|Year : 2018 | Volume
| Issue : 3 | Page : 59-65
Predictive analysis of the severity of hip arthritis using platelet-to-lymphocyte ratio: a cross-sectional study
Xiu Jiao1, Ai-Qing Zhu2
1 Department of Clinical Laboratory, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, Shandong Province, China
2 Department of Dermatology and Sexually Transmitted Diseases, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, Shandong Province, China
|Date of Submission||26-May-2018|
|Date of Decision||07-Jun-2018|
|Date of Acceptance||10-Jun-2018|
|Date of Web Publication||10-Sep-2018|
Department of Clinical Laboratory, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, Shandong Province
Source of Support: None, Conflict of Interest: None
Background and objectives: Inflammatory changes play an important role in the pathogenesis of hip arthritis. However, there are currently no available effective inflammatory markers for the prediction of the severity of hip arthritis. Platelet-to-lymphocyte ratio (PLR) has been shown to be correlated with the severity of rheumatoid arthritis, psoriatic arthritis, and colon cancer. This study hypothesizes that PLR is correlated with the severity of hip arthritis and that it can be used as a marker for evaluating the severity of hip arthritis in a Chinese patient population.
Methods: This prospective, single-center, cross-sectional study includes 260 patients with hip arthritis from the wards of Yantai Affiliated Hospital of Binzhou Medical University, China [130 patients with mild and moderate hip arthritis (Kellgren-Lawrence Grading Scale grade 1–2) and 130 patients with severe hip arthritis (Kellgren-Lawrence Grading Scale grade 3–4)]. In addition, 130 healthy controls are also included in this study. This study protocol was approved by Medical Ethics Committee, Yantai Affiliated Hospital of Binzhou Medical University of China in June 2018 (approval No. 20180601001). This study is performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Study protocol is 1.0. Written informed consent is obtained from each patient. On the day of admission, patient clinical data are collected, and blood biochemistry tests and hip X-ray examinations are performed.
Results: The primary outcome measure is PLR. Secondary outcome measures are platelet count, lymphocyte count, X-ray morphology of the hip, logistic regression analysis results of risk factors for the severity of hip arthritis, area under the ROC curve, cut-off value, sensitivity and specificity of PLR in predicting the severity of hip arthritis. A pilot study involving 182 patients with hip arthritis, consisting of 98 patients with mild and moderate hip arthritis and 84 patients with severe hip arthritis, was performed between January 2014 and June 2017 at Yantai Affiliated Hospital of Binzhou Medical University. PLR was 115.71 ± 29.31 and 146.17 ± 52.00 in 98 patients with mild and moderate hip arthritis and 84 patients with severe hip arthritis, respectively. Logistic regression analysis of this pilot study revealed that diabetes, age, increased body mass index, and increased PLR were associated with aggravation of hip arthritis and were also independent risk factors of this disorder.
Conclusion: PLR at a designated cut-off value can be used as a predictor of the severity of hip arthritis. We hope to perform a study involving 390 patients to further shed light on the correlation between PLR and the severity of hip arthritis: whether PLR has the required sensitivity, specificity, and accuracy in predicting the severity of hip arthritis, and what the optimal cut-off value of PLR is in the predicting the severity of hip arthritis based on the ROC curve.
Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016820).
Keywords: platelet-to-lymphocyte ratio; hip arthritis; Kellgren-Lawrence Grading Scale; prediction; sensitivity; specificity; X-ray; inflammation
|How to cite this article:|
Jiao X, Zhu AQ. Predictive analysis of the severity of hip arthritis using platelet-to-lymphocyte ratio: a cross-sectional study. Clin Trials Orthop Disord 2018;3:59-65
|How to cite this URL:|
Jiao X, Zhu AQ. Predictive analysis of the severity of hip arthritis using platelet-to-lymphocyte ratio: a cross-sectional study. Clin Trials Orthop Disord [serial online] 2018 [cited 2019 Feb 21];3:59-65. Available from: http://www.clinicalto.com/text.asp?2018/3/3/59/240468
| Introduction|| |
Hip arthritis is a common type of osteoarthritis, and inflammatory reaction plays an important role in the pathogenesis of hip arthritis., The currently identified inflammation-related factors include interleukin-1α (IL-1α), interleukin-1β (IL-1β), and tumor necrosis factor-alpha (TNF-α). These inflammatory factors are closely correlated with the severity of hip arthritis. However, detection methods used to measure these inflammatory factors are more complicated than routine blood tests. Therefore, there is a need to identify an inflammatory indicator to predict the severity of hip arthritis more conveniently and quickly.
Recent evidence suggests that some inflammatory indicators measured in a routine blood test can predict the severity of some inflammatory diseases. Platelets and lymphocytes are important indicators routinely analyzed in clinical blood samples and they participate in the occurrence and progression of inflammatory reactions. Several studies have demonstrated that the platelet-lymphocyte ratio (PLR) can be a good predictor of outcome in several diseases,, [Table 1].
|Table 1: Three retrospective clinical studies regarding platelet-lymphocyte ratio (PLR) changes in many diseases|
Click here to view
PLR has been shown to be correlated with the severity of rheumatoid arthritis, psoriatic arthritis, and colon cancer.,, However, whether PLR is correlated with the severity of hip arthritis remains controversial.
This study is the first to investigate the correlation between PLR and the severity of hip arthritis in a Chinese population. Identification of a simple and inexpensive indicator to predict the severity of hip arthritis is of high clinical importance. The purpose of this study is to investigate the correlation of PLR with the severity of hip arthritis and then determine whether PLR at a designated cut-off value can be used as a predictor of the severity of hip arthritis.
| Subjects and Methods|| |
A prospective, single-center, cross-sectional study.
This study protocol has been approved by Medical Ethics Committee by Yantai Affiliated Hospital of Binzhou Medical University in June 2018 (approval No. 20180601001) (Additional file 1 [Additional file 1]). This study is performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association and follows the Strengthening The Reporting of OBservational Studies in Epidemiology (STROBE) statement (Additional file 2 [Additional file 2]). Study protocol: 1.0.
Written informed consent regarding study protocol and procedure is obtained from each participant (Additional file 3 [Additional file 3]).
This study is performed at Yantai Affiliated Hospital of Binzhou Medical University, China.
At the time of release of recruitment information, the study protocol and recruitment information are approved by our hospital’s Medical Ethics Committee.
Recruitment is accomplished by playing videos on electronic LED screens in waiting rooms, rest rooms, and guidance offices to advertise the study among patients (or their family members) in the clinics and wards at Yantai Affiliated Hospital of Binzhou Medical University, China.
Recruitment is also disseminated through relevant WeChat groups to advertise the study to recruit healthy volunteers as controls.
After being informed of the study, patients interested in participating or their close relatives should provide written informed consent and confirmed participants are included according to our eligibility criteria (see below).
Participants receive routine blood and urine tests, liver and kidney function examination, and X-ray examination of the hip joint without charge. Participants are eligible to receive free transportation to and from the hospital.
Two hundred and sixty patients with hip arthritis from the clinics and wards of Yantai Affiliated Hospital of Binzhou Medical University, China and 130 healthy volunteers acting as the control group who receive healthy examination are included in this study. Inclusion and exclusion criteria, determined by physicians involved in the study, are as follows.
- Patients with hip arthritis confirmed by X-ray examination
- Availability of complete patient data, including age, sex, body mass index, adverse reactions, and related blood test results (platelet-related parameters and lymphocyte counts)
- Provision of written informed consent
- Other joint diseases, such as rheumatoid arthritis and ankylosing spondylitis
- Infections occurring in other regions
- A previous history of blood diseases
Grouping and blinding
The severity of hip arthritis is graded according to the Kellgren-Lawrence (K-L) grading scale. Two patient groups, i.e., mild and moderate hip arthritis (K-L grades 1–2; n = 130) and severe hip arthritis (K-L grades 3–4; n = 130), and one healthy control group (n = 130) are used in this study.
K-L grading criteria: grade 0: no changes on lateral X- ray images; grade 1: doubtful narrowing of joint space and possible osteophytic lipping; grade 2: definite osteophytes, normal or narrow joint space; grade 3: moderate multiple osteophytes, definite narrowing of joint space, some sclerosis of subchondral bone; grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour.
Randomization and blinded grouping are not used. The X-ray image readers and the assessors who perform the blood biochemistry tests are blinded to the study protocol.
Platelet and lymphocyte counts: 5 mL of fasting venous blood is collected from each patient. Routine blood tests are performed using Mindray BC-5390 blood analyzer and included reagents. Platelet and lymphocyte counts are measured.
X-ray examination of the hip joint: lateral photography of the hip joint is performed using an X-ray machine (YISO, Siemens, Germany).
Primary outcome measure
- PLR: The ratio of platelet to lymphocyte counts is calculated.
Secondary outcome measures
- Platelet counts: Platelet counts are analyzed using a blood cell analyzer. The normal range of platelet counts is 100–300 × 109/L.
- Lymphocyte counts: Lymphocyte count, 0.8–4.0 × 109/L, is an important cellular component of the body’s immune response function. Lymphocyte count is determined using a blood cell analyzer.
- Morphology of the hip joint: Morphology of the hip joint is determined using an X-ray machine.
- Logistic regression analysis is performed on risk factors that could be involved in aggravating hip arthritis including age, sex, body mass, smoking, alcohol consumption, diabetes, hypertension, platelet count, lymphocyte count, and PLR as independent variables, and taking aggravation of hip arthritis (K-L grades 3–4) as the dependent variable. Logistic regression analysis is performed to screen for risk factors that aggravate hip arthritis.
- Area under the receiver operating characteristic (ROC) curve of PLR in predicting the severity of hip arthritis: ROC curves are drawn including the sensitivity of PLR in predicting the severity of hip arthritis as the Y-axis, indicating the true positive rate, and (1–specificity of PLR in the prediction of severity of hip arthritis) as the X-axis, indicating the false positive rate. The area under the ROC curve will be in the range of 0.5–1.0. In the case of area under ROC curve (AUC) > 0.5, an AUC closer to 1 indicates better diagnostic accuracy. In the case of an AUC = 0.5, the method has no diagnostic value.
- Cut-off value of PLR in predicting the severity of hip arthritis: The optimal cut-off value is selected as follows: A ROC curve closer to the upper left corner indicates higher diagnostic accuracy. The cut-off value is selected as the point of the ROC curve closest to the upper left corner, which is the best threshold with the least error and with the smallest total number of false positives and false negatives.
- Sensitivity of PLR in predicting the severity of hip arthritis: This is a true positive rate. A higher sensitivity indicates a lower rate of missed diagnoses.
- Specificity of PLR in predicting the severity of hip arthritis: This is a true negative rate. A higher specificity indicates a lower rate of missed diagnoses.
Adverse reactions (dizziness, nausea, and vomiting) occurring during blood biochemistry testing and X-ray examinations are recorded in detail. Onset time and type of adverse reactions occurring during the follow-up period, as well as measures to be taken, are reported to the project manager and the medical ethics committee within 24 hours.
A total of 390 participants are included in this study, including 130 patients with mild and moderate hip arthritis, 130 patients with severe hip arthritis, and 130 healthy controls. Trial procedure is shown in [Figure 1].
|Figure 1: Study flow chart.|
Note: PLR: platelet-to lymphocyte ratio; ROC: receiver operating characteristic; K-L: Kellgren-Lawrence Grading Scale.
Click here to view
In accordance with the results of a pilot study, PLR in the severe hip arthritis group was 146.17 ± 52.00. Assuming error = 10, standard deviation = 52, and confidence level of 1 – α = 95%, an effective sample size of n = 107 for severe hip arthritis group was calculated using PASS 11.0 software (PASS, Kaysville, UT, USA). Assuming a participant loss rate of 20%, we require a sample size of n = 130 for severe hip arthritis group. Following the principle of equal sample size in each group, a total sample size of n = 390 are used in this study.
All data are statistically processed using the SPSS 19.0 software (IBM, Armonk, NY, USA) following the intention-to-treat principle. Normally distributed measurement data are expressed as means and standard deviations. Non-normally data are expressed as lower quartiles (q1), medians, and upper quartiles (q3). Count data are expressed as percentages.
Selection of statistical methods
One-way analysis of variance and the least significant different test are performed to compare platelet count, lymphocyte count, PLR, age, and body mass index among three groups at different time points. Pearson chi-square test is performed to compare sex, smoking, alcohol drinking, smoking, diabetes, and hypertension among three groups. Pearson correlation is used to analyze the correlation between PLR and the severity of hip arthritis. Logistic regression analysis is used to analyze the risk factors for aggravating hip arthritis. Odds ratio value and 95% confidence interval are calculated. The value of PLR in the prediction of the severity of hip arthritis is evaluated using ROC curve, cut-off value, specificity and specificity. An inspection level of α = 0.05 (bilateral) is considered.
The patients included in the final analysis are mainly the population assigned to the per protocol set.
Data collection and management
Case report forms are filled by the investigators accurately, completely, and on time. Written records are transferred to an electronic format by professional staff using a double data entry strategy.
Research data are statistically analyzed and reported by professional statisticians. A final report is made by principle investigators and the database is locked. All data relating to this study are preserved by Yantai Affiliated Hospital of Binzhou Medical University, China.
Independent Data Monitoring Committee composition
The role and responsibilities of the Independent Data Monitoring Committee relative to the investigators and ethics committee are identified. The role and responsibilities of the Independent Data Monitoring Committee are relative to the project steering committee, doctors with related professional backgrounds, epidemiologists, statisticians, clinical trial managers, and ethics experts.
All surgeons participating in this study have a wealth of experience in similar operations and can skillfully perform surgical procedures. All surgeries are performed by senior physicians. Physicians responsible for imaging evaluation should have underwent professional training and have abundant experience in this research field.
The monitors visit the trial institute regularly or according to the actual situation to carry out clinical quality audit work. The monitors report the progress of the trial to the Ethics Committee every 2 months and update the trial progress in the registration database.
Compensation to patients
Patients included in the clinical trial undergo related blood biochemical examination without charge. They are able to receive transportation and registration fees for admission examination.
| Results|| |
Results of a pilot study involving 182 patients performed during 2014–2017 are reported here.
Comparison of baseline data between the two groups
According to the K-L grading scale, 182 patients were assigned to a mild and moderate hip arthritis group (n = 98) or a severe hip arthritis group (n = 84). There were no significant differences in sex, smoking, alcohol drinking, and hypertension between the two groups (P > 0.05). Significant differences in age, body mass index, diabetes mellitus, platelet count, lymphocyte count, and PLR existed between the two groups (P < 0.05; [Table 2].
Logistic regression analysis results regarding the severity of hip arthritis
Univariate Logistic regression analysis revealed that diabetes (P = 0.008), age (P < 0.001), increased body mass index (P = 0.047), and increased PLR (P = 0.002) were related with aggravation of hip arthritis. Multivariate logistic regression analysis revealed that diabetes (P < 0.001), age (P < 0.001), increased body mass index (P < 0.001), and increased PLR (P = 0.010) were independent risk factors for aggravation of hip arthritis. The data are shown in [Table 3].
|Table 3: Univariate and multivariate Logistic regression analysis results|
Click here to view
| Discussion|| |
Previous contributions and existing problems
Inflammatory changes play an important role in the pathogenesis of hip arthritis. Recent evidence suggests that some inflammation-related indicators such as PLR, measured in routine blood tests, are being used as predictors in several inflammatory diseases. Platelets are an important indicator measured in clinical blood analysis. They are detached from the cytoplasm of mature bone marrow-derived megakaryocytes and have biological activity. They have been shown to participate in the occurrence and progression of inflammatory reactions and play a role in immunity. Gasparyan et al. reported that the lymphocyte is a common inflammatory marker and its role in many inflammation-related diseases has been studied.,,,,,,,,,,,,,, PLR has been shown to be related to the severity, development, and prognosis of systemic inflammatory diseases.,, Hip arthritis has also been identified as a low-grade inflammatory disease. Little information has been reported in a Chinese patient population regarding whether PLR is related to the severity of hip arthritis.
Novelty of this study
A retrospective study has reported platelet/lymphocyte ratios and mean platelet volume as new inflammatory markers for predicting the severity of hip arthritis. However, there are few reports on the diagnostic value of inflammatory markers for predicting hip severity. This cross-sectional study assigns patients to a mild and moderate hip arthritis group (n = 130) or a severe hip arthritis group (n = 130) according to K-L grading criteria of the hip joint and simultaneously includes 130 normal volunteers as controls to investigate the correlation between PLR and the severity of hip arthritis. This helps determine whether PLR is a good indicator for predicting the severity of hip arthritis in Chinese patients.
Limitations of this study
First, randomization and blinded grouping are not be used. Second, measurement bias may occur. Third, this study does not measure other indices. For example, interleukin-1α, interleukin-1β, and tumor necrosis factor-α would have been used in combination with PLR to predict the severity of hip arthritis. All these limitations may influence the reliability of the results of this study.
Significance of this study
Results from this study indicate whether (1) PLR is correlated with the severity of hip arthritis, (2) PLR can be used as a predictor of the severity of hip arthritis, (3) PLR is of guidance significance in the diagnosis of hip arthritis, and (4) PLR provides a good indicator for monitoring the diagnosis and treatment of hip arthritis.
| Trial Status|| |
Date of Registration: June 6, 2018, Chinese Clinical Trial Registry.
Date of recruitment: Between August 2018 and March 2019.
Estimated study completion date: May 2019.
Study status: recruiting.
Additional file 1: Hospital ethics approval (Chinese).
Additional file 2: STROBE checklist.
Additional file 3: Informed consent form (Chinese).
Conception and design of this study: XJ; patient recruitment, data collection and analysis: XJ and AQZ. All authors approved the final version of this manuscript for publication.
Conflicts of interest
There are no conflicts of interest.
Institutional review board statement
This study is performed in strict accordance with the Declaration of Helsinki. Study approval was obtained in June 2018 from Medical Ethics Committee, Yantai Affiliated Hospital of Binzhou Medical University, China (approval No. 20180601001). This study was registered with the Chinese Clinical Trial Registry on June 26, 2018 (registration number: ChiCTR1800016820).
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patients have given their consent for patients’ images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity.
This study protocol is developed based on the Strengthening The Reporting of OBservational Studies in Epidemiology (STROBE)statement.
The statistical methods of this study were reviewed by the biostatisticians of Yantai Affiliated Hospital of Binzhou Medical University, China.
Copyright license agreement
The Copyright License Agreement has been signed by all authors before publication.
Data sharing statement
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Study protocol and informed consent will be available immediately after publication without end date. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com.
Checked twice by iThenticate.
Externally peer reviewed.
Open access statement
This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-Non-Commercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
Peer review started: May 27, 2018
First decision: June 4, 2018
P-Reviewer: Abramovitz M; C-Editor: LWW, Zhao M; S-Editor: Wang J, Li CH; L-Editor: Song K; T-Editor: Jia Y
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[Table 1], [Table 2], [Table 3]