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The primary clinical outcome measure was progression free survival (PFS). Secondary outcomes included overall survival (OS), time to worsening of symptoms, objective tumour response rate, adverse events and changes in lung cancer symptom scale. Data for two populations were presented: patients with non-squamous NSCLC histology and patients with adenocarcinoma histology. The clinical evidence was derived from a double-blind, placebo-controlled randomised controlled trial (RCT), the JMEN trial. The trial compared the use of pemetrexed + best supportive care (BSC ) as maintenance therapy, with placebo + BSC in patients with NSCLC (\u003Cjats:italic>n\u003C\u002Fjats:italic> = 663) who had received four cycles of platinum-based chemotherapy (CTX) and whose disease had not progressed. In the licensed population (patients with non-squamous histology), the trial demonstrated greater median PFS for patients treated with pemetrexed than for patients in the placebo arm [4.5 vs 2.6 months; hazard ratio (HR) 0.44; 95% confidence interval (CI) 0.36 to 0.55, \u003Cjats:italic>p\u003C\u002Fjats:italic> < 0.00001]. Median OS was also greater for the pemetrexed- treated patients (15.5 vs 10.3 months; HR 0.70; 95% CI 0.56 to 0.88, \u003Cjats:italic>p\u003C\u002Fjats:italic> = 0.002). In addition, tumour response and disease control rates were statistically significantly greater for patients who received pemetrexed. Patient survival rates at 1 year and 2 years were higher in the pemetrexed arm. The incremental cost-effectiveness ratios (ICERs) estimated by the manufacturer’s model were £33,732 per quality adjusted life-year (QALY) for the licensed nonsquamous population, and £39,364 per QALY for the adenocarcinoma subgroup. 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The BMJ Economic Evaluation Working, BMJ, 313, 275, 10.1136\u002Fbmj.313.7052.275",{"doi":485},"10.1136\u002Fbmj.313.7052.275",{"id":24,"text":487,"url":24,"identifiers":488},"Ciuleanu, 2009, Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study, Lancet, 374, 1432, 10.1016\u002FS0140-6736(09)61497-5",{"doi":489},"10.1016\u002FS0140-6736(09)61497-5",{"id":24,"text":491,"url":24,"identifiers":492},"Ou, 2009, Asian ethnicity is a favorable prognostic factor for overall survival in non-small cell lung cancer (NSCLC) and is independent of smoking status, J Thorac Oncol, 4, 1083, 10.1097\u002FJTO.0b013e3181b27b15",{"doi":493},"10.1097\u002FJTO.0b013e3181b27b15",false,{"id":496,"createTime":497,"updateTime":498,"relativeEntities":499,"slug":500,"properties":501,"entityType":115,"verifyStatus":116,"verifyTime":497,"verifyNote":117,"languages":518,"translateLanguages":24,"viewCount":25,"primaryUrl":519,"fullTextUrl":24,"authors":520,"publicationType":407,"publisherRelationship":835,"citationCount":25,"citationInfo":885,"publishDate":24,"publishYear":24,"citationAnalyzeStatus":23,"lastCitationAnalyze":887,"indexDatabases":888,"openAccess":24,"references":889,"isForceReanalyzing":494},"71741278-2632-4a3d-8065-e01e9a5a7fa7","2024-10-09T21:21:40.862+00:00","2026-07-10T09:39:32.026+00:00",[],"Preoperative-intravenous-iron-for-anaemia-in-elective-major-open-abdominal-surgery-the-PREVENTT-RCT",{"mag":502,"gsPaper":504,"pmc":506,"openalex":508,"abstract":510,"title":512,"pm":514,"doi":516},{"VOID":503},"3130491448",{"VOID":505},"[\"12393042007096797916\"]",{"VOID":507},"7957457",{"VOID":509},"W3130491448",{"EN":511},"\u003Cjats:sec id=\"abs1-1\">\n                  \u003Cjats:title>Background\u003C\u002Fjats:title>\n                  \u003Cjats:p>Anaemia affects 30–50% of patients before they undergo major surgery. Preoperative anaemia is associated with increased need for blood transfusion, postoperative complications and worse patient outcomes after surgery. International guidelines support the use of intravenous iron to correct anaemia in patients before surgery. However, the use of preoperative intravenous iron for patient benefit has not been assessed in the setting of a formal clinical trial.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-2\">\n                  \u003Cjats:title>Objectives\u003C\u002Fjats:title>\n                  \u003Cjats:p>To assess if intravenous iron given to patients with anaemia before major abdominal surgery is beneficial by reducing transfusion rates, postoperative complications, hospital stay and re-admission to hospital, and improving quality of life outcomes.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-3\">\n                  \u003Cjats:title>Design\u003C\u002Fjats:title>\n                  \u003Cjats:p>A multicentre, double-blinded, randomised, controlled, Phase III clinical trial, with 1 : 1 randomisation comparing placebo (normal saline) with intravenous iron (intravenous ferric carboxymaltose 1000 mg). Randomisation and treatment allocation were by a secure web-based service.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-4\">\n                  \u003Cjats:title>Setting\u003C\u002Fjats:title>\n                  \u003Cjats:p>The study was conducted across 46 hospitals in England, Scotland and Wales between September 2013 and September 2018.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-5\">\n                  \u003Cjats:title>Participants\u003C\u002Fjats:title>\n                  \u003Cjats:p>Patients aged > 18 years, undergoing elective major open abdominal surgery, with anaemia [Hb level of > 90 g\u002Fl and < 120 g\u002Fl (female patients) and < 130 g\u002Fl (male patients)] who could undergo randomisation and treatment 10–42 days before their operation.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-6\">\n                  \u003Cjats:title>Intervention\u003C\u002Fjats:title>\n                  \u003Cjats:p>Double-blinded study comparing placebo of normal saline with 1000 mg of ferric carboxymaltose administered 10–42 days prior to surgery.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-7\">\n                  \u003Cjats:title>Main outcome measures\u003C\u002Fjats:title>\n                  \u003Cjats:p>Co-primary end points were risk of blood transfusion or death at 30 days postoperatively, and rate of blood transfusions at 30 days post operation.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-8\">\n                  \u003Cjats:title>Results\u003C\u002Fjats:title>\n                  \u003Cjats:p>A total of 487 patients were randomised (243 given placebo and 244 given intravenous iron), of whom 474 completed the trial and provided data for the analysis of the co-primary end points. The use of intravenous iron increased preoperative Hb levels (mean difference 4.7 g\u002Fl, 95% confidence interval 2.7 to 6.8 g\u002Fl; \u003Cjats:italic>p\u003C\u002Fjats:italic> < 0.0001), but had no effect compared with placebo on risk of blood transfusion or death (risk ratio 1.03, 95% confidence interval 0.78 to 1.37; \u003Cjats:italic>p\u003C\u002Fjats:italic> = 0.84; absolute risk difference +0.8%, 95% confidence interval –7.3% to 9.0%), or rates of blood transfusion (rate ratio 0.98, 95% confidence interval 0.68 to 1.43; \u003Cjats:italic>p\u003C\u002Fjats:italic> = 0.93; absolute rate difference 0.00, 95% confidence interval –0.14 to 0.15). There was no difference in postoperative complications or hospital stay. The intravenous iron group had higher Hb levels at the 8-week follow-up (difference in mean 10.7 g\u002Fl, 95% confidence interval 7.8 to 13.7 g\u002Fl; \u003Cjats:italic>p\u003C\u002Fjats:italic> < 0.0001). There were a total of 71 re-admissions to hospital for postoperative complications in the placebo group, compared with 38 re-admissions in the intravenous iron group (rate ratio 0.54, 95% confidence interval 0.34 to 0.85; \u003Cjats:italic>p\u003C\u002Fjats:italic> = 0.009). There were no differences between the groups in terms of mortality (two per group at 30 days post operation) or in any of the prespecified safety end points or serious adverse events.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-9\">\n                  \u003Cjats:title>Conclusions\u003C\u002Fjats:title>\n                  \u003Cjats:p>In patients with anaemia prior to elective major abdominal surgery, there was no benefit from giving intravenous iron before the operation.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-10\">\n                  \u003Cjats:title>Future work\u003C\u002Fjats:title>\n                  \u003Cjats:p>The impact of iron repletion on recovery from postoperative anaemia, and the association with reduced re-admission to hospital for complications, should be investigated.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-11\">\n                  \u003Cjats:title>Limitations\u003C\u002Fjats:title>\n                  \u003Cjats:p>In the preoperative intravenous iron to treat anaemia in major surgery (PREVENTT) trial, all patients included had anaemia and only 20% had their anaemia corrected before surgery. The definition and causality of iron deficiency in this setting is not clear.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-12\">\n                  \u003Cjats:title>Trial registration\u003C\u002Fjats:title>\n                  \u003Cjats:p>Current Controlled Trials ISRCTN67322816 and ClinicalTrials.gov NCT01692418.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>\n               \u003Cjats:sec id=\"abs1-13\">\n                  \u003Cjats:title>Funding\u003C\u002Fjats:title>\n                  \u003Cjats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in \u003Cjats:italic>Health Technology Assessment\u003C\u002Fjats:italic>; Vol. 25 No. 11. See the NIHR Journals Library website for further project information.\u003C\u002Fjats:p>\n               \u003C\u002Fjats:sec>",{"EN":513},"Preoperative intravenous iron for anaemia in elective major open abdominal surgery: the PREVENTT 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Women who did not plan to breastfeed, who had a clinical reason that precluded breastfeeding continuation or who were unable to consent were excluded.\u003C\u002Fjats:p>\u003C\u002Fjats:sec>\u003Cjats:sec id=\"abs1-6\">\u003Cjats:title>Intervention\u003C\u002Fjats:title>\u003Cjats:p>The intervention Mam-Kind was informed by a survey of infant feeding co-ordinators, rapid literature review, focus groups with service users and peer supporters and interviews with health-care professionals and a Stakeholder Advisory Group. It consisted of face-to-face contact at 48 hours after birth and proactive one-to-one peer support from the Mam-Kind buddy for 2 weeks, followed by mother-led contact for a further 2–6 weeks.\u003C\u002Fjats:p>\u003C\u002Fjats:sec>\u003Cjats:sec id=\"abs1-7\">\u003Cjats:title>Main outcome measures\u003C\u002Fjats:title>\u003Cjats:p>Recruitment and retention of Mam-Kind buddies, uptake of Mam-Kind by participants, feasibility of delivering Mam-Kind as specified and of data collection methods, and acceptability of Mam-Kind to mothers, buddies and health-care professionals.\u003C\u002Fjats:p>\u003C\u002Fjats:sec>\u003Cjats:sec id=\"abs1-8\">\u003Cjats:title>Results\u003C\u002Fjats:title>\u003Cjats:p>Nine buddies were recruited to deliver Mam-Kind to 70 participants (61% of eligible women who expressed an interest in taking part in the study). Participants were aged between 19 and 41 years and 94% of participants were white. Intervention uptake was 75% and did not vary according to age or parity. Most contacts (79%) were initiated by the buddy, demonstrating the intended proactive nature of the intervention and 73% (\u003Cjats:italic>n\u003C\u002Fjats:italic> = 51) of participants received a contact within 48 hours. Follow-up data were available for 78% of participants at 10 days and 64% at 8 weeks. Data collection methods were judged feasible and acceptable. Data completeness was > 80% for almost all variables. Interviews with participants, buddies and health service professionals showed that the intervention was acceptable. Buddies delivered the intervention content with fidelity (93% of intervention objectives were met), and, in some cases, developed certain MI skills to a competency level. However, they reported difficulties in changing from an information-giving role to a collaborative approach. These findings were used to refine the training and intervention specification to emphasise the focus of the intervention on providing mother-centric support. Health-care professionals were satisfied that the intervention could be integrated with existing services.\u003C\u002Fjats:p>\u003C\u002Fjats:sec>\u003Cjats:sec id=\"abs1-9\">\u003Cjats:title>Conclusions\u003C\u002Fjats:title>\u003Cjats:p>The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial. The feasibility study highlighted the need to strengthen strategies for birth notification and retention of participants, and provided some insights on how this could be achieved in a full trial.\u003C\u002Fjats:p>\u003C\u002Fjats:sec>\u003Cjats:sec id=\"abs1-10\">\u003Cjats:title>Limitations\u003C\u002Fjats:title>\u003Cjats:p>The response rate to the survey of infant feeding co-ordinators was low (19.5%). 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