Low-cost Intervention Research Articles

Triggered by worry: A dynamic network analysis of COVID-19 pandemic-related anxiety and parental stress

BackgroundMajor disruptions to daily life routines made families and parents particularly vulnerable to psychological distress during the COVID-19 lockdowns. However, the specific psychopathological processes related to within-person variation and maintenance of anxiety symptomatology and parental distress components in the parental population have been largely unexplored in the literature. Methods: In this preregistered intensive longitudinal study, a multilevel dynamic network was used to model within-person interactions between anxiety symptomatology, psychopathological processes, parental distress, and protective lifestyle components in a sample of 495 parents—each responding to daily assessments over a 40-day period. A total of 30,195 observations were collected across the subjects. ResultsExtensive worry, threat monitoring, and uncontrollability of worry were identified as overreaching psychopathological processes related to the aggravation of other symptoms of anxiety and parental distress. A strong association was found between parental stress and parental burnout. Anger toward one's child was associated with both parental stress and parental burnout. Protective factors showed the lowest strength centrality, with few and weak connections to other symptoms and processes in the network. LimitationsAssociations may exist between the study variables on a different time scale; hence, different time lags should be used in future research. Conclusions: Accessible, low-cost interventions that address worry, threat monitoring, and the uncontrollability of worry could serve as potential targets for reducing the symptom burden of anxiety and distress in the parental population.

Feasibility and outcomes of using DIALOG+ in primary care to improve quality of life and mental distress of patients with long-term physical conditions: an exploratory non-controlled study in Bosnia and Herzegovina, Colombia and Uganda

IntroductionThe management of long-term physical conditions is a challenge worldwide, absorbing a majority resources despite the importance of acute care. The management of these conditions is done largely in primary care and so interventions to improve primary care could have an enormous impact. However, very little data exist on how to do this. Mental distress is frequently comorbid with long term physical conditions, and can impact on health behaviour and adherence, leading to poorer outcomes. DIALOG+ is a low-cost, patient-centred and solution-focused intervention, which is used in routine patient-clinician meetings and has been shown to improve outcomes in mental health care. The question arises as to whether it could also be used in primary care to improve the quality of life and mental health of patients with long-term physical conditions. This is particularly important for low- and middle-income countries with limited health care resources.MethodsAn exploratory non-controlled multi-site trial was conducted in Bosnia and Herzegovina, Colombia, and Uganda. Feasibility was determined by recruitment, retention, and session completion. Patient outcomes (quality of life, anxiety and depression symptoms, objective social situation) were assessed at baseline and after three approximately monthly DIALOG+ sessions.ResultsA total of 117 patients were enrolled in the study, 25 in Bosnia and Herzegovina, 32 in Colombia, and 60 in Uganda. In each country, more than 75% of anticipated participants were recruited, with retention rates over 90% and completion of the intervention exceeding 92%. Patients had significantly higher quality of life and fewer anxiety and depression symptoms at post-intervention follow-up, with moderate to large effect sizes. There were no significant improvements in objective social situation.ConclusionThe findings from this exploratory trial suggest that DIALOG+ is feasible in primary care settings for patients with long-term physical conditions and may substantially improve patient outcomes. Future research may test implementation and effectiveness of DIALOG+ in randomized controlled trials in wider primary care settings in low- and middle-income countries.Trial registrationAll studies were registered prospectively within the ISRCTN Registry. ISRCTN17003451, 02/12/2020 (Bosnia and Herzegovina), ISRCTN14018729, 01/12/2020 (Colombia) and ISRCTN50335796, 02/12/2020 (Uganda).

Distributed Generation Control Using Ripple Signaling and a Multiprotocol Communication Embedded Device

Remotely performing real-time distributed generation control and a demand response is a basic aspect of the grid ancillary services provided by grid operators, both the transmission grid operators (TSOs) and distribution grid operators (DNOs), in order to ensure that voltage, frequency and power loads of the grid remain within safe limits. The stochastic production of electrical power to the grid from the distributed generators (DGs) from renewable energy sources (RES) in conjunction with the newly appeared stochastic demand consumers (i.e., electric vehicles) hardens the efforts of the DNOs to keep the grid’s operation within safe limits and prevent cascading blackouts while staying in compliance with the SAIDI and SAIFI indices during repair and maintenance operations. Also taking into consideration the aging of the existing grid infrastructure, and making it more prone to failure year by year, it is yet of great significance for the DNOs to have access to real-time feedback from the grid’s infrastructure—which is fast, has low-cost upgrade interventions, is easily deployed on the field and has a fast response potential—in order to be able to perform real-time grid management (RTGM). In this article, we present the development and deployment of a control system for DG units, with the potential to be installed easily to TSO’s and DNO’s substations, RES plants and consumers (i.e., charging stations of electric vehicles). This system supports a hybrid control mechanism, either via ripple signaling or through a network, with the latter providing real-time communication capabilities. The system can be easily installed on the electric components of the grid and can act as a gateway between the different vendors communication protocols of the installed electrical equipment. More specifically, a commercially available, low-cost board (Raspberry Pi) and a ripple control receiver are installed at the substation of a PV plant. The board communicates in real-time with a remote server (decision center) via a 5G modem and with the PV plants inverters via the Modbus protocol, which acquires energy production data and controls the output power of each inverter, while one of its digital inputs can be triggered by the ripple control receiver. The ripple control receiver receives on-demand signals with the HEDNO, triggering the digital input on the board. When the input is triggered, the board performs a predefined control command (i.e., lower the inverter’s power output to 50%). The board can also receive control commands directly from the remote server. The remote server receives real-time feedback of the acquired inverter data, the control signals from the ripple control receiver and the state and outcome of each performed control command.

A smartphone-based intervention for young people who self-harm (‘PRIMARY’): study protocol for a multicenter randomized controlled trial

BackgroundSelf-harm in young people is a public health concern connected with severe mental health problems, such as personality pathology. Currently, there are no specific evidence-based interventions available for young people who self-harm. Therefore, we developed PRe-Intervention Monitoring of Affect and Relationships in Youth (PRIMARY), a smartphone-based intervention, co-designed by clinicians and young people with lived experience of mental ill-health. PRIMARY combines the Experience Sampling Method (ESM) with weekly report sessions. The study aims to examine the effectiveness of PRIMARY with regard to reducing self-harm, and improving emotion regulation and quality of relationships.MethodsThis study is a multicenter, parallel groups, randomized controlled trial (RCT) comparing the PRIMARY intervention to a waiting list control group. PRIMARY comprises 28 consecutive days of questionnaires five times each day (i.e., ESM) and four weekly report sessions. Participants will comprise 180 young people referred for treatment to the participating Dutch mental healthcare institutions and (1) are aged 12 to 25 years, and (2) engaged in ≥ 1 act of self-harm in the past year. Participants are randomly allocated to a study group after screening in a 1:1 ratio by an independent researcher using computer-generated randomization sequences with stratified block randomization by age (12 to 15 years / 16 to 25 years). Staff will conduct assessments with all participants at baseline (Wave 1), after 28 days (Wave 2), and in a subsample after 10 weeks of subsequent specialized treatment (Wave 3). The primary outcomes are self-harm, emotion regulation, and quality of relationships. Secondary outcomes include patient and clinician satisfaction. Exploratory analyses of ESM data will examine the relationship between emotions, social relationships, and self-harm.DiscussionThe results of this trial will clarify whether an innovative smartphone-based intervention is effective for reducing self harm and improving emotion regulation and the quality of social relationships. It has the potential to fill a treatment gap of interventions specifically targeting self-harm. If proven effective, it would provide an accessible, easy-to-implement, low-cost intervention for young people. Furthermore, the ESM-data will allow detailed analyses into the processes underlying self-harm, which will contribute to theoretical knowledge regarding the behavior.Trial registrationISRCTN42088538 (https://doi.org/10.1186/ISRCTN42088538), retrospectively registered on the 26th of October 2022.

Do barrier dressings reduce cardiac implantable device infection: Protocol for a randomized controlled trial (BARRIER-PROTECT)

BackgroundCardiac implantable electronic device (CIED) procedures can be associated with serious complications, including infection with significant mortality and morbidity, necessitating removal of the device and prolonged hospitalization. One potential pathophysiological mechanism is pocket contamination at the time of device implantation. Therefore, steps taken to prevent contamination at this stage can potentially reduce CIED infections.The barrier dressing, an adhesive material applied to the skin, has the potential to reduce the colonization of the surgical site with host flora that can predispose to infection. There are a limited number of randomized prospective studies on barrier dressing use during various surgeries, but it has never been systematically studied in CIED implantation. ObjectivesDo Barrier Dressings Reduce Cardiac Implantable Device Infection? (BARRIER-PROTECT trial; NCT04591366) is a single-centre, prospective, double-armed, single-blinded, randomized controlled trial designed to evaluate the use of an intra-operative adhesive barrier dressing to reduce the risk of end-of-procedure pocket swab positivity. We hypothesize that adhesive draping during implant procedures will reduce the risk of contamination from the skin flora. Also, we aim to investigate if the end-of-procedure pocket swab culture positivity can be used as a potential surrogate marker of CIED infection. Methods and DesignPatients undergoing a second or later procedure on the same device pocket (pulse generator change, lead/pocket revision or upgrade) will be enrolled. Eligible and consenting patients will be equally randomized to the use of barrier dressing or not using an automated web-based system. Patients, but not the operator, will be blinded to the arm. The person performing the pocket swabs will also be blinded. The primary endpoint is the end-of-procedure pocket swab culture positivity. The main secondary endpoint is the CIED infection rate. DiscussionThis is the first randomized controlled trial to assess the effectiveness of using a barrier adhesive draping on reducing the end-of-procedure pocket swab culture positivity. In this study, we are exploring a low-cost intervention that may significantly reduce CIED infection. Also, having a valid surrogate marker for CIED infection at the time of implant will facilitate design of future clinical trials.

Elastic tape reduces dyspnea and improves health status in the short term in nonobese COPD males: A randomized controlled trial

Introduction and objectivesThe elastic tape (ET) is a novel intervention that acutely improves exercise capacity in laboratory tests; however, its effect on a patient's daily life remains unknown. This randomized controlled trial evaluated the effects of ET on daily life physical activity (DLPA), dyspnea symptoms, health status, and health-related quality of life (HRQoL) in individuals with COPD. MethodsFifty males with moderate to very severe COPD were randomly assigned to an intervention group (ETG, n = 25), receiving ET on the chest wall and abdomen, or a control group (CG, n = 25). The intervention was for 14 days. DLPA (accelerometry; steps per day, and sedentary time), dyspnea symptoms (transition dyspnea index, TDI; and modified Medical Research Council, mMRC), health status (COPD assessment test, CAT), and health-related quality of life (HRQoL, CRQ) were evaluated at baseline and on Day 21 after the intervention. ResultsNo change in the DLPA was observed in between-group comparison. CG presented a reduction in step counts after 21days (-707,p <0.05) while ETG. maintained (-114,p > 0.94). However, ET reduced dyspnea symptoms in all TDI domains (functional, task, and effort) and on the mMRC scale after 14 days compared with CG (p < 0.01). Also, the ETG improved CAT score compared to the CG, reaching minimal clinical important difference (MCID) (-4.4 score, p <0.01). The ETG also improved in most CRQ domains reaching MCID after 21 days. ConclusionsET does not modify DLPA but reduces dyspnea and improves health status and HRQoL in nonobese males with moderate to very severe COPD in the short term. This novel and low-cost intervention improves COPD symptoms.

Impact of kangaroo father care in stable very low birth weight infants on father-infant bonding

Background and objectivesKangaroo Mother Care is an evidence-based low-cost intervention to improve infant survival, neurodevelopment, and the quality of mother-infant bonding. Similarly, Kangaroo Father Care(KFC) may promote bonding of fathers with their infants and make them feel less stressed. We planned this study to evaluate the impact of KFC on father-infant bonding using a self-administered Postpartum Bonding Questionnaire (PBQ). MethodsThis prospective observational before-after study was conducted in 30 fathers of stable very low birth weight infants in a tertiary NICU over 3 months. We evaluated the impact of KFC on father-infant bonding by administering the PBQ before and after 7 successive days of KFC. ResultsWe observed a statistically significant improvement in the scores for impaired bonding (p = 0.003), anger and rejection (p = 0.022) and anxiety about care (p = 0.005) after 7 days of KFC. ConclusionKFC for 7 days significantly increased bonding between father and infant and helped fathers who had impaired bonding, anger and anxiety towards care of their infant.

BREATHLEssness in INDIA (BREATHE-INDIA)-Study protocol for the co-design of a community breathlessness intervention in India using realist methods and intervention mapping.

Breathlessness that persists despite treatment of causal disease(s) is disabling, associated with high therapy-related costs and poor socioeconomic outcomes. Low resource countries bear a disproportionate burden of respiratory problems, often characterised by disabling breathlessness. Low-cost self-management breathlessness-targeted interventions are effective and deliverable in community settings but have been developed in high-income countries. We aim to understand how breathlessness self-management works in 'real life' populations and cultural contexts, to develop programme theory and co-design a prototype intervention to improve persistent breathlessness management in India. Using a Realist approach, Intervention Mapping and the Medical Research Council Complex Intervention Framework we will undertake two phases of work supported by our Expert Group (of respiratory, primary, palliative care physicians) and key stakeholder groups (opinion leader clinicians, community health workers and people with lived experiences of breathlessness). 1) Realist review and evaluation to identify and refine evidence and theory for breathlessness self-management, producing intervention and implementation programme theory. We will identify literature through our Expert Group, scoping searches and systematic searches (Medline, Ebscohost, CINAHL, Scopus, Psychinfo). We will map intervention components to 'what works, for whom, and where.' 2) Intervention development using Intervention Mapping to map intervention and implementation programme theory to intervention components, develop materials to support intervention delivery, and co-design a prototype educational intervention ready for early acceptability and delivery-feasibility testing and evaluation planning in India. Use of stakeholder groups is to allow people with experience of breathlessness and/or its management to contribute their views on content developed by our team based upon review of secondary data sources. Experts and Stakeholders are therefore not research subjects but are included as extended members of the study team and will not follow informed consent procedures. Experts and stakeholders will be acknowledge in outputs arising from our project if they wish to be. Our review conduct will be consistent with RAMESES quality standards. At the conclusion of our study, we will have co-designed a breathlessness intervention for use in the community setting in India ready for further evaluation of: effectiveness, socioeconomic outcomes, acceptability and transferability to other low resource settings.

A Quasi-experimental Study Evaluating the Effectiveness of Cryotherapy on Chemotherapy-induced Oral Mucositis Prevention at the Uganda Cancer Institute

Abstract: Introduction. Low-cost interventions such as cryotherapy are not routinely practiced in sub-Saharan Africa to prevent chemotherapeutic-induced oral mucositis. We investigated the feasibility and effect of cryotherapy on oral mucositis at the Uganda Cancer Institute. Methods. This was a quasi-experimental nonequivalent research study design. We had two groups with each group meant to have 100 participants. We analyzed based on participants who underwent the protocol procedures. Results. Only cancer types were significantly different between the control and intervention groups (χ2=31.09, df =18, p=.030). Twenty percent (n=19) out of the 95, while 8.2% (n=7) out of the 85 in the control and intervention groups respectively developed moderate to severe mucositis (Mantel-Cox and Generalized Wilcoxon p= .026 and p=.031, respectively). Conclusion. The use of cryotherapy in our local setting and many sub-Saharan African countries is feasible and affordable to prevent and control chemotherapy-induced oral mucositis.

Making Germs Visible – Assessing the Impact of a School-Based, Low-Cost Intervention on Hand Hygiene Knowledge, Attitude and Practice of Children in Rural India

Handwashing with soap at critical moments is one of the most important factors in controlling the spread of germs and preventing the spread of infection. The objective of this study was to determine the effectiveness of a low-cost, school-based intervention that simulated germs and their spread on hand hygiene knowledge, attitude and practice of primary school children. Five hundred and sixty-two students from 28 rural schools were enrolled in this pre-posttest study. Endline data was collected 4 weeks after conducting the intervention at baseline. The mean scores for knowledge, attitude and practice improved significantly after the intervention (p < .05). Significant positive gains were also observed in children’s understanding of germs, the associated illness threat and washing hands with soap as a prevention mechanism. The present study suggests that entertainment-education-based interventions have the potential to improve hygiene behavior among children while being low-cost.

Cost-Effectiveness of Algebraic Technological Applications

COVID-19 contributed to the largest student performance decline in mathematics since 1990. The nation needs cost-effective mathematic interventions to address this drop and improve students’ mathematics performance. This study presents a cost-effectiveness analysis (CEA) of three algebraic technological applications, across four conditions: From Here to There (FH2T), Dragon Box 12+ (DragonBox), Immediate Feedback and Active Control. This CEA study uses impact measures from a student-level randomized control trial comparing student learning from the three treatment conditions to the Active Control condition with an analytic sample of 1,850 middle school students across 9 schools, 34 teachers, and 127 classes. The results from the CEA indicate FH2T costs $39 per student and produces an average effect of 0.135 on algebraic achievement resulting in a cost-effectiveness ratio of $291. DragonBox costs $55 per student and produces an average effect of 0.269 on algebraic achievement resulting in a cost-effectiveness ratio of $206. Overall, the current CEA study demonstrates the efficiency of FH2T and DragonBox as low-cost interventions for improving students’ algebraic performance and addressing the nation’s decline in mathematics.

Effectiveness of Facebook Groups and Pages on Participant Recruitment Into a Randomized Controlled Trial During the COVID-19 Pandemic: Descriptive Study.

In response to the unprecedented challenges posed by the COVID-19 pandemic, conventional recruitment approaches were halted, causing the suspension of numerous clinical trials. Previously, Facebook (Meta Platforms, Inc) has emerged as a promising tool for augmenting participant recruitment. While previous research has explored the use of Facebook for surveys and qualitative studies, its potential for recruiting participants into randomized controlled trials (RCTs) remains underexplored. This study aimed to comprehensively examine the effectiveness of using Facebook groups and pages to facilitate participant recruitment during the COVID-19 pandemic for an RCT on the effectiveness of a remote parenting program, 1-2-3 Magic, in families who have children with attention-deficit/hyperactivity disorder (ADHD) in the United Kingdom. We disseminated 5 Facebook posts with an attached digital flyer across 4 prominent ADHD UK support groups and pages run by the National Attention Deficit Disorder Information and Support Services, reaching an audience of around 16,000 individuals over 2 months (January 7 to March 4, 2022). Eligibility criteria mandated participants to be parents or caregivers of a child with diagnosed ADHD aged 12 years or younger, be residing in the United Kingdom, have access to stable internet, and have a device with the Zoom (Zoom Video Communications) app. Participants were required to have never attended 1-2-3 Magic training previously. Prospective participants expressed their interest through Microsoft Forms (Microsoft Corporation). The trial aimed to recruit 84 parents. It is important to note that the term "parent" or "caregiver" in the RCT and in this study within a trial refers to anybody who has legal responsibility for the child. Overall, 478 individuals registered their interest through Microsoft Forms within the stipulated 2-month window. After the eligibility check, 135 participants were contacted for a baseline meeting through Zoom. The first 84 participants who attended a baseline meeting and returned a completed consent form were enrolled. Subsequently, another 16 participants were added, resulting in a final sample of 100 participants. This recruitment strategy incurred negligible expenses and demanded minimal human resources. The approach yielded favorable outcomes by efficiently attracting eligible participants in a condensed time frame, transcending geographical barriers throughout the United Kingdom, which would have been tedious to achieve through traditional recruitment methods. Our experience demonstrated that digital flyers posted in the targeted Facebook groups were a cost-effective and quick method for recruiting for an RCT, which opened during the COVID-19 pandemic when lockdown restrictions were in place in the United Kingdom. Trialists should consider this low-cost recruitment intervention for trials going forward, and in the case of a global pandemic, this novel recruitment method enabled the trial to continue where many have failed. International Standard Randomized Controlled Trial Number (ISRCTN) 15281572; https://www.isrctn.com/ISRCTN15281572.

Awareness campaign to improve hygiene practices: Evidence from a randomized controlled trial in the tribal areas of Pakistan

In a recent survey, it was determined that less than 15% of the population in the north-western tribal areas of Pakistan purify water prior to consumption. This is worrisome as most water sources in this region are unsuitable for drinking due to bacterial contamination, seepage of chemicals from agricultural practices and deposition of human waste into water bodies. To promote health-preserving behaviors, an awareness campaign was carried out in the region with the central theme being water purification. The results indicate that water purification, on average, increased by 11 percentage points for the treated group relative to the control group. Given the success of this low-cost intervention, promotion of sanitation and hygiene practices via informational campaigns should be considered a tool to enhance health literacy.

Implementation of a Triathlon Program for Primary School Students as part of Health and Physical Education

Introduction: The significance of triathlon is reflected in the teaching and development of motor, social and emotional skills. Because triathlon has great educational potential, this case study sought to explore whether a modified Physical Activity Enjoyment Scale (PACES) survey can be used as a suitable measure of enjoyment of physical activity in elementary school children when applied to a sports-specific task such as triathlon. Methods: The sample consisted of 12 female elementary school students (10.3 ± 1.3 years) from an inner-city high school. A modified triathlon program was delivered for one hour per week over a four-week duration with a modified PACES survey distributed each week. Survey responses were coded and then averaged over the four-week duration with the children’s responses subsequently analyzed using a Wilcoxon Signed Ranks Test to examine differences in the coded characteristic response scores of the survey. Further comparisons were made using a Student’s t-test and a coefficient of variation (CV). Results: A greater sense of pleasure and fun was reported by the participants at the conclusion of the four-week triathlon program while there was no change in the children’s sense of excitement (p &lt; 0.5). Characteristic responses to ‘neutral’ decreased with a simultaneous increase in the ‘slightly enjoyed’ response when viewed over the four-week duration of the program (p &lt;0.001) Conclusions: This PACES case study was designed as a feasible, simple, and innovative approach to monitor enjoyment levels in elementary school children who participated in a triathlon program. Overall, the positive enjoyment reported from this simple, low-cost intervention could be used to inform the development of future sport-specific elementary school programs.

Effects of digital chatbot on gender attitudes and exposure to intimate partner violence among young women in South Africa.

South Africa has among the highest rates of intimate partner violence (IPV) globally, with young women at heightened risk due to inequitable gender roles, limited relationship skills, and inadequate social support. Despite an urgent need for violence prevention in low- and middle-income settings, most efficacious approaches are time-intensive and costly to deliver. Digital, interactive chatbots may help young women navigate safer relationships and develop healthier gender beliefs and skills. Young women (18-24 years old) across South Africa were recruited via Facebook for participation in an individually randomised controlled trial (n = 19,643) during the period of June 2021-September 2021. Users were randomly allocated, using a pipeline algorithm, to one of four trial arms: Pure Control (PC) had no user engagement outside of study measures; Attention Treatment (T0) provided didactic information about sexual health through a text-based chatbot; Gamified Treatment (T1) was a behaviourally-informed gamified text-based chatbot; Narrative Treatment (T2) was a behaviourally-informed drama delivered through pre-recorded voice notes. All chatbots were delivered in WhatsApp, through which users were invited to complete brief "quizzes" comprising adapted versions of validated scales. Primary outcomes were short-form adaptations of scales for gender attitudes (Gender Relations Scale) and past-month IPV (WHO Multi-country Study Instrument). Secondary outcomes were identification of unhealthy relationship behaviours (Intimate Partner Violence Attitudes Scale) and brief screener for depressive symptoms (Patient Health Questionnaire). A direct chat link to a trained counsellor was a safety measure (accessed by 4.5% of the sample). We estimated treatment effects using ordinary least squares and heteroskedasticity robust standard errors. The trial retained 11,630 (59.2%) to the primary endpoint of gender attitudes. Compared to control, all treatments led to moderate and significant changes in attitudes towards greater gender equity (Cohen's D = 0.10, 0.29, 0.20 for T0, T1, and T2, respectively). The gamified chatbot (T1) had modest but significant effects on IPV: 56% of young women reported past-month IPV, compared to 62% among those without treatment (marginal effects = -0.07, 95%CI = -0.09to-0.05). The narrative treatment (T2) had no effect on IPV exposure. T1 increased identification of unhealthy relationship behaviours at a moderate and significant level (Cohen's D = 0.25). Neither T1 nor T2 had a measurable effect on depressive symptoms as measured by the brief screener. Interpretation: A behaviourally-informed, gamified chatbot increased gender equitable attitudes and was protective for IPV exposure among young women in South Africa. These effects, while modest in magnitude, could represent a meaningful impact given potential to scale the low-cost intervention.

A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol

BackgroundA birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions.MethodsThis two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang’a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country.DiscussionAmple evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings.Trial registrationTrial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022.

Pain Assessment and Management Practices via Education & Reinforcement (PAMPER): A Quality Improvement Initiative.

To establish neonatal pain management practices as an essential developmental supportive measure at a tertiary care unit. This quality improvement initiative was conducted as per Point-of-Care-Quality-Improvement Model over 6 mo, followed by 2 y of sustenance phase at a Neonatal Intensive Care Unit (NICU) in northern India. Infants of birth weight ≤1800 g were included and assessed for pain. Pain Assessment and Management Practices via Education and Reinforcement (PAMPER) group was created by resident doctors and nursing staff. The Premature Infant Pain Profile score was used for the assessment of pain. Limiting factors were analyzed using a fishbone diagram and interventions were done in multiple Plan-Do-Study-Act cycles. At the end of interventions, 100% of procedures were assessed for pain. The mean (standard deviation) documented pain score for the first seven days was reduced from 12.8 (0.3) in the baseline phase to 7 (2.5). These interventions helped to sustain the practice in >70% of infants in the next 2 y. Low-cost interventions improved the pain assessment and management policy of authors' NICU with the establishment of a standard protocol. Audits and reinforcement at regular intervals helped in its long-term sustenance.

Vitamin K Supplementation for Prevention of Teratogenic Neurological Calcification in Fetuses with Congenital Zika Syndrome: A Research Protocol

Introduction: Congenital Zika Syndrome (CZS) manifests in infants exposed to the Zika virus (ZIKV) in utero. Recent studies have documented the correlation between bone morphogenetic protein (BMP) and fetal brain calcification in these infants; however, potential treatment avenues remain unaccomplished. Unfortunately, the increase in ZIKV cases has engendered fetal neurodevelopmental defects including brain calcification which permanently impairs neurological function. The dominant pathogenic explanation results from osteogenic factor upregulation. Previous research has identified this underlying factor, highlighting the mechanism to combat the neurodegenerative impacts of ZIKV. Since the correlation between ZIKV and BMP is novel, studies addressing the mitigation of infant brain calcification are limited. Data from established ZIKV research was used to determine the potential utilization of matrix Gla protein (MGP) to inhibit the BMP pathway which calcifies fetal neural tissue. This rationale is founded on evidence showing (a) the efficacy of MGP in combating BMP-dependent calcification, and (b) the activation of MGP with Vitamin K2 (VK2). This study aims to establish a protocol for supplementing pregnant Zika patients with the VK2 derivative menaquinone-4 (MK-4), with the goal of preventing CZS-associated neurological calcification. Methods: A literature search was performed to evaluate the feasibility of VK2 injections for the prevention of neural calcification in CZS patients. The preventative potential of VK2 against CZS-related calcification will be tested using in vivo pregnant mouse (Mus musculus) models. Treatment groups will receive MK-4 administered with propylene glycol, while the control group will receive a placebo. Neurological calcification of fetuses and neonates will be monitored using pelvic ultrasound and micro-CT. Plasma and cerebral MK-4 content will be quantified using liquid chromatography-tandem mass spectrometry. Results: Anticipated results should demonstrate reduced subcortical calcification in the MK-4-treated murine cohort. Discussion: Protocol implementation precipitates the development of preventative CZS treatments. These findings indicate that low-dose maternal VK2 supplementation could provide a potential avenue for prevention of brain calcification in utero after vertical transmission of ZIKV. Conclusion: The proposed treatment would be the first of its kind, providing affected populations with a low-cost intervention for neurological damage caused by CZS, decreasing the burden of disease as ZIKV prevalence grows.

Improving hepatitis B screening and vaccination rates in a veterans affairs resident-based primary care clinic

IntroductionIn 2022, the Advisory Committee on Immunization Practices (ACIP) updated its recommendation regarding hepatitis B vaccination and advised vaccination for all adults aged 19–59 regardless of risk factors and those...

Text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial

IntroductionIncreases in pain and interference with quality of life is a common concern among people with chronic non-cancer pain (CNCP) who are tapering opioid medications. Research indicates that access to...