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Ethics approval and consent to participate
This study was performed in accordance with the Declaration of Helsinki. All individuals were informed about the study and signed an informed consent before the study. And this study was approved by the ethics committee of Beijing Tongren Hospital Capital Medical University and registered with
PMC9854051
Consent for publication
The individual images and evaluation data involved in the paper were published with the informed consent of the individuals.
PMC9854051
Competing interests
All authors declare that they have no potential conflict of interest.
PMC9854051
References
PMC9854051
Background
fatigue, Fatigue
MULTIPLE SCLEROSIS (MS), ADVERSE EFFECTS
Fatigue is one of the most common problems in patients with multiple sclerosis (MS) and has adverse effects on their sleep status and self-efficacy. This study aimed to determine the effect of distance nurse-led fatigue management on fatigue, sleep quality, and self-efficacy in patients with MS.
PMC9926409
Methods
fatigue, Fatigue
MULTIPLE SCLEROSIS
This quasi-experimental study was performed on 60 patients with MS in Arak, Iran. Subjects were randomly assigned into intervention and control groups. The intervention group received eight sessions of nurse-led fatigue management training through the Skyroom platform. The control group received only the usual programs...
PMC9926409
Results
fatigue
After the intervention, the mean score of fatigue severity in the intervention group was significantly lower than the control group (2.52 ± 0.40 vs 5.65 ± 0.52) (
PMC9926409
Conclusion
fatigue
Distance nurse-led fatigue management improved fatigue, sleep quality, and self-efficacy in patients with MS. We recommend the use of these courses as an important step toward improving fatigue, sleep quality, and self-efficacy among these patients.
PMC9926409
Keywords
PMC9926409
Background
neurologic disease, chronic diseases, sleep disturbance
CHRONIC DISEASES, MULTIPLE SCLEROSIS (MS)
Multiple sclerosis (MS) is the most common progressive neurologic disease in young adults worldwide [Another problem reported by some MS patients is sleep disturbance. Studies confirm the high prevalence of poor sleep quality in patients with MS [Self-efficacy is one of the impressionable psychological variables of MS,...
PMC9926409
Methods
This quasi-experimental study was conducted from March to August 2020 in the MS Association of Arak city, in the center of Iran. This charity association provides services including free and semi-free educational, therapeutic, and medical services for all patients. The Ethics Committee of Shiraz University of Medical S...
PMC9926409
Participants
The number of participants was determined using MedCalc software, with α = 0.05, β = 0.2, MeanIn the present study, for the purpose of sampling, the research assistant attended the MS association and provided the eligible patients who referred to the association with explanations about the research plan. The patients w...
PMC9926409
Intervention
fatigue
EVENT
During the study, both the intervention and control groups received the routine care provided in the MS Association mentioned above. Moreover, the intervention group also received a nurse-led fatigue management program. This program consisted of eight training sessions of 60–90 min, which were provided through the nati...
PMC9926409
Data collection
Fatigue
MULTIPLE SCLEROSIS
Patients completed self-report questionnaires online and individually before and eight weeks after the intervention. Data collection tools included general information questionnaire, and Persian versions of Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), and Multiple Sclerosis Self-Efficacy Scale (...
PMC9926409
General information questionnaire
DISEASE
General information questionnaire included demographic information and disease-related information. Demographic information included age, gender, marital status, education level, and employment status. The information related to the disease also included the duration of the disease, the number of hospitalizations, and ...
PMC9926409
Fatigue severity scale
visual pain, fatigue
Krupp et al. designed the FSS in 1989 to measure fatigue in people with MS. The main fatigue intensity scale is a 9-item questionnaire, each part of which contains statements rated on a seven-point Likert scale from 1 "strongly disagree" to 7 "strongly agree". The total score of the scale is obtained from the average s...
PMC9926409
Pittsburgh sleep quality index
This tool was developed by Buysse et al. in 1998 to examine the sleep quality and help identify people with good or poor sleep quality in the general population. This questionnaire contains 18 questions in 7 components. The score of each component is a minimum of 0 and maximum of 3. The sum of the scores of these seven...
PMC9926409
MS patient self-efficacy scale
SCHWARTZ
This scale was developed by Rigby et al. in 2003 in England to assess the self-efficacy of adult patients with MS. It is a multi-dimensional and self-report instrument developed with 14 items. The scoring of this scale is from completely disagree = 1 to completely agree = 6. The range of scores varies from 14 to 84, an...
PMC9926409
Data Analysis
Data analysis was done using SPSS software version 23. To evaluate the normality of the data distribution, we used the Kolmogorov–Smirnov test. Chi-square test was used to compare two groups based on qualitative variables. Also, paired t-test and Wilcoxon test were used for within-group comparisons, and Mann–Whitney U ...
PMC9926409
Discussion
fatigue
OVARIAN CANCER, CARDIOVASCULAR DISEASES, MULTIPLE SCLEROSIS, BLIND, LEAKAGE
The findings of the study showed that the nurse-led fatigue management and the familiarity with fatigue reduction methods can improve fatigue, sleep quality, and self –efficacy of patients with MS. The high effect size values of the changes indicate that these improvements are clinically important. Evidence shows that ...
PMC9926409
Conclusion
fatigue
The findings of this study showed that the distance nurse-led fatigue management can improve fatigue, sleep quality, and self -efficacy in patients with MS. These findings showed the important role of nurses in community-oriented care of patients with MS. Since nurses can play an effective role in the management of pat...
PMC9926409
Acknowledgements
This manuscript was extracted from the Master’s thesis by Mahla Qomi, which was sponsored by the Vice Chancellor for Research of Shiraz University of Medical Sciences, Shiraz, Iran. Hereby, appreciation goes to the Vice Chancellor for Research of Shiraz University of Medical Sciences for its financial support. The auth...
PMC9926409
Authors’ contributions
MQ, ZKh, MR, and MEM made substantial contributions to the conception and design of the study. Data was collected by MQ. Data analysis and interpretation were done by ZKh, MQ, and MR. MQ conducted the intervention. ZKh and MQ participated in drafting the manuscript. ZKh, MQ, MR, and MEM revised the manuscript criticall...
PMC9926409
Funding
The present study was financially supported by the Vice Chancellor for Research of Shiraz University of Medical Sciences, Shiraz, Iran (Grant No. 22080). The funding body did not play any roles in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
PMC9926409
Availability of data and materials
Data resource and statistical analysis outputs can be provided by the corresponding author on reasonable request.
PMC9926409
Declarations
PMC9926409
Ethics approval and consent to participate
The approval of the study was obtained from the Ethics Committee of Shiraz University of Medical Sciences (ethics code: IR.SUMS.REC.1399.1035) and the officials of the MS Association. Furthermore, all methods were carried out in accordance with Declaration of Helsinki and relevant guidelines and regulations. The goals ...
PMC9926409
Consent to publication
Not applicable.
PMC9926409
Competing interest
The authors declare no competing interests.
PMC9926409
References
PMC9926409
Keywords
stroke, IOH, Hypotension, hypotension
STROKE, DEL
Intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Hypotension Prediction Index (HPI) is a machine learning derived algorithm that predicts IOH shortly before it occurs. We tested the hypothesis that the application of the HPI in combination with a pre-defined Goal Directed Therapy (...
PMC10372133
Introduction
cancer mass reduction, blood loss, IOH, hypotension, organ injury, postoperative organ dysfunction, Hypotension
BLOOD LOSS, EVENT, EDWARDS
Intraoperative hypotension (IOH) represents a common event during noncardiac surgery and has been associated with worse postoperative outcomes [The use of cardiac output (CO) monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm has been shown to improve ...
PMC10372133
Materials and methods
postoperative pain, stroke, aortic regurgitation, infection, mean, systolic and diastolic arterial pressure, hypotension, hypertension, hypotensive
CARDIAC ARRHYTHMIAS, COAGULATION DISORDERS, LOCAL INFILTRATION, STROKE, EVENT, PERMANENT ATRIAL FIBRILLATION, AORTIC REGURGITATION, COMPLICATIONS, INFECTION, SECONDARY, EVENTS, HYPERTENSION, HYPOTENSIVE, EDWARDS
This study was a single-centre RCT registered at ClinicalTrials.gov (identifier NCT04547491) and conducted at the IRCCS Policlinico Universitario Agostino Gemelli Foundation (Rome, Italy) in accordance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The study was approved by th...
PMC10372133
Sample size calculation
Based on previous results [
PMC10372133
Statistical analysis
Hypotensive, hypotensive
HYPOTENSIVE, EDWARDS, SECONDARY, EVENTS, HYPOTENSIVE, COMPLICATIONS
Continuous data are presented as medians with interquartile ranges (25th to 75th IQR). Categorical data are presented as frequencies with percentages. Normality distribution of a variable was assessed graphically and with the Shapiro–Wilk test.Hypotensive events (defined as a MAP < 65 mmHg for > 1 min) and severe hypot...
PMC10372133
Acknowledgements
Not applicable.
PMC10372133
Author contributions
LF: conception and design of the study, acquisition, analysis and interpretation of data, drafting the article for relevant intellectual content. PPG: acquisition, analysis and interpretation of data, drafting the article for relevant intellectual content. FV: acquisition, analysis and interpretation of data, drafting ...
PMC10372133
Funding
DEL
Open access funding provided by Università Cattolica del Sacro Cuore within the CRUI-CARE Agreement. The authors did not receive support from any organization for the submitted work. No funding was received to assist with the preparation of this manuscript. No funding was received for conducting this study. No funds, g...
PMC10372133
Data availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10372133
Declarations
PMC10372133
Conflict of interest
MONGE, EDWARDS
L. Frassanito and M. I. Monge Garcia received honorarium from Edwards Lifesciences Ltd for scientific advice.
PMC10372133
Ethical approval
The study was approved by the Internal Ethic Committee (ID 3664, protocol number 10077/21).
PMC10372133
Consent to participate
A written informed consent was obtained from the patients included in the study.
PMC10372133
Consent for publication
The authors affirm that human research participants provided written informed consent for publication.
PMC10372133
References
PMC10372133
Purpose
knee osteoarthritis
KNEE OSTEOARTHRITIS
To evaluate the cost-effectiveness of Platelet Rich Plasma (PRP), Plasma Rich in Growth Factors (PRGF), Hyaluronic Acid (HA) and ozone as effective treatment approaches in knee osteoarthritis management from Iran Health care perspective.
PMC9832742
Methods
KNEE OSTEOARTHRITIS
A decision tree model was conducted to assess the cost-effectiveness of four common intra-articular treatment approaches in patients with mild and moderate knee osteoarthritis. The data on clinical effectiveness was obtained from a randomized controlled trial (RCT) conducted in Iran and used to estimate utility values....
PMC9832742
Results
knee osteoarthritis
KNEE OSTEOARTHRITIS
In this study, HA intra-articular injection-related costs ($581.67/patient) were defined as the highest cost, followed by PRGF ($328.10/patient), PRP (318.58/patient), and Ozone (103.20/patient). According to the utility value, PRP and PRGF (0.68) have the same and the most utility among Intra-articular injections in k...
PMC9832742
Conclusion
KNEE OSTEOARTHRITIS
The study result demonstrated that intra-articular injection of PRP, compare to other injections, is a cost-effective treatment option for patients with mild and moderate knee osteoarthritis. In addition, intra-articular injection of PRP was identified as the best injection, with the highest level of net monetary benef...
PMC9832742
Keywords
PMC9832742
Introduction
hip joints, Osteoarthritis, OA, Pain, crepitation, stiffness, weight loss
AIDS, OSTEOARTHRITIS, JOINT DISORDER
Osteoarthritis (OA), which is considered one of the leading causes of disability, is a chronic, progressive, and the most common form of joint disorder. Pain, crepitation, stiffness, and decreased range of motion in involved joints, especially knee and hip joints, were reported as OA results [As we know, there is a vas...
PMC9832742
Methods
PMC9832742
Model design
knee osteoarthritis
KNEE OSTEOARTHRITIS
A decision tree model was constructed with four treatment arms to assess the cost-utility of Intra-articular Injections in patients' diagnosed with mild and moderate knee osteoarthritis using Kelgreen Lawrence scale. In one arm, patients would receive PRP as the intervention. The others were comparators including PRGF,...
PMC9832742
Model inputs
PMC9832742
Treatment utility values
Utility values and probability of success in treatments were extracted from a randomized controlled trial (RCT) conducted by Raeissadat SA et al. [Clinical effectiveness was defined as a positive response to the treatment as more than 70% (i.e., if there was a 30% decrease in WOMAC scores of the intervention in the fol...
PMC9832742
Treatment cost
In the present study, the health care provider perspective was used to evaluate the costs of intra-articular injection approaches. In this regard, only direct costs, including the cost of products such as kits, the procedures for preparation, and medication-related costs were considered for the analysis, and indirect c...
PMC9832742
Model analysis
The incremental cost-effectiveness ratio (ICER) and the net monetary benefit (NMB) was used to assess the cost-utility analysis at the WTP threshold value of USD $ 10.000. According to Paulden et al. [Deterministic sensitivity analysis (DSA) using a tornado diagram was performed to investigate the variation of the ICER...
PMC9832742
Results
PMC9832742
Intra-articular effectiveness of treatments
In terms of the utility value, 12 months after the injection, contrary to the baseline value, the utility was increased over time. As shown in Table The Utility Value Estimated for Intra-Articular Injections
PMC9832742
Cost-utility analysis
Incremental costs, incremental effects, ICER, and NMB were presented in Table Cost-Utility Analysis
PMC9832742
Sensitivity analysis
In terms of sensitivity analysis, the Tornado Analysis Diagram and the Monte Carlo Simulation were performed. In this study, the net monetary benefit of PRP, which is defined as the optimal strategy, was considered as the base for comparisons. As shown in Fig. Tornado DiagramWe assess the variation in utility of interv...
PMC9832742
Discussion
knee osteoarthritis, OA, chronic progressive disease
DISEASE, KNEE OSTEOARTHRITIS, MEDICAL COMPLICATION
Knee OA is a chronic progressive disease in nature and pre-existing nonsurgical treatments have not yet been proven as a curative treatment for this disease. In advanced cases, joint replacement surgery is the gold standard treatment. Therefore, considering the medical complications of such major surgeries, as well as ...
PMC9832742
Limitation
One of the main limitations of the present study is the lack of indirect costs calculations like reduced productivity of interventions and transportation costs. In addition, in this study, the costs of common conservative treatment, such as oral or topical analgesics, physical therapy, and medical equipment were not co...
PMC9832742
Acknowledgements
We gratefully acknowledge Dr. Eric M. Samuelson for his helpful comments on the manuscript.
PMC9832742
Authors’ contributions
MR
SAR and NM contributed to the design and development of the study protocols. SMR conceptualized the study, guided the development of the protocols, and helped with the literature review and interpretation of the results. SAR, NM, and MR developed the protocols of the study, performed statistical analysis and contribute...
PMC9832742
Funding
There is no funding to declare.
PMC9832742
Availability of data and materials
All data is available and can be provided by the corresponding author upon rational request.
PMC9832742
Declarations
PMC9832742
Ethics approval and consent to participate
This study was performed in accordance with the Declaration of Helsinki. The protocol of study was approved by the research deputy of the Shahid Beheshti University of Medical Sciences, Tehran, Iran with the reference number of IR.SBMU.MSP.REC.1399.447. Our data was derived from a randomized controlled trial (RCT) cond...
PMC9832742
Consent for publication
Not applicable.
PMC9832742
Competing interests
All authors declare that there is no conflict of interest regarding the publication of this paper.
PMC9832742
References
PMC9832742
Objectives
implant failure
To assess the effect of preoperative oral clindamycin in reducing early implant failure in healthy adults undergoing conventional implant placement.
PMC9469834
Materials and methods
infection
ADVERSE EVENTS, INFECTION, POSTOPERATIVE COMPLICATIONS
We conducted a prospective, randomised, double-blind, placebo-controlled clinical trial in accordance with the ethical principles and Consolidated Standards of Reporting Trials statement. We included healthy adults who underwent a single oral implant without previous infection of the surgical bed or the need for bone g...
PMC9469834
Results
Both the control group and clindamycin group had 31 patients each. Two implant failures occurred in the clindamycin group (NNH = 15,
PMC9469834
Conclusions
implant failure
Preoperative clindamycin administration during oral implant surgery in healthy adults may not reduce implant failure or post-surgical-complications.
PMC9469834
Clinical relevance
Oral clindamycin is not efficacy.
PMC9469834
Trial registration
The present trial was registered (EudraCT number: 2017-002,168-42). It was approved by the Committee for the Ethics of Research with Medicines of Euskadi (CEIm-E) on 31 October 2018 (internal code number: 201862) and the Spanish Agency of Medicines and Medical Devices (AEMPS) on 18 December 2018.
PMC9469834
Keywords
Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature.
PMC9469834
Introduction
allergic, postoperative infections, implant failure
INFECTIOUS ENDOCARDITIS, COMPLICATIONS, POSTOPERATIVE INFECTION
Oral implants are considered a predictable and safe treatment modality for the rehabilitation of missing teeth [Consequently, researchers have advocated prophylactic antibiotics to prevent postoperative infections and oral implant failures [Prophylactic antibiotics are generally recommended during surgery for patients ...
PMC9469834
Materials and methods
PMC9469834
Trial design and ethical aspects
This study was a prospective, randomised, parallel, double-blind, and placebo-controlled clinical trial (EudraCT number: 2017–002,168-42). It was approved by the Committee for the Ethics of Research with Medicines of Euskadi (CEIm-E) on 31 October 2018 (internal code number: 201862) and the Spanish Agency of Medicines ...
PMC9469834
Participants
bleeding, allergy, ulcerous colitis
BLEEDING, ALLERGY, SURGICAL SITE INFECTION
The trial was conducted at the Dental Clinic of the Postgraduate in Oral Implantology and Microsurgery at the University of the Basque Country (Leioa, Spain). Patients were only eligible for the study when they were healthy adults (at least 18 years old) who had attended the dental clinic and were indicated for the pla...
PMC9469834
Interventions
Postoperative pain, mandibular block, ®
All participants in the test group were administered a single dose of 600-mg clindamycin (two capsules of 300 mg) 1 h before surgery. Those in the control group received two capsules of placebo 1 h before surgery. The placebo and antibiotics had similar characteristics. The participants were provided an envelope with t...
PMC9469834
Outcomes
postoperative pain, bleeding, fever, peri-implant radiolucency, erythema, abscess, infection, fistula, implant failure
SUPPURATION, ADVERSE REACTIONS, BLEEDING, INFLAMMATION, ERYTHEMA, ABSCESS, INFECTION, SECONDARY, OSTEOMYELITIS
A single experimented observer evaluated all patients on post-operative days 1, 7, 14, 28, and 56. The primary outcome was implant failure. Failure was defined as the loss or removal of an implant for any reason.The secondary outcome was any clinical or radiographic signs indicative of an infection. Were recorded, peri...
PMC9469834
Sample size
We calculated the sample size using the statistical program WinEpi: Working in Epidemiology;
PMC9469834
Randomisation
From the total sample, we performed a block-switching restricted randomisation comprising a block length of four patients, with a similar probability (0.5) of allocation to each treatment within the block (two patients for each treatment within each block). Randomisation was performed using the statistical program STAT...
PMC9469834
Allocation concealment
The participants were assigned after determining their eligibility as per the inclusion criteria and obtaining their informed and written consent to participate. An assistant outside the study prepared sealed and numbered envelopes with the antibiotic or placebo to be administered, according to the instructions. Each n...
PMC9469834
Blinding
infection
INFECTION
We performed randomisation and allocation concealment with double blinding as follows: neither the participants nor the expert who placed the implant were aware of the treatment received. The professional who evaluated for infection or the loss of implant was also unaware of the treatment.
PMC9469834
Statistical analysis
STATA ® 15 software (College Station, TX, 77,845, USA) was used for the intention-to-treat data analysis. We calculated the variances for each variable, and assessed the association between treatment groups and different variables using the Student’s This study was conducted in compliance with the CONSORT checklist.
PMC9469834
Results
PMC9469834
Participant flow
Figure Flow chart of the enrolment process
PMC9469834
Recruitment
coronavirus disease 2019
CORONAVIRUS DISEASE 2019, RECRUITMENT
Participant recruitment began in October 2019 and ended in June 2021, and each participant was followed-up until day 56 post-surgery. The trial was temporarily halted owing to the pandemic caused by coronavirus disease 2019 and ended upon monitoring all included participants on day 56 post-surgery (August 2021).
PMC9469834
Baseline data
Table Participant characteristics
PMC9469834
Analysed numbers
Thirty-one participants each from the clindamycin-treated and control groups were eventually included in the analysis. The analysis was performed in all cases using the original assigned groups.
PMC9469834
Outcomes and estimation
ARI, postoperative infections, implant failure
COMPLICATIONS, POSTOPERATIVE INFECTION
Overall, two implant failures occurred in participants treated with clindamycin (RR: not estimable, ARI = 0.06; CI: − 0.03–0.16, NNH = 15.5; and CI: 6–∞). The ARI indicated that 6% of the patients would experience implant failure under clindamycin treatment and would not have received placebo. The NNH predicted that fo...
PMC9469834
Harms
diarrhoea, ARI
ADVERSE EVENTS, GASTROINTESTINAL DISORDERS
Only one clindamycin-treated participant experienced adverse events (gastrointestinal disorders and diarrhoea), thus yielding no significant differences between the groups (RR: not estimable, ARI = 0.03; CI: − 0.05–0.11, NNH = 31; CI: 8.5–∞, and
PMC9469834
Discussion
PMC9469834
Interpretation
allergic, postoperative infections, postoperative infection
PENICILLIN ALLERGY, POSTOPERATIVE INFECTION
The present clinical trial demonstrated that a single 600-mg preoperative dose of oral clindamycin did not differ from placebo in preventing oral implant failures or postoperative infections following oral implant surgery under ordinary conditions in healthy adults.Several reviews and meta-analyses have demonstrated th...
PMC9469834
Limitations
infection, allergic, allergy
INFECTION, ALLERGY
It is crucial to consider the underpowering of the study while interpreting the clinical outcomes.Unfortunately, the participants did not undergo any allergy test for penicillin; therefore, they could have been allergic to penicillin.The intention-to-treat analysis and the use of rescue antibiotics could have masked th...
PMC9469834