intention to treat analysis


Summary: Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.

Top Publications

  1. Ascierto P, Del Vecchio M, Robert C, Mackiewicz A, Chiarion Sileni V, Arance A, et al. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017;18:611-622 pubmed publisher
    ..Although the treatment landscape for advanced melanoma has changed since this study was initiated, the clinical use of ipilimumab in refractory patients with unmet medical needs could warrant further assessment. Bristol-Myers Squibb. ..
  2. Wechsler M, Akuthota P, Jayne D, Khoury P, Klion A, Langford C, et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017;376:1921-1932 pubmed publisher
    ..Funded by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases; number, NCT02020889 .). ..
  3. Sanford N, Yeap B, Larvie M, Daartz J, Munzenrider J, Liebsch N, et al. Prospective, Randomized Study of Radiation Dose Escalation With Combined Proton-Photon Therapy for Benign Meningiomas. Int J Radiat Oncol Biol Phys. 2017;99:787-796 pubmed publisher
    ..322). In the modified intention to treat analysis, there was no difference in progression-free survival (P=.234) and overall survival (P=...
  4. Ross M, Kreider A, Huang Y, Matone M, Rubin D, Localio A. Propensity Score Methods for Analyzing Observational Data Like Randomized Experiments: Challenges and Solutions for Rare Outcomes and Exposures. Am J Epidemiol. 2015;181:989-95 pubmed publisher
    ..Challenges in this data set include a rare outcome, a rare exposure, substantial and important differences between exposure groups, and a very large sample size. ..
  5. Pocock S, Stone G. The Primary Outcome Fails - What Next?. N Engl J Med. 2016;375:861-70 pubmed publisher
  6. White I, Horton N, Carpenter J, Pocock S. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011;342:d40 pubmed publisher
  7. Abrahams H, Gielissen M, Donders R, Goedendorp M, van der Wouw A, Verhagen C, et al. The efficacy of Internet-based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial. Cancer. 2017;123:3825-3834 pubmed publisher
    ..Cancer 2017;123:3825-34. © 2017 American Cancer Society. ..
  8. Corren J, Parnes J, Wang L, Mo M, Roseti S, Griffiths J, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017;377:936-946 pubmed publisher
    ..Funded by MedImmune [a member of the AstraZeneca Group] and Amgen; PATHWAY number, NCT02054130 .). ..
  9. Karpe K, Talaulikar G, Walters G. Calcineurin inhibitor withdrawal or tapering for kidney transplant recipients. Cochrane Database Syst Rev. 2017;7:CD006750 pubmed publisher
    ..These conclusions must be tempered by the lack of long-term data in most of the studies, particularly with regards to chronic antibody-mediated rejection, and the suboptimal methodological quality of the included studies. ..

More Information


  1. Ramanan A, Dick A, Jones A, McKay A, Williamson P, Compeyrot Lacassagne S, et al. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017;376:1637-1646 pubmed publisher
    ..Funded by the NIHR Health Technology Assessment Programme and Arthritis Research UK; SYCAMORE EudraCT number, 2010-021141-41 .). ..
  2. Moran G, Krishnadasan A, Mower W, Abrahamian F, LoVecchio F, Steele M, et al. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial. JAMA. 2017;317:2088-2096 pubmed publisher
    ..It is unknown if antimicrobial regimens possessing in vitro MRSA activity provide improved outcomes compared with treatments lacking MRSA activity...
  3. Brown P, Ballman K, Cerhan J, Anderson S, Carrero X, Whitton A, et al. Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2017;18:1049-1060 pubmed publisher
    ..After resection of a brain metastasis, SRS radiosurgery should be considered one of the standards of care as a less toxic alternative to WBRT for this patient population. National Cancer Institute. ..
  4. Faries M, Thompson J, Cochran A, Andtbacka R, Mozzillo N, Zager J, et al. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. N Engl J Med. 2017;376:2211-2222 pubmed publisher
    ..Funded by the National Cancer Institute and others; MSLT-II number, NCT00297895 .). ..
  5. Delitto A, Piva S, Moore C, Fritz J, Wisniewski S, Josbeno D, et al. Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial. Ann Intern Med. 2015;162:465-73 pubmed publisher
    ..National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases. ..
  6. Bahwere P, Akomo P, Mwale M, Murakami H, Banda C, Kathumba S, et al. Soya, maize, and sorghum-based ready-to-use therapeutic food with amino acid is as efficacious as the standard milk and peanut paste-based formulation for the treatment of severe acute malnutrition in children: a noninferiority individually randomize. Am J Clin Nutr. 2017;106:1100-1112 pubmed publisher
    ..It is also better at correcting iron deficiency anemia than PM-RUTF. This trial was registered at as PACTR201505001101224. ..
  7. Modest D, Ricard I, Stintzing S, Fischer von Weikersthal L, Decker T, Kiani A, et al. Evaluation of survival across several treatment lines in metastatic colorectal cancer: Analysis of the FIRE-3 trial (AIO KRK0306). Eur J Cancer. 2017;84:262-269 pubmed publisher
    ..When OS curves separate, only few patients receive active systemic treatment in short courses, suggesting that earlier treatment effects are responsible for later kinetics of survival curves. ..
  8. Limaye A, Stapleton R, Peng L, Gunn S, Kimball L, Hyzy R, et al. Effect of Ganciclovir on IL-6 Levels Among Cytomegalovirus-Seropositive Adults With Critical Illness: A Randomized Clinical Trial. JAMA. 2017;318:731-740 pubmed publisher
    ..Additional research is necessary to determine the clinical efficacy and safety of CMV suppression in this setting. Identifier: NCT01335932. ..
  9. Bais C, Mueller B, Brady M, Mannel R, Burger R, Wei W, et al. Tumor Microvessel Density as a Potential Predictive Marker for Bevacizumab Benefit: GOG-0218 Biomarker Analyses. J Natl Cancer Inst. 2017;109: pubmed publisher
    ..Evaluation of candidate biomarkers was an exploratory objective...
  10. Mu D, Zhang D, Wang D, Wang G, Li C, Meng Z, et al. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial. Anesth Analg. 2017;124:1992-2000 pubmed publisher
    ..80). For low-risk elderly patients undergoing elective total hip or knee replacement surgery, multidose parecoxib supplemented to IV morphine decreased the incidence of postoperative delirium without increasing adverse events. ..
  11. Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, et al. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017;318:548-556 pubmed publisher
    ..Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function...
  12. Chiappella A, Martelli M, Angelucci E, Brusamolino E, Evangelista A, Carella A, et al. Rituximab-dose-dense chemotherapy with or without high-dose chemotherapy plus autologous stem-cell transplantation in high-risk diffuse large B-cell lymphoma (DLCL04): final results of a multicentre, open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2017;18:1076-1088 pubmed publisher
    ..These results do not support further consideration of the use of intensification of R-CHOP as an upfront strategy in patients with diffuse large B-cell lymphoma with poor prognosis. Fondazione Italiana Linfomi. ..
  13. Metz L, Li D, Traboulsee A, Duquette P, Eliasziw M, Cerchiaro G, et al. Trial of Minocycline in a Clinically Isolated Syndrome of Multiple Sclerosis. N Engl J Med. 2017;376:2122-2133 pubmed publisher
    ..Funded by the Multiple Sclerosis Society of Canada; number, NCT00666887 .). ..
  14. Mann J, Ørsted D, Brown Frandsen K, Marso S, Poulter N, Rasmussen S, et al. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017;377:839-848 pubmed publisher
    ..However, the long-term effects of liraglutide on renal outcomes in patients with type 2 diabetes are unknown...
  15. Saver J, Carroll J, Thaler D, Smalling R, MacDonald L, Marks D, et al. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017;377:1022-1032 pubmed publisher
    ..Funded by St. Jude Medical; RESPECT number, NCT00465270 .). ..
  16. Kragholm K, Wissenberg M, Mortensen R, Hansen S, Malta Hansen C, Thorsteinsson K, et al. Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2017;376:1737-1747 pubmed publisher
    ..Funded by TrygFonden and the Danish Heart Foundation.). ..
  17. van Schaik T, Yeung K, Verhagen H, de Bruin J, Van Sambeek M, Balm R, et al. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2017;66:1379-1389 pubmed publisher
    ..Endograft durability and the need for continued endograft surveillance remain key issues. ..
  18. Gerstein H, Bosch J, Dagenais G, Diaz R, Jung H, Maggioni A, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367:319-28 pubmed publisher
    ..Although it reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight. (Funded by Sanofi; ORIGIN number, NCT00069784.). ..
  19. Fu W, Song Z, Zhou L, Xue Y, Ding Y, Suo B, et al. Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection. Dig Dis Sci. 2017;62:1580-1589 pubmed publisher
    ..pylori eradication. Cefuroxime may be a good alternative medicine for eradication instead of amoxicillin for the patients unsuitable to take penicillin. ..
  20. Søndergaard L, Kasner S, Rhodes J, Andersen G, Iversen H, Nielsen Kudsk J, et al. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2017;377:1033-1042 pubmed publisher
    ..Funded by W.L. Gore and Associates; Gore REDUCE number, NCT00738894 .). ..
  21. Little R, D AGOSTINO R, Cohen M, Dickersin K, Emerson S, Farrar J, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367:1355-60 pubmed publisher
  22. Rodrigo G, Castro Rodríguez J. What is the role of tiotropium in asthma?: a systematic review with meta-analysis. Chest. 2015;147:388-396 pubmed publisher
    ..Major benefits were concentrated in the increase in lung function and in the case of patients with severe asthma, in the reduction of exacerbations. ..
  23. Laursen R, Larnkjær A, Ritz C, Hauger H, Michaelsen K, Mølgaard C. Probiotics and Child Care Absence Due to Infections: A Randomized Controlled Trial. Pediatrics. 2017;140: pubmed publisher
    ..A daily administration of a combination of B animalis subsp lactis and L rhamnosus for 6 months did not reduce the number of days absent from child care in healthy infants at the time of enrollment in child care. ..
  24. Brunoni A, Moffa A, Sampaio Junior B, Borrione L, Moreno M, Fernandes R, et al. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017;376:2523-2533 pubmed publisher
    ..Funded by Fundação de Amparo à Pesquisa do Estado de São Paulo and others; ELECT-TDCS number, NCT01894815 .). ..
  25. Faivre Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017;18:1116-1125 pubmed publisher
  26. Lo Coco F, Di Donato L, Schlenk R. Targeted Therapy Alone for Acute Promyelocytic Leukemia. N Engl J Med. 2016;374:1197-8 pubmed publisher
  27. Mohammadi M, Attaran B, Malekzadeh R, Graham D. Furazolidone, an Underutilized Drug for H. pylori Eradication: Lessons from Iran. Dig Dis Sci. 2017;62:1890-1896 pubmed publisher
    ..i.d. or q.i.d. is likely to provide the highest cure rates with lowest side effects; this remains to be experimentally tested. Detailed suggestions for further development of furazolidone-containing regimens are provided. ..
  28. Daum R, Miller L, Immergluck L, Fritz S, Creech C, Young D, et al. A Placebo-Controlled Trial of Antibiotics for Smaller Skin Abscesses. N Engl J Med. 2017;376:2545-2555 pubmed publisher
    ..Uncomplicated skin abscesses are common, yet the appropriate management of the condition in the era of community-associated methicillin-resistant Staphylococcus aureus (MRSA) is unclear...
  29. Jiao L, Chen L, White D, Tinker L, Chlebowski R, VAN HORN L, et al. Low-fat Dietary Pattern and Pancreatic Cancer Risk in the Women's Health Initiative Dietary Modification Randomized Controlled Trial. J Natl Cancer Inst. 2018;110: pubmed publisher
    ..01). A low-fat dietary intervention was associated with reduced pancreatic cancer incidence in women who were overweight or obese in the WHI-DM trial. Caution needs to be taken in interpreting the findings based on subgroup analyses. ..
  30. Tieu J, Middleton P, Crowther C, Shepherd E. Preconception care for diabetic women for improving maternal and infant health. Cochrane Database Syst Rev. 2017;8:CD007776 pubmed publisher
    ..We have identified three ongoing studies that we will consider in the next review update. ..
  31. Bergeron A, Chevret S, Granata A, Chevallier P, Vincent L, Huynh A, et al. Effect of Azithromycin on Airflow Decline-Free Survival After Allogeneic Hematopoietic Stem Cell Transplant: The ALLOZITHRO Randomized Clinical Trial. JAMA. 2017;318:557-566 pubmed publisher
    ..The potential for harm related to relapse requires further investigation. Identifier: NCT01959100. ..
  32. García Donas J, Font A, Pérez Valderrama B, Virizuela J, Climent M, Hernando Polo S, et al. Maintenance therapy with vinflunine plus best supportive care versus best supportive care alone in patients with advanced urothelial carcinoma with a response after first-line chemotherapy (MAJA; SOGUG 2011/02): a multicentre, randomised, controlled,. Lancet Oncol. 2017;18:672-681 pubmed publisher
    ..Vinflunine maintenance had an acceptable safety profile. Further studies of the role of vinflunine are warranted. Pierre-Fabre Médicament. ..
  33. Chen Y, Chen L, Li W, Lee A, Vermorken J, Wee J, et al. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2017;98:170-176 pubmed publisher
    ..This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required. ..
  34. Antman E. Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs. Circulation. 2017;135:2062-2072 pubmed publisher
  35. Hochhaus A, Larson R, Guilhot F, Radich J, Branford S, Hughes T, et al. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017;376:917-927 pubmed publisher
    ..Funded by Novartis Pharmaceuticals; IRIS numbers, NCT00006343 and NCT00333840 .). ..
  36. Linnemayr S, Huang H, Luoto J, Kambugu A, Thirumurthy H, Haberer J, et al. Text Messaging for Improving Antiretroviral Therapy Adherence: No Effects After 1 Year in a Randomized Controlled Trial Among Adolescents and Young Adults. Am J Public Health. 2017;107:1944-1950 pubmed publisher
  37. Foster J, Dawson J, Davis P, Dahlen H. Routine oro/nasopharyngeal suction versus no suction at birth. Cochrane Database Syst Rev. 2017;4:CD010332 pubmed publisher
    ..Further high-quality studies are required in preterm infants or term newborn infants with thick meconium amniotic fluid. Studies should investigate long-term effects such as neurodevelopmental outcomes. ..
  38. Peters S, Camidge D, Shaw A, Gadgeel S, Ahn J, Kim D, et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377:829-838 pubmed publisher
    ..We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease...
  39. Badros A, Hyjek E, Ma N, Lesokhin A, Dogan A, Rapoport A, et al. Pembrolizumab, pomalidomide, and low-dose dexamethasone for relapsed/refractory multiple myeloma. Blood. 2017;130:1189-1197 pubmed publisher
    ..Pembrolizumab, pomalidomide, and low-dose dexamethasone have acceptable safety and durable responses in RRMM patients. This trial was registered at as #NCT02289222. ..
  40. Al Tawil K, Babu A, Loeffler M, Williams T. Second generation cephalosporin antibiotic prophylaxis and Clostridium difficile infection in hip and knee arthroplasty. Ann R Coll Surg Engl. 2017;99:351-354 pubmed publisher
  41. Rolnik D, Wright D, Poon L, O Gorman N, Syngelaki A, De Paco Matallana C, et al. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017;377:613-622 pubmed publisher
    ..Preterm preeclampsia is an important cause of maternal and perinatal death and complications. It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of preterm preeclampsia...
  42. Bauersachs R, Berkowitz S, Brenner B, Buller H, Decousus H, Gallus A, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499-510 pubmed publisher
    ..Funded by Bayer Schering Pharma and Ortho-McNeil; numbers, NCT00440193 and NCT00439725.). ..
  43. Hock Ong M, Fook Chong S, Annathurai A, Ang S, Tiah L, Yong K, et al. Improved neurologically intact survival with the use of an automated, load-distributing band chest compression device for cardiac arrest presenting to the emergency department. Crit Care. 2012;16:R144 pubmed publisher
    ..06. A resuscitation strategy using LDB-CPR in an ED environment was associated with improved neurologically intact survival on discharge in adults with prolonged, non-traumatic cardiac arrest. ..
  44. Sujatha Bhaskar S, Jafari M, Gahagan J, Inaba C, Koh C, Mills S, et al. Defining the Role of Minimally Invasive Proctectomy for Locally Advanced Rectal Adenocarcinoma. Ann Surg. 2017;266:574-581 pubmed publisher
    ..National examination of open proctectomy (OP), laparoscopic proctectomy (LP), and robotic proctectomy (RP) in pathological outcomes and overall survival (OS)...
  45. Asfar P, Schortgen F, Boisramé Helms J, Charpentier J, Guérot E, Megarbane B, et al. Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial. Lancet Respir Med. 2017;5:180-190 pubmed publisher
    ..In patients with septic shock, setting FiO2 to 1·0 to induce arterial hyperoxia might increase the risk of mortality. Hypertonic (3%) saline did not improve survival. The French Ministry of Health. ..
  46. Kelly A, Garner S, Foukaneli T, Godec T, Herbert N, Kahan B, et al. The effect of variation in donor platelet function on transfusion outcome: a semirandomized controlled trial. Blood. 2017;130:214-220 pubmed publisher
    ..8-38.9) donors (mean difference, 2.3; 95% CI, -1.1 to 5.7; P = .18). These results support the current policy of not selecting platelet donors on the basis of platelet function for prophylactic platelet transfusion. ..
  47. Zhou C, Wu L, Liu Q, An H, Jiang B, Zuo F, et al. Evaluation of smoking cessation intervention in patients with chronic diseases in smoking cessation clinics. Medicine (Baltimore). 2017;96:e7459 pubmed publisher
    ..The psychological intervention and psychological plus drugs intervention exerted good effects on smoking cessation in a short time (1 month). Nevertheless, the advantages did not appear during long-time (6 months) follow-up. ..
  48. Futier E, Lefrant J, Guinot P, Godet T, Lorne E, Cuvillon P, et al. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017;318:1346-1357 pubmed publisher
    ..Perioperative hypotension is associated with an increase in postoperative morbidity and mortality, but the appropriate management strategy remains uncertain...
  49. Boutelle K, Rhee K, LIANG J, Braden A, Douglas J, Strong D, et al. Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. JAMA Pediatr. 2017;171:622-628 pubmed publisher
    ..However, parent-based treatment (PBT), which is provided to the parent without the child, could be similarly effective and easier to disseminate...
  50. Palmer W, Lee D, Burns J, Croome K, Rosser B, Patel T, et al. Liver Transplantation for Hepatocellular Carcinoma: Impact of Wait Time at a Single Center. Ann Hepatol. 2017;16:402-411 pubmed publisher
    ..2%. In this large, single-center experience with long-term data, factors of tumor biology, but not a longer wait time, were associated with recurrence-free and overall survival. ..
  51. Rodda S, Morris W, Hamm J, Duncan G. ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017;98:581-589 pubmed publisher
    ..There was a statistically significant decline in physical function and urinary function scales in the LDR-PB arm compared with the DE-EBRT arm. ..
  52. Alcock G, Liley H, Cooke L, Gray P. Prevention of neonatal late-onset sepsis: a randomised controlled trial. BMC Pediatr. 2017;17:98 pubmed publisher
    ..Date: 06/03/2001; Australian New Zealand Clinical Trials Registry (ANZCTR), TRN registration number: ACTRN12617000455369 . Date: 28/03/2017 (retrospectively registered). ..
  53. Mountain G, Windle G, Hind D, Walters S, Keertharuth A, Chatters R, et al. A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial. Age Ageing. 2017;46:627-634 pubmed publisher on 262 (intervention = 136; usual care = 126) participants were analysed using intention to treat analysis. Mean SF-36 MH scores at 6 months differed by 2.3 points (95 CI: -1.3 to 5.9; P = 0...
  54. Zhou Y, Jin X, Kang Y, Liang G, Liu T, Deng N. Midazolam and propofol used alone or sequentially for long-term sedation in critically ill, mechanically ventilated patients: a prospective, randomized study. Crit Care. 2014;18:R122 pubmed publisher
    ..Current Controlled Trials ISRCTN01173443. Registered 25 February 2014. ..
  55. Rodda S, Tyldesley S, Morris W, Keyes M, Halperin R, Pai H, et al. ASCENDE-RT: An Analysis of Treatment-Related Morbidity for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost with a Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017;98:286-295 pubmed publisher
    ..30). The incidence of acute and late GU morbidity was higher after LDR-PB boost, and there was a nonsignificant trend for worse GI morbidity. No differences in the frequency of erectile dysfunction were observed. ..
  56. Earl H, Hiller L, Howard H, Dunn J, Young J, Bowden S, et al. Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18:755-769 pubmed publisher
    ..Cancer Research UK core funding for Clinical Trials Unit at the University of Birmingham, Eli Lilly, Bristol-Myers Squibb, and Pfizer. ..
  57. Ejlertsen B, Tuxen M, Jakobsen E, Jensen M, Knoop A, Højris I, et al. Adjuvant Cyclophosphamide and Docetaxel With or Without Epirubicin for Early TOP2A-Normal Breast Cancer: DBCG 07-READ, an Open-Label, Phase III, Randomized Trial. J Clin Oncol. 2017;35:2639-2646 pubmed publisher
    ..Conclusion This study provides evidence to support no overall outcome benefit from adjuvant anthracyclines in patients with early TOP2A-normal breast cancer. ..
  58. Carey D, Puls R, Amin J, Losso M, Phanupak P, Foulkes S, et al. Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study. Lancet Infect Dis. 2015;15:793-802 pubmed publisher
    ..These findings support the routine use of efavirenz 400 mg. The coadministration of rifampicin and efavirenz 400 mg needs further investigation. Bill & Melinda Gates Foundation, and UNSW Australia. ..
  59. Guasch Ferré M, Salas Salvado J, Ros E, Estruch R, Corella D, Fito M, et al. The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?. Nutr Metab Cardiovasc Dis. 2017;27:624-632 pubmed publisher
  60. Bajpai J, Chandrasekharan A, Talreja V, Simha V, Chandrakanth M, Rekhi B, et al. Outcomes in non-metastatic treatment naive extremity osteosarcoma patients treated with a novel non-high dosemethotrexate-based, dose-dense combination chemotherapy regimen 'OGS-12'. Eur J Cancer. 2017;85:49-58 pubmed publisher
  61. Elkins M, Moseley A. Intention-to-treat analysis. J Physiother. 2015;61:165-7 pubmed publisher
  62. Chertow G, Block G, Correa Rotter R, Drueke T, Floege J, Goodman W, et al. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med. 2012;367:2482-94 pubmed publisher
    ..Funded by Amgen; EVOLVE number, NCT00345839.). ..
  63. Weitz J, Lensing A, Prins M, Bauersachs R, Beyer Westendorf J, Bounameaux H, et al. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017;376:1211-1222 pubmed publisher
    ..Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin...
  64. Kenngott H, Clemens G, Gondan M, Senft J, Diener M, Rudofsky G, et al. DiaSurg 2 trial--surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial--DRKS00004550. Trials. 2013;14:183 pubmed publisher
    ..The trial protocol has been registered in the German Clinical Trials Register DRKS00004550. ..
  65. Bosch J, Gerstein H, Dagenais G, Diaz R, Dyal L, Jung H, et al. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012;367:309-18 pubmed publisher
    ..Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN number, NCT00069784.). ..
  66. Morris W, Tyldesley S, Rodda S, Halperin R, Pai H, McKenzie M, et al. Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An Analysis of Survival Endpoints for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost to a Dose-Escalated External Beam Bo. Int J Radiat Oncol Biol Phys. 2017;98:275-285 pubmed publisher
    ..13; P=.62). Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years. ..
  67. Smith T, Kahaly G, Ezra D, Fleming J, Dailey R, Tang R, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. N Engl J Med. 2017;376:1748-1761 pubmed publisher
    ..Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy...
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