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METHODS | PMC10640691 |
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Study Design and Participants | This was a phase 3, randomized, open-label, multicenter clinical trial conducted in the US. Eligible adults were randomly assigned (1:1) to receive coadministration of a booster dose (50 µg) of mRNA-1273 and the first dose of RZV (RZV1) (Coad group), or the mRNA-1273 booster followed 2 weeks later by RZV1 (Sequential [Seq] group). All study participants received the second dose of RZV (RZV2) 2 months post-RZV1 and were followed for safety endpoints until 6 months post-RZV2 (ClinicalTrials.gov identifier NCT05047770).Eligible adults aged ≥50 years were healthy or medically stable who had completed a 2-dose mRNA-1273 primary vaccination series at least 6 months prior to study vaccination. A full list of eligibility criteria is provided in the The study was conducted according to the Good Clinical Practice guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and ethical principles derived from the Declaration of Helsinki. The protocol was approved by all applicable institutional review boards (Advarra Institutional Review Board, Western Copernicus Group Institutional Review Board). Written informed consent was obtained from each participant prior to enrollment. | PMC10640691 |
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Randomization | Participants were stratified by age (50–59, 60–69, ≥70 years) and centrally randomized to either the Seq or Coad group. The randomization system allocated a participant identification number and provided the treatment number to be administered. | PMC10640691 |
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Objectives | The primary objectives were (1) to demonstrate noninferiority in terms of humoral immunogenicity of 2 doses of RZV when RZV1 was coadministered with an mRNA-1273 booster dose compared to RZV1 administered 2 weeks after mRNA-1273; and (2) to demonstrate noninferiority in terms of humoral immunogenicity of a booster dose of mRNA-1273 when coadministered with RZV1 compared to its administration 2 weeks prior to RZV1. Secondary objectives were to characterize the immune responses to RZV and mRNA-1273 and to evaluate safety and reactogenicity of the study vaccines, and are provided in the | PMC10640691 |
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Study Interventions and Procedures | immune-mediated diseases | ADVERSE EVENTS | The composition of RZV and mRNA-1273 is provided in the Anti-gE antibodies were measured using an enzyme-linked immunosorbent assay at GSK [Solicited local and systemic adverse events (AEs) with onset within 7 days after each vaccination were recorded using electronic diaries. Unsolicited AEs were recorded for 30 days after each vaccination. Serious adverse events (SAEs), intercurrent medical conditions, potential immune-mediated diseases (pIMDs), pregnancies, AEs of special interest (AESIs), and cases of COVID-19 and HZ were collected up to 6 months after RZV2. All solicited AEs were considered causally related to study vaccination. Causal relationship to vaccination of all other AEs was assessed by the investigators and independently by the sponsor. A joint safety review team with GSK and Moderna representatives oversaw participant safety. Randomization was temporarily paused as per protocol after 10% of participants were vaccinated and safety data were collected for 7 days postvaccination.The protocol-defined list of AESIs, AE intensity grading table, causality assessment criteria by the investigator, and protocol-defined study holding rules are provided in the | PMC10640691 |
Statistical Analysis | EVENT | The exposed set included all participants who received at least 1 dose of a study vaccine. The per-protocol set (PPS) included study participants who met eligibility criteria, received all vaccinations according to their random assignment, complied with protocol-defined procedures, did not receive prohibited medications or vaccines, had available postvaccination immunogenicity data, and where the administration site was known.Anti-gE antibody concentrations and anti–S protein antibody concentrations were expressed as between-group ratios of the geometric mean concentration (GMC) 1 month post-RZV2 and 1 month post–mRNA-1273 booster, respectively. The 95% confidence intervals (CIs) of the between-group GMC ratios were computed using an analysis of covariance model on the logGMCs were calculated by taking the anti-log of the mean of the log concentration transformations. Noninferiority of the anti-gE antibody or anti-S antibody response was demonstrated if the upper limit of the 95% CI of the adjusted GMC ratio (Seq over Coad) was <1.5, 1 month post-RZV2 or post–mRNA-1273 booster, respectively.Assuming a GMC ratio of 1.1 between the Seq and Coad groups, the global power to meet both co-primary objectives with 245 evaluable participants in the Seq and Coad groups was 90%. Assuming that about 10% of the randomized participants would not be evaluable, approximately 546 participants (273 in each study group) were planned.Descriptive immunogenicity analyses were also performed. A vaccine response following RZV was defined as a participant who had at least a 4-fold greater anti-gE antibody concentration post-RZV2 compared to prevaccination for initially seropositive participants, or compared to the antibody cutoff value (97 mIU/mL) for participants who were seronegative at prevaccination.Mean geometric increase (MGI) was defined as the within-participant ratios of the postvaccination to the prevaccination antibody concentration, thereby representing fold-rise in antibody concentration.Safety was evaluated descriptively, without predefined statistical criteria. For solicited systemic AEs, the frequency of occurrence of any event in the sequential group was calculated by counting whether the event occurred following mRNA-1273 or following RZV1 administered 2 weeks later. If a participant had the same event after both mRNA-1273 and RZV1, it was counted only once at maximum severity.All statistical analyses were performed using SAS version 9.4 software. | PMC10640691 |
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RESULTS | PMC10640691 |
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Participants | zoster | ZOSTER | The study was conducted between 7 October 2021 and 29 August 2022 at 47 sites in the US. From a total of 545 participants randomized, 539 were vaccinated (exposed set; 272 in the Seq and 267 in the Coad group), and 91.2% in the Seq and 92.6% in the Coad group completed the study (Participant flow. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of RZV. The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV. Abbreviations: D, study day; LTFU, lost to follow-up; mRNA-1273, Moderna's messenger RNA COVID-19 vaccine; PPS, per-protocol set; RZV, recombinant zoster vaccine.The study groups were well balanced in terms of demography (Demographic Characteristics of Study Participants (Exposed Set)Data are presented as No. (%) unless otherwise indicated. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of recombinant zoster vaccine (RZV). The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV.Abbreviations: Min, Max, minimum and maximum values; mRNA-1273, Moderna's mRNA COVID-19 vaccine; SD, standard deviation. | PMC10640691 |
Immunogenicity Results | zoster, Zoster Vaccine | ZOSTER | Noninferiority of the humoral immune response to the gE and S antigens was demonstrated according to the protocol-specified criteria. For the PPS, the adjusted GMC ratio (Seq over Coad) was 1.01 (95% CI, .89–1.13) for anti-gE antibodies 1 month post-RZV2 (Analysis of Anti–Glycoprotein E Antibody Responses 1 Month After the Second Dose of Recombinant Zoster Vaccine When the First Dose Was Coadministered With an mRNA-1273 Booster Dose or Administered Sequentially 2 Weeks Later (Per-Protocol Set)Data in parentheses indicate the 95% confidence interval. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of recombinant zoster vaccine (RZV). The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV.Abbreviations: aGMC, adjusted geometric mean concentration ratio (Seq/Coad); GMC, geometric mean concentration of antibody; MGI, mean geometric increase, defined as the within-subject ratios of the postvaccination antibody concentration to the prevaccination (day 1) antibody concentration; mRNA-1273, Moderna's mRNA COVID-19 vaccine.Seropositivity is the percentage of participants whose anti–glycoprotein E (gE) antibody concentration is equal to or greater than the assay cutoff value (97 milli-international units [mIU]/mL).Vaccine response post–dose 2 is the percentage of participants who have at least a 4-fold greater anti-gE antibody concentration postdose compared to prevaccination for initially seropositive participants or compared to the antibody cutoff value (97 mIU/mL) for participants who are seronegative at prevaccination.Analysis of Anti-Spike Antibody Responses 1 Month After the mRNA-1273 Booster Dose When Coadministered With the First Dose of Recombinant Zoster Vaccine or When Administered Sequentially 2 Weeks Earlier (Per-Protocol Set)Data in parentheses indicate the 95% confidence interval. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of recombinant zoster vaccine (RZV). The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV.Abbreviations: aGMC, adjusted geometric mean concentration ratio (Seq/Coad); GMC, geometric mean concentration of antibody; MGI, mean geometric increase, defined as the within-subject ratios of the postvaccination antibody concentration to the prevaccination (day 1) antibody concentration; mRNA-1273, Moderna's mRNA COVID-19 vaccine.Two doses of RZV induced robust antibody responses in all age groups and in both study groups (One month post–mRNA-1273 booster, the MGI in anti-S antibodies was 18.7 (95% CI, 15.2–22.9) in the Seq group and 16.6 (95% CI, 13.7–20.0) in the Coad group ( | PMC10640691 |
Safety Results | pulmonary embolism, myalgia, fatigue, hyperlipidemia, cutaneous vasculitis, headache | ADVERSE EVENTS, HYPERLIPIDEMIA, CUTANEOUS VASCULITIS, PULMONARY EMBOLISM | The frequency of any or grade 3 intensity solicited local AEs post–mRNA-1273 or post-RZV1 were similar in both study groups (Percentage of solicited local and systemic adverse events reported per participant after the mRNA-1273 and first RZV vaccinations (exposed set). The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of RZV. The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV. Definitions of grade 3 intensity are provided in the The most frequently reported solicited systemic AEs (percentages for Seq and Coad groups, respectively) were myalgia (57.7%, 64.0%), fatigue (49.3%, 51.7%), and headache (38.6%, 39.0%) (The frequency of solicited AEs of any or grade 3 intensity reported per participant post-RZV2 was similar in the 2 study groups (There were 41.5% of participants in the Seq group and 46.1% in the Coad group who reported at least 1 unsolicited AE within 30 days of any study vaccination (Five participants in the Seq group and 6 in the Coad group reported SAEs. One SAE in the Seq group, pulmonary embolism, in a participant with a history of hyperlipidemia and tobacco use, and with an onset on day 3 after mRNA-1273 vaccination (prior to receiving RZV1), based on temporal association, was assessed by the investigator and sponsor as related to mRNA-1273 and led to discontinuation from further study vaccinations (Three participants in the Seq group and 2 in the Coad group reported AESIs, of which 1 was the pulmonary embolism SAE described above (One participant in each study group reported a pIMD, of which cutaneous vasculitis (no skin biopsy performed) in a participant in the Seq group, with onset on day 10 after mRNA-1273 and spontaneous resolution prior to administration of RZV1, was assessed as related to mRNA-1273 by the investigator and sponsor based on temporal association ( | PMC10640691 |
DISCUSSION | This is the first clinical study to evaluate the safety and immunogenicity of the mRNA-1273 COVID-19 vaccine booster when coadministered with RZV or when administered sequentially. As with sequential administration, coadministration elicited robust anti-gE and anti-S antibody responses, with MGIs exceeding 34-fold and 16-fold, respectively. Notably, in terms of these humoral immune responses, coadministration of the vaccines proved to be noninferior to their sequential administration, confirming an absence of evidence for immune interference upon coadministration. The validity of this result is further strengthened by the same observation of noninferiority from analysis on the exposed set. Although for both RZV and mRNA-1273, no validated immunologic mechanistic correlate of protection has been established to date, there is evidence that anti-gE and anti-S antibody responses, as measured in this study, can be considered as reasonable surrogate endpoints likely to predict clinical efficacy for these respective vaccines [The reactogenicity and safety profile of mRNA-1273 and RZV1 coadministration was within their respective Reference Safety Information [Potential limitations of the study include the open-label design, which could have influenced safety reporting and causality assessments, although this would be expected to be biased against the Coad group. Coadministration of mRNA-1273 was only assessed post-RZV1; however, since reactogenicity is similar following RZV1 or RZV2 [In conclusion, the results of this study have shown no safety concerns and a lack of immunologic interference when a booster dose of the COVID-19 mRNA-1273 vaccine was coadministered with the adjuvanted RZV in adults aged ≥50 years. These results provide important data that were previously lacking, to support both the public health agencies whose guidance to healthcare providers has been that COVID-19 vaccines can be administered without regard to timing of other age-appropriate vaccines and those that are awaiting such data to make evidence-based and unreserved recommendations [ | PMC10640691 |
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Supplementary Data | PMC10640691 |
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Supplementary Material | Click here for additional data file. | PMC10640691 |
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Trademark Statement | Shingrix is a trademark owned by or licensed to GSK and Spikevax is a trademark of Moderna. | PMC10640691 |
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Notes | PMC10640691 |
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Plain Language Statement | COVID-19 disease |
Booster vaccinations against COVID-19 disease are likely to be necessary for the foreseeable future. Doctors and patients are interested to know whether COVID-19 booster vaccines can be given at the same time as other vaccines in adults.
The results of our study showed that an mRNA-based COVID-19 booster vaccine could be coadministered with recombinant shingles vaccine.When given together, both vaccines were well tolerated and induced immune responses similar to those observed when they were administered sequentially.
Administering more than 1 vaccine during a healthcare visit is an efficient way to improve coverage and reduce the number of doctor visits needed to receive all vaccines.Coadministration of COVID-19 booster vaccines and the recombinant shingles vaccine could be an attractive option for patients and healthcare professionals. | PMC10640691 |
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References | PMC10640691 |
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Background | LISB | Ultrasound-guided low interscalene brachial plexus block (LISB) can provide satisfactory anesthesia for surgery at or below the elbow. However, the anesthesia effect of ultrasound-guided middle interscalene brachial plexus block (MISB) has not been fully investigated. We hypothesized that MISB provides a non-inferior anesthesia effect to LISB for surgery at or below the elbow. | PMC9808947 |
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Methods | A total of 82 patients with ASA I-III (18–65 years) scheduled for elective surgery at or below the elbow were randomized to the MISB group or the LISB group equally, located 1/2 or 2/3 of the caudal distance from C6 to the clavicle. Both groups were administered 15 mL 0.5% ropivacaine at the lower part of the brachial plexus with the first injection and equivalent volume at the upper part with the second injection. | PMC9808947 |
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Results | SECONDARY | For the primary outcome, 92.3% in the MISB group experienced successful anesthesia compared to 94.6% in the LISB group [difference: –2.3%, 95% confidence interval (CI) –13.4% to 8.8%], exceeding the predefined non-inferiority margin -15%. For the secondary outcomes, the incidence of pleura suppression for the first injection (7.7% vs. 45.9%, | PMC9808947 |
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Conclusions | MISB provides a non-inferior anesthesia effect to LISB for surgery at or below the elbow. | PMC9808947 |
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Trial registration | Chinese Clinical Trial Register (identifier: ChiCTR2100054196). | PMC9808947 |
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Keywords | PMC9808947 |
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Key points | LISB | PNEUMOTHORAX |
We proposed the middle interscalene brachial plexus block (MISB) for the first time and assessed its efficacy for the sensory and motor block.MISB provides a non-inferior anesthesia effect to low interscalene brachial plexus block (LISB) for surgery at or below the elbow.MISB may be considered a valuable alternative for LISB, especially for patients with poor ultrasound images or a high risk of pneumothorax.Both MISB and LISB improved the success rate of the inferior trunk compared to the classical interscalene brachial plexus block.We observed the diffusion of the local anesthetics with MRI 3D STIR SPACE images. | PMC9808947 |
Introduction | trauma | The classic interscalene brachial plexus block (CISB) was performed at the C6 level in the cricoid cartilage, which has evident advantages such as not requiring moving the patient's arm or forearm in the case of trauma or abnormality, a better anesthesia effect for upper limb and shoulder surgery, and easy to learn [ | PMC9808947 |
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Materials and methods | PMC9808947 |
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Ethics | Ethic for this randomized, prospective, observer-blinded clinical study was approved by the Medical Ethics Committee of the third affiliated hospital of Chongqing Medical University (president Fei Hao), China 2/12/2021, approval number 2021/35. The study protocol was registered with the Chinese registry of clinical trials ( | PMC9808947 |
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Patients | allergic reaction, toxicity, edema, impaired neurological function, pain, infection, psychiatric | ALLERGIC REACTION, EDEMA, DYSFUNCTION, INFECTION, COAGULATION DISORDER | Inclusion criteria were patients aged 18 to 65 years; American Society of Anesthesiologists classification (ASA) I–III; ability to express pain; and patients undergoing elective surgery at or below the elbow. Exclusion criteria were patients who had neck tissue abnormality, infection, or edema; impaired neurological function; coagulation disorder; a history of an allergic reaction to local anesthetics or opioids; weighing < 40 kg (to reduce the risk of anesthetic toxicity) or > 100 kg (to reduce the difficulty of performing ISB); psychiatric dysfunction and patients who refused to sign informed consent. | PMC9808947 |
Randomization and blinding | On the day of surgery, consented patients were randomly assigned to the LISB or MISB group (1:1) using SPSS 25.0 software (Statistical Program for Social Sciences, SPSS Inc., Chicago, Illinois, USA) by C.-M.G. who was not involved in the study. Allocation anonymity was ensured by enclosing assignments in sealed, opaque, and sequentially numbered envelopes opened by X.Y. Then, X.Y. prepared 0.5% ropivacaine (30 mL) for patients during the study period only upon their arrival in the operation room [ | PMC9808947 |
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Intervention technique | LISB | INFILTRATION | Venous access was established after arrival in the operating room without any premedication before anesthesia. During the same time, the vital signs of the patients were monitored every three minutes using a non-invasive blood pressure parameter, pulse oximeter, and electrocardiogram. Patients were kept supine with their heads facing away from the block side. All blocks were performed by the senior anesthesiologist (Z.-H.C.), who had performed over 200 ultrasound-guided peripheral nerve blocks. After sterilizing the region with povidone-iodine, 2% lidocaine (1 mL) was injected for local site subcutaneous infiltration. An 11 MHz linear probe (HITACHI ALOKA ARIETTA, America) was also wrapped with a sterilized plastic cover. The probe was located at a caudal 2/3 distance from C6 to the clavicle in the LISB group (Fig. Location and an ultrasound image of LISB and MISB. Note: | PMC9808947 |
Perioperative analgesia and management | shoulder abduction, paralysis | PARTIAL PARALYSIS, COLD | Data on age, sex, weight, height, BMI, surgical site, and ASA classification were collected. The anesthesia effects were defined as below: "success ", the surgery was performed under the block with or without additional sufentanil and propofol intravenously administered at a maximum usage of 10 ug or 2 mg/kg, respectively; "failure", reverted to trachea intubation or general anesthesia due to inadequate analgesia or other adverse invents. After the block procedure, a blinded anesthesiologist (S.m.Q.) performed sensory, and motor blockade evaluation, unaware of the allocation at 5 min, 15 min since the needle was withdrawn from the patient and the end of the surgery. The extent of sensory block and loss of cold sensation were assessed using an ice cube in areas supplied by six nerves according to a 3-point scale (0 = normal cold sensation, no block; 1 = partial block of cold sensation, partial block, and 2 = no cold sensation, complete anesthesia): ulnar (fifth finger), musculocutaneous (lateral forearm), radial (dorsal skin between the thumb and second finger), median (a palmar aspect of the second finger), medial cutaneous nerve of the forearm (medial side of the forearm), and axillary (stump shoulder). The extent of the motor block was assessed by specific motor activity: ulnar (fourth and fifth finger flexion), musculocutaneous (elbow flexion), radial (finger extension), median (wrist flexion), and axillary (shoulder abduction) (0 = normal, 1 = partial paralysis, 2 = complete paralysis) [ | PMC9808947 |
Magnetic resonance imaging of the brachial plexus | Magnetic resonance imaging was performed immediately after surgery on a 1.5 T magnet (Siemens Aera MR, Germany) to observe the diffusion of the local anesthetics. MRI examination consents were obtained from the two patients of the corresponding group. The patient in the supine and head advanced position was placed in the head, neck, and spine matrix coils. The magnetic field center was scheduled for the C6 level and scanned sequences included the transverse T1WI, T2WI, and coronal T2WI. M.R. neurography was performed using 3D short-tau inversion recovery and SPACE imaging (3D STIR SPACE), TR 3000 ms, TE 248 ms, TI 180 ms, 448 × 448 mm field-of-view (FOV), 448 × 448 resolution, 1 mm slice thickness. The original images were transmitted to the Siemens workstation to process maximum intensity projection (MIP), multiplanar reconstructions (MPR) and image analysis. | PMC9808947 |
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Outcome measures | toxicity, dyspnea, hoarseness, nausea, vomiting | HORNER SYNDROME, PNEUMOTHORAX | The primary outcome was the anesthesia success rate with a non-inferiority test. Secondary outcomes included: incidence of suppression of the pleura when administering the first injection; the sensory and motor blockade scores of all branch nerves at 5 min, 15 min, and the end of surgery; evaluation of the motor response of double injections; the time to perform ISB, which was defined as the time from the start of initial scanning to the withdrawal of the needle; intraoperative dosage of propofol and sufentanil; the cumulative consumption of tramadol within 24 h after surgery; resting and moving VAS scores at 2, 4, 6, 12 and 24 h after surgery; duration of surgery defined as the time from the start of surgical incision to the end of the last stitch; time to readiness for surgery defined as the time from withdrawal of the needle to the start of surgical incision would also be recorded. Simultaneously, ISB-related side effects such as nausea, vomiting, Horner Syndrome, dyspnea, hoarseness, pneumothorax, and anesthetic toxicity were recorded. | PMC9808947 |
Sample size and statistical analysis | LISB | This study was designed to compare the non-inferiority of the anesthesia success rate in MISB and LISB undergoing surgery at or below the elbow. Previous studies reported that the success rate of low interscalene brachial plexus block anesthesia for surgery at or near the elbow was approximately 95% when opiates and midazolam were used in advance, and a low dose of propofol was used for continuous sedation [The primary endpoint was assessed by the non-inferiority test for the difference between two proportions (the null hypothesis that the difference in the anesthesia success rate was greater than or equal to 15% vs. the alternative hypothesis that the difference was less than 15%). The 95% confidence interval for the difference in anesthesia success rate between MISB and LISB was calculated. If the lower 95% confidence limit was above –15%, the anesthesia effect of MISB was deemed to be non-inferior to LISB.For other outcomes, after confirming the normality of distribution using the Shapiro–Wilk test, continuous variables were compared using the t-test or Mann–Whitney test. As appropriate, continuous variables were presented as means ± SDs or median (interquartile range). Categorical variables were compared by the chi-square or Fisher exact test and presented as numbers and percentages. Data analysis was performed using SPSS software (Statistical Program for Social Sciences, SPSS Inc., Chicago, Illinois, USA). with a two-tailed | PMC9808947 |
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Results | PMC9808947 |
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Patient characteristics | SD, fifty-four | MAY | One hundred fifty-four consecutive patients were assessed for eligibility between January 2022 and May 2022. Of these, 59 patients did not meet the inclusion criteria and 13 refused to participate. The remaining 82 patients were randomized into the LISB (Consort flow study diagram. Note: MISB = middle interscalene brachial plexus block; LISB = low interscalene brachial plexus blockBaseline characteristics of study patientsNote: Data are presented as mean ± SD, or number (%). | PMC9808947 |
Primary outcome | The anesthesia success rate was 92.3% in the MISB group and 94.6% in the LISB group. The mean difference in the anesthesia success rate between the two groups was –2.3%, with a 95% confidence interval (CI) of –13.4% to 8.8%. With the non-inferiority margin set at − 15%, MISB was confirmed to provide a non-inferior anesthesia effect compared to LISB. (Fig. Mean difference in the anesthesia success rate. A non-inferiority test for the difference between two proportions was performed to determine the differences between MISB and LISB. The black line at the mean difference − 15% indicates the non-inferiority margin. The region to the right of the black line indicates non-inferiority, the region to the left of the black line indicates inferiority, and the region to the right of the dotted line indicated superiority. CI, confidence interval | PMC9808947 |
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Secondary outcomes | inferior sensory blockade, paralysis | PARTIAL PARALYSIS, SECONDARY, COLD | For the incidences of suppression of the pleura when administering the first volume of local anesthetics, 3 patients (7.7%) in the MISB group showed significantly less than 17 patients (45.9%) in the LISB group (Comparison of the primary and secondary outcomes between the two groups35/2(94.6%/ 5.4%)36/3(92.3%/ 7.7%)Note: Data are presented as mean ± SD, median (range), or number (%). In addition to an inferior sensory blockade for the ulnar and medial cutaneous nerve of the forearm nerves at 5 min and 15 min evaluations in the MISB group compared to LISB, similar extents of sensory and motor block were observed for all branch nerves at different times in the two groups (Table Comparison of the sensory and motor blockade scores at different time points between the two groupsNote: Data were presented as presented as numbers (percentages), and compared by the chi-square or Fisher exact test. 0 = normal, no cold sensation or no paralysis; 1 = partial block of cold sensation or partial paralysis; 2 = no cold sensation, complete anesthesia or complete paralysis. At the first injection, the proportion of patients in the MISB group with fingers elicited motor response was lower (17.9% vs. 62.2%, Motor response of double injection and the MRI images of ropivacaine diffusion in the two groups. Note: | PMC9808947 |
Acknowledgements | We thank the patients for their participation in this study. | PMC9808947 |
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Author’s contributions | Yang Zhao: Conceptualization, Formal analysis, Funding acquisition, Writing original draft, Software, Validation. Shiming Qin: Methodology, Project administration, Data curation, Software, writing original draft. Xue Yang: Methodology, Project administration, Software, Supervision. Chongmei Gao: Methodology, Investigation, Software. Xia Yuan: Methodology, Software. Tao Li: Methodology, Software, editing. Zhaohui Chen: Conceptualization, Project administration, Methodology, Writing – review & editing, Visualization, Validation. The author(s) read and approved the final manuscript. | PMC9808947 |
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Funding | This study was supported by the Project of North Sichuan Medical College (NO. CBY21-QA42) and Innovation Project of Guangxi Graduate Education (NO. YCBZ2022091). | PMC9808947 |
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Availability of data and materials | The data used and/or analyzed during the current study are also available from the corresponding author upon reasonable request. | PMC9808947 |
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Declarations | PMC9808947 |
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Ethics approval and consent to participate | This randomized, prospective, observer-blinded clinical study was registered with the Chinese registry of clinical trials at | PMC9808947 |
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Consent for publication | Not applicable. | PMC9808947 |
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Competing interests | The authors declare no competing interests. | PMC9808947 |
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References | PMC9808947 |
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1. Introduction | psychiatric, PMS | DISORDER, PREMENSTRUAL SYNDROME (PMS), PMS, SECONDARY, COMPLICATIONS | Premenstrual syndrome (PMS) continues to impact the health outcomes and emotional well-being of reproductive-age women, globally. Several studies have provided conflicting evidence concerning the role of dietary approaches in improving PMS symptoms. Accordingly, this study aimed to evaluate the possible influence of a healthy diet and motivational strategies on PMS symptoms and health-related quality of life among Omani adolescents. This open-label, randomized, prospective controlled trial was conducted at two randomly selected secondary schools, in Al Seeb Willayah, in Muscat region. Adolescents with PMS symptoms, who were in grade 10 or 11, aged 16 years or above, had regular menstrual cycles, and were not known to have psychiatric disorder were included in this study. Participants in the intervention group received an individual face-to-face dietary consultation and motivational phone consultation. The health outcomes, including the PMS symptoms in both groups, and quality of life, were recorded using the Daily Record of Severity of Problems questionnaire (DRSP) and the 14-item Self-Reporting-Based Perceived Stress Scale tools, respectively. The primary outcome was the difference in the mean premenstrual symptom scores between the two groups. Secondary outcomes included the quality of life and stress levels of participants. The study period was from 1 February and ended 30 June 2021. SPSS was used to analyze the data, and intention-to-treat analysis was utilized. A total of 72 adolescents with PMS were randomized into intervention and control groups (Reproductive-age women experience a high risk and incidence of premenstrual syndrome (PMS) and its deleterious complications [Robust evidence supports the use of selective serotonin re-uptake inhibitors (SSRIs) as a first-line treatment for PMS [ | PMC10742710 |
2. Materials and Methods | SECONDARY, PMS | This is a prospective, open-label, randomized controlled trial of two parallel groups. It was conducted in two randomly selected secondary schools in Al Seeb Willayah, in Muscat region. The consecutive sampling approach was used to recruit the study participants. Candidates who qualified for the initial eligibility criteria were interviewed by the principal and co-principal investigators. Subjects who had one symptom or more of PMS in accordance with | PMC10742710 |
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2.1. Inclusion and Exclusion Criteria | anxiety disorder, PMDD, psychiatric, post-traumatic stress disorder, premenstrual dysphoric disorder, depression, psychotic disorders, diabetes | DISORDER, PMS, DIABETES | Adolescents who were in grade 10 or 11, aged 16 years or above, and had regular menstrual cycles were included in this study. Exclusion criteria included those who were known to have a psychiatric disorder (such as depression, generalized anxiety disorder, post-traumatic stress disorder, psychotic disorders), and diabetes. In addition, those with a history of oral contraceptive use, and those who were previously administered with, or adhered to, dietary recommendations for PMS management or those who utilized herbal remedies were further excluded. Adolescents with a confirmed diagnosis of premenstrual dysphoric disorder (PMDD) were also excluded and referred to the nearest local healthcare center for urgent management by a well-trained family physician. | PMC10742710 |
2.2. Sample Size | PMS | The sample size for the primary outcome was calculated based on the difference in mean DRSP scores for a two-group parallel clinical trial with equal allocation. The acceptable effect at which superiority could be declared if there was a decrease in the summary DRSP score of six on the DRSP tool in the intervention group compared to the control group was used. The true difference was considered to be seven, and the conservative estimate of an expected standard deviation in the population in the trial was considered to be 1.5, resulting in an effect at a size of 0.67. For a power of 80% and α of 5%, the required sample size in each group was 28 subjects. Anticipating a dropout of 25%, the expected sample size was 35 PMS subjects in each group. nMaster 2.0 software was used to calculate the sample size [ | PMC10742710 |
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2.3. Recruitment and Randomization | SECONDARY, RECRUITMENT | Consecutive sampling was used for the recruitment stage. Cluster randomization of the schools was carried out to minimize the contamination anticipated from recruiting subjects from the same school. Notably, the study was conducted in two randomly selected secondary schools in Al Seeb Wilayat in Muscat region. The participants in the intervention group (school A) and those in the control group (school B) were recruited from two separate schools, which were located in different areas and were maintained at an adequate distance from each other within Al Seeb Wilayat. | PMC10742710 |
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2.4. Treatment Protocol | FBDs | Participants in the intervention group received individual face-to-face dietary consultations with a well-experienced clinical dietician, who evaluated the overall nutritional status of the participants, followed by an explanation of the concept of a healthy diet, including a discussion on the six food groups essential for healthy eating. The food-based dietary guidelines (FBDs), customized for Omani adolescents, were used to generate healthy, balanced diet recommendations for the participants [ | PMC10742710 |
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2.5. Assessment Approach | THYROID DISEASE, PMS | At baseline, the sociodemographic questionnaire was administered to both study groups, which included basic sociodemographic features such as age, and chronic conditions such as thyroid disease, medication use, smoking, alcohol status and substance use. The dietitian evaluated the dietary habits of participants in both the control and intervention groups. The assessment covered the number of servings of milk and dairy products, meat, fish, legumes, vegetables, fruits, refined carbohydrate-rich foods, caffeine, and carbonated drinks, as well as fat-rich foods. In addition, at baseline, and by the end of the study, the DRSP (Arabic version) was disseminated to participants of the control and intervention groups. The DRSP tool is known for its high sensitivity, specificity, and validity in calculating PMS and PMDD incidence rates [Moreover, a PSS was filled out by the participants at baseline and by the end of the study. It is a self-reporting instrument that assesses the degree to which the individual perceives his/her situation as stressful [ | PMC10742710 |
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2.6. Statistical Analysis | SECONDARY | The trial was reported using the intention-to-treat analysis method. The difference in the DRSP scores (primary outcome) and PSS scores (secondary outcomes) from baseline to the end of the intervention was compared between the randomized groups using analysis of covariance (ANCOVA), and differences in scores reported as adjusted mean differences and 95% confidence intervals (i.e., adjusted for the baseline score as the covariate). Categorical outcomes were compared between groups using Chi-square tests. All tests were two-tailed and a | PMC10742710 |
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4. Discussion | premenstrual syndrome | PREMENSTRUAL SYNDROME, PATHOLOGY, PMS | Our study revealed no significant association between healthy and well-balanced dietary intake and symptoms of premenstrual syndrome based on the daily record of severity of problems questionnaire (DRSP). Additionally, no significant association was found between a healthy diet in adolescents with premenstrual syndrome, and quality of life as measured by the PSS.Our results support the outcomes of several studies that demonstrate an insignificant relationship between PMS symptoms and carbohydrate intake [Findings from a UAE-based study by Hashim et al. highlighted the detrimental effects of salt-based diets, high sugar intake, fat-based food intake, high-calorie diets, and smoking on physical symptoms of PMS [The pathology of PMS and the diversity of its symptoms appear to impact these results, which require further evaluation via prospective studies. To date, no clinical study can explain and elaborate on the multifactorial symptomatology of PMS [ | PMC10742710 |
4.1. Limitations | This study has some limitations. First, the small sample size impacts the generalizability of the findings. In addition, the lack of blinding, despite the study’s randomized controlled design, increased the risk of selection bias. Moreover, the use of self-reported questionnaires might have further impacted the reliability of results. Lastly, the lack of an objective scale with which to measure adherence to dietary advice might have had a negative impact on the final results. | PMC10742710 |
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4.2. Recommendations | PMS | In spite of a variety of cross-sectional studies evaluating the relationships between PMS and dietary patterns, the paucity of evidence to date has substantiated the need for further prospective randomized studies with larger sample sizes to understand the potential factors impacting the PMS manifestations. These randomized studies should also explore the possible role of geographical variations and culture-based diets on PMS progression and its clinical manifestations in adolescent and adult females. Clinical trials should further explore the interactions between diets and medications and their possible influence on PMS development in females of various age groups. | PMC10742710 |
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5. Conclusions | PMS | PMS | The overall findings from this study revealed a nonsignificant association between healthy balanced diet, motivational follow-ups, and PMS symptom improvements. Although our research did not find statistically significant results supporting the effectiveness of dietary modifications and motivational support as treatments for PMS, it is crucial to recognize the study’s limitations, including the small sample size. Future prospective studies with larger and more diverse sample sizes are needed to allow for a more robust analysis of the relationships between dietary habits, motivational interventions, and PMS symptomatology. | PMC10742710 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10742710 |
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Author Contributions | M.H.A.K. contributed to the conceptualization, methodology, investigation, resources, writing—original draft, project administration, funding acquisition, and supervision. Z.A.B. contributed to the conceptualization, methodology, investigation, resources, writing—original draft, project administration, funding acquisition. A.A.A., R.A.M., F.A.R., A.A.S. and A.A.M. contributed to the investigation and project administration. S.J. contributed to the methodology, formal analysis, and writing—original draft. All authors have read and agreed to the published version of the manuscript. | PMC10742710 |
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Institutional Review Board Statement | Ethical approval for this study was obtained from the Directorate General of Planning and Studies, Ministry of Health, Oman (MoH/CSR/20/23884). Additionally, the trial is registered with the WHO/Iranian Registry of Clinical Trials # IRCT20201129049526N1. | PMC10742710 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10742710 |
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Data Availability Statement | Data supporting the reported results can be provided by the corresponding authors upon request. | PMC10742710 |
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Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10742710 |
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References | Flow chart.Baseline characteristics.24 h recall analysis of participants in the intervention group at pre-intervention period, and at weeks 1, 4, and 8 at post-intervention period.Analysis of Covariance (ANCOVA) of subsections and total scores of the Daily Record of Severity of Problems questionnaire (DRSP).* Change from baseline to end of 1 month. ** Change from baseline to end of 2 months.Analysis of covariance (ANCOVA) of perceived stress scores (PSS).** Change from baseline to end of 2 months. | PMC10742710 |
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Background/Objectives | Trauma | PATHOLOGY | The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a unique pragmatic, multi-centre, patient and assessor masked, randomised controlled trial. We evaluate the clinical characteristics and pathology of this large trial cohort of patients with open globe injuries undergoing vitreoretinal surgery, including the associations between patient characteristics and their baseline vision. | PMC10220025 |
Subjects/Methods | Diabetic Retinopathy, trauma | REGRESSION, DIABETIC RETINOPATHY | We (i) summarise demographics, injury history and ocular history of the 280 participants recruited into the ASCOT trial using descriptive statistics; (ii) analyse the national and seasonal variation across England and Scotland in these participant characteristics; and (iii) explore the associations between participant demographic, trauma history, ocular history and presenting baseline visual acuity (measured using the Early Treatment Diabetic Retinopathy Study, ETDRS) using multivariable regression analyses. | PMC10220025 |
Results | hyphaemia, presenting vision, haemorrhaging | HYPHAEMIA, SCAR, LENS | The majority of participants with open globe penetrating injuries were of white ethnicity (233, 84%), male (246, 88%), with a median age of 43 years (IQR 30–55 years). There was considerable variability in presenting visual acuity with 75% unable to read any letters on the ETDRS chart, whilst the median ETDRS letter score was 58 (IQR 24–80) for those who could read ≥1 letter. The most common causes of injury were workplace related (31%) or interpersonal violence (24%). Previous eye surgery, visual axis corneal scar, lens status, hyphaemia and vitreous haemorrhaging were found to be associated with presenting vision as measured by the ETDRS chart. | PMC10220025 |
Conclusion | PATHOLOGY | The ASCOT trial provides valuable insights into the spectrum of pathology of patients with open globe eye injuries undergoing vitreoretinal surgery. The identified causes of injury and clinical presentation of the cases will help in training and resource planning to deal with these often challenging surgical cases. | PMC10220025 |
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Trial registration | EudraCT No. 014-002193-37. HTA Project 12/35/64. | PMC10220025 |
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Subject terms | PMC10220025 |
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Introduction | vitreous humour, visual loss, monocular blindness, traumatic, monocular visual impairment, ocular trauma, injuries, trauma | LOSS OF VISION, OPTIC NERVE, RETINA | Ocular trauma is a leading cause of monocular visual impairment and monocular blindness worldwide [Frequently the posterior segment of the eye, comprising the vitreous humour, retina, choroid, and optic nerve, is affected by injuries that result in visual loss and to prevent severe loss of vision, posterior segment (vitreoretinal) surgery is necessary. In a one-year population-based prospective study of ocular trauma in Scotland, among cases of serious eye injury blinding outcomes occurred in 26% [Experimental studies have suggested that steroid (triamcinolone acetonide, TA) treatment can reduce the severity of PVR [ASCOT is the only large scale prospective multi-centre national trial to have been undertaken on traumatic open globe injuries and therefore, for the first time, provides a unique opportunity to evaluate the detailed clinical characteristics of a large cohort of patients with open globe injuries. A previous national study of serious eye trauma in Scotland reported an incidence of 1.96/100,000 but did not report any detail on clinical presentations [ | PMC10220025 |
Subjects and methods | Full details of the ASCOT study design have been published [ | PMC10220025 |
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Data collection and outcomes | Diabetic Retinopathy, trauma | DIABETIC RETINOPATHY | In this report, we analyse participant baseline demographics, trauma history and ocular history including baseline biomicroscopic ocular exam results prior to surgery. The baseline eye exam included the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score measured using the standard validated ETDRS chart at a starting distance of 4 m in the eye operated on. If 20 or more letters were read at 4 m, 30 was added to the total letter score. If less than 20 letters were read correctly at 4 m then the distance was moved to 1 m and the number of letters read at 1 m formed the total score. If no letters were seen at 1 m then the score is 0 and test for Counting Fingers, Hand Movements and Light Perception. | PMC10220025 |
Statistical analysis | vision, lens, zero/very low vision, hyphaemia, trauma | ENDOPHTHALMITIS, RECRUITMENT, RETINAL DETACHMENT, LENS, MACULAR DISEASE, VITREOUS HAEMORRHAGE, REGRESSION, SCARRING, HYPHAEMIA | The target sample size for ASCOT was 300 patients (150 per arm) over a 3-and-a-half-year recruitment period. As actual recruitment rate was slower than projected, the recruitment period was extended to a total of 75 months; 280 eligible patients were recruited and all are included within this analysis.Baseline characteristics are summarised as mean (standard deviation—SD) for approximately normally distributed continuous variables or median (Interquartile range—IQR) where skewed. Categorical variables are summarised by frequencies and percentages. Descriptive data summaries are based on observations only and the number of missing observations are reported. The Pearson’s chi-squared test was used to assess seasonal variation in the injury numbers by month, and cause of injury.To explore the associations between baseline visual acuity (measured using an ETDRS chart at a starting distance of 4 m) and participant characteristics of interest, multivariable regression analyses were conducted. The clinically important characteristics of interest, informed by previous studies and study team clinical opinions were: previous primary repair, trauma classification, extent of trauma, previous eye surgery, macular disease, other historical ocular conditions, visual axial corneal scarring, hyphaemia, lens state, vitreous haemorrhage, endophthalmitis, retinal status and PVR. Given the high distribution of participants with an ETDRS score of 0 letters indicating very low/no vision, a zero-inflated Negative Binomial model was used to explore associations. This model incorporates two parts; (i) a logistic regression model that models the probability of zero/very low vision (ETDRS = 0) and (ii) a Negative Binomial model that models the amount of vision as measured by the ETDRS letter count score. The Negative Binomial model (part ii) included all the clinically important variables of interest. The logistic regression model (part i) used a subset of the clinically important variables that were first identified to be associated with zero vision (see Supplementary file Retinal detachment at baseline and associations between the clinically important characteristics of interest were explored in an additional analysis using a logistic regression model. Estimates from the logistic regression models are summarised as Odds Ratios (OR). Estimates from the zero-inflated Negative binomial model are presented as Incidence Rate Ratios (IRR) which represent the relative risk of a higher ETDRS score for the associated variable. Estimates are accompanied with 95% confidence intervals. A | PMC10220025 |
Results | PMC10220025 |
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Regional variability | rupture, ocular co-morbidities, injuries, corneal injury | LOW VISION | The majority (148, 53%) of ASCOT participants were recruited from hospitals in London, a quarter came from the Midlands & Northern England (70, 25%), 55 (20%) were recruited in Southern England and 7 from Scotland (3%). London had a higher proportion of Black, Asian and Minority Ethnic (BAME) participants (24%) than any other region (Southern England: 4%, Midlands and North England: 11% and Scotland: 0%). This variation reflects the regional ethnic diversity in the wider population, at the most recent 2011 census 40% of London residents identified as BAME versus 8% in Southern England, 11% in the Midlands and North England and 4% in Scotland [There was little difference between the causes of injury across the regions. In London, nearly half (70, 47%) of all injuries were categorised as penetrating, with 46 (31%) as rupture. However, all other regions had substantially higher amounts of ruptures than penetrations. Similarly, injuries in London were more frequently to zone 1 of the eye (corneal injury) than to zone 2 (scleral anterior) (39% vs 35% [58 vs 52]), whereas the reverse was true in other regions. There was a higher history of ocular co-morbidities for patients in London (21, 14%) and Midlands & North England (7, 10%).More than 25% of patients in London and Scotland had an ETDRS score above zero (zero indicating very low vision of counting fingers or worse). | PMC10220025 |
Seasonal variation | ocular injuries, injuries | RECRUITMENT | The dates of ocular injuries were investigated for seasonal trends. Only injuries from 2014 were included as the date of injury was not collected accurately prior to this time, resulting in 255 participants included within this analysis. The most common month for injury was April and injuries in April were consistently high across each year of recruitment. January, February, June and November had slightly fewer injuries occurring than in other months (see Fig. | PMC10220025 |
Seasonal variation in the number of ocular injuries. | ocular injuries, injuries | Number of injuries shown by year (represented by different colours) and month.Workplace incidents and interpersonal violence accounted for the majority of ocular injuries and there were fluctuations in the months these injuries occurred (see Fig. | PMC10220025 |
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Causes of ocular injuries. | injuries | Proportion of injuries (as a percentage) by cause of injury (workplace, road traffic accident, interpersonal violence, sports injury and other) and month of injury. | PMC10220025 |
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Discussion | detachments, iris abnormalities, cataract, Vitreous haemorrhage, ocular trauma, vitreous haemorrhage, retinal detachment, glaucoma, hyphaema, ocular co-morbidities, injuries, trauma | SCAR, POOR VISION, CATARACT, VITREOUS HAEMORRHAGE, ENDOPHTHALMITIS, MACULAR DISEASE, PATHOLOGY, DETACHMENTS, EYE DISEASE, RECRUITMENT, CORNEA, VITREOUS HAEMORRHAGE, RETINAL DETACHMENT, SCARRING, EYE, RECRUITMENT, LENS, HYPHAEMA, OPACITIES, GLAUCOMA, ANTERIOR | The ASCOT study was a prospective randomised controlled trial designed to test the efficacy of intraocular and periocular triamcinolone given at the time of vitrectomy surgery in cases of open globe injury. It recruited nationally in the UK from 27 sites. The baseline data therefore represents the cases considered suitable for inclusion by the principal investigators at the individual sites and is not a comprehensive epidemiological study on open globe injuries. Nevertheless, it provides detailed data on a large cohort of patients undergoing vitrectomy surgery.The study population were overwhelmingly (88%) male, consistent with other analyses of eye trauma epidemiology [There was a broad range of causal mechanisms of the injury in the study cases. The most common setting was the workplace (31%)followed by a significant number of the injuries (24%) due to interpersonal violence. In the UK, regulations relating to eye protection in the workplace are included in 1992 legislation on personal protective equipment at work, which came into effect in 1993 (recently updated in 2022 to also cover more causal employment relationships in addition to contracted employees) [The baseline clinical characteristics provide a useful insight into the range of pathology likely to be encountered by vitreoretinal surgeons. The initial view of the posterior segment is often compromised with 26% presenting with a visual axis corneal scar and 34% a hyphaema. Anterior segment pathology is likely with only 25% having a clear lens (35% had a cataract which may require combined surgery) and 60% having iris abnormalities. Vitreous haemorrhage was present in 66% with three-quarters of these being fundus obscuring. Approximately half of all patients had retinal detachment at the time of vitrectomy surgery with PVR already present in half of these. However, all patients in ASCOT were listed for vitrectomy, rather than being observed. The rapid development of PVR is notable, as the mean interval between injury and surgery was 20 days. The fovea was detached in over half (60%) of detachments.In the largest retrospective review to date of open globe injuries (848 patients), Andreoli et al. report that approximately 1/3 of patients (29%) proceed to vitrectomy surgery [Endophthalmitis was rare (2%) on presentation. Pre-existing eye disease was uncommon: four of the 280 patients had glaucoma and one had had previous macular disease recorded—this may reflect the younger age range of patients sustaining open globe eye trauma.The presenting clinical characteristics which were associated with better presenting vision were often related to ocular media opacities. The presence of corneal scarring, cataract, hyphaema and vitreous haemorrhage conferred less good presenting vision. Eyes which had previously undergone surgery also had less good vision possibly relating to more complex pre-existing intraocular pathology. Eyes with ACIOLs had better visual acuity – this may reflect a more longstanding and stable situation prior to the need for vitreoretinal intervention, however, this should be interpreted with caution as there were only two patients with ACIOLs. The presence of PVR (and by implication retinal detachment) on presentation was also associated with less good presenting vision. PVR is associated with poor vision and poor outcomes from surgery both with and without previous ocular trauma [The associations with retinal detachment at presentation are also notable. The zone of injury clearly influences the likelihood of retinal and vitreous involvement in the injury and as expected more posterior injuries were more likely to have retinal detachment on presentation. The association with hyphaema could potentially reflect the potential of intraocular blood to promote PVR through fibrogenic growth factors.Recruitment for the study was centred in London, particularly Moorfields Eye Hospital which was the lead site. The patient cohort is therefore not a comprehensive study of open globe injury in the UK. To compare regions, cases were grouped together to provide cohorts of a meaningful size for analysis. The cases recruited in London were generally less severe (a greater proportion of corneal, zone 1 (cornea), injuries) than elsewhere with more ocular co-morbidities. These observations must, however, be treated with caution as they may be influenced by recruitment bias in the trial centres.There was a trend for recruitment to be higher in spring (March and April) and October although this was not statistically significant with the patient numbers in the study. Notably workplace injuries had a trend to more common in spring and summer with interpersonal violence being more common in January and December. It is possible that a reduction in work and an increase in in social interaction results in the reversal of causation seen in December and January. Although a bias in case recruitment may influence the monthly cases numbers overall, it is unlikely to have affected the variation in injury causation seen. | PMC10220025 |
Conclusion | rupture, injuries | OPACITIES, PATHOLOGY | The ASCOT study provides detailed clinical data on an extensive cohort of patients with open globe penetrating injuries undergoing vitreoretinal surgery. Although not a comprehensive epidemiological study, this study provides valuable insights into the spectrum of pathology encountered by vitreoretinal surgeons. We have documented the common settings for injury—in the workplace and through interpersonal violence, highlighted a trend in seasonal variation and reported the clinical presentations of the cases—predominantly penetrating or globe rupture and often with media opacities limiting the fundal view. These observations can help training and in planning the resources needed to deal with often challenging surgical cases. | PMC10220025 |
Summary | PMC10220025 |
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What was known before | monocular visual impairment, Trauma, blindness, trauma | BLINDNESS |
Ocular trauma is a leading cause of monocular visual impairment and blindness worldwide, affecting 55 million people every year.Ocular trauma is a serious health problem that has extensive, variable, physical and psychological impacts on patients and their relatives.The primary aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is to assess whether, adjunctive intravitreal and sub-Tenon’s triamcinolone acetonide given at the time of surgery improves visual acuity at 6 months compared with standard surgery. | PMC10220025 |
What this study adds | rupture | OPACITIES |
Common settings for open globe injury for the ASCOT cohort include the workplace and through interpersonal violence, with a trend in seasonal variation.There is considerable variability in presenting visual acuity for patients with open globe eye injuries undergoing vitreoretinal surgery.Clinical presentations of cases are predominantly penetrating or globe rupture and often with media opacities limiting the fundal view. | PMC10220025 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41433-022-02206-z. | PMC10220025 |
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Acknowledgements | Authors contributing to this paper are supported by the United Kingdom Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners. We thank Beverley White-Alao and staff in the wider KCTU who supported the electronic data capture and randomisation systems and data management for the ASCOT study. | PMC10220025 |
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Author contributions | CM | DC is the chief investigator for ASCOT. SC, GP, VC, CB and DC wrote the statistical analysis plan for this manuscript. SC, GP and VC conducted the statistical analysis for this manuscript. SC, GP and DC wrote the first draft of the manuscript. SC, GP, VC, PB, MZ, EC, SS, CB and DC interpreted the data and critically reviewed the manuscript. PB, VC, and CB are co-investigators for ASCOT. DC, VC, PB and CB designed the ASCOT study. ER was the ASCOT trial manager. CM and JK were involved in the trial design, trial and data management. All authors read and approved the final manuscript. | PMC10220025 |
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Funding | NIHR300593, Cancer | CANCER | The ASCOT trial is funded by a project grant from the National Institute for Health Research Health Technology Assessment (HTA) programme (HTA 12/35/64). CB’s post is part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. SC is funded by an NIHR advanced research fellowship (NIHR300593). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. | PMC10220025 |
Data availability | The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. | PMC10220025 |
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Competing interests | The authors declare no competing interests. | PMC10220025 |
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References | PMC10220025 |
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Background | There is some initial evidence suggesting that mindsets about the adequacy and health consequences of one’s physical activity ( | PMC9909519 |
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Objective | This research examined how wearable fitness trackers and meta-mindset interventions influence AAMs, affect, behavior, and health. | PMC9909519 |
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Methods | A total of 162 community-dwelling adults were recruited via flyers and web-based platforms (ie, Craigslist and Nextdoor; final sample size after attrition or exclusion of 45 participants). Participants received an Apple Watch (Apple Inc) to wear for 5 weeks, which was equipped with an app that recorded step count and could display a (potentially manipulated) step count on the watch face. After a baseline week of receiving no feedback about step count, participants were randomly assigned to 1 of 4 experimental groups: they received either accurate step count (reference group; 41/162, 25.3%), 40% deflated step count (40/162, 24.7%), 40% inflated step count (40/162, 24.7%), or accurate step count+a web-based meta-mindset intervention teaching participants the value of adopting more positive AAMs (41/162, 25.3%). Participants were blinded to the condition. Outcome measures were taken in the laboratory by an experimenter at the beginning and end of participation and via web-based surveys in between. Longitudinal analysis examined changes within the accurate step count condition from baseline to treatment and compared them with changes in the deflated step count, inflated step count, and meta-mindset conditions. | PMC9909519 |
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Results | Participants receiving accurate step counts perceived their activity as more adequate and healthier, adopted a healthier diet, and experienced improved mental health (Patient-Reported Outcomes Measurement Information System [PROMIS]-29) and aerobic capacity but also reduced functional health (PROMIS-29; compared with their no-step-count baseline). Participants exposed to deflated step counts perceived their activity as more inadequate; ate more unhealthily; and experienced more negative affect, reduced self-esteem and mental health, and increased blood pressure and heart rate (compared with participants receiving accurate step counts). Inflated step counts did not change AAM or most other outcomes (compared with accurate step counts). Participants receiving the meta-mindset intervention experienced improved AAM, affect, functional health, and self-reported physical activity (compared with participants receiving accurate step counts only). Actual step count did not change in either condition. | PMC9909519 |
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Conclusions | AAMs––induced by trackers or adopted deliberately––can influence affect, behavior, and health independently of actual physical activity. | PMC9909519 |
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Trial Registration | ClinicalTrials.gov NCT03939572; https://www.clinicaltrials.gov/ct2/show/NCT03939572 | PMC9909519 |
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Introduction | PMC9909519 |
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