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Objective Gynecological cancer (GC) survivors have unmet needs when they complete primary cancer treatment. Despite this, no known research has summarized these needs and survivors’ suggestions to address them. We conducted a scoping review to fill these gaps and develop a model useful to guide clinical discussions and/or intervention. Methods English, full length, and accessible primary studies describing the needs of GC survivors were included. No restrictions on date nor country of publication were applied. Two reviewers extracted data, which was verified by a third reviewer. Results Seventy-one studies met the inclusion criteria for data extraction. Results were thematically grouped into seven dimensions: physical needs, sexuality-related concerns, altered self-image, psychological wellbeing, social support needs, supporting the return to work, and healthcare challenges and preferences. After consulting with a stakeholder group (a GC survivor, clinicians, and researchers), the dimensions were summarized into a proposed model to guide clinical assessments and/or intervention. Conclusion Results illuminate the diverse needs of GC survivors as they complete primary cancer treatment and their recommendations for care to meet these needs. Practice Implications The resulting model can be used to guide assessments, discussions and/or interventions to optimally prepare GC survivors for transition out of primary cancer treatment.

Objective Carotid endarterectomy is recommended for the prevention of ischaemic stroke due to carotid stenosis. However, the risk of stroke after carotid endarterectomy has been estimated at 2% - 5%. Monitoring intra-operative cerebral oxygenation with near infrared spectroscopy (NIRS) has been assessed as a strategy to reduce intra- and post-operative complications. The aim was to summarise the diagnostic accuracy of NIRS to detect intra-operative ischaemic events, the values associated with ischaemic events, and the relative contribution of external carotid contamination to the NIRS signal in adults undergoing carotid endarterectomy. Data sources EMBASE, MEDLINE, Cochrane Centre Register of Controlled Trials, and reference lists through May 2019 were searched. Review methods Non-randomised and randomised studies assessing NIRS as an intra-operative monitoring tool in carotid endarterectomy were included. Studies using NIRS as the reference were excluded. Risk of bias was assessed using the Newcastle Ottawa Scale, RoB-2, and QUADAS-2. Results Seventy-six studies were included (n = 8 480), under local (n = 1 864) or general (n = 6 582) anaesthesia. Seven studies were eligible for meta-analysis (n = 524). As a tool for identifying intra-operative ischaemia, specificity increased with more stringent NIRS thresholds, while there was unpredictable variation in sensitivity across studies. A Δ20% threshold under local anaesthesia resulted in pooled estimates for sensitivity and specificity of 70.5% (95% confidence interval, CI, 54.1 - 82.9) and 92.4% (95% CI 85.5 - 96.1) compared with awake neurological monitoring. These studies had low or unclear risk of bias. NIRS signal consistently dropped across clamping and recovered to pre-clamp values upon de-clamp in most studies, and larger decreases were observed in patients with ischaemic events. The contribution of extracranial signal to change in signal across clamp varied from 3% to 50%. Conclusion NIRS has low sensitivity and high specificity to identify intra-operative ischaemia compared with awake monitoring. Extracranial signal contribution was highly variable. Ultimately, data from high quality studies are desperately needed to determine the utility of NIRS.

OBJECTIVES This systematic review aims to provide an up-to-date summary of the current literature examining the relationship between intraoperative regional cerebral oxygen saturation and neurological complications after cardiac surgery. METHODS Observational and interventional studies investigating the link between regional cerebral oxygen saturation and postoperative delirium, cognitive dysfunction and stroke were included. After database searching and study screening, study characteristics and major findings were extracted. RESULTS Twenty-seven studies were identified. Of the observational studies (n = 17), 8 reported that regional cerebral oxygen desaturations were significantly associated with neurological complications after cardiac surgery. Of the interventional studies (n = 10), 3 provided evidence for monitoring cerebral oximetry during cardiac surgery as a means of reducing incidence of postoperative cognitive dysfunction or stroke. There was significant heterogeneity in the tools and rigor used to diagnose neurological complications. CONCLUSIONS Studies to date show an inconsistent relationship between regional cerebral oxygen saturation and neurological outcomes after cardiac surgery, and lack of clear benefit of targeting cerebral oximetry to minimize neurological complications. Standardized assessments, definitions of impairment and desaturation thresholds will help determine the benefits of cerebral oximetry monitoring during cardiac surgery.

The objective of this overview of systematic reviews was to examine the associations between sleep duration and health outcomes in adults. Four electronic databases were searched in December 2018 for systematic reviews published in the previous 10 years. Included reviews met the a priori determined population (community-dwelling adults aged 18 years and older), intervention/exposure/comparator (various levels of sleep duration), and outcome criteria (14 outcomes examined). To avoid overlap in primary studies, we used a priority list to choose a single review per outcome; reviews that examined the effect of age and those that looked at dose–response were prioritized. A total of 36 systematic reviews were eligible and 11 were included. Reviews included comprised 4 437 101 unique participants from 30 countries. Sleep duration was assessed subjectively in 96% of studies and 78% of studies in the reviews were prospective cohort studies. The dose–response curves showed that the sleep duration that was most favourably associated with health was 7–8 h per day. Modification of the effect by age was not apparent. The quality of the evidence ranged from low to high across health outcomes. In conclusion, the available evidence suggests that a sleep duration of 7–8 h per day is the one most favourably associated with health among adults and older adults. (PROSPERO registration no.: CRD42019119529.) Novelty This is the first overview of reviews that examines the influence of sleep duration on a wide range of health outcomes in adults. Seven to 8 h of sleep per day was most favourably associated with health. Effect modification by age was not evident.

This overview of systematic reviews examined the effect of balance and functional strength training on health outcomes in adults aged 18 years or older, to inform the Canadian 24-hour Movement Guidelines. Four electronic databases were searched for systematic reviews published between January 2009 and May 2019. Eligibility criteria were determined a priori for population (community-dwelling adults), intervention (balance and functional training), comparator (no intervention or different types/doses), and outcomes (critical: falls and fall-related injuries; adverse events; important: physical functioning and disability; health-related quality of life; physical activity; and sedentary behaviour). Two reviewers independently screened studies for eligibility and performed AMSTAR 2 assessment. One review was selected per outcome. Of 3288 records and 355 full-text articles, 5 systematic reviews were included, encompassing data from 15 890 participants in 23 countries. In adults 65 years and older, balance and functional training and Tai Chi reduced the rate of falls and the number of people who fell, and improved aspects of physical functioning and physical activity. The effect on health-related quality of life and falls requiring hospitalization was uncertain. While inconsistently monitored, only 1 serious adverse event was reported. No evidence was available in adults under age 65 years. Included systematic reviews and primary evidence reported by review authors ranged in quality. Overall, participation in balance and functional training reduced falls and improved health outcomes in adults 65 years of age and older. PROSPERO registration no.: CRD42019134865. Novelty This overview informs updated guidelines for balance training in adults. Balance and functional training reduced falls and improved health outcomes.

The objective of this overview of systematic reviews was to determine the benefits and harms of resistance training (RT) on health outcomes in adults aged 18 years or older, compared with not participating in RT. Four electronic databases were searched in February 2019 for systematic reviews published in the past 10 years. Eligibility criteria were determined a priori for population (community dwelling adults), intervention (exclusively RT), comparator (no RT or different doses of RT), and health outcomes (critical: mortality, physical functioning, health-related quality of life, and adverse events; important: cardiovascular disease, type 2 diabetes mellitus, mental health, brain health, cognitive function, cancer, fall-related injuries or falls, and bone health). We selected 1 review per outcome and we used the GRADE process to assess the strength of evidence. We screened 2089 records and 375 full-text articles independently, in duplicate. Eleven systematic reviews were included, representing 364 primary studies and 382 627 unique participants. RT was associated with a reduction in all-cause mortality and cardiovascular disease incidence, and an improvement in physical functioning. Effects on health-related quality of life or cognitive function were less certain. Adverse events were not consistently monitored or reported in RT studies, but serious adverse events were not common. Systematic reviews for the remaining important health outcomes could not be identified. Overall, RT training improved health outcomes in adults and the benefits outweighed the harms. (PROSPERO registration no.: CRD42019121641.) Novelty This overview was required to inform whether there was new evidence to support changes to the recommended guidelines for resistance training.

Objective This review will explore definitions of early palliative care and describe how it has been implemented for those diagnosed with a life-limiting chronic illness. Introduction People with life-limiting chronic illnesses who receive palliative care interventions have increased quality of life, better symptom management, and are more likely to have advance care plans than patients who do not have life-limiting chronic illness. It is therefore best practice to encourage early identification of persons in need of palliative care services. However, there is uncertainty over what is considered to be "early palliative care" and this presents a barrier to evaluating associated outcomes. Inclusion criteria All literature that defines an early palliative care approach in adults (aged 18 years and older) with a life-limiting chronic illness in any health care setting will be included in this review. All countries and sociocultural settings will be included. Methods This scoping review will follow JBI methodology. A comprehensive search of academic and gray literature using MEDLINE (Ovid), CINAHL (EBSCO), Embase (Ovid), PsycINFO (Ovid), Web of Science Core Collection, Ovid Cochrane Library, and ProQuest (Health and Medicine and Sociology Collections) will be utilized. Articles will be screened for inclusion by two independent reviewers. Results will be extracted using a customized tool and summarized in a final report using a narrative synthesis presented in table form.

Background While there is strong evidence that bite protection methods such as permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on malaria infection. This study will estimate the protective efficacy of treated uniforms and DEET insect repellent on the incidence of malaria infection among military personnel in an operational setting. Permethrin-treated uniforms used with DEET lotion will be compared to etofenprox-treated uniforms with DEET lotion. The effect of DEET lotion will be estimated by comparing permethrin-treated uniforms with DEET or placebo lotion. Method A cluster randomised double-blind placebo-controlled trial is planned to evaluate the effectiveness of the interventions on preventing malaria infections in soldiers on active duty at Mgambo National Service Camp in Tanga, Tanzania. The arms are (1) permethrin-treated uniform with 30% DEET liposome formula; (2) permethrin-treated uniform with placebo lotion; (3) candidate insect repellent system, i.e. etofenprox-treated uniform with 30% DEET liposome formula; and (4) placebo, i.e. untreated uniforms with placebo lotion. The primary outcome is the incidence of Plasmodium falciparum malaria infection detected by polymerase chain reaction (PCR) by active case detection using surveys every 2 weeks for 12 months. Rapid diagnostic tests will be used for the diagnosis of participants with symptoms. The unit of randomisation will be combania: companies formed by recruits aged 18 to 25 years; combania do activities together and sleep in the same dormitory. Unequal randomisation will be used to optimise statistical power for the primary comparison between permethrin-treated uniforms with DEET and etofenprox-treated uniforms with DEET. Discussion This trial will provide the estimate of the effects of permethrin with DEET compared to those of the new fabric treatment etofenprox with DEET and any additional effect of using DEET. The results will inform strategies to protect military personnel and civilians who have more outdoor or occupational malaria exposure than the general public. Trial registration ClinicalTrials.govNCT02938975.

BackgroundHealth information systems are crucial to provide data for decision-making and demand for data is constantly growing. However, the link between data and decisions is not always rational or linear and the management of data ends up overloading frontline health workers, which may compromise quality of healthcare delivery. Despite limited evidence, there is an increasing push for the digitalization of health information systems, which poses enormous challenges, particularly in remote, rural settings in low- and middle-income countries. Paper-based tools will continue to be used in combination with digital solutions and this calls for efforts to make them more responsive to local needs. Paper-based Health Information Systems in Comprehensive Care (PHISICC) is a transdisciplinary, multi-country research initiative to create and test innovative paper-based health information systems in three sub-Saharan African countries.Methods/DesignThe PHISICC initiative is being carried out in remote, rural settings in Côte d’Ivoire, Mozambique and Nigeria through partnership with ministries of health and research institutions. We began with research syntheses to acquire the most up-to-date knowledge on health information systems. These were coupled with fieldwork in the three countries to understand the current design, patterns and contexts of use, and healthcare worker perspectives. Frontline health workers, with designers and researchers, used co-creation methods to produce the new PHISICC tools. This suite of tools is being tested in the three countries in three cluster-randomized controlled trials. Throughout the project, we have engaged with a wide range of stakeholders and have maintained the highest scientific standards to ensure that results are relevant to the realities in the three countries.DiscussionWe have deployed a comprehensive research approach to ensure the robustness and future policy uptake of findings. Besides the innovative PHISICC paper-based tools, our process is in itself innovative. Rather than emphasizing the technical dimensions of data management, we focused instead on frontline health workers’ data use and decision-making. By tackling the whole scope of primary healthcare areas rather than a subset of them, we have developed an entirely new design and visual language for a suite of tools across healthcare areas. The initiative is being tested in remote, rural areas where the most vulnerable live.

IntroductionFront-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.Methods and analysisStudy areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.Ethics and disseminationEthics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.Trial registration numberPACTR201904664660639; Pre-results.

Background With increasing spatial heterogeneity of malaria transmission and a shift of the disease burden towards older children and adults, pregnant women attending antenatal care (ANC) have been proposed as a pragmatic sentinel population for malaria surveillance. However, the representativeness of routine ANC malaria test-positivity and its relationship with prevalence in other population subgroups are yet to be investigated. Methods Monthly ANC malaria test-positivity data from all Tanzanian health facilities for January 2014 to May 2016 was compared to prevalence data from the School Malaria Parasitaemia Survey 2015, the Malaria Indicator Survey (MIS) 2015/16, the Malaria Atlas Project 2015, and a Bayesian model fitted to MIS data. Linear regression was used to describe the difference between malaria test-positivity in pregnant women and respective comparison groups as a function of ANC test-positivity and potential covariates. Results The relationship between ANC test-positivity and survey prevalence in children follows spatially and biologically meaningful patterns. However, the uncertainty of the relationship was substantial, particularly in areas with high or perennial transmission. In comparison, modelled data estimated higher prevalence in children at low transmission intensities and lower prevalence at higher transmission intensities. Conclusions Pregnant women attending ANC are a pragmatic sentinel population to assess heterogeneity and trends in malaria prevalence in Tanzania. Yet, since ANC malaria test-positivity cannot be used to directly predict the prevalence in other population subgroups, complementary community-level measurements remain highly relevant.

Fluoroquinolones (FQ) form the backbone in experimental treatment regimens against drug-susceptible tuberculosis. However, little is known on whether the genetic variation present in natural populations of Mycobacterium tuberculosis (Mtb) affects the evolution of FQ-resistance (FQ-R). To investigate this question, we used nine genetically distinct drug-susceptible clinical isolates of Mtb and measured their frequency of resistance to the FQ ofloxacin (OFX) in vitro. We found that the Mtb genetic background led to differences in the frequency of OFX-resistance (OFX-R) that spanned two orders of magnitude and substantially modulated the observed mutational profiles for OFX-R. Further, in vitro assays showed that the genetic background also influenced the minimum inhibitory concentration and the fitness effect conferred by a given OFX-R mutation. To test the clinical relevance of our in vitro work, we surveyed the mutational profile for FQ-R in publicly available genomic sequences from clinical Mtb isolates, and found substantial Mtb lineage-dependent variability. Comparison of the clinical and the in vitro mutational profiles for FQ-R showed that 51% and 39% of the variability in the clinical frequency of FQ-R gyrA mutation events in Lineage 2 and Lineage 4 strains, respectively, can be attributed to how Mtb evolves FQ-R in vitro. As the Mtb genetic background strongly influenced the evolution of FQ-R in vitro, we conclude that the genetic background of Mtb also impacts the evolution of FQ-R in the clinic.

IntroductionThe importance of integrated, people-centred health systems has been recognised as a central component of Universal Health Coverage. Integration has also been highlighted as a critical element for building resilient health systems that can withstand the shock of health emergencies. However, there is a dearth of research and systematic synthesis of evidence on the synergistic relationship between integrated health services and pandemic preparedness, response, and recovery in low-income and lower-middle-income countries (LMICs). Thus, the authors are organising a scoping review aiming to explore the application of integrated health service delivery approaches during the emerging COVID-19 pandemic in LMICs.Methods and analysisThis scoping review adheres to the six steps for scoping reviews from Arksey and O’Malley. Peer-reviewed scientific literature will be systematically assembled using a standardised and replicable search strategy from seven electronic databases, including PubMed, Embase, Scopus, Web of Science, CINAHL Plus, the WHO’s Global Research Database on COVID-19 and LitCovid. Initially, the title and abstract of the collected literature, published in English from December 2019 to June 2020, will be screened for inclusion which will be followed by a full-text review by two independent reviewers. Data will be charted using a data extraction form and reported in narrative format with accompanying data matrix.Ethics and disseminationNo ethical approval is required for the review. The study will be conducted from June 2020 to May 2021. Results from this scoping review will provide a snapshot of the evidence currently being generated related to integrated health service delivery in response to the COVID-19 pandemic in LMICs. The findings will be developed into reports and a peer-reviewed article and will assist policy-makers in making pragmatic and evidence-based decisions for current and future pandemic responses.

Background The World Health Organization (WHO) recommends Xpert MTB/RIF in place of smear microscopy to diagnose tuberculosis (TB), and many countries have adopted it into their diagnostic algorithms. However, it is not clear whether the greater accuracy of the test translates into improved health outcomes. Objectives To assess the impact of Xpert MTB/RIF on patient outcomes in people being investigated for tuberculosis. Search methods We searched the following databases, without language restriction, from 2007 to 24 July 2020: Cochrane Infectious Disease Group (CIDG) Specialized Register; CENTRAL; MEDLINE OVID; Embase OVID; CINAHL EBSCO; LILACS BIREME; Science Citation Index Expanded (Web of Science), Social Sciences citation index (Web of Science), and Conference Proceedings Citation Index ‐ Social Science & Humanities (Web of Science). We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Pan African Clinical Trials Registry for ongoing trials. Selection criteria We included individual‐ and cluster‐randomized trials, and before‐after studies, in participants being investigated for tuberculosis. We analysed the randomized and non‐randomized studies separately. Data collection and analysis For each study, two review authors independently extracted data, using a piloted data extraction tool. We assessed the risk of bias using Cochrane and Effective Practice and Organisation of Care (EPOC) tools. We used random effects meta‐analysis to allow for heterogeneity between studies in setting and design. The certainty of the evidence in the randomized trials was assessed by GRADE. Main results We included 12 studies: eight were randomized controlled trials (RCTs), and four were before‐and‐after studies. Most included RCTs had a low risk of bias in most domains of the Cochrane 'Risk of bias' tool. There was inconclusive evidence of an effect of Xpert MTB/RIF on all‐cause mortality, both overall (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.75 to 1.05; 5 RCTs, 9932 participants, moderate‐certainty evidence), and restricted to studies with six‐month follow‐up (RR 0.98, 95% CI 0.78 to 1.22; 3 RCTs, 8143 participants; moderate‐certainty evidence). There was probably a reduction in mortality in participants known to be infected with HIV (odds ratio (OR) 0.80, 95% CI 0.67 to 0.96; 5 RCTs, 5855 participants; moderate‐certainty evidence). It is uncertain whether Xpert MTB/RIF has no or a modest effect on the proportion of participants starting tuberculosis treatment who had a successful treatment outcome (OR) 1.10, 95% CI 0.96 to 1.26; 3RCTs, 4802 participants; moderate‐certainty evidence). There was also inconclusive evidence of an effect on the proportion of participants who were treated for tuberculosis (RR 1.10, 95% CI 0.98 to 1.23; 5 RCTs, 8793 participants; moderate‐certainty evidence). The proportion of participants treated for tuberculosis who had bacteriological confirmation was probably higher in the Xpert MTB/RIF group (RR 1.44, 95% CI 1.29 to 1.61; 6 RCTs, 2068 participants; moderate‐certainty evidence). The proportion of participants with bacteriological confirmation who were lost to follow‐up pre‐treatment was probably reduced (RR 0.59, 95% CI 0.41 to 0.85; 3 RCTs, 1217 participants; moderate‐certainty evidence). Authors' conclusions We were unable to confidently rule in or rule out the effect on all‐cause mortality of using Xpert MTB/RIF rather than smear microscopy. Xpert MTB/RIF probably reduces mortality among participants known to be infected with HIV. We are uncertain whether Xpert MTB/RIF has a modest effect or not on the proportion treated or, among those treated, on the proportion with a successful outcome. It probably does not have a substantial effect on these outcomes. Xpert MTB/RIF probably increases both the proportion of treated participants who had bacteriological confirmation, and the proportion with a laboratory‐confirmed diagnosis who were treated. These findings may inform decisions about uptake alongside evidence on cost‐effectiveness and implementation., Plain language summary Does using the Xpert MTB/RIF diagnostic test instead of smear microscopy when evaluating people for tuberculosis reduce death and successful treatment completion? What is the aim of the review? Tuberculosis (TB) is a bacterial infection that is spread by inhaling tiny droplets from the coughs or sneezes of an infected person. It mainly affects the lungs, but it can affect any part of the body. Tuberculosis can usually be cured by taking anti‐tuberculosis antibiotics for six months. Some bacteria are resistant, and then need to be treated with combinations of different antibiotics. Many countries use the Xpert MTB/RIF test to diagnose tuberculosis. We wanted to find out if using this test affected health outcomes, such as death or successful treatment in people suspected of having tuberculosis. What was studied in this review? A rapid, accurate diagnosis of tuberculosis ensures people who are ill start taking the right antibiotics as soon as possible. This might reduce the number of people dying, but also, if rifampicin‐resistant tuberculosis is detected early, they are more likely to get appropriate treatment. It also helps ensure people who do not have tuberculosis are not treated unnecessarily. The Xpert MTB/RIF test is an automated molecular test, commonly used to identify tuberculosis and rifampicin resistance at the same time, in less than two hours. The World Health Organization (WHO) recommends using the Xpert MTB/RIF test to diagnose tuberculosis instead of smear microscopy – using a microscope to look for bacteria in samples of sputum (a mixture of saliva and mucus, coughed up from the lungs). This review investigates whether using Xpert MTB/RIF instead of microscopy improves health outcomes. What are the main results of the review? We searched for studies that assessed health outcomes in people who had sought treatment and were suspected of having tuberculosis and who were diagnosed using either the Xpert MTB/RIF test or smear microscopy. We found 12 relevant studies. Eight studies included only adults; four included people of all ages. Ten studies took place in sub‐Saharan Africa, one in Brazil, and one in Indonesia. The studies followed people for between two months and two years. An effect of using the Xpert MTB/RIF test to diagnose tuberculosis, compared with smear microscopy, could not be ruled in or out a for the numbers of people who: · died (5 studies; 10,409 people); · were successfully treated (3 studies; 4802 people); · died within six months (3 studies; 8143 people); or · were treated for tuberculosis (5 studies; 8793 people). Compared with smear microscopy, use of the Xpert MTB/RIF test probably: · reduced the number of HIV‐positive people who died during follow‐up (5 studies; 1789 people); · increased the number of people with confirmed tuberculosis who started treatment (3 studies; 1217 people); and · increased the number of treated people who had a confirmed diagnosis of tuberculosis (6 studies; 2068 people). None of the studies reported people's satisfaction, or the number of visits before tuberculosis was diagnosed. Only one study looked at the treatment of tuberculosis resistant to rifampicin. Key messages The results showed that there was a beneficial effect of Xpert MTB/RIF for some health outcomes, and inconclusive results (where an effect could not be ruled in or out) for others. Together, these findings can help inform decisions about the uptake of Xpert MTB/RIF, alongside information on cost‐effectiveness and implementation. How up to date is this review? We included studies published to 24 July 2020.

Background The symptom burden in inflammatory bowel disease (IBD) has a significant negative impact on the health-related quality of life (HRQOL). Patients with IBD report physical, psychological and social discomfort even during remission. Aim To synthesize the best available evidence to determine the worldwide incidence, prevalence and determinants of discomfort in adults with inflammatory bowel disease (IBD). Methods Following PRISMA recommendations, we searched the Medline, CINAHL, PsycInfo, Embase, Cochrane, Campbell and JBI Evidence Synthesis databases for studies on either incidence or prevalence of discomfort in English until January 2021. Data were extracted using the Joanna Briggs Institute’s standardized extraction tools. Data that directly reported or could be used to calculate the incidence and prevalence of discomfort were extracted. Ten studies were eligible for inclusion in this review. Overall, the methodological quality of the included studies was considered moderate. Data measuring the incidence of discomfort in 6 out of 10 identified studies using the same measurement tool (EQ-5D) were pooled in a meta-analysis. Additional results have been presented in a narrative form, including tables. Results There is no standardized definition or tool utilized to describe or measure discomfort in IBD. Synthesized findings demonstrate that discomfort is prevalent among adults living with IBD. Determinants of discomfort included health literacy, disease activity, hospitalization/surgery, age and gender, delayed diagnosis, local practice standards and quality of IBD care. Conclusions More research is needed to identify the impact of discomfort on health-related outcomes for people with IBD and consequently appraise discomfort interventions for their efficacy.

Background: Several studies have previously reported the presence of altered cerebral perfusion during sepsis. However, the role of non-invasive neuromonitoring, and the impact of altered cerebral perfusion, in sepsis patients with delirium remains unclear. Methods: We performed a systematic review of studies that used near-infrared spectroscopy (NIRS) and/or transcranial Doppler (TCD) to assess adults (≥18 years) with sepsis and delirium. From study inception to July 28, 2020, we searched the following databases: Ovid MedLine, Embase, Cochrane Library, and Web of Science. Results: Of 1546 articles identified, 10 met our inclusion criteria. Although NIRS-derived regional cerebral oxygenation was consistently lower, this difference was only statistically significant in one study. TCD-derived cerebral blood flow velocity was inconsistent across studies. Importantly, both impaired cerebral autoregulation during sepsis and increased cerebrovascular resistance were associated with delirium during sepsis. However, the heterogeneity in NIRS and TCD devices, duration of recording (from 10 seconds to 72 hours), and delirium assessment methods (e.g., electronic medical records, confusion assessment method for the intensive care unit), precluded meta-analysis. Conclusion: The available literature demonstrates that cerebral perfusion disturbances may be associated with delirium in sepsis. However, future investigations will require consistent definitions of delirium, delirium assessment training, harmonized NIRS and TCD assessments (e.g., consistent measurement site and length of recording), as well as the quantification of secondary and tertiary variables (i.e., Cox, Mxa, MAPOPT), in order to fully assess the relationship between cerebral perfusion and delirium in patients with sepsis.

OBJECTIVES: Despite wide usage of the PRISMA Statement reporting guideline by systematic review authors, compliance with its items regarding literature search reporting is suboptimal. We sought to develop an international standard for literature search reporting aligned with the PRISMA Statement to improve the quality and reproducibility of reported literature searches.METHODOLOGY: We formed an executive committee to lead the PRISMA-S extension development. The study protocol was published prior to study inception. To identify potential items for inclusion, we performed a literature search. Identified items were reviewed for overlap and consolidated. We then used a three-step Delphi survey process to assess the items. The first survey asked 163 international experts to rate each item, and the second and third rounds asked respondents to select the 25 most necessary items for a checklist. Potential items moved to rounds 2 and 3 based on pre-specified criteria. Remaining items were discussed at an in-person consensus conference. After the consensus conference, the remaining items were consolidated into a checklist. Executive committee members developed an accompanying explanation and elaboration document. The checklist and documentation were distributed for pilot testing. RESULTS: We identified 405 potential items from 61 sources located through the literature search process. Sources included both explicit reporting guidelines and studies assessing reproducibility of search strategies. These were consolidated into 123 potential items for the Delphi survey. We received 52 responses (32% response rate) to the first survey, and 35 (67% response rate) to both surveys two and three. The results of the Delphi process were reported at the consensus conference meeting in May 2016. Post-consensus conference, 34 items remained. The checklist was finalized into 13 items and 10 sub-items. Pilot testing is underway. This document is the draft for the Explanation & Elaboration for Draft 1, released for review/testing.CONCLUSIONS: The PRISMA-S extension for the PReferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting guideline will provide a consensus-driven international standard for literature search reporting. Using this new reporting guideline may enable librarians and information specialists to produce higher quality, more reproducible, transparent search strategies for systematic reviews and other literature review-based publications.

Background Clinical trial participants are required to sign an informed consent form (ICF). However, information is lacking on the most effective methods to convey trial relevant information prior to inviting participants to sign the ICF, being particularly pertinent in low-income countries. A previous study on Pemba Island, Tanzania, found that a verbal information session (IS) was significantly better than providing an ICF alone. However, knowledge gaps remained. Building on these findings, we investigated the effect of adding a slideshow or a theater to the IS in the informed consent procedure of an anthelminthic clinical trial. Methodology/principal findings A total of 604 caregivers were randomized into the control group that only received an ICF (n = 150) or an ICF plus one of three intervention strategies: (i) verbal IS (n = 135), (ii) verbal IS with a slideshow (n = 174) or (iii) verbal IS followed by a theater (n = 145). All modes of information covered the same key messages. Participants’ understanding was assessed using a semi-structured questionnaire. The mean score of caregivers in the control group (ICF only) was 4.41 (standard deviation = 1.47). Caregivers attending the IS alone were more knowledgeable than those in the control group (estimated difference in mean scores: 2.40, 95% confidence interval (CI) 1.95 to 2.86, p < 0.01). However, there was no evidence of an improvement compared to the IS only when participants attended a slideshow (0.09, 95% CI -0.53 to 0.35, p = 0.68) or a theater (0.28, 95% CI -0.27 to 0.82, p = 0.32). Three out of 10 key messages remained largely misunderstood, regardless of the mode of information group. Conclusions/significance Our study confirmed that, in this setting, an ICF alone was not sufficient to convey clinical trial-related information. An IS was beneficial, however, additional theater and slideshows did not further improve understanding. Future research should explore methods to improve communication between study teams and participants for different key messages, study types and settings., Author summary Legally, participants of clinical trials must sign an informed consent form prior to the start of a trial. To be truly informed, participants (or their caregivers, if underaged) need to understand the trial objectives, procedures, benefits, potential risks and their rights throughout the study. However, in regions where literacy and health literacy are still quite low, delivering information exclusively in written format using an informed consent form is not the best way to convey information. A previous study on Pemba Island, Tanzania, found that a spoken information session in addition to the informed consent form alone, significantly improved the clinical trial-related knowledge of the caregivers of participants. However, not all questions could be answered correctly. In the current study, we explored the addition of two further modes of information to the information session: a slideshow or a theater show. Caregivers’ understanding was measured using a questionnaire. We confirmed that having an oral information session is significantly better than only receiving the informed consent form. However, adding a slideshow and theater did not further improve caregivers’ knowledge. We conclude that future studies should work on improving these modes of information or explore new ones.

BackgroundThe effect of number of health items on out-of-pockets (OOPs) has been identified as a source of bias in measuring OOPs. Evidence comes mostly from cross-sectional comparison of different survey instruments to collect data on OOPs. Very few studies have attempted to validate these questionnaires, or distinguish bias arising from the comprehensiveness of the OOPs list versus specificity of OOPs questions.ObjectivesThis study aims to estimate biases arising from the specificity of OOPs questions by comparing provider and household’s information.MethodsA generic questionnaire to collect data on household’s OOPs was developed following the nomenclature proposed in division 6 of the classification of household final consumption 2018. The four categories within such division are used to set the comprehensiveness of the OOPs list, the specificity within each category was tailored to the design of the nationally representative living standard survey in Ghana where a field experiment was conducted to test the validity of different versions. Households were randomised to 11, 44 or 56 health items. Using data from provider records as the gold standard, we compared the mean positive OOPs, and estimated the mean ratio and variability in the ratio of household expenditures to provider data for the individual households using the Bland-Altman method of assessing agreement.FindingsWe found evidence of a difference in the overall mean ratio in the specificity for OOPs in inpatient care and medications. Within each of these two categories, a more detailed disaggregation yielded lower OOPs estimates than less detailed ones. The level of agreement between household and provider OOPs also decreased with increasing specificity of health items.ConclusionOur findings suggest that, for inpatient care and medications, systematically decomposing OOPs categories into finer subclasses tend to produce lower OOPs estimates. Less detailed items produced more accurate and reliable OOPs estimates in the context of a rural setting.

Background Vaccination coverage levels fall short of the Global Vaccine and Action Plan 90% target in low- and middle- income countries (LMICs). Having identified traditional and religious leaders (TRLs) as potential public health change agents, this study aimed at assessing the effect of training them to support routine immunisation for the purpose of improving uptake of childhood vaccines in Cross River State, Nigeria. Methods A cluster-randomised controlled study was conducted between 2016 and 2019. Of the 18 Local Government Areas (LGA) in Cross River State, eight (four urban and four rural LGAs) were randomized into the intervention and control study arms. A multi-component intervention involving the training of traditional and religious leaders was implemented in the four intervention LGAs. Baseline, midline and endline surveys collected information on children aged 0–23 months. The effect of the intervention on outcomes including the proportion fully up-to-date with vaccination, timely vaccination for pentavalent and measles vaccines, and pentavalent 1–3 dropout rates were estimated using logistic regression models using random effects to account for the clustered data. Results A total of 2598 children at baseline, 2570 at midline, and 2550 at endline were included. The intervention was effective in increasing the proportion with at least one vaccine (OR 12.13 95% CI 6.03–24.41p Conclusion Informal training to enhance the traditional and religious leaders’ knowledge of vaccination and their leadership role can empower them to be good influencers for childhood vaccination. They constitute untapped resources in the community to boost routine immunisation. Pan African Clinical Trial Registry (PACTR) PACTR202008784222254.

Out of pocket health payment (OOPs) has been identified by the System of Health Accounts (SHA) as the largest source of health care financing in most low and middle-income countries. This means that most low and middle-income countries will rely on user fees and co-payments to generate revenue, rationalize the use of services, contain health systems costs or improve health system efficiency and service quality. However, the accurate measurement of OOPs has been challenged by several limitations which are attributed to both sampling and non-sampling errors when OOPs are estimated from household surveys, the primary source of information in LICs and LMICs. The incorrect measurement of OOP health payments can undermine the credibility of current health spending estimates, an otherwise important indicator for tracking UHC, hence there is the need to address these limitations and improve the measurement of OOPs. In an attempt to improve the measurement of OOPs in surveys, the INDEPTH-Network Household out-of-pocket expenditure project (iHOPE) developed new modules on household health utilization and expenditure by repurposing the existing Ghana Living Standards Survey instrument and validating these new tools with a ‘gold standard’ (provider data) with the aim of proposing alternative approaches capable of producing reliable data for estimating OOPs in the context of National Health Accounts and for the purpose of monitoring financial protection in health. This paper reports on the challenges and opportunities in using and linking household reported out-of-pocket health expenditures to their corresponding provider records for the purpose of validating household reported out-of-pocket health expenditure in the iHOPE project.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

This systematic review determined if the composition of time spent in movement behaviours (i.e., sleep, sedentary behaviour (SED), light physical activity, and moderate-to-vigorous physical activity (MVPA)) is associated with health in adults. Five electronic databases were searched in August 2019. Studies were eligible for inclusion if they were peer-reviewed, examined community-dwelling adults, and used compositional data analysis to examine the associations between the composition of time spent in movement behaviours and health outcomes. Eight studies (7 cross-sectional, 1 prospective cohort) of >12 000 unique participants were included. Findings indicated that the 24-h movement behaviour composition was associated with all-cause mortality (1 of 1 analyses), adiposity (4 of 4 analyses), and cardiometabolic biomarkers (8 of 15 analyses). Reallocating time into MVPA from other movement behaviours was associated with favourable changes to most health outcomes and taking time out of SED and reallocating it into other movement behaviours was associated with favourable changes to all-cause mortality. The quality of evidence was very low for all health outcomes. In conclusion, these findings support the notion that the composition of movement across the entire 24-h day matters, and that recommendations for sleep, SED, and physical activity should be combined into a single public health guideline. (PROSPERO registration no.: CRD42019121641.) Novelty The 24-h movement behaviour composition is associated with a variety of health outcomes. Reallocating time into MVPA is favourably associated with health. Reallocating time out of SED is associated with favourable changes to mortality risk.

The purpose of this overview of systematic reviews was to determine the relationship between different types and patterns of sedentary behaviour and selected health outcomes in adults and older adults. Five electronic databases were last searched in May, 2019, with a 10-year search limit. Included reviews met the a priori population (community-dwelling adults aged 18 years and older), intervention/exposure/comparator (various types and/or patterns of sedentary behaviour), and outcomes criteria. Eighteen systematic reviews were included in the evidence synthesis. High levels of sedentary behaviour are unfavourably associated with cognitive function, depression, function and disability, physical activity levels, and physical health-related quality of life in adults. Reducing or breaking up sedentary behaviour may benefit body composition and markers of cardiometabolic risk. Total sedentary behaviour and TV viewing were most consistently associated with unfavourable health outcomes, while computer and Internet use may be favourably associated with cognitive function for older adults. The quality of evidence within individual reviews (as assessed by review authors) varied from low to high, while the certainty of evidence was low to very low. These findings have important public health implications, suggesting that adults should avoid high levels of sedentary behaviour and break-up periods of prolonged sitting. (PROSPERO registration nos.: CRD42019123121 and CRD42019127157.)Novelty High levels of sedentary behaviour are unfavourably associated with important health outcomes in adults. Reducing or breaking up sedentary behaviour may benefit body composition and markers of cardiometabolic risk. Computer and Internet use may be favourably associated with cognitive function in older adults.

Tuberculosis (TB) is the leading cause of mortality among infectious diseases. In 2018, 1.5 million people died due to TB [1]. Early diagnosis of TB is key in achieving WHO End TB targets and molecular diagnostic tests have been developed. However, molecular tests cannot differentiate between viable and non-viable bacteria [2, 3], leading to challenges in the interpretation of positive test results in patients with recent TB. Footnotes This manuscript has recently been accepted for publication in the European Respiratory Journal . It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article. Conflict of interest: Dr. Haraka has nothing to disclose. Conflict of interest: Dr. Denkinger reports working for FIND until April 2019. FIND is a non-for-profit foundation, whose mission is to find diagnostic solutions to overcome diseases of poverty in LMICs. It works closely with the private and public sectors and receives funding from some of its industry partners. It has organizational firewalls to protect it against any undue influences in its work or the publication of its findings. All industry partnerships are subject to review by an independent Scientific Advisory Committee or another independent review body, based on due diligence, TTPs and public sector requirements. FIND catalyzes product development, leads evaluations, takes positions, and accelerates access to tools identified as serving its mission. It provides indirect support to industry (e.g., access to open specimen banks, a clinical trial platform, technical support, expertise, laboratory capacity strengthening in LMICs, etc.) to facilitate the development and use of products in these areas. FIND also supports the evaluation of prioritized assays and the early stages of implementation of WHO-approved (guidance & PQ) assays using donor grants. In order to carry out test validations and evaluations, has product evaluation agreements with several private sector companies for the diseases FIND works in which strictly define its independence and neutrality vis-a-vis the companies whose products get evaluated, and describes roles and responsibilities. Conflict of interest: Dr. Ross has nothing to disclose. Conflict of interest: Dr. Mantsoki has nothing to disclose. Conflict of interest: Dr. Gagneux has nothing to disclose. Conflict of interest: Dr. Reither has nothing to disclose.