Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial)

Keywords Economic evaluation, mental health, depression, Lebanon, Kenya, group interpersonal therapy ALL Metrics - Views Downloads How to cite this article Abou Jaoude GJ, Madeghe B, Maradian SPA et al. Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial) [version 1; peer review: 1 approved]. NIHR Open Res 2025, 5:17 (https://doi.org/10.3310/nihropenres.13838.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol [version 1; peer review: 1 approved] Gerard Joseph Abou Jaoude https://orcid.org/0000-0001-6022-3036 1, Beatrice Madeghe2, Sandra Pardi Arsen Maradian3, [...] Perrine Posbic3, Joel Machoka https://orcid.org/0009-0001-7305-7433 4, George Wambiri Ndamaiyu2, Elizabeth Simes https://orcid.org/0000-0003-1704-6278 1, Ciara O’Donnell https://orcid.org/0009-0009-4302-2043 1, Sophie Wallace-Hanlon1, Rachel Evans5, Pasco Fearon1, Elizabeth Allison1, Steve Pilling1, Lena Verdeli6, Bryan Cheng6, Fouad Mohamed Fouad7, Carol Ngunu8, Rabih El Chammay3, Manasi Kumar2, Peter Fonagy1, Jolene Skordis1Gerard Joseph Abou Jaoude https://orcid.org/0000-0001-6022-3036 1, Beatrice Madeghe2, [...] Sandra Pardi Arsen Maradian3, Perrine Posbic3, Joel Machoka https://orcid.org/0009-0001-7305-7433 4, George Wambiri Ndamaiyu2, Elizabeth Simes https://orcid.org/0000-0003-1704-6278 1, Ciara O’Donnell https://orcid.org/0009-0009-4302-2043 1, Sophie Wallace-Hanlon1, Rachel Evans5, Pasco Fearon1, Elizabeth Allison1, Steve Pilling1, Lena Verdeli6, Bryan Cheng6, Fouad Mohamed Fouad7, Carol Ngunu8, Rabih El Chammay3, Manasi Kumar2, Peter Fonagy1, Jolene Skordis1 PUBLISHED 04 Mar 2025 Author details Author details 1 University College London, London, England, UK 2 University of Nairobi, Nairobi, Nairobi County, Kenya 3 National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon 4 Health Strat, Nairobi, Kenya 5 Bangor University, Bangor, Wales, UK 6 Columbia University, New York, New York, USA 7 American University of Beirut, Beirut, Beirut Governorate, Lebanon 8 Nairobi City County Government, Nairobi, Kenya 2 University of Nairobi, Nairobi, Nairobi County, Kenya 3 National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon 4 Health Strat, Nairobi, Kenya 5 Bangor University, Bangor, Wales, UK 6 Columbia University, New York, New York, USA 7 American University of Beirut, Beirut, Beirut Governorate, Lebanon 8 Nairobi City County Government, Nairobi, Kenya Gerard Joseph Abou Jaoude Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Beatrice Madeghe Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Sandra Pardi Arsen Maradian Roles: Conceptualization, Methodology, Writing – Review & Editing Roles: Conceptualization, Methodology, Writing – Review & Editing Perrine Posbic Roles: Project Administration, Writing – Review & Editing Roles: Project Administration, Writing – Review & Editing Joel Machoka Roles: Project Administration, Writing – Review & Editing Roles: Project Administration, Writing – Review & Editing George Wambiri Ndamaiyu Roles: Project Administration, Writing – Review & Editing Roles: Project Administration, Writing – Review & Editing Elizabeth Simes Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Ciara O’Donnell Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Sophie Wallace-Hanlon Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Rachel Evans Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Pasco Fearon Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Elizabeth Allison Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Steve Pilling Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Lena Verdeli Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Bryan Cheng Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Fouad Mohamed Fouad Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Carol Ngunu Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Rabih El Chammay Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Manasi Kumar Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Peter Fonagy Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Jolene Skordis Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS One in six women experience postnatal depression globally. Treatment is often unavailable, which increasing risks of long-term depression among mothers and poorer developmental outcomes for their children. This protocol outlines the first within-trial economic evaluation to inform policymakers about the value for money of culturally adapted group interpersonal therapy (group-IPT) to improve child cognitive development and postnatal depression outcomes. We will conduct a full economic evaluation of group-IPT within the Supporting Mothers’ Mental Health with Interpersonal Therapy (SUMMIT) trial. SUMMIT is an individually randomised, controlled superiority trial in Kenya and Lebanon. The economic evaluation will adopt a societal perspective, comprising provider and patient perspectives. This will be based on an intention-to-treat analysis, over a 52-week time horizon in line with trial follow-up. The cost and cost-effectiveness of group-IPT will be compared with high-quality standard care in the control arm. Costs and outcomes will be analysed to estimate an incremental cost-effectiveness ratio (ICER) based on child cognitive development, the primary trial outcome. We will also estimate ICERs for statistically significant secondary trial outcomes, which include maternal depression and quality of life. Two-way sensitivity analyses will vary cost drivers and outcomes within confidence bounds to investigate uncertainty. To inform policymakers on affordability, we will estimate the cost of group-IPT at scale relative to available public resources. We will also investigate how group-IPT outcomes are distributed across socioeconomic groups and whether participating mothers experience financial hardship due to care-seeking. The SUMMIT trial and economic evaluation received ethical approval from University College London’s Research Ethics Committee in the United Kingdom (23699/001), Saint Joseph University Secretariat of the University Ethics Centre in Lebanon (CEHDF 1854) and Kenyatta National Hospital and the University of Nairobi in Kenya (KNH/ERC/Mod&SAE/425). Economic evaluation results will be disseminated to various local and international stakeholders via peer-reviewed journal publications, policy briefs, conferences and workshops. The ISRCTN Registry: ISRCTN15154316. Registered on 27 September 2023: https://doi.org/10.1186/ISRCTN15154316 One in six mothers experience depression following childbirth, also known as postnatal depression. Currently, care and support for postnatal depression is limited, with substantial gaps in provision. Left uncared for, postnatal depression can persist and affect maternal wellbeing, worsen mother-child interactions and negatively impact early child development. Our study will evaluate whether group interpersonal therapy, aimed at improving postnatal depression and child development outcomes, provides good value for money, improves the equity of health and developmental outcomes, and is affordable at scale. Our study is being carried out as part of a randomised trial comparing group interpersonal therapy against high-quality standard care in Kenya and Lebanon. To estimate value for money, we collect and analyse information on costs and outcomes. We will capture costs incurred by care providers, as well as costs incurred by patients. We will measure whether the costs incurred by patients risk pushing their families into poverty. Benefits to participating mothers and their children will be captured using measures that allow us to estimate changes in child cognitive development, levels of postnatal depression and maternal health and wellbeing. We will also look at how outcomes are spread across socioeconomic groups to understand whether some groups benefit more than others. Policymakers have limited budgets at their disposal and require information on how resources can be used to maximise health outcomes and social welfare. Our study ultimately aims to inform policymakers in Kenya, Lebanon and other comparable settings about how best to allocate resources for the care of postnatal depression. Economic evaluation, mental health, depression, Lebanon, Kenya, group interpersonal therapy Corresponding Author(s) Gerard Joseph Abou Jaoude ([email protected]) Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) under its ‘Research and Innovation for Global Health Transformation (RIGHT) Programme’ (Grant Reference Number PB-PG-NIHR200851). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Abou Jaoude GJ et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Abou Jaoude GJ, Madeghe B, Maradian SPA et al. Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial) [version 1; peer review: 1 approved]. NIHR Open Res 2025, 5:17 (https://doi.org/10.3310/nihropenres.13838.1) First published: 04 Mar 2025, 5:17 (https://doi.org/10.3310/nihropenres.13838.1) Latest published: 04 Mar 2025, 5:17 (https://doi.org/10.3310/nihropenres.13838.1) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Around 17% of women globally experience postnatal depression1. Postnatal depression disproportionately affects women from lower socioeconomic backgrounds, with inequitable distributions within and between countries1,2 Despite widespread prevalence, treatment for postnatal depression is often unavailable, particularly in low- and middle-income countries (LMICs)3–5. In the absence of intervention, postnatal depression can be long-lasting for mothers and their children can experience poorer learning and developmental outcomes6–8. Postnatal depression impacts children by lowering the quality and sensitivity of mother-child interactions9,10. Substantial evidence has shown that this increases the likelihood of children experiencing cognitive impairments and poorer physical and mental wellbeing6,7,9. Risk factors such as poverty and limited parental education, which are more prevalent in LMICs, can worsen the impact of postnatal depression on child outcomes11–13. Interventions for postnatal depression therefore provide an opportunity to improve both maternal wellbeing and child developmental outcomes. To address gaps in the availability of mental health services, the WHO Mental Health Gap Action Programme outlines interventions that should be considered for implementation at scale in resource scare settings14. One recommended intervention, group Interpersonal Therapy (group-IPT) for depression15, does not require psychiatrists or specialised mental health workers who are often in short supply – particularly in LMICs. Group sessions may also be more culturally appropriate and acceptable in some settings, compared with individual treatment16. Group-IPT has been tested with a range of participants, including mothers, in a number of high-income and LMIC settings. Specifically for postnatal depression, studies in high-income settings have found that group-IPT improves maternal depression outcomes17,18 and results from a pilot of group-IPT for young mothers living with HIV in Kenya reported improved postnatal depression outcomes19. Encouragingly, findings from a two-year follow-up study in Australia suggest that improved depression outcomes from group-IPT persisted20. While group-IPT is increasingly being adapted and implemented, and evidence on its effectiveness continues to grow, little economic evidence exists to inform policymakers about its relative cost effectiveness and affordability. For effective implementation at scale, group-IPT should be affordable and feasible, as well as cost-effective compared with available alternatives. To our knowledge, only two studies report economic evaluations of group-IPT. One study conducted with prisoners living with major depressive disorders in the United States found that group-IPT was more cost-effective than treatment-as-usual21. While positive, these findings are not transferrable to mothers with postnatal depression, nor LMIC settings more widely. Another study piloted group-IPT among adolescents with depression and functional impairment in Nepal22. Costs were estimated alongside the study, but a cost-effectiveness analysis was not conducted. There is therefore an urgent need for economic evaluations to inform policy on the likely costs and cost-effectiveness of group-IPT, particularly in relation to postnatal depression and child development outcomes. To the best of our knowledge, no study has investigated the cost-effectiveness of group-IPT to reduce postnatal depression and improve early child development outcomes. The economic evaluation described in this protocol, embedded within the Supporting Mothers’ Mental Health with Interpersonal Therapy (SUMMIT) trial, aims to address this gap in evidence to inform effective policy and resource allocation for group-IPT. The SUMMIT trial is an individually randomised controlled superiority trial testing whether providing culturally adapted group-IPT to women with postnatal depression improves child cognitive development, maternal depression and the mother-child relationship. The recruitment of participants in the trial commenced on 2 January 2023 in Beirut, Lebanon and Nairobi, Kenya. It is anticipated the trial will end in June 2025. Participants were randomised to the intervention arm or the high-quality standard care (HQ-SC) control arm. All participants received HQ-SC, with participants in the intervention arm also receiving group-IPT. The trial will last for 52 weeks after screening and recruitment at baseline, with six points in time when study measures are collected over the duration of the trial, including baseline (T1), T2 at eight weeks, T3 at 13 weeks (end of group-IPT sessions), T4 at 24 weeks, T5 at 36 weeks and T6 at 52 weeks following baseline. The SUMMIT trial is described in detail elsewhere23. Here, we outline the plan for the within-trial economic evaluation. Participants were involved in the piloting of economic evaluation measures during the feasibility phase of the study. Secondary outcome measures, the baseline questionnaire and the cross-sectional patient care-seeking and cost survey were tested during the feasibility trial. Participant feedback regarding acceptability and understanding helped inform measures subsequently included in the SUMMIT trial. The planned economic evaluation will not involve patients or the public in conceptualising other aspects of the study design or data analysis. However, relevant country stakeholders will be engaged during the dissemination of economic evaluation results. In Kenya, studies have generally found that between 13% and 19% of women experience postnatal depression, with some higher estimates24,25. While many women do not seek care, most that do seek care go to public sector facilities. These range from level 1 community facilities, which primarily provide screening services and some basic treatment, up to level 6 National Referral Hospitals. SUMMIT study sites in Nairobi County include four level 3 facilities (Huruma Lions Health Centre, Riruta Health Centre, Githurai Health Centre, and Kangemi Health Centre), one level 5 (Mbagathi Hospital) and one level 6 facility (Mathari Teaching and Referral Hospital). Level 3 facilities in Kenya are prohibited from charging user fees26 and are typically staffed with at least one doctor, clinical officers and nurses providing a comprehensive set of primary care services26–28. Mbagathi and Mathari are large hospitals, both of which conduct research. Mbagathi is a secondary referral hospital while Mathari offers specialised mental health services. Prevalence estimates for postnatal depression in Lebanon range between 12.8% and 21.8%29,30, and a recent study has indicated that rates of postnatal depression are higher in Lebanon than in other countries31. The Beirut port explosion in 2020 and subsequent hyperinflation increased rates of mental health conditions generally32, while the conflict with Israel may have a further negative effect on mental health, and postnatal depression specifically. In Lebanon, all health facilities participating in the SUMMIT trial are primary health centres (PHCs), located in Beirut and affiliated with the Ministry of Public Health Network. These facilities include Makased Center PHC, Howard Karagheusian Commemorative Center, Dar Al Fatwa PHC, Dar El Hawraa PHC, and Hariri Foundation PHC. In both countries, participants were screened using the Patient Health Questionnaire – depression module (PHQ-9)33. Mothers aged 18 years or older, with an infant aged 6–35 weeks at the time of screening, were eligible to participate if they scored 12 or above on the PHQ-9 – defined as an indication of postnatal depression. Mothers with psychotic conditions including bipolar disorder, anorexia nervosa, or substance dependency, and mothers whose index infants had severe physical or neurodevelopmental problems, were excluded from the trial. All eligible mothers who consented to participate, were randomly allocated to the control or intervention arm, with 412 participants enrolled over a 10-month period in both countries (N=224 in the group-IPT arm, N=188 in the control arm). As mentioned previously, all participating mothers received HQ-SC, while mothers in the intervention arm also received group-IPT. Standard care pathways for postnatal depression in Lebanon and Kenya differ between countries, with varying access and types of services provided. Overall, however, there is limited provision of care for postnatal depression in both settings and in some cases no services or activities are provided. In the SUMMIT trial, HQ-SC reflected standard care provision in each country with a guided psychoeducation intervention that consisted of two group sessions, each lasting 60–90 minutes, and a self-help book. The first group session focused both on psychoeducation and nutritional guidance. This was followed by an optional second session, during which mothers received an introduction to the WHO Doing What Matters in Times of Stress self-help workbook – on which the guided psychoeducation sessions were based. Intervention arm participants received culturally adapted group-IPT in addition to HQ-SC, following the completion of HQ-SC sessions. Group-IPT aims to address interpersonal triggers of depression and consists of an initial individual session lasting up to 2 hours, followed by weekly group sessions and a concluding individual session lasting a further 2–3 hours. Sessions are in-person and involve one or more facilitators talking with and supporting participants to identify links between depression and problems in life, encouraging group learning while developing the communication and interpersonal skills required to manage problems more effectively. In addition to initial and concluding sessions, group-IPT in the SUMMIT trial included eight weekly group sessions as per the WHO group-IPT manual15. Sessions took place in a room within the health facilities participating in the trial. Each group comprised 6–10 participants and lasted 90 minutes. Group-IPT sessions in Lebanon were facilitated by a licensed psychologist, while sessions in Kenya were facilitated by two community health workers per group. Group-IPT was adapted for cultural relevance and appropriateness in each country as part of the SUMMIT trial and more detail is provided on both group-IPT and HQ-SC in the main trial protocol paper23. The primary outcome of the SUMMIT trial is the cognitive development of the index child, as measured by the Malawi Developmental Assessment Tool (MDAT)34. The MDAT will be administered at the trial endline, at 52-weeks (T6) following baseline measurement. Secondary trial outcomes include levels of depression among participating mothers, measured using the PHQ-933, and two measures to assess the general health and well-being of participating mothers, the EuroQoL-5 Dimensions (EQ-5D-5L) questionnaire and the ICEpop CAPability measure for Adults (ICECAP-A)35,36. The PHQ-9 is administered at every timepoint, while the EQ-5D-5L and ICECAP-A are administered at four points in time during the trial, at baseline and then at 13, 24 and 52 weeks respectively. Measures at baseline and at the end of group-IPT intervention delivery, 13 weeks after baseline, will enable us to estimate the immediate effect of group-IPT on depression, general health and wellbeing compared with the HQ-SC control. Follow-up measures after the end of group-IPT intervention delivery, at 24 weeks and 52 weeks following baseline, will enable us to assess whether any effects of group-IPT on secondary outcomes persist or ‘fade out’ over time. Where required, permission was obtained to use measures prior to their inclusion in the SUMMIT trial. Activity-based micro-costing will be carried out and supplemented with a top-down approach where required due to available data (e.g. facility overheads). A time horizon of 52 weeks (12 months) will be adopted. This is in line with the main trial duration for outcome measurement, where the final timepoint is 52 weeks after participant recruitment at baseline. Direct and indirect cost data are being collected from providers and patients, in line with the societal perspective of the study. Cost categories and data sources are summarised in Table 1. Provider costs are being incurred by local trial partners and the facilities developing and implementing group-IPT within the trial. Financial costs from trial partner project accounts will be entered into a costing tool in Microsoft Excel. The tool will capture cost structures during start-up and implementation of HQ-SC and group-IPT and estimate costs of different intervention components such as manual adaptation, group facilitation and supervision. Interviews with project staff and monthly staff timesheets will inform the allocation of costs across intervention components. Economic costs will be estimated by assigning current market value to any donated or volunteer time reported in project records or interviews with project and facility staff. Facility capital and overhead costs will be informed by data collected during facility visits, from observations, facility records, and staff interviews. Data collected from facilities will be inputted into an Excel-based cost-capture tool which separately captures surface area use, utilities and other costs. All study facilities have been visited in Lebanon except for Dar El Hawraa PHC, as it is similar in size and function to other included PHC facilities. In Kenya, Mathari Teaching Referral Hospital and Huruma Lions Health Centre were not visited as they are, respectively, largely comparable to Mbagathi Hospital and other included level 3 facilities. To capture costs from the patient perspective, a cross-sectional survey was administered to study participants at the end of group-IPT intervention delivery, 13 weeks after baseline. The survey asks about costs related to sessions that participants attended and about any health problems or care-seeking in the preceding month. This includes questions to capture the direct and indirect costs of attending sessions, such as travel costs or lost income, as well as any direct or indirect costs of subsequent referrals or care-seeking. Currencies and years of cost data are being recorded and will be adjusted for inflation to a base year of analysis (2023) separately for each country. The number of sessions attended per participant is being captured through trial participant case report forms and will be used to estimate annual costs per participant. Each session recorded in participant case report form attendance data will be costed based on the type of session (HQ-SC session or a group-IPT initial, group or concluding session) and the facility where the session took place. Costs will be captured and presented separately by trial arm, and for Kenya and Lebanon. To improve comparability between countries, costs will be presented both in local currencies (Kenyan Shillings and Lebanese Liras) and international dollars (Int$) adjusted for purchasing power parity. In line with the main trial analysis23, the cost-effectiveness analysis will be carried out on an intention-to-treat (ITT) basis. We will adhere to the Consolidated Health Economic Evaluation Reporting Standards (2022) and draw on best-practice guidance outlined in relevant economic evaluation reference cases37,38. Start-up and implementation costs will be included in the main analysis, which will report financial and economic costs of group-IPT, along with incremental cost-effectiveness ratios (ICERs) compared with HQ-SC. An ICER will be calculated for the trial primary outcome, which is child cognitive development measured by the MDAT at endline (T6, 52-week follow-up). The ICER will be equal to the arithmetic mean difference in cost between group-IPT and HQ-SC divided by the arithmetic mean difference in effect (MDAT score). Given the 52-week time horizon of analysis, costs and outcomes will not require conversion to present value using a discount rate. We will also calculate ICERs for secondary trial outcomes on which the trial is shown to have a significant effect. If the trial is found to have a significant effect on depression levels of participating mothers, an ICER will be calculated based on the PHQ-9. To facilitate comparison with other economic evaluations of health interventions, we will report an ICER for the incremental cost per quality-adjusted life year (QALY) gained. QALYs will be calculated based on participant responses to the EQ-5D-5L self-reported questionnaire. Given that group-IPT has the potential to impact more than just health-related quality of life, we will also report the incremental cost per year of full capability (YFC) based on participant responses to the ICECAP-A, which uses Sen’s capability approach to measure general wellbeing39. This may not only better capture intervention effects but also enable comparison against other public policy interventions outside health40. Two-way sensitivity analyses will investigate the impact on ICERs of varying key cost drivers (e.g. staff) as well as uncertainty around effectiveness. Sensitivity analyses will also test for variations in ICERs of statistically significant adult outcomes at different timepoints, mainly at the end of group-IPT intervention delivery 13 weeks after baseline (T3) and follow-ups at 24 weeks (T4) and 52 weeks (T6) after baseline. To inform policymakers on the likely cost-effectiveness of group-IPT relative to HQ-SC, estimated ICERs, namely incremental costs per QALY gained, will be evaluated against country cost-effectiveness thresholds for Kenya and Lebanon41. Interventions can be cost-effective, but this does not guarantee they are affordable or feasible in a given context. Information on the total cost required to scale up an intervention is needed for policymakers deciding how best to allocate resources. We will therefore estimate the total implementation costs to providers of scaling up group-IPT provision nationally. Total costs will be estimated separately for Kenya and Lebanon, based on national prevalence estimates of postnatal depression. The total cost to providers will also be expressed as a percentage of national health spending and gross domestic product to enable policymakers in each country to assess whether group-IPT is affordable in their context. To assess whether some population groups benefit disproportionately from group-IPT, we will investigate how group-IPT outcomes are distributed across socioeconomic groups. This will be done by analysing the marginal mean difference in outcomes between trial arms within socioeconomic groups. Socioeconomic quintiles will be constructed based on household income, assets, participant and household characteristics. Quintiles will be generated using data collected through a questionnaire administered to participating mothers at baseline. In addition to the distribution of group-IPT outcomes across quintiles, we will estimate whether participants experienced financial hardship due to costs they incurred. Catastrophic health expenditure is a commonly used measure of financial hardship, defined as when patient costs exceed a specified proportion of their income or capacity to pay (non-essential spending or consumption)42,43. Costs incurred by SUMMIT participants, which will be captured through the cross-sectional patient care-seeking and cost survey mentioned above, will be defined as catastrophic if they exceed the commonly used cut-off of 10% of their income44. This protocol describes the first full economic evaluation of group interpersonal therapy to improve both early child development and postnatal depression outcomes. The study will also contribute to a global lack of economic evaluations of group interpersonal therapy more generally. This protocol provides transparency on data collection and economic analysis, facilitating comparability with future evaluations of group interpersonal therapy. Results will be presented for both Kenya and Lebanon, addressing the absence of studies available to inform policymakers in low- or middle-income settings. We will disseminate economic evaluation results in several ways, in English and local languages where necessary. Results will be presented to policymakers, the scientific community, and the public more widely through the following activities: (1) peer-reviewed journal publications, (2) policy briefs and workshops or webinars, (3) conferences, and (4) non technical materials on the SUMMIT project webpage and social media channels. The SUMMIT trial and economic evaluation received ethical approval from University College London Research Ethics Committee in the United Kingdom (approved 17/10/2022, reference number 23699/001), Saint Joseph University Secretariat of the University Ethics Centre in Lebanon (approved 29/11/2022, reference number CEHDF 1854) and Kenyatta National Hospital and the University of Nairobi in Kenya (approved 23/11/2022, reference number KNH/ERC/Mod&SAE/425). Written informed consent was obtained before the initiation of any trial-related procedures. The trial’s objectives, methodologies, expected benefits, and potential risks were explained to prospective participants by trained and competent research assistants, specifically authorised to oversee the consent process. The consent process was conducted in the native languages of prospective participants to ensure clarity and comprehension, and the research team took measures to confirm that the information was fully grasped by prospective participants. Participants were provided with a minimum of 24 hours following the receipt of information to reflect on their decision. Potential participants were assured that their participation would be entirely voluntary and that they may withdraw from the trial at any stage without the need to specify a reason. Consent forms and the Patient Information Sheet (PIS) were available in the native languages of prospective participants (English, Swahili, and Arabic). GAJ wrote the first draft, reviewed by JS. All authors reviewed and contributed to subsequent drafts. PF, PFe, EA, SP, LV, FMF, CN, RC, MK and JS acquired funding for the study. GAJ, JS, MK, SPAM and PF conceptualised the study. JS supervised the work. Faculty Opinions recommendedReferences - 1. Wang Z, Liu J, Shuai H, et al.: Mapping global prevalence of depression among postpartum women. Transl Psychiatry. 2021; 11(1): 543. PubMed Abstract | Publisher Full Text | Free Full Text - 2. Fisher J, de Mello MC, Patel V, et al.: Prevalence and determinants of common perinatal mental disorders in women in low- and lower-middle-income countries: a systematic review. Bull World Health Organ. 2012; 90(2): 139G–149G. PubMed Abstract | Free Full Text - 3. Atif N, Lovell K, Rahman A, editors: Maternal mental health: the missing “m” in the global maternal and child health agenda. Semin Perinatol. Elsevier, 2015; 39(5): 345–52. PubMed Abstract | Publisher Full Text - 4. Almond P: Postnatal depression: a global public health perspective. Perspect Public Health. 2009; 129(5): 221–7. PubMed Abstract | Publisher Full Text - 5. Hanlon C: Maternal depression in low- and middle-income countries. Int Health. 2013; 5(1): 4–5. PubMed Abstract | Publisher Full Text - 6. Sutherland S, Nestor BA, Pine AE, et al.: Characteristics of maternal depression and children’s functioning: a meta-analytic review. J Fam Psychol. 2022; 36(5): 671–680. PubMed Abstract | Publisher Full Text | Free Full Text - 7. Dadi AF, Miller ER, Mwanri L: Postnatal depression and its association with adverse infant health outcomes in low- and middle-income countries: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2020; 20(1): 416. PubMed Abstract | Publisher Full Text | Free Full Text - 8. Rogers A, Obst S, Teague SJ, et al.: Association between maternal perinatal depression and anxiety and child and adolescent development: a meta-analysis. JAMA Pediatr. 2020; 174(11): 1082–92. PubMed Abstract | Publisher Full Text | Free Full Text - 9. Murray L, Fiori‐Cowley A, Hooper R, et al.: The impact of postnatal depression and associated adversity on early mother‐infant interactions and later infant outcome. Child Dev. 1996; 67(5): 2512–26. PubMed Abstract | Publisher Full Text - 10. Herba CM, Glover V, Ramchandani PG, et al.: Maternal depression and mental health in early childhood: an examination of underlying mechanisms in low-income and middle-income countries. Lancet Psychiatry. 2016; 3(10): 983–92. PubMed Abstract | Publisher Full Text - 11. Goodman JH: Perinatal depression and infant mental health. Arch Psychiatr Nurs. 2019; 33(3): 217–24. PubMed Abstract | Publisher Full Text - 12. Sockol LE: A systematic review and meta-analysis of interpersonal psychotherapy for perinatal women. J Affect Disord. 2018; 232: 316–28. PubMed Abstract | Publisher Full Text - 13. Stein A, Pearson RM, Goodman SH, et al.: Effects of perinatal mental disorders on the fetus and child. Lancet. 2014; 384(9956): 1800–19. PubMed Abstract | Publisher Full Text - 14. World Health Organization: mhGAP intervention guide for mental, neurological and substance use disorders in non-specialized health settings: mental health Gap Action Programme (mhGAP). World Health Organization, 2016. PubMed Abstract - 15. World Health Organization: Group Interpersonal Therapy (IPT) for depression. World Health Organization, 2016. Reference Source - 16. Rose-Clarke K, Pradhan I, Shrestha P, et al.: Culturally and developmentally adapting group interpersonal therapy for adolescents with depression in rural Nepal. BMC Psychol. 2020; 8(1): 83. PubMed Abstract | Publisher Full Text | Free Full Text - 17. Mulcahy R, Reay RE, Wilkinson RB, et al.: A randomised control trial for the effectiveness of group interpersonal psychotherapy for postnatal depression. Arch Womens Ment Health. 2010; 13(2): 125–39. PubMed Abstract | Publisher Full Text - 18. Mennen FE, Molina AP, Monro WL, et al.: Effectiveness of an Interpersonal Psychotherapy (IPT) group depression treatment for Head Start mothers: a cluster-randomized controlled trial. J Affect Disord. 2021; 280(Pt B): 39–48. PubMed Abstract | Publisher Full Text - 19. Yator O, John-Stewart G, Khasakhala L, et al.: Preliminary effectiveness of group interpersonal psychotherapy for young Kenyan mothers with HIV and depression: a pilot trial. Am J Psychother. 2022; 75(2): 89–96. PubMed Abstract | Publisher Full Text - 20. Reay RE, Owen C, Shadbolt B, et al.: Trajectories of long-term outcomes for postnatally depressed mothers treated with group interpersonal psychotherapy. Arch Womens Ment Health. 2012; 15(3): 217–28. PubMed Abstract | Publisher Full Text - 21. Johnson JE, Stout RL, Miller TR, et al.: Randomized cost-effectiveness trial of group Interpersonal Psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019; 87(4): 392–406. PubMed Abstract | Publisher Full Text | Free Full Text - 22. Rose-Clarke K, Prakash BK, Magar J, et al.: School-based group interpersonal therapy for adolescents with depression in rural Nepal: a mixed methods study exploring feasibility, acceptability, and cost. Glob Ment Health (Camb). 2022; 9: 416–428. PubMed Abstract | Publisher Full Text | Free Full Text - 23. Fonagy P, El Chammay R, Ngunu C, et al.: Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya—individually randomised superiority trial. Trials. 2024; 25(1): 217. PubMed Abstract | Publisher Full Text | Free Full Text - 24. Madeghe BA, Kimani VN, Vander Stoep A, et al.: Postpartum depression and infant feeding practices in a low income urban settlement in Nairobi-Kenya. BMC Res Notes. 2016; 9(1): 506. PubMed Abstract | Publisher Full Text | Free Full Text - 25. Ongeri L, Wanga V, Otieno P, et al.: Demographic, psychosocial and clinical factors associated with postpartum depression in Kenyan women. BMC Psychiatry. 2018; 18(1): 318. PubMed Abstract | Publisher Full Text | Free Full Text - 26. Zeng W, Musiega A, Oyasi J, et al.: Understanding the performance of county health service delivery in Kenya: a mixed-method analysis. Health Policy Plan. 2022; 37(2): 189–199. PubMed Abstract | Publisher Full Text | Free Full Text - 27. Ministry of Health: Kenya Health Policy 2014–2030 towards attaining the highest standard of health. Ministry of Health, Republic of Kenya, Nairobi, 2014. Reference Source - 28. Government of Kenya: The Health Act, 2017. Kenya Gazette Supplement No 101 (Acts No21), Repbulic of Kenya, Nairobi, 23rd June 2017. 2017. Reference Source - 29. El-Hachem C, Rohayem J, Bou Khalil R, et al.: Early identification of women at risk of postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) in a sample of Lebanese women. BMC Psychiatry. 2014; 14: 242. PubMed Abstract | Publisher Full Text | Free Full Text - 30. Chaaya M, Campbell OMR, El Kak F, et al.: Postpartum depression: prevalence and determinants in Lebanon. Arch Womens Ment Health. 2002; 5(2): 65–72. PubMed Abstract | Publisher Full Text | Free Full Text - 31. Hobeika E, Malaeb D, Obeid S, editors, , et al.: Postpartum depression and anxiety among Lebanese women: correlates and scales psychometric properties. Healthcare (Basel). MDPI, 2023; 11(2): 201. PubMed Abstract | Publisher Full Text | Free Full Text - 32. Tohme P, Grey I, El-Tawil MT, et al.: Prevalence and correlates of mental health difficulties following the beirut port explosion: the roles of mentalizing and resilience. Psychol Trauma. 2024; 16(1): 30–38. PubMed Abstract | Publisher Full Text - 33. Kroenke K, Spitzer RL: The PHQ-9: a new depression diagnostic and severity measure. Psychiatric Annals. Slack Incorporated Thorofare, NJ, 2013; 32(9): 509–515. Publisher Full Text - 34. Gladstone M, Lancaster GA, Umar E, et al.: The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS Med. 2010; 7(5): e1000273. PubMed Abstract | Publisher Full Text | Free Full Text - 35. Herdman M, Gudex C, Lloyd A, et al.: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011; 20(10): 1727–36. PubMed Abstract | Publisher Full Text | Free Full Text - 36. Al-Janabi H, Flynn TN, Coast J: Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012; 21(1): 167–76. PubMed Abstract | Publisher Full Text | Free Full Text - 37. Husereau D, Drummond M, Augustovski F, et al.: Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. MDM Policy Pract. 2022; 7(1): 23814683211061097. PubMed Abstract | Publisher Full Text | Free Full Text - 38. Wilkinson T, Sculpher MJ, Claxton K, et al.: The international decision support initiative reference case for economic evaluation: an aid to thought. Value Health. 2016; 19(8): 921–928. PubMed Abstract | Publisher Full Text - 39. Mitchell PM, Roberts TE, Barton PM, et al.: Assessing sufficient capability: a new approach to economic evaluation. Soc Sci Med. 2015; 139: 71–9. PubMed Abstract | Publisher Full Text - 40. Flynn TN, Huynh E, Peters TJ, et al.: Scoring the ICECAP-A capability instrument. Estimation of a UK general population tariff. Health Econ. 2015; 24(3): 258–69. PubMed Abstract | Publisher Full Text | Free Full Text - 41. Woods B, Revill P, Sculpher M, et al.: Country-level cost-effectiveness thresholds: initial estimates and the need for further research. Value Health. 2016; 19(8): 929–935. PubMed Abstract | Publisher Full Text | Free Full Text - 42. Xu K, Evans DB, Kawabata K, et al.: Household catastrophic health expenditure: a multicountry analysis. Lancet. 2003; 362(9378): 111–7. PubMed Abstract | Publisher Full Text - 43. Wagstaff A, van Doorslaer E: Catastrophe and impoverishment in paying for health care: with applications to Vietnam 1993–1998. Health Econ. 2003; 12(11): 921–34. PubMed Abstract | Publisher Full Text - 44. Wagstaff A, Flores G, Hsu J, et al.: Progress on catastrophic health spending in 133 countries: a retrospective observational study. Lancet Glob Health. 2018; 6(2): e169–e179. PubMed Abstract | Publisher Full Text Author details Author details 1 University College London, London, England, UK 2 University of Nairobi, Nairobi, Nairobi County, Kenya 3 National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon 4 Health Strat, Nairobi, Kenya 5 Bangor University, Bangor, Wales, UK 6 Columbia University, New York, New York, USA 7 American University of Beirut, Beirut, Beirut Governorate, Lebanon 8 Nairobi City County Government, Nairobi, Kenya 2 University of Nairobi, Nairobi, Nairobi County, Kenya 3 National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon 4 Health Strat, Nairobi, Kenya 5 Bangor University, Bangor, Wales, UK 6 Columbia University, New York, New York, USA 7 American University of Beirut, Beirut, Beirut Governorate, Lebanon 8 Nairobi City County Government, Nairobi, Kenya Gerard Joseph Abou Jaoude Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Beatrice Madeghe Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Sandra Pardi Arsen Maradian Roles: Conceptualization, Methodology, Writing – Review & Editing Roles: Conceptualization, Methodology, Writing – Review & Editing Perrine Posbic Roles: Project Administration, Writing – Review & Editing Roles: Project Administration, Writing – Review & Editing Joel Machoka Roles: Project Administration, Writing – Review & Editing Roles: Project Administration, Writing – Review & Editing George Wambiri Ndamaiyu Roles: Project Administration, Writing – Review & Editing Roles: Project Administration, Writing – Review & Editing Elizabeth Simes Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Ciara O’Donnell Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Sophie Wallace-Hanlon Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Rachel Evans Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Pasco Fearon Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Elizabeth Allison Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Steve Pilling Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Lena Verdeli Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Bryan Cheng Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Fouad Mohamed Fouad Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Carol Ngunu Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Rabih El Chammay Roles: Funding Acquisition, Methodology, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Writing – Review & Editing Manasi Kumar Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Peter Fonagy Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Jolene Skordis Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This project is funded by the National Institute for Health and Care Research (NIHR) under its ‘Research and Innovation for Global Health Transformation (RIGHT) Programme’ (Grant Reference Number PB-PG-NIHR200851). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright © 2025 Abou Jaoude GJ et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Abou Jaoude GJ, Madeghe B, Maradian SPA et al. Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial) [version 1; peer review: 1 approved]. NIHR Open Res 2025, 5:17 (https://doi.org/10.3310/nihropenres.13838.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 04 Mar 2025 Views 0 How to cite this report: Lunat F. Reviewer Report For: Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial) [version 1; peer review: 1 approved]. NIHR Open Res 2025, 5:17 (https://doi.org/10.3310/nihropenres.15036.r35067) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-17/v1#referee-response-35067 https://openresearch.nihr.ac.uk/articles/5-17/v1#referee-response-35067 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 08 May 2025 Approved VIEWS 0 This study presents the protocol for an economic evaluation embedded within the SUMMIT trial. The protocol describes the aims to assess the cost-effectiveness of group interpersonal therapy (group-IPT) for postnatal depression compared with high-quality standard care in Kenya and Lebanon. ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close This study presents the protocol for an economic evaluation embedded within the SUMMIT trial. The protocol describes the aims to assess the cost-effectiveness of group interpersonal therapy (group-IPT) for postnatal depression compared with high-quality standard care in Kenya and Lebanon. The study seeks to provide policy relevant evidence that will guide the allocation of resources for care of Postnatal depression in low and middle income countries. The study is designed appropriately with attention to societal perspective, sensitivity analysis, equity impacts, and scaling-up considerations, all aligned with the NIHR and international reporting standards. The rationale and objectives are clearly defined looking to quantify cost-effectiveness, affordability at scale and equity implications of group Interpersonal Therapy. The description of design and methodology is sufficiently detailed. It would be useful to provide a clearer explanation and rationale for the choice of the MDAT as the primary measure of child cognitive development. In Lebanon, group-IPT is delivered by licensed psychologists, whereas in Kenya, it is delivered by community health workers. This is a key difference that may result in significant cost differences and potentially affect the intervention's effectiveness and scalability. The protocol does not clearly specify how it will control for or separately analyse the effects of facilitator qualifications on costs and outcomes. The sensitivity analysis approach is not fully explained and could be described in more detail to expand on the statistical methods for sensitivity analysis, as this would enhance replicability. A point of concern is that the trial registration was completed after participant recruitment had started and much later than the ideal 6 weeks. This should be checked and clarified if possible in accordance with https://www.nihr.ac.uk/about-us/who-we-are/policies-and-guidelines/clinical-trial-registration-and-disclosure-of-results Overall this is a strong protocol with minor refinements needed. It will be interesting in future publications to understand the further cultural adaptations made to the manual and the differences in delivery between the two countries in terms of personnel delivering the intervention and associated cost implications, It would also be useful to discuss adjustments for inflation and economic crisis (especially hyperinflation risks in Lebanon). The study is designed appropriately with attention to societal perspective, sensitivity analysis, equity impacts, and scaling-up considerations, all aligned with the NIHR and international reporting standards. The rationale and objectives are clearly defined looking to quantify cost-effectiveness, affordability at scale and equity implications of group Interpersonal Therapy. The description of design and methodology is sufficiently detailed. It would be useful to provide a clearer explanation and rationale for the choice of the MDAT as the primary measure of child cognitive development. In Lebanon, group-IPT is delivered by licensed psychologists, whereas in Kenya, it is delivered by community health workers. This is a key difference that may result in significant cost differences and potentially affect the intervention's effectiveness and scalability. The protocol does not clearly specify how it will control for or separately analyse the effects of facilitator qualifications on costs and outcomes. The sensitivity analysis approach is not fully explained and could be described in more detail to expand on the statistical methods for sensitivity analysis, as this would enhance replicability. A point of concern is that the trial registration was completed after participant recruitment had started and much later than the ideal 6 weeks. This should be checked and clarified if possible in accordance with https://www.nihr.ac.uk/about-us/who-we-are/policies-and-guidelines/clinical-trial-registration-and-disclosure-of-results Overall this is a strong protocol with minor refinements needed. It will be interesting in future publications to understand the further cultural adaptations made to the manual and the differences in delivery between the two countries in terms of personnel delivering the intervention and associated cost implications, It would also be useful to discuss adjustments for inflation and economic crisis (especially hyperinflation risks in Lebanon). - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Maternal Mental Health in minority communities in the UK and in Low and Middle income countries (Primarily Pakistan and Kenya). CITE HOW TO CITE THIS REPORT Lunat F. Reviewer Report For: Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial) [version 1; peer review: 1 approved]. NIHR Open Res 2025, 5:17 (https://doi.org/10.3310/nihropenres.15036.r35067) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-17/v1#referee-response-35067 https://openresearch.nihr.ac.uk/articles/5-17/v1#referee-response-35067 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | | |---|---| | 1 | | | Version 1 04 Mar 25 | read | Sign up for content alerts You are now signed up to receive this alert Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. Consider the following examples, but note that this is not an exhaustive list: Examples of 'Non-Financial Competing Interests' - Within the past 4 years, you have held joint grants, published or collaborated with any of the authors of the selected paper. - You have a close personal relationship (e.g. parent, spouse, sibling, or domestic partner) with any of the authors. - You are a close professional associate of any of the authors (e.g. scientific mentor, recent student). - You work at the same institute as any of the authors. - You hope/expect to benefit (e.g. favour or employment) as a result of your submission. - You are an Editor for the journal in which the article is published. Examples of 'Financial Competing Interests' - You expect to receive, or in the past 4 years have received, any of the following from any commercial organisation that may gain financially from your submission: a salary, fees, funding, reimbursements. - You expect to receive, or in the past 4 years have received, shared grant support or other funding with any of the authors. - You hold, or are currently applying for, any patents or significant stocks/shares relating to the subject matter of the paper you are commenting on. Sign up for content alerts and receive a weekly or monthly email with all newly published articles Register with NIHR Open Research Already registered? Sign in close Error If you are a previous or current NIHR award holder, sign up for information about developments, publishing and publications from NIHR Open Research. We'll keep you updated on any major new updates to NIHR Open Research Sign In If you've forgotten your password, please enter your email address below and we'll send you instructions on how to reset your password. Email us for further assistance. The email address should be the one you originally registered with F1000. Email address not valid, please try again You registered with F1000 via Google, so we cannot reset your password. To sign in, please click here. If you still need help with your Google account password, please click here. You registered with F1000 via Facebook, so we cannot reset your password. To sign in, please click here. If you still need help with your Facebook account password, please click here. Code not correct, please try again Server error, please try again. If your email address is registered with us, we will email you instructions to reset your password. If you think you should have received this email but it has not arrived, please check your spam filters and/or contact for further assistance. Please wait...