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Evaluation of the clinical application of a leaflet for clinical practice guidelines in patients with herniated intervertebral discs: a study protocol for a randomized controlled trial.

ABSTRACT: INTRODUCTION:This study aims to demonstrate the effectiveness of using clinical practice guideline (CPG) leaflets as a communication tool between doctors and patients. We will collect basic data on whether using leaflets based on traditional Korean medicine (TKM) CPGs accomplishes the goal of improving clinical decision-making for diagnosis and treatment by TKM doctors. We will also evaluate the leaflets as a communication tool in the treatment of lumbar herniated intervertebral discs (HIVDs) in terms of patient and physician satisfaction and ease of treatment. METHODS AND ANALYSIS:We will evaluate efficacy through a comparison of satisfaction and clinical outcomes in randomly allocated groups of HIVD lumbar patients visiting the Jaseng Hospital of Korean Medicine who do or do not receive CPG-based treatment. Following the evaluation, we will make recommendations on whether to implement CPG interventions for patients selecting TKM treatment after HIVD diagnosis and the method of clinical treatment. Finally, we will evaluate the perception of and satisfaction with CPGs among TKM doctors and patients.

SUBMITTER: Lee JA

PROVIDER: S-EPMC5381399 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Evaluation of the clinical application of a leaflet for clinical practice guidelines in patients with herniated intervertebral discs: a study protocol for a randomized controlled trial.

Lee Ju Ah JA Choi Jiae J Choi Tae-Young TY Jun Ji Hee JH Ha In-Hyuk IH Lee Myeong Soo MS

Integrative medicine research 20160413 2

<h4>Introduction</h4>This study aims to demonstrate the effectiveness of using clinical practice guideline (CPG) leaflets as a communication tool between doctors and patients. We will collect basic data on whether using leaflets based on traditional Korean medicine (TKM) CPGs accomplishes the goal of improving clinical decision-making for diagnosis and treatment by TKM doctors. We will also evaluate the leaflets as a communication tool in the treatment of lumbar herniated intervertebral discs (H ...[more]

PMID: 28462111

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Project description:BackgroundThis study aims to demonstrate the effectiveness of using clinical practice guideline (CPG) leaflets as a communication tool between doctors and patients. We evaluated the leaflets as a communication tool in the treatment of lumbar herniated intervertebral discs (HIVDs) in terms of patient and physician satisfaction and ease of treatment.MethodsThis study is a 2-parallel-arm, assessor-blinded, randomized controlled trial at Jaseng Hospital, Seoul, South Korea. We evaluated efficacy through a comparison of satisfaction and clinical outcomes in randomly allocated groups of HIVD lumbar patients visiting Jaseng Hospital of Korean Medicine. We used leaflets on the basis of Korean medicine CPG recommendations as an intervention. The intervention group received treatment and diagnosis using the leaflet, and the control group received the typical intervention, which was provided without the leaflet.ResultsThe levels of patient satisfaction with and understanding of the doctors' explanation was 92% in the leaflet group and 64% in the nonleaflet group, which showed that, compared with patient satisfaction in the nonleaflet group, patient satisfaction was considerably higher by 28% in the leaflet group. In addition, the level of the reliability with treatment was 92% in the leaflet group and 64% in the control group. However, there were no significant differences in statistical analyses. The level of doctors' satisfaction with communicating with patients using the leaflet was 100% in the leaflet group. Given this satisfaction, the ease of persuasion of treatment was highest (84%) and followed the improvement in the patient's understanding of the treatment (16%) in the leaflet group. In addition, in the nonleaflet user group, almost all doctors thought that having a leaflet would be a more effective treatment.ConclusionAlthough this study failed to show significant differences between the intervention and control groups, the leaflet, which included CPG information in the treatment of HIVD patients, was an effective communication tool between patients and doctors. However, further studies with larger samples should be conducted to investigate the effectiveness of the communication tool based on the CPG.Trial registration numberClinical Research Information Service: KCT0001762.

Project description:Replacement of the intervertebral disc with a viable, tissue-engineered construct that mimics native tissue structure and function is an attractive alternative to fusion or mechanical arthroplasty for the treatment of disc pathology. While a number of engineered discs have been developed, the average size of these constructs remains a fraction of the size of human intervertebral discs. In this study, we fabricated medium (3 mm height × 10 mm diameter) and large (6 mm height × 20 mm diameter) sized disc-like angle ply structures (DAPS), encompassing size scales from the rabbit lumbar spine to the human cervical spine. Maturation of these engineered discs was evaluated over 15 weeks in culture by quantifying cell viability and metabolic activity, construct biochemical content, MRI T2 values, and mechanical properties. To assess the performance of the DAPS in the in vivo space, pre-cultured DAPS were implanted subcutaneously in athymic rats for 5 weeks. Our findings show that both sized DAPS matured functionally and compositionally during in vitro culture, as evidenced by increases in mechanical properties and biochemical content over time, yet large DAPS under-performed compared to medium DAPS. Subcutaneous implantation resulted in reductions in NP cell viability and GAG content at both size scales, with little effect on AF biochemistry or metabolic activity. These findings demonstrate that engineered discs at large size scales will mature during in vitro culture, however, future work will need to address the challenges of reduced cell viability and heterogeneous matrix distribution throughout the construct. STATEMENT OF SIGNIFICANCE:This work establishes, for the first time, tissue-engineered intervertebral discs for total disc replacement at large, clinically relevant length scales. Clinical translation of tissue-engineered discs will offer an alternative to mechanical disc arthroplasty and fusion procedures, and may contribute to a paradigm shift in the clinical care for patients with disc pathology and associated axial spine and neurogenic extremity pain.

Project description:BackgroundClinical Practice Guidelines (CPGs) play an important role in clinical practice, and they require appropriate evaluation, especially in application. This study explores the application evaluation method of CPGs for Traditional Chinese Medicines (TCM). It uses the Analytic Hierarchy Process (AHP) and clinical cases to evaluate the consistency between CPGs of TCM and clinical practice.MethodsTo evaluate the consistency between CPGs of TCM and clinical cases, a 3-level AHP construction was built. Weightings were calculated by collecting questionnaires according to AHP theory. To test the evaluation system, a retrospective study was performed. The study evaluated the China Association of Chinese Medicine's Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine Diseases of Modern Medicine (CPGs of DTCID) (ZYYXH/T50-135-2008). A total of 150 cases were involved. The evaluation system was used to assess the consistency between CPGs of DTCID and clinical cases of angina pectoris.ResultsThe results showed that the overall consistency between CPGs of DTCID and the 150 cases was 42.32 ± 6.94%, ranging from 35.21 to 63.37%. The overall consistency was not affected by age, gender, type of angina pectoris, condition of percutaneous coronary intervention (PCI), or angina classification as determined by the Canadian Cardiovascular Society. The consistencies of each index were as follows: Diagnosis of TCM, 100%; Diagnosis of Western medicine, 100%; Syndrome classification, 38.25 ± 4.40%; Syndrome key point, 34.17 ± 8.15%; TCM Decoction, 31.08 ± 23.64%; TCM particular treatment, 7.92 ± 19.13%; and Recuperation and prevention, 0. The most frequent syndromes were qi-deficiency, phlegm and blood stasis (n = 124) (82.7%). The overall consistency of qi-deficiency, turbid phlegm and blood stasis was lower than the overall consistency of the group without that syndrome. The difference was statistically significant (P < 0.05). 42 cases (28%) applied the TCM decoction recommended by CPGs of DTCID. Of these, Gualouxiebaibanxia decoction was applied in 34 cases. Wendan decoction, the most frequently used, was applied in 64 cases (42.7%).ConclusionThis study indicates that the AHP system can perform quantitative evaluation of consistency between TCM CPG and clinical practice. It also found the factors affecting the application of TCM CPGs and might indicate the need for revisions of CPGs.

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Evaluation of the clinical application of a leaflet for clinical practice guidelines in patients with herniated intervertebral discs: a study protocol for a randomized controlled trial.

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Evaluation of the clinical application of a leaflet for clinical practice guidelines in patients with herniated intervertebral discs: a study protocol for a randomized controlled trial.

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