scholarly journals Reduced physical activity and weight gain are associated with an increase of depressive symptoms during the COVID-19 pandemic. A general practitioners’ prospective observational study

2021 ◽  
Vol 10 ◽  
pp. 204800402110477
Author(s):  
Simon Wernhart ◽  
Eberhard Weihe ◽  
Tienush Rassaf
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Weight Gain ◽  
Observational Study ◽  
General Practitioners ◽  
Outcome Measures ◽  
Prospective Observational Study ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Reduced Physical Activity

Objectives We aimed to assess associations between depressive symptoms, lifestyle, and somatic symptoms during the COVID-19 pandemic. Design A prospective, observational study using a self-designed questionnaire. Setting Three general practitioners’ (GP) offices in rural Germany. Participants 271 adult patients without manifest cardiovascular or pulmonary disease with (n = 82) and without (n = 189) hypertension reporting to our GP offices. Main outcome measures The reported increase of depressive symptoms (loneliness, sleeplessness, joylessness, listlessness) prior to the first documented case in Germany on 27.01.2020 (t0) as opposed to patients’ health perception during the Corona pandemic (t1) was the primary outcome measure. The secondary outcome measures were changes in physical activity (PA), dyspnea and angina in the two groups. Results Out of 271 patients (50.8 ± 16.8 years, 55.1% females), 1.5% were tested positive for COVID-19. Overall, listlessness (8.5%, p = 0.001), sleeplessness (5.2%, p = 0.001) and joylessness (4.2%, p = 0.003) were increased. Dyspnea significantly increased (9.2%, p < 0.001) and employment status worsened (6.5%, p < 0.001). There were significant associations between the increase of depressive symptoms, weight increase (p = 0.017), and reduction in physical activity (p = 0.046). However, after adjusting for age, hypertensive patients did not show more depressive symptoms (p = 0.704), dyspnea (p = 0.063) or angina (p = 0.432), nor was there any difference in PA (p = 0.906) compared to healthy individuals. Conclusions We demonstrate an association between the deterioration of depressive symptoms, weight gain, and reduced physical activity during COVID-19, both in hypertensives and healthy controls. Hypertension is no driver of symptom deterioration during the pandemic. The trial was registered in the German Clinical Trials Registry (DRKS00022157).

scholarly journals Efficacy and Safety of Blood Stasis Based Herbal Medicine for Patients with Traffic Accident : A Prospective Observational Study

2020 ◽  
Vol 37 (3) ◽  
pp. 151-160
Author(s):  
Sung Min Bong ◽  
Hyo Rim Jo ◽  
Woo Seok Jang ◽  
Seong Kyeong Choi ◽  
Won Suk Sung ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Observational Study ◽  
Outcome Measures ◽  
Prospective Observational Study ◽  
Blood Stasis ◽  
Secondary Outcome ◽  
Korean Medicine ◽  
Significant Difference ◽  
Vas Scores ◽  
Eq Vas

Background: Blood stasis (BS) is commonly used for pattern identification in traumatic injuries, including traffic accidents (TAs). Various studies have identified the efficacy of Korean medicine treatments for TA patients, but studies focusing on the BS-based herbal medicine (BSHM), including Tongdo-san (TDS), are rare.<br/>Methods: This was a single-center, prospective observational study, conducted from August 24th, 2018 to December 27th, 2018, which included 40 TA patients. Participants underwent routine Korean medicine treatments including acupuncture, electronic moxibustion, cupping, physical therapy, and herbal medicine. In the herbal medicine treatment, participants took BSHM with more than 3 days including taking TDS. The primary outcome measures were the scores from a 100 mm visual analogue scale (VAS) and numerical rating scale (NRS). Secondary outcome measures included scores from EuroQol-5 dimension (EQ-5D) and EQVAS questionnaires, the BS and cold/heat indices, and safety assessments.<br/>Results: There were significant improvements in the VAS, NRS, EQ-5D, EQ-VAS scores, and BS index after treatment. In the sub-analysis, VAS, NRS, EQ-5D, and EQ-VAS scores were higher in groups with a higher BS index. The moderate and severe BS index groups showed more improvement than the minor BS index group, and there was a significant difference in the EQ-5D scores. There was no significant differences observed in cold/heat index groups scores.<br/>Conclusion: BS is associated with TA-related symptoms. BSHM, including TDS, may significantly reduce BS, pain, and discomfort.

scholarly journals Is the Course of Headache Complaints Related to the Course of Orofacial Pain and Disability in Patients Treated for Temporomandibular Pain? An Observational Study

2021 ◽  
Vol 11 (17) ◽  
pp. 7780
Author(s):  
Hedwig A. van der Meer ◽  
Letícia B. Calixtre ◽  
Caroline M. Speksnijder ◽  
Raoul H. H. Engelbert ◽  
Maria W. G. Nijhuis-van der Sanden ◽  
...  
Keyword(s):  
Observational Study ◽  
Usual Care ◽  
Outcome Measures ◽  
Repeated Measures ◽  
Multidisciplinary Treatment ◽  
Pain Scale ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Pain Patients ◽  
Over Time

Migraine, tension-type headache (TTH) and headaches attributed to temporomandibular disorders (TMD) are prevalent in patients with TMD-pain. The objective was to describe the course of headache complaints as compared to the course of TMD complaints in TMD-pain patients with headache during usual care multidisciplinary treatment for TMD. This was a 12-week longitudinal observational study following adults with TMD-pain and headache during a usual-care multidisciplinary TMD-treatment. The Graded Chronic Pain Scale was used for both TMD and headache to measure pain-related disability (primary outcome measure), pain intensity, days with pain and days experiencing disability (secondary outcome measures). Stratified for the headache type, general linear modelling for repeated measures was used to analyze changes over time in the TMD complaints and the headache complaints. TMD-pain patients with migraine (n = 22) showed significant decrease of pain-related disability for both TMD and headache complaints over time. No difference in the effect over time was found between the two complaints. Patients with TMD-pain and TTH (n = 21) or headache attributed to TMD (n = 17) did not improve in disability over time. For the secondary outcome measures, the results were equivocal. In conclusion, TMD-pain patients with migraine, improvement in TMD-related disability was comparable to headache-related disability for TMD-pain patients with TTH or with headache attributed to TMD, no improvements in disability were found.

scholarly journals Discussing suicidality with depressed patients: an observational study in Dutch sentinel general practices

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e027624 ◽  
Author(s):  
Elke Elzinga ◽  
Renske Gilissen ◽  
Gé A Donker ◽  
Aartjan T F Beekman ◽  
Derek P de Beurs
Keyword(s):  
The Netherlands ◽  
Observational Study ◽  
Outcome Measures ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Suicidal Thoughts ◽  
Depressed Patients ◽  
General Practices ◽  
Male Patients ◽  
Suicide Prevention Training

ObjectivesThis paper aims to describe the degree to which general practitioners (GPs) explore suicidal behaviour among depressed patients in the Netherlands.DesignAn observational study of consultations between GPs and depressed patients.Setting39 sentinel GP practices within the Netherlands in 2017.ParticipantsPatients with a registration of depression.Primary and secondary outcome measuresPrimary outcome measure is suicide exploration by the GP. Secondary outcome measures at patient level, assessed by surveying GPs, include prevalence and severity of suicidal thoughts. Secondary outcome measures at GP level include follow-up actions of GP and reasons not to explore suicidality.ResultsA total of 1034 questionnaires were included in the analyses. GPs assessed and explored suicidality in 44% of patients with depression (66% in patients with a new episode of depression). GPs explored suicidal feelings more often in patients with a new episode of depression (OR 4.027, p<0.001, 95% CI 2.924 to 5.588), male patients (OR 1.709, p<0.001, 95% CI 1.256 to 2.330) or younger patients (OR 1.017, p<0.001, 95% CI 1.009 to 1.026). Multilevel analysis showed that 22% of the variation in suicide exploration is due to differences in GP practice. Thirty-eight per cent of the patients who were asked by their GP, reported (severe) suicidal ideation. Most GPs (68%) did not explore suicidal feelings because they thought the patient would not be suicidal.ConclusionGPs explored suicidal thoughts in less than half of all depressed patients and in two-thirds of patients with a new episode of depression. Suicide prevention training is recommended to enhance suicide exploration.

scholarly journals Later sleep timing predicts accelerated summer weight gain among elementary school children: a prospective observational study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jennette P. Moreno ◽  
Javad Razjouyan ◽  
Houston Lester ◽  
Hafza Dadabhoy ◽  
Mona Amirmazaheri ◽  
...  
Keyword(s):  
Physical Activity ◽  
Observational Study ◽  
Sleep Duration ◽  
Obesity Prevention ◽  
Prospective Observational Study ◽  
Light Exposure ◽  
Activity Level ◽  
Activity Levels ◽  
School Year ◽  
Children’S Sleep

Abstract Objectives and background Social demands of the school-year and summer environment may affect children’s sleep patterns and circadian rhythms during these periods. The current study examined differences in children’s sleep and circadian-related behaviors during the school-year and summer and explored the association between sleep and circadian parameters and change in body mass index (BMI) during these time periods. Methods This was a prospective observational study with 119 children ages 5 to 8 years with three sequential BMI assessments: early school-year (fall), late school-year (spring), and beginning of the following school-year in Houston, Texas, USA. Sleep midpoint, sleep duration, variability of sleep midpoint, physical activity, and light exposure were estimated using wrist-worn accelerometry during the school-year (fall) and summer. To examine the effect of sleep parameters, physical activity level, and light exposure on change in BMI, growth curve modeling was conducted controlling for age, race, sex, and chronotype. Results Children’s sleep midpoint shifted later by an average of 1.5 h during summer compared to the school-year. After controlling for covariates, later sleep midpoints predicted larger increases in BMI during summer, (γ = .0004, p = .03), but not during the school-year. Sleep duration, sleep midpoint variability, physical activity levels, and sedentary behavior were not associated with change in BMI during the school-year or summer. Females tended to increase their BMI at a faster rate during summer compared to males, γ = .06, p = .049. Greater amounts of outdoor light exposure (γ = −.01, p = .02) predicted smaller increases in school-year BMI. Conclusions Obesity prevention interventions may need to target different behaviors depending on whether children are in or out of school. Promotion of outdoor time during the school-year and earlier sleep times during the summer may be effective obesity prevention strategies during these respective times.

scholarly journals Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Measures ◽  
Remote Monitoring ◽  
Search Algorithm ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Digital Products ◽  
Clinical Trial Registry ◽  
Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

scholarly journals Pulsed Shortwave Therapy in Cervical Osteoarthritis: an NSAID- Controlled, Randomized Clinical Trial

2021 ◽  
Author(s):  
A. Rachid El Mohammad ◽  
Sree Koneru ◽  
Richard Staelin ◽  
Kenneth McLeod ◽  
Omar Tabbouche ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Outcome Measures ◽  
Neck Disability Index ◽  
Primary Outcome Measure ◽  
Pain Medication ◽  
Secondary Outcome ◽  
Pain Duration ◽  
Cox 2 ◽  
Neck Disability ◽  
Pain At Rest

AbstractAssess treatment superiority of pulsed shortwave therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis. Two hundred chronic pain suffers (average pain duration about 2 years) diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatment arms: COX-2 NSAID treatment; etoricoxib 60 mg/day for 4 weeks; or PSWT treatment worn 24 h/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI), a 10-question assessment on a 50-point scale. Secondary outcome measures included pain (at rest and during activity) measured on a visual analog scale (VAS) of 0–100 mm, dose count of rescue pain medication (paracetamol) use, and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority. After 4 weeks of treatment, subjects in both study arms reported statistically significant (p < 0.0001) reductions in NDI, with final scores of 11.24-NSAID and 9.34-PSWT, VASrest, with final scores of 30.08-NSAID; 22.76-PSWT, and VASactivity, with final scores of 36.40-NSAID; 27.42-PSWT. The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm (3.66 points; 95% CI 2.3 to 5.02; p < 0.0001). Similarly, the reductions from baseline in VASrest and VASactivity were significantly greater in the PSWT arm than NSAID arm (10.89 mm; 95% CI 6.90 to 14.87; p < 0.0001; and 12.05 mm; 95% CI 7.76 to 16.33; p < 0.0001, respectively). The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm. Both NSAID and PSWT treatments resulted in statistically significant improvements in quality of life (NDI) and reduction in pain (VAS) resulting from cervical osteoarthritis. However, the PSWT intervention showed superior improvements in all outcome measures when compared to the NSAID arm with no adverse effects. Clinicaltrials.gov (NCT03542955).

Transoral Dermoid Cyst Excision: A Multicenter Prospective Observational Study

2018 ◽  
Vol 159 (6) ◽  
pp. 981-986 ◽  
Author(s):  
Jin Pyeong Kim ◽  
Dong Kun Lee ◽  
Jeong Hwan Moon ◽  
Jung Je Park ◽  
Seung Hoon Woo
Keyword(s):  
Observational Study ◽  
Oral Cavity ◽  
Dermoid Cyst ◽  
Prospective Observational Study ◽  
University Hospital ◽  
Secondary Outcome ◽  
Transoral Surgery ◽  
Cyst Excision ◽  
Surgery Group ◽  
Multicenter Prospective Observational Study

Objective Transoral surgery is becoming a preferred technique because it does not leave any scar after surgery. However, transoral surgery for a dermoid cyst of the oral cavity is not standardized yet, due to the anatomic complexity of this region. The aim of this study was to evaluate the safety and efficacy of a transoral dermoid cyst excision. Study Design Multicenter prospective observational study. Setting University hospital. Subjects and Methods This study was designed as a 4-year prospective multicenter evaluation of dermoid cyst excisions within the floor of mouth. Clinical outcomes and complications related to procedures were evaluated among patients. The primary outcome was the efficacy of the procedure, and the secondary outcome was cosmetic satisfaction of each procedure. Results Twenty-one patients underwent transoral dermoid cyst excisions, and 22 underwent transcervical excisions. In the transoral surgery group, the mean size of the dermoid cyst was 5.35 cm (95% CI, 4.79-5.91), and in the transcervical surgery group, it was 6.19 cm (95% CI, 5.67-6.71). There was no significant differences with respect to overall demographic characteristics between the groups. However, the duration of the operation was shorter with the transoral group than with the transcervical group ( P = .001), and cosmetic satisfaction was much better in the transoral group ( P < .001). Conclusion Transoral dermoid cyst excision is a potentially safe and effective method that can lead to easy and quick removal of an oral cavity dermoid cyst, with excellent cosmetic outcomes.

scholarly journals Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (CHOICES) Study]

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023540 ◽  
Author(s):  
Andrei V Krassioukov ◽  
Katharine D Currie ◽  
Michèle Hubli ◽  
Tom E Nightingale ◽  
Abdullah A Alrashidi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Arterial Stiffness ◽  
Outcome Measures ◽  
Cardiovascular Health ◽  
Secondary Outcome ◽  
Exercise Interventions ◽  
Cord Injury ◽  
Randomised Controlled

IntroductionRecent studies demonstrate that cardiovascular diseases and associated complications are the leading cause of morbidity and mortality in individuals with spinal cord injury (SCI). Abnormal arterial stiffness, defined by a carotid–to-femoral pulse wave velocity (cfPWV) ≥10 m/s, is a recognised risk factor for heart disease in individuals with SCI. There is a paucity of studies assessing the efficacy of conventional training modalities on arterial stiffness and other cardiovascular outcomes in this population. Therefore, this study aims to compare the efficacy of arm cycle ergometry training (ACET) and body weight-supported treadmill training (BWSTT) on reducing arterial stiffness in individuals with chronic motor complete, high-level (above the sixth thoracic segment) SCI.Methods and analysisThis is a multicentre, randomised, controlled, clinical trial. Eligible participants will be randomly assigned (1:1) into either ACET or BWSTT groups. Sixty participants with chronic (>1 year) SCI will be recruited from three sites in Canada (Vancouver, Toronto and Hamilton). Participants in each group will exercise three times per week up to 30 min and 60 min for ACET and BWSTT, respectively, over the period of 6 months. The primary outcome measure will be change in arterial stiffness (cfPWV) from baseline. Secondary outcome measures will include comprehensive assessments of: (1) cardiovascular parameters, (2) autonomic function, (3) body composition, (4) blood haematological and metabolic profiles, (5) cardiorespiratory fitness and (6) quality of life (QOL) and physical activity outcomes. Outcome measures will be assessed at baseline, 3 months, 6 months and 12 months (only QOL and physical activity outcomes). Statistical analyses will apply linear-mixed modelling to determine the training (time), group (ACET vs BWSTT) and interaction (time × group) effects on all outcomes.Ethics and disseminationEthical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated.Trial registration numberNCT01718977; Pre-results.Trial statusRecruitment for this study began on January 2013 and the first participant was randomized on April 2013. Recruitment stopped on October 2018.

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