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Registration | This study was approved by the Human Subjects Protection Tunisia center (TN2020-NAT-INS-40) and by ClinicalTrial.gov with the approval number ClinicalTrials.gov ID: NCT04883203. The research ethical considerations were respected including free, informed, written, clear and loyal consent, confidentiality, protection, an... | PMC9940050 | ||
Results | PMC9940050 | |||
Effect of intervention on duration of viral ribonucleic acid (RNA) conversion | REGRESSION | The median duration of viral RNA conversion was 37 days (IQR: 29–45.50 days) in intervention group and 28 days (IQR: 23–39 days) in the placebo group (The recovery delays according to vitamin D supplementation (Monitoring Ct values revealed a stable trend over time in both intervention group (Scatter plots and linear r... | PMC9940050 | |
Ancillary analysis | At one year of follow-up, persistent COVID-19 symptoms were noted in 34.5% and 38.9.% of patients who received the VDs and the placebo, respectively ( | PMC9940050 | ||
Discussion | COVID-19 infection | VITAMIN D DEFICIENCY, COVID-19 INFECTION | The main results of the present study including 117 COVID-19 patients with mild-to-moderate symptoms and a positive control RT-PCR on the 14th day following the confirmation of the diagnosis are that the recovery delay was longer in the VDs group than in the placebo group. To the best of the author’s knowledge, the pre... | PMC9940050 |
Acknowledgements | The authors thank all healthcare workers as well as associations and volunteers for all the efforts they have made in the national COVID-19 containment center. | PMC9940050 | ||
Authors’ contributions | Conceptualization, A.S.B. and H.A.; methodology, A.S.B., H.A., and I.Z.; software, A.S.B, H.A., and A.M.; validation, A.S.B., H.A., and M.B.F.; formal analysis, A.M., C.B., W.D., M.K., and H.A.; investigation, S.M., M.B.B., A.N., S.N., and R.K.; resources, S.M. and CL.; data curation, A.S.B., H.A., and S.M; writing-ori... | PMC9940050 | ||
Funding | This research received no external funding. | PMC9940050 | ||
Availability of data and materials | The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request | PMC9940050 | ||
Declarations | PMC9940050 | |||
Ethics approval and consent to participate | This study was approved by the Human Subjects Protection Tunisia center (TN2020-NAT-INS-40) and by ClinicalTrial.gov with approval numberClinicalTrials.gov ID: NCT04883203. The research ethical considerations were respected including free, informed, written, clear and loyal consent, confidentiality, protection, and ass... | PMC9940050 | ||
Consent for publication | Not applicable. | PMC9940050 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9940050 | ||
References | PMC9940050 | |||
Supplementary Material | appendicitis, trauma | APPENDICITIS, COMPLICATIONS, ACUTE APPENDICITIS | While non-operative treatment has emerged as an alternative to surgery for the treatment of uncomplicated acute appendicitis in children, comparative patient-centred outcomes are not well documented. We investigated these in a feasibility randomised trial. Of 57 randomised participants, data were available for 26. Comp... | PMC9906255 |
Reviewer comments | PMC9906255 | |||
Ethics statements | PMC9906255 | |||
Patient consent for publication | Not applicable. | PMC9906255 | ||
Ethics approval | This study involves human participants and was approved by Hampshire A Research Ethics Committee (ref 16/SC/0596). Participants gave informed consent to participate in the study before taking part. | PMC9906255 | ||
References | PMC9906255 | |||
Purpose | ADVERSE REACTIONS | In the context of the current comfort medicine and enhanced recovery after surgery, there is a demand for a new anesthesia method to reduce adverse reactions and accelerate recovery after surgery. This randomized controlled trial aimed to compare the efficacy and safety between opioid-free anesthesia (OFA) combined wit... | PMC10654206 | |
Methods | nausea, vomiting | SECONDARY | In this study, 75 patients scheduled for thyroid surgery under general anesthesia were randomly allocated into two groups. The primary outcome included the incidence of nausea within 24 h after surgery. The main secondary outcomes included the incidence of vomiting and the visual analog score (VAS) scores within 24 h a... | PMC10654206 |
Results | In the OFA group, the incidence of postoperative nausea was 6.1%, compared to 39.4% in the control group ( | PMC10654206 | ||
Conclusion | nausea, pain | Compared with opioid-based anesthesia, the OFA combined with the ultrasound-guided ICPB can better improve patients' postoperative recovery, reduce nausea, and decrease pain scores. | PMC10654206 | |
Trial registration | Chinese Clinical Trial Regisrty, ChiCTR2200056344, | PMC10654206 | ||
Keywords | PMC10654206 | |||
Introduction | nausea, ICPB, bowel movements, postoperative nausea and vomiting, constipation, pain, PONV, nerve block | ADVERSE EFFECTS, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | In the past 20 years, significant advancements have been made in the application of opioids to pain control. However, with the widespread use of opioids, there is a growing awareness of their adverse effects. Among them, opioid-induced constipation and nausea are the most common side effects [Opioid-free anesthesia (OF... | PMC10654206 |
Methods | PMC10654206 | |||
Study and ethics | PONV, pain | Ethical approval for the study was granted by the Ethics Committee of Dalian Municipal Central Hospital (yn-2021-085-01). It has been registered with the Chinese Clinical Trial Regist (ChiCTR2200056344). The patient was included from February 2022 to September 2022. The written informed consent was obtained from all pa... | PMC10654206 | |
Inclusion and exclusion criteria | chronic pain, infection, thyroid tumors, coagulation dysfunction | INFECTION, CHRONIC PAIN, THYROID TUMORS, GIANT | The inclusion criteria of the trial included ASA I-II patients aged 18–70 years who underwent elective thyroid surgery. The exclusion criteria included patients with a history of neck surgery; patients with a history of infection at the surgical site; patients with coagulation dysfunction; patients with giant thyroid t... | PMC10654206 |
Randomization and blinding | pain | BLIND | The patients were allocated randomly to the OFA group or the control group according to a computer-generated random number table. Allocation to the treatment group was performed using the sealed opaque envelope technique. Sealed envelopes were marked as the OFA group or the control group and were opened only when the p... | PMC10654206 |
Outcomes | PONV, nausea, hypoxemia, pain | ADVERSE EVENTS, SECONDARY | The primary outcome included the incidence of nausea within 24 h after surgery. We use the simplified PONV impact scale by Myles et al. to record PONV [The secondary outcomes included the incidence of intraoperative hemodynamic adverse events, defined as MAP exceeding ± 20%, pulse rate > 100 beats/min or < 40 beats/min... | PMC10654206 |
Anesthesia process | hypertension, hypotensive, residual neuromuscular block | MUSCLE RELAXATION, INTRAOPERATIVE HYPERTENSION, EVENTS, HYPERTENSION, HYPOTENSIVE | The anesthetic dosage in the OFA group was determined based on previously reported methods and its feasibility was assessed in a pilot series before this study [After the patient entered the operating room and the venous access was opened, general anesthesia was induced using etomidate 0.3 mg/kg and remifentanil 1-2 μg... | PMC10654206 |
Statistical analysis | nausea | The sample size was calculated according to the incidence of nausea within 24 h after surgery in 20 patients before this experiment (the OFA group: 5%; the control group: 40%). The power analysis results of PASS software (90% power and a 5% significant level) suggested that each group should incorporate 31 patients. Co... | PMC10654206 | |
Results | PMC10654206 | |||
Study endpoints | PMC10654206 | |||
Discussion | PONV, pain | To the best of our knowledge, this is the first randomized and prospective study comparing the effects of OFA combined with ultrasound-guided ICPB and opioid-based anesthesia in thyroid surgery. These results indicate that this combined strategy is feasible. It may reduce the use of vasoactive drugs during surgery, dec... | PMC10654206 | |
Author contributions | RS | RECRUITMENT | Study design: CB, ZL. Patient recruitment: ZL, RS. Data acquisition and analysis: RS, XL. Drafting the manuscript: ZL, CB. All authors read and approved the final version of the manuscript. | PMC10654206 |
Funding | This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. | PMC10654206 | ||
Declarations | PMC10654206 | |||
Conflict of interest | The authors declare that they have no conflicts of interest. | PMC10654206 | ||
References | PMC10654206 | |||
Key summary points | PMC9902414 | |||
Aim | To evaluate the effect of a transitional care intervention among older medical inpatients. | PMC9902414 | ||
Findings | The follow-home transitional care intervention did not have an impact on readmission and mortality rates. | PMC9902414 | ||
Message | In a real-world context, several aspects make it difficult to measure the true impact of a multicomponent intervention. | PMC9902414 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s41999-022-00730-5. | PMC9902414 | ||
Purpose | readmission | To evaluate the effect of a transitional care intervention (TCI) on readmission among older medical inpatients. | PMC9902414 | |
Methods | This non-randomised quasi-experimental study was conducted at Horsens Regional Hospital in Denmark from 1 February 2017 to 31 December 2018. Inclusion criteria were patients ≥ 75 years old admitted for at least 48 h. First, patients were screened for eligibility. Then, the allocation to the intervention or control grou... | PMC9902414 | ||
Results | The study included 1205 patients (intervention: | PMC9902414 | ||
Conclusion | The TCI did not impact readmission, mortality or DAOH. Future research should conduct a pilot test, address intervention fidelity and consider real-world challenges. | PMC9902414 | ||
Trial registration | Clinical trial number: NCT04796701. Registration date: 24 February 2021. | PMC9902414 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s41999-022-00730-5. | PMC9902414 | ||
Keywords | PMC9902414 | |||
Introduction | readmissions | ADVERSE EVENTS | Transitions between hospital and primary care settings are identified as high-risk scenarios for patient safety that often result in adverse events, such as unplanned readmissions [Transitional care interventions (TCIs) are one strategy for preventing readmissions. Transitional care is defined as ‘a set of actions desi... | PMC9902414 |
Methods | PMC9902414 | |||
Design and setting | This study was a non-randomised quasi-experimental study conducted at Horsens Regional Hospital from 1 February 2017 to 31 December 2018. Horsens is a public hospital in the Central Denmark Region with 21,746 acute hospital admissions in 2017 and a total of 240 beds. The hospital receives patients primarily from the fo... | PMC9902414 | ||
Population | Patients were eligible for inclusion if they met the following criteria: ≥ 75 years old, living in the municipalities of Odder, Skanderborg, Hedensted or Horsens and had been admitted to Medical Ward 2 for at least 48 h. Each weekday morning, patients were screened for inclusion criteria. If the patient was eligible fo... | PMC9902414 | ||
Intervention group | In addition to usual care, patients were offered the follow-home TCI if they lived in the municipalities of Hedensted, Odder or Skanderborg at the time of the index admission. All patients in the intervention group signed an informed consent form. Eligible patients were consecutively approached and enrolled. | PMC9902414 | ||
Control group | Patients living in the municipality of Horsens at the time of the index admission received the usual care. The control group was identified through the CROSS-TRACKS register [All relevant legal approvals to collect data on the intervention and control groups were obtained. For details, see Declarations.The study is rep... | PMC9902414 | ||
Follow-home intervention | ‘The Template for Intervention Description and Replication (TIDieR) Checklist and Guide’ [ | PMC9902414 | ||
Intervention development | The intervention was originally developed in an urban setting in Denmark [ | PMC9902414 | ||
Delivering the intervention | Three healthcare professionals from Medical Ward 2 were dedicated as project workers. Two were registered nurses with four and 12 years of job experience, respectively, and one was a social and healthcare assistant with 17 years of experience. | PMC9902414 | ||
Intervention components | disease deterioration | Overall, the hospital-based intervention consisted of three components covering the pre-discharge and post-discharge phases.Pre-discharge phase: discharge transportation and home visitOn the day of discharge, patients were physically escorted home from the hospital by a project worker, either in a project car or by bed... | PMC9902414 | |
Usual care | The usual care was provided equally to all patients in the intervention and control group, thus all patients receive the same level of standard care. At Horsens Regional Hospital, planning of the discharge begins no later than the second day after hospital admission. Overall, the nurses are responsible for the daily as... | PMC9902414 | ||
Variables and data sources | PMC9902414 | |||
Outcome measures | SECONDARY | The primary outcome was the all-cause 30-day unplanned readmission rate. The secondary outcomes were (1) the all-cause mortality rate measured at 30 and 90 days after discharge and (2) days alive and out of hospital (DAOH) and without GP visits (DAOHGP).Readmission was defined as any unplanned hospital admission within... | PMC9902414 | |
Data sources | Data were obtained from CROSS-TRACKS [ | PMC9902414 | ||
Statistical analysis | Comorbidity | REGRESSION | The power analysis was calculated based on readmission rates of 22% in the control group and 12% in the intervention group [Data management and statistical analysis plans were conducted prior to the study.We used chi-square tests to describe and compare the baseline characteristics. When observations were not normally ... | PMC9902414 |
Ethics | Approval was obtained from the Danish Data Protection Agency (case no. 1-16-02-105-19). The CROSS-TRACKS case no. was 008-2. Approval by the Central Denmark Region Ethical Committee was not required. Patients in the intervention group could withdraw their consent at any time. The intervention did not harm any patients.... | PMC9902414 | ||
Patient and public involvement | Neither the patients nor the public were involved in planning or evaluating this study. | PMC9902414 | ||
Results | PMC9902414 | |||
30-day readmission | readmission | In total, 128 patients (20.8%) in the intervention group and 119 (20.2%) in the control group were readmitted within 30 days after discharge from index admission. No difference in the risk of readmissions was found between the groups in the adjusted analysis (RR: 1.00; 95% CI: 0.80, 1.26; The sub-group analysis showed ... | PMC9902414 | |
30-day mortality | One hundred and fifteen (18.7%) patients from the intervention group and 108 (18.3%) from the control group died within 30 days after discharge. The adjusted risk for 30-day mortality was 1% higher in the intervention group than in the control group (RR: 1.01; 95% CI 0.80, 1.29; The Kaplan–Meier survival estimates of 3... | PMC9902414 | ||
90-day mortality | In total, 166 (27.0%) in the intervention group and 151 (25.6%) in the control group died within 90 days after discharge, resulting in a slightly higher adjusted risk of 7% (RR: 1.07; 95% CI 0.89, 1.30; The Kaplan–Meier survival estimates of 90-day mortality are displayed in Fig. Kaplan–Meier survival estimates of 90-d... | PMC9902414 | ||
Days alive and out of hospital (DAOH) | In the intervention and control groups, 646 (75.5%) and 453 (76.8%) patients, respectively, were alive and out of hospital for more than 23 days within 30 days after discharge. This corresponds to a slightly lower adjusted risk of 2% in the intervention group compared with the control group (RR: 0.98; 95% CI 0.92, 1.05... | PMC9902414 | ||
Days alive and out of hospital and GP visit (DAOHGP) | Almost similar numbers were seen when GP visits were taken into account. In other words, 433 (70.4%) of the patients in the intervention group were alive and out of hospital and had not visited the GP for more than 23 days within 30 days after discharge. The number was 434 (73.6%) for the patients in the control group.... | PMC9902414 | ||
Other analysis | SE | The risk of 30-day readmission two years before the intervention was 20.06% in the intervention group (Hedensted, Odder and Skanderborg) and 24.92% in the control group (Horsens). The risk after the intervention was 20.81% in the intervention group and 20.17% in the control group. Hence, the risk difference was + 0.75%... | PMC9902414 | |
Other results | ADVERSE EVENTS | No significant modifications were made to the intervention during the study period, and no adverse events were reported. | PMC9902414 | |
Discussion | weakness | The intervention did not have a significant impact on 30-day readmission, 30- and 90-day mortality rates, DAOH or DAOHGP, as all RRs were close to 1. The no evidence of effect is generally caused by weakness in the design, implementation failure or no intervention effect. Plausible explanations to the lack of intervent... | PMC9902414 | |
Comparison with previous research | Unfortunately, the results of no intervention impact on the outcome measures are common in the research field of TCIs. Over the last couple of decades, research has shown diverging effects on readmission and mortality among older medical patients. Some studies have reported positive impacts, while others have reported ... | PMC9902414 | ||
Design | readmissions | Our intervention consisted of three components and was, thus, a low-intensity intervention.A systematic review comparing the effects of different TCIs on readmissions among older medical patients found a noticeable impact among ‘high-intensity’ interventions and in interventions with duration of 1 month or more [Additi... | PMC9902414 | |
Programme implementation | infidelity | Some of the intervention components took a long time to implement in the municipalities. Most of the patients, relatives, district nurses and GPs in the three intervention municipalities did not use the seven-day telephone consultation offer in the first period of the study. The degree of usage and implementation could... | PMC9902414 | |
Concurrent municipality-based projects and home care services | readmissions | The initiative ‘Get Home Safe’ in Horsens home care was implemented during the study period. The aims were to (1) ensure the feeling of safe transitions from the hospital to patients’ own homes or community beds and (2) prevent hospital (re)admissions. As Horsens municipality served as our study’s control group, this i... | PMC9902414 | |
Study population | comorbidity, impaired nutritional status | DISEASES | The inclusion criteria in this study were few and broad, resulting in a rather unselected and heterogeneous population. Thus, the group comprised patients representing various of conditions, diseases and severities. This unselected patient group could lead to a null effect. A systematic review found a pronounced positi... | PMC9902414 |
Readmission and other outcomes | The difference in readmission rates between the groups was smaller after the intervention than before. The decreased risk difference over time was attributed to the control group. The rate decreased in the control group, while it was constant over time in the intervention group. Therefore, it seems that the interventio... | PMC9902414 | ||
Strengths and limitations | Our study has several strengths. Using CROSS-TRACKS’s wide range of data is a major strength. This enables detailed descriptions of the study population and a wide variety of sub-group analyses.The heterogeneous population of general medical patients reflects a real-world population in regional hospital settings. This ... | PMC9902414 | ||
Clinical and research implications | This study illustrates the ‘real-world’ challenges in planning, implementing and evaluating a TCI in an ever-changing setting, with a complex study population and a long study period. To address this, it is essential to plan the study thoroughly based on previous research findings and to conduct pilot tests prior to im... | PMC9902414 | ||
Conclusion | weakness | This modified TCI consisting of a discharge transportation, home visit, cross-sectorial video conference and seven-day telephone showed no evidence of effect. We do not know whether this was caused by implementation failure, weakness in the study design, lack of intervention effect or uncontrollable factors in the prim... | PMC9902414 | |
Acknowledgements | We would like to thank the included patients, the primary healthcare in Hedensted, Odder and Skanderborg municipalities and healthcare professionals at Horsens Regional Hospital for their assistance during this study. | PMC9902414 | ||
Author contributions | All authors listed have contributed to the conception or design, or the acquisition, analysis or interpretation of data. The corresponding first author, LFR, drafted the work, and all co-authors critically revised the work. All authors approved the final version and are accountable for all aspects of the work in ensuri... | PMC9902414 | ||
Funding | This work was supported by (1) the Fund for Advancement of Health Research in the Central Denmark Region (grant number N/A) and (2) The National Pool Fund ‘Continuity of care for the frail elderly’ (grant number N/A). | PMC9902414 | ||
Data availability | All data relevant to the study are included in the article or uploaded as supplementary information. | PMC9902414 | ||
Declarations | PMC9902414 | |||
Conflict of interest | All authors have signed the ICMJE Disclosure Statement, and the authors have no relevant financial or non-financial interests to disclose. | PMC9902414 | ||
Consent to participate | Informed consent was obtained from all participants included in the intervention group. | PMC9902414 | ||
Ethical approval | Approval was obtained from the Danish Data Protection Agency (case no. 1-16-02-105-19). The CROSS-TRACKS case no. was 008-2. Approval by the Central Denmark Region Ethical Committee was not required. Patients in the intervention group could withdraw their consent at any time. The intervention did not harm any patients.... | PMC9902414 | ||
References | PMC9902414 | |||
Materials and Methods | PMC10312059 | |||
Subjects | somatic illness, nausea, psychiatric disorder, substance abuse | HEARING IMPAIRMENT, CARDIAC ARRHYTHMIAS, DRUG ALLERGY | One hundred and sixty 18- to 30-year-old healthy, ASA 1 (according to the American Society of Anesthesiologists physical status classification system), right-handed volunteers participated in the study. The trial (NCT0262440) was approved by the Ethics Committee of the Hospital District of Southwest Finland and the Fin... | PMC10312059 |
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