{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T05:26:47Z","timestamp":1790746007046,"version":"4.1.0"},"reference-count":41,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2022,6,15]],"date-time":"2022-06-15T00:00:00Z","timestamp":1655251200000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100018063","name":"Bowel Research UK","doi-asserted-by":"publisher","award":["374"],"award-info":[{"award-number":["374"]}],"id":[{"id":"10.13039\/100018063","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,5,13]]},"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Approximately 5%\u201310% of new rectal cancers are locally advanced (locally advanced rectal cancer (LARC)) at presentation with 4%\u20138% recurring (locally recurrent rectal cancer (LRRC)) after initial treatment. Patients with potentially curable disease have to consider many trade-offs when considering major exenterative surgery. There are no decision tools for these patients and current resources have found to not meet minimum international standards. The overall aim of this study is to produce a validated patient decision aid (PtDA) to assist patients considering radical pelvic exenteration for LARC and LRRC created in line with international minimum standards.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This study is a national, multicentre mixed methods project and has been designed in keeping with guidance from the International Patient Decision Aids Standard.<\/jats:p>\n                  <jats:p>This study is in four stages. In stage 1, we will develop the PtDA and its content using agile developmental methodology. In stage 2, we will assess the content and face validity of the PtDA using mixed-methods with key stakeholders. In stage 3, we will assess the feasibility and efficacy of the PtDA. In stage 4, we will establish the barriers and facilitators to the use of a PtDA in the outpatient setting. Questionnaires including the QQ-10, EORTC PATSAT-C33, Preparation for Decision-Making Scale and the NoMAD survey will be analysed during the study. Interviews will be analysed using thematic analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Research ethics approval from North of Scotland Research Ethics Service 19\/NS\/0056 (IRAS 257890) has been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through bowel research UK charity. External endorsement will be sought from the International Patient Decision Standards Collaboration inventory of PtDAs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>PROSPERO registration number<\/jats:title>\n                  <jats:p>CRD42019122933.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-056984","type":"journal-article","created":{"date-parts":[[2022,6,15]],"date-time":"2022-06-15T13:05:36Z","timestamp":1655298336000},"page":"e056984","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Designing and evaluating a patient decision aid for patients with locally advanced or locally recurrent rectal cancer: a national multicentre mixed methods study protocol"],"prefix":"10.1136","volume":"12","author":[{"given":"Anwen","family":"Williams","sequence":"first","affiliation":[{"name":"Department of Colorectal Surgery, Swansea University Health Board, Swansea, UK"},{"name":"The School of Medicine, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4155-1741","authenticated-orcid":false,"given":"Hayley Anne","family":"Hutchings","sequence":"additional","affiliation":[{"name":"The School of Medicine, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2673-8946","authenticated-orcid":false,"given":"Dean Anthony","family":"Harris","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Swansea University Health Board, Swansea, UK"},{"name":"The School of Medicine, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martyn","family":"Evans","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Swansea University Health Board, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deena","family":"Harji","sequence":"additional","affiliation":[{"name":"Manchester University NHS Foundation Trust, Manchester, Greater Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,6,15]]},"reference":[{"key":"2025101811585877000_12.6.e056984.1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"2025101811585877000_12.6.e056984.2","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1002\/bjs.9192","article-title":"Consensus statement on the multidisciplinary management of patients with recurrent and primary rectal cancer beyond total mesorectal excision planes","volume":"100","year":"2013","journal-title":"Br J Surg"},{"key":"2025101811585877000_12.6.e056984.3","doi-asserted-by":"crossref","first-page":"1996","DOI":"10.1002\/cncr.29993","article-title":"Changes in treatment patterns for patients with locally advanced rectal cancer in the United States over the past decade: an analysis from the National cancer data base","volume":"122","author":"Sineshaw","year":"2016","journal-title":"Cancer"},{"key":"2025101811585877000_12.6.e056984.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60484-0"},{"key":"2025101811585877000_12.6.e056984.5","doi-asserted-by":"crossref","first-page":"2631","DOI":"10.1200\/JCO.2016.72.1464","article-title":"Impact of recurrence and salvage surgery on survival after multidisciplinary treatment of rectal cancer","volume":"35","author":"Ikoma","year":"2017","journal-title":"J Clin Oncol"},{"key":"2025101811585877000_12.6.e056984.6","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1002\/jso.20104","article-title":"Survival of patients with untreated rectal cancer","volume":"87","author":"Solum","year":"2004","journal-title":"J Surg Oncol"},{"key":"2025101811585877000_12.6.e056984.7","doi-asserted-by":"publisher","DOI":"10.1097\/DCR.0b013e31827a7868"},{"key":"2025101811585877000_12.6.e056984.8","doi-asserted-by":"crossref","first-page":"835","DOI":"10.1007\/s10151-018-1883-1","article-title":"Systematic review of outcomes following pelvic exenteration for the treatment of primary and recurrent locally advanced rectal cancer","volume":"22","author":"Platt","year":"2018","journal-title":"Tech Coloproctol"},{"key":"2025101811585877000_12.6.e056984.9","article-title":"Decision AIDS for people facing health treatment or screening decisions","author":"Stacey","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"2025101811585877000_12.6.e056984.10","doi-asserted-by":"publisher","DOI":"10.1093\/fampra\/17.6.455"},{"key":"2025101811585877000_12.6.e056984.11","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6947-13-S2-S2","article-title":"A systematic development process for patient decision AIDS","volume":"13","author":"Coulter","year":"2013","journal-title":"BMC Med Inform Decis Mak"},{"key":"2025101811585877000_12.6.e056984.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1109283"},{"key":"2025101811585877000_12.6.e056984.13","article-title":"Ten years of the International patient decision aid standards collaboration: evolution of the core dimensions for assessing the quality of patient decision AIDS","volume":"13 Suppl 2","author":"Volk","year":"2013","journal-title":"BMC Med Inform Decis Mak"},{"key":"2025101811585877000_12.6.e056984.14","doi-asserted-by":"publisher","DOI":"10.1177\/0272989X13501721"},{"key":"2025101811585877000_12.6.e056984.15","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.16.0101"},{"key":"2025101811585877000_12.6.e056984.16","first-page":"CD001431","article-title":"Decision AIDS for people facing health treatment or screening decisions","volume":"2","author":"O'Connor","year":"2003","journal-title":"Cochrane Database Syst Rev"},{"key":"2025101811585877000_12.6.e056984.17","unstructured":"Alphabetical list of decision AIDS by health topic. Available: https:\/\/decisionaid.ohri.ca\/azlist.html [Accessed 17 Oct 2020]."},{"key":"2025101811585877000_12.6.e056984.18","doi-asserted-by":"crossref","DOI":"10.1016\/j.surge.2021.12.008","article-title":"Quality of Internet information to aid patient decision making in locally advanced and recurrent rectal cancer","author":"Williams","year":"2022","journal-title":"Surgeon"},{"key":"2025101811585877000_12.6.e056984.19","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j2224"},{"key":"2025101811585877000_12.6.e056984.20","doi-asserted-by":"publisher","DOI":"10.1046\/j.1369-6513.2000.00093.x"},{"key":"2025101811585877000_12.6.e056984.21","doi-asserted-by":"publisher","DOI":"10.1111\/j.1369-7625.2006.00404.x"},{"key":"2025101811585877000_12.6.e056984.22","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2005.04.010"},{"key":"2025101811585877000_12.6.e056984.23","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6947-13-S2-S14","article-title":"\"Many miles to go \u2026\": a systematic review of the implementation of patient decision support interventions into routine clinical practice","volume":"13 Suppl 2","author":"Elwyn","year":"2013","journal-title":"BMC Med Inform Decis Mak"},{"key":"2025101811585877000_12.6.e056984.24","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-012-2077-6"},{"key":"2025101811585877000_12.6.e056984.25","doi-asserted-by":"crossref","first-page":"938","DOI":"10.1177\/0272989X21997330","article-title":"Guidance and\/or decision coaching with patient decision AIDS: Scoping reviews to inform the International patient decision aid standards (IPDAS)","volume":"41","author":"Rahn","year":"2021","journal-title":"Med Decis Making"},{"key":"2025101811585877000_12.6.e056984.26","doi-asserted-by":"crossref","first-page":"IMI.S11570","DOI":"10.4137\/IMI.S11570","article-title":"Challenges of systematic reviewing integrative health care","volume":"8","author":"Coulter","year":"2013","journal-title":"Integr Med Insights"},{"key":"2025101811585877000_12.6.e056984.27","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.38926.629329.AE"},{"key":"2025101811585877000_12.6.e056984.28","doi-asserted-by":"publisher","DOI":"10.1016\/S0738-3991(98)00026-3"},{"key":"2025101811585877000_12.6.e056984.29","doi-asserted-by":"publisher","DOI":"10.1111\/j.1552-6909.2002.tb00083.x"},{"key":"2025101811585877000_12.6.e056984.30","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.jncimonographs.a024212"},{"key":"2025101811585877000_12.6.e056984.31","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6947-13-S2-S7","article-title":"Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers","volume":"13 Suppl 2","author":"Trevena","year":"2013","journal-title":"BMC Med Inform Decis Mak"},{"key":"2025101811585877000_12.6.e056984.32","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2005.05.004"},{"key":"2025101811585877000_12.6.e056984.33","doi-asserted-by":"crossref","first-page":"897","DOI":"10.1177\/0272989X211011100","article-title":"Do personal stories make patient decision AIDS more effective? an update from the International patient decision AIDS standards","volume":"41","author":"Shaffer","year":"2021","journal-title":"Med Decis Making"},{"key":"2025101811585877000_12.6.e056984.34","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6947-13-S2-S9","article-title":"Do personal stories make patient decision AIDS more effective? A critical review of theory and evidence","volume":"13 Suppl 2","author":"Bekker","year":"2013","journal-title":"BMC Med Inform Decis Mak"},{"key":"2025101811585877000_12.6.e056984.35","doi-asserted-by":"crossref","first-page":"i","DOI":"10.3310\/hta2140","article-title":"Evaluating patient-based outcome measures for use in clinical trials","volume":"2","author":"Fitzpatrick","year":"1998","journal-title":"Health Technol Assess"},{"key":"2025101811585877000_12.6.e056984.36","doi-asserted-by":"crossref","first-page":"1893","DOI":"10.1007\/s11136-018-1847-y","article-title":"The importance of content and face validity in instrument development: lessons learnt from service users when developing the recovering quality of life measure (ReQoL)","volume":"27","author":"Connell","year":"2018","journal-title":"Qual Life Res"},{"key":"2025101811585877000_12.6.e056984.37","doi-asserted-by":"publisher","DOI":"10.1093\/intqhc\/mzs051"},{"key":"2025101811585877000_12.6.e056984.38","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"2025101811585877000_12.6.e056984.39","unstructured":"Bodemer N , Gaissmaier W . Risk Communication in Health. In: Roeser S , Hillerbrand R , Sandin P , et al , eds. Handbook of risk theory: Epistemology, decision theory, ethics, and social implications of risk. Dordrecht: Springer Netherlands, 2012: 621\u201360."},{"key":"2025101811585877000_12.6.e056984.40","unstructured":"Satisfaction with cancer care \u2013 core questionnaire. Available: https:\/\/qol.eortc.org\/questionnaire\/qlq-patsat-c33\/ [Accessed 23 Mar 2021]."},{"key":"2025101811585877000_12.6.e056984.41","unstructured":"Nomad study. Available: http:\/\/www.normalizationprocess.org\/nomad-study\/ [Accessed 23 Mar 2021]."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-056984","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T18:59:07Z","timestamp":1760813947000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-056984"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6]]},"references-count":41,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2022,6,15]]},"published-print":{"date-parts":[[2022,6]]}},"alternative-id":["10.1136\/bmjopen-2021-056984"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-056984","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6]]}}}