骨骼肌肉系統(tǒng)：骨關(guān)節(jié)炎基礎(chǔ)與臨床研究中的哲學(xué)思想與方法學(xué)

1、骨關(guān)節(jié)炎基礎(chǔ)與臨床研究中的哲學(xué)思想與方法學(xué)Basic elements of scientific researchAnimals models of OAClinical trails of OAContentsInnovativeIntegrityCumulativeRatiocinationBasic elements of scientific researchInnovativePICOEP：ProblemsI：InterventionsC：ComparisonO：OutcomesE：EvaluationBasic elements of scientific researchInt

2、egrityThe backgroundResearch purposeResearch contentResearch methodsResearch processResults of the studyResearch budgetStudy timeBasic elements of scientific researchCumulativeBasic elements of scientific researchA B CBackground knowledgeProspective knowledgeRatiocinationAnalogical reasoningClusteri

3、ng reasoningLogical reasoningBasic elements of scientific researchOARSIAnimal Model buildingIntervention methodsCartilage measurementThe subchondral bone measurementsSynovial measurementJoint fluid measurementMeasurement of bloodUrine measurementAnimals models of OAThe most important models availabl

4、e in rabbits for studying joint degenerationScoring of alterations in joint structuresMacroscopic scoringOARSI Categories of Clinical TrialsNon-operative rehabilitation trials,Post-operative rehabilitation trials,Trials examining the effectiveness of devices (e.g., assistive devices, bracing, physic

5、al agents, electrical stimulation, etc.) Outcomes related to symptoms and functionOutcomes related to disease modicationClinical trails of OAProvide a thorough description of the participants (e.g. demographics, how the diagnosis of OA was determined, comorbidities, baseline outcome measures)Describ

6、e methods of patient recruitment for the studyDescribe the inclusion and exclusion criteriaEntering Patients into the TrialDemographic characteristics should include participant age, sex, race/ethnicity, height, weight, body mass index (BMI), educational status, marital status, living arrangements,

7、and employment status (full-time, part-time, unemployed).American College of Rheumatologys (ACR) diagnostic criteria for hip, knee, or hand OAAltman R, Asch E, Bloch D, Bole G, Brandt KD, Christy W, et al. Development of criteria for the classication and reporting of osteoarthritis. Arthritis Rheum

8、1986;29:1039-49.Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, et al. The American College of Rheumatology criteria for the classication and reporting of osteoarthritis of the hand. Arthritis Rheum 1990;33:1601-10.Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt

9、K, et al. The American College of Rheumatology criteria for the classication and reporting of osteoarthritis of the hip. Arthritis Rheum 1991;34:505-14.It may not be necessary for all rehabilitation studies to report disease severity through radiographic or other forms of imaging, particularly if th

10、e main outcomes of the study are only concerned with symptom or function modication.Trials investigating the efcacy of mechanical interventions that are targeted towards a particular joint compartmentUnloading knee brace that aims to unload either the medial or lateral tibiofemoral jointDocumentatio

11、n of comorbidities and potential confounders of treatment outcomeChronic Diseases or conditions (e.g., diabetes, osteoporosis, heart disease, hypertension, neurological disorders)History of previous injury or surgery related to the study target joint with OAOther current pain sitesPast and current t

12、obacco and alcohol usePast and current medications for treatment of joint pain/OAPast and current non-pharmacological treatments (e.g., exercise, orthotics, etc.) of joint pain/OA (Providing as much detail as possible concerning the application of these interventions such as dosage and duration, set

13、ting in which the treatments were applied, whether they were active or passive interventions, could be helpful in determining their role as a potential confounder)History of most recent cortico-steroid and/or hyaluronan injection for target joint pain/OA and other jointsPrevious use of study interve

14、ntionsSubject expectations of treatment effectivenessOccupational activity (sedentary, moderately physical labor, hard physical labor)Recreational activity (sedentary, moderately physically active, highly physically active)For post-operative rehabilitation trials:Surgical complications or other intr

15、a-operative ndings that may inuence outcome measuresWas pre-operative rehabilitation providedIf study focus is on outpatient rehabilitation, report any inpatient or home-based therapy that may have been receivedBaseline symptoms, function, physical activity levels, health-related quality of life.Rel

16、iable and validated measuresInclusion and exclusion criteria should be clearly dened. Participants may be included based on age limits, sex, diagnostic criteria of OA, joint(s) or joint compartment being targeted.Exclusion criteria should also be clearly dened. Participants may be excluded based on

17、age limits, sex, and presence of inammatory arthritides (gout, RA, psoriatic arthritis, etc.). Comorbidities that serve as a basis for exclusion should also be described.Overview of the study designDescription and rationale for selection of control/comparator groups (e.g., placebo vs comparator inte

18、rvention)Thorough description of interventions so that others can replicate the interventions (algorithms for treatment selection/progression, dosage (intensity, frequency, duration), adherence strategies, home programs, training of treatment providers and treatment delity methods)Blinding procedure

19、sManaging and recording adverse eventsConduct of the StudyShould include reliable and valid measures of pain, patient-reported function and disability, performance-based measures of function, patient global assessmentExplanatory trials should include measures to conrm hypothesized mechanisms of trea

20、tment effectResults of outcome measures should be benchmarked with known age and/or condition-matched normative values or previously established outcome values if available.The primary outcome should be expressed in terms of mean, standard deviation, and 95% condence intervals.Authors should also consider reporting mean differences between groups and the standard deviation and 95% condence intervals of the differences.Outcome MeasuresRecommended Core Set of MeasuresPainPatient-reported outcome measuresPerformance-based measuresPatient