A Randomized, Placebo-Controlled Trial of the Discontinuation of Long-Term Antipsychotics in Dementia

The objectives of this randomized clinical trial were to investigate the impact of the discontinuation of long-term antipsychotics in residents with dementia in chronic care institutions and to identify clinical predictors of safe discontinuation. Subjects included 34 residents with dementia who were on antipsychotics for more than 6 months and whose behavior was currently stable. Subjects were randomized to either continue receiving their regular dosage of antipsychotics or to receive placebo for 6 months. Early withdrawal from the study was not statistically different between the groups (relative risk [RR] = 1.57, 95% confidence interval [CI] 0.76–3.26), and though not significantly different, subjects in the placebo group were more likely to be withdrawn from the study because of worsening behavior (RR = 1.25, 95% CI 0.33–4.76). Three subjects in the placebo group were withdrawn from the study due to worsening of extrapyramidal symptoms. The active treatment group had more behavioral problems (e.g., physical aggression towards others, p < .05) compared to the placebo group. The placebo group developed more apathy, but balancing this outcome was a relative improvement in congitive functioning. Baseline antipsychotic dose was predictive of behavioral worsening upon discontinuation of long-term antipsychotic drugs. The primary limitation of the study was the small sample size. In conclusion, a trial of discontinuation of antipsychotics should be considered in this population.

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Congenital Micropenis: Aetiology And Management

Journal of the Endocrine Society ◽

10.1210/jendso/bvab172 ◽

2021 ◽

Author(s):

Marianna Rita Stancampiano ◽

Kentaro Suzuki ◽

Stuart O’Toole ◽

Gianni Russo ◽

Gen Yamada ◽

...

Keyword(s):

Racial Differences ◽

Small Sample Size ◽

Small Sample ◽

Long Term Outcomes ◽

Penile Length ◽

Appearance Quality ◽

Wide Range ◽

The Impact

Abstract In the newborn, penile length is determined by a number of androgen dependent and independent factors. The current literature suggests that there are inter-racial differences in stretched penile length in the newborn and although congenital micropenis should be defined as a stretched penile length of less than 2.5SDS of the mean for the corresponding population and gestation, a pragmatic approach would be to evaluate all boys with a stretched penile length below 2 cm, as congenital micropenis can be a marker for a wide range of endocrine conditions. However, it remains unclear as to whether the state of micropenis, itself, is associated with any long-term consequences. There is a lack of systematic studies comparing the impact of different therapeutic options on long-term outcomes, in terms of genital appearance, quality of life and sexual satisfaction. To date, research has been hampered by a small sample size and inclusion of a wide range of heterogeneous diagnoses; for these reasons, condition specific outcomes have been difficult to compare between studies. Lastly, there is a need for a greater collaborative effort in collecting standardized data so that all real-world or experimental interventions performed at an early age can be studied systematically into adulthood.

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The Impact of Improved Thermistor Calibration on the Expendable Bathythermograph Profile Data

Journal of Atmospheric and Oceanic Technology ◽

10.1175/jtech-d-17-0024.1 ◽

2017 ◽

Vol 34 (9) ◽

pp. 1947-1961 ◽

Cited By ~ 2

Author(s):

Marlos Goes ◽

Elizabeth Babcock ◽

Francis Bringas ◽

Peter Ortner ◽

Gustavo Goni

Keyword(s):

Small Sample Size ◽

Heat Content ◽

Small Sample ◽

Profile Data ◽

Expendable Bathythermograph ◽

Different Types ◽

Long Term Trends ◽

The Mean ◽

The Impact

AbstractExpendable bathythermograph (XBT) data provide one of the longest available records of upper-ocean temperature. However, temperature and depth biases in XBT data adversely affect estimates of long-term trends of ocean heat content and, to a lesser extent, estimates of volume and heat transport in the ocean. Several corrections have been proposed to overcome historical biases in XBT data, which rely on constantly monitoring these biases. This paper provides an analysis of data collected during three recent hydrographic cruises that utilized different types of probes, and examines methods to reduce temperature and depth biases by improving the thermistor calibration and reducing the mass variability of the XBT probes.The results obtained show that the use of individual thermistor calibration in XBT probes is the most effective calibration to decrease the thermal bias, improving the mean thermal bias to less than 0.02°C and its tolerance from 0.1° to 0.03°C. The temperature variance of probes with screened thermistors is significantly reduced by approximately 60% in comparison to standard probes. On the other hand, probes with a tighter weight tolerance did not show statistically significant reductions in the spread of depth biases, possibly because of the small sample size or the sensitivity of the depth accuracy to other causes affecting the analysis.

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Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

ERJ Open Research ◽

10.1183/23120541.00460-2020 ◽

2020 ◽

Vol 6 (4) ◽

pp. 00460-2020

Author(s):

Michael G. Crooks ◽

Jack Elkes ◽

William Storrar ◽

Kay Roy ◽

Mal North ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Small Sample Size ◽

Controlled Trial ◽

Small Sample ◽

Self Management ◽

Open Label ◽

Management Interventions ◽

Randomised Controlled ◽

The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

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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

Polish Journal of Public Health ◽

10.2478/pjph-2019-0029 ◽

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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The Role of Dopamine Receptor D2 in Bridging the Intention-Behavior Gap in Sport Participation

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052379 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2379

Author(s):

Seiyeong Park ◽

Junhye Kwon ◽

Chiyoung Ahn ◽

Hae-Sung Cho ◽

Hyo Youl Moon ◽

...

Keyword(s):

University Students ◽

Dopamine Receptor ◽

Sport Participation ◽

Small Sample Size ◽

Behavioral Model ◽

Small Sample ◽

Male Students ◽

Future Research ◽

Dopamine Receptor D2 ◽

The Impact

Previous studies have identified that a behavior can occur through the strongest predictor intention, but there is a gap between intention and behavior. Dopamine receptor D2 (DRD2) is known to account for a variance in sporting behaviors in human and animal subjects. However, the relationship between DRD2 and sport participation has been poorly studied, and the limited available reports are inconsistent. The present study was performed to examine the impact of DRD2 on sport participation among Korean university students based on the integrated behavioral model (IBM). Data were collected from enrolled university students in Seoul (N = 45). Participants answered survey questions first, and then they gave investigators their hair to provide DNA information (i.e., the A1 allele of DRD2). DRD2 had a significant effect on sport participation, but only in male students. Male students who carried the A1 allele of DRD2 significantly participated in 105.10 min more sporting activities than male students who did not. Moreover, the effect of intention on sport participation was significantly decreased when considering DRD2. Despite the small sample size, the results of this study could be a preliminary case for a larger study and indicate the direction of future research. Our results suggest that DRD2 may have played an important role as the “actual skill” shown in the IBM.

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Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT

Gerontology ◽

10.1159/000510903 ◽

2020 ◽

Vol 66 (6) ◽

pp. 542-548

Author(s):

Wendy L. Cook ◽

Penelope M.A. Brasher ◽

Pierre Guy ◽

Stirling Bryan ◽

Meghan G. Donaldson ◽

...

Keyword(s):

Hip Fracture ◽

Small Sample Size ◽

Controlled Trial ◽

Geriatric Care ◽

Small Sample ◽

Community Dwelling ◽

Post Discharge ◽

Mobility Performance ◽

Discharge Care ◽

Comprehensive Geriatric Care

Background: Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. Objective: To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. Methods: A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. Results: We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (n = 26) and usual care (UC, n = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, p = 0.13). Adverse events were similar in the 2 groups. Conclusion: The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

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DIAGNOSIS OF ENDOCRINE DISEASE: The diagnostic performance of adrenal biopsy: a systematic review and meta-analysis

Acta Endocrinologica ◽

10.1530/eje-16-0297 ◽

2016 ◽

Vol 175 (2) ◽

pp. R65-R80 ◽

Cited By ~ 40

Author(s):

Irina Bancos ◽

Shrikant Tamhane ◽

Muhammad Shah ◽

Danae A Delivanis ◽

Fares Alahdab ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Performance ◽

Small Sample Size ◽

Controlled Trial ◽

Meta Analysis ◽

Small Sample ◽

Cochrane Central Register ◽

Moderate Risk ◽

Adrenal Biopsy ◽

Adrenocortical Carcinomas

ObjectiveTo perform a systematic review of published literature on adrenal biopsy and to assess its performance in diagnosing adrenal malignancy.MethodsMedline In-Process and Other Non-Indexed Citations, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial were searched from inception to February 2016. Reviewers extracted data and assessed methodological quality in duplicate.ResultsWe included 32 observational studies reporting on 2174 patients (39.4% women, mean age 59.8 years) undergoing 2190 adrenal mass biopsy procedures. Pathology was described in 1621/2190 adrenal lesions (689 metastases, 68 adrenocortical carcinomas, 64 other malignancies, 464 adenomas, 226 other benign, 36 pheochromocytomas, and 74 others). The pooled non-diagnostic rate (30 studies, 2013 adrenal biopsies) was 8.7% (95%CI: 6–11%). The pooled complication rate (25 studies, 1339 biopsies) was 2.5% (95%CI: 1.5–3.4%). Studies were at a moderate risk for bias. Most limitations related to patient selection, assessment of outcome, and adequacy of follow-up. Only eight studies (240 patients) could be included in the diagnostic performance analysis with a sensitivity and specificity of 87 and 100% for malignancy, 70 and 98% for adrenocortical carcinoma, and 87 and 96% for metastasis respectively.ConclusionsEvidence based on small sample size and moderate risk of bias suggests that adrenal biopsy appears to be most useful in the diagnosis of adrenal metastasis in patients with a history of extra-adrenal malignancy. Adrenal biopsy should only be performed if the expected findings are likely to alter the management of the individual patient and after biochemical exclusion of catecholamine-producing tumors to help prevent potentially life-threatening complications.

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Nipple Confusion

PEDIATRICS ◽

10.1542/peds.92.2.300 ◽

1993 ◽

Vol 92 (2) ◽

pp. 300-301

Author(s):

DOREN FREDRICKSON

Keyword(s):

Breast Feeding ◽

Statistical Power ◽

White Women ◽

Small Sample Size ◽

False Negative ◽

Small Sample ◽

Bottle Feeding ◽

Feeding Duration ◽

Breast Feed ◽

The Impact

To the Editor.— I wish to comment on the study reported by Cronenwett et al,1 which was a fascinating prospective study among married white women who planned to breast-feed. Women were randomly selected to perform either exdusive breast-feeding or partial breast-feeding with bottled human milk supplements to determine the impact of infant temperament and limited bottle-feeding on breast-feeding duration. The authors admit that small sample size and lack of statistical power make a false-negative possible.

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The impact of vestibular symptoms and electronystagmography results on recovery from sudden sensorineural hearing loss

Journal of Basic and Clinical Physiology and Pharmacology ◽

10.1515/jbcpp-2020-0354 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Gaelle Vofo ◽

Marrigje Aagje de Jong ◽

Michal Kaufman ◽

Julia Meyler ◽

Ron Eliashar ◽

...

Keyword(s):

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Small Sample Size ◽

Small Sample ◽

Sudden Sensorineural Hearing Loss ◽

Sensorineural Hearing ◽

Caloric Test ◽

Routine Identification ◽

The Impact ◽

Caloric Tests

Abstract Objectives Idiopathic sudden sensorineural hearing loss (SSNHL) represents a frequently encountered otological entity, of various types and severity, with an array of associated symptoms including vertigo. This is a devastating life-changing condition with a blurry prognosis. The objective of this study was to determine the clinical association of vestibular impairment by electronystagmography (ENG) and caloric tests, and their ability to predict prognosis. Methods An observational, crossectional study was carried out amongst patients admitted with SSNHL. Each consenting patient had an audiometry test performed on admission as well as ENG and caloric tests. Treatment included oral steroids and carbogen with intratympanic steroids used only as salvage treatment. Follow-up was completed after 6 months when hearing gains were evaluated. Finally, an association was sought between the rate of recovery and ENG and caloric test results. Results Of 35 patients included, marked recovery was seen in patients without vertigo when compared to those with vertigo (p=0.003). A statistically significant association was found between the presence of vertigo and hearing deterioration (p=0.008). More so, normal electronystagmography results were associated with marked recovery (p=0.04). Conclusions The vestibular end organs are both subjectively and objectively affected in SSNHL as demonstrated by the abnormal ENG and caloric tests in our study despite the small sample size. Concomitant vestibular involvement carries poorer prognosis and routine identification may help foresee the recovery of patients with SSNHL and as such, aid in patient counseling. ENG and caloric tests are easily available and may be recommended for all patients with SSNHL.

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The impact of Vaccination worldwide on SARS-CoV-2 infection: A Review on Vaccine Mechanisms, Results of Clinical Trials, Vaccinal Coverage and Interactions with Novel Variants

Current Medicinal Chemistry ◽

10.2174/0929867328666210902094254 ◽

2021 ◽

Vol 28 ◽

Author(s):

Douglas Henrique Pereira Damasceno ◽

Arthur Aguiar Amaral ◽

Cecília Andrade Silva ◽

Ana Cristina Simões e Silva

Keyword(s):

Immune Response ◽

Clinical Trials ◽

Placebo Group ◽

Mechanisms Of Action ◽

Novel Variants ◽

The Impact ◽

Positive Results ◽

Epidemiological Information ◽

Long Term Studies

Background: The COVID-19 pandemic demanded a global effort towards quickly developing safe and effective vaccines against SARS-CoV-2. Objective: This review aimed to discuss the main vaccines available, their mechanisms of action, results of clinical trials and epidemiological behavior. The implications of viral variants were also debated. Methods: A non-systematic literature review was performed between February and March 2021 by searching the Pubmed, Scopus, and SciELO databases, using different combinations of the following terms: "vaccines", "clinical trials" , "SARS-CoV-2", "Coronavirus", "COVID-19", "mechanisms of action". Data regarding clinical trials of SARS-CoV-2 vaccines and epidemiological information were also searched. Results: The mechanisms of action included vector-virus, mRNA and inactivated virus vaccines. The vaccines showed positive results in phases 2/3 clinical trials. The efficacy of the mRNA 1273 and of mRNA BNT 162b2 vaccines were 94.1% and 95%, respectively. The effectiveness of the ChAdOx1 nCoV-19 vaccine varied according to the scheme, with an overall value of 70.4%. The Gam-COVID-Vac vaccine had an efficacy of 91.6%. Regarding the Ad26.COV2.S vaccine, 99% or more of seroconversion was observed in all subgroups 29 days after vaccination. The CoronaVac vaccine induced an immune response in 92% of the volunteers receiving 3ug and in 98% with 6ug, in comparison to 3% in the placebo group. Conclusion: Global efforts have resulted in vaccines available in record time, with good safety and immunogenicity profile. However, only long-term studies can provide more information on duration of immunity and the need for additional doses.

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