OARSI Clinical Trials Recommendations: Design and conduct of implementation trials of interventions for osteoarthritis
Tài liệu tham khảo
Hochberg, 2012, American College of Rheumatology 2012 recommendations for the use of non-pharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip and knee, Arthritis Care Res, 64, 465, 10.1002/acr.21596
Zhang, 2010, OARSI recommendations for the management of hip and knee osteoarthritis Part III: changes in evidence following systematic cumulative update of research published through January 2009, Osteoarthritis Cartilage, 18, 476, 10.1016/j.joca.2010.01.013
Richmond, 2010, American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis (OA) of the knee, J Bone Joint Surg, 92, 990, 10.2106/JBJS.I.00982
Do, 2011, Monitoring healthy people 2010 arthritis management objectives: education and clinician counseling for weight loss and exercise, Ann Fam Med, 9, 136, 10.1370/afm.1210
Cisternas, 2009, Ambulatory visit utilization in a national, population-based sample of adults with osteoarthritis, Arthritis Rheum, 61, 1694, 10.1002/art.24897
Song, 2013, Racial and ethnic differences in physical activity guidelines attainment among people at high risk of or having knee osteoarthritis, Arthritis Care Res (Hoboken), 65, 195, 10.1002/acr.21803
Centers for Disease C, Prevention, 2013, State-specific prevalence of walking among adults with arthritis – United States, 2011, MMWR Morb Mortal Wkly Rep, 62, 331
Hunter, 2011, Quality of osteoarthritis management and the need for reform in the US, Arthritis Care Res (Hoboken), 63, 31, 10.1002/acr.20278
Li, 2011, Quality of nonpharmacological care in the community for people with knee and hip osteoarthritis, J Rheumatol, 38, 2230, 10.3899/jrheum.110264
Brand, 2013, Chronic disease management: a review of current performance across quality of care domains and opportunities for improving osteoarthritis care, Rheum Dis Clin North Am, 39, 123, 10.1016/j.rdc.2012.10.005
Glauser, 2011, Management of mild-to-moderate osteoarthritis: a study of the primary care perspective, Postgrad Med, 123, 126, 10.3810/pgm.2011.01.2254
DeHaan, 2007, Knee osteoarthritis clinical practice guidelines – how are we doing?, J Rheumatol, 34, 2099
Maserejian, 2014, Variations among primary care physicians in exercise advice, imaging, and analgesics for musculoskeletal pain: results from a factorial experiment, Arthritis Care Res (Hoboken), 66, 147, 10.1002/acr.22143
Jordan, 2004, The use of conventional and complementary treatments for knee osteoarthritis in the community, Rheumatology (Oxford), 43, 381, 10.1093/rheumatology/keh045
Ganz, 2006, Quality of osteoarthritis care for community-dwelling adults, Arthritis Care Res, 55, 241, 10.1002/art.21844
Bohensky, 2012, Trends in elective knee arthroscopies in a population-based cohort, 2000-2009, Med J Aust, 197, 399, 10.5694/mja11.11645
Kim, 2011, Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006, J Bone Joint Surg Am, 93, 994, 10.2106/JBJS.I.01618
Hawker, 2008, Knee arthroscopy in England and Ontario: patterns of use, changes over time, and relationship to total knee replacement, J Bone Joint Surg Am, 90, 2337, 10.2106/JBJS.G.01671
Hawker, 2002, The effect of education and income on need and willingness to undergo total joint arthroplasty, Arthritis Rheum, 46, 3331, 10.1002/art.10682
Rahman, 2011, Effect of sociodemographic factors on surgical consultations and hip or knee replacements among patients with osteoarthritis in British Columbia, Canada, J Rheumatol, 38, 503, 10.3899/jrheum.100456
Judge, 2010, Equity in access to total joint replacement of the hip and knee in England: cross sectional study, BMJ, 341, c4092, 10.1136/bmj.c4092
Steel, 2006, Need for and receipt of hip and knee replacement–a national population survey, Rheumatology (Oxford), 45, 1437, 10.1093/rheumatology/kel131
Skinner, 2003, Racial, ethnic, and geographic disparities in rates of knee arthroplasty among medicare patients, N Engl J Med, 349, 1350, 10.1056/NEJMsa021569
Nelson, 2014, A systematic review of recommendations and guidelines for the management of osteoarthritis: the Chronic Osteoarthritis Management Initiative of the U.S. Bone and Joint Initiative, Semin Arthritis Rheum, 434, 701, 10.1016/j.semarthrit.2013.11.012
Curran, 2012, Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact, Med Care, 50, 217, 10.1097/MLR.0b013e3182408812
2013, Vol. 2014
Glasgow, 1999, Evaluating the public health impact of health promotion interventions: the RE-AIM framework, Am J Public Health, 89, 1322, 10.2105/AJPH.89.9.1322
Glasgow, 2003, Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition, Am J Public Health, 93, 1261, 10.2105/AJPH.93.8.1261
Kessler, 2011, A proposal to speed translation of healthcare research into practice: dramatic change is needed, Am J Prev Med, 40, 637, 10.1016/j.amepre.2011.02.023
Glasgow, 2008, What types of evidence are most needed to advance behavioral medicine?, Ann Behav Med, 35, 19, 10.1007/s12160-007-9008-5
Klesges, 2005, Beginning with the application in mind: designing and planning health behavior change interventions to enhance dissemination, Ann Behav Med, 29, 66, 10.1207/s15324796abm2902s_10
Feldstein, 2008, A practical, robust implemenation and sustainability model (PRISM) for integrating research findings into practice, Jt Comm J Qual Patient Saf, 34, 228, 10.1016/S1553-7250(08)34030-6
Graham, 2006, Lost in knowledge translation: time for a map?, J Contin Educ Health Prof, 26, 13, 10.1002/chp.47
Straus, 2013
Field, 2014, Using the Knowledge to Action Framework in practice: a citation analysis and systematic review, Implement Sci, 9, 172, 10.1186/s13012-014-0172-2
Straus, 2011, Knowledge translation is the use of knowledge in health care decision making, J Clin Epidemiol, 64, 6, 10.1016/j.jclinepi.2009.08.016
Knowledge Translation Canada. Vol. 2015.
Tugwell, 2007, Knowledge translation for effective consumers, Phys Ther, 87, 1728, 10.2522/ptj.20070056
Sibley, 2014, Applying knowledge translation theory to physical therapy research and practice in balance and Gait assessment: a case report, Phys Ther
Brachaniec, 2009, Partnership in action: an innovative knowledge translation approach to improve outcomes for persons with fibromyalgia, Physiother Can, 61, 123, 10.3138/physio.61.3.123
Kastner, 2012, Application of the Knowledge-to-Action and Medical Research Council frameworks in the development of an osteoporosis clinical decision support tool, J Clin Epidemiol, 65, 1163, 10.1016/j.jclinepi.2012.04.011
Sibley, 2011, Moving balance and mobility evidence in to action: a primer in knowledge translation, Gait Posture, 33, 527, 10.1016/j.gaitpost.2011.03.002
Brosseau, 2015, Internet-based implementation of non-pharmacological interventions of the “people getting a grip on arthritis” educational program: an international online knowledge translation randomized controlled trial design protocol, JMIR Res Protoc, 4, e19, 10.2196/resprot.3572
Cane, 2012, Validation of the theoretical domains framework for use in behaviour change and implementation research, Implement Sci, 7, 37, 10.1186/1748-5908-7-37
French, 2012, Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework, Implement Sci, 7, 38, 10.1186/1748-5908-7-38
McEvoy, 2014, A qualitative systematic review of studies using the normalization process theory to research implementation processes, Implement Sci, 9, 2, 10.1186/1748-5908-9-2
Finch, 2012, From theory to ‘measurement’ in complex interventions: methodological lessons from the development of an e-health normalisation instrument, BMC Med Res Methodol, 12, 69, 10.1186/1471-2288-12-69
Tunis, 2003, Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy, JAMA, 290, 1624, 10.1001/jama.290.12.1624
Allen, 2012, Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials, BMC Musculoskelet Disord, 13, 60, 10.1186/1471-2474-13-60
Thorpe, 2009, A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers, CMAJ, 180, E47, 10.1503/cmaj.090523
Zwarenstein, 2008, Improving the reporting of pragmatic trials: an extension of the CONSORT statement, BMJ, 337, a2390, 10.1136/bmj.a2390
Schwartz, 1967, Explanatory and pragmatic attitudes in therapeutical trials, J Chronic Dis, 20, 637, 10.1016/0021-9681(67)90041-0
Medical Research Council G, 2000
Craig, 2008, Developing and evaluating complex interventions: the new Medical Research Council guidance, BMJ, 337, a1655, 10.1136/bmj.a1655
Altman, 2001, The revised CONSORT statement for reporting randomized trials: explanation and elaboration, Ann Intern Med, 134, 663, 10.7326/0003-4819-134-8-200104170-00012
Schulz, 2002, Blinding in randomised trials: hiding who got what, Lancet, 359, 696, 10.1016/S0140-6736(02)07816-9
Minns Lowe, 2011, Blind outcome assessment: the development and use of procedures to maintain and describe blinding in a pragmatic physiotherapy rehabilitation trial, Clin Rehabil, 25, 264, 10.1177/0269215510380824
Gooch, 2012, Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial, Osteoarthritis Cartilage, 20, 1086, 10.1016/j.joca.2012.06.017
Moher, 2010, CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials, BMJ, 340, c869, 10.1136/bmj.c869
Walsh, 2013, Exercise and self-management for people with chronic knee, hip or lower back pain: a cluster randomised controlled trial of clinical and cost-effectiveness. Study protocol, Physiotherapy, 99, 352, 10.1016/j.physio.2012.09.002
Tejedor Varillas, 2012, Can an intervention on clinical inertia have an impact on the perception of pain, functionality and quality of life in patients with hip and/or knee osteoarthritis? Results from a cluster randomised tria, Aten Primaria, 44, 65, 10.1016/j.aprim.2011.01.007
Ravaud, 2009, ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial, BMJ, 338, b421, 10.1136/bmj.b421
Victor, 2005, Lack of benefit of a primary care-based nurse-led education programme for people with osteoarthritis of the knee, Clin Rheumatol, 24, 358, 10.1007/s10067-004-1001-9
Ravaud, 2004, Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design, Ann Rheum Dis, 63, 703, 10.1136/ard.2003.009803
Vitiello, 2009, Cognitive behavioral therapy for insomnia improves sleep and decreases pain in older adults with co-morbid insomnia and osteoarthritis, J Clin Sleep Med, 5, 355, 10.5664/jcsm.27547
Tsai, 2013, A pilot cluster-randomized trial of a 20-week Tai Chi program in elders with cognitive impairment and osteoarthritic knee: effects on pain and other health outcomes, J Pain Symptom Manage, 45, 660, 10.1016/j.jpainsymman.2012.04.009
Marra, 2012, Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis, Arthritis Care Res (Hoboken), 64, 1837, 10.1002/acr.21763
Rosemann, 2007, Case management of arthritis patients in primary care: a cluster-randomized controlled trial, Arthritis Rheum, 57, 1390, 10.1002/art.23080
Hurley, 2007, Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial, Arthritis Care Res, 57, 1211, 10.1002/art.22995
Reininga, 2007, Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial, BMC Musculoskelet Disord, 8, 4, 10.1186/1471-2474-8-4
Veenhof, 2006, Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: a randomized clinical trial, Arthritis Rheum, 55, 925, 10.1002/art.22341
Dziedzic, 2014, Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care – the Management of OsteoArthritis In Consultations (MOSAICS) study protocol, Implement Sci, 9, 95, 10.1186/s13012-014-0095-y
Halloran, 1999, Design and interpretation of vaccine field studies, Epidemiol Rev, 21, 73, 10.1093/oxfordjournals.epirev.a017990
Donner, 2004, Pitfalls of and controversies in cluster randomization trials, Am J Public Health, 94, 416, 10.2105/AJPH.94.3.416
Hutton, 2001, Are distinctive ethical principles required for cluster randomized controlled trials?, Stat Med, 20, 473, 10.1002/1097-0258(20010215)20:3<473::AID-SIM805>3.0.CO;2-D
Eldridge, 2008, Internal and external validity of cluster randomised trials: systematic review of recent trials, BMJ, 336, 876, 10.1136/bmj.39517.495764.25
Taljaard, 2013, The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees, BMJ, 346, f2838, 10.1136/bmj.f2838
Eldridge, 2009, Bias in identifying and recruiting participants in cluster randomised trials: what can be done?, BMJ, 339, b4006, 10.1136/bmj.b4006
Ashcroft, 1998, Human research subjects, selection of
Snowdon, 1999, Zelen randomization: attitudes of parents participating in a neonatal clinical trial, Control Clin Trials, 20, 149, 10.1016/S0197-2456(98)00049-X
Puffer, 2003, Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals, BMJ, 327, 785, 10.1136/bmj.327.7418.785
Farrin, 2005, Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, exercise, active management and manipulation (UK BEAM) feasibility study, Clin Trials, 2, 119, 10.1191/1740774505cn073oa
Brealey, 2003, UK Back pain Exercise and Manipulation (UK BEAM) trial–national randomised trial of physical treatments for back pain in primary care: objectives, design and interventions [ISRCTN32683578], BMC Health Serv Res, 3, 16, 10.1186/1472-6963-3-16
Campbell, 2012, Consort 2010 statement: extension to cluster randomised trials, BMJ, 345, e5661, 10.1136/bmj.e5661
Eldridge, 2004, Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care, Clin Trials, 1, 80, 10.1191/1740774504cn006rr
Murray, 1998
Campbell, 2000, Analysis of cluster randomized trials in primary care: a practical approach, Fam Pract, 17, 192, 10.1093/fampra/17.2.192
Brown, 2006, The stepped wedge trial design: a systematic review, BMC Med Res Methodol, 6, 54, 10.1186/1471-2288-6-54
Hussey, 2007, Design and analysis of stepped wedge cluster randomized trials, Contemp Clin Trials, 28, 182, 10.1016/j.cct.2006.05.007
Mdege, 2011, Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation, J Clin Epidemiol, 64, 936, 10.1016/j.jclinepi.2010.12.003
Sanson-Fisher, 2007, Limitations of the randomized controlled trial in evaluating population-based health interventions, Am J Prev Med, 33, 155, 10.1016/j.amepre.2007.04.007
Hutson, 2004, The utility of partial cross-over designs in early phase randomized prevention trials, Control Clin Trials, 25, 493, 10.1016/j.cct.2004.07.005
Pearson, 2010, Parable of two agencies, one of which randomizes, Ann Am Acad Polit Soc Sci, 628, 11, 10.1177/0002716209351500
Kotz, 2012, Researchers should convince policy makers to perform a classic cluster randomized controlled trial instead of a stepped wedge design when an intervention is rolled out, J Clin Epidemiol, 65, 1255, 10.1016/j.jclinepi.2012.06.016
Dreischulte, 2012, Implement Sci, 7, 24, 10.1186/1748-5908-7-24
Kairalla, 2012, Adaptive trial designs: a review of barriers and opportunities, Trials, 13, 145, 10.1186/1745-6215-13-145
Brown, 2009, Adaptive designs for randomized trials in public health, Annu Rev Public Health, 30, 1, 10.1146/annurev.publhealth.031308.100223
Coffey, 2008, Adaptive clinical trials: progress and challenges, Drugs R D, 9, 229, 10.2165/00126839-200809040-00003
Cook, 2010, Review of draft FDA adaptive design guidance, J Biopharm Stat, 20, 1132, 10.1080/10543406.2010.514455
Collins, 2004, A conceptual framework for adaptive preventive interventions, Prev Sci, 5, 185, 10.1023/B:PREV.0000037641.26017.00
Lei, 2011, A “SMART” design for building individualized treatment sequences, Annu Rev Clin Psychol, 8, 21, 10.1146/annurev-clinpsy-032511-143152
Adams, 2013, An adaptive physical activity intervention for overweight adults: a randomized controlled trial, PLoS One, 8, e82901, 10.1371/journal.pone.0082901
Hall, 2011, Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study, Transl Behav Med, 1, 573, 10.1007/s13142-011-0075-6
Murphy, 2005, An experimental design for the development of adaptive treatment strategies, Stat Med, 24, 1455, 10.1002/sim.2022
Collins, 2007, The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions, Am J Prev Med, 32, S112, 10.1016/j.amepre.2007.01.022
Nahum-Shani, 2012, Experimental design and primary data analysis methods for comparing adaptive interventions, Psychol Methods, 17, 457, 10.1037/a0029372
Kilbourne, 2013, Cluster randomized adaptive implementation trial comparing a standard versus enhanced implementation intervention to improve uptake of an effective re-engagement program for patients with serious mental illness, Implement Sci, 8, 136, 10.1186/1748-5908-8-136
Campbell, 2000, Framework for design and evaluation of complex interventions to improve health, BMJ, 321, 694, 10.1136/bmj.321.7262.694
Campbell, 2007, Designing and evaluating complex interventions to improve health care, BMJ, 334, 455, 10.1136/bmj.39108.379965.BE
Abraham, 2008, A taxonomy of behavior change techniques used in interventions, Health Psychol, 27, 379, 10.1037/0278-6133.27.3.379
Hotopf, 2002, The pragmatic randomized controlled trial, Adv Psychiatr Treat, 8, 326, 10.1192/apt.8.5.326
Power, 2004, Developing complex interventions for rigorous evaluation–a case study from rural Zimbabwe, Health Educ Res, 19, 570, 10.1093/her/cyg073
Haynes, 1999, Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving, BMJ, 319, 652, 10.1136/bmj.319.7211.652
Stiefel, 2012, A Guide to Measuring the Triple Aim: Population Health, Experience of Care, and Per Capita Cost
Reinertsen, 2007
Lee, 2010, Turning doctors into leaders, Harv Bus Rev, 88, 50
Dickinson, 2008
Siriwardena, 2009, Engaging clinicians in quality improvement initiatives: art or science?, Qual Prim Care, 17, 303
Reinertsen, 2007
Bradley, 1999, Development and evaluation of complex interventions in health services research: case study of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group, BMJ, 318, 711, 10.1136/bmj.318.7185.711
Oakley, 2006, Process evaluation in randomised controlled trials of complex interventions, BMJ, 332, 413, 10.1136/bmj.332.7538.413
Wight, 2002, Unpacking the “black box”: the importance of process data to explain outcomes, 151
Oakley, 2005, Design and analysis of social intervention studies in health research, 246
World Health Organization, 2008
Helitzer, 1999, Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren, Am J Clin Nutr, 69, 816S, 10.1093/ajcn/69.4.816S
Tabak, 2012, Bridging research and practice: models for dissemination and implementation research, Am J Prev Med, 43, 337, 10.1016/j.amepre.2012.05.024
Grimshaw, 2012, Knowledge translation of research findings, Implement Sci, 7, 50, 10.1186/1748-5908-7-50
Parmelli, 2011, The effectiveness of strategies to change organisational culture to improve healthcare performance: a systematic review, Implement Sci, 6, 33, 10.1186/1748-5908-6-33
Boaz, 2011, Effective implementation of research into practice: an overview of systematic reviews of the health literature, BMC Res Notes, 4, 212, 10.1186/1756-0500-4-212
Baker, 2010, Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes, Cochrane Database Syst Rev, CD005470
Dzewaltowski, 2004, Behavior change intervention research in community settings: how generalizable are the results?, Health Promot Int, 19, 235, 10.1093/heapro/dah211
Hlatky, 2006, Cost-effectiveness as an outcome in randomized clinical trials, Clin Trials, 3, 543, 10.1177/1740774506073105