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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Consent for publication | Not applicable. | PMC10476380 | ||
Competing interests | FB reports consulting fees from Löwenstein Medical and Air Liquid Medical Systems and research support from Covidien and Getinge Group, outside this work, and research support from GE Healthcare related to this work. JCR reports part‐time salary for research activities from Air Liquide Medical Systems and grants from C... | PMC10476380 | ||
References | PMC10476380 | |||
Key Points | PMC10346120 | |||
Question | viral suppression | Does the Friendship Bench intervention improve antiretroviral therapy (ART) adherence, viral suppression, and mental health symptoms in people living with HIV in rural Zimbabwe? | PMC10346120 | |
Findings | In this cluster randomized trial of 516 participants, the intervention showed no significant effect on adherence to ART. | PMC10346120 | ||
Meaning | The intervention did not affect adherence, possibly due to the absence of skill-based adherence training and the ceiling effect. | PMC10346120 | ||
Importance | CMD, depression, anxiety, Common mental disorders | Common mental disorders (CMD), which include depression and anxiety, are prevalent among people living with HIV and are associated with suboptimal antiretroviral therapy (ART) adherence. | PMC10346120 | |
Objective | virologic suppression | To assess the effect of a lay health worker–led psychological intervention on ART adherence, virologic suppression, and mental health symptoms. | PMC10346120 | |
Design, Setting, and Participants | CMD, psychosis | DISEASE, RECRUITMENT | Open-label pragmatic cluster trial with 1:1 block randomization of 16 health facilities in rural Bikita, Zimbabwe. Recruitment occurred from October 2018 to December 2019, and participants were followed up for 12 months, ending in December 2020. Participants were adults aged 18 years and older, who spoke English or Sho... | PMC10346120 |
Intervention | The Friendship Bench, consisting of 6 lay health worker–led weekly problem-solving therapy sessions and optional peer-led group support. | PMC10346120 | ||
Main Outcomes and Measures | SECONDARY | The primary outcome was mean adherence during 2 to 6 months of follow-up, and the secondary outcomes were mean adherence during 1 to 12 months of follow-up, change in SSQ-14 and Patient Health Questionnaire (PHQ-9) scores (3, 6, 9, and 12 months), and viral load suppression (6 and 12 months). | PMC10346120 | |
Results | A total of 516 participants were recruited (244 in Friendship Bench and 272 in enhanced standard care facilities); 438 (84.9%) were female and the mean (SD) age was 45.6 (10.9) years. Mean (SD) adherence between 2 to 6 months was 89.9% (18.4%) in the Friendship Bench group and 87.2% (20.1%) in the control group. The in... | PMC10346120 | ||
Conclusions and Relevance | CMD | In this randomized trial of HIV-positive participants with CMD, the Friendship Bench intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and a ceiling effect. | PMC10346120 | |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10346120 | ||
Introduction | HIV is vital for improving mental health, HIV in 2020.Treating mental disorders | Zimbabwe carries a high HIV burden, with an estimated 1.2 million people living with HIV in 2020.Treating mental disorders in people with HIV is vital for improving mental health | PMC10346120 | |
Methods | PMC10346120 | |||
Ethics Statement | Ethics committees of the Medical Research Council of Zimbabwe, the Research Council of Zimbabwe, and the Canton of Bern, Switzerland approved the study. Individuals provided written informed consent. This report follows the Consolidated Standards of Reporting Trials ( | PMC10346120 | ||
Study Design | The study was a pragmatic cluster randomized open-label superiority trial in 16 health facilities in rural Zimbabwe (see | PMC10346120 | ||
Setting | AIDS | AIDS | Bikita is a rural district about 300 km south of Harare. From 18 facilities participating in the International Epidemiology Databases to Evaluate AIDS Southern Africa (IeDEA-SA),ART followed national treatment guidelines, except for additional CD4 testing at baseline and additional viral load testing at baseline, 6, an... | PMC10346120 |
Randomization and Masking | RECRUITMENT | We randomized 16 health facilities in a 1:1 ratio to intervention or control group. Randomization was stratified by health facility size (3 strata). All facilities were randomized at the same time using block randomization with a block size of 2 within each stratum. Treatment assignment was known to participants, clini... | PMC10346120 | |
Participants | psychotic symptoms, CMD | DISEASE | We assessed study eligibility of individuals waiting for ART clinic appointment. Adults aged 18 years or older from Bikita who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), had received first-line ART for at least 6 months, had no World Health Organization (WHO) sta... | PMC10346120 |
Trial Profile | ART indicates antiretroviral therapy; SSQ-14, Shona Symptoms Questionnaire-14; WHO, World Health Organization. | PMC10346120 | ||
Interventions | CMD, psychiatric | Participants in the intervention group were offered the FB intervention in addition to enhanced standard of care (SC). Participants in the control group received SC only.The FB intervention consisted of 6 weekly individual counseling sessions and an optional peer-led group support. Trained lay health workers facilitate... | PMC10346120 | |
Measures | EVENT | We used the Medication Event Monitoring System (MEMS) electronic pill box (AARDEX) to measure adherence. We calculated monthly mean adherence as the percentage of days participants opened the box once or twice (depending on the regimen). We treated adherence of less than 10% as missing, assuming participants did not us... | PMC10346120 | |
Outcomes | CMD, depression | The primary outcome was mean adherence between 2 to 6 months of follow-up. Secondary outcomes included mean adherence between 1 to 12 months; change from baseline SSQ-14 and PHQ-9 score at 3, 6, 9, and 12 months; and change in viral suppression (viral load <1000 copies per mL) at months 6 and 12; and positive screening... | PMC10346120 | |
Sample Size | The study was powered to detect an absolute 10% difference in mean adherence | PMC10346120 | ||
Statistical Analysis | viral suppression | SECONDARY | The primary analysis was per intention to treat. We first calculated participants’ monthly mean adherence scores and then analyzed these scores using linear mixed-effects models to assess the difference in mean adherence. Models included a random intercept and slope to account for the correlation within participants. A... | PMC10346120 |
Results | PMC10346120 | |||
Participants and Baseline Characteristics | In this study, 516 individuals (mean [SD] age 45.6 [10.9] years; 438 [84.9%] female) were included, with 244 participants in 8 clusters in the FB group and 272 participants in 8 clusters in the control group ( | PMC10346120 | ||
Sociodemographic and Clinical Characteristics of Participants at Baseline | depressive | DISORDERS | Abbreviations: ART, antiretroviral therapy; AUDIT-C, Alcohol Use Disorders Identification Test-Concise Test; HFIS, Household Food Insecurity Access Scale; MOS-SS, Medical Outcomes Study Social Support; NNRTI, nonnucleoside reverse transcriptase inhibitors; PHQ, Patient Health Questionnaire; SSQ, Shona Symptoms Question... | PMC10346120 |
Outcomes | In unadjusted analyses, the primary outcome of mean (SD) ART adherence between months 2 and 6 was slightly higher in the FB group (89.9% [18.4]) than in the SC group (87.2% [20.1]) (mean difference, 1.93 percentage points; 95% CI, −1.20 to 5.06 percentage points; | PMC10346120 | ||
Adherence, Viral Load Suppression, Shona Symptoms Questionnaire (SSQ)-14 Score, and Patient Health Questionnaire (PHQ)-9 Score by Group | Figure shows mean monthly adherence scores (A), proportions of participants with viral load of less than 1000 copies/mL (B), mean SSQ-14 scores, and mean PHQ-9 scores. Error bars represent 95% CIs for means and proportions. FB indicates Friendship Bench; SC, standard care. | PMC10346120 | ||
Effect of the Friendship Bench Intervention on Adherence, Viral Load, and Mental Health | Abbreviations: PHQ, Patient Health Questionnaire; SSQ, Shona Symptoms Questionnaire.All analyses were prespecified and accounted for clustering of individuals in health facilities.Adjusted for facility size, age, and sex. | PMC10346120 | ||
Retention | Retention in the FB and adherence interventions was high ( | PMC10346120 | ||
Retention in Mental Health and Adherence Interventions | Abbreviations: NA, not applicable; VL, viral load. | PMC10346120 | ||
Safety Outcomes | deaths, psychiatric, self-harm | EVENT | In total, 16 participants reported self-harm or attempted self-harm; 11 (4.5%) were in the FB group and 5 (1.8%) were in the SC group. In the FB group, 9 participants (3.7%) reported a history of self-harm before baseline, and 2 participants (0.8%) reported a new incident self-harm event after baseline. No new incident... | PMC10346120 |
Discussion | depression, CMD, virologic suppression, viral suppression | In this cluster randomized trial, we examined the effect of the FB intervention on ART outcomes and mental health symptoms in adults with HIV in rural Zimbabwe. The intervention did not demonstrate a clear effect on ART adherence, viral suppression, and symptoms of depression (PHQ-9 scores) but had a beneficial effect ... | PMC10346120 | |
Strengths and Limitations | CMD | Our study’s strengths include a large sample size, long follow-up, and pragmatic study design resembling clinical practice conditions in rural Zimbabwe. Further strengths of our study include using electronic pill bottles for adherence monitoring and using a locally developed tool to measure CMD symptoms.Our study has ... | PMC10346120 | |
Conclusions | nonadherence, CMD, virologic failure | The FB intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and ceiling effect. The intervention improved CMD symptoms, but the effect was smaller than previously shown in an urban setting. More work is needed to evaluate the effect of the approach... | PMC10346120 | |
Objective | METASTASIS | Lumbosacral vertebral osteoblastic metastasis is treated with percutaneous vertebroplasty (PVP) combined with | PMC10731753 | |
Methods | METASTASES | We retrospectively analyzed 62 patients with lumbosacral vertebral osseous metastases treated at our hospital between 2016 and 2019. All the patients met the inclusion criteria for | PMC10731753 | |
Results | pain | Compared to the PVP treatment group, the pain level in the combined treatment group was significantly reduced ( | PMC10731753 | |
Conclusions | PVP combined | PMC10731753 | ||
Keywords | PMC10731753 | |||
Material and Methods | PMC10731753 | |||
Clinical data collection | Low back pain, pain, organ failure, primary malignant tumor, Cancer | PRIMARY TUMOR, DISEASES OF THE HEART, SPINAL METASTASES, CANCER | The subjects of this study were inpatients in the Department of Orthopedics, Chengdu Seventh People’s Hospital (Affiliated Cancer Hospital of Chengdu Medical College), between February 2016 and June 2019.The inclusion criteria were (a) clinical diagnosis of spinal metastases with a pathological diagnosis of the primary... | PMC10731753 |
Surgical materials and instruments |
Bone cement injection molding instruments and medicinesDOMEStic PVP instruments, including a puncture needle and screw-in syringe pressure device (Shandong Guanlong Company) (Fig. Percutaneous vertebroplasty devicesRadioactive sourceThe closed radioactive isotope Contrast agentWe used 76% compound meglumine injection,... | PMC10731753 | ||
Research methods | tumor, isodose | TUMOR | The injection doses of bone cement and I ions, as well as the needle insertion coordinates and depth indications of the applicator, were calculated using the treatment planning system (TPS) software. Specifically, routine preoperative examinations included routine blood tests, blood type, coagulation, blood sugar, live... | PMC10731753 |
Patient grouping | The patients treated with PVP combined with | PMC10731753 | ||
Clinical data collection | pain | We explained the purpose and significance of the clinical investigation to the patient, solicited their cooperation and trust, determined the initial visual analog pain scale (VAS) and KPS scores, and recorded the results. | PMC10731753 | |
Postoperative treatment | dehydration, infection | DEHYDRATION, INFECTION, LEAKAGE | Postoperative CT scans were used to observe the distribution of bone cement and particles in the vertebral body, whether there was bone cement leakage, among others; observe the symptoms and signs of the patient, whether there was an infection, among others; and provide preventive anti-inflammatory, hemostasis, dehydra... | PMC10731753 |
Postoperative follow-up | The patients were instructed to retest the VAS before surgery and at 1 month, 3 months, 6 months, 1 year, and 3 years after surgery to evaluate recovery. The KPS was monitored before surgery and at 1 month after surgery. | PMC10731753 | ||
Statistical methods | PRIMARY TUMOR, REGRESSION, METASTASIS | All data were analyzed using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA). A All patients in this group were scored using the KPS scoring system before and 1 month after the operation, and a Univariate analysis (Kaplan–Meier analysis) was conducted. Patients were divided into groups according to sex, age, ... | PMC10731753 | |
Results | PMC10731753 | |||
Basic information on the selected patients | METASTASIS, BONE METASTASES | In total, 62 patients with lumbosacral bone metastases were randomly divided into a PVP combined with Preclinical data analysis of 62 cases of osteoblastic metastasis in patients with lumbosacral vertebral | PMC10731753 | |
Evaluation of clinical efficacy | All patients in the combined treatment group were followed up after surgery, and the patients and their families cooperated to complete the evaluation of various efficacy indicators. At the end of the study, 14 of the 31 patients survived. Similarly, all patients in the pure PVP group were followed up after surgery, an... | PMC10731753 | ||
Univariate analysis | PMC10731753 | |||
Kaplan–Meier analysis | tumor | PRIMARY TUMOR, TUMOR, METASTASIS, METASTASES | The log-rank method was used to compare the effects of sex, age, location, KPS score, spinal segment, primary tumor growth, organ metastasis, and surgical method on the survival rate of patients. Survival curves of the survival rates are shown in Table Survival time for 62 cases of lumbosacral vertebral osteoblastic me... | PMC10731753 |
Cox regression multivariate analysis | REGRESSION, METASTASIS, METASTASES, PRIMARY TUMOR | As a multivariate survival analysis model, the Cox regression model can effectively process the final examination data, control various confounding factors, quantitatively analyze the effect strength and direction of the observation indicators, and comprehensively analyze the effect of prognostic factors. To further de... | PMC10731753 | |
Relative risk (RR value) | death, prostate cancer, pain | PRIMARY TUMOR, REGRESSION, PROSTATE CANCER | For each level of age, the risk of death increased by 3.170 times. Similarly, for each level of the spinal segment, the risk of death increased by 1.909 times, and for each level of primary tumor nature, the risk of death increased by 2.298 times.The prognostic index (PI) can be calculated according to the prognostic f... | PMC10731753 |
Acknowledgements | Not applicable. | PMC10731753 | ||
Authors’ contributions | Zuozhang | Lei Xu and Xin Huang performed the surgical operation. Yan Lou and Wei Xie performed the postoperative follow-up. Jun He and Zuozhang Yang performed statistical analysis. Yihao Yang and Ya Zhang collected the clinical data and performed the preoperative preparation. | PMC10731753 | |
Funding | This work was supported by the Chengdu Medical Research Project (2022220). | PMC10731753 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10731753 | ||
Declarations | PMC10731753 | |||
Ethics approval and consent to participate | Cancer | CANCER | This study was approved by the Department of Orthopedics, Chengdu Seventh People’s Hospital (Affiliated Cancer Hospital of Chengdu Medical College). All the patients were consented to participate. | PMC10731753 |
Consent for publication | All the patients gave consent for publication. | PMC10731753 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10731753 | ||
References | PMC10731753 | |||
Background | peripheral facial paresis | One year after persistent peripheral facial paresis (PFP), prescriptions of conventional rehabilitation are often downgraded into maintenance rehabilitation or discontinued, the patient entering what is seen as a chronic stage. This therapeutic choice is not consistent with current knowledge about behavior-induced plas... | PMC10084642 | |
Methods | nerve injury | Eighty-two adult subjects with chronic unilateral PFP (> 1 year since facial nerve injury) will be included in four tertiary, maxillofacial surgery (2), otolaryngology (1) and rehabilitation (1) centers to be randomized into two rehabilitation groups. In the experimental group, the PM&R specialist will implement the GS... | PMC10084642 | |
Discussion | peripheral facial paresis | This study will increase the level of knowledge on the effects of intense facial motor streng-
Facial paralysisthening prescribed through a GSC in patients with chronic peripheral facial paresis. | PMC10084642 | |
Trial registration | ClinicalTrials.gov, | PMC10084642 | ||
Protocol version | Version N°4.0—04/02/2021. | PMC10084642 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12883-023-03096-8. | PMC10084642 | ||
Keywords | PMC10084642 | |||
Background | PFP, Peripheral facial paresis, motor impairments, Bell’s palsy | DISORDER | Peripheral facial paresis (PFP) is a common disorder, which often affects adults between 40 and 50, with no gender predominance. PFP results from an injury to the facial nerve, from its pontine nucleus to its neuromuscular junctions; its severity depends on lesion location, cause and degree of injury. Seventy percent o... | PMC10084642 |
Objectives | nerve injury | The primary objective of this study is to evaluate changes in subjective facial motor function after six months of Guided Self-rehabilitation Contract compared to conventional therapy alone, in chronic stages following facial nerve injury. Secondary objectives include the evaluation of differences in changes between th... | PMC10084642 | |
Methods/design | PMC10084642 | |||
Ethical approval and trial registration | The VISAGE study has been designed in accordance with the Helsinki Declaration. The study protocol, patient information letter, and informed consent form have been approved by the Institutional Review Board ‘Est-III’ (Nancy, France) on October 3 | PMC10084642 | ||
Research design | peripheral facial paresis, nerve injury | VISAGE is a single-blind, prospective, controlled, randomized multicenter study in 82 participants with chronic unilateral peripheral facial paresis (> 1 year since facial nerve injury). The trial will be run in four tertiary centers, including maxillofacial surgery (2), otolaryngology (1) and neurorehabilitation (1) u... | PMC10084642 | |
Interventions | PMC10084642 | |||
Conventional therapy | In the Conventional Physical Therapy group (CONV), the study PM&R specialist prescribes physiotherapy and/or speech therapy sessions at inclusion (D-30), for a six-month period starting at D1. For this purpose, a list of physical and speech therapists specialized in PFP rehabilitation and working in the Greater Paris a... | PMC10084642 | ||
Outcome measures | Anxiety, nerve injury, paralysis, synkinesis, Depression, depressive disorders | To evaluate motor function beyond one year after facial nerve injury, the primary outcome measure will be the composite score of the Sunnybrook Facial Grading System. This scale, created by Ross et al. in 1996, assesses resting symmetry compared to the normal side for each third of the face through rating of resting sy... | PMC10084642 | |
Setting and recruitment | This multicenter trial involves four French centers: the Neurorehabilitation and the Maxillo-facial & Plastic Surgery departments at | PMC10084642 | ||
Procedures | MONDOR | This is a single-blind controlled trial, with randomization into two parallel groups, inclusion and randomization being computerized online (Cleanweb Telemedecine Technologies, France) in each investigator center. Clinical assessments, video recordings and 3D analyses of included subjects will be performed in a single ... | PMC10084642 | |
Randomization procedure | The randomization list will be computer-generated by a statistician from the Clinical Research Unit of | PMC10084642 | ||
Study population | Eligible patients must be diagnosed with stable, chronic,— | PMC10084642 | ||
Data management | All information required by the protocol will be entered in the eCRF. Data will be collected as they are obtained. Any missing data will be coded. Every site will have access to the eCRF via a web-based data collection system. Investigators will be given a document offering guidance on using this tool. Each investigato... | PMC10084642 | ||
Data monitoring | A Clinical Research Associate (CRA) appointed by the sponsor will be responsible for the proper processing of the study, for collecting, documenting, recording and reporting all handwritten data, in accordance with the Standard Operating Procedures applied within the ‘DRCI’ (Clinical Research and Innovation Department ... | PMC10084642 | ||
Harms | ADVERSE EVENTS | In this study involving human participants (as defined in category 2 of art. L1121-1 of the French Public Health Code), adverse events (serious or not) will not be notified to the sponsor. Notification will be implemented within the framework of the vigilance set up in usual care procedures. No data monitoring committe... | PMC10084642 | |
Audit | EVENT | In accordance with Good Clinical Practice, the sponsor is responsible for obtaining the agreement of all parties involved in the research to ensure direct access to all research sites, source data, source documents and reports for quality control and audit purposes by the sponsor. Investigators will make the documents ... | PMC10084642 | |
Statistical methods | PMC10084642 | |||
Sample size | paresis | MINOR, PARESIS, SECONDARY | The required number of subjects has been determined to be 82, from preliminary data in literature: to our knowledge the sole RCT about rehabilitation in subacute/chronic stages of PFP (participants enrolled from 9 months into the onset of paresis) using SFGS included 50 participants, among whom only 24 benefited from r... | PMC10084642 |
Statistical analysis | paresis | REGRESSION, PARESIS, SECONDARY | Descriptive statistical analysis will be carried out to evaluate randomization groups in terms of demographic, and initial clinical and kinematic characteristics, including PFP cause, delay since injury, side of paresis, previous drug treatments, and comorbidities. Quantitative data will be described using means (± SD)... | PMC10084642 |
Safety | Assistance Publique—Hôpitaux de Paris (APHP), sponsor of this research, has contracted an insurance for the duration of the study, in compliance with the law on biomedical research, guaranteeing its own civil liability, as well as that of any investigator or staff involved in conducting the research. | PMC10084642 | ||
Discussion | muscle overactivity, central motor disorders, chronic facial paresis, peripheral facial paresis | To our knowledge, this study will be the first controlled study evaluating a facial motor strengthening program, through the strategy of Guided Self-rehabilitation Contracts, in the challenging treatment of chronic facial paresis. The study also represents uncommon involvement of a neurorehabilitation team, classically... | PMC10084642 | |
Why facial motor strengthening in chronic facial paresis? | muscle overactivity | FACIAL PARESIS | The goal of a motor strengthening program for facial paresis is to provide for a fitter In terms of peripheral transmission of the emotional motor command, the phenomenon of activity-dependent plasticity of peripheral In terms of muscle overactivity and excitability of the peripheral motoneurone, a number of studies sh... | PMC10084642 |
Characteristics of the two rehabilitation groups | muscle overactivity | CONTRACTIONS | Several differences may be anticipated between the two rehabilitation treatments. Neither quality not quantity of rehabilitation have been imposed on the therapists involved in the control group, in order to best reflect real life. It is thus likely that frequency, techniques, duration of rehabilitation sessions will b... | PMC10084642 |
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