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Intervention protocol
stroke
STROKE
Patients in the control group were managed according to the standard anesthetic techniques at the discretion of the attending anesthesiologists without any specific protocol. The attending anesthesiologists made all decisions regarding the amount and rate of fluid administration and the use of vasoconstrictors and inot...
PMC10561433
Outcome measures
blood loss, thromboembolic, gastrointestinal, infectious
POSTOPERATIVE COMPLICATIONS, BLOOD LOSS, POSTOPERATIVE COMPLICATION, DISEASE, WOUND DEHISCENCE, NEUROLOGIC COMPLICATION, COMPLICATIONS
All data were prospectively collected based on the standard format of our protocol. Patients’ medical history and demographic information, including age, sex, height, weight, ASA physical status classification, underlying disease, and history of any intraperitoneal surgery within the last 5 years, were collected. The f...
PMC10561433
Statistical analysis
The primary analysis used a per-protocol analysis to focus on the efficacy of GDHT, including only patients who strictly followed the protocol. Intention-to-treat analysis was also conducted as a sensitivity analysis to provide insight into the effectiveness of GDHT in diverse clinical settings. Data are presented as m...
PMC10561433
Results
arrhythmia, PCD, COPD, chronic obstructive pulmonary diseaseTable, renal dysfunction
COPD, ARRHYTHMIA, POSTOPERATIVE COMPLICATIONS
Among the 159 eligible patients, 77 patients were excluded due to preoperative renal dysfunction, patient refusal, arrhythmia, and other reasons (Fig.  Study flowchart Demographic and baseline medical statusData are expressed as mean ± standard deviation, number (percentage), or median (interquartile range). *This was ...
PMC10561433
Discussion
bladder cancer
SYSTEMIC DISEASE, POSTOPERATIVE COMPLICATIONS, COMPLICATION, BLADDER CANCER, COMPLICATIONS
This study investigated the effect of intraoperative GDHT on postoperative complications in patients who underwent open radical cystectomy. The intervention and control groups showed no significant difference in the incidence of overall complications during the hospital stay. There were also no significant differences ...
PMC10561433
Conclusions
POSTOPERATIVE COMPLICATIONS
In summary, we did not find any benefit of GDHT in terms of in-hospital postoperative complications during the hospital stay in the patients who underwent open radical cystectomy. Future research should focus on developing multi-disciplinary, individualized protocols and reliable hemodynamic indicators that reflect the...
PMC10561433
Electronic supplementary material
Below is the link to the electronic supplementary material. Supplementary Material 1 Supplementary Material 2 Supplementary Material 3 Supplementary Material 4 Supplementary Material 5
PMC10561433
Acknowledgements
None.
PMC10561433
Authors’ contributions
Study conception/design: Min Hur, Jin-Tae KimData acquisition/analysis/interpretation: Hyun-Kyu Yoon, Min Hur, Dong Hyuk Kim, Ja Hyeon KuDrafting of paper: Hyun-Kyu Yoon, Min Hur, Jin-Tae KimRevising of paper critically for important intellectual content: Hyun-Kyu Yoon, Jin-Tae KimFinal approval of paper: all authors.
PMC10561433
Funding
None.
PMC10561433
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10561433
Declarations
PMC10561433
Ethics approval and consent to participate
This study was approved by the Institutional Review Board of Seoul National University Hospital (Seoul, Republic of Korea, Approval number: 1712-125-909) and registered at ClinicalTrials.gov (NCT03505112, Date of registration: 23/04/2018, principal investigator: Jin-Tae Kim). The study was conducted in accordance with ...
PMC10561433
Consent for publication
Not applicable.
PMC10561433
Competing interests
The authors declare no competing interests.
PMC10561433
References
PMC10561433
Introduction
heart failure
CHRONIC HEART FAILURE, DISEASE, HEART FAILURE
One of the frequent issues that lowers elderly people's quality of life is chronic heart failure, a progressive and life-limiting disease. The purpose of this study was to evaluate the effects of home-based palliative care (HBPC) on the quality of life of elderly patients with heart failure who received discharge order...
PMC10481455
Methods
heart failure
HEART FAILURE
One hundred heart failure patients were divided into two intervention and control groups for this randomized clinical trial study. The patients were then given the pre-test questionnaires, such as the demographic questionnaire and the Quality of Life Index (QLI) by Ferrans and Powers. The intervention group was given t...
PMC10481455
Results
heart failure
HEART FAILURE
The mean age for the elderly in the intervention and in the control groups were 69.46 ± 11.61 and 66.14 ± 12.09 years, respectively. The palliative care program at home made a statistically significant difference in the quality of life and all of its components in the elderly with heart failure in the intervention grou...
PMC10481455
Conclusion
HEART FAILURE
Home-based palliative care has a positive effect on the quality of life for elderly people who have heart failure, making it a worthwhile intervention to enhance their quality of life.
PMC10481455
Trial registrations
(IRCT20211213053389N1). Date of registration: (19/02/2022).
PMC10481455
Keywords
PMC10481455
Introduction
death, HF, heart disease, aging disorder, heart failure
DISEASE, HEART FAILURE, AGING DISORDER, HEART DISEASE
A common aging disorder is heart failure (HF). HF is an advanced heart problem and one of the main causes of death and burden in many countries, particularly in low- and middle-income countries, mostly in the Eastern Mediterranean Region [Numerous studies have demonstrated that people with heart disease experience vari...
PMC10481455
Methodology
PMC10481455
Participants
This experimental study was carried out as a randomized controlled clinical trial with a 1:1 allocation ratio in the heart departments of hospitals affiliated with the Kerman University of Medical Sciences from December 2021 to September 2022. The number and accessibility of patients were the deciding factors in select...
PMC10481455
Sampling
heart failure
HEART FAILURE, DISEASE
Elderly patients with heart failure who were discharged from hospitals affiliated with the Kerman University of Medical Sciences made up the study population. The Centers for Disease Control and World Health Organization defined aged populations as ≥ 65 chronological years in human studies. By definition, older adults ...
PMC10481455
Randomization
In this study, 100 eligible patients were selected through convenience sampling and were then assigned to the control and intervention groups through permuted block randomization. The allocation sequence was performed using the free web system Explanation of sample size and sampling
PMC10481455
Data collection
PMC10481455
Instruments
diabetes
DISEASE, GASTROINTESTINAL DISORDERS, DIABETES
A three-part questionnaire was used to collect demographic and background information form and standard Ferrans and Powers' Quality of Life Index (QLI), to meet the study's objectives. The tools used in this study were translated into Persian, and the language of the used instruments was Persian.The patient's age, gend...
PMC10481455
Quality of Life Index (QLI)
The cardiovascular patients' quality of life was assessed using the Quality of Life Index (QLI) developed by Ferrans and Powers (1984). This 70-item survey instrument uses a 6-item Likert scale to measure four factors underlying the QLI: health, socioeconomic, psychological/spiritual, and family connections (1 to 6). T...
PMC10481455
Intervention
heart failure
DISEASE, CHRONIC HEART FAILURE, HEART FAILURE
The researcher visited the coronary care units (CCUs) of hospitals affiliated with the Kerman University of Medical Sciences to conduct the study and obtained the required approvals. Using the convenience sampling technique, the researcher divided the selected eligible patients into intervention and control groups. The...
PMC10481455
Data analysis
REGRESSION
SPSS software version 22 was used to enter and save patient data. The data on the demographic and quantitative variables were summarized using absolute and relative frequency, mean, and standard deviation. The normality of the data was checked using the Kolmogorov–Smirnov test. The data were analyzed with the chi-squar...
PMC10481455
Ethical Considerations
This study was conducted following the ethical code IR.KMU.REC.1400.633 issued by Kerman University of Medical Sciences and the arrangements made with the officials at Razi Nursing and Midwifery College and hospital management. Some instructions were provided to the participants about the objectives of the study, volun...
PMC10481455
Discussion
heart failure symptoms
HEART FAILURE
The present study examined the effectiveness of HBPC in the quality of life of older adults with heart failure. The findings showed no significant difference in the pre-intervention QOL scores between the intervention and control groups. The home-based palliative care program significantly improved the quality of life ...
PMC10481455
Conclusion
heart failure
HEART FAILURE
The findings showed that patients with heart failure who received HBPC had a higher quality of life. Improving the quality of life of elderly heart failure patients requires significant palliative care in addition to symptom management. Hence, palliative care should be incorporated into the treatment of this particular...
PMC10481455
Limitations
heart failure symptoms, fatigue
One of the limitations of this study was that the patients refused to attend the sessions due to fatigue brought on by heart failure symptoms. By placing restrictions on participation in the study, attempting to win patients' trust and cooperation, and encouraging patients to attend intervention sessions at times that ...
PMC10481455
Acknowledgements
heart failure
HEART FAILURE
The authors would like to appreciate the cooperation of heart failure patients who participated in the study, the collaboration of the Research Council, the officials at Kerman University of Medical Sciences, and the staff in the CCUs of hospitals affiliated with Kerman University of Medical Sciences.
PMC10481455
Authors’ contributions
E.N, and P.MS wrote the main manuscript text and  M.HK. prepared figures 1-3. All authors reviewed the manuscript.
PMC10481455
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
PMC10481455
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
PMC10481455
Declarations
PMC10481455
Ethics approval and consent to participate
This project was approved by the Ethics Committee of Kerman University of Medical Sciences with the ethics code IR.KMU.REC.1400.633. The protocol for this study was registered under the number IRCT20211213053389N1 on February 19, 2022. In all stages of the research project, the ethical principles mentioned in the Helsi...
PMC10481455
Consent for publication
Not applicable.
PMC10481455
Competing interests
The authors declare no competing interests.
PMC10481455
References
PMC10481455
Purpose
spinopelvic, Pelvic fragility fractures
Pelvic fragility fractures have steadily risen over the past decades. The primary treatment goal is the fastest possible mobilisation. If conservative therapy fails, surgical fixation is a promising approach. This study compares the outcome of bisegmental transsacral stabilisation (BTS) and spinopelvic fixation (SP) as...
PMC10175409
Methods
blood loss, fracture, pain
BLOOD LOSS, COMPLICATIONS
We performed a prospective, non-randomised, case-controlled study. Patients were included if they remained bedridden due to pain despite conservative treatment. Group assignment depended on sacral anatomy and fracture type. The outcome was estimated by blood loss calculation, cut-seam time, fluoroscopy time, complicati...
PMC10175409
Results
blood loss
BLOOD LOSS, URINARY TRACT INFECTIONS
Seventy-three patients were included (SP: 49, BTS: 24). There was no difference in blood loss (BTS: 461 ± 628 mL, SP: 509 ± 354 mL). BTS showed a significantly lower cut-seam time (72 ± 23 min) than SP (94 ± 27 min). Fluoroscopy time did not differ (BTS: 111 ± 61 s vs. 103 ± 45 s). Thirteen percent of BTS and 16% of SP...
PMC10175409
Conclusion
Blood loss
BLOOD LOSS
Both methods allow early mobilization of BFFS patients. Blood loss can be kept low. Hence, transfusion requirement is correspondingly low. The IMC/ICU and the total inpatient stay are lower than reported in the literature. Both BTS and SP can be recommended as safe and low-complication methods for use in BFFS patients....
PMC10175409
Supplementary Information
The online version contains supplementary material available at 10.1007/s00068-022-02123-6.
PMC10175409
Keywords
PMC10175409
Introduction
spinopelvic, fractures, blood loss
BLOOD LOSS, FRAGILITY FRACTURE, COMPLICATIONS
Fragility fractures of the pelvis (FFP) in the geriatric population are steadily increasing since the past few decades [In cases of FFP, purely transsacral fractures occur in up to two-thirds of cases [The literature describes a variety of different surgical stabilisation procedures for the treatment of BFFS. In additi...
PMC10175409
Patients and methods
H-type fracture, fracture, dysplasia, pain, trauma
DYSPLASIA
In this single-centre, prospective, non-randomised, case-controlled study (evidence level 2), the perioperative outcome results of patients with minimally invasive, stabilised BFFS (FFP4b) [Bisegmental transsacral fixation was used whenever two transsacral bone corridors at the S1 and S2 segment level could be used for...
PMC10175409
Before start of complaints
Epidemiological data such as age, sex, height, and weight were used to assess group equality. During inpatient admission, the patients were interviewed about their individual life situation and social integrity. The physical condition was assessed with the Modified Frailty Index 5 (mFI5) [
PMC10175409
Perioperative phase
loss of blood volume, pain
At the time of study enrolment, all patients were by definition immobile because of pain despite adequate medical analgesia. The individual outcome was estimated by evaluation of surgical-side effects reflected in the perioperative circulation management. The loss of blood volume (BV
PMC10175409
Postoperative inpatient course
COMPLICATIONS
Demand and duration of treatment on an intensive/intermediate care unit (ICU/IMC) as well as total duration of inpatient stay were recorded to reflect the impact of surgical intervention to postoperative outcome. Complications occurring during this phase were also recorded. The accommodation status following hospitalis...
PMC10175409
Statistical analysis
To compare the ratio of sexes between the BTS and SP cohorts, Pearson’s Chi-square test (Fisher exact) was used. For the comparison of epidemiological data (age, body height and weight, BMI); mFi5; mobility level; and Hb
PMC10175409
Results
spinopelvic, fracture
Out of 124 patients with BFFS, 73 were indicated for surgical therapy given the ongoing pain-related immobility after conservative treatment. According to the above-mentioned criteria for individual fracture morphology and sacral anatomy, 49 and 24 patients, respectively, were treated with SP and BTS. Overall, 89% (Des...
PMC10175409
Before start of complaints
AIDS
Twenty-two (92%) patients in the BTS group lived independently at home. Two patients (8%) lived in assisted living facilities. In the SP group, 44 (90%) patients lived independently at home, three (6%) were in assisted living, and two (4%) patients had previously lived in a nursing home. No significant differences coul...
PMC10175409
Perioperative phase
pain
COMPLICATIONS
All patients were bedridden because of pain at the time of study inclusion. The preoperative laboratory analysis showed comparable HbGraph showing comparison of BVAll 73 surgical procedures (SP: 49, BTS: 24) were performed by three experienced pelvic surgeons either by themselves (total: 44, SP: 29, BTS: 15) or as a su...
PMC10175409
Postoperative inpatient course
infections, cardiac diseases, haematoma
NEUROLOGICAL COMPLICATION, URINARY TRACT INFECTIONS, CARDIAC DISEASES, INFECTIONS, HAEMATOMA, COMPLICATIONS
In the total cohort, 62 (85%) patients could be transferred back to the peripheral general ward directly after surgery. Eleven (15%) patients (8/49 [16%] in the SP group and 3/24 [13%] in the BTS group) required temporary care in an ICU/IMC postoperatively, but no significant differences were noted (Postoperative inpat...
PMC10175409
Discussion
thrombosis, primarily urinary tract infections, pneumonia, pelvic fractures, blood loss, fracture, prerenal renal failure, organ dysfunction, implant failure
THROMBOSIS, PNEUMONIA, URINARY TRACT INFECTIONS, BLOOD LOSS, COMPLICATION, SECONDARY, COMPLICATIONS
The perioperative outcome of geriatric patients with FFP is primarily limited by the underlying individual comorbidities. This can only be positively influenced to a limited extent during acute inpatient treatment. Therefore, surgical treatment should aim at mobilizing patients as quickly as possible to prevent seconda...
PMC10175409
Conclusion
blood loss
BLOOD LOSS
According to the results of this study, an early mobilisation of BFFS patients in stance and gait can already be achieved in the immediate postoperative inpatient setting with both the BTS and SP methods. This is an expression of the fact that both methods can achieve sufficient mechanical stabilisation of the posterio...
PMC10175409
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 17 KB)
PMC10175409
Funding
Thomas
This work was funded by Investitionsbank Sachsen-Anhalt - Research and Development to Thomas Mendel.
PMC10175409
Declarations
PMC10175409
Conflict of interest
The authors declare that they have no conflict of interest.
PMC10175409
Ethical approval
This article does not contain any studies with animals performed by any of the authors. The study was approved by the independent Medical Ethics Committee of the Medical Council of Saxony-Anhalt, Germany, and confirmed under approval no. 32/16.
PMC10175409
References
PMC10175409
Background
Edited by: Ahmad Alkhatib, University of Taipei, TaiwanReviewed by: Lokesh Tiwari, All India Institute of Medical Sciences, India; Roohangiz Nashibi, Ahvaz Jundishapur University of Medical Sciences, IranThis article was submitted to Digital Public Health, a section of the journal Frontiers in Public HealthThe initial ...
PMC10034105
Methods
MAY, COVID-19 INFECTION
This was a randomized controlled trial conducted at the Narayana Hrudyalaya, Bengaluru, India, on hospitalized patients with mild-to-moderate COVID-19 infection enrolled between 31 May and 22 July 2021. The patients (
PMC10034105
Results
As compared with the standard of care alone, the proportional odds of having a higher score on the 7-point ordinal scale on day 14 were ~1.8 for the adjunct tele-yoga group (OR = 1.83, 95% CI, 1.11–3.03). On day 5, there were significant reductions in CRP (
PMC10034105
Conclusion
The observed 1.8-fold improvement in the clinical status on day 14 of patients of COVID-19 with adjunct use of tele-yoga contests its use as a complementary treatment in hospital settings.
PMC10034105
Introduction
pneumonia
PNEUMONIA
The rapid global spread of the coronavirus-related pneumonia outbreak, which was described first in December 2019, led to the evolution of one of the most extensive pandemics in human history so far (
PMC10034105
Design and amendments
MAY, RECRUITMENT
The protocol was approved by the Institutional Ethics Committee of Narayana Health City and conducted in compliance with the Declaration of Helsinki. The study protocol was approved for funding by the Department of Science and Technology, Government of India. All patients or legally authorized representatives provided ...
PMC10034105
Participants
Given a significant proportion of the requirement for timely hospitalization and management of patients with COVID-19, we recruited hospitalized patients with COVID-19 in this trial. Patients with mild and moderate COVID-19 were referred and managed at the Mazumdar Shaw Medical Center, Narayana Hrudyalaya, Bengaluru, I...
PMC10034105
Inclusion criteria
infection
INFECTION
Age 18–60 years old, both genders.Willing and able to provide written informed consent prior to performing study procedures.Oxygen saturation measured by pulse oximetry (SpOSARS-CoV-2 infection confirmed by PCR test ≤ 4 days before randomization.
PMC10034105
Exclusion criteria
MOD, dementia, multiple organ dysfunction
RESPIRATORY FAILURE, SEPTIC SHOCK
Breastfeeding and pregnant patients were excluded based on their declaration and pregnancy test results when required.Patients with SpOPatients diagnosed with critical COVID-19: respiratory failure, septic shock, and/or multiple organ dysfunction (MOD) or failure (MOF).Already enrolled in another COVID-19 trial or cur...
PMC10034105
Outcomes
SECONDARY
We used the seven-category ordinal scale that has been used in different COVID-19 therapeutic trials (All the patients provided written or electronic informed consent before randomization. The secondary outcome set included the following: scores on the COVID Outcomes Scale on day 7, follow-up for clinical status and al...
PMC10034105
Clinical and laboratory monitoring
PMC10034105
Assessments
ADVERSE EVENTS, DISEASE PROGRESSION, DISEASE
Data were collected daily, from randomization until day 28, in the patient proforma. For patients who were discharged before day 7, structured telephone calls were made to the patient or the family on days 7, 14, and 28 by an interviewer who was unaware of the assigned trial group to assess the vital status and return ...
PMC10034105
Intervention
INFLAMMATION, CONTRACTION
We built a yoga protocol adjusted to isolated patients and staff, including delivery through tele-(videos) and in-person intervention. The recorded videos were used for the asynchronous delivery of tele-intervention. Instructional short videos were prepared in different languages constituting the intervention. While th...
PMC10034105
Standard of care
The standard of care was based on the recommendations of the Indian Council of Medical Research, which was updated as per the evolving evidence generated in drug trials and international consensus guidelines (
PMC10034105
Randomization
Randomization was done in permuted blocks of four in sequences created by the unblinded research staff in Microsoft Excel version 19.0 who provided masked allotment to the yoga trainers. Owing to the nature of the intervention, blinding was not possible, but outcome measures were blinded for the randomization groups. E...
PMC10034105
Statistical analysis
PMC10034105
Sample size calculation
REGRESSION, REGRESSION
The sample size of 230 patients with a 1:1 randomization of adjunct tele-yoga to the standard of care provides ~80% power to detect a 15% difference between treatment groups in time cumulative hospital discharge (i.e., with or without limiting abilities) rates of 80% in the adjunct tele-yoga group and 75% in the standa...
PMC10034105
Primary outcome
hypothyroid, coronavirus disease, diabetes
HYPOTHYROID, HYPERTENSION, DIABETES
For the analysis of outcomes, 113 and 112 patients were included for the adjunct tele-yoga and the standard of care groups, respectively; the analysis was by the originally assigned groups. The primary outcome (status on the 7-point ordinal scale on day 14) was assessed in all patients who were still hospitalized on da...
PMC10034105
Secondary outcomes
There were significant differences between the adjunct tele-yoga and standard care groups in terms of improvement in clinical status on the 7th day (partially adjusted for age odds ratio, 3.61; 95% CI, 2.11–6.05; Biomarker levels on day 5 post-randomization. Changes in the biomarkers on day 5 were analyzed with respect...
PMC10034105
Adverse effects
deaths
None of the eight deaths through day 28 [five (1%) in the standard of care, and three (2%) in the adjunct tele-yoga group] occurred in the patients with COVID-19 could be attributed to the tele-yoga intervention (
PMC10034105
Discussion
breathlessness
DISEASE, COMPLICATIONS
This study is a pioneer clinical trial that investigated the short-term acute interventional benefits of adjunct tele-yoga practice for the clinical management of hospitalized patients with COVID-19. We could establish a ~1.9-fold improvement in the clinical status on the 14th day, in hospitalized patients with mild an...
PMC10034105
Data availability statement
Datasets are available on request to the corresponding author.
PMC10034105
Ethics statement
The study protocol was approved by the Institutional Ethics Committees of the Narayana Health City and Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India. The patients provided their written informed consent to participate in this study.
PMC10034105
Author contributions
MR, RNay
VM, RNag, and NM take responsibility for the integrity of the data and the accuracy of the data analysis and drafting of the manuscript. RNag, NM, and VM contributed to concept and design. SP, SS, AG, MR, RNay, and VM contributed in acquisition, analysis, or interpretation of data. NM, RNag, MK, and HN did critical rev...
PMC10034105
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10034105
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10034105
Supplementary material
The Supplementary Material for this article can be found online at: Click here for additional data file.
PMC10034105
References
PMC10034105
Objective:
early-stage borderline personality disorder
Preliminary evidence indicates that interventions designed to support family and friends (‘carers’) of young people with early-stage borderline personality disorder effectively improve carer outcomes. None of these interventions have been tested in a randomised controlled trial.
PMC10619189
Method:
borderline personality disorder, BPD
This clustered, partially nested, randomised controlled trial was conducted at Orygen, Melbourne, Australia. Carers of young people (aged 15–25 years) with borderline personality disorder features were randomly assigned as a unit in a 1:1 ratio, balanced for young person’s sex and age, to receive a 15-day intervention ...
PMC10619189
Results:
A total of 79 carers were randomised (pool of 281, 197 excluded, 94 declined) and 73 carers (51 females [69.9%], M
PMC10619189