FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

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.

Identifying womens preferences for treatment of urinary tract infection: a discrete choice experiment

Por: van der Worp · H. · Brandenbarg · D. · Boek · P. A. · Braams · J. H. W. · Brink · L. J. F. · Keupers · J. · Blanker · M. H.
Objective

To identify the preferences of women regarding management of urinary tract infections (UTIs).

Design

A discrete choice experiment of the preferences for certain treatment attributes was conducted by survey. Attributes included treatment duration, time to complaint resolution, complication risk, side effect risk and contribution to antimicrobial resistance.

Setting

General population in the Netherlands, recruited via social media.

Participants

Women aged 18 years or older.

Primary and secondary outcome measures

The primary outcome was the relative importance of the attributes for treatment choice, using a conditional logit model. The secondary outcome was the heterogeneity in these preferences.

Results

The discrete choice experiment was completed by 833 women. Most attributes were important to decisions for UTI treatment. Women were willing to accept management with, for example, a higher chance of complications or longer time to resolution, if it could help avoid antimicrobial resistance. However, there was heterogeneity in the preferences. Women who had one previous UTI had a stronger preference for faster symptom resolution compared with those who had no previous UTI. Younger women also preferred faster symptom resolution. Finally, women with a low or middle education level gave less importance to preventing antimicrobial resistance than women with a high education level.

Conclusions

The current study indicated that a considerable part of women valued alternatives to antimicrobial treatment and were prepared to tolerate management that was less optimal in certain respects to avoid antimicrobial treatment.

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.

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).

Association between neighbourhood deprivation, fetal growth, small-for-gestational age and preterm birth: a population-based prospective cohort study

Por: Gootjes · D. V. · Posthumus · A. G. · Jaddoe · V. W. V. · Steegers · E. A. P.
Objective

To study the associations between neighbourhood deprivation and fetal growth, including growth in the first trimester, and adverse pregnancy outcomes.

Design

Prospective cohort study.

Setting

The Netherlands, Rotterdam.

Participants

8617 live singleton births from the Generation R cohort study.

Exposition

Living in a deprived neighbourhood.

Main outcome measures

Fetal growth trajectories of head circumference, weight and length.

Secondary outcomes measures

Small-for-gestational age (SGA) and preterm birth (PTB).

Results

Neighbourhood deprivation was not associated with first trimester growth. However, a higher neighbourhood status score (less deprivation) was associated with increased fetal growth in the second and third trimesters (eg, estimated fetal weight; adjusted regression coefficient 0.04, 95% CI 0.02 to 0.06). Less deprivation was also associated with decreased odds of SGA (adjusted OR 0.91, 95% CI 0.86 to 0.97, p=0.01) and PTB (adjusted OR 0.89, 95% CI 0.82 to 0.96, p=0.01).

Conclusions

We found an association between neighbourhood deprivation and fetal growth in the second and third trimester pregnancy, but not with first trimester growth. Less neighbourhood deprivation is associated with lower odds of adverse pregnancy outcomes. The associations remained after adjustment for individual-level risk factors. This supports the hypothesis that living in a deprived neighbourhood acts as an independent risk factor for fetal growth and adverse pregnancy outcomes, above and beyond individual risk factors.

Protocol for a systematic review of economic evaluations of preoperative smoking cessation interventions for preventing surgical complications

Por: McCaffrey · N. · Higgins · J. · Lal · A.
Introduction

The short-term economic benefit of embedding best practice tobacco dependence treatment (TDT) into healthcare services prior to surgery across different populations and jurisdictions is largely unknown. The aim of this systematic review is to summarise the cost-effectiveness of preoperative smoking cessation interventions for preventing surgical complications compared with usual care. The results will provide hospital managers, clinicians, healthcare professionals and policymakers with a critical summary of the economic evidence on providing TDT routinely before surgery, aiding the development and dissemination of unified, best practice guidelines, that is, implementation of article 14 of the WHO Framework Convention on Tobacco Control.

Methods and analysis

A comprehensive search of peer-reviewed literature will be conducted from database inception until 23 June 2021 (Cochrane, Econlit, Embase, Health Technology Assessment, Medline Complete, Scopus). Published, English-language articles describing economic evaluations of preoperative smoking cessation interventions for preventing surgical complications will be included. One researcher will complete the searches and two researchers will independently screen results for eligible studies. Any disagreement will be resolved by the third researcher. A narrative summary of included studies will be provided. Study characteristics, economic evaluation methods and cost-effectiveness results will be extracted by one reviewer and descriptive analyses will be undertaken. A second reviewer will review data extracted for accuracy from 10% of the included studies. Reporting and methodological quality of the included studies will be evaluated independently by two reviewers using the Consolidated Health Economic Evaluation Reporting Standards statement and the Quality of Health Economic Studies Instrument checklist, respectively.

Ethics and dissemination

This research does not require ethics approval because the study is a planned systematic review of published literature. Findings will be presented at health economic, public health and tobacco control conferences, published in a peer-reviewed journal and disseminated via social media.

Trial registration number

CRD42021257740.

Comparing organ donation decisions for next-of-kin versus the self: results of a national survey

Por: Liu · C. W. · Chen · L. N. · Anwar · A. · Lu Zhao · B. · Lai · C. K. Y. · Ng · W. H. · Suhitharan · T. · Ho · V. K. · Liu · J. C. J.
Objectives

Intensive care audits point to family refusal as a major barrier to organ donation. In this study, we sought to understand refusal by accounting for the decision-maker’s mindset. This focused on: (1) how decisions compare when made on behalf of a relative (vs the self); and (2) confidence in decisions made for family members.

Design

Cross-sectional survey in Singapore.

Setting

Participants were recruited from community settings via door-to-door sampling and community eateries.

Participants

973 adults who qualified as organ donors in Singapore.

Results

Although 68.1% of participants were willing to donate their own organs, only 51.8% were willing to donate a relative’s organs. Using machine learning, we found that consistency was predicted by: (1) religion, and (2) fears about organ donation. Conversely, participants who were willing to donate their own organs but not their relative’s were less driven by these factors, and may instead have resorted to heuristics in decision-making. Finally, we observed how individuals were overconfident in their decision-making abilities: although 78% had never discussed organ donation with their relatives, the large majority expressed high confidence that they would respect their relatives’ wishes on death.

Conclusions

These findings underscore the distinct psychological processes involved when donation decisions are made for family members. Amidst a global shortage of organ donors, addressing the decision-maker’s mindset (eg, overconfidence, the use of heuristics) may be key to actualizing potential donors identified in intensive care units.

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.

Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International C

Por: Seligman · W. H. · Fialho · L. · Sillett · N. · Nielsen · C. · Baloch · F. M. · Collis · P. · Demedts · I. K. M. · Fleck · M. P. · Floriani · M. A. · Gabriel · L. E. K. · Gagnier · J. J. · Keetharuth · A. · Londral · A. · Ludwig · I. I. L. · Lumbreras · C. · Moscoso Daza · A. · Muhamma
Objectives

The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives.

Design

A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance.

Results

The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors.

Conclusion

Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.

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.

'Stressed, uncomfortable, vulnerable, neglected: a qualitative study of the psychological and social impact of the COVID-19 pandemic on UK frontline keyworkers

Por: May · T. · Aughterson · H. · Fancourt · D. · Burton · A.
Objectives

Non-healthcare keyworkers face distinct occupational vulnerabilities that have received little consideration within broader debates about ‘essential’ work and psychological distress during the COVID-19 pandemic. The aim of this study was therefore to explore the impact of the pandemic on the working lives and mental health and well-being of non-healthcare keyworkers in the UK.

Design

In-depth, qualitative interviews, analysed using a reflexive thematic analysis.

Setting

Telephone or video call interviews, conducted in the UK between September 2020 and January 2021.

Participants

23 participants aged 26–61 (mean age=47.2) years employed in a range of non-healthcare keyworker occupations, including transport, retail, education, postal services, the police and fire services, waste collection, finance and religious services.

Results

Keyworkers experienced adverse psychological effects during the COVID-19 pandemic, including fears of COVID-19 exposure, contagion and subsequent transmission to others, especially their families. These concerns were often experienced in the context of multiple exposure risks, including insufficient personal protective equipment and a lack of workplace mitigation practices. Keyworkers also described multiple work-related challenges, including increased workload, a lack of public and organisational recognition and feelings of disempowerment.

Conclusions

In efforts to reduce psychosocial concerns among non-healthcare keyworkers, there is a need for appropriate support during the COVID-19 pandemic and in preparation for other infections (eg, seasonal influenza) in the future. This includes the provision of psychological and workplace measures attending to the intersections of personal vulnerability and work conditions that cause unique risks and challenges among those in frontline keyworker occupations.

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.

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.

Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness

Por: Prevost · V. · Clarisse · B. · Leconte · A. · Delorme · C. · Benoit · S. · Tran · T.
Introduction

Mindfulness meditation is likely to promote better management of stress, pain and negative emotions. We propose to address the benefit of meditation in an open setting associating people with cancer (target population), medical staff and witnesses (neither patient nor medical staff). This study aims (1) to evaluate the effects of meditation on wellness improvement and (2) to identify criteria and modalities for a subsequent randomised study.

Methods and analysis

We propose a longitudinal pilot study consisting of a non-randomised experimental preintervention/postintervention survey. The intervention consists in delivering a meditation programme (12 weekly meditation sessions of 1.5 hours each), specifically adapted to our target population and addressing our research hypothesis in an open setting involving people with cancer, medical staff and witnesses (equally distributed in two groups of 15 participants). The main objective is to evaluate participants’ adherence to the programme. The effects of meditation will be evaluated on stress, quality of life, feeling of personal effectiveness, on the development of mindfulness and empathy, and on satisfaction and perception of a change in quality of life. We will also measure the putative added value of ‘meditating together’. This study is expected to allow validating the evaluation tools and refining the modalities of the workshops. We expect to demonstrate the evolution that this meditation-based intervention induces in the participants. We aim to promote bridge-building, between patients, medical staff but also others. In this way, one’s own suffering may be understood in the light of others’ suffering, thereby promoting the sense of otherness and giving insights into ‘living better with’. This exploratory study will investigate the relevance of this hypothesis, which could then be explored by a randomised study.

Ethics and dissemination

The protocol was approved by the local ethics committee (Comité de Protection des Personnes Est II). Trial findings will be published in peer-reviewed journals.

Trial registration number

NCT04410185.

Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study

Por: Funabashi · M. · Pohlman · K. A. · Gorrell · L. M. · Salsbury · S. A. · Bergna · A. · Heneghan · N. R.
Introduction

Spinal and peripheral joint manipulation (SMT) and mobilisation (MOB) are widely used and recommended in the best practice guidelines for managing musculoskeletal conditions. Although adverse events (AEs) have been reported following these interventions, a clear definition and classification system for AEs remains unsettled. With many professionals using SMT and MOB, establishing consensus on a definition and classification system is needed to assist with the assimilation of AEs data across professions and to inform research priorities to optimise safety in clinical practice.

Methods and analysis

This international multidisciplinary electronic Delphi study protocol is informed by a scoping review and in accordance with the ‘Guidance on Conduction and Reporting Delphi Studies’. With oversight from an expert steering committee, the study comprises three rounds using online questionnaires. Experts in manual therapy and patient safety meeting strict eligibility criteria from the following fields will be invited to participate: clinical, medical and legal practice, health records, regulatory bodies, researchers and patients. Round 1 will include open-ended questions on participants’ working definition and/or understanding of AEs following SMT and MOB and their severity classification. In round 2, participants will rate their level of agreement with statements generated from round 1 and our scoping review. In round 3, participants will rerate their agreement with statements achieving consensus in round 2. Statements reaching consensus must meet the a priori criteria, as determined by descriptive analysis. Inferential statistics will be used to evaluate agreement between participants and stability of responses between rounds. Statements achieving consensus in round 3 will provide an expert-derived definition and classification system for AEs following SMT and MOB.

Ethics and dissemination

This study was approved by the Canadian Memorial Chiropractic College Research Ethics Board and deemed exempt by Parker University’s Institutional Review Board. Results will be disseminated through scientific, professional and educational reports, publications and presentations.

Photodiagnosis of genital herpes and warts within a specialist online sexual health service: an observational (mixed methods) study of user experience and clinical outcomes

Por: Engen · J. · Black · A. · Holdsworth · G. · Howroyd · C. · Courtenay · M. · Baraitser · P.
Objectives

To evaluate the feasibility and acceptability of a pilot, free, online photodiagnosis service for genital herpes and warts with postal treatment delivered by a specialist digital sexual health service.

Setting

An online sexual health service available free of charge in South East London, UK.

Participants

Routinely collected data from 237 users of the pilot service during the study period and qualitative interviews with a purposive sample of 15 users.

Intervention

A pilot, free, online photodiagnosis service for genital herpes and warts with postal treatment delivered by a specialist digital sexual health service.

Primary and secondary outcome measures

Proportion of users who successfully uploaded photographs and the proportion diagnosed, treated and referred to face-to-face clinical services. User experience of this service.

Results

The service was accessed by 237 users during the study period with assessment possible for 86% of users based on the photographs provided. A diagnosis of genital herpes or warts was made for 40.5% and 89.6% were subsequently treated through the service. Eighteen per cent were diagnosed as normal/not needing treatment and 42% were signposted to clinic for further clinical assessment.

Qualitative data showed that users felt able and willing to provide genital images for diagnosis. Those who were treated or reassured expressed high satisfaction with the service, valuing the convenience, discreetness and support provided. However, users, particularly those who required referral to other services requested more personal and detailed communication when a clinical diagnosis is given remotely.

Conclusions

Findings suggest that online photodiagnosis was feasible and acceptable. However, effective and acceptable management of those who require referral needs careful remote communication.

Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical st

Por: Jaya · A. A. G. P. S. · Tantri · A. R. · Heriwardito · A. · Mansjoer · A.
Introduction

Adult open-heart surgery is a major surgery that causes surgical stress response and activation of the immune system, contributing further to postoperative complications. Transversus thoracis muscle plane block (TTPB) may potentially benefit in reducing the surgical stress response. This study aims to know the effectiveness of preoperative TTPB in adult open-heart surgery for reducing the surgical stress response.

Methods and analysis

This study is a prospective, double-blind, randomised control trial comparing the combination of general anaesthesia and TTPB versus general anaesthesia only in adult open-heart surgery. Forty-two eligible subjects will be randomly assigned to the TTPB group or control group. The primary outcomes are the difference between the two groups in the means of postoperative cortisol and interleukin-6 plasma levels at 24 hours and 48 hours after cardiac intensive care unit admission. The secondary outcomes are the difference between the two groups in the means of total 24-hour postoperative morphine consumption and time of first postoperative patient-controlled analgesia (PCA) dose.

Ethics and dissemination

The study protocol and informed consent forms have been reviewed and approved by the Ethics Committee of Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo Hospital. The result will be released to the medical community through presentation and publication in peer-reviewed journals.

Trial registration number

NCT04544254.

❌