Erratum: Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer (New England Journal of Medicine (2016) 375 (1425-1437) DOI: 10.1056/NEJMoa1606221);Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer

New England Journal of Medicine

Volumn 375, Issue 15, 2016, Pages 1425-1437

  Donovan, Jenny L ^a,c   Hamdy, Freddie C ^e   Lane, J Athene ^a   Mason, Malcolm ^f   Metcalfe, Chris ^a   Walsh, Eleanor ^a   Blazeby, Jane M ^a   Peters, Tim J ^b,i   Holding, Peter ^e   Bonnington, Susan ^h   Lennon, Teresa ⁱ   Bradshaw, Lynne ^d   Cooper, Deborah ^j   Herbert, Phillipa ^k   Howson, Joanne ^m   Jones, Amanda ^g   Lyons, Norma ⁿ   Salter, Elizabeth ^d   Thompson, Pauline ^o   Tidball, Sarah ^g   Blaikie, Jan ⁿ   Gray, Catherine ^j   Bollina, Prasad ⁿ   Catto, James ^m   Doble, Andrew ^k   Doherty, Alan ^o   Gillatt, David ^d   Kockelbergh, Roger ^h   Kynaston, Howard ^g   Paul, Alan ^j   Powell, Philip ⁱ   Prescott, Stephen ^j   Rosario, Derek J ^m   Rowe, Edward ^d   Davis, Michael ^a   Turner, Emma L ^a   Martin, Richard M ^a   Neal, David E ^e,l   more..

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY OF BRISTOL   (United Kingdom)

^c UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^d NORTH BRISTOL NHS TRUST   (United Kingdom)

^e UNIVERSITY OF OXFORD   (United Kingdom)

^f CARDIFF UNIVERSITY   (United Kingdom)

^g CARDIFF AND VALE UNIVERSITY HEALTH BOARD   (United Kingdom)

^h UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

ⁱ FREEMAN HOSPITAL   (United Kingdom)

^j LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

^k ADDENBROOKE S HOSPITAL   (United Kingdom)

^l UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^m UNIVERSITY OF SHEFFIELD   (United Kingdom)

ⁿ WESTERN GENERAL HOSPITAL   (United Kingdom)

^o QUEEN ELIZABETH HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

ANDROGEN DEPRIVATION THERAPY; ANXIETY; ARTICLE; CANCER RADIOTHERAPY; CONFORMAL RADIOTHERAPY; CONTROLLED STUDY; DEPRESSION; DRUG RESPONSE; ERECTILE DYSFUNCTION; GLEASON SCORE; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; INTENTION TO TREAT ANALYSIS; INTESTINE FUNCTION; LOOSE FECES; LOWER URINARY TRACT SYMPTOM; MAJOR CLINICAL STUDY; MALE; NEGATIVE SYNDROME; NOCTURIA; OUTCOME ASSESSMENT; PATIENT MONITORING; PRIORITY JOURNAL; PROSTATE CANCER; PROSTATE SURGERY; PROSTATECTOMY; QUALITY OF LIFE; QUESTIONNAIRE; RADIATION DOSE; RECTUM HEMORRHAGE; SEXUAL FUNCTION; SHORT FORM 12; SHORT FORM 36; URINARY TRACT FUNCTION; URINE INCONTINENCE; AGED; COMPARATIVE STUDY; DIGESTIVE SYSTEM DISEASE; HEALTH STATUS; MIDDLE AGED; MORTALITY; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; URINARY TRACT DISEASE; WATCHFUL WAITING;

AGED; DIGESTIVE SYSTEM DISEASES; ERECTILE DYSFUNCTION; HEALTH STATUS; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PROSTATECTOMY; PROSTATIC NEOPLASMS; QUALITY OF LIFE; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME; UROLOGIC DISEASES; WATCHFUL WAITING;

EID: 84991265987     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMx230003     Document Type: Erratum

References (44)

1. Hamdy FC, Donovan JL, Lane JA et al. 10-Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med 2016; 375:1415-24.
2. Wilt TJ, MacDonald R, Rutks I, Shamliyan TA, Taylor BC, Kane RL. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008; 148: 435-48.
3. Chou R, Croswell JM, Dana T, et al. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2011; 155: 762-71.
4. Chen RC, Chang P, Vetter RJ, et al. Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials. J Natl Cancer Inst 2014; 106: 1-7.
5. Whiting PF, Moore TH, Jameson CM, et al. Symptomatic and quality-of-life outcomes after treatment for clinically localised prostate cancer: a systematic review. BJU Int 2016; 118: 193-204.
6. Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008; 358: 1250-61.
7. Smith DP, King MT, Egger S, et al. Quality of life three years after diagnosis of localised prostate cancer: population based cohort study. BMJ 2009; 339: b4817.
8. Bellardita L, Valdagni R, van den Bergh R, et al. How does active surveillance for prostate cancer affect quality of life? A systematic review. Eur Urol 2015; 67: 637-45.
9. Steineck G, Helgesen F, Adolfsson J, et al. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med 2002; 347: 790-6.
10. Johansson E, Steineck G, Holmberg L, et al. Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial. Lancet Oncol 2011; 12: 891-9.
11. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203-13.
12. Lane JA, Donovan JL, Davis M, et al. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncol 2014; 15: 1109-18.
13. Metcalfe C, Peters TJ, Hamdy FC. Prostate Testing for Cancer and Treatment (ProtecT) Study: statistical analysis plan, version 1.0. Bristol, United Kingdom: University of Bristol, 2015: 1-22.
14. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013; 309: 814-22.
15. Lane A, Metcalfe C, Young GJ, et al. Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. BJU Int 2016 August 17 (Epub ahead of print)
16. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004; 23: 322-30.
17. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the Expanded Prostate Cancer Index Composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology 2000; 56: 899-905.
18. Donovan JL, Peters TJ, Abrams P, Brookes ST, de aa Rosette JJ, Schäfer W. Scoring the short form ICSmaleSF questionnaire. J Urol 2000; 164: 1948-55.
19. Gandek B, Ware JE, Aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998; 51: 1171-8.
20. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983; 67: 361-70.
21. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-76.
22. Male sexual dysfunction. Arnheim, the Netherlands: European Association of Urology (https://uroweb.org/guideline/male-sexual-dysfunction/).
23. Prostate cancer: diagnosis and management. London: National Institute for Health and Care Excellence (https://www.nice.org.uk/guidance/cg175/resources/prostate-cancer-diagnosis-and-management-35109753913285).
24. Urinary incontinence. Arnheim, the Netherlands: European Association of Urology (https://uroweb.org/guideline/urinary-incontinence/#4).
25. Erectile dysfunction. Linthicum, MD: American Urological Association (https://www.auanet.org/education/guidelines/erectile-dysfunction.cfm).
26. Rubin DB. Inference and missing data. Biometrika 1976; 63: 581-92.
27. Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol 2015; 67: 460-7.
28. MacLennan S, Bekema HJ, Williamson PR, et al. A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey. Trials 2015; 16: 76.
29. Resnick MJ, Koyama T, Fan K-H, et al. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med 2013; 368: 436-45.
30. Bill-Axelson A, Garmo H, Holmberg L, et al. Long-term distress after radical prostatectomy versus watchful waiting in prostate cancer: a longitudinal study from the Scandinavian Prostate Cancer Group-4 randomized clinical trial. Eur Urol 2013; 64: 920-8.
31. Wei JT, Dunn RL, Sandler HM, et al. Comprehensive comparison of healthrelated quality of life after contemporary therapies for localized prostate cancer. J Clin Oncol 2002; 20: 557-66.
32. Parker PA, Davis JW, Latini DM, et al. Relationship between illness uncertainty, anxiety, fear of progression and quality of life in men with favourable-risk prostate cancer undergoing active surveillance. BJU Int 2016; 117: 469-77.
33. Buckley BS, Lapitan MC, Glazener CM. The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery. Neurourol Urodyn 2012; 31: 465-9.
34. Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol 2012; 62: 1-15.
35. Yaxley JW, Coughlin GD, Chambers SK, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016; 388: 1057-66.
36. Barry MJ, Gallagher PM, Skinner JS, Fowler FJ Jr. Adverse effects of roboticassisted laparoscopic versus open retropubic radical prostatectomy among a nationwide random sample of Medicare-age men. J Clin Oncol 2012; 30: 513-8.
37. Prostate cancer: diagnosis and management. London: National Institute for Health and Care Excellence, 2014 (https://www.nice.org.uk/guidance/cg175).
38. Simpkin AJ, Tilling K, Martin RM, et al. Systematic review and meta-analysis of factors determining change to radical treatment in active surveillance for localized prostate cancer. Eur Urol 2015; 67: 993-1005.
39. Donovan JL, Lane JA, Peters TJ, et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol 2009; 62: 29-36.
40. Lane JA, Wade J, Down L, et al. A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance. J Clin Epidemiol 2011; 64: 628-36.
41. Turner EL, Metcalfe C, Donovan JL, et al. Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). Br J Cancer 2014; 110: 2829-36.
42. Williams N, Hughes LJ, Turner EL, et al. Prostate-specific antigen testing rates remain low in UK general practice: a crosssectional study in six English cities. BJU Int 2011; 108: 1402-8.
43. Andriole GL, Crawford ED, Grubb RL III, et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009; 360: 1310-9.
44. Schröder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009; 360: 1320-8.