{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T17:38:03Z","timestamp":1780335483586,"version":"3.54.1"},"reference-count":37,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2022,9,20]],"date-time":"2022-09-20T00:00:00Z","timestamp":1663632000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Perit Dial Int"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Gastrointestinal (GI) health is considered vital to the success of peritoneal dialysis (PD) and is critically important to patients, caregivers and clinicians. However, the multiplicity of GI outcome measures in trials undermines the ability to evaluate the frequency, impact and treatment of GI symptoms in patients receiving PD. Therefore, this study aimed to assess the range and consistency of GI outcomes reported in contemporary PD trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study design:<\/jats:title>\n                    <jats:p>Systematic review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting and population:<\/jats:title>\n                    <jats:p>Individuals with kidney failure requiring PD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Selection criteria:<\/jats:title>\n                    <jats:p>All randomised controlled trials involving patients on PD, identified from the PUBMED, EMBASE and COCHRANE Central Registry of controlled Trials (CENTRAL) database, from January 2010 to July 2022.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions:<\/jats:title>\n                    <jats:p>Any PD-related intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes:<\/jats:title>\n                    <jats:p>The frequency and characteristics of GI outcome measures were analysed and classified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Of the 324 eligible PD trials, GI outcomes were only reported in 61 (19%) trials, mostly as patient-reported outcomes (45 trials; 74%). The most frequently reported outcomes were\n                      <jats:italic>nausea<\/jats:italic>\n                      in 27 (43%),\n                      <jats:italic>diarrhoea<\/jats:italic>\n                      in 26 (43%),\n                      <jats:italic>vomiting<\/jats:italic>\n                      in 22 (36%),\n                      <jats:italic>constipation<\/jats:italic>\n                      in 21 (34%) and\n                      <jats:italic>abdominal pain<\/jats:italic>\n                      in 19 (31%) of trials.\n                      <jats:italic>PD peritonitis<\/jats:italic>\n                      was the primary non-GI outcome reported in 24 (40%) trials, followed by\n                      <jats:italic>death<\/jats:italic>\n                      in 13 (21%) trials) and exit-site infection in 9 (15%) trials). Across all trials, 172 GI outcome measures were extracted and grouped into 29 different outcomes. Nausea and diarrhoea contributed to 16% and 15% of GI outcomes, respectively, while vomiting, constipation and abdominal pain contributed to 13%, 12% and 12%, respectively. Most (90%) GI outcomes were patient-reported adverse effects with no defined metrics.\n                      <jats:italic>Faecal microbiome<\/jats:italic>\n                      was reported as the primary study outcome in 3 (100%) trials using the subjective global assessment score, GI symptom rating scale and faecal microbiological and biochemical analysis. Two trials reported nausea as a primary study outcome using\n                      <jats:italic>symptom assessment score (SAS) and kidney disease quality of life-short-form-36.<\/jats:italic>\n                      One trial each reported\n                      <jats:italic>anorexia and abdominal pain<\/jats:italic>\n                      as the primary study outcome using\n                      <jats:italic>SAS<\/jats:italic>\n                      .\n                      <jats:italic>Bowel habits, constipation and stool type<\/jats:italic>\n                      were also reported as the primary study outcome in one trial each using the\n                      <jats:italic>Bristol stool form scale. GI bleeding<\/jats:italic>\n                      was reported as the secondary outcome in three (37%) out of eight trials reporting it.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Limitations:<\/jats:title>\n                    <jats:p>Restricted sampling frame to focus on contemporary trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Despite the clinical importance of GI outcomes among patients on PD, they are reported in only 19% of PD trials, using inconsistent metrics, often as patient-reported adverse events. Efforts to standardise GI outcome reporting are critical to optimising comparability, reliability and value of trial evidence to improve outcomes for patients receiving PD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/08968608221126849","type":"journal-article","created":{"date-parts":[[2022,9,21]],"date-time":"2022-09-21T00:52:06Z","timestamp":1663721526000},"page":"315-323","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Range and consistency of gastrointestinal outcomes reported in peritoneal dialysis trials: A systematic review"],"prefix":"10.1177","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3543-4047","authenticated-orcid":false,"given":"Ashik","family":"Hayat","sequence":"first","affiliation":[{"name":"Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia"},{"name":"Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia"},{"name":"Translational Research Institute, Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5163-4351","authenticated-orcid":false,"given":"Rachael C","family":"Walker","sequence":"additional","affiliation":[{"name":"Eastern Institute of Technology, Napier, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea K","family":"Viecelli","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia"},{"name":"Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia"},{"name":"Translational Research Institute, Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karine E","family":"Manera","sequence":"additional","affiliation":[{"name":"Sydney School of Public Health, The University of Sydney, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Jaure","sequence":"additional","affiliation":[{"name":"Sydney School of Public Health, The University of Sydney, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rathika","family":"Krishnasamy","sequence":"additional","affiliation":[{"name":"Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia"},{"name":"Sunshine Coast University Hospital, Queensland, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine M","family":"Pascoe","sequence":"additional","affiliation":[{"name":"Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3502-9837","authenticated-orcid":false,"given":"Yeoungjee","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia"},{"name":"Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia"},{"name":"Translational Research Institute, Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5491-3460","authenticated-orcid":false,"given":"David W","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia"},{"name":"Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia"},{"name":"Translational Research Institute, Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,9,20]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2007.01321.x"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/jorc.12265"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.ackd.2006.10.001"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/jorc.12152"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-139X.2005.18215.x"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1159\/000494145"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.2002.33407"},{"issue":"4","key":"e_1_3_3_9_2","first-page":"471","article-title":"Gut microbiome in chronic kidney disease","volume":"101","author":"Wing MR","year":"2016","unstructured":"Wing MR, Patel SS, Ramezani A, et al. 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