Meropenem Assessment before and after Implementation of a Small-Dose, Short-Interval Standard Dosing Regimen

ABSTRACTBackground: Small-dose, short-interval dosing for meropenem has been shown to yield pharmacokinetic and pharmacodynamic properties similar to those associated with traditional dosing of this drug. However, few studies have examined clinical outcomes in the general population.Objectives: To characterize differences in effects between a small-dose, short-interval dosing regimen for meropenem (500 mg every 6 h) and the traditional regimen (1000 mg every 8 h) on clinical outcomes and costs to the health care system.Methods: This retrospective cohort study included 194 patients who received the traditional meropenem dosage (July 2006 to August 2008) and 188 patients who received the small-dose, short-interval regimen (December 2008 and October 2009) at a large tertiary care hospital and a community hospital. The primary outcome (clinical success), the secondary outcomes (30-day in-hospital mortality, time to defervescence, duration of therapy, and length of stay), and drug costs were compared between cohorts.Results: The 2 cohorts did not differ significantly in terms of baseline characteristics. There was no statistically significant difference between the small-dose, short-interval regimen and the traditional dosing regimen in terms of the primary outcome: clinical success was achieved in 83.5% (162/194) and 80.8% (152/188) of the patients, respectively. Likewise, there was no statistically significant difference in any of the secondary outcomes. The average drug cost per patient per visit was $222.23 with small-dose, short-interval dosing and $355.90 with traditional dosing, a significant difference of more than $130 per patient per visit.Conclusion: The small-dose, short-interval meropenem dosing regimen resulted in clinical outcomes similar to those achieved with the traditional dosing regimen at significantly lower cost. RÉSUMÉContexte : Selon des études, un schéma posologique de méropénème avec administration d’une faible dose à intervalle réduit produit des résultats pharmacocinétiques et pharmacodynamiques semblables à ceux obtenus avec une posologie traditionnelle. Mais peu d’études ont examiné les résultats cliniques dans la population générale.Objectif : Offrir un portrait des différences entre les effets d’un schema posologique de méropénème avec administration d’une faible dose à intervalle réduit (500 mg toutes les 6 heures) et d’une posologie traditionnelle (1000 mg toutes les 8 heures) pour ce qui est des résultats cliniques et des coûts pour le système de santé.Méthodes : La présente étude de cohorte rétrospective incluait 194 patients ayant reçu le méropénème selon le schéma posologique traditionnel (entre juillet 2006 et août 2008) et 188 patients l’ayant reçu avec administration d’une faible dose à intervalle réduit (entre décembre 2008 et octobre 2009) dans un grand hôpital de soins tertiaires et un hôpital communautaire. Le principal paramètre d’évaluation (succès clinique), les paramètres d’évaluation secondaires (taux de mortalité à l’hôpital dans les 30 jours, période de défervescence, durée du traitement et durée du séjour) et les coûts des médicaments ont été comparés entre les cohortes.Résultats : Les deux cohortes n’étaient pas significativement différentes en ce qui touche aux caractéristiques de base. Il n’y avait aucune difference statistiquement significative entre le schéma posologique avec administration d’une faible dose à intervalle réduit et la posologie traditionnelle en ce qui concerne le principal paramètre d’évaluation : le succès clinique a été obtenu respectivement chez 83,5 % (162/194) et chez 80,8 % (152/188) des patients. De même, aucune différence statistiquement significative n’a été relevée pour les paramètres d’évaluation secondaires. Par contre, le coût moyen des médicaments par patient par visite était de 222,23 $ pour le schéma posologique avec administration d’une faible dose à intervalle réduit et de 355,90 $ pour la posologie traditionnelle, une difference significative de plus de 130 $ par patient par visite (p < 0,001).Conclusion : Le schéma posologique de méropénème avec administration d’une faible dose à intervalle réduit produisait des résultats cliniques semblables à ceux de le posologie traditionnelle, et ce, pour un prix significativement plus faible.

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1611. Evaluating Clinical Outcomes and Efficacy of Daptomycin in Combination with a Beta-Lactam for the Treatment of Vancomycin-Resistant Enterococcus (VRE) Bacteremia

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1791 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S799-S800

Author(s):

Nerea Irusta ◽

Ana Vega ◽

Yoichiro Natori ◽

Lilian M Abbo ◽

...

Keyword(s):

Clinical Outcomes ◽

Primary Outcome ◽

Small Sample Size ◽

Univariate Analysis ◽

Small Sample ◽

Significant Difference ◽

Vancomycin Resistant ◽

Secondary Outcomes ◽

Related Mortality

Abstract Background In-vitro studies have shown synergistic bactericidal activity with daptomycin (DAP) plus β-lactam antimicrobials against vancomycin resistant enterococci (VRE). There is a paucity of data regarding clinical outcomes with this combination in VRE bloodstream infections (BSI). The purpose of this study was to assess the efficacy of DAP plus a β-lactam with in-vitro activity vs. other therapies for treatment of VRE BSI. Methods IRB-approved, single-center, retrospective study of patients with VRE BSI from 01/2018-09/2019. Patients were excluded if < 18 years old, pregnant, or incarcerated. The primary outcome was time-to-microbiological clearance. Secondary outcomes included infection-related mortality, 30-day all-cause mortality, and incidence of recurrent BSI within 30 days of index culture. Targeted DAP doses were ≥ 8mg/kg and based on MIC. Factors associated with significance for outcomes, via univariate analysis, were evaluated with multivariable logistic regression (MLR), removed in a backward-step approach. Results A total of 85 patients were included, 23 of which received DAP plus a β-lactam. The comparator arm included linezolid or DAP monotherapy. Patients with combination therapy had significantly higher Charlson Comorbidity Index (CCI) (p=0.013) and numerically higher Pitt Bacteremia scores (PBS) (p=0.087) (Table 1). There was no difference seen in the primary outcome (Table 2). Secondary outcomes are provided in Table 2. The presence of polymicrobial infection and higher PBS were significantly associated with infection-related mortality (p=0.008 and p=0.005, respectively) by MLR. A Mann Whitney U test indicated that presence of infection-related mortality was greater for patients with higher MICS (U=20.5, p=0.06). The presence of an underlying source may be related to recurrence of BSI (p=0.075). Table 1: Patient Characteristics Table 2. Primary and Secondary Outcomes Conclusion We did not find a significant difference in time-to-microbiological clearance, although patients treated with DAP and a β-lactam had higher CCI and PBS. These results are limited by retrospective design, small sample size, and potential selection bias. Prospective randomized studies are needed to further validate these findings. Disclosures All Authors: No reported disclosures

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8 The Adoption of Rescue Colloid During Resuscitation Decreases Fluid Administered and Returns End Organ Perfusion

Journal of Burn Care & Research ◽

10.1093/jbcr/iraa024.012 ◽

2020 ◽

Vol 41 (Supplement_1) ◽

pp. S8-S9

Author(s):

Paul Comish ◽

Manuel Castillo-Angeles ◽

Deborah Carlson ◽

Herb Phelan ◽

Brett Arnoldo ◽

...

Keyword(s):

Clinical Outcomes ◽

Urine Output ◽

Primary Outcome ◽

Organ Function ◽

Significant Difference ◽

Thermal Injuries ◽

Secondary Outcomes ◽

Total Urine ◽

A Prospective Study ◽

Injured Patients

Abstract Introduction Traditionally lactated ringers (LR) has been utilized for the resuscitation of thermally injured patients. Both the Parkland and Brooke formula’s include the addition of albumin as part of their ongoing resuscitation after the initial 24 hours. Over the last five years, the addition of albumin to current protocols has been reported to decrease fluid creep. Our institution has adopted these practices and here we present our findings during the adoption phase of rescue albumin during resuscitation. Methods A prospectively collected burn registry was queried for patients greater than 18 years, between July 2017 and December 2018, who sustained a thermal injury and required a formal resuscitation. Patients were included in the rescue albumin group if the treating team administered 25% albumin for a sustained urine output less than 0.5ml/kg over 2–3 hours. Our primary outcome was a total volume of resuscitation ml LR/%TBSA/kg. Our secondary outcomes were the change in resuscitation rate and the change in urine output three hours before and three hours after the administration of albumin normalized to %TBSA/kgs. Finally, we compared clinical outcomes of ICU days and length of stay (LOS) between the rescue albumin and no rescue albumin group. Results A total of 92 patients with thermal injuries were included: median age was 40 (IQR 31–57), 73% were male, and 30 patients received rescue albumin. The TBSA was increased in those who received rescue albumin (47% vs 38% p=0.02). Despite a higher TBSA in the albumin group the total LR given during resuscitation normalized to TBSA and KG was not significantly different (ml LR/%TBSA/kg: 3.66 vs. 4.31, p=0.149). Similarly, the total urine output (UOP) and the adjusted UOP showed no significant difference, total UOP 1,781 ml no albumin vs 1,483ml rescue albumin (p=0.149) and UOP/kg 21.7ml no albumin vs 18.9 ml rescue albumin (p=0.341). But our secondary outcomes did demonstrate there was a decrease in the LR rate by -0.06 ml/%TBSA/kg/hr (SD 0.13) and an increase in the UOP by 1.61 ml/kg/hr (SD 3.25), see Figure 1. Conclusions Rescue albumin administration decreases the amount of fluid administered during resuscitation, and increases end organ function as evidenced by increase UOP. This was observed in patients who sustained larger burns and were failing traditional increases in resuscitation LR. These findings are the basis for a modification to our current protocol and a prospective study of the clinical outcomes. Applicability of Research to Practice We believe these findings support the limited use of albumin in patients who fail a conventional LR based resuscitation.

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Clinical outcome and safety of selective renal artery embolization using permanent occlusive agents for acute renal bleeding

Egyptian Journal of Radiology and Nuclear Medicine ◽

10.1186/s43055-020-00328-6 ◽

2020 ◽

Vol 51 (1) ◽

Author(s):

Mohamed S. Alwarraky ◽

Mohamed M. Abdallah ◽

Mohamed S. Elgharbawy

Keyword(s):

Renal Artery ◽

Medical Records ◽

Primary Outcome ◽

Clinical Success ◽

Single Session ◽

Artery Embolization ◽

Cyanoacrylate Glue ◽

Significant Difference ◽

Renal Artery Embolization ◽

Secondary Outcomes

Abstract Background To evaluate how far is selective renal artery embolization (RAE) using permanent agents effective in treating acute renal artery bleeding. We retrospectively reviewed the medical records of patients (n = 45) with renal bleeding who were managed by selective RAE using coils, N-butyl-cyanoacrylate glue (NBCA glue), and polyvinyl alcohol (PVA). Data retrieved included the cause, number, and type of the bleeding lesions as well as the results of the embolization for 1 year after RAE. Clinical success was the primary outcome while re-bleeding and complications were the secondary outcomes. Results There were 55 bleeding lesions detected by angiography in the included 45 patients. Coils were used in 23/45 patients (51.1%), NBCA glue in 15/45 patients (33.3%), and PVA in 7 patients (15.6%). Bleeding could be controlled with embolization in a single session in 41/45 patients with primary clinical success 91.1%. Four patients needed re-embolization sessions to control bleeding and only one patient was controlled, giving secondary clinical success of 92.3%. Three patients failed to respond to embolization and nephrectomy was done. Iatrogenic dissection of the segmental branch was seen in one patient. Post embolization syndrome was seen in 14/45 patients (31.1%). Non-target embolization was seen in 2 patients: one during treatment with NBCA glue and the other with PVA. No other complications were recorded. No significant differences between clinical success among coil, NBCA glue, and PVA subgroups (P > 0.05). Conclusion Selective RAE using permanent agents is effective in controlling renal bleeding and no significant difference among coil, NBCA glue, and PVA.

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Effect of Sustained Uterine Compression versus Uterine Massage on Blood Loss after Vaginal Delivery: A Randomized Controlled Trial

American Journal of Perinatology ◽

10.1055/s-0041-1739409 ◽

2021 ◽

Author(s):

Labib M. Ghulmiyyah ◽

Alaa El-Husheimi ◽

Ihab M. Usta ◽

Cristina Colon-Aponte ◽

Ghina Ghazeeri ◽

...

Keyword(s):

Blood Loss ◽

Vaginal Delivery ◽

Postpartum Hemorrhage ◽

Primary Outcome ◽

Dropout Rate ◽

Significant Difference ◽

Uterine Massage ◽

Secondary Outcomes ◽

Group 2 ◽

Group 1

Objective This study aimed to compare the effectiveness of sustained uterine compression versus uterine massage in reducing blood loos after a vaginal delivery. Study Design This was a prospective randomized trial conducted at the American University of Beirut Medical Center (AUBMC) between October 2015 and October 2017. Inclusion criteria were women with a singleton pregnancy at ≥36 weeks of gestation, with less than three previous deliveries, who were candidates for vaginal delivery. Participants were randomized into two groups, a sustained uterine compression group (group 1) and a uterine massage group (group 2). Incidence of postpartum hemorrhage (blood loss of ≥500 mL) was the primary outcome. We assumed that the incidence of postpartum hemorrhage at our institution is similar to previously published studies. A total of 545 women were required in each arm to detect a reduction from 9.6 to 4.8% in the primary outcome (50% reduction) with a one-sided α of 0.05 and a power of 80%. Factoring in a 10% dropout rate. Secondary outcomes were admission to intensive care unit (ICU), postpartum complications, drop in hemoglobin, duration of hospital stay, maternal pain, use of uterotonics, or of surgical procedure for postpartum hemorrhage. Results A total of 550 pregnant women were recruited, 273 in group 1 and 277 in group 2. There was no statistically significant difference in baseline characteristics between the two groups. Type of anesthesia, rate of episiotomy, lacerations, and mean birth weight were also equal between the groups. Incidence of the primary outcome was not different between the two groups (group 1: 15.5%, group 2: 15.4%; p = 0.98). There was no statistically significant difference in any of the secondary outcomes between the two groups, including drop in hemoglobin (p = 0.79). Conclusion There was no difference in blood loss between sustained uterine compression and uterine massage after vaginal delivery. Key Points

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Efficiency and safety of ondansetron in preventing postanaesthesia shivering

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2016.0152 ◽

2016 ◽

Vol 98 (6) ◽

pp. 358-366 ◽

Cited By ~ 1

Author(s):

k He ◽

H Zhao ◽

HC Zhou

Keyword(s):

Lower Risk ◽

Randomised Controlled Trials ◽

Primary Outcome ◽

Outcome Measure ◽

Meta Analysis ◽

Primary Outcome Measure ◽

Cochrane Library ◽

Significant Difference ◽

Secondary Outcomes ◽

Randomised Controlled

Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies. However, its efficiency and safety are still disputable. We therefore performed an updated meta-analysis of randomised controlled trials (RCTs) for evaluation and to clarify this issue. Methods A literature search using the PubMed, Embase™ and Cochrane Library databases was performed (from inception to January 2015). RCTs that evaluated the efficiency and safety of ondansetron in the prevention of PAS were included in the meta-analysis. The primary outcome measure was incidence of PAS, and secondary outcomes included subgroup analysis and the side effects of ondansetron. Results A total of 8 RCTs containing 905 subjects were identified as suitable for this review. Compared with placebo, ondansetron was associated with a significant reduction of PAS (relative risk [RR]: 0.33, 95% confidence interval [CI]: 0.19–0.58, p=0.0001) while no difference was detected between ondansetron and pethidine (RR: 0.89, 95% CI: 0.41–1.94, p=0.78). There was no significant difference between ondansetron and placebo or pethidine in terms of risk of bradycardia but ondansetron was associated with a lower risk of hypotension (RR: 0.26, 95% CI: 0.08–0.79, p=0.020) than placebo. There was no difference in hypotension when ondansetron was compared with pethidine. Conclusions Ondansetron can prevent PAS effectively and reduce the risk of hypotension.

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879. Evaluation of the Incidence of Hypertension, Diabetes, and Hyperlipidemia in Patients on Antiretroviral Therapy

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1074 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S531-S531

Author(s):

Niha Idrees ◽

Yu Jin Hwang ◽

Sabreen Arman ◽

Razan Hendi ◽

Sarah M Michienzi ◽

...

Keyword(s):

Weight Gain ◽

Primary Outcome ◽

Integrase Inhibitor ◽

Transcriptase Inhibitor ◽

Drug Classes ◽

Significant Difference ◽

Chi Squared ◽

Secondary Outcomes ◽

Metabolic Comorbidities

Abstract Background Although integrase inhibitor (INSTI)-based regimens have been associated with weight gain, there is limited data on whether INSTIs cause long-term metabolic consequences. This study evaluated the effect of INSTIs on the development of metabolic comorbidities compared to non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)-based therapies in patients in the Illinois Department of Corrections. Methods This retrospective cohort study consisted of incarcerated adult patients living with HIV and receiving a guideline-recommended regimen between 7/12/10 and 12/31/19. Patients with a pre-existing diagnosis of diabetes, hypertension, or hyperlipidemia, or lack of medical follow-up data were excluded. The primary outcome was to compare the incidence of a metabolic comorbidity between regimens. Secondary outcomes compared the incidence of weight gain, diabetes, hypertension, and hyperlipidemia as separate outcomes between drug classes. Demographics and pertinent labs were collected. Data was analyzed with ANOVA, chi-squared, and paired t-tests. The primary outcome was adjusted for age, race, use of antipsychotic medications, and family history of metabolic comorbidities. Results A total of 206 patients were included in the analysis with mean follow-up time of 31.5 ± 19.4 months. Majority of patients were Black (69%) and male (91%). A total of 42 patients developed a metabolic comorbidity (Table 1). After adjustment for confounding factors, there was a significant difference in the development of comorbidities between the treatment groups (p=0.031) with INSTI use being more likely to develop a comorbidity than NNRTI (p=0.004). No difference was found between INSTI and PI use (p=0.518). Development of hypertension was significantly higher in the INSTI group than NNRTI group (p=0.014), while the development of diabetes and hyperlipidemia were not. Weight and BMI were significantly higher regardless of antiretroviral (Table 2). No differences were found in the primary outcome between agents within the same drug class or between 1st or 2nd generation INSTIs. Table 1. Results of Primary and Secondary Outcomes Table 2. Impact of HIV regimen on weight and BMI after 1 year Conclusion All antiretrovirals were linked to weight gain but INSTIs were associated with increased incidence of hypertension. Disclosures All Authors: No reported disclosures

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Impact of hand dominance on effectiveness of chest compressions in a simulated setting: a randomised, crossover trial

Australasian Journal of Paramedicine ◽

10.33151/ajp.16.672 ◽

2019 ◽

Vol 16 ◽

Author(s):

Jamie Cross ◽

Tommy Lam ◽

Joel Arndell ◽

John Quach ◽

Buck Reed ◽

...

Keyword(s):

Primary Outcome ◽

Crossover Trial ◽

Recovery Period ◽

Outcome Data ◽

Dominant Hand ◽

Hand Dominance ◽

Modest Improvement ◽

Significant Difference ◽

Secondary Outcomes ◽

The Impact

Aim External cardiac compressions (ECC) are a critical component in determining the effectiveness of cardiopulmonary resuscitation (CPR). Guidelines prior to the 2010 International Liaison Committee on Resuscitation directed rescuers to place the heel of the dominant hand directly on the chest when performing ECC, however current guidelines are silent on this issue. Existing research is inconsistent in findings, and heterogeneous in design and participants. The aims of this pilot study were to: 1) investigate the impact of hand dominance on effectiveness of ECC; and 2) generate outcome data to inform sample size calculations for a larger future study.Methods This study utilised a single blinded, prospective randomised crossover trial design. Each participant was allocated to a ‘dominant hand on chest’ (DHOC) or ‘non-dominant hand on chest’ (NDHOC) group. On a simulation manikin, participants in the DHOC group performed 3 minutes of ECC with dominant hand on the chest and non-dominant hand supporting, followed by a ‘rest and recovery’ period and then a second 3-minute period of ECC with the hand reversed such that the non-dominant hand was on the chest. The NDHOC group performed the same series of compressions but in reverse order. The primary outcome measure was effectiveness of ECC, determined by a percentage-based ‘CPR score’ (‘CS’). Secondary outcomes were compression depth, rate and release. The Wilcoxon rank-sum (Mann-Whitney) test was used due to the non-normal distribution of the data. Due to the crossover design, hierarchical linear regression was used to assess for a period or cross over effect. Results For the primary outcome of this study, we have found no significant difference in CS between DHOC and NDHOC (69.9% (SD=29.9) vs. 69.1% (SD=34.1); p=0.92), respectively. There were no differences in the secondary outcomes of compression rate and depth, though compression release was improved in the DHOC group (53% vs. 42%; p=0.02).ConclusionIn this randomised crossover study conducted in a simulation context there was no difference in ECC effectiveness measured by an overall effectiveness outcome according to placement of the dominant or non-dominant hand on the chest during compressions. A modest improvement in ECC release was seen in the dominant hand on chest group. While the study was underpowered, the results support an approach involving rescuers placing whichever hand they are most comfortable with on the chest irrespective of handedness.

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Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care

Psychological Medicine ◽

10.1017/s0033291718001666 ◽

2018 ◽

Vol 49 (6) ◽

pp. 1005-1014 ◽

Cited By ~ 1

Author(s):

Heidi Frølund Pedersen ◽

Johanne L. Agger ◽

Lisbeth Frostholm ◽

Jens S. Jensen ◽

Eva Ørnbøl ◽

...

Keyword(s):

Primary Outcome ◽

Psychological Treatment ◽

Secondary Outcome ◽

Health Improvement ◽

Extended Version ◽

Functional Somatic Syndromes ◽

Global Improvement ◽

Acceptance And Commitment ◽

Significant Difference ◽

Secondary Outcomes

AbstractBackgroundPsychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type.MethodsIn a randomised controlled three-armed trial, consecutively referred patients aged 20–50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses.ResultsA total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4–6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC.ConclusionsPatients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.

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The appropriateness of referrals to a pediatric emergency department via a telephone health line

CJEM ◽

10.1017/s1481803500011106 ◽

2009 ◽

Vol 11 (02) ◽

pp. 139-148 ◽

Cited By ~ 10

Author(s):

Tawfik Al-Abdullah ◽

Amy C. Plint ◽

Alyson Shaw ◽

Rhonda Correll ◽

Isabelle Gaboury ◽

...

Keyword(s):

Emergency Department ◽

Resource Use ◽

Primary Outcome ◽

Pediatric Emergency ◽

Pediatric Emergency Department ◽

Lengths Of Stay ◽

Triage Category ◽

Significant Difference ◽

Secondary Outcomes ◽

Explicit Criteria

ABSTRACT Objective: We compared the appropriateness of visits to a pediatric emergency department (ED) by provincial telephone health line–referral, by self- or parent-referral, and by physician-referral. Methods: A cohort of patients younger than 18 years of age who presented to a pediatric ED during any of four 1-week study periods were prospectively enrolled. The cohort consisted of all patients who were referred to the ED by a provincial telephone health line or by a physician. For each patient referred by the health line, the next patient who was self- or parent-referred was also enrolled. The primary outcome was visit appropriateness, which was determined using previously published explicit criteria. Secondary outcomes included the treating physician's view of appropriateness, disposition (hospital admission or discharge), treatment, investigations and the length of stay in the ED. Results: Of the 578 patients who were enrolled, 129 were referred from the health line, 102 were either self- or parent-referred, and 347 were physician-referred. Groups were similar at baseline for sex, but health line–referred patients were significantly younger. Using explicitly set criteria, there was no significant difference in visit appropriateness among the health line–referrals (66%), the self- or parent-referrals (77%) and the physician-referrals (73%) (p = 0.11). However, when the examining physician determined visit appropriateness, physician-referred patients (80%) were deemed appropriate significantly more often than those referred by the health line (56%, p < 0.001) or by self- or parent-referral (63%, p = 0.002). There was no significant difference between these latter 2 referral routes (p = 0.50). In keeping with their greater acuity, physician-referred patients were significantly more likely to have investigations, receive some treatment, be admitted to hospital and have longer lengths of stay. Patients who were self- or parent-referred, and those who were health line–referred were similar to each other in these outcomes. Conclusion: There was no significant difference in visit appropriateness based on the route of referral when we used set criteria; however, there was when we used treating physician opinion, triage category and resource use.

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Effectiveness and tolerability of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis

Rheumatology ◽

10.1093/rheumatology/keab313 ◽

2021 ◽

Author(s):

Janne Heuvelmans ◽

Nathan den Broeder ◽

Geke A H van den Elsen ◽

Alfons A den Broeder ◽

Bart J F van den Bemt

Keyword(s):

Rheumatoid Arthritis ◽

Retrospective Cohort ◽

Primary Outcome ◽

Real Life ◽

Treat To Target ◽

Oral Methotrexate ◽

Real Life Setting ◽

Significant Difference ◽

The Mean ◽

Secondary Outcomes

Abstract Objectives The aim of this study was to compare the effectiveness and tolerability between oral methotrexate (MTX) and subcutaneous MTX in a large group of rheumatoid arthritis (RA) patients in a real-life setting. Methods In this retrospective cohort study, adult patients with clinical diagnosis of RA who started MTX treatment (monotherapy or combined with hydroxychloroquine), either started with oral or subcutaneous MTX. The primary outcome was superiority testing of between group difference in change in DAS28CRP between baseline and 3–6 months, and subsequent non inferiority testing (NI margin 0.6) analyses in case of non-superiority. Secondary outcomes included MTX dose, side effects, laboratory abnormalities, and use of comedication. Results 640 RA patients were included: 259 started with oral MTX and 381 with subcutaneous. There was no significant difference in ΔDAS28CRP, after adjusting for confounding, 0.13 (95%-CI: -0.14, 0.40), and oral MTX strategy was non inferior to subcutaneous. The mean MTX dose was slightly lower for the oral strategy (18.0 SD6.9 vs 19.9 SD8.2, p= 0.002), which was accompanied by a lower cumulative incidence of adverse events (41% vs 52%, p= 0.005). No differences were seen in use of other comedication. Conclusions Starting with oral MTX in RA in a real-life setting is non inferior to a subcutaneous MTX treatment with regard to disease activity control, at least when used in dosages up to 25 mg and on a background of HCQ cotreatment and a treat-to-target approach. In addition, tolerability was better. This supports the strategy of starting with oral MTX.

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