title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Demographic and clinical characters of active and sham MM groups. | LATERAL EPICONDYLITIS | MM–Mill’s manipulation, y–year, m–meter, kg–kilogram, LE–Lateral epicondylitis, m–months. | PMC9925075 | |
Pre and post primary and secondary outcome measures of active and sham MM groups. | Depression, Anxiety | TENNIS ELBOW | *Significant, MM–Mill’s manipulationVAS–Visual analog scale, MRI–Magnetic resonance imaging, PRTEE—Patient-rated Tennis Elbow Evaluation, kg–Kilogram, GPI–Global perceived improvement, TSK–AV—The Tampa Scale for Kinesiophobia–adjusted version, HADS—Hospital Anxiety and Depression Scale, EuroQol EQ-5D –European quality ... | PMC9925075 |
3.2 Compliance with the study protocol | All registered outcome measures are reported in this manuscript. There was minimal loss to follow-up, as presented in | PMC9925075 | ||
3.3 Effects of the intervention | PMC9925075 | |||
3.3.1 Primary and secondary outcomes | Functional disability, pain | The time and group (4 × 2) linear mixed model (LMM) of primary variable (pain intensity—VAS) reports statistically significant difference (p<0.001) between active and sham groups at baseline, 4 weeks, 8 weeks and at 6 months follow up. The post intervention at 4 weeks 1.6 (CI 95% 0.97 to 2.22) shows improvement in the ... | PMC9925075 | |
Pre and post primary outcome measures of active and sham MM groups. | depression | SECONDARY | The time and group (4 × 2) linear mixed model (LMM) of all the other variables (patient perception, kinesiophobia, depression and quality of life) reports statistically significant difference (p = 0.001) between active and sham groups at baseline, 4 weeks, 8 weeks and at 6 months follow up. The post intervention at 4 w... | PMC9925075 |
Pre and post-secondary outcome measures of active and sham ESWT groups. | PMC9925075 | |||
Pre and post mean difference and confidence interval (upper limit and lower limit) of primary and secondary outcome scores of active and sham MM groups. | PMC9925075 | |||
3.4 Adverse events with the study intervention | ADVERSE REACTIONS | There was no adverse reactions or side effects noted in both the experimental and control groups during and after the corticosteroid injection and joint manipulation treatment. | PMC9925075 | |
4. Discussion | abnormal motion or compensation, pain | SECONDARY | Participants in the active group showed significant improvement compared to the sham group at various intervals in all the outcome measures. Sham group also showed a statistically significant improvement over time across the primary and secondary outcomes. A study by Olaussen M et al, observed that corticosteroid (CS) ... | PMC9925075 |
4.1 Strengths and weaknesses | Type-1 errors | We used 8 weeks and 6 months’ follow-up with several outcomes to register the development of improvement after different interventions. The clinical setting and the choice of ordinary, well known physiotherapeutic approach ensured the external validity. This study strictly adhered to the CONSORT guidelines for randomiz... | PMC9925075 | |
5. Conclusion | depression, pain | Corticosteroid injection with deep transverse friction massage and Mill’s manipulation is effective in terms of reducing pain, improving tissue healing, functional disability, handgrip strength, patient perception, kinesiophobia and depression status and, health related quality of life in people with lateral epicondyla... | PMC9925075 | |
Supporting information | PMC9925075 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (RTF)Click here for additional data file.(XLSX)Click here for additional data file.(DOCX)Click here for additional data file. | PMC9925075 | ||
References | PMC9925075 | |||
Background: | COPD | COPD | COPD causes high morbidity and mortality, emphasizing the need for palliative care. | PMC10227092 |
Aim: | COPD | COPD | To assess the effectiveness of palliative care in patients with COPD. | PMC10227092 |
Design: | depression, death, COPD, anxiety | COPD | Cluster randomized controlled trial (COMPASSION study; Netherlands Trial Register (NTR): NL7644, 07-04-2019). Healthcare providers within the intervention group were trained to implement palliative care components into routine COPD care. Patients completed questionnaires at baseline, after 3 and 6 months; medical recor... | PMC10227092 |
Setting: | Eight hospital regions in the Netherlands. | PMC10227092 | ||
Participants: | ACUTE EXACERBATION OF COPD | Patients hospitalized for an acute exacerbation of COPD and positive ProPal-COPD score. | PMC10227092 | |
Results: | COPD | COPD | Of 222 patients included, 106 responded to the questionnaire at 6 months. Thirty-six of 98 intervention patients (36.7%) received the intervention. Intention-to-treat-analysis showed no effect on the primary outcome (adjusted difference: 1.09; 95% confidence interval: −5.44 to 7.60). In the intervention group, fewer in... | PMC10227092 |
Conclusions: | organ failure, COPD | COPD, SECONDARY | We found no evidence that palliative care improves quality of life in patients with COPD. However, it can potentially reduce acute healthcare use. The consequences of the COVID-19 pandemic led to suboptimal implementation and insufficient power, and may have affected some of our findings.
Patients in advanced stages of... | PMC10227092 |
Introduction | cancer, death, COPD, deaths | COPD, SECONDARY, CANCER, CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Chronic obstructive pulmonary disease (COPD) causes considerable morbidity and is the third leading cause of death worldwide.In patients with cancer, quality of life can be improved and healthcare use reduced by timely initiation of palliative care.In a recent systematic review, only 4 out of 20 palliative care interve... | PMC10227092 |
Methods | PMC10227092 | |||
Design | A cluster randomized controlled trial was performed. A detailed study protocol has been published previously. | PMC10227092 | ||
Setting | This study took place in pulmonary care departments of eight hospitals in the Netherlands, that collaborated with affiliated general practitioners, primary care nurses and palliative care consultation teams, further referred to as ‘hospital regions’ or ‘clusters’. | PMC10227092 | ||
Randomization | Hospital regions were randomized to the intervention or control condition (four clusters in each group) by an independent statistician, stratified by the number of COPD-related hospital admissions per year. | PMC10227092 | ||
Intervention | An integrated palliative care intervention was developed following national guidelines, literature and stakeholders’ input and comprised (1) palliative care conversations tailored to the patient’s needs, (2) care coordination and continuity and (3) aftercare if a patient had died (Description of the implementation stra... | PMC10227092 | ||
Participants | MAY | Between May 2019 and August 2020, patients admitted to the hospital for an acute exacerbation were invited by a pulmonologist or nurse to participate and subsequently screened with the ProPal-COPD tool (see ProPal-COPD tool.Inclusion and exclusion criteria of study participants. | PMC10227092 | |
Blinding | Complete blinding of participants for group allocation was impossible, but patients were not explicitly told whether their hospital was assigned to the intervention or control group. Further, healthcare providers of control regions were blinded for the ProPal-COPD score (whether positive and thus needing palliative car... | PMC10227092 | ||
Data collection | death, COPD | COPD | Demographics and patient-reported outcome measures were collected using a questionnaire at three time points. At baseline, patients completed a paper questionnaire during hospitalization. After 3 and 6 months, a follow-up questionnaire was sent to the patient’s home or email, depending on the patient’s preference. Pati... | PMC10227092 |
Outcome measures | The primary outcome was quality of life measured with the validated 46-item Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) scale. | PMC10227092 | ||
Data analyses | Data cleaning and descriptive statistics were performed using SPSS, version 25, and outcome analyses were conducted using R software, version 3.6.2. We calculated that 347 participants were required to find an effect of minimum nine points at the primary outcome with an assumed standard deviation of 25, taking clusteri... | PMC10227092 | ||
Ethics approval and consent | All participants received oral and written study information and gave written informed consent. Ethical approval was granted by the Medical Ethics Committee of Arnhem-Nijmegen (file number 2018-4833) on 15 October 2018. | PMC10227092 | ||
Results | PMC10227092 | |||
Participant characteristics | COPD | MAY, COPD | Between May 2019 and August 2020, 735 patients admitted to the hospital for an acute exacerbation COPD were screened for eligibility (Flow diagram of inclusion of participants and response rates of questionnaires at baseline (T0), after 3 months (T3) and 6 months (T6).Demographic- and clinical characteristics of partic... | PMC10227092 |
Intervention delivery | In the intervention group, an outpatient palliative care conversation occurred in 36 of 98 patients within 6 months after inclusion (36.7%). In eight patients, a conversation took place later than after 6 months. Reasons for no outpatient palliative care conversation were: transferral to a different care setting (prima... | PMC10227092 | ||
Discussion | PMC10227092 | |||
Main findings | COPD | COPD, SENSITIVITY | In this cluster randomized controlled trial, we assessed the effectiveness of palliative care components integrated into regular COPD care. We found no effects on quality of life nor other patient-reported outcome measures. However, intervention patients were less frequently admitted to the ICU than control patients, a... | PMC10227092 |
Interpretation of findings | organ failure, COPD | COPD, RECRUITMENT, DISEASE COURSE | Similar to our study, a recent systematic review found no effect of palliative care interventions on the quality of life of patients with COPD; effects on acute healthcare use were inconclusive.Our findings could be explained in several ways. First, we did not reach sufficient statistical power to detect effects on the... | PMC10227092 |
Strengths and limitations | death, COPD | COPD | This study is the first large randomized controlled trial assessing the effectiveness of palliative care integrated into regular COPD care. As part of a hybrid type 2 effectiveness-implementation study,However, our study also has limitations. Next to insufficient study power, we had a high rate of missing data due to t... | PMC10227092 |
Conclusions | COPD | COPD, DISEASE | The effect of integrated palliative care on clinical outcomes in patients with COPD remains inconclusive. We found no evidence that palliative care improves quality of life in patients with COPD, but it can potentially reduce ICU admissions. Better implementation of palliative care components is needed to enhance relia... | PMC10227092 |
Supplemental Material | PMC10227092 | |||
References | PMC10227092 | |||
Supplementary Information | depression, anxiety | The aim of the present research was to develop and test the efficacy of a novel online contingent attention training (i.e., OCAT) to modify attention and interpretation biases, improve emotion regulation, and reduce emotional symptom levels in the face of major stressors. Two proof-of-principle studies were carried out... | PMC10166036 | |
Keywords | PMC10166036 | |||
Significance statement | depression, anxiety | DISORDERS | Cognitive biases (e.g., attention and interpretation biases) are conceptualized as central mechanisms for the onset and maintenance of emotional disorders such as depression and anxiety. Cognitive models have posited that these biases emerge under stressful situations, impairing peoples’ ability to regulate negative em... | PMC10166036 |
General introduction | depression, Depression, ABM, anxiety | DISORDERS | Depression and anxiety disorders are highly prevalent worldwide (Steel et al., Importantly, novel approaches conveying the use of precise knowledge on neurocognitive mechanisms of stress and emotional dysfunctions have been developed in recent years (see, for instance, Goodwin et al., These attentional and interpretati... | PMC10166036 |
Study 1. Effectiveness of OCAT to target cognitive biases, emotion regulation and psychological symptoms during a stressful exam period in undergraduate students | The main aim of this first study was to validate the new OCAT variant and analyze its efficacy as a 10-session online protocol to modify both attention and interpretation biases and transfer to improvements in the use of emotion regulation strategies and/or emotional symptomatology. Following previous research (Sanchez... | PMC10166036 | ||
Method | PMC10166036 | |||
Participants | Sixty-four undergraduate students took part in the study in exchange for course credits. All participants were recruited three-weeks before they began their final examination period and they were then randomly allocated to start the active OCAT or the control sham-training group in the same time period (i.e., within th... | PMC10166036 | ||
General procedure | As depicted in Fig. | PMC10166036 | ||
Data analysis plan | Prior to the analysis, normality and homoscedasticityFinally, exploratory analyses were conducted to test the influence of cognitive bias changes as a response of cognitive training to account for training effects in transfer psychological measures (see Sanchez et al., | PMC10166036 | ||
Results | PMC10166036 | |||
Exploratory analyses of relations between in-training cognitive and symptom changes | ’ depression | Analyses showed that larger decreases in the time attending to negative words were significantly related to larger decreases in participants’ depression levels from pre- to post-training ( | PMC10166036 | |
Interim discussion | depressive, anxiety | The aim of this first pilot study was to analyze the efficacy of OCAT on targeting attention and interpretation biases as well as its transfer effects to emotion regulation and emotional symptom levels in an unselected sample of undergraduate students who were about to confront a naturalistic stressor (i.e., beginning ... | PMC10166036 | |
Study 2. Validation and effectiveness of OCAT to target cognitive biases, emotion regulation and psychological symptoms during COVID-19 lockdown in a community sample | depression, anxiety | The beginning of COVID-19 pandemic comprised a significant major stressor for the general population, resulting in increased rates of depression and anxiety (Shevlin et al., | PMC10166036 | |
Method | PMC10166036 | |||
Participants | Fifty-eight participants took part in the study voluntarily. They were recruited by advertising on social media and social networks. As in Study 1, participants were randomly allocated to the active OCAT and the control sham-training group through a simple randomization procedure. Six participants of the active OCAT gr... | PMC10166036 | ||
General procedure | post-training cognitive bias | MINOR, RECRUITMENT | The general procedure was identical to study 1, except for the following minor differences. Due to the COVID-19 lockdown restrictions, participants were contacted through advertising in social media and social networks, and the entire procedure was conducted online. Thus, after participants were randomized to the OCAT ... | PMC10166036 |
Experimental task and materials | Experimental task and materials were the same as in study 1. | PMC10166036 | ||
Attention and interpretation dependent variables | Attention and interpretation were assessed in the same manner as in study 1. Further, reliability analyses were conducted on the measures in the current study. As in study 1, the results showed excellent internal consistencies of both attention and interpretation bias measures at Time 1 and Time 2 (see Table Internal c... | PMC10166036 | ||
Psychological measures | depression, anxiety | Given the null finding for reappraisal transfer in study 1, reappraisal was assessed using a different reappraisal measure, the reappraisal subscale of the Emotion Regulation Questionnaire (ERQ—Gross & John, The rest of the self-reported variables (i.e., depression, anxiety, and brooding rumination) were assessed using... | PMC10166036 | |
Data analysis plan | The data analysis plan followed in the present study was identical to the one used in the study 1. | PMC10166036 | ||
Results | PMC10166036 | |||
Effects of the OCAT on cognitive bias measures | PMC10166036 | |||
Interim discussion | anxiety | Previous research has shown that attention and interpretation biases play a major role in psychological adjustment during COVID-19 lockdown (Blanco et al., Following the results of Study 1, we also hypothesized that training-related improvements in attention and interpretation biases would transfer to improved ruminati... | PMC10166036 | |
General discussion | depression, anxiety | MACLEOD | Cognitive processing (e.g., attention and interpretation) of emotional information have been postulated as crucial variables implicated in the onset and maintenance of diverse forms of psychopathology such as depression and anxiety (Mathews & MacLeod, Overall, the results of both studies show that the OCAT app is effec... | PMC10166036 |
Acknowledgements | We thank Ricardo Rey and Angela Socastro for their collaboration during the sample recollection of both studies. | PMC10166036 | ||
Author contributions | TB | IB: conceptualization, methodology, formal analysis, investigation, data curation, writing—original draft preparation; OM-G: methodology, investigation, data curation, writing—review & editing; TB: investigation, data curation, writing—review & editing. EHWK: supervision, writing—review & editing; RDR: supervision, wri... | PMC10166036 | |
Funding | This work was supported by a grant of the Program for the Attraction of Scientific Talent of the Community of Madrid (Spain), reference 2017-T1/SOC-5359, and grants of the Spanish Ministry of Science, Program “Generation of Knowledge” ref. PGC2018-095723-A-I00; and ref. PID2021-127480NB-I00, awarded to the last author.... | PMC10166036 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10166036 | ||
Declarations | PMC10166036 | |||
Ethics approval and consent to participate | These studies was approved by the Complutense University Ethical Committee. All participants signed a consent form prior to their participation on the studies. | PMC10166036 | ||
Consent for publication | Not applicable. | PMC10166036 | ||
Competing interests | Authors report no competing interests. | PMC10166036 | ||
References | PMC10166036 | |||
Background | PONV, postoperative nausea and vomiting, pain | Butorphanol slightly influences the respiratory and circulatory systems, has a better effect on relieving the discomfort caused by mechanical traction, and has a low incidence of postoperative nausea and vomiting (PONV). Combined butorphanol and propofol may suppress postoperative visceral pain, which is avoidable in g... | PMC10044711 | |
Methods | visceral pain, pain | ADVERSE EVENTS, SECONDARY | This was a randomized, placebo-controlled, and double-blinded trial. Patients undergoing gastrointestinal endoscopy were randomized to intravenously receive either butorphanol (Group I) or normal saline (Group II). The primary outcome was visceral pain after the procedure 10 min after recovery. The secondary outcomes i... | PMC10044711 |
Results | A total of 206 patients were enrolled in the trial. Ultimately, 203 patients were randomly assigned to Group I ( | PMC10044711 | ||
Conclusions | visceral pain | The trial indicated that adding butorphanol to propofol results in a lower incidence of visceral pain after surgery without noticeable fluctuations in circulatory and respiratory functions for gastrointestinal endoscopy patients. | PMC10044711 | |
Trial registration | Clinicaltrials.gov NCT04477733 (PI: Ruquan Han; date of registration: 20/07/2020). | PMC10044711 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02053-9. | PMC10044711 | ||
Keywords | PMC10044711 | |||
Background | pain, Cancer | GASTROINTESTINAL CANCER, CANCER | More than two million people die of gastrointestinal cancer, accounting for approximately 60% of new cases, based on Global Cancer Statistics 2018 [Propofol is widely used in endoscopy due to its fast onset of action, short action time, and quick and complete postoperative recovery [Butorphanol is a mixed opioid recept... | PMC10044711 |
Methods | PMC10044711 | |||
Study design and participants | This dual-center, randomized, placebo-controlled study was conducted at Beijing Tiantan Hospital, Capital Medical University, and Beijing Daxing People’s Hospital between August 14th, 2020, and September 30th, 2021. This study was approved by the China Ethics Committee of Registering Clinical Trials (Registration numbe... | PMC10044711 | ||
Blinding and randomization | Patients were randomly assigned to receive butorphanol (Group I) or normal saline (Group II) in a 1:1 ratio based on computer-generated stratified randomization numbers. The random numbers were sealed in separate opaque envelopes until the analysis was complete. Patients in Group I received 10 μg/kg butorphanol intrave... | PMC10044711 | ||
Perioperative management | intravascular hypovolemia | The regimens were standardized in both groups. Patients were deprived of water for 2 h and fasted for 8 h before surgery. Based on the requirements of anesthesia and surgery, venous access (central vein of the upper limb) was established. As perioperative fasting and bowel preparation are believed to cause intravascula... | PMC10044711 | |
Data collection and outcomes | nausea or vomiting, bradycardia, visceral pain, fatigue, pain, dizziness, hypoxemia, hypotension, headache, abdominal bloating | ADVERSE EVENTS, SECONDARY | Baseline data were recorded, such as age, sex, height, weight, body mass index, ASA physical status, and type of operation. The MAP, HR, RR, and SpOThe primary outcome was the incidence of visceral pain after the procedure. Because there is no universal scale for quantifying visceral pain, we defined a visual analog sc... | PMC10044711 |
Sample size calculation | pain | We used PASS software to calculate the necessary sample size for this study. A cohort study reported that 45% of participants (124 of 277) undergoing colonoscopy and gastroscopy complained of pain during follow-up [ | PMC10044711 | |
Statistical analysis | visceral pain | SECONDARY | The data were analyzed using SPSS 26.0, and the figures were created by GraphPad Prism 9.0. All analyses were based on the intention-to-treat (ITT) principle. The Kolmogorov–Smirnov test was used to analyze continuous outcomes to judge the normality of their distributions. Normally distributed continuous variables were... | PMC10044711 |
Results | PMC10044711 | |||
Visceral pain | nausea or vomiting, bloating, visceral pain, fatigue, abdominal pain, pain, dizziness, hypoxemia, headache, abdominal bloating | ADVERSE EVENTS, ADVERSE EVENT | The incidence of visceral pain at 10 min after recovery was significantly lower with butorphanol (31.5% Comparison of efficacy and safety outcomes (median and interquartile range or frequency and percentage)Incidence of visceral pain recovery at 10 (The incidence of visceral pain at 20 and 30 min after recovery showed ... | PMC10044711 |
Discussion | hypoxemia, visceral pain, fatigue, pain | ADVERSE EVENTS, COMPLICATIONS | This study demonstrates that butorphanol results in a statistically lower incidence of visceral pain after surgery and reduced propofol consumption for gastrointestinal endoscopy without noticeable fluctuations in circulatory and respiratory functions. Intravenous butorphanol neither prolongs recovery time nor increase... | PMC10044711 |
Acknowledgements | Not Applicable. | PMC10044711 | ||
Authors’ contributions | HL | Each author's individual contributions to the manuscript are as follows: HL, RH: Conceptualization and design. JW, HL: Investigation. XW: Writing - Original draft of the manuscript and statistical analysis. HL, RH: Writing - Review & Editing. XW, HL and RH had full access to the data in the study and take responsibilit... | PMC10044711 | |
Funding | No funding. | PMC10044711 | ||
Availability of data and materials | The datasets generated and analyzed during the current study are not publicly available due to institutional restrictions but are available from the corresponding author on reasonable request. | PMC10044711 | ||
Declarations | PMC10044711 |
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