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Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
  1. Mohammad Sohrab Hossain1,2,
  2. Lisa A Harvey1,2,
  3. Hueiming Liu2,
  4. Md. Shofiqul Islam3,
  5. Md. Akhlasur Rahman3,
  6. Stephen Muldoon4,
  7. Fin Biering-Sorensen5,
  8. Ian D Cameron1,2,
  9. Harvinder S Chhabra6,
  10. Richard I Lindley2,
  11. Stephen Jan2
  1. 1 John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, Sydney, New South Wales, Australia
  2. 2 George Institute for Global Health, Sydney, New South Wales, Australia
  3. 3 Centre for the Rehabilitation of the Paralysed, Savar, Bangladesh
  4. 4 Livability International, Fermanagh, Northern Ireland
  5. 5 Clinic for Spinal Cord Injuries, University of Copenhagen, Hornbæk, Denmark
  6. 6 Indian Spinal Injuries Centre, New Delhi, India
  1. Correspondence to Professor Lisa A Harvey; lisa.harvey{at}


Introduction People with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.

Methods and analysis Our process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.

Ethics and dissemination Ethics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.

Trial registration number ACTRN12615000630516.

  • rehabilitation medicine
  • neurology
  • adult neurology
  • rehabilitation medicine

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  • Contributors MSH, LAH, IDC, RLL, SJ and SM were responsible for the design of the intervention and the trial. MSH, LAH, IDC, RLL, SJ, SM FB-S and HSC secured funding. SJ was responsible for the economic analyses. SJ, HL, MSH and LAH were responsible for the design of the process evaluation. MSH and HL were responsible for collection of the qualitative data. MSI, SM and MAR were responsible for the local site. All authors have read and approved the final manuscript.

  • Funding The trial is funded by a 5-year grant from the National Health and Medical Research Council of Australia (APP1080259).

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval The human ethics review committees of the Centre for the Rehabilitation of the Paralysed, Bangladesh (CRP-R&E-0401-126), and The University of Sydney, Australia (2015/041).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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