1. |
Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c332.
|
2. |
Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials, 2007, 8: 39.
|
3. |
Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial reports: the CONSORT-outcomes 2022 extension. JAMA, 2022, 328(22): 2252-2264.
|
4. |
Cuschieri S. The CONSORT statement. Saudi J Anaesth, 2019, 13(Suppl 1): S27-S30.
|
5. |
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg, 2012, 10(1): 28-55.
|
6. |
Bhaloo Z, Adams D, Liu Y, et al. Primary outcomes reporting in trials (PORTal): a systematic review of inadequate reporting in pediatric randomized controlled trials. J Clin Epidemiol, 2017, 81: 33-41.
|
7. |
Mayo-Wilson E, Fusco N, Li T, et al. Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. J Clin Epidemiol, 2017, 86: 39-50.
|
8. |
Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One, 2008, 3(8): e3081.
|
9. |
Ioannidis JP, Evans SJ, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
|
10. |
Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA, 2013, 309(8): 814-822.
|
11. |
Butcher NJ, Mew EJ, Monsour A, et al. Outcome reporting recommendations for clinical trial protocols and reports: a scoping review. Trials, 2020, 21(1): 620.
|
12. |
Butcher NJ, Monsour A, Mew EJ, et al. Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT). Trials, 2019, 20(1): 161.
|
13. |
Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
|
14. |
Butcher NJ, Mew EJ, Saeed L, et al. Guidance for reporting outcomes in clinical trials: scoping review protocol. BMJ Open, 2019, 9(2): e023001.
|
15. |
Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial protocols: the SPIRIT-outcomes 2022 extension. JAMA, 2022, 328(23): 2345-2356.
|
16. |
OMERACT. OMERACT (outcome measures in rheumatology): domain resources.
|
17. |
Williamson P, Altman D, Blazeby J, et al. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy, 2012, 17(1): 1-2.
|
18. |
Carli F, Bousquet-Dion G, Awasthi R, et al. Effect of multimodal prehabilitation vs postoperative rehabilitation on 30-day postoperative complications for frail patients undergoing resection of colorectal cancer: a randomized clinical trial. JAMA Surg, 2020, 155(3): 233-242.
|
19. |
Page MJ, McKenzie JE, Forbes A. Many scenarios exist for selective inclusion and reporting of results in randomized trials and systematic reviews. J Clin Epidemiol, 2013, 66(5): 524-537.
|
20. |
Mayo-Wilson E, Li T, Fusco N, et al. Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy. J Clin Epidemiol, 2017, 91: 95-110.
|
21. |
Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
|
22. |
Zarin DA, Tse T, Williams RJ, et al. The ClinicalTrials. gov results database-update and key issues. N Engl J Med, 2011, 364(9): 852-860.
|
23. |
Persell SD, Peprah YA, Lipiszko D, et al. Effect of home blood pressure monitoring via a smartphone hypertension coaching application or tracking application on adults with uncontrolled hypertension: a randomized clinical trial. JAMA Netw Open, 2020, 3(3): e200255.
|
24. |
Terwee CB, Peipert JD, Chapman R, et al. Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures. Qual Life Res, 2021, 30(10): 2729-2754.
|
25. |
Carrasco-Labra A, Devji T, Qasim A, et al. Minimal important difference estimates for patient-reported outcomes: a systematic survey. J Clin Epidemiol, 2021, 133: 61-71.
|
26. |
Devji T, Carrasco-Labra A, Guyatt G. Mind the methods of determining minimal important differences: three critical issues to consider. Evid Based Ment Health, 2021, 24(2): 77-81.
|
27. |
Okereke OI, Vyas CM, Mischoulon D, et al. Effect of long-term supplementation with marine omega-3 fatty acids vs placebo on risk of depression or clinically relevant depressive symptoms and on change in mood scores: a randomized clinical trial. JAMA, 2021, 326(23): 2385-2394.
|
28. |
Hochberg MC, Guermazi A, Guehring H, et al. Effect of intra-articular sprifermin vs placebo on femorotibial joint cartilage thickness in patients with osteoarthritis: the FORWARD randomized clinical trial. JAMA, 2019, 322(14): 1360-1370.
|
29. |
International Conference on Harmonisation. E9: statistical principles for clinical trials: current step 4 version.
|
30. |
Mignard C, Maho-Vaillant M, Golinski ML, et al. Factors associated with short-term relapse in patients with pemphigus who receive rituximab as first-line therapy: a post hoc analysis of a randomized clinical trial. JAMA Dermatol, 2020, 156(5): 545-552.
|
31. |
Yu L, Luo L, Long X, et al. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: a randomized trial. Helicobacter, 2019, 24(4): e12596.
|
32. |
Kitt J, Fox R, Frost A, et al. Long-term blood pressure control after hypertensive pregnancy following physician-optimized self-management: the POP-HT randomized clinical trial. JAMA, 2023, 330(20): 1991-1999.
|
33. |
Ferreira-González I, Permanyer-Miralda G, Busse JW, et al. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol, 2007, 60(7): 651-657.
|
34. |
Cordoba G, Schwartz L, Woloshin S, et al. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ, 2010, 341: c3920.
|
35. |
Eunethta (European Network for Health Technology Assessment). Guideline: endpoints used for relative effectiveness assessment of pharmaceuticals: composite endpoints.
|
36. |
Chappell LC, Bell JL, Smith A, et al. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet, 2019, 394(10201): 849-860.
|
37. |
Sholzberg M, Tang GH, Rahhal H, et al. Effectiveness of therapeutic heparin versus prophylactic heparin on death, mechanical ventilation, or intensive care unit admission in moderately ill patients with COVID-19 admitted to hospital: RAPID randomised clinical trial. BMJ, 2021, 375: n2400.
|
38. |
Dyrbye LN, Shanafelt TD, Gill PR, et al. Effect of a professional coaching intervention on the well-being and distress of physicians: a pilot randomized clinical trial. JAMA Intern Med, 2019, 179(10): 1406-1414.
|
39. |
Dankiewicz J, Cronberg T, Lilja G, et al. Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): a randomized clinical trial-rationale and design. Am Heart J, 2019, 217: 23-31.
|
40. |
De Los Reyes A, Augenstein TM, Wang M, et al. The validity of the multi-informant approach to assessing child and adolescent mental health. Psychol Bull, 2015, 141(4): 858-900.
|
41. |
FDA-NIH BiomarkerWorking Group. BEST (biomarkers, endpoints, and other tools) resource.
|
42. |
Hossain SJ, Tofail F, Mehrin SF, et al. Six-year follow-up of childhood stimulation on development of children with and without anemia. Pediatrics, 2023, 151(Suppl 2): e2023060221E.
|
43. |
Cook JA, Julious SA, Sones W, et al. Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA2 five-stage study, including a workshop. Health Technol Assess, 2019, 23(60): 1-88.
|
44. |
Ferreira ML, Herbert RD, Ferreira PH, et al. A critical review of methods used to determine the smallest worthwhile effect of interventions for low back pain. J Clin Epidemiol, 2012, 65(3): 253-261.
|
45. |
Mouelhi Y, Jouve E, Castelli C, et al. How is the minimal clinically important difference established in health-related quality of life instruments. Review of anchors and methods. Health Qual Life Outcomes, 2020, 18(1): 136.
|
46. |
Treasure T, Farewell V, Macbeth F, et al. Pulmonary metastasectomy versus continued active monitoring in colorectal cancer (PulMiCC): a multicentre randomised clinical trial. Trials, 2019, 20(1): 718.
|
47. |
European Medicines Agency. Guideline on multiplicity issues in clinical trials.
|
48. |
Akl EA, Shawwa K, Kahale LA, et al. Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guide. BMJ Open, 2015, 5(12): e008431.
|
49. |
National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The prevention and treatment of missing data in clinical trials. Washington (DC): National Academies Press (US), 2010.
|
50. |
Rodgers H, Bosomworth H, Krebs HI, et al. Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. Lancet, 2019, 394(10192): 51-62.
|
51. |
Kahan BC, Ahmad T, Forbes G, et al. Public availability and adherence to prespecified statistical analysis approaches was low in published randomized trials. J Clin Epidemiol, 2020, 128: 29-34.
|
52. |
Bardy AH. Bias in reporting clinical trials. Br J Clin Pharmacol, 1998, 46(2): 147-150.
|
53. |
Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ, 2010, 340: c365.
|