Clinical trials

Sessler, 2015, Clinical research methodology 2: observational clinical research, Anesth Analg, 121, 1043, 10.1213/ANE.0000000000000861 Sessler, 2015, Clinical research methodology 1: study designs and methodologic sources of error, Anesth Analg, 121, 1034, 10.1213/ANE.0000000000000815 Hannan, 2008, Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations, JACC Cardiovasc Interv, 1, 211, 10.1016/j.jcin.2008.01.008 National Institutes of Health. NIH's Definiton of a Clinical Trial 2017 [updated 8/8/2017; cited 2018 9/16/2018]. Available from: https://grants.nih.gov/policy/clinical-trials/definition.htm National Institutes of Health. NIH Clinical Research Trials and You: The Basics 2017 [updated 10/20/2017; cited 2018 9/16/2018]. Available from: https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. Bhatt, 2016, Adaptive designs for clinical trials, New Engl J Med, 375, 65, 10.1056/NEJMra1510061 Body, 2016 Evans, 2010, Fundamentals of clinical trial design, J Exp Stroke Transl Med, 3, 19, 10.6030/1939-067X-3.1.19 Sessler, 2015, Clinical research methodology 3: randomized controlled trials, Anesth Analg, 121, 1052, 10.1213/ANE.0000000000000862 Efird, 2011, Blocked randomization with randomly selected block sizes, Int J Environ Res Public Health, 8, 15, 10.3390/ijerph8010015 Kernan, 1999, Stratified randomization for clinical trials, J Clin Epidemiol, 52, 19, 10.1016/S0895-4356(98)00138-3 Simon, 1979, Restricted randomization designs in clinical trials, Biometrics, 35, 503, 10.2307/2530354 Campbell, 2000, Cluster randomized trials in general (family) practice research, Stat Methods Med Res, 9, 81, 10.1177/096228020000900202 Murray, 2004, Design and analysis of group-randomized trials: a review of recent methodological developments, Am J Public Health, 94, 423, 10.2105/AJPH.94.3.423 Rutterford, 2015, Methods for sample size determination in cluster randomized trials, Int J Epidemiol, 44, 1051, 10.1093/ije/dyv113 Chen, 2016, Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers, Bmj, 352, i637, 10.1136/bmj.i637 Riveros, 2013, Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals, PLoS Medicine, 10, 10.1371/journal.pmed.1001566 Hudson, 2015, Sharing and reporting the results of clinical trials, Jama, 313, 355, 10.1001/jama.2014.10716 Doshi, 2013, Restoring invisible and abandoned trials: a call for people to publish the findings, Bmj, 346, f2865, 10.1136/bmj.f2865 van Assen, 2014, Why publishing everything is more effective than selective publishing of statistically significant results, PloS one, 9, e84896, 10.1371/journal.pone.0084896 Graf, 2007, Best practice guidelines on publication ethics: a publisher's perspective, Int J Clin Pract Suppl, 1 Harriman, 2016, When are clinical trials registered? An analysis of prospective versus retrospective registration, Trials, 17, 187, 10.1186/s13063-016-1310-8 Deans, 2010, Practice misalignments in randomized controlled trials: Identification, impact, and potential solutions, Anesthesia and analgesia, 111, 444, 10.1213/ANE.0b013e3181aa8903 Deans, 2004, Defining the standard of care in randomized controlled trials of titrated therapies, Current Opin Crit Care, 10, 579, 10.1097/01.ccx.0000145097.36069.44 Minneci, 2008, The importance of usual care control groups for safety monitoring and validity during critical care research, Intensiv Care Med, 34, 942, 10.1007/s00134-008-0999-6 Rey, 2011, Intervention to reduce catheter-related bloodstream infections in a pediatric intensive care unit, Intensiv Care Med, 37, 678, 10.1007/s00134-010-2116-x Barkun, 2009, Evaluation and stages of surgical innovations, Lancet, 374, 1089, 10.1016/S0140-6736(09)61083-7 Ergina, 2009, Challenges in evaluating surgical innovation, Lancet, 374, 1097, 10.1016/S0140-6736(09)61086-2 McCulloch, 2009, No surgical innovation without evaluation: the IDEAL recommendations, Lancet, 374, 1105, 10.1016/S0140-6736(09)61116-8 2008, Patients’ preferences within randomised trials: systematic review and patient level meta-analysis, Bmj, 337 Britton, 1998, Choosing between randomised and non-randomised studies: a systematic review, Health Technol Assess, 2, 1, 10.3310/hta2130 King, 2005, Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials, Health Technol Assess, 9, 1, 10.3310/hta9350 Hussain-Gambles, 2004, Why ethnic minority groups are under-represented in clinical trials: a review of the literature, Health Soc Care Community, 12, 382, 10.1111/j.1365-2524.2004.00507.x Murthy, 2004, Participation in cancer clinical trials: race-, sex-, and age-based disparities, Jama, 291, 2720, 10.1001/jama.291.22.2720 Somerson, 2014, Lack of diversity in orthopaedic trials conducted in the United States, J Bone Joint Surg Am, 96, 00531, 10.2106/JBJS.M.00531 Pressler, 2013, The use of propensity scores and observational data to estimate randomized controlled trial generalizability bias, Stat Med, 32, 3552, 10.1002/sim.5802 Sheth, 2016, Enrollment bias: frequency and impact on patient selection in endovascular stroke trials, J. Neurointerventional Surg, 8, 353, 10.1136/neurintsurg-2014-011628 Yoon, 2014, Sex bias exists in basic science and translational surgical research, Surgery, 156, 508, 10.1016/j.surg.2014.07.001 Katz, 2011, Departures from community equipoise may lead to incorrect inference in randomized trials, J Clin Epidemiol, 64, 280, 10.1016/j.jclinepi.2010.04.008 Brewin, 1989, Patient preferences and randomised clinical trials, Bmj, 299, 313, 10.1136/bmj.299.6694.313 Corrigan, 2003, The conflict between random assignment and treatment preference: implications for internal validity, Eval Progr Plan, 26, 109, 10.1016/S0149-7189(03)00014-4 Minneci, 2015, Is an RCT the Best Way to investigate the effectiveness of nonoperative management of pediatric appendicitis?, Ann Surg Minneci, 2015, The effectiveness of patient choice in non-operative versus surgical management of pediatric uncomplicated acute appendictiis, JAMA Surg Patsopoulos, 2011, A pragmatic view on pragmatic trials, Dialogues Clin Neurosci, 13, 217, 10.31887/DCNS.2011.13.2/npatsopoulos Abes, 2007, Nonoperative treatment of acute appendicitis in children, J Pediatr Surg, 42, 1439, 10.1016/j.jpedsurg.2007.03.049 Armstrong, 2014, Non-operative management of early, acute appendicitis in children: is it safe and effective?, J Pediatr Surg, 49, 782, 10.1016/j.jpedsurg.2014.02.071 Di Saverio, 2014, Ann Surg, 260, 109, 10.1097/SLA.0000000000000560 Eriksson, 1995, Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis, Br J Surg, 82, 166, 10.1002/bjs.1800820207 Georgiou, 2017, Efficacy and safety of nonoperative treatment for acute appendicitis: a meta-analysis, Pediatrics, 139, 10.1542/peds.2016-3003 Gorter, 2015, Initial antibiotic treatment for acute simple appendicitis in children is safe: short-term results from a multicenter, prospective cohort study, Surgery, 157, 916, 10.1016/j.surg.2015.01.008 Hansson, 2009, Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients, Brit J Surg., 96, 830 Hansson, 2012, Antibiotics as first-line therapy for acute appendicitis: evidence for a change in clinical practice, World J Surg, 10.1007/s00268-012-1641-x Harnoss, 2017, Antibiotics versus surgical therapy for uncomplicated appendicitis: systematic review and meta-analysis of controlled trials (PROSPERO 2015: CRD42015016882), Ann Surg, 265, 889, 10.1097/SLA.0000000000002039 Huang, 2017, Comparison of antibiotic therapy and appendectomy for acute uncomplicated appendicitis in children: a meta-analysis, JAMA Pediatr, 171, 426, 10.1001/jamapediatrics.2017.0057 Kaneko, 2004, Ultrasound-based decision making in the treatment of acute appendicitis in children, J Pediatr Surg, 39, 1316, 10.1016/j.jpedsurg.2004.05.011 Koike, 2014, Intraluminal appendiceal fluid is a predictive factor for recurrent appendicitis after initial successful non-operative management of uncomplicated appendicitis in pediatric patients, J Pediatr Surg, 49, 1116, 10.1016/j.jpedsurg.2014.01.003 Lundholm, 2017, Long-term results following antibiotic treatment of acute appendicitis in adults, World J Surg, 41, 2245, 10.1007/s00268-017-3987-6 Mahida, 2016, High failure rate of nonoperative management of acute appendicitis with an appendicolith in children, J Pediatr Surg, 51, 908, 10.1016/j.jpedsurg.2016.02.056 Salminen, 2015, Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: the APPAC randomized clinical trial, Jama, 313, 2340, 10.1001/jama.2015.6154 Scott, 2018, Nonoperative management of appendicitis, Clin Pediatr, 57, 200, 10.1177/0009922817696465 Shindoh, 2010, Predictive factors for negative outcomes in initial non-operative management of suspected appendicitis, J Gastrointest Surg, 14, 309, 10.1007/s11605-009-1094-1 Steiner, 2015, A role for conservative antibiotic treatment in early appendicitis in children, J Pediatr Surg, 50, 1566, 10.1016/j.jpedsurg.2015.04.008 Styrud, 2006, Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial, World J Surg, 30, 1033, 10.1007/s00268-005-0304-6 Svensson, 2015, Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial, Ann Surg, 261, 67, 10.1097/SLA.0000000000000835 Vons, 2011, Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial, Lancet, 377, 1573, 10.1016/S0140-6736(11)60410-8 Lee, 2017, Expanding the inclusion criteria for nonoperative management of uncomplicated appendicitis: outcomes and cost, J Pediatr Surg Tanaka, 2015, Long-term outcomes of operative versus nonoperative treatment for uncomplicated appendicitis, J Pediatr Surg, 50, 1893, 10.1016/j.jpedsurg.2015.07.008 Minneci, 2017, Nonoperative treatment of appendicitis, JAMA Pediatr, 171, 1126, 10.1001/jamapediatrics.2017.2940