{
  "abstract": "Background: onitoring the implementation of observational studies are rare, unlike experimental studies. This article aims to describe the development and implementation of a monitoring plan and framework for a large-scale cohort and quasi-experimental study: the NIMHANS-NH-SKAN Stroke project. Methods: The monitoring framework was developed through a systematic, stepwise process involving expert consultation workshops conducted by an Independent Monitoring Team in collaboration with the study team. A logical framework approach was used to identify key processes throughout the study implementation. These processes were then disaggregated into critical activities (sub-processes) to generate an initial list of monitoring items. These items were prioritized using the Vital–Essential–Desirable (VED) strategy through consensus building. The shortlisted items were further refined using SMART criteria (Specific, Measurable, Achievable, Relevant, and Time-bound) to finalize checklist components. Key Performance Indicators were subsequently derived from the finalized checklist items. The framework emphasized usability, feasibility, and relevance to implementation, enabling systematic monitoring of critical study processes. Results: A total of 89 activities were identified and consolidated into 10 checklists, from which 16 Key Performance Indicators (KPIs) were derived. The monitoring framework primarily emphasized indicator-based assessment of project outputs and outcomes while ensuring adherence to key processes and quality standards. KPIs were expressed as proportions to facilitate standardized performance assessment across sites and time periods. The checklists comprised a combination of in-person observations and record reviews. Monitoring findings were synthesized into periodic reports based on KPI proportions, enabling objective evaluation of implementation performance and identification of areas requiring corrective action. Conclusions: Timely and systematic monitoring is critical to ensure rigor in large-scale projects, and the approach described in this study provides a replicable framework for the development of robust monitoring systems in similar community-based large-scale observational studies in India and similar countries.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Psychiatric Social Work, NIMHANS, Bengaluru, Karnataka, India",
    "Senior Research Officer, NIMHANS-NH-SKAN Stroke Project, NIMHANS, Bengaluru, Karnataka, India",
    "Senior Community Mobiliser, NIMHANS-NH-SKAN Stroke Project, NIMHANS, Bengaluru, Karnataka, India",
    "Department of Community Medicine, Yenepoya Medical College, Yenepoya (Deemed to be University), Mangalore, Karnataka, India",
    "Department of Community Medicine, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India",
    "Department of Community Medicine, Rajarajeswari Medical College and Hospital, Bengaluru, Karnataka, India",
    "Department of Community Medicine, Kasturba Medical College Mangalore, Karnataka, Manipal Academic of Higher Education, Manipal, Karnataka, India",
    "Department of Community Medicine, K. H. Patil Institute of Medical Sciences, Gadag, Karnataka, India",
    "Department of Community Medicine, Karwar Institute of Medical Sciences, Karwar, Karnataka, India",
    "Department of Community Medicine, Koppal Institute of Medical Sciences, Koppal, Karnataka, India",
    "Department of Epidemiology, NIMHANS, Bengaluru, Karnataka, India",
    "Department of Community Medicine, Chikkamagaluru Institute of Medical Sciences, Chikkamagaluru, Karnataka, India",
    "Department of Pathology, Sanjay Gandhi Institute of Trauma and Orthopaedics, Bengaluru, Karnataka, India",
    "Mazumdar Shaw Medical Centre, Narayana Institute of Neurosciences, Bengaluru, Karnataka, India",
    "Neurosurgeon, Narayana Institute of Neurosciences, Bengaluru, Karnataka, India",
    "SKAN Research Trust, Bengaluru, Karnataka, India",
    "Skan Project, NIMHANS, Bengaluru, Karnataka, India",
    "Senior Research Officer, Skan Project, NIMHANS, Bengaluru, Karnataka, India"
  ],
  "article_type": "Research Article",
  "arxiv": null,
  "author_total": 20,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Mutharaju Arelingaiah",
      "orcid": "0000-0002-1517-8560"
    },
    {
      "affs": [
        1
      ],
      "name": "Arpitha Arun"
    },
    {
      "affs": [
        2
      ],
      "name": "Bangalore Sivilan Madhuri"
    },
    {
      "affs": [
        3
      ],
      "name": "Kibballi Madhukeshwar Akshaya"
    },
    {
      "affs": [
        4
      ],
      "name": "Huluvadi Shivalingaiah Anwith",
      "orcid": "0000-0002-6199-9992"
    },
    {
      "affs": [
        5
      ],
      "name": "Shivappa Usha"
    },
    {
      "affs": [
        6
      ],
      "name": "Ramesh Holla"
    },
    {
      "affs": [
        7
      ],
      "name": "Aravind Karinagannanavar"
    },
    {
      "affs": [
        8
      ],
      "name": "Malatesh Undi"
    },
    {
      "affs": [
        9
      ],
      "name": "Sharankumar Holyachi"
    },
    {
      "affs": [
        10
      ],
      "name": "Pradeep S. Banandur"
    },
    {
      "affs": [
        10
      ],
      "name": "Gautham Melur Sukumar"
    },
    {
      "affs": [
        10
      ],
      "name": "Banavaram Anniappan Arvind"
    },
    {
      "affs": [
        11
      ],
      "name": "Betagalli Mallappa Shivaraj"
    },
    {
      "affs": [
        12
      ],
      "name": "Khandiga Sharma Lakshmi"
    },
    {
      "affs": [
        13
      ],
      "name": "Thimappa Hegde"
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    {
      "affs": [
        14
      ],
      "name": "Komal Prasad"
    },
    {
      "affs": [
        15
      ],
      "name": "Lavanya Garady"
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    {
      "affs": [
        16
      ],
      "name": "Ankesh Ashwini"
    },
    {
      "affs": [
        17
      ],
      "name": "Upashana Medhi"
    }
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  "bibtex": "https://research.draconitic.com/paper/ejgnrjqg7mhrz.bib",
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  "doi": "10.1371/journal.pone.0361702",
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  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
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  "pmcid": "PMC13734449",
  "pmid": "42981312",
  "published": "2026-11-04",
  "publisher": "Public Library of Science",
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  "title": "Operationalizing independent oversight in large-scale public health cohorts: Monitoring protocol for the NIMHANS–NH–SKAN Stroke project",
  "title_text": "Operationalizing independent oversight in large-scale public health cohorts: Monitoring protocol for the NIMHANS–NH–SKAN Stroke project",
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