{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T07:21:12Z","timestamp":1783408872837,"version":"3.54.6"},"reference-count":45,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Siemens Healthineers India","award":["ThisworkwassupportedbyaCorporateSocialResponsibility(CSR)initiativeofSiemensHealthineersIndia[GrantNo.4511676495]"],"award-info":[{"award-number":["ThisworkwassupportedbyaCorporateSocialResponsibility(CSR)initiativeofSiemensHealthineersIndia[GrantNo.4511676495]"]}]},{"name":"Siemens Healthineers India","award":["whichfundedthefieldworkandprovidedsupportforauthorsKS"],"award-info":[{"award-number":["whichfundedthefieldworkandprovidedsupportforauthorsKS"]}]},{"name":"Siemens Healthineers India","award":["SSR"],"award-info":[{"award-number":["SSR"]}]},{"name":"Siemens Healthineers India","award":["andYCB"],"award-info":[{"award-number":["andYCB"]}]},{"name":"DBT Wellcome Trust India Alliance CRC grant","award":["DBTWellcomeTrustIndiaAllianceCRCgrant[GrantNo.IA\/CRC\/20\/1\/600007]"],"award-info":[{"award-number":["DBTWellcomeTrustIndiaAllianceCRCgrant[GrantNo.IA\/CRC\/20\/1\/600007]"]}]},{"name":"DBT Wellcome Trust India Alliance CRC grant","award":["whichprovidedsupportforauthorsPNSandYCB."],"award-info":[{"award-number":["whichprovidedsupportforauthorsPNSandYCB."]}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns5:p>Background Non-communicable diseases (NCDs), particularly hypertension and diabetes, represent a rising public health burden in India, driven by lifestyle changes and complex social determinants. In Karnataka\u2019s Chamarajanagar district, previous research identified a high NCD prevalence alongside systemic gaps in the continuum of care and multisectoral action. The IMPACT NCD project is an implementation research study that aims to strengthen the primary healthcare system's capacity and foster multisectoral collaboration for effective NCD prevention and management. Its primary scientific objective is to conduct a rigorous implementation evaluation. This evaluation examines the causal pathways and contextual factors that influence the success of these real-world interventions to understand what works, for whom, and why. Methodology The study is guided by a theory-driven implementation research design. Interventions, developed using a participatory approach, include two main components: Capacity building and technical support for healthcare workers at Ayushman Arogya Mandirs (AAMs) on NCD screening, follow-up, and the continuum of care. Sensitisation workshops for local elected officials, police personnel, and students in grades 8 to 12. The effectiveness of these strategies will be evaluated using a sequential mixed-methods approach to understand the pathways and mechanisms of change. First, quantitative program data will be analysed using Principal Component Analysis (PCA) and cluster analysis to stratify primary units by performance. Subsequently, a purposive sample of high-performing and low-performing units will be selected for in-depth qualitative analysis through interviews and observations to test and refine the project's Theory of Change. Discussion The project\u2019s strong focus on implementation evaluation is critical. By moving beyond simply measuring outcomes to understanding the underlying processes and contextual factors, the study aims to identify mechanisms that drive implementation success and sustainability mechanisms of change, the study will generate crucial insights into how complex, multisectoral NCD programs can be effectively embedded within existing government systems.<\/ns5:p>","DOI":"10.12688\/wellcomeopenres.24926.1","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T17:40:06Z","timestamp":1761759606000},"page":"609","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Strengthening the continuum of care and multisectoral action for non-communicable diseases in Chamarajanagar district, India: an implementation research protocol (IMPACT NCD)"],"prefix":"10.12688","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5045-5121","authenticated-orcid":false,"given":"Yogish","family":"Channa Basappa","sequence":"first","affiliation":[{"name":"Centre for Health Systems Bengaluru Karnataka Institute of Public Health Bengaluru"},{"name":"Family Medicine and Population Health (FAMPOP), Faculty of Medicine and Health Sciences Antwerp University of Antwerp"},{"name":"Centre of Adivasi Health Bengaluru Karnataka Institute of Public Health Bengaluru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8461-0548","authenticated-orcid":false,"given":"Shibani","family":"Sushmitha Ray","sequence":"additional","affiliation":[{"name":"Centre for Health Systems Bengaluru Karnataka Institute of Public Health Bengaluru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shwetanjali","family":"Kumari","sequence":"additional","affiliation":[{"name":"CSR Head Mumbai Siemens Healthineers India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1105-6450","authenticated-orcid":false,"given":"Kaushik","family":"Siddappa","sequence":"additional","affiliation":[{"name":"Centre for Health Systems Bengaluru Karnataka Institute of Public Health Bengaluru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nazia","family":"J Shekhaji","sequence":"additional","affiliation":[{"name":"Health and Family Welfare Services Department Bengaluru Karnataka Government of Karnataka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0968-0826","authenticated-orcid":false,"given":"Prashanth","family":"N Srinivas","sequence":"additional","affiliation":[{"name":"Centre for Health Systems Bengaluru Karnataka Institute of Public Health Bengaluru"},{"name":"Centre of Adivasi Health Bengaluru Karnataka Institute of Public Health Bengaluru"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2560","published-online":{"date-parts":[[2025,10,29]]},"reference":[{"key":"ref-1","article-title":"Global action plan for the prevention and control of noncommunicable diseases 2013\u20132020.","year":"2013"},{"key":"ref-2","article-title":"Noncommunicable diseases: risk factors.","year":"2024"},{"key":"ref-3","article-title":"Noncommunicable diseases.","year":"2024"},{"key":"ref-4","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.1079827","article-title":"Integration of communicable and Non-Communicable Diseases within the health system of India: a window of opportunity.","volume":"10","author":"S Bhattacharya","year":"2023","journal-title":"Front Public Health."},{"key":"ref-5","article-title":"National Multisectoral Action Plan for prevention and control of Noncommunicable Diseases (2017\u20132022).","year":"2017"},{"key":"ref-6","article-title":"Global Burden of Disease 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The comments have strengthened the protocol. We revised the manuscript accordingly and address each point below.  \n<b>Rationale and objectives \u2014 objectives need greater specificity as measurable research questions, and the knowledge gap beyond previous studies should be stated more explicitly.<\/b>  Response: We agree with this observation. The new &quot;Evaluation question and implementation assessment&quot; section translates the objectives as specific evaluation questions with defined primary and secondary implementation dimensions. The Theory of Change section now articulates the testable hypotheses. The Introduction states the knowledge gap explicitly by noting that global literature on multisectoral action originates predominantly from high-income countries and overlooks the socioeconomic realities of rural India. IMPACT NCD addresses this by investigating causal pathways to generate contextual evidence on integrating multisectoral strategies within government systems.  \n<b>Methods \u2014 sample size justification missing for the 9\u201312 primary units and 18\u201324 sub-units.<\/b>  Response: The Qualitative case selection section now justifies the sample based on the principle of information power rather than thematic saturation. We select four to six high-performing and four to six low-performing primary health facilities to capture the full spectrum of implementation outcomes and achieve theoretical replication. We select two villages within the catchment of each selected primary health facility to yield eighteen to twenty-four villages. This provides a volume sufficient to capture local contextual variation.  \n<b>Methods \u2014 PCA and cluster analysis specifications incomplete (variables, clustering criteria, performance thresholds).<\/b>  Response: We shifted from Principal Component Analysis to Latent Profile Analysis to provide a model-based classification better suited for identifying distinct performance strata. We added the full specification to the manuscript. Input variables includes clinical and administrative indicators including individuals aged 30 and above enrolled, screened, diagnosed, initiated on treatment, and linked to Ayushman Bharat Health Accounts. These are combined with implementation metrics like follow-up booklets distributed and line-list creation alongside standardised contextual factors includes density covariates for ASHA, Community Health Officer. The &quot;Statistical Estimation and Stratification&quot; subsection details the specific estimation parameters, model selection criteria, and performance thresholds.  \n<b>Methods \u2014 number of planned interviews per stakeholder category not specified.<\/b>  Response: The Participant Selection section now states a target of 35 to 45 in-depth interviews to maximise representation across categories. The breakdown includes nine to twelve Medical Officers or Community Health Officers, nine to twelve ASHAs or Primary Health Care Officers, nine to twelve programme beneficiaries, and three to four each among Gram Panchayat officials or elected members, police personnel, and school teachers or administrative staff. These are drawn equally from the high-performing and low-performing strata.\n<b> <\/b>  \n<b>Methods \u2014 interview guides and observation protocols not provided.<\/b>  Response: We have uploaded the full in-depth interview guide and the observation checklist as extended data on figshare, where the project pamphlet and follow-up booklet are already available.  \n<b>Methods \u2014 mixed-methods integration strategy not described.<\/b>  Response: A new &quot;Mixed-methods Integration Strategy&quot; subsection describes integration at the sampling stage and at the interpretive stage is explained in protocol.  \n<b>Methods \u2014 intervention content and format insufficiently detailed for replication.<\/b>  Response: The intervention descriptions are expanded. Objective 1 specifies structured half-day participatory workshops with a curriculum covering national screening guidelines, standardisation of blood pressure measurement, and hands-on data-entry training delivered through didactic presentation and role-play. Objective 2 states session durations including three to four hours for Gram Panchayat members and staff and two to three hours for all police cadres. It identifies the enforcement focus under the Cigarettes and Other Tobacco Products Act 2003 and broader non-communicable disease prevention. The core messaging and presentation formats are standardised across the district. Given the participatory nature of these workshops, a detailed analysis of their implementation dynamics will be provided in a subsequent manuscript.  We trust these revisions comprehensively address the points raised","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-609\/v1#referee-comment-6619","order":1,"name":"referee-comment-6619","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.27456.r140690, Kibachio Joseph Mwangi, Division of Non-Communicable Diseases, Ministry of Health, Nairobi, 30 Dec 2025, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-609\/v1#referee-response-140690","order":2,"name":"referee-response-140690","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Yogish Channa Basappa<\/b>; \n<i>Posted: 21 Jun 2026<\/i>; We thank Dr Kibachio Joseph Mwangi for the careful and constructive assessment. The comments have materially strengthened the protocol. This includes the articulation of the evaluation questions and outcomes, the specification of the quantitative stratification method, and the level of detail provided for replication. We revised the manuscript accordingly and respond to each point below. Section names refer to the revised version.  \n<b>1. The objectives are described at a high level; please articulate specific evaluation questions and specify primary versus secondary implementation outcomes, with mapping to the Theory of Change and a statement of how causality will be judged.<\/b>  We added a new section titled &quot;Evaluation question and implementation assessment&quot;. It states the specific evaluation questions regarding how health system capacity building combined with technical and hands-on support translates into sustained patient follow-up, and how stakeholder sensitisation influences local awareness and engagement. It distinguishes the primary implementation dimensions of adoption and fidelity from the secondary dimensions of acceptability and feasibility. Primary dimensions are assessed through routine programme data with proxy programme indicators and qualitative exploration of how staff integrate the tools into daily workflows. Secondary dimensions are captured through qualitative exploration of lived experience. The section makes explicit that causal inference rests on a generative logic rather than experimental attribution. We examine how the introduction of project resources triggers specific behavioural or systemic mechanisms within a given context to produce the observed outcomes, documenting context-mechanism-outcome configurations across high-performing and low-performing units identified through programme and project data.  \n<b>2. The design is described as sequential mixed methods in one place and convergent in another; please clarify and consider a sequential explanatory design.<\/b>  We thank the reviewer for identifying this inconsistency, which we corrected. The study is described as a sequential explanatory mixed-methods design. A quantitative phase stratifies primary units by performance applying Latent Profile Analysis and a qualitative phase explains the observed patterns. We removed the earlier reference to a &quot;convergent&quot; design in the Data analysis strategy section. A new &quot;Mixed-methods Integration Strategy&quot; subsection clarifies that integration occurs at two points. The quantitative stratification frames the qualitative sampling. At the interpretive stage, we will apply a triangulation approach to merge these datasets through a joint display matrix that maps programme metrics against the emergent qualitative themes for each high-performing and low-performing unit.  \n<b>3a. Please indicate the rules for handling missing data and outliers.<\/b>  We added explicit rules to the Statistical Estimation and Stratification subsection. Facility records with incomplete core indicators are handled applying complete-case analysis for the profile model. The number and characteristics of any excluded units are reported. Outlying standardized values are checked against the source records and are retained, corrected, or excluded only where they reflect data-entry error.  \n<b>3b. Please pre-specify the analytic approach with inductive codes and coding reliability procedures, including the double-coding proportion and the method of reconciliation.<\/b>  We specified these procedures in the Qualitative data analysis section. The analysis is framework analysis anchored in the refined Theory of Change, combining deductive codes derived from the framework with inductive codes for emergent themes.  \n<b>3c. Please provide explicit selection criteria and a rubric for classifying high and low performance and positive and limited influence.<\/b>  Performance classification is specified objectively in the Statistical Estimation and Stratification subsection through Latent Profile Analysis. The optimal performance model is selected applying the Bayesian Information Criterion and the Bootstrap Likelihood Ratio Test. Units are assigned to their modal profile applying posterior class-membership probabilities at a 0.70 threshold generated by this statistical model. High-performing and low-performing units are those with modal membership in the profiles showing the highest and lowest mean values on the standardised performance indicators. At the embedded village level, &quot;positive influence&quot; and &quot;limited influence&quot; cases are distinguished applying prospectively defined community-responsiveness criteria. These criteria contrast villages with high engagement in NCD activities against those with minimal participation, as set out in the Qualitative case selection section.  \n<b>3d. Please clarify whether any qualitative participants will be under 18; if so, detail assent, guardian consent, and safeguarding.<\/b>  We confirm all participants in the qualitative evaluation are adults including health personnel, Gram Panchayat members and officials, police personnel, schoolteachers and administrative staff, and adult programme beneficiaries. Students take part only in the Objective 2 sensitization activities and are not enrolled as research participants in the evaluation. The school-side interviewees are teachers and staff. No participant in the qualitative evaluation is under 18. Assent or guardian consent for research participation does not arise. We believe these revisions address the substantive concerns raised and have improved the clarity, rigour, and replicability of the protocol. We thank the reviewer again for the time and expertise.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-609\/v1#referee-comment-6618","order":3,"name":"referee-comment-6618","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by Wellcome Trust DBT India Alliance [IA\/CRC\/20\/1\/600007]; Siemens Healthineers India [4511676495]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}