PROTOCOL: Family and Community Interventions under Integrated Management of Childhood Illness Strategy for Reduction of Neonatal and Under-five Mortality among Children in Low-And-Middle-Income Countries: A Systematic Review

1.1 Description of the Problem

Millennium Development Goal 4, as defined by the United Nations in 2000, aims to reduce the 1990 under-five mortality rate (U5MR) by two thirds in the year 2015. A reduction U5MR will reflect the impact of child survival interventions and global policies aimed at international development (Mosley 2003). Nearly 98% of the 7.6 million child deaths globally each year occur in Low-and-Middle-Income countries (LMICs) and 64% of them are from preventable infectious causes namely sepsis, pneumonia, diarrhea and Malaria (Liu 2012). About 40% of the child deaths occur among neonates (0-28 days), from preventable causes such as preterm birth and intrapartum complications and sepsis (Liu 2012 and Lawn, 2012). Though U5MR has decreased from 9.6 million in 2000 (Black 2003) to 7.6 million in 2010, reduction of U5MR could still improve in many developing countries where U5MR remains high (Liu 2012). A slower decline of U5MR has been attributed to stagnant neonatal mortality rate (NMR) (Save the Children 2013) and prevailing high childhood morbidity rates (Murray 2007). Annual decline of NMR during 2000-2010 was slower than annual mortality decline among children 1-59 months when compared to 1990-2000 (Lawn 2012). Hence, child survival strategies should focus on infectious and neonatal causes of mortality (Liu 2012) and direct the resources towards vulnerable socio-economic groups for improved neonatal survival (Lawn 2012).

Available evidence suggests that interventions such as exclusive breastfeeding, clean delivery and skilled attendance at delivery, tetanus toxoid immunization to pregnant mothers, newborn resuscitation, and appropriate management of infections can prevent most neonatal deaths (Darmstadt 2005). In addition, prompt and appropriate management of acute diarrheal diseases (ADD), acute respiratory infections (ARI), and malaria and childhood under-nutrition can also prevent child mortality (Jones 2003). Research has shown that comprehensive training of health care providers (HCPs) on management of childhood morbidities at health facilities and in outreach services, can prevent a significant proportion of childhood mortality (Gove 1997). Studies have reported that available child health services are under-utilized, care-seeking behavior during acute illnesses is neither prompt (timely) nor appropriate (Sreeramareddy, 2006a; Sreeramareddy, 2012) which could be a reason for a slower progress towards achieving MDG-4 in many LMICs. Stagnation in neonatal mortality rate has been attributed to unsafe delivery and newborn care practices particularly in underserved rural communities and urban slums (Osrin, 2002; Sreeramareddy, 2006b; and Seward, 2012). Counseling the parents/care takers about symptoms and danger signs of child illness may improve the care-seeking behavior during the episodes of childhood illness. Therefore, behavior change communication aimed at improving utilization of child health services, seeking prompt and appropriate treatment during illness, improving perinatal and child care practices assume importance in LMICs where U5MR remains high.

1.2 Description of the interventions

Previously child survival interventions were usually implemented as separate disease specific programs for common causes of child mortality. These interventions and others such as exclusive breastfeeding, vaccination and oral rehydration therapy (ORT), are effective, children attending primary care settings are often known to have multiple and overlapping morbidities which need an integrated approach to treat them adequately (Bryce 2005b). The World Health Organization (WHO) and United Nations Children Fund (UNICEF) jointly with other technical partners developed the Integrated Management of Childhood Illness (IMCI) strategy to reduce U5MR in 1997 (Tulloch 1999). IMCI strategy aims to address the limitations encountered in disease specific child health programs by integrating treatment of common childhood morbidities that cause child mortality. Since its conception and after piloting the strategy in a few countries, more than 70 countries have fully implemented IMCI strategy (Lambrechts 1999). Three components of the IMCI strategy are:1) improving case management skills of healthcare providers (HCPs) particularly in the outpatient facilities (health worker interventions), 2) strengthening health systems (health system interventions) and 3) improving family and community health practices (WHO 2003; WHO 2005) (community interventions).

Health worker interventions are implemented by training healthcare providers about use of evidence-based, locally adapted guidelines for managing the leading causes of childhood illnesses. Training is provided in-service for duration of standard 11 days or shortened 5-10 days and a follow-up visit by the trainer after one month to reinforce the newly acquired skills for using IMCI guidelines and job-aids such as wall charts, diagnostic algorithms, etc. Health system interventions are mainly related to the key policies and management of health systems such as a)

Ensuring availability of essential drugs and supplies (job aids),

Implementation of household and community interventions of IMCI is done in one or more of the following ways: 1)

Counseling parents/caregivers at health facilities about care seeking behavior, danger signs, and home management of childhood illness, compliance to treatment advice, child feeding and utilization of preventive services

1.3 How the interventions might work

Training component of Integrated Management of Childhood Illness (IMCI) is expected to improve case management skills of healthcare providers, thus reducing mortality from acute respiratory infections, acute diarrheal diseases and malaria. The health system interventions would improve the infrastructure of health facilities i.e. health staff, job aids, and treatment facilities (drugs) for treatment of childhood illnesses. While the health worker training and health system interventions together would improve the quality of care provided at health facilities; the family and community interventions may improve family's care seeking behavior and community childcare practices. Improved quality of care as a result of training and health system interventions together with community interventions may lead to increase in utilization of child health services. All the three IMCI interventions are expected to act synergistically towards reducing child mortality (Ahmed et al. 2010; Lulseged 2002). A causal chain (figure 1) shows various family and community interventions of IMCI strategy and ensuing programmatic pathways of intermediate and final health outcomes. Family and community interventions are expected to improve care seeking behaviors of family members/caregivers for common childhood illnesses (choosing appropriate care and seeking prompt care (within 24 hours), community practices regarding perinatal and newborn care, caregiver's compliance to HCP's treatment and advice. Family interventions are also expected increase uptake of preventive services, improve child feeding practices also. In addition to these expected change, social mobilization through involvement of women's groups, community leaders will raise the general awareness and demand for improving household and community practices with regards to child health. All these improvements will increase the utilization of preventive and curative services and overall improvements in health and nutritional status of under-five children, thus decreasing child mortality (Bryce, Victora, Habicht, Black, & Scherpbier 2005b).

1.4 Why it is important to do this review

Evidence about impact of Integrated Management of Childhood Illness (IMCI) is available from community trials, WHO multi-country evaluation report and a few systematic reviews. Primary studies which have assessed the impact of IMCI strategy on health care providers' performance have demonstrated that IMCI strategy can improve the quality of care at the health facilities (Amaral et al. 2004; Amaral et al. 2005; Amaral et al. 2008; Arifeen et al. 2005; Bryce et al. 2005a; Huicho et al. 2005). Primary studies which have assessed the impact of health care provider training alone as an intervention to strengthen IMCI program have shown a variable effect on outcomes of childhood illness (Ahmed, Mitchell, & Hedt 2010; Goga & Muhe 2011; Lulseged 2002). However, evidence from primary studies about the impact of one or more of IMCI interventions on child mortality is inconclusive (Amaral, Leite, Cunha, &Victora 2005; Arifeen et al. 2009; Bhandari et al. 2012; Huicho, Davila, Gonzales, Drasbek, Bryce, &Victora 2005). A report about Multi-Country Evaluation on Effectiveness of Integrated Management of Childhood Illness (IMCI), Cost and Impact (MCE-IMCI) suggested that IMCI delivery systems should be expanded to include other potential channels such as private health sector and adopt stronger community-based approaches rather than being just health facility-based (Bryce, Victora, Habicht, Black, & Scherpbier 2005b). A mixed methods multi-country survey has highlighted that financial shortages, logistic difficulties in follow-up after training in IMCI case management training and human resource shortages (in terms of number and/or skills) as challenges to IMCI scale-up (Goga et al. 2009; Goga and Muhe 2011).

To date, we found three systematic reviews on this topic by searching in Index Medicus, Scopus and Cochrane library. A narrative review that focused on parents/caregiver's role in IMCI strategy has underscored that ICMI trained workers lacked communication skills about counseling the parents/caregivers about danger signs and homecare of sick child (Paranhos et al. 2011). A systematic review comparing the effect of standard 11-days training versus shortened 5-10 days training on quality of care has concluded that standard (11-days) IMCI training was marginally better and underscored the need for implementing other IMCI interventions irrespective of the training duration. This review also found that for a third of sick children, the HCPs did not adhere to IMCI guidelines (Rowe et al. 2012). A Cochrane systematic review protocol aims to synthesize the evidence on effect of integration of individual IMCI components as a healthcare package on both HCPs and its beneficiaries (Gera et. al. 2012). However, a Cochrane review of both experimental and quasi-experimental studies has shown that there is very little evidence that integrating primary health care services at the point-of-delivery may improve the utilization and outputs of healthcare delivery (Dudley & Garner, 2011). However, among the published reviews, one review did not perform meta-analysis but only summarised the results on impact of IMCI interventions on mortality rates and utilization rates of child health care services (Rowe et al. 2012) while another review qualitatively synthesized the caregiver's (mothers and/or family members) child health care practices (Paranhos et al. 2011). A published Cochrane systematic review protocol aims to synthesize impact of various combinations of three IMCI interventions on mortality, quality of care and key IMCI indicators. Though family and community interventions of our review overlap with interventions to be included in a review by Gera et al. we aim to focus only on various components of family and community interventions (see section 3.1.2) and assess entire intermediate outcomes related to proximate determinants to childhood mortality. Moreover, none of the above reviews have focussed on the impact of IMCI interventions on community child health care practices as underscored by another review (Paranhos et al. 2011) or focussed the review on the impact of standalone community interventions on child mortality rates plus childcare practices of the family and community. Moreover, published reviews have not compared the impact of supply side interventions (health worker and health system interventions) with demand side interventions (community interventions). In addition, from the existing reviews evidence is lacking about the impact of family and community interventions on compliance to homecare of a sick child, care seeking behavior and preventive practices (Thompson and Harutyunyan 2009). Hence, synthesizing the evidence about impact of family and community interventions of IMCI strategy on its beneficiaries is timely and policy relevant. We aim to report the effect of household and community interventions inclusive of social mobilization on under-five mortality and other intermediate outcomes such as care seeking and community child care practices. We also aim to compare the outcomes demand side interventions (community) with outcome of supply side interventions (health worker plus health system).

Main objective

To assess the effect of family and community interventions under Integrated Management of Childhood Illness (IMCI) strategy on childhood mortality rates, utilization of child health services and community child health practices in LMICs.

3.1 Criteria For Considering Studies For The Review (PICOs)

3.4 Data synthesis

Analysis will be conducted in RevMan 5 and/or Stata as appropriate. Meta-analysis will be done separately for RCTs and n-RCTs in accordance to current recommendations (Higgins, 2011). Due to diversity in interventions, participants and outcomes we anticipate the use of random effects models. If we find at least two studies that evaluated similar interventions and reported similar outcomes, we will calculate pooled risk ratios, mean differences or standardised mean differences using a random-effects model. Pooled estimates will be calculated by generic inverse variance method and will be generated as Forrest plots. If there are not enough (at least two) studies evaluating similar interventions and reporting a similar outcomes, we will report the median and range of effects, if relevant, or measures of effect from individual studies. We will do separate meta-analysis for the following IMCI interventions or their combinations 1) community interventions only, 2) health worker interventions only, 3) health worker interventions combined with health system and/or community interventions. If meta-analyses is possible, we will compare the outcomes across combinations of IMCI interventions. If meta-analyses was not possible we will prepare a ‘Summary of findings’ table, including an assessment of the quality of evidence for each of the main outcomes or types of outcomes listed above. Quality of evidence will be assessed using the GRADE approach for each outcome and will be classified in four levels as ‘high’, ‘moderate’, ‘low’ and ‘very low’ (Guyatt 2008).