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Feasibility and validity of using death surveillance data and SmartVA for fact and cause of death in clinical trials in rural China: a substudy of the China salt substitute and stroke study (SSaSS)
  1. Liping Huang1,2,
  2. Jie Yu1,3,
  3. Bruce Neal1,4,
  4. Yishu Liu1,
  5. Xuejun Yin1,
  6. Zhixin Hao5,
  7. Yangfeng Wu5,6,
  8. Lijing L Yan5,7,
  9. Jason HY Wu1,
  10. Rohina Joshi1,8,
  11. Jingpu Shi9,
  12. Xiangxian Feng10,
  13. Jianxin Zhang11,
  14. Yuhong Zhang12,
  15. Ruijuan Zhang13,
  16. Bo Zhou9,
  17. Zhifang Li10,
  18. Jixin Sun11,
  19. Yi Zhao12,
  20. Yan Yu13,
  21. Sallie-Anne Pearson14,15,16,
  22. Zhengming Chen17,
  23. Maoyi Tian1,5
  1. 1 The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
  2. 2 Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
  3. 3 Department of Cardiology, Peking University Third Hospital, Beijing, China
  4. 4 Department of Epidemiology and Biostatistics, Imperial College London, London, UK
  5. 5 The George Institute for Global Health at Peking University Health Science Center, Beijing, China
  6. 6 Peking University Clinical Research Institute, Beijing, China
  7. 7 Global Health Research Center, Duke Kunshan University, Kunshan, China
  8. 8 The George Institute for Global Health, India, Hyderabad, India
  9. 9 Department of Evidence-based Medicine, First Hospital of China Medical University, Shenyang, China
  10. 10 School of Preventive Medicine, Changzhi Medical College, Changzhi, China
  11. 11 Department of Non-communicable Diseases, Center for Disease Control of Heibei, Shijiazhuang, China
  12. 12 School of Public Health, Ningxia Medical University, Yinchuan, China
  13. 13 School of Public Health, Xi’an Jiaotong University Health Science Center, Xi'an, China
  14. 14 Menzies Centre for Health Policy, University of Sydney, Sydney, New South Wales, Australia
  15. 15 Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
  16. 16 Medicines Policy Research Unit, Centre for Big Data Research in Health, University of New South Wales, Randwick, New South Wales, Australia
  17. 17 Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK
  1. Correspondence to Dr Maoyi Tian, The George Institute for Global Health at Peking University Health Science Center, Beijing, China; mtian{at}georgeinstitute.org.cn

Abstract

Background In rural China, mortality surveillance data may be an alternative to primary data collection in clinical trials; SmartVA (verbal autopsy) is also a potential alternative for endpoint adjudication. The feasibility and validity of both need to be assessed.

Methods We used mortality data from the first 24 months of the China Salt Substitute and Stroke Study (SSaSS) trial and assessed the agreement between (1) mortality surveillance data and face-to-face visits for fact of death; (2) mortality surveillance data and SSaSS adjudication for causes of death; (3) SmartVA and SSaSS adjudication for causes of death; (4) cause-specific mortality fraction of different methods. Face-to-face visits and SSaSS adjudication were taken as reference methods. The agreement was measured by sensitivity, specificity and positive predictive value (PPV) across different 10th Revision of International Statistical Classification of Diseases chapters.

Results One thousand three hundred and sixty-five deaths were included. Mortality surveillance data had 82% sensitivity for fact of death and 81% sensitivity for causes of death, with substantial variances across different disease types and reasonable quality for circulatory death (91% sensitivity and 94% PPV). The sensitivity of SmartVA for causes of death was 61%, with reasonable quality for deaths of external causes of morbidity (90% sensitivity). The leading causes of death from different sources were the same with some variances in the fractions.

Conclusion Using mortality surveillance data for fact of death in clinical trials need to account for under-reporting. A face-to-face visit to all participants at the completion of trials may be warranted. Neither mortality surveillance data nor SmartVA provided valid data source for endpoint events.

  • mortality
  • outcome research evaluation
  • randomised trials
  • surveillance
  • death certification

Data availability statement

Data are available on reasonable request. These data come from an ongoing clinical trial and can only be shared with a reasonable request.

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Data availability statement

Data are available on reasonable request. These data come from an ongoing clinical trial and can only be shared with a reasonable request.

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Footnotes

  • LH and JY are joint first authors.

  • Twitter @Huang_LP, @JieYu43856396, @BruceNeal1, @XuejunYin, @Dr_WuJ, @rohinajoshi, @MaoyiT

  • Deceased Professor Jingpu Shi deceased on 27 October 2020.

  • Contributors LH: software, formal analysis, investigation, data curation, writing—original draft, Visualisation. JY: data curation, project administration. BN: conceptualisation, methodology, writing—review and editing, supervision, funding acquisition. YL: investigation, data curation, project administration. XY: investigation, data curation, project administration. JH: writing—review and editing. YW: conceptualisation, methodology, writing—review and editing, funding acquisition. LLY: conceptualisation, Methodology, writing—review and editing. ZH: supervision, project administration. RJ: writing—review and editing. JS: investigation, supervision, resources. XF: investigation, supervision, resources. JZ: investigation, supervision, resources. YZ: investigation, supervision, resources. RZ: investigation, supervision, resources. BZ: investigation, data curation, project administration, supervision. ZL: investigation, data curation, project administration, supervision. JS: investigation, data curation, project administration, supervision. YZ: investigation, data curation, project administration, supervision. YY: investigation, data curation, project administration, supervision. S-AP: writing—review and editing. ZC: writing—review and editing. MT: investigation, supervision, project administration, writing—review and editing, funding acquisition.

  • Funding The SSaSS trial is funded by Australian National Health and Medical Research Council (Grant ID: APP1049417 & APP1164206). BN is supported by an NHMRC Principal Research Fellowship (APP1106947). JHW is supported by a UNSW Scientia Fellowship. LH, BN and JHW are researchers within a National Health and Medical Research Council Centre for Research Excellence in reducing salt intake using food policy interventions (APP1117300). RJ is supported by an NHF Future Leader Fellowship (APP 102059).

  • Competing interests After 24 months, salt substitute has been provided by Jiangsu Sinokone Technology for free to the SSaSS trial.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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