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Tuberculosis contact investigation in African Portuguese-speaking countries at End TB Strategy era: a scoping review

Por: Loesch · R. B. R. · Ribeiro · R. M. · Conceicao · C.
Objectives

The contact investigation of tuberculosis (TB) index case is one of the critical elements pointed by the WHO to reach the end of the TB epidemic. The scoping review aimed to map out the recommended and the adopted processes applied to active contact investigation of TB index case in African Portuguese-speaking countries (PALOP).

Design

Scoping review.

Data sources

We searched B-on, Cochrane Library, PubMed, Web of Science, Scopus, WHOLIS, IRIS, OKR, each country’s Ministry of Health websites, WHO, Global Fund, World Bank and bibliographic reference lists from February to May 2020.

Eligibility criteria

All available literature on TB contact investigation in each country part of PALOP (Angola, Cape Verde, Guinea-Bissau, Mozambique and Sao Tome and Principe) published from 1 January 2010 to 31 January2020.

Data extraction and synthesis

A data-charting form was developed to extract data on documents' characteristics and variables pertinent to the TB contact investigation process. Before qualitative analysis, we thematically synthesised findings and converted them into appropriate text units.

Results

Fifteen documents were included in the scoping review. The recommended processes for TB contact investigation were identified only for Cape Verde and Mozambique. It included clinical evaluation, counselling and testing for HIV, chest radiography, tuberculin skin test, sputum smear microscopy or Xpert MTB/RIF. The adopted processes were detected only in research studies from Angola, Guinea-Bissau and Mozambique. Therefore, they cannot be assumed as adopted within the scope of the national programmes of the respective countries.

Conclusion

This review highlights the scarcity of references on TB contact investigation in PALOP at the End TB Strategy era. Furthermore, it is well clear the importance of an information system that provides actual data for assessing the real impact of such interventions in controlling the disease in African Portuguese-speaking countries.

Using machine learning to identify quality-of-care predictors for emergency caesarean sections: a retrospective cohort study

Por: Andersen · B. R. · Ammitzboll · I. · Hinrich · J. · Lehmann · S. · Ringsted · C. V. · Lokkegaard · E. C. L. · Tolsgaard · M. G.
Objectives

Emergency caesarean sections (ECS) are time-sensitive procedures. Multiple factors may affect team efficiency but their relative importance remains unknown. This study aimed to identify the most important predictors contributing to quality of care during ECS in terms of the arrival-to-delivery interval.

Design

A retrospective cohort study. ECS were classified by urgency using emergency categories one/two and three (delivery within 30 and 60 min). In total, 92 predictor variables were included in the analysis and grouped as follows: ‘Maternal objective’, ‘Maternal psychological’, ‘Fetal factors’, ‘ECS Indication’, ‘Emergency category’, ‘Type of anaesthesia’, ‘Team member qualifications and experience’ and ‘Procedural’. Data was analysed with a linear regression model using elastic net regularisation and jackknife technique to improve generalisability. The relative influence of the predictors, percentage significant predictor weight (PSPW) was calculated for each predictor to visualise the main determinants of arrival-to-delivery interval.

Setting and participants

Patient records for mothers undergoing ECS between 2010 and 2017, Nordsjællands Hospital, Capital Region of Denmark.

Primary outcome measures

Arrival-to-delivery interval during ECS.

Results

Data was obtained from 2409 patient records for women undergoing ECS. The group of predictors representing ‘Team member qualifications and experience’ was the most important predictor of arrival-to-delivery interval in all ECS emergency categories (PSPW 25.9% for ECS category one/two; PSPW 35.5% for ECS category three). In ECS category one/two the ‘Indication for ECS’ was the second most important predictor group (PSPW 24.9%). In ECS category three, the second most important predictor group was ‘Maternal objective predictors’ (PSPW 24.2%).

Conclusion

This study provides empirical evidence for the importance of team member qualifications and experience relative to other predictors of arrival-to-delivery during ECS. Machine learning provides a promising method for expanding our current knowledge about the relative importance of different factors in predicting outcomes of complex obstetric events.

A pilot randomised controlled trial of an energy management programme for adults on maintenance haemodialysis: the fatigue-HD study

Por: Farragher · J. F. · Ravani · P. · Manns · B. · Elliott · M. · Thomas · C. · Donald · M. · Verdin · N. · Hemmelgarn · B. R.
Background

Identifying interventions to reduce fatigue and improve life participation are top research priorities of people on maintenance haemodialysis.

Objective

Our primary objective was to explore the feasibility of conducting a randomised controlled trial of an energy management programme for people on maintenance haemodialysis.

Design

Parallel-arm, 1:1, blinded, pilot randomised controlled trial.

Participants

Participants were recruited from 6 dialysis units in Calgary, Canada. Eligible patients were on maintenance haemodialysis, clinically stable and reported disabling fatigue on the Fatigue Severity Scale items 5, 7, 8 and 9.

Randomisation

Participants were randomised using a computer-generated random number sequence according to permuted blocked randomisation, stratified by dialysis unit.

Blinding

Participants were blinded to treatment allocation.

Interventions

Participants received an attention control (general disease self-management education) or the Personal Energy Planning (PEP) programme, a tailored, web-supported 7–9 weeks energy management programme.

Outcomes

Eligibility, recruitment and attrition rates were recorded, and standardised intervention effects (Hedge’s G) were calculated for fatigue and life participation questionnaires at one1-week postintervention and 12-week postintervention.

Results

159 of 253 screened patients were eligible to be approached. 42 (26%) had fatigue, were interested and consented to participate, of whom 30 met eligibility criteria and were randomised (mean age 62.4 years (±14.7), 60% male). 22 enrolled participants (73%) completed all study procedures. Medium-sized intervention effects were observed on the Canadian Occupational Performance Measure (COPM)-Performance Scale, Global Life Participation Scale and Global Life Participation Satisfaction Scale at 1-week postintervention follow-up, compared with control. At 12-week follow-up, large and very large intervention effects were observed on the COPM-Performance Scale and COPM-Satisfaction Scale, respectively.

Conclusion

It is feasible to enrol and follow patients on haemodialysis in a randomised controlled trial of an energy management intervention. As the intervention was associated with improved life participation on some measures, a larger trial is justified.

Defining CD4 T helper and T regulatory cell endotypes of progressive and remitting pulmonary sarcoidosis (BRITE): protocol for a US-based, multicentre, longitudinal observational bronchoscopy study

Por: Koth · L. L. · Harmacek · L. D. · White · E. K. · Arger · N. K. · Powers · L. · Werner · B. R. · Magallon · R. E. · Grewal · P. · Barkes · B. Q. · Li · L. · Gillespie · M. · Collins · S. E. · Cardenas · J. · Chen · E. S. · Maier · L. A. · Leach · S. M. · OConnor · B. P. · Hamzeh · N. Y.
Introduction

Sarcoidosis is a multiorgan granulomatous disorder thought to be triggered and influenced by gene–environment interactions. Sarcoidosis affects 45–300/100 000 individuals in the USA and has an increasing mortality rate. The greatest gap in knowledge about sarcoidosis pathobiology is a lack of understanding about the underlying immunological mechanisms driving progressive pulmonary disease. The objective of this study is to define the lung-specific and blood-specific longitudinal changes in the adaptive immune response and their relationship to progressive and non-progressive pulmonary outcomes in patients with recently diagnosed sarcoidosis.

Methods and analysis

The BRonchoscopy at Initial sarcoidosis diagnosis Targeting longitudinal Endpoints study is a US-based, NIH-sponsored longitudinal blood and bronchoscopy study. Enrolment will occur over four centres with a target sample size of 80 eligible participants within 18 months of tissue diagnosis. Participants will undergo six study visits over 18 months. In addition to serial measurement of lung function, symptom surveys and chest X-rays, participants will undergo collection of blood and two bronchoscopies with bronchoalveolar lavage separated by 6 months. Freshly processed samples will be stained and flow-sorted for isolation of CD4 +T helper (Th1, Th17.0 and Th17.1) and T regulatory cell immune populations, followed by next-generation RNA sequencing. We will construct bioinformatic tools using this gene expression to define sarcoidosis endotypes that associate with progressive and non-progressive pulmonary disease outcomes and validate the tools using an independent cohort.

Ethics and dissemination

The study protocol has been approved by the Institutional Review Boards at National Jewish Hospital (IRB# HS-3118), University of Iowa (IRB# 201801750), Johns Hopkins University (IRB# 00149513) and University of California, San Francisco (IRB# 17-23432). All participants will be required to provide written informed consent. Findings will be disseminated via journal publications, scientific conferences, patient advocacy group online content and social media platforms.

Kidney disease and risk of dementia: a Danish nationwide cohort study

Por: Kjaergaard · A. D. · Johannesen · B. R. · Sorensen · H. T. · Henderson · V. W. · Christiansen · C. F.
Objectives

It is unclear whether kidney disease is a risk factor for developing dementia. We examined the association between kidney disease and risk of future dementia.

Design and setting

Nationwide historical registry-based cohort study in Denmark based on data from 1 January 1995 until 31 December 2016.

Participants

All patients diagnosed with kidney disease and matched general population cohort without kidney disease (matched 1:5 on age, sex and year of kidney disease diagnosis).

Primary and secondary outcome measures

All-cause dementia and its subtypes: Alzheimer’s disease, vascular dementia and other specified or unspecified dementia. We computed 5-year cumulative incidences (risk) and hazard ratios (HRs) for outcomes using Cox regression analyses.

Results

The study cohort comprised 82 690 patients with kidney disease and 413 405 individuals from the general population. Five-year and ten-year mortality rates were twice as high in patients with kidney disease compared with the general population. The 5-year risk for all-cause dementia was 2.90% (95% confidence interval: 2.78% to 3.08%) in patients with kidney disease and 2.98% (2.92% to 3.04%) in the general population. Compared with the general population, the adjusted HRs for all-cause dementia in patients with kidney disease were 1.06 (1.00 to 1.12) for the 5-year follow-up and 1.08 (1.03 to 1.12) for the entire study period. Risk estimates for dementia subtypes differed substantially and were lower for Alzheimer’s disease and higher for vascular dementia.

Conclusions

Patients diagnosed with kidney disease have a modestly increased rate of dementia, mainly driven by vascular dementia. Moreover, patients with kidney disease may be underdiagnosed with dementia due to high mortality and other comorbidities of higher priority.

Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study

Por: Chapola · J. · Lee · F. · Bula · A. · Mapanje · C. · Phiri · B. R. · Kamtuwange · N. · Tsidya · M. · Tang · J. H. · Chinula · L.
Introduction

Cervical cancer is the leading cause of cancer deaths among women in Malawi, but preventable through screening. Malawi primarily uses visual inspection with acetic acid (VIA) for screening, however, a follow-up for positive screening results remains a major barrier, in rural areas. We interviewed women who underwent a community-based screen-and-treat campaign that offered same-day treatment with thermocoagulation, a heat-based ablative procedure for VIA-positive lesions, to understand the barriers in accessing post-treatment follow-up and the role of male partners in contributing to, or overcoming these barriers.

Methods

We conducted in-depths interviews with 17 women recruited in a pilot study that evaluated the safety and acceptability of community-based screen-and-treat programme using VIA and thermocoagulation for cervical cancer prevention in rural Lilongwe, Malawi. Ten of the women interviewed presented for post-treatment follow-up at the healthcare facility and seven did not. The interviews were analysed for thematic content surrounding barriers for attending for follow-up and role of male partners in screening.

Results

Transportation was identified as a major barrier to post-thermocoagulation follow-up appointment, given long distances to the healthcare facility. Male partners were perceived as both a barrier for some, that is, not supportive of 6-week post-thermocoagulation abstinence recommendation, and as an important source of support for others, that is, encouraging follow-up attendance, providing emotional support to maintaining post-treatment abstinence and as a resource in overcoming transportation barriers. Regardless, the majority of women desired more male partner involvement in cervical cancer screening.

Conclusion

Despite access to same-day treatment, long travel distances to health facilities for post-treatment follow-up visits remained a major barrier for women in rural Lilongwe. Male partners were identified both as a barrier to, and an important source of support for accessing and completing the screen-and-treat programme. To successfully eliminate cervical cancer in Malawi, it is imperative to understand the day-to-day barriers women face in accessing preventative care.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT04407676; Pre-results.

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