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PubMed2026

Higher versus Routine Intraoperative Blood Pressure Targets in Noncardiac Surgery: A Systematic Review and Meta-analysis with Trial Sequential Analysis of Randomized Trials.

BACKGROUND: Observational studies consistently link intraoperative hypotension to adverse postoperative outcomes, leading guidelines to recommend maintaining mean arterial pressure 60 to 65 mmHg or greater during noncardiac surgery. Whether targeting higher intraoperative blood pressure values improves clinical outcomes remains uncertain. METHODS: The authors conducted a Preferred Reporting Items for Systematic Reviews and Meta-analyses-guided search on PubMed, Cochrane Central Register of Controlled Trials, Scopus, and Embase from inception to April 2026. Randomized trials comparing higher intraoperative blood pressure targets, either as fixed absolute thresholds or personalized to preoperative baseline, versus routine blood pressure management in adults undergoing elective noncardiac surgery with general anesthesia were included. Outcomes included in-hospital or 30-day mortality, postoperative delirium, acute kidney injury (AKI), 30-day major cardiovascular events, acute myocardial injury, stroke, length of stay, and intraoperative hypotension. RESULTS: Fifteen trials (15,603 patients) were included. Higher targets did not reduce AKI (risk ratio [RR], 0.95; 95% CI, 0.85 to 1.06; P = 0.36; I 2 = 16%) or acute myocardial injury (RR, 1.02; 95% CI, 0.94 to 1.12; P = 0.59; I 2 = 0%) compared with routine targets, with firm evidence from trial sequential analysis. Higher targets were associated with a significant reduction in postoperative delirium (RR, 0.73; 95% CI, 0.54 to 0.98; P = 0.04; I 2 = 26%), although trial sequential analysis indicated the cumulative evidence remained insufficient to draw firm conclusions. No significant effect was observed on in-hospital or 30-day mortality (RR, 1.00; 95% CI, 0.75 to 1.34; P = 1.00; I 2 = 0%); evidence on 30-day major cardiovascular events, stroke, and length of stay was similarly insufficient to draw firm conclusions. CONCLUSION: In adults undergoing elective noncardiac surgery, targeting higher intraoperative blood pressure values does not improve major postoperative outcomes compared with routine management. A potential reduction in postoperative delirium warrants confirmation in adequately powered trials.

Humans↗
PubMedDate not supplied

Statistical models appropriate for designs often used in group-randomized trials.

Group-randomized trials are characterised by the allocation of identifiable groups rather than individuals to study conditions; members within those groups are then observed to assess the effect of the intervention. It is convenient to categorize the designs employed in group-randomized trials along two dimensions, each with two levels. The first distinguishes between designs having just one or two time intervals and those having three or more intervals. The second distinguishes between nested cohort and nested cross-sectional designs. Following a brief review of the design and analytic issues common to group-randomized trials, and their general solutions, this paper presents the adaptations of the mixed-model analysis of covariance and random coefficients models that are required for the four combinations that result from this categorization scheme. The assumptions, strengths and weaknesses of each model are discussed.

Cohort Studies↗
PubMedDate not supplied

Prospective randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C for non-resectable pancreatic and biliary carcinoma: multicenter randomized trial.

BACKGROUND/AIMS: The efficacy of combination chemotherapy, which consists of fluorouracil, doxorubicin and mitomycin, was compared with that of palliative surgery-only in patients (control) having non-resectable pancreatic and biliary carcinomas in a multicenter randomized trial. METHODOLOGY: The patients were assigned to combination chemotherapy consisting of concomitant 5-fluorouracil 200 mg/m2, doxorubicin 15 mg/m2, and mitomycin 5 mg/m2 by intravenous administration. This combination chemotherapy was given concurrently as the initial dose within 1 week after palliative operation, and this regimen was repeated for at least 2 whole courses at 4-week intervals before the next course of therapy. Forty-two cases of this combination chemotherapy group and 41 of the control group were completely eligible for analysis. RESULTS: Regarding the overall 50% inhibition of tumor progression and that of gallbladder carcinoma, there were significantly better outcomes in the modified FAM therapy group. In this group, tumor reduction was achieved in 1 complete response (CR) and 2 partial response (PR) patients. With respect to the overall and differentiated survival times according to the tumor sites and the clinical efficacy, there was no difference between the groups. The most frequent adverse reactions were gastrointestinal manifestations such as anorexia, nausea, vomiting, and diarrhea; also noted was alopecia. CONCLUSIONS: Since this combination chemotherapy inhibited the tumor progression for significantly longer duration and, to a lesser extent, reduced the tumor size in non-resectable gallbladder carcinomas compared to a non-administrated chemotherapy group, this study will function as the basis for pursuing a more effective chemotherapy.

Adult↗
PubMed1990

Recombinant tissue-type plasminogen activator versus urokinase in peripheral arterial and graft occlusions: a randomized trial.

A randomized prospective trial was undertaken to compare intraarterial administration of recombinant human tissue-type plasminogen activator (rt-PA) with urokinase (UK) in 32 patients with peripheral arterial or bypass graft occlusions. Sixteen patients were randomized to receive rt-PA and 16 to receive UK. The rt-PA dose was administered as a 10-mg bolus into the thrombus, followed by 5 mg/h for up to 24 hours. The UK dose was administered as a 60,000 IU bolus into the thrombus, followed by 240,000 IU/h for 2 hours, 120,000 IU/h for 2 hours, and 60,000 IU/h for up to 20 hours. Serial arteriograms were obtained at baseline and at 4, 8 or 16, and 24 hours. The endpoint was defined as 95% of greater clot lysis. The cumulative numbers of patients with successful thrombolysis (rt-PA vs UK) were four vs none at 4 hours, seven vs one at 8 hours, seven vs three at 16 hours, and eight vs six at 24 hours. Lysis occurred more rapidly in the rt-PA group (P = .04). Major bleeding complications occurred in five rt-PA patients and two UK patients (P = .39). At 24 hours, fibrinogen levels were significantly lower in the rt-PA group than in the UK group (P = .01). There was no apparent difference in 30-day clinical success.

Adult↗
PubMed1985

The effectiveness of continuing medical education in changing the behavior of physicians caring for patients with acute myocardial infarction. A controlled randomized trial.

A randomized controlled trial was done to assess the ability of continuing medical education to change physicians' knowledge and behavior in the care of patients with acute myocardial infarction. Patient care practices on eight objectives were audited 6 months before and after physicians completed a 2-hour educational program. Sixty-three physicians from eight randomly selected communities constituted the experimental group and 40 physicians from four similar communities served as controls. The average score for desired care practices over all objectives increased from 48.5% to 60% (p less than 0.001). Three objectives showed significantly greater gains for physicians in the experimental group. The generalizability of these effects was also studied in two additional educational contexts: a multitopic and a unitopic university-based continuing medical education program. Similar significant changes in behavior resulted in both contexts. Significant overall increases in knowledge occurred and persisted for all groups. Continuing medical education can effect changes in physicians' knowledge and care practices that can persist for at least 6 months.

Cardiology↗
PubMed2000

Organization and ethical aspects of randomized trials in gynecologic oncology.

Randomized trials remain often the most reliable method for evaluating the efficacy of therapies in Gynaecological Oncology. However, a trial can only be ethical acceptable if well conceived and well executed. One of the most important ethical issues in randomized trials is the informed consent. Patients must always be aware that they are part of an experiment and give voluntary informed consent. Only in very rare occasions an informed consent might be omitted (e.g. after agreement of a National Ethical Committee). Each randomized trial must have a good chance of settling an open question. The measures of outcome, should be carefully stated in the protocol. Each new protocol should be reviewed on at least 4 levels: by competent colleagues, an Ethical Review Board, a panel of scientists and the well-informed patient. Every randomized trial should be published in a peer reviewed medical journal, also when the results are negative or when the trial is stopped during accrual. Interim analyses of randomized trials result often in incorrect conclusions. These interim analyses should always be carefully planned and interpreted by an independent data-monitoring committee. International cooperative groups, such as the EORTC, often are the only organizations to perform large phase-III randomized trials. The creation of a Gynaecological Cancer Intergroup (GCIG) will increase the cooperation between the different international groups.

Ethics, Medical↗
PubMedDate not supplied

Immediate versus postponed combination chemotherapy (CAMP) for unresectable non-small cell lung cancer: a randomized trial.

A randomized control trial was performed in good performance status patients with unresectable non-small cell lung cancer to test a strategy of early aggressive combination chemotherapy (CAMP [cyclophosphamide, doxorubicin, methotrexate, and procarbazine]) versus a strategy of delaying such treatment until clinical deterioration. Thirty-seven patients received immediate CAMP and 35 patients received initial low-dose single-agent CCNU (CAMP was postponed). Immediate CAMP therapy produced an objective response rate of 44% in patients with measurable lesions, and CCNU produced none. Median survival was 193 days for the immediate-CAMP group and 175 days for the postponed-CAMP group (P = 0.26). Measures of quality of life were made and no difference emerged between the two treatment strategies. This trial failed to show substantial benefit from immediate combination chemotherapy in minimally symptomatic patients with non-small cell lung cancer.

Antineoplastic Agents↗
PubMed2006

Endogenous markers of two separate hypoxia response pathways (hypoxia inducible factor 2 alpha and carbonic anhydrase 9) are associated with radiotherapy failure in head and neck cancer patients recruited in the CHART randomized trial.

PURPOSE: Randomized controlled trials have generally shown a benefit from accelerated radiotherapy in head and neck squamous cell carcinoma (HNSCC). However, the large randomized United Kingdom trial CHART (Continuous Hyperfractionated Accelerated Radiotherapy) failed to show a benefit of strongly accelerated over standard radiotherapy (RT) in 918 patients with HNSCC. In this study, we investigated the impact of tumor hypoxia on the outcome of HNSCC patients in the CHART trial. There are two distinct hypoxia inducible factors (HIFs) that control different gene response pathways and we assessed them both with endogenous markers of hypoxia, hypoxia inducible factor HIF-2 alpha (HIF-2) and carbonic anhydrase CA9, an indicator of HIF-1 alpha (HIF-1) function. METHODS: Tissue from pre-RT biopsies performed in 198 of 918 patients recruited was analyzed for the immunohistochemical expression of HIF-2 and CA9. RESULTS: A significant association of high HIF2 and of high CA9 reactivity with poor locoregional control (P < .0001 and P = .0002, respectively) and poor survival (P = .0004 and 0.002, respectively) was noted. In multivariate analysis, HIF-2 and CA9 maintained their independent prognostic significance. Coexpression of both pathways had an additive effect, supporting their independent role. The uni-directional hypothesis, that a benefit from randomization to CHART should be seen in the nonhypoxic tumors, was supported by the data (one-tailed P = .04). CONCLUSION: Expression of endogenous markers of hypoxia for the HIF-1 and HIF-2 pathway is strongly associated with radiotherapy failure. Using immunohistochemical methods it is possible to identify subgroups of HNSCC patients who are highly curable with radiotherapy, or who are excellent candidates for clinical trials on hypoxia-targeting drugs in two distinct pathways.

Antigens, Neoplasm↗
PubMed2005

INvestigation of STEnt grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial.

PURPOSE: This study describes the design of an ongoing randomized trial initiated to compare the 2-year outcome of uncomplicated type B aortic dissection when treated by endovascular implantation of a Medtronic Talent stent graft adjunctive to best medical treatment versus best medical treatment alone. METHODS: Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment." Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion. RESULTS: Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months. CONCLUSIONS: The INSTEAD trial is the first randomized trial investigating the role of endoluminal treatment of uncomplicated type B aortic dissection. By the end of December 2004, 125 patients were randomized, accounting for 92% of the target. Final results of the INSTEAD trial should be available in 2006.

Aged↗
PubMedDate not supplied

Cephalothin, cefoxitin, or metronidazole in elective colonic surgery? A single-blind randomized trial.

A randomized controlled trial aimed at comparing the individual efficacy of cephalothin, cefoxitin, and metronidazole in the prevention of postoperative wound infection was performed among 74 colorectal surgical patients. Of 28 patients on cephalothin, seven (25 per cent) developed a postoperative infection, but among 23 patients in each of the other two groups, only one (4 per cent) in each group became infected. These results confirm the primary importance of anaerobes in the causation of postoperative sepsis after colorectal surgery.

Adult↗
PubMed1992

[Prophylactic drainage after thyroidectomy: a randomized trial].

A randomized clinical trial of surgical drainage in thyroid surgery was performed with 97 patients. Using equivalence testing it is reported that morbidity was not significantly different between the two groups and the length of hospital stay was shorter in the undrained group. It is possible to perform thyroidectomy without drainage in a selected population.

Adult↗
PubMed1987

Commercial discharge packs and breast-feeding counseling: effects on infant-feeding practices in a randomized trial.

A randomized controlled trial was conducted to evaluate two interventions for prolonging the duration of breast-feeding in a multiethnic sample of 343 low-income urban women. One intervention compared research breast-feeding bedside counseling by a trained counselor, who also made eight telephone calls during the first 3 months of the infant's life, with the routine breast-feeding counseling provided in the hospital by nurses. The other intervention compared commercial discharge packs provided by formula companies with research discharge packs designed to be consistent with the WHO Code of Marketing of Breastmilk Substitutes. When infants were 4 months old, a telephone interviewer unaware of treatment status contacted 95% (324/343) of the women to determine the infants' feeding and health histories. Compared with routine counseling, research counseling delayed the first introduction of solid foods to the infant's diet (P = .03, one-tailed) but did not exert a statistically significant effect on breast-feeding by 4 months' postpartum. Women who received the research discharge pack, compared with those who received the commercial pack, were more likely to prolong exclusive breast-feeding (P = .004, one-tailed), to be partially breast-feeding at 4 months postpartum (P = .04, one-tailed), and to delay the daily use of solid foods in the infant's diet (P = .017, one-tailed). Among the women who received research counseling, the research discharge pack was associated with lower rates of rehospitalization of infants than was the commercial pack (1% v 14%; P = .014, two-tailed). We conclude that in high-risk maternity populations, commercial discharge materials for breast-feeding women should be replaced by materials consistent with the WHO Code.

Adult↗
PubMed2000

Evaluation of time of nasal packing after nasal surgery: a randomized trial.

A randomized, prospective trial was carried out to compare the rate of hemorrhagic complications after removal of nasal packing left for 24 and 48 hours. A total of 104 patients underwent nasal surgery and were randomly assigned to 1 of 2 groups: group 1, 24 hours of nasal packing; group 2, 48 hours of nasal packing. No statistical difference was observed between the groups in terms of occurrence of hemorrhagic complications. Hypertension was the only prognostic factor for postoperative bleeding. The routine use of 48-hour postoperative nasal packing after nasal surgery is not justified because of the low incidence of bleeding and the potential associated morbidity. At the end of the procedure, surgeons should evaluate the risk of postoperative bleeding (ie, presence of hypertension) and decide whether 24-hour nasal packing is enough.

Adolescent↗
PubMed1999

[Roaming through the methodology. XIV. The premature ending of a randomized trial].

A randomized controlled trial that is stopped prematurely because of a striking benefit or a strong untoward effect is most probably suffering from a 'random high'. At premature stopping the conclusions will often either be too optimistic or too pessimistic. In the early phases of an investigation the intermediate results show wider fluctuations around the hypothetical 'truth' than in the later phases. Subjective arguments involved in the stopping of a trial may be eliminated by a so-called triple blind design: the data monitoring and safety committee receives the intermediate results but is not told which data are from the experimental group and which ones from the placebo group.

Bias↗
PubMed2005

Conceptual issues in the analysis of cost data within cluster randomized trials.

Cluster randomized controlled trials (RCTs) are increasingly used in economic evaluations of social, educational and health care interventions. Methodological research has, therefore, been spread across several disciplines, with the result that it has taken many years for guidelines on good statistical practice in the design and analysis of such trials to become easily accessible to health service researchers. These guidelines remain incomplete, however, because they do not take account of issues specific to the analysis of cost data. In particular, they fail to recognize that the calculation of confidence intervals around costs needed to inform health care priority setting raises unique methodological issues. If poorly designed trials are to be avoided in future (including those by the authors), then collaboration between triallists and health economists is required. This paper sets out a framework that should facilitate such collaboration and draws attention to problems that must be addressed quickly in the design of cluster-based economic evaluations.

Cluster Analysis↗