Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID

Zheng-kun Hou; Feng-bin Liu; Ji-qian Fang; Xiao-ying Li; Li-juan Li; Chu-hua Lin

doi:10.1007/s11655-012-1104-0

Your Location：

Home >

Browse articles >

Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID

Updated：2021-08-27

- Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID
- Chinese Journal of Integrative Medicine Vol. 19, Issue 3, Pages: 172-181(2013)
- Affiliations：
  
  1. First Affiliation Hospital, Guangzhou University of Chinese Medicine,Guangzhou,China
  2. School of Public Health, Sun Yat-Sen University,Guangzhou,China
  3. Wuyi Hospital of Chinese Medicine, Wuyi,Guangdong Province,China
  4. Guangzhou Women and Children Medical Center,Guangzhou,China
- Author bio：
- Funds：
  
  Supported by the National Natural Science Foundation of China (No. 81073163) and Eleventh Five-Year National Key Technology Research and Development Program (No. 2006BAI04A12)
- DOI：10.1007/s11655-012-1104-0
  CLC：
- Published：2013，
  
  Published Online：18 August 2012，
Scan for full text
Hou, Zk., Liu, Fb., Fang, Jq. et al. Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID., Chin. J. Integr. Med. 19, 172–181 (2013). https://doi.org/10.1007/s11655-012-1104-0

Zheng-kun Hou, Feng-bin Liu, Ji-qian Fang, et al. Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID. [J]. Chinese Journal of Integrative Medicine 19(3):172-181(2013)
Hou, Zk., Liu, Fb., Fang, Jq. et al. Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID., Chin. J. Integr. Med. 19, 172–181 (2013). https://doi.org/10.1007/s11655-012-1104-0 DOI：

Zheng-kun Hou, Feng-bin Liu, Ji-qian Fang, et al. Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID. [J]. Chinese Journal of Integrative Medicine 19(3):172-181(2013) DOI： 10.1007/s11655-012-1104-0.

摘要

The reporting of patient-reported outcomes (PRO) instrument development is vital for both researchers and clinicians to determine its validity

thus

we propose the Preferred Reporting Items for PRO Instrument Development (PRIPROID) to improve the quality of reports. Abiding by the guidance published by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network

we had performed 6 steps for items development: identified the need for a guideline

performed a literature review

obtained funding for the guideline initiative

identified participants

conducted a Delphi exercise and generated a list of PRIPROID items for consideration at the face-to-face meeting. Twenty three items subheadings under 7 topics were included: title and structured abstract

rationale

objectives

intention

eligibility criteria

conceptual framework

items generation

response options

scoring

times

administrative modes

burden assessment

properties assessment

statistical methods

participants

main results

and additional analysis

summary of evidence

limitations

clinical attentions

and conclusions

item pools or final form

and funding. The PRIPROID contains many elements of the PRO research

and this assists researchers to report their results more accurately and to a certain degree use this instrument to evaluate the quality of the research methods.

Abstract

The reporting of patient-reported outcomes (PRO) instrument development is vital for both researchers and clinicians to determine its validity

thus

we had performed 6 steps for items development: identified the need for a guideline

performed a literature review

obtained funding for the guideline initiative

identified participants

rationale

objectives

intention

eligibility criteria

conceptual framework

items generation

response options

scoring

times

administrative modes

burden assessment

properties assessment

statistical methods

participants

main results

and additional analysis

summary of evidence

limitations

clinical attentions

and conclusions

item pools or final form

and funding. The PRIPROID contains many elements of the PRO research

and this assists researchers to report their results more accurately and to a certain degree use this instrument to evaluate the quality of the research methods.

关键词

Patient Reported Outcomequality of lifemeasurementquestionnaireinstrument development

Keywords

Patient Reported Outcomequality of lifemeasurementquestionnaireinstrument development

references

Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:698–702.

Moher D, Liberati A, Tetzlaff J, Altman DG, the PRISMA Group. Preferred reporting items for systematic reviews and neta-analyses: the PRISMA statement. Int J Surg 2010;8:336–341.

von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 2008;61:344–349.

Vlahov D. Transparent reporting of evaluations with nonrandomized designs (TREND). J Urban Health 2004;81:163–164.

Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002;11:193–205.

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006;4:79.

U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. Accessed 2011 November. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

European Medicines Agency. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. Accessed 2011 November. Available from: URL: http://www.ispor.org/workpaper/EMEA-HRQL-Guidance.pdf

Promote group: Patient-Reported Outcomes Moving Toward Evidence, coordinate by Istituto Superiore di Sanità. The role of patient reported outcomes in the regulatory process needs to be better defined. Accessed 2011 November. Available from: URL: http://www.iss.it/binary/pros/cont/04_RispostaEdit_BMJ.pdf

Johnson C, Aaronson N, Blazeby JM, Bottomley A, Fayers P, Koller M, et al. Eortc Quality of Life Group: guidelines for developing questionnaire modules. Accessed 2011 November. Available from: URL: http://groups.eortc.be/qol/Pdfpresentations/GuidelinesforDevelopingquestionnaire-FINAL.pdf

Cull A, Sprangers M, Bjordal K, Aaronson N, West K, Bottomley A. Eortc Quality of Life Group: translation procedure. Accessed 2011 November. Available from: URL: http://groups.eortc.be/qol/downloads/200202translation_manual.pdf

Liu BY, Fang JQ. Guidance for the application of questionnaire for clinical evaluation on Traditional Medicine. Proceedings of Conference on Clinical Evaluation Standard for Traditional Medicine Research. China Academy of Chinese Medical Sciences, and Sun Yat-sen University. Beijing, China; 2007:1–22.

Fang JQ, Liu FB, Hao YT, Liu BY, Xie YM. Guidance for medical questionnaire development and application. Proceedings of Education Conference on Questionnaire Development and Application Methods. First Affiliated Hospital of Guangzhou University of Chinese Medicine. Guangzhou, China; 2010:152–194.

Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med 2010;7:e1000217.

PHT Corporation. PHT comments on FDA’s PRO Final Guidance. Accessed 2011 November. Available from: URL: http://www.news-medical.net/news/20091224/PHTcomments-on-FDAs-PRO-Final-Guidance.aspx

ePRO Resource Center. FDA’s Guidance on patient reported outcomes in clinical research. Accessed 2011 November. Available from: URL: http://www.invivodata.com/epro-resources/fda-draft-guidance-patient-reportedoutcomes-pro/

Fayers P, Hays R. Assessing quality of life in clinical trials: methods and practice. 2nd ed. London, England: Oxford University Press; 2005:1–73.

Fang JQ. The measurements and applications of quality of life. 1st ed. Beijing: Peking University Medical Press; 2000:51–77.

Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000;9:887–900.

Bradley C. Comments on “Guidance for industry patient-reported outcome measures: use in medical product development to support labelling claims” draft guidance, February 2006. Accessed 2011 November. Available from: URL: http://digirep.rhul.ac.uk/items/d4c4a3e3-6af4-6637-147f-e5247fce0115/1/brad1.pdf

Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer 2009;45:347–353.

Arpinelli F, Bamfi F. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company. Health Qual Life Outcomes 2006;31:85.

Ross J, Shea E. Electronic Patient-Reported Outcomes: Following FDA guidance from a Vendor Perspective. Accessed 2011 November. Available from: URL: http://www.almacgroup.com/papers/Papers/ePRO%20poster.pdf

Efficace F, Bottomley A, Osoba D, Gotay C, Flechtner H, D’haese S, et al. Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials—does HRQOL evaluation in prostate cancer research inform clinical decision making? J Clin Oncol 2003;21:3502–3511.

Norquist JM, Girman C, Fehnel S, Demuro-Mercon C, Santanello N. Choice of recall period for patient-reported outcome measures: criteria for consideration. Accessed 2011 November. Available from: URL: http://www.rtihs.org/request/index.cfm?fuseaction=display&PID=15608

Gondek K, Sagnier PP, Gilchrist K, Woolley JM. Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels. J Clin Oncol 2007;10;25:5087–5093.

Hao Y. Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges. Expert Rev Pharmacoecon Outcomes Res 2010;10:407–420.

Isaac M, Vamvakas S, Pavlovic M. EMA perspective on PRO instrument qualification and harmonization. Accessed 2011 November. Available from: URL: http://www.c-path.org/PROSlides/Workshop/PROWorkshop-Isaac.pdf

Bottomley A, Jones D, Claassens L. Patient-reported outcomes (PROs): regulatory guidelines for the use of quality of life measures in medicinal product submission. Accessed 2011 November. Available from: URL: http://www.eortc.be/probe/documents/PROandregulationsforclinicaltrialsAB.pdf

Mueller K. How to clean up dirty data in patient reported outcomes. Accessed 2011 November. Available from: URL: http://www.phuse.eu/download.aspx?type=cms&docID=2507

Staquet M, Berzon R, Osoba D, Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res 1996;5:496–502.

Leung KF, Liu FB, Zhao L, Fang JQ, Chan K, Lin LZ. Development and validation of the Chinese Quality of Life Instrument. Health Qual Life Outcomes 2005;3:26.

Zhao L, Leung KF, Liu FB, Chen J, Chan K. Responsiveness of the Chinese Quality of Life Instrument in patients with congestive heart failure. Chin J Integr Med 2008;14:173–179.

Hou ZK, Liu FB, Li XY, Chen XL, Zhuang KH, Li PW. Reflections on the denotation and connotation of crossculture in health-related quality of life research. Proceedings of 2010 International Conference on Semiconductor Laser and Photonics (ICSLP 2010). The Institute of Electrical and Electronics Engineers (IEEE). Chengdu, China; 2010:133–140.

Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S. Publication guidelines for quality improvement in health care: evolution of the SQUIRE project. Qual Saf Health Care 2008;17:i3–i9.

Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and Processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008:W60–W67.

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 2008;5:e20.

Altman DG, Moher D. Developing guidelines for reporting healthcare research: scientific rationale and procedures. Med Clin (Span) 2005;125:8–13.

von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Lancet 2007;370:1453–1457.

Simera I, Altman DG, Moher D, Schulz KF, Hoey J. Guidelines for reporting health research: the EQUATOR network’s survey of guideline authors. PLoS Med 2008;5:869–874.

Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:1008–1015.

FULL TEXT LINK

More>

Views

1049

Downloads

CSCD

Alert me when the article has been cited

Submit

Tools

Publicity Resources

Standardized treatment of chinese medicine decoction for cancer pain patients with opioid-induced constipation: A multi-center prospective randomized controlled study

Effectiveness of Bufei Yishen Granule (补肺益肾颗粒) combined with acupoint sticking therapy on quality of life in patients with stable chronic obstructive pulmonary disease

Effects of Chinese medicine five-element music on the quality of life for advanced cancer patients: A randomized controlled trial

Chinese medicine improves postoperative quality of life in endometriosis patients: A randomized controlled trial

Application of the dermatology life quality index in clinical trials of biologics for psoriasis

Related Author

No data

Related Institution

Department of Oncology, First Affiliated Hospital of Guangzhou University of Chinese Medicine

Department of Respiratory, Huaihe Hospital of Henan University

Department of Respiratory, Kaifeng Hospital of Traditional Chinese Medicine

Department of Respiratory, the Second People’s Hospital of Jiaozuo City

Department of Acupuncture and Moxibustion, the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Address：1 Caochang, xiyuan, Beijing, People's Republic of China Postal code：100091
Tel：010-62886827, 62877592 Fax：010-62874291
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备05067934号-1 京公网安备11010802024621
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰