Comparison Arm Research Articles

Efficacy and safety of sofosbuvir in the treatment of SARS-CoV-2: an open label phase II trial

Objective:
 Despite the worldwide spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), an effective specific antiviral treatment for coronavirus disease of 2019 (COVID-19) is yet to be identified .We did this study to investigate the safety and efficacy of sofosbuvir as antiviral therapy among hospitalized adult patients with SARS-CoV-2.
 Methods: 
 Patients were randomized into intervention arm receiving sofosbuvir or comparison arm receiving usual antiviral agents in addition to standard of care. The primary end point of the study was clinical recovery as defined by normal body temperature and normal oxygen saturation. The main secondary outcome was all-cause mortality during the admission in hospital or within 14 days after discharge if applicable. Reports of severe adverse events were observed in the intervention arm. 
 Results:
 Fifty-seven patients enrolled into either the clinical trial arm (n=27) or the comparison arm (n=30). Primary outcome was achieved by 24 (88.9%) and 10 (33.3%) in the intervention and comparison arms, respectively. Median hospital length of stay was significantly shorter in the intervention arm (10 days [IQR: 5-12] vs. 11.5 days [IQR: 8.5-17.75], P = 0.016).
 All-cause mortality was two and thirteen in intervention and comparison groups, respectively. No serious adverse events were reported by the patients receiving sofosbuvir during the study.
 Conclusion:
 Among patients hospitalized with SARS-CoV-2, those who received sofosbuvir had more clinical recovery rate and had a shorter hospital length of stay than those who received usual antiviral agents in the study and these differences were statistically significant.

Association of tobacco exposure with demographic and clinicopathological factors in patients of oral squamous cell carcinoma - A single-center experience.

Almost a third of the global load of oral squamous cell carcinoma (OSCC) occurs in India and can be attributed to the widespread use of tobacco and tobacco-related products in this part of the sub-continent. Records of 274 patients of OSCC treated between January 2018 and December 2019 in our institute were analyzed for the study for history of tobacco abuse and distribution of associated demographic, clinical, and pathological factors. The age of the patients in the study ranged from 31 to 82 years with a median age of 60 years. The ratio of oral cancer in males: females was 3:1. Exposure to tobacco was seen in the majority of patients (89%) who reported with oral carcinoma. Smokeless tobacco in the form of gutka was the most common abused tobacco, followed by bidi in our study. Tongue and buccal mucosa (38% and 36%, respectively) were the most common sites. Significant statistical correlation of tobacco use was seen with age, gender, clinical, and pathological tumor stages. With tobacco being the main cause of OSCC, further studies with a larger number of patients and preferably with a comparison arm of non-tobacco OSCC would help in elucidating the exact clinical and statistical correlation of tobacco with the clinicopathological factors.

Effect of a complex lifestyle intervention to optimize metabolic health among females of reproductive age in urban Uganda, a randomized controlled trial

BackgroundThe metabolic health of urban Ugandans, mostly females, is increasingly becoming sub-optimal. ObjectivesWe assessed the effect of a complex lifestyle intervention, based on a small change approach, on metabolic health among females of reproductive age in urban Uganda. MethodsA cluster randomized controlled two-arm trial with a 1:1 allocation involving church communities in Kampala (Uganda) was undertaken. The intervention arm received infographics and face-to-face group sessions, whereas the comparison arm received infographics only. Eligible participants were aged 18 to 45 years with a waist circumference of ≥80 cm and without cardiometabolic diseases. The study included a 3-month intervention and a 3-month postintervention follow-up. The primary outcome was a reduction in waist circumference. Secondary outcomes included optimization of cardiometabolic health, physical activity, and fruit and vegetable intake. Intention to treat analyses were performed using linear mixed models. This trial was registered at clinicaltrials.gov as NCT04635332. ResultsThe study was conducted between 21 November 2020 and 8 May 2021. Six church communities were randomly selected, 3 (n = 66) per study arm. At 3 months and postintervention follow-up, 118 and 100 participants were analyzed, respectively. At 3 months, waist circumference tended to be lower in the intervention arm (−1.48 cm (95% CI: −3.05, 0.10) P = 0.06). The intervention showed an effect on fasting blood glucose concentrations (−6.95 mg/dL (95% CI: −13.37, −0.53) P = 0.034). Participants in the intervention arm consumed more fruits (62.6 g (95% CI: 1.9, 123.3) P = 0.046) and vegetables (66.2 g (95% CI: 25.5, 106.8) P = 0.002), whereas physical activity increased with no notable differences across the study arms. At 6 months, we found an intervention effect on waist circumference (−1.87 cm (95% CI: −3.32, −0.44) P = 0.011), fasting blood glucose concentration (−6.48 mg/dL (95% CI: −12.76, −0.21) P = 0.043), fruit consumption (29.7 g (95% CI: 5.8, 53.7) P = 0.015), and physical activity (2675.1 MET-mins/wk (95% CI: 1045.7, 4304.4) P = 0.001). ConclusionsThe intervention improved and sustained physical activity and fruit and vegetable intake, but these changes were accompanied by minimal cardiometabolic health improvements. If maintained over time, the attained lifestyle improvements may result in substantial cardiometabolic health improvements.

Effectiveness of the Eggs Make Kids demand-creation campaign at improving household availability of eggs and egg consumption by young children in Nigeria: A quasi-experimental study.

Using a quasi-experimental design, our study aimed to determine the effectiveness of the 'Eggs Make Kids Sharp & Bright and Strong & Active'demand-creation campaign in Nigeria. The intervention arm received emotionally compelling radio and television advertisements about eggs, and was exposed to promotional activities and advertising about eggs at points of purchase, schoolsand health facilities; the comparison arm received no intervention. Children 6-59 months of age (intervention: n = 1359; comparison: n = 1485) were assessed 14 months apart. Intent-to-treat analyses with analysis of covariance method assessed the impact of the intervention on caregivers' behaviour towards eggs, caregivers' willingness to pay for eggs, availability of eggs in households, and consumption of eggs by children 6-59 months of age. Analyses were adjusted for possible confounders and perceived effects of COVID-19 on finances and food consumption. Compared to the comparison arm, the intervention arm showed a greater prevalence of household egg acquisition (odds ratio = 1.34, p < 0.0001), and larger improvements in caregiver self-efficacy (β = 0.242, p = 0.004) and intent to feed eggs to children (β = 0.080, p = 0.021). No effects were found on children's egg consumption or caregivers' reported willingness to pay for eggs. The lack of impact on child egg consumption despite increased acquisition of eggs and caregiver self-efficacy suggests that other barriers to child consumption may exist. Additional research should further investigate factors that may influence intrahousehold distribution of eggs and whether these may also influence other nutritious foods.

Educational intervention and livestock ownership successfully improved the intake of animal source foods in 6-23 months old children in rural communities of Northern Ethiopia: Quasi-experimental study.

Animal source foods (ASFs) are rich in high-quality proteins, including essential amino acids and highly bioavailable micronutrients vital for child growth and cognitive development. But, the daily consumption of ASFs among 6-23 months old children is very low in Tigray, Northern Ethiopia. The study aimed to assess the effectiveness of nutrition education intervention to improve the consumption of ASFs among 6-23 months old children from rural communities with strict religious fasting traditions of avoiding intake of ASFs in Northern Ethiopia. A quasi-experimental study was conducted in two food insecure districts namely Samre Seharti (intervention) and Tanqua Abergele (comparison). The mother-child pairs in the intervention group (n = 140) received nutrition education based on the barriers and available resources for optimal consumption of ASFs among children and followed up for nine months. The mother-child pairs in the comparison group (n = 153) received routine nutrition education. The data were collected using a pre-tested structured questionnaire. The baseline and endline data assessment included interviews on socio-demographic and socio-economic status, dietary intake, and child feeding practices. The effectiveness of the intervention was measured using the difference-in-difference (DID) analysis model. At endline, the consumption of ASFs among children was 19.5 percentage points higher in the intervention group compared with the comparison group (p = 0.008). In addition, there was a significant increase in egg consumption among children in the intervention group (DID of 16.9, p = 0.012) from the comparison group. No child was consuming meat at baseline in both the intervention and comparison arms and it was very low at endline (5.2% vs. 7.9%). Overall, the proportion of children that consumed eggs in the intervention group was higher than in the comparison group in households that owned sheep and goats (4.8% vs. 21.4%, p = 0.050) and chicken (6.3% vs. 43.8%, p = 0.002) after education interventions. However, no statistically significant difference was observed between cow ownership and milk consumption among children (p&gt;0.05). Age-appropriate educational interventions for mothers and owning small livestock in the household can improve the consumption of ASFs and eventually the minimum diet diversity of children in communities with strict religious traditions of avoiding ASFs during the fasting seasons.

Extended Knee Control programme lowers weekly hamstring, knee and ankle injury prevalence compared with an adductor strength programme or self-selected injury prevention exercises in adolescent and adult amateur football players: a two-armed cluster-randomised trial with an additional comparison arm

ObjectiveTo evaluate the preventive efficacy of an extended version of the Knee Control injury prevention exercise programme (IPEP) compared with an adductor strength programme and to a comparison group using...

NRG RTOG 1005: A Phase III Trial of Hypo Fractionated Whole Breast Irradiation with Concurrent Boost vs. Conventional Whole Breast Irradiation Plus Sequential Boost Following Lumpectomy for High Risk Early-Stage Breast Cancer

<h3>Purpose/Objective(s)</h3> Randomized trials support a supplemental radiation dose (Boost) to the lumpectomy (L) cavity region after whole breast irradiation (WBI), providing a 20-30% relative reduction of in-breast recurrence (IBR); with the disadvantage that it extends treatment duration ⁓ 1 week. Hypofractionated WBI (H-WBI) in ≤ 3 weeks is used after L to deliver adjuvant WBI with acceptable toxicity and comparable IBR as conventional WBI (C-WBI) 50 Gy in 2 Gy fractions (F). NRG RTOG 1005 sought to determine whether a boost delivered concomitantly with H-WBI over 15 F is non-inferior for IBR compared to boost delivered sequentially after C-WBI in patients (pts) considered at High Risk of IBR. <h3>Materials/Methods</h3> Protocol-specified High Risk pts post L with stages 0, I & II breast cancer were randomized to C-WBI 50 Gy in 25 F or 42.7 Gy in 16 F plus sequential boost of 12 Gy in 6 F or 14 Gy in 7 F (Arm I) or H-WBI 40 Gy in 15 F plus concomitant boost of 8 Gy in 15 F of 0.53 Gy per day (Arm II). Radiation was target based 3-dimensional conformal radiation therapy (3DCRT) or intensity modulated radiation therapy (IMRT) and quality review (QA) was required. Stratification was by age (<50 vs ≥ 50), adjuvant chemotherapy (Y vs N), ER status (+ vs -) and histologic grade (1, 2 v 3). The primary endpoint is IBR. Assuming Arm I 5‐year IBR of 1.59%, 90% CI upper bound hazard ratio (HR) of 2.12 and 1‐sided significance level = 0.05, 2150 pts with at least 46 IBR events provide >80% power to conclude non‐inferiority. IBR was analyzed comparing the cause-specific hazards. Adverse Events (AE) were graded with NCI CTCAE v4. Physician-reported NRG-RTOG Global Cosmetic Score (GCS) was grouped as excellent/good vs fair/poor, and arms compared with chi-square. <h3>Results</h3> 2262 of 2354 randomized pts were eligible (Arm I n=1124; Arm II n=1138). Median age 55 years, 34% Stage II, 52% grade 3, 30% ER-, 17% close/+ margins consistent with a "High Risk" population. Radiation was 3DCRT 81%, IMRT 19%, and the QA was per protocol 81% and 88% on Arm I vs II, respectively. With a median follow-up of 7.3 years and 56 IBR events, the 5 and 7-year IBR were 2.0% and 2.2% on Arm I and 1.9% and 2.6% on Arm II. The non-inferiority comparison (Arm I reference level) resulted in a HR (90% CI): 1.32 (0.84, 2.05) and p = 0.039, thus meeting non-inferiority. No differences in AEs noted between arms, with low rates of ≥ grade 3 treatment-related AEs, 3.3% vs 3.5% for Arm I vs II, respectively (p=0.79). No difference in 3-year excellent/good cosmesis by arm: 86% for Arm I vs 84% Arm II (p=0.61). <h3>Conclusion</h3> Concomitant boost with H-WBI results in non-inferior IBR compared to sequential boost after C-WBI in high-risk cases and reduces overall treatment time. Using target based 3DCRT or IMRT, there are no differences in toxicity or cosmetic outcome for concomitant v sequential boost or the WBI fractionation regimen.

Safety of Upfront Locoregional Therapy in Conjunction with Atezolizumab and Bevacizumab for Unresectable Hepatocellular Carcinoma

<h3>Purpose/Objective(s)</h3> The use of atezolizumab and bevacizumab for advanced hepatocellular carcinoma (HCC) is a recently established standard of care. Addition of locoregional therapies (LRT) such as external beam radiotherapy (RT), radioembolization (Y90), transarterial chemoembolization (TACE), and/or radiofrequency ablation (RFA) may hold promise for further improving outcomes, but the safety of these approaches with atezolizumab/bevacizumab has not been established. This study assessed the safety of upfront LRT in conjunction with this immunotherapy regimen in HCC. <h3>Materials/Methods</h3> We reviewed all patients initiating atezolizumab with or without bevacizumab (IO) for HCC from July 2020 to January 2022 at a single institution. Patients receiving LRT (RT, Y90, TACE, and/or RFA) within 30 days of IO initiation (LRT+IO) were identified alongside a comparison arm of all patients initiating IO alone. Bevacizumab was typically held until after LRT. Treatment-related toxicities were recorded according to CTCAE definitions from the date of treatment initiation until discontinuation of IO or last follow up. Baseline, 1 month, and 3-month Child-Pugh (CP) score, ALBI score, transaminases, and total bilirubin were additionally recorded and analyzed using a repeated-measure mixed effects model. <h3>Results</h3> 50 HCC patients initiating atezolizumab were identified, 49 (98%) of these in combination with bevacizumab. Median follow up was 6.5 months (range 1.2-20), median age was 64 (34-79). 37 (74%) patients had BCLC stage C disease and 12 (34%) BCLC stage B. The majority of patients (86%) had CP class A liver function. Baseline characteristics were balanced between arms on univariate analysis (p>0.05). Of 27 (54%) patients in the LRT+IO arm, 9 received RT alone, 4 received RT combined with Y90 or TACE, 10 received Y90 alone, 3 received TACE alone, and 1 received RFA. The majority of the LRT+IO arm (63%) received LRT after the first infusion of atezolizumab. Grade 3 toxicities were observed in 2 (7.4%) patients in the LRT+IO arm, compared to 2 (8.6%) patients in the IO-only arm (p=0.87); grade 2 toxicity incidence was 63% in the LRT+IO arm versus 43% in the IO-only arm (p=0.17). The receipt of LRT+IO was associated with transient increase in CP and ALBI scores at 1 month relative to IO alone (median score increase 1 and 0.34, respectively, p<0.01); this association did not persist at 3 months. There was no treatment-related liver failure or grade 4/5 toxicity reported in either arm. LRT+IO was not associated with increased ALT, AST, or total bilirubin at 1 or 3 months. <h3>Conclusion</h3> In this single institution retrospective cohort study, upfront locoregional therapy with atezolizumab and bevacizumab for HCC was not associated with a significantly greater incidence of grade 2/3 toxicity or clinically significant liver dysfunction relative to the initiation of atezolizumab and bevacizumab alone. Further studies are needed to verify the safety of combination therapy and to assess clinical benefit.

Reaching Adolescent Girls and Young Women With HIV Self-Testing and Contraception at Girl-Friendly Drug Shops: A Randomized Trial in Tanzania

PurposeWe hypothesized that an intervention designed to create girl-friendly drug shops would increase access to sexual and reproductive health products and services among adolescent girls and young women (AGYW) (ages 15–24 years) in Tanzania. MethodsWe conducted a four-month randomized trial at 20 drug shops in Shinyanga, Tanzania from August–December 2019 to determine if the Malkia Klabu (“Queen Club”) intervention increased AGYW patronage and the provision of HIV self-testing (HIVST), contraception, and health facility referrals to AGYW (primary outcomes). Drug shops were randomized 1:1 to the intervention or comparison arm. All shops were provided with OraQuick HIVST kits to give to AGYW for free. Intervention shops implemented Malkia Klabu, a loyalty program for AGYW created using human-centered design through which AGYW could also access free contraception. We compared outcomes in intention-to-treat analyses using shop observations and shopkeeper records. ResultsBy endline, shops implementing Malkia Klabu had higher AGYW patronage than comparison shops (rate ratio: 4.4; 95% confidence interval: 2.0, 9.8). Intervention shops distributed more HIVST kits (median per shop: 130.5 vs. 58.5, P = .02) and contraceptives (325.5 vs. 7.0, P < .01) to AGYW and provided more referrals for HIV, family planning, or pregnancy services combined (3.5 vs. 0.5, P = .02) than comparison shops. DiscussionThe Malkia Klabu intervention increased AGYW patronage and the provision of HIVST kits, contraception, and referrals to AGYW at drug shops, despite HIVST kits being freely available at all participating shops. Enhancing drug shops with girl-friendly services may be an effective strategy to reach AGYW with sexual and reproductive health services.

Key learnings from an outcome and embedded process evaluation of a direct to beneficiary mobile health intervention among marginalised women in rural Bihar, India

IntroductionMobile Vaani was implemented as a pilot programme across six blocks of Nalanda district in Bihar state, India to increase knowledge of rural women who were members of self-help groups...

Pharmacological Management of Neuropathic Pain after Radiotherapy in Head and Neck Cancer Patients: A Systematic Review.

Background: Neuropathic pain (NP) in head and neck cancer (HNC) patients represents a treatment challenge. Most studies investigating drugs against NP are conducted in patients suffering with diabetic neuropathy or postherpetic neuralgia, while data are limited in cancer pain management. Additionally, regarding cancer therapy-related NP, most of the studies do not focus on HNC patients. The aim of this review is to identify the studies on systematically administered medication for NP management that included HNC patients under radiotherapy. Methods: A systematic literature search was performed, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, in PubMed, Cochrane Library, Web of Science and ClinicalTrials.gov on 30 October 2021. The medical subject heading (MeSH) terms were (“head and neck cancer” OR “tumor”) AND “neuropathic pain” AND “medication” AND “radiotherapy.” The Cochrane Collaboration tool was used for quality assessment. Results: The search identified 432 articles. Three more articles were identified after searching the reference lists of the retrieved articles. A total of 10 articles met the eligibility inclusion criteria and were included in this review; 6 on gabapentin, 1 on pregabalin, 1 on nortriptyline, 1 on methadone, and 1 on ketamine. Statistically significant results in pain reduction compared to placebo or standard pain medication were found in the studies on pregabalin (p = 0.003), methadone (p = 0.03), ketamine (p = 0.012), and in two out of six gabapentin studies (p < 0.004). Two of the studies (both concerning gabapentin) had no comparison arm. Conclusions: Treatments including pregabalin, methadone, ketamine, and gabapentin were found to provide pain relief against HNC NP. While there is a plethora of pharmacological treatments available for the management of NP, only a few studies have been conducted regarding the pharmacological management of therapy-related NP in HNC patients. More studies should be conducted regarding the pharmacological approaches in HNC therapy-related NP so that specific treatment algorithms can be developed.

A Web-Based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial.

BackgroundPredictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents’ obesogenic behavior. However, most of the existing adolescent interventions target these variables in isolation. Furthermore, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents’ obesity status. However, HL has not been included in obesity interventions targeting adolescents.ObjectiveThis study aims to pilot the feasibility of a 2-armed web-based obesity prevention intervention in school settings and assess the preliminary effectiveness of adding an HL module to an obesity prevention intervention for adolescents.MethodsThis web-based pilot feasibility study will take place in the Northeastern United States. Participants will be adolescents (aged 13-16 years) attending school, and recruitment will be conducted through flyers to parents and adolescents in participating classes or advisory groups at the school. The intervention includes 2 arms: an experimental arm that will receive an HL module and 3 obesity prevention modules and a comparison arm that will receive a vaping module and 3 obesity prevention modules. A blinded randomized procedure will be used to allocate classrooms and advisory groups to the experimental and comparison arms. The intervention will be fully web-based. Participants will complete measures of their HL and obesogenic behavior–related health knowledge, motivation, and behaviors at 3 time points (baseline, 1 month after the intervention, and 3 months after the intervention) via web-based surveys. The primary outcomes will be the measures of study feasibility (recruitment, retention, completion, and treatment fidelity rates). Secondary outcomes will be preliminary efficacy, as measured by logistic and linear regressions and calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point.ResultsThis study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the web-based intervention design is complete and ready for use. Recruitment, data collection, and intervention implementation are scheduled to begin in September 2022. These results are expected to be published in 2023.ConclusionsThis study’s feasibility findings will inform changes to the intervention content and randomized controlled trial design. The study’s efficacy findings will inform the sample size for the full-scale randomized controlled trial and the preliminary utility of the intervention.Trial RegistrationClinicalTrials.gov NCT04252677; https://clinicaltrials.gov/ct2/show/NCT04252677International Registered Report Identifier (IRRID)PRR1-10.2196/40191

Mindfulness-Based Interdisciplinary Pain Management Program for Complex Polymorbid Pain in Veterans: A Randomized Controlled Trial

ObjectiveTo evaluate the effects of interdisciplinary pain management on pain-related disability and opioid reduction in polymorbid pain patients with 2 or more comorbid psychiatric conditions. DesignTwo-arm randomized controlled trial testing a 3-week intervention with assessments at pre-treatment, post-treatment, 6-month, and 12-month follow-up. SettingDepartment of Veterans Affairs medical facility. Participants103 military veterans (N=103) with moderate (or worse) levels of pain-related disability, depression, anxiety, and/or posttraumatic stress disorder randomly assigned to usual care (n=53) and interdisciplinary pain management (n=50). All participants reported recent persistent opioid use. Trial participants had high levels of comorbid medical and mental health conditions. InterventionsExperimental arm—a 3-week, interdisciplinary pain management program guided by a structured manual; comparison arm—usual care in a large Department of Veterans Affairs medical facility. Main Outcome MeasuresOswestry Disability Index (pain disability); Timeline Followback Interview and Medication Event Monitoring System (opioid use). Analysis used generalized linear mixed model with all posttreatment observations (posttreatment, 6-month follow-up, 12-month follow-up) entered simultaneously to create a single posttreatment effect. ResultsVeterans with polymorbid pain randomized to the interdisciplinary pain program reported significantly greater decreases in pain-related disability compared to veterans randomized to treatment as usual (TAU) at posttreatment, 6-month, and 12-month follow-up. Aggregated mean pain disability scores (ie, a summary effect of all posttreatment observations) for the interdisciplinary pain program were -9.1 (95% CI: -14.4, -3.7, P=.001) points lower than TAU. There was no difference between groups in the proportion of participants who resumed opioid use during trial participation (32% in both arms). ConclusionThese findings offer the first evidence of short- and long-term interdisciplinary pain management efficacy in polymorbid pain patients, but more work is needed to examine how to effectively decrease opioid use in this population.

Effect of short-term educational intervention on complementary feeding index among infants in rural Bangladesh: a randomized control trial

BackgroundTimely, adequate and appropriate Complementary Feeding (CF) is essential for the growth and cognitive development of infants, but until today, evidence-based information is scarce in terms of impact evaluation of CF index (CFI). The study aimed to examine the effect of the short-term intervention of promoting CF practices on the nutritional status of infants in rural Bangladesh.MethodsAn educational-intervention study followed a randomized controlled trial (RCT) design (NCT03024710). Mothers and family members in the intervention arm received intensive counselling on CF through community health workers (CHWs), whereas existing healthcare services were received in the comparison arm. The study was carried out in the rural Matlab sub-district of Bangladesh between April 2011 and March 2013. In the specified study areas among 360 mother-infant pairs systematically assigned into intervention group and comparison group. Short-term educational intervention on CF was provided for the intervention group and existing services were un-intervened for the comparison group. The outcome of interventions was evaluated after the implementation period using Generalized equation estimation model.ResultsAt baseline, the study participants were not different except mean height (p = 0.04), weight-for-age Z score (WAZ) (p = 0.03) and religion (p = 0.04) in between two groups. The mean CFI was significantly higher at intervention area than the comparison and higher category of CFI (score 10 or more) was significantly higher at intervention area than comparison. After adjustment, one-unit CFI increased height-for-age z score by 0.07 units and decreased WAZ by 0.13 units in the intervention group but not significantly changed observed at comparison group.ConclusionGuided short-term nutritional intervention and developed CFI indicated a significantly better score in intervention area than comparison groups and would be a well adaptable tool for future studies.Trial registrationThe trial was registered (NCT03024710) at clinical trial registration website. Date of registration: 1/19/2017.Name of the registry: Clinical Trial.gov.Date of registration: 19/1/2017 (retrospective registered).URL of trial:https://clinicaltrials.gov/ct2/show/NCT03024710

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial

IntroductionCombination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs...

Effect of targeting and generator type on efficacy of extracorporeal shock wave lithotripsy.

Analysis of the effect of technical factors, i.e. the type of stone targeting and shock wave generator, on ESWL efficacy. Evaluation of secondary outcomes to determine an optimal strategy for performing the procedure. In the period from 01/2016 to 07/2021, we analyzed data from patients indicated for ESWL for nephrolithiasis and proximal or distal ureterolithiasis. This was a tricenter retrospective study to evaluate stone-free rates (SFR) while taking into account the number of ESWL sessions in four selected groups of patients with comparable characteristics. A patient is considered stone-free in the absence of residual lithiasis or with an asymptomatic residue of up to 2 mm. The real-time ultrasound-guided (USG) arm consisted of a group of 120 patients on the electromagnetic STORZ SLK lithotripter in the period from 02/2017 to 02/2020. A total of three comparison arms with x-ray guidance were created: A: 68 patients between 01/2016 and 03/2017 on the Medilit 7 electrohydraulic lithotripter. B: 72 patients from 04/2017 to 10/2017 on the Sonolith i-sys electroconductive lithotripter (EDAP). C: 120 patients from 03/2018 to 07/2021 on the STORZ SLK electromagnetic lithotripter. By comparing the US and x-ray guidance using the STORZ SLK lithotripter, the effect of targeting when using an identical device (electromagnetic generator) was evaluated. By comparing the arms A, B, and C, the efficacy in different types of generators - electromagnetic, electroconductive, electrohydraulic - was assessed when the same type of targeting (fluoroscopy) was used. The secondary parameters that were monitored included: the rate of use of auxiliary techniques in stone management; radiation exposure for the patient and/or operator; analgesic consumption; and the time required to perform the procedure. When US versus x-ray guidance was compared in an electromagnetic lithotripter, SFRs of 90% vs. 85% (P=0.329), i.e. statistically comparable results, were obtained. By comparing electromagnetic, electroconductive, and electrohydraulic generators with fluoroscopy, SFRs of 85%, 88.9%, and 88.2% were obtained, respectively (P=0.727). When the degree of need for intraoperative analgesic administration was assessed, the electromagnetic generator was found to have a significantly lower consumption (20.8% vs. 30.6% vs. 48.5%) (P=0.0005). Values less than 1095 HU and 108.5 mm were shown to be optimal cut-off values for stone density and skin-to-stone distance, respectively. Based on our comparative analysis, the noninferiority of US stone targeting was demonstrated compared to fluoroscopic targeting. No significant differences in ESWL efficacy were found using electrohydraulic, electroconductive or electromagnetic shock wave generators. With the electromagnetic lithotripter, there was a significantly lower analgesic consumption than with the electrohydraulic type.

Effectiveness of the Eggs Make Kids Demand-Creation Campaign to Improve Household Availability of Eggs and Egg Consumption in Young Children in Nigeria

ObjectivesTo determine the effectiveness of the “Eggs Make Kids Smart & Bright and Strong & Active” demand-creation campaign on caregivers’ behavior towards eggs, caregivers’ willingness-to-pay for eggs, the availability of eggs in household, and the consumption of eggs in children 6–59 months of age in Kaduna state, Nigeria.MethodsAn egg demand-creation campaign in Kaduna state targeting families of children 6–59 months of age was implemented between October 2019 and December 2020. A quasi-experimental design was used to evaluate the impact of the campaign. The intervention arm received emotionally compelling radio and TV advertisement and promotional activities and advertising at point-of-purchase, schools, and health facilities about eggs; the comparison arm received no intervention. Children 6–59 months of age in both arms (intervention n = 1359; comparison n = 1485) were assessed 14 months apart before and after the implementation of the intervention. Intent-to-treat analyses with analysis of covariance method were used to assess impact of the intervention on caregivers’ behavior towards eggs, caregivers’ willingness-to-pay for eggs, the availability of eggs in household, and the consumption of eggs in children 6–59 months of age. Analyses were adjusted for possible confounders and perceived effects of SARS-CoV2 on household finances and food consumption.ResultsThere was improved prevalence of household egg acquisition in the intervention arm compared to the comparison arm (odds ratio = 1.34, p-value < 0.0001). The intervention arm showed larger improvements in caregiver self-efficacy (β = 0.242, p-value = 0.004) and intent to feed eggs (β = 0.080, p-value = 0.021) than the comparison arm. No effects were found on child egg consumption or caregivers’ willingness-to-pay for eggs.ConclusionsIn Nigeria, a 14-month egg demand creation campaign improved household egg acquisition and benefited caregiver self-efficacy and intent to feed eggs but did not improve child egg consumption. Further research is needed to identify how to increase child egg consumption in the context of availability of eggs in households and favorable caregiver behavior.Funding SourcesFunding for this study was provided by the Netherland's Ministry of Foreign Affairs.

Toxicity and outcomes of BRAF and MEK inhibitor “ramp-up” dosing strategies for patients with melanoma: A real-world institutional experience.

e21600 Background: Combination BRAF inhibitor (BRAFi) and MEK inhibitor (MEKi) therapy is a widely accepted treatment option for patients (pts) with BRAF-V600E mutant melanoma. Although effective, these combinations exhibit high rates of adverse events (AEs), with 44% - 66% requiring dose modification or interruption and up to 26% discontinuing due to AEs in the adjuvant setting. Enhanced tolerance to BRAFi/MEKi is expected to improve pts quality of life and potentially enhance clinical outcomes. Clinicians at Roswell Park Comprehensive Cancer Center (RPCCC) have implemented a dose escalation regimen upon initiation of BRAFi/MEKi in efforts to enhance the tolerance of these combinations for pts with BRAF-V600E mutant melanoma in the adjuvant and advanced setting. Here we present a retrospective analysis of the toxicity profiles and outcomes associated with this “ramp-up” approach. Methods: Pts presenting to RPCCC in Buffalo, NY for management of stage III or IV melanoma harboring BRAF-V600E mutations were retrospectively observed from 1/2012 to 12/2020. Pts starting BRAFi/MEKi combinations, regardless of prior lines of therapy, were included unless concurrently receiving immune checkpoint inhibition. The “ramp-up” regimen involves a 25% dose of BRAFi and 50% dose of MEKi, which is gradually increased over 4 weekly intervals until full dose is achieved. Pts started on full-dose BRAFi/MEKi were included as a comparison arm. Observations included 1) demographics, 2) treatment regimens and disruptions, 3) rate and severity of AEs, 4) outcomes including best overall response rates (ORR), progression-free survival (PFS) and overall survival (OS). Results: A total of 88 pts were analyzed (21 and 35 receiving “ramp-up” BRAFi/MEKi in the adjuvant and advanced (unresectable stage III or stage IV) setting, respectively, and 32 received full-dose (non-ramp-up) BRAFi/MEKi in the advanced setting). Demographics were similar except pts in the “ramp-up” cohorts were higher in average age (62.0 vs 56.0, p = 0.032) than pts starting at full-dose. Pts receiving adjuvant BRAFi/MEKi at “ramp-up” dosing exhibited a 4.8% (n = 1) rate of grade 3 or higher (Gr3+) AEs and 33.3% (n = 7) AE-related discontinuation rate (9.9 month average time to discontinuation). In the advanced setting, “ramp-up” vs full-dose treated pts exhibited Gr3+ AE rates of 25.7% (n = 9) vs 43.8% (n = 14; p = 0.197) and AE-related discontinuation rates of 34.4% (n = 12) vs 40.6% (n = 13; p = 0.592), respectively. Trends in overall AEs, ORR, PFS, and OS were similar to historical observations across all groups. Conclusions: This real-world analysis suggests that “ramp-up” incremental dosing of BRAFi/MEKi for pts with melanoma in the adjuvant and advanced setting may improve the tolerance and toxicity profiles of these agents without compromising their clinical efficacy, and may be of particular utility in pts with advanced age.

The effect of electronic job aid assisted one-to-one counselling to support exclusive breastfeeding among 0-5-month-old infants in rural Bangladesh.

Exclusive breastfeeding (EBF) for the first 6 months has established benefits, yet had slow improvements globally. Little is known about electronic job aid‐assisted counselling to support EBF. As a secondary outcome of a cluster randomized controlled trial in Bangladesh, we assessed the effect of electronic job aid‐supported nutrition counselling and practical demonstration on EBF. We randomized pregnant women to one of five study arms in the trial and followed mother–child dyads until 2 years of age. Community health workers (CHWs) provided breastfeeding counselling with or without prenatal and complementary nutrient supplements in all four intervention arms. The comparison arm continued with the usual practice where mothers could receive nutrition counselling at routine antenatal and postnatal care, and during careseeking for childhood illnesses. We assessed breastfeeding indicators at birth and monthly until the child was 6 months old, in both intervention and comparison arms. To evaluate the effect of nutrition counselling on breastfeeding, we combined all four intervention arms and compared them with the comparison arm. Intervention newborns had half the risk (relative risk [RR]: 0.54, 95% confidence interval [CI]: 0.39, 0.76) of receiving prelacteal feeds than those in the comparison arm. EBF declined steeply in the comparison arm after 3 months of age. EBF was 16% higher in the intervention than the comparison arm at 4 months (RR: 1.16, 95% CI: 1.08, 1.23) and 22% higher at 5 months of age (RR: 1.22, 95% CI: 1.12, 1.33). Maternal background and household characteristics did not modify the intervention effect, and we observed no difference in EBF among caesarean versus vaginal births. Breastfeeding counselling and practical demonstration using an electronic job aid by CHWs are promising interventions to improve EBF and are scalable into existing community‐based programmes.

Breastfeeding Interpersonal Communication, Mobile Phone Support, and Mass Media Messaging Increase Exclusive Breastfeeding at 6 and 24 Weeks Among Clients of Private Health Facilities in Lagos, Nigeria

BackgroundAlthough most health facilities in urban Nigeria are privately owned, interventions to promote optimal breastfeeding practices in private facilities have not previously been implemented. ObjectivesWe tested the impact of a breastfeeding promotion intervention on early initiation of breastfeeding and exclusive breastfeeding among clients of private facilities in Lagos, Nigeria. MethodsThe intervention included training for health-care providers on the Baby-Friendly Hospital Initiative and breastfeeding counseling skills, provision of interpersonal communication and support to women at facilities and on WhatsApp, distribution of behavior change communication materials, and mobile phone and mass media messaging. We used logistic regression models adjusted for clustering to measure intervention impact in a cohort of women (n = 1200) at 10 intervention and 10 comparison facilities interviewed during their third trimester and at 6 and 24 weeks postpartum. ResultsThe intervention significantly increased the percentage of infants who were exclusively breastfed at 6 weeks (83% intervention; 76% comparison; P = 0.02) and 24 weeks (66% intervention; 52% comparison; P < 0.001), but had no impact on early initiation of breastfeeding (35% intervention; 33% comparison; P = 0.65). Among infants who were exclusively breastfed at 6 weeks, the odds of continued exclusive breastfeeding at 24 weeks were higher in the intervention arm than in the comparison arm (OR, 1.6; 95% CI: 1.2-2.1). Infants had increased odds of being exclusively breastfed at 6 weeks if their mothers discussed breastfeeding with a private health provider (OR, 2.3; 95% CI: 1.5-3.4), received text or WhatsApp messages about breastfeeding (OR, 1.7; 95% CI: 1.0-2.7), or heard breastfeeding radio spots (OR, 4.2; 95% CI: 1.2-14.7). Infants had increased odds of exclusive breastfeeding at 24 weeks if their mothers participated in a WhatsApp breastfeeding support group (OR, 1.5; 95% CI: 1.0-2.2). ConclusionsA breastfeeding intervention in private health facilities in Lagos increased exclusive breastfeeding. Implementation of breastfeeding interventions in private facilities could extend the reach of breastfeeding promotion programs in urban Nigeria. This trial was registered at clinicaltrials.gov as NCT04835051.