Ahmed Sheraz, Ariff Shabina, Soofi Sajid Bashir, Hussain Amjad, Hotwani Aneeta, Yaqoob Muhammad, Qureshi Shahida M, Ahmed Imran, Islam Mohammad Shahidul, Saha Samir K, Bhutta Zulfiqar A
From *The Aga Khan University, Karachi, Pakistan; and †Child Health Research Foundation, Dhaka, Bangladesh.
Pediatr Infect Dis J. 2016 May;35(5 Suppl 1):S65-9. doi: 10.1097/INF.0000000000001110.
The Aetiology of Neonatal Infection in South Asia (ANISA) study is a population-based study with sites in Bangladesh, India and Pakistan. It aims to determine community-acquired incidence, etiology and associated risk factors for neonatal infections. Matiari, a rural site in Pakistan, was chosen for the study due to its high neonatal mortality rate and the presence of an established pregnancy and birth surveillance system. This article summarizes various challenges, remedial measures taken and lessons learned during the implementation of the ANISA study protocol in the unique rural setting of Matiari where the majority of births take place at home and accessibility to health care is limited.
Achieving and maintaining project targets of early registration of birth and collection of biological specimens in households have been challenging in Matiari. Capturing births of study subjects that occur outside the catchment areas and those taking place during public holidays and acquiring parental consent for specimen collection from healthy controls require extensive community mobilization. Contamination and power outages that affect the laboratory equipment are 2 of the major logistic challenges faced. We keep track of pregnancy outcomes through mobile phones and reimburse the costs for birth notifications to the caller. We created separate dedicated mobile teams that visit newborns outside the catchment area and carry out possible serious bacterial infection assessments. We also formed mobile teams for specimen collection from residences of newborns as there is no facility for specimen collection at this site. Our study personnel work on holidays and weekends to improve the study's performance. We nurture strong community liaison by employing staff from within the community. We train the study physicians on communication and counseling skills required for overcoming refusal for referral and specimen collection. The contamination rate is controlled by repeated training and supervision and extensive monitoring of phlebotomy activities. The majority of phlebotomy procedures are recorded on video in the field to provide feedback to phlebotomists for improving their performance.
The contextual challenges faced in field implementation of the ANISA protocol in the rural setting of Matiari are unique. These challenges are being successfully addressed through hard work, strict monitoring and improvisation. This experience can be used for improving study performance in similar settings elsewhere.
南亚新生儿感染病因（ANISA）研究是一项基于人群的研究，在孟加拉国、印度和巴基斯坦设有研究点。其目的是确定社区获得性新生儿感染的发病率、病因及相关危险因素。巴基斯坦的一个农村地区马蒂亚里因其较高的新生儿死亡率以及已建立的妊娠和出生监测系统而被选为研究地点。本文总结了在马蒂亚里独特的农村环境中实施ANISA研究方案期间遇到的各种挑战、采取的补救措施以及吸取的经验教训，在该地区，大多数分娩在家中进行，获得医疗保健的机会有限。
在马蒂亚里，要实现并维持项目设定的在家中尽早登记出生信息和采集生物样本的目标具有挑战性。要记录在集水区以外发生的研究对象的出生情况以及在公共假日发生的出生情况，并获得健康对照者的父母同意采集样本，需要进行广泛的社区动员。影响实验室设备的污染和停电是面临的两大后勤挑战。我们通过手机跟踪妊娠结局，并向打电话者报销出生通知费用。我们组建了单独的专门流动小组，前往集水区以外探访新生儿，并进行可能的严重细菌感染评估。由于该地点没有样本采集设施，我们还组建了流动小组，从新生儿家中采集样本。我们的研究人员在节假日和周末工作，以提高研究效率。我们通过雇佣社区内部人员来加强与社区的紧密联系。我们对研究医生进行培训，使其掌握克服转诊和样本采集拒绝问题所需的沟通和咨询技巧。通过反复培训、监督以及对静脉穿刺活动的广泛监测来控制污染率。大多数静脉穿刺操作在现场进行视频记录，以便向静脉穿刺人员提供反馈，以提高其操作水平。
在马蒂亚里农村地区实施ANISA方案时面临的实际挑战具有独特性。通过努力工作、严格监测和改进，这些挑战正得到成功解决。这一经验可用于改善其他类似环境中的研究工作。
