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Comparative-effectiveness research of COVID-19 treatment: a rapid scoping review

Por: Pham · B. · Rios · P. · Radhakrishnan · A. · Darvesh · N. · Antony · J. · Williams · C. · Ramkissoon · N. · Cormack · G. V. · Grossman · M. R. · Kampman · M. · Patel · M. · Yazdi · F. · Robson · R. · Ghassemi · M. · Macdonald · E. · Warren · R. · Muller · M. P. · Straus · S. E. · Tricco · A
Objectives

The COVID-19 pandemic has stimulated growing research on treatment options. We aim to provide an overview of the characteristics of studies evaluating COVID-19 treatment.

Design

Rapid scoping review

Data sources

Medline, Embase and biorxiv/medrxiv from inception to 15 May 2021.

Setting

Hospital and community care.

Participants

COVID-19 patients of all ages.

Interventions

COVID-19 treatment.

Results

The literature search identified 616 relevant primary studies of which 188 were randomised controlled trials and 299 relevant evidence syntheses. The studies and evidence syntheses were conducted in 51 and 39 countries, respectively.

Most studies enrolled patients admitted to acute care hospitals (84%), included on average 169 participants, with an average age of 60 years, study duration of 28 days, number of effect outcomes of four and number of harm outcomes of one. The most common primary outcome was death (32%).

The included studies evaluated 214 treatment options. The most common treatments were tocilizumab (11%), hydroxychloroquine (9%) and convalescent plasma (7%). The most common therapeutic categories were non-steroidal immunosuppressants (18%), steroids (15%) and antivirals (14%). The most common therapeutic categories involving multiple drugs were antimalarials/antibiotics (16%), steroids/non-steroidal immunosuppressants (9%) and antimalarials/antivirals/antivirals (7%). The most common treatments evaluated in systematic reviews were hydroxychloroquine (11%), remdesivir (8%), tocilizumab (7%) and steroids (7%).

The evaluated treatment was in favour 50% and 36% of the evaluations, according to the conclusion of the authors of primary studies and evidence syntheses, respectively.

Conclusions

This rapid scoping review characterised a growing body of comparative-effectiveness primary studies and evidence syntheses. The results suggest future studies should focus on children, elderly ≥65 years of age, patients with mild symptoms, outpatient treatment, multimechanism therapies, harms and active comparators. The results also suggest that future living evidence synthesis and network meta-analysis would provide additional information for decision-makers on managing COVID-19.

Study protocol: an observational study of distress, immune function and persistent pain in HIV

Por: Madden · V. J. · Msolo · N. · Mqadi · L. · Lesosky · M. · Bedwell · G. J. · Hutchinson · M. R. · Peter · J. G. · Parker · R. · Schrepf · A. · Edwards · R. R. · Joska · J. A.
Introduction

Many people with HIV report both distress and pain. The relationship between distress and pain is bidirectional, but the mechanisms by which distress exacerbates pain are unclear. The inflammatory response to challenge (inflammatory reactivity, IR) may be a partial mediator, given that neuroimmune interactions provide a substrate for IR to also influence neurological reactivity and, thus, pain-related neural signalling. This prospective, observational, case–control study will characterise the relationships between distress, IR, pain-related signalling as captured by induced secondary hyperalgesia (SH), and pain, in people with HIV who report persistent pain (PP) (cases) or no pain (controls).

Methods and analysis

One hundred people with suppressed HIV, reporting either PP or no pain, will be assessed two or four times over 6 months. The primary outcomes are distress (Hopkins 25-item symptom checklist), IR (multiplex assay after LPS challenge), and PP (Brief Pain Inventory), assessed at the baseline timepoint, although each will also be assessed at follow-up time points. Induced SH will be assessed in a subsample of 60 participants (baseline timepoint only). To test the hypothesis that IR partly mediates the relationship between distress and pain, mediation analysis will use the baseline data from the PP group to estimate direct and indirect contributions of distress and IR to pain. To test the hypothesis that IR is positively associated with SH, data from the subsample will be analysed with generalised mixed effects models to estimate the association between IR and group membership, with SH as the dependent variable.

Ethics and dissemination

Information obtained from this study will be published in peer-reviewed journals and presented at scientific meetings. The study has been approved by the Human Research Ethics Committee of the University of Cape Town (approval number: 764/2019) and the City of Cape Town (ref: 24699).

Trial registration number

NCT04757987.

Protocol on establishing a prospective enhanced surveillance of vaccine preventable diseases in residential aged care facilities in Central Queensland, Australia: an observational study

Por: Hashan · M. R. · Chapman · G. · Walker · J. · Jayne Davidson · S. · Auriac · J. · Smoll · N. · Kirk · M. · Akbar · D. · Booy · R. · Khandaker · G.
Introduction

Infectious diseases are a major cause of mortality and morbidity among the highly vulnerable occupants of residential aged care facilities (RACFs). The burden of vaccine preventable diseases (VPDs) among RACFs residents is mostly unknown and there is a lack of quality data from population-based prospective VPD surveillance in RACFs. The increasing burden of emerging and existing VPDs (eg, COVID-19, influenza, pneumococcal, pertussis and varicella-zoster) necessitates the establishment of an active enhanced surveillance system to provide real-time evidence to devise strategies to reduce the burden of VPDs in RACFs.

Method and analysis

This study proposes a prospective active enhanced surveillance that will be implemented in RACFs across the Central Queensland (CQ) region. The study aims to measure the burden, identify aetiologies, risk factors, predictors of severe outcomes (eg, hospitalisations, mortality) and impact of the existing National Immunization Program (NIP) funded vaccines in preventing VPDs in this vulnerable population. CQ Public Health Unit (CQPHU) will implement the active surveillance by collecting demographic, clinical, pathological, diagnostic, therapeutic and clinical outcome data from the RACFs based on predefined selection criteria and case report forms as per routine public health practices. Descriptive statistics, univariate and multivariate regression analysis will be conducted to identify the predictors of morbidity and clinical outcomes following infection.

Ethics and dissemination

The study has been approved by the CQHHS Human Research Ethics Committee (HREC) (reference number HREC/2021/QCQ/74305). This study involves data that is routinely collected as part of the surveillance of notifiable conditions under the Public Health Act 2005. The CQHHS HREC approved a request to waive consent requirements of study participants as researchers will be provided non-identifiable data. The findings from the study will be actively disseminated through publication in peer-reviewed journals, conference presentations, social and print media, federal, state, and local authorities to reflect on the results that may facilitate revision of policy and highlight the stakeholders, funding bodies both locally and internationally.

Missing Piece Study protocol: prospective surveillance to determine the epidemiology of group A streptococcal pharyngitis and impetigo in remote Western Australia

Por: Barth · D. D. · Mullane · M. J. · Sampson · C. · Chou · C. · Pickering · J. · Nicol · M. P. · Davies · M. R. · Carapetis · J. · Bowen · A. C.
Introduction

Group A β-haemolytic Streptococcus (GAS), a Gram-positive bacterium, causes skin, mucosal and systemic infections. Repeated GAS infections can lead to autoimmune diseases acute rheumatic fever (ARF) and rheumatic heart disease (RHD). Aboriginal and Torres Strait Islander peoples in Australia have the highest rates of ARF and RHD in the world. Despite this, the contemporaneous prevalence and incidence of GAS pharyngitis and impetigo in remote Australia remains unknown. To address this, we have designed a prospective surveillance study of GAS pharyngitis and impetigo to collect coincident contemporary evidence to inform and enhance primary prevention strategies for ARF.

Methods and analysis

The Missing Piece Study aims to document the epidemiology of GAS pharyngitis and impetigo through collection of clinical, serological, microbiological and bacterial genomic data among remote-living Australian children. The study comprises two components: (1) screening of all children at school for GAS pharyngitis and impetigo up to three times a year and (2) weekly active surveillance visits to detect new cases of pharyngitis and impetigo. Environmental swabbing in remote schools will be included, to inform environmental health interventions. In addition, the application of new diagnostic technologies, microbiome analysis and bacterial genomic evaluations will enhance primary prevention strategies, having direct bearing on clinical care, vaccine development and surveillance for vaccine clinical trials.

Ethics and dissemination

Ethical approval has been obtained from the Western Australian Aboriginal Health Ethics Committee (Ref: 892) and Human Research Ethics Committee of the University of Western Australia (Ref: RA/4/20/5101). Study findings will be shared with community members, teachers and children at participating schools, together with academic and medical services. Sharing findings in an appropriate manner is important and will be done in a suitable way which includes plain language summaries and presentations. Finally, findings and updates will also be disseminated to collaborators, researchers and health planners through peer-reviewed journal publications.

Glial-modulating agents for the treatment of pain: protocol for a systematic review

Por: Gilron · I. · Xiao · M. Z. X. · Balanaser · M. · Carley · M. · Ghasemlou · N. · Salter · M. W. · Hutchinson · M. R. · Moulin · D. E. · Moore · R. A. · Ross-White · A.
Introduction

Evidence suggests a role for Central nervous system glia in pain transmission and in augmenting maladaptive opioid effects. Identification of drugs that modulate glia has guided the evaluation of glial suppression as a pain management strategy. This planned systematic review will describe evidence of the efficacy and adverse effects of glial-modulating drugs in pain management.

Methods and analysis

A detailed search will be conducted on the Cochrane Central Register of Controlled Trials, Medline, and Embase from their inception until the date the final searches are run to identify relevant randomised controlled trials. The reference lists of retrieved studies, as well as online trial registries, will also be searched. English language, randomised, double-blind trials comparing various glial-modulating drugs with placebo and/or other comparators, with participant-reported pain assessment, will be included. Two reviewers will independently evaluate studies for eligibility, extract data and assess trial quality and potential bias. Risk of bias will be assessed using criteria outlined in the Cochrane Handbook for Systematic Review of Interventions. Primary outcomes for this review will include any validated measure of pain intensity and/or pain relief. Dichotomous data will be used to calculate risk ratio and number needed to treat or harm. The quality of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation.

Ethics and dissemination

This systematic review does not require formal ethics approval. The findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42021262074.

Smoking cessation strategy in the national cervical cancer screening program (SUCCESS): study protocol for a pragmatic cluster randomised trial and process evaluation in Dutch general practice

Por: Mansour · M. B. · Crone · M. R. · Sert · E. · van Weert · H. C. · Chavannes · N. H. · van Asselt · K. M.
Introduction

Cervical cancer screening in general practice could be a routine moment to provide female smokers with stop smoking advice and support. The aim of this study is to assess the effect of a stop smoking strategy delivered by trained practice assistants after the cervical smear, and to evaluate the implementation process.

Methods and analysis

The study is a two-arm, pragmatic cluster randomised trial, in Dutch general practice. Randomisation takes place 1:1 at the level of the general practice. Practices either deliver the SUCCESS stop smoking strategy or the usual care condition. The strategy consists of brief stop smoking advice based on the Ask-Advise-Connect method and is conducted by trained practice assistants after routine cervical cancer screening. The primary outcome is the performance of a serious quit attempt in the 6 months after screening. Secondary outcomes are 7-day point prevalence abstinence, reduction in the number of cigarettes per day and transition in motivation to quit smoking. Follow-up for these measurements takes place after 6 months. Analysis on the primary outcome aims to detect a 10% difference between treatment arms (0.80 power, p=0.05, using a one-sided test), and will be performed according to the intention to treat principle. The process evaluation will assess feasibility, acceptability and barriers or enablers to the strategy’s implementation. For this purpose, both qualitative and quantitative data will be collected via questionnaires and in-depth interviews, respectively, in both individual study participants and involved staff.

Ethics and dissemination

The Dutch Ministry of Health, Welfare and Sport approved of the trial after an advisory report from the Health Council (Nr. 2018/17). A licence was provided to conduct the study under the Population Screening Act. Study results will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial registration number

NL5052 (NTR7451).

Prevalence of blindness and its determinants in Bangladeshi adult population: results from a national cross-sectional survey

Por: Shakoor · S. A. · Rahman · M. · Hossain · A. H. M. E. · Moniruzzaman · M. · Bhuiyan · M. R. · Hakim · F. · Zaman · M. M.
Objective

The objective of this study was to determine the prevalence of blindness and its determinants in Bangladeshi adult population.

Study design

A cross-sectional population-based survey conducted at household level with national representation. Samples were drawn from the 2011 national census frame using a multistage stratified cluster sampling method.

Setting and participants

The survey was done in urban and rural areas in 2013 using a probability proportionate to size sampling approach to locate participants from 72 primary sampling units. One man or one woman aged ≥40 years was randomly selected from their households to recruit 7200. In addition to sociodemographic data, information on medication for hypertension and diabetes was obtained. Blood pressure and capillary blood glucose were measured. Eyelids, cornea, lens, and retina were examined in addition to visual acuity and refraction testing.

Primary outcome measures

The following definition was used to categorise subjects having (1) blindness: visual acuity

Results

We could recruit 6391 (88.8%) people among whom 2955 (46.2%) were men. Among them, 1922 (30.1%) were from urban and 4469 (69.9%) were from rural areas. The mean age was 54.3 (SD 11.2) years. The age-standardised prevalence, after best correction, of blindness and low vision was 1.0% (95% CI 0.5% to 1.4%) and 12.1% (95% CI 10.5% to 13.8%), respectively. Multivariable logistic regression indicated that cataract, age-related macular degeneration and diabetic retinopathy were significantly associated with low vision and blindness after adjustment for age and sex. Population attributable risk of cataract for low vision and blindness was 79.6%.

Conclusions

Low vision and blindness are common problems in those aged 40 years or older. Extensive screening and eye care services are necessary for wider coverage engaging all tiers of the healthcare system especially focusing on cataract.

How the reduction of working hours could influence health outcomes: a systematic review of published studies

Por: Voglino · G. · Savatteri · A. · Gualano · M. R. · Catozzi · D. · Rousset · S. · Boietti · E. · Bert · F. · Siliquini · R.
Objectives

The health effects of work-time arrangements have been largely studied for long working hours, whereas a lack of knowledge remains regarding the potential health impact of reduced work-time interventions. Therefore, we conducted this review in order to assess the relationships between work-time reduction and health outcomes.

Design

Systematic review of published studies. Medline, PsycINFO, Embase and Web of Science databases were searched from January 2000 up to November 2019.

Outcomes

The primary outcome was the impact of reduced working time with retained salary on health effects, interventional and observational studies providing a quantitative analysis of any health-related outcome were included. Studies with qualitative research methods were excluded.

Results

A total of 3876 published articles were identified and 7 studies were selected for the final analysis, all with a longitudinal interventional design. The sample size ranged from 63 participants to 580 workers, mostly from healthcare settings. Two studies assessed a work-time reduction to 6 hours per day; two studies evaluated a weekly work-time reduction of 25%; two studies evaluated simultaneously a reduced weekly work-time reduction proportionally to the amount of time worked and a 2.5 hours of physical activity programme per week instead of work time; one study assessed a reduced weekly work-time reduction from 39 to 30 hours per week. A positive relationship between reduced working hours and working life quality, sleep and stress was observed. It is unclear whether work time reduction determined an improvement in general health outcomes, such as self-perceived health and well-being.

Conclusions

These findings suggest that the reduction of working hours with retained salary could be an effective workplace intervention for the improvement of employees’ well-being, especially regarding stress and sleep. Further studies in different contexts are needed to better evaluate the impact of work-time reduction on other health outcomes.

Modern contraceptive use among young women aged 15-24 years in selected municipalities of Western Nepal: results from a cross-sectional survey in 2019

Por: Angdembe · M. R. · Sigdel · A. · Paudel · M. · Adhikari · N. · Bajracharya · K. T. · How · T. C.
Objective

To estimate the modern contraceptive prevalence rate (mCPR) and its predictors among young women aged 15–24 years.

Design

Cross-sectional analysis of Adolescent Youth Project baseline survey.

Setting

29 municipalities within Lumbini Province and Sudurpaschim Province in Western Nepal.

Participants

683 young women aged 15–24 years who were living in the catchment area of the selected 30 private OK network health facilities at the study sites from November to December 2019 and who provided informed consent or assent.

Outcome measure

mCPR among young women aged 15–24 years.

Results

The mean age of the respondents was 19 years, 61.7% never had sex and 63.9% were unmarried. The mCPR was 11.9% (95% CI 9.5 to 14.8). Of those who reported using a modern method of contraception, injectables (37.9%) were the most common, followed by male condom (35.9%) and implants (8.8%). Majority (86.4%) of the respondents reported currently not using any method of contraception. In the binary logistic regression analysis, the odds of contraceptive use were higher among women aged 20–24 years (adjusted OR (AOR)=5.50, 95% CI 2.94 to 10.29) and those of Janajati caste/ethnicity (AOR=2.08, 95% CI 1.16 to 3.71), while the odds were lower among women who faced high level of barriers (individual, family/societal, service provider and health facility barriers) to contraceptive use (AOR=0.36, 95% CI 0.14 to 0.98).

Conclusions

The mCPR among young women aged 15–24 years was low but similar to the national level. Sexual and reproductive health programmes aiming to improve the mCPR in this population of young women should consider the reported level of sexual activity. Reaching young women to improve their knowledge and self-efficacy for contraception is critical to ensure they can access contraception when needed. The focus should be on reaching not just young women but also key influencers and service providers and making health facilities adolescent-friendly to reduce barriers to contraceptive uptake and to realise self-efficacy.

Primary Care Severe Asthma Registry and Education Project (PCSAR-EDU): Phase 1 - an e-Delphi for registry definitions and indices of clinician behaviour

Por: D'Urzo · K. A. · Tamari · I. E. · Chapman · K. R. · Maleki-Yazdi · M. R. · Greiver · M. · Upshur · R. E. · Biro · L. · O'Neill · B. · Moineddin · R. · Aliarzadeh · B. · Kulasegaram · K. · To · T. · D'Urzo · A. D.
Introduction

Although most asthma is mild to moderate, severe asthma accounts for disproportionate personal and societal costs. Poor co-ordination of care between primary care and specialist settings is recognised as a barrier to achieving optimal outcomes. The Primary Care Severe Asthma Registry and Education (PCSAR-EDU) project aims to address these gaps through the interdisciplinary development and evaluation of both a ‘real-world’ severe asthma registry and an educational programme for primary care providers. This manuscript describes phase 1 of PCSAR-EDU which involves establishing interdisciplinary consensus on criteria for the: (1) definition of severe asthma; (2) generation of a severe asthma registry and (3) definition of an electronic-medical record data-based Clinician Behaviour Index (CBI).

Methods and analysis

In phase 1, a modified e-Delphi activity will be conducted. Delphi panellists (n≥13) will be invited to complete a 30 min online survey on three separate occasions (i.e., three separate e-Delphi ‘rounds’) over a 3-month period. Expert opinion will be collected via an open-ended survey (‘Open’ round 1) and 5-point Likert scale and ranking surveys (‘Closed’ round 2 and 3). A fourth and final Delphi round will occur via synchronous meeting, whereby panellists approve a finalised ideal ‘core criteria list’, CBI and corresponding item weighting.

Ethics and dissemination

Ethical approval has been obtained for the activities involved in phase 1 from the University of Toronto’s Human Research Ethics Programme (approval number 39695). Future ethics approvals will depend on information gathered in the proceeding phase; thus, ethical approval for phase 2 and 3 of this study will be sought sequentially. Findings will be disseminated through conference presentations, peer-reviewed publications and knowledge translation tools.

Impact of the implementation of the WHO Safe Childbirth Checklist on essential birth practices and adverse events in two Brazilian hospitals: a before and after study

Objective

The WHO Safe Childbirth Checklist (SCC) is a promising initiative for safety in childbirth care, but the evidence about its impact on clinical outcomes is limited. This study analysed the impact of SCC on essential birth practices (EBPs), obstetric complications and adverse events (AEs) in hospitals of different profiles.

Design

Quasi-experimental, time-series study and pre/post intervention.

Setting

Two hospitals in North-East Brazil, one at a tertiary level (H1) and another at a secondary level (H2).

Participants

1440 women and their newborns, excluding those with congenital malformations.

Interventions

The implementation of the SCC involved its cross-cultural adaptation, raising awareness with videos and posters, learning sessions about the SCC and auditing and feedback on adherence indicators.

Primary and secondary outcome measures

Simple and composite indicators related to seven EBPs, 3 complications and 10 AEs were monitored for 1 year, every 2 weeks, totalling 1440 observed deliveries.

Results

The checklist was adopted in 83.3% (n=300) of deliveries in H1 and in 33.6% (n=121) in H2. The hospital with the highest adoption rate for SCC (H1) showed greater adherence to EBPs (improvement of 50.9%;p

Conclusions

A multifaceted SCC-based intervention can be effective in improving adherence to EBPs and clinical outcomes in childbirth. The context and adherence to the SCC seem to modulate its impact, working better in a hospital of higher complexity.

Histopathological profile of cervical biopsies in northern Malawi: a retrospective cross-sectional study

Por: Kaseka · P. U. · Kayira · A. · Chimbatata · C. S. · Chisale · M. R. O. · Kamudumuli · P. · Wu · T.-S. J. · Mbakaya · B. C. · Sinyiza · F. W.
Objectives

According to the WHO (2014), cervical cancer is the second most common cancer in women globally. More than 85% of the global cervical cancer morbidity and mortality occur in low-income and middle-income countries and the highest risk region is in Eastern and Southern Africa. Malawi has the highest age-standardised rate of cervical cancer in the world. This study was carried out to determine the histopathological profile of cervical biopsies in a public tertiary hospital in Mzuzu, northern region of Malawi.

Setting

A public tertiary hospital in Mzuzu, northern region of Malawi.

Participants

This was a retrospective study of all cervical biopsy specimen reports received in a public tertiary hospital in northern Malawi over a period of 5 years from July 2013 to June 2018. Demographic, clinical and diagnostic data were obtained from original histopathology reports.

Results

A total of 500 cervical biopsy reports were reviewed during the study period. The mean age of the patients was 41.99±12.5. Age ranged from 15 to 80 years. Cervicitis accounted for 46.0% (n=162) of the total non-malignant lesions seen, followed by cervical intraepithelial neoplasm, at 24.4% (n=86) and endocervical polyp, at 20.5% (n=72). Squamous cell carcinoma (SCC) accounted for 15.6% (n=78) of the total cervical biopsies studied and 85.7% of all total malignant lesions. Adenocarcinoma and undifferentiated carcinoma were 8.8% and 4.4%, respectively of the total malignant diagnosis. All patients with malignant lesions had HIV.

Conclusion

Our study shows that cervicitis and SCC were most common among non-malignant and malignant cervical biopsies, respectively. Since the frequency of cervical cancer is high, there is a need to have well detailed national policies to be put in place to increase detection of preinvasive lesions in order to reduce the prevalence of cervical cancer.

Impact of major disease outbreaks in the third millennium on adolescent and youth sexual and reproductive health and rights in low and/or middle-income countries: a systematic scoping review protocol

Por: Akbarialiabad · H. · Shidhaye · R. · Shidhaye · P. · Cuijpers · P. · Weaver · M. R. · Bahrololoom · M. · Kiburi · S. · Njuguna · I. N. · Taghrir · M. H. · Kumar · M.
Introduction

Sexual and Reproductive Health and Rights (SRHR) of young people continue to present a high burden and remain underinvested. This is more so in low and middle-income countries (LMICs), where empirical evidence reveals disruption of SRHR maintenance, need for enhancement of programmes, resources and services during pandemics. Despite the importance of the subject, there is no published review yet combining recent disease outbreaks such as (H1N1/09, Zika, Ebola and SARS-COV-2) to assess their impact on adolescents and youth SRHR in LMICs.

Methods and analysis

We will adopt a four-step search to reach the maximum possible number of studies. In the first step, we will carry out a limitedpreliminary search in databases for getting relevant keywords (appendix 1). Second, we will search in four databases: Pubmed, Cochrane Library, Embase and PsycINFO. The search would begin from the inception of the first major outbreak in 2009 (H1N1/09) up to the date of publication of the protocol in early 2022. We will search databases using related keywords, screen title & abstract and review full texts of the selected titles to arrive at the list of eligible studies. In the third stage, we will check their eligibility to the included article’s reference list. In the fourth stage, we will check the citations of included papers in phase 2 to complete our study selection. We will include all types of original studies and without any language restriction in our final synthesis. Our review results will be charted for each pandemic separately and include details pertaining to authors, year, country, region of the study, study design, participants (disaggregated by age and gender), purpose and report associated SRHR outcomes. The review will adhere to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guideline (PRISMA-ScR).

Patient and public involvement

Patients or public were not involved in this study.

Ethics and dissemination

Ethical assessment is not required for this study. The results of the study will be presented in peer-reviewed publications and conferences on adolescent SRHR.

Uptake of the multi-arm multi-stage (MAMS) adaptive platform approach: a trial-registry review of late-phase randomised clinical trials

Por: Noor · N. M. · Love · S. B. · Isaacs · T. · Kaplan · R. · Parmar · M. K. B. · Sydes · M. R.
Background

For medical conditions with numerous interventions worthy of investigation, there are many advantages of a multi-arm multi-stage (MAMS) platform trial approach. However, there is currently limited knowledge on uptake of the MAMS design, especially in the late-phase setting. We sought to examine uptake and characteristics of late-phase MAMS platform trials, to enable better planning for teams considering future use of this approach.

Design

We examined uptake of registered, late-phase MAMS platforms in the EU clinical trials register, Australian New Zealand Clinical Trials Registry, International Standard Randomised Controlled Trial Number registry, Pan African Clinical Trials Registry, WHO International Clinical Trial Registry Platform and databases: PubMed, Medline, Cochrane Library, Global Health Library and EMBASE. Searching was performed and review data frozen on 1 April 2021. MAMS platforms were defined as requiring two or more comparison arms, with two or more trial stages, with an interim analysis allowing for stopping of recruitment to arms and typically the ability to add new intervention arms.

Results

62 late-phase clinical trials using an MAMS approach were included. Overall, the number of late-phase trials using the MAMS design has been increasing since 2001 and been accelerated by COVID-19. The majority of current MAMS platforms were either targeting infectious diseases (52%) or cancers (29%) and all identified trials were for treatment interventions. 89% (55/62) of MAMS platforms were evaluating medications, with 45% (28/62) of the MAMS platforms having at least one or more repurposed medication as a comparison arm.

Conclusions

Historically, late-phase trials have adhered to long-established standard (two-arm) designs. However, the number of late-phase MAMS platform trials is increasing, across a range of different disease areas. This study highlights the potential scope of MAMS platform trials and may assist research teams considering use of this approach in the late-phase randomised clinical trial setting.

PROSPERO registration number

CRD42019153910.

Testing and treatment for latent tuberculosis infection in people living with HIV and substance dependence: a prospective cohort study

Por: Runels · T. · Ragan · E. J. · Ventura · A. S. · Winter · M. R. · White · L. F. · Horsburgh · C. R. · Samet · J. H. · Saitz · R. · Jacobson · K. R.
Objective

To quantify the proportion of people living with HIV (PLWH) with other tuberculosis (TB) risk factors that completed the latent tuberculosis infection (LTBI) care cascade and describe factors associated with attrition. The care cascade was defined as follows: (1) receipt of an LTBI test and result, (2) initiation of LTBI treatment and (3) completion of LTBI treatment.

Design

Prospective cohort study.

Setting

Reactivation of LTBI remains a large source of active TB disease in the USA. PLWH and those who use substances are at greater risk and are harder to engage and retain in care.

Participants

Participants enrolled in a Boston cohort of PLWH from 2012 to 2014.

Primary and secondary outcome measures

Our primary outcome was the number and proportion of participants who completed each stage of the cascade and the factors associated with completing each stage. Our secondary outcomes were differences between participants tested with an interferon gamma release assay (IGRA) versus tuberculin skin test and differences between participants who tested positive versus negative for LTBI.

Results

Only 189 of 219 (86.3%) participants completed testing. Five of the 11 with LTBI initiated and three completed treatment. Participants tested with an IGRA were more likely to complete testing (OR 3.87, 95% CI 1.05 to 14.30) while among participants successfully tested, being foreign-born was associated with a positive test result (OR 3.95; 95% CI 1.13 to 13.77).

Conclusions

Although the majority completed LTBI testing, our findings warrant further investigation in a larger cohort to better understand factors that lead to suboptimal treatment initiation and completion in a low-burden country.

Adolescent stress experiences over time study (ASETS) protocol: design and methods of a prospective longitudinal study of sexual minority adolescents in the USA

Por: Schrager · S. M. · Mamey · M. R. · Rhoades · H. · Goldbach · J. T.
Introduction

Sexual minority adolescents (SMA) report higher rates of anxiety, self-harm, depression and suicide than heterosexual peers. These disparities appear to persist into adulthood and may worsen for certain subgroups, yet the mechanisms that drive these concerns remain poorly understood. Minority stress theory, the predominant model for understanding these disparities, posits that poorer outcomes are due to the stress of living in a violently homophobic and discriminatory culture. Although numerous studies report associations between minority stress and behavioural health in adolescence, no study has comprehensively examined how minority stress may change throughout the course of adolescence, nor how stress trajectories may predict health outcomes during this critical developmental period.

Methods and analysis

Between 15 May 2018 and 1 April 2019, we recruited a US national sample of diverse SMA (n=2558) age 14–17 through social media and respondent-driven sampling strategies. A subset of participants (n=1076) enrolled in the longitudinal component and will be followed each 6 months until 1 July 2022. Primary outcomes include symptoms of depression, anxiety and post-traumatic stress disorder; suicidality and self-harm and substance use. The key predictor is minority stress, operationalised as the Sexual Minority Adolescent Stress Inventory. We will use parallel cohort-sequential latent growth curve models to test study hypotheses within a developmental framework.

Ethics and dissemination

All participants provided assent to participate, and longitudinal participants provided informed consent at the first follow-up survey after reaching age 18. All study procedures were reviewed and approved by the University of Southern California Social–Behavioral Institutional Review Board, including a waiver of parental permission given the potential for harm due to unintentional ‘outing’ to a parent during the consent process. The final anonymous data set will be available on request, and research findings will be disseminated through academic channels and products tailored for the lay community.

How is the organisational settings, content and availability of comprehensive multidisciplinary pulmonary rehabilitation for people with COPD in primary healthcare in Norway: a cross-sectional study

Por: Frisk · B. · Sundor · I. E. · Donasen · M. R. · Refvem · O. K. · Borge · C. R.
Objective

To examine the organisational settings, content and availability of comprehensive multidisciplinary pulmonary rehabilitation (PR) programmes for people with chronic obstructive pulmonary disease (COPD) in primary healthcare in Norway.

Design

This was a cross-sectional survey study examining the content, organisational settings and availability of comprehensive multidisciplinary PR for people with COPD.

Setting and participants

When the survey was conducted, Norway had 436 municipalities/primary healthcare services who were invited to participate.

Outcome measures

The main outcome was the question related to accessibility to a PR programme in primary healthcare. We also examined in what degree the single interventions which are a part of a PR programme were one of the municipalities services and if there were regional differences regarding PR.

Results

Of the 436 municipalities, 158 answered the survey (36% response rate), and the survey covered for 45% of the total population in Norway. Five per cent of the responders reported having multidisciplinary PR for patients with COPD. The most frequently reported single interventions that can be a part of a multidisciplinary PR programme were reported as follows: group exercise training for all diagnoses (27%), reablement (25%) and home-care treatment by a physiotherapist and/or occupational therapist (24%). Southern-Eastern Norway had a significantly lower number of these interventions than Western Norway, Central Norway, and Northern Norway (p

Conclusion

Only 5% of the Norwegian primary healthcare services (municipalities) had a multidisciplinary PR programme for patients with COPD. PR is the most important and cost-effective treatment within integrated care of patients with COPD. National strategies are therefore needed to increase the availability of PR for patients with COPD in Norwegian municipalities.

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study)

Por: Johnson · M. I. · Paley · C. A. · Jones · G. · Mulvey · M. R. · Wittkopf · P. G.
Objective

To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults.

Design

Systematic review and meta-analysis.

Data sources

Medline, Cochrane Central, Embase (and others) from inception to July 2019 and updated on 17 May 2020.

Eligibility criteria for study selection

Randomised controlled trials (RCTs) comparing strong non-painful TENS at or close to the site of pain versus placebo or other treatments in adults with pain, irrespective of diagnosis.

Data extraction and synthesis

Reviewers independently screened, extracted data and assessed risk of bias (RoB, Cochrane tool) and certainty of evidence (Grading and Recommendations, Assessment, Development and Evaluation). Mean pain intensity and proportions of participants achieving reductions of pain intensity (≥30% or >50%) during or immediately after TENS. Random effect models were used to calculate standardised mean differences (SMD) and risk ratios. Subgroup analyses were related to trial methodology and characteristics of pain.

Results

The review included 381 RCTs (24 532 participants). Pain intensity was lower during or immediately after TENS compared with placebo (91 RCTs, 92 samples, n=4841, SMD=–0·96 (95% CI –1·14 to –0·78), moderate-certainty evidence). Methodological (eg, RoB, sample size) and pain characteristics (eg, acute vs chronic, diagnosis) did not modify the effect. Pain intensity was lower during or immediately after TENS compared with pharmacological and non-pharmacological treatments used as part of standard of care (61 RCTs, 61 samples, n=3155, SMD = –0·72 (95% CI –0·95 to –0·50], low-certainty evidence). Levels of evidence were downgraded because of small-sized trials contributing to imprecision in magnitude estimates. Data were limited for other outcomes including adverse events which were poorly reported, generally mild and not different to comparators.

Conclusion

There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

PROSPERO registration number

CRD42019125054.

Assessing tobacco smoke exposure in pregnancy from self-report, urinary cotinine and NNAL: a validation study using the New Hampshire Birth Cohort Study

Por: Peacock · J. L. · Palys · T. J. · Halchenko · Y. · Sayarath · V. · Takigawa · C. A. · Murphy · S. E. · Peterson · L. A. · Baker · E. R. · Karagas · M. R.
Objectives

Accurate assessment of tobacco smoke exposure is key to evaluate its effects. We sought to validate and establish cut-offs for self-reported smoking and secondhand smoke (SHS) exposure during pregnancy using urinary cotinine and 4-(methylnitrosamino)-1-(-3-pyridyl)-1-butanol (NNAL) in a large contemporary prospective study from the USA, with lower smoking prevalence than has previously been evaluated.

Design

Prospective birth cohort.

Setting

Pregnancy clinics in New Hampshire and Vermont, USA.

Participants

1396 women enrolled in the New Hampshire Birth Cohort Study with self-reported smoking, urinary cotinine, NNAL and pregnancy outcomes.

Primary and secondary outcome measures

Cut-offs for urinary cotinine and NNAL concentrations were estimated from logistic regression models using Youden’s method to predict SHS and active smoking. Cotinine and NNAL were each used as the exposure in separate multifactorial models for pregnancy outcomes.

Results

Self-reported maternal smoking was: 72% non-smokers, 5.7% ex-smokers, 6.4% SHS exposure, 6.2% currently smoked, 10% unreported. Cotinine and NNAL levels were low and highly intercorrelated (r=0.91). Geometric mean cotinine, NNAL were 0.99 ng/mL, 0.05 pmol/mL, respectively. Cotinine cut-offs for SHS, current smoking were 1.2 ng/mL and 1.8 ng/mL (area under curve (AUC) 95% CI: 0.52 (0.47 to 0.57), 0.90 (0.85 to 0.94)). NNAL cut-off for current smoking was 0.09 pmol/mL (AUC=0.82 (95% CI 0.77 to 0.87)). Using cotinine and NNAL cut-offs combined gave similar AUC to cotinine alone, 0.87 (95% CI 0.82 to 0.91). Cotinine and NNAL gave almost identical effect estimates when modelling pregnancy outcomes.

Conclusions

In this population, we observed high concordance between self-complete questionnaire smoking data and urinary cotinine and NNAL. With respect to biomarkers, either cotinine or NNAL can be used as a measure of tobacco smoke exposure overall but only cotinine can be used to detect SHS.

Association between prelabour caesarean section and perinatal outcomes: analysis of demographic and health surveys from 26 low-income and middle-income countries

Por: Opiyo · N. · Bellizzi · S. · Torloni · M. R. · Souza · J. P. · Betran · A. P.
Objectives

Caesarean section (CS) conducted before labour (prelabour CS (PLCS)), compared with vaginal birth, may pose additional maternal and perinatal risks. No multicountry analysis has examined PLCS in low-income and middle-income countries (LMICs). This study assessed rates, risk factors and associations of PLCS with perinatal outcomes in LMICs.

Design

Population-based cross-sectional surveys.

Setting

Demographic and Health Surveys conducted between 2015 and 2018 in 26 LMICs (13 countries in Africa, 11 in Asia and 2 in the Americas).

Participants

Women aged 15–49 years with singleton term births.

Outcome measures

Main outcomes were early neonatal mortality, neonatal mortality, early breastfeeding (within 1 hour of birth), skin-to-skin contact and duration of hospital stay.

Results

255 227 women were included in the main analysis. Average rates of primary PLCS ranged from 1.3% in Zambia to 19.5% in Maldives. Median PLCS rate was 1.8% in the poorest versus 5.8% in the richest subgroups.

Higher maternal age, education, economic status and BMI, lower parity, urban residence, delivery in private hospitals, larger baby size, having health insurance, more antenatal care (ANC) visits, ANC by a doctor and ANC in private hospitals were associated with increased primary PLCS.

Across the 26 countries, primary PLCS, compared with vaginal delivery, was associated with increased neonatal mortality (adjusted odds ratio, aOR 1.2, 95% CI 1.0 to 1.5), decreased early breastfeeding (aOR 0.4, 95% CI 0.3 to 0.5) and skin-to-skin contact (aOR 0.4, 95% CI 0.3 to 0.5) and longer hospital stay (aOR 6.6, 95% CI 5.9 to 7.4). No significant association was found for early neonatal mortality (aOR 1.2, 95% CI 0.9 to 1.5).

Conclusion

Primary PLCS, compared with vaginal birth, is associated with adverse perinatal outcomes in singleton term pregnancies in LMICs. Caesarean births should be audited regularly to monitor trends, appropriateness and context-specific drivers of CS.

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