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Competing interests
{28} | The authors declare that they have no competing interests. | PMC10566182 |
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References | PMC10566182 |
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Background | neck pain, pain | Action observation (AO) has emerged as a potential neurorehabilitation therapy for patients with neck pain (NP), but evidence of its effectiveness is scarce. This study aims to assess the effect of a single session of AO when compared to observing a natural landscape on NP intensity, fear of movement, fear-avoidance beliefs, neck muscles’ strength, pressure pain threshold, and tactile acuity. | PMC10729350 |
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Methods | pain | Sixty participants with NP were randomly allocated to the AO group (n = 30) or control group (n = 30). Both groups watched an 11-minute video: the AO group watched a video of a person matched for age and sex performing neck exercises, while the control group watched a video of natural landscapes. Neck pain intensity, fear of movement, fear-avoidance beliefs, tactile acuity, pressure pain thresholds, and neck muscle strength were assessed both at baseline and post-intervention. General linear models of repeated measures (ANCOVA of two factors) were used to explore between-group differences at post-intervention. | PMC10729350 |
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Results | pain | There was a significant main effect of time for pain intensity (p = 0.02; η2p = 0.09; within-group mean change and 95% CI: AO=-1.44 (-2.28, -0.59); control=-1.90 (-2.74, -1.06), but no time versus group interaction (p = 0.46). A time versus group significant interaction was found for one out of the six measurement sites of two-point discrimination and the neck flexors strength (p < 0.05) favoring the control group. No other statistically significant differences were found for the remaining variables). | PMC10729350 |
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Conclusions | hypoalgesia, pain | Results suggest a similar acute benefit for both a single session of AO and observing natural landscapes for promoting hypoalgesia, but no impact on kinesiophobia, fear-avoidance beliefs, or pressure pain thresholds. Also, AO had no positive effect on two-point discrimination and muscle strength. Further research is needed, with longer interventions. | PMC10729350 |
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Trial registration | Clinialtrials.gov (NCT05078489). | PMC10729350 |
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Keywords | PMC10729350 |
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Background | chronic idiopathic NP (secondary aim)., AO, disability, pain | Neck pain (NP) was documented among the worldwide leading causes of years lived with disability as the fourth leading cause of disability-adjusted life years [More recently, interventions targeting the central nervous system instead of the peripheral tissues, such as those requiring mental practice or observation of movements without the actual movement execution have shown promising results across different clinical conditions, including NP. Mental practice interventions include motor imagery, action observation (AO) training, and mirror therapy [AO involves the observation and perception of human movement based on the mirror neuron system [This study aims to assess the immediate effect of a single session of observing neck movements (AO) on NP intensity (primary aim), fear of movement, fear-avoidance beliefs, neck muscles’ strength, pressure pain threshold, and tactile acuity when compared to observing a natural landscape in individuals with chronic idiopathic NP (secondary aim). We hypothesized that AO would have a larger effect on decreasing pain intensity than observing a natural landscape. | PMC10729350 |
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Methods | PMC10729350 |
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Study design, ethics approval, and registration | This study was a randomized controlled trial with two groups (the AO group and the control group). It was approved by the Ethics Committee of the University of Aveiro (21-CED/2020). All participants signed an informed consent before entering the study. Before the enrollment of the first participant, the study was registered at clinialtrials.gov (NCT05078489) on 14/10/2021. | PMC10729350 |
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Procedures | PMC10729350 |
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Randomization and allocation concealment | The participants were randomly assigned to the AO group and the control group through a computerized random list generator ( | PMC10729350 |
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Instruments and procedures | pain | BLIND | Participants were assessed for age, gender, number of years of formal education, weight, height, and pain duration at baseline. In addition, participants were assessed for pain intensity and frequency, disability, catastrophizing, fear of movement, fear-avoidance beliefs, tactile acuity, and pressure pain threshold, both at baseline and post-intervention as detailed below. The person who assessed participants also administered the intervention and, therefore, was not blind to the participant’s group allocation. | PMC10729350 |
Pain intensity, duration, and frequency | neck pain, Pain, pain | Pain intensity at the moment was assessed using a 10-cm Visual Analogue Scale (VAS), anchored “no pain at all” and “worst pain imaginable” [NP duration and frequency were determined with closed questions (pain duration: “For how long have you had pain in the neck region?”; response options: i) between 3 and 6 months; ii) between 6 months to 1 year; iii) between 1 and 2 years; iv) between 2 and 4 years; and v) more than five years; Pain frequency: “How many times, in the past week, did you feel neck pain?”; response options: (i) never; (ii) rarely (once per week); (iii) occasionally (2 to 3 times per week); (iv) many times (more than 3 times per week); (v) always). | PMC10729350 |
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Neck disability index | Disability | Disability was assessed using the Neck Disability Index (NDI). This instrument was originally developed by Vernon and Mior [ | PMC10729350 |
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Pain catastrophizing scale | Pain | Pain catastrophizing was assessed using the Portuguese version of the Pain Catastrophizing Scale (PCS). The PCS is a 13-item scale with three subscales and participants are instructed to recall past painful experiences and to indicate to what level they have experienced each on a 5-point Likert scale: 0 (not at all) to 4 (all the time) [ | PMC10729350 |
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Tampa scale of kinesiophobia | Fear of movement was assessed with the 13-item Portuguese version of the Tampa Scale for Kinesiophobia (TSK) [ | PMC10729350 |
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Fear-avoidance beliefs questionnaire | Fear-avoidance beliefs were assessed with the Portuguese version of the 16 items Fear-Avoidance Beliefs Questionnaire (FABQ), originally developed by Waddell et al. [ | PMC10729350 |
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Tactile acuity | Tactile acuity was assessed with the two-point discrimination (TPD) test using an aesthesiometer (Baseline Two-Point Aesthesiometer). This test assesses the ability of the individual to precisely perceive the location and quality of touch, which is assumed as an indirect measure of cortical reorganization [ | PMC10729350 |
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Neck muscle strength | craniocervical flexion | WEST, CONTRACTION, CONTRACTIONS | Neck muscle strength was assessed with a hand-held dynamometer (Advanced Force Gauge, 2500 N; Mecmesin, West Sussex, UK). Participants were briefed about the procedure and went through a trial in the limbs for familiarization. Before the neck muscles assessment, participants performed warm-up exercises by doing 10 active repetitions of neck flexion, extension, and right and left side flexion. The testing procedure consisted of three consecutive isometric contractions held for three seconds for each of the four neck movements (extension, flexion, right and left side flexion), with 30 s of rest between repetitions. For neck flexors, the head was held slightly above the plinth and with craniocervical flexion and participants were instructed to push against the dynamometer placed on the center of the forehead above the eyebrows [Resistance was set at a rate of about 3 kg/s and the maximum isometric strength value was recorded at the peak of the participant’s ability to maintain contraction [ | PMC10729350 |
Pressure pain threshold | pain | Pressure pain threshold (PPT) was measured with an electronic pressure algometer (JTECH Medical Industries, Salt Lake City, US) at the right and left upper trapezius muscles (at the middle distance between the posterior angle of the acromion and C7), at the right and left articular pillar between C1 and C2 (1 cm laterally) and C5/C6 using previously published procedures [ | PMC10729350 |
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Training of the assessors | Prior to the study, the assessors underwent a three-stage training procedure: (i) a three-hour session of training with a senior researcher, (ii) data collection in at least three participants who did not enter the final sample size, and (iii) a final session to clarify any doubts and difficulties from implementing the study protocol. | PMC10729350 |
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Intervention and control | Participants in both groups were instructed to sit on a comfortable chair in a quiet, empty room with white walls in front of a laptop (Fig.
Setting of the intervention | PMC10729350 |
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Action observation | craniocervical flexion | Participants were asked to observe video clips of a person performing two different exercises of craniocervical flexion (Fig.
Neck exercises. | PMC10729350 |
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Control | Participants in this group observed a video that displayed natural scenes with no human movement stimuli, similar to other previous studies [
Natural landscapes | PMC10729350 |
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Statistical analysis | All data analyses were performed using Statistical Package for Social Science (SPSS) 25.0 for Windows (SPSS Inc, Chicago, IL). Mean and standard deviation (SD) and count and proportion were used to describe continuous and categorical variables, respectively. Data were assessed for outliers, normality using Kolmogorov-Smirnov test and homogeneity of variance. Between-group differences for baseline characteristics were explored using a Student t-test (continuous variables) or a non-parametric equivalent (e.g.Mann-Whitney test), and using a Chi-square for nominal variables. A general linear model of repeated measures (ANCOVA of two factors) was used to assess the impact of the intervention on the outcome measures (i.e. VAS, TSK, FABQ-PA, FABQ-W, tactile acuity, and muscle strength). The within-subject factor was time (baseline vs. post-intervention), the between-subject factor was the intervention (AO vs. control), and covariates were sex, age, and baseline values of FABQ-PA. Partial eta squared was used as an indicator of effect size and interpreted as small (0.01), medium (0.0.06), and large (0.14) effect size [ | PMC10729350 |
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Results | Of 107 individuals screened for eligibility, 24 were excluded because they did not meet the inclusion criteria, one was unable to assume the testing positions, 22 declined to participate and 60 entered the study (30 individuals in each group). The flow of participants is represented in Fig.
Flowchart of study participants | PMC10729350 |
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Sample characteristics | Pain | The AO group consisted of 24 females (80%) and 6 (20%) males, and the control group had 22 (73.3%) females and 8 (26.7%) males. The mean age (± SD) in the AO group was 37.4 (± 9.9) years old, and in the control group was 42.3 (± 10.2) years old (see Table
Sociodemographic characteristicsUndergraduate EducationMaster’s degreeDoctor Degree11 (36.7%)3 (10.0%)3 (10.0%)10 (33.3%)4 (13.3%)1 (3.3%)† Without normal distribution (non-parametric test corroborated the parametric test)Abbreviations: AO- Action Observation; Kg- Kilograms; cm-centimeters; SD- Standard DeviationA detailed characterization of the baseline clinical data of the sample is presented in Table
Participants’ characteristics at baselinePain Frequency(n, %)Pain Duration(n, %)† Without normal distribution (non-parametric test corroborated the parametric test)Abbreviations: AO- Action Observation; FABQ-PA – Fear Avoidance Belief Questionnaire – Physical Activity Subscale; FABQ-W – Fear Avoidance Belief Questionnaire – Work Subscale; L- Left; NDI – Neck Disability Index; N – Newtons; PCS – Pain Catastrophizing Scale; PPT- Pressure Pain Thresholds; R- Right; SD- Standard Deviation; TPD - Two-point discrimination; TSK - Tampa Scale of Kinesiophobia; VAS- Visual Analogue Scale | PMC10729350 |
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Post-intervention assessment | PMC10729350 |
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Neck pain intensity | Pain, pain | There was a significant decrease in pain intensity from baseline to post-intervention (F [1, 53] = 5.51; p = 0.02; η2p = 0.09), but no interaction between time and group (F [1, 53] = 0.57; p = 0.46; η2p = 0.01). Table
Adjusted within-group differences for pain intensity, fear of movement, fear-avoidance beliefs, tactile acuity, pressure pain thresholds, and muscle strength at baseline and post-intervention4.96[4.26, 5.65]3.06[2.10,4.02]-1.90[-2.74, -1.06]5.01[4.31, 5.70]3.57[2.61, 4.53]-1.44[-2.28, -0.59]27.27[25.15, 29.39]24.73[22.28, 27.19]− 2.54[-3.91, -1.17]27.73[25.61, 29.85]27.24[24.78, 29.69]-0.49[-1.86, 0.87]9.42[7.33, 11.52]9.33[7.11, 11.52]0.09[-1.66, 1.48]6.24[4.15, 8.33]7.09[4.88, 9.29]+ 0.85[-0.72,2.37]14.75[12.13, 17.38]12.64[9.89, 15.39]− 2.11[-3.43, -0.80]16.95[14.32, 19.57]15.13[12.38, 17.88]− 1.82[-3.13, -0.50]1.77[1.29, 2.25]1.31[0.84, 1.79]-0.46[-0.74, -0.17]1.77[1.29, 2.24]1.83[1.36, 2.30]+ 0.06[-0.22,0.34]1.59[1.14, 2.04]1.40[0.93, 1.87]-0.19[-0.49, 0.12]1.97[1.52, 2.42]1.70[1.23, 2.18]-0.27[-0.58, 0.04]1.80[1.29, 2.32]1.45[0.94, 1.96]-0.35[-0.59, -0.12]2.07[1.56, 2.59]1.93[1.41, 2.44]-0.14[-0.38,0.09]2.00[1.46, 2.54]1.62[1.06, 2.18]-0.38[-0.74, -0.02]2.12[1.58, 2.66]2.02[1.46, 2.58]− 0.10[-0.46,0.26]2.54[1.91, 3.18]2.13[1.46, 2.80]-0.41[-0.82, -0.01]2.47[1.84, 3.11]2.38[1.71, 3.04]-0.09[-0.50,0.31]2.58[1.91, 3.26]2.36[1.67, 3.05]-0.22[-0.63, 0.18]2.64[1.97, 3.31]2.63[1.94, 3.32]-0.01[-0.42,0.39]11.00[8.64, 13.36]11.16[8.64, 13.68]+ 0.16[-0.94, 1.26]10.85[8.49, 13.21]10.00[7.48, 12.52]-0.85[-1.95, 0.25]10.79[8.81, 12.77]10.64[8.39, 12.89]-0.15[-1.16, 0.84]10.36[8.38, 12.34]10.03[7.78, 12.28]-0.33[-1.33, 0.67]11.24[8.89, 13.59]11.04[8.71, 13.37]-0.20[-1.18,0.78]11.46[9.11, 13.81]11.32[8.98, 13.65]-0.14[-1.13,0.83]10.47[8.19, 12.75]10.57[8.38, 12.76]+ 0.10[-0.87,1.08]11.04[8.77, 13.32]11.13[8.94, 13.32]+ 0.09[-0.89,1.06]11.53[9.45, 13.61]11.14[9.03, 13.26]-0.39[-1.59,0.82]11.78[9.70, 13.86]11.34[9.23, 13.46]-0.44[-1.64,0.77]11.22[9.46, 12.98]11.73[9.74, 13.72]+ 0.51[-0.44, 1.46]10.68[8.91, 12.44]10.75[8.76, 12.74]-0.07[-0.88,1.02]62.12[55.31, 68.93]64.71[57.51, 71.91]+ 2.59[-0.28,5.45]57.59[50.78, 64.40]55.57[48.37, 62.77]-2.02[-4.89,0.84]60.38[53.64, 67.12]62.71[55.88, 69.54]+ 2.33[-0.79,5.45]57.93[51.19, 64.67]55.83[49.00, 62.66]-2.10[-5.22,1.02]59.72[52.86, 66.57]61.39[53.99, 68.79]+ 1.67[-1.36,4.71]55.08[48.23, 61.94]54.57[47.17, 61.98]-0.51[-3.55,2.52]100.33[89.52,111.14]100.25[88.69,111.82]-0.08[-4.11,3.96]93.30[82.49, 104.11]88.88[77.31,100.44]-4.42[-8.46,-0.40]Abbreviations: AO- Action Observation; CI -Confidence Interval; FABQ-PA – Fear Avoidance Belief Questionnaire – Physical Activity Subscale; FABQ-W – Fear Avoidance Belief Questionnaire – Work Subscale; L- Left; N – Newtons; PPT- Pressure Pain Thresholds; R- Right; TPD - Two-point discrimination; TSK - Tampa Scale of Kinesiophobia; VAS- Visual Analogue Scale | PMC10729350 |
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Fear of movement and fear-avoidance beliefs, tactile acuity, muscle strength, and pressure pain thresholds | For fear of movement, FABQ-PA, FABQ-W, and PPT (p > 0.05) there was no significant main effect for time nor a significant interaction between time and group (p > 0.05; Table For tactile acuity, there were no statistically significant main effects for time or interactions (p > 0.05, Table For muscle strength, there was a significant interaction for the flexors muscle strength (F [1, 53] = 4.83; p = 0.03; η2p = 0.08), but not for extensors or right and left side flexors (p > 0.05; Table | PMC10729350 |
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Discussion | AO, chronic idiopathic NP, pain | This study assessed the immediate effects of observing neck movements (AO) on NP intensity, fear of movement, fear-avoidance beliefs, neck muscles’ strength, and tactile acuity in individuals with chronic idiopathic NP when compared to the effects of observing a natural environment.Contrary to our hypothesis that AO would have a larger impact on pain intensity, a similar decrease in pain was found for both groups suggesting that both AO and observing a natural landscape have hypoalgesic effects. The control group reported a mean decrease in pain intensity of 37% and the AO group of 30%, from baseline to post-intervention, suggesting that these changes are clinically relevant [Previous studies using a single session of AO in patients with NP have reported increased PPT in one body site out of three measured in the neck [We were unable to find any study on individuals with NP that investigated the impact of AO on psychological variables, two-point discrimination, or strength. Our finding of a significant interaction between time and group favoring the control group for two-point discrimination at C3-C4 was not expected. A study demonstrated through magnetic resonance imaging that observing video clips of a touched hand activates the somatosensory cortices due to the mirror neuron system [We found no changes in kinesiophobia or fear-avoidance beliefs both in the AO group and in the control group, despite the decrease in pain intensity. It has been suggested that observing movements perceived as potentially harmful or dangerous activates the sympathetic nervous system, due to fear [ | PMC10729350 |
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Clinical implications and future research | pain | The results of this study suggest that both observing neck exercises and natural landscapes may be used in clinical practice to reduce pain, potentially facilitating the administration of exercise and complementing pain education. Participants’ perceptions of the intervention were not assessed, but a few participants reported feeling relaxed after watching the natural landscape video and a decrease in the muscle tension in the neck region after the AO. These variables can be assessed in future studies. Future studies should investigate the effects of administering AO for longer periods and different dosages. | PMC10729350 |
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Limitations of the study | chronic pain | CHRONIC PAIN, BLIND | The present study results need to be interpreted considering its limitations. Assessors were not blind to the intervention received by each participant, which could have increased type I errors. Only immediate effects were assessed. The lack of a previously established and validated protocol of AO therapy in the treatment of chronic pain places a critical question as to whether the protocol followed in this study had the appropriate duration. The participants’ attention or the ability to imagine the movement being observed were not assessed and these might be critical for the success of AO. Nevertheless, an effort was made to minimize distraction when participants were receiving the intervention by administering it in a quiet room with white walls and nothing more than the table where the computer was placed and the chair where the participant sat. | PMC10729350 |
Acknowledgements | This work was supported by the national funds through FCT - Fundação para a Ciência e a Tecnologia, I.P., within CINTESIS R&D Unit (UIDB/4255/2020 and UIDP/4255/2020) and within the scope of the project RISE (LA/P/0053/2020). | PMC10729350 |
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Author contributions | T.A.S. - acquisition, analysis, and interpretation of data; and drafted the manuscript. M.B.A. - acquisition, analysis, and interpretation of data. R.A. - design of the work, analysis and interpretation of data. A.G.S. - conception and design of the work; interpretation of data; and revised the drafted version. All authors: approved the submitted version and agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. | PMC10729350 |
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Funding | Not applicable. | PMC10729350 |
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Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request. | PMC10729350 |
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Declarations | PMC10729350 |
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Ethics approval and consent to participate | This study received ethical approval from the Ethics Committee of the University of Aveiro (21-CED/2020). All participants signed informed consent before entering the study.All methods were performed with the relevant guidelines and regulations (Declaration of Helsinki). | PMC10729350 |
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Consent for publication | Not applicable. | PMC10729350 |
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Competing interests | The authors declare no competing interests. | PMC10729350 |
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Abbreviations | ScalePressure Pain | Action ObservationCentimetersFear Avoidance Belief Questionnaire – Physical Activity SubscaleFear Avoidance Belief Questionnaire – Work SubscaleKilogramsLeftNeck Disability IndexNeck PainNewtonsPain Catastrophizing ScalePressure Pain ThresholdsRightStandard DeviationTwo-point discriminationTampa Scale of KinesiophobiaVisual Analogue Scale | PMC10729350 |
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References | PMC10729350 |
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Abstract | PMC10476909 |
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Background | ANL, HCC | HEPATOCELLULAR CARCINOMA | The aim of the study was to observe the safety and efficacy of anlotinib (ANL) alone or combined with S-1 in the first-line treatment of advanced hepatocellular carcinoma (HCC). | PMC10476909 |
Patients and methods | toxicity, ANL, HCC | ADVERSE REACTIONS, DISEASE | Fifty-four patients with untreated advanced HCC who could not be resected were randomly divided into the ANL group (n = 27) and ANL+S-1 group (n = 27). The ANL group was given 10 mg ANL orally once a day for 14 consecutive days, stopped for 1 week, and repeated every 21 days. The ANL+S-1 group was given 10 mg ANL once a day orally and 40 mg S-1 twice a day orally for 14 consecutive days, stopped for 1 week, repeated every 21 days. All patients were treated until the disease progressed or toxicity became unacceptable. For patients who could not tolerate adverse reactions, the ANL dose should be reduced to 8 mg per day. CT or MRI was reviewed every 6 weeks to evaluate the efficacy. | PMC10476909 |
Results | ANL | DISEASE | A total of 44 patients were included in the results analysis, including 22 patients in the ANL group and 22 patients in the ANL+S-1 group. In the ANL group, the objective response rate (ORR) was 4.5% (1/22), the disease control rate (DCR) was 77.3% (17/22), the median progression-free survival (PFS) was 4.2 months (95% CI: 3.6–6.0) and the median overall survival (mOS) was 7.0 months (95% CI: 6.3–9.0). In the ANL+S-1 group, the ORR was 18.2% (4/22), the DCR was 59.1% (13/22), the median PFS was 4.0 months (95% CI: 3.6–5.4) and the mOS was 6.0 months (95% CI: 5.5–7.4). There was no significant difference in ORR ( | PMC10476909 |
Conclusions | ANL, HCC | ADVERSE REACTIONS | ANL monotherapy was effective in the treatment of advanced HCC, and adverse reactions have been able to tolerated. | PMC10476909 |
Keywords | PMC10476909 |
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Introduction | tumor, ANL, tumor-related deaths, lung cancer, HCC | HEPATOCELLULAR CARCINOMA, TUMOR, OF PRIMARY LIVER CANCER, LUNG CANCER | Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, accounting for 90% of primary liver cancers. China has a high incidence of HCC, accounting for more than half of the new cases in the world each year, and ranks second only to lung cancer in tumor-related deaths.Common treatments for HCC include tumor resection, liver transplantation, transarterial chemoembolization, radiotherapy and molecular targeted drug therapy.Sorafenib is the first drug approved for the treatment of HCC, and both the SHARP study and Oriental study have confirmed that sorafenib can significantly prolong the survival of patients with advanced HCC. In the SHARP study of Westerners, the median overall survival (mOS) of sorafenib alone was 10.7 monthsStudies have shown that anlotinib (ANL) is effective and well tolerated as a treatment for patients with advanced HCC.The purpose of this study was to explore the safety and efficacy of ANL alone or in combination with Tigio (S-1) in the treatment of advanced HCC. | PMC10476909 |
Patients and methods | PMC10476909 |
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Study design and participants | Tumors, HCC, BCLC | ONCOLOGY, TUMORS | This is a prospective, single-center, real-world study to evaluate the efficacy and safety of ANL with or without S-1 in the first-line treatment of patients with advanced HCC. From February 2019 to August 2021, 54 HCC patients with Barcelona Clinic Liver Cancer (BCLC) stage C (stage I–II, Child‒Pugh A–B, and at least one criteria: PS1-2 or vascular invasion/extrahepatic spread)The main inclusion criteria were as follows: (1) Age ≥ 18 years old, BCLC stage C. (2) Eastern Cooperative Oncology Group (ECOG) physical status score: 0–2, and the estimated survival time was at least 3 months. (3) At least one measurable lesion evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1·1). (4) Hemoglobin ≥ 95 g/L, leukocytes ≥ 4.0 × 10 | PMC10476909 |
Procedures | ANL | ADVERSE REACTIONS, DISEASE | The patients were randomly divided into the ANL group (n = 27) and the ANL+S-1 group (n = 27). Patients in the ANL group were treated with 10 mg of ANL once a day for 14 days. The ANL+S-1 group was treated with 10 mg of ANL once a day and 40 mg of S-1 twice a day. Both drugs were taken continuously for 14 days, discontinued for one week and repeated every 21 days. The two groups were treated with drugs until the disease progressed or could not tolerate adverse reactions. For patients who could not tolerate adverse reactions, the dose of ANL was reduced to 8 mg daily. The curative effect was evaluated by magnetic resonance imaging (MRI) or computed tomography (CT) every 6 weeks. | PMC10476909 |
Statistical analysis | The chi-square test was used to compare the counting data of the two groups, the Kaplan‒Meier method was used to generate a survival curve, and the log-rank test was used to compare the difference in PFS and OS between the two groups. We used SPSS software (version 25.0) to perform all the statistical analyses. All statistical tests were bilateral tests, and p < 0.05 was statistically significant. This study was registered at the Chinese Clinical Trial Registry (chictr.org.cn), registration number: ChiCTR1900022129. | PMC10476909 |
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Results | PMC10476909 |
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Antitumor activity | ANL | A total of 44 patients were involved in the efficacy analysis (efficacy-evaluable population), with 22 cases in the ANL group and 22 cases in the ANL+S-1 group. In the ANL group, 1 (4.5%) patient achieved a PR, but none achieved a CR. The ORR was 4.5% (1/22), and the DCR was 77.3% (17/22). The median PFS was 4.2 months (95% CI, 3.6–6.0) (Comparison of progression-free survival (PFS) between the anlotinib (ANL) group and ANL+S1 group.Comparison of overall survival (OS) between the anlotinib (ANL) group and the ANL+ S1 group. | PMC10476909 |
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Safety | hand-foot, ANL, diarrhea, fatigue, major adverse reactions, hypertension | ADVERSE REACTIONS, ADVERSE EFFECTS, HYPERTENSION, EVENTS, HYPERTENSION | The most frequent adverse effects (AEs) were hypertension and fatigue. Hypertension, hand-foot skin, and diarrhea were among the grade 3 treatment-related AEs that occurred in 7 (15.9%) of the patients. Most of these events can be reversed by adjusting the dose of ANL or by taking other drugs (such as antihypertensive drugs). In the ANL group, 4 patients reduced the dose of ANL due to grade 3 or 4 adverse reactions. In the ANL+S-1 group, 3 patients reduced the dose of ANL due to grade 3 or 4 adverse reactions. There were no treatment-related fatalities. The treatment-related AEs did not interrupt the study. Incidence and grade of major adverse reactions in the ANL group and ANL+ S-1 groupThe comparison of adverse reactions was the comparison of any grade data between the ANL and ANL+S-1 groups.ALT = alanine transaminase; ANL = anlotinib | PMC10476909 |
Discussion | NSCLC, ANL, fatigue, HCC, hypertension, hemoptysis, hand and foot syndrome | ADVERSE REACTIONS, ADVERSE REACTIONS, LOSS OF APPETITE, NSCLC, HYPERTENSION | In this phase II prospective clinical trial, we observed the efficacy and safety of ANL alone or in combination with S-1 in patients with advanced HCC. To the best of our knowledge, this is the first controlled study to evaluate ANL alone or in combination with S-1 in patients with advanced HCC. The results showed that ANL had certain antitumor activity in the treatment of advanced HCC and that adverse reactions could be controlled. However, it would be necessary to compare ANL with standard treatment in a randomized trial with more patients included before this drug appears in standard practice for HCC.Anlotinib is a novel multitarget tyrosine kinase inhibitor that mainly inhibits vascular endothelial growth factor receptor 2 and 3 (VEGFR2/3), fibroblast growth factor 1–4 (FGFR1-4), platelet-derived growth factor receptor α and β (PDGFR α/β), C-Kit and Ret.The mechanism of action of ANL is similar to that of apatinib.In this study, the main adverse reactions included hypertension, loss of appetite, fatigue, increased liver transaminase and hand and foot skin reactions, most of which were grade 1–2, and only a few patients with grade 3–4 adverse reactions needed to reduce the dose of ANL, indicating that the side effects of ANL were tolerable. Adverse reactions in NSCLC patients treated with ANL included hypertension (67.4%), hand and foot syndrome (43.9%), hemoptysis (14.0%), elevated thyroid stimulating hormone (TSH) (46.6%) and corrected QT interval (26.2%).The study has some limitations. First, this was a single-center study. Second, the study had a small sample size, with only 22 patients per cohort. The study is not powered enough to compare the ANL and ANL+S1 groups and to conclude that S1 does not add to efficacy. | PMC10476909 |
Conclusions | ANL, HCC | ADVERSE REACTIONS | In conclusion, ANL monotherapy is effective in the treatment of advanced HCC, and adverse reactions can be tolerated. However, ANL combined with S-1 did not improve ORR and DCR or prolong PFS and OS in advanced HCC patients. | PMC10476909 |
Acknowledgments | Funding: Beijing Medical and Health Public Welfare Foundation, Medical Science Research Foundation Project (YWJKJJHKYJJ-F3054D), Guangxi Medical and Health Key Discipline Construction Project.Disclosure: No potential conflicts of interest were disclosed. | PMC10476909 |
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References | PMC10476909 |
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Background | Web-based tailored interventions offer rich opportunities for improved access to and personalization of behavioral interventions. However, despite the promise of this approach, the engagement and underrepresentation of minority groups remain major issues. | PMC10134014 |
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Objective | weight loss, overweight or obesity | This study evaluated whether engagement (log-in status and log-in duration) with different types of tailored behavioral content from the Families Improving Together for weight loss web-based intervention was associated with changes in moderate to vigorous physical activity (MVPA) among African American families with overweight or obesity. | PMC10134014 |
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Methods | weight-related behaviors, weight loss | Parent-adolescent dyads were randomized to a web-based tailored intervention or web-based health education comparison program. The web-based intervention (N=119) was completed by parents and targeted 6 weight-related behaviors to support their adolescent children’s weight loss goals (session contents included energy balance, fast food, fruits and vegetables, physical activity [PA], sedentary behavior, and sweetened beverages). MVPA was measured using accelerometers at baseline and after the intervention. | PMC10134014 |
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Results | Using a hierarchical approach, the log-in status and duration for each web-based session were used to evaluate the additive effects of engagement with different types of tailored behavioral content on MVPA after the web-based intervention. Among parents, logging in to the PA session was not associated with greater MVPA ( | PMC10134014 |
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Conclusions | The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of tailored web-based interventions, especially for promoting PA in African American families. | PMC10134014 |
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Trial Registration | ClinicalTrials.gov NCT01796067; https://clinicaltrials.gov/ct2/show/NCT01796067 | PMC10134014 |
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Introduction | PMC10134014 |
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Background | weight loss | CHILDHOOD OBESITY | Childhood obesity remains a major public health concern, especially for racial and ethnic minority youth who experience significantly higher rates of overweight and obesity than their non-Hispanic White peers [Efforts to understand the best practices for engaging African American families in behavioral weight loss programs have focused on reducing barriers to participation, such as distrust, the lack of transportation, and the lack of interest [ | PMC10134014 |
Objective | weight loss, overweight or obesity | SECONDARY | This study aimed to address this gap by evaluating a multitheoretical approach to engaging African American families in a tailored web-based weight loss program, including a novel focus on positive parenting practices. The Family Systems Theory highlights the importance of nurturance and positive parenting practices for promoting positive family interactions [Another approach to improving engagement among African American families is through deep-level cultural tailoring. Previous research has demonstrated that interventions that are culturally adapted lead to improved health outcomes among racial minority groups [This study expands upon past web-based tailored interventions by integrating several novel tailoring components, including positive parenting (parenting style, monitoring, and communication), deep-level cultural tailoring variables (ethnic identity, spirituality, cultural, and personal values), and other constructs (autonomy support, motivation, and social support). Specifically, drawing from this novel multitheoretical framework, this study seeks to better understand the effects of engagement with different types of tailored behavioral content (eg, PA vs diet-related content). Increasingly, researchers find that engagement (eg, total log-in duration and dose) is related to the efficacy of web-based interventions [This study presents the secondary findings from the Families Improving Together (FIT) for weight loss trial, which compared a parent-focused 8-week web-based tailored intervention and a web-based health education program among African American families with adolescent children with overweight or obesity [Thus, the primary aim of this study was to evaluate whether engagement with different types of tailored behavioral sessions from our multitheoretical web-based tailored intervention (eg, PA vs diet) was associated with changes in MVPA among African American parents and their adolescent children. We hypothesized that there would be a behavior-specific pathway such that engagement with tailored PA-related content would be associated with greater MVPA after the web-based intervention. | PMC10134014 |
Methods | PMC10134014 |
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Overview of the FIT Trial | weight loss, overweight or obesity | The FIT trial was a randomized group cohort study that tested the efficacy of a motivational plus family-based weight loss (M+FWL) intervention compared with a comprehensive health education control group for reducing BMI among African American adolescents with overweight or obesity and their caregivers [In phase 1, families were randomized to an 8-week face-to-face group-based M+FWL or comprehensive health education program [ | PMC10134014 |
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Participants | EVENTS | Participants were recruited through community partnerships, culturally relevant advertisements, and community events [ | PMC10134014 |
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Ethics Approval | This study was reviewed and approved by the Institutional Review Board of the University of South Carolina (approval no. Pro00016136). The parents signed informed consent forms, and adolescents provided verbal assent. | PMC10134014 |
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Overview of the Web-Based Program | weight loss | After completing the phase 1 of the intervention, all participants (adolescents and parents) completed a tailoring questionnaire before being randomized to the web-based tailored intervention or the web-based comparison program. The tailoring questionnaire was used in the intervention to provide an individually tailored program that integrated the perspectives of both parents and their adolescent children, whereas those in the web-based comprehensive program received generalized health information. Parents were targeted to participate in the web-based program, as the intervention was designed to promote positive parenting skills to support adolescent weight loss. Both web-based programs consisted of 8 weekly web-based sessions delivered through a secure website. At the start of each week, parents received an automated text reminder to complete the week’s sessions. A research assistant (blinded to condition) provided additional reminders later in the week (by phone, email, or text) and was available to provide technical support as needed. The web-based program was developed in collaboration with the University of Michigan Center for Health Communication Research. | PMC10134014 |
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Web-Based Tailored Intervention | PMC10134014 |
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Overview of the Program | ’s behavior, weight loss | The web-based intervention was tailored on numerous constructs from both parents and adolescents, including parenting, behavior, and cultural variables (Overview of the content and tailoring strategies used in the web-based intervention.The program began with a welcome session in week 1, which included an overview of the program and an introduction of the 6 content sessions. In the first week, parents developed a calorie-related goal for their adolescent children and completed a tailored autonomy-supportive parenting exercise to assess their current parenting styles and practices. In the following weeks, each session followed the same basic structure completing a check-in on goals, providing feedback on the adolescents’ progress, completing a content session, and developing an action plan for the upcoming week. Each session began with a check-in survey, in which parents reported their adolescent children’s behavior in the 6 targeted areas and their progress while meeting their calorie goal. This information was used to provide parents with ongoing tailored feedback about their adolescents’ progress (compared with previous reports). Parents were then guided to select one of the 6 content sessions to complete. The order of these sessions was tailored based on the adolescents’ progress and their willingness to change each behavior such that behaviors that were more challenging and those that the adolescents were willing to work on appeared first, followed by behaviors that were less challenging or those that the adolescents were less willing to change. However, parents were free to select the session they wanted to complete in a given week. In the final session during week 8, the content focused on ways in which parents could continue to support their adolescent children with their weight loss goals, including reviewing the autonomy-supportive parenting strategies and tips for applying them to the 6 targeted health behaviors. Parents completed one last check-in and received feedback on their adolescents’ progress across the 8-week program. | PMC10134014 |
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Description of Content Sessions | adolescent-reported, weight loss | Each content session involved behavior-specific content, a check-in on barriers to autonomy-supportive parenting, introduction of a new positive parenting practice, a worksheet to practice parenting skills, conversation practice with a brief video and worksheet, and the development of an action plan for the upcoming week. The behavior-specific content included information about why the behavior was important for weight loss and current guidelines, as well as tailored feedback about their adolescent children’s progress with that behavior since starting the web-based program. Information and feedback were tailored around the parents’ personal and cultural values and the adolescents’ previously reported motivation for behavior change.Next, parents reported their current barriers to implementing autonomy-supportive parenting (eg, “What gets in the way of you being autonomy supportive?”) and received tailored feedback, which was based on parent-reported barriers to communication, parent- and adolescent-reported communication, the parents’ cultural views, and the adolescents’ report of perceived social support around health behaviors from their parents. Parents were then introduced to the new positive parenting strategy, including a definition and when or how to use it. Parents completed a worksheet to practice implementing the strategy (eg, reframing the controlling language with an autonomy-supportive language). They then watched a brief video with a parent-adolescent dyad (tailored to match the race and sex of the participant and their adolescent) that provided a real example of how to implement the parenting strategy in a conversation about the targeted behavior (Example script from brief video demonstrating conversation practice (positive parenting practice paired with discussion of a weight-related behavior).After watching the video, parents completed a conversation worksheet and set an action plan for the upcoming week, which was tailored based on whether it was a behavior that required change or maintenance, parent- and adolescent-reported communication, parents’ views on gender roles and cultural values, and adolescents’ personal values. The goal of the conversation worksheet was to prepare parents to talk to their adolescent children about the target behavior (eg, “Why would your child want to work on this behavior?” “What is going well with this behavior?” and “What has been difficult?”) and implement the positive parenting strategy (eg, “How will you show them you are listening?” and “How will you monitor your child’s progress in an autonomy-supportive way?”). The worksheet included a printable page with discussion prompts and space for notes to guide the conversations with their adolescent children. | PMC10134014 |
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Measures | All measures were collected by trained measurement staff (blinded to condition) at baseline, postintervention time point (8 weeks), and post–web-based intervention time point (16 weeks). | PMC10134014 |
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Log-in Status and Duration | For the web-based tailored intervention only, program use data were used to evaluate whether participants logged into a given session and how long they spent logged in. Log-in status was defined based on whether a participant logged into a given session at all. The log-in duration was calculated based on the time stamp for logging in, requesting a page, and logging out. If a participant did not interact with the website for >30 minutes, then the session ended at the time the participant requested the last page. In a given week, the participants were able to log in and out of a content session multiple times to complete the session. Thus, log-in duration reflects the total accumulated time spent on a content session in a given week. | PMC10134014 |
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BMI Measurements | Height (cm) and weight (kg) measurements were obtained using a Seca 880 digital scale and Shorr height board. BMI values were calculated using the standard BMI formula (kg/m | PMC10134014 |
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PA Measurements | MVPA measurements were obtained using 7-day estimates from omnidirectional Actical accelerometers. For the adolescents, cut points developed for use in youth populations were used [ | PMC10134014 |
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Analysis Plan | To evaluate the effect of engagement with different types of tailored behavioral content, a hierarchical mixed model approach was used. Specifically, model 1 tested the effects of total log-in duration; total number of sessions completed (0-8); and covariates, including baseline MVPA, baseline BMI, demographics (income, sex, and age), time-related variables for PA (weekend and season), and a dummy code for the face-to-face group-based treatment (0=control and 1=intervention). Model 2 added engagement with the PA content session (log-in status and duration). Model 3 added engagement with the sedentary behavior session, and model 4 added engagement with the energy balance session. Finally, model 5 included diet-focused content sessions, including the fruits and vegetables, sweetened beverages, and fast food sessions. The log-in status for each content session was a dummy-coded variable (0=no log-in and 1=log-in), and the log-in duration was a continuous variable. In addition, to account for nesting within treatment groups during the face-to-face phase of the program, the mixed modeling approach included a random effect for group-based treatment. Likelihood ratio tests were used to compare the models.To aid in interpreting the results, all continuous variables were mean centered, including covariates and predictors. Before analysis, outliers for the log-in duration were recoded to reflect a maximum of 3 times the IQR using a winsorizing approach [ | PMC10134014 |
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Results | PMC10134014 |
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PA Results | PMC10134014 |
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Parents | In model 1, which included the total log-in duration, total number of sessions completed, and covariates, there was a positive effect of total log-in duration such that parents who spent more time logged in during the 8-week program had greater MVPA (In summary, parents who logged into the PA session had lower MVPA, but MVPA increased with greater log-in duration for the PA and sedentary behavior sessions. These associations remained even after accounting for engagement with other content sessions. In addition, logging in to the fast food session was associated with greater MVPA, but the log-in duration for this session was not significantly associated with MVPA. Although model 1 indicated that total log-in duration was positively associated with greater MVPA, this effect was no longer significant when engagement for the different content sessions was included in the model. | PMC10134014 |
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Adolescents | For adolescents, model 1 revealed a negative effect of total log-in duration ( | PMC10134014 |
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Discussion | PMC10134014 |
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Principal Findings | This study investigated whether engagement with different tailored behavioral sessions, measured in terms of log-in status and duration, was associated with improvements in MVPA among African American families. Among parents, logging into the PA session was not associated with greater MVPA. However, consistent with our hypothesis, MVPA did increase with greater log-in duration for the PA and sedentary activity sessions, suggesting that greater exposure to the tailored PA-related content had a positive impact on parents’ MVPA. Surprisingly, the results also indicated that logging into the fast food session was associated with greater MVPA, but log-in duration for the fast food session was not significantly associated with parent MVPA. Consistent with past reviews, which have found that the clustering effects of PA and diet are complex [The results also indicated that engagement with different behavioral content sessions was not significantly related to MVPA after the web-based intervention among adolescents, suggesting that the effects observed in parents did not carry over to their adolescent children. Although parent involvement is viewed as an important component for adolescent eHealth interventions [ | PMC10134014 |
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Implications for Future Research | weight-related behaviors | This study has several important implications for future tailored web-based interventions. First, this is one of the first studies to demonstrate a behavior-specific pathway between engagement with tailored content and behavioral outcomes. Although previous studies have highlighted the importance of adherence by evaluating engagement at the aggregate level (eg, total log-in frequency or dose) [Second, we found that although parents were more likely to complete some sessions (eg, energy balance, sedentary behavior, and sweetened beverages), a lower percentage of participants completed the fast food and fruit and vegetable sessions. Future research is needed to further understand the barriers related to engagement with these weight-related behaviors among African American families, especially regarding structural barriers related to cost and access to healthy foods [ | PMC10134014 |
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Strengths and Limitations | This study has several strengths, including the use of a multitheoretical framework, deep-level cultural tailoring, an underrepresented racial minority sample, and an objective measure of PA. The study design allowed us to compare the effects of engagement with different types of tailored behavioral sessions (eg, diet- vs PA-related contents). However, 1 limitation is that our study design did not allow us to differentiate the unique or additive effects of different types of tailoring (eg, tailoring around parentings vs deep-level cultural factors). Furthermore, because the web-based comparison program included links to external websites, we were unable to measure the log-in duration in a comparable manner with the web-based intervention. Decisions around selecting an appropriate comparator remain a central issue in the literature on tailored interventions [Another limitation of this study is that adolescents were not directly involved in the web-based intervention, which may have weakened the overall impact of the intervention. Despite these limitations, the web-based tailored intervention integrated several novel tailoring constructs, including expanding upon the use of positive parenting practices and deep-level cultural tailoring, and found positive effects of engagement on parent MVPA. Although previous tailored studies have drawn from a relatively narrow range of theories and constructs [ | PMC10134014 |
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Conclusions | The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of web-based tailored interventions, especially for improving PA in African American families. Among parents, MVPA did increase with greater log-in duration for the PA and sedentary activity sessions, suggesting that greater exposure to the tailored PA-related content had a positive impact on parents’ PA. Future web-based studies may benefit from integrating program use data that captures engagement with different types of tailored theoretical construct components.This research was supported by a grant (R01 HD072153) funded by the National Institute of Child Health and Human Development to DKW and by a grant from the National Institute of General Medical Sciences (T32 GM081740).Conflicts of Interest: None declared.Fixed effects of log-in status and duration on moderate to vigorous physical activity for parents (N=119).Fixed effects of log-in status and duration on moderate to vigorous physical activity for adolescents (N=119). | PMC10134014 |
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Abbreviations | Weight Loss interventionmoderate | Families Improving TogetherMotivational and Family-Based Weight Loss interventionmoderate to vigorous physical activityphysical activity | PMC10134014 |
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Background | toxicity, GCA | GCA, GIANT CELL ARTERITIS | Giant cell arteritis (GCA) is primarily treated with glucocorticoids (GCs), which have substantial toxicity. Tocilizumab, an interleukin-6-receptor inhibitor (IL-6Ri), showed beneficial effects in GCA, leading to its approval. This study investigated the efficacy and safety of sarilumab (another IL-6Ri) in GCA | PMC10577982 |
Methods | RECRUITMENT, REMISSION, GCA | This Phase 3, double-blind study comprised a 52-week treatment period and a 24-week follow-up phase. Eligible GCA patients were randomized to receive sarilumab 200 mg (SAR200 + 26W) or 150 mg (SAR150 + 26W) with a 26-week GC taper, or placebo with a 52-week (PBO + 52W) or 26-week (PBO + 26W) GC taper. The primary efficacy endpoint was sustained remission (SR) at week 52. Additional endpoints were SR at week 24, cumulative GC dose, and safety. The study was discontinued prematurely due to protracted recruitment timelines, because of the impact of COVID-19. Therefore, only descriptive statistics were summarized. | PMC10577982 |
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Results | Of the planned 360 subjects, only 83 were randomized and 36 were included in the week 52 analysis. At week 52, 46% ( | PMC10577982 |
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Conclusions | Owing to the small sample size due to the early termination, it is difficult to draw clear conclusions from this study. There were no unexpected safety findings. | PMC10577982 |
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Trial registration | ClinicalTrials.gov NCT03600805. Registered on July 26, 2018. | PMC10577982 |
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