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Nevin Manimala Statistics

Reconsidering research exclusion for serious mental illness: Ethical principles, current status, and recommendations

J Psychiatr Res. 2021 Sep 2;143:138-143. doi: 10.1016/j.jpsychires.2021.09.016. Online ahead of print.

ABSTRACT

BACKGROUND: Historically, individuals managing serious mental illness (SMI) have often been excluded from research, typically because of concern that these individuals may not be able to understand and provide truly informed consent. As treatment has improved, the assumption that individuals managing SMI may not be capable of consent needs to be re-examined. Systematic exclusion from research may limit empirically tested treatments available for people managing SMI, and may contribute to the health care disparities seen in this population.

OBJECTIVES: This article examines this issue by documenting current rates of research exclusion for high disease burden conditions, based on empirical review of studies in ClinicalTrials.gov.

RESEARCH DESIGN: Current rates of exclusion from studies for psychiatric conditions were assessed through systematic review of relevant clinical trials on ClinicalTrials.gov.

SUBJECTS: Subjects in this inquiry are either articles accessed in the literature reviews, or descriptions of studies in public data on ClinicalTrials.gov.

MEASURES: The primary measure was a previously published coding system to document the extent and types of research exclusion related to psychiatric status.

RESULTS: Among studies of interventions for substance use disorders and chronic pain, individuals managing SMI were more likely to be excluded than those with other psychiatric disorders at statistically significant levels. This was not the case among studies of interventions for ischemic heart disease. In studies of substance use disorders, 9% explicitly excluded SMI and 83% could exclude people with SMI based on broader exclusion criteria. In studies of chronic pain these two categories of exclusion were 16% and 55%, and in studies of ischemic heart disease, these two categories of exclusion were 1% and 20%.

CONCLUSIONS: Evidence indicates that it is ethically and scientifically more appropriate to exclude based on capacity to consent than membership in the group of individuals managing SMI. The discussion outlines techniques researchers can use for more equitable and generalizable sampling.

PMID:34487990 | DOI:10.1016/j.jpsychires.2021.09.016

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Revision orbital decompression for thyroid eye disease

Am J Otolaryngol. 2021 Sep 2;43(1):103196. doi: 10.1016/j.amjoto.2021.103196. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the indications, surgical techniques and outcomes for revision orbital decompression surgery for thyroid eye disease in open, endoscopic, and combined open and endoscopic approaches.

METHODS: A retrospective review of all revision orbital decompression procedures for thyroid eye disease from a single large academic institution over a 17-year period (01/01/2004-01/01/2021) was performed. Patient demographics, as well as indications and types of surgery were reviewed. Outcome measures included changes in proptosis, intraocular pressure, visual acuity and diplopia.

RESULTS: Thirty procedures were performed on 21 patients. There was a median of 9.4 months between primary orbital decompression and revision decompression surgery. There were 6 bilateral procedures, and 2 of these patients underwent additional revision surgeries due to decreased visual acuity with concern for persistent orbital apex compression or sight-threatening ocular surface exposure in the setting of proptosis. Twenty-five procedures were performed as open surgeries with 5 endoscopic/combined cases. Combined Ophthalmology/Otolaryngology surgery via combined open/endoscopic approaches was favoured for persistent orbital apex disease. Visual acuity remained preserved in all patients. The overall median reduction in proptosis was 2 mm and intraocular pressure change was 1 mmHg regardless of surgical approach. The overall rate of new onset diplopia after surgery was 15%. These patients had open approaches. All endoscopic/combined approach patients had pre-existing diplopia. There were no statistically significant differences between the open and endoscopic/combined groups in regard to change in visual acuity, reduction in proptosis or intraocular pressure.

CONCLUSION: Revision orbital decompression is an uncommon procedure indicated for those patients with progressive symptoms despite previous surgery and intensive medical management. Both endoscopic and non-endoscopic techniques offer favourable outcomes with respect to visual acuity, decrease in intraocular pressure, and improvement in proptosis and overall lead to a low incidence of new onset diplopia.

LEVEL OF EVIDENCE: Level IV.

PMID:34487995 | DOI:10.1016/j.amjoto.2021.103196

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Recalibrating the Glasgow Coma Score as an Age-Adjusted Risk Metric for Neurosurgical Intervention

J Surg Res. 2021 Sep 2;268:696-704. doi: 10.1016/j.jss.2021.08.002. Online ahead of print.

ABSTRACT

BACKGROUND: The Glasgow Coma Scale (GCS) score is the most frequently used neurologic assessment in traumatic brain injury (TBI). The risk for neurosurgical intervention based on GCS is heavily modified by age. The objective is to create a recalibrated Glasgow Coma Scale (GCS) score that accounts for an interaction by age and determine the predictive performance of the recalibrated GCS (rGCS) compared to the standard GCS for predicting neurosurgical intervention.

METHODS: This retrospective cohort study utilized the National Trauma Data Bank and included all patients admitted from 2010-2015 with TBI (ICD9 diagnosis code 850-854.19). The study population was divided into 2 subsets: a model development dataset (75% of patients) and a model validation dataset (remaining 25%). In the development dataset, logistic regression models were used to calculate conditional probabilities of having a neurosurgical intervention for each combination of age and GCS score, to develop a point-based risk score termed the rGCS. Model performance was examined in the validation dataset using area under the receiver operating characteristic (AUROC) curves and calibration plots.

RESULTS: There were 472,824 patients with TBI. The rGCS ranged from 1-15, where rGCS 15 denotes the baseline risk for neurosurgical intervention (4.4%) and rGCS 1 represents the greatest risk (62.6%). In the validation dataset there was a statistically significant improvement in predictive performance for neurosurgical intervention for the rGCS compared to the standard GCS (AUROC: 0.71 versus 0.67, difference, -0.04, P<0.001), overall and by trauma level designation. The rGCS was better calibrated than the standard GCS score.

CONCLUSIONS: The relationship between GCS score and neurosurgical intervention is significantly modified by age. A revision to the GCS that incorporates age, the rGCS, provides risk of neurosurgical intervention that has better predictive performance than the standard ED GCS score.

PMID:34487962 | DOI:10.1016/j.jss.2021.08.002

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The Correlation between Altmetric Score and Traditional Bibliometrics in Orthopaedic Literature

J Surg Res. 2021 Sep 3;268:705-711. doi: 10.1016/j.jss.2021.07.025. Online ahead of print.

ABSTRACT

BACKGROUND: Clinicians and medical researchers increasingly turn to nonformal online platforms to promote research. Altmetric Attention Score (AAS) is a quantitative measurement of online influence of research in real time. The objective of this study is to determine if AAS correlates with traditional bibliometrics in the orthopaedic literature.

MATERIALS AND METHODS: From the 15 orthopaedic journals with the highest impact factor, the 10 most cited articles from each journal were reviewed for 2014 -2017. For each article, AAS was collected using the Altmetric Bookmarklet application and citation count from SCOPUS. Journal impact factor was recorded using Journal Citation Reports. Statistical analysis included Pearson’s and Spearman’s correlation coefficients.

RESULTS: A total of 600 articles were analyzed. A significant positive correlation was found between citation count and AAS for 2014 (r = 0.3188, p < 0.0001), and no correlation for 2015 (r = 0.1504, P = 0.0653), 2016 (r = 0.0087, P = 0.9157), and 2017 (r = 0.0061, P = 0.9408). There was no significant correlation between impact factor and AAS in 2014 (r = 0.4312, P = 0.1085), 2015 (r = 0.3850, P = 0.1565), 2016 (r = 0.1460, P = 0.6035) and 2017 (r = 0.0451 P = 0.8732).

CONCLUSIONS: AAS and traditional bibliometrics are currently not strongly correlated in orthopaedic literature. Citations take years to accumulate and AAS represents immediate influence of an article. An amalgamation of traditional bibliometrics and AAS may prove useful in determining the short- and long-term impact and influence of publications in orthopaedics.

PMID:34487963 | DOI:10.1016/j.jss.2021.07.025

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Acceptability, usefulness, and satisfaction with a web-based video-tailored physical activity intervention: The TaylorActive randomized controlled trial: Acceptability, usefulness and satisfaction with the TaylorActive randomised controlled trial

J Sport Health Sci. 2021 Sep 3:S2095-2546(21)00098-3. doi: 10.1016/j.jshs.2021.09.001. Online ahead of print.

ABSTRACT

PURPOSE: This study examined the usage, acceptability, usability, perceived usefulness, and satisfaction of a web-based video-tailored physical activity (PA) intervention (“TaylorActive”) in adults.

METHODS: In 2013-2014, 501 Australian adults aged 18+ years were randomized into a video-tailored intervention, text-tailored intervention, or control group. Over 3 months, the intervention groups received access to 8 sessions of personally tailored PA advice delivered via the TaylorActive website. Only the delivery method differed between the intervention groups: video-tailored vs. text-tailored. Google Analytics and telephone surveys conducted at post intervention (3 months) were used to assess intervention usage, acceptability, usability, perceived usefulness, and satisfaction. Quantitative and qualitative process data were analyzed using descriptive statistics and thematic content analysis.

RESULTS: Of 501 recruited adults, 259 completed the 3 months post-intervention survey (52% retention). Overall, usage of the TaylorActive website with respect to number of website visits, intervention sessions, and action plans completed was modest in both the video-tailored (7.6 ± 7.2 visits, mean ± SD) and text-tailored (7.3 ± 5.4 visits) groups with no significant between-group differences. The majority of participants in all groups used the TaylorActive website less than once in 2 weeks (66.7% video-tailored, 62.7% text-tailored, 87.5% control; p < 0.001). Acceptability was rated mostly high in all groups and, in some instances, significantly higher in the intervention groups compared to the control group (p < 0.01). Usability was also rated high; mean Systems Usability Scores (SUS) were 77.3 (video-tailored), 75.7 (text-tailored), and 74.1 (control) with no significant between-group differences. Perceived usefulness of the TaylorActive intervention was low, though mostly rated higher in the intervention groups compared to the control group (p < 0.01). Satisfaction with the TaylorActive website was mixed. Participants in both intervention groups liked its ease of use, personalized feedback, and tracking of progress, but also found completing action plans and survey questions for each session repetitive and tedious.

CONCLUSION: Providing personally tailored PA advice on its own (either through video or text) is likely insufficient to ensure good retention, usage, perceived usefulness, and satisfaction with a web-based PA intervention. Strategies to address this may include the incorporation of additional intervention components such as activity trackers, social interactions, gamification, as well as the use of advanced artificial intelligence and machine learning technologies to allow more personalized dialogue with participants.

PMID:34487910 | DOI:10.1016/j.jshs.2021.09.001

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Frequency Of Metabolic Syndrome In Patients With Psoriasis

J Ayub Med Coll Abbottabad. 2021 Jul-Sep;33(3):484-487.

ABSTRACT

BACKGROUND: Psoriasis is a non-communicable, long-lasting disorder of the skin comprising various immunological inflammatory changes. Increasing evidence suggests that psoriasis is closely related to multiple organ systems, potentially arising due to underlying co-morbid conditions such as diabetes, hypertension, dyslipidaemia and obesity. Aim of this study was to know the frequency of metabolic syndrome in psoriasis patients.

METHODS: This cross-sectional study was conducted from May to November 2020 in a Tertiary-care hospital. Eighty patients diagnosed with psoriasis were selected using non-probability consecutive sampling. Informed written consent was obtained from each patient and a questionnaire was filled. Blood pressure, waist circumference, body surface area covered by psoriasis, Psoriasis Area Severity Index were recorded on initial visit. Fasting blood sugar, serum triglyceride and HDL cholesterol levels were advised. Patients were diagnosed to have metabolic syndrome if ≥3 out of 5 criteria for the modified version of National Cholesterol Education Program Adult Panel III were met.

RESULTS: There were 62 male and 18 female patients. A total of 39 patients (48.8%) met the criteria for metabolic syndrome. Amongst these, 26/62 (41.9%) males vs 13/18 (72.2%) females fulfilled the criteria. The mean BMI of males was 26.0 while those of females was 28.3, comparison of which demonstrated a noteworthy difference (p=0.04). A statistically significant (p=0.038) positive correlation (r) of 0.233 was observed between body surface area and BMI.

CONCLUSIONS: Metabolic syndrome is seen frequently in patients of Psoriasis. Female patients have a significant frequency of metabolic syndrome and tend to have a higher BMI than males.

PMID:34487662

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The Comparison Of Efficacy Between Losartan And Diltiazem As Antiproteinuric Agent In Non-Diabetic Renal Diseases

J Ayub Med Coll Abbottabad. 2021 Jul-Sep;33(3):492-495.

ABSTRACT

BACKGROUND: Multiple options have been tried to counter the proteinuria secondary to renal diseases. Clinicians and researchers are trying to find the best option for this purpose.

OBJECTIVE: To compare efficacy of Losartan and Diltiazem in management of proteinuria in nondiabetic renal diseases at a tertiary care hospital of Pakistan. It was a Quasi-experimental study, conducted at the Department of nephrology Pak Emirates Military Hospital Rawalpindi. Five months, November 2020 to March 2021.

METHODS: A total of 122 patients of non-diabetic renal diseases with significant proteinuria were included in the study. They were randomly divided into two groups via lottery method. Group I received losartan while group II received Diltiazem in standard dose for three months. After three months they underwent 24 hours’ urinary protein levels and divided into complete, partial and non-responders to treatment. Age, gender, duration of illness and type of antiproteinuric treatment was correlated with response to treatment among the study population.

RESULTS: Out of 122 patients, 80 (65.6%) were males while 42 (34.4%) were females. Membranous nephropathy 20 (16.4%) was the commonest non-diabetic renal disease seen in our study participants. Thirty (24.5%) had complete remission after three months of treatment, 60 (49.2%) had partial response while 32 (26.3%) had no response to treatment. Chisquare test revealed that use of losartan had statistically significant relationship (p-value<0.001) with good response among the study participants.

CONCLUSIONS: Membranous nephropathy leading to proteinuria was the commonest non-diabetic renal disease encountered in our setup. Around 2/3rd of our patients showed either complete or partial response to treatment and Losartan was superior to Diltiazem in achieving response in our study participants.

PMID:34487664

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Educational Environment In The Transition Phase Of Curriculum At Ayub Medical College Abbottabad, Pakistan

J Ayub Med Coll Abbottabad. 2021 Jul-Sep;33(3):456-461.

ABSTRACT

BACKGROUND: Evaluation of the educational environment is key to the delivery of high-quality medical education. Especially, when an institute is in the transition phase of curriculum. In curriculum transformation phase of Ayub Medical College Abbottabad, no such evaluation has been done. This study aimed to find the direction of Educational environment in the transition phase curriculum of Ayub Medical College Abbottabad and compare different domains of educational environment with gender, residency, pre-medical education’s medium of instruction, and doctors among sibling or parents.

METHODS: This descriptive cross-sectional survey was conducted among students of integrated and traditional curriculum of Ayub Medical College, Abbottabad from 1st December 2019 to 29th February 2020. By Non-probability convenience sampling technique, pre-validated Dundee Ready Educational Environment Measure questionnaire was used. Descriptive and inferential statistics were calculated in SPSS v22.

RESULTS: A total 149 (100%) participants, 66 (44.3%) males and 83 (55.7%) females with mean age of 20.5±1.07 years responded. Among total, 76 (51%) were from integrated curriculum and 73 (49%) were of traditional curriculum. Significant difference was found among different aspect of education environments and both classes.

CONCLUSIONS: The current transitional phase of curriculum at Ayub Medical College Abbottabad is more positive than negative. Some areas like student social-self-perception still need improvement. Moreover, gender and place of birth affect student’s perception about their learning environment.

PMID:34487656

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Association Of Subchorionic Hematoma With Preterm Labour In Patients With Threatened Abortion

J Ayub Med Coll Abbottabad. 2021 Jul-Sep;33(3):451-455.

ABSTRACT

BACKGROUND: One of the frequent obstetric complications in first trimester is vaginal bleeding. It has an incidence of 16%-25%. Subchorionic haemorrhage is the most common cause of first trimester miscarriage associated with vaginal bleeding. The objective of the study was to determine the association of subchorionic hematoma (SCH) with preterm labour in pregnant females with threatened abortion.

METHODS: A Cohort Study was designed and conducted in the Obstetrics and Gynaecology Department, Zanana hospital, Dera Ismail Khan (D.I. Khan). A sample size of 418 subjects was equally divided into two equal groups. Non-probability consecutive sampling was used for collection of samples. Pregnant women presenting with sub chorionic hematoma were considered as cases while pregnant women without sub chorionic hematoma were considered as controls. The diagnosis of sub chorionic haemorrhage was established by ultrasound. Data was analysed by SPSS version 22.0 for description, i.e., frequencies and percentages were calculated for categorical variables and for continuous variables, mean±standard deviation (±SD) was calculated. To compare preterm labour in both groups Chi-square test was applied and p≤0.05 was taken as significant. Stratification was done with regard to age, gestational age, parity, history of hypertension, and weight to see the effect of these variables on preterm labour. Chi-square test was used for post stratification for both groups and p ≤ 0.05 was considered statistically significant and relative risk was calculated.

RESULTS: The age range was from 18-40 years in group A with a mean age of 29.08±2.88 years while it was 28.41±2.94 years in group B. Mean gestational age was 13.99±3.15 weeks in group A and 11.42±3.37 weeks in group B. Mean parity was 0.91±1.14 in group A and 0.78±1.09 in group B respectively. Mean weight of subjects in group A was 68.31±10.27 and 67.55±10.09 Kg in group B. Majority of the patients were of 18-30 years in both groups (group A; 78.5% and group B; 78.9%). History of hypertension was noted in 33% in group A and 12.9% in group B. In group A, preterm labour was seen in 40 (19.1%) patients as compared to 61 (29.2%) patients in group B, (p=0.02, R.R=0.65).

CONCLUSIONS: Subchorionic hematoma in patients with threatened abortion during the first half of the pregnancy may not increase the risk of preterm labour.

PMID:34487655

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Comparison Of Axillary Drain Output In Conventional And Advanced Compressive Energy Source Like Ultrasonic Scalpel And Ligasure Dissection Of Axilla In Breast Cancer Surgery

J Ayub Med Coll Abbottabad. 2021 Jul-Sep;33(3):431-436.

ABSTRACT

BACKGROUND: Breast cancer is the most common malignancy worldwide. Surgical treatment of axilla is a part of treatment of locally advanced breast cancer. Conventional knot tying plus electrocautery and advanced compressive energy sources are used to reduce the continued axillary serous fluid discharge when drains are in place and seroma formation afterwards.

METHODS: This double-blind comparative study was carried out from April 2018 to October 2019. In total 180 patients undergoing axillary dissection for treatment of locally advanced breast cancer were recruited. Patients were divided into two groups (C and H) depending upon method of dissection used for axillary surgery.

RESULTS: For most participants, amount of axillary drain volume in Group C was between 400-700 ml (in 48.9% participants) and for Group H more than 700 ml (in 44.4% participants). This difference is not statistically significant (p=0.288). Duration of hospital stay (p=0.003) and duration of drain placement was significantly longer (p=0.019) for most participants in Group H. More hospital visits were required for the said group. There was statistically significant co-relation between immediate complications and haemostasis techniques (p=0.003) with more incidence of Seroma noticed in Group H than in Group C.

CONCLUSIONS: Current study shows limited benefits of using ultrasonic scalpels in breast cancer surgeries. Variables such as BMI, Age and chemotherapy need to be controlled in order to derive a true comparison.

PMID:34487651