Maternal and perinatal death surveillance and response: a systematic review of qualitative studies.

Objective: To understand the experiences and perceptions of people implementing maternal and/or perinatal death surveillance and response in low- and middle-income countries, and the mechanisms by which this process can achieve its intended outcomes. Methods: In June 2022, we systematically searched seven databases for qualitative studies of stakeholders implementing maternal and/or perinatal death surveillance and response in low- and middle-income countries. Two reviewers independently screened articles and assessed their quality. We used thematic synthesis to derive descriptive themes and a realist approach to understand the context-mechanism-outcome configurations. Findings: Fifty-nine studies met the inclusion criteria. Good outcomes (improved quality of care or reduced mortality) were underpinned by a functional action cycle. Mechanisms for effective death surveillance and response included learning, vigilance and implementation of recommendations which motivated further engagement. The key context to enable effective death surveillance and response was a blame-free learning environment with good leadership. Inadequate outcomes (lack of improvement in care and mortality and discontinuation of death surveillance and response) resulted from a vicious cycle of under-reporting, inaccurate data, and inadequate review and recommendations, which led to demotivation and disengagement. Some harmful outcomes were reported, such as inappropriate referrals and worsened staff shortages, which resulted from a fear of negative consequences, including blame, disciplinary action or litigation. Conclusion: Conditions needed for effective maternal and/or perinatal death surveillance and response include: separation of the process from litigation and disciplinary procedures; comprehensive guidelines and training; adequate resources to implement recommendations; and supportive supervision to enable safe learning.

Death audits and reviews for reducing maternal, perinatal and child mortality.

BACKGROUND: The United Nations' Sustainable Development Goals (SDGs) include reducing the global maternal mortality rate to less than 70 per 100,000 live births and ending preventable deaths of newborns and children under five years of age, in every country, by 2030. Maternal and perinatal death audit and review is widely recommended as an intervention to reduce maternal and perinatal mortality, and to improve quality of care, and could be key to attaining the SDGs. However, there is uncertainty over the most cost-effective way of auditing and reviewing deaths: community-based audit (verbal and social autopsy), facility-based audits (significant event analysis (SEA)) or a combination of both (confidential enquiry). OBJECTIVES: To assess the impact and cost-effectiveness of different types of death audits and reviews in reducing maternal, perinatal and child mortality. SEARCH METHODS: We searched the following from inception to 16 January 2019: CENTRAL, Ovid MEDLINE, Embase OvidSP, and five other databases. We identified ongoing studies using ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, and searched reference lists of included articles. SELECTION CRITERIA: Cluster-randomised trials, cluster non-randomised trials, controlled before-and-after studies and interrupted time series studies of any form of death audit or review that involved reviewing individual cases of maternal, perinatal or child deaths, identifying avoidable factors, and making recommendations. To be included in the review, a study needed to report at least one of the following outcomes: perinatal mortality rate; stillbirth rate; neonatal mortality rate; mortality rate in children under five years of age or maternal mortality rate. DATA COLLECTION AND ANALYSIS: We used standard Cochrane Effective Practice and Organisation of Care (EPOC) group methodological procedures. Two review authors independently extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. We planned to perform a meta-analysis using a random-effects model but included studies were not homogeneous enough to make pooling their results meaningful. MAIN RESULTS: We included two cluster-randomised trials. Both introduced death review and audit as part of a multicomponent intervention, and compared this to current care. The QUARITE study (QUAlity of care, RIsk management, and TEchnology) concerned maternal death reviews in hospitals in West Africa, which had very high maternal and perinatal mortality rates. In contrast, the OPERA trial studied perinatal morbidity/mortality conferences (MMCs) in maternity units in France, which already had very low perinatal mortality rates at baseline. The OPERA intervention in France started with an outreach visit to brief obstetricians, midwives and anaesthetists on the national guidelines on morbidity/mortality case management, and was followed by a series of perinatal MMCs. Half of the intervention units were randomised to receive additional support from a clinical psychologist during these meetings. The OPERA intervention may make little or no difference to overall perinatal mortality (low certainty evidence), however we are uncertain about the effect of the intervention on perinatal mortality related to suboptimal care (very low certainty evidence).The intervention probably reduces perinatal morbidity related to suboptimal care (unadjusted odds ratio (OR) 0.62, 95% confidence interval (CI) 0.40 to 0.95; 165,353 births; moderate-certainty evidence). The effect of the intervention on stillbirth rate, neonatal mortality, mortality rate in children under five years of age, maternal mortality or adverse effects was not reported. The QUARITE intervention in West Africa focused on training leaders of hospital obstetric teams using the ALARM (Advances in Labour And Risk Management) course, which included one day of training about conducting maternal death reviews. The leaders returned to their hospitals, established a multidisciplinary committee and started auditing maternal deaths, with the support of external facilitators. The intervention probably reduces inpatient maternal deaths (adjusted OR 0.85, 95% CI 0.73 to 0.98; 191,167 deliveries; moderate certainty evidence) and probably also reduces inpatient neonatal mortality within 24 hours following birth (adjusted OR 0.74, 95% CI 0.61 to 0.90; moderate certainty evidence). However, QUARITE probably makes little or no difference to the inpatient stillbirth rate (moderate certainty evidence) and may make little or no difference to the inpatient neonatal mortality rate after 24 hours, although the 95% confidence interval includes both benefit and harm (low certainty evidence). The QUARITE intervention probably increases the percent of women receiving high quality of care (OR 1.87, 95% CI 1.35 - 2.57, moderate-certainty evidence). The effect of the intervention on perinatal mortality, mortality rate in children under five years of age, or adverse effects was not reported. We did not find any studies that evaluated child death audit and review or community-based death reviews or costs. AUTHORS' CONCLUSIONS: A complex intervention including maternal death audit and review, as well as development of local leadership and training, probably reduces inpatient maternal mortality in low-income country district hospitals, and probably slightly improves quality of care. Perinatal death audit and review, as part of a complex intervention with training, probably improves quality of care, as measured by perinatal morbidity related to suboptimal care, in a high-income setting where mortality was already very low. The WHO recommends that maternal and perinatal death reviews should be conducted in all hospitals globally. However, conducting death reviews in isolation may not be sufficient to achieve the reductions in mortality observed in the QUARITE trial. This review suggests that maternal death audit and review may need to be implemented as part of an intervention package which also includes elements such as training of a leading doctor and midwife in each hospital, annual recertification, and quarterly outreach visits by external facilitators to provide supervision and mentorship. The same may also apply to perinatal and child death reviews. More operational research is needed on the most cost-effective ways of implementing maternal, perinatal and paediatric death reviews in low- and middle-income countries.

Human resources for primary health care in sub-Saharan Africa: progress or stagnation?

BACKGROUND: The World Health Organization defines a "critical shortage" of health workers as being fewer than 2.28 health workers per 1000 population and failing to attain 80% coverage for deliveries by skilled birth attendants. We aimed to quantify the number of health workers in five African countries and the proportion of these currently working in primary health care facilities, to compare this to estimates of numbers needed and to assess how the situation has changed in recent years. METHODS: This study is a review of published and unpublished "grey" literature on human resources for health in five disparate countries: Mali, Sudan, Uganda, Botswana and South Africa. RESULTS: Health worker density has increased steadily since 2000 in South Africa and Botswana which already meet WHO targets but has not significantly increased since 2004 in Sudan, Mali and Uganda which have a critical shortage of health workers. In all five countries, a minority of doctors, nurses and midwives are working in primary health care, and shortages of qualified staff are greatest in rural areas. In Uganda, shortages are greater in primary health care settings than at higher levels. In Mali, few community health centres have a midwife or a doctor. Even South Africa has a shortage of doctors in primary health care in poorer districts. Although most countries recognize village health workers, traditional healers and traditional birth attendants, there are insufficient data on their numbers. CONCLUSION: There is an "inverse primary health care law" in the countries studied: staffing is inversely related to poverty and level of need, and health worker density is not increasing in the lowest income countries. Unless there is money to recruit and retain staff in these areas, training programmes will not improve health worker density because the trained staff will simply leave to work elsewhere. Information systems need to be improved in a way that informs policy on the health workforce. It may be possible to use existing resources more cost-effectively by involving skilled staff to supervise and support lower level health care workers who currently provide the front line of primary health care in most of Africa.

Views and experiences of long-acting reversible contraception among ethnic minorities in high-income countries: a systematic review of qualitative studies.

BackgroundEthnic minorities in high-income countries have higher rates of unintended pregnancies but are less likely to use highly efficacious long-acting reversible contraception (LARC). The reasons for this are unclear. AIM: To understand the views and experiences of ethnic minorities within high-income countries about LARC. METHODOLOGY: Medline, CINAHL, EMBASE and Sociological Abstracts were searched systematically to find qualitative articles about views on LARC. Titles and abstracts were screened to select qualitative studies about LARC whose participants were mainly from ethnic minorities in high-income countries. Quality assessment was conducted using the Critical Appraisal Skills Programme (CASP) tool. Thematic synthesis was conducted. RESULTS: Seventeen studies (19 articles) met the inclusion criteria, 14 of which were from the USA (227 participants identified as Latina, 222 Black, 15 multiracial, 4 Asian). Two studies included 32 Chinese women in the UK and Australia and one included 20 Aboriginal women in Australia. Factors influencing uptake of LARC included side effects, convenience, and perceived efficacy of LARC compared with other methods; women's ideas, concerns and expectations; and external influences (partner, family/friends, health professionals and society). Convenience of LARC, control over reproductive decisions, and desire to prevent pregnancy were the main facilitators. Barriers included specific cultural concerns about irregular bleeding, concerns about racial discrimination, and family/friends having negative views on LARC. CONCLUSIONS: Ethnic minority women often have additional needs and concerns about LARC compared with the White majority. Further research is needed to develop and evaluate customised respectful counselling on contraception options for ethnic minority women and their partners.

Determinants of behaviors influencing implementation of maternal and perinatal death surveillance and response in low- and middle-income countries: A systematic review of qualitative studies.

BACKGROUND: Maternal and Perinatal Death Surveillance and Review (MPDSR) can reduce mortality but its implementation is often suboptimal, especially in low- and middle-income countries (LMICs). OBJECTIVES: To understand the determinants of behaviors influencing implementation of MPDSR in LMICs (through a systematic review of qualitative studies), in order to plan an intervention to improve its implementation. SEARCH STRATEGY: Terms for maternal or perinatal death reviews and qualitative studies. SELECTION CRITERIA: Qualitative studies regarding implementation of MPDSR in LMICs. DATA COLLECTION AND ANALYSIS: We coded the included studies using the Theoretical Domains Framework and COM-B model of behavior change (Capability, Opportunity, Motivation). We developed guiding principles for interventions to improve implementation of MPDSR. MAIN RESULTS: Fifty-nine studies met our inclusion criteria. Capabilities required to conduct MPDSR (knowledge and technical/leadership skills) increase cumulatively from community to health facility and leadership levels. Physical and social opportunities depend on adequate data, human and financial resources, and a blame-free environment. All stakeholders were motivated to avoid negative consequences (blame, litigation, disciplinary action). CONCLUSIONS: Implementation of MPDSR could be improved by (1) introducing structural changes to reduce negative consequences, (2) strengthening data collection tools and information systems, (3) mobilizing adequate resources, and (4) building capabilities of all stakeholders.

Treating acute exacerbations of COPD with Chinese herbal medicine to aid antibiotic use reduction (Excalibur): a randomised double-blind, placebo-controlled feasibility trial.

Background: Although many acute exacerbations of COPD (AECOPD) are triggered by non-bacterial causes, they are often treated with antibiotics. Preliminary research suggests that the Chinese herbal medicine "Shufeng Jiedu" (SFJD), may improve recovery and therefore reduce antibiotic use in patients with AECOPD. Aims: To assess the feasibility of conducting a randomised placebo-controlled clinical trial of SFJD for AECOPD in UK primary care. Methods: GPs opportunistically recruited patients experiencing an AECOPD. Participants were randomised 1:1 to usual care plus SFJD or placebo for 14 days. Participants, GPs and research nurses were blinded to treatment allocation. GPs could prescribe immediate, delayed or no antibiotics, with delayed prescribing encouraged where appropriate. Participants were asked to complete a participant diary, including EXACT-PRO and CAT™ questionnaires for up to 4 weeks. Outcomes included recruitment rate and other measures of study feasibility described using only descriptive statistics and with no formal comparisons between groups. We also conducted qualitative interviews with recruited and non-recruited COPD patients and clinicians, analysed using framework analysis. Results: Over 6 months, 19 participants (6 SFJD, 13 placebo) were recruited. Sixteen (84%) participants returned diaries or provided a diary by recall. Overall, 1.3 participants were recruited per 1,000 patients on the COPD register per month open. Median duration of treatment was 9.8 days in the intervention group vs 13.3 days in the placebo group. The main reason for discontinuation in both groups was perceived side-effects. in both groups. Point estimates for both the EXACT-PRO and CAT™ outcomes suggested possible small benefits of SFJD. Most patients and clinicians were happy to try SFJD as an alternative to antibiotics for AECOPD. Recruitment was lower than expected because of the short recruitment period, the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from "rescue packs" before seeing their GP, and workforce challenges in primary care. Conclusion: Recruitment was impaired by the COVID-19 pandemic. Nevertheless, we were able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges such as including the trial medication in COPD patients' "rescue packs" and delegating recruitment to a central trials team. Clinical Trial Registration: Identifier, ISRCTN26614726.

Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform.

BACKGROUND: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. METHODS: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. RESULTS: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. CONCLUSIONS: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Whole plant extracts versus single compounds for the treatment of malaria: synergy and positive interactions.

BACKGROUND: In traditional medicine whole plants or mixtures of plants are used rather than isolated compounds. There is evidence that crude plant extracts often have greater in vitro or/and in vivo antiplasmodial activity than isolated constituents at an equivalent dose. The aim of this paper is to review positive interactions between components of whole plant extracts, which may explain this. METHODS: Narrative review. RESULTS: There is evidence for several different types of positive interactions between different components of medicinal plants used in the treatment of malaria. Pharmacodynamic synergy has been demonstrated between the Cinchona alkaloids and between various plant extracts traditionally combined. Pharmacokinetic interactions occur, for example between constituents of Artemisia annua tea so that its artemisinin is more rapidly absorbed than the pure drug. Some plant extracts may have an immunomodulatory effect as well as a direct antiplasmodial effect. Several extracts contain multidrug resistance inhibitors, although none of these has been tested clinically in malaria. Some plant constituents are added mainly to attenuate the side-effects of others, for example ginger to prevent nausea. CONCLUSIONS: More clinical research is needed on all types of interaction between plant constituents. This could include clinical trials of combinations of pure compounds (such as artemisinin + curcumin + piperine) and of combinations of herbal remedies (such as Artemisia annua leaves + Curcuma longa root + Piper nigum seeds). The former may enhance the activity of existing pharmaceutical preparations, and the latter may improve the effectiveness of existing herbal remedies for use in remote areas where modern drugs are unavailable.

A "reverse pharmacology" approach for developing an anti-malarial phytomedicine.

A "reverse pharmacology" approach to developing an anti-malarial phytomedicine was designed and implemented in Mali, resulting in a new standardized herbal anti-malarial after six years of research. The first step was to select a remedy for development, through a retrospective treatment-outcome study. The second step was a dose-escalating clinical trial that showed a dose-response phenomenon and helped select the safest and most efficacious dose. The third step was a randomized controlled trial to compare the phytomedicine to the standard first-line treatment. The last step was to identify active compounds which can be used as markers for standardization and quality control. This example of "reverse pharmacology" shows that a standardized phytomedicine can be developed faster and more cheaply than conventional drugs. Even if both approaches are not fully comparable, their efficiency in terms of public health and their complementarity should be thoroughly considered.

Evaluation and pharmacovigilance of projects promoting cultivation and local use of Artemisia annua for malaria.

BACKGROUND: Several non-governmental organisations (NGOs) are promoting the use of Artemisia annua teas as a home-based treatment for malaria in situations where conventional treatments are not available. There has been controversy about the effectiveness and safety of this approach, but no pharmacovigilance studies or evaluations have been published to date. METHOD: A questionnaire about the cultivation of A. annua, treatment of patients, and side-effects observed, was sent to partners of the NGO Anamed in Kenya and Uganda. Some of the respondents were then selected purposively for more in-depth semi-structured interviews. RESULTS: Eighteen partners in Kenya and 21 in Uganda responded. 49% reported difficulties in growing the plant, mainly due to drought. Overall about 3,000 cases of presumed malaria had been treated with A. annua teas in the previous year, of which about 250 were in children and 54 were in women in the first trimester of pregnancy. The commonest problem observed in children was poor compliance due to the bitter taste, which was improved by the addition of sugar or honey. Two miscarriages were reported in pregnant patients. Only four respondents reported side-effects in other patients, the commonest of which was vomiting. 51% of respondents had started using A. annua tea to treat illnesses other than malaria. CONCLUSIONS: Local cultivation and preparation of A. annua are feasible where growing conditions are appropriate. Few adverse events were reported even in children and pregnant women. Where ACT is in short supply, it would make sense to save it for young children, while using A. annua infusions to treat older patients who are at lower risk. An ongoing pharmacovigilance system is needed to facilitate reporting of any adverse events.

Experiences of out-of-hours task-shifting from GPs: a systematic review of qualitative studies.

BACKGROUND: The current GP workforce is insufficient to manage rising demand in patient care within out-of-hours (OOH) primary care services. To meet this challenge, non-medical practitioners (NMPs) are employed to fulfil tasks traditionally carried out by GPs. It is important to learn from experiences of task-shifting in this setting to inform optimal delivery of care. AIM: To synthesise qualitative evidence of experiences of task-shifting in the OOH primary care setting. DESIGN & SETTING: Systematic review of qualitative studies and thematic synthesis. METHOD: Electronic searches were conducted across CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsychINFO, Cochrane, MEDLINE, Embase, and OpenGrey for qualitative studies of urgent or OOH primary care services, utilising task-shifting or role delegation. Included articles were quality appraised and key findings collated through thematic synthesis. RESULTS: A total of 2497 studies were screened, of which six met the inclusion criteria. These included interviews with 15 advanced nurse practitioners (ANPs), three physician assistants (PAs), two paramedics, and a focus group of 22 GPs, and focus groups with 33 nurses. Key findings highlight the importance of clearly defining and communicating the scope of practice of NMPs, and of building their confidence by appropriate training, support, and mentoring. CONCLUSION: While NMPs may have the potential to make a substantial contribution to OOH primary care services, there has been very little research on experiences of task-shifting. Evidence to date highlights the need for further training specific to OOH services. Mentorship and support to manage the sometimes challenging cases presenting to OOH could enable more effective OOH services and better patient care.

Effectiveness of Medicinal Plants for Glycaemic Control in Type 2 Diabetes: An Overview of Meta-Analyses of Clinical Trials.

Aims: To rank the effectiveness of medicinal plants for glycaemic control in Type 2 Diabetes (T2DM). Methods: MEDLINE, EMBASE, CINAHL and Cochrane Central were searched in October 2020. We included meta-analyses of randomised controlled clinical trials measuring the effectiveness of medicinal plants on HbA1c and/or Fasting Plasma Glucose (FPG) in patients with T2DM. Results: Twenty five meta-analyses reported the effects of 18 plant-based remedies. Aloe vera leaf gel, Psyllium fibre and Fenugreek seeds had the largest effects on HbA1c: mean difference -0.99% [95% CI-1.75, -0.23], -0.97% [95% CI -1.94, -0.01] and -0.85% [95% CI -1.49, -0.22] respectively. Four other remedies reduced HbA1c by at least 0.5%: Nigella sativa, Astragalus membranaceus, and the traditional Chinese formulae Jinqi Jiangtang and Gegen Qinlian. No serious adverse effects were reported. Several other herbal medicines significantly reduced FPG. Tea and tea extracts (Camellia sinensis) were ineffective. However, in some trials duration of follow-up was insufficient to measure the full effect on HbA1c (<8 weeks). Many herbal remedies had not been evaluated in a meta-analysis. Conclusion: Several medicinal plants appear to be as effective as conventional antidiabetic treatments for reducing HbA1c. Rigorous trials with at least 3 months' follow-up are needed to ascertain the effects of promising plant-based preparations on diabetes.

Characteristics of registered clinical trials on traditional Chinese medicine for coronavirus disease 2019 (COVID-19): A scoping review.

INTRODUCTION: Traditional Chinese medicine (TCM) has been fully committed to the treatment of coronavirus disease 2019 (COVID-19) in China. An increasing number of clinical trials have been registered to evaluate the effects of TCM for COVID-19. The aim of this study was to review the existing TCM clinical trial registrations and identify potentially promising and available TCM therapies, in order to provide a reference for the global management of COVID-19. METHODS: All clinical trials on TCM for COVID-19 registered in registry platforms worldwide were searched. The data of registration temporal trend, design, objective, interventions, and relevant information were reviewed and summarized. RESULTS: 161 TCM trials were identified from three registries (January 26 to May 14 2020,). Of these, 94 (58.4%) were randomized controlled trials and 114 trials (70.8%) assessed therapeutic effects; while the remainder focused on prevention, rehabilitation, and the epidemiology of TCM syndromes. Eight trials (5.0%) had completed their recruitment. TCM interventions with potential for further evaluation in terms of prevention were moxibustion, Huoxiang Zhengqi pill and Jinye Baidu granules. For treatment of COVID-19, Qingfei Paidu decoction, Huashi Baidu decoction, Lianhua Qingwen capsules, Toujie Quwen granules and Xiyanping injection, and Xuebijing injection were to be tested for their therapeutic effects and symptoms relief. For rehabilitation, Tai Chi and Liuzijue were to be tested for improving patients' lung function. CONCLUSION: Some potentially promising TCM interventions have been identified and deserve further evaluation to establish their evidence base, particularly on populations outside of China.

Couples' decision-making on post-partum family planning and antenatal counselling in Uganda: A qualitative study.

BACKGROUND: Although health workers have been trained to provide post-partum family planning (PPFP), uptake remains low in Uganda. An important reason is that women want the agreement of their partner, who is often absent at the time of delivery. In order to address this, we aimed to understand the views of couples and explore barriers and facilitators to implementation of antenatal couples' counselling on PPFP in Uganda. METHODS: We conducted individual interviews with a purposive sample of 12 postpartum and 3 antenatal couples; and 34 focus groups with a total of 323 participants (68 adolescent women, 83 women aged 20-49, 79 men, 93 health workers) in four contrasting communities (urban and rural) in South-West and Central Uganda. These were recorded, transcribed, translated, and analysed thematically. RESULTS: Although most participants felt that it is important for partners to discuss family planning, half of the couples were unaware of each other's views on contraception. Most had similar views on motivation to use family planning but not on preferred contraceptive methods. Most liked the idea of antenatal couples' counselling on PPFP. The main barrier was the reluctance of men to attend antenatal clinics (ANC) in health facilities. Respondents felt that Village Health Teams (VHTs) could provide initial counselling on PPFP in couples' homes (with telephone support from health workers, if needed) and encourage men to attend ANC. Suggested facilitators for men to attend ANC included health workers being more welcoming, holding ANC clinics at weekends and "outreach" clinics (in rural villages far from health facilities). CONCLUSION: Antenatal couples' counselling has the potential to facilitate agreement PPFP, but some men are reluctant to attend antenatal clinics. Counselling at home by VHTs as well as simple changes to the organisation of antenatal clinics, could make it possible to deliver antenatal couples' counselling on PPFP.

Blood glucose and prognosis in children with presumed severe malaria: is there a threshold for 'hypoglycaemia'?

OBJECTIVES: Hypoglycaemia (glucose <2.2 mmol/l) is a defining feature of severe malaria, but the significance of other levels of blood glucose has not previously been studied in children with severe malaria. METHODS: A prospective study of 437 consecutive children with presumed severe malaria was conducted in Mali. We defined hypoglycaemia as <2.2 mmol/l, low glycaemia as 2.2-4.4 mmol/l and hyperglycaemia as >8.3 mmol/l. Associations between glycaemia and case fatality were analysed for 418 children using logistic regression models and a receiver operator curve (ROC). RESULTS: There was a significant difference between blood glucose levels in children who died (median 4.6 mmol/l) and survivors (median 7.6 mmol/l, P < 0.001). Case fatality declined from 61.5% of the hypoglycaemic children to 46.2% of those with low glycaemia, 13.4% of those with normal glycaemia and 7.6% of those with hyperglycaemia (P < 0.001). Logistic regression showed an adjusted odds ratio (AOR) of 0.75 (0.64-0.88) for case fatality per 1 mmol/l increase in baseline blood glucose. Compared to a normal blood glucose, hypoglycaemia and low glycaemia both significantly increased the odds of death (AOR 11.87, 2.10-67.00; and 5.21, 1.86-14.63, respectively), whereas hyperglycaemia reduced the odds of death (AOR 0.34, 0.13-0.91). The ROC [area under the curve at 0.753 (95% CI 0.684-0.820)] indicated that glycaemia had a moderate predictive value for death and identified an optimal threshold at glycaemia <6.1 mmol/l, (sensitivity 64.5% and specificity 75.1%). CONCLUSIONS: If there is a threshold of blood glucose which defines a worse prognosis, it is at a higher level than the current definition of 2.2 mmol/l.

Is single acupoint Sanyinjiao (SP 6) effective in managing insomnia? A systematic review of randomized controlled trials.

Insomnia is a symptom of physical or mental disorder and refers to decreased sleep time and potentially low quality. There is evidence showing that acupuncture could enhance management of insomnia, and Sanyinjiao (SP 6) is one of the promising acupoints. This review aimed to evaluate the effectiveness of stimulating single acupoint SP 6 in managing insomnia. The study was registered under PROSPERO CRD42019140855. English and Chinese databases were searched for randomized controlled trials on single acupoint SP 6 stimulation in management of insomnia. Quality of methodology was assessed by two authors independently using the Cochrane Risk of Bias Tool, and reporting quality was assessed by the STRICTA checklist. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI), and secondary outcomes were improvement in clinical effect and sleep duration assessed by polysomnogram (PSG). The extracted data were pooled and meta-analyzed with RevMan 5.3 software. Four trials involving 288 participants were included in this review. The findings showed that SP 6 stimulation could improve sleep quality (MD -0.30, 95% CI [-0.52, -0.08]), lengthen deep sleep duration (MD 80.46, 95% CI [56.47, 104.45]), rapid eye movement (REM) duration (MD 91.53, 95% CI [68.41, 114.65]), and increase improvement in clinical effect. Quality of reporting and methodology was limited in all included trials. Some limited evidence showed that single acupoint stimulation of SP 6 could improve sleep quality, lengthen deep sleep and REM duration of patients with insomnia. However, the findings in this review should be interpreted with caution due to methodological limitations.

Digital interventions for parents of acutely ill children and their treatment-seeking behaviour: a systematic review.

BACKGROUND: Consultations for self-limiting infections in children are increasing. It has been proposed that digital technology could be used to enable parents' decision making in terms of self-care and treatment seeking. AIM: To evaluate the evidence that digital interventions facilitate parents deciding whether to self-care or seek treatment for acute illnesses in children. DESIGN AND SETTING: Systematic review of studies undertaken worldwide. METHOD: Searches of MEDLINE and EMBASE were made to identify studies (of any design) published between database inception and January 2019 that assessed digital interventions for parents of children (from any healthcare setting) with acute illnesses. The primary outcome of interest was whether the use of digital interventions reduced the use of urgent care services. RESULTS: Three studies were included in the review. They assessed two apps and one website: Children's On-Call - a US advice-only app; Should I See a Doctor? - a Dutch self-triage app for any acute illness; and Strategy for Off-Site Rapid Triage (SORT) for Kids - a US self-triage website for influenza-like illness. None of the studies involved parents during intervention development and it was shown that many parents did not find the two apps easy to use. The sensitivity of self-triage interventions was 84% for Should I See a Doctor? compared with nurse triage, and 93.3% for SORT for Kids compared with the need for emergency-department intervention; however, both had lower specificity (74% and 13%, respectively). None of the interventions demonstrated reduced use of urgent-care services. CONCLUSION: There is little evidence to support the use of digital interventions to help parent and/or carers looking after children with acute illness. Future research should involve parents during intervention development, and adequately powered trials are needed to assess the impact of such interventions on health services and the identification of children who are seriously ill.

Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): A systematic review.

BACKGROUND: The World Health Organization characterized the Coronavirus disease 2019 (COVID-19) as a pandemic on March 11th. Many clinical trials on COVID-19 have been registered, and we aim to review the study characteristics and provide guidance for future trials to avoid duplicated effort. METHODS: Studies on COVID-19 registered before March 3rd, 2020 on eight registry platforms worldwide were searched and the data of design, participants, interventions, and outcomes were extracted and analyzed. RESULTS: Three hundred and ninety-three studies were identified and 380 (96.7%) were from mainland China, while 3 in Japan, 3 in France, 2 in the US, and 3 were international collaborative studies. Two hundred and sixty-six (67.7%) aimed at therapeutic effect, others were for prevention, diagnosis, prognosis, etc. Two hundred and two studies (51.4%) were randomized controlled trials. Two third of therapeutic studies tested Western medicines including antiviral drugs (17.7%), stem cell and cord blood therapy (10.2%), chloroquine and derivatives (8.3%), 16 (6.0%) on Chinese medicines, and 73 (27.4%) on integrated therapy of Western and Chinese medicines. Thirty-one studies among 266 therapeutic studies (11.7%) used mortality as primary outcome, while the most designed secondary outcomes were symptoms and signs (47.0%). Half of the studies (45.5%) had not started recruiting till March 3rd. CONCLUSION: Inappropriate outcome setting, delayed recruitment and insufficient numbers of new cases in China implied many studies may fail to complete. Strategies and protocols of the studies with robust and rapid data sharing are warranted for emergency public health events, helping the timely evidence-based decision-making.

Sublingual sugar for hypoglycaemia in children with severe malaria: a pilot clinical study.

BACKGROUND: Hypoglycaemia is a poor prognostic indicator in severe malaria. Intravenous infusions are rarely feasible in rural areas. The efficacy of sublingual sugar (SLS) was assessed in a pilot randomized controlled trial among hypoglycaemic children with severe malaria in Mali. METHODS: Of 151 patients with presumed severe malaria, 23 children with blood glucose concentrations < 60 mg/dl (< 3.3 mmol/l) were assigned randomly to receive either intravenous 10% glucose (IVG; n = 9) or sublingual sugar (SLS; n = 14). In SLS, a teaspoon of sugar, moistened with a few drops of water, was gently placed under the tongue every 20 minutes. The child was put in the recovery position. Blood glucose concentration (BGC) was measured every 5-10 minutes for the first hour. All children were treated for malaria with intramuscular artemether. The primary outcome measure was treatment response, defined as reaching a BGC of >or= 3.3 mmol/l (60 mg/dl) within 40 minutes after admission. Secondary outcome measures were early treatment response at 20 minutes, relapse (early and late), maximal BGC gain (CGmax), and treatment delay. RESULTS: There was no significant difference between the groups in the primary outcome measure. Treatment response occurred in 71% and 67% for SLS and IVG, respectively. Among the responders, relapses occurred in 30% on SLS at 40 minutes and in 17% on IVG at 20 minutes. There was one fatality in each group. Treatment failures in the SLS group were related to children with clenched teeth or swallowing the sugar, whereas in the IVG group, they were due to unavoidable delays in beginning an infusion (median time 17.5 min (range 3-40).Among SLS, the BGC increase was rapid among the nine patients who really kept the sugar sublingually. All but one increased their BGC by 10 minutes with a mean gain of 44 mg/dl (95%CI: 20.5-63.4). CONCLUSION: Sublingual sugar appears to be a child-friendly, well-tolerated and effective promising method of raising blood glucose in severely ill children. More frequent repeated doses are needed to prevent relapse. Children should be monitored for early swallowing which leads to delayed absorption, and in this case another dose of sugar should be given. Sublingual sugar could be proposed as an immediate "first aid" measure while awaiting intravenous glucose. In many cases it may avert the need for intravenous glucose.