Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection

Background: Public health and clinical recommendations are established from systematic reviews and retrospective meta-analyses combining effect sizes, traditionally, from aggregate data and more recently, using individual participant data (IPD) of published studies. However, trials often have outcomes and other meta-data that are not defined and collected in a standardized way, making meta-analysis problematic. IPD meta-analysis can only partially fix the limitations of traditional, retrospective, aggregate meta-analysis; prospective meta-analysis further reduces the problems. Methods: We developed an initiative including seven clinical intervention studies of balanced energy-protein (BEP) supplementation during pregnancy and/or lactation that are being conducted (or recently concluded) in Burkina Faso, Ethiopia, India, Nepal, and Pakistan to test the effect of BEP on infant and maternal outcomes. These studies were commissioned after an expert consultation that designed recommendations for a BEP product for use among pregnant and lactating women in low- and middle-income countries. The initiative goal is to harmonize variables across studies to facilitate IPD meta-analyses on closely aligned data, commonly called prospective meta-analysis. Our objective here is to describe the process of harmonizing variable definitions and prioritizing research questions. A two-day workshop of investigators, content experts, and advisors was held in February 2020 and harmonization activities continued thereafter. Efforts included a range of activities from examining protocols and data collection plans to discussing best practices within field constraints. Prior to harmonization, there were many similar outcomes and variables across studies, such as newborn anthropometry, gestational age, and stillbirth, however, definitions and protocols differed. As well, some measurements were being conducted in several but not all studies, such as food insecurity. Through the harmonization process, we came to consensus on important shared variables, particularly outcomes, added new measurements, and improved protocols across studies. Discussion: We have fostered extensive communication between investigators from different studies, and importantly, created a large set of harmonized variable definitions within a prospective meta-analysis framework. We expect this initiative will improve reporting within each study in addition to providing opportunities for a series of IPD meta-analyses

Complementary or Substitutes? The Relationship Between Monetary Donation and Volunteerism: A Case Study of Quaid-I-Azam University Islamabad

Charitable organisations are always in a search of potential donors to donate money and volunteer time as well. For this purpose, they search for such potential donors who are willing to give time and money to help financially poor students. The previous literature has split into two aspects, whether monetary donation is a complement of volunteering time, or it is a substitute. The current study aims to clarify the relationship between the occurrence of monetary donation and time and to investigate whether certain demographic and some intrinsic factors variates with this relationship. Primary data has been collected from students of Quaid-i-Azam University Islamabad. For determining the relationship, a correlation test is applied which resulted in that occurrence of willingness to donate and volunteer is complementary (r=0.39). In addition, a multinomial logit is applied to ensure that a combination of gender, urban/rural, monthly income of the family, satisfaction level and religiosity trigger the complementarity between the occurrence of donation and volunteerism. If we tap such type of donors who are willing to give money and volunteer time, we can help many students who are suffering from financial hardship and are intended to leave their academic career incomplete

Rates and causes of stillbirth in a demographic surveillance site in Karachi, Pakistan

ObjectiveTo determine burden, timing and causes of stillbirths in aprospective cohort of pregnant from a low income community settingin peri urban KarachiIntroductionStillbirth remained a neglected issue absent from mention inMillennium Development Goals. An estimated 2.6 million babies arestillborn every year withhighest rate in Pakistan, 43.1 stillbirths/1000births. There is lack of good quality prospective population based datain Pakistanregarding burden, timing and causes of stillbirthsMethodsFrom Jan – Dec 2012, Community Helath Workers (CHWs)identified pregnant women through 3 monthly household visits.Pregnant women were then followed up till end of their pregnancy.In case of a stillbirth, a detailed verbal autopsy (VA) interview wasundertaken 2 weeks after the outcome by a research assistant. VAforms were then reviewed by 2 independent Physicians who assigneda cause for stillbirth. In case of disagreement, VA form was reviewedby a third physician. A consensus between two physicians wasrequired for a definitive cause.ResultsThere were a total of 273 stillbirths (3.04%) reported. Stillbirthrate was 30.7/1000 births. Distribution of antepartum and intrapartumstillbirths was 83% and 17%. Three most common causes of stillbirthsincluded pregnancy induced Hypertension(37%), antepartumhemorrhage (10%) and obstructed labor(6%) (fig. 1).ConclusionsWe have reported a high burden of stillbirths that take placeduring the intrapartum period. This reemphasizes need for goodquality antenatal care in these settings. Appropriate measure needsto be taken targeting most common causes of stillbirths, focusing onimproved antepartum health care facilitie

Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Background: Maternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age (SGA) births. High levels of food insecurity, antenatal undernourishment, and childhood undernutrition necessitate the supplementation of fortified balanced energy protein (BEP) during pregnancy in low-income settings especially with scarce literature available in this subject. Hence, this paper extensively covers the protocol of such a trial conducted in an urban slum of Karachi, Pakistan. Methods: The trial is community-based, open-labelled, four-arm, and randomized controlled that will include parallel group assignments with a 1:1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. All pregnant women (PW), if identified between \u3e 8 and \u3c 19 weeks of gestation based on ultrasound, will be offered routine antenatal care (ANC) counseling and voluntary participation in the trial after written informed consent. A total number of 1836 PW will be enrolled with informed consent and randomly allocated to one of the four arms receiving: (1) ANC counseling only (control group), (2) ANC counseling plus BEP supplement (intervention arm 1), (3) ANC counseling plus BEP supplement plus 2 doses azithromycin (intervention arm 2), or (4) ANC counseling plus BEP supplement plus daily single dose of nicotinamide and choline (intervention arm 3). Trial registration: ClinicalTrials.gov NCT04012177 . Registered on July 9, 2019

Newborn weight change and predictors of underweight in the neonatal period in Guinea-Bissau, Nepal, Pakistan and Uganda

In low- and middle-income countries (LMIC), growth impairment is common; however, the trajectory of growth over the course of the first month has not been well characterised. To describe newborn growth trajectory and predictors of growth impairment, we assessed growth frequently over the first 30 days among infants born ≥2000 g in Guinea-Bissau, Nepal, Pakistan and Uganda. In this cohort of 741 infants, the mean birth weight was 3036 ± 424 g. For 721 (98%) infants, weight loss occurred for a median of 2 days (interquartile range, 1-4) following birth until weight nadir was reached 5.9 ± 4.3% below birth weight. At 30 days of age, the mean weight was 3934 ± 592 g. The prevalence of being underweight at 30 days ranged from 5% in Uganda to 31% in Pakistan. Of those underweight at 30 days of age, 56 (59%) had not been low birth weight (LBW), and 48 (50%) had reached weight nadir subsequent to 4 days of age. Male sex (relative risk [RR] 2.73 [1.58, 3.57]), LBW (RR 6.41 [4.67, 8.81]), maternal primiparity (1.74 [1.20, 2.51]) and reaching weight nadir subsequent to 4 days of age (RR 5.03 [3.46, 7.31]) were highly predictive of being underweight at 30 days of age. In this LMIC cohort, country of birth, male sex, LBW and maternal primiparity increased the risk of impaired growth, as did the modifiable factor of delayed initiation of growth. Interventions tailored to infants with modifiable risk factors could reduce the burden of growth impairment in LMIC

Determinants of Willingness to Donate and Volunteer to Help their Poor Fellow Students in the University

Each society consists of poor and rich. Those who are rich have more chances to have a better and more education, health facilities and other amenities of life but the poor segment of society is more likely to be deprived of these and get trapped in the vicious circle of poverty. Assuming that the government is unable to reach each citizen because of increasing proportion of the poor population. For the harmonious development of the society, it is the responsibility of every individual of society to contribute to the betterment of poor segment. Do people have such preferences? The current study is undertaken with the objectives to investigate the willingness to donate and volunteer behavior of the students and to find out the factors which help in the cause of educational uplift of the poor fellow students in the Quaid I Azam University, Islamabad. The study used primary data of 251 respondents. The study employed descriptive analysis, the logistic regression model for the realization of the mentioned objectives. The study found that 50% of the student is willing to contribute and help their poor colleagues financially. In addition, the study also demonstrates that extrinsic factors i.e., Gender, Income of family and living away from home, are more influencing on a willingness to donate as compare to intrinsic i.e., Satisfaction and Religiosity. The policy implication is that the government should fulfill her responsibility in contributing to the education of poor and there must be facilitation for organizing societies to channelize the donated funds for the betterment of society in letter and spirit

Nutritional support for lactating women with or without azithromycin for infants compared to breastfeeding counseling alone in improving the 6-month growth outcomes among infants of peri-urban slums in Karachi, Pakistan-The protocol for a multiarm assessor-blinded randomized controlled trial (Mumta LW trial)

Background: Globally, 45% of under-five deaths are either directly or indirectly attributable to malnutrition, and most of these deaths are in low- and middle-income countries (LMICs). Children are particularly vulnerable in the first 6 months of life. An estimated 4.7 million infants under the age of 6 months are moderately wasted, whereas 3.8 million are severely wasted. Although the children of malnourished women have an increased risk of stunting and wasting, there is little information on this issue.Methods: This is a community-based, open-label, multiarm randomized controlled trial that will include parallel group assignments with a 1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. The women in the control group (control arm) will receive standard counseling only, whereas the lactating women in the first intervention group (intervention arm 1) will receive two sachets of balanced energy protein (BEP) supplementation per day from enrollment until the infant reaches 6 months of age. The lactating women in the second intervention group (intervention arm 2) will receive the same BEP supplementation as those in intervention arm 1 while their babies will also receive a single stat dose (20 mg/kg orally) of azithromycin at 42 days. The primary outcome will be the relative length velocity from 0 to 6 months by intervention arm. The primary analysis will be intention-to-treat analysis

Entrepreneurial Leadership and Creativity in Projects: A Moderated-Mediated Mechanism.

For managers/leaders without creativity and innovation, it's difficult to compete effectively on the market. Employee top success is not often enough to achieve a strategic edge in which creative attitudes and innovation can be counted as materials to create. An entrepreneurial leadership style is recognised as a crucial source of enhancing creativity in project-based organisations. However current research will provide empirical evidence in which leadership leads to creativity in projects through Innovative Work Behaviour (IWB) and Entrepreneurial SelfEfficacy (ESE) as a moderator. For this purpose, the leaders/managers in the project-based organisations are in the twin cities of Peshawar and Nowshera, KP; Pakistan was taken as a population of the study. All the four variables were measured through adopted instruments from the previous studies. Due to time, cost and other constraints, the study has employed the convenience sampling technique to gathered data. The collected data was run through various statistical techniques such as data cleaning, internal consistency, CFA and relationship via Structural Educational Modelling using CB AMOS 23. The results of the study found that Entrepreneurial leadership has significant and positive association with creativity in projects. The study also examined that innovative work behaviour partially mediates the association between Entrepreneurial leadership and has significant and positive association with creativity in projects. Further, the study also found that entrepreneurial self-efficacy moderates the association between entrepreneurial leadership and has significant and positive association with creativity in projects

Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: An open-label randomized controlled trial

Background: Maternal undernutrition is a direct risk factor for infant growth faltering.Objectives: We evaluated the effect of postnatal balanced energy protein (BEP) supplementation in lactating women and azithromycin (AZ) in infants on infant growth outcomes.Methods: A randomized controlled superiority trial of lactating mother-newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of breastfeeding, nutrition, infant immunization, and health promotion plus iron-folate supplementation until the infant was 6 mo old. In intervention arm 1, mothers additionally received two 75-g sachets of BEP per day. In intervention arm 2, along with the standard-of-care and BEP to the mother, the infant also received 1 dose of azithromycin (20 mg/kg) at the age of 42 d . The primary outcome was infant length velocity at 6 mo. The total sample size was 957 (319 in each arm).Results: From 1 August, 2018 to 19 May, 2020, 319 lactating mother-newborn dyads were randomly assigned in each arm, and the last follow-up was completed on 20 November, 2020. The mean difference in length velocity (cm/mo) between BEP alone and control was 0.01 (95% confidence interval [CI]: -0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI: 0.03, 0.13), and between BEP + AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) nonfatal events (injectable treatment and/or hospitalizations) were recorded.Conclusions: Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 mo, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition. This trial was registered at clinicaltrials.gov as NCT03564652