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PubMed2003

Education of key personnel in student pubs leads to a decrease in alcohol consumption among the patrons: a randomized controlled trial.

AIMS: To decrease alcohol consumption among patrons in student pubs by server-training programmes. DESIGN: Randomized controlled trial. SETTING: University campus. PARTICIPANTS: A total of 1322 students visiting local student pubs during ordinary pub evenings. INTERVENTION: Educational programmes were given to bartenders (n = 40) in a randomized design in six of 12 pubs on a university campus. Bartenders in control pubs were not given the programme. MEASUREMENTS: Breath alcohol concentration (BAC), expressed in percentage, among the patrons and the reported social atmosphere in the pub ('high', 'cosy' and 'rowdy') measured on a visual analogue scale in the pub before and after the intervention programme was given. FINDINGS: BACs of patrons in the intervention pubs were reduced by more than those of the patrons in the control pubs at a 1-month follow-up. The mean difference in BAC between intervention and control groups was -0.011% (95% confidence interval, 0.022-0.000). The intervention group also decreased more in reported level of 'rowdy' social atmosphere than did the control group. The mean difference was -6 points (95% confidence interval -11 to -1). No differences were found in reported 'cosy' and 'high' atmosphere. CONCLUSION: Alcohol levels among the patrons were decreased and the 'rowdy' social atmosphere reduced in the intervention group. Server-training programmes for personnel in student pubs could be a component in the prevention of alcohol problems in university student populations.

Adult↗

PubMed2003

Somatic growth of preterm infants during skin-to-skin care versus traditional holding: a randomized, controlled trial.

We performed this randomized trial to determine whether infants receiving skin-to-skin care (SSC) grew more rapidly and had a shorter duration of hospital stay compared with infants held by their parents in a traditional way. Infants who met eligibility criteria (<or=32 wk of gestation, <or=1500 g, minimal ventilatory support, and hemodynamically stable) were randomized to traditional holding (TH) or SSC groups. Parents in both groups were allowed to hold infants for a total of 8 hours per day (periods of up to 4 hr, twice/d). During the study, infants in the TH group were held 4.8 +/- 3.5 times per week and 76 +/- 39 minutes per day, and infants in the SSC group were held 4.0 +/- 2.8 times per week and 79 +/- 40 minutes per day. No significant differences were observed in weight accretion or linear growth. However, exposure to SSC was associated with greater head growth, even after controlling for head circumference at birth (p =.03). SSC may increase the likelihood of successful breastfeeding.

Breast Feeding↗

PubMed2002

Correlates of adherence and contamination in a randomized controlled trial of exercise in cancer survivors: an application of the theory of planned behavior and the five factor model of personality.

In this study, we examined correlates of adherence and contamination in a randomized controlled trial (RCT) of exercise in cancer survivors using the theory of planned behavior and the Five Factor Model of personality (FFM). We randomly assigned cancer survivors in group psychotherapy classes to either a waiting-list control group (n = 45) or a home-based, moderate intensity exercise program (n = 51). At baseline, participants completed measures of the theory of planned behavior, the FFM, past exercise, physical fitness, medical variables, and demographics. We then monitored exercise over a 10-week period by weekly self-reports. Hierarchical multiple regression analyses indicated that the independent predictors of overall RCT exercise across both conditions were past exercise (beta = .36, p < .001), assignment to experimental condition (beta = .34, p < .001), sex (beta = .30, p < .001), and intention (beta = .14, p < .10). For exercise adherence in the exercise condition, the independent predictors were sex (beta = .38, p < .01), extraversion (beta = .30, p < .05), normative beliefs (beta = -.27, p < .05), and perceived behavioral control (beta = .23, p < .10). Finally, the independent predictors of exercise contamination in the control condition were past exercise (beta = .70, p < .001), sex (beta = .20, p < .05), and intention (beta = .17, p < .10). We conclude that the correlates of exercise adherence and contamination differ in kind as well as in degree. Explanations for these findings and practical implications for conducting exercise RCTs in this population are offered.

Adult↗

PubMed2000

A randomized controlled trial of alternative modes of service provision to young children with cerebral palsy in Bangladesh.

OBJECTIVE: To compare the efficacy of an outreach program for young children with cerebral palsy with center-based and "minimal intervention" control groups. DESIGN: Randomized controlled trial conducted in a group of 85 children between the ages of 1.5 and 5 years. Urban children were allocated to a daily center-based mother-child group or to monthly training of their parents along with a pictorial guidance manual. Rural children were allocated either to parent training or health advice. Outcome measures were changes in children's adaptive skills, maternal stress and adaptation to the child, satisfaction with social support, and knowledge of handling a physically disabled child. RESULTS: Fifty-eight children were successfully followed up. The pattern of change in children's adaptive skills was as predicted (ie, least progress in the health advice group). Positive effects of intervention also included increased maternal knowledge and perceived helpfulness of support from formal sources. However, maternal adaptation increased most in the health advice group with minimal intervention. When children had attended a program at least 4 times, their skills improved, and mothers' adaptation did increase. CONCLUSIONS: Outreach training for mothers in Bangladesh can help them to improve the skills of their young children with cerebral palsy and is perceived as helpful.

Bangladesh↗

PubMed1989

Control of cisplatin-induced delayed emesis with metoclopramide and dexamethasone: a randomized controlled trial.

Forty-two patients with advanced lung cancer undergoing chemotherapy containing cisplatin (80 mg/m2) were submitted to a randomized controlled trial to evaluate the effect of the combination of metoclopramide and dexamethasone for the treatment of delayed cisplatin-induced emesis occurring more than 24 hours after cisplatin administration. All patients received intravenously (i.v.) high-dose metoclopramide and dexamethasone on the day of cisplatin treatment. Excellent emetic control (no emesis during the 24 hours following cisplatin administration) was achieved in 30 out of 41 patients (73%) with this combination. Patients treated i.v. with metoclopramide and dexamethasone on days 2-7 experienced less delayed emesis, nausea and anorexia compared to those treated with a placebo (delayed emesis, 25 vs 50%, respectively, P = 0.105; more than four days of nausea, 10 vs 35%, respectively, P = 0.059; less than three days of anorexia, 80 vs 50%, respectively, P = 0.048). Although the results of the study showed no statistically significant advantage with the combination of i.v. metoclopramide and dexamethasone for patients treated with cisplatin, in view of the short duration of anorexia and the marginal reduction in nausea. Female patients tended to have more emetic episodes and extrapyramidal side effects (except akathisia) than male patients, but the differences were not statistically significant except for acute emesis (P less than 0.005).

Adult↗

PubMed2005

Potential consequences for recruitment, power, and external validity of requirements for additional risk factors for eligibility in randomized controlled trials in secondary prevention of stroke.

BACKGROUND AND PURPOSE: Eligibility criteria determine the external validity (generalizability) of the results of randomized controlled trials. To increase the number of outcome events, and hence statistical power, some recent stroke prevention trials have required additional vascular risk factors for eligibility. METHODS: To assess the merits of additional eligibility criteria in stroke prevention trials, we analyzed data from 3 trials and 1 hospital-referred series of patients with a transient ischemic attack or minor ischemic stroke. Patients were stratified according to 2 sets of additional risk factors similar to those used in recent trials (MATCH, SPORTIF and PRoFESS); risk of stroke, myocardial infarction, or vascular death was calculated in relation to the number of risk factors. RESULTS: Although the observed risk during follow-up did increase with the number of risk factors present (P<0.01 for both sets), the risks in patients with > or =1 risk factors were not substantially greater than those in all patients. Consequently, although the proportions of patients with no risk factors in the 4 cohorts differed substantially between the 2 sets of eligibility criteria (21% to 28% versus 56% to 73%), in neither case could their exclusion be justified on statistical grounds. CONCLUSIONS: The degree of patient selection introduced by use of additional vascular risk factors as eligibility criteria for trials can differ substantially between apparently similar sets of risk factors. Given that the potential for additional eligibility criteria to undermine generalizability and prolong recruitment outweighs any benefits in terms of statistical power, the exclusion of patients with no risk factors is difficult to justify.

Aged↗

PubMed2005

Effects of a leukocyte depleting arterial line filter on perioperative morbidity in patients undergoing cardiac surgery: a controlled randomized trial.

BACKGROUND: Activated leukocytes may increase morbidity in cardiac surgery. The objective of this study is to investigate the influence on morbidity of leukocyte-depleting blood filters placed into the arterial line of cardiopulmonary bypass circuits. METHODS: Simple, blind, prospective, randomized and controlled clinical trial carried out in a cardiac surgery ICU at a university center. We included 159 consecutive low-risk patients (ie, Parsonnet score < 10) undergoing cardiac surgery who were initially stratified in three risk levels according to the Parsonnet score at admission into the hospital (ie, low, < 4; middle, 4 to 7; and high, 8 to 10). Once stratified, all patients were randomized to undergo cardiopulmonary bypass either with a conventional blood filter or with a leukocyte filter (randomization ratio, 2:1). The outcome variable was morbidity. Patients were considered to have a high morbidity if any of the following clinical situations were present (ie, pulmonary dysfunction, cardiac dysfunction, perioperative infections, postoperative hyperthermia, and hyperdynamic states). RESULTS: The leukocyte filter was used in 52 patients and the conventional filter in 107 patients. The morbidity rate was similar in both groups, but patients with leukocyte filter had a lower incidence of perioperative infections, fever, and hyperdynamic states as compared with patients with the conventional filter. CONCLUSIONS: Leukocyte filtration in patients undergoing cardiac surgery with extracorporeal perfusion showed no measurable effects on postoperative morbidity. However, although not statistically significant, a decrease was observed in the rates of perioperative infection, fever, and hyperdynamic states.

Blood Transfusion↗

PubMed2007

Simple antenatal preparation to improve breastfeeding practice: a randomized controlled trial.

OBJECTIVE: To address the impact of simple antenatal educational interventions on breastfeeding practice. METHODS: A randomized controlled trial was carried out in a tertiary referral center from May 2002 to December 2004. A random sample of eligible low-risk antenatal patients was recruited from clinics in the National University Hospital, Singapore. Group A received breastfeeding educational material and individual coaching from a lactation counselor. Group B received breastfeeding educational material with no counseling. Group C received routine antenatal care only. RESULTS: A total of 401 women were recruited. Mothers receiving individual counseling and educational material practiced exclusive and predominant breastfeeding more often than mothers receiving routine care alone at 3 months (odds ratio [OR] 2.6, 95% confidence interval [CI] 1.2-5.4) and 6 months (OR 2.4, 95% CI 1.0-5.7) postpartum. More mothers practiced exclusive and predominant breastfeeding at 6 months among women receiving individual counseling compared with women exposed to educational material alone (OR 2.5, 95% CI 1.0-6.3). CONCLUSION: Where breastfeeding practices are suboptimal, simple one-encounter antenatal education and counseling significantly improve breastfeeding practice up to 3 months after delivery. Provision of printed or audiovisual educational material is not enough. Health care workers should make every effort to have one face-to-face encounter to discuss breastfeeding with expectant mothers before they deliver. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT002770192 LEVEL OF EVIDENCE: I.

Breast Feeding↗

PubMedDate not supplied

Analyses of cost data in economic evaluations conducted alongside randomized controlled trials.

OBJECTIVE: The adoption and diffusion of new medical treatments depend increasingly on evidence of costs and cost-effectiveness. This evidence is increasingly being generated from economic data collected in randomized clinical trials. The objective of this article is to evaluate the statistical methods used for analysis of cost data in economic evaluations conducted alongside randomized controlled trials. METHODS: Systematic review of economic evaluations based on patient-level cost or resource-use data collected in randomized trials was published in 2003. One hundred fifteen articles were identified from the MEDLINE database. The use of statistical methods for 1) joint comparison of costs and effects and assessment of stochastic uncertainty, 2) incremental cost estimation, and 3) handling of incomplete or censored cost data was evaluated. RESULTS: Only 42 (37%) of the 115 economic evaluations presented a cost-effectiveness ratio or estimated net benefits and 24 (57%) of these reported the uncertainty of this statistic. A comparison of costs alone was more common with 92 (80%) of the 115 studies statistically comparing costs between treatment groups. Of these, about two-thirds (62; 68%) used at least one statistical test appropriate for drawing inferences for arithmetic means. Incomplete cost data were reported in 67 (58%) studies with only two using a published statistical approach for handling censored cost data. CONCLUSION: The quality of statistical methods used in economic evaluations conducted alongside randomized controlled trials was poor in the majority of studies published in 2003. Adoption of appropriate statistical methods is required before the results from such studies can consistently provide valid information to decision-makers.

Cost-Benefit Analysis↗

PubMed2004

Water-based exercise for cardiovascular fitness in people with chronic stroke: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of an 8-week, water-based exercise program (experimental group) with that of an upper-extremity function program (control group) to increase cardiovascular fitness within a community setting for people with stroke. DESIGN: Single-blind randomized controlled trial. SETTING: Public community center. PARTICIPANTS: A volunteer sample of 12 community-dwelling people with stroke with mild to moderate residual motor deficits. INTERVENTION: Study subjects participated in group exercise programs for 1 hour, 3 times a week for 8 weeks. The experimental group exercised in chest-deep water at targeted heart rates. The control group performed arm and hand exercises while sitting. Main outcome measures The primary outcome measure was cardiovascular fitness (V(O2)max). Secondary measures were maximal workload, muscle strength, gait speed, and the Berg Balance Scale score. RESULTS: The experimental group attained significant improvements over the control group in cardiovascular fitness, maximal workload, gait speed, and paretic lower-extremity muscle strength. The relatively short program (8 wk) of water-based exercise resulted in a 22% improvement in cardiovascular fitness in a small group of people with stroke who had relatively high function. CONCLUSIONS: A water-based exercise program undertaken as a group program may be an effective way to promote fitness in people with stroke.

Aged↗

PubMed1984

A randomized controlled trial of cefaclor compared with trimethoprim-sulfamethoxazole for treatment of acute otitis media.

We performed a randomized controlled trial of cefaclor administered twice daily compared with trimethoprim-sulfamethoxazole (TMP-SMZ) administered twice daily for the treatment of acute otitis media. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 of 37 (95%) patients given TMP-SMZ compared with 28 of 40 (70%) given cefaclor (P = 0.017). Haemophilus influenzae was eliminated in 13 of 14 (93%) patients given TMP-SMZ compared with 10 of 18 (56%) given cefaclor (P = 0.047). Clinical outcomes failed to distinguish between patients given TMP-SMZ or cefaclor. Symptoms improved despite persistent infection in 11 of 13 (85%) patients; middle-ear effusion persisted after therapy in 38 of 61 (62%) patients despite eradication of pathogens. We conclude that twice daily TMP-SMZ is more efficacious than twice daily cefaclor for the treatment of acute otitis media and that clinical outcomes may fail to detect differences between antibacterial agents in comparative drug trials in acute otitis media.

Acute Disease↗

PubMed2003

Effect of awareness of a randomized controlled trial on use of experimental therapy.

CONTEXT: Use of experimental therapies during but outside of randomized controlled trials (RCTs) has not been studied. OBJECTIVE: To determine whether initiation of an RCT leads to increased use of the experimental therapy outside the trial. DESIGN AND SETTING: Data on national apheresis use during 3 Canadian RCTs for multiple sclerosis (1986-1988), thrombotic thrombocytopenic purpura (1982-1988), and myeloma cast nephropathy (1998-2000) were obtained from 19 major medical centers in Canada. The multiple sclerosis and myeloma cast nephropathy trials had data on apheresis use for 3 years prior to and during the trials, which permitted a time-series analysis to determine the impact of the RCTs on the use of apheresis. The ongoing myeloma cast nephropathy trial provided data on the number of patients inside and outside of the RCTs in trial and nontrial centers. Initial and follow-up questionnaires were sent to 24 Canadian physicians in trial and nontrial centers to determine if they had noted an increase in apheresis activity during the trials and, if so, their explanation for it. MAIN OUTCOME MEASURE: Change in number of patients undergoing apheresis for thrombotic thrombocytopenic purpura, multiple sclerosis, and myeloma cast nephropathy prior to and during the respective RCTs compared with all patients undergoing apheresis during the same periods. RESULTS: During all 3 RCTs, there were large increases in use of apheresis. The majority of the increased use of apheresis was outside of the trials: for multiple sclerosis, 30 of 49 patients per year (61% of increase); thrombotic thrombocytopenic purpura, 49 of 56 patients per year (72% of increase); and myeloma cast nephropathy, 60 of 72 patients per year (57% of increase). The myeloma cast nephropathy study noted that this increase occurred in both nontrial and trial centers. Among questionnaire respondents (n = 22; 92% response rate), most physicians noted an increase in apheresis activity during the trials and attributed it to a "jumping-the-gun" phenomenon. CONCLUSIONS: During 3 Canadian RCTs, apheresis increased, but most of the increase occurred outside the trials. This behavior during an RCT, in the absence of clear efficacy, can be termed jumping the gun.

Blood Component Removal↗

PubMed2005

Routine use of antimicrobials by pregnant Indian women does not improve birth outcome: a randomized controlled trial.

Low birth-weight is a leading health problem in developing countries. In a randomized controlled trial, the effect of antimicrobials in pregnant women on improving birth-weight and duration of gestation was evaluated. Two hundred twenty-four pregnant women in their second trimester were randomized to receive metronidazole (200 mg 3 times daily for 7 days) and cephalexin (500 mg twice daily for 5 days) orally by one group. The mean (+/-SD) birth-weights were 2,545 g (+/-374) and 2584 g (+/-358, p=0.51), the low birth-weight rates (<2.5 kg) were 40% and 36% (p = 0.28), and the prematurity rates were 8% and 11% (p = 0.6) in the treated group and the control group respectively. Due to small sample size, it is cautiously concluded that routine antimicrobials for genital and urinary tract infections of pregnant women do not improve birth-weight or duration of gestation. Rather an unexpected observation was the proportion requiring caesarian section or forceps, which was five-fold higher in the treated group (p = 0.001), and given no plausible explanations, this finding needs confirmation. Stunted mothers (<25th centile or 146.4 cm) had two-fold higher risk for low birth-weight (p = 0.04) and assisted delivery (p = 0.1). Low maternal body mass index (<25th centile or 18) had six-fold higher risk for stillbirth or abortion (p = 0.007), and high body mass index (>75th centile or 21.2) had three-fold higher risk for assisted delivery (p = 0.003).

Adult↗

PubMed2006

Brief intervention on maternal smoking: a randomized controlled trial.

OBJECTIVES: To determine if mothers receiving a smoking cessation intervention emphasizing health risks of environmental tobacco smoke (ETS) for their children have a higher quit rate than mothers who received routine smoking cessation advice, which focused on their own health, or a control group of mothers. SETTING: Tertiary referral centre. METHODS: Randomized control trial. A total of 363 mothers were randomly assigned to a smoking cessation intervention either aimed at their children's health (n = 111) or their own health (n = 131), or to a control group receiving no smoking cessation advice (n = 121). RESULTS: Provision to mothers of both groups of health risks of tobacco smoke resulted in significantly higher rate of cessation of smoking and smoking location change than those of the control group, with child intervention group having significantly higher rate of cessation of smoking and smoking location change than those of the maternal intervention group (P < 0.05). Post-intervention knowledge scores differed significantly for all groups; however, child intervention group was the only significantly better group than the others (P < 0.05). According to the multivariate analysis results, intervention grouping and presence of smoking friends were independent factors determining smoking cessation (P < 0.05). Intervention grouping, post-intervention knowledge, presence of other household members who smoked and family income were independent factors determining smoking location change (P < 0.05). Family income, intervention grouping and presence of smoking friends were significant independent factors influencing post-intervention knowledge (P < 0.05). CONCLUSION: Discussion during short paediatric visits on effects of smoking on child's or maternal health may result in a significant smoking cessation, smoking location change rate or knowledge change. Those who cannot give up smoking usually change their location of smoking. Provision of information on effects of smoking on child's health, rather than maternal, may result in more significant changes in behaviour or knowledge. Maternal education on smoking should include information on effects of smoking on both child's and maternal health, but should be especially focused on child's health.

Adolescent↗

PubMed1997

Early physician notification of patient disability risk and clinical guidelines after low back injury: a randomized, controlled trial.

STUDY DESIGN: Back-injured workers with high disability risk scores on a predictive questionnaire participated in a randomized, controlled trial of physician notification, with outcomes follow-up 3 months after injury. OBJECTIVES: To test whether physician intervention improves return to work and self-assessment outcomes for people at relatively high risk for disability. SUMMARY OF BACKGROUND DATA: Only a small number of back-injured workers suffer significant disability. Quick identification of these people would facilitate more efficient targeting and trials of interventions. Controlling variations in practice through practice guidelines has been recommended as a promising strategy for improving care and reducing disability. METHODS: Workers filing back injury reports responded to a disability prediction questionnaire. Those with high risk scores were randomly assigned to control or intervention groups. Patient-designated physicians in the intervention group received two letters identifying the patient's risk and making recommendations for care, including the Agency for Health Care Policy and Research's algorithms for acute low back pain. Predictive accuracy of the questionnaire and efficacy of physician intervention were evaluated on the basis of work status and self-assessments 3 months after injury. RESULTS: Of the 268 workers completing the questionnaire portion of the study, 32 (12%) were out of work because of back pain 3 months after injury. The questionnaire's predictive accuracy included maximum kappa of 0.277 and a receiver operating curve area of 0.78. Fifty-three people completed the physician intervention trial. The intervention had no significant impact on return to work, self-assessed pain, or satisfaction with health care. CONCLUSIONS: Stratification of back-injured people according to disability risk can can increase intervention efficiency by identifying those who require treatment and sparing those who do not. The apparent failure of risk notification and practice guidelines to reduce disability in this study may be improved by different application methods in the future.

Adolescent↗

PubMed1986

A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media.

We performed a randomized controlled trial of amoxicillin plus clavulanate versus cefaclor for treatment of acute otitis media. Total daily doses given in three divided doses were 40 mg/kg amoxicillin plus 10 mg/kg clavulanate, and 40 mg/kg cefaclor. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 (97%) of 36 patients given amoxicillin-clavulanate compared with 24 (75%) of 32 given cefaclor (P = 0.028). When analysis was restricted to patients with positive urine or serum drug assays during therapy, pathogens were eliminated in 33 (97%) of 34 patients given amoxicillin-clavulanate compared with 21 (75%) of 28 given cefaclor (P = 0.026). Bacterial isolates associated with bacteriologic failure of cefaclor therapy were Streptococcus pneumoniae (two patients), beta-lactamase-negative Haemophilus influenzae (four), and beta-lactamase-positive Branhamella catarrhalis (two). The single failure with amoxicillin-clavulanate therapy was associated with non-beta-lactamase-producing H. influenzae isolated from the middle ear exudate. We conclude that cefaclor is less efficacious than amoxicillin-clavulanate for the treatment of acute otitis media.

Acute Disease↗

PubMed2004

E-mail or snail mail? Randomized controlled trial on which works better for surveys.

OBJECTIVE: To compare e-mail with regular mail for conducting surveys of physicians. DESIGN: Randomized controlled trial. SETTING: Ontario, Canada. PARTICIPANTS: A random sample of physicians listed in the College of Family Physicians of Canada's membership database. INTERVENTIONS: Survey delivered by e-mail and by post. MAIN OUTCOME MEASURES: Response rates and times, and completeness and characteristics of responses to the survey. RESULTS: Overall response rate was 44.7% (33.6% of e-mail recipients, 52.7% of post recipients who have e-mail, and 47.8% of post recipients without e-mail). While the e-mail rate was significantly lower than for both post groups, e-mail responses were received much faster. There was no significant difference among groups as to completeness of responses, but e-mail responses had more frequent and longer comments. CONCLUSION: E-mail provides faster but fewer responses to surveys. Content of structured-response questions was similar in all groups, but e-mail provided more and longer responses to open-ended questions. Where a quick response to a survey is required, e-mail is superior.

Adult↗

PubMed2026

Timeliness of publication of randomized controlled trials in rheumatology: A systematic review.

OBJECTIVE: To systematically review the (1) timeliness of publication of randomized controlled trials (RCTs) in rheumatology, (2) impact of the COVID-19 pandemic on time to publication, and (3) factors associated with publication delays. METHODS: We searched Medline, Embase, EBM Reviews, Cochrane Central Register of Controlled Trials, and Scopus from January 1, 2018, to June 30, 2023 for Phase 3, superiority, parallel-design RCTs that evaluated any treatment for a rheumatologic illness or a rheumatologic treatment for COVID-19 and reported clinical primary efficacy outcome. Outcomes of interest were time to publication after trial completion and publication delay of >2 years after trial completion. RESULTS: 448 RCTs were included in this systematic review. Median time from completion to publication was 549 days and 65.9 % RCTs were published within 2 years of completion. Compared with RCTs on rheumatologic diseases, RCTs on COVID-19 were published sooner (253 vs. 549 days; p < 0.001) and were more likely to be published within 2 years (adjusted OR 9.49, 95 % CI 2.07 to 43.61). Compared with RCTs completed before March 1, 2020, RCTs completed after March 1, 2020, were published sooner (327 vs. 724 days; p < 0.001) and were more likely to be published within 2 years (adjusted OR 9.40, 95 % CI 5.14 to 17.21). Time from RCT completion to submission accounted for most (67 %) of the time to publication. CONCLUSIONS: Publication delay continues to be an important concern in dissemination of clinical research. Most of the delays in publication were attributable to delays in submission to journals after trial completion.

Humans↗