actionable policy information when increased all-cause mortality is unexplained by reported specific causes. To assess the contribution of unexplained mortality to the excess death metric, we parsed excess deaths in the COVID-19 pandemic into changes in explained versus unexplained (unreported or unspecified) causes.

Design

Retrospective repeated cross-sectional analysis, US death certificate data for six influenza seasons beginning October 2014, comparing population-adjusted historical benchmarks from the previous two, three and five seasons with 2019–2020.

Setting

48 of 50 states with complete data.

Participants

16.3 million deaths in 312 weeks, reported in categories—all causes, top eight natural causes and respiratory causes including COVID-19.

Outcome measures

Change in population-adjusted counts of deaths from seasonal benchmarks to 2019–2020, from all causes (ie, total excess deaths) and from explained versus unexplained causes, reported for the season overall and for time periods defined a priori: pandemic awareness (19 January through 28 March); initial pandemic peak (29 March through 30 May) and pandemic post-peak (31 May through 26 September).

Results

Depending on seasonal benchmark, 287 957–306 267 excess deaths occurred through September 2020: 179 903 (58.7%–62.5%) attributed to COVID-19; 44 022–49 311 (15.2%–16.1%) to other reported causes; 64 032–77 054 (22.2%–25.2%) unexplained (unspecified or unreported cause). Unexplained deaths constituted 65.2%–72.5% of excess deaths from 19 January to 28 March and 14.1%–16.1% from 29 March through 30 May.

Conclusions

Unexplained mortality contributed substantially to US pandemic period excess deaths. Onset of unexplained mortality in February 2020 coincided with previously reported increases in psychotropic use, suggesting possible psychiatric or injurious causes. Because underlying causes of unexplained deaths may vary by group or region, results suggest excess death calculations provide limited actionable information, supporting previous calls for improved cause-of-death data to support evidence-based policy.

Epidemiology, management and the associated burden of mental health illness, atopic and autoimmune conditions, and common infections in alopecia areata: protocol for an observational study series

Por: Harries · M. · Macbeth · A. E. · Holmes · S. · Thompson · A. R. · Chiu · W. S. · Gallardo · W. R. · Messenger · A. G. · Tziotzios · C. · de Lusignan · S.
Introduction

Alopecia areata (AA) is a common cause of immune-mediated non-scarring hair loss. Links between AA and common mental health, autoimmune and atopic conditions, and common infections have previously been described but remain incompletely elucidated and contemporary descriptions of the epidemiology of AA in the UK are lacking.

Methods and analysis

Retrospective study series using a large population-based cohort (5.2 million) from the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database, exploring four themes: AA epidemiology, mental health comorbidities, autoimmune/atopic associations and common infections.

In the epidemiology theme, we will describe the incidence and point prevalence of AA overall and by age, sex and sociodemographic factors. Healthcare utilisation (primary care visits and secondary care referrals) and treatments for AA will also be assessed. In the mental health theme, we will explore the prevalence and incidence of mental health conditions (anxiety, depressive episodes, recurrent depressive disorder, adjustment disorder, agoraphobia, self-harm and parasuicide) in people with AA compared with matched controls. We will also explore the mental health treatment patterns (medication and psychological interventions), time off work and unemployment rates. Within the autoimmune/atopic associations theme, we will examine the prevalence of atopic (atopic dermatitis, allergic rhinitis, asthma) and autoimmune conditions (Crohn’s disease, ulcerative colitis, coeliac disease, type 1 diabetes, Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE), polymyalgia rheumatica, Sjögren’s syndrome, psoriasis, vitiligo, multiple sclerosis, pernicious anaemia) in people with AA compared with matched controls. We will also estimate the incidence of new-onset atopic and autoimmune conditions after AA diagnosis. Within the common infections theme, we will examine the incidence of common infections (respiratory tract infection, pneumonia, acute bronchitis, influenza, skin infection, urinary tract infection, genital infections, gastrointestinal infection, herpes simplex, herpes zoster, meningitis, COVID-19) in people with AA compared with matched controls.

Ethics and dissemination

The Health Research Authority decision tool classed this a study of usual practice, ethics approval was not required. Study approval was granted by the RCGP RSC Study Approval Committee. Results will be disseminated through peer-reviewed publications.

Observational study registration number

NCT04239521.

Patient perspectives on integrated healthcare for HIV, hypertension and type 2 diabetes: a scoping review

Por: Singh · S. · Kirk · O. · Jaffar · S. · Karakezi · C. · Ramaiya · K. · Kallestrup · P. · Kraef · C.
Introduction

Antiretroviral therapy has reduced mortality and led to longer life expectancy in people living with HIV. These patients are now at an increased risk of non-communicable diseases (NCDs). Integration of care for HIV and NCDs has become a focus of research and policy. In this article, we aim to review patient perspectives on integration of healthcare for HIV, type 2 diabetes and hypertension.

Methods

The framework for scoping reviews developed by Arksey and O'Malley and updated by Peter et al was applied for this review. The databases PubMed, Web of Science and Cochrane library were searched. Broad search terms for HIV, NCDs (specifically type 2 diabetes and hypertension) and healthcare integration were used. As the review aimed to identify definitions of patient perspectives, they were not included as an independent term in the search strategy. References of included publications were searched for relevant articles. Titles and abstracts for these papers were screened by two independent reviewers. The full texts for all the publications appearing to meet the inclusion criteria were then read to make the final literature selection.

Results

Of 5502 studies initially identified, 13 articles were included in this review, of which 11 had a geographical origin in sub-Saharan Africa. Nine articles were primarily focused on HIV/diabetes healthcare integration while four articles were focused on HIV/hypertension integration. Patient’s experiences with integrated care were reduced HIV-related stigma, reduced travel and treatment costs and a more holistic person-centred care. Prominent concerns were long waiting times at clinics and a lack of continuity of care in some clinics due to a lack of healthcare workers. Non-integrated care was perceived as time-consuming and more expensive.

Conclusion

Patient perspectives and experiences on integrated care for HIV, diabetes and hypertension were mostly positive. Integrated services can save resources and allow for a more personalised approach to healthcare. There is a paucity of evidence and further longitudinal and interventional evidence from a more diverse range of healthcare systems are needed.

Developing a preference-based measure for weight-specific health-related quality of life in adolescence: the WAItE UK valuation study protocol

Por: Robinson · T. · Hill · S. · Oluboyede · Y.
Introduction

Adolescent obesity is a public health problem in the UK. The Weight-Specific Adolescent Instrument for Economic Evaluation (WAItE) has been developed as the first weight-specific health-related quality of life measure appropriate for economic evaluation, but currently cannot be used to generate quality-adjusted life years (QALYs), which are the basis of cost-utility analysis. Generic measures (such as the EQ-5D-Y or CHU-9D) may be insensitive to small but important health changes in overweight or obese adolescents. This study aims to generate a preference-based scoring algorithm for the WAItE.

Methods and analysis

A discrete choice experiment (DCE) will be administered to value health states described by the WAItE classification system. These health states will be presented to members of the adult general population of the UK via an online survey. A range of regression models will be used to produce the utility algorithm for the WAItE. The DCE-visual analogue scale and time trade-off (TTO) anchoring methods will be used anchor the value set on to the 0–1 QALY scale.

Ethics and dissemination

The Newcastle University Medical School Ethics Committee approved the study (references 4772/2020 (DCE) and 9978/2020 (TTO)). The developed algorithm can be applied to future economic evaluations of weight management interventions and treatments for adolescents.

Impact of multimodal warming during general anaesthesia on postoperative cognitive dysfunction in elderly patients with gynaecological cancer: study protocol for a single-blinded randomised controlled trial

Por: Zhang · J. · Song · S. · Zhu · Q.
Background

Cognitive impairment after anaesthesia and surgery is a recognised consequence. This often leads to poor health outcomes and increases healthcare resource utilisation and associated costs, especially in elderly people. However, thus far, there have not been any effective therapies for managing postoperative cognitive dysfunction (POCD). Furthermore, research on the association of multimodal warming with POCD and the clinical outcomes in older patients after gynaecological surgery has not been rigorous. For these reasons, our investigation aims to evaluate whether perioperative multimodal warming would reduce the incidence of POCD and improve prognosis in elderly patients with gynaecological cancer.

Methods and analysis

This is a single-centre, prospective, single-blinded randomised controlled trial. One hundred and fifty patients for gynaecological cancer surgery and 16 non-surgical controls aged 65 years or older will be studied in this trial. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, at day 7 and 3 months after gynaecological cancer surgery. In addition, POCD and cognitive decline will be assessed using the reliable change index using the control group’s results. The primary outcome is the prevalence of POCD in elderly gynaecological cancer surgery patients and association between perioperative multimodal warming and POCD.

Ethics and dissemination

The protocol for this prospective observational study was approved by the ethics committee of the West China Second University Hospital, Sichuan University (NO. KX215). Recruitment will commence in April 2021 and continue to April 2022. The findings of this trial will be disseminated in peer-reviewed journals and scientific meetings.

Trial registration number

ChiCTR2100041663.

Virtual team-based care planning with older persons in formal care settings: a scoping review protocol

Por: Gao · H. · Yous · M.-L. · Connelly · D. · Hung · L. · Garnett · A. · Hay · M. E. · Snobelen · N. · Salatino · S.
Introduction

COVID-19 has necessitated greater adoption of virtual care (eg, telephone (audio), videoconference) delivery models. Virtual care provides opportunities for innovative practice in care planning with older persons and meaningful family engagement by synchronously involving multiple care providers. Nevertheless, there remains a paucity of summarising evidence regarding virtual team-based care planning for older persons. The purpose of this scoping review is to summarise evidence on the utilisation of virtual team-based care planning for older persons in formal care settings. Specifically, (1) what has been reported in the literature on the impact or outcomes of virtual team-based care planning? (2) What are the facilitators and barriers to implementation?

Methods and analysis

This scoping review will follow a rigorous and well-established methodology by the Joanna Briggs Institute, supplemented by the Arksey & O’Malley and Levac, Colquhoun, & O’Brien frameworks. A three-step search strategy will be used to conduct a search on virtual team-based care planning for older persons in formal care settings. Keywords and index terms will be identified from an initial search in PubMed and AgeLine, and used to conduct the full search in the databases PubMed, EMBASE, CINAHL, AgeLine, PsycInfo and Scopus. Reference lists of included articles and grey literature retrieved through Google and Google Scholar will also be reviewed. Three researchers will screen titles and abstracts, and will conduct full-text review for inclusion. Extracted data will be mapped in a table.

Ethics and dissemination

Research ethics approval is not required for data collection from publicly accessible information. Findings will be presented at conferences, submitted for open-access publication in a peer-reviewed journal and made accessible to multiple stakeholders. The scoping review will summarise the literature on virtual team-based care planning for the purpose of informing the implementation of a virtual PIECES™ intervention (Physical/Intellectual/Emotional health, Capabilities, Environment, and Social).

Hospital management of major stroke types in Chinese adults: a population-based study of 20 000 hospitalised stroke cases

Por: Qin · H. · Turnbull · I. · Chen · Y. · Wright · N. · Liu · L. · Pei · P. · Tang · W. · Xiang · S. · Guo · Y. · Zhao · X. · Clarke · R. · Li · L. · Wang · Y. · Chen · Z. · On behalf of The China Kadoorie Biobank Collaborative Group
Objectives

To compare hospital treatments for major stroke types in Chinese adults by stroke pathological types, sex, age, calendar year, hospital tier, region and other factors.

Design

Cross-sectional analysis of medical records retrieved from 20 229 stroke cases in the China Kadoorie Biobank.

Setting

Ten diverse areas (five urban, five rural) in China.

Participants

First-incident stroke cases who were recruited during an 11-year follow-up of 0.5M participants in the China Kadoorie Biobank.

Methods

Electronic copies of medical records of stroke cases were retrieved for clinical adjudication by local neurologists. Stroke cases were classified as ischaemic stroke (IS) (including lacunar infarction (LACI) and non-LACI (non-LACI)), intracerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) and unspecified stroke types.

Results

Among 20 299 first-ever stroke cases, 17 306 (85%) had IS, 7123 had non-LACI, 6690 had LACI, 3493 had silent LACI, 2623 (13%) had ICH and 370 (2%) had SAH. Among IS cases, antiplatelet treatment was used by 64% (65% non-LACI, 66% LACI, 56% silent LACI), lipid-lowering by 50% (52% non-LACI, 53% LACI, 43% silent LACI) and blood pressure-lowering by ~42% of all IS types, with positive trends in the use of these treatments by calendar year and hospital tier. Among ICH cases, 53% used blood pressure-lowering and 10% used lipid-lowering treatments, respectively. In contrast, traditional Chinese medicines (TCMs) were used by 59% of IS (50% non-LACI, 62% LACI, 74% silent LACI), 38% of ICH and 30% of SAH cases, with positive trends by calendar year and by hospital tier.

Conclusions

Among IS cases, use of antiplatelet and lipid-lowering medications increased in recent years, but use of TCM still exceeded use of blood pressure-lowering treatment. In contrast, blood pressure-lowering treatment was widely used for ICH, but only half of all ICH cases used blood pressure-lowering treatment.

Regional variations and prevalence of psoriasis in Germany from 2010 to 2017: a cross-sectional, spatio-epidemiological study on ambulatory claims data

Por: Andrees · V. · Wolf · S. · Augustin · M. · Mohr · N. · Augustin · J.
Objectives

Global prevalence rates of psoriasis differ significantly, with lowest rates in the equator region and increasing tendencies towards the north but also differences within-country. Information on regional variations in Germany is missing. This study aims to analyse the change of psoriasis prevalence in Germany over time and to detect regional variations.

Design

Cross sectional, spatio-epidemiological study on regional psoriasis prevalence in Germany.

Setting

Claims data study based on nationwide outpatient billing data on county level.

Methods

Analyses based on outpatient billing data for 2010–2017 derived from all people insured in statutory health insurances (about 72.8 million). We performed descriptive spatio-temporal analyses of prevalence rates using probability mapping and statistical smoothing methods, identified spatial clusters and examined a north-south gradient using spatial statistics.

Results

The prevalence increased from 147.4 per 10 000 in 2010 to 173.5 in 2017. In 2017, counties’ prevalence rates ranged between 93.8 and 340.9. Decreased rates occurred mainly in southern counties, increased rates in northern and eastern counties. Clusters of low rates occur in southern and south-western Germany, clusters of high rates in the north and north-east. The correlation between counties’ latitudes and their prevalence rates was high with Pearson’s r=0.65 (p

Conclusion

Increased prevalence of psoriasis over time and marked regional variations in Germany were observed which need further investigation.

Trends and causes of adult mortality from 2007 to 2017 using verbal autopsy method, Addis Ababa, Ethiopia

Por: Fenta · E. H. · Sisay · B. G. · Gebreyesus · S. H. · Endris · B. S.
Objectives

We aim to analyse the trends and causes of mortality among adults in Addis Ababa.

Setting

This analysis was conducted using verbal autopsy data from the Addis Ababa Mortality Surveillance in Addis Ababa, Ethiopia.

Participants

All deceased adults aged 15 years and above between 2007–2012 and 2015–2017 were included in the analysis.

Outcome measures

We collected verbal autopsy and conducted physician review to ascertain cause of death.

Result

A total of 7911 data were included in this analysis. Non-communicable disease (NCD) accounted for 62.8% of adult mortality. Mortality from communicable diseases, maternal conditions and nutritional deficiencies followed this by accounting for 30.3% of total mortality. Injury accounted for 6.8% of total mortality. We have observed a significant decline in mortality attributed to group one cause of death (43.25% in 2007 to 12.34% in 2017, p

Conclusion

We documented an epidemiological shift in cause of mortality from communicable diseases to NCD over 10 years. There is a great progress in reducing mortality due to communicable diseases over the past years. However, the burden of NCDs call for actions for improving access to quality health service, improved case detection and community education to increase awareness. Integrating NCD intervention in to a well-established and successful programme targeting communicable diseases in the country might be beneficial for improving provision of comprehensive healthcare.

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.

High-risk factors for adverse pregnancy outcomes in systemic lupus erythaematosus: a retrospective study of a Chinese population

Por: Jiang · M. · Chang · Y. · Wang · Y. · Fu · Q. · Lin · S. · Wu · J. · Di · W.
Objective

To clarify high-risk factors for adverse pregnancy outcomes (APOs) in systemic lupus erythaematosus (SLE).

Design

A retrospective chart review study.

Setting

Data were collected in a tertiary medical centre, Shanghai, China, from November 2010 to December 2018.

Participants

A total of 513 pregnancies with SLE were retrospectively analysed. Twenty-seven patients who underwent artificial abortions due to personal reasons were excluded.

Primary outcome measures

APOs were primary outcomes, including foetal loss, premature birth, small for gestational age (SGA), asphyxia neonatorum, composite foetal APOs and hypertensive disorders of pregnancy (HDP). Multivariable logistic regression and Spearman correlation analysis were performed to determine the risk factors for APOs in SLE.

Results

Risk factors for foetal loss included prepregnancy hypertension, hypocomplementaemia-C3, anticardiolipin antibodies-IgM positivity and disease flares during pregnancy. Risk factors for premature birth included disease flares, use of immunosuppressive agents and HDP. Moreover, twin pregnancy, disease flares and HDP were risk factors for SGA, and prepregnancy hypertension was an independent risk factor for asphyxia neonatorum. Independent risk factors for composite foetal APOs included twin pregnancy, prepregnancy hypertension, disease flares during pregnancy, HDP, hypocomplementaemia-C3 and the use of immunosuppressive agents. Risk factors for SLE complicated with HDP included prepregnancy hypertension, renal disorders and thrombocytopaenia. Conversely, the use of aspirin was a protective factor against foetal loss and premature birth. The ds-DNA value had a low diagnostic value for APOs, whereas the extent of complement reduction may predict the incidence of composite foetal APOs and foetal loss. Proteinuria occurring in the first 20 gestational weeks may lead to APOs.

Conclusion

Established risk factors for each APO were identified in this study. Indicators with more predictive significance have been screened out from conventional indicators, which may help clinicians predict the pregnancy outcome of patients with SLE more accurately and minimise the incidence of APOs.

Multimorbidity patterns of chronic conditions and geriatric syndromes in older patients from the MoPIM multicentre cohort study

Por: Bare · M. · Herranz · S. · Roso-Llorach · A. · Jordana · R. · Violan · C. · Lleal · M. · Roura-Poch · P. · Arellano · M. · Estrada · R. · Nazco · G. J. · on behalf of the MoPIM study group · Bare · Herranz · Jordana · Gorgas · Ortonobes · Lleal · Roura-Poch · Sevilla · Sola · Gonzale
Objectives

To estimate the frequency of chronic conditions and geriatric syndromes in older patients admitted to hospital because of an exacerbation of their chronic conditions, and to identify multimorbidity clusters in these patients.

Design

Multicentre, prospective cohort study.

Setting

Internal medicine or geriatric services of five general teaching hospitals in Spain.

Participants

740 patients aged 65 and older, hospitalised because of an exacerbation of their chronic conditions between September 2016 and December 2018.

Primary and secondary outcome measures

Active chronic conditions and geriatric syndromes (including risk factors) of the patient, a score about clinical management of chronic conditions during admission, and destination at discharge were collected, among other variables. Multimorbidity patterns were identified using fuzzy c-means cluster analysis, taking into account the clinical management score. Prevalence, observed/expected ratio and exclusivity of each chronic condition and geriatric syndrome were calculated for each cluster, and the final solution was approved after clinical revision and discussion among the research team.

Results

740 patients were included (mean age 84.12 years, SD 7.01; 53.24% female). Almost all patients had two or more chronic conditions (98.65%; 95% CI 98.23% to 99.07%), the most frequent were hypertension (81.49%, 95% CI 78.53% to 84.12%) and heart failure (59.86%, 95% CI 56.29% to 63.34%). The most prevalent geriatric syndrome was polypharmacy (79.86%, 95% CI 76.82% to 82.60%). Four statistically and clinically significant multimorbidity clusters were identified: osteoarticular, psychogeriatric, cardiorespiratory and minor chronic disease. Patient-level variables such as sex, Barthel Index, number of chronic conditions or geriatric syndromes, chronic disease exacerbation 3 months prior to admission or destination at discharge differed between clusters.

Conclusions

In older patients admitted to hospital because of the exacerbation of chronic health problems, it is possible to define multimorbidity clusters using soft clustering techniques. These clusters are clinically relevant and could be the basis to reorganise healthcare circuits or processes to tackle the increasing number of older, multimorbid patients.

Trial registration number

NCT02830425.

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.

Development and validation of multivariable prediction models for adverse COVID-19 outcomes in patients with IBD

Por: Sperger · J. · Shah · K. S. · Lu · M. · Zhang · X. · Ungaro · R. C. · Brenner · E. J. · Agrawal · M. · Colombel · J.-F. · Kappelman · M. D. · Kosorok · M. R.
Objectives

Develop an individualised prognostic risk prediction tool for predicting the probability of adverse COVID-19 outcomes in patients with inflammatory bowel disease (IBD).

Design and setting

This study developed and validated prognostic penalised logistic regression models using reports to the international Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease voluntary registry from March to October 2020. Model development was done using a training data set (85% of cases reported 13 March–15 September 2020), and model validation was conducted using a test data set (the remaining 15% of cases plus all cases reported 16 September–20 October 2020).

Participants

We included 2709 cases from 59 countries (mean age 41.2 years (SD 18), 50.2% male). All submitted cases after removing duplicates were included.

Primary and secondary outcome measures

COVID-19 related: (1) Hospitalisation+: composite outcome of hospitalisation, ICU admission, mechanical ventilation or death; (2) Intensive Care Unit+ (ICU+): composite outcome of ICU admission, mechanical ventilation or death; (3) Death. We assessed the resulting models’ discrimination using the area under the curve of the receiver operator characteristic curves and reported the corresponding 95% CIs.

Results

Of the submitted cases, a total of 633 (24%) were hospitalised, 137 (5%) were admitted to the ICU or intubated and 69 (3%) died. 2009 patients comprised the training set and 700 the test set. The models demonstrated excellent discrimination, with a test set area under the curve (95% CI) of 0.79 (0.75 to 0.83) for Hospitalisation+, 0.88 (0.82 to 0.95) for ICU+ and 0.94 (0.89 to 0.99) for Death. Age, comorbidities, corticosteroid use and male gender were associated with a higher risk of death, while the use of biological therapies was associated with a lower risk.

Conclusions

Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of patients with IBD. A free online risk calculator (https://covidibd.org/covid-19-risk-calculator/) is available for healthcare providers to facilitate discussion of risks due to COVID-19 with patients with IBD.

Social and life skills in adolescents who have self-harmed: analysis of survey responses from a national sample of adolescents in Norway

Por: Fadum · E. A. · Carlsen · E. O. · Ramberg · M. · Strand · L. A. · Haberg · S. E. · Borud · E. · Martinussen · M.
Objective

Social and life skills (SLS) may be important in the prevention and treatment of self-harm, but few studies have described this relationship. We examined three components of SLS in adolescents who reported self-harm that was, according to themselves, diagnosed by a clinician.

Design

Cross-sectional.

Setting

National screening prior to military service.

Participants

176 284 residents of Norway born in 1999–2001 received a declaration of health. We included 171 486 individuals (84 153 (49%) women and 87 333 (51%) men) who were 17 (n=1 67 855) or 18 years of age (n=3631) when they completed the declaration.

Outcome measure

The main outcome was clinically diagnosed self-harm, defined as self-harm that the adolescents themselves stated had been diagnosed by a clinician. Components of SLS were social interactions; coping strategies; and emotional regulation/aggression. The association between SLS and self-reported clinically diagnosed self-harm was assessed in hierarchical multiple regression models controlling for sex; school absence; and feelings of emotional pain.

Results

Three percent (n=5507) of the adolescents reported clinically diagnosed self-harm. The three components of SLS together added little to the prediction of clinically diagnosed self-harm (R2=0.02). After controlling for school absence and emotional pain, emotional regulation/aggression was the only SLS-component that was independently associated with clinically diagnosed self-harm (OR 1.33, 95% CI 1.31 to 1.36). The young men who said they had been clinically diagnosed for self-harm scored slightly worse on social interactions (Hedge’s g (g) = –0.13, pg = –0.18, p

Conclusion

Young women and young men who reported clinically diagnosed self-harm had more problems with emotional regulation/aggression than other adolescents, but did not have worse social interactions or coping strategies.

Current trends in the application of causal inference methods to pooled longitudinal non-randomised data: a protocol for a methodological systematic review

Por: Yeboah · E. · Mauer · N. S. · Hufstedler · H. · Carr · S. · Matthay · E. C. · Maxwell · L. · Rahman · S. · Debray · T. · de Jong · V. M. T. · Campbell · H. · Gustafson · P. · Jänisch · T. · Bärnighausen · T.
Introduction

Causal methods have been adopted and adapted across health disciplines, particularly for the analysis of single studies. However, the sample sizes necessary to best inform decision-making are often not attainable with single studies, making pooled individual-level data analysis invaluable for public health efforts. Researchers commonly implement causal methods prevailing in their home disciplines, and how these are selected, evaluated, implemented and reported may vary widely. To our knowledge, no article has yet evaluated trends in the implementation and reporting of causal methods in studies leveraging individual-level data pooled from several studies. We undertake this review to uncover patterns in the implementation and reporting of causal methods used across disciplines in research focused on health outcomes. We will investigate variations in methods to infer causality used across disciplines, time and geography and identify gaps in reporting of methods to inform the development of reporting standards and the conversation required to effect change.

Methods and analysis

We will search four databases (EBSCO, Embase, PubMed, Web of Science) using a search strategy developed with librarians from three universities (Heidelberg University, Harvard University, and University of California, San Francisco). The search strategy includes terms such as ‘pool*’, ‘harmoniz*’, ‘cohort*’, ‘observational’, variations on ‘individual-level data’. Four reviewers will independently screen articles using Covidence and extract data from included articles. The extracted data will be analysed descriptively in tables and graphically to reveal the pattern in methods implementation and reporting. This protocol has been registered with PROSPERO (CRD42020143148).

Ethics and dissemination

No ethical approval was required as only publicly available data were used. The results will be submitted as a manuscript to a peer-reviewed journal, disseminated in conferences if relevant, and published as part of doctoral dissertations in Global Health at the Heidelberg University Hospital.

Nomogram to predict risk of incident chronic kidney disease in high-risk population of cardiovascular disease in China: community-based cohort study

Por: Zhang · Q. · Zhang · J. · Lei · L. · Liang · H. · Li · Y. · Lu · J. · Zhou · S. · Li · G. · Zhang · X. · Chen · Y. · Pan · J. · Lu · X. · Chen · Y. · Lin · X. · Li · X. · An · S. · Xiu · J.
Aims

To develop a nomogram for incident chronic kidney disease (CKD) risk evaluation among community residents with high cardiovascular disease (CVD) risk.

Methods

In this retrospective cohort study, 5730 non-CKD residents with high CVD risk participating the National Basic Public Health Service between January 2015 and December 2020 in Guangzhou were included. Endpoint was incident CKD defined as an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 during the follow-up period. The entire cohorts were randomly (2:1) assigned to a development cohort and a validation cohort. Predictors of incident CKD were selected by multivariable Cox regression and stepwise approach. A nomogram based on these predictors was developed and evaluated with concordance index (C-index) and area under curve (AUC).

Results

During the median follow-up period of 4.22 years, the incidence of CKD was 19.09% (n=1094) in the entire cohort, 19.03% (727 patients) in the development cohort and 19.21% (367 patients) in the validation cohort. Age, body mass index, eGFR 60–89 mL/min/1.73 m2, diabetes and hypertension were selected as predictors. The nomogram demonstrated a good discriminative power with C-index of 0.778 and 0.785 in the development and validation cohort. The 3-year, 4-year and 5-year AUCs were 0.817, 0.814 and 0.834 in the development cohort, and 0.830, 0.847 and 0.839 in the validation cohort.

Conclusion

Our nomogram based on five readily available predictors is a reliable tool to identify high-CVD risk patients at risk of incident CKD. This prediction model may help improving the healthcare strategies in primary care.

Protocol for 'Resilient Caregivers: a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer

Por: Genter · P. · Hoeg · B. L. · Hamre · C. J. · Andersen · E. A. W. · Dalton · S. O. · Ribers · B. · Bidstrup · P. E.
Introduction

Intimate partners of patients with cancer often experience significant distress, but there is a lack of psychological interventions that specifically target this population. ‘Resilient Caregivers’ is a novel resilience-based intervention for distressed partner cancer caregivers. The intervention was developed according to a resilience framework focusing on meta-reflective skills, coping strategies and value clarification. The aim of this study is to evaluate the effectiveness of this intervention in a randomised trial.

Methods and analysis

Eighty participants will be invited through the Oncology Department at Herlev Hospital, Denmark and randomised to either the intervention or usual care. Participants are eligible if they are partners (married or unmarried) of patients diagnosed with cancer and experience distress (>4 on the distress thermometer). ‘Resilient Caregivers’ consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer. The primary outcome is symptoms of anxiety, while secondary outcomes include distress, depression, quality of life, sleep quality and resilience. Data will be collected at baseline, 3, 6 and 12 months follow-up using validated scales, and analysed using mixed models for repeated measures.

Ethics and dissemination

This study will follow the ethical principles in the Declaration of Helsinki and has been reviewed by the Ethics Committee of the Capital Region of Denmark (Journal no. 18055373). Written informed consent will be obtained from all participants. Results will be reported through scientific peer-reviewed journals and relevant conferences.

Trial registration number

NCT04610034.

Pregnancy anaemia, child health and development: a cohort study in rural India

Por: Heesemann · E. · Mähler · C. · Subramanyam · M. A. · Vollmer · S.
Objective

To assess how pregnancy anaemia affects the offspring’s early childhood development, child haemoglobin (Hb) levels child growth and diseases incidence 2 years after birth in a low-income setting. Furthermore, we investigate the mediating role of childhood Hb levels with disease incidences and skills.

Design

Prospective cohort study.

Setting and participants

The study participants are 941-999 mother–child dyads from rural Madhepura in Bihar, India. In 2015, the women were recruited during pregnancy from registers in mother–child centres of 140 villages for the first wave of data collection. At the time of the second wave in 2017, the children were 22–32 months old.

Primary and secondary outcome measures

The recruited women were visited at home for a household survey and the measurement of the women’s and child’s Hb level, child weight and height. Data on the incidence of diarrhoea and respiratory diseases or fever were collected from interviews with the mothers. To test motor, cognitive, language and socioemotional skills of the children, we used an adapted version of the child development assessment FREDI.

Results

The average Hb during pregnancy was 10.2 g/dL and 69% of the women had pregnancy anaemia. At the age of 22–32 months, a 1 g/dL increase in Hb during pregnancy was associated with a 0.17 g/dL (95% CI: 0.11 to 0.23) increase in Hb levels of the child. Children of moderately or severely anaemic women during pregnancy showed 0.57 g/dL (95% CI: –0.78 to –0.36) lower Hb than children of non-anaemic women. We find no association between the maternal Hb during pregnancy and early skills, stunting, wasting, underweight or disease incidence. While childhood anaemia does not correlate with childhood diseases, we find an association of a 1 g/dl increase in the child's Hb with 0.04 SDs higher test scores.

Conclusions

While pregnancy anaemia is a risk factor for anaemia during childhood, we do not find evidence for an increased risk of infectious diseases or early childhood development delays.

Health and well-being in small island communities: a cross-sectional study in the Solomon Islands

Por: Furusawa · T. · Pitakaka · F. · Gabriel · S. · Sai · A. · Tsukahara · T. · Ishida · T.
Objectives

This study explored the health problems of inhabitants of small South Pacific Islands under the influence of climate change, focusing on three communities in the Solomon Islands.

Design

Cross-sectional study of the Solomon Islands’ populations.

Setting

A field survey was conducted in Taro Island, a small, urbanised island with a whole-community relocation plan; Manuopo community of Reef Islands, a small remote island on an atoll environment and Sasamungga, an intermediately urbanised community on a larger island. The Sasamungga community was used for comparison.

Participants

Each community’s participants were recruited through local health authorities, and 113, 155 and 116 adults (aged 18+ years) from Taro, Manuopo and Sasamungga, respectively, participated voluntarily.

Methods

Each participant’s body height, weight and body mass index were measured. A drop of blood was sampled for malaria testing; glycated haemoglobin and C reactive protein levels, measured from another drop of blood, were markers for diabetes and inflammation, respectively. The Primary Care Screening Questionnaire for Depression measured depressive mental states.

Primary and secondary outcome measures

Regarding health status, the dependent variables—communicable diseases, non-communicable diseases and mental state—and independent variables—differences in communities and socioeconomic status—were measured through health check-ups and interviews of individual participants.

Results

Taro Island inhabitants had a higher risk of obesity (OR 1.13, 95% CI 1.02 to 1.27, p=0.0189), and Manuopo inhabitants had a higher risk of depression (1.25, 95% CI 1.08 to 1.44, p=0.0026) than Sasamungga inhabitants. Manuopo inhabitants recognised more serious problems of food security, livelihood, place to live and other aspects of daily living than other communities’ inhabitants.

Conclusions

The three small island communities’ observation identified different health problems: the urbanised community and remote community had a high risk of non-communicable diseases and mental disorders, respectively. These health problems should be monitored continuously during future climate-related changes.

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