scholarly journals Randomized Prospective Trial Exploring the Impact of Structured Journaling in Patients With Sarcoma on the Management of Treatment-Related Adverse Events

2021 ◽  
pp. OP.21.00309
Author(s):  
N. J. Speece ◽  
Menglin Xu ◽  
Gabriel Tinoco ◽  
David A. Liebner ◽  
James L. Chen
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Symptom Management ◽  
Low Cost ◽  
Prospective Trial ◽  
Prospective Randomized Trial ◽  
Event Management ◽  
Self Monitoring ◽  
Patient Focus Group ◽  
The Impact

PURPOSE: Treatment-related adverse events associated with systemic anticancer therapy (SACT) can deter patients with sarcoma from completing treatment. With self-monitoring, patients may be better empowered to self-advocate for improved symptom management. We hypothesized that by incorporating journaling, a structured form of self-monitoring, care team communication, and symptom management would improve. We thus designed a prospective randomized trial exploring journaling as a therapeutic adjuvant for symptom management ( NCT03258892 ). METHODS: Participants with sarcoma initiating SACT were randomly assigned to receive either a symptom management journal at the start of SACT or after completing two cycles of SACT. Symptom journals were designed jointly by a cancer patient focus group and by education experts. Journals were reviewed with clinical staff at each visit. Participant responses were obtained through questionnaires. Patient call volume was obtained through the electronic health record. RESULTS: Of 64 participants consented for the trial, 53 were evaluable for analysis. Fifty-five percent of participants reported that the journal was at least moderately useful. These participants were more likely to report improved communication scores ( P = .027), symptom management ( P = .011), and quality of life (QOL) ( P = .019). Participants who received the journal early were less likely to report a decrease in QOL as compared with the late journal group ( P = .757 v P = .035). CONCLUSION: To our knowledge, this is the first prospective randomized trial evaluating the use of structured journaling as a low-cost means to improve treatment-related adverse event management and QOL in patients with sarcoma undergoing SACT. These promising results will need to be confirmed by additional studies.

scholarly journals Pentoxifylline with metformin treatment improves biochemical parameters in patients with nonalcoholic steatohepatitis

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Milica Culafic ◽  
Sandra Vezmar Kovacevic ◽  
Violeta Dopsaj ◽  
Branislav Oluic ◽  
Nemanja Bidzic ◽  
...  
Keyword(s):  
Nonalcoholic Steatohepatitis ◽  
Biochemical Parameters ◽  
Liver Enzymes ◽  
Low Cost ◽  
Combined Treatment ◽  
Prospective Trial ◽  
Nonalcoholic Fatty Liver ◽  
Blood Tests ◽  
Nash Group ◽  
The Impact

Summary Background The progression of the nonalcoholic fatty liver disease to nonalcoholic steatohepatitis (NASH) is multifactorial, and there is still a lack of approved medications for its treatment. The study aimed to evaluate the impact of combined treatment with Pentoxifylline and Metformin on biochemical parameters in patients with NASH. Setting: Outpatient hepatology clinic. Methods A prospective trial was conducted. The first cohort included patients with biopsy-proven NASH, while the second cohort consisted of patients with biopsy-confirmed NAFLD. Blood tests were checked at baseline and every three months. Pentoxifylline at a dosage of 400 mg t.i.d. and Metformin at the dosage of 500 mg t.i.d. were introduced for six months in NASH group. The impact of the treatment was assessed based on biochemical results after combined treatment with low-cost medications. Results All 33 NASH patients completed 24 weeks of treatment. We observed significant improvement (p<0.05) of median values after treatment for the following parameters: serum uric acid levels decreased by 51.0 micromol/L, calcium decreased for 0.27 mmoL/L, magnesium showed an increase of 0.11 mmoL/L. Insulin resistance improved as a reduction of HOMA – IR by 1.3 was detected. A significant decrease of median in liver enzymes, alanine aminotransferase, aspartate aminotransferase and gammaglutamyltransferase by 24.0 IU/L, 9.1 IU/L, 10.8 IU/L respectively, was noted. Conclusions Pentoxifylline and Metformin may provide possible treatment option in NASH. Some new potential benefit of the therapy in improving liver function whilst decreasing cardiovascular risk was perceived.

Evaluating the impact of a very low-cost intervention to increase practices’ engagement with data and change prescribing behaviour: a randomized trial in English primary care

2021 ◽  
Author(s):  
Helen J Curtis ◽  
Seb Bacon ◽  
Richard Croker ◽  
Alex J Walker ◽  
Rafael Perera ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Trial ◽  
Broad Spectrum ◽  
Low Cost ◽  
Antibiotic Prescribing ◽  
Prescribing Practices ◽  
Behavioural Science ◽  
Clinical Trial Registration ◽  
Prescribing Behaviour ◽  
The Impact

Abstract Background Unsolicited feedback can solicit changes in prescribing. Objectives Determine whether a low-cost intervention increases clinicians’ engagement with data, and changes prescribing; with or without behavioural science techniques. Methods Randomized trial (ISRCTN86418238). The highest prescribing practices in England for broad-spectrum antibiotics were allocated to: feedback with behavioural impact optimization; plain feedback; or no intervention. Feedback was sent monthly for 3 months by letter, fax and email. Each included a link to a prescribing dashboard. The primary outcomes were dashboard usage and change in prescribing. Results A total of 1401 practices were randomized: 356 behavioural optimization, 347 plain feedback, and 698 control. For the primary engagement outcome, more intervention practices had their dashboards viewed compared with controls [65.7% versus 55.9%; RD 9.8%, 95% confidence intervals (CIs): 4.76% to 14.9%, P &lt; 0.001]. More plain feedback practices had their dashboard viewed than behavioural feedback practices (69.1% versus 62.4%); but not meeting the P &lt; 0.05 threshold (6.8%, 95% CI: −0.19% to 13.8%, P = 0.069). For the primary prescribing outcome, intervention practices possibly reduced broad-spectrum prescribing to a greater extent than controls (1.42% versus 1.12%); but again not meeting the P &lt; 0.05 threshold (coefficient −0.31%, CI: −0.7% to 0.1%, P = 0.104). The behavioural impact group reduced broad-spectrum prescribing to a greater extent than plain feedback practices (1.63% versus 1.20%; coefficient 0.41%, CI: 0.007% to 0.8%, P = 0.046). No harms were detected. Conclusions Unsolicited feedback increased practices’ engagement with data, with possible slightly reduced antibiotic prescribing (P = 0.104). Behavioural science techniques gave greater prescribing effects. The modest effects on prescribing may reflect saturation from similar initiatives on antibiotic prescribing. Clinical Trial Registration ISRCTN86418238.

The Impact of Local Anesthetic Volume and Concentration on Pain During Prostate Biopsy: A Prospective Randomized Trial

2012 ◽  
Vol 26 (2) ◽  
pp. 174-177 ◽  
Author(s):  
İlter Tüfek ◽  
Haluk Akpinar ◽  
Fatih Atuğ ◽  
Can Öbek ◽  
Halil Ertürk Esen ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Local Anesthetic ◽  
Prostate Biopsy ◽  
Prospective Randomized Trial ◽  
The Impact

scholarly journals A prospective randomized trial of perioperative seizure prophylaxis in patients with intraparenchymal brain tumors

2013 ◽  
Vol 118 (4) ◽  
pp. 873-883 ◽  
Author(s):  
Adam S. Wu ◽  
Victoria T. Trinh ◽  
Dima Suki ◽  
Susan Graham ◽  
Arthur Forman ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Adverse Events ◽  
Randomized Trial ◽  
Tumor Resection ◽  
Prospective Randomized Trial ◽  
Observation Group ◽  
Prophylaxis Group ◽  
Seizure Prophylaxis ◽  
Clinically Significant ◽  
Early Seizures

Object Seizures are a potentially devastating complication of resection of brain tumors. Consequently, many neurosurgeons administer prophylactic antiepileptic drugs (AEDs) in the perioperative period. However, it is currently unclear whether perioperative AEDs should be routinely administered to patients with brain tumors who have never had a seizure. Therefore, the authors conducted a prospective, randomized trial examining the use of phenytoin for postoperative seizure prophylaxis in patients undergoing resection for supratentorial brain metastases or gliomas. Methods Patients with brain tumors (metastases or gliomas) who did not have seizures and who were undergoing craniotomy for tumor resection were randomized to receive either phenytoin for 7 days after tumor resection (prophylaxis group) or no seizure prophylaxis (observation group). Phenytoin levels were monitored daily. Primary outcomes were seizures and adverse events. Using an estimated seizure incidence of 30% in the observation arm and 10% in the prophylaxis arm, a Type I error of 0.05 and a Type II error of 0.20, a target accrual of 142 patients (71 per arm) was planned. Results The trial was closed before completion of accrual because Bayesian predictive probability analyses performed by an independent data monitoring committee indicated a probability of 0.003 that at the end of the study prophylaxis would prove superior to observation and a probability of 0.997 that there would be insufficient evidence at the end of the trial to choose either arm as superior. At the time of trial closure, 123 patients (77 metastases and 46 gliomas) were randomized, with 62 receiving 7-day phenytoin (prophylaxis group) and 61 receiving no prophylaxis (observation group). The incidence of all seizures was 18% in the observation group and 24% in the prophylaxis group (p = 0.51). Importantly, the incidence of early seizures (< 30 days after surgery) was 8% in the observation group compared with 10% in the prophylaxis group (p = 1.0). Likewise, the incidence of clinically significant early seizures was 3% in the observation group and 2% in the prophylaxis group (p = 0.62). The prophylaxis group experienced significantly more adverse events (18% vs 0%, p < 0.01). Therapeutic phenytoin levels were maintained in 80% of patients. Conclusions The incidence of seizures after surgery for brain tumors is low (8% [95% CI 3%–18%]) even without prophylactic AEDs, and the incidence of clinically significant seizures is even lower (3%). In contrast, routine phenytoin administration is associated with significant drug-related morbidity. Although the lower-than-anticipated incidence of seizures in the control group significantly limited the power of the study, the low baseline rate of perioperative seizures in patients with brain tumors raises concerns about the routine use of prophylactic phenytoin in this patient population.

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