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.

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Draft Guidance ◽  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.

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.

scholarly journals Prospective, Clinical Pilot Study with Eleven 4-Mm Extra-Short Implants Splinted to Longer Implants for Posterior Maxilla Rehabilitation

2020 ◽  
Vol 9 (2) ◽  
pp. 357 ◽  
Author(s):  
Daniel Torassa ◽  
Pablo Naldini ◽  
José Luis Calvo-Guirado ◽  
Enrique Fernández-Bodereau
Keyword(s):  
Pilot Study ◽  
Clinical Performance ◽  
Small Sample Size ◽  
Treatment Protocol ◽  
Small Sample ◽  
Short Implants ◽  
Posterior Maxilla ◽  
Bone Height ◽  
Maxillary Region

In many clinical situations, rehabilitation with implants in the posterior maxillary region is complicated by limited bone availability. In this context, the use of 4 mm long implants (known as extra-short implants) may be used thanks to the concept of osseointegration enhancement. It has been demonstrated that short implants offer an alternative to the regeneration procedures involved in placing longer implants in areas where bone height is compromised. This prospective pilot study tested a treatment protocol in which 11 extra-short (4 mm) implants were splinted to 11 mesially placed longer (8 mm) implants in the posterior maxillary regions of partially edentulous patients, without using supplementary bone regeneration procedures. Eleven patients were included in this single cohort study. The clinical performance of the extra-short implants was assessed during a two-year follow-up period, obtaining a 100% survival rate and mean bone loss of 0.3 mm. Implant stability measured by resonance frequency analysis (RFA) at the time of placement was 54.9 ± 4.9, increasing to 77.0 ± 2.6 at 24 months. The study demonstrated the gradual consolidation of osseointegration in bone of less-than-ideal quality in the posterior maxillary region. The results obtained show that a partially edentulous maxilla with reduced bone height may be rehabilitated by using an extra-short implant splinted to a mesial implant of 8mm length or longer. Despite the small sample size, this pilot study observed that extra-short implants achieved adequate bone stability and clinical performance after a 24-month follow-up.

Predictive value of serum gelsolin and Gc globulin in sepsis – a pilot study

2018 ◽  
Vol 56 (8) ◽  
pp. 1373-1382 ◽  
Author(s):  
Zoltán Horváth-Szalai ◽  
Péter Kustán ◽  
Balázs Szirmay ◽  
Ágnes Lakatos ◽  
Per Hjort Christensen ◽  
...  
Keyword(s):  
Septic Shock ◽  
Pilot Study ◽  
Small Sample Size ◽  
Small Sample ◽  
Predictive Values ◽  
Reactive Protein ◽  
Turbidimetric Assay ◽  
Therapeutic Decision Making

Abstract Background: Simultaneous determination of the two main actin scavenger proteins in sepsis has not been investigated until now. In our pilot study, we elucidated the predictive values of Gc globulin and gelsolin (GSN) in sepsis by comparing them to classic laboratory and clinical parameters. Methods: A 5-day follow-up was performed, including 46 septic patients, 28 non-septic patients and 35 outpatients as controls. Serum Gc globulin and GSN levels were determined by automated immune turbidimetric assay on a Cobas 8000/c502 analyzer. Patients were retrospectively categorized according to the sepsis-3 definitions, and 14-day mortality was also investigated. Results: First-day GSN also differentiated sepsis from non-sepsis (AUC: 0.88) similarly to C-reactive protein (AUC: 0.80) but was slightly inferior to procalcitonin (PCT) (AUC: 0.98) with a cutoff value of GSN at 22.29 mg/L (sensitivity: 83.3%; specificity: 86.2%). Only first-day SOFA scores (0.88) and GSN (0.71) distinguished septic survivors from non-survivors, whereas lactate (0.99), Gc globulin (0.76) and mean arterial pressure (MAP) (0.74) discriminated septic shock from sepsis. Logistic regression analyses revealed SOFA scores and GSN being significant factors regarding 14-day mortality. First-day GSN levels were higher (p<0.05) in septic survivors than in non-survivors. Gc globulin levels remained higher (p<0.01) in sepsis when compared with septic shock during the follow-up period. Conclusions: Both serum GSN and Gc globulin may have predictive values in sepsis. Considering the small sample size of our study, further measurements are needed to evaluate our results. Measurement of Gc globulin and GSN maybe useful in assessment of sepsis severity and in therapeutic decision-making.

scholarly journals Mindfulness Based Specific Phobia Intervention: A Pilot Study of Dissociated Ego State Resolution

2020 ◽  
Vol 39 (1-2) ◽  
Author(s):  
Genine Smith ◽  
Glenn Hartelius
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Research Question ◽  
Specific Phobia ◽  
Small Sample ◽  
Medical Assistance ◽  
Individual Session ◽  
Post Test ◽  
Larger Sample

This pilot study was designed to investigate the efficacy of a mindfulness based intervention for the treatment of needle phobia. The research question was whether one session of the dissociated ego state [DES] trauma release intervention would result in significant and durable release of needle phobia. It was hypothesized that the process tested in this study may reduce needle phobia by locating, identifying, and engaging with a dissociated aspect of the psyche developed from earlier trauma. Six participants who self reported fear of needles and resulting avoidance of medical assistance completed one 60-minute, individual session of a mindfulness based protocol for the release of specific phobia. After the DES intervention session, all participants but one reported reduced subjective units of distress while holding the needle against their skin: reduction of 61% post-test, 71% at 3-month follow-up, and 70% at 6-month follow up. Results at 6-month follow-up were statistically significant despite small sample size. Future investigations should involve larger sample sizes, populations drawn from various settings, more facilitators and a randomized, waitlist group.

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.

A pilot study of a low-intensity health education intervention on activity and quality-of-life measures for cancer survivors.

2016 ◽  
Vol 34 (3_suppl) ◽  
pp. 221-221
Author(s):  
Arnab Basu ◽  
Sreyasi Bhattacharya ◽  
Kenneth David Miller
Keyword(s):  
Physical Activity ◽  
Pilot Study ◽  
Health Education ◽  
Cancer Survivors ◽  
Dietary Habits ◽  
Small Sample ◽  
Composite Score ◽  
Low Intensity ◽  
The Impact

221 Background: There is an increasing need for effective targeted health education interventions for cancer survivors related to dietary habits, physical activity and cancer related psychosocial challenges. Methods: We designed an educational program for cancer survivors (n=37 ) presenting for outpatient follow up visits. The program was composed of a 30-60 minute survivorship visit and a series of six 7-10 minute video tutorials shown two at a time either remotely or in person every two months over a six month period about the importance of diet, physical activity and psychosocial aspects of cancer survivorship. Baseline assessments of perceived state of health, physical activity, diet, and the Impact of cancer were made through a series of validated questionnaires, including SF-12, IPAQ, FRDHQ and IOC. Patients were then sent another follow-up survey in approximately 1 year to be filled online; those who could not respond were followed up by phone. Weight and height data were registered during 1 year follow-up visit. Results: 37 Patients initially participated in the study, of these, all 37 either replied/were followed up after a 1 year time period. 87% were women and 70% were African American, 25(66%) of patients had a prior diagnosis of breast carcinoma, 4 (11%) had a prior diagnosis of colorectal Carcinoma. 16 (43%), 13(35%) and 7(18%) of patients had <5 , 5-10 and >10 years since last surgery/chemotherapy. We demonstrated that this type of low intensity intervention is feasible in a medically underserved group of cancer survivors. There was a trend towards an improved Physical Composite Score (25.1 vs 43.1) and Mental Composite Score (54.1 vs 58.1) on the SF-12 questionnaire at the time of follow-up, indicating improved health and functional well being. There were no large noticeable differences in fat related dietary habits. Due to a small sample size, stated differences did not reach the threshold of statistical significance. Conclusions: Our pilot study suggests that a low intensity intervention is feasible and may be associated with improvement in health behaviors in cancer survivors. Larger studies are needed to explore the efficacy of this, and similar interventions.

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.

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.

scholarly journals The Symbiotic Mutualism between Co-Creation and Entrepreneurship

2021 ◽  
Vol 13 (11) ◽  
pp. 6285
Author(s):  
Sandra Misiak-Kwit ◽  
Małgorzata Wiścicka-Fernando ◽  
Kelaniyage Shihan Dilruk Fernando
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Strong Association ◽  
Sampling Technique ◽  
Small Sample ◽  
Entrepreneurial Intentions ◽  
Added Value ◽  
Primary Data ◽  
Exploratory Research ◽  
Symbiotic Mutualism

In this manuscript, the authors aim to explore firstly the association between entrepreneurial mindset and co-creation experience, secondly the association between co-creation experience and entrepreneurial intentions, and thirdly the association between entrepreneurial mindset and entrepreneurial intentions within the sustainability context. In this paper, the authors present the results of the pilot study. Primary data were collected from 500 university students from China, Georgia, Poland, Romania, and Sri Lanka by using a convenient sampling technique, and a literature review was the primary method of the concept development. The authors selected the above-mentioned countries to collect primary data by using a convenient sampling technique based on accessibility; they also visited all analysed countries in order to conduct the pilot survey personally. Descriptive statistics and the Spearman’s rank correlation coefficient were applied as primary statistical methods. The findings reveal that there is a very strong association between co-creation experience and entrepreneurial intentions, a very weak negative association between entrepreneurial mindset and co-creation experience, and, surprisingly, a weak association between entrepreneurial mindset and entrepreneurial intentions. The added value of the conducted pilot research involves filling in a gap regarding the relationship between experience and the subjective norm. In the presented pilot research, co-creation experience was compared with not only entrepreneurial mindset but with entrepreneurial intentions as well. An additional value of this exploratory research is compiling an international comparison. The main contribution of this pilot study is examining the symbiotic mutualism between co-creation and entrepreneurship. Among many platforms of associations, the following can be differentiated: creativity, innovativeness, openness, engagement, awareness, motivation, trust (level of social capital), and recognizing the significance of social and sustainable development objectives. Due to the small sample size, the results cannot be generalised. Results refer only to the respondents. However, the findings of the pilot study are the basis for further research studies on symbiotic mutualism between entrepreneurship and co-creation.

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