scholarly journals The Assessment of the Innovativeness of a New Medicine in Italy

2021 ◽  
Vol 8 ◽  
Author(s):  
Filomena Fortinguerra ◽  
Serena Perna ◽  
Roberto Marini ◽  
Alessandra Dell'Utri ◽  
Maurizio Trapanese ◽  
...  
Keyword(s):  
Decision Process ◽  
Classification Tree ◽  
Orphan Drugs ◽  
Important Variable ◽  
Medical Product ◽  
Chi Square ◽  
New Approach ◽  
Exact Test ◽  
Therapeutic Value

Objectives: Starting from April 2017, the Italian Medicine Agency (AIFA) has approved new criteria for defining any new medicinal product with an innovative indication. The purpose of the study is to analyze the activity of innovativeness evaluation according to the new approach, to estimate the weight of each criterion considered for innovativeness definition, and to evaluate how the new approach works in terms of consistency and reproducibility.Methods: A retrospective analysis was performed on the final reports evaluating the drug innovativeness assessment published on the AIFA's website between April 2017 and January 2021. Descriptive statistics, chi-square test, whether the conditions were respected, or Fisher's exact test was used to explore the association between characteristics of drugs and the innovativeness status and the association between the three criteria. Profiles of the decision process and their relationship with innovativeness response were described. In order to evaluate the weight of each criterion in predicting the innovativeness status, a Classification Tree (CT) algorithm was applied.Results: Overall, of the 109 published drugs reports, 37 (33.9%) were recognized as fully innovative, 29 (26.6%) were considered conditionally innovative, while for 43 (39.4%) reports innovativeness was not recognized. Considering the three criteria of the decision process, the added therapeutic value was the only criterion statistically associated with a drug's degree of innovation (p < 0.001). The therapeutic need and the quality of clinical evidence were statistically associated (p = 0.008) even if only a mild association was observed. The added therapeutic value was the most important variable in predicting the innovativeness status according to the classification tree (CT) model applied, achieving an accuracy of 89.4%. No difference was found between orphans and non-orphan drugs or oncological and non-oncological drugs.Discussion: The added therapeutic value is the most important criterion of the multidimensional approach for the innovativeness status definition of a new medical product. A mild association was found between the therapeutic need and the quality of evidence. Overall, similar decision profiles bring the same evaluation of innovativeness status, indicating a good consistency and reproducibility between decisions.

Use of SAMe-TT₂R₂ Score to Predict the Quality of Anticoagulation Control in Patients with Atrial Fibrillation Receiving Warfarin in Thailand

2020 ◽  
Vol 103 (6) ◽  
pp. 548-552
Keyword(s):  
Atrial Fibrillation ◽  
Therapeutic Range ◽  
Statistical Significance ◽  
Discrimination Performance ◽  
Poor Quality ◽  
Chi Square ◽  
Exact Test ◽  
Time In Therapeutic Range ◽  
Anticoagulation Control

Objective: To predict the quality of anticoagulation control in patients with atrial fibrillation (AF) receiving warfarin in Thailand. Materials and Methods: The present study retrospectively recruited Thai AF patients receiving warfarin for three months or longer between June 2012 and December 2017 in Central Chest Institute of Thailand. The patients were classified into those with SAMe-TT₂R₂ of 2 or less, and 3 or more. The Chi-square test or Fisher’s exact test was used to compare the proportion of the patients with poor time in therapeutic range (TTR) between the two groups of SAMe-TT₂R₂ score. The discrimination performance of SAMe-TT₂R₂ score was demonstrated with c-statistics. Results: Ninety AF patients were enrolled. An average age was 69.89±10.04 years. Most patients were persistent AF. An average CHA₂DS₂-VASc, SAMe-TT₂R₂, and HAS-BLED score were 3.68±1.51, 3.26±0.88, and 1.98±0.85, respectively. The present study showed the increased proportion of AF patients with poor TTR with higher SAMe-TT₂R₂ score. The AF patients with SAMe-TT₂R₂ score of 3 or more had a larger proportion of patients with poor TTR than those with SAMe-TT₂R₂ score of 2 or less with statistical significance when TTR was below 70% (p=0.03) and 65% (p=0.04), respectively. The discrimination performance of SAMe-TT₂R₂ score was demonstrated with c-statistics of 0.60, 0.59, and 0.55 when TTR was below 70%, 65% and 60%, respectively. Conclusion: Thai AF patients receiving warfarin had a larger proportion of patients with poor TTR when the SAMe-TT₂R₂ score was higher. The score of 3 or more could predict poor quality of anticoagulation control in those patients. Keywords: Time in therapeutic range, Poor quality of anticoagulation control, Warfarin, SAMe-TT₂R₂, Labile INR

scholarly journals Beloved Whiskers: Management Type, Care Practices and Connections to Welfare in Domestic Cats

Animals ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 2308
Author(s):  
Daiana de Souza Machado ◽  
Luana da Silva Gonçalves ◽  
Rogério Ribeiro Vicentini ◽  
Maria Camila Ceballos ◽  
Aline Cristina Sant’Anna
Keyword(s):  
Behavioral Problems ◽  
Online Survey ◽  
Principal Component ◽  
Chi Square ◽  
Exact Test ◽  
Frequent Use ◽  
Chi Square Test ◽  
Categorical Principal Component Analysis ◽  
Care Practices

The quality of cat care practices depends in part on the type of management applied, which either positively or negatively impacts cat welfare. This study investigated whether the type of cat management (indoor vs. outdoor) was related to other cat care practices adopted by cat owners, associated with the quality of human-cat relationships and cat welfare. An online survey was distributed via social networks. Descriptive statistics, categorical Principal Component Analysis, Fisher’s Exact test and Chi-square test in contingency table were applied. A total of 16,302 cat owners returned the survey. Most Brazilian owners reported indoor management of their cats; this was related to owners living in apartments, more frequent use of cat care practices, and more interactions with their pets. Outdoor management was related to cats living in houses or farms, sleeping outdoors or around the neighborhood, and owners had fewer interaction with their pets. In conclusion, owners practicing indoor management seemed to be closer to their cats than owners reporting outdoor management. However, obesity and owner-reported behavioral problems were associated with indoor management.

Malocclusion: Social, Functional and Emotional Influence on Children

2012 ◽  
Vol 37 (1) ◽  
pp. 103-108 ◽  
Author(s):  
PA Martins-Júnior ◽  
LS Marques ◽  
ML Ramos-Jorge ML
Keyword(s):  
Quality Of Life ◽  
Negative Impact ◽  
Negative Influence ◽  
Open Bite ◽  
Anterior Open Bite ◽  
Chi Square ◽  
Exact Test ◽  
Chi Square Test ◽  
The Impact

Objectives: To determine the association between types of malocclusion and quality of life in children between 8-10 years of age and establish correlations between the severity of the malocclusion and particular bio-psychosocial variables. Study design: The sample was made up of 102 schoolchildren aged 8-10 years. Clinical exams were performed using the criteria of the Dental Aesthetic Index (DAI) to determine the presence and severity of malocclusions. The impact on quality of life was assessed using the Child Perceptions Questionnaire (CPQ8-10). Statistical analysis involved the chi-square test, Fisher's exact test and Spearman's correlation analysis. Results: Malocclusions affected 61% of the children examined. There was a positive correlation between total CPQ8-10 and DAI scores (P = 0.034). The following types of malocclusion had a significant effect on the quality of life of the children: upper anterior irregularity ≥ 2 mm, anterior open bite ≥ 2mm and diastema ≥ 2mm. Children with malocclusion experienced a greater negative impact on quality of life in comparison to those without malocclusion. Conclusions: Malocclusions had a negative influence over the quality of life of children between 8-10 years of age. More severe malocclusions had a greater impact with regard to social, emotional and functional aspects.

scholarly journals Influence of symptoms of depression on the quality of life of men diagnosed with prostate cancer

2018 ◽  
Vol 21 (1) ◽  
pp. 70-78
Author(s):  
Taysi Seemann ◽  
Fernanda Pozzobom ◽  
Melissa de Carvalho Souza Vieira ◽  
Leonessa Boing ◽  
Zenite Machado ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Cross Sectional Study ◽  
Chi Square ◽  
Related Factors ◽  
Cross Sectional ◽  
European Organization ◽  
Exact Test ◽  
Symptoms Of Depression

Abstract Objective: to evaluate the prevalence of symptoms of depression among men diagnosed with prostate cancer and their association with quality of life and treatment-related factors. Methods: a cross-sectional study of 85 men with a mean age of 66±8 years who were diagnosed with prostate cancer was performed. The survey was based on a questionnaire with previously validated instruments which investigated social, demographic and economic characteristics, the history of the disease, quality of life (European Organization for Research and Treatment of Cancer Questionnaire C30 - EORTC QLQ-C30 / QLQ-PR25) and symptoms of depression (Beck Depression Inventory). The presence of symptoms of depression was considered an outcome, and statistical analyzes were performed using the Chi-square test, Fisher's exact test, Mann Whitney U test and Poisson regression (p<0.05). Results: significant results were found for quality of life in relation to symptoms of depression in the functional, global and symptomatic health scale (p<0.001). This demonstrates that the presence of symptoms of depression is related to a negative quality of life. Conclusions: for a greater understanding of prostate cancer and its consequences on the quality of life of patients it is important to consider possible disorders in psychological aspects caused by the illness, as symptoms of depression are frequent in patients undergoing treatment for prostate cancer.

scholarly journals The Importance of the Nurse as Part of a Multidisciplinary Team in Care of Children With Disabilities

2020 ◽  
Vol 18 (1-2) ◽  
Author(s):  
Andrea Gračanin
Keyword(s):  
Children With Disabilities ◽  
Chi Square ◽  
Important Place ◽  
Exact Test ◽  
Active Involvement ◽  
Disease Outcomes ◽  
Anonymous Questionnaire ◽  
Rehabilitation Professional ◽  
General Opinion

Previously, the general opinion was that the nurse was only in charge of patient care, but research to date has shown that the scope of work of a nurse is extremely complex and therefore, it occupies an important place in the treatment and care of them.Multidisciplinary teamwork has contributed to more effective treatment, better disease outcomes, shorter hospital stay, prevention of complications and a better quality of life. This way of working, besides the child itself, emphasizes the whole family, which makes it possible active involvement of parents through all stages of treatment, rehabilitation, professional therapy and support. Through this research, parents and caregivers of children with disabilities have acknowledged the involvement of the nurse as an important role, that she is an integral part of the care team for atypical children, that the scope of her work responsibilities and daily activities contribute to improving the quality of care, communication and social care as well as integration. The survey instrument was an anonymous questionnaire, and the obtained data were compared using Fisher’s exact test and Chi-square tests to examine whether there was statistical significance.The results change the awareness of the work, roles and importance of the work of the nurse with children with disabilities and emphasize active participation in all spheres of life of atypical children.

Predictors of quality of life, symptoms of anxiety, and depression in Latino patients with cervical cancer.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 171-171
Author(s):  
Oscar Galindo Vazquez ◽  
Mayra CU Menes ◽  
David Ortiz ◽  
Abelardo Meneses-Garcia ◽  
Jose Luis Aguilar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Cancer ◽  
Depression Scale ◽  
Psychosocial Care ◽  
Poor Quality ◽  
Anxiety And Depression ◽  
Chi Square ◽  
European Organization ◽  
Exact Test

171 Background: Cervical cancer is considered one of the most frequent cancers among women and with the greatest causes of death in the world. In Mexico it is considered the second cause of death. Objective: The identify predictors of quality-of-life, symptomatology of anxiety and depression in patients with cervical cancer. Methods: 192 patients with cervical cancer aged between 44 and 60 years were included, through interview and consultation of the clinical file, information on sociodemographic and clinical variables were obtained. Instrument: European Organization Scale for Cancer Research and Treatment and Quality of Life (EORTC QLC-C30) and Hospital Anxiety and Depression Scale (HADS). Statistical analysis: Chi square or Fisher´s exact test. The association of the variables was evaluated by logistic regression analysis. Results: 48% had poor quality of life, 24% with depression, and 29% with anxiety.The predictors of a low quality of life are: presenting one or more comorbidities, family history with cancer, presenting anxious, and depressive symptoms Conclusions: Psychological assumptions are predictors of variables such as quality of life, in a population with cervical cancer, in Mexico this group of patients have low educational and economic levels. Psychosocial care programs are required in this group of Latina women.

scholarly journals Choosing Wisely – Implication based on Indian data in our patients with breast cancer (INR vs. USD)

2021 ◽  
Vol 6 ◽  
pp. 6-10
Author(s):  
Ajay Bapna ◽  
Nidhi Patni ◽  
Sanjeev Patni
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Metronomic Chemotherapy ◽  
Chi Square ◽  
Exact Test ◽  
Chi Square Test ◽  
Cost Implications ◽  
The Cost ◽  
Indian Data

Objectives: Breast cancer is increasing in India due to aging population, better awareness among general public, willingness to seek treatment of cancers, and easier access to cancers centers. We present our single-center data over a 2-year period and discuss cost implications taking the example of metronomic chemotherapy maintenance and predictive markers in early breast cancer. Material and Methods: Prospectively collected data of all consecutive patients with breast cancer registered between September 2017 and August 2019 were evaluated. Clinical features, stage, receptor status, and other features were tabulated. Statistical analysis was using SAS version 9.4 – Chi-square test and Fisher’s exact test were performed. P ≤ 0.05 was considered as statistically significant. Results: For the 484 consecutive patients, the median age was 50 years. This included EBC (201, 42%), LABC (141, 29%), and MBC (142, 29%). ER expression was seen in 52% of cases (253/484), PR in 47% (229/484), and Her2 was positive in 47% (229/484). Finally, 83 patients (17%) were identified as TNBC. HR-positive Her2-negative EBC constituted 111/484 patients (23%). Discussion: If our 83 TNBC patients were given metronomic maintenance chemotherapy, their 3-year overall survival (OS) is projected to increase from 54% to 100% at a cost of INR 8191/- per patient (equivalent to USD 109/-). If our 111 HR-positive Her2-negative EBC patients were evaluated for risk by biomarker test validated in Indian patients, 76 of these would be spared the toxicity of adjuvant CT. This would also result in saving on the cost of chemotherapy medication of INR 4,035,296/- in India (equivalent to USD 53,699/- if treated in USD). In addition, they would also have better quality of life (QoL). Conclusion: It is possible to identify patients with low risk early breast cancer using Can assist and save them from unnecessary cost and/or toxicity.

scholarly journals Variables affecting pricing of orphan drugs: the Italian case

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Claudio Jommi ◽  
Elisabetta Listorti ◽  
Federico Villa ◽  
Simone Ghislandi ◽  
Armando Genazzani ◽  
...  
Keyword(s):  
Treatment Cost ◽  
Randomized Clinical Trials ◽  
Univariate Analysis ◽  
Target Population ◽  
Orphan Drugs ◽  
Positive Correlation ◽  
Annual Treatment ◽  
Therapeutic Value ◽  
Annual Treatment Cost

Abstract Background and aim Evidence on determinants of prices for orphan medicines is scarce and not available for Italy. The aim of this paper is to provide an evidence on variables affecting the annual treatment cost of orphan drugs in Italy, testing the hypothesis of a negative correlation with the dimension of the target population and a positive correlation with the added therapeutic value of the drug and the quality of the evidence of pivotal studies. Methods Drugs with a European orphan designation reimbursed in Italy in the last 6 years (2014–2019) were considered. Univariate, cluster analysis and multiple regression models were used to investigate the correlation between the annual treatment cost and, as explanatory variables, the dimension of the target population, the existence of Randomized Clinical Trials as a proxy of the quality of the pivotal studies, the added therapeutic value. Results In the univariate analysis prevalence and added therapeutic value, as expected, have a negative and positive correlation with cost respectively. The correlation with RCT is not significant. In the multivariate model, coefficients for prevalence and added value are confirmed but for the latter are not significant anymore. We also found, through an interaction analysis, that the existence of an RCT has a positive impact on annual treatment cost when the target population is very small. Conclusions Our results suggest that value arguments and sustainability (dimension of the target population and its impact on budget impact) issues are considered for orphan drugs pricing: the role played by sustainability is systematically supported by our results. A more transparent and reproducible price negotiation process for orphan drugs is needed in Italy. This paper has contributed to highlight the implicit drivers of this process.

scholarly journals Quality of life following a major lower limb ampu tation in Johann esburg, South Africa.

2012 ◽  
Vol 68 (2) ◽  
Author(s):  
L. Godlwana ◽  
A. Stewart ◽  
E. Musenga
Keyword(s):  
Quality Of Life ◽  
South Africa ◽  
Lower Limb ◽  
Limb Amputation ◽  
Chi Square ◽  
Exact Test ◽  
Vas Score ◽  
Post Test ◽  
The Impact

To determine the impact of lower limb amputation on qualityof life in people in the Johannesburg metropolitan area of South Africa, duringtheir reintegration to their society/community of origin.A longitudinal pre- test- post test design was utilized. Consecutive samplingwas used to recruit and interview participants (n=73) who met the inclusioncriteria. Ethical clearance was obtained. The hospitals and participants gaveinformed consent.The EQ-5D, Barthel Index, and Modified Household Economic andSocial Status Index were used to collect data. Participants were interviewed preoperatively and then followed upthree months post-operatively. Data were analysed using STATA version 10. Categorical data were analysedusing Chi-square/Fischer’s exact test and continuous data were analysed using Wilcoxon signed rank and medianregression.Most (n=21, 52.5 %) participants had no income. One participant was homeless, 17.5% (n=7) lived in shacks.The preoperative and postoperative median VAS of the EQ-5D was 60 and 70 respectively showing no significantimprovement in QOL (median EQ-5D VAS). The preoperative and postoperative median total BI score was 20 and 19respectively, showing a significant reduction in function (median total BI) three months postoperatively (p<0.001).Preoperative mobility was a predictor of postoperative quality of life. Being female was a predictor of higher qualityof life.The average EQ-5D VAS score and overall function (total BI) were generally scored high both preoperativelyand postoperatively but there was no significant improvement in EQ-5D VAS score and there was a significant reductionin function after three months. Higher scores in mobility preoperatively is a predictor of higher quality of lifepostoperatively.

scholarly journals Exploring Quality of Life Reported by Norwegian Older Adults Using Classification Tree Approach on Group Profiles

2021 ◽  
Author(s):  
Lidia Santora ◽  
Don Byrne ◽  
Christian Klöckner
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Living Arrangement ◽  
Classification Tree ◽  
Postal Questionnaire ◽  
Subjective Quality Of Life ◽  
Chi Square ◽  
Interaction Detection ◽  
Ongoing Assessment

AbstractThis study aims to explore the variation between- and within subgroups of older adults with regard to low, medium, and high levels of self-reported quality of life (QoL) measured by the WHOQOL-BREF scale. The contribution of interacting personal and contextual life conditions to QoL was examined in a sample of 1,910 (sample frame 6,000) Norwegian men and women aged 62 to 99 years. The data collected by a postal questionnaire were analyzed using the Chi-square Automatic Interaction Detection (CHAID) classification method in order to detect unique profiles of groups who shared common characteristics. The CHAID model revealed 15 relatively homogenous groups, but distinct from one another, whose profiles were defined by unique constellations of several interacting variables significantly related to a given QoL level. Mental functioning was predominantly linked to perception of life meaning along with health status, and/or in some cases living arrangement, loneliness, neighborhood quality, and satisfaction with income, and placed an individual at different likelihood levels of reporting low, medium, or high QoL. Socio-demographics had no statistically significant impact on QoL for any subgroup. Through this individual-oriented approach, a periodically ongoing assessment of subjective quality of life (QoL) may be sufficiently powerful to allow detecting and addressing personal concerns and specific needs that detract from quality of life in advancing age.

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