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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 inotropes. Patients in the GDHT group were managed according to the predefined GDHT algorithm (Fig.
Algorithm for goal-directed hemodynamic therapySVI stroke volume index, MAP mean arterial pressure, CI cardiac index, NE norepinephrine, TTE transthoracic echocardiography, TEE transesophageal echocardiography | 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 following intraoperative and postoperative data were also recorded: type of urinary diversion, operation duration, anesthesia duration, intraoperative and postoperative fluid intake, amount of transfusion, estimated blood loss, intraoperative use of inotropes/vasopressors, and durations of hospital and intensive care unit (ICU) stays. We recorded eGFR, serum creatinine, and C-reactive protein (CRP) on postoperative day (POD) 1, and any changes in these parameters during the hospital stay were also recorded.The primary outcome was the incidence of a composite of in-hospital postoperative complications. Postoperative complications included seven categories according to the organ system: gastrointestinal, infectious, wound-related (wound dehiscence), cardiac, thromboembolic, genitourinary, and neurologic complications. These complications were assessed according to the Clavien-Dindo classification for radical cystectomy [ | 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 mean ± standard deviation, median (interquartile range), or number and percentage. The normality of the distribution of continuous variables was tested using the Kolmogorov–Smirnov test. Continuous variables were analyzed using the Student’s | PMC10561433 |
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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 obtained from 72 patients (37 patients for the GDHT group and 35 patients for the control group, respectively)GDHT: goal-directed hemodynamic therapy, ASA: American Society of Anesthesiologists, COPD: chronic obstructive pulmonary diseaseTable
Comparisons of intraoperative characteristics between two groupsData are expressed as number (percentage), median (interquartile range), or mean ± standard deviationGDHT: goal-directed hemodynamic therapy, CI: confidence interval, RBC: red blood cell, MAP: mean arterial pressure, ICU: intensive care unit
Comparisons of postoperative fluid balance between two groupsData are expressed as median (interquartile range)GDHT: goal-directed hemodynamic therapy, CI: confidence intervalRegarding the primary outcome, there was no significant difference in the incidence of a composite of in-hospital postoperative complications (28/39 [71.8%] vs. 30/36 [83.3%], risk difference [95% CI], -0.12 [-0.30 to 0.07],
Comparisons of postoperative complications and clinical outcomes between two groupsData are expressed as numbers (percentages) or median (interquartile range)GDHT: goal-directed hemodynamic therapy, CI: confidence interval, NA: not applicable, BNP: brain natriuretic peptide, PCD: percutaneous catheter drainage, PCN: percutaneous nephrostomy, ICU: intensive care unit
Grades of postoperative complications by the Clavien-Dindo classificationData are expressed as numbers (percentages)GDHT: goal-directed hemodynamic therapy, CI: confidence interval
Changes in postoperative laboratory results. ( | 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 in the incidence of each of the seven complications, duration of hospital stays, and the grade of complications. Changes in postoperative eGFR, serum creatinine, and CRP were comparable between the two groups.Radical cystectomy is the standard therapy for localized bladder cancer with muscle invasion [In the present study, GDHT did not lead to improved postoperative outcomes. Several reasons might explain this result. First, the two groups had no significant difference in the amount of fluid administered during surgery. Although the amount of fluid administration during surgery was low in the GDHT group, the difference between the groups was not statistically significant. The changes in the trends for administering less fluid during surgery and improvements in perioperative care due to the adoption of the enhanced recovery after surgery (ERAS) protocol may have affected these results [Previous studies have reported a U-shaped association between fluid administration during surgery and mortality, indicating that too much or too little intraoperative fluid administration may harm the patients [Our study had some limitations that need to be addressed. First, the sample size was calculated based on the total complication rate of 40% calculated in the preliminary investigation, but the actual complication rate in our study was much higher. This discrepancy may be attributed to the retrospective nature of the pilot study, which likely had missing data on postoperative complications. Second, since the accuracy and reliability of SVI and CI, used as indicators of the patient’s hemodynamic status in the GDHT protocol and obtained by arterial pulse contour analysis, are limited, this limitation might have influenced our results. Third, we did not include an assessment of baseline hemodynamic status at the awake state, which may raise uncertainty about the accuracy of post-induction assessment reflecting the individual patient’s baseline requirement. Fourth, we excluded patients with severe systemic diseases to minimize their potential influence on the effect of GDHT. However, these exclusion criteria also led to the omission of high-risk patients, thereby limiting the generalizability of our study. Hence, further large-scale randomized controlled trials are needed to confirm the benefits of individualized hemodynamic management in high-risk patients undergoing radical cystectomy. Fifth, due to an overly optimistic setting of the effects of GDHT on reducing postoperative complications, our study could be underpowered to detect a significant difference in the primary outcome. Sixth, the involvement of multiple surgeons and changes in anesthesia practice during the study period may have introduced confounding factors to our results. Lastly, we chose a per-protocol analysis to gauge the efficacy of GDHT more accurately. However, we acknowledge that this analysis could introduce biases and may not represent real-world practice despite aligning with the intention-to-treat analysis. | 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 paradigm shift in perioperative patient management. | PMC10561433 |
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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 |
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Acknowledgements | None. | PMC10561433 |
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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 |
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Funding | None. | PMC10561433 |
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Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10561433 |
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Declarations | PMC10561433 |
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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 the Declaration of Helsinki, and written informed consent was obtained from all the patients. | PMC10561433 |
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Consent for publication | Not applicable. | PMC10561433 |
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Competing interests | The authors declare no competing interests. | PMC10561433 |
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References | PMC10561433 |
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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 orders from hospitals affiliated with Kerman University of Medical Sciences in 2022. | 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 the home care plan. To measure the quality of life one month after the intervention, the quality of life questionnaire was lastly filled out by both groups following the last care session. Software called SPSS 22 was used to enter and analyze the patient data. | 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 group immediately after the intervention and one month after the intervention compared to before ( | 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 |
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Trial registrations | (IRCT20211213053389N1). Date of registration: (19/02/2022). | PMC10481455 |
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Keywords | PMC10481455 |
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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 various negative physical, psychological, emotional, and spiritual consequences. The combination of these symptoms restricts the patients' daily activities and makes it difficult for them to handle personal and social responsibilities, which lowers their quality of life. On the other hand, a decrease in quality of life is directly related to frequent hospitalizations and increased patient mortality. The World Health Organization (WHO) defines the quality of life as “an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns” [Palliative care has received support recently as part of the treatment of patients with heart failure [As the symptoms of these patients start affecting their quality of life, the burden of the disease increases, and thus, while the treatment for the disease continues, an advanced care plan is needed to increase the comfort of patients and relieve their symptoms [ | PMC10481455 |
Methodology | PMC10481455 |
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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 selecting these centers. | PMC10481455 |
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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 are identified as individuals ≥ 65 [ | 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 |
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Data collection | PMC10481455 |
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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, gender, marital status, occupation, income, level of education, smoking status, length of the disease, number of prior heart-related hospitalizations, history of disease education, and other conditions like gastrointestinal disorders, diabetes, and blood pressure were measured using a demographic information questionnaire. Besides, the Quality of Life Index (QLI; Ferrans & Powers, 1984) was used to measure the patient’s quality of life. | 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). There are 35 items in each section, and items addressing the importance and satisfaction are similar. There are 15 items for measuring the health and functioning dimension, eight items for measuring the socioeconomic status, seven for measuring the psychological/spiritual dimension, and five items for measuring the family connections dimension. The scores were calculated using the Syntax program. To center the scale on zero and arrive at the QOL score, we subtracted 3.5 from the satisfaction response for each item, producing scores–2.5, -1.5, -0.5, + 0.5, + 1.5, and + 2.5. The scores of each option in the importance section were multiplied by the numbers obtained in the subsequent step. The outcomes from each option were then combined. The sum of the scores was then divided by the number of answered items, which ranged from + 15 to -15, to eliminate the impact of unanswered items. The range of scores was then established from 0 to 30, and the negative scores were eliminated by adding a fixed amount of + 15 to each of the calculated numbers.Accordingly, a score of 0–9 indicated a poor quality of life, 10–19 indicated a moderately good quality of life, and 20–30 indicated a good quality of life. Cronbach's alpha for the QLI (total scale), which ranged from 0.73 to 0.99 in 48 studies, supported the internal consistency of the scale. Furthermore, the alpha ranges for the four subscales were as follows: 0.70 to 0.94 for the health and functioning subscale; 0.78 to 0.96 for the psychological/spiritual subscale; 0.71 to 0.92 for the socioeconomic subscale; and 0.63 to 0.92 for the family connections subscale [ | PMC10481455 |
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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 patients were given the necessary information about the research objectives, and their written informed consent was obtained.The older adults in the intervention group attended 8 individual sessions for one and a half hours twice a week. The home-based palliative heart failure program was conducted for one month with prior arrangements with the patients. The older adults in the control group only received routine care during this time. The intervention was delivered by one of the authors who was a senior cardiovascular nurse and was familiar with the interventions. The program focused on information about the disease, mental and physical aspects of self-care for old client and their families, an examination of coping strategies in stressful situations, and techniques to boost self-confidence (Table The content of the HBPC programDuring the intervention, the researcher performed the nursing assessment, education, and counseling and provided emotional support to patients. At the first visit, the researcher assessed the patients’ knowledge and abilities in self-management, their family support system, and their educational and counseling needs including symptoms and self-care of heart failure. An educational brochure was also provided to the patients. The brochure provided some instructions about heart failure, symptom management and monitoring, medication use, and the date of follow-up. The first face-to-face intervention session focused on enhancing participants’ knowledge about the effect of home-based palliative care on heart failure.The researcher would provide emotional support to patients, encouraged them to express their feelings, listened actively to patients’ responses, reassured the patients that their feelings were normal, and supported them in taking small steps to resolve the problem. In addition, the researchers provided 24-h phone calls for the participants to help them solve their problems. Every week after 2 face-to-face session interventions, the researchers contacted the patients by phone at home to assess potential problems and to make an appointment for the next intervention. Finally, the follow-up evaluations conducted after the 8The researcher completed the questionnaire for the intervention and control groups before the first session (before the intervention) and after the last session (after the intervention). The researcher re-completed the questionnaires for the intervention and control groups over the phone at the scheduled times after one month had passed (follow-up). The content of the intervention was constructed based on the guide for the care of patients with advanced chronic heart failure at home, which was compiled by the Secretariat of the Strategic Council for the Development of Health Guidelines of the Ministry of Health and Medical Education of Iran. In designing the intervention, the clinical guidelines for the management of chronic heart failure, which were compiled by the Department of Standardization and Compilation of Clinical Guidelines and the Office of Technology Evaluation, Standardization and Health Tariff of the Ministry of Health and Medical Education of Iran, were used. Also, the content of the intervention is based on the country's ethical guidelines on the subject of supportive palliative care in patients at the end of life, which were prepared by the Medical Ethics Department of the Endocrine and Metabolism Research Institute of Tehran University of Medical Sciences and supported by the World Health Organization Office in the Ministry of Health and Medical Education of Iran. Finally, the validity and caliber of the intervention were assessed by palliative care specialists at Kerman University of Medical Sciences. | 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-square test, independent samples t-test, and repeated measures ANOVA. The impact of each independent variable on the outcome variables was assessed using multivariate linear regression analysis with a test power of 0.80 and a significance level of 0.05. | PMC10481455 |
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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, voluntary entrance to and withdrawal from the study, and the application of the results. If required, the authorities were also given access to the findings. The study was conducted based on the legal, ethical, and professional norms of the community. The protocol for this study was registered under number IRCT20211213053389N1 on 19/02/2022. | PMC10481455 |
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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 and all its components for the patients in the intervention group immediately after the intervention compared to the pre-intervention phase. However, there was significant difference in the QOL scores for the patients in the control group but these changes were less than the intervention group. These findings were in line with the results reported by Hosseini et al. [In line with the findings reported by Wong et al. [The results revealed that the group receiving palliative care at home and the control group differed in terms of the quality of life one month after the intervention, as reported by Bahadur et al. [In addition, Greener et al. discovered that palliative care can enhance patients' quality of life and lessen their heart failure symptoms [ | 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 group of patients because it places a strong emphasis on comprehensive care. We recommend further exploration of the role of HBPC for diverse populations and its impact on health equity. Additionally, while the majority of studies have addressed older adults, no study has examined partnerships between geriatric medicine and palliative care specialists. Future research may clarify whether multidisciplinary collaboration across palliative care, primary care, and geriatric medicine offers unique benefits for home-bound patients. One area for strengthening palliative care trials is explicitly basing them in behavioral intervention and theories of palliative care delivery and studies should be designed to identify the active ingredients of effective palliative care and their causal pathways in impacting outcomes. | 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 did not conflict with their routines and treatment, it was attempted to solve the problem. | PMC10481455 |
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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 |
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Funding | The author(s) received no financial support for the research, authorship, and/or publication of this article. | PMC10481455 |
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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 |
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Declarations | PMC10481455 |
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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 Helsinki Statement were followed. The researcher gave oral and written information and obtained written informed consent from all participants before the interviews. Participation was voluntary, and the participants had the right to withdraw at any time. All procedures were carried out following associated guidelines and regulations. All stages of the study were approved by the Kerman University of Medical Sciences. | PMC10481455 |
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Consent for publication | Not applicable. | PMC10481455 |
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Competing interests | The authors declare no competing interests. | PMC10481455 |
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References | PMC10481455 |
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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 minimally invasive techniques for bilateral fragility fractures of the sacrum (BFFS). | PMC10175409 |
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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, complications, duration of stay at the intensive/intermediate care unit (ICU/IMC), and total inpatient stay. The mobility level at discharge was recorded. | 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 patients required ICU/IMC stay (BTS: 0.6 ± 1.8 days, SP: 0.5 ± 1.5 days) during inpatient stay (BTS: 9 ± 4 days, SP: 8 ± 3 days). Fourteen patients suffered from urinary tract infections (BTS: 8%; SP: 25%). In-patient mortality was low (BTS: 4.2%, SP: 4.1%). At discharge, the BTS group was almost back to the initial mobility level. In SP patients, mobility was significantly lower than before complaints ( | 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. BTS is superior to SP with respect to surgery duration and level of mobility at discharge. | PMC10175409 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00068-022-02123-6. | PMC10175409 |
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Keywords | PMC10175409 |
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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 addition to the classic sacroiliac screw fixation with [Hence, the aim of this study was to compare the perioperative outcome of the bisegmental transsacral stabilisation (BTS) and spinopelvic fixation (SP) as two specific minimally invasive fixation techniques of the posterior pelvic ring in BFFS with regard to surgical side influences on blood loss, complications, postoperative mobility, and social integrity. | 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 fracture fixation (Fig. a and b X-ray pelvic overview (If an H-type fracture with TFC below the first sacral corpus or a sacral dysplasia was present [a and b X-ray pelvic overview (All patients were operated in prone position. Additional stabilisation of the anterior pelvic ring was consistently omitted, as the authors are of the opinion that in FFP, the ligamentary integrity is usually not impaired in a relevant manner due to the low-energy trauma.Between 2015 and 2018, a total of 124 BFFS patients were treated at our hospital. The diagnosis was usually confirmed with a pelvic radiography and computed tomography. In some cases, a contralateral sacral lesion was detected only after additional magnetic resonance imaging (MRI). Conservative treatment was initially attempted in all cases with the aim of early functional full weight-bearing under adequate pain medication WHO Level 3 for a total of 3–5 days [ | 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 |
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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 |
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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 hospitalisation and the mobility level at the time of discharge was recorded to assess the treatment-related impairment of patient’s independency. | PMC10175409 |
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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 |
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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% (Descriptive data of bisegmental transsacral stabilization (BTS) and spinopelvic (SP) fixation group | PMC10175409 |
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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 could be found between both groups. The dependence on orthopaedic aids in the time before the onset of complaints compared to the time of discharge is presented later in the text. | PMC10175409 |
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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 supervising assistant during training procedures (total: 29, SP: 20, BTS: 9), each of whom has an annual caseload of at least 20 pelvic procedures per year beyond this study. The comparison of the cut-seam time (a and b Graph showing significant differences of In the intraoperative course, there were no complications with either of the two surgical methods. | 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 inpatient length of stay of both groups with/without the need for treatment in an ICU/IMC ward. Bars represent the postoperative days for the individual patients (dark grey—ICU/IMC, light grey—normal ward). The error bars show the mean and standard deviation within the cohort. The rhombus symbolises a patient’s deathNeither in the SP nor in the BTS group implant malposition or neurological complications occurred. Preoperatively, a total of 12 patients were on anticoagulant medication with coumarin derivatives or direct oral anticoagulants due to previous cardiac diseases (SP: 11, BTS: 1). Of these, six patients could be switched preoperatively to a low molecular weight heparin in a prophylactic dose. In six other cases, surgery had to be performed under therapeutic anticoagulation (SP: 6, BTS: 0). One of these developed a wound haematoma requiring revision surgery. Implant-associated complications or infections did not occur in either group. Fourteen patients suffered from uncomplicated urinary tract infections (BTS: Before the onset of complaints (TP1), there was no significant difference between the groups in terms of mobility (BTS: 4.0 [3.3–5.0] versus SP: 4.0 [2.0–5.0], Comparison of mobility level of SP and BTS groups related to examination time pointsAt TP1, 97% of the entire population lived at home. At TP3, 19% of all patients could be discharged directly to the home environment. 50% of all patients could be transferred to an inpatient rehabilitation facility with good rehabilitation potential. Due to comorbidities requiring treatment or an increased need for care, 25% were transferred to an acute geriatric ward or short-term care. Table Overview of the living conditions before the onset of complaints and after the inpatient treatment in relation to and the surgical method used | 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 secondary complications such as pneumonia, thrombosis, and urinary tract infections. This includes adequate fracture stabilisation for sufficient relief of symptoms. At the same time, surgical invasiveness and perioperative blood loss should be kept to a minimum to prevent haemorrhagic circulatory depression with resulting organ dysfunction such as prerenal renal failure [Regarding minimally invasive stabilization of pelvic fractures, Riesner et al. described an external blood loss of only 70 mL on average in a study of 23 triangular stabilizations [The duration of surgery is considered a trigger for the incidence of secondary complications, especially in elderly patients. Consequently, surgery should be kept as short as possible. Vanderschot et al. reported a mean operation time of 60 min for the implantation of a single transsacral rod in 19 patients [The length of inpatient stay correlates significantly with the loss of independence, the degree of care dependency, and the rate of institutionalized accommodation [Intraoperative and secondary complications can significantly affect the perioperative outcome. Gericke et al. recorded a general complication rate of 28.4% in 74 minimally invasive treated FFP patients, primarily urinary tract infections. The reported rate of surgical-side complications was 9.5%, and the leading cause was implant failure in 6.8% of cases [The 1-year mortality rate of geriatric patients with FFP is reported in the literature to be between 10 and 27% [Only a few studies describe the course of treatment immediately following the acute inpatient stay. Kanakaris et al. differentiated FFP patients into the following four categories: unaided community ambulatory, aided community ambulatory, household ambulatory, and non-functional ambulatory. In 56.6% cases, patients were able to regain their pre-injury status after one year, while 32% lost one and 11.3% lost two status levels [The prospective design of our comparative cohort study is a major strength. In addition, the groups compared are very homogeneous both in terms of epidemiological data and regarding the consideration of one specific fracture type. However, our study also has some limitations. The choice of osteosynthesis procedure was based on the individual anatomy of the sacrum and the described fracture types [ | 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 posterior pelvic ring. Due to the minimally invasive procedure in each case, blood loss can be kept low, whereby the calculation based on the Hb balance is a reliable method that takes both external and internal blood loss into account. The transfusion requirement is correspondingly low. The required duration of an intensive care stay as well as a total inpatient stay are low when compared to the reported times in the published literature. Both BTS and SP are recommended to be safe and low-complication surgical methods for use in geriatric patients with FFP4b injuries. However, BTS is superior to SP with respect to the duration of surgery and the mobility level attained at discharge. | PMC10175409 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 17 KB) | PMC10175409 |
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Funding | Thomas | This work was funded by Investitionsbank Sachsen-Anhalt - Research and Development to Thomas Mendel. | PMC10175409 |
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Declarations | PMC10175409 |
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Conflict of interest | The authors declare that they have no conflict of interest. | PMC10175409 |
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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 |
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References | PMC10175409 |
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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 insights from the studies on COVID-19 had been disappointing, indicating the necessity of an aggravated search for alternative strategies. In this regard, the adjunct potential of yoga has been proposed for enhancing the effectiveness of the standard of care with respect to COVID-19 management. We tested whether a telemodel of yoga intervention could aid in better clinical management for hospitalized patients with mild-to-moderate COVID-19 when complemented with the standard of care. | PMC10034105 |
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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 |
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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 |
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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 |
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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 written informed consent. Given the uncertainty in the recruitment and random allocation of the study subjects in chaotic hospital settings amid the pandemic, the trial was initially planned as a non-randomized clinical trial wherein an integrative yoga-based supportive care was planned to be administrated as an adjunct intervention for hospitalized patients with COVID-19. However, the protocol was amended on 14 May 2020, based on the emerging feasibility of conducting the randomization trial as emphasized by the clinicians due to the superior design of randomized vs. non-randomized trials. The study was registered at the clinical trial registry of India (CTRI/2020/09/027915, registered on 21/09/2020). | PMC10034105 |
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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, India. SARS-CoV-2 cases, confirmed by polymerase chain reaction (PCR), were included as mild or moderate according to FDA guidance with the following eight symptoms: ( | PMC10034105 |
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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 currently on any physiotherapy-based interventions.Unable to provide informed consent (e.g., moderate–severe dementia diagnosis).Those with more than 4 L per minute of supplemental oxygen ( | 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 all-cause mortality on the 28th-day post-randomization, duration of days at the hospital, 5th-day changes post-randomization for viral load expressed as cyclic threshold (Ct), and inflammatory markers and perceived stress scores on day 14. Other auxiliary markers were HbA1c, blood hemogram, and kidney function markers. All protocol amendments were authorized and approved by the institutional review board or independent ethics committee. | PMC10034105 |
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Clinical and laboratory monitoring | PMC10034105 |
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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 to routine activities. All samples were processed by PCR for genes N and E of SARS-CoV-2. Demographic, clinical, laboratory, and radiology data from patients' medical records were collected by the research team. The data were evaluated by a trained team of physicians. The date of disease onset was defined as the day when the symptom was noticed. Data on symptoms, vital signs, and laboratory values on biomarkers of disease progression, biomarkers [C-reactive protein (CRP), D-dimer, interleukin 6 (IL-6), ferritin, and lactate dehydrogenase (LDH)], and treatment measures during the hospital stay were collected. Patient assessments included physical examination, respiratory status (respiratory rate, type of oxygen supplementation, and blood oxygen saturation), adverse events, and concomitant medications. Blood-based investigations were done on days 1 and 5 post-randomization/hospitalization as per the routine analysis regime followed in the hospital settings. These investigations included measurement of blood cell counts, serum creatinine, glucose, total bilirubin, liver transaminases, and inflammatory biomarkers. Perceived stress was assessed using the Perceived Stress Scale 10 (PSS-10) ( | PMC10034105 |
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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 these videos were self-explanatory, yoga was delivered as supervised sessions with modules presented as recorded videos supervised by trained yoga therapists along with the distribution of practical training materials including both audio and video inputs. On day 1, the hands-on intervention was carried out in the COVID-19 wards through teams of certified yoga therapists in personal protective suites, within 4 h of randomization. The intervention was further continued in the hospital settings using tele-mode until discharge day using tele-(videos) along with facilitation through the physical presence of an instructor. The intervention was delivered daily two times for a duration of 10 min. For those who were discharged before 14 days post-randomization, tele-yoga sessions were continued from their home settings. Typical morning sessions were of 15-min duration and included flexibility exercises [hands in and out breathing (2 min), hands stretch breathing (2 min), and shoulder rotation (2 min) as part of their regular warm up]. These exercises were followed by quick relaxation and subsequent 8 min of pranayama (breathing exercises), consisting of abdominal breathing (3 min), alternate nostril breathing or Nadishuddhi pranayama (3 min), and Bhramari pranayama (2 min). These practices have been reported to have effects on the strengthening of the respiratory muscles, and respiratory function, including the development of awareness of expansion and contraction of the airways and continuous and rhythmic breathing, which has been reported to aid in thorough oxygenation of the lungs and reduce inflammation. The practice sessions ended with guided relaxation of 2 min with a resolve. Evening sessions were 10 min and focused on the aforementioned breathing exercises and concluded with guided meditation.Clinical guidelines were followed up for treating patients via tele-yoga and hands-on techniques in cooperation with the medical heads of departments. The instructor or therapist monitored and ensured that the practices were done as per the module protocol and corrected the patients along with the doubt clarifications. | PMC10034105 |
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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 |
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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. Eligible patients were randomly assigned in a 1:1 ratio to receive either standard of care or adjunct yoga. Allocation assignment was concealed from investigators and patients. | PMC10034105 |
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Statistical analysis | PMC10034105 |
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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 standard of care group, on day 14, using a two-sided 5% alpha. Analysis was performed with SPSS version 23 [IBM Corp., (N.Y., USA)].The trial was analyzed by comparing patients randomized to adjunct tele-yoga vs. those randomized to standard of care, with the placebo group serving as the referent. The primary outcome was analyzed with a multivariable proportional odds model adjusted with age, sex, and comorbidities. Further adjustments with baseline (pre-randomization) COVID Outcomes Scale category and duration of acute respiratory symptoms are reported as The heterogeneity of treatment effect by prespecified baseline characteristics was evaluated by adding an interaction term between randomized group assignment and the baseline characteristic of interest in the primary model. Baseline characteristics evaluated in the heterogeneity of treatment effect analyses included baseline COVID Outcomes Scale category, and duration of symptoms prior to randomization, age, sex, and race/ethnicity.All-cause mortality was estimated using the Kaplan–Meier product limit method. The adjunct tele-yoga group was compared with the standard of care group using the log-rank test, and the mean estimates and 95% CIs were provided.We also used the paramed command in SPSS to perform mediation analysis by fitting a linear regression model to the outcomes with yoga treatment, and the mediators included were the covariates. We applied the causal mediation method, to investigate whether biomarkers could be a causal pathway between intervention and the outcome. Regression models were fitted to the mediators with treatments included as covariates. | PMC10034105 |
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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 day 14 or who were telephonically interviewed after being discharged from the hospital. The distribution of patients' scores on the seven-level ordinal scale at 14 days is shown in Clinical status on the coronavirus disease (COVID) outcomes scale 14 days. The primary outcome was assessed in all patients who were still in the hospital on day 14 exactly and in outpatients (by means of telephonic interview) as close to day 14 as possible. OR—odds ratio was derived from the multivariable proportional odds model adjusted for baseline age, sex, and comorbidities (diabetes, hypertension, and hypothyroid). | 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 to the baseline values. Analysis of covariance was done using the rank transformation to study the influence of adjunct tele-yoga intervention on biomarker levels. *Indicates | PMC10034105 |
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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 |
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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 and moderate COVID-19 (odds ratio = 1.83, 95% CI = 1.11–3.03) as compared to those with the only standard of care. The odds of improvement with yoga intervention were higher on the 7th day (odds ratio = 3.61, 95% CI = 2.13–6.10). However, the effectiveness of the intervention was not found to be sustained at the 28th-day follow-up (odds ratio 1.70, 95% CI = 0.97–2.99, We could not observe a significant effect of adjunct tele-yoga on the Perceived Stress Scale in patients with COVID-19 (This clinical exploration is one of the earliest to be reported among several other concomitant attempts to establish the efficacy of additional systems of medicine, against the combat of COVID-19, as evidenced by 67 such registered trials in the Clinical Trial Registry of India (CTRI) (The study has several strengths. One of the strengths of the study is the inclusion of WHO criteria for assessing the benefit on clinical status for patients hospitalized with mild and moderate COVID-19. This is the first report wherein yoga-based intervention was provided in a tele-mode to patients with COVID-19. This was done to prevent healthcare employees from being infected. Importantly, the trial included inflammatory markers as study outcomes, wherein an anti-inflammatory mediating influence of yoga intervention could be established to improve the outcomes of hospitalized patients with mild-to-moderate COVID-19. A key feature of the trial was the early implementation of treatment within 7 days of symptom onset (median duration of 3 days) which has been considered important for the treatment protocol, in particular antivirals such as remdesivir.The trial was limited to hospitalized patients with COVID-19 which restricts the generalizability of the findings to other populations involving home-based care. The intervention duration was limited to 14 days, and assessments were limited to 28 days follow-up; however, the continued intervention could have led to sustained positive effects with respect to late complications of COVID-19. Reporting long-term outcomes of trial participants should have been considered. Given the nature of the intervention, the study used an open-label design, which could have led to biases in patient care and reporting of data. Due to logistic challenges, the laboratory-based parameters could not be collected on the prespecified 14th day time point. There was also an imbalance in the baseline distribution of the covariate, breathlessness, indicating differences in the severity status of the subjects between groups. However, we confirmed the robustness of the primary outcome with a Overall, we could observe clinically relevant effects among hospitalized patients with mild-to-moderate COVID-19, contesting the use of tele-yoga as a complementary treatment for patients with this disease. However, the positive signal found in this small-scale trial warrants the conduction of larger trials using tele-yoga for the treatment of COVID-19. | PMC10034105 |
Data availability statement | Datasets are available on request to the corresponding author. | PMC10034105 |
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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 |
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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 revision of the manuscript for important intellectual content. VM contributed in statistical analysis. VM, NM, and RNag obtained funding and contributed in administrative, technical, or material support. All authors contributed to the article and approved the submitted version.We thank the patients who participated in this study, their families, and all participating investigators as well as their clinical and nursing staff. | PMC10034105 |
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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 |
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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 endorsed by the publisher. | PMC10034105 |
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Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10034105 |
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References | PMC10034105 |
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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 |
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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 comprising: (1) the three-session, in-person, Making Sense of BPD (MS-BPD) multi-family group programme, plus two self-directed online psychoeducational modules (MS-BPD + Online, | PMC10619189 |
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Results: | A total of 79 carers were randomised (pool of 281, 197 excluded, 94 declined) and 73 carers (51 females [69.9%], M | PMC10619189 |
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