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Defocus curves and area-of-focus metric
Defocus curves under monocular uncorrected visual acuity showed that group A achieved higher VAs over +1.00 D to -3.00 D than group B (- The defocus curves and the area-of-focus metric of the 2 groups.
PMC10187746
Subjective visual quality
visual disturbance, photophobia, abnormal color vision
LENS
The VF-14-questionnaire aggregate score of group A was statistically higher than that of group B (Most patients did not have an obvious visual disturbance after surgery. Two patients in group A developed abnormal color vision and mild photophobia after surgery, and the symptoms were relieved 3 months post-surgery, whil...
PMC10187746
Objective visual quality
The comparison of MTF average height values at the same spatial frequencies
PMC10187746
Discussion
Cataract, cataracts, visual impairment, cataract, abnormal color vision, IOL, corneal irregular astigmatism
CATARACT, IOL, GROUP B, NEAR VISION, RECRUITMENT, CATARACT, LENS, CATARACTS
Cataract extraction combined with IOL implantation is the only effective method for the treatment of cataracts at present. Patients put forward higher requirements for the postoperative effect of cataracts to meet the needs and improve the quality of life. A previous studyTypically, doctors implanted monofocal IOL for ...
PMC10187746
Acknowledgment
PMC10187746
References
PMC10187746
Objective:
To study the effect of the birthing room design on nulliparous women’s childbirth experience up to 1 year after birth.
PMC9755691
Background:
Although it is known that the birth environment can support or hinder birth processes, the impact of the birthing room design on maternal childbirth experience over time is insufficiently studied.
PMC9755691
Methods:
The Room4Birth randomized controlled trial was conducted at a labor ward in Sweden. Nulliparous women in active stage of spontaneous labor were randomized (
PMC9755691
Results:
Women randomized to the new room had a more positive childbirth experience reported on the VAS-OCE 3 months (
PMC9755691
Method
PMC9755691
Study Design and Setting
This study reports women’s childbirth experiences 2 hr, 3 months, and 12 months after participation in the Room4Birth randomized controlled superiority trial (RCT) in Sweden (Randomization was undertaken between January 2019 and October 2020 at a labor ward located in western Sweden and with an annual birth rate of aro...
PMC9755691
Sample and Recruitment
RECRUITMENT
Eligible participants for randomization were women aged 18 or more, classified as Robson 1 (Participant recruitment was carried out by the midwives and assistant nurses at the labor ward. Eligible women were asked to participate after labor ward arrival and confirmed active stage of labor, if both a regular room and th...
PMC9755691
Data Collection and Outcome Measures
Participants’ demographic data were collected from obstetric records and through a self-reported, digital questionnaire 2 hr after birth (After 3 (Overview of data collection. Participants’ self-reported experiences on a Visual Analogue Scale of Overall Childbirth Experience (VAS-OCE), Fear of Birth Scale (FOBS), and C...
PMC9755691
Statistical Analysis
REGRESSION
To compare differences between the two randomized groups, χA linear mixed effects model was used to describe the group differences in childbirth experience over the three time points. This regression model was chosen since it can provide information about the women’s individual change in childbirth experience over time...
PMC9755691
Results
The study sample consisted of 406 women, where 204 were randomized to the new room and 202 to the regular room (CONSORT flow chart of randomization and follow-up. The demographic characteristics of the responders to the follow-up questionnaires did not differ between the randomized groups (Participants’ Demographic Inf...
PMC9755691
Self-Reported Childbirth Experience
The women’s overall childbirth experience on a VAS-OCE 2 hr after birth was similar in both randomized groups, as previously presented (Overall Childbirth Experience (VAS-OCE) and Fear of Birth (FOBS) 2 hr, 3 Months, and 12 Months After Birth. Women in the new room scored higher within the CEQ2 domain Participants’ Ch...
PMC9755691
Childbirth Experience Measured Over Time
The childbirth experience scored on a VAS-OCE decreased at 3 months (Childbirth experience 2 hr, 3 months, and 12 months after birth in the two randomized groups measured with a linear mixed-effects model. (A) Visual Analogue Scale of Overall Childbirth Experience (VAS-OCE) 1–10, (B) fear during past childbirth on a Fe...
PMC9755691
Methodological Considerations
The advantages of our study include its randomized design and the high response rates of the follow-up questionnaires. Another strength is that the participants were asked to report their childbirth experiences at three different time points during their first year after birth. This made it possible to study how the ex...
PMC9755691
Conclusion
The findings of this study show the benefit of acknowledging the physical design of hospital-based birthing rooms. Nulliparous women randomized to a birthing room designed with person-centered considerations aimed at supporting the physiology of birth reported more positive overall childbirth experiences 3 and 12 month...
PMC9755691
Implications for Practice
From a mental health perspective, it is essential to understand the importance of emotional well-being in the transition to parenthood.A birthing room designed with person-centered considerations, where women and companions can adapt features and functions in the room in accordance with personal needs and requirements,...
PMC9755691
Supplemental Material
PMC9755691
Supplemental Material, sj-pdf-1-her-10.1177_19375867221124232 - Impact of Birthing Room Design on Maternal Childbirth Experience: Results From the Room4Birth Randomized Trial
Click here for additional data file.Supplemental Material, sj-pdf-1-her-10.1177_19375867221124232 for Impact of Birthing Room Design on Maternal Childbirth Experience: Results From the Room4Birth Randomized Trial by Lisa Goldkuhl, Hanna Gyllensten, Cecily Begley, Christina Nilsson, Helle Wijk, Göran Lindahl, Kerstin Uv...
PMC9755691
References
PMC9755691
Background
chemotherapy-associated insomnia, breast cancer, Acupuncture, insomnia, Insomnia
BREAST CANCER
Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patient...
PMC10134666
Methods
chemotherapy-associated insomnia, anxiety, breast cancer, fatigue, pain, Insomnia, depression
BREAST CANCER
This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medici...
PMC10134666
Results
There were 87.7% (121/138) participants who completed the primary endpoint (week-6). The active acupuncture regimen was not superior to the sham control in reducing ISI score from baseline to 6 weeks (mean difference: − 0.4, 95% CI − 1.8–1.1;
PMC10134666
Supplementary Information
The online version contains supplementary material available at 10.1186/s13058-023-01645-0.
PMC10134666
Keywords
PMC10134666
Background
Breast cancer, insomnia, cancer and cancer-related symptoms
MALIGNANCIES, BREAST CANCER
Breast cancer patients are at significantly greater risk of developing insomnia than those with other malignancies and the general population [Over the past two decades, acupuncture has gained increasing popularity in the treatment of insomnia, cancer and cancer-related symptoms [
PMC10134666
Methods
PMC10134666
Design and settings
WEST, RECRUITMENT, RECRUITMENT
This was an assessor-participant-data analyst blinded, randomized, sham-controlled trial. The trial was approved by Institutional Review Board of the University of Hong Kong (HKU)/Hospital Authority Hong Kong (HK) West Cluster (UW 19-045) and Research Ethics Committee of HK Sanatorium & Hospital (REC-2019-14). The tria...
PMC10134666
Participants
sleep disorders, hearing, visual or language defects, hematological dysfunction, insomnia, Insomnia, electroacupuncture, insomnia disorder
DISORDERS, OBSTRUCTIVE SLEEP APNOEA, BREAST CANCER
Patients were eligible if they were: (i) females aged 18–75; (ii) had a diagnosis of stage I–IV breast cancer; (iii) underwent or had completed chemotherapy no more than 6 months; (iv) insomnia occurred at least 3 nights/week and lasted at least one month, with the fulfilment of the diagnostic criteria for brief insomn...
PMC10134666
Randomization
Permuted block randomization (block sizes of 2/4/6) was used. After baseline assessments, participants were randomly assigned to two groups at a ratio of 1:1 according to the randomization sequence. The randomization sequence was generated by an independent biostatistician using Microsoft Excel prior to study initiatio...
PMC10134666
Blinding and allocation concealment
INTERACTIONS, EYE
Investigators and research staffs who performed screening, assessments, and data entry/re-entry/analysis were blinded to group allocation. Participants were informed that they would have same chance of allocating to either group and would be blinded to allocation. Treatment was delivered individually in a separate room...
PMC10134666
Intervention
Acupuncture
Participants continued routine care and symptom management during study. Acupuncture treatment was carried out by registered Chinese Medicine Practitioners (CMPs) had at least 5-year clinical practice experience and completed training workshop prior to study initiation. The training workshop included introduction of tr...
PMC10134666
Active acupuncture regimen
comorbid symptoms, insomnia
Active acupuncture regimen consisted of electroacupuncture on body acupoints and auricular acupressure. Six fixed acupoints (EX-HN1, GV20, GV24, PC6, KI3 and SP6) were utilized for treating insomnia [Recommendation of additional acupoints based on comorbid symptoms
PMC10134666
Sham acupuncture regimen
Sham points that are located at 1–2 cm adjacent to meridian-based acupoints were used for sham electroacupuncture [
PMC10134666
Concomitant use of psychotropic medications
Psychotropic medications were allowed to be prescribed at the discretion of psychiatrists and general physicians during study. The proportion of participants who were prescribed with sleeping medications (sedatives, hypnotics and anxiolytics), dosage and weekly frequency of use were recorded. The dosage used was conver...
PMC10134666
Assessments
PMC10134666
Primary outcome
Details of outcomes have been reported previously [
PMC10134666
Secondary outcomes
Anxiety, fatigue, anxiety, pain, depressive, depression/anxiety, depression, Depression
Secondary outcomes included sleeping measures, depression and anxiety, fatigue and pain, and quality of life. Actiwatch [The severity of depression/anxiety was measured using Hospital Anxiety and Depression Scale (HADS) which is a 14-item questionnaire with two subscales to evaluate the severity of depressive and anxie...
PMC10134666
Adverse events
ADVERSE EVENT
Adverse events (AEs) were recorded during study. Whether an AE related to treatment was determined by acupuncturists. Serious AEs were immediately reported to principal investigator and Ethics Committee within 24 h of the occurrence.
PMC10134666
Credibility, expectancy, adherence, and successiveness of blinding
The credibility of treatment was assessed using the 4-item, 6-point Credibility Rating Scale [
PMC10134666
Data security and monitoring
All data were secured in compliance with HK Personal Data (Privacy) Ordinance (CAP 486). A data and safety monitoring board (DSMB) was established [
PMC10134666
Statistical analysis
PMC10134666
Estimation of sample size
non-cancer, primary insomnia, chemotherapy-associated insomnia, breast cancer
PRIMARY INSOMNIA, BREAST CANCER
There was no study has previously been conducted in the female with breast cancer experiencing chemotherapy-associated insomnia. The sample size was estimated based on anticipated changes of ISI score. Based on previous trials among non-cancer population with primary insomnia [
PMC10134666
Data analysis
The efficacy was analyzed in the intention-to-treat population, defined as participants who completed baseline assessments. For missing data, the multiple imputation method was used under the missing-at-random (MAR) assumption. The sensitivity of MAR assumption of missing data was tested with a pattern-mixture model [C...
PMC10134666
Results
PMC10134666
Cessation rate and sleeping medications used
The active acupuncture group had a higher cessation rate of sleeping medication during 18–20 weeks than the sham control (56.5% vs. 14.3%, Cessation rate over time. *
PMC10134666
Secondary outcomes
Secondary outcomes are summarized in Table
PMC10134666
Adverse events
Treatment-related AEs were mild (Additional file
PMC10134666
Credibility for treatment and blinding design
Credibility score for treatment was not significantly different between groups (Additional file
PMC10134666
Discussion
chemotherapy-associated insomnia, anxiety, breast cancer, chemotherapy-induced cognitive decline, insomnia, electroacupuncture, depression
BREAST CANCER
The main purpose of this trial was to determine whether the active acupuncture regimen could produce superior efficacy over the sham control in improving chemotherapy-associated insomnia in breast cancer patients. Following 12 sessions of treatment, participants on the active acupuncture regimen showed significantly gr...
PMC10134666
Conclusion
chemotherapy-associated insomnia, anxiety, breast cancer, insomnia, depression
BREAST CANCER
The active acupuncture regimen produced better outcomes than the sham control in improving sleep onset latency, total sleep time and sleep efficiency in breast cancer women with chemotherapy-associated insomnia, although there was no significant difference in reducing insomnia severity. Active acupuncture had significa...
PMC10134666
Acknowledgements
ONCOLOGY
We acknowledge the DSMB members, Dr. Chi Ho Chung (The Jockey Club School of Public Health and Primary Care Faculty of Medicine, the Chinese University of Hong Kong), Dr. Tai Chung Lam (Department of Clinical Oncology, HKU), and Dr. Jihui Zhang (Department of Psychiatry, The Chinese University of Hong Kong) for reviewi...
PMC10134666
Author contributions
WFY
JLZ drafted the manuscript. ZJZ, LXL, JLZ, HYC, THS, TYC, KFC, and WFY participated in study design. THS and TYC referred participants. ZSQ conducted data analysis. ZJZ revised the manuscript. JLZ and SCY carried out treatments. PYC performed assessments. SFX, YH, CYC provided critical comments. All authors approved th...
PMC10134666
Funding
This trial was funded by Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China (Ref no: 16172761). The funding body was not involved in study design and conduct, data collection, management, analysis and interpretation.
PMC10134666
Availability of data and materials
The data underlying this article will be shared on reasonable request addressed to zhangzj@hku.hk.
PMC10134666
Declarations
PMC10134666
Ethics approval and consent to participate
WEST
The trial was approved by Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (UW 19-045) and Research Ethics Committee of Hong Kong Sanatorium & Hospital (REC-2019-14). The research was carried out in accordance with the Declaration of Helsinki.
PMC10134666
Consent for publication
Not applicable.
PMC10134666
Competing interests
The authors declared no potential competing interests with respect to the research, authorship, and publication of this article.
PMC10134666
References
PMC10134666
Methods:
This was a
PMC10254966
Results:
Subjects (
PMC10254966
Conclusion:
The overall effects of SDX/d-MPH on growth velocity (the change in weight and height from one time point to the next) were minimal, and the range of changes was not considered clinically significant.
PMC10254966
Introduction
attention-deficit/hyperactivity disorder, ADHD
SPENCER, GROWTH SUPPRESSION
Methylphenidate (MPH) is a commonly prescribed medication for attention-deficit/hyperactivity disorder (ADHD) because of its efficacy for symptom reduction and overall favorable safety record. MPH is often prescribed for long-term use in patients with ADHD (Storebø et al. This formulation of SDX/d-MPH (Azstarys™; Coriu...
PMC10254966
Methods
This
PMC10254966
Subjects
ADHD
The subjects were children aged 6–12 years with ADHD at the start of the dose-optimization (DO) phase of the study. Subjects included those rolled over from the antecedent pivotal study (Kollins et al.
PMC10254966
Study design
The study design included a 30-day screening phase, a 3-week DO phase, a 360-day treatment phase, and a follow-up visit. Only new subjects underwent screening and DO. During the DO phase, new subjects were titrated to their optimized dose based on the best dose response and individual tolerability to the treatment (Chi...
PMC10254966
Weight and height measurements
Body weight (in kg) and height (in cm) were measured at each monthly visit. Body weight was measured using a calibrated scale while subjects remained in their normal clothing, with shoes and jacket (and/or outer clothing) removed. Height was measured using a stadiometer with the subject's shoes removed.
PMC10254966
Results
PMC10254966
Subject disposition
Subject disposition has been previously described (Childress et al. Subject disposition.
PMC10254966
Subject demographics and baseline characteristics
SD
The mean (SD) age for the subjects was 9.1 (1.9) years; 60.9% of the subjects were male, and 39.1% were female. The mean (SD; minimum, maximum) for weight was 38.6 (13.9; 21.0, 97.0) kg, BMI was 19.2 (4.6; 13.1, 37.5) kg/mSubjects' Demographics. Treatment Phase Safety PopulationSD, standard deviation.
PMC10254966
Growth velocity
PMC10254966
Weight
weight loss
The mean (SD) body weight at baseline was 38.6 (13.9) kg with a Mean observed body weight versus mean predicted body weight Baseline Observed Mean Body Weight and Height, Predicted Weight and Height, Weight and Height Z-Score, and Weight and Height Percentiles: Treatment Phase Safety PopulationSD, standard deviation.At...
PMC10254966
Height
height gain
The mean (SD) height at baseline was 139.6 (11.9) cm with a A comparison of observed height versus predicted height showed a steady increase of the mean observed height over time, which was at a lower rate than the predicted velocity of height gain at each monthly visit (Mean observed height versus mean predicted heigh...
PMC10254966
Discussion
weight gain, Spencer, ADHD
SPENCER, DRUG EFFECT
The safety and tolerability results from this 1-year open-label study of SDX/d-MPH in children with ADHD have been previously reported (Childress et al. Other studies of MPH in children with ADHD also observed similarly higher baseline weight and height than their reference samples (Swanson et al. A The mean weight cha...
PMC10254966
Conclusion
In this study, we show that long-term treatment for up to 1 year with SDX/d-MPH was associated with modest reductions in expected weight and lower-than-expected increases in height, effects that plateaued or diminished later in treatment. Although both weight and height decreased compared with the reference population,...
PMC10254966
Clinical Significance
This phase 3 clinical trial of SDX/d-MPH in children aged 6–12 years showed that the overall effects of SDX/d-MPH on growth velocity were minimal and changes were in a range considered not clinically significant.
PMC10254966
Acknowledgments
Tiloke
Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Gautam Bijur, PhD, Charlette Tiloke, PhD, and editing support by Kathleen Blake, PhD, all of Ashfield MedComms, an Inizio company, and funded by Corium, LLC.
PMC10254966
Authors' Contributions
All the authors were actively involved in data interpretation, critical review of the data, article writing, and editing.
PMC10254966
Disclosures
A.C.C serves as consultant for Aadrvark, Arbor, Aytu, Ironshore, Neos Therapeutics, Neurocentria, Noven, Otsuka, Purdue, Rhodes, Sky, Sunovion, Tris Pharma, Zevra Therapeutics (previously KemPharm, Inc.), Supernus, Jazz, Corium, LLC, and Lumos. She has served on the speaker's bureau for Takeda (Shire), Arbor, Ironshore...
PMC10254966
References
PMC10254966
Background
deaths
Over one million yearly deaths are attributable to
PMC9942299
Methods
human immunodeficiency virus (HIV) infected
We assessed 26 PNSP isolates obtained from the nasopharynx from 537 healthy human immunodeficiency virus (HIV) infected adults in Dar es Salaam, Tanzania, participating in the randomized clinical trial CoTrimResist (ClinicalTrials.gov identifier: NCT03087890, registered on 23rd March, 2017). Next generation whole genom...
PMC9942299
Results
Fifty percent (13/26) of PNSP were resistant to erythromycin, of these 54% (7/13) and 46% (6/13) had MLS
PMC9942299
Conclusion
The
PMC9942299
Materials and methods
PMC9942299
Bacterial isolates
Twenty-six penicillin non-susceptible Serotyping of
PMC9942299
Antimicrobial susceptibility testing
The E-test strip (bioMérieux, Marcy-I-Etoile, France) was used to determine the minimum inhibitory concentrations (MIC) for azithromycin, erythromycin and penicillin. The disk diffusion method was used to determine tetracycline and clindamycin susceptibility [
PMC9942299
Whole genome sequencing and analysis
Whole genome sequencing was performed using the Next generation sequencing platform HiSeq X10 (Illumina, San Diego, CA, USA) at MicrobesNG (Microbes NG, Birmingham, UK). Quality filtering and sequencing short read trimming were performed by MicrobesNG using SPAdes and annotated in GenBank. Short read sequences were ass...
PMC9942299
Statistical analysis
Categorical variables were presented in frequencies, percentages, and proportions. Categorical variables were compared using chi square test. A p-value < 0.05 was considered as threshold for statistical significance. Statistical analysis was performed using STATA version 16 (College Station, TX).
PMC9942299
Discussion
RESPIRATORY TRACT INFECTIONS, COMMUNITY-ACQUIRED PNEUMONIA
We observed a discrepancy in azithromycin susceptibility depending on whether using breakpoints from EUCAST or CLSI guidelines for interpretation. All 13 PNSP isolates harboring genetic determinants for macrolide resistance were correctly identified as resistant to erythromycin and azithromycin (all with MIC ≥ 4 µg/mL)...
PMC9942299
Acknowledgements
Authors thank members of the bacteriology research laboratory of the Muhimbili University of Health and Allied Science in Dar es Salaam, Tanzania, for their assistance during data collection and preliminary laboratory procedures.
PMC9942299
Author contributions
BB and NL conceived the study. JM collected study data. JM and SM performed the microbiological investigations. BB and JM performed statistical analysis. JM drafted the manuscript. BB, SJM, and NL revised the manuscript. All authors approved the final version.
PMC9942299
Funding
INFECTIOUS DISEASES
This research was supported by (i) Helse Bergen HF, Haukeland University Hospital, Bergen, Norway, project number 912132, , (ii) National Advisory Unit on Tropical Infectious Diseases, Haukeland University Hospital, Bergen, Norway, (iii) CAMRIA - Combatting Anti-Microbial Resistance with Interdisciplinary Approaches, C...
PMC9942299
Availability of data and materials
Data are available on reasonable request.
PMC9942299
Declarations
PMC9942299