Campbell International Development Group Title Registration Form

Transcription

1 Campbell International Development Group Title Registration Form Please complete this form to outline your proposal for a Campbell International Development Group systematic review. the completed form to Martina Vojtkova, Coordinator, Campbell International Development Group: mvojtkova@3ieimpact.org. Tel: Before completing this form: Make sure that your proposal falls within our scope, and that it has not already been covered in another Campbell or Cochrane review. Check existing registered titles at: and Authors are advised to use the Cochrane Handbook for Systematic Reviews of Interventions (see Be aware that preparing a Campbell review requires a significant, long-term commitment. At least two authors are required before a title can be registered. 1. Title of review Suggested format: [intervention/s] for [outcome/s] in [problem/population] in [location/situation] Example: Water and sanitation interventions for reducing child diarrhoea in low and middle income countries. Impact of nutrition support programs in reducing maternal mortality and morbidity: a systematic review 2. Background and objective(s) of review Briefly describe the problem, the intervention(s), the relevance to policy and practice, and the objective(s) of the review, including important sub-questions. Will you develop a logic model (theory of change) to illustrate the hypothesized mechanism of action (that is, how the intervention is expected to work)? Is there potential for differences in relative effects between advantaged and disadvantaged populations? Especially in low income countries, maternal health has been a much neglected issue, although many maternal deaths are preventable (Cook 2004; DFID 2011). Each year more than 350,000 women die from preventable complications related to pregnancy and childbirth (Ki-Moon 2010), a decrease from 535,900 deaths in 2005 (Hill 2007). Almost all (99%) of these deaths are in low and middle income countries, with 450 deaths per 100,000 births (DFID 2010) compared with 18 deaths per 100,000 births in the US (MacKay 2011). Although the Global Strategy for Women s and Children s Health suggests 570,000 maternal deaths can be prevented between 2011 and 2015 (Ki-Moon 2010), reducing maternal mortality (and morbidity) is still a major challenge. It is nearly 40 times more likely for a pregnant woman or mother to die in low income countries than in high income countries (UN 2011). More than 50% of maternal deaths occur in just six countries India, Nigeria, International Development Group title registration form revised 11 th April

2 Pakistan, Afghanistan, Ethiopia and the Democratic Republic of Congo (Hogan 2010). Although the maternal mortality ratio for low income countries as a whole has dropped by 34% between 1990 and 2008 (UN 2011), this is a very long way from the 2015 target of a 75% reduction. With 640 maternal deaths per 100,000 live births, sub Saharan Africa is of particular concern (UN 2011). Many of the contributing causes to maternal mortality (such as severe anaemia and short stature leading to obstructed labour) have nutritional links or origins, and these may reach back to before the woman s own birth (Rush 2000). Just under half the world s pregnant women have anaemia, with the vast majority from Africa or Asia; with iron-deficiency anaemia causing 18% of maternal mortality worldwide (WHO 2009), attributed to the greater risk of anaemic mothers dying from postpartum haemorrhage (Stoltzfus 2003). Maternal mortality and morbidity is inextricably linked with stillbirth and neonatal deaths and there have been recent calls for health systems to deliver more effectively for both mothers and babies (Pattinson 2011). Relevant interventions range from large national programs, such as those in Nepal where maternal mortality has declined by 67% (PMNCH 2010) to local programs or interventions targeted at particular groups of women. While some of the potential solutions seem straightforward (increasing amount and diversity of food during pregnancy and lactation; iron, folic acid and vitamin A supplementation; preventing or treating infections (including malaria and HIV); promoting breastfeeding and building energy stores between pregnancies), there are many access, contextual, behavioural and system barriers to implementation of nutritional programs for women of reproductive age. Nutrition programs have not always been well integrated with maternal and child health (MCH) programs and "there is an emerging consensus that the convergence of nutrition and MCH is essential" according to Streatfield This systematic review will be highly relevant to policy and practice, through synthesising the evidence for which programs are likely to successfully address maternal nutrition and therefore lead to improvements in maternal mortality and morbidity and by outlining what is necessary to implement effective programs and interventions. Objectives: To assess the effects of nutritional programs (or programs directed at influencing maternal nutritional status) on maternal mortality and morbidity (including sentinel events or near misses ) As we are looking at effects of interventions as well as the impact of those interventions and/or programs including the interventions, and the factors influencing adoption, we are proposing a mixed methods synthesis. The review questions are therefore grouped according to the methods appropriate for each part of the synthesis. 1 ASSESSING EFFECTS OF INTERVENTIONS (QUANTITATIVE METHODS) What effects do the following interventions or programs have on maternal mortality and morbidity? 1.1 specific nutrition interventions and do these differ by regimens or timing? These will include supplementation (with vitamins, minerals, micro-nutrients, macro-nutrients), food fortification and direct provision of foods 1.2 programs (including food programs) and non-nutritional interventions directed at influencing maternal nutritional status These will include programs to increase women s access to food; information, education, and communication (IEC) programs; and programs to help prevent and treat anaemia 1.3 Multicomponent or complex interventions* with nutrition components These will include combined interventions such as hygiene and nutrition during pregnancy; and antenatal care programs with a nutrition component such as nutritional advice 1.4 integrated maternal and child health programs with a nutritional component or other large International Development Group title registration form revised 11 th April

3 maternal/perinatal programs with a nutritional component reporting maternal mortality These will include care programs targeted at both women and their infants; and health service expansion e.g. with additional work force and resources 2 DESCRIPTIVE (SYSTEMATIC DATA EXTRACTION) 2.1 Do these effects vary by country, baseline maternal mortality rates, cultural customs, maternal educational status, maternal social status? 2.2 Does uptake of programs or interventions vary by country, setting (home, community health, primary health, secondary and tertiary health), type of health care worker(s) involved, baseline maternal mortality rates, cultural customs, maternal educational status, maternal social status, maternal age, maternal nutritional status? 2.3 Are there additional access, cost, and workforce issues? 3 WHAT IS THE ROLE OF BEHAVIOUR AND HOW ARE EFFECTS MODIFIED? (QUALITATIVE METHODS) 3.1 Why do rates of adherence vary and how do these variations in adherence influence effects of interventions? 3.2 What are the barriers and enablers to implementing interventions and how might they be overcome or increased respectively? 4 WHAT NEEDS TO BE DONE TO TRANSLATE EVIDENCE INTO PRACTICE AND POLICY? (IMPLEMENTATION RESEARCH) 4.1 Have any implementation strategies been evaluated for any of the above interventions or programs and if so, what have been the effects of these strategies? 4.2 What are the issues in scaling up, transfer and sustainability of programs and what is needed to optimise scaling up, transfer and sustainability? We have developed an initial logic model identifying important elements and relationships (Anderson 2011) to understand the influence of various factors on how interventions, strategies or programs may work and to guide the preparation and presentation of the review. We anticipate that the logic model will need multiple iterations as we proceed through the review process. * Complex interventions in health care, whether therapeutic or preventative, comprise a number of separate elements which seem essential to the proper functioning of the interventions although the 'active ingredient' of the intervention that is effective is difficult to specify.... Complex interventions are built up from a number of components, which may act both independently and interdependently. (Medical Research Council 2000) References Anderson LM, Petticrew M, Rehfuess E, Armstrong R, Ueffing E, Baker P, Francis D, Tugwell P. Using logic models to capture complexity in systematic reviews. Research Synthesis Methods 2011;epub Cook RJ, Bevilacqua MBG. Invoking human rights to reduce maternal deaths. Lancet 2004;363:74 Hill K et al. Estimates of maternal mortality worldwide between 1990 and 2005: an assessment of available data. Lancet 2007;370(9595): DFID (2011). Millennium Development Goal Five. Hogan MC et al. Maternal mortality for 181 countries, : a systematic analysis of progress towards Millennium Development Goal 5. Lancet 2010;375(9726): Ki-Moon B. Global Strategy for Women's and Children's Health summary [accessed 25 November 2010] International Development Group title registration form revised 11 th April

4 MacKay AP, Berg CJ, Liu X, Duran C, Hoyert DL. Changes in pregnancy mortality ascertainment United States, Obstetrics and Gynecology 2011;118(1): Medical Research Council: A framework for development and evaluation of complex interventions to improve health. London: Medical Research Council, Pattinson R, Kerber K, Buchmann E, Friberg IK, Belizan M, Lansky S, Weissman E, Mathai M, Rudan I, Walker N, Lawn JE, for the Lancet s Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; DOI /S (10) PMNCH. Tracking $40 billion in commitments for maternal and child health. The Partnership for Maternal, Newborn and Child Health press release 12 November 2010 Rush D. Nutrition and maternal mortality in the developing world. American Journal of Clinical Nutrition 2000;72(Suppl):212S-40S Streatfield PK et al. Mainstreaming nutrition in maternal, newborn and child health: barriers to seeking services from existing maternal, newborn child health programmes. Maternal and Child Nutrition 2008;4: Stoltzfus RJ. Iron deficiency: global prevalence and consequences. Food Nutrition Bulletin 2003;24:S UN. The Millennium Development Goals Report Geneva: UN, WHO. Global health risks: mortality and burden of disease attributable to selected major risks. Geneva, Switzerland, World Bank. Repositioning nutrition as central to development: a strategy for large scale action Existing reviews Briefly describe any existing systematic reviews on the topic, and justify the need for this review if existing reviews exist or are in progress. There are systematic reviews that cover some components or interventions such as micro-nutrient supplementation, but our proposed review is the only one that we are aware of that encompasses such a wide scope in terms of target population and breadth and depth of the various interventions. A protocol for a Cochrane review Strategies for integrating family planning services with maternal, neonatal and child health, and nutrition services has been published recently (Bain-Brickley 2011). Reference: Bain-Brickley D, Chibber K, Spaulding A, Azman H, Lindegren ML, Kennedy CE, Kennedy GE. Strategies for integrating family planning services with maternal, neonatal and child health, and nutrition services. Cochrane Database of Systematic Reviews 2010, Issue 7. International Development Group title registration form revised 11 th April

5 4. Define the population Who is included and who is excluded? Are disadvantaged populations included, defined across PROGRESS-Plus categories? 1 Women and girls of reproductive age from low and middle income countries (LMIC) and marginalised and/or disadvantaged women and girls of reproductive age from high income countries (HIC). All components of PROGRESS and age from PROGRESS plus (particularly for teenage women) will be incorporated. 5. Define the intervention(s) What is given, by whom, to whom, and for how long? What are the comparison conditions (what is usually provided to control/comparison groups who don t receive the intervention)? Are interventions aimed at the disadvantaged? Interventions/comparators: Nutrition programs or packages which include nutrition interventions compared with standard care or no program/intervention or delayed intervention; or different types of nutrition programs or packages. The specific types of interventions have already been described in section 2 (as requested). Additional details about types of interventions and details such as types of providers and timing of interventions are outlined in the attached logic model. 6. Outcome(s) What are the intended effects of the intervention? What are the potential or unintended effects of the intervention? Primary and secondary (intermediate) outcomes for the review should all be mentioned, together with beneficial and, if applicable, adverse effects. Note relevant and important outcomes for the appropriate disadvantaged groups. Outcomes: will include maternal mortality and near misses (Pattinson 2009), prolonged or obstructed labour, postpartum haemorrhage, or other serious complications of pregnancy, breastfeeding and perinatal death (fetal or neonatal) as primary outcomes. Secondary outcomes will include miscarriage, gestational weight gain, postpartum depression, maternal infections, anaemia, nutritional status, dietary changes, lethargy, weakness, daily functioning, immune status, intrauterine growth restriction, preterm birth, low birthweight, health care seeking for maternal and/or neonatal morbidities, cost effectiveness of programs or measures of resource utilisation. We will also include neonatal and infant morbidities and mortality as long as the relevant study or program evaluation has reported maternal mortality or morbidity. Longer term outcomes such as postpartum maternal health and infant and child growth and development will be included if available. 1 Disadvantage can be measured across categories of social differentiation, using the mnemonic PROGRESS-Plus. PROGRESS is an acronym for Place of Residence, Race/Ethnicity, Occupation, Gender, Religion, Education, Socioeconomic Status, and Social Capital, and Plus represents additional categories such as Age, Disability, and Sexual Orientation. International Development Group title registration form revised 11 th April

6 System and policy changes will also be included. Qualitative outcomes will include barriers and enablers and other assessments relevant to context and implementation. Reference: Pattinson RC, Say L, Souza JP, van den Broek N, Rooney C. WHO maternal death and near-miss classifications. Bull World Health Organization 2009;87: Methodology What types of studies are to be included and excluded: please describe eligible study designs, measures, and duration of follow-ups. Briefly describe proposed data sources, search strategies and methods of synthesis. Where the review aims to include quantitative and qualitative evidence, specify which of the review questions noted in section 2 will be addressed using each type of evidence. QUANTITATIVE ANALYSIS Types of studies: Randomised controlled trials (including cluster trials), other controlled trials, or observational cohort studies without controls), interrupted time series, before and after studies. QUALITATIVE ANALYSIS Qualitative studies will be included where they address behaviours such as adherence or report information on barriers and enablers and scaling up or sustainability of programs. Qualitative information will also be sought from studies providing quantitative data. Measures such as maternal mortality are likely to be reported differently e.g. different degrees of ascertainment. We will attempt to detect differences in measurement methods and to comment on any impact that these differences may have had. Data sources will include traditional database searches (Pubmed, EMBASE, Web of Science, Cochrane Library, CINAHL, LILACS, Popline) extensively supplemented with snowballing, reference checking, iterative searches, web searches, identifying and contacting organisations and individuals. No language or publication status restrictions will be applied. We will attempt to obtain translations where possible if the review team is unable to translate particular papers. Search dates will be from 1990 to present A specific data extraction sheet will be designed and at least two authors will assess study eligibility, extract data and assess potential risk of bias. Any disagreements will be resolved through discussion. Critical appraisal will include assessing selection, attrition, performance, detection, measurement and reporting biases. For RCTs, we will use the Cochrane risk of bias tool (Higgins 2011), for systematic reviews, the AMSTAR tool (Shea 2009) and for other study designs, the methods outlined by NICE (NICE 2009). We will consider using the JBI- QARI tool for critically appraising qualitative studies or qualitative content within quantitative studies. Methods of synthesis: We propose a mixed design and mixed methods systematic review. We will use the principles and methods of the International Development Group title registration form revised 11 th April

7 Cochrane and Campbell Collaborations (Higgins 2011) integrated with evaluation of program impact, context (setting, population characteristics, feasibility, sustainability, scalability) and analysis of barriers and enablers. Where appropriate we will conduct meta-analyses. Summary estimates of effect will be computed and reported separately by study design in the primary analyses, although we will consider conducting secondary analyses which also incorporate estimates of effects from observational studies. If not appropriate to conduct meta-analyses and/or synthesise effect sizes, we will present review findings in tabular and narrative form. We will use RevMan 5 to prepare our review and possibly we will also use WinBUGS 1.4 for some analyses. We may import figures from other software if necessary. For observational studies, we will use adjusted effect sizes or other methods to address potential confounding. We use thematic analyses to synthesise qualitative findings and we will interpret qualitative and quantitative findings through theory 'lenses' (e.g. program, behaviour change and adoption theory (Michie 2008, WHO 2006, Streatfield 2008). References Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version [updated March 2011]. The Cochrane Collaboration, Available from Michie S. Designing and implementing behaviour change interventions to improve population health. J Health Serv Res Policy 2008;13(Suppl 3):64-9 National Institute of Health and Clinical Excellence (NICE). Methods for the development of NICE public health guidance (second edition). London, UK: NICE, April 2009 Shea BJ, Hamel C, Wells GA, Bouter LM, Kristjansson E, Grimshaw J, Henry DA, Boers M. AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews. J Clin Epidemiol 2009;62(10): Streatfield PK, Koehlmoos TP, Alam N, Mridha MK. Mainstreaming nutrition in maternal, newborn and child health: barriers to seeking services from existing maternal, newborn, health programmes. Maternal and Child Nutrition 2008;4: World Health Organization (WHO). Turning research into practice: suggested actions from case studies of sexual and reproductive health. Geneva, Switzerland: Department of Reproductive Health and Research, WHO, Review team List names of those who will be cited as authors on the final publication. Lead reviewer Name: Philippa Middleton This is the person who Title: Ms develops and co-ordinates the review team, discusses and assigns roles for individual members of the review team, Affiliation: The University of Adelaide Address: State, Province or County: SA Postal Code: 5006 liaises with the editorial base Country: Australia and takes responsibility for the Phone: on-going updates of the review philippa.middleton@adelaide.edu.au There should be at least one Name: Caroline Crowther Affiliation: The University of Adelaide International Development Group title registration form revised 11 th April

8 co-author If applicable If applicable If applicable If applicable If applicable Country: Australia Name: Tanya Bubner Affiliation: The University of Adelaide Country: Australia Name: Vicki Flenady Affiliation: Mater Medical Research Institute Country: Australia Name: Zulfiqar Bhutta Affiliation: Aga Khan University Country: Pakistan Name: Tran Son Thach Affiliation: University of Medicine and Pharmacy Country: Vietnam Name: Zohra Lassi Affiliation: Aga Khan University Country: Pakistan 9. Roles and responsibilities Please give brief description of content and methodological expertise within the review team. It is recommended to have at least one person on the review team who has content expertise, at least one person who has methodological expertise and at least one person who has statistical expertise. It is also recommended to have one person with information retrieval expertise. Please note that this is the recommended optimal review team composition. Content: Professor Bhutta and Zohra Lassi and their team are international leaders in the field of maternal and child nutrition. Their current work includes assessing impacts of maternal balanced energy protein supplementation and food support programs, calcium supplementation in pregnancy and multiple micronutrient supplements in pregnancy and they will lead these topics in the systematic review proposed here. Philippa Middleton, Professor Crowther and Associate Professor Vicki Flenady are authors of Cochrane reviews and other systematic reviews covering maternal nutrition. Tanya Bubner brings public health and primary health care research expertise. Methodology: Professor Bhutta and Zohra Lassi have authored many research syntheses, as have Professor Crowther, Philippa Middleton and Associate Professor Vicki Flenady. Philippa Middleton has extensive experience in designing appropriate research methods and applying them as well as conducting risk of bias assessments. All members have skills and experience in theoretical analysis, particularly Philippa Middleton, Tanya Bubner, Zulfiqar Bhutta and Zohra Lassi. Statistics: Dr Tran Son Thach will provide statistical expertise, assisted by Professor Bhutta, Zohra Lassi, Vicki Flenady and Philippa Middleton. Search: Philippa Middleton (who has library and information management qualifications) will design the search strategies. International Development Group title registration form revised 11 th April

9 10. Potential conflicts of interest For example, have any of the authors been involved in the development of relevant interventions, primary research, or prior published reviews on the topic? Most authors have published in the area of maternal nutrition. Professor Bhutta has conducted trials and other studies which may be considered for inclusion in this review. Professor Bhutta and Zohra Lassi are currently conducting or planning trials or studies which may be considered for inclusion in this review. 11. Support Do you need support in any of these areas: methodology and causal inference, systematic searches, coding, statistical analysis (meta-analysis)? We may need assistance with causal inferences and statistical analysis beyond that routinely used in systematic reviews 12. Funding Do you receive any financial support? If so, where from? If not, are you planning to apply for funding? Where? Funding has been awarded through the Australian Agency for International Development (AusAID) and 3ie. 13. Proposed deadlines Note, if the protocol or review are not submitted within 6 months and 18 months of title registration, respectively, the review area is opened up for other reviewers. Date you plan to submit a draft protocol: 1 st December 2011 Date you plan to submit a draft review: 1 st April Declaration Authors responsibilities By completing this form, you accept responsibility for preparing, maintaining and updating the review in accordance with Campbell Collaboration policy. The Campbell International Development Group will provide as much support as possible to assist with the preparation of the review. A draft protocol must be submitted to the Group within six months. If drafts are not submitted before the agreed deadlines, or if we are unable to contact you for an extended period, the Group has the right to de-register the title or transfer the title to alternative authors. The Group also has the right to de-register or transfer the title if it does not meet the standards of the Group and/or the Campbell Collaboration. International Development Group title registration form revised 11 th April

10 You accept responsibility for maintaining the review in light of new evidence, comments and criticisms, and other developments, and updating the review at least once every three years, or, if requested, transferring responsibility for maintaining the review to others as agreed with the Group. Publication in the Campbell Library The support of the International Development Group in preparing your review is conditional upon your agreement to publish the protocol, finished review and subsequent updates in the Campbell Library. Concurrent publication in other journals is encouraged. However, a Campbell systematic review should be published either before, or at the same time as, its publication in other journals. Authors should not publish Campbell reviews in journals before they are ready for publication in CL. Authors should remember to include the statement: This is a version of a Campbell review, which is available in The Campbell Library. I understand the commitment required to undertake a Campbell review, and agree to publish in the Campbell Library. Signed on behalf of the authors: Form completed by: Philippa Date: 24 October 2011 Middleton and Tanya Bubner and Thach son Tran in consultation with the other authors International Development Group title registration form revised 11 th April

11 For Campbell use: Title registration submission date: Title registration approval date: International Development Group title registration form revised 11 th April