Vulnerable newborn types: analysis of subnational, population-based birth cohorts for 541 285 live births in 23 countries, 2000-2021.

OBJECTIVE: To examine prevalence of novel newborn types among 541 285 live births in 23 countries from 2000 to 2021. DESIGN: Descriptive multi-country secondary data analysis. SETTING: Subnational, population-based birth cohort studies (n = 45) in 23 low- and middle-income countries (LMICs) spanning 2000-2021. POPULATION: Liveborn infants. METHODS: Subnational, population-based studies with high-quality birth outcome data from LMICs were invited to join the Vulnerable Newborn Measurement Collaboration. We defined distinct newborn types using gestational age (preterm [PT], term [T]), birthweight for gestational age using INTERGROWTH-21st standards (small for gestational age [SGA], appropriate for gestational age [AGA] or large for gestational age [LGA]), and birthweight (low birthweight, LBW [<2500 g], nonLBW) as ten types (using all three outcomes), six types (by excluding the birthweight categorisation), and four types (by collapsing the AGA and LGA categories). We defined small types as those with at least one classification of LBW, PT or SGA. We presented study characteristics, participant characteristics, data missingness, and prevalence of newborn types by region and study. RESULTS: Among 541 285 live births, 476 939 (88.1%) had non-missing and plausible values for gestational age, birthweight and sex required to construct the newborn types. The median prevalences of ten types across studies were T+AGA+nonLBW (58.0%), T+LGA+nonLBW (3.3%), T+AGA+LBW (0.5%), T+SGA+nonLBW (14.2%), T+SGA+LBW (7.1%), PT+LGA+nonLBW (1.6%), PT+LGA+LBW (0.2%), PT+AGA+nonLBW (3.7%), PT+AGA+LBW (3.6%) and PT+SGA+LBW (1.0%). The median prevalence of small types (six types, 37.6%) varied across studies and within regions and was higher in Southern Asia (52.4%) than in Sub-Saharan Africa (34.9%). CONCLUSIONS: Further investigation is needed to describe the mortality risks associated with newborn types and understand the implications of this framework for local targeting of interventions to prevent adverse pregnancy outcomes in LMICs.

Taming troubled teens: the social production of mental morbidity amongst young mothers in Pelotas, Brazil.

Explanations for the association between teen-childbearing and subsequent mental morbidity vary considerably, from those based on neurological theories of development to those investigating underlying social and economic determinants. Based on longitudinal epidemiological and ethnographic sub-studies of the 1982 Pelotas birth cohort study, this paper explores the hypothesis that teen childbearing and subsequent mental morbidity have become associated through the interplay of culture, society, and biology in situations where teen pregnancy has become a stigmatised object of scientific and public health attention. Results show that the effect of teen childbearing on subsequent mental morbidity remained significant in the multivariate analysis. Ethnographic analysis, together with epidemiological effect modification analyses, suggest that this association is partially accounted for by the fact that it is more pronounced amongst a specific subgroup of women of low socio-economic status who, being more politicised about societal injustice, were also more critically engaged with - and thus troubled by - the inequitable institutionalisation of life-cycle transitions. With time, these women became highly critical of the institutionalised identification of early childbearing as a key violation of life-cycle norms and the differential class-based application of scientific knowledge on its causes and consequences. Public health campaigns should consider how the age-based institutionalisation of developmental norms has enabled the stigmatisation of those identified as transgressors.

Alternatives to randomisation in the evaluation of public health interventions: design challenges and solutions.

BACKGROUND: There has been a recent increase in interest in alternatives to randomisation in the evaluation of public health interventions. We aim to describe specific scenarios in which randomised trials may not be possible and describe, exemplify and assess alternative strategies. METHODS: Non-systematic exploratory review. RESULTS: In many scenarios barriers are surmountable so that randomised trials (including stepped-wedge and crossover trials) are possible. It is possible to rank alternative designs but context will also determine which choices are preferable. Evidence from non-randomised designs is more convincing when confounders are well-understood, measured and controlled; there is evidence for causal pathways linking intervention and outcomes and/or against other pathways explaining outcomes; and effect sizes are large. CONCLUSION: Non-randomised trials might provide adequate evidence to inform decisions when interventions are demonstrably feasible and acceptable, and where evidence suggests there is little potential for harm, but caution that such designs may not provide adequate evidence when intervention feasibility or acceptability is doubtful, and where existing evidence suggests benefits may be marginal and/or harms possible.

Alternatives to randomisation in the evaluation of public-health interventions: statistical analysis and causal inference.

BACKGROUND: In non-randomised evaluations of public-health interventions, statistical methods to control confounding will usually be required. We review approaches to the control of confounding and discuss issues in drawing causal inference from these studies. METHODS: Non-systematic review of literature and mathematical data-simulation. RESULTS: Standard stratification and regression techniques will often be appropriate, but propensity scores may be useful where many confounders need to be controlled, and data are limited. All these techniques require that key putative confounders are measured accurately. Instrumental variables offer, in theory, a solution to the problem of unknown or unmeasured confounders, but identifying an instrument which meets the required conditions will often be challenging. Obtaining measurements of the outcome variable in both intervention and control groups before the intervention is introduced allows balance to be assessed, and these data may be used to help control confounding. However, imbalance in outcome measures at baseline poses challenges for the analysis and interpretation of the evaluation, highlighting the value of adopting a design strategy that maximises the likelihood of achieving balance. Finally, when it is not possible to have any concurrent control group, making multiple measures of outcome pre- and postintervention can enable the estimation of intervention effects with appropriate statistical models. CONCLUSION: For non-randomised designs, careful statistical analysis can help reduce bias by confounding in estimating intervention effects. However, investigators must report their methods thoroughly and be conscious and critical of the assumptions they must make whenever they adopt these designs.

Newborn care: the effect of a traditional illness, asram, in Ghana.

AIMS: To explore the role of a traditional illness of the newborn, asram, in care-seeking in rural Ghana. METHODS: Data are from formative research into newborn care which included collecting qualitative data from 14 villages in Brong Ahafo region of Ghana through 25 birth narratives, 30 in-depth interviews and two focus groups with recently delivered/pregnant women, 20 in-depth interviews and six focus groups with birth attendants/grandmothers, 12 in-depth interviews and two focus groups with husbands, and six in-depth interviews with asram healers. RESULTS: The study confirmed that asram is characterised by symptoms which include green/black veins, a big head and the newborn growing lean. However, a complex classification of 14 types of asram covering a wide array of symptoms was identified. Asram was perceived as a common illness which cannot be treated at health facilities and to which many danger signs in the newborn are attributed, and thus it affects care-seeking. Asram treatment includes frequent cold herbal baths and air-drying; however, oral treatments and preventive bathing are also used. Any modification of asram treatment was reported to require the sanction of a healer. CONCLUSION: Understanding traditional illnesses as a potential barrier to newborn care-seeking is essential for designing care-seeking interventions. An asram diagnosis can prevent sick newborns being taken to health facilities and traditional treatment exposes them to the risk of hypothermia.

Review of the theoretical frameworks for the study of child development within public health and epidemiology.

BACKGROUND: Care for child development has gained international momentum in research and community-based programming. It encompasses various domains including cognitive, psychomotor, emotional, behavioural and social development, and a multitude of factors that have the potential to influence its trajectories. However, the multidisciplinary nature of child development initiatives is marred by a lack of unified perspectives across disciplines, especially basic conceptual understanding generated in the fields of education and psychology, which are not effectively exploited in public health programmes and epidemiological research. METHODS: The article suggests a four-point evaluation criteria to child development theories based on the ability to communicate in (1) Cross-disciplines, (2) an Overarching facility to address various developmental domains, (3) the capacity to link child development with Lifelong developmental potentials and, most importantly, (4) Epidemiological capability to provide supporting empirical evidence for community-based public health interventions (COLE criteria). RESULTS: Key child development theories have been reviewed by broadly grouping them into three categories on the basis of content and approach, such as descriptive theories, psychological construct-based theories, and context-based theories. The strengths and challenges of these theories have been evaluated on the basis of COLE criteria. CONCLUSION: Although most of these theories can contribute at different levels in child development initiatives, context-based theories have been particularly proposed to practitioners, researchers and policy makers for community-based programming, principally for its potential to address issues of social inequality, poverty and childcare practices, which are at the core of public health initiatives, and provide multiple level of opportunities to intervene.

How did formative research inform the development of a home-based neonatal care intervention in rural Ghana?

Formative research is often used to inform intervention design, but the design process is rarely reported. This study describes how an integrated home visit intervention for newborns in Ghana was designed. As a first step in the design process, the known intervention parameters were listed, information required to refine the intervention was then identified and a formative research strategy designed. The strategy included synthesizing available data, collecting data on newborn care practices in homes and facilities, on barriers and facilitators to adopting desired behaviors and on practical issues such as whom to include in the intervention. The data were used to develop an intervention plan through workshops with national and international stakeholders and experts. The intervention plan was operationalized by district level committees. This included developing work plans, a creative brief for the materials and completing a community volunteer inventory. The intervention was then piloted and the intervention materials were finalized. The design process took over a year and was iterative. Throughout the process, literature was reviewed to identify the best practice. The intervention focuses on birth preparedness, using treated bednets in pregnancy, early and exclusive breastfeeding, thermal care, special care for small babies and prompt care seeking for newborns with danger signs. The need for a problem-solving approach was identified to help ensure behavior change. A subset of behaviors were already being performed adequately, or were the focus of other interventions, but were important to reinforce in the visits. These include attending antenatal care and care seeking for danger signs in pregnancy. On the basis of the intervention content, the timing of newborn deaths and the acceptability of visits, two antenatal and three visits in the first week of life (days 1, 3 and 7) were planned. Several household members were identified to include in the visits as they were involved in newborn care or they made financial decisions. Birth attendants and health workers were often the locus of control for immediate newborn care, and sensitization activities were designed to improve their practices and to help ensure that families received consistent messages. An existing cadre of community volunteers was identified to deliver the intervention-these volunteers were already trusted and accepted by the community, already visited pregnant women at home and had the time and commitment to deliver the intervention. A supervision and remuneration system was developed through discussions with the volunteers and at the planning workshops. The need for community entry activities was identified to garner community support for the intervention, to encourage self-identification of pregnant and delivered women and to motivate the volunteer through community recognition. Formative research is an essential step in helping to ensure the development of an effective, appropriate and sustainable intervention.

Early initiation of breast-feeding in Ghana: barriers and facilitators.

To explore why women in Ghana initiate breast-feeding early or late, who gives advice about initiation and what foods or fluids are given to babies when breast-feeding initiation is late. Qualitative data were collected through 52 semistructured interviews with recent mothers, 8 focus group discussions with women of child-bearing age and 13 semistructured interviews with health workers, policy makers and implementers. The major reasons for delaying initiation of breast-feeding were the perception of a lack of breast milk, performing postbirth activities such as bathing, perception that the mother and the baby need rest after birth and the baby not crying for milk. Facilitating factors for early initiation included delivery in a health facility, where the staff encouraged early breast-feeding, and the belief in some ethnic groups that putting the baby to the breast encourages the milk. Policy makers tended to focus on exclusive breast-feeding rather than early initiation. Most activities for the promotion of early initiation of breast-feeding were focused on health facilities with very few community activities. It is important to raise awareness about early initiation of breast-feeding in communities and in the policy arena. Interventions should focus on addressing barriers to early initiation and should include a community component.

Impact of early infant feeding practices on mortality in low birth weight infants from rural Ghana.

OBJECTIVE: To assess the impact of early infant feeding practices on low birth weight- (LBW) specific neonatal mortality in rural Ghana. STUDY DESIGN: A total of 11 787-breastfed babies were born between July 2003 and June 2004 and survived to day 2. Overall, 3411 (30.3%) infants had weight recorded within 48 h. Two hundred and ninety-six (8.7%) infants were <2.5 kg and 15 died in the neonatal period. Associations were examined using multivariate logistic regression. RESULT: Initiation of breastfeeding after day 1 was associated with a threefold increase in mortality risk (adjusted odds ratio (adjOR) 3.23, 95% confidence interval (95% CI) (1.07-9.82)) in infants aged 2 to 28 days. Prelacteal feeding was associated with a threefold significantly increased mortality risk (adjOR 3.12, 95% CI (1.19-8.22)) in infants aged 2 to 28 days but there was no statistically significant increase in risk associated with predominant breastfeeding (adjOR 1.91, 95% CI (0.60-6.09)). There were no modifications of these effects by birth weight. The sample size was insufficient to allow assessment of the impact of partial breastfeeding. CONCLUSION: Improving early infant feeding practices is an effective, feasible, low-cost intervention that could reduce early infant mortality in LBW infants in developing countries. These findings are especially relevant for sub-Saharan Africa where many LBW infants are born at home, never taken to a health facility and mortality rates are unacceptably high.

Spousal sexual violence and poverty are risk factors for sexually transmitted infections in women: a longitudinal study of women in Goa, India.

OBJECTIVES: To describe factors associated with incident sexually transmitted infections (STI) in a population-based sample of women in Goa, India. METHODS: A random sample of women aged 18-45 years was enrolled in Goa from November 2001 to May 2003. All subjects who consented to participate and completed the recruitment procedure were interviewed six and 12 months after recruitment. Incident chlamydia, gonorrhoea or trichomoniasis from vaginal and/or urine specimens were detected using a commercial polymerase chain reaction and the InPouch TV Culture Kit. RESULTS: Of the 2180 women followed up, 64 had an incident STI (incidence of 1.8% in the first six months, and 1.4% in the second six months). Incident STI was associated with low socioeconomic status, marital status, and with concurrent bacterial vaginosis. Incidence was highest among women who were married and exposed to sexual violence (10.9%), were concerned about their husbands' affairs (10.5%), or were separated, divorced or widowed women (11.0%). CONCLUSIONS: Socially disadvantaged women are at increased risk of STI in this population. Sexual intercourse outside marriage was rarely reported in this population, and women are at risk of becoming infected within marriage, especially those with sexual violence. This highlights the vulnerabilities of socially disadvantaged married women in India, and the need for healthcare professionals to screen STI patients for violence, and provide the necessary support. The results also stress the importance of effectively diagnosing and treating married men with STI and promoting safer sex within marriage.

Informed consent in Ghana: what do participants really understand?

OBJECTIVES: To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15-45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge. METHODS: 60 semistructured interviews and 12 focus groups were conducted to explore subjects' perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge that not all trial capsules are the same. The subjects' fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling. RESULTS: Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers' characteristics were not associated with subjects' knowledge. CONCLUSIONS: Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education.

Detecting common mental disorders in primary care in India: a comparison of five screening questionnaires.

BACKGROUND: Screening of patients for common mental disorders (CMDs) is needed in primary-care management programmes. This study aimed to compare the screening properties of five widely used questionnaires. METHOD: Adult attenders in five primary-care settings in India were recruited through systematic sampling. Four questionnaires were administered, in pairs, in random order to participants: the General Health Questionnaire (GHQ, 12 items); the Primary Health Questionnaire (PHQ, nine items); the Kessler Psychological Distress Scale (K10, 10 items), and from which we could extract the score of the shorter 6-item K6; and the Self-Reporting Questionnaire (SRQ, 20 items). All participants were interviewed with a structured lay diagnostic interview, the Revised Clinical Interview Schedule (CIS-R). RESULTS: Complete data were available for 598 participants (participation rate 99.3%). All five questionnaires showed moderate to high discriminating ability; the GHQ and SRQ showed the best results. All five showed moderate to high degrees of correlation with one another, the poorest being between the two shortest questionnaires, K6 and PHQ. All five had relatively good internal consistency. However, the positive predictive value (PPV) of the questionnaires compared with the diagnostic interview ranged from 51% to 77% at the optimal cut-off scores. CONCLUSIONS: There is little difference in the ability of these questionnaires to identify cases accurately, but none showed high PPVs without a considerable compromise on sensitivity. Hence, the choice of an optimum cut-off score that yields the best balance between sensitivity and PPV may need to be tailored to individual settings, with a higher cut-off being recommended in resource-limited primary-care settings.

Vitamin A supplementation increases ratios of proinflammatory to anti-inflammatory cytokine responses in pregnancy and lactation.

Vitamin A supplementation reduces child mortality in populations at risk of vitamin A deficiency and may also reduce maternal mortality. One possible explanation for this is that vitamin A deficiency is associated with altered immune function and cytokine dysregulation. Vitamin A deficiency in pregnancy may thus compound the pregnancy-associated bias of cellular immune responses towards Th-2-like responses and exacerbate susceptibility to intracellular pathogens. We assessed mitogen and antigen-induced cytokine responses during pregnancy and lactation in Ghanaian primigravidae receiving either vitamin A supplementation or placebo. This was a double-blind, randomized, placebo-controlled trial of weekly vitamin A supplementation in pregnant and lactating women. Pregnancy compared to postpartum was associated with a suppression of cytokine responses, in particular of the proinflammatory cytokines interferon (IFN)-gamma and tumour necrosis factor (TNF)-alpha. Mitogen-induced TNF-alpha responses were associated with a decreased risk of peripheral parasitaemia during pregnancy. Furthermore, vitamin A supplementation was significantly associated with an increased ratio of mitogen-induced proinflammatory cytokine (IFN-gamma) to anti-inflammatory cytokine (IL-10) during pregnancy and in the postpartum period. The results of this study indicate that suppression of proinflammatory type 1 immune responses and hence immunity to intracellular infections, resulting from the combined effects of pregnancy and vitamin A deficiency, might be ameliorated by vitamin A supplementation.

The burden and determinants of reproductive tract infections in India: a population based study of women in Goa, India.

BACKGROUND/OBJECTIVE: Reproductive tract infections (RTI) present major health, social, and economic problems in developing countries. Our objective was to describe the prevalence and risk factors of RTIs in a population based sample of women aged 18-45 years. METHOD: 2494 women of 3000 randomly selected from the population defined by a primary health centre catchment area consented to participate. Participants were interviewed regarding complaints and risk factors. Laboratory specimens were collected for the diagnosis of RTIs. Analyses of risk factors were carried out separately for the outcomes of sexually transmitted infections: chlamydia, gonorrhoea, trichomoniasis; and endogenous infections: bacterial vaginosis (BV) and candida. RESULTS: Endogenous infections were relatively common (BV 17.8%; candida 8.5%), and sexually transmitted infections (STI) were infrequent (4.2%). Factors indicative of poverty and marginalisation were associated with STIs and BV. Gender disadvantage, particularly spousal violence, was associated with BV, while concern about a husband's extramarital relationships, an indicator of sexual risk, was associated with STI. Husband's discharge was strongly associated with STI, and a non-white vaginal discharge was associated with both STI and BV. Condom use and oral contraceptive use were associated with a reduced risk of BV. CONCLUSIONS: Most of the population burden of RTIs is attributed to endogenous infections. Socioeconomic deprivation and gender disadvantage are associated with raised risk for BV, while the risk factors for STIs indicated that disadvantaged women were likely to be infected by their husbands.

Ophthalmic nurse practitioner led diabetic retinopathy screening. Results of a 3-month trial.

PURPOSE: To describe the design and implementation of a nurse led diabetic retinopathy screening clinic. To present the results of a 3-month trial period assessing the concordance of retinopathy grading between a nurse practitioner and an ophthalmologist. METHOD: Patients attending for annual diabetic eye review during an initial 3-month trial period were assessed in a dedicated diabetic eye clinic by an ophthalmic nurse practitioner and an ophthalmologist, with both grading the degree of diabetic retinopathy using to the Wisconsin grading system. Each was masked as to the other's findings. The concordance of retinopathy grading between ophthalmic nurse practitioner and ophthalmologist was assessed. RESULTS: A total of 95 patients (189 eyes) were assessed during the study period. A 92% concordance was achieved between the ophthalmologist and the ophthalmic nurse practitioner. In total, 72 eyes were graded as having some degree of retinopathy by the ophthalmologist. The sensitivity of the nurse practitioner for diagnosing the presence of diabetic retinopathy was 93%, and the specificity 91%. Nine eyes with severe nonproliferative diabetic retinopathy or worse, and four with clinically significant macular oedema were seen. All were correctly identified by the nurse practitioner. CONCLUSIONS: The structure and management protocols of the clinic are described. An excellent concordance between ophthalmologist and nurse practitioner was achieved in this group of patients with relatively less advanced retinopathy.

Technical aspects and complications of laparoscopic banding for morbid obesity--a radiological perspective.

Morbid obesity is a significant clinical problem in the western world. Various surgical restrictive procedures have been described as an aid to weight reduction when conservative treatments fail. Adjustable laparoscopic gastric banding (LAPBAND) has been popularized as an effective, safe, minimally invasive, yet reversible technique for the treatment of morbid obesity. Radiological input is necessary in the follow-up of these patients and the diagnosis of complications peculiar to this type of surgery. In this review we will highlight the technical aspects of radiological follow-up and the lessons learnt over the last 5 years.

Polymeric versus elemental diet as primary treatment in active Crohn's disease: a randomized, double-blind trial.

OBJECTIVE: Enteral feeding is now an established primary therapy for active Crohn's disease. This first-double blind randomized trial was designed to compare the therapeutic efficacy of a polymeric diet (PD) with an elemental diet (ED). METHODS: Patients with active Crohn's disease (Crohn's disease activity index [CDAI] > 150, increased bowel uptake of Tc-HMPAO-labeled leukocytes, and abnormal C-reactive protein [CRP]), were randomized to receive either an ED or a PD. The two preparations were identical except for the nitrogen source, which was amino acid based in ED and intact protein in PD. Enteral feeding was considered successful if clinical remission was achieved as defined by a final CDAI of < or = 150, a reduction in the CDAI by at least 100 points from baseline level, and a normal CRP. RESULTS: Twenty-one patients were enrolled of whom 11 were randomized to PD and 10 to ED. The two groups were comparable at entry. Clinical remission was obtained in eight (80%) patients receiving ED and six (55%) patients receiving PD, p = 0.1. The treatment failed in three and two patients in the PD and ED groups, respectively. Another two patients were intolerant to the feed (PD). Reduction in the CDAI after treatment with ED (359 +/- 67 to 112 +/- 19) was similar to that seen with PD (303 +/- 27 to 97 +/- 11). Similar changes in the CRP were also observed (16 +/- 5 to 4 +/- 1.6) and (62 +/- 20 to 9 +/- 6), respectively. Overall, enteral feeding was successful in 14 patients (63%). CONCLUSIONS: Enteral nutrition is effective in treatment of active Crohn's disease. Differences in nitrogen sources of enteral feeds are not relevant to their therapeutic efficacy, as polymeric and elemental diets are equally effective.

Oral nutritional supplementation is effective in the maintenance of remission in Crohn's disease.

BACKGROUND: Enteral feeding with either elemental or polymeric diets is an established primary therapy for active Crohn's disease. However, the role of supplementing normal food with elemental diet in the long-term management of Crohn's disease has hitherto not been explored. PATIENTS AND METHODS: A series of 39 consecutive patients with Crohn's disease in clinical remission were studied. Of these, 21 patients (Group 1) received oral nutritional supplementation, taken in addition to their normal diet. Their outcome (relapse rate, Crohn's disease activity index, inflammatory markers) was compared with that of 18 patients (Group 2), who were maintained on a normal unrestricted diet over an observation period of 12 months. RESULTS: A total of 17 patients (81%) tolerated the nutritional supplementation. On an intention-to-treat basis, 10 patients (48%) remained in remission for 12 months, compared to 4/18 (22%) patients in Group 2, p<0.0003. Their Crohn's disease activity index and CRP remained stable while their weight and body mass index improved during the period of nutrition therapy Seven patients in Group 1 and 14 in Group 2 relapsed at a mean of 7.4+/-0.9 and 6.2+/-0.4 months, respectively. The response to nutrition supplement was independent of age, sex, disease duration or location. Four patients (19%) were intolerant to enteral feeding. CONCLUSIONS: Nutritional supplementation is safe, well tolerated and effective in the long-term management of patients with quiescent Crohn's disease.