scholarly journals Outcome Squares integrating efficacy and safety, as applied to functioning pituitary adenoma surgery

2021 ◽  
Author(s):  
Friso de Vries ◽  
Daniel J Lobatto ◽  
Marco J T Verstegen ◽  
Pieter J Schutte ◽  
Irene C Notting ◽  
...  
Keyword(s):  
Surgical Procedures ◽  
Retrospective Chart Review ◽  
Complication Rates ◽  
Efficacy And Safety ◽  
Tertiary Referral Centre ◽  
Patient Level ◽  
Good Outcome ◽  
Poor Outcome

Abstract Purpose Transsphenoidal surgery is standard care in the treatment of hormone-secreting pituitary adenomas. Current clinician-reported surgical outcome measures are one-dimensional, typically focussing primarily on complete or partial resection and secondarily on complication rates. However, outcomes are best reflected by the delicate balance of efficacy and complications at patient level. This study proposes a novel way to classify and report outcomes, integrating efficacy and safety at the patient level. Methods Retrospective chart review of all pure endoscopic transsphenoidal surgical procedures for acromegaly, Cushing’s disease, and prolactinoma between 2010-2018 in a single tertiary referral centre. We present our results in a classic (remission and complications separate) and in a novel Outcome Square integrating both outcomes, focusing on intended and adverse effects (long-term complications). This resulted in four outcome groups, ranging from good to poor. We use this approach to present these outcomes for several subgroups. Results 198 surgical procedures were included (44 reoperations). Remission was achieved in 127 operations (64%). Good outcome was observed after 121 (61%), and poor outcome after 6 (3%) operations. When intended effect of surgery was applied (instead of remission), good outcome as intended was achieved after 148 of 198 surgeries (75%) and poor outcome after 4 (2%). Conclusion Quality of a surgical intervention can be presented in 4 simple categories, integrating both efficacy and safety with flexibility to adapt to the individualized situation at patient, disease, and surgical strategy and to the outcome of interest.

Abstract 110: Long-Term Health Status Outcomes in Young Women with Acute Myocardial Infarction: Results from the VIRGO Study

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Rachel P Dreyer ◽  
Kelly M Strait ◽  
Judith H Lichtman ◽  
Nancy Lorenze ◽  
Gail D'Onofrio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Health Status ◽  
Young Women ◽  
Short Form ◽  
P Values ◽  
Poor Outcome

Background: Despite the excess risk of mortality in young women following acute myocardial infarction (AMI), little effort has been made to describe their long-term outcomes, particularly with respect to their health status (symptoms, function and quality of life). Accordingly, we assessed gender differences in 1-year health status outcomes after AMI. Methods: Data was used from the VIRGO study, an observational cohort of patients aged ≤55 years with AMI in the US and Spain (n=3,501, 67% women). Clinical data was abstracted from medical records and health status was obtained through patient interviews at the time of hospitalization and at 1-year later [Short Form 12 (SF-12) and the Seattle Angina Questionnaire (SAQ)]. Patient scores were categorized as “bad” if they had below average scores on the SF-12 components, had a score below 100 on the SAQ physical limitations (PL) or the SAQ angina frequency (AF), or had a score below 75 on the SAQ quality of life (QOL) at either baseline or 1-year. Patients were classified as having a “poor” outcome for a measure if they had a “bad” score at both baseline and 1-year or had a “bad” score at 1-year. Logistic regression models were used to assess factors associated with having a “poor” outcome for each scale. Results: The median age was 48 years (IQR: 44, 52). Women were more likely to present with diabetes (39% vs. 27%), obesity (51% vs. 45%), stroke (5% vs. 2%), heart failure (5% vs. 2%), lung disease (13% vs. 5%), and depression (48% vs. 24%, all P values <0.0001). Women were more likely to have “poor outcomes” compared with men (SF-12 PCS 46% vs. 30%; SF-12 MCS 47% vs. 30%; SAQ AF 32% vs. 25%; SAQ PL 29% vs. 20%; SAQ QOL 42% vs. 28%, all p-values <0.001). Female gender, prior AMI/percutaneous coronary intervention/coronary artery bypass grafting, and smoking within 30 days were independent predictors of having a “poor” outcome for all health status measures. Specifically, women had an increased odds of having a “poor” outcome on the SF-12 PCS (OR=2.05; 95% CI 1.69, 2.48), MCS (OR=1.98; 95% CI 1.65, 2.39), SAQ AF (OR=1.39; 95% CI 1.15, 1.67), SAQ PL (OR=1.62; 95% CI 1.32, 1.99) and the SAQ QOL scale (OR=1.84; 95% CI 1.53, 2.22), as compared with men. Conclusion: Compared with men, young women are more likely to have “poor” health status outcomes after AMI. This information is critically important in developing targets for gender-specific interventions to improve young women’s recovery post AMI.

65 Complication rate of cuffed versus uncuffed PICC lines placed by interventional radiology in pediatric patients

2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e46-e46
Author(s):  
Maria Al Bandari ◽  
John Donnellan ◽  
Filomena Tavares
Keyword(s):  
Chart Review ◽  
Pediatric Patients ◽  
Retrospective Chart Review ◽  
Electronic Record ◽  
Subject Area ◽  
Mechanical Failure ◽  
Complication Rates ◽  
Tertiary Referral Centre ◽  
Complications Rate ◽  
Premature Removal

Abstract Primary Subject area Paediatric Radiology Background Peripherally inserted central catheters are commonly used in pediatrics to offer stable access for administering prolonged courses of antibiotics, chemotherapy, parenteral nutrition, or other intravenous fluids. Objectives To assess the complication rates of cuffed versus uncuffed PICCs in a pediatric tertiary referral centre. Design/Methods Research ethics board approval was sought and granted. A dual arm study design was employed with a retrospective chart review of PICCs inserted between June 2017 - June 2018, and a prospective chart review of PICCS inserted between January 2019 - June 2019 at a large tertiary pediatric referral center. Data collected from the electronic record included age, weight, and diagnosis. Line type, size, location, insertion and removal dates, and indications were recorded. Primary outcome was removal of PICC after completion of therapy or premature removal due to the following complications: infection, thrombosis, or mechanical failure (defined as catheter breakage, blockage, or dislodgement). Results The study included 266 patients. Across all patients weighing &lt; 10 kg, 90.5% of those with cuffed PICCs and 65% of those with uncuffed catheters completed therapy. The predominant complication resulting in premature removal was mechanical failure, but this was only observed in patients with uncuffed catheters (25%). Infection was also observed only in uncuffed catheters (10%), and thrombosis (4.8%) was only in the cuffed lines. For patients weighing ≥ 10 kg, 86% of those with cuffed PICCs and 77.2% with uncuffed catheters completed therapy. More complications were observed in uncuffed catheters (infection 7.7%, mechanical failure 6.6%, thrombosis 5%). Infection resulting in premature removal occurred in 7% of cuffed catheters. There was no reported mechanical failure or thrombosis in the cuffed group. The distribution of diagnoses was relatively homogenous between the groups for most diagnoses. However, there was a higher percentage of oncology patients in the uncuffed group (23%) than the cuffed group (7%) due to the need for power-injectable lines, which were not available in a cuffed variant during this study. Conclusion All-cause pediatric PICC-associated complications rate in the neonate group for patients &lt; 10kg in the uncuffed group is 35% and in the cuffed group is 4.8%. Whereas in the pediatric group ≥ 10kg, all-cause pediatric PICC-associated complications rate in the uncuffed group is 19.3% and in the cuffed group is 7%. There were no mechanical complications in the cuffed group and the vast majority of lines made it to completion of therapy. This work supports utilization of cuffed PICC lines in selected pediatric patients.

Surgical Repair of Ileovesical Fistulas: Long-term Complications, Quality of Life, and Patient Satisfaction

2014 ◽  
Vol 80 (12) ◽  
pp. 1207-1211 ◽  
Author(s):  
Jeffrey W. Hastings ◽  
Malika Garg ◽  
Elizabeth T. Lynn ◽  
Celia M. Divino
Keyword(s):  
Quality Of Life ◽  
Patient Satisfaction ◽  
Statistical Significance ◽  
Retrospective Chart Review ◽  
Administrative Database ◽  
Low Incidence ◽  
Assess Quality

Ileovesical fistulas (IVFs) are an uncommon complication of Crohn's disease. The aim of this study is to compare long-term surgical outcomes, assess quality of life, and quantify patient satisfaction after IVF repair. A retrospective chart review followed by a prospective survey was carried out. Survey questions focused on patient satisfaction and quality of life after repair of IVF. Fifty-one patients were identified from an administrative database. Mean follow-up was 4.3 years with a response rate of 51 per cent. At the time of the study, 0 per cent mortality and 16 per cent morbidity were recorded. No recurrence was noted. There was no statistical significance in incidence of complications between laparoscopic and open surgery. Statistically significant differences in single-stage versus multistage operations were found in postoperative day of discharge ( P < 0.001) and patient satisfaction ( P = 0.049). Ninety-eight per cent of patients reported extreme satisfaction with their surgery and an improvement in quality of life. A low incidence of morbidity and recurrence supports early surgical intervention in IVFs.

scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
Open Label ◽  
Parallel Group ◽  
Secondary Objective ◽  
Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

scholarly journals Long-Term Results of Neurological Outcome, Quality of Life, and Cosmetic Outcome After Cranioplastic Surgery: A Single Center Study of 202 Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Henrik Giese ◽  
Jennifer Antritter ◽  
Andreas Unterberg ◽  
Christopher Beynon
Keyword(s):  
Quality Of Life ◽  
Regression Analysis ◽  
Neurological Outcome ◽  
Long Term Results ◽  
Complication Rates ◽  
Long Term Outcome ◽  
Sf 36

Objective: An increased interest in the surgical procedures of decompressive craniectomy (DC) and subsequent cranioplasty (CP) has emerged during the last decades with specific focus on mortality and complication rates. The aim of the present study was to evaluate long-term neurological and cosmetic outcomes as well as Quality of Life (QoL) after CP surgery.Methods: We retrospectively reviewed the medical records of CP patients treated at our institution between 2004 and 2014 and performed a follow-up examination, with evaluation of neurological outcome using the modified Rankin Scale (mRS) and the Glasgow outcome scale (GOS), QoL (SF-36 and EQ-5D-3L). Furthermore, the cosmetic results after CP were analyzed.Results: A total of 202 CP-patients were included in the present study. The main indications for DC and subsequent CP were space-occupying cerebral ischemia (32%), traumatic brain injury (TBI, 26%), intracerebral or subarachnoid hemorrhage (32%) and infection (10%). During a mean follow-up period of 91.9 months 46/42.6% of patients had a favorable neurological outcome (mRS ≤ 3/GOS ≥ 4). Patients with ischemia had a significant worse outcome (mRS 4.3 ± 1.5) compared with patients after TBI (3.1 ± 2.3) and infectious diseases requiring CP (2.4 ± 2.3). The QoL analysis showed that &lt;1/3rd of patients (31.2%) had a good QoL (SF-36) with a mean EQ-5D-VAS of 59 ± 26. Statistical analysis confirmed a significant worse QoL of ischemia patients compared to other groups whereas multivariate regression analysis showed no other factors which may had an impact on the QoL. The majority (86.5%) of patients were satisfied with the cosmetic result after CP and regression analysis showed no significant factors associated with unfavorable outcomes.Conclusion: Long-term outcome and QoL after CP were significantly influenced by the medical condition requiring DC. Early detection and evaluation of QoL after CP may improve the patient's outcome due to an immediate initiation of targeted therapies (e.g., occupational- or physiotherapy).

scholarly journals Efficacy of the trans‑obturator and retropubic mid‑urethral slings for stress urinary incontinence

2019 ◽  
Vol 88 (3-4) ◽  
pp. 115-124
Author(s):  
Matej Keršič ◽  
Maruša Keršič ◽  
Tina Kunič ◽  
Matija Barbič ◽  
Ivan Verdenik ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Incontinence ◽  
Surgical Treatment ◽  
Short Form ◽  
Long Term Results ◽  
Efficacy And Safety ◽  
Severity Scale ◽  
Exclusion Criteria

Background: The aim of our study was to report the extended long-term results of the use of tension-free vaginal tape (TVT) and trans-obturator tape (TOT) for the treatment of female urinary stress incontinence (SUI) at the Division of Gynaecology and Obstetrics / UMC Ljubljana. There are few data on this topic in the literature. Our aim was to find out whether and how the procedure improved the patients’ quality of life and for how long, whether the patients had complications after the procedure, and how this type of procedure affected the long-term results.Methods: A retrospective clinical trial comparing the use of TVT and TOT was carried out from January to August 2017 and included all the patients operated on at the Division of Gynaecology and Obstetrics / UMC Ljubljana with TVT or TOT procedure for stress or mixed urinary incontinence (UI) associated with urethral hyper mobility (the stress component was clinically predominant). The exclusion criteria were more than 10 years from procedure, age more than 80 years in 2016, previous anti-incontinence surgery and/or pelvic organ prolapse more than stage I on POP–q in any vaginal compartment. After inclusion and exclusion criteria, 1104 patients were sent quality-of-life questionnaires (PGI-S, PGI-I, SANDVIK SEVERITY SCALE, UDI-6, IIQ-7, ICIQ-UI Short Form (Slovenian)) with questions about the diagnosis, procedures, complications, reoperations, post-operative results, and satisfaction with the procedure. Till August 2017 (6 months after sending) we received 466 questionnaires (42.2 % response rate). After 225 questionnaires were excluded due to incomplete data, 241 questionnaires were analysed.Results: In the analysed group of patients (N = 241), 189 (78 %) had TOT and 52 (22 %) had TVT. Our retrospective study has confirmed that the efficacy and safety of TOT and TVT in the surgical treatment of SUI are comparable. The TOT and TVT groups did not differ significantly from each other in PGI-S, PGI-I, SANDVIK SEVERITY SCALE, UDI-6, IIQ-7, and ICIQ-UI Short Form or in postoperative complication rate. Repeat surgery was needed in 25/189 (13.2 %) TOT patients and 12/52 (23.1 %) TVT patients; p = 0.082. Urinary retention appeared in 18/189 (9.5 %) TOT patients and 7/52 (13.5 %) TVT patients; p = 0.411. Mesh erosion/inflammation appeared in 12/189 (6.3 %) TOT patients and 2/52 (38 %) TVT patients; p = 0495.Conclusion: We can conclude that the efficacy and safety of TOT and TVT in the surgical treatment of SUI are comparable. The choice of the technique should be based on the relative pros and cons of techniques and the surgeon’s experience.

scholarly journals A pilot study of topiramate in children with Lennox-Gastaut syndrome

1999 ◽  
Vol 57 (2A) ◽  
pp. 167-175 ◽  
Author(s):  
MARILISA M. GUERREIRO ◽  
MARIA LUIZA G. MANREZA ◽  
ANNA ELISA SCOTONI ◽  
E.A. SILVA ◽  
CARLOS A. M. GUERREIRO ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Adjunctive Therapy ◽  
Term Treatment ◽  
Daily Activities ◽  
Efficacy And Safety ◽  
Long Term Treatment ◽  
Chronic Use

We conducted an open, add-on study with topiramate (TPM) as adjunctive therapy in Lennox-Gastaut syndrome (LGS), to assess the long-term efficacy and safety and to evaluate quality of life (QL) measurements in the chronic use of TPM. We studied 19 patients (11 male; age ranging from 4 to 14 years) with uncontrolled seizures receiving 2-3 anti-epileptic drugs. Patients were followed up to 36 months of treatment. A questionnaire was used to query parents about QL. Seven patients completed the study at 36 months and seizure frequency was reduced > 75% in 4, and < 50% in 3 patients. Two children became seizure free for more than 24 months. Most side effects were CNS related, with the most frequent being somnolence and anorexia. These were generally transient. One patient dropped-out due to powder in the urine. None of the patients required hospitalization. At 36 months, patients' alertness (2/7), interaction with environment (5/7), ability to perform daily activities (5/7), and verbal performance (6/7) improved on TPM. We conclude that TPM may be useful as adjunctive therapy in the treatment of LGS. The efficacy of TPM was maintained in long-term treatment in more than 40% of patients, long term safety was confirmed and QL improved on TPM.

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