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Nagoya Journal of Medical Science May 2022The number of patients with ischemic cardiovascular diseases is significantly increasing as populations age. Therapeutic angiogenesis has been developed as a new... (Review)
Review
The number of patients with ischemic cardiovascular diseases is significantly increasing as populations age. Therapeutic angiogenesis has been developed as a new treatment strategy for such patients. In recent years, the presence of mesenchymal stem cells in adipose tissues was reported, and regenerative medicine using these cells has attracted attention worldwide. In this review, we describe how the transplantation of adipose-derived regenerative cells enhances angiogenesis and tissue regeneration because of their multilineage potential and cytokine secretion. Then, the current status of therapeutic angiogenesis using adipose-derived regenerative cells in the field of cardiovascular medicine was also described. These cells present great advantages over bone marrow mononuclear cells, as these need easier, shorter, and less invasive preparations as well as less ethical concerns and immunological problems. The efficacy of adipose-derived regenerative cell transplantation in the treatment of various diseases was examined in several clinical trials with favorable results. Currently, a multicenter study of therapeutic angiogenesis using these cells is being conducted in patients with critical limb ischemia. In conclusion, we expect that this method will soon be established as a treatment for cardiovascular diseases that have been refractory to conventional treatments.
Topics: Adipose Tissue; Cardiovascular Diseases; Humans; Ischemia; Multicenter Studies as Topic; Stem Cell Transplantation; Wound Healing
PubMed: 35967953
DOI: 10.18999/nagjms.84.2.208 -
BMC Palliative Care Dec 2022Since 2016, France is the only country in the World where continuous deep sedation until death (CDSUD) is regulated by law. CDSUD serves as a response to refractory...
The APSY-SED study: protocol of an observational, longitudinal, mixed methods and multicenter study exploring the psychological adjustment of relatives and healthcare providers of patients with cancer with continuous deep sedation until death.
BACKGROUND
Since 2016, France is the only country in the World where continuous deep sedation until death (CDSUD) is regulated by law. CDSUD serves as a response to refractory suffering in palliative situations where the patients' death is expected to occur in the following hours or days. Little is known on the psychological adjustment surrounding a CDSUD procedure for healthcare providers (HCPs) and relatives. Our study aims to gather qualitative and quantitative data on the specific processes behind the psychological adjustment of both relatives and HCPs, after the administration of CDSUD for patients with cancer.
METHODS
The APSY-SED study is a prospective, longitudinal, mixed-methods and multicenter study. Recruitment will involve any French-speaking adult cancer patient for who a CDSUD is discussed, their relatives and HCPs. We plan to include 150 patients, 150 relatives, and 50 HCPs. The evaluation criteria of this research are: 1/ Primary criterion: Psychological adjustment of relatives and HCPs 6 and 13 months after the death of the patient with cancer (psychological adjustment = intensity of anxiety, depression and grief reactions, CDSUD-related distress, job satisfaction, Professional Stress and Professional experience). Secondary criteria: a)occurrence of wish for a CDSUD in patients in palliative phase; b)occurrence of wish for hastened death in patients in palliative phase; c)potential predictors of adjustment assessed after the discussion concerning CDSUD as an option and before the setting of the CDSUD; d) Thematic analysis and narrative account of meaning-making process concerning the grief experience.
DISCUSSION
The APSY-SED study will be the first to investigate the psychological adjustment of HCPs and relatives in the context of a CDSUD procedure implemented according to French law. Gathering data on the grief process for relatives can help understand bereavement after CDSUD, and participate in the elaboration of specific tailored interventions to support HCPs and relatives. Empirical findings on CDSUD among patients with cancer in France could be compared with existing data in other countries and with results related to other medical fields where CDSUD is also conducted.
TRIAL REGISTRATION
This protocol received the National Registration Number: ID-RCB2021-A03042-39 on 14/12/2021.
Topics: Adult; Humans; Emotional Adjustment; Deep Sedation; Prospective Studies; Health Personnel; Neoplasms; Observational Studies as Topic; Multicenter Studies as Topic
PubMed: 36464684
DOI: 10.1186/s12904-022-01106-z -
BMJ Open Jun 2022Recent studies on cognitive training in patients with Alzheimer's disease (AD) showed positive long-term effects on cognition and daily living, suggesting remote...
INTRODUCTION
Recent studies on cognitive training in patients with Alzheimer's disease (AD) showed positive long-term effects on cognition and daily living, suggesting remote computer-based programmes to increase training sessions while reducing patient's travelling. The aim of this study is to examine short-term and long-term benefits of computer-based cognitive training at home in patients with mild to moderate AD, as a complement to the training in speech and language therapists' (SLT) offices. The secondary purpose is to study training frequency required to obtain noticeable effects.
METHODS AND ANALYSES
This is a national multicentre study, conducted in SLT offices. The patients follow training in one of three conditions: once a week in SLT office only (regular condition) and once a week in SLT office plus one or three times per week at home. The trainings' content in SLT office and at home is identical. For all three groups near and far transfer will be compared with evaluate training frequency's effect. Our primary outcome is executive and working memory scores in experimental tasks, and the secondary is neuropsychological tests and questionnaires' scores. Linear models' analyses are considered for all measures with a random intercept for patients and another for per practice. The fixed effects will be: three modality groups and time, repeated measures, (T0-pretraining, T1-post-training, T2-long-term follow-up) and the interaction pairs.
ETHICS AND DISSEMINATION
The study got ethics approval of the national ethical committee CPP Sud Méditerranée III (No 2019-A00458-49) and of the National Commission for Information Technology and Liberties (No 919217). Informed consent is obtained from each participant. Results will be disseminated in oral communications or posters in international conferences and published in scientific journals.
TRIAL REGISTRATION NUMBER
NCT04010175.
Topics: Alzheimer Disease; Cognition; Humans; Memory, Short-Term; Multicenter Studies as Topic; Neuropsychological Tests; Research Design
PubMed: 35725247
DOI: 10.1136/bmjopen-2021-050993 -
BMJ Open Aug 2022To gain consensus on the items that determine adequacy of shift staffing. (Review)
Review
OBJECTIVES
To gain consensus on the items that determine adequacy of shift staffing.
DESIGN
This was a three-round Delphi study to establish consensus on what defines adequacy of shift staffing in a general hospital ward. A literature review, focus group and five semistructured expert interviews were used to generate items for the Delphi study.
SETTING
Multicentre study in The Netherlands.
PARTICIPANTS
Nurses, head nurses, nursing managers, and capacity consultants and managers working for Dutch hospitals.
RESULTS
Twenty-six items were included in the Delphi study. One hundred and sixty-eight, 123 and 93 participants were included in the first, second and third round, respectively. After three rounds, six items were included (mostly related to direct patient care) and nine items were excluded. No consensus was reached on 12 items, including one item that was added after the first round.
CONCLUSIONS
This is the first study to specify items that determine adequacy of staffing. These items can be used to measure adequacy of staffing, which is crucial for enhancing nurse staffing methods. Further research is needed to refine the items of staffing adequacy and to further develop and psychometrically test an instrument for measuring staffing adequacy.
Topics: Consensus; Delphi Technique; Hospitals, General; Humans; Multicenter Studies as Topic; Patients' Rooms; Workforce
PubMed: 35918122
DOI: 10.1136/bmjopen-2021-058403 -
BMJ Open May 2023There is no established methodology for the perioperative management of head and neck cancer surgery and free tissue transfer reconstruction (HNS-FTR). A single dose of...
Preoperative steroid for enhancing patients' recovery after head and neck cancer surgery with free tissue transfer reconstruction: protocol for a phase III, placebo-controlled, randomised, double-blind study (J-SUPPORT 2022, PreSte-HN Study).
INTRODUCTION
There is no established methodology for the perioperative management of head and neck cancer surgery and free tissue transfer reconstruction (HNS-FTR). A single dose of corticosteroid administered immediately before surgery has been shown to reduce postoperative pain and nausea/vomiting after some types of surgery. However, the efficacy of this strategy has not been demonstrated in HNS-FTR, and the increased risk of infectious complications associated with its use cannot be ruled out. This phase III, placebo-controlled, randomised, double-blind, comparative, multicentre study seeks to determine if preoperative administration of corticosteroid hormone has an adjunctive effect in terms of reducing pain and nausea/vomiting after surgery and improving the quality of postoperative recovery.
METHODS AND ANALYSIS
Using the minimisation method, patients undergoing HNS-FTR are currently being recruited and randomly assigned to a study arm at a 1:1 allocation rate. The study treatment arm consists of 8.0 mg of dexamethasone phosphate dissolved in 100 mL of saline administered as a single dose by intravenous infusion. These treatments will be administered in a double-blind fashion. All patients will receive perioperative care according to the common multicentre enhanced recovery after surgery programme. The primary endpoint is the quality of postoperative recovery, as determined by the area under the curve (AUC) for total score on the Japanese version of the Quality of Recovery Score (QOR-40J) on postoperative days 2 and 4. The point estimate and CI for the difference in the AUC between the groups on postoperative days 2 and 4 will be calculated.
ETHICS AND DISSEMINATION
The study will be performed in accordance with the Declaration of Helsinki and Japan's Clinical Trials Act. The study protocol was approved by the Certified Review Board of National Cancer Center Hospital East (Reference K2021004).
TRIAL REGISTRATION NUMBER
The study was registered in the Japan Registry of Clinical Trials (jRCTs031210593; V.3.0, November 2021, available at https://jrct.niph.go.jp/en-latest-detail/jRCTs031210593).
Topics: Humans; Double-Blind Method; Nausea; Vomiting; Steroids; Head and Neck Neoplasms; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Clinical Trials, Phase III as Topic
PubMed: 37258074
DOI: 10.1136/bmjopen-2022-069303 -
Trials Nov 2023Providing optimal care for critically ill patients is an extremely important but also highly demanding task, both emotionally and physically. The "ICU Support" team...
BACKGROUND
Providing optimal care for critically ill patients is an extremely important but also highly demanding task, both emotionally and physically. The "ICU Support" team meeting concept aims to support intensive care unit (ICU) teams by promoting interprofessional communication, peer support, and patient safety by providing a structure for daily team meetings. This protocol describes a study to explore the effectiveness of "ICU Support" for patient- and staff-centered outcomes.
METHODS
ICU Support will be implemented at nine university hospitals located in Germany, following a two-arm randomized parallel group design with an intervention and a control condition and three data collection periods. In the intervention arm, leading ICU personnel (physicians and nurses) will be trained in ICU Support and implement the ICU Support elements into the daily work routine of their units upon completion of data collection period T0 (baseline). In the control arm, ICU Support will not be implemented until the completion of the data collection period T1 (1 month after study start). Until then, the regular daily schedule of the ICU teams will be maintained. The final data collection period (T2) will take place 4 months after the start of the study. Primary outcomes include the number of intensive care complications per patient during their ICU stay during T1 and the sick-related absence of ICU staff during T1. Secondary outcomes include, among others, the average severity of intensive care complications per patient and employee self-reported data regarding their teamwork and patient safety behaviors.
DISCUSSION
The need for healthy and well-trained ICU staff is omnipresent; thus, structured and evidence-based interventions aimed at supporting ICU teams and facilitating patient safety are required. This multicenter study aims to explore the effectiveness of ICU Support for patient- and staff-centered outcomes. The insights derived from this study have the potential to significantly improve ICU patient safety, staff communication, and connectedness and decrease sickness-related expenses and social costs associated with high work demands among ICU staff.
TRIAL REGISTRATION
German Clinical Trials Register DRKS00028642 . Registered on 4 April 2022.
Topics: Humans; COVID-19; SARS-CoV-2; Intensive Care Units; Critical Care; Patient-Centered Care; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 38008760
DOI: 10.1186/s13063-023-07754-7 -
Wiener Klinische Wochenschrift Sep 2021The aim of this study was to determine whether the neutrophil to lymphocyte ratio (NLR) can predict severe Coronavirus disease 2019 (COVID-19). (Meta-Analysis)
Meta-Analysis
PURPOSE
The aim of this study was to determine whether the neutrophil to lymphocyte ratio (NLR) can predict severe Coronavirus disease 2019 (COVID-19).
PATIENTS AND METHODS
A multicenter case-control study was conducted to investigate whether the NLR can help predict the severity of COVID-19. Patients confirmed to have COVID-19 between 16 January 2020 and 15 March 2020 were enrolled. Furthermore, meta-analyses were conducted based on both previous studies and our case-control study.
RESULTS
In the case-control study, 213 patients (severe: 81) were included. The results suggested that the NLR was an independent risk factor (odds ratio [OR], 1.155, 95% confidence interval [95% CI]: 1.043-1.279, P = 0.006) and a great predictor (the area under the ROC curve was 0.728, 95% CI: 0.656-0.800) for severe COVID-19. In total, 18 datasets from 16 studies combined with our case-control study (severe: 1211; non-severe: 5838) were included in the meta-analyses and the results showed that the NLR of the severe COVID-19 group was significantly higher than that of the non-severe group (SMD = 1.10, 95% CI: 0.90-1.31, P < 0.001). Based on the 2 × 2 data from 6 studies, the SROC of NLR for predicting severe COVID-19 was 0.802, with a sensitivity of 0.67 (95% CI: 0.61-0.72) and a specificity of 0.75 (95% CI: 0.73-0.78).
CONCLUSION
Based on a multicenter case-control study and a meta-analysis, we found that the initial NLR was a great predictor of severe COVID-19.
Topics: COVID-19; Case-Control Studies; Humans; Lymphocyte Count; Lymphocytes; Multicenter Studies as Topic; Neutrophils; Prognosis; Retrospective Studies; SARS-CoV-2
PubMed: 34342712
DOI: 10.1007/s00508-021-01917-9 -
Journal of Medical Ethics Mar 1991
Topics: Ethics, Medical; Multicenter Studies as Topic; Research
PubMed: 2033632
DOI: 10.1136/jme.17.1.45 -
Frontiers in Public Health 2023Multicenter clinical trials play an indispensable role for assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous...
BACKGROUND
Multicenter clinical trials play an indispensable role for assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous studies have shown that these studies often suffer from inadequate reporting of key details related to their design, implementation, and analysis, both in the protocol and final reports. This limitation reduces the practical and scientific value of the findings. Furthermore, the lack of guidance on how to report multicenter features can contribute to poor reporting. Therefore, this study aims to develop guidelines to improve the reporting of multicenter trials, including two Extensions of the CONSORT 2010 and the SPIRIT 2013.
METHODS/DESIGN
The standard methodology for developing health research reporting guidelines involves the following steps: (i) Identifying the need for development and launching the research project; (ii) Preparing the registration and reviewing the literatures; (iii) Proposing the initial Checklists and conducting the Delphi exercise; (iv) Arranging the consensus meeting and formulating the Checklists; (v) Conducting the pilot test and drafting explanatory documents (E&E); (vi) Seeking comments from advisory group and finalizing the guidelines; and (vii) Developing the publication and dissemination strategies.
CONCLUSION
By using the CONSORT and SPIRIT checklists as starting points, the development of extensions specific to multicenter trials can help researchers design and report high-quality clinical research. This, in turn, can facilitate the application of study findings in the current evidence-based healthcare system.
Topics: Checklist; Consensus; Multicenter Studies as Topic; Research Design; Research Report
PubMed: 37780430
DOI: 10.3389/fpubh.2023.1241152 -
PloS One 2023Mental health is a significant concern for patients diagnosed with glaucoma, as visual impairment can have a profound impact on psychological well-being. Conversely,...
INTRODUCTION
Mental health is a significant concern for patients diagnosed with glaucoma, as visual impairment can have a profound impact on psychological well-being. Conversely, psychological vulnerability in glaucoma patients can negatively influence treatment adherence to ocular hypotensive therapy, thereby potentially exacerbating disease progression in a vicious cycle. The study protocol proposed herein aims to explore the impact of psychological states such as anxiety, depression, and stress on both medication adherence and progression of glaucoma.
MATERIALS AND METHODS
This study is to be a prospective multicenter study conducted at four tertiary medical centers. Patients recently diagnosed with glaucoma and not yet treated will be enrolled. Anxiety, depression, and stress scales will be administered at baseline, one year, and two years, along with glaucomatous assessments to be performed every six months. Validated questionnaires (Generalized Anxiety Disorder Assessment [GAD-7], Patient Health Questionnaire [PHQ-9], and Perceived Stress Scale-10 [PSS-10]) will assess anxiety, depression, and stress, respectively. The primary objective is to correlate post-diagnosis psychological status with medication adherence and disease progression. The effects of pre- and post-diagnosis changes in anxiety, depression, and stress on disease progression will be analyzed. Kaplan-Meier survival analysis and logistic regression will be performed to identify clinical characteristics associated with increased risk of developing anxiety, depression, and stress in glaucoma patients.
Topics: Humans; Prospective Studies; Glaucoma; Anxiety Disorders; Anxiety; Disease Progression; Depression; Multicenter Studies as Topic
PubMed: 37816064
DOI: 10.1371/journal.pone.0292599