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Associations of household food insufficiency with childhood depression and anxiety: a nationwide cross-sectional study in the USA

Por: Zheng · S. · Ngo · A. L. · Forman · M. R. · Barcellos · A. L. · Liao · L. · Ferrara · A. · Zhu · Y.
Objective

Household food insufficiency (HFIS) is a major public health threat to children. Children may be particularly vulnerable to HFIS as a psychological stressor due to their rapid growth and accelerated behavioural and cognitive states, whereas data focusing on HFIS and childhood mental disorders are as-yet sparse. We aimed to examine the associations of HFIS with depression and anxiety in US children.

Design

Cross-sectional study.

Setting

The 2016–2018 National Survey of Children’s Health, a nationally-representative study.

Participants

Primary caregivers of 102 341 children in the USA.

Primary and secondary outcome measures

Physician diagnosed depression and anxiety were assessed by questionnaires administered to primary caregivers of 102 341 children. Multivariable logistic regression models estimated adjusted OR (aOR) for current depression or anxiety associated with HFIS measured through a validated single-item instrument.

Results

Among children aged 3–17 years, 3.2% and 7.4% had parent-reported physician-diagnosed current depression and anxiety, respectively. Compared with children without HFIS, children with HFIS had approximately twofold higher weighted prevalence of anxiety or depression. After adjusting for covariates, children with versus without HFIS had a 1.53-fold (95% CI 1.15 to 2.03) and 1.48-fold (95% CI 1.20 to 1.82) increased odds of current depression and anxiety, respectively. Associations were slightly more pronounced among girls (aOR (95% CI): depression 1.69 (1.16 to 2.48); anxiety 1.78 (1.33 to 2.38)) than boys (1.42 (0.98 to 2.08); 1.32 (1.00 to 1.73); both P-for-interaction

Conclusions

HFIS was independently associated with depression and anxiety among US children. Girls presented slightly greater vulnerability to HFIS in terms of impaired mental health. Children identified as food-insufficient may warrant mental health assessment and possible intervention. Assessment of HFIS among children with impaired mental health is also warranted. Our findings also highlight the importance of promptly addressing HFIS with referral to appropriate resources and inform its potential to alleviate childhood mental health issues.

Delay in the induction of labour process: a retrospective cohort study and computer simulation of maternity unit workload

Por: Robertson · K. · Hardingham · I. · D'Arcy · R. · Reddy · A. · Clacey · J.
Objectives

Delay in the induction of labour (IOL) process is associated with poor patient experience and adverse perinatal outcome. Our objective was to identify factors associated with delay in the IOL process and develop interventions to reduce delay.

Design and settings

We performed a retrospective cohort study of maternity unit workload in a large UK district general hospital. Electronic hospital records were used to quantify delay in the IOL process and linear regression analysis was performed to assess significant associations between delay and potential causative factors. A novel computer maternity unit simulation model, MUMSIM (Maternity Unit Management SIMulation), was developed using real-world data and interventions were tested to identify those associated with a reduction in delay.

Participants

All women giving birth at Stoke Mandeville Hospital, Buckinghamshire National Health Service (NHS) Trust in 2018 (n=4932).

Primary outcome measure

Delay in the IOL process of more than 12 hours.

Results

The retrospective analysis of real-world maternity unit workload showed 30% of women had IOL and of these, 33% were delayed >12 hours with 20% delayed >24 hours, 10% delayed >48 hours and 1.3% delayed >72 hours. Delay was significantly associated with the total number of labouring women (p=0.008) and the number of booked IOL (p=0.009) but not emergency IOL, spontaneously labouring women or staffing shortfall. The MUMSIM computer simulation predicted that changing from slow release 24-hour prostaglandin to 6-hour prostaglandin for primiparous women would reduce delay by 4% (p

Conclusions

Planned obstetric workload of booked IOL is associated with delay rather than the unpredictable workload of women in spontaneous labour or emergency IOL. We present a novel maternity unit computer simulation model, MUMSIM, which allows prediction of the impact of interventions to reduce delay.

Liver dysfunction in idiopathic pulmonary arterial hypertension: prevalence, characteristics and prognostic significance, a retrospective cohort study in China

Por: Luo · C. · Wu · W. · Wu · C. · Qiu · H. · Yuan · P. · Jiang · R. · Zhao · Q. · Gong · S. · Zhang · R. · Li · J. · He · J. · Liu · J. · Wang · L.
Objectives

The aim was to elucidate the relationship between liver function and idiopathic pulmonary arterial hypertension (IPAH).

Design and setting

Retrospective, longitudinal study in urban tertiary care centre in Shanghai, China.

Participants

407 IPAH consecutive incident patients age 18–65 years were retrospectively enrolled from January 2008 to December 2018.

Outcome measurements

The primary endpoint was all-cause mortality. The cut-off value was determined by receiver operating characteristic curve (ROC), which was validated by Cox proportional hazard model was internally validated by bootstrap analysis and used for survival analysis. The Cox model was (internally) validated and cross-validated areas under the curve (AUC) should be reported.

Results

The prevalence of abnormal liver function tests (LFTs) at baseline was 77.6%. Hyperbilirubinaemia is the most common abnormal biochemical liver test: abnormal total bilirubin (TBIL in 51.6% patients). During the follow-up, 160 patients died. Patients with mixed liver dysfunction have worse prognosis than those with normal LFTs or isolated abnormal bilirubin metabolism. Comparing with patients with hepatocellular injury, the survival of patients with abnormal bilirubin metabolism is lower. Multivariable Cox models revealed a positive association between TBIL, -glutamyltransferase (GGT) and mortality showing that each Ig increment in TBIL and GGT was associated with a higher all-cause mortality (TBIL: HR 4. 29 (95% CI 1. 21 to 15. 27), p=0. 02; GGT: HR 2. 76 (95% CI 1. 18 to 6. 45), p=0. 02). A novel formula named Liver Function Predict Index (LFPI) was constructed (LFPI=–0.002*6MWD+1.014*lg GGT+1.458*lg TBIL) to predict prognosis. ROC curve analysis did further identify 2.729 as the best cut-off value for LFPI (AUC 0.75, p

Conclusions

Liver dysfunction is frequent in IPAH, and characterised by a predominantly cholestatic enzyme profile. LFTs abnormalities are associated with worse survival and LFPI was a new and simple predictor for prognosis of IPAH.

Impact of prehabilitation on objectively measured physical activity levels in elective surgery patients: a systematic review

Por: Wagnild · J. M. · Akowuah · E. · Maier · R. H. · Hancock · H. C. · Kasim · A.
Objective

To systematically review the impact of prehabilitation on objectively measured physical activity (PA) levels in elective surgery patients.

Data sources

Articles published in Web of Science Core Collections, PubMed, Embase (Ovid), CINAHL (EBSCOHost), PsycInfo (EBSCOHost) and CENTRAL through August 2020.

Study selection

Studies that met the following criteria: (1) written in English, (2) quantitatively described the effect(s) of a PA intervention among elective surgery patients prior to surgery and (3) used and reported objective measures of PA in the study.

Data extraction and synthesis

Participant characteristics, intervention details, PA measurement, and clinical and health-related outcomes were extracted. Risk of bias was assessed following the revised Cochrane risk of bias tool. Meta-analysis was not possible due to heterogeneity, therefore narrative synthesis was used.

Results

6533 unique articles were identified in the search; 21 articles (based on 15 trials) were included in the review. There was little evidence to suggest that prehabilitation is associated with increases in objectively measured PA, but this may be due to insufficient statistical power as most (n=8) trials included in the review were small feasibility/pilot studies. Where studies tested associations between objectively measured PA during the intervention period and health-related outcomes, significant beneficial associations were reported. Limitations in the evidence base precluded any assessment via meta-regression of the association between objectively measured PA and clinical or health-related outcomes.

Conclusions

Additional large-scale studies are needed, with clear and consistent reporting of objective measures including accelerometry variables and outcome variables, to improve our understanding of the impact of changes in PA prior to surgery on surgical and health-related outcomes.

PROSPERO registration number

CRD42019151475.

Longitudinal Outcomes of Gender Identity in Children (LOGIC): protocol for a prospective longitudinal cohort study of children referred to the UK gender identity development service

Por: Kennedy · E. · Spinner · L. · Lane · C. · Stynes · H. · Ranieri · V. · Carmichael · P. · Omar · R. · Vickerstaff · V. · Hunter · R. · Wright · T. · Senior · R. · Butler · G. · Baron-Cohen · S. · Young · B. · King · M.
Introduction

Gender identity development services (GIDS) worldwide have seen a significant increase in referrals in recent years. Many of these referrals consist of children and young people (CYP) who experience gender-related distress. This study aims to improve understanding of outcomes of CYP referred to the UK GIDS, specifically regarding gender identity, mental health, physical health and quality of life. The impact of factors such as co-occurring autism and early social transition on outcomes over time will be explored.

Methods and analysis

This is a prospective cohort study of CYP aged 3–14 years when referred to the UK GIDS. Eligible participants will be ≤14 years at the time their referral was accepted and will be on the waitlist for the service when baseline measures are completed. Children aged under 12 years will complete the measures in an interview format with a researcher, while young people aged 12 years and over and their parents/caregivers will complete online or paper-based questionnaires. Participants will complete follow-up measures 12 months and 24 months later. The final sample size is expected to be approximately 500. Logistic regression models will be used to explore associations between prespecified explanatory variables and gender dysphoria. Appropriate regression models will also be used to investigate explanatory variables for other outcomes. Subgroup analyses based on birth-assigned gender, age at referral and co-occurring autistic traits will be explored.

Ethics and dissemination

The study has been approved by the Health Research Authority and London – Hampstead Research Ethics Committee (reference: 19/LO/0857). The study findings will be published in peer-reviewed journals and presented at both conferences and stakeholder events. Findings will be used to inform clinical practice.

Transmission dynamics and the effects of non-pharmaceutical interventions in the COVID-19 outbreak resurged in Beijing, China: a descriptive and modelling study

Por: Cui · X. · Zhao · L. · Zhou · Y. · Lin · X. · Ye · R. · Ma · K. · Jiang · J.-F. · Jiang · B. · Xiong · Z. · Shi · H. · Wang · J. · Jia · N. · Cao · W.
Objective

To evaluate epidemiological characteristics and transmission dynamics of COVID-19 outbreak resurged in Beijing and to assess the effects of three non-pharmaceutical interventions.

Design

Descriptive and modelling study based on surveillance data of COVID-19 in Beijing.

Setting

Outbreak in Beijing.

Participants

The database included 335 confirmed cases of COVID-19.

Methods

To conduct spatiotemporal analyses of the outbreak, we collected individual records on laboratory-confirmed cases of COVID-19 from 11 June 2020 to 5 July 2020 in Beijing, and visitor flow and products transportation data of Xinfadi Wholesale Market. We also built a modified susceptible-exposed-infected-removed model to investigate the effect of interventions deployed in Beijing.

Results

We found that the staff working in the market (52.2%) and the people around 10 km to this epicentre (72.5%) were most affected, and the population mobility entering-exiting Xinfadi Wholesale Market significantly contributed to the spread of COVID-19 (p=0.021), but goods flow of the market had little impact on the virus spread (p=0.184). The prompt identification of Xinfadi Wholesale Market as the infection source could have avoided a total of 25 708 (95% CI 13 657 to 40 625) cases if unnoticed transmission lasted for a month. Based on the model, we found that active screening on targeted population by nucleic acid testing alone had the most significant effect.

Conclusions

The non-pharmaceutical interventions deployed in Beijing, including localised lockdown, close-contact tracing and community-based testing, were proved to be effective enough to contain the outbreak. Beijing has achieved an optimal balance between epidemic containment and economic protection.

Investigating and addressing the immediate and long-term consequences of the COVID-19 pandemic on patients with substance use disorders: a scoping review and evidence map protocol

Por: Naji · L. · Dennis · B. · Morgan · R. L. · Sanger · N. · Worster · A. · Paul · J. · Thabane · L. · Samaan · Z.
Introduction

The COVID-19 pandemic has driven unprecedented social and economic reform in efforts to curb the impact of disease. Governments worldwide have legislated non-essential service shutdowns and adapted essential service provision in order to minimise face-to-face contact. We anticipate major consequences resulting from such policies, with marginalised populations expected to bear the greatest burden of such measures, especially those with substance use disorders (SUDs).

Methods and analysis

We aim to conduct (1) a scoping review to summarise the available evidence evaluating the impact of the COVID-19 pandemic on patients with SUDs, and (2) an evidence map to visually plot and categorise the current available evidence evaluating the impact of COVID-19 on patients with SUDs to identify gaps in addressing high-risk populations.

Ethics and dissemination

Ethics approval is not required for this scoping review as we plan to review publicly available data. This is part of a multistep project, whereby we intend to use the findings generated from this review in combination with data from an ongoing prospective cohort study our team is leading, encompassing over 2000 patients with SUDs receiving medication-assisted therapy in Ontario prior to and during the COVID-19 pandemic.

Sonographic Evaluation of the Mechanism of Active Labor (SonoLabor Study): observational study protocol regarding the implementation of the sonopartogram

Por: Dira · L. M. · Tudorache · S. · Antsaklis · P. · Daskalakis · G. · Themistoklis · D. · Belciug · S. · Stoean · R. · Novac · M. · Cara · M. L. · Dragusin · R. · Florea · M. · Patru · C. · Zorila · L. · Nagy · R. · Ruican · D. · Iliescu · D. G.
Introduction

Over the last decades, a large body of literature has shown that intrapartum clinical digital pelvic estimations of fetal head position, station and progression in the pelvic canal are less accurate, compared with ultrasound (US) scan. Given the increasing evidence regarding the advantages of using US to evaluate the mechanism of labour, our study protocol aims to develop sonopartograms for fetal cephalic presentations. They will allow for a more objective evaluation of labour progression than the traditional labour monitoring, which could enable more rapid decisions regarding the mode of delivery.

Methods/analysis

This is a prospective observational study performed in three university hospitals, with an unselected population of women admitted in labour at term. Both clinical and US evaluations will be performed assessing fetal head position, descent and rotation. Specific US parameters regarding fetal head position, progression and rotation will be recorded to develop nomograms in a similar way that partograms were developed. The primary outcome is to develop nomograms for the longitudinal US assessment of labour in unselected nulliparous and multiparous women with fetal cephalic presentation. The secondary aims are to assess the sonopartogram differences in occiput anterior and posterior deliveries, to compare the labour trend from our research with the classic and other recent partogram models and to investigate the capability of the US labour monitoring to predict the outcome of spontaneous vaginal delivery.

Ethics and dissemination

All protocols and the informed consent form comply with the Ministry of Health and the professional society ethics guidelines. University ethics committees approved the study protocol. The trial results will be published in peer-reviewed journals and at the conference presentations. The study will be implemented and reported in line with the Strengthening the Reporting of Observational Studies in Epidemiology statement.

Trial registration number

ClinicalTrials.gov Registry (NCT02326077).

Patient satisfaction in China: a national survey of inpatients and outpatients

Por: Liang · H. · Xue · Y. · Zhang · Z.-r.
Objectives

Patient satisfaction is an important indicator of hospital healthcare quality. Little up-to-date information of patient satisfaction in China is available. This study attempts to gain a holistic understanding of patient satisfaction in China and identify the key antecedents of patient satisfaction.

Design

A cross-sectional national survey was conducted in 2018.

Setting

Hospitals in 27 provinces and 4 municipalities in 4 regions of China.

Participants

A random sample of 15 699 patients who visited 1304 hospitals were surveyed, with around 500 from each of the 27 provinces and 4 municipalities.

Primary and secondary outcome measures

The Hospital Consumer Assessment of Healthcare Providers and Systems questionnaire was used to measure patients’ overall satisfaction and willingness to recommend the hospital.

Results

We found significant variation in overall patient satisfaction but little variation in hospital recommendation across the four broad regions. Moreover, we examined determinants of patient satisfaction and their likelihood to recommend the hospital. The overall satisfaction for inpatients and outpatients is commonly influenced by communication with doctors (inpatient: β=0.524, p

Conclusions

There are regional differences of patient satisfaction in China. Patient satisfaction is influenced by a variety of hospital factors and province/municipality factors. The influencing factors of patient satisfaction may not motivate patients to recommend the hospital.

Comprehensive review of statistical methods for analysing patient-reported outcomes (PROs) used as primary outcomes in randomised controlled trials (RCTs) published by the UKs Health Technology Assessment (HTA) journal (1997-2020)

Por: Qian · Y. · Walters · S. J. · Jacques · R. · Flight · L.
Objectives

To identify how frequently patient-reported outcomes (PROs) are used as primary and/or secondary outcomes in randomised controlled trials (RCTs) and to summarise what statistical methods are used for the analysis of PROs.

Design

Comprehensive review.

Setting

RCTs funded and published by the United Kingdom’s (UK) National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.

Data sources and eligibility

HTA reports of RCTs published between January 1997 and December 2020 were reviewed.

Data extraction

Information relating to PRO use and analysis methods was extracted.

Primary and secondary outcome measures

The frequency of using PROs as primary and/or secondary outcomes; statistical methods that were used for the analysis of PROs as primary outcomes.

Results

In this review, 37.6% (114/303) of trials used PROs as primary outcomes, and 82.8% (251/303) of trials used PROs as secondary outcomes from 303 NIHR HTA reports of RCTs. In the 114 RCTs where the PRO was the primary outcome, the most used PRO was the Short-Form 36 (8/114); the most popular methods for multivariable analysis were linear mixed model (45/114), linear regression (29/114) and analysis of covariance (13/114); logistic regression was applied for binary and ordinal outcomes in 14/114 trials; and the repeated measures analysis was used in 39/114 trials.

Conclusion

The majority of trials used PROs as primary and/or secondary outcomes. Conventional methods such as linear regression are widely used, despite the potential violation of their assumptions. In recent years, there is an increasing trend of using complex models (eg, with mixed effects). Statistical methods developed to address these violations when analysing PROs, such as beta-binomial regression, are not routinely used in practice. Future research will focus on evaluating available statistical methods for the analysis of PROs.

Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial: rationale and design of the THERMAC trial

Por: van de Voort · E. M. F. · Struik · G. M. · Koppert · L. B. · Moelker · A. · Debets · R. · Yo · G. · Macco · M. J. P. V. · Sinke · R. H. J. A. · Franckena · M. · Birnie · E. · Verhoef · C. · Klem · T. M. A. L.
Introduction

Breast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%–99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients’ quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study.

Methods and analysis

The aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response.

Ethics and dissemination

This study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals.

Trial registration number

NL9205 (www.trialregister.nl); Pre-results.

Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial

Por: Almeida · A. S. · Ceron · R. O. · Anschau · F. · Kopittke · L. · Lira · K. B. · Delvaux · R. S. · Rode · J. · Rey · R. A. W. · Wittke · E. I. · Rombaldi · A. R.
Introduction

Myocardial protection is essential for successful cardiac surgery, and the search for an ideal cardioplegic solution has continued since its beginning. In this context, Custodiol, del Nido and modified del Nido are single-dose cardioplegic solutions with good safety profiles and great relevance in modern surgical practice. While these solutions have all been evaluated for their impact on patient outcomes independently, limited research exists comparing them directly. Thus, the present study aims to examine the effects of these cardioplegic solutions on myocardial protection and clinical outcomes in adult patients undergoing elective cardiac surgery. The assessment of the increase in myocardial injury biomarkers in patients submitted to all treatment methods may be considered a major strength of our study.

Methods and analysis

This is a clinical trial study protocol that will compare myocardial protection and clinical outcomes among three patient groups based on which cardioplegic solution was used. Patients will be randomised to receive del Nido (n=30), modified del Nido (n=30) or Custodiol (n=30). Myocardial injury biomarkers will be measured at the baseline and 2 hours, 12 hours and 24 hours after the cardiopulmonary bypass. Clinical outcomes will be assessed during the trans operative period and the intensive care unit stay, in addition to other haematological parameters.

Ethics and dissemination

This protocol and its related documents were approved by the Research Ethics Committee of the Hospital Nossa Senhora da Conceicão, Brazil, registered under no. 4.029.545. The findings of this study will be published in a peer-reviewed journal in the related field.

Trial registration number

RBR-7g5s66.

Population pharmacokinetics and pharmacodynamics of investigational regimens drugs in the TB-PRACTECAL clinical trial (the PRACTECAL-PKPD study): a prospective nested study protocol in a randomised controlled trial

Por: Nyang'wa · B.-T. · Kloprogge · F. · Moore · D. A. J. · Bustinduy · A. · Motta · I. · Berry · C. · Davies · G. R.
Introduction

Drug-resistant tuberculosis (TB) remains a global health threat, with little over 50% of patients successfully treated. Novel regimens like the ones being studied in the TB-PRACTECAL trial are urgently needed. Understanding anti-TB drug exposures could explain the success or failure of these trial regimens. We aim to study the relationship between the patients’ exposure to anti-TB drugs in TB-PRACTECAL investigational regimens and their treatment outcomes.

Methods and analysis

Adults with multidrug-resistant TB randomised to investigational regimens in TB-PRACTECAL will be recruited to a nested pharmacokinetic-pharmacodynamic (PKPD) study. Venous blood samples will be collected at 0, 2 and 23 hours postdose on day 1 and 0, 6.5 and 23 hours postdose during week 8 to quantify drug concentrations in plasma. Trough samples will be collected during week 12, 16, 20 and 24 visits. Opportunistic samples will be collected during weeks 32 and 72. Drug concentrations will be quantified using liquid chromatography-tandem mass spectrometry. Sputum samples will be collected at baseline, monthly to week 24 and then every 2 months to week 108 for MICs and bacillary load quantification. Full blood count, urea and electrolytes, liver function tests, lipase, ECGs and ophthalmology examinations will be conducted at least monthly during treatment.

PK and PKPD models will be developed for each drug with nonlinear mixed effects methods. Optimal dosing will be investigated using Monte-Carlo simulations.

Ethics and dissemination

The study has been approved by the Médecins sans Frontières (MSF) Ethics Review Board, the LSHTM Ethics Committee, the Belarus RSPCPT ethics committee and PharmaEthics and the University of Witwatersrand Human Research ethics committee in South Africa. Written informed consent will be obtained from all participants. The study results will be shared with public health authorities, presented at scientific conferences and published in a peer-reviewed journal.

Trial registration number

NCT04081077; Pre-results.

Risk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors

Por: Malm · E. · Nielsen · S. M. · Berg · J. · Ioannidis · J. P. A. · Furst · D. · Smolen · J. S. · Taylor · P. C. · Kristensen · L. E. · Tarp · S. · Ellingsen · T. · Christensen · R.
Introduction

Inflammatory arthritis (IA) conditions, including rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, are characterised by inflammatory infiltration of the joints. Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively, reduce the effects of proinflammatory cytokines and immune cells to ameliorate disease. However, immunosuppression can be associated with high rates of serious adverse events (SAEs), including serious infections, and maybe an increased risk of malignancies and cardiovascular events. Currently, there is no empirical evidence on the extent to which contextual factors and risk of bias (RoB) domains may modify these harm signals in randomised trials.

Methods and analysis

We will search MEDLINE (via PubMed) for systematic reviews published since April 2015 and all Cochrane reviews. From these reviews, randomised trials will be eligible if they include patients with an IA condition with at least one group randomly allocated to bDMARD and/or tsDMARD treatments. A predefined form will be used for extracting data on population characteristics (eg, baseline characteristics or eligibility criteria, such as medication background) and specific harm outcome measures, such as number of withdrawals, numbers of patients discontinuing due to adverse events and number of patients having SAEs. RoB in individual trials will be assessed using a modified Cochrane RoB tool. We will estimate the potentially causal harm effects related to the experimental intervention compared with control comparator as risk ratios, and heterogeneity across randomised comparisons will be assessed statistically and evaluated as inconsistency using the I2 Index. Our metaregression analyses will designate population and trial characteristics and each RoB domain as independent variables, whereas the three harm domains will serve as dependent variables.

Ethics and dissemination

Ethics approval is not required for this study. Results will be disseminated through publication in international peer-reviewed journals.

PROSPERO registration number

CRD42020171124.

Adolescents and age of consent to HIV testing: an updated review of national policies in sub-Saharan Africa

Por: Barr-DiChiara · M. · Tembo · M. · Harrison · L. · Quinn · C. · Ameyan · W. · Sabin · K. · Jani · B. · Jamil · M. S. · Baggaley · R. · Johnson · C.
Objectives

In sub-Saharan Africa (SSA) where HIV burden is highest, access to testing, a key entry point for prevention and treatment, remains low for adolescents (aged 10–19). Access may be hampered by policies requiring parental consent for adolescents to receive HIV testing services (HTS). In 2013, the WHO recommended countries to review HTS age of consent policies. Here, we investigate country progress and policies on age of consent for HIV testing.

Design

Comprehensive policy review.

Data sources

Policies addressing HTS were obtained through searching WHO repositories and governmental and non-governmental websites and consulting country and regional experts.

Eligibility criteria

HTS policies published by SSA governments before 2019 that included age of consent.

Data extraction and synthesis

Data were extracted on HTS age of consent including exceptions based on risk and maturity. Descriptive analyses of included policies were disaggregated by Eastern and Southern Africa (ESA) and Western and Central Africa (WCA) subregions.

Results

Thirty-nine policies were reviewed, 38 were eligible; 19/38 (50%) permitted HTS for adolescents ≤16 years old without parental consent. Of these, six allowed HTS at ≥12 years old, two at ≥13, two at ≥14, five at ≥15 and four at ≥16. In ESA, 71% (n=15/21) allowed those of ≤16 years old to access HTS, while only 24% (n=6/25) of WCA countries allowed the same. Maturity exceptions including marriage, sexual activity, pregnancy or key population were identified in 18 policies. In 2019, 63% (n=19/30) of policies with clear age-based criteria allowed adolescents of 12–16 years old to access HIV testing without parental consent, an increase from 37% (n=14/38) in 2013.

Conclusions

While many countries in SSA have revised their HTS policies, many do not specify age of consent. Revision of SSA consent to HTS policies, particularly in WCA, remains a priority to achieve the 2025 goal of 95% of people with HIV knowing their status.

Outcomes evaluating quality of life and their measurement properties in early-onset scoliosis: protocol for a systematic review

Por: Baird · C. · Archer · J. · Gardner · A. · Rushton · A. B. · Heneghan · N. R.
Introduction

Early-onset scoliosis (EOS) is a rare spinal deformity affecting children under the age of 10. Both the condition and its treatment have associated morbidity and can impact quality of life. Understanding this impact can be achieved by using appropriate patient-reported and/or carer-reported outcome measures. The aim of the review described in this protocol is to evaluate the evidence on measurement properties relevant to health-related quality of life outcomes in the EOS population. The focus will be on outcome measures relevant to patients undergoing treatment of EOS under the age of 10.

Methods/analysis

This protocol is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. The MEDLINE, EMBASE, EMCARE, PubMed, PsychINFO and CINAHL databases will be searched using a two-stage search strategy. The first stage will identify measures of HRQoL used in EOS through screening of titles and abstracts. The second stage will assess the measurement properties of those measures identified through screening of full-text articles. The measurement properties of interest are the ‘reliability’, ‘validity’ and ‘responsiveness’ of the instrument. Only English language articles will be considered. Two reviewers will independently review the search results against the eligibility criteria, perform data extraction and assess for risk of bias, with disputes handled by a third reviewer. Data will be quantitatively pooled where possible or reported as a narrative synthesis. The summarised results for each measurement property will be rated against the criteria for good measurement properties following the COSMIN methodology. Two reviewers will assess the body of evidence for each measurement property using modified Grading of Recommendations, Assessment, Development and Evaluation guidelines.

Ethics and dissemination

No ethical approval is required for this review and the results will be submitted for publication in peer-reviewed publications.

PROSPERO registration number

CRD42020219721.

Relapse prevention group therapy via video-conferencing for substance use disorder: protocol for a multicentre randomised controlled trial in Indonesia

Por: Yamada · C. · Siste · K. · Hanafi · E. · Ophinni · Y. · Beatrice · E. · Rafelia · V. · Alison · P. · Limawan · A. · Shinozaki · T. · Matsumoto · T. · Sakamoto · R.
Background

Substance use disorder (SUD) is a leading contributor to the global burden of disease. In Indonesia, the availability of formal treatment for SUD falls short of the targeted coverage. A standardised therapeutic option for SUD with potential for widespread implementation is required, yet evidence-based data in the country are scarce. In this study, we developed a cognitive behavioural therapy (CBT)-based group telemedicine model and will investigate effectiveness and implementability in a multicentre randomised controlled trial.

Methods

A total of 220 participants will be recruited from the social networks of eight sites in Indonesia: three hospitals, two primary healthcare centres and three rehabilitation centres. The intervention arm will participate in a relapse prevention programme called the Indonesia Drug Addiction Relapse Prevention Programme (Indo-DARPP), a newly developed 12-week module based on CBT and motivational interviewing constructed in the Indonesian context. The programme will be delivered by a healthcare provider and a peer counsellor in a group therapy setting via video-conferencing, as a supplement to participants’ usual treatments. The control arm will continue treatment as usual. The primary outcome will be the percentage increase in days of abstinence from the primarily used substance in the past 28 days. Secondary outcomes will include addiction severity, quality of life, motivation to change, psychiatric symptoms, cognitive function, coping, and internalised stigma. Assessments will be performed at baseline (week 0), post-treatment (week 13), and 3 and 12 months post-treatment completion (weeks 24 and 60). Retention, participant satisfaction, and cost-effectiveness will be assessed as the implementation outcomes.

Ethics and dissemination

The study protocol was reviewed and approved by the Ethics Committees of Universitas Indonesia and Kyoto University. The results will be disseminated via academic journals and international conferences. Depending on trial outcomes, the treatment programme will be advocated for adoption as a formal healthcare-based approach for SUD.

Trial registration number

UMIN000042186.

Protocol for a prospective, international cohort study on the Management and Outcomes of Perioperative Care among European Diabetic Patients (MOPED)

Por: Buggy · D. J. · Nolan · R. · Coburn · M. · Columb · M. · Hermanides · J. · Hollman · M. W. · Zarbock · A.
Introduction

Diabetes is common (about 20 million patients in Europe) and patients with diabetes have more surgical interventions than the general population. There are plausible pathophysiological and clinical mechanisms suggesting that patients with diabetes are at an increased risk of postoperative complications. When postoperative complications occur in the general population, they increase major adverse events and subsequently increase 1-year mortality. This is likely to be worse in patients with diabetes. There is variation in practice guidelines in different countries in the perioperative management of patients with diabetes undergoing major surgery and whether this may affect postoperative outcome has not been investigated on a large scale. Neither is it known whether different strata of preoperative glycaemic control affects outcome.

Methods and analysis

A prospective, observational, international, multicentre cohort study, recruiting 5000 patients with diabetes undergoing elective or emergency surgery in at least n=50 centres. Inclusion criteria are any patient with diabetes undergoing surgery under any substantive anaesthetic technique. Exclusion criteria are not being a confirmed diabetic patient and patients with diabetes undergoing procedures under monitored sedation or local anaesthetic infiltration only. Follow-up duration is 30 days after surgery. Primary outcome is days at home at 30 days. Secondary outcomes are Comprehensive Complications Index, Quality of Recovery (QoR-15) score on Day 1 postoperatively, 30-day mortality, length of hospital stay and incidence of specific major adverse events (Myocardial Infarction (MI), Myocardial Injury after Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI), Postoperative Pulmonary Complications (PPC), Cerebrovascular Accident (CVA), Pulmonary Embolism (PE), DVT, surgical site infection, postoperative pulmonary infection). Tertiary outcomes include time to resumption of normal diabetes therapy, incidence of diabetic ketoacidosis or hypoglycaemia, incidence and duration of use of intravenous insulin infusion therapy and change in diabetic management at 30 days.

Ethics and dissemination

This study will adhere to the principles of the Declaration of Helsinki (amendment 2013) by the World Medical Association and the ICH-Good Clinical Practice (GCP) Guidelines E6(R2). Specific national and local regulatory authority requirements will be followed as applicable. Ethical approval has been granted by the Institutional Review Board of the Mater Misericordiae University Hospital, Dublin, Ireland (Reference: 1/378/2167). As enrolment for this study is ongoing, ethical approval from additional centres is being added continuously. The main results of Management and Outcomes of Perioperative Care among European Diabetic Patients and its substudies will be published in peer-reviewed international medical journals and presented at Euroanaesthesia congress and other international and national meetings.

Trial registration number

NCT04511312.

Exploring ethnic minority womens experiences of maternity care during the SARS-CoV-2 pandemic: a qualitative study

Por: John · J. R. · Curry · G. · Cunningham-Burley · S.
Objective

To explore the experiences of pregnancy, childbirth, antenatal and postnatal care in women belonging to ethnic minorities and to identify any specific challenges that these women faced during the SARS-CoV-2 pandemic.

Design

This was a qualitative study using semistructured interviews of pregnant women or those who were 6 weeks postnatal from Black, Asian and minority ethnic backgrounds. The study included 16 women in a predominantly urban Scottish health board area.

Results

The finding are presented in four themes: ‘communication’, ‘interactions with healthcare professionals’, ‘racism’ and ‘the pandemic effect’. Each theme had relevant subthemes. ‘Communication’ encompassed respect, accent bias, language barrier and cultural dissonance; ‘interactions with healthcare professionals’: continuity of care, empathy, informed decision making and dissonance with other healthcare systems; ‘racism’ was deemed to be institutional, interpersonal or internalised; and ‘the pandemic effect’ consisted of isolation, psychological impact and barriers to access of care.

Conclusions

This study provides insight into the specific challenges faced by ethnic minority women in pregnancy, which intersect with the unique problems posed by the ongoing SARS-CoV-2 pandemic to potentially widen existing ethnic disparities in maternal outcomes and experiences of maternity care.

Lag times in the publication of network meta-analyses: a survey

Por: Tonin · F. S. · Araujo · A. G. · Fachi · M. M. · Ferreira · V. L. · Pontarolo · R. · Fernandez-Llimos · F.
Objective

We assessed the extent of lag times in the publication and indexing of network meta-analyses (NMAs).

Study design

This was a survey of published NMAs on drug interventions.

Setting

NMAs indexed in PubMed (searches updated in May 2020).

Primary and secondary outcome measures

Lag times were measured as the time between the last systematic search and the article submission, acceptance, online publication, indexing and Medical Subject Headings (MeSH) allocation dates. Time-to-event analyses were performed considering independent variables (geographical origin, Journal Impact Factor, Scopus CiteScore, open access status) (SPSS V.24, R/RStudio).

Results

We included 1245 NMAs. The median time from last search to article submission was 6.8 months (204 days (IQR 95–381)), and to publication was 11.6 months. Only 5% of authors updated their search after first submission. There is a very slightly decreasing historical trend of acceptance (rho=–0.087; p=0.010), online publication (rho=–0.080; p=0.008) and indexing (rho=–0.080; p=0.007) lag times. Journal Impact Factor influenced the MeSH allocation process, but not the other lag times. The comparison between open access versus subscription journals confirmed meaningless differences in acceptance, online publication and indexing lag times.

Conclusion

Efforts by authors to update their search before submission are needed to reduce evidence production time. Peer reviewers and editors should ensure authors’ compliance with NMA standards. The accuracy of these findings depends on the accuracy of the metadata used; as we evaluated only NMA on drug interventions, results may not be generalisable to all types of studies.

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