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Funding
Not applicable.
PMC10512624
Availability of data and materials
The data used and/or analyzed during the current study (without any identifying information) are available in Figshare at
PMC10512624
Declarations
PMC10512624
Ethics approval and consent to participate
The study protocol and informed consent were approved by Iran National Committee for Ethics in Biomedical Research (approval number IR.IAU.KHUISF.REC.1400.088) and was conducted in accordance with principles of the Declaration of Helsinki. All patients provided written informed consent prior to enrollment.
PMC10512624
Consent for publication
Not applicable.
PMC10512624
Competing interests
The authors declare no competing interests.
PMC10512624
References
PMC10512624
Purpose
knee arthroplasty, UC
The study sought to investigate the effectiveness of a cryocompression Game Ready™ (GR) versus usual care protocol (UC) on early post-operative recovery following total knee arthroplasty.
PMC10471706
Methods
This study prospectively randomised 72 total knee arthroplasties to a 2-week (from day 0) intervention of GR treatment (
PMC10471706
Results
There were no significant group-by-time interactions regarding any of the outcomes. The GR group had 19% lost to follow-up at 2 weeks, while the UC group had 8%. The GR group demonstrated significantly better knee extension ROM at day 1 (
PMC10471706
Conclusion
Despite patients gaining significantly more knee extension during the initial two-week intervention period when using GR compared to UC, this effect was likely due to chance. No further significant differences were observed between the groups during or after cession of the intervention.
PMC10471706
Level of evidence
Level 2.
PMC10471706
Keywords
PMC10471706
Introduction
Pain, blood loss, inflammation, pain, knee arthroplasty, TKA, tissue damage
BLOOD LOSS, INFLAMMATION
Pain and inflammation are expected during the recovery period immediately following total knee arthroplasty (TKA), given the extensive soft tissue damage and blood loss caused [Cryocompression therapy is a non-invasive and non-pharmacological modality used in managing acute inflammation and pain, demonstrating benefits...
PMC10471706
Materials and methods
A single centre, prospective randomised controlled trial (RCT) was undertaken to evaluate the benefit of a post-operative cryocompression protocol using the GRPro
PMC10471706
Surgery
thromboembolic, TKA
INFILTRATION
TKA was performed with the Rosa® Knee System (Zimmer Biomet, Warsaw, IN, USA) using the Persona® Knee implant. Surgery was performed under spinal anaesthesia along with an adductor canal block and local anaesthetic infiltration. Antibiotics (2 g cefazolin) and tranexamic acid (1 g) were given at the time of induction a...
PMC10471706
Usual care (UC) and game ready (GR) treatment protocols
TKA, UC
Both treatment groups commenced their intervention on day 0 upon their return to the ward after their TKA and continued for a period of two weeks (spanning the in-patient and early out-patient setting). The UC group underwent regular icing (bag of crushed ice) along with tubigrip static compression (on average 17 mmHg)...
PMC10471706
Baseline measurements
Pre-operative baseline demographic characteristics of age and gender were recorded, along with active knee ROM (flexion and extension) and knee circumference at the mid-patella point, as detailed further below. Pre-operative ROM measurements were taken with a hand-held goniometer by the treating orthopaedic surgeon whi...
PMC10471706
Post-operative clinical outcomes
swelling, Pain, active knee flexion and extension ROM, pain, knee arthroplasty, ’ pain
A range of subjective and objective measures were collected throughout the post-operative period. For early post-operative subjective measures, patients were provided with a study logbook to record pain (VAS) scores and medication usage over the first 2 weeks, which was subsequently collected from patients at their 2-w...
PMC10471706
Statistical analysis
An a priori power calculation was undertaken for the primary outcome measure (VAS difference of 1 point at 2-weeks post-surgery), determined based on the recommendations of Cohen [
PMC10471706
Discussion
Su, pain
RECRUITMENT
The most important outcome from the current study was that patients using the GR cryocompression device over the first two post-operative weeks after TKA demonstrated better knee extension ROM compared with a UC ice and tubigrip protocol. Despite reaching statistical significance, due to the high dropout rate, this fin...
PMC10471706
Funding
The Game Ready devices were provided free of charge, apart from this there was no additional funding for the study.
PMC10471706
Declarations
PMC10471706
Conflict of interest
Not applicable.
PMC10471706
Ethical approval
Ethics approval was obtained from the Hollywood Private Hospital Human Research Ethics Committee (HPH542).
PMC10471706
References
PMC10471706
Keywords
bleeding, postoperative pain, intraoperative bleeding, sclerosing, pain
RECURRENCE, BLEEDING, ORAL PYOGENIC GRANULOMA, INTRAOPERATIVE BLEEDING
Oral pyogenic granuloma (PG) is traditionally treated by surgical excision which is associated with bleeding, pain and a high rate of recurrence. Our research aimed to clinically assess the effectiveness of diode laser versus sclerotherapy, as bloodless approach, in the treatment of oral PG. We randomly divided 20 pati...
PMC10020281
Introduction
thrombosis, postoperative pain, sclerosing, fibrosis, benign vascular lesions, reactive hyperplasia, oedema, trauma
THROMBOSIS, RECURRENCE, PYOGENIC GRANULOMA, FIBROSIS, COMPLICATIONS, ORAL PYOGENIC GRANULOMA, REACTIVE HYPERPLASIA, OEDEMA
Pyogenic granuloma (PG) is considered one of the most common forms of reactive hyperplasia that develops as a result of chronic tissue trauma that triggers a repair response [Although the etiopathogenesis of PG is unclear, various factors appear to have a role in its development [There are numerous differential diagnos...
PMC10020281
Materials and methods
PMC10020281
Study design
We conducted a two-arm parallel randomised controlled clinical trial on twenty patients with oral PG. A convenience sample of patients was recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Alexandria University, Egypt. The study ...
PMC10020281
Inclusion and exclusion criteria
allergic, sclerosing, diabetes, renal diseases
COAGULATION DISORDERS
We included patients aged 19–50 years of both genders who were diagnosed clinically, with confirmed histological confirmation, with gingival oral PG. The sizes of participants’ lesions were not less than 7 mm. Patients were excluded if they had uncontrolled diabetes, renal diseases, coagulation disorders or were allerg...
PMC10020281
Sample size estimation
The sample size was estimated based on a 5% alpha error and study power of 80%. The reported percentage of patients with excellent healing according to Landry’s healing index after three weeks of follow-up for the sclerotherapy group was 100% while it was 42.9% for the laser group [
PMC10020281
Grouping and randomisation
Simple randomisation of twenty patients diagnosed with oral PG into two groups (the laser [test] and sclerotherapy [control] groups) was carried out using a computer-generated list of random numbers (
PMC10020281
Intervention
renal toxicity, necrotic, sclerosing, pain
ULCERATED, NECROTIC, COMPLICATIONS
Before starting treatment (preoperatively), we obtained a complete medical and dental history from all the patients in both groups to figure out the size, texture, consistency, pain, location and duration of the lesion. We then performed phase I therapy and instructed patients to maintain oral hygiene measures [Small i...
PMC10020281
Outcome assessment
bleeding, pain
BLEEDING, RECURRENCE, EPITHELIALISATION, ULCERATION, INTRAOPERATIVE BLEEDING
All patients were evaluated clinically for the following:Intraoperative bleeding was reported for participants in both groups. It was interpreted as mild (subsided 20 min after applying pressure with gauze), moderate (required haemostatic irrigation) or severe (required suturing and, possibly, vitamin K or an infusion ...
PMC10020281
Statistical analysis
Categorical data were presented as frequencies and percentages and analysed using Fisher’s exact test for intergroup comparisons and Cochran’s q test followed by multiple pairwise comparisons using McNemar’s test with the Bonferroni correction. Quantitative data were presented as mean values and standard deviations. No...
PMC10020281
Results
bleeding, postoperative pain
RECURRENCE, BLEEDING, RECURRENCE
The study was conducted on 20 patients that were randomly and equally allocated to two groups. Males and females were equally represented in the laser-treated group; however, in the control group, there were four (40%) males and six (60%) females, with no statistically significant difference between the two groups (Lan...
PMC10020281
Acknowledgements
We thank Dr Zeinab Darwish for her contribution to the histological examination of the biopsy specimens.
PMC10020281
Author contributions
SK.A: Conceptualisation; Methodology; Data curation; Validation; Supervision; Writing-original draft; Writing-review and editing. SN.E: Methodology; Data curation; Visualisation; Writing-original draft. NM. EL Sayed: Methodology; Supervision.
PMC10020281
Funding
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). There is no financial support from any institution or company.
PMC10020281
Data availability
All data included in this current study are available from the corresponding author upon request.
PMC10020281
Declarations
PMC10020281
Conflict of interest
The authors declare that they have no competing interests.
PMC10020281
Ethical approval
The study was conducted after obtaining ethical approval from the Research Ethics Committee of the Faculty of Dentistry, Alexandria University, Egypt (IRB NO:00010556-IORG 0008839). This study was registered in the U.S National Institutes of Health Clinical Trials Registry (NCT05099081). It was also performed in accord...
PMC10020281
References
PMC10020281
1. Introduction
obesity, chronic kidney disease, stroke, cancer, metabolic syndrome, diabetes
OBESITY, CARDIOVASCULAR DISEASE, STROKE, CANCER, METABOLIC SYNDROME, DISEASES, DIABETES
Japan has introduced a nationwide lifestyle intervention program (specific health guidance) for people aged 40–74 years. Medical insurers apply a reminder system to improve their utilization rates. This study examined the effectiveness of two methods of reminders (mailed letters and telephone calls) in a randomized con...
PMC10001113
2. Materials and Methods
PMC10001113
2.1. Sample and Procedures
metabolic syndrome
METABOLIC SYNDROME
The target population was National Health Insurance subscribers in Yokohama City, Kanagawa Prefecture, Japan (approximately 510 thousand subscribers as of April 2021). Yokohama is the capital of Kanagawa Prefecture and is located 30 km southwest of central Tokyo. As of April 2021, Yokohama City had a population of appr...
PMC10001113
2.2. Intervention
We adopted letter and telephone reminder interventions in this study. The interventions were administered by the staff of Yokohama City. The information provided to the participants via either letter or telephone call was not personalized.
PMC10001113
2.2.1. Letter Reminder
A reminder was mailed to the participants’ home addresses. The main components of the letter were an “explanation of the specific health guidance (including information that the specific health guidance was free of charge)”, “the expiration date of the specific health guidance”, “information on the medical centers/hosp...
PMC10001113
2.2.2. Telephone Reminder
The public health nurse called the participants on weekdays using the phone numbers that the participants had provided as their contact information when they were enrolled in the National Health Insurance program. The information provided to the participants was compiled into a manual. The main contents were “a brief e...
PMC10001113
2.3. Measures
PMC10001113
2.3.1. Outcomes
The outcome variable was whether or not the participants utilized specific health guidance in FY2021. Information on the participants’ use of specific health guidance was obtained from the Data Management System of Yokohama City.
PMC10001113
2.3.2. Participants’ Characteristics
CHRONIC KIDNEY FAILURE, CEREBROVASCULAR DISEASES, DISEASES, CARDIOVASCULAR DISEASES
We used the participants’ demographics (sex and age) and the results of the health checkups obtained via the Data Management System. The results of the health checkups included the abdominal circumference, body mass index, diastolic blood pressure, systolic blood pressure, HbA1c, fasting blood glucose, triglyceride, hi...
PMC10001113
2.4. Statistical Analysis
First, the participants’ characteristics were compared between the three groups using the chi-square test, Fisher’s exact test, and Kruskal–Wallis test. For continuous variables, confirmed to be not normally distributed by the Shapiro–Wilk test, the non-parametric test was conducted (i.e., the Kruskal–Wallis test). Sec...
PMC10001113
4. Discussion
cancer, metabolic syndrome
CANCER, DISEASE, METABOLIC SYNDROME
In this study, we examined the effectiveness of two reminder methods in regard to the rate of utilization of specific health guidance (i.e., letters and telephone calls) using a randomized controlled trial design. Most medical insurers in Japan use a call–recall methodology to improve the implementation rate of specifi...
PMC10001113
5. Conclusions
metabolic syndrome
METABOLIC SYNDROME
We examined the effectiveness of two types of reminder methods (i.e., letters and telephone calls) in regard to the utilization of specific health guidance using a randomized controlled trial design for individuals with metabolic syndrome or those who were at risk of developing it. The results suggest that low priority...
PMC10001113
Author Contributions
Conceptualization, H.M. (Hiroshi Murayama), S.S. and Y.T.; methodology, H.M. (Hiroshi Murayama); formal analysis, H.M. (Hiroshi Murayama); investigation, S.S., K.M., H.M. (Haruna Maeda) and Y.T.; data curation, K.M. and H.M. (Haruna Maeda); writing—original draft preparation, H.M. (Hiroshi Murayama); writing—review and...
PMC10001113
Institutional Review Board Statement
The study protocol was approved by the Ethics Committee of the Tokyo Metropolitan Institute of Gerontology (approved on 10 September 2020). This study was retrospectively registered in the UMIN Clinical Trials Registry (UMIN000041793).
PMC10001113
Informed Consent Statement
Patient consent was waived because this study used data from the governmental administrative system (the Data Management System of Yokohama City).
PMC10001113
Data Availability Statement
The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
PMC10001113
Conflicts of Interest
The authors declare no conflict of interest.
PMC10001113
References
Flow diagram of the sampling and allocation processes.Participants’ characteristics.Values represent n (%) or mean ± standard deviation. Comparison of the utilization rate of specific health guidance between the groups.Values represent n (%).
PMC10001113
Background
In clinical studies, the EQ-5D-5L is often employed with disease-specific health-related quality of life instruments. The questions in the former are more general than the latter; however, it is known that responses to general questions can be influenced by preceding specific questions. Thus, the responses to the EQ-5D...
PMC9843919
Methods
Cancer
ADVANCED CANCER, CANCER
We prepared questionnaire booklets containing the EQ-5D-5L, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and the Functional Assessment of Cancer Therapy General with different orders. Using a quasi-randomized design, they were distributed to the patients undergoi...
PMC9843919
Results
The mean EQ-5D-5L index was 0.796, 0.760, and 0.789 for groups 1 (n = 300), 2 (n = 306), and 3 (n = 331), respectively. The difference between Groups 2 and 1 was − 0.036 (95% CI − 0.065 to − 0.007; p = 0.015). The proportion of patients with an incomplete EQ-5D-5L was 0.11, 0.11, and 0.05 for Groups 1, 2, and 3, respec...
PMC9843919
Conclusions
Although the EQ-5D-5L index differed according to the instrument orders, the difference size would not be considerably larger than the minimally important difference. The patients tended to complete the EQ-5D-5L when they were placed at the end of the questionnaire.
PMC9843919
Supplementary Information
The online version contains supplementary material available at 10.1186/s12955-022-02085-8.
PMC9843919
Keywords
PMC9843919
Introduction
Cancer
CANCER
Since the results of a cost-effectiveness analysis help to properly allocate limited medical resources, many countries utilize it for decision-making regarding healthcare systems [The EQ-5D is frequently employed with disease-specific health-related quality of life (HRQOL) instruments in clinical studies, such as rando...
PMC9843919
Methods
PMC9843919
Data collection
EQF, multiple primary tumors, colorectal, breast cancer, Cancer
ONCOLOGY, SOLID TUMORS, METASTATIC CANCER, CANCER
This research used data from Quality of Life Mapping Algorithm for Cancer (QOL-MAC) study’s data that mainly purported to develop mapping algorithms for the EORTC QLQ-C30 and the FACT-G on the EQ-5D-5L index. Its details have been published elsewhere [In the QOL-MAC research, patients with unresectable, locally advance...
PMC9843919
The HRQOL instruments
anxiety/depression
The EQ-5D-5L is a multi-attribute preference-based measure comprising five questions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression [The 30-item EORTC QLQ-C30 (version 3) is a cancer-specific HRQOL instrument [The FACT-G (version 4) is a cancer-specific HRQOL instrument containing 27 qu...
PMC9843919
Statistical analysis
REGRESSION
The QOL-MAC study’s sample size was determined based on the main purpose (i.e., the mapping algorithms’ development) and feasibility. Hence, no sample size calculation for the order effects’ evaluation was conducted.We employed two analysis populations: the eligible and the completed EQ-5D-5L. The former included all e...
PMC9843919
Discussion
This study investigated the impact of the preceding cancer-specific HRQOL instruments on the subsequent EQ-5D-5L’s responses. Regarding the mobility question, the answers differed between the groups with the EQ-5D-5L placed first and second or third. The responses to the usual activities question varied between those w...
PMC9843919
Responses to EQ-5D-5L
Cancer
CANCER
The assimilation and contrast effects may explain the order effects on the EQ-5D-5L responses. If respondents answered a specific question before a general one, they may interpret the latter as having a similar meaning to the former, which is called the assimilation effect [For example, regarding usual activities, the ...
PMC9843919
EQ-5D-5L index
cancer
CANCER
We focused on the EQ-5D-5L index based on the Japanese value set, because the mean differences in the EQ-5D-5L’s index were similar among the three value sets. Thus far, no prior research has estimated the minimally important difference (MID) of the EQ-5D-5L index in cancer. Hence, we briefly estimated it for interpret...
PMC9843919
Correlation
REGRESSION
Few correlation coefficients between the EQ-5D-5L index and the subscales of disease-specific HRQOL instruments differed among the instrument orders. This finding suggests that only a small assimilation or contrast effect existed; alternatively, both these effects existed in the population, however, mutually nullified ...
PMC9843919
HRQOL instruments with missing values
The reasons why the EQ-5D-5L indexes, subscales of the FACT-G and those of the EORTC QLQ-C30 tended to be missing when the EQ-5D-5L was placed last are not clear. However, the first possible reason is that answering the EQ-5D-5L’s general questions may be easier after responding to the disease-specific HRQOL instrument...
PMC9843919
Limitation
This study has certain limitations. First, the questionnaire booklets’ assignment to the patients was quasi-randomized and not strictly randomized with random numbers generated. Additionally, the medical staff could identify the questionnaire booklet types if they looked inside them. Thus, we cannot dismiss the possibi...
PMC9843919
Conclusions
ADVANCED CANCER
In the patients undergoing drug therapy for advanced cancer, the preceding cancer-specific HRQOL instruments were found to impact the mobility and usual activities questions in the EQ-5D-5L. This resulted in a difference in the EQ-5D-5L index; however, our findings indicated that the difference size would not be consid...
PMC9843919
Acknowledgements
We thank the patients and the researchers who participated in the QOL-MAC study that was supported by the of the Public Health Research Foundation. We are grateful to Associate Prof. Koji Oba and Assistant Prof. Yoshinori Takeuchi at the University of Tokyo for their comments on the manuscript’s earlier version. We wou...
PMC9843919
Author contributions
YH, TS, NT, TK, KK, SN, TF, and KS contributed to the study’s conception and design. NT contributed to the data acquisition. SI, YH, and YM contributed to the data analysis. All authors interpreted the data. SI and YH composed the manuscript’s first draft; all authors revised it critically. All authors read and approve...
PMC9843919
Funding
The QOL-MAC research was sponsored by the Public Health Research Foundation that received the research fund by the Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, under the study contract. This research was also supported by AMED under Grant Number JP22lk0201701.
PMC9843919
Availability of data and materials
The data that support this study’s findings are available from the Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health; however, restrictions apply to their availability, which were used under license for the current study. Hence, they are not publicly available.
PMC9843919
Declarations
PMC9843919
Ethics approval and consent to participate
The study protocol was approved by each participating hospital. All patients provided written informed consent before their enrollment.
PMC9843919
Consent for publication
Not applicable.
PMC9843919
Competing interests
The authors declare that they have no competing interests.
PMC9843919
References
PMC9843919
Introduction
Since the nineteenth century to date, relapse has been one of the most difficult and unsolved problems in orthodontics. Some degree of relapse is inevitable and more deleterious in some patients in comparison to othersFactors affecting compliance have been previously investigated in the literatureAccordingly, to achiev...
PMC10219970
Aim
SECONDARY
Our primary aim was to assess the impact of audiovisual instructions with additional weekly electronic reminder messages, on improving the adherence to instructed wear time of Hawley retainer, in comparison to verbal instructions alone. The secondary outcomes were to assess gingival and periodontal health after 6 month...
PMC10219970
Methods
PMC10219970
Study design
cleft lip, craniofacial deformities, orthodontic, palate
SYSTEMIC DISEASE, PERIODONTAL DISEASE
This was a double-arm parallel-group prospective superiority randomized clinical trial, performed in a single center at the orthodontic department of the First Affiliated Hospital of Zhengzhou University from November 19, 2020, to October 12, 2022. Prior to the study commencement, ethical approval was obtained from the...
PMC10219970
Procedures
®
PLAQUE
A total of fifty-two participants each receiving a Hawley retainer with embedded TheraMon® microsensor (MC Technology GmbH, Hargelsberg, Austria) were randomly allocated to receive either (A) audiovisual instructions and electronic weekly reminder (Audiovisual group) or (B) verbal only instructions (control group). Per...
PMC10219970
Intervention
SECONDARY
For the audiovisual group, participants watched four short videos upon delivery of the retainer (“Hold that smile—Why are retainers so important?’’, “Retainers keep your teeth from becoming crooked again”, and two additional illustrative videos on how to use and take care of the retainer)The primary outcome was to asse...
PMC10219970
Sample size calculation
Sample size calculation was performed using G*power software (version 3.9.6.2 for Mac OS). A total sample size of 42 patients was sufficient to detect an effect size of 0.25 at a power of 0.95 (95%) and a partial eta square of 0.06 at a significance level of 0.05. To account for dropouts, the sample size was increased ...
PMC10219970
Statistical analysis
Statistical tests were performed by SPSS software 22.0 (Statistical Package for Social Science, Armonk, NY: IBM Corp) with an alpha level of 0.05 (significance set at Inter-observer reliability was assessed using interclass correlation coefficient (ICC) between investigators and to assess measurement error.For statisti...
PMC10219970
Results
Fifty-two participants (mean age 26.1; range 16 to 35 years) were randomly assigned to either the audiovisual (26 participants) or control group (26 participants). Females represented almost two-thirds of the sample (69.2%) in comparison to males (30.8%). All participants were from the Chinese Han ethnicity. Three part...
PMC10219970
Patient experiences
Forty-four participants completed the questionnaire at the end of the study, twenty-one from the control group, and twenty-three from the audiovisual group (Table Results of patient experience questionnaire.1–4 d11 (52.38%)5–8 d8 (38.10%)9 ≤ d2 (9.52%)1–4 d11 (47.83%)5–8 d8 (34.78%)9 ≤ d4 (17.39%)1–4 d6 (28.57%)5–8 d9 ...
PMC10219970