scholarly journals Resultados de supervivencia del cáncer colorrectal metastásico (CCRm) en una cohorte de una práctica en Medellín, Colombia

2021 ◽  
Vol 8 (1) ◽  
pp. 18-28
Author(s):  
Mauricio Lema ◽  
Beatriz Elena Preciado Franco ◽  
Camila Lema ◽  
Ana María Romero Millán ◽  
Sara Paulina Mora Vélez ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Randomized Clinical Trials ◽  
Small Sample Size ◽  
Case Series ◽  
Biologic Agents ◽  
Small Sample ◽  
Phase Iii ◽  
Survival Outcomes ◽  
The Impact

Therapy for mCRC is based on surgery, cytotoxic chemotherapy, and biologic agents. In randomized clinical trials, median progression-free survival (PFS) and overall survival (OS) hover around 10mo and 29mo, respectively. There are no published results on survival outcomes of patients with mCRC in Colombia. Objective: Describe the survival outcomes of patients with mCRC treated by Mauricio Lema in Medellín, Colombia. Methods: This is a retrospective, case series (2008-2020) of mCRC, ≥18 years old, treated with systemic therapy for metastatic disease, and ≥3-month follow-up.  Stratification factors included: use of biologic (anti-VEGF or anti-EGFR) plus chemotherapy in 1st-Line (yes/no) and metastasectomy (yes/no). Survival analyses were evaluated using Kaplan- Meier curves. Results from the general population are described, and they are also discriminated against by the use of a biological agent in the first-line of systemic therapy. Results: 89 patients with mCRC were included. The Median follow-up was 35 months (IQR: 21-57). Median PFS and OS were 12.1mo (95%CI: 10.4-13.8) and 29.3mo (95%CI: 23.2-34.4), respectively. Median OS in patients receiving biologics was 28.8mo (95%CI: 22.1 – 35.6) vs 33.7mo (95%CI: 16.4 – 51.0) in the chemo-only group (p=0.01). Median OS in the metastasectomy and non-metastasectomy groups were 36.1 (95% CI: 26.5 - 45.7) and 25.0 months (95% CI: 15.4 - 34.5), respectively (NS). Conclusion: In this case series of patients’ survival outcomes were similar to thosereported in large phase III trials. A small sample size precludes any conclusion as to the impact of biologic agents on survival in this study.

Aortic Valve Intervention During Aortic Root Surgery in Children: A Systematic Review

2020 ◽  
Vol 11 (5) ◽  
pp. 611-618
Author(s):  
Maria Rodriguez ◽  
Anahita Malvea ◽  
Dayre McNally ◽  
Vid Bijelic ◽  
Ming Guo ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Root ◽  
Small Sample Size ◽  
Case Series ◽  
Small Sample ◽  
Aortic Root Surgery ◽  
Valve Sparing ◽  
One Year

Background: Pediatric aortic root dilatation is a life-threatening condition that lacks guidelines for surgical management. We aimed to analyze the data on aortic valve interventions during root surgery to guide decision-making. Methods: A search was performed of MEDLINE, Embase, CENTRAL, ClinicalTrials.gov , and WHO ICTRP. Citations were screened in duplicate and independently to identify randomized controlled trials, cohorts, and case series involving populations aged 0 to 18 years, who received valve-sparing and valve-replacing aortic root surgeries between 1999 and 2019. Outcomes considered included mortality (perioperative, one year, five year), reintervention rates. Results: After duplicate removal, 689 citations were screened through abstract and full text review, identifying five eligible studies. All five were observational studies evaluating valve-sparing procedures. There were 81 patients with a mean study age range of 9.9 to 13.9 years. Both reimplantation (74%) and remodeling (26%) subtypes were done. Range of mean duration of follow-up was 1.2 to 4.4 years. There was no mortality reported until the one-year follow-up period. The long-term mortality rate was calculated as 0.02 per patient-year (95% CI: 0.01-0.05). The long-term reintervention rate was 0.08 per patient-year (95% CI: 0.05-0.13). Conclusions: There is limited experience on aortic valve intervention during aortic root surgery in children. Single-arm studies on valve-sparing surgeries show excellent survival up to one year. Mortality and reintervention rates increase in the longer term. The small sample size and lack of controlled studies do not allow for direct comparisons between procedure types.

scholarly journals Histologic and Tomographic Findings of Bone Block Allografts in a 4 Years Follow-up: A Case Series

2016 ◽  
Vol 27 (6) ◽  
pp. 775-780 ◽  
Author(s):  
Daniel Deluiz ◽  
Luciano Santos Oliveira ◽  
Paul Fletcher ◽  
Fábio Ramôa Pires ◽  
Justine Monnerat Tinoco ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Case Series ◽  
Small Sample ◽  
Histological Evaluation ◽  
Bone Block ◽  
Mucogingival Surgery ◽  
Native Bone ◽  
Implant Placement

Abstract The aim of this paper is to report histologic and tomographic findings of fresh frozen bone block allografts bearing dental implants in functional occlusion in a long-term follow-up. Four patients with implants functionally loaded for 4 years on augmented ridges requiring additional mucogingival surgery or implant placement were included in this case series. Cone-beam tomography scans were compared volumetrically between the baseline (first implant placement) and current images. Biopsies of the grafts were retrieved and sent to histological analysis. Volumetric reduction of the grafts varied from 2.1 to 7.7%. Histological evaluation demonstrated well-incorporated grafts with different degrees of remodeling. While data presented in this report are from a small sample size and do not allow definitive conclusions, the biopsies of the grafted sites were very similar to the host's native bone. Remodeling of the cortical portion of the allografts seems to take longer than the cancellous portion. The presence of unincorporated graft remains did not impair the implant success or the health of the surrounding tissues. This is the first time histologic and tomographic long term data of bone allograft have been made available in dentistry.

PP216 Indirect Treatment Comparison Assessment: An Improvement Intervention In The Scottish Medicines Consortium

2021 ◽  
Vol 37 (S1) ◽  
pp. 27-28
Author(s):  
John Scott ◽  
Moira McMurray ◽  
Rickie O'Connell ◽  
Pauline McGuire ◽  
Noreen Downes
Keyword(s):  
Focus Group ◽  
Small Sample Size ◽  
Small Sample ◽  
Guidance Document ◽  
Draft Guidance ◽  
Treatment Comparison ◽  
Direct Head ◽  
Indirect Treatment ◽  
The Impact

IntroductionThe Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines on behalf of the National Health Service Scotland based on pharmaceutical company submissions. As the appraisals are conducted close to the point of marketing authorization, there is often a lack of direct head-to-head data. In 2019, assessment of relevant comparative efficacy was informed via indirect treatment comparisons (ITC) in 55 percent (36/66) of submissions. While the ITCs are essential to the decision-making process, they are frequently incomplete.MethodsA focus group was conducted with the clinical assessment team (n = 11) to explore problems in the submission process and to identify areas for improvement. It was agreed that providing improved guidance to companies prior to submission may prevent future inconsistencies. A working group (n = 5) was tasked with identifying and implementing potential solutions. The group reviewed the focus group findings, relevant literature, and guidance from other organizations. Draft guidance was developed that was reviewed by two pharmaceutical industry representatives (SMC subcommittee members).ResultsFindings from the focus group highlighted issues broadly related to the incomplete presentation and reporting of ITCs. The improved guidance document outlined specific requirements in a checklist format for reporting and presenting the results of different ITC data. This guidance was published in February 2020. To evaluate the impact of the updated guidance and to identify any further changes required, a follow-up focus group and survey of industry representatives is planned for March 2021.ConclusionsThe aim of the ITC guidance is to provide pharmaceutical companies with direction to improve the quality and transparency of reporting, which will in turn improve the quality of HTAs and thus strengthen the recommendations provided by the SMC. The follow-up focus groups and survey will assess the impact of the guidance. It is acknowledged that the results of this process may be limited by the small sample size and short duration of the assessment.

Erythema Induratum: Case Series Illustrating the Utility of the Interferon-γ Release Assay in Determining the Association with Tuberculosis

2013 ◽  
Vol 17 (4_suppl) ◽  
pp. S6-S11 ◽  
Author(s):  
Vimal Prajapati ◽  
McKay Steed ◽  
Parbeer Grewal ◽  
Muhammad N. Mahmood ◽  
Geetika Verma ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Case Series ◽  
Complete Response ◽  
Interferon Γ ◽  
Small Sample ◽  
Release Assay ◽  
Novel Method ◽  
Nodular Vasculitis ◽  
Lost To Follow Up

Background: The interferon-γ release assay (IGRA) is a novel method for detecting previous sensitization to tuberculosis (TB). Despite having several advantages over the tuberculin skin test (TST), including higher specificity and no influence from past bacille Calmette-Guérin (BCG) exposure, there are a limited number of reports describing its application in patients with erythema induratum (EI)/nodular vasculitis (NV), which is usually but not always related to TB. Objectives: The aim of our case series was to evaluate the usefulness of the IGRA for determining a TB association in patients with EI/NV. Methods: Retrospective chart reviews were conducted on four patients diagnosed with EI/NV at our institution in whom an IGRA had been performed. Results: All four subjects had positive TST results. The IGRA was also positive and therefore supported a link with TB in two cases. One patient responded completely to anti-TB therapy, whereas the second was lost to follow-up. Both cases unrelated to TB, by virtue of negative IGRAs, demonstrated complete response to immunosuppressive therapy (methotrexate), with one individual having failed anti-TB therapy first. Conclusion: Our case series highlights the utility of the IGRA for establishing a TB association in patients with EI/NV. Although limited by a small sample size, we propose adjunctive use of this test at the time of EI/NV diagnosis, especially in the setting of previous BCG exposure, so that management can be tailored according to whether an underlying relationship with TB exists.

The Impact of Three Gross Irn Bru on an Out-Patient Clinic for Depressed Men

1992 ◽  
Vol 20 (1) ◽  
pp. 73-78
Author(s):  
Jacqueline M. Atkinson ◽  
Denise A. Coia
Keyword(s):  
Sample Size ◽  
Multidisciplinary Team ◽  
Small Sample Size ◽  
Small Sample ◽  
Patient Relationship ◽  
Methodological Issues ◽  
Clinical Behaviour ◽  
Methodological Problems ◽  
The Impact

Using an ABA design, the impact of the unexpected delivery of Irn Bru to an out-patient clinic for depressed men was investigated using the Montgomery-Åsberg scale for depression. A significant improvement in both behaviour and affect was seen immediately, some benefit still showing at one month follow-up. The effect of the procedure on the multidisciplinary team is also discussed. Some methodological issues, including small sample size are explored. Despite the methodological problems the serious element of the study points to the important impact of unexpected, non-therapeutic elements on clinical behaviour, possibly as a result of the challenge to the therapist-patient relationship.

Patient characteristics and survival outcomes associated with early versus delayed molecular testing in metastatic NSCLC.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 211-211
Author(s):  
David A. Smith ◽  
Craig H. Reynolds ◽  
Debra A. Patt ◽  
Gregory Smith ◽  
Robyn K. Harrell ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Performance Status ◽  
Patient Characteristics ◽  
Small Sample ◽  
Rank Test ◽  
Survival Outcomes ◽  
Poor Performance Status ◽  
Molecular Testing ◽  
Metastatic Nsclc

211 Background: Evidence-based guidelines recommend molecular testing for appropriate patients with advanced NSCLC at the time of diagnosis of adenocarcinoma. This study evaluated patient demographics, clinical characteristics and survival outcomes associated with early molecular testing (EMT) as compared to delayed molecular testing (DMT) in patients with metastatic NSCLC. Methods: Retrospective analysis of patients’ electronic medical records from The US Oncology Network Practices that utilize iKnowMed (iKM). Patients with a diagnosis of metastatic NSCLC between March 2011 and June 2012, >2 visits and >6 months of follow-up were eligible. EMT and DMT was defined as occurring <45 days and >45 days of diagnosis, respectively. Patient characteristics were compared using t-test and chi-square tests as appropriate. Logistic regression was used to predict the likelihood of higher performance status in the cohorts. Progression-free survival (PFS) and overall survival (OS) were compared using Cox proportional hazards models controlling for age, gender, stage at diagnosis, performance status and comorbidities. Results: A total of 350 patients were eligible and had a median follow-up of 17.3 months. Average age was 64, majority were female (55%) and diagnosed with adenocarcinoma (93%). There were no significant differences in demographic characteristics between EMT and DMT cohorts, however DMT patients were more likely to have ECOG 0 or 1 (OR=2.95, 95%CI=1.33-6.54, p=0.008). No difference in OS or PFS was observed between EMT and DMT patients, p>0.05 (log-rank test). However, poor performance status was found to increase risk of progression/death in multivariate OS and PFS analysis, p<0.02 and p<0.01, respectively. Conclusions: While patients undergoing EMT were nearly three times more likely to exhibit poorer performance status as compared to DMT cohort, their survival outcomes were no different, reinforcing the importance of molecular testing in these patients who may otherwise be less likely to receive treatment. Although limited to small sample size, results of this analysis call for further investigation of potential benefits of EMT in metastatic NSCLC in real-world setting.

Gait in People With Nonhealing Diabetes-Related Plantar Ulcers

2019 ◽  
Vol 99 (12) ◽  
pp. 1602-1615 ◽  
Author(s):  
Malindu E Fernando ◽  
Robert G Crowther ◽  
Peter A Lazzarini ◽  
Kunwarjit S Sangla ◽  
Scott Wearing ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Clinical Importance ◽  
Small Sample ◽  
Pelvic Obliquity ◽  
Foot Ulcers ◽  
Abnormal Gait ◽  
Gait Parameters ◽  
And Control ◽  
The Impact

Abstract Background Abnormalities in gait have been associated with high plantar pressures and diabetes-related plantar foot ulcers. Whether these are a transient response to the ulcer or are representative of long-term lower limb biomechanical abnormalities is currently unknown. Objective The aim of this study was to examine whether 12 gait parameters identified as being associated with nonhealing diabetes-related plantar foot ulcers at baseline remained associated during a 6-month follow-up period. Design This was a longitudinal observational case-control study. Methods Gait assessments were performed at entry and twice during follow-up over a 6-month period in 12 participants with nonhealing diabetes-related plantar foot ulcers (case participants) and 62 people with diabetes and no history of foot ulcers (control participants) using a standardized protocol. Linear mixed-effects random-intercept models were used to identify gait parameters that consistently differed between case participants and control participants at all assessments after adjustment for age, sex, body mass index, presence of peripheral neuropathy, and follow-up time. Standardized mean differences (SMD) were used to measure effect sizes. Results Five of the 12 gait parameters were significantly different between case participants and control participants at all 3 time points. Case participants had a more abducted foot progression angle (SMD = 0.37), a higher pelvic obliquity at toe-off (SMD = −0.46), a greater minimum pelvic obliquity (SMD = −0.52), a lower walking speed (SMD = −0.46), and a smaller step length (SMD = −0.46) than control participants. Limitations The limitations included a small sample size, the observational nature of the study, and the inability to evaluate the impact of gait on wound healing. Conclusions This study identified abnormal gait parameters consistently associated with nonhealing diabetes-related plantar foot ulcers. Further research is needed to test the clinical importance of these gait characteristics.

Inflammatory breast cancer (IBC) in native Hawaiians and Pacific Islanders: Frequency of IBC and impact of socioeconomic status on survival outcomes.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19083-e19083
Author(s):  
Kyle S.Y. Miyazaki ◽  
Jared David Acoba ◽  
Takeo Fujii
Keyword(s):  
Breast Cancer ◽  
Socioeconomic Status ◽  
Racial Differences ◽  
Small Sample Size ◽  
Medical Center ◽  
Small Sample ◽  
Survival Outcomes ◽  
Breast Cancer Patients ◽  
Epidemiological Characteristics

e19083 Background: IBC is one of the most aggressive types of breast cancer, accounting for only 1-4% of all breast cancer cases while causing 8-10% of breast cancer related deaths. Previous studies have demonstrated that IBC has distinct epidemiological characteristics, but the prevalence of IBC particularly in Native Hawaiian (NH) and Pacific Islander (PI) populations, and the socioeconomic disparities related to survival outcomes, are not fully understood. Our primary objective was to determine the frequency at which NH and PI breast cancer patients are diagnosed with IBC, and the association between socioeconomic status and overall survival (OS). Methods: Patients with newly-diagnosed primary invasive breast cancer were identified from January 1, 2000 through December 31, 2018 using Queen’s Medical Center Tumor Registry. Clinical T4d was used to differentiate IBC and non-IBC. OS was defined as the time from diagnosis to death or last follow-up. Patients who were alive at the date of last follow-up were censored. Univariate and multivariate cox proportional hazard models were used to assess the effects of variables of interest on OS. Results: A total of 3,715 patients were included in analysis. There were 98 (2.6%) patients with IBC and 3,617 (97.4%) with non-IBC. Proportion of IBC relative to non-IBC was significantly higher in PI (9.0%) than in White (W) (2.7%) (P < 0.001). Proportion of IBC was higher in NH (4.7%) than W but the difference was not statistically significant (P = 0.08). In multivariate analysis among the non-IBC group, OS was significantly shorter for both PI and NH than W (HR 1.72, [95%CI, 1.13-2.6]; P = 0.01, HR 1.48 [95% CI, 1.14-1.93]; P = 0.003, respectively). There were no significant racial differences seen in OS among IBC patients. Being under or uninsured was also significantly associated with short OS outcomes among patients with non-IBC but not those with IBC. Conclusions: PI have a significantly high proportion of IBC relative to non-IBC. Race and insurance status were not associated with OS in IBC although they were significantly associated with short OS in non-IBC. This result suggests that in IBC, the potential effect of racial disparity on OS is negated by the aggressive and insidious nature of the cancer. The effect of a relatively small sample size cannot be excluded, and further study in a larger population is warranted.

Pilot Study in the Identification of Stability Values for Determining Immediate and Early Loading of Implants

2007 ◽  
Vol 33 (1) ◽  
pp. 13-22 ◽  
Author(s):  
Tatsuo Shiigai
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Small Sample ◽  
Insertion Torque ◽  
Implant Survival ◽  
Implant Stability ◽  
Early Loading ◽  
Implant Loading ◽  
The Impact

Abstract This pilot study assessed the impact of implant stability criteria on implant loading time. Insertion torque (IT) and baseline implant stability quotients (ISQ) from resonance frequency analysis were recorded for 41 tapered-screw implants placed in the mandibles of 20 patients. Immediate (IL), early (EL) (6 weeks postoperative), or delayed (DL) (12 weeks postoperative) prosthetic loading was performed based on results and study criteria. Postoperative ISQ values were also recorded at 6 time intervals for the IL and EL groups and after healing for the DL group. All implants were definitively restored after 6 weeks of provisionalization. There were no failures, complications, or stability differences based on loading time. At week 12 of follow-up, ISQ values were slightly higher for IL implants compared with EL implants. IL and EL implants showed significantly higher cumulative ISQ values compared with DL implants. High IT and baseline ISQ values in all groups corresponded to high implant survival. Postoperative ISQ values in the IL and EL groups were less certain indicators of implant survival because of fluctuations relative to baseline values. Small sample size and inequitable patient distribution across groups skewed results. More research is needed before definitive results can be drawn. IL and EL were safely performed within the IT and ISQ ranges in this study, but it is unknown whether EL criteria would have also sufficed for IL.

An influence of social isolation on the level of physical activity as well as on well-being and mental state of people during the coronavirus COVID-19 pandemic

2019 ◽  
Vol 129 (4) ◽  
pp. 127-131
Author(s):  
Agnieszka Parfin ◽  
Krystian Wdowiak ◽  
Marzena Furtak-Niczyporuk ◽  
Jolanta Herda
Keyword(s):  
Physical Activity ◽  
Social Isolation ◽  
Small Sample Size ◽  
Statistical Tests ◽  
Population Group ◽  
Well Being ◽  
Small Sample ◽  
Subjective Well Being ◽  
Tract Infections ◽  
The Impact

AbstractIntroduction. The COVID-19 is the name of an infectious disease caused by a new strain of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). It was first diagnosed in December 2019 in patients in Wuhan City, Hubei Province, China. The symptoms are dominated by features of respiratory tract infections, in some patients with a very severe course leading to respiratory failure and, in extreme cases to death. Due to the spread of the infection worldwide, the WHO declared a pandemic in March 2020.Aim. An investigation of the impact of social isolation introduced due to the coronavirus pandemic on selected aspects of life. The researchers focused on observing changes in habits related to physical activity and their connections with people’s subjective well-being and emotional state.Material and methods. The study was carried out within the international project of the group „IRG on COVID and exercise”. The research tool was a standardized questionnaire.Results. Based on the data collected and the analysis of the percentage results, it can be observed that the overwhelming majority of people taking up physical activity reported a better mood during the pandemic. However, statistical tests do not confirm these relationships due to the small sample size.Conclusions. Isolation favours physical activity. Future, in-depth studies, by enlarging the population group, are necessary to confirm the above observations.

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