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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (10): 1092-1098.doi: 10.3736/jcim20121005

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Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: Item selection

Ping Wang1, Xu-dong Tang1(), Bao-yan Liu2(), Ming-jie Zi3   

  1. 1. Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 10091, China
    2. Clinical Evaluation Center, China Academy of Chinese Medical Sciences, Beijing 10091, China
    3. GCP Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 10091, China
  • Received:2012-04-08 Accepted:2012-06-15 Online:2012-10-20 Published:2018-10-15
  • Contact: Xu-dong Tang, Bao-yan Liu E-mail:txdly@sina.com.cn;tliuby@mail.cintcm.ac.cn

Objective: To develop a patient-reported outcome instrument for chronic gastrointestinal diseases and to select items by analyzing the data from clinical investigation.

Methods: The instrument was developed by establishing the item pool through reviewing the literature on subject of chronic gastrointestinal diseases, interviewing typical cases, focus group discussion and referring to related instruments, and then the processes of selecting and optimizing items, forming primary instrument and testing in a small sample pilot survey. A clinical investigation was conducted in 4 hospitals in Beijing. The data of 274 effective respondents with chronic gastrointestinal diseases were obtained and analyzed for selecting items using SPSS 16.0 software by applying methods such as Cronbach’s α coefficient, correlation coefficient, t test, dispersion logistic regression and factor analysis.

Results: In the patient-reported outcome instrument, 35 items were selected from investigation. Among the 35 items, 2 items were deleted, and 6 items were modified for further investigation.

Conclusion: The results of item selection provide a good reference for the primary instrument, which still needs further modification, and lots of work needed to be done, at the base of large sample size.

Key words: gastrointestinal diseases, outcome assessment (health care), item selection, clinical trials

Table 1

Results of item selection by tendency of dispersion, correlation coefficient, stepwise regression, t test, and factor analysis"

Item Tendency of
dispersion
(Standard deviation)
Correlation
coefficient
Stepwise
regression
(P value)
t test Factor analysis
(Load coefficient)
tvalue Pvalue
1. Fatigue 1.149 0.506 0.000 10.173 0.000 0.363
2. Disturbed sleep 1.315 0.567 0.000 10.449 0.000 0.340
3. No hungry sensation 1.178 0.404 0.000 4.921 0.000 0.674
4. Decreased appetite 1.206 0.482 0.000 8.135 0.000 0.738
5. Afraid of society 1.078 0.400 0.000 6.505 0.000 0.285
6. Dry mouth or bitter taste in mouth 1.218 0.447 0.000 6.237 0.000 0.729
7. Bad breath 1.257 0.359 0.000 4.778 0.000 0.687
8. Pharyngeal foreign body sensation 1.248 0.403 0.000 6.745 0.000 0.330
9. Acid regurgitation 1.156 0.333 0.000 4.802 0.000 0.624
10. Hiccup or belching 1.196 0.394 0.000 6.108 0.000 0.432
11. Nausea or vomiting 0.876 0.377 0.000 6.436 0.000 0.424
12. Heartburn (burning pain behind the sternum) 1.079 0.411 0.000 6.825 0.000 0.754
13. Retrosternal pain 1.147 0.522 0.000 8.837 0.000 0.836
14. Stomachache 1.168 0.486 0.000 7.881 0.000 0.803
15. Gastric distension 1.184 0.515 0.000 7.931 0.000 0.809
16. Gastric discomfort 1.165 0.552 0.000 10.200 0.000 0.507
17. Stomach burning 1.127 0.479 0.000 8.495 0.000 0.742
18. Abdominal pain 1.078 0.548 0.000 7.496 0.000 0.778
19. Abdominal distention 1.171 0.597 0.000 10.574 0.000 0.638
20. Degree of retrosternal pain 0.999 0.519 0.000 7.731 0.000 0.852
21. Degree of heartburn 0.984 0.491 0.000 7.371 0.000 0.751
22. Degree of stomachache 1.058 0.434 0.000 6.354 0.000 0.806
23. Degree of gastric distension 1.067 0.520 0.000 8.015 0.000 0.827
24. Degree of abdominal pain 0.961 0.567 0.000 7.240 0.000 0.823
25. Degree of abdominal distention 1.111 0.570 0.000 9.683 0.000 0.678
26. Diarrhoea 1.097 0.182 0.000 3.594 0.000 0.803
27. Constipation 1.274 0.327 0.000 3.934 0.000 0.280
28. Incomplete sensation after defecation 1.209 0.497 0.000 6.933 0.000 0.517
29. Defecation urgency 1.220 0.339 0.000 5.475 0.000 0.772
30. Weight loss 1.011 0.283 0.000 2.669 0.009 0.587
31. Emotional fluctuation 1.093 0.529 0.000 7.833 0.000 0.819
32. Anxiety or nervous 1.135 0.528 0.000 8.784 0.000 0.844
33. Worry about disease 1.199 0.475 0.000 7.775 0.000 0.646
34. Impact on social activities 1.097 0.505 0.000 8.752 0.000 0.680
35. Impact on family status and function 0.975 0.377 0.000 5.879 0.000 0.771

Table 2

Changes of Chronbach’s α coefficient after item deleted"

Item Chronbach’s α coefficient Item Chronbach’s α coefficient
Reflux=0.824 General symptoms=0.678
9. Acid regurgitation 0.846* 1. Fatigue 0.637
12. Substernal burning sensation 0.764 2. Disturbed sleep 0.615
13. Retrosternal pain 0.795 3. No hungry sensation 0.635
17. Stomach burning 0.811 4. Decreased appetite 0.572
20. Degree of retrosternal pain 0.783 30. Weight loss 0.668
21. Heartburn 0.771 Defecation=0.755
Indigestion=0.803 18. Abdominal pain 0.696
7. Bad breath 0.828* 24. Degree of abdominal pain 0.714
10. Hiccup or belching 0.800 26. Diarrhoea 0.725
14. Stomachache 0.778 28. Incomplete sensation after defecation 0.689
15. Gastric distension 0.761 29. Defecation urgency 0.732
16. Gastric discomfort 0.777 Emotion=0.714
19. Abdominal distention 0.774 8. Pharyngeal foreign body sensation 0.793*
22. Degree of stomachache 0.782 31. Emotional fluctuation 0.555
23. Degree of gastric distension 0.763 32. Anxiety or nervous 0.544
25. Degree of abdominal distention 0.779 33. Worry about disease 0.679

Table 3

Results of item selection"


Item

Dispersion
tendency

Correlation
coefficient

Chronbach’s
coefficient

ttest

Feasibility
analysis

Stepwise
regression

Factor
analysis

Times of
unselected

1. Fatigue


1

2. Disturbed sleep





1

3. No hungry sensation






4. Decreased appetite






5. Afraid of society





3

6. Dry mouth or bitter taste in mouth






7. Bad breath





2

8. Pharyngeal foreign body sensation





2

9. Acid regurgitation





2

10. Hiccup or belching





2

11. Nausea or vomiting





3

12. Heartburn (burning pain behind
the sternum)





1

13. Retrosternal pain






14. Stomachache






15. Gastric distension






16. Gastric discomfort





1

17. Stomach burning






18. Abdominal pain





1

19. Abdominal distention






20. Degree of retrosternal pain





1

21. Degree of heartburn





1

22. Degree of stomachache





1

23. Degree of gastric distension





1

24. Degree of abdominal pain





1

25. Degree of abdominal distention




空空

26. Diarrhoea





2

27. Constipation





2

28. Incomplete sensation after defecation






29. Defecation urgency





1

30. Weight loss





2

31. Emotional fluctuation





2

32. Anxiety or nervous





1

33. Worry about disease






34. Impact on social activities






35. Impact on family status and function





2
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