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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 |
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