title
stringlengths 1
1.19k
| keywords
stringlengths 0
668
| concept
stringlengths 0
909
| paragraph
stringlengths 0
61.8k
| PMID
stringlengths 10
11
|
|---|---|---|---|---|
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. Data were collected before and two months after the intervention using the Fatigue Severity Scale, the Pittsburgh Sleep Quality Index, and the Multiple Sclerosis Self-Efficacy Scale. The significance level in this study was determined 0.05. | 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, which affects the physical performance of patients with MS [Nurses play an important role in empowering patients to manage chronic diseases [ | 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 Sciences approved the study. | 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 who agreed to participate in the study filled the informed consent form. Then, with block randomization (15 blocks of 4), they were placed in one of the two intervention and control groups. The selection order of the blocks was determined using the block randomization website. Finally, equal number of people were placed in each group. A total of 60 patients were included in the study. Three people from the intervention group were excluded from the study due to not participating in the online training sessions. Finally, the data of 57 patients (27 in the intervention group and 30 in the control group) were analyzed. The study flow diagram is presented in Fig. Study flow diagram. The diagram shows the progress of the participants throughout the study. After random allocation of patients to the intervention and control groups, three patients in the intervention group did not receive the allocated intervention. Finally, the data of 27 individuals in the intervention group and 30 individuals in the control group were analyzed | 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 native Skyroom platform. It is an Iranian platform that does not require the installation of any application, and users can enter the desired event with just a click. In this study, at first, the nurse-researcher sent a specific link to enter the class to each person in the intervention group, and they entered the class with their own username and password. One meeting was held every week, which included the topics of energy conservation and storage strategies, sleep hygiene, relaxing breathing exercises, and exercise at home (Table Nurse-led fatigue management training program | 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 (MSSES). | 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 comorbidities. | 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 score of the statements and varies from 1 to 7. An average score of more than 4 is defined as fatigue. The validity of the tool showed that the FSS in patients with MS had a significant correlation with the visual pain scale ( | 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 components constitutes the total score of the tool, which ranges from 0 to 21. A score higher than 5 indicates a severe problem in at least two fields or a moderate problem in at least three fields of the questionnaire items. In the study of Buysse et al., the instrument had a sensitivity of 89.6% and specificity of 86.5% in differentiating individuals who sleep well and individuals who sleep poorly. The reliability of PSQI was determined through the test–retest correlation coefficient of 0.85 ( | 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, and higher scores mean higher self-efficacy. In the study of Rigby et al., the correlation between the score of the participants in this tool and the Schwartz general self-efficacy scale was reported 0.64, which indicates the validity of this tool. The reliability of this tool was confirmed through test–retest (r = 0.081, | 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 test was used to compare other quantitative variables between the groups. Moreover, analysis of covariance (ANCOVA) was used to eliminate the effect of age and education level on the findings. Cohen's d effect size was calculated for within-group and between-group changes. The effect sizes of 0.8, 0.5 and 0.2 were considered large, medium, and weak, respectively [ | 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 few studies have examined the impact of the nurses-led fatigue management on sleep quality and patients’ self-efficacy. However, these interventions in other patient groups have shown positive effects [It is worth noting that patients who entered the current study had high fatigue scores at baseline. The findings showed that distance nurse-led fatigue management can reduce fatigue in patients with MS. Similarly, in a study of patients with ovarian cancer, nurse-led home based exercise, and cognitive behavioral therapy were effective in reducing the patients’ fatigue [Another finding of the study was that the distance nurse-led fatigue management could improve sleep quality of the patients. Similarly, in the study of Al-Sharman et al., aerobic exercises were effective on sleep quality and biological markers in patients with MS [One of the other findings of the present study was the improvement of self-efficacy after participating in the distance nurse-led fatigue program. Similarly, in a study in Shanghai, China, a nurse-led phone follow-up education program based on self-efficacy was effective on the improvement of self -efficacy of patients with cardiovascular diseases [Evidence shows that during COVID-19 pandemic, patients with MS experienced higher fatigue and weaker mental health indicators. In addition, they left their home less frequently and had less daily activities [Based on our searches, the present study seems to be the first study on nurse-led fatigue management in patients with multiple sclerosis. Hence, the lessons learned from this research should be useful in designing and implementing future studies. One of the strengths of this study is the provision of non-attendance and distance training. This intervention provided the participants access to training they needed and there was no need to visit in person to receive training during COVID-19 pandemic. Hence, we recommend to emphasize the use of distance nursing for this group of patients. Another strength of this study is assigning the personal username and password for each participant to enter the Skyroom website, which reduced the possibility of sharing educational materials between the members of the intervention and control groups. In addition, patients in the intervention group were urged not to talk about the educational program with other patients. However, there is a possibility of information leakage between the two groups, which is one of the limitations of the study. In addition, due to the nature of our intervention, it was not possible to blind the participants, but in order to blind the researcher, pre- and post-intervention data were collected by a research assistant. Another limitation of this study was the short-term follow-up period. Therefore, the effectiveness of similar interventions should be examined for a longer period of time. One more limitation is that the attrition occurred only in the intervention group. Nevertheless, two groups were comparable based on general information and baseline main variables. Moreover, since quasi-experimental studies are subject to threats of internal validity, we recommend that the study design be improved in future research projects. | 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 patients with MS, they should pay more attention to the patients’ fatigue. Moreover, it is necessary for them to learn fatigue reduction skills and include them in patient care protocols. We recommend teaching these skills to nursing students and including these skills in the nursing continuing education. In addition, we recommend the inclusion of nurse-led fatigue management as an inexpensive non-pharmacological intervention in the management of patients with MS. The distance nature of similar interventions provides the possibility of access to the people in remote areas, as well as providing services to patients in situations such as the COVID-19 pandemic. We recommend further research with a longer follow-up period on the effectiveness of similar interventions. | 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 authors would like to thank Clinical Research Development Center of Nemazee Hospital, Dr. Nasrin Shokrpour for editorial assistance, and Mr Ali Mohammad Keshtvarz and Dr Parvin Ghaem Maghami for their assistance in data analysis. We would also like to thank the respectable authorities and personnel of the MS Association, Arak, and all patients who earnestly helped us with this project. | 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 critically for important intellectual content and final approval of the manuscript. | 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 and process of the research were also explained to the patients. All participants signed the informed consent form. Participation in the study was voluntary and participants could withdraw at any time. In addition, the participants' information was kept confidential. | 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 (GDT) hemodynamic protocol reduces IOH during major gynaecologic oncologic surgery. We enrolled women scheduled for major gynaecologic oncologic surgery under general anesthesia with invasive arterial pressure monitoring. Patients were randomized to a GDT protocol aimed at optimizing stroke volume index (SVI) or hemodynamic management based on HPI guidance in addition to GDT. The primary outcome was the amount of IOH, defined as the timeweighted average (TWA) mean arterial pressure (MAP) < 65 mmHg. Secondary outcome was the TWA-MAP < 65 mmHg during the first 20 min after induction of GA. After exclusion of 10 patients the final analysis included 60 patients (30 in each group). The median (25–75th IQR) TWA-MAP < 65 mmHg was 0.14 (0.04–0.66) mmHg in HPI group versus 0.77 (0.36–1.30) mmHg in Control group, P < 0.001. During the first 20 min after induction of GA, the median TWA-MAP < 65 mmHg was 0.53 (0.06–1.8) mmHg in the HPI group and 2.15 (0.65–4.2) mmHg in the Control group, P = 0.001. Compared to a GDT protocol aimed to SVI optimization, a machine learning-derived algorithm for prediction of IOH combined with a GDT hemodynamic protocol, reduced IOH and hypotension after induction of general anesthesia in patients undergoing major gynaecologic oncologic surgery.Trial registration number: NCT04547491. Date of registration: 10/09/2020.Open access funding provided by Università Cattolica del Sacro Cuore within the CRUI-CARE Agreement. | 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 tissue perfusion and oxygenation [The multicentric INPRESS randomized controlled trial (RCT) demonstrated that applying an individualized blood pressure target to be achieved with norepinephrine infusion in addition to a GDT reduces postoperative organ dysfunction, suggesting that using a target approach to minimize IOH would reduce organ injury [Despite careful hemodynamic monitoring and protocols for vasopressor and fluid administration, accurate control of MAP remains a challenge [It is difficult to predict IOH. Current treatment is often initiated when hypotension is already manifest, and anaesthesiologists only react to it. An algorithm developed using machine learning techniques and based on the arterial pressure waveform analysis, named Hypotension Prediction Index (HPI, Edwards Lifesciences, Irvine, USA), has been recently developed [Major gynaecologic oncologic surgery for cancer mass reduction is often associated with unstable hemodynamics and significant blood loss [The primary aim of this single-centre RCT was to compare the cumulative amount of IOH (defined as a MAP value below 65 mmHg) in 2 groups of patients undergoing major gynaecologic oncologic surgery managed using a GDT protocol aimed to optimize cardiac output or the HPI hemodynamic guidance combined to a different GDT protocol. Secondly, we compared IOH during the first 20 min after induction of GA and the amount of severe hypotension in the 2 groups. In addition, we also tested the threshold of 50 mmHg for IOH. | 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 the Institutional Ethics Committee (ID 3672, protocol N. 0049955/20) and registered in ClinicalTrials.gov (identifier NCT04547491). The full protocol and datasets are available at [email protected] on a collaborative basis.The inclusion criteria were patients ≥ 18 years old with American Society of Anesthesiologists (ASA) physical status II-IV, scheduled to major gynaecologic oncologic surgery with expected duration > 2 h under GA and planned continuous invasive blood pressure monitoring. Exclusion criteria were significant cardiac arrhythmias, such as permanent atrial fibrillation, aortic regurgitation, coagulation disorders, emergency surgery, preoperative infection, the requirement of dialysis, contraindication to radial artery cannulation and patient’s refusal of the treatment of personal data.Eligibility of consecutive patients scheduled to major gynaecologic oncologic surgery fulfilling the inclusion criteria was assessed by an investigator involved in the trial based on preoperative medical records. Written informed consent was obtained from the enrolled patients the day prior to surgery by a study staff member and enrolment ceased when the target sample size was obtained.Randomization codes to the HPI group or to the GDT group (Control group) were generated, in a 1:1 ratio, by an independent research team member, using a reproducible web-based system that uses the pseudo-random number generator of Wichmann and Hill as modified by McLeod (On arrival at the operating room, a large-bore venous catheter was inserted in a forearm vein. Standard monitoring (Life Scope TR, Nihon Kohden Co, Tokyo, Japan) included a 5-lead electrocardiogram, pulse oximetry and a non-invasive blood pressure cuff placed on the left arm. In all study participants, after mild sedation with midazolam and local infiltration with Lidocaine 2%, an arterial catheter was placed in the right radial artery before induction.Patients in the HPI group received invasive blood pressure monitoring with the Acumen IQ sensor transducer connected to the HemoSphere platform (Edwards Lifesciences, Irvine, CA). Patients in the Control group had a Flotrac sensor transducer connected to the EV1000 platform (Edwards Lifesciences). In both groups, the arterial pressure waveform was measured continuously with a sampling rate of 100 Hz. The HemoSphere and the EV1000 monitors displayed hemodynamic parameters calculated from the waveform every 20 s, including the HPI (that was detected only by the HemoSphere used in the HPI group). The signal quality of the arterial waveform was carefully checked with a fast flush test when starting the monitoring. Hemodynamic parameters displayed on both dedicated monitors (HemoSphere for HPI-group and EV1000 for Control-group) included mean, systolic and diastolic arterial pressure (MAP, SBP, DBP), heart rate (HR), stroke volume (SV), stroke volume index (SVI), stroke volume variation (SVV), pulse pressure variation (PPV), CO and cardiac index (CI).All patients were offered central neuraxial anesthesia for postoperative pain management, either intrathecal morphine 100 μg for expected laparoscopic surgery or T12-L1 epidural catheter placement for expected laparotomic surgery.Induction of GA was performed with propofol 2–3 mg·kgAll physicians involved in the study were trained on the use of the HPI and were informed about the study protocol. In the HPI group, the HPI parameter was displayed on the HemoSphere screen in addition to other hemodynamic parameters. Intraoperatively, a researcher was dedicated to recording any details related to the surgery or anesthesia. When the HPI reached the value of 85 or more, the number blinked red, and an audible alarm alerted the anaesthesiologist to the risk of hypotension. In this eventuality, the HemoSphere monitor with the Acumen software displayed a secondary screen with the following additional variables: SVV (already present in the basic screen), the peak rate of arterial pressure (dP/dtTreatment algorithm for the two groups. In HPI group (Panel In the Control group the anaesthesiologists applied perioperative GDT according to the institutional optimization protocol (Fig. The primary outcome measure was the time-weighted average (TWA) MAP under 65 mmHg during surgery. The TWA combines the number, duration, and severity of hypotensive events, corrected for the total time of measurement (“amount of hypotension”) [In order to evaluate the potential risk of overtreatment in the HPI group, we included the incidence of hypertension (defined as MAP > 110 mmHg) and severe hypertension (MAP > 130 mmHg) as the TWA-MAP above the thresholds of 110 and 130 mmHg during the entire monitoring time [Treatment choice (vasopressor, inotrope, fluids, erythrocyte transfusion) and cumulative administered dose in response to an alarm in the HPI group and to hypotension in the Control group was also evaluated and compared, as well as time from alarm to start of an intervention in the HPI group and from the onset of hypotension to start of treatment in the Control group. An alarm was deemed present when the HPI prediction value reached 85 or higher for at least 1 min and ended when the value normalized (< 85) for at least 1 min. Time to first intervention was used in case of multiple treatments to an alarm or hypotensive event; all alarms or hypotensive events per patient were considered for this analysis. All alarms or hypotensive events per patient were used for the analysis.Intraoperative exploratory outcomes included the amount of crystalloid and colloid infusion, and cumulative dose of vasoactive drugs. Postoperative exploratory outcomes included the occurrence of major complications before hospital discharge, and mortality at 30 days. | 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 hypotensive events (defined as a MAP < 50 mmHg for > 1 min) were analyzed in terms of number, duration, area under the threshold of 65 mmHg and 50 mmHg, and TWA of the area under the threshold. The area under the curve (AUC) MAP below a threshold was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes [Continuous primary and secondary outcomes were compared using 2-sample Wilcoxon rank-sum test and Hodges Lehman estimation of location shift with corresponding asymptotic 95% CI, as the variables were not normally distributed. Differences on secondary categorical outcomes were assessed with the Chi-square test or Fisher’s exact test in case of expected frequencies < 5.Postoperative explorative outcomes including major complications before hospital discharge and 30-day mortality were evaluated by reviewing in-hospital electronic medical records or by contacting the patients by telephone and were reported as number and proportion.Data analysis was performed using R (R Foundation for Statistical computing, Austria, version 4.1.2), Matlab (The MathWorks Inc, Natick, MA, USA) and Acumen Analytics software (Edwards Lifesciences). A 2-sided probability value of | 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 the article for relevant intellectual content. AP: acquisition, analysis and interpretation of data, drafting the article for relevant intellectual content. MIMG: conception and design of the study, drafting the article for relevant intellectual content. CS: acquisition, analysis and interpretation of data, drafting the article for relevant intellectual content. BAZ: conception and design of the study, drafting the article for relevant intellectual content. SC: conception and design of the study, drafting the article for relevant intellectual content. MA: conception and design of the study, drafting the article for relevant intellectual content. GD: conception and design of the study, drafting the article for relevant intellectual content. All authors read and approved the final version of the manuscript. | 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, grants, or other support was received. | 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. The direct medical costs were estimated according to tariffs for public medical centers and hospitals, approved by the Iran Ministry of Health and Medical Education in 2021. The incremental cost-effectiveness ratio (ICER) and the net monetary benefit (NMB) were used to evaluate the cost-utility analysis. Deterministic and probabilistic sensitivity analyses are performed to investigate the robustness of the results and account for the different sources of uncertainty. | 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 knee osteoarthritis management. However, the PRP injection method was identified as the most cost-effective intervention due to its high NMB and ICER estimates. Based on the Monte Carlo Simulation, PR intervention, compared to other ones, was introduced as the dominant strategy regarding knee OA management, with a WTP of $10,000 for 100% of cases. | 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 benefit, for knee OA management.
| 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 vast range of treatment approaches related to OA management, such as non-pharmacological and pharmacological approaches. Non-pharmacological approaches include weight loss, the use of ambulatory aids, exercise, muscle strengthening, and physiotherapy. In contrast, pharmacological treatments include simple analgesics and nonsteroidal anti-inflammatory drugs (NSAIDS). If such treatments would not be effective, therefore, intra-articular knee injections may be considered one of the most efficient non-surgical approaches [Intra-articular injection of platelet-rich plasma (PRP), intra-articular injection of plasma rich in growth factors (PRGF), intra-articular injection of hyaluronic acid (HA), and intra-articular injection of ozone are defined as Intra-articular knee injections [One of the well-established non-surgical treatment options which have received significant attention from clinicians is Intra-articular injections, which several studies demonstrated their effectiveness. Regarding this, there are number studies that investigate the cost-effectiveness of intra-articular injections. Some of these studies compared two intra-articular injectable options such as PRP and HA [ | 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, HA, and Ozon (Fig. Cost-effectiveness model of Intra-Articular injections | 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 follow-up period, it is considered effective).Moreover, to estimate the utility value we use the Wailoo study [ | 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 costs were not included, although their importance (considered the same between different groups in order to make the analysis easier). To estimate the treatments cost we used the medical tariffs for public medical centers and hospitals, approved by the Iran Ministry of Health and Medical Education in 2021. (Conversion rate: 1 dollar equals 42,000 Rials) [ | 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/ NMB when parameters are varied independently. The parameters of the model were varied by ± 20 to assess the effect that each variation on the ICER and NMB.Probabilistic sensitivity analysis (PSA) was performed to investigate the uncertainty of ICER and the possibility of PRP effectiveness. In this regard, a Monte Carlo Simulation approach with 10,000 hypothetical samples was used., Gamma Distribution and Uniform Distribution models were used for cost and utility parameters, respectively.This analysis was performed using the TreeAge Pro Software (2020). | 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 interventions specifically and as it as shown in Fig. NMB gain in different WTP thresholdBased on the Monte Carlo Simulation, which is shown in Fig. Monte Carlo Simulation chart | 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 the financial burden of a long recovery period and the need for rehabilitation has led to an increased effort to find alternative treatments. Up to now, several intra-articular injections, such as PRP, PRGF, HA, and Ozone have proven their effectiveness in numerous clinical trial articles and systematic reviews [In recent years, a majority of studies have focused on comparing the effectiveness of injectable and non-injectable interventions regarding knee OA treatment [The study results revealed that among intra-articular injections for knee osteoarthritis treatment, PRP, in comparison to PRGF, HA, and Ozone, by acquisition of the most ICER (7583.16), is the most cost-effective injection. In addition, regarding the net monetary benefit, PRP was reported as the best intervention with the highest net monetary benefit (6385.40$). Moreover, based on the sensitivity analysis results, the acceptability of PRP and PRGF, and the probability of efficacy of PRP and PRGF were the most important variables affecting the outcomes of the study (Fig. The current results are reasonable due to the economic conditions in Iran. High molecular weight HA, used in the original study, was Hyalgan, an importable drug without the cover of insurance, that by considering the lower value of the national currency of Iran, would be an expensive drug (180$), however during last years the preparation kits of PRP as well as PRGF are made in Iran, so though the greater tarrifs for PRP and PRGF injections in medical system in Iran, the total cost of the treatment would be greater in HA group due to the expense of Hyalgan.Based on our results, we recommend the decision makers in Iran that it would be wise to include the PRP under the insurance coverage, till then if a physician wants to choose between PRP, PRGF, Hyalgan, and Ozone in Iran, the first choice could be PRP on the same situation, considering its cost-utility.During last year's, scientists in Iran tried to produce high molecular weight HA internally by cheaper means, so comparing the effectiveness as well as cost-utility of these products with the current available HA in Iranian markets, could be considered as the topic of future studies. | 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 considered in the cost-utility analyses. The costs considered in the present study may differ in different situations. It is due to different provider perspectives, providing centers (public or private), contractual agreements, insurance status, and so on. Based on the mentioned reasons, it appears that we could not interpret the results for the general population exactly. A wide range of variations of the drugs and kits costs, as well as the medical tariffs, over time, which is considered another limitation, the reproducibility of the results would not be precise. To cope with such problems, in the following studies, the researcher may calculate the exact costs of different treatments and procedures. | 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 contributed to the idea and literature review. All the authors participated in drafting and its final approval. The author(s) read and approved the final manuscript. | 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) conducted by Raeissadat SA et al. [ | 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 grafting. They were randomly treated with a single dose of oral clindamycin (600 mg) 1 h before surgery or a placebo. All surgical procedures were performed by one surgeon. A single trained observer evaluated all patients on postoperative days 1, 7, 14, 28, and 56. Early dental implant failure was defined as the loss or removal of an implant for any reason. We recorded the clinical, radiological, and surgical variables, adverse events, and postoperative complications. The study outcomes were statistically analysed to evaluate differences between the groups. Furthermore, we calculated the number required to treat or harm (NNT/NNH). | 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 at risk of infectious endocarditis, with reduced host response, surgery at infected sites, extensive and prolonged surgeries, and the implantation of large foreign materials [Recent systematic reviews and meta-analyses of randomised clinical trials (RCT) [Despite current studies published in this field, there is a lack of consensus among clinicians while prescribing antibiotics in oral implant surgery. Moreover, their prescriptions may not frequently follow evidence-based recommendations [Recent surveys have confirmed that more than half of the dentists who routinely place implants prescribe antibiotics [Amoxicillin is one of the most extensively studied and prescribed antibiotics [Clindamycin has appeared as one of the choices for oral implant surgery according to multiple surveys performed in the last few years among oral care professionals [A single 600-mg dose of clindamycin 1 h preoperatively was reported as one of the routinely prescribed regimens for implant surgery in Sweden [Clindamycin has been studied to this purpose previously [According to several researchers and national guidelines, clindamycin is principally prescribed for patients allergic to amoxicillin to prevent the loss of dental implants. However, no clinical trial has been published yet to support its efficacy neither in allergic nor in non-allergic patients to penicillin. Therefore, we intended to conduct an RCT that provides information regarding this. As a consequence, we aimed to assess the effect of a single 600-mg dose of oral clindamycin administered 1 h pre-operatively in reducing early implant failure and on post-surgical complications in healthy adults undergoing a conventional implant installation.The null hypothesis was postulated as follows: there are no differences in the cumulative incidence of implant failures following an oral implant surgery in medically and periodontally healthy adults and straightforward conditions upon administering a single 600-mg dose of oral clindamycin 1 h preoperatively versus placebo. | 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 and Medical Devices (AEMPS) on 18 December 2018. This study was conducted in accordance with ethical principles, including the World Medical Association Declaration of Helsinki (World Medical Association, 2013) and the Consolidated Standards of Reporting Trials (CONSORT) statement [ | 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 placement of a single oral implant, without a previous surgical site infection or bone-graft procedure. We performed consecutive sampling of the accessible population.Participants were excluded before randomisation for the following reasons: allergy to any drugs used in the trial, decompensated systemic pathologies (cardiac, respiratory, endocrine, metabolic, hepatic, haematological, the risk of bacterial endocarditis, or immunosuppression), valvular or orthopaedic prostheses, and a history or use of bisphosphonates, anticoagulants, or antiplatelet agents. Moreover, we excluded participants whose amannesis reports that they have had been irradiated in the cervical and maxillofacial territory, were pregnant, suspected of being pregnant or breastfeeding, or with a history of antibiotic-associated ulcerous colitis. All participants underwent a radiographical assessment at the implant site, as stated in the clinic’s protocol. Those requiring bone graft treatment were excluded from the trial. We recorded the PPD and bleeding on probing to determine their periodontal status. Only healthy participants were included in this study.Participants were excluded following randomisation upon their request, by an abandonment of the trial, by loss to follow-up, and/or antibiotic consumption in the last 15 days prior to the surgery. | 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 the medication or placebo at the dental clinic 1 h before the surgery.All surgical procedures were performed by one surgeon with an extensive experience in oral implant surgery. The surgeries commenced with the following anaesthetic technique: anaesthetic block of the area using articaine (4%) with epinephrine 1:1000.000, using a mandibular block technique for implant placement in the mandible, and an infiltrative technique in the maxilla. A full-thickness mucoperiosteal flap was made via a crestal incision in the edentulous section and an intrasulcular incision in the adjacent teeth. Releasing incisions were made only on the highly resorbed ridges or in the presence of marked bone concavities. Straumann Roxolid® (TI-Zr) SLActive® (Sand-blasted large grift acid-etched) (Basel, 4002 Switzerland) implants were placed. The surgeon inserted a 1.8 mm Straumann Tissue Level Standard Plus® (TL) polished neck implant in non-aesthetic zone. Straumann Bone Level Tapered ® (BLT) type implants were inserted in the aesthetic areas of the maxilla. The manufacturer-recommended drilling sequence was used for both types of implants. None of the participants underwent a second-stage implant surgery. The bone width and available bone height determined the diameter (3.3 or 4.1 mm) and length of the implant (8, 10, or 12 mm), and therefore the drilling sequence. Al implants were placed freehand. Following the implant placement, the implant insertion torque was measured using a Straumann® ratchet wrench with a dynamometer (Nos. 046.119 and 046.049). In all cases, primary closure of the flap was done using a 5–0 non-resorbable. Polyester monofilament suture with a single interrupted suturing technique.Postoperative pain management consisted of 600-mg ibuprofen or 1-g paracetamol prescribed every 8 h on the days the participants considered it necessary, but no more than 4 days.The clindamycin and placebo capsules were presented in blister packs, individually packed, and labelled to maintain blinding. The samples were labelled with the sample number, protocol code, the number of units, dosage form, the route of administration, and expiration date.The planned antibiotic was one tablet (875/125 mg) of amoxicillin/clavulanic acid administered every 8 h for 7 days. One of the inclusion criteria was no allergy to amoxicillin or clavulanic acid. | 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-implant radiolucency, manual mobility, and Osstell® resonance frequency analysis (Implant stability quotient, ISQ < 60, including suppuration, fistula, abscess, osteomyelitis, and fever > 38 °C. Furthermore, we assessed postoperative pain, localised inflammation, bleeding, and intraoral and extraoral erythema using the visual analogue scale.In addition, we recorded the adverse reactions. | 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 STATA® 15 (College Station, TX, 77,845, USA). | 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 number corresponded to the treatment assigned during randomisation, and each patient was successively assigned the corresponding treatment number. One of the researchers delivered the treatment in a closed envelope 1 h before the implant placement. All the professionals directly in contact with the participants and the participants themselves were unaware of the treatment. | 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 for every 15 participants treated with clindamycin, one implant failure would occur beyond those that would have happened under placebo treatment. Nevertheless, there were no significant differences between the groups (Three patients suffered postoperative infections, and two of them were administered rescue antibiotic treatment. By contrast, the remaining patient did not receive the rescue antibiotic owing to implant failure and removal. Both participants who received the rescue antibiotic belonged to the control group, whereas the participant with implant failure belonged to the clindamycin group (RR: 0.5; CI: 0.05–5.23, ARR = 0.03; CI: − 0.07–0.13, NNT = 31; and CI: 7.2–∞). The ARR suggested that 3.2% of the patients would not experience postoperative infections under clindamycin treatment, which they would experience under placebo. The NNT indicated that 31 patients would need to be treated with clindamycin to prevent one patient from suffering a postoperative infection. However, there were no significant differences between the groups (Considering the occurrence of postoperative infections or oral implant failures per participant as the overall complications, there were two participants in each treatment group with complications (RR = 1; CI: 0.15–6.66, ARR = 0; CI: − 0.12–0.12, NNT: not estimable, and | 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 that a single 2-g preoperative dose of oral amoxicillin may be effective against oral implant surgery; nonetheless, the effectiveness of this treatment was questionable (NNT varied from 25 to 77), and the use of prophylactic antibiotics in oral implant surgery remains controversial [Recent publications have described a wide variation in antibiotic regimens and types prescribed in different countries [Clindamycin is frequently prescribed for penicillin-allergic patients as an alternative to oral surgery; however, researchers have recently reported on the lack of high-quality clinical evidence for its use in oral implant surgery [The present clinical trial represented a further step towards understanding the lack of evidence supporting clindamycin’s prophylactic use.Moreover, the trial can likely investigate the controversy regarding the association between oral implant failures, penicillin allergy, and the use of clindamycin (Salgado-Peralvo et al., 2021a; Salgado-Peralvo et al., 2021b). Considering the exclusion of all participants allergic to penicillin from the trial, we could delimitate the correlation between the possible higher occurrence of implant failures and clindamycin use. Hypothetically, the role of unknown genetic factors in penicillin-allergic participants was excluded from this equation.The low incidence of postoperative infections may be the supposed outcome of standard antiseptic-sterile surgical measures, in combination with the performance of an expert surgeon and limited surgical duration. Nevertheless, the postoperative infection rates (3.2% for the clindamycin group and 6.4% for the control group) were considerably higher but similar to those reported in other clinical trials performed with alternate antibiotics (2.2% for the amoxicillin group and 3.1% for the control group) (Rodríguez Sánchez et al., 2018). | 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 the development of a serious infection and the eventual failure of the implant. | PMC9469834 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.