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Funding | Not applicable. | PMC10512624 |
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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 |
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Declarations | PMC10512624 |
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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 |
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Consent for publication | Not applicable. | PMC10512624 |
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Competing interests | The authors declare no competing interests. | PMC10512624 |
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References | PMC10512624 |
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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 |
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Methods | This study prospectively randomised 72 total knee arthroplasties to a 2-week (from day 0) intervention of GR treatment ( | PMC10471706 |
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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 |
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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 |
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Level of evidence | Level 2. | PMC10471706 |
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Keywords | PMC10471706 |
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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 in the post-operative setting promoting vasoconstriction, reducing blood flow and inflammation [While elastic wraps and icepacks are commonly used modalities in the post-TKA setting, cryocompression therapy is not routinely implemented post-operatively. The Game Ready GRPro® 2.1 (GR) system offers a novel, easy to administer method of administering constant cryotherapy at a consistent temperature with intermittent pneumatic compression. The limited literature evaluating the GR system demonstrates it is a safe, user friendly device with improved outcomes and patient satisfaction [ | 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 |
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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 and continued for 24 h post-operatively. Both groups followed the same post-operative multimodal analgesia regime, with patients receiving standardised post-operative analgesia which included paracetamol (1 g 6 hourly), non-steroidal anti-inflammatories (200 mg celecoxib 12 hourly), if tolerated, and slow-release (SR) opioid-based medication with top-up opioid analgesia as needed. Patients primarily received 50–100 mg of tapentadol SR along with immediate-release (IR) tapentadol. Where this was not tolerated, it was substituted for oxycodone with naloxone SR and oxycodone IR. Dressings were applied after wound closure which remained intact for 2 weeks following surgery and compressive crepe bandaging was applied in theatre, which was removed the following day. Both groups were able to fully weight bear on day one and followed the same standardised rehabilitation protocol guided by the in-patient physiotherapy team, along with routine day one post-operative x-rays, bloods and thromboembolic prophylaxis. | 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) [GRProBoth groups followed a 2-week protocol of either ice plus tubigrip (UC) or use of the GR device for a period of 20 min, 6 times a day, with an off time of at least one hour between applications. Specific application times were not set but the regime was to commence first thing in the morning, and with patients requiring a one hour “off” period between sittings the intervention times were dispersed between morning, afternoon and evening. Patients were provided a logbook to keep track of their routine and to assist them in complying to the frequency protocol. The GR device was set on a low pressure (cycle of 5–15 mmHg) for days 0–5 and then a medium pressure (cycle of 5–50 mmHg) from days 6–14. A standardised temperature of 5 °C was used which was well tolerated by all patients. The physiotherapist initially set up the GR device controls for the patient in hospital and instructed them how to use and adjust the system as needed. While in hospital both interventions were initiated by nursing and physiotherapy staff and then carried on by the patients themselves on discharge. | PMC10471706 |
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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 which has shown to have high inter-rater and intra-rater reliability [ | PMC10471706 |
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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-week out-patient appointment. The VAS was used to assess patients’ pain levels, on a whole number rating scale from 0 (no pain) to 10 (worst pain). VAS was recorded at day 1, day 2, week 1 and week 2, and subsequently at the patient’s 6-week out-patient appointment. Opioid usage was recorded from in-patient medication charts and then from the patient’s logbook following hospital discharge, converted to milligram of morphine equivalents for standardisation. In-patient hospital LOS was recorded upon discharge.KOOS was assessed at 6-weeks post-surgery. Given the early timeframe that the study was focused on, only the overall KOOS score has been reported, along with subscales for Pain, Symptoms and QOL. A Patient Satisfaction Questionnaire (PSQ) was also employed to evaluate the patient’s level of satisfaction with their method of cryocompression therapy and its ability to relieve their pain and improve their ability to perform daily activities. It also assessed their satisfaction in ease of use and application, perceived swelling control, sleep and mobility. A categorical tool was devised: 1 = very satisfied; 2 = somewhat satisfied; 3 = somewhat dissatisfied; 4 = very dissatisfied, with an overall score between 9 (best) to 36 (worst). These were completed at the 2-week, 6-week and 3-month post-operative time-points.Objective measurements collected in hospital were non-blinded and undertaken and recorded by the patient’s treating physiotherapist, commencing on day 1 after the bulky crepe compression bandage was removed. Ongoing knee ROM and circumference measurements were taken and recorded by a blinded research assistant at follow-up appointments in the orthopaedic surgeon’s private practice. Both active knee flexion and extension ROM were recorded using a hand-held long-arm goniometer which has shown high test–retest reliability following knee arthroplasty with an intraclass correlation (ICC) of 0.99 [Ethics approval was provided by the Hollywood Private Hospital Research Ethics Committee, approval number HPH542. | PMC10471706 |
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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 |
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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 finding may be a result of chance. Our findings correlate to those of Ueyama et al. [Previous literature evaluating the GR system have used differing treatment protocols and this may have contributed to the variation in our findings. No previous studies have found any significant improvements in knee ROM. Su et al. [The lack of significant differences between the two groups rejected the study hypothesis. There is an associated cost with use of GR compared to regular icing which must be considered, so although our results show marginal favour towards the use of GR it would be more suited to patients in the private hospital setting. Through the mixed model statistical analysis using gender and age as confounding factors, we discovered that males significantly reported on average less pain on the VAS than females and older patients consumed less opioids. These findings align with previous literature demonstrating a higher prevalence and experience of pain in females [It can be difficult to ascertain if a patient is truly happy and satisfied with the outcome of their TKA. There is a large amount of scope for interpretation of questions posed in PROMs which can lead to variation in results and ultimately may not be the best measurement for patient satisfaction [Several study limitations are acknowledged. Firstly, study onset and recruitment coincided with the onset of the COVID-19 pandemic which impacted data collection due to reduced patient clinic attendance. Losses to follow-up over the 6-week post-operative period could imply that our significant results are due to chance and thus cannot be interpreted as being clinically significant. These circumstances are not unique to our study with the COVID-19 effect on clinical trials being well documented [ | PMC10471706 |
Funding | The Game Ready devices were provided free of charge, apart from this there was no additional funding for the study. | PMC10471706 |
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Declarations | PMC10471706 |
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Conflict of interest | Not applicable. | PMC10471706 |
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Ethical approval | Ethics approval was obtained from the Hollywood Private Hospital Human Research Ethics Committee (HPH542). | PMC10471706 |
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References | PMC10471706 |
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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 patients with oral PG into two groups, with those in the test group being managed via diode laser application and those in the control group via injections of ethanolamine oleate as a sclerosing agent. All patients were evaluated intraoperatively for bleeding severity and postoperatively for pain. The quality of healing was also assessed using Landry healing index after the 1st, 2nd and 4th weeks. Additionally, the patients were recalled after 3, 6 and 9 months from the end of treatment for recurrence evaluation. Our results revealed that intraoperative bleeding did not differ significantly between both groups while postoperative pain decreased significantly in the sclerotherapy group compared to the laser group. For different intervals, the sclerotherapy group had a higher healing quality index than the laser group, although the difference was not statistically significant. However, recurrence occurred in the laser group, there were no cases of recurrence in the sclerotherapy group in all intervals. In conclusion, diode laser treatment of PG is a reliable, less invasive, and sensitive procedure that requires an experienced operator and specialised equipment. However, ethanolamine oleate sclerotherapy is an inexpensive, simple technique besides being less prone to recurrence problems, especially when treatment duration is not a concern.Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | 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 diagnoses for PG, therefore biopsy findings are critical and conclusive in establishing the diagnosis [Many treatment modalities for PG have been introduced. Surgical excision is considered the treatment of choice; however, simple excision is associated with a relatively high rate of recurrence [Despite various treatment options, recurrence of PG is frequent, especially after normal surgical excision [Diode lasers have been used as an alternative to surgical treatment for PG because of their benefits such as haemostasis, easier gingival reshaping, decreased postoperative pain and oedema in addition to its safety near calcified tissues due to its poor absorption by teeth and bones [Sclerotherapy involves injecting a chemical agent into the vessels, which causes endothelial damage, thrombosis and vessels fibrosis, leading to lesion destruction [Ethanolamine oleate (EO), as a sclerosing agent, is a safe and effective treatment for benign vascular lesions located all over the body [Traditional PG treatment approach by surgical excision, can be costly, invasive and require an office visit or operative suite setting [Although recent studies confirmed the efficacy of sclerotherapy, as well as laser, being noninvasive treatment approaches compared to conventional invasive surgical excision of PG [The null hypothesis was that there would be no significant difference in post-operative complications, healing quality index and recurrence rate following treatment of oral pyogenic granuloma with diode laser in comparison with sclerotherapy. | PMC10020281 |
Materials and methods | PMC10020281 |
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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 was conducted during the period between December 2020 and December 2021, after obtaining ethical approval from the Research Ethics Committee of the Faculty of Dentistry, Alexandria University, Egypt (IRB NO:00010556-IORG 0,008,839). This study was registered in the U.S National Institutes of Health Clinical Trials Registry (NCT05099081). It was also performed in accordance with the principles of the modified Helsinki code for human clinical studies, as revised in 2013 [ | PMC10020281 |
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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 allergic to any of the sclerosing drug constituents. Immune-compromised patients and pregnant and lactating women were also excluded from the study. | 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 |
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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 |
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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 incisional biopsy samples 2 × 2 mm were taken under local anaesthesia from the most ulcerated area and sent for histological analysis to confirm the diagnosis of the clinical picture. The tissue samples were fixed in 10% neutral formalin and embedded in paraffin. Five-micrometre sections were obtained and submitted for routine hematoxylin and eosin staining [After histopathological confirmation of PG, we divided the twenty patients into two groups as follows:Laser-treated group (test): This group was made up of ten patients treated using diode lasers (Medency Primo, Piazza della Libertà, 49, 36,077 Altavilla Vicentina VI, Italy). The surgical area was anaesthetised using a local anaesthetic agent (Alexandricaine 1/100,000, Alexandria Co. for Pharmaceuticals & Chemical Industries, Awayed Alexandria, Egypt). Diode lasers (with a wavelength of 980 nm) were operated in the continuous wave mode with an output power of 3 W in the contact mode. The tip was moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised [Clinical photographs showing a laser-treated case. Sclerotherapy-treated (control) group: This group was made up of ten patients who were treated with injections of a sclerosing agent (Ethanolamine oleate® 5% Amp, EPICO, Egypt). After anaesthetising the surgical site with a local anaesthetic agent, the lesion was injected with the sclerosing agent, 5% EO, diluted in distilled water (Otsuka water for injection (5 ml), Egypt Otsuka Pharmaceutical Co. S.A.E, Egypt) to yield a 2.5% concentration that is used to prevent systemic complications such as renal toxicity. According to their respective sizes, 1.5–3 ml of the solution was injected slowly into the lesion using a 23-gauge needle until it leaked out from the surface. Then, the lesion was compressed for five minutes and observed daily for a week after injection until it became necrotic and fell off spontaneously. (Fig. Clinical photographs showing a sclerotherapy-treated case. Postoperatively, patients from both groups were prescribed a twice-daily nonsteroidal anti-inflammatory drug, Diclofenac Potassium (Catafast | 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 of fresh frozen plasma).Postoperative pain intensity perceived on the 2The healing quality index was measured according to Landry’s classification [43], which grades the wound on a scale from 1 to 5, where 1 represents very poor healing and 5 represents excellent healing. It records healing based on tissue colour, bleeding, ulceration, granulation tissue and epithelialisation. The healing process was evaluated through follow-up visits on the 1st, 2nd and 4.th postoperative weeks. (Figs. 4.Calibration in healing using Landry’s healing quality index criteria was performed for two examiners prior to the study, inter- and intra-examiner reliability were calculated; and kappa ranged from 0.82–0.88 indicating excellent agreement between examiners and across time [44].Recurrence: patients were recalled for follow-up on the 3rd, 6th and 9th postoperative months to check for any signs of recurrence. | 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. Normality was checked for all quantitative variables using descriptive statistics, plots (histogram, box and whisker and Q-Q plots), and normality tests. Normally distributed continuous data were analysed using the independent-sample | PMC10020281 |
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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 (Landry’s healing quality indexVery poor1Tissue colour: ≥ 50% of gingiva redResponse to palpation: bleedingGranulation tissue: presentIncision margin: is not epithelialized, with loss of epithelium beyond the lesion siteSuppuration: presentPoor2Tissue colour: ≥ 50% of gingiva redResponse to palpation: bleedingGranulation tissue: presentIncision margin: is not epithelialized, with connective tissue exposedGood3Tissue colour: ≥ 25% and < 50% of gingiva redResponse to palpation: no bleedingGranulation tissue: noneIncision margin: shows no connective tissue exposedVery good4Tissue colour: < 25% of gingiva redResponse to palpation: no bleedingGranulation tissue: noneIncision margin: no connective tissue exposedExcellent5Tissue colour: all tissues pinkResponse to palpation: no bleedingGranulation tissue: noneIncision margin: no connective tissue exposedSummary of statistics of demographic data (sex and age)*; significant (The majority (80%) of the participants in the test laser-treated group and all the participants in the control sclerotherapy-treated group had mild bleeding; however, there was no significant difference in the proportions of participants with mild bleeding between the two groups (A representative graph showing a comparison between the two groups. On the second and seventh days, the participants in the laser-treated group had significantly more intense postoperative pain than those in the sclerotherapy-treated group (Regarding the healing quality index, the sclerotherapy-treated group had higher values at different intervals than the laser-treated group, but the differences were not statistically significant (Mean and Standard deviation (SD) values for healing index for different groupsDifferent superscript letters indicate a statistically significant difference within the same vertical column *; significant (Recurrence occurred in two participants in the laser-treated group after three months and in one participant after 6 months while no participant experienced recurrence in the sclerotherapy-treated group in all intervals, with the difference between the two groups being not statistically significant difference ( | PMC10020281 |
Acknowledgements | We thank Dr Zeinab Darwish for her contribution to the histological examination of the biopsy specimens. | PMC10020281 |
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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 |
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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 |
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Data availability | All data included in this current study are available from the corresponding author upon request. | PMC10020281 |
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Declarations | PMC10020281 |
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Conflict of interest | The authors declare that they have no competing interests. | PMC10020281 |
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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 accordance with the principles of the modified Helsinki code for human clinical studies, as revised in 2013, and the CONSORT guidelines for reporting randomised clinical trials. Written informed consent was obtained from each participant. | PMC10020281 |
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References | PMC10020281 |
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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 controlled trial. Subscribers to National Health Insurance in Yokohama City, Kanagawa Prefecture, who were eligible for specific health guidance in 2021, were recruited. A total of 1377 people who met the criteria of having or being at risk of developing metabolic syndrome (male: 77.9%, mean age: 63.1 ± 10.0 years) were randomly assigned to one of three groups: a “no reminder” group, a “letter reminder” group, or a “telephone reminder” group. The utilization rates of specific health guidance were not significantly different between the three groups (10.5%, 15.3%, and 13.7%, respectively). However, in the case of the telephone reminder group, a subgroup analysis showed that the utilization rate was significantly higher among participants who received the reminder than those who did not answer the calls. Although the effectiveness of a telephone reminder might be underestimated, this study suggests that neither method impacted the utilization rates of specific health guidance among the population at risk of metabolic syndrome.Cardiometabolic diseases (CMDs), such as cardiovascular disease, stroke, diabetes, and chronic kidney disease, are the leading causes of mortality worldwide [In 2008, Japan introduced a nationwide screening program (i.e., health checkups) to identify individuals with high obesity and cardiovascular risks (known as metabolic syndrome). In addition, the country established specific health guidance (i.e., a lifestyle intervention program) to reduce cardiovascular risk factors [Meta-analyses revealed that lifestyle intervention can reduce cardiometabolic risks [Many medical insurers in Japan use reminders to improve the utilization rates of specific health guidance. Systematic reviews have reported the effectiveness of such reminder systems for cancer screening [The purpose of this study was to examine the effectiveness of reminders in promoting the utilization of specific health guidance using a randomized controlled trial design. In this study, we used two reminder methods (letters and telephone calls). In addition, this study focused on people who are considered at high risk of metabolic syndrome, given the requirement for reminders among this population. | PMC10001113 |
2. Materials and Methods | PMC10001113 |
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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 approximately 3.78 million. At the time of this study, National Health Insurance covered approximately 20% of the total city population.Among the National Health Insurance subscribers in Yokohama, 460,928 were eligible for health checkups in the fiscal year (FY) of 2021 (i.e., between April 2021 and March 2022), and 113,945 received health checkups. Of these, 13,638 were eligible for specific health guidance based on national criteria. Among them, 10,763 people who were deemed to require immediate medical attention (based on the national criteria using the results of health checkups, renal function tests, blood pressure, complete blood counts, lipid panels, blood sugar levels, and liver function tests) were excluded. Consequently, we included 1377 people (355 met the criteria for metabolic syndrome and 1022 were considered to be at risk of metabolic syndrome). In FY2021, among those who underwent health checkups, 14.8% and 56.9% were judged as “applicable” and “at risk” of metabolic syndrome, respectively. The implementation rate of specific health guidance in Yokohama City was 9.3% in FY2020.This study adopted a random sampling method to enhance the internal validity of the findings. The participants were randomly assigned to three groups: the “no reminder” group (n = 458), the “letter reminder” group (n = 459), or the “telephone reminder” group (n = 460). Random assignment was conducted by the staff of Yokohama City. The staff provided a unique number to every participant and assigned them randomly to one of the three groups using a random number generator. This process was performed each month. The data analysts, but not the participants, were blinded to the information on the group assignment. A flow diagram of the sampling and allocation processes is shown in | 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 |
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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/hospitals/clinics where the specific health guidance is provided”, and “telephone number for inquiries”. The expiration date was determined according to the month in which the participants underwent a health checkup. The coupon for specific health guidance was valid for two months from the time of dispatch. | PMC10001113 |
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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 explanation of the results of the health checkups”, “the 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”, and “information on the medical centers/hospitals/clinics where the specific health guidance is provided and the way to make an appointment”. In cases of disconnection, the public health nurse re-called the participant on different weekdays (up to three times). If family members answered the phone, the public health nurse told them to re-call on different days and asked them to encourage the participant to receive specific health guidance.Of 460 individuals assigned to the telephone reminder group, the public health nurse was able to directly reach 274 participants (59.6%) and to leave a message with the family members of 34 participants (7.4%). The public health nurse could not reach the remaining 152 participants, and they did not receive the telephone reminder. | PMC10001113 |
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2.3. Measures | PMC10001113 |
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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 |
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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, high-density lipoprotein cholesterol, history of diseases (cerebrovascular diseases, cardiovascular diseases, chronic kidney failure, and dialysis therapy), smoking habits (“Do you currently smoke habitually?”; yes or no), exercise habits (“Do you exercise lightly for at least 30 min two days a week for at least one year?”; yes or no), and frequency of drinking (“How often do you drink alcohol?”; every day, sometimes, rarely, or never). | PMC10001113 |
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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). Second, the outcome variable (i.e., the utilization of specific health guidance) was compared between the three groups using the chi-square test. For multiple comparisons, the Bonferroni correction was adopted with a significance level (α) of 1.7% (i.e., Previous studies have suggested that reminders of health checkups increase the uptake rate by a factor of approximately 1.5–1.7 times [ | PMC10001113 |
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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 specific health guidance. However, its effectiveness has not been yet sufficiently verified. This study focused on widely used reminder methods that can contribute to the establishment of evidence-based health activities.The analysis did not demonstrate an improvement in the utilization rate after either letter or telephone reminders compared to no reminder. This result differs from those of previous studies regarding general health checkups and cancer screening [Earlier studies regarding the use of a letter invitation/reminder to attend health checkups reported a lack of impact of letters [Previous studies revealed that telephone reminders are more effective than letter reminders [Although this study showed no difference in the utilization rate of specific health guidance between the three groups, this does not necessarily mean that reminders are ineffective. This study focused on individuals who met the criteria for metabolic syndrome or were considered at risk of developing metabolic syndrome. Therefore, the findings suggest that reminders directed towards this population may be given lower priority. Based on this study, future investigations could be conducted to verify which populations will benefit most from the reminders system.This study has several limitations. First, as previously mentioned, the current study targeted only those with metabolic syndrome or subjects at risk of developing this disease. The effects on other populations need to be investigated in future studies to enhance the external validity. Second, this study was conducted in Yokohama. The possibility that the results may differ between regions with different medical resources and resident characteristics cannot be denied, and the generalizability of the findings must be carefully considered. Third, this study was performed in FY2021, the second year of the COVID-19 pandemic. People’s attitudes toward the utilization of specific health guidance could have been influenced by the outbreak. Therefore, the present findings might not necessarily be applicable to the “post-COVID-19 era”. Fourth, many other factors prevent people from using specific health guidance (e.g., the inconvenience of making an appointment for specific health guidance and inaccessibility of the implementation site). Therefore, it might not be sufficient to improve the utilization rate by implementing reminders alone. Fifth, we were not able to investigate how many participants in the letter reminder group actually read the letter. The effects of the letter reminder might have differed between those who read the letter and those who did not. This means that we might have underestimated the effectiveness of the letter. Finally, this study investigated the effectiveness of letter and telephone reminders. However, there are some other reminder options (e.g., short message service (SMS) and e-mail), and these effects should be examined in the future. | 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 is assigned to the task of reminding people in the population at risk of metabolic syndrome. Nonetheless, this study possibly underestimated the effectiveness of reminders. Reminders using either letters or telephone calls are labor- and cost-intensive to some degree. Thus, more effective and efficient methods should be explored for the implementation of reminders.Medical insurers utilize a reminder method to increase the implementation rate of health checkups and health guidance worldwide. Previous studies regarding the effectiveness of reminders are mainly derived from Western countries such as the United Kingdom. However, as it has been implied that the population’s demographic characteristics may affect the effectiveness of reminders [ | 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 editing, H.M. (Hiroshi Murayama), S.S., K.M., S.S., H.M. (Haruna Maeda) and Y.T.; project administration, H.M. (Haruna Maeda), S.S. and Y.T. All authors have read and agreed to the published version of the manuscript. | PMC10001113 |
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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 |
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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 |
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Data Availability Statement | The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request. | PMC10001113 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC10001113 |
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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 |
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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-5L have the possibility of being influenced by the preceding disease-specific health-related quality of life instruments. This may lead to bias in the cost-effectiveness analysis results. Therefore, this study aimed to evaluate the impact of the preceding cancer-specific health-related quality of life instruments on the EQ-5D-5L responses. | PMC9843919 |
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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 undergoing drug therapy for advanced cancer, who were classified into three groups: Groups 1, 2, and 3 (the EQ-5D-5L placed first, second, and last, respectively). We compared the EQ-5D-5L index and the missingness of EQ-5D-5L among the groups. | 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, respectively. The difference of the proportions between group 3 and 1 and between 3 and 2 was − 0.06 (95% CI − 0.10 to − 0.02; p = 0.003) and − 0.06 (95% CI − 0.10 to − 0.02; p = 0.003), respectively. | PMC9843919 |
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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 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12955-022-02085-8. | PMC9843919 |
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Keywords | PMC9843919 |
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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 randomized controlled trials that often provide health utility information for health economic evaluation. The EQ-5D and the disease-specific HRQOL instruments are used simultaneously; this is because the former’s five items incompletely describe patients’ health status for clinical assessment due to the smallness of the number of items, while the latter can detect disease-specific symptoms and treatment impacts with high sensitivity. Additionally, the two are utilized concurrently in research developing mapping algorithms from the disease-specific HRQOL instruments onto the EQ-5D indexes [However, theory of order effects and previous studies evaluating the order effects on the responses of the HRQOL instruments indicate the EQ-5D’s possible susceptibility to it. In this paper, order effects refer to the phenomenon that the different orders in which instruments or questions presented influence the responses to them. On the one hand, the order effects on HRQOL instruments consisting of many questions has been unobserved in three studies [If instrument orders impact the EQ-5D-5L responses, the order effects could bias the cost-effectiveness analysis results. For example, when health state utilities are extracted from multiple studies in which different orders of the disease-specific HRQOL instruments and the EQ-5D-5L are adopted, the aforementioned analysis’ results may be influenced due to the order effects. In mapping research, the latter may or may not be preceded by disease-specific measures that may also bias mapping algorithms, resulting in biased results of the cost-effectiveness analysis.This research investigated the impact of the preceding disease-specific HRQOL instruments on responses to the EQ-5D-5L in the field of oncology. Specifically, we focused on two common cancer-specific HRQOL instruments, namely, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy General (FACT-G) and evaluated the differences in the responses to the EQ-5D-5L’s five questions, its mean index, its correlations with the cancer-specific HRQOL instruments’ subscales, and the missingness of its index among the instrument orders. | PMC9843919 |
Methods | PMC9843919 |
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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 advanced, recurrent, or metastatic cancers were recruited from 14 hospitals in Japan from November 2018 to March 2019. The eligible patients had lung, stomach, colorectal, breast cancer, or other solid tumors; they were aged 20 years or above and were undergoing drug therapy, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–3. Those who were receiving treatment for multiple primary tumors or were unable to respond to the questionnaires were excluded. All enrolled patients provided written informed consent before participating in the study.We utilized those questionnaire booklets that contained the EQ-5D-5L, FACT-G, and EORTC QLQ-C30 in different orders; let us denote them as E, F, and Q, respectively. We created six types of questionnaire booklets, each of which contained the HRQOL instruments in any of the following orders: EFQ, EQF, FEQ, QEF, FQE, or QFE. For example, EFQ represents questionnaire booklets comprising the HRQOL instruments in the following order: EQ-5D-5L > FACT-G > EORTC QLQ-C30. We designed the booklets in such a manner that the medical staff could not identify these measures’ order by observing their covers.We distributed the questionnaire booklets to the patients by a quasi-randomization design using the order in which patients enrolled; therefore, each patient was assigned to any of the six groups defined by its types. Firstly, we repeatedly lined the six questionnaire booklet types in a fixed order (specifically, EFQ > EQF > FQE > FEQ > QFE > QEF) and sent them to all hospitals. Subsequently, each hospital’s medical staff recruited the patients and distributed the questionnaire booklets in the aforementioned order. Finally, the patients answered the questionnaire booklets, which were principally collected in the hospital. When this was unfeasible, the patients returned them directly to the data center. | 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 questions [ | PMC9843919 |
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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 enrolled and suitable patients; it was used for the statistical analysis of the missing EQ-5D-5L indexes. The latter comprised all participating and eligible patients whose EQ-5D-5L indexes were calculated; it was utilized for the statistical analysis of the EQ-5D-5L items and index.The patients were classified into three groups based on the EQ-5D-5L’s placement in the questionnaire booklets: Groups 1, 2, and 3 consisted of the two booklet types that had the EQ-5D-5L in the first, second, and last places, respectively. The differences in the responses of this scale’s each item between the groups were examined using the Wilcoxon rank sum test. Furthermore, the differences in the mean EQ-5D-5L indexes between the groups were estimated using analysis of variance with the EQ-5D-5L’s order as the only explanatory variable. Additionally, we conducted multivariable analysis and analysis with inverse probability weighting (IPW) (see Additional file Using a linear binomial regression (also called linear probability model) with the EQ-5D-5L’s order as the only explanatory variable, we compared the proportions of those patients whose EQ-5D-5L were incomplete due to some reason; who failed to return the questionnaire booklets to the data center; who submitted the questionnaire booklets unanswered; and who returned these booklets with some incomplete responses. Additional details regarding the statistical analysis including multivariable analysis and analysis of proportions of the FACT-G and the EORTC QLQ-C30 with missing subscales are provided in Additional file Each p-value was two-tailed, and p < 0.05 was considered to be nominally statistically significant. All statistical analyses were conducted using SAS software, version 9.4 (SAS Institute). | PMC9843919 |
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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 with the EQ-5D-5L positioned first and second. As compared to the mean EQ-5D-5L indexes of the former, those of the latter were lower. Few correlation coefficients between the EQ-5D-5L index and the subscales of disease-specific HRQOL instruments differed between the groups with the EQ-5D-5L positioned first and second. The patients in the group with the EQ-5D-5L placed last tended to complete the EQ-5D-5L. | PMC9843919 |
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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 specific questions’ contrast effect may help in explaining the difference in the responses between the groups with the EQ-5D-5L placed second and last; this is because most questions that would be related to usual activities overlap between the FACT-G and the EORTC QLQ-C30, such as GF1, GF2, and Q6; GF6 and Q7; and GP3 and Q26 (Table Questions in the FACT-G or the EORTC QLQ-C30 that may be related to the EQ-5D-5LThe question of the FACT-G or the EORTC QLQ-C30 should overlap with those of the other instrument in the same lineEORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; FACT-G, Functional Assessment of Cancer Therapy GeneralOne of the previous studies has examined and found assimilation effect of specific health questions on self-rated health question [ | 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 interpretation using the completed EQ-5D-5L population. In the distribution-based approach, 0.3 and 0.5 standard deviations are often used [ | 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 the discrepancy in the correlation. In either case, the order effects on the coefficients of the subscales in regression models for mapping algorithms were considered to be limited. | PMC9843919 |
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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 instruments’ specific ones than before answering them. The second possible reason is that patients may tend to decide to respond to the questionnaire after looking over the questionnaire with the EQ-5D-5L placed last. This is because the last instrument may be the instrument recalled mainly in the decision-making process, since in psychology it is known that, in free recall-task, the last item in a word list is easier to be recalled than other items (called recency effect) [ | PMC9843919 |
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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 possibility that they distributed the questionnaire booklets in an order different from instruction. However, they had no motivation to allocate these questionnaire booklets selectively to the patients with specific characteristics. Indeed, the patients’ observed characteristics were not unbalanced. Second, the patients might not have answered from the questionnaire booklet’s start, thus resulting in the order effects’ underestimation. Third, the order effects’ impact on the EQ-5D-5L may be different from this study when more severe patients or other disease-specific instruments are examined. | PMC9843919 |
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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 considerably larger than the MID. Few correlation coefficients between the EQ-5D-5L index and the subscales of the disease-specific HRQOL instruments varied among the instrument orders. The patients tended to complete the EQ-5D-5L when it was placed at the end of the questionnaire. | PMC9843919 |
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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 would like to thank Editage ( | PMC9843919 |
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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 approved the final manuscript. | PMC9843919 |
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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 |
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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 |
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Declarations | PMC9843919 |
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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 |
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Consent for publication | Not applicable. | PMC9843919 |
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Competing interests | The authors declare that they have no competing interests. | PMC9843919 |
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References | PMC9843919 |
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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 achieve better compliance, new behavioral modeling interventions need to be evaluated in orthodontics. For instance, in self-efficacy theory, patients’ expectations about their ability to comply depend on their clear understanding of the desired outcomesAn alternative method is a multimodal approach, which mixes auditory and visual senses (audiovisual) to induce a positive expressive reaction that results in a relaxing behavior and full capacity for concentration | PMC10219970 |
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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 months, and to assess participants’ experiences and effect on behavioral compliance that could henceforth be identified. | PMC10219970 |
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Methods | PMC10219970 |
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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 ethical committee at Zhengzhou University with reference number (2021-KY-1026-002). All methods were performed in accordance with the relevant guidelines and regulations of the ethical committee. The trial was registered with the Thai Clinical Trials Registry (TCTR) with trial number (TCTR20230220002). Participants who met the inclusion criteria were recruited prior to debonding. The inclusion criteria were: participants aged 16–35 years, and have a smartphone with the capability to use the WeChat application. The exclusion criteria were: cleft lip or palate; systemic disease or medical condition; periodontal disease; craniofacial deformities; taking any medication that affects gingival health; and history of orthodontic treatment and retention. All participants were informed about the study objectives and signed the respective consent forms. Informed consent was obtained from all subjects and/or their legal guardian(s). Reporting was done following the Consolidated Standards of Reporting Trials (CONSORT guidelines) (Fig. Consort flow diagram. | 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). Permuted block randomization ensuring 1:1 allocation ratio (block size = 4) was performed by independent personnel using a computer-generated number list. Allocation was concealed by using sequentially sealed opaque envelopes.In debonding visit, all participants received standardized oral hygiene instructions with scaling and polishing procedures. Participants were instructed to temporarily wear a 1 mm thickness maxillary and mandibular vacuum-formed retainers (ACE®, DENTSPLY) for 3–4 days for 22 h each day until the Hawley retainer was manufactured. Standardized laboratory steps were undertaken by one experienced technician. Microsensors were embedded totally in the maxillary posterior palatal region of the acrylic covering (Palapress®; Kulzer GmbH, Mitsui Chemicals, Hanau, Germany) (Fig. Microsensor embedded in upper removable Hawley retainer.At recall appointment (T0), participants in both groups were instructed to wear the Hawley retainer on a full-time basis for 22 daily hours for 6 months, with two follow-up visits after 3 months (T1), and 6 months from the start of retention (T2). Hawley retainer microsensor was activated at the same visit, by using a pen reader through an onboard antenna to the laptop, with attached TheraMon® client software (version 1.3.0.4, MC Technology GmbH, Hargelsberg, Austria). The microsensor was adjusted to monitor compliance wear within temperature range from 33.5 to 38.5 °C (attributable to variations in intra-oral temperature) every 15 minutesDaily wear times (in hours) over the 3-month period, upper graph shows sub-optimal compliance with 10 h of wear, lower graph shows a compliant patient with 23 h of daily wear.Participants’ gingival and plaque indices were recorded and compared at T0 and T2. Maxillary and mandibular periodontal measures were measured on all surfaces of indexed teeth 16, 36, 12, 32, 24/25, 44/45 to be a representative of the full dentitionParticipants completed an additional questionnaire at T2; the questionnaire assessed participants’ experiences and satisfaction with the Hawley retainer. Questionnaires were based on perspectives of the NHS, and patients’ subjective experiences | 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 assess the impact of the intervention on the adherence to the wear time instructions of the Hawley retainer in comparison to the control group, on a full-time basis (22 h) over a period of 6 months. The secondary outcomes were: (1) assessment and comparison of gingival and periodontal health after 6 months between the two groups, and (2) patients’ experiences and satisfaction with retainer wear. | PMC10219970 |
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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 by 20% to 52 participants | PMC10219970 |
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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 statistical analysis of outcomes, within-group outcomes were analyzed using paired sample | PMC10219970 |
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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 participants dropped out from the audiovisual group, and five from the control group (Fig. Baseline characteristics. | PMC10219970 |
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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 (42.86%)9 ≤ d6 (28.57%)1–4 d11 (47.83%)5–8 d7 (30.43%)9 ≤ d5 (21.74%)*Significant at | PMC10219970 |
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