Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol

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Abstract

Introduction

Ending preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, <2.5 kg) infants. The majority of LBW infants are born in low- and middle-income countries (LMICs) and account for more than 60%–80% of newborn deaths. Feeding promotion tailored to meet the nutritional needs of LBW infants in LMICs may serve a crucial role in curbing newborn mortality rates and promoting growth. The Low Birthweight Infant Feeding Exploration (LIFE) study aims to establish foundational knowledge regarding optimal feeding options for LBW infants in low-resource settings throughout infancy.

Methods and analysis

LIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants.

Ethics and dissemination

This study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities.

Trial registration numbers

NCT04002908 and CTRI/2019/02/017475.

Related collections

Most cited references 53

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Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

A Tong, P SAINSBURY, J. Craig (2007)

Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.

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Using the framework method for the analysis of qualitative data in multi-disciplinary health research

Nicola K Gale, Gemma Heath, Elaine Cameron … (2013)

Background The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. Discussion The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. Summary Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.

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The Patient Health Questionnaire-2: validity of a two-item depression screener.

Kurt Kroenke, Robert L Spitzer, Janet B W Williams (2003)

A number of self-administered questionnaires are available for assessing depression severity, including the 9-item Patient Health Questionnaire depression module (PHQ-9). Because even briefer measures might be desirable for use in busy clinical settings or as part of comprehensive health questionnaires, we evaluated a 2-item version of the PHQ depression module, the PHQ-2. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). The PHQ-2 was completed by 6000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-2 depression severity increased from 0 to 6, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and healthcare utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-2 score > or =3 had a sensitivity of 83% and a specificity of 92% for major depression. Likelihood ratio and receiver operator characteristic analysis identified a PHQ-2 score of 3 as the optimal cutpoint for screening purposes. Results were similar in the primary care and obstetrics-gynecology samples. The construct and criterion validity of the PHQ-2 make it an attractive measure for depression screening.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2021

Publication date (Electronic): 2 December 2021

Volume: 11

Issue: 12

Electronic Location Identifier: e048216

Affiliations

[1 ]departmentAriadne Labs , Harvard T.H. Chan School of Public Health / Brigham and Women's Hospital , Boston, Massachusetts, USA

[2 ]departmentDepartment of Paediatrics , SCB Medical College and Hospital , Cuttack, Orissa, India

[3 ]departmentJawaharlal Nehru Medical College , KLE Academy of Higher Education and Research , Belgaum, Karnataka, India

[4 ]departmentDepartment of Neonatology , JJM Medical College , Davangere, Karnataka, India

[5 ]departmentDepartment of Obstetrics and Gynaecology , City Hospital , Cuttack, Orissa, India

[6 ]departmentDepartment of Paediatrics , SS Institute of Medical Sciences and Research Center , Davangere, Karnataka, India

[7 ]departmentInstitute for Global Health and Infectious Diseases , University of North Carolina at Chapel Hill School of Medicine , Chapel Hill, North Carolina, USA

[8 ]departmentDepartment of Pediatrics , University of North Carolina Project Malawi , Lilongwe, Malawi

[9 ]departmentDepartment of Pediatrics , University of North Carolina at Chapel Hill School of Medicine , Chapel Hill, North Carolina, USA

[10 ]departmentDepartment of Pediatrics and Child Health , Muhimbili University of Health and Allied Sciences , Dar es Salaam, Tanzania

[11 ]departmentDepartment of Global Health and Population , Harvard T.H. Chan School of Public Health , Boston, Massachusetts, USA

[12 ]departmentDepartment of Nutrition , University of North Carolina at Chapel Hill Gillings School of Global Public Health , Chapel Hill, North Carolina, USA

[13 ]departmentHubert Department of Global Health , Emory University School of Public Health , Atlanta, Georgia, USA

[14 ]departmentCenter for Nutrition , Boston Children's Hospital , Boston, Massachusetts, USA

[15 ]departmentMaternal, Newborn, Child Health and Nutrition Program , PATH , Seattle, Washington, USA

[16 ]departmentDepartment of Pediatric Newborn Medicine , Brigham and Women's Hospital , Boston, Massachusetts, USA

[17 ]departmentDepartment of Medicine , Harvard Medical School , Boston, Massachusetts, USA

Author notes

[Correspondence to ] Dr Linda Vesel; lvesel@ 123456ariadnelabs.org

Author information

Linda Vesel http://orcid.org/0000-0003-3753-4172

Friday Saidi http://orcid.org/0000-0003-1190-1499

Anne CC Lee http://orcid.org/0000-0003-2654-9862

Krysten North http://orcid.org/0000-0001-9283-4413

Katherine EA Semrau http://orcid.org/0000-0002-8360-1391

Article

Publisher ID: bmjopen-2020-048216

DOI: 10.1136/bmjopen-2020-048216

PMC ID: 8640640

PubMed ID: 34857554

SO-VID: 77af8237-0b1b-42b0-91f8-4488cbbfd503

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

History

Date received : 19 December 2020

Date accepted : 28 October 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;

Award ID: OPP1192260

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ScienceOpen disciplines: Medicine

Keywords: epidemiology,neonatology,nutrition & dietetics,public health,qualitative research

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ScienceOpen disciplines: Medicine

Keywords: epidemiology, neonatology, nutrition & dietetics, public health, qualitative research

Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

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AIP Publishing: Coronavirus

Most cited references 53

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

Using the framework method for the analysis of qualitative data in multi-disciplinary health research

The Patient Health Questionnaire-2: validity of a two-item depression screener.

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Author notes

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