{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T22:58:43Z","timestamp":1785365923106,"version":"3.55.0"},"reference-count":124,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2020,6,28]],"date-time":"2020-06-28T00:00:00Z","timestamp":1593302400000},"content-version":"unspecified","delay-in-days":27,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,3,6]]},"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Diabetic foot ulcer represents a major health problem globally. Preliminary studies have indicated that systemic treatment of diabetic foot ulcer patients with hyperbaric oxygen therapy have beneficial effects on wound healing, risk of amputation, glycaemic control, atherosclerosis, inflammatory markers and other clinical and laboratory parameters. This protocol for a systematic review aims at identifying the beneficial and harmful effects of adding hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>This protocol was performed following the recommendations of the Cochrane Collaboration and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials assessing the effects of hyperbaric oxygen therapy in the treatment of diabetic foot ulcer versus any control group with any intervention defined as standard wound care or similar, together with sham interventions. Our primary outcome will be: all-cause mortality, serious adverse events and quality of life. Our secondary outcomes will be: healing of index wound, major amputation and wound infection. Any eligible trial will be assessed and classified as either high risk of bias or low risk of bias, and our conclusions will be based on trials with low risk of bias. The analyses of the extracted data will be performed using Review Manager 5 and Trial Sequential Analysis. For both our primary and secondary outcomes, we will create a \u2018Summary of Findings\u2019 table and use GRADE (Grading of Recommendations Assessment, Development and Evaluation) assessment to assess the quality of the evidence.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>We use publicly accessible documents as evidence, there is no participant involvement at an individual level and an institutional ethics approval is not required. The results of the review will be sought published in a peer-reviewed journals, also in the event of insignificant results or null results, and thereby it will be disseminated to clinicians and public available.<\/jats:p><\/jats:sec><jats:sec><jats:title>PROSPERO registration number<\/jats:title><jats:p>CRD42019139256.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2019-031708","type":"journal-article","created":{"date-parts":[[2020,6,30]],"date-time":"2020-06-30T06:19:43Z","timestamp":1593497983000},"page":"e031708","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Effects of adding adjunctive hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers: a protocol for a systematic review with meta-analysis and trial sequential analysis"],"prefix":"10.1136","volume":"10","author":[{"given":"Julie","family":"Vinkel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2289-272X","authenticated-orcid":false,"given":"Niels Frederich Rose","family":"Holm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janus C","family":"Jakobsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ole","family":"Hyldegaard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2020,6,29]]},"reference":[{"key":"2024052015073820000_10.6.e031708.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67698-2"},{"key":"2024052015073820000_10.6.e031708.2","unstructured":"World Health Organization . Global report on diabetes. World Health organization., 2016. Available: http:\/\/www.who.int\/iris\/handle\/10665\/204871 [Accessed 10 Apr 2019]."},{"key":"2024052015073820000_10.6.e031708.3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.293.2.217"},{"key":"2024052015073820000_10.6.e031708.4","doi-asserted-by":"crossref","first-page":"1545","DOI":"10.1016\/S0140-6736(03)13169-8","article-title":"Diabetic foot ulcers","volume":"361","author":"Jeffcoate","year":"2003","journal-title":"The Lancet"},{"key":"2024052015073820000_10.6.e031708.5","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-012-0004-9"},{"key":"2024052015073820000_10.6.e031708.6","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1002\/dmrr.2698","article-title":"IWGDF guidance on the diagnosis, prognosis and management of peripheral artery disease in patients with foot ulcers in diabetes","volume":"32 Suppl 1","author":"Hinchliffe","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.7","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.848"},{"key":"2024052015073820000_10.6.e031708.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2005.04.009"},{"key":"2024052015073820000_10.6.e031708.9","doi-asserted-by":"publisher","DOI":"10.1097\/01.ajp.0000210910.49923.09"},{"key":"2024052015073820000_10.6.e031708.10","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8227(99)00112-6"},{"key":"2024052015073820000_10.6.e031708.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2012.10.013"},{"key":"2024052015073820000_10.6.e031708.12","doi-asserted-by":"crossref","DOI":"10.1007\/s11908-018-0645-6","article-title":"Diabetic foot infections: update on management","volume":"20","author":"Nikoloudi","year":"2018","journal-title":"Curr Infect Dis Rep"},{"key":"2024052015073820000_10.6.e031708.13","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.2699"},{"key":"2024052015073820000_10.6.e031708.14","unstructured":"Digital NHS . National Diabetes Foot Care Audit, Hospital Admissions Report 2014-2016. V1.0. England and Wales, 2017. https:\/\/files.digital.nhs.uk\/publication\/0\/b\/ndfa_2014-2016_-_hospital_admissions_report.pdf"},{"key":"2024052015073820000_10.6.e031708.15","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.21.5.855"},{"key":"2024052015073820000_10.6.e031708.16","first-page":"25","article-title":"Quality of life of diabetes amputees following major and minor lower limb amputations","volume":"74","author":"Nazri","year":"2019","journal-title":"Med J Malaysia"},{"key":"2024052015073820000_10.6.e031708.17","doi-asserted-by":"crossref","first-page":"303","DOI":"10.4088\/PCC.v09n0408","article-title":"Reactions to amputation: recognition and treatment","volume":"9","author":"Bhuvaneswar","year":"2007","journal-title":"Prim Care Companion J Clin Psychiatry"},{"key":"2024052015073820000_10.6.e031708.18","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1016\/j.ando.2017.11.005","article-title":"Cost of diabetic foot in France, Spain, Italy, Germany and United Kingdom: a systematic review","volume":"79","author":"Tchero","year":"2018","journal-title":"Ann Endocrinol"},{"key":"2024052015073820000_10.6.e031708.19","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-008-1089-6"},{"key":"2024052015073820000_10.6.e031708.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2015.11.025"},{"key":"2024052015073820000_10.6.e031708.21","doi-asserted-by":"crossref","DOI":"10.1111\/iwj.12496","article-title":"The 2015 IWGDF guidance on the prevention and management of foot problems in diabetes","volume":"13","author":"Bakker","year":"2016","journal-title":"Int Wound J"},{"key":"2024052015073820000_10.6.e031708.22","doi-asserted-by":"crossref","first-page":"537","DOI":"10.1111\/iwj.12642","article-title":"Comparison of five systems of classification of diabetic foot ulcers and predictive factors for amputation","volume":"14","author":"Jeon","year":"2017","journal-title":"Int Wound J"},{"key":"2024052015073820000_10.6.e031708.23","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1016\/j.fas.2016.10.009","article-title":"Inter-Observer agreement of the wagner, University of Texas and pedis classification systems for the diabetic foot syndrome","volume":"24","author":"Bravo-Molina","year":"2018","journal-title":"Foot Ankle Surg"},{"key":"2024052015073820000_10.6.e031708.24","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1002\/dmrr.2746","article-title":"Classification of diabetic foot ulcers","volume":"32 Suppl 1","author":"Game","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.25","doi-asserted-by":"crossref","first-page":"434","DOI":"10.12968\/jowc.2018.27.7.434","article-title":"Classification, microbiology and treatment of diabetic foot infections","volume":"27","author":"Ghotaslou","year":"2018","journal-title":"J Wound Care"},{"key":"2024052015073820000_10.6.e031708.26","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-1754"},{"key":"2024052015073820000_10.6.e031708.27","doi-asserted-by":"publisher","DOI":"10.1086\/511036"},{"key":"2024052015073820000_10.6.e031708.28","doi-asserted-by":"publisher","DOI":"10.4103\/0973-3930.50707"},{"key":"2024052015073820000_10.6.e031708.29","doi-asserted-by":"crossref","first-page":"S90","DOI":"10.1002\/dmrr.464","article-title":"Diabetic foot ulcer classification system for research purposes: a progress report on criteria for including patients in research studies","volume":"20 Suppl 1","author":"Schaper","year":"2004","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.30","doi-asserted-by":"publisher","DOI":"10.1053\/j.semvascsurg.2012.04.005"},{"key":"2024052015073820000_10.6.e031708.31","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1002\/dmrr.2246","article-title":"A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes","volume":"28 Suppl 1","author":"Game","year":"2012","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.32","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1002\/dmrr.2249","article-title":"A systematic review of the effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral arterial disease","volume":"28 Suppl 1","author":"Hinchliffe","year":"2012","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.33","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-0287"},{"key":"2024052015073820000_10.6.e031708.34","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.8.1354"},{"key":"2024052015073820000_10.6.e031708.35","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1002\/dmrr.2697","article-title":"IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes","volume":"32 Suppl 1","author":"Bus","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.36","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1002\/dmrr.2696","article-title":"IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes","volume":"32 Suppl 1","author":"Bus","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.37","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1002\/dmrr.2700","article-title":"IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes","volume":"32 Suppl 1","author":"Game","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"2024052015073820000_10.6.e031708.38","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1016\/j.diabres.2016.12.007","article-title":"Prevention and management of foot problems in diabetes: a summary guidance for daily practice 2015, based on the IWGDF guidance documents","volume":"124","author":"Schaper","year":"2017","journal-title":"Diabetes Res Clin Pract"},{"key":"2024052015073820000_10.6.e031708.39","doi-asserted-by":"crossref","first-page":"651","DOI":"10.1111\/j.1749-6632.1964.tb56312.x","article-title":"Clinical experience and implications of hyperbaric oxygenation. The historical perspective of hyperbaric therapy","volume":"117","author":"Jacobson","year":"1965","journal-title":"Ann N Y Acad Sci"},{"key":"2024052015073820000_10.6.e031708.40","first-page":"285","article-title":"Hyperbaric oxygenation (hybaroxia): current status, possiblities and limitations","volume":"1","author":"Brown","year":"1965","journal-title":"Adv Surg"},{"key":"2024052015073820000_10.6.e031708.41","unstructured":"Weaver LK . Hyperbaric oxygen therapy indications. Thirteenth edn. North Palm Beach, Florida 33408: Best Publishing Company, 2014."},{"key":"2024052015073820000_10.6.e031708.42","doi-asserted-by":"crossref","first-page":"131S","DOI":"10.1097\/PRS.0b013e3181fbe2bf","article-title":"Hyperbaric oxygen: its mechanisms and efficacy","volume":"127 Suppl 1","author":"Thom","year":"2011","journal-title":"Plast Reconstr Surg"},{"key":"2024052015073820000_10.6.e031708.43","first-page":"949","article-title":"[Life without blood]","volume":"104","author":"Boerema","year":"1960","journal-title":"Ned Tijdschr Geneeskd"},{"key":"2024052015073820000_10.6.e031708.44","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1046\/j.1524-475X.2002.10402.x","article-title":"The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1,144 patients","volume":"10","author":"Fife","year":"2002","journal-title":"Wound Repair Regen"},{"key":"2024052015073820000_10.6.e031708.45","doi-asserted-by":"crossref","unstructured":"Hopf HW , Kelly M , Shapshak D . Oxygen and the Basic Mechanisms of Wound Healing.. In: Physiology and medicine of hyperbaric oxygen therapy. 1st ed. Philadelphia, PA, USA: Saunders Elsevier, 2008: 203\u201328.","DOI":"10.1016\/B978-1-4160-3406-3.50016-0"},{"key":"2024052015073820000_10.6.e031708.46","first-page":"17","article-title":"Wound oxygen levels during hyperbaric oxygen treatment in healing wounds","volume":"33","author":"Rollins","year":"2006","journal-title":"Undersea Hyperb Med"},{"key":"2024052015073820000_10.6.e031708.47","first-page":"253","article-title":"Side effects of hyperbaric oxygen therapy","volume":"41","author":"Camporesi","year":"2014","journal-title":"Undersea Hyperb Med"},{"key":"2024052015073820000_10.6.e031708.48","doi-asserted-by":"crossref","first-page":"2088","DOI":"10.1016\/j.clinthera.2017.08.014","article-title":"Efficacy and safety of hyperbaric oxygen therapy used in patients with diabetic foot: a meta-analysis of randomized clinical trials","volume":"39","author":"Zhao","year":"2017","journal-title":"Clin Ther"},{"key":"2024052015073820000_10.6.e031708.49","first-page":"113","article-title":"The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients","volume":"43","author":"hadanny","year":"2016","journal-title":"Undersea Hyperb Med"},{"key":"2024052015073820000_10.6.e031708.50","doi-asserted-by":"crossref","first-page":"178","DOI":"10.1017\/S0266462308080252","article-title":"Cost-Effectiveness and budget impact of adjunctive hyperbaric oxygen therapy for diabetic foot ulcers","volume":"24","author":"Chuck","year":"2008","journal-title":"Int J Technol Assess Health Care"},{"key":"2024052015073820000_10.6.e031708.51","doi-asserted-by":"crossref","first-page":"731","DOI":"10.1017\/S0266462303000710","article-title":"Cost-Effectiveness of adjunctive hyperbaric oxygen in the treatment of diabetic ulcers","volume":"19","author":"Guo","year":"2003","journal-title":"Int J Technol Assess Health Care"},{"key":"2024052015073820000_10.6.e031708.52","first-page":"205","article-title":"A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers","volume":"42","author":"Huang","year":"2015","journal-title":"Undersea Hyperb Med"},{"key":"2024052015073820000_10.6.e031708.53","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1089\/wound.2016.0718","article-title":"Hyperbaric oxygen therapy: side effects defined and quantified","volume":"6","author":"Heyboer","year":"2017","journal-title":"Adv Wound Care"},{"key":"2024052015073820000_10.6.e031708.54","doi-asserted-by":"crossref","first-page":"1493","DOI":"10.1111\/dme.13054","article-title":"Association of diabetic foot ulcer and death in a population-based cohort from the United Kingdom","volume":"33","author":"Walsh","year":"2016","journal-title":"Diabet. Med."},{"key":"2024052015073820000_10.6.e031708.55","first-page":"275","article-title":"Potential benefits of hyperbaric oxygen therapy on atherosclerosis and glycaemic control in patients with diabetic foot","volume":"61","author":"Karadurmus","year":"2010","journal-title":"Endokrynol Pol"},{"key":"2024052015073820000_10.6.e031708.56","doi-asserted-by":"crossref","unstructured":"Aydin F , Kaya A , Karapinar L , et al . Igf-1 increases with hyperbaric oxygen therapy and promotes wound healing in diabetic foot ulcers. J Diabetes Res 2013;567834.","DOI":"10.1155\/2013\/567834"},{"key":"2024052015073820000_10.6.e031708.57","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw736"},{"key":"2024052015073820000_10.6.e031708.58","first-page":"319","article-title":"Impact of different therapeutic modalities on healing of diabetic foot ulcers","volume":"12","author":"Ashmawy","year":"2015","journal-title":"Eur J Gen Pract"},{"key":"2024052015073820000_10.6.e031708.59","doi-asserted-by":"crossref","first-page":"679","DOI":"10.1111\/dme.12632","article-title":"Heart rate-corrected QT interval prolongation as a prognostic marker for 3-year survival in people with type 2 diabetes undergoing above-ankle amputation","volume":"32","author":"Fagher","year":"2015","journal-title":"Diabet Med"},{"key":"2024052015073820000_10.6.e031708.60","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1016\/j.diabres.2018.01.021","article-title":"Association between QTc interval prolongation and outcomes of diabetic foot ulcers: data from a 4-year follow-up study in China","volume":"138","author":"Wang","year":"2018","journal-title":"Diabetes Res Clin Pract"},{"key":"2024052015073820000_10.6.e031708.61","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1111\/j.1464-5491.2006.01798.x","article-title":"Effect of hyperbaric oxygen on cardiac neural regulation in diabetic individuals with foot complications","volume":"23","author":"Sun","year":"2006","journal-title":"Diabet Med"},{"key":"2024052015073820000_10.6.e031708.62","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.25.11.2010"},{"key":"2024052015073820000_10.6.e031708.63","doi-asserted-by":"publisher","DOI":"10.1007\/s001250100001"},{"key":"2024052015073820000_10.6.e031708.64","doi-asserted-by":"publisher","DOI":"10.1007\/BF00403326"},{"key":"2024052015073820000_10.6.e031708.65","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462313000263"},{"key":"2024052015073820000_10.6.e031708.66","first-page":"1","article-title":"Hyperbaric oxygen therapy for the treatment of diabetic foot ulcers: a health technology assessment","volume":"17","year":"2017","journal-title":"Ont Health Technol Assess Ser"},{"key":"2024052015073820000_10.6.e031708.67","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1016\/j.pmrj.2009.03.012","article-title":"Hyperbaric oxygen therapy for wound healing and limb salvage: a systematic review","volume":"1","author":"Goldman","year":"2009","journal-title":"PM&R"},{"key":"2024052015073820000_10.6.e031708.68","doi-asserted-by":"publisher","DOI":"10.1001\/archsurg.138.3.272"},{"key":"2024052015073820000_10.6.e031708.69","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2012.10.021"},{"key":"2024052015073820000_10.6.e031708.70","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2014.03.005"},{"key":"2024052015073820000_10.6.e031708.71","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.4863"},{"key":"2024052015073820000_10.6.e031708.72","article-title":"Hyperbaric oxygen therapy for chronic wounds","volume":"6","author":"Kranke","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"2024052015073820000_10.6.e031708.73","doi-asserted-by":"crossref","unstructured":"Golledge J , Singh TP . Systematic review and meta\u2010analysis of clinical trials examining the effect of hyperbaric oxygen therapy in people with diabetes\u2010related lower limb ulcers. Diabet. Med. 2019;376.doi:10.1111\/dme.13975","DOI":"10.1111\/dme.13975"},{"key":"2024052015073820000_10.6.e031708.74","doi-asserted-by":"publisher","DOI":"10.1053\/ejvs.2002.1911"},{"key":"2024052015073820000_10.6.e031708.75","doi-asserted-by":"publisher","DOI":"10.1177\/1534734613486154"},{"key":"2024052015073820000_10.6.e031708.76","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1111\/j.1742-481X.2012.01034.x","article-title":"Diabetic foot ulcers treated with hyperbaric oxygen therapy: a review of the literature","volume":"11","author":"Bishop","year":"2014","journal-title":"Int Wound J"},{"key":"2024052015073820000_10.6.e031708.77","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.10.1551"},{"key":"2024052015073820000_10.6.e031708.78","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-0654"},{"key":"2024052015073820000_10.6.e031708.79","unstructured":"Lin TF CS , Niu KC . The vascular effects of hyperbaric oxygen therapy in treatment of early diabetic foot. Undersea Hyperb Med 2001;28"},{"key":"2024052015073820000_10.6.e031708.80","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2011.01.019"},{"key":"2024052015073820000_10.6.e031708.81","doi-asserted-by":"publisher","DOI":"10.4103\/0970-9185.92444"},{"key":"2024052015073820000_10.6.e031708.82","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-120"},{"key":"2024052015073820000_10.6.e031708.83","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.03.013"},{"key":"2024052015073820000_10.6.e031708.84","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-10-90"},{"key":"2024052015073820000_10.6.e031708.85","doi-asserted-by":"crossref","first-page":"264","DOI":"10.7326\/0003-4819-151-4-200908180-00135","article-title":"Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement","volume":"151","author":"Moher","year":"2009","journal-title":"Ann Intern Med"},{"key":"2024052015073820000_10.6.e031708.86","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.g7647","article-title":"Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation","volume":"349","author":"Shamseer","year":"2015","journal-title":"BMJ"},{"key":"2024052015073820000_10.6.e031708.87","doi-asserted-by":"crossref","DOI":"10.1186\/s13643-016-0391-5","article-title":"Pharmacological interventions for delirium in intensive care patients: a protocol for an overview of reviews","volume":"5","author":"Barbateskovic","year":"2016","journal-title":"Syst Rev"},{"key":"2024052015073820000_10.6.e031708.88","doi-asserted-by":"crossref","DOI":"10.1186\/s13643-017-0509-4","article-title":"Stress ulcer prophylaxis versus placebo or no prophylaxis in adult hospitalised acutely ill patients-protocol for a systematic review with meta-analysis and trial sequential analysis","volume":"6","author":"Marker","year":"2017","journal-title":"Syst Rev"},{"key":"2024052015073820000_10.6.e031708.89","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0193924","article-title":"Digoxin for atrial fibrillation and atrial flutter: a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials","volume":"13","author":"Sethi","year":"2018","journal-title":"PLoS One"},{"key":"2024052015073820000_10.6.e031708.90","doi-asserted-by":"crossref","unstructured":"Barbateskovic M , Kraus SR , Collet MO , et al . Haloperidol for delirium in critically ill patients \u2013 protocol for a systematic review. Acta Anaesthesiol Scand 2018.","DOI":"10.1111\/aas.13088"},{"key":"2024052015073820000_10.6.e031708.91","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-032389"},{"key":"2024052015073820000_10.6.e031708.92","doi-asserted-by":"crossref","DOI":"10.1186\/s13643-019-1099-0","article-title":"Short-Term versus long-term psychotherapy for adult psychiatric disorders: a protocol for a systematic review with meta-analysis and trial sequential analysis","volume":"8","author":"Juul","year":"2019","journal-title":"Syst Rev"},{"key":"2024052015073820000_10.6.e031708.93","doi-asserted-by":"crossref","first-page":"549","DOI":"10.1111\/aas.13329","article-title":"Dexmedetomidine for the management of delirium in critically ill patients-A protocol for a systematic review","volume":"63","author":"Maagaard","year":"2019","journal-title":"Acta Anaesthesiol Scand"},{"key":"2024052015073820000_10.6.e031708.94","doi-asserted-by":"crossref","DOI":"10.1186\/s13643-019-1173-7","article-title":"The effects of adding angiotensin receptor neprilysin inhibitors to usual care in patients with heart failure: a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis","volume":"8","author":"Nielsen","year":"2019","journal-title":"Syst Rev"},{"key":"2024052015073820000_10.6.e031708.95","first-page":"231","article-title":"International Conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) adopts consolidated guideline on good clinical practice in the conduct of clinical trials on medicinal products for human use","volume":"48","year":"1997","journal-title":"Int Dig Health Legis"},{"key":"2024052015073820000_10.6.e031708.96","unstructured":"Higgins JPT , Green S . Cochrane Handbook for systematic reviews of interventions. The Cochrane Collaboration, 2011. www.handbook.cochrane.org"},{"key":"2024052015073820000_10.6.e031708.97","unstructured":"The Nordic Cochrane Centre . Cochrane Revman version 5.3, 2014. Available: https:\/\/community.cochrane.org\/help\/tools-and-software\/revman-5"},{"key":"2024052015073820000_10.6.e031708.98","unstructured":"CTU . TSA\u2014trial sequential analysisCopenhagen trial unit. Available: http:\/\/www.ctu.dk\/tsa\/ [Accessed 10 Apr 2019]."},{"key":"2024052015073820000_10.6.e031708.99","unstructured":"Thorlund K , Engstr\u00f8m J , Wetterslev J , et al . User manual for trial sequential analysis (TSA) Copenhagen trial unit, centre for clinical intervention research, Denmark;, 2011. Available: http:\/\/www.ctu.dk\/tsa\/files\/tsa_manual.pdf [Accessed 10 Apr 2019]."},{"key":"2024052015073820000_10.6.e031708.100","unstructured":"StataCorp . Stata release 14. statistical software. College Station, tx: StataCorp Lp, 2014. Available: http:\/\/www.stata.com [Accessed 10 Apr 2019]."},{"key":"2024052015073820000_10.6.e031708.101","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwj069"},{"key":"2024052015073820000_10.6.e031708.102","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-135-11-200112040-00010"},{"key":"2024052015073820000_10.6.e031708.103","first-page":"Mr000033","article-title":"Industry sponsorship and research outcome","volume":"12","author":"Lundh","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"2024052015073820000_10.6.e031708.104","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)01085-X"},{"key":"2024052015073820000_10.6.e031708.105","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1995.03520290060030"},{"key":"2024052015073820000_10.6.e031708.106","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39465.451748.AD"},{"key":"2024052015073820000_10.6.e031708.107","doi-asserted-by":"publisher","DOI":"10.3310\/hta16150"},{"key":"2024052015073820000_10.6.e031708.108","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1186"},{"key":"2024052015073820000_10.6.e031708.109","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.327.7414.557"},{"key":"2024052015073820000_10.6.e031708.110","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2380"},{"key":"2024052015073820000_10.6.e031708.111","doi-asserted-by":"publisher","DOI":"10.2307\/2533446"},{"key":"2024052015073820000_10.6.e031708.112","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/31.1.140"},{"key":"2024052015073820000_10.6.e031708.113","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(86)90046-2"},{"key":"2024052015073820000_10.6.e031708.114","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780060325"},{"key":"2024052015073820000_10.6.e031708.115","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.10.007"},{"key":"2024052015073820000_10.6.e031708.116","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyn188"},{"key":"2024052015073820000_10.6.e031708.117","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyn179"},{"key":"2024052015073820000_10.6.e031708.118","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-9-86"},{"key":"2024052015073820000_10.6.e031708.119","first-page":"57","article-title":"Interpreting meta-analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals","volume":"2","author":"Thorlund","year":"2010","journal-title":"Clin Epidemiol"},{"key":"2024052015073820000_10.6.e031708.120","doi-asserted-by":"crossref","first-page":"1611","DOI":"10.1213\/ANE.0000000000000892","article-title":"Systematic reviews of anesthesiologic interventions reported as statistically significant: problems with power, precision, and type 1 error protection","volume":"121","author":"Imberger","year":"2015","journal-title":"Anesth Analg"},{"key":"2024052015073820000_10.6.e031708.121","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-011890"},{"key":"2024052015073820000_10.6.e031708.122","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39489.470347.AD"},{"key":"2024052015073820000_10.6.e031708.123","first-page":"677","article-title":"Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations","volume":"169","author":"Sch\u00fcnemann","year":"2003","journal-title":"CMAJ"},{"key":"2024052015073820000_10.6.e031708.124","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.09.011"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-031708","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,20]],"date-time":"2024-05-20T22:16:53Z","timestamp":1716243413000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-031708"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6]]},"references-count":124,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2020,6,29]]},"published-print":{"date-parts":[[2020,6]]}},"alternative-id":["10.1136\/bmjopen-2019-031708"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-031708","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6]]}}}