Fuerza muscular y parámetros espaciotemporales de la marcha en personas con enfermedad de Parkinson. Un estudio piloto / Muscle strength and spatiotemporal gait parameters in people with Parkinson´s disease. A pilot study

Introducción: La debilidad muscular en personas con enfermedad de Parkinson (EP) ha sido frecuentemente reconocida como un síntoma inespecífico. En otras patologías neurológicas, la debilidad de las extremidades inferiores, específicamente la debilidad de los cuádriceps, es el factor que causa mayor incapacidad para caminar. Pocas investigaciones han evaluado la relación entre la fuerza muscular de los miembros inferiores, utilizando herramientas objetivas en personas con EP y el desempeño de la marcha. El objetivo de este estudio fue analizar la correlación entre la fuerza muscular de los miembros inferiores, utilizando un dinamómetro isocinético, y los parámetros espaciotemporales de la marcha en la EP, en comparación con controles sanos emparejados por edad y sexo. Sujetos y métodos: El estudio se llevó a cabo con siete personas con EP –Hoehn y Yahr (HY) entre II y III– y siete controles sanos. Se realizaron pruebas isocinéticas de rodilla y tobillo a 60 y 120°/s y la prueba de marcha de 10 metros, a velocidad de marcha cómoda y rápida, en todos los sujetos reclutados. Resultados: Se observaron diferencias significativas en las medidas relacionadas con la fuerza de las extremidades inferiores y en los parámetros de la marcha entre las personas con EP y los controles. Los parámetros de la marcha mostraron excelentes correlaciones (rho = 0,7) para ambas extremidades inferiores: trabajo de flexión plantar de tobillo/desgaste corporal a 180°/s con número de pasos (indirecto) y zancada (directa) a ambas velocidades, y entre pico de torsión de flexión plantar de tobillo/desgaste corporal a 180°/s con número de pasos (indirecto) y zancada (directa) a velocidad máxima; y entre trabajo de extensión de rodilla/desgaste corporal a 60°/s con zancada (directa) a velocidad autoseleccionada. Conclusiones: La fuerza muscular de las extremidades inferiores de las personas con EP (estadios de HY II-III) se...(AU)

Introduction: Muscle weakness in persons with Parkinson disease (PD) has been frequently recognized as a nonspecific symptom. In other neurological conditions, lower limb weakness, specifically quadriceps weakness, is the factor that causes greater gait disability. Little research has evaluated the relationship between lower limb muscle strength, using objective tools, in PD persons and gait performance. The aim of this study was to analyze the correlation between lower limb muscle strength, using an isokinetic dynamometer, and the spatiotemporal gait parameters in PD, compared with age- and sex- matched healthy controls. Subjects and methods: The study was conducted with 7 persons with PD –Hoehn and Yahr (HY) between II-III– and 7 healthy controls. Isokinetic knee and ankle tests at 60 and 120°/s and the 10-meter walking test at comfortable and fast walking speed, were performed on all recruited subjects. Results: Significant differences in lower limb strength-related measures and gait parameters were observed between persons with PD and controls. Gait parameters showed excellent correlations (rho ≥ 0.7) for both lower limb: ankle plantar flexion work/body wearing at 180°/s with number of steps (indirect) and stride (direct) at both speeds, and between the ankle plantar flexion peak torque/ body wearing at 180°/s with number of steps (indirect) and stride (direct) at maximum speed; and between knee extension work/body wearing at 60°/s) with stride (direct) at self-selected speed. Conclusions: Persons with PD (HY II-III stages) lower limb muscle strength correlates excellently with gait pattern, showing lower isokinetic strength than healthy subjects of the same age and sex. This protocol showed safety to be performed in a larger sample.(AU)

Terapia manual para la mejora del flujo sanguíneo de las arterias uterinas en el área vascular endometrial/subendometrial en mujeres infértiles mediante ultrasonografía tridimensional: estudio piloto / Manual therapy for the improvement of blood flow of the uterus arteries in the endometrial/subendometrial vascular area in infertilized women through three-dimensional ultrasonography: Pilot study

Objetivo Evaluar cuantitativamente el efecto de la técnica manual de fisioterapia sobre el volumen endometrial y los valores del histograma en participantes infértiles. Métodos Estudio piloto, analítico, intervencionista, con grupo control, desarrollado en la Clínica Juana Crespo sobre 34 participantes infértiles. Se midió el volumen endometrial y subendometrial del útero, los índices de vascularización (IV%), el índice de flujo de vascularicación (IVF%) y el índice de flujo (IF%) mediante ultrasonografía Doppler 3D, después de aplicar la técnica manual de movilización de tejidos blandos de las fosas ilíacas. Resultados En el grupo experimental la comparación de los volúmenes endometriales totales antes (M=41,09) y después de la aplicación de la técnica fisioterápica (M=47,29) presentó diferencias estadísticamente significativas, z=–3,946 (p<0,001), r=–0,73, al igual que el estudio de los histogramas, alcanzando diferencias significativas en el índice de flujo (IF%) entre los registros pre (M=35,22) y post (M=37,62), z=–2,849 (p<0,005), r=–52. El índice de flujo de vascularización (IFV%) y el índice de vascularización (IV%) no tuvieron diferencias significativas entre el tiempo pre y post. Los histogramas IV%, IF%, IFV% indican p<0,005. Conclusiones La técnica de fisioterapia aumenta los volúmenes endometriales totales y el IF% endometrial después de su aplicación, aunque no varían las variables IV% e IFV% (AU)

Objective To quantitatively assess the effect of physical therapy manual technique on endometrial volume and histogram values in infertile participants. Methods Pilot, analytical, interventional study, with a control group, developed at the Juana Crespo Clinic on 34 infertile participants. The endometrial and subendometrial volume of the uterus, Vascularization Indices (VI%), Vascularization Flow Index (VFI%) and Flow Index (IF%) were measured by 3D Doppler Ultrasonography, after applying the manual mobilization technique in soft tissue of the iliac fossa. Results In the experimental group, the comparison of the total endometrial volumes before (M=41.09) and after the application of the physiotherapy technique (M=47.29) presented statistically significant differences, z=-3.946 (p<0.001), r=-, 73, like the study of histograms, reaching significant differences in the flow index (IF%) between the pre (M=35.22) and post (M=37.62) records, z=-2.849 (p<0.005), r=- 52. The vascularization flow index (IFV%) and the vascularization index (IV%) did not have significant differences between the pre and post time. Histograms IV%, IF%, IFV% indicate p<0.005. Conclusions The physiotherapy technique increases the total endometrial volumes and the endometrial IF% after its application, although the IV% and IFV% variables do not vary (AU)

Efficacy of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy: A prospective, randomized, pilot trial.

BACKGROUND: Although colonoscopic retroflexion has been proved effective in reducing missed adenomas, there is still a lack of comprehensive and in-depth research focused on the ascending colon. We aimed to conduct a randomized controlled trial and tandem colonoscopy to investigate whether cecal retroflexion observed during colonoscopy can reduce missed adenomas in the ascending colon. METHODS: Men and women required to be between 45 and 80 years of age were screened for enrollment in the trial. Patients were randomly assigned according to a 1:1 ratio to either the trial group or control group. Patients in the trial group underwent 2 forward examination and a cecal retroflexion observed in the ascending colon, while patients in the control group underwent only 2 forward examinations in the ascending colon. The primary outcome was adenoma miss rate. The secondary outcomes contained adenoma detection rate, polyp miss rate, polyp detection rate, insertion time and withdrawal time. Differences between groups in the primary outcome and in the other categorical indicators were tested using chi-squared test and Fisher exact test. For the comparison of continuous outcomes, the Student t test was applied. RESULTS: A total of 60 subjects were eligible for the study between April to June 2020, of which 55 were randomized and eligible for analysis (26 to the control group and 29 to the trial group). The characteristics of patients were no significant differences statistically between the trial group and the control group. Similarly, the characteristics of the colonoscopy procedures included cecal insertion distance, the length of cecum and ascending colon, insertion time, withdrawal time, quality of bowel preparation, numerical rating scale for pain, polyps detected, and adenomas detected, and there were no significant differences statistically between the 2 groups (P = .864, P = .754, P = .700, P = .974, P = .585, P = .835, P = .373, P = .489). The characteristics of the polyps were also no significant differences statistically between the 2 groups. CONCLUSION: This pilot trial failed to show benefit of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy; however, further conclusions require a prospective study with a higher level of evidence. (NCT03355443).

Feasibility of a Stop Smoking Program for Healthcare Workers in an Italian Hospital: Econometric Analysis in a Total Worker Health® Approach.

Background: Over 20% of healthcare workers (HCWs) are active smokers. Smoking is a targeted issue for workplace health promotion (WHP) programs. Objective: Our study aims to evaluate the effectiveness of the Stop Smoking Promotion (SSP) intervention, a 6-hour training course for HCWs, which took place from May 2018 to July 2019. Methods: We compared HCWs who successfully quit smoking (n = 15) to those who did not (n = 25) in terms of Sickness Absence Days (SADs). Moreover, we conducted an econometric analysis by calculating the return on investment and implementing a break-even analysis. Findings: Among the 40 enrolled workers, a success rate of 37.5% was observed after a span of over two years from the SSP intervention (with nurses and physicians showed the best success rate). Overall, participants showed a noticeable absenteeism reduction after the SSP intervention, with a reduction rate of 85.0% in a one-year period. The estimated ROI for the hospital was 1.90, and the break-even point was 7.85. In other words, the organization nearly doubled its profit from the investment, and the success of at least eight participants balanced costs and profits. Conclusion: Our pilot study confirms that WHP programs are simple and cost-saving tools which may help improve control over the smoking pandemic in healthcare settings.

Infant and Young Child Feeding practices up to 23 months in Namuno District, Cabo Delgado, Mozambique.

BACKGROUND: Inadequate breastfeeding and complementary feeding practices are key determinants of child malnutrition and impact one-third of the under-five mortality rate worldwide. The district of Namuno in Cabo Delgado (Mozambique) has been long registering a high prevalence of acute malnutrition. To date, no data exists about Infant and Young Child Feeding (IYCF) practices in the area. The current pilot study explores the feeding practices among children aged 0-23 months in Namuno and sets out its main drivers. METHODS: This cross-sectional study was realized between August and September 2019 and drew on questionnaires for mothers/caregivers of children aged 0 to 23 months. We computed IYCF indicators and correlated them with mothers'/caregivers' school attendance, delivery setting, and distance between home and the place where livelihood activities took place (workplace), using univariate and multivariate (age-adjusted) logistic regression analysis. RESULTS: The survey was data derived from a sample of 632 mothers/caregivers. 62% of 0-23-month-old children received colostrum whilst only 31% of 0-5 months babies were on exclusive breastfeeding (EBF). Among 6-23 months old children, 17% consumed foods and beverages from at least five out of eight defined food groups, 31% received a minimum frequency of meals, and 23% had a minimum acceptable diet. Data revealed a positive correlation between early initiation of breastfeeding and delivery in a maternity ward (OR 6.9, CI 3.2-16.1, p-value < 0.001). No difference in the IYCF indicators between female and male babies was detected. CONCLUSIONS: In the Namuno district, IYCF practices did not fulfill WHO/UNICEF's indicators and recommendations. This suggests that efforts should be focused on EBF-enabling interventions to improve children's dietary consumption patterns.

Feasibility, effectiveness and acceptability of two perturbation-based treadmill training protocols to improve reactive balance in fall-prone older adults (FEATURE): protocol for a pilot randomised controlled trial.

INTRODUCTION: Perturbation-based balance training (PBT) targets the mechanism of falls (eg, slipping, tripping) to specifically train the recovery actions needed to avoid a fall. This task-specific training has shown great promise as an effective and efficient intervention for fall prevention in older adults. However, knowledge about the dose-response relationship of PBT, as well as its feasibility and acceptability in older adults with increased risk of falling is still limited. Thus, the aim of this study is to compare the effectiveness of two different treadmill PBT protocols for improving reactive balance control in fall-prone older adults, and to evaluate the feasibility and acceptability of these protocols. METHODS AND ANALYSIS: The study is designed as a pilot randomised controlled trial with a 6-week intervention and 6-week follow-up period. Thirty-six community-dwelling, fall-prone (Timed Up and Go >12 s, habitual gait speed <1.0 m/s and/or fall history) older adults will be randomised (1:1) to receive six (weeks 1-6) or two treadmill PBT sessions (weeks 1+6) plus four conventional treadmill training sessions (weeks 2-5). Training sessions are conducted 1×/week for 30 min. Each PBT will include 40 perturbations in anterior-posterior and mediolateral directions. Reactive balance after perturbations in standing (Stepping Threshold Test (STT)) and walking (Dynamic Stepping Threshold Test (DSTT)) will be assessed as the primary outcome for effectiveness. Secondary outcomes are spatiotemporal and kinematic parameters collected during STT, DSTT and PBT, maximum perturbation magnitude for each PBT session, static and dynamic balance, physical capacity, physical activity, concerns with falling and executive functions. Feasibility will be assessed via training adherence, drop-out rate, perturbations actually performed and adverse events; and acceptability via self-designed questionnaire and focus groups. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Medical Faculty Heidelberg (S-602/2022). Findings will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00030805.

Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial.

INTRODUCTION: Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing. METHODS AND ANALYSIS: The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation. ETHICS AND DISSEMINATION: This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal. TRIAL REGISTRATION: ISRCTN20579216.

Brainwave activities reflecting depressed mood: a pilot study.

Early diagnosis and treatment of depression are desirable but currently difficult due to a lack of established biomarkers. Although biomarkers for depression based on electroencephalogram (EEG) data have long been explored, most existing methods are thought to capture cognitive decline caused by depression and are unsuccessful in detecting signs of depression. Here we report that some brainwave activities involving phase resetting reflect the depressed mood at the time, which can be easily monitored by measuring the resting EEG with eyes closed for 1 min with a few electrodes. We instructed 10 participants (nine healthy and one diagnosed with depression, aged 18-34) to record their EEG for 14-26 days. We found that indicators of depressed mood were correlated with the occurrence frequency of EEG phase resetting. For most participants, the correlation coefficients swung systematically between large positive and large negative values with respect to EEG frequency; however, the frequencies at which they were maximum or minimum differed among participants. Although this study is in the pilot phase and needs further experimentation, the results are expected to lead to innovative biomarkers for early detection of depression and may contribute to a better understanding and treatment of depression.

Feasibility and safety of exercise during chemotherapy in people with gastrointestinal cancers: a pilot study.

PURPOSE: Sarcopenia is a poor prognostic factor in cancer patients, and exercise is one of the treatments to improve sarcopenia. However, there is currently insufficient evidence on whether exercise can improve sarcopenia in patients with advanced cancers. This study examined the feasibility of exercise in advanced gastrointestinal (GI) cancer patients treated with palliative chemotherapy. METHODS: Between 2020 and 2021, 30 patients were enrolled in a resistance and aerobic exercise program for six weeks. The exercise intervention program (EIP) consisted of low, moderate, and high intensity levels. Patients were asked to select the intensity level according to their ability. The primary endpoint was the feasibility of the EIP measured by compliance during the six weeks. A compliance of over 50% was considered acceptable. The secondary endpoints were changes in weight and muscle mass, safety, quality of life (QoL) and overall survival (OS). RESULTS: The median age of the study's participants was 60 (30-77). The total compliance to the EIP was 63.3% (19/30 patients). Sixteen (53.3%) patients had a compliance of over 80%. The attrition rate was 30.0% (9/30). The mean exercise time was 41.4 min, and the aerobic exercise was 92.3% and the resistant exercise was 73.7%, and both exercise was 66.5%. Most patients performed the moderate intensity level exercises at home or near their home. The mean skeletal muscle index (SMI) was 43.5 cm2/m2 pre-chemotherapy and 42.2 cm2/m2 after six weeks of chemotherapy, with a decrease of -1.2 ± 2.8 cm2/m2 (-3.0%) (p = 0.030). In the poor compliance group, the mean SMI decrease was -2.8 ± 3.0 cm2/m2 which was significantly different (p = 0.033); however, in the good compliance group, the mean SMI decrease was -0.5 ± 2.5 cm2/m2 which was maintained over the six weeks (p = 0.337). The good compliance group had a significantly longer median OS compared with the poor compliance group (25.3 months vs. 7.9 months, HR = 0.306, 95% CI = 0.120-0.784, p = 0.014). The QoL showed a better score for insomnia (p = 0.042). There were no serious adverse events. CONCLUSIONS: The EIP during palliative chemotherapy in advanced GI cancer patients showed good compliance. In the good compliance group, muscle mass and physical functions were maintained for six weeks. The EIP was safe, and the QoL was maintained. Based on this study, further research in exercise intervention in advanced cancer patients is needed. CLINICAL TRIAL REGISTRATION: The clinical trial registration number is KCT 0005615 (CRIS, https://cris.nih.go.kr/cris/en/ ); registration date, 23rd Nov 2020.

Exploring the prevalence of Human Papillomavirus (HPV) genotypes in PAP smear samples of women in northern region of United Arab Emirates (UAE): HPV Direct Flow CHIP system-based pilot study.

OBJECTIVE: The aim of this study was to explore the prevalence of low and high-risk HPV genotypes in PAP smear samples of women in northern region of the UAE using HPV direct flow CHIP method. METHODS: A cross-sectional retrospective study was conducted between September 2021 to April 2022. A total of 104 liquid-based cervical cytology samples were obtained from women aged 20-59 years attending the Gynaecology out-patient department of Thumbay University Hospital and other hospitals of Northern Emirates of UAE, processed for the routine cytological examination to identify and differentiate morphological changes of the PAP smear samples. HPV genotyping was performed using HPV direct flow CHIP method. RESULTS: In total, 112 HPV genotypes were detected in 63 women (60.57%) included 18 abnormal cytological and 45 normal epithelial samples. 63 LR and 49 HR HPV genotypes were identified in all the 63 positive samples. Highest rate of infection with multiple LR and HR HPV genotypes were detected in women aged 40-49 years (25.9%) and 20-29 years (23.5%). Infection by HPV6 (13.46%), HPV11 (9.61%), HPV16 (9.61%), HPV62/81 (7.69%) and HPV45 (7.69%) were the most common genotypes. A moderate increase than expected incidence of HPV45 and 62/81 (7.69%) were detected. Co-infection with multiple low and high-risk genotypes is present in 20.2% cases; in that, HPV6 (15.9%) was the most common followed by HPV62/81 (12.7%) and HPV16 (11.11%). The prevalence of HPV18 was found to be 1.6%. CONCLUSION: The genotypes 6, 45, 16, 11, 67, 62/81 were the most common HPV infections in the women between the age group of 21 and 59-years-old. A moderate increase of HPV45, 62/81 and much less prevalence of HPV18 were detected in the study population. 43.27% of the normal epithelia were positive to different low and high-risk HPV genotypes. This finding highlights the importance of molecular genotyping of HPV to emphasize the cervical screening triage.

Could red and near-infrared emitting fabric technology improve the severity of psoriasis, polymorphous light eruption, and alopecia areata?

AIM: Low-level light therapy (LLLT) may offer an adjunctive therapeutic tool for inflammatory skin conditions. This pilot study assessed the efficacy of a red/near-infrared (NIR)-emitting fabric for psoriasis, polymorphous light eruption (PMLE), and alopecia areata (AA). METHODS: Fourteen patients (five with psoriasis, five with PMLE, and four with AA) were instructed to wear a red/NIR-emitting (Lumiton®) garment during the 12-week study. Efficacy was assessed subjectively by patient-reported improvement and objectively by the redness, thickness, and scale of elbow psoriasis plaques, the frequency of PMLE flares, and the Severity of Alopecia Tool (SALT) score. RESULTS: Three patients with psoriasis completed the study while two self-discontinued. The three patients who completed the study noted improvement and two had improvements in lesion redness, thickness, or scale, while one was clinically stable. Three patients with PMLE completed the study, and none had a disease flare during the study period. Three patients with AA completed the study: two reported disease improvement and all three had an improved SALT score. CONCLUSION: Use of a wellness apparel that emits red and NIR light may be associated with improved disease severity in patients with mild elbow psoriasis, PMLE, and limited AA. Limitations of this study include continuation on topical, intralesional, or systemic medications and small sample size.

The Implementation of Glasses-free 3D Display in ICL Surgery: A Pilot Study.

PURPOSE: To compare the efficacy and safety of the glasses-free three-dimensional (3D) display and conventional optical microscope in Implantable Collamer Lens (ICL; STAAR Surgical) surgery. METHODS: This randomized controlled trial enrolled 51 eyes of 26 patients who received ICL surgery. After random allocation, patients received surgery under either a glasses-free 3D display (16 eyes) or a conventional optical microscope (35 eyes). The surgical duration, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), intraocular pressure, vault, postoperative manifest refraction spherical equivalent (MRSE), and complications were evaluated. RESULTS: Mean surgical time was 5.04 ± 2.74 minutes for the glasses-free 3D group and 4.65 ± 2.63 minutes for the conventional microscope group (P = .639). Postoperative UDVA was -0.02 ± 0.04 and -0.04 ± 0.05 logMAR (P = .169), CDVA was -0.03 ± 0.04 and -0.02 ± 0.05 logMAR (P = .434), and IOP was 17.01 ± 3.15 and 14.82 ± 2.20 mm Hg (P = .055) at 1 month of follow-up, respectively. Vault was 562.86 ± 192.89 and 520.18 ± 215.19 µm, and MRSE was +0.25 ± 0.21 and +0.10 ± 0.51 diopters, respectively, at 1 month postoperatively; all were comparable between the glasses-free 3D group and conventional microscope group (all P > .05). No complication occurred in both groups. CONCLUSIONS: The glasses-free 3D group achieved similar efficacy and safety compared to the conventional microscope group, and glasses-free 3D surgery is expected to show a significant advantage in clinical and medical education. [J Refract Surg. 2023;39(9):612-619.].

Feasibility, comprehensibility and acceptability of the VISION-Cog, a novel tool to assess cognitive impairment in visually impaired older adults: a cross-sectional pilot study in Singapore.

OBJECTIVES: We pilot-tested the VISually Independent test battery Of NeuroCOGnition (VISION-Cog) to determine its feasibility, comprehensibility and acceptability in evaluating cognitive impairment (CI) in visually impaired older Asian adults. DESIGN: The VISION-Cog was iteratively fine-tuned through pilot studies and expert-panel discussion. In the first pilot study (Stage 1), we recruited 15 visually impaired and cognitively normal participants aged ≥60 years to examine the pilot VISION-Cog's feasibility (length of time to administer), comprehensibility (clarity of instructions) and acceptability (participant burden). We then presented the pilot results to the expert panel (Stage 2) who decided via agreement on a revised version of the VISION-Cog. Subsequently, we conducted a second pilot study (Stage 3) on another four participants to ascertain improvement in feasibility, comprehensibility and acceptability of the revised version. SETTING: Singapore Eye Research Institute. PARTICIPANTS: Nineteen Asian adults aged ≥60 years with visual impairment (defined as near visual acuity worse than N8) were recruited. OUTCOME MEASURE: Revised VISION-Cog. RESULT: The VISION-Cog was deemed feasible, taking approximately 60 min to complete on average. All participants agreed that the test instructions were clear, and the battery did not cause undue discomfort or frustration. The data collector rated all tests as very user-friendly (score of 5/5). Minor modifications to the pilot VISION-Cog were suggested by the panel to improve its safety, clarity of instructions and content validity, which were incorporated and iteratively tested in the second pilot study until no further issues emerged. CONCLUSIONS: Using an iterative mixed-methods process, we have developed a feasible, comprehensible and acceptable 5-domain and 9-item visually independent VISION-Cog test battery suitable to assist CI diagnosis in older adults with visual impairment. We will assess its diagnostic potential against clinician-based assessment of CI in subsequent phases.

Comparison of home-based palliative care delivered by community health workers versus usual care: research protocol for a pilot randomized controlled trial.

BACKGROUND: Research studies demonstrate that palliative care can improve patient outcomes such as quality of life, symptom burden and patient satisfaction with care (Gomes B, et al. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013(6):CD00776) (World Health Organization. Palliative Care. Published 2020.). While 76% of patients who need palliative care live in limited-resource countries, access to high quality palliative services in these countries is minimal (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care (2nd ed). 2020.). In 2014 the Worldwide Hospice Palliative Care Alliance, with strong endorsement by the WHO, released the Palliative Care Toolkit to provide a training and implementation toolkit for empowering community members to deliver palliative care in resource poor settings (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care at the End of Life. Geneva, Switzerland 2014.). They encouraged researchers and public health practitioners to conduct rigorous evaluation of the toolkit in diverse settings and contexts. To address this need, we will conduct a pilot randomized controlled trial (RCT) to examine implementation and explore potential effect of an intervention based upon the Palliative Care Toolkit, as adapted and used by community health workers (CHWs) working with a cancer center in Kolkata, India to deliver home-based palliative care for rural patients. METHODS: Utilizing a randomized controlled trial design, intervention patients (n = 45) receive home-based palliative services (Pal-Care) delivered by community health workers (CHWs), with comparison against a control group of patients (n = 45) who receive usual cancer-center-based palliative services. Primary outcome measures include evaluation of CHW training outcomes, roles and responsibilities of the CHWS and how they assist patients, trial recruitment, stakeholder perceptions of the intervention, and fidelity to study protocol. Secondary outcomes measure patient self-report of health-related quality of life, symptom burden, palliative needs and patient care experience, outcomes The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention (Gaglio B, et al. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38?46.). Data will be analyzed in SAS. All measures will be evaluated overall and by patient age, gender and cancer type and by CHW caseload. DISCUSSION: Pal-Care is a RCT funded by the NCI to explore utilization of CHWs to deliver a home-based palliative care intervention built upon the WHO Palliative Care toolkit (PCT), as compared to a usual care control group. The long-term goal of this research is to develop an effective and sustainable model for delivering home-based palliative care for cancer patients in underserved areas. TRIAL REGISTRATION (TRN): ClinicalTrials.gov ID# NCT04972630.

Pregnancy is associated with reduced progression of symptomatic adenomyosis: a retrospective pilot study.

BACKGROUND: Adenomyosis is a common gynecological disease in women of reproductive age and causes various symptoms such as dysmenorrhea and heavy menstrual bleeding. However, the influence of pregnancy on the progression of adenomyosis remains unclear. The insight into whether the size of adenomyosis is increased, decreased, or unchanged during pregnancy is also undetermined. The current study aimed to evaluate the influence of pregnancy in patients with symptomatic adenomyosis. METHODS: This study retrospectively enrolled patients diagnosed with adenomyosis by magnetic resonance imaging between 2015 and 2022 at The University of Tokyo Hospital. Uterine size changes were evaluated by two imaging examinations. In the pregnancy group, the patients did not receive any hormonal and surgical treatments, except cesarean section, but experienced pregnancy and delivery between the first and second imaging examinations. In the control group (nonpregnancy group), the patients experienced neither hormonal and surgical treatments nor pregnancy from at least 1 year before the first imaging to the second imaging. The enlargement rate of the uterine size per year (percentage) was calculated by the uterine volume changes (cm3) divided by the interval (years) between two imaging examinations. The enlargement rate of the uterine size per year was compared between the pregnancy group and the control group. RESULTS: Thirteen and 11 patients with symptomatic adenomyosis were included in the pregnancy group and in the control group, respectively. The pregnancy group had a lower enlargement rate per year than the control group (mean ± SE: -7.4% ± 3.6% vs. 48.0% ± 18.5%, P < 0.001), indicating that the size of the uterus with adenomyosis did not change in the pregnancy group. CONCLUSIONS: Pregnancy is associated with reduced progression of symptomatic adenomyosis.

Early drain removal after live liver donor hepatectomy is safe - a randomized controlled pilot study.

INTRODUCTION: The current study aimed to assess the safety of early drain removal after live donor hepatectomy (LDH). METHODS: One hundred eight consecutive donors who met the inclusion criteria were randomized to early drain removal (EDR - postoperative day (POD) 3 - if serous and the drain bilirubin level was less than 3 mg/dl - "3 × 3" rule) and routine drain removal (RDR - drain output serous and less than 100 ml). The primary outcome was to compare the safety. The secondary outcome was to compare the postoperative morbidity. RESULTS: Preoperative, intraoperative, and postoperative parameters except for the timing of drain removal were comparable. EDR was feasible in 46 out of 54 donors (85.14%) and none required re-intervention after EDR. There was significantly better pain relief with EDR (p = 0.00). Overall complications, pulmonary complications, and hospital stay were comparable on intention-to-treat analysis. However, pulmonary complications (EDR - 1.9% vs RDR - 16.3% P = 0.030), overall complications (18.8% vs 36.3%, P = 0.043), and hospital stay (8 vs 9, P = 0.014) were more in the RDR group on per treatment analysis. Bile leaks were seen in three donors (3.7% in the EDR group vs 1.9% in RDR, P = 0.558), and none of them required endo-biliary interventions. Re-exploration for intestinal obstruction was required for 3 donors in RDR (0% vs 5.7%; p = 0.079). CONCLUSION: EDR by the "3 × 3" rule after LDH is safe and associated with better pain relief. On per treatment analysis, EDR was associated with significantly less hospital stay and lower pulmonary and overall complications. CLINICAL TRIAL REGISTRY: Clinical Trials.gov - NCT04504487.

The effect of short-term cranial electrotherapy stimulation on sleep quality in athletes: A pilot study.

BACKGROUND: To verify the effect of a 5-day cranial electrotherapy stimulation (CES) intervention on sleep quality in professional athletes. METHODS: 25 professional athletes with poor sleep quality participated in the study. Athletes belonging to the CES group (12 athletes) received a 5-day CES intervention, and those in the control group did not receive any intervention. Objectively and subjected assessed sleep quality was measured 1 week before and after the intervention using an Actigraphy activity recorder, Pittsburgh sleep quality index (PSQI), and Insomnia Severity Index (ISI). RESULTS: Objectively measured sleep efficiency increased after CES intervention (P = .013), while the difference between the pretest and posttest of the control group was not significant. For total sleep time (TST), the main effects and interaction were not significant. However, the analysis on wake after sleep onset showed wake after sleep onset decreased after CES intervention (P = .015). No significant interaction was found in subjectively assessed sleep quality but only revealed an improvement in both groups. CONCLUSION: The CES intervention of 30 minutes per day for 5 consecutive days enhanced objective sleep quality in athletes with sleep quality problems. The intervention increased sleep efficiency by lowering awake time after falling asleep.

Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study.

BACKGROUND: An effective testing strategy is essential for pandemic control of the novel Coronavirus disease 2019 (COVID-19) caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Breath gas analysis can expand the available toolbox for diagnostic tests by using a rapid, cost-beneficial, high-throughput point-of-care test. We conducted a bi-center clinical pilot study in Germany to evaluate breath gas analysis using multi-capillary column ion mobility spectrometry (MCC-IMS) to detect SARS-CoV-2 infection. METHODS: Between September 23, 2020, and June 11, 2021, breath gas measurements were performed on 380 patients (SARS-CoV-2 real-time polymerase chain reaction (PCR) positive: 186; PCR negative: 194) presenting to the emergency department (ED) with respiratory symptoms. RESULTS: Breath gas analysis using MCC-IMS identified 110 peaks; 54 showed statistically significant differences in peak intensity between the SARS-CoV-2 PCR-negative and PCR-positive groups. A decision tree analysis classification resulted in a sensitivity of 83% and specificity of 86%, but limited robustness to dataset changes. Modest values for the sensitivity (74%) and specificity (52%) were obtained using linear discriminant analysis. A systematic search for peaks led to a sensitivity of 77% and specificity of 67%; however, validation by transferability to other data is questionable. CONCLUSIONS: Despite identifying several peaks by MCC-IMS with significant differences in peak intensity between PCR-negative and PCR-positive samples, finding a classification system that allows reliable differentiation between the two groups proved to be difficult. However, with some modifications to the setup, breath gas analysis using MCC-IMS may be a useful diagnostic toolbox for SARS-CoV-2 infection. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov on September 21, 2020 (NCT04556318; Study-ID: HC-N-H-2004).

Surf therapy for improving child and adolescent mental health: A pilot randomised control trial.

The aim of this pilot randomised control trial (RCT) was to test, 1) feasibility and acceptability of a surf therapy program to improve symptoms of mental ill-health among children and adolescents, and 2) the design and procedures of an evaluative study. This pilot RCT compared a 6-week mentor-supported surf therapy program with a wait list control group, in Australian children and adolescents aged 8-18yrs (M age = 11.28, SD = 2.34; 15 females), who were help seeking for issues relating to their mental health. Exclusion criteria included if an individual was actively suicidal or experiencing a psychotic episode or being unavailable for program dates. The primary outcome was the feasibility and acceptability of the intervention and study design assessed via 11 pre-defined criteria. A secondary outcome was to investigate the effectiveness signal of the intervention on child indicators of depression and anxiety, assessed via the Revised Children's Anxiety and Depression Scale-Short Form and the Strengths and Difficulties Questionnaire. Random allocation was computer generated and while it was not possible to blind participants, researchers collecting assessments were blinded to group allocation. Thirty-six youth were randomised (intervention = 18; wait list controls = 18), representing an 84% participation rate among eligible youth. Of the 11 a priori feasibility and acceptability criteria, 4 of 5 relating to the intervention, and 4 of 6 addressing the study design were fully met, with the unmet factors guiding program revision. At the completion of the intervention, children and adolescents receiving the intervention reported reductions in symptoms of depression (ES = 0.57), anxiety (ES = 0.43), emotional problems, (ES = 0.79), peer problems (ES = 0.56), hyperactivity/inattention (ES = 0.28), and overall difficulties (ES = 0.64). These reductions were not sustained 6-weeks after completion of the intervention. Surf therapy is an acceptable and feasible intervention for addressing symptoms of mental ill-health among children and adolescents. Preliminary evidence suggests that surf therapy improves symptoms of mental ill-health in the short-term but that these improvements were not sustained after the intervention is ceased.

The undoing-hypothesis in athletes - three pilot studies testing the effect of positive emotions on athletes' psychophysiological recovery.

Three pilot studies were performed to investigate the undoing-hypothesis (i.e., fast psychophysiological recovery due to positive emotions after stressor) in an athletic sample - after 1) a psychosocial stressor (study 1, N = 19), 2) a physiological stressor (study 2, N = 14), and 3) a simulated competition (study 3, N = 13). Therefore, the effect of positive emotion interventions on cardiovascular (heart rate, blood pressure, heart rate variability) and psychological (perceived positive and negative emotions, arousal, valence) recovery was tested in comparison to neutral interventions. Additionally, study 3 examined the impact on performance after the intervention. Results only confirmed the undoing-hypothesis after a psychosocial stressor (study 1), showing greater increases in perceived positive emotions and a long-lasting decline in diastolic blood pressure after the positive emotion induction compared to the neutral condition. No effects on performance were found. Despite missing significance, descriptive analyzes indicated that our results are in line with the undoing-hypothesis, calling for further research in a greater sample to explore its full potential for athletes. Especially its impact on performance should be examined in future studies.