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Journal of the Korean Association of... Apr 2024Teriparatide has been effective in treating people diagnosed with medication-related osteonecrosis of the jaw (MRONJ). However, its efficacy is not well established to...
Teriparatide has been effective in treating people diagnosed with medication-related osteonecrosis of the jaw (MRONJ). However, its efficacy is not well established to be accepted as a standard of care. The objective of this paper was to investigate the efficacy of recombinant human parathyroid hormone for the treatment of MRONJ. We report three cases of MRONJ patients with osteoporosis as the primary disease who were treated with a teriparatide agent along with other adjunctive measures. Each patient was administered a teriparatide injection subcutaneously for 16 weeks, 36 weeks, or 60 weeks. Surgical intervention including partial resection, sequestrectomy, decortication, and saucerization took place during the teriparatide administration. Complete lesion resolution was identified clinically and radiographically in all three patients. In patients diagnosed with MRONJ, teriparatide therapy is an efficacious and safe therapeutic option to improve healing of bone lesions. These findings demonstrate that teriparatide in combination with another therapy, especially bone morphogenetic protein, platelet-rich fibrin, or antibiotic therapy, can be an effective protocol for MRONJ.
PubMed: 38693133
DOI: 10.5125/jkaoms.2024.50.2.103 -
Journal of the Korean Association of... Apr 2024To access the knowledge of undergraduate and postgraduate students of the dental college on basic anatomy, physiology, clinical examination, and pathology of the...
OBJECTIVES
To access the knowledge of undergraduate and postgraduate students of the dental college on basic anatomy, physiology, clinical examination, and pathology of the temporomandibular joint (TMJ).
MATERIALS AND METHODS
A total of 610 undergraduate and postgraduate students of dental college, were included in this study. The questionnaire was pretested for validation and distributed online through Google forms.
RESULTS
A pairwise comparison showed that the percentage of correct answers for interns significantly differed from that of IV Bachelor of Dental Surgery (P=0.050) and postgraduate students (P=0.048) (below average: up to 6 correct answers, good: 7-11 correct answers, excellent: 12 or more correct answers).
CONCLUSION
TMJ diseases are common in daily life but frequently go undiagnosed and untreated due to a lack of clinical expertise. This demonstrates the necessity of providing instructions that give students in-depth knowledge and abilities for TMJ issues in clinical practice.
PubMed: 38693130
DOI: 10.5125/jkaoms.2024.50.2.80 -
BMJ Open May 2024A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation... (Observational Study)
Observational Study
Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation...
INTRODUCTION
A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.
METHODS AND ANALYSIS
We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical ('diagnostic study') and a qualitative, modelling and economic ('an integration into care study') part. The diagnostic study aims to evaluate GIFT's performance in identifying asymptomatic women with discharge-causing STIs ( (CT), (NG), (TV) and (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.
ETHICS AND DISSEMINATION
Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d'Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).
TRIAL REGISTRATION NUMBER
NCT05723484.
Topics: Humans; Female; Vaginosis, Bacterial; Prospective Studies; Biomarkers; Sexually Transmitted Diseases; Cross-Sectional Studies; Point-of-Care Testing; Feasibility Studies; Interleukin-1alpha; Interleukin-1beta; Adult; Cytokines; South Africa; Zimbabwe; Observational Studies as Topic; Multicenter Studies as Topic
PubMed: 38692732
DOI: 10.1136/bmjopen-2024-084918 -
BMJ Open May 2024Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy...
INTRODUCTION
Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT).
METHODS AND ANALYSIS
This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson's disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention.
ETHICS AND DISSEMINATION
This study, registered as 'Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)' at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient's recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial.
TRIAL REGISTRATION NUMBER
NCT04608604.
Topics: Humans; Physical Therapy Modalities; Exercise Therapy; Parkinsonian Disorders; Double-Blind Method; Randomized Controlled Trials as Topic; Gait; Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Home Care Services; Aged; Male; Female; Gait Disorders, Neurologic
PubMed: 38692728
DOI: 10.1136/bmjopen-2023-081317 -
BMJ Open May 2024Familial hypercholesterolaemia (FH) is an autosomal dominant inherited disorder of lipid metabolism and a preventable cause of premature cardiovascular disease. Current...
Implementation of a primary-tertiary shared care model to improve the detection of familial hypercholesterolaemia (FH): a mixed methods pre-post implementation study protocol.
INTRODUCTION
Familial hypercholesterolaemia (FH) is an autosomal dominant inherited disorder of lipid metabolism and a preventable cause of premature cardiovascular disease. Current detection rates for this highly treatable condition are low. Early detection and management of FH can significantly reduce cardiac morbidity and mortality. This study aims to implement a primary-tertiary shared care model to improve detection rates for FH. The primary objective is to evaluate the implementation of a shared care model and support package for genetic testing of FH. This protocol describes the design and methods used to evaluate the implementation of the shared care model and support package to improve the detection of FH.
METHODS AND ANALYSIS
This mixed methods pre-post implementation study design will be used to evaluate increased detection rates for FH in the tertiary and primary care setting. The primary-tertiary shared care model will be implemented at NSW Health Pathology and Sydney Local Health District in NSW, Australia, over a 12-month period. Implementation of the shared care model will be evaluated using a modification of the implementation outcome taxonomy and will focus on the acceptability, evidence of delivery, appropriateness, feasibility, fidelity, implementation cost and timely initiation of the intervention. Quantitative pre-post and qualitative semistructured interview data will be collected. It is anticipated that data relating to at least 62 index patients will be collected over this period and a similar number obtained for the historical group for the quantitative data. We anticipate conducting approximately 20 interviews for the qualitative data.
ETHICS AND DISSEMINATION
Ethical approval has been granted by the ethics review committee (Royal Prince Alfred Hospital Zone) of the Sydney Local Health District (Protocol ID: X23-0239). Findings will be disseminated through peer-reviewed publications, conference presentations and an end-of-study research report to stakeholders.
Topics: Humans; Hyperlipoproteinemia Type II; Primary Health Care; Genetic Testing; Research Design; New South Wales; Early Diagnosis
PubMed: 38692720
DOI: 10.1136/bmjopen-2023-082699 -
BMJ Open May 2024To investigate the differences in myopia prevalence and ocular biometry in children and adolescents in Chongqing and Tibet, China.
OBJECTIVE
To investigate the differences in myopia prevalence and ocular biometry in children and adolescents in Chongqing and Tibet, China.
DESIGN
Cross-sectional study.
SETTING
The study included children and adolescents aged 6-18 years in Chongqing, a low-altitude region, and in Qamdo, a high-altitude region of Tibet.
PARTICIPANTS
A total of 448 participants in Qamdo, Tibet, and 748 participants in Chongqing were enrolled in this study.
METHODS
All participants underwent uncorrected visual acuity assessment, non-cycloplegic refraction, axial length (AL) measurement, intraocular pressure (IOP) measurement and corneal tomography. And the participants were grouped according to age (6-8, 9-11, 12-14 and 15-18 years group), and altitude of location (primary school students: group A (average altitude: 325 m), group B (average altitude: 2300 m), group C (average altitude: 3250 and 3170 m) and group D (average altitude: 3870 m)).
RESULTS
There was no statistical difference in mean age (12.09±3.15 vs 12.2±3.10, p=0.549) and sex distribution (males, 50.4% vs 47.6%, p=0.339) between the two groups. The Tibet group presented greater spherical equivalent (SE, -0.63 (-2.00, 0.13) vs -0.88 (-2.88, -0.13), p<0.001), shorter AL (23.45±1.02 vs 23.92±1.19, p<0.001), lower prevalence of myopia (39.7% vs 47.6%, p=0.008) and flatter mean curvature power of the cornea (Km, 43.06±1.4 vs 43.26±1.36, p=0.014) than the Chongqing group. Further analysis based on age subgroups revealed that the Tibet group had a lower prevalence of myopia and higher SE in the 12-14, and 15-18 years old groups, shorter AL in the 9-11, 12-14 and 15-18 years old groups, and lower AL to corneal radius of curvature ratio (AL/CR) in all age subgroups compared with the Chongqing group, while Km was similar between the two groups in each age subgroup. Simple linear regression analysis showed that SE decreased with age in both the Tibet and Chongqing groups, with the Tibet group exhibiting a slower rate of decrease (p<0.001). AL and AL/CR increased with age in both the Tibet and Chongqing groups, but the rate of increase was slower in the Tibet group (p<0.001 of both). Multiple linear regression analysis revealed that AL had the greatest effect on SE in both groups, followed by Km. In addition, the children and adolescents in Tibet presented thinner corneal thickness (CCT, p<0.001), smaller white to white distance (WTW, p<0.001), lower IOP (p<0.001) and deeper anterior chamber depth (ACD, p=0.015) than in Chongqing. Comparison of altitude subgroups showed that the prevalence of myopia (p=0.002), SE (p=0.031), AL (p=0.001) and AL/CR (p<0.001) of children at different altitudes was statistically different but the Km (p=0.189) were similar. The highest altitude, Tengchen County, exhibited the lowest prevalence of myopia and greatest SE among children, and the mean AL also decreased with increasing altitude.
CONCLUSIONS
Myopia prevalence in Tibet was comparable with that in Chongqing for students aged 6-8 and 9-11 years but was lower and myopia progressed more slowly for students aged 12-14 and 15-18 years than in Chongqing, and AL was the main contributor for this difference, which may be related to higher ultraviolet radiation exposure and lower IOP in children and adolescents at high altitude in Tibet. Differences in AL and AL/CR between Tibet and Chongqing children and adolescents manifested earlier than in SE, underscoring the importance of AL measurement in myopia screening.
Topics: Humans; Adolescent; Child; Cross-Sectional Studies; Male; Female; Altitude; Tibet; Myopia; Prevalence; China; Biometry; Refraction, Ocular; Visual Acuity; Axial Length, Eye; Intraocular Pressure; Cornea
PubMed: 38692719
DOI: 10.1136/bmjopen-2023-078018 -
BMJ Open May 2024Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania...
Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol.
INTRODUCTION
Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted life years attributed to NCDs has doubled over the past 30 years, from 18% to 36%. To mitigate the escalating burden of severe NCDs, the Tanzanian government, in collaboration with local and international partners, seeks to extend the integrated package of essential interventions for severe NCDs (PEN-Plus) to district-level facilities, thereby improving accessibility. This study aims to estimate the cost of initiating PEN-Plus for rheumatic heart disease, sickle cell disease and type 1 diabetes at Kondoa district hospital in Tanzania.
METHODS AND ANALYSIS
We will employ time-driven activity-based costing (TDABC) to quantify the capacity cost rates (CCR), and capital and recurrent costs associated with the implementation of PEN-Plus. Data on resource consumption will be collected through direct observations and interviews with nurses, the medical officer in charge and the heads of laboratory and pharmacy units/departments. Data on contact times for targeted NCDs will be collected by observing a sample of patients as they move through the care delivery pathway. Data cleaning and analysis will be done using Microsoft Excel.
ETHICS AND DISSEMINATION
Ethical approval to conduct the study has been waived by the Norwegian Regional Ethics Committee and was granted by the Tanzanian National Health Research Ethics Committee NIMR/HQ/R.8a/Vol.IX/4475. A written informed consent will be provided to the study participants. This protocol has been disseminated in the Bergen Centre for Ethics and Priority Setting International Symposium, Norway and the 11th Muhimbili University of Health and Allied Sciences Scientific Conference, Tanzania in 2023. The findings will be published in peer-reviewed journals for use by the academic community, researchers and health practitioners.
Topics: Humans; Tanzania; Noncommunicable Diseases; Hospitals, District; Costs and Cost Analysis; Anemia, Sickle Cell; Research Design
PubMed: 38692717
DOI: 10.1136/bmjopen-2023-080510 -
BMJ Open May 2024Despite potential links between diabetes and sensorineural hearing loss (SNHL), routine hearing assessments for diabetic patients are not standard practice. Our study...
INTRODUCTION
Despite potential links between diabetes and sensorineural hearing loss (SNHL), routine hearing assessments for diabetic patients are not standard practice. Our study aimed to investigate the prevalence of SNHL and its association with diabetes-related factors among patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS
This cross-sectional study was conducted at the Diabetes Clinic, Jinnah Postgraduate Medical Centre, Karachi, Pakistan, from May to September 2021. A total of 396 patients fulfilling the inclusion criteria participated after informed consent. Data collection involved a sociodemographic profile, Michigan Neuropathy Screening Instrument examination followed by pure-tone audiometry and laboratory tests including haemoglobin A1C (HbA1c). HL was defined using better ear four-frequency pure-tone average of ≥26 dB HL and graded as per WHO criteria. Statistical analyses were performed using SPSS. χ, independent ttest and multinomial logistic regression analyses were applied. P<0.05 at 95% CI was considered significant.
RESULTS
Our study revealed a high prevalence of SNHL among patients with T2DM. Mild HL was seen in 55.8%, while 18.7% suffered from moderate HL. Common audiological symptoms included difficulty understanding speech in noisy surroundings (44.2%), balance problems (42.9%), sentence repetition (35.9%), tinnitus (32.3%) and differentiating consonants (31.1%). Hearing impairment predominantly affected low (0.25-0.5 kHz) and high (4-8 kHz) frequencies with a significant difference at 4 kHz among both sexes ( (394)=2.8, p=0.004). Peripheral neuropathy was significantly associated with SNHL on multinomial logistic regression after adjusting with age, sex, body mass index and the presence of any comorbidities. Diabetes duration, HbA1c or family history of diabetes was found unrelated to SNHL severity.
CONCLUSIONS
The study highlights the substantial prevalence of SNHL among patients with T2DM and emphasises the importance of targeted audiological care as part of a holistic approach to diabetes management. Addressing HL early may significantly improve communication and overall quality of life.
Topics: Humans; Diabetes Mellitus, Type 2; Male; Female; Cross-Sectional Studies; Hearing Loss, Sensorineural; Middle Aged; Pakistan; Prevalence; Audiometry, Pure-Tone; Adult; Aged; Diabetic Neuropathies; Peripheral Nervous System Diseases; Glycated Hemoglobin; Risk Factors
PubMed: 38692716
DOI: 10.1136/bmjopen-2023-081035 -
BMJ Open May 2024There are no data regarding the prevalence of comorbidity (ie, additional conditions in reference to an index disease) and multimorbidity (ie, co-occurrence of multiple...
OBJECTIVES
There are no data regarding the prevalence of comorbidity (ie, additional conditions in reference to an index disease) and multimorbidity (ie, co-occurrence of multiple diseases in which no one holds priority) in patients with liver cirrhosis. We sought to determine the rate and differences between comorbidity and multimorbidity depending on the aetiology of cirrhosis.
DESIGN
This is a subanalysis of the San MAtteo Complexity (SMAC) study. We have analysed demographic, clinical characteristics and rate of comorbidity/multimorbidity of patients with liver cirrhosis depending on the aetiology-alcoholic, infectious and non-alcoholic fatty liver disease (NAFLD). A multivariable analysis for factors associated with multimorbidity was fitted.
SETTING
Single-centre, cross-sectional study conducted in a tertiary referral, academic, internal medicine ward in northern Italy (November 2017-November 2019).
PARTICIPANTS
Data from 1433 patients previously enrolled in the SMAC study were assessed; only those with liver cirrhosis were eventually included.
RESULTS
Of the 1433 patients, 172 (median age 79 years, IQR 67-84; 83 females) had liver cirrhosis. Patients with cirrhosis displayed higher median Cumulative Illness Rating Scale (CIRS) comorbidity (4, IQR 3-5; p=0.01) and severity (1.85, IQR 16.-2.0; p<0.001) indexes and lower educational level (103, 59.9%; p=0.003). Patients with alcohol cirrhosis were significantly younger (median 65 years, IQR 56-79) than patients with cirrhosis of other aetiologies (p<0.001) and more commonly males (25, 75.8%). Comorbidity was more prevalent in patients with alcohol cirrhosis (13, 39.4%) and multimorbidity was more prevalent in viral (64, 81.0%) and NAFLD (52, 86.7%) cirrhosis (p=0.015). In a multivariable model for factors associated with multimorbidity, a CIRS comorbidity index >3 (OR 2.81, 95% CI 1.14 to 6.93, p=0.024) and admission related to cirrhosis (OR 0.19, 95% CI 0.07 to 0.54, p=0.002) were the only significant associations.
CONCLUSIONS
Comorbidity is more common in alcohol cirrhosis compared with other aetiologies in a hospital, internal medicine setting.
Topics: Humans; Male; Female; Cross-Sectional Studies; Liver Cirrhosis; Multimorbidity; Aged; Internal Medicine; Comorbidity; Aged, 80 and over; Italy; Hospitalization; Prevalence; Middle Aged; Non-alcoholic Fatty Liver Disease
PubMed: 38692714
DOI: 10.1136/bmjopen-2023-077576 -
BMJ Open May 2024Falls are common in older people and individuals with neurological conditions. Parkinson's disease (PD) is known for postural instability causing mobility disabilities,...
Role of virtual reality in examining the effect of fear of falling (FOF) on postural stability in individuals without and with Parkinson's disease in Egypt: a mixed-methods feasibility study protocol.
BACKGROUND
Falls are common in older people and individuals with neurological conditions. Parkinson's disease (PD) is known for postural instability causing mobility disabilities, falls and reduced quality of life. The fear of falling (FOF), a natural response to unstable balance, can worsen postural control problems. Evaluating FOF relies largely on affected persons' subjective accounts due to limited objective assessment methods available. The aim of this mixed-methods feasibility study is to develop an assessment method for FOF while in motion and walking within virtual environments. This study will assess a range of FOF-related responses, including cognitive factors, neuromuscular response and postural stability.
METHODS AND ANALYSIS
This feasibility study will consist of four phases: the first two phases will include people without PD, while the other two will include people diagnosed with PD. Participants will be assessed for direct and indirect responses to real life, as well as virtual environment walking scenarios that may induce FOF. Data from questionnaires, different neurophysiological assessments, movement and gait parameters, alongside evaluations of usability and acceptability, will be collected. Semistructured interviews involving both participants and research assistants shall take place to elicit their experiences throughout different phases of the assessments undertaken. Demographic data, the scores of assessment scales, as well as feasibility, usability and acceptability of the measurement methods, will be illustrated via descriptive statistics. Movement and gait outcomes, together with neurophysiological data, will be extracted and calculated. Exploring relationships between different factors in the study will be achieved using a regression model. Thematic analysis will be the approach used to manage qualitative data.
ETHICS AND DISSEMINATION
This feasibility study was approved by the Ethics Committee of the Faculty of Physical Therapy, Kafr El Sheikh University, Egypt (number: P.T/NEUR/3/2023/46). The results of this study will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov Registry (NCT05931692).
Topics: Humans; Parkinson Disease; Postural Balance; Accidental Falls; Feasibility Studies; Fear; Egypt; Virtual Reality; Male; Female; Quality of Life; Aged; Middle Aged; Adult; Walking
PubMed: 38692713
DOI: 10.1136/bmjopen-2023-080592