scholarly journals Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Rafael Vaz Machry ◽  
Gustavo Fonseca Cipriani ◽  
Henrique Umpierre Pedroso ◽  
Rafaela Ramos Nunes ◽  
Thayme Luisa Souza Pires ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Glycemic Control ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registration ◽  
Bolus Insulin ◽  
The Impact

Abstract Background Diabetes mellitus (DM) is a prevalent disease among elderly population. As the disease progresses, insulin may become necessary. The use of pens application seems to be more practical. However, the influence of this method on glycemic control needs to be defined in elderly people. Methods Randomized clinical trial comparing pens and syringes for insulin application among patients with type 2 DM over 60 years old and Glycated Hemoglobin > 8.5% at baseline. The follow-up was 24 weeks, with monthly medical visits to adjust the treatment. All patients received insulin NPH and, if necessary, insulin Regular. We assessed glycemic control, adherence to treatment, hypoglycemia occurrence, need for adjustment in treatment and impact on quality of life, Results We included 121 patients with mean age of 65.75 years. Sixty-one were randomized for pen group (PG) and 60 patients for syringe group (SG). At baseline, mean HbA1c was 10.34 ± 1.66% and 9.90 ± 1.25% (p = 0.103) in PG and SG respectively. Mean HbA1c was 8.39 ± 1.28% in PG and 8.85 ± 1.74% in SG (p = 0.101) at 24 weeks. However, there was a more significant reduction in PG (− 1.94 ± 1.93% in PG and − 1.04 ± 1.46% in SG, p < 0.05) during follow-up. We found no difference in treatment adherence rates, hypoglycemia, greater need for insulin doses or oral medication, and progression to basal-bolus insulin scheme. We also found no difference in the impact of the disease on quality of life between groups. Conclusion Although we did not find any difference in the impact on quality of life, frequency of hypoglycemia or adherence, the PG showed a reduction in HbA1c higher in 24 weeks of follow-up. Clinical trial registration: NCT02517242

Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16524-e16524
Author(s):  
Rahber Thariani ◽  
David K Blough ◽  
William Barlow ◽  
Norah Lynn Henry ◽  
Julie Gralow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Tumor Marker ◽  
Tumor Markers ◽  
Societal Value ◽  
Cancer Tumor ◽  
The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

Improvement in Migraine-Specific Quality of Life in A Clinical Trial of Rizatriptan

Cephalalgia ◽  
1997 ◽  
Vol 17 (8) ◽  
pp. 867-872 ◽  
Author(s):  
NC Santanello ◽  
AB Polis ◽  
SL Hartmaier ◽  
MS Kramer ◽  
GA Block ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Functional Disability ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Test Statistic ◽  
Related Quality ◽  
Health Related ◽  
The Impact

A validated migraine-specific questionnaire (24-h Migraine Quality of Life Questionnaire1: 24-h MQoLQ) was used to assess the impact of migraine and migraine therapy on health related quality of life during an acute migraine attack. Male and female migraineurs aged 18-55 years were randomized to placebo ( n = 41), rizatriptan 2.5 mg ( n = 47), 5 mg ( n = 74), or 10 mg ( n = 85) in a triple-blind, placebo-controlled clinical trial. Rizatriptan 5 mg and 10 mg were significantly more efficacious than placebo on pain relief and functional disability. After accounting, for multiple comparisons to placebo, rizatriptan 10 mg showed significantly better responses compared to placebo on three of five domains of 24-h MQoLQ (social functioning, migraine symptoms, and feelings/concerns). The O'Brien's Rank Sum Test statistic showed a statistically significant overall difference on the 24-h MQoLQ between the 10 mg rizatriptan and placebo groups ( p = 0.005) and for the overall close trend ( p 0.001).

scholarly journals Impact of oral rehabilitation on the quality of life of partially dentate elders in a randomised controlled clinical trial: 2 year follow-up

PLoS ONE ◽  
2018 ◽  
Vol 13 (10) ◽  
pp. e0203349 ◽  
Author(s):  
Gerald McKenna ◽  
Patrick Finbarr Allen ◽  
Martina Hayes ◽  
Cristiane DaMata ◽  
Ciaran Moore ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Oral Rehabilitation ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Partially Dentate

scholarly journals Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study

2019 ◽  
Vol 7 (1) ◽  
pp. e000761 ◽  
Author(s):  
Sapna Patel ◽  
Marconi Abreu ◽  
Anna Tumyan ◽  
Beverley Adams-Huet ◽  
Xilong Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Medication Adherence ◽  
Basal Insulin ◽  
Adherence Rate ◽  
Patient Reported ◽  
Bolus Insulin

ObjectiveMedication adherence is impacted by regimen complexity. The SIMPLE (Simple basal Insulin titration, Metformin Plus Liraglutide for type 2 diabetes with very Elevated HbA1c) study compared GLP1RA plus basal insulin (GLP1RA+BI) to basal-bolus insulin (BBI) regimen in participants with very uncontrolled type 2 diabetes mellitus (T2DM). This analysis aimed to evaluate medication adherence to GLP1RA+BI compared with BBI, the effect of adherence on clinical and patient-reported outcomes, and baseline predictors of adherence.Research design and methodsThis was an analysis of the SIMPLE study based on prespecified outcome. The study took place in pragmatic, real-world setting. A total of 120 adults with T2DM and HgbA1c≥10% were randomized to detemir plus liraglutide, or detemir plus aspart before each meal; 6-month follow-up. The main outcomes evaluated were: adherence, HgbA1c, weight, quality of life, and hypoglycemia. Adherence rate was calculated for each study medication at each follow-up visit; participants were classified as ≥80% or <80% adherent.ResultA higher percentage of participants in the GLP1RA+BI compared with the BBI group had ≥80% adherence to detemir (59.3% vs 35.7%, p=0.02) as well as liraglutide versus aspart (57.4% vs 30.4%, p=0.007). Higher age was predictive of ≥80% adherence (OR per 5-year increment=1.48, 95% CI 1.09 to 2.0, p=0.01). Higher adherence led to greater improvement in HbA1c and weight in both groups. Treatment with GLP1RA+BI compared with BBI led to greater improvement in HbA1c, weight, and quality of life and lower risk of hypoglycemia even after adjusting for the difference in adherence between groups.ConclusionsAdherence was higher with the simplified regimen of GLP1RA+BI compared with BBI. Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence.Trial registration numberNCT01966978

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