Abstract
Background
We developed an evidence-based medical record for doctor-patient relationship building through an integrated therapy of traditional Chinese and Western medicine (DPEBMR) to assess the efficacy in patients with digestive system diseases. The instrument was categorized into a doctor section and a patient section. In this article, our main goal was to test the validity and reliability of the patient’s section for DPEBMR (DPEBMR-P).
Methods
One hundred patients were recruited. Doctors and patients used a predefined format to jointly record the illness. Cronbach’s α and factor analysis were used to evaluate the reliability and structure validity, respectively.
Results
Cronbach’s α of all 12 items from DPEBMR-P was 0.906, which demonstrated high reliability. The Kaiser-Meyer-Olkin value was 0.811 and Bartlett’s spherical test value was 452.2 (P<0.05), which meant it was suitable for performing factor analysis. A total of 3 items were identified as factors, and each had high loading: items of mental status (0.584 to 0.833), items of therapeutic effect (0.518 to 0.797), and items of appetite (0.857 to 0.882).
Conclusions
The DPEBMR-P indicated substantial reliability and structure validity.
Keywords: Gastrointestinal diseases, reliability, validity
Introduction
The definition of health-related quality of life (HRQoL) is a multidimensional concept, which includes physical, mental, and social dimensions (1-4). The assessment of patients’ HRQoL could assist clinicians in evaluating the efficacy of the interventions. In the field of gastrointestinal diseases, there are many disease-specific HRQoL instruments; however, they all have limitations. For instance, GERD-HRQL assessed the symptom’s severity rather than HRQoL (5). The Reflux questionnaire mixed HRQoL and symptoms (6). GERD-QOL was a pure HRQoL instrument (7), but its social domain was vague, and it only recruited patients with GERD who had received esomeprazole.
To overcome these limitations, we developed a new instrument titled the evidence-based medical record about doctor-patient building through integrated therapy of traditional Chinese and Western medicine (DPEBMR) which could be applied in patients with gastrointestinal diseases who received any of the possible therapies. The instrument was categorized as into a doctor section and a patient section. In this article, our main goal was to test the validity and reliability of patients section for DPEBMR (DPEBMR-P).
Methods
The study measured the reliability and validity of the DPEBMR-P among 98 patients with gastrointestinal diseases. DPEBMR-P contains 12 items, and the details of these items are in Figure 1.
Figure 1.
Items of patient section of evidence-based medical record about doctor-patient building through integrated therapy of traditional Chinese and Western medicine (DPEBMR-P).
Participants
The inclusion criteria were the following: adults with functional dyspepsia, gastroesophageal reflux disease, chronic non-atrophic gastritis, precancerous lesions of gastric carcinoma, peptic ulcers, irritable bowel syndrome, ulcerative colitis or chronic constipation which were diagnosed through gastroscopy, enteroscopy or biopsy. The exclusion criteria were the following: a diagnosis was made at least 6 months before, any co-morbidity with 2 or more systems, patients with major mental illness.
Interventions
The study did not restrict the treatment regimens of included patients. However, our hospital had standard therapies for the relevant diseases. For patients who had Helicobacter pylori infections, they received quadruple therapy if they were allergic to amoxicillin. Otherwise, they were treated with a sequential therapy. More detailed information can be found in supplementary. For patients without Helicobacter pylori infection, Chinese traditional medicine (lianzhuliyi pill and huaganjian) was prescribed if they had no heartburn or regurgitation, or we chose step-down therapy—initial two weeks: proton pump inhibitor; following two weeks: Chinese traditional medicine (lianzhuliyi pill and huaganjian). For patients with precancerous lesions of gastric carcinoma, another Chinese traditional medicine (sijunzi soup, banxiaxiexin soup, xiaoyao powder, xiangsu drink and zhishu pill) was used.
Statistical analysis
All data were analyzed using the SAS software, version 9.2. All statistical inferences were made of two-sided test, and a value of P<0.05 was considered to be statistically significant. For missing data, the Last Observation Carried Forward method was used to impute. The inter-item correlation matrix was performed to evaluate the repeatability of the item. Principal components factor analysis and Cronbach’s alpha were used to calculate the construct validity and internal consistency, respectively. If the initial eigenvalue of the item was larger than 1, it was regarded as a factor (8). If the value of Cronbach’s alpha was larger than 0.7, it meant internal consistency was high (9).
Results
Of the 100 patients recruited, 98 completed the fourth follow-up. The mean age of these patients was 48.6 (SD: 14.7). More than half of them were female (57.1%). Most of them (79.6%) received only traditional Chinese medicine (TCM), some (18.4%) accepted both TCM and western drugs, and the rest (2%) were treated by only western drugs. The results of the inter-item correlation matrix failed to find any large correlation coefficients among the different items, which indicated the repeatability of the item was low.
Construct validity
The score of the Kaiser-Meyer-Olkin Measure of Sampling Adequacy was 0.811 (more than 0.5), which indicated sufficient common factors among variables. Meanwhile, the Bartlett’s test of sphericity had a significant result (P<0.05). Thus, it was appropriate to conduct a principal component factor analysis test. A total of 3 items were identified as factors, and they accounted for 68% of the total variance. Then, we conducted a principle component analysis test with a varimax rotation to test the 3 factors.
The results (Table 1) indicate that each item had a high loading: items of mental status (0.584 to 0.833), items of therapeutic effect (0.518 to 0.797), and items of appetite (0.857 to 0.882).
Table 1. Factors loading.
| Item | Explanatory variable | Cumulative explanatory variable | Factor load capacity | ||
|---|---|---|---|---|---|
| Factor 1: mental status | Factor 2: curative effect | Factor 3: food intake | |||
| No. 3 I feel strength all over the body | 24.833 | 24.833 | 0.833 | ||
| No. 2 I think I look good | 0.820 | ||||
| No. 4 At least two persons think I’m energetic when doing things | 0.754 | ||||
| No. 1 At least two persons said I look good | 0.584 | ||||
| No. 6 I think I’m in a better mood | 24.275 | 49.108 | 0.797 | ||
| No. 10 I accept TCM treatment | 0.778 | ||||
| No. 11 At least two persons think I complain less of pain | 0.604 | ||||
| No. 9 At least two persons said I had accept traditional Chinese medicine (TCM) treatment | 0.603 | ||||
| No. 12 I feel that there are less symptoms | 0.583 | ||||
| No. 5 At least two persons think I’m not so irritable | 0.518 | ||||
| No. 7 At least two persons said I eat more than before | 18.890 | 67.998 | 0.882 | ||
| No. 8 I think I eat more than before | 0.857 | ||||
| No. 3 I feel strength all over the body | 2.980 | 2.913 | 2.267 | ||
Internal consistency
Table 2 displays the results of the reliability test. The Cronbach’s alpha for overall scale was 0.906 and sub-scales ranged from 0.894 to 0.905. Thus, DPEBMR-P had a high internal consistency.
Table 2. Results of reliability test.
| Item | Scale mean if item deleted | Scale variance if item deleted | Corrected item-total correlation | Squared multiple correlation | Cronbach’s alpha if item deleted |
|---|---|---|---|---|---|
| No. 1 At least two persons said I look good | 20.38 | 34.7 | 0.612 | 0.544 | 0.9 |
| No. 2 I think I look good | 20.56 | 34.866 | 0.708 | 0.675 | 0.895 |
| No. 3 I feel strength all over the body | 20.52 | 35.546 | 0.619 | 0.583 | 0.899 |
| No. 4 At least two persons think I’m energetic when doing things | 20.44 | 33.881 | 0.729 | 0.714 | 0.894 |
| No. 5 At least two persons think I’m not so irritable | 20.24 | 34.617 | 0.667 | 0.582 | 0.897 |
| No. 6 I think I’m in a better mood | 20.48 | 35.515 | 0.559 | 0.531 | 0.902 |
| No. 7 At least two persons said I eat more than before | 20.02 | 34.446 | 0.675 | 0.812 | 0.896 |
| No. 8 I think I eat more than before | 20.08 | 34.163 | 0.668 | 0.792 | 0.897 |
| No. 9 At least two persons said I had accept traditional Chinese medicine (TCM) treatment | 20.33 | 35.826 | 0.51 | 0.461 | 0.905 |
| No. 10 I accept TCM treatment | 20.98 | 37.431 | 0.608 | 0.507 | 0.901 |
| No. 11 At least two persons think I complain less of pain | 20.59 | 34.707 | 0.634 | 0.536 | 0.899 |
| No. 12 I feel that there are less symptoms. | 20.88 | 35.831 | 0.685 | 0.652 | 0.897 |
Discussion
Our study developed a new 12-item instrument to assess the efficacy of therapies in patients with gastrointestinal diseases. The patient section has a high degree of internal consistency and construct validity.
Our study has several strengths: first, our study was a real-world study which means that the results can be applied more extensively in patients with gastrointestinal diseases. Moreover, previous studies only focused on specific patients: GERD (5-7,10,11), dyspepsia or irritable bowel syndrome (12), and esophagitis (13). Our tool was more practical than the previous ones. Furthermore, our study considered others’ sayings towards patients which previous studies had paid little attention to. Previous studies even with the generic instrument SF-36 and the EQ-5D did not include the items related to what the others said towards the patients (14,15). However, our feelings or thoughts might be influenced by others’ sayings (16). Thus, it is necessary to include items about what the others are saying because HRQoL as an instrument is a multidimensional tool which should include any factors which can influence the patients’ health status. Finally, to the best of our knowledge, our study was the first to recruit patients who received TCM treatment. TCM has been proven to be an effective intervention in treating patients with GERD (17,18), and so it was necessary to include patients who received TCM.
Still, some limitations should be discussed. First of all, the sample size of our study was limited which might make the results unstable. However, our research was continuously performed, and we will recruit more patients in the future to make the results more robust. Also, the age range in our study was from 33.9 to 63.3. Thus, our results may not be applicable to older or younger patients.
Conclusions
DPEBMR-P is a useful tool to assess the efficacy of therapies in patients with gastrointestinal diseases.
Details of therapies
H. pylori test: positive. Initially, patients received eradication (Table S1).
Table S1. Sequential therapy for helicobacter pylori infection.
| Medicine | Dosage | Direction (take orally) | Medication time (morning) | Medication time (night) | Before/after meal |
|---|---|---|---|---|---|
| 1–7 day | |||||
| Rabeprazole sodium/pantoprazole/omeprazole enteric tablet | 20 mg | Twice | 6 am | 6 pm | Before |
| Colloidal bismuth subcitrate | 0.3 g | Twice | 6 am | 6 pm | Before |
| Amoxicillin | 1 g | Twice | 8 am | 8 pm | After |
| 8–14 day | |||||
| Rabeprazole sodium/pantoprazole/omeprazole enteric tablet | 20 mg | Twice | 6 am | 6 pm | Before |
| Colloidal bismuth subcitrate | 0.3 g | Twice | 6 am | 6 pm | Before |
| Carat enzyme dispersible tablets | 0.5 g | Twice | 8 am | 8 pm | After |
| Tinidazole | 0.5 g | Twice | 8 am | 8 pm | After |
If patients are sensitive to amoxicillin: quadruple chemotherapy for Helicobacter pylori infection (Table S2).
Table S2. Sequential therapy for helicobacter pylori infection in patients sensitive to amoxicillin.
| Medicine (1–14 day) | Dosage | Direction (take orally) | Medication time (morning) | Medication time (night) | Before/after meal |
|---|---|---|---|---|---|
| Rabeprazole sodium/pantoprazole/omeprazole enteric tablet | 20 mg | Twice | 6 am | 6 pm | Before |
| Colloidal bismuth subcitrate | 0.3 g | Twice | 6 am | 6 pm | After |
| Carat enzyme dispersible tablets | 0.5 g | Twice | 8 am | 8 pm | After |
| Tinidazole | 0.5 g | Twice | 8 am | 8 pm | After |
Acknowledgements
Funding: This study was funded by the National Natural Science Funds of China (No. 81774146 and 81303151) and the Beijing NOVA Program (No. xxjh2015A093 and No. Z1511000003150125).
Ethical Statement: The study was approved by Ethics Committee from Xiyuan Hospital, China Academy of Traditional Chinese Medicine.
Footnotes
Conflicts of Interest: The authors have no conflicts of interest to declare.
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