| Studies on comparing the Evaluation Of conservative treatment effect for Osteonecrosis of the Femeral Head (ONFH) between patients’ self-reported and doctor’s clinical assessment.ObjectiveTo assess the correlation of the outcomes between patients’ self-reported and doctor’s clinical assessment for the Conservative Treatment effect for Osteonecrosis of the Femeral Head.MethodCollecting the datas of126cases of patients that accepted conservative treatment in Wangjing hospital of China Acadamy of Chinese Medicine Science from September2010to January2012, entering the basic information of the participants, including name,sex, age, occupation, the special factors, the method of treatment and the side of the collected hip. To assess the effect of conservative treatment for ONFH with two methods, Patients’ self-reported measures (including EQ-5D, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Syndrome scale for Traditional chinese medicine) and Doctors report outcome measures (including iconography grade and Harris Hip Score). Follow up those participants for a visit, and research the outcome scores before and after treatment (3months or6months follow-up), review radiography examination, fill out the forms, then establish a database. And analyse the data statistically by appropriate means.Results1. General informationFollow-up visits for126cases of ONFH patients who accepted conservative treatment in Wangjing hospital are completed completely, with the proportion of100%.90cases are male and36female; The age ranges from17to64years old, mean41; The occupation of the participants are various, including peasants, manual workers, office workers, teachers, students, ect. The special factors include hormone, alcohol, trauma or no special factors, especially the hormone (47cases) and alcohol (58cases).The method of conservative treatment for the sick hip include simple technique、physical therap with traditional Chinese medicine, treatment with traditional Chinese medicine by many ways, Core decompression operation, alive bone implantation operation and tantalum stick implantation operation, ect. Patients before and after treatment were divided into three month group (n=80) and six month group (n=46),and according to the outcome of iconography grades (ARCO stages) after treatment, each group are divided into anabatic group and stable group.2. Each result of the evaluation method before and after conservative treatment for participants from defferent groups.(paired design "t" test as the statistical method).2.1The result of3month group (69cases)2.1.1Harris Hip Score1) The stable group of3month groupIn stable group of3month group, according to the Harris hip score,51cases are stable after treatment and18rest are anabatic,with the stable rate74%, average Harris hip score before conservative treatment is81.49±13.88, after treatment85.40±9.77, indicating change has significant difference statistically (P=0.016<0.05);2) The anabatic group of3monthIn anabatic group of3month group, according to the Harris hip score,4cases are stable after treatment and7rest are anabatic, with the stable rate36.6%, average Harris hip score before treatment is84.63±10.40, after treatment72.27±11.98, indicating change has significant difference statistically (P=0.012<0.05)2.2.2EQ-5D score1) The stable group of3month groupIn stable group of3month group, according to the EQ-5D score,31cases are stable after treatment and38rest are anabatic, with the stable rate44.9%, average EQ-5D score before conservative treatment is0.53±0.12, after treatment0.48±0.14, indicating change has significant difference statistically (P=0.044<0.05);2) The anabatic group of3monthIn anabatic group of3month group, according to the EQ-5D score,4cases are stable after treatment and7rest are anabatic, with the stable rate36.6%,average EQ-5D score before treatment is0.51+0.15, after treatment0.46±0.13, indicating change has no significant difference statistically (P=0.437>0.05);2.2.3WOMAC score1) The stable group of3month groupIn stable group of3month group, according to the WOMAC score,30cases are stable after treatment and39rest are anabatic, with the stable rate43.4%, average WOMAC score before conservative treatment is31.18+8.13, after treatment35.60+11.06, indicating change has significant difference statistically (P=0.003<0.05);2) The anabatic group of3monthIn anabatic group of3month group, according to the WOMAC score,4cases are stable after treatment and7rest are anabatic, with the stable rate36.6%,average WOMAC score before treatment is30.63±8.60, after treatment32.00±9.31, indicating change has no significant difference statistically (P=:0.579>0.05);2.2.4Syndrome score1) The stable group of3month groupIn stable group of3month group, according to the Syndrome score,40cases are stable after treatment and29rest are anabatic, with the stable rate42.0%, average Syndrome score before conservative treatment is10.82±6.28, after treatment14.76±6.56, indicating change has significant difference statistically (P=0.001<0.05);2) The anabatic group of3monthIn anabatic group of3month group, according to the Syndrome score,3cases are stable after treatment and8rest are anabatic, with the stable rate27.2%,average Syndrome score before treatment is9.18±7.22, after treatment13.72±6.26, indicating change has no significant difference statistically (P=0.211>0.05)3The correlation between patients’ self-reported and doctor’s clinical assessment between the results of3month patients and6month patients after treatment.(standalone "t" test as the statistical method)3.1The correlation of Harris hip scores between3month patients and6month patients after treatment.The average Harris hip score of the3month group after treatment is81.00+13.46, and the6month group83.60±11.00, indicating change has no significant difference statistically (P=0.242>0.05); meanwhile, for Harris hip score for pain, the figure is different,that37.91±8.28of3month group and39.20±4.94of6month group,with the change having no difference statistically (P=0.206>0.05);and for activity function, the figure is31.24±5.72(3month group) and35.76±6.23(6month group),which change has significant difference statistically (P=0.28<0.05);3.2The correlation of patients’self-reported outcomes between3month patients and6month patients after treatment.The average EQ-5D score of the3month group after treatment is0.482±0.14, and the6month group0.50±0.10, indicating change has no significant difference statistically (P=0.285>0.05); meanwhile, for WOMAC score, the figure is35.11±10.86of3month group and33.52±8.43of6month group,with the change having no difference statistically(P=0.450>0.05);and for Syndrome score, the figure is14.6±6.49(3month group) and11.6±7.29(6month group),which change has significant difference statistically (P=0.0180.05)Conclusion1. It has certain clinical curative effect for treatment of ONFH using the method of conservative treatment with traditional Chinese medicine.2. The difference of evaluation results between patients’ self-reported and doctor’s clinical assessment for the treatment of ONFH can exist properly.3. With the extension of follow-up time, the evaluation result of patients’ self-reported for the treatment of ONFH gradually improves, and more agree with the doctors clinical assessment.4. Bringing in EQ-5D scale, WOMAC scale and Syndrome scale to assess the treatment effect of ONFH, it can collect more information from patients, but its reliability and validity also need further researchment. |
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