{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,11]],"date-time":"2026-01-11T23:00:43Z","timestamp":1768172443632,"version":"3.49.0"},"reference-count":43,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,8,17]],"date-time":"2016-08-17T00:00:00Z","timestamp":1471392000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      To present the baseline patient\u2010reported outcome measures (\n                      <jats:styled-content style=\"fixed-case\">PROM<\/jats:styled-content>\n                      s) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external\u2010beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      A total of 1643 randomized men, aged 50\u201369 years and diagnosed with clinically localized disease identified by prostate\u2010specific antigen (\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      ) testing, in nine\n                      <jats:styled-content style=\"fixed-case\">UK<\/jats:styled-content>\n                      cities in the period 1999\u20132009 were included. Validated\n                      <jats:styled-content style=\"fixed-case\">PROM<\/jats:styled-content>\n                      s for disease\u2010specific (urinary, bowel and sexual function) and condition\u2010specific impact on quality of life (Expanded Prostate Index Composite [\n                      <jats:styled-content style=\"fixed-case\">EPIC<\/jats:styled-content>\n                      ], 2005 onwards; International Consultation on Incontinence Questionnaire\u2010Urinary Incontinence [\n                      <jats:styled-content style=\"fixed-case\">ICIQ<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">UI<\/jats:styled-content>\n                      ], 2001 onwards; the International Continence Society short\u2010form male survey [\n                      <jats:styled-content style=\"fixed-case\">ICS<\/jats:styled-content>\n                      male\n                      <jats:styled-content style=\"fixed-case\">SF<\/jats:styled-content>\n                      ]; anxiety and depression (Hospital Anxiety and Depression Scale [\n                      <jats:styled-content style=\"fixed-case\">HADS<\/jats:styled-content>\n                      ]), generic mental and physical health (12\u2010item short\u2010form health survey [\n                      <jats:styled-content style=\"fixed-case\">SF<\/jats:styled-content>\n                      \u201012]; EuroQol quality\u2010of\u2010life survey, the\n                      <jats:styled-content style=\"fixed-case\">EQ<\/jats:styled-content>\n                      \u20105D\u20103L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      testing time points for selected measures.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 1438 participants completed biopsy questionnaires (88%) and 77\u201388% of these were analysed for individual\n                      <jats:styled-content style=\"fixed-case\">PROM<\/jats:styled-content>\n                      s. Fewer than 1% of participants were using pads daily (5\/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312\/1423). Bowel symptoms were rare, except for loose stools (16%, 118\/754). One third of participants reported erectile dysfunction (241\/735) and for 16% (118\/731) this was a moderate or large problem. Depression was infrequent (80\/1399, 6%) but 20% of participants (278\/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65\u201370 years), whilst urinary bother and physical health were somewhat worse than in younger men (49\u201354 years, all\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001). Only minor differences existed in mental or physical health, anxiety and depression between\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      testing and biopsy assessments.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The ProtecT trial baseline\n                      <jats:styled-content style=\"fixed-case\">PROM<\/jats:styled-content>\n                      s response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.13582","type":"journal-article","created":{"date-parts":[[2016,7,14]],"date-time":"2016-07-14T11:25:52Z","timestamp":1468495552000},"page":"869-879","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":56,"title":["Patient\u2010reported 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"],"prefix":"10.1111","volume":"118","author":[{"given":"Athene","family":"Lane","sequence":"first","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"},{"name":"Bristol Randomised Trials Collaboration University of Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Metcalfe","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"},{"name":"Bristol Randomised Trials Collaboration University of Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grace J.","family":"Young","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"},{"name":"Bristol Randomised Trials Collaboration University of Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tim J.","family":"Peters","sequence":"additional","affiliation":[{"name":"School of Clinical Sciences University of Bristol Bristol UK"},{"name":"Collaboration for Leadership in Applied Health Research and Care West United Hospitals Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Blazeby","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerry N. L.","family":"Avery","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Dedman","sequence":"additional","affiliation":[{"name":"Clinical Practice Research Datalink Group Medicines and Healthcare Products Regulatory Agency London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liz","family":"Down","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malcolm D.","family":"Mason","sequence":"additional","affiliation":[{"name":"School of Medicine Cardiff University Cardiff UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Neal","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgery University of Oxford Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Freddie C.","family":"Hamdy","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgery University of Oxford Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenny L.","family":"Donovan","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine University of Bristol Bristol UK"},{"name":"Collaboration for Leadership in Applied Health Research and Care West United Hospitals Bristol Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the ProtecT Study group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,8,17]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0810084"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0810696"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-155-11-201112060-00375"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa012794"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1113162"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.879"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dju132"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2014.08.075"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)00280-6"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70162-0"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70361-4"},{"key":"e_1_2_8_13_1","unstructured":"DonovanJ HamdyF NealDet al.Prostate Testing for Cancer and Treatment (ProtecT) feasibility study.2003. 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