Interventions to enhance medication adherence in pregnancy- a systematic review.

BACKGROUND: Sub-optimal medication adherence in pregnant women with chronic disease and pregnancy-related indications has the potential to adversely affect maternal and perinatal outcomes. Adherence to appropriate medications is advocated during and when planning pregnancy to reduce risk of adverse perinatal outcomes relating to chronic disease and pregnancy-related indications. We aimed to systematically identify effective interventions to promote medication adherence in women who are pregnant or planning to conceive and impact on perinatal, maternal disease-related and adherence outcomes. METHODS: Six bibliographic databases and two trial registries were searched from inception to 28th April 2022. We included quantitative studies evaluating medication adherence interventions in pregnant women and women planning pregnancy. Two reviewers selected studies and extracted data on study characteristics, outcomes, effectiveness, intervention description (TIDieR) and risk of bias (EPOC). Narrative synthesis was performed due to study population, intervention and outcome heterogeneity. RESULTS: Of 5614 citations, 13 were included. Five were RCTs, and eight non-randomised comparative studies. Participants had asthma (n = 2), HIV (n = 6), inflammatory bowel disease (IBD; n = 2), diabetes (n = 2) and risk of pre-eclampsia (n = 1). Interventions included education +/- counselling, financial incentives, text messaging, action plans, structured discussion and psychosocial support. One RCT found an effect  of the tested intervention on self-reported antiretroviral adherence but not objective adherence. Clinical outcomes were not evaluated. Seven non-randomised comparative studies found an association between the tested intervention and at least one outcome of interest: four found an association between receiving the intervention and both improved clinical or perinatal outcomes and adherence in women with IBD, gestational diabetes mellitus (GDM), and asthma. One study in women with IBD reported an association between receiving the intervention and maternal outcomes but not for self-reported adherence. Two studies measured only adherence outcomes and reported an association between receiving the intervention and self-reported and/or objective adherence in women with HIV and risk of pre-eclampsia. All studies had high or unclear risk of bias. Intervention reporting was adequate for replication in two studies according to the TIDieR checklist. CONCLUSIONS: There is a need for high-quality RCTs reporting replicable interventions to evaluate medication adherence interventions in pregnant women and those planning pregnancy. These should assess both clinical and adherence outcomes.

Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set.

BACKGROUND: A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority. OBJECTIVES: To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth. SEARCH STRATEGY: Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021. SELECTION CRITERIA: Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention. DATA COLLECTION AND ANALYSIS: Interventions, outcomes reported, definitions and outcome measurement tools were extracted. MAIN RESULTS: Forty randomised and 200 non-randomised studies were included. Fifty-eight different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). A total of 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. A total of 242 outcome measurement instruments were used, with 0-22 tools per outcome. CONCLUSIONS: Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research.

Antenatal care in Nepal: a qualitative study into missed opportunities in the first trimester.

BACKGROUND: Use of timely antenatal care has been identified as key to facilitating healthy pregnancies worldwide. Although considerable investment has been made to enhance maternal health services in Nepal, approximately one-third of women do not attend antenatal care until after the first trimester (late). These women miss out on the benefits of screening and interventions that are most effective in the first trimester. OBJECTIVE: This study aimed to identify the missed opportunities of women who do not attend antenatal care in the first trimester, and to explore some of the factors underlying late attendance and consider potential solutions for minimizing these missed opportunities in the future. STUDY DESIGN: This study was conducted in 3 hospitals in Nepal. Focus groups (n=18) with a total of 48 postnatal women and 49 staff members, and 10 individual interviews with stakeholders were conducted. Purposive sampling facilitated the obtainment of a full range of maternity experiences, staff categories, and stakeholder positions. Data were qualitative and analyzed using a thematic approach. RESULTS: Limited awareness among women of the importance of early antenatal care was reported as a key factor behind attendance only after the first trimester. The family and community were described as significant influencers in women's decision-making regarding the timing of antenatal care. The benefits of early ultrasound scanning and effective supplementation in pregnancy were the major missed opportunities. Increasing awareness, reducing cost, and enhancing interprofessional collaboration were suggested as potential methods for improving timely initiation of antenatal care. CONCLUSION: Limited awareness continues to drive late attendance to antenatal care after the first trimester. Investment in services in the first trimester and community health education campaigns are needed to improve this issue and enhance maternal and neonatal outcomes.

Does provision of antenatal care in Southern Asia improve neonatal survival? A systematic review and meta-analysis.

BACKGROUND: Southern Asia has one of the highest burdens of neonatal mortality worldwide (26/1000 live births). Ensuring that women receive antenatal care from a skilled provider may play an important role in reducing this burden. OBJECTIVE: This study aimed to determine whether antenatal care received from a skilled provider could reduce neonatal mortality in Southern Asia by systematically reviewing existing evidence. STUDY DESIGN: Seven databases were searched (MEDLINE, Embase, Cochrane Library, CINAHL, PubMed, PsycINFO, and International Bibliography of the Social Sciences [IBSS]). The key words included: "neonatal mortality," "antenatal care," and "Southern Asia." Nonrandomized comparative studies conducted in Southern Asia reporting on neonatal mortality in women who received antenatal care compared with those who did not were included. Two authors carried out the screening and data extraction. The Risk of Bias Assessment tool for Non-randomized Studies (RoBANS) was used to assess quality of studies. Results were reported using a random-effects model based on odds ratios with 95% confidence intervals. RESULTS: Four studies were included in a meta-analysis of adjusted results. The pooled odds ratio was 0.46 (95% confidence interval, 0.24 to 0.86) for neonatal deaths among women having at least 1 antenatal care visit during pregnancy compared with women having none. In the final meta-analysis, 16 studies could not be included because of lack of adjustment for confounders, highlighting the need for further higher-quality studies to evaluate the true impact. CONCLUSION: This review suggests that in Southern Asia, neonates born to women who received antenatal care have a lower risk of death in the neonatal period compared with neonates born to women who did not receive antenatal care. This should encourage health policy to strengthen antenatal care programs in Southern Asia.

Systematic review and narrative synthesis of the impact of Appreciative Inquiry in healthcare.

BACKGROUND: Appreciative Inquiry is a motivational, organisational change intervention, which can be used to improve the quality and safety of healthcare. It encourages organisations to focus on the positive and investigate the best of 'what is' before thinking of 'what might be', deciding 'what should be' and experiencing 'what can be'. Its effects in healthcare are poorly understood. This review seeks to evaluate whether Appreciative Inquiry can improve healthcare. METHODS: Major electronic databases and grey literature were searched. Two authors identified reports of Appreciative Inquiry in clinical settings by screening study titles, abstracts and full texts. Data extraction, in duplicate, grouped outcomes into an adapted Kirkpatrick model: participant reaction, attitudes, knowledge/skills, behaviour change, organisational change and patient outcomes. RESULTS: We included 33 studies. One randomised controlled trial, 9 controlled observational studies, 4 qualitative studies and 19 non-controlled observational reports. Study quality was generally poor, with most having significant risk of bias. Studies report that Appreciative Inquiry impacts outcomes at all Kirkpatrick levels. Participant reaction was positive in the 16 studies reporting it. Attitudes changed in the seventeen studies that reported them. Knowledge/skills changed in the 14 studies that reported it, although in one it was not universal. Behaviour change occurred in 12 of the 13 studies reporting it. Organisational change occurred in all 23 studies that reported it. Patient outcomes were reported in eight studies, six of which reported positive changes and two of which showed no change. CONCLUSION: There is minimal empirical evidence to support the effectiveness of Appreciative Inquiry in improving healthcare. However, the qualitative and observational evidence suggests that Appreciative Inquiry may have a positive impact on clinical care, leading to improved patient and organisational outcomes. It is, therefore, worthy of consideration when trying to deliver improvements in care. However, high-quality studies are needed to prove its effects. PROSPERO REGISTRATION NUMBER: CRD42015014485.

A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal.

BACKGROUND: Maternal and neonatal mortality rates remain high in many economically underdeveloped countries, including Nepal, and good quality antenatal care can reduce adverse pregnancy outcomes. However, identifying how to best improve antenatal care can be challenging. OBJECTIVE: To identify the interventions that have been investigated in the antenatal period in Nepal for maternal or neonatal benefit. We wanted to understand their scale, location, cost, and effectiveness. STUDY DESIGN: Online bibliographic databases (Cochrane Central, MEDLINE, Embase, CINAHL Plus, British Nursing Index, PsycInfo, Allied and Complementary Medicine) and trial registries (ClinicalTrials.gov and the World Health Organization Clinical Trials Registry Platform) were searched from their inception till May 24, 2020. We included all studies reporting any maternal or neonatal outcome after an intervention in the antenatal period. We screened the studies and extracted the data in duplicate. A meta-analysis was not possible because of the heterogeneity of the interventions and outcomes, so we performed a narrative synthesis of the included studies. RESULTS: A total of 25 studies met our inclusion criteria. These studies showed a variety of approaches toward improving antenatal care (eg, educational programs, incentive schemes, micronutrient supplementation) in different settings (home, community, or hospital-based) and with a wide variety of outcomes. Less than a quarter of the studies were randomized controlled trials, and many were single-site or reported only short-term outcomes. All studies reported having made a positive impact on antenatal care in some way, but only 3 provided a cost-benefit analysis to support implementation. None of these studies focused on the most remote communities in Nepal. CONCLUSION: Our systematic review found good quality evidence that micronutrient supplementation and educational interventions can bring important clinical benefits. Iron and folic acid supplementation significantly reduces neonatal mortality and maternal anemia, whereas birth preparedness classes increase the uptake of antenatal and postnatal care, compliance with micronutrient supplementation, and awareness of the danger signs in pregnancy.

Is the Quality of Mobile Health Applications for Burns Being Adequately Assessed?

High-quality mobile health applications (mHealth apps) have the potential to enhance the prevention, diagnosis, and treatment of burns. The primary aim of this study was to evaluate whether the quality of mHealth apps for burns care is being adequately assessed. The secondary aim was to determine whether these apps meet regulatory standards in the United Kingdom. We searched AMED, BNI, CINAHL, Cochrane Library, Embase, Emcare, Medline, and PsychInfo to identify studies assessing mHealth app quality for burns. The PRISMA reporting guideline was adhered to. Two independent reviewers screened abstracts to identify relevant studies. The quality of identified studies was assessed according to the framework proposed by Nouri et al, including design, information/content, usability, functionality, ethical issues, security/privacy, and user-perceived value. Of the 28 included studies, none assessed all seven domains of quality. Design was assessed in 4 of 28 studies; information/content in 26 of 28 studies; usability in 12 of 28 studies; functionality in 10 of 28 studies; ethical issues were never assessed in any studies; security/privacy was not assessed; subjective assessment was made in 9 of 28 studies. About 17 of 28 studies included apps that met the definition of "medical device" according to Medicines and Healthcare products Regulatory Agency guidance, yet only one app was appropriately certified with the UK Conformity Assessed mark. The quality of mHealth apps for burns is not being adequately assessed. The majority of apps should be considered medical devices according to UK standards, yet only one was appropriately certified. Regulatory bodies should support mHealth app developers, so as to improve quality control while simultaneously fostering innovation.

A cross-sectional study to evaluate antenatal care service provision in 3 hospitals in Nepal.

BACKGROUND: Globally, many mothers and their babies die during pregnancy and childbirth. A key element of optimizing outcomes is high-quality antenatal care. The Government of Nepal has significantly improved antenatal care and health outcomes through high-level commitment and investment; however, only 69% of patients attend the 4 recommended antenatal appointments. OBJECTIVE: This study aimed to evaluate the quality and perceptions of antenatal care in Nepal to understand compliance with the Nepalese standards. STUDY DESIGN: This cross-sectional study was conducted at a tertiary referral and private hospital in Kathmandu and a secondary hospital in Makwanpur, Nepal. The study recruited 538 female inpatients on postnatal wards during the 2-week data collection period from May 2019 to June 2019. A review of case notes and verbal survey of women to understand the pregnancy information they received and their satisfaction with antenatal care were performed. We created a summary score of the completeness of antenatal care services received ranging from 0 to 50 (50 indicating complete conformity with standards) and investigated the determinants of attending 4 antenatal care visits and patient satisfaction. RESULTS: The median antenatal care attendance was 4 visits at the secondary and referral hospitals and 8 visits at the private hospital. However, 24% of the patients attended <4 visits. Furthermore, 117 of 538 patients (22%) attended the first-trimester visit, and 65 of 538 patients (12%) attended visits at all points recommended in the standards. More than 90% of the women had blood pressure monitoring, hemoglobin estimation, blood grouping and Rhesus typing, and HIV and syphilis screening. Approximately 50% of the women had urinalysis at every visit (interquartile range, 20-100). Moreover, 509 of 538 patients (95%) reported receiving pregnancy information, but retention was variable: 509 of 538 patients (93%) received some information about danger signs, 290 of 502 patients (58%) remembered headaches, and 491 of 502 patients (98%) remembered fluid leaking. The antenatal care completeness score revealed that the private hospital offered the most complete clinical services (mean, 28.7; standard deviation, 7.1) with the secondary hospital performing worst (mean, 19.1; standard deviation, 7.1). The factors influencing attendance at 4 antenatal care visits in the multivariable model were beginning antenatal care in the first trimester of pregnancy (odds ratio, 2.74; 95% confidence interval, 1.36-5.52) and having a lower level of education (no school: odds ratio, 0.46 [95% confidence interval, 0.23-0.91]; grades 1-5: odds ratio, 0.49 [95% confidence interval, 0.26-0.92]). Overall, 303 of 538 women (56%) were satisfied with their antenatal care. The multivariable analysis revealed that satisfaction was more likely in women attending the private hospital than in women attending the referral hospital (odds ratio, 3.63; 95% confidence interval, 1.68-7.82) and lower in women who felt the antenatal care facilities were not adequate (odds ratio, 0.35; 95% confidence interval, 0.21-0.63) and who wanted longer antenatal appointments (odds ratio, 0.5; 95% confidence interval, 0.33-0.75). CONCLUSION: Few women achieved full compliance with the Nepali antenatal care standards; however, some services were delivered well. To improve, each antenatal contact needs to meet its clinical aims and be respectful. To achieve this communication and counseling training for staff, investment in health promotion and delivery of core services are needed. It is important that these interventions address key issues, such as attendance in the first trimester of pregnancy, improving privacy and optimizing communication around danger signs. However, they must be designed alongside staff and service users and their efficacy tested before widespread investment or implementation.

The effects of interactive training of healthcare providers on the management of life-threatening emergencies in hospital.

BACKGROUND: Preparing healthcare providers to manage relatively rare life-threatening emergency situations effectively is a challenge. Training sessions enable staff to rehearse for these events and are recommended by several reports and guidelines. In this review we have focused on interactive training, this includes any element where the training is not solely didactic but provides opportunity for discussions, rehearsals, or interaction with faculty or technology. It is important to understand the effective methods and essential elements for successful emergency training so that resources can be appropriately targeted to improve outcomes. OBJECTIVES: To assess the effects of interactive training of healthcare providers on the management of life-threatening emergencies in hospital on patient outcomes, clinical care practices, or organisational practices, and to identify essential components of effective interactive emergency training programmes. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and ERIC and two trials registers up to 11 March 2019. We searched references of included studies, conference proceedings, and contacted study authors. SELECTION CRITERIA: We included randomised trials and cluster-randomised trials comparing interactive training for emergency situations with standard/no training. We defined emergency situations as those in which immediate lifesaving action is required, for example cardiac arrests and major haemorrhage. We included all studies where healthcare workers involved in providing direct clinical care were participants. We excluded studies outside of a hospital setting or where the intervention was not targeted at practicing healthcare workers. We included trials irrespective of publication status, date, and language. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC) Group. Two review authors independently extracted data and assessed the risk of bias of each included trial. Due to the small number of studies and the heterogeneity in outcome measures, we were unable to perform the planned meta-analysis. We provide a structured synthesis for the following outcomes: survival to hospital discharge, morbidity rate, protocol or guideline adherence, patient outcomes, clinical practice outcomes, and organisation-of-care outcomes. We used the GRADE approach to rate the certainty of the evidence and the strength of recommendations for each outcome. MAIN RESULTS: We included 11 studies that reported on 2000 healthcare providers and over 300,000 patients; one study did not report the number of participants. Seven were cluster randomised trials and four were single centre studies. Four studies focused on obstetric training, three on obstetric and neonatal care, two on neonatal training, one on trauma and one on general resuscitations. The studies were spread across high-, middle- and low-income settings.Interactive training may make little or no difference in survival to hospital discharge for patients requiring resuscitation (1 study; 30 participants; 98 events; low-certainty evidence). We are uncertain if emergency training changes morbidity rate, as the certainty of the evidence is very low (3 studies; 1778 participants; 57,193 patients, when reported). We are uncertain if training alters healthcare providers' adherence to clinical protocols or guidelines, as the certainty of the evidence is very low (3 studies; 156 participants; 558 patients). We are uncertain if there were improvements in patient outcomes following interactive training for emergency situations, as we assessed the evidence as very low-certainty (5 studies, 951 participants; 314,055 patients). We are uncertain if training for emergency situations improves clinical practice outcomes as the certainty of the evidence is very low (4 studies; 1417 participants; 28,676 patients, when reported). Two studies reported organisation-of-care outcomes, we are uncertain if interactive emergency training has any effect on this outcome as the certainty of the evidence is very low (634 participants; 179,400 patient population).We examined prespecified subgroups and found no clear commonalities in effect of multidisciplinary training, location of training, duration of the course, or duration of follow-up. We also examined areas arising from the studies including focus of training, proportion of staff trained, leadership of intervention, and incentive/trigger to participate, and again identified no clear mediating factors. The sources of funding for the studies were governmental, local organisations, or philanthropic donors. AUTHORS' CONCLUSIONS: We are uncertain if there are any benefits of interactive training of healthcare providers on the management of life-threatening emergencies in hospital as the certainty of the evidence is very low. We were unable to identify any factors that may have allowed us to identify an essential element of these interactive training courses.We found a lack of consistent reporting, which contributed to the inability to meta-analyse across specialities. More trials are required to build the evidence base for the optimum way to prepare healthcare providers for rare life-threatening emergency events. These trials need to be conducted with attention to outcomes important to patients, healthcare providers, and policymakers. It is vitally important to develop high-quality studies adequately powered and with attention to minimising the risk of bias.

Coenzyme Q10 supplementation in traumatic brain injury: a scoping review protocol.

OBJECTIVE: The objective of this review is to map evidence on coenzyme Q10 (CoQ10) use in traumatic brain injury (TBI). INTRODUCTION: Traumatic brain injury is an insult to the brain structure caused by external force and resulting in physiological disruption to brain function. Globally, 60% of all TBIs occur from road traffic accidents. In 2016, the World Health Organization reported that road traffic accidents were among the top 10 leading causes of death. Following the initial brain injury, a secondary injury can occur due primarily to a significant increase in production of free radicals causing oxidative stress, which can dictate the patient's ability to survive. Coenzyme Q10 is known to protect neuronal cells from oxidative stress; the mechanism for this has been examined in studies using rats. This review will examine what is known about CoQ10 in TBI and identify gaps in the literature, which may guide future research. INCLUSION CRITERIA: The review will include both human and animal subjects who have experienced a TBI in the acute/laboratory-controlled setting and where CoQ10 is supplemented. Animal studies will be included. The review will consider experimental and quasi-experimental study designs including randomized controlled trials, non-randomized controlled trials, before and after studies, and interrupted time-series studies. Studies published in English will be considered, with no date restriction. METHODS: Searches will be conducted in the Cochrane Library, MEDLINE, Embase, CINAHL and trial registries. Data will be extracted and presented on details about the population, concept, context, study methods and key findings.

The incidence of cardiac arrest in the intensive care unit: A systematic review and meta-analysis.

The incidence of cardiac arrest in the intensive care unit (ICU-CA) has not been widely reported. We undertook a systematic review and meta-analysis of studies reporting the incidence of cardiac arrest in adult, general intensive care units. The review was prospectively registered with PROSPERO (CRD42017079717). The search identified 7550 records, which included 20 relevant studies for qualitative analysis and 16 of these were included for quantitative analyses. The reported incidence of ICU-CA was 22.7 per 1000 admissions (95% CI: 17.4-29.6) with survival to hospital discharge of 17% (95% CI: 9.5-28.5%). We estimate that at least 5446 patients in the UK have a cardiac arrest after ICU admission. There are limited data and significant variation in the incidence of ICU-CA and efforts to synthesise these are limited by inconsistent reporting. Further prospective studies with standardised process and incidence measures are required to define this important patient group.

Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

INTRODUCTION: Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study. METHODS AND ANALYSIS: Relevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed. ETHICS AND DISSEMINATION: Ethical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.