title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Sensitivity analysis | SE, chronic neck pain, NDI, NRS | SENSITIVITY | The results of the sensitivity analysis are presented in Table
Results of uncertainty analysisFor the base case analysis, QALY was calculated with EQ-5D in societal perspectives. The distribution of cost and QALY was calculated by non-parametric bootstrap. The incremental net benefit (INB) was calculated using the 1xW... | PMC10666315 |
Discussion | chronic cervical pain, NDI, chronic neck pain, neck pain, NRS | MINOR, SENSITIVITY | This economic evaluation was performed based on an RCT that compared pharmacopuncture and usual care for chronic neck pain. Compared to the usual care group, the pharmacopuncture group had higher intervention costs, lower direct non-medical costs, and lower indirect costs (costs due to productivity loss). Consequently,... | PMC10666315 |
Conclusions | neck pain, chronic neck pain | Pharmacopuncture is more cost-effective than the usual care for chronic neck pain. The same results were found in various sensitivity analyses. The current study’s findings provide useful information to clinicians and policy makers who are considering new treatment options for neck pain. Additional studies are needed t... | PMC10666315 | |
Acknowledgements | Not applicable. | PMC10666315 | ||
Authors' contributions | IHH | DRK and ESK had the original idea, collected data, performed the analyses, interpreted the analyses, and wrote the original draft. HJS, SYP, KSP, YJL, and IHH supervised the progress of the project, financed the acquisition, and approved the final version. | PMC10666315 | |
Funding | This research was supported by a grant from the Traditional Korea Medicine R&D Program through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, Republic of Korea (grant number: HB16C0035). | PMC10666315 | ||
Availability of data and materials | Patient samples can be obtained via the HIRA website by completing the End User Agreement for Patient Samples. Patient samples are provided in a DVD (text file) format and a fee for the samples may be charged. See | PMC10666315 | ||
Declarations | PMC10666315 | |||
Ethics approval and consent to participate | RECRUITMENT | The study protocol was approved by the institutional review board (IRB) of Jaseng hospital of Korean medicine at each institution before the participant recruitment process commenced (JASENG 2019-06-009, JASENG 2019-06-010, JASENG 2019-06-011, and JASENG 2019-06-008). Written informed consent was obtained from all pati... | PMC10666315 | |
Consent for publication | Not applicable. | PMC10666315 | ||
Competing interests | The authors declare no competing interests. | PMC10666315 | ||
References | PMC10666315 | |||
ABSTRACT | The authors report no commercial, proprietary or financial interest in the products or companies described in this article. | PMC10202449 | ||
Objective: | The objective of this two-arm parallel randomized controlled trial was to evaluate the treatment effects and lip profile changes in skeletal Class II patients subjected to premolars extraction treatment | PMC10202449 | ||
Methods: | BLIND | Forty six subjects fulfilling inclusion criteria were randomly distributed into Group PE (mean age 13.03±1.78 years) and Group FF (mean age 12.80±1.67 years) (n=23 each). Group PE was managed by therapeutic extraction of maxillary first premolars and mandibular second premolars, followed by mini-implant-supported space... | PMC10202449 | |
Results: | Extraction treatment resulted in greater increase of nasolabial angle (NLA: 3.1 [95% CI 2.08, 4.19], | PMC10202449 | ||
Conclusions: | maxillary incisors, overjet | Premolar extraction therapy is a better treatment modality, compared to fixed functional appliance therapy for Class II patients with moderate skeletal discrepancy, increased overjet, protruded maxillary incisors and protruded lips, as it produces better dentoalveolar response and permits greater improvement of the sof... | PMC10202449 | |
RESUMO | PMC10202449 | |||
Objetivo: | O objetivo desse estudo randomizado controlado paralelo de dois braços foi avaliar os efeitos do tratamento e as mudanças no perfil labial em pacientes esqueléticos Classe II submetidos a tratamento com extração de pré-molares (EP) | PMC10202449 | ||
Métodos: | MOLES | Quarenta e seis indivíduos que preencheram os critérios de inclusão foram distribuídos aleatoriamente em Grupo EP (idade média 13,03±1,78 anos) e Grupo FF (idade média 12,80±1,67 anos) (n=23 cada). O grupo EP foi tratado com extração dos primeiros pré-molares superiores e segundos pré-molares inferiores, seguida de fec... | PMC10202449 | |
Resultados: | ANL | O tratamento com extrações resultou em maior aumento do ângulo nasolabial (ANL: 3,1 [IC 95% 2,08, 4,19], | PMC10202449 | |
Conclusões: | MOLES | O tratamento com extração de pré-molares é uma modalidade de tratamento melhor do que os aparelhos funcionais fixos para pacientes Classe II com discrepância esquelética moderada, sobressaliência aumentada, incisivos superiores protruídos e lábios protruídos, pois produz melhor resposta dentoalveolar e permite maior me... | PMC10202449 | |
Keywords: | PMC10202449 | |||
INTRODUCTION | Class II malocclusion, malocclusion, orthodontic | Class II malocclusion is a frequent condition, with a prevalence of around 30% of the patients seeking orthodontic treatment.Depending on the underlying condition, multiple treatment strategies are available for the management of Class II malocclusion.Treatment by both fixed and removable functional appliances is effec... | PMC10202449 | |
MATERIAL AND METHODS | PMC10202449 | |||
TRIAL DESIGN AND SETTING | This study was conducted as a two-arm parallel randomized controlled trial. There were no changes after commencement of the study. Subjects for the trial were recruited and treated in the outpatient clinic of Department of Orthodontics of a tertiary care centre, from 2016 to 2019. | PMC10202449 | ||
SAMPLE SIZE CALCULATION | The sample size was calculated using G*Power software v. 3.0.8 (Universität Kiel, Germany), based on a significance value of 0.05 and a power of 80%. Power analysis determined that a minimum of 18 subjects were required in each group to demonstrate a significant change of upper lip to H line of 1.25mm, which was simila... | PMC10202449 | ||
PARTICIPANTS AND ELIGIBILITY CRITERIA | Patient selection and follow-up were conducted in accordance with CONSORT guidelines (
| PMC10202449 | ||
Descriptive statistics of the participants. | * Group PE (Premolar extraction treatment). * Group FF (Fixed Functional appliance therapy).
| PMC10202449 | ||
Patient selection and follow up flow chart. | skeletal Class II malocclusion, systemic disorders, orthodontic, overjet | Selection criteria included skeletal Class II malocclusion, at least – Class II molar and canine relationship, Cervical Vertebrae Maturity Index (CVMI) confirming circumpubertal phase of skeletal development, average or horizontal growth pattern, no crowding in the maxillary arch, minimal crowding (<3mm) in the mandibu... | PMC10202449 | |
RANDOMIZATION | RECRUITMENT | Following recruitment and consent, a random list of all the subjects was created online (https://www.random.org/) by an individual who was not involved in the trial. The allocation sequence was concealed from research personnel and assessor, using sealed opaque envelopes, which were numbered sequentially and were chose... | PMC10202449 | |
INTERVENTION | overbite, overjet, Fatigue | ROTH | Clinical management in Group PE included extraction of maxillary first premolars and mandibular second premolars. Since subjects had varying pretreatment molar relationship, extractions were carried out in the mandibular arch in order to achieve similar molar relation bilaterally at the end of the treatment. The 0.018 ... | PMC10202449 |
OUTCOME | Class II malocclusion | Primary outcome was to test the hypothesis that there would be no statistically significant difference in soft tissue and profile change of patients with Class II malocclusion treated with premolars extraction and those treated with fixed functional treatment. Lateral cephalograms (Pretreatment - T1 and Post-treatment ... | PMC10202449 | |
Angular measurement (degrees) and linear measurements (mm) used in the study: (1) SNA; (2) SN - ANS PNS; (3) U1 - ANS PNS; (4) SNB; (5) FMA; (6) SN -GoGn; (7) IMPA; (8) ANB; (9) N - A - Pog; (10) Interincisal angle; (11) A - VP; (12) N - ANS; (13) N - PNS; (14) U1 - VP; (15) U1 - HP; (16) U6 - VP; (17) U6 - HP; (18) B ... | PMC10202449 | |||
Landmarks used for cephalometric evaluation. | PMC10202449 | |||
Cephalometric parameters. | SECONDARY | The secondary outcome included skeletal and dental treatment changes, overall treatment duration and overall failure rate of implants / fixed functional appliance. | PMC10202449 | |
INTERIM ANALYSES AND STOPPING GUIDELINES | Not applicable. | PMC10202449 | ||
BLINDING | BLIND | It was not feasible to blind for the clinical procedures. Blinding was done for statistical analysis only. | PMC10202449 | |
ERROR OF THE METHOD AND STATISTICAL ANALYSIS | Ten cephalograms were randomly selected and retraced after a two-weeks interval, to determine the intra and inter-operator reliability. Allocation of all the traced cephalograms was done by a random list created online (https://www.random.org/). The reliability of recorded measurements was determined using intra-class ... | PMC10202449 | ||
RESULTS | PMC10202449 | |||
OUTCOME | The mean age of the subjects of Groups PE and FF at the start of study was 13.03±1.78 and 12.80±1.67 years, respectively. Average duration of premolar extraction treatment was 2.22±0.28 years, and of fixed functional treatment was 2.08±0.24 years, with no significant difference between the two groups (Table 1). Subject... | PMC10202449 | ||
Superimposition of average cephalometric tracings of Group PE (Premolar extraction treatment) and Group FF (Fixed functional appliance therapy) at T1. | ICC of intra-examiner and inter-examiner measurements was 0.96 and 0.92, respectively, depicting highly reliable measurements. The Student
| PMC10202449 | ||
Comparison of cephalometric parameters of Group PE (Premolar extraction treatment) and Group FF (Fixed Functional appliance therapy) at T1. | NS - Not Significant.
| PMC10202449 | ||
Comparison of soft tissue changes (T2-T1) between Group PE (Premolar extraction treatment) and Group FF (Fixed Functional appliance therapy). | NS = Not Significant, * p < 0.05, ** p < 0.001.
| PMC10202449 | ||
Comparison of skeletal changes (T2-T1) between Group PE (Premolar extraction treatment) and Group FF (Fixed Functional appliance therapy). | NS = Not Significant, * p < 0.05, ** p < 0.001.
| PMC10202449 | ||
Comparison of dental changes (T2-T1) between Group PE (Premolar extraction treatment) and Group FF (Fixed Functional appliance therapy). | overbite, overjet | NS = Not Significant, * p < 0.05, ** p < 0.001.Both treatment mechanics were compared for 40 cephalometric parameters. Apart from the skeletal changes in the maxilla and mandible, growth pattern, overjet, overbite, interincisal angle and soft tissue chin position (With regard to the soft tissue changes (
| PMC10202449 | |
Superimposition of average cephalometric tracings of Group PE (Premolar extraction treatment) and Group FF (Fixed Functional appliance therapy) at T2. | With regard to the skeletal changes (Along the vertical plane, effect of both protocols had no significant difference (SN-ANS PNS; N-ANS; N-PNS; FMA; SN-GoGn, With regard to the dentoalveolar changes ( | PMC10202449 | ||
APPLIANCE / IMPLANT FAILURE | Failure of the functional appliance | The implant failure rate was 7.9% - i.e., only 7 of the total implants placed became loose. Failure of the functional appliance was reported in 3 cases: One of the subjects had recurrent breakages of the functional appliance spring and was thus excluded from the present study. | PMC10202449 | |
DISCUSSION | malocclusion, overbite, mesial displacement, L6-GoMe, overjet, Maxillary incisors, mandibular incisors | SECONDARY, ROOT RESORPTION | Successful orthodontic treatment is not just about establishing a static as well as dynamic occlusal relationship, but also to achieve an esthetic soft tissue profile.In the present study, there was a possibility of treatment outcome being influenced by associated growth. To overcome this, use of untreated Class II con... | PMC10202449 |
LIMITATIONS | Ideally untreated Class II subjects should have been included in the present study as control. Although closely matched groups were included in the study, findings of the present study should be considered with caution, due to the short term observation period. Further studies with larger sample composition and long te... | PMC10202449 | ||
GENERALIZABILITY | The results can be generalized to the average patient of most orthodontic clinical settings, as the present study was conducted in orthodontic departments of a government institute, based on broad inclusion criteria, and treatments were performed by experienced clinicians. | PMC10202449 | ||
CONCLUSION | maxillary incisors, malocclusion, mandibular incisors, overjet | LIP | The null hypothesis of this study was rejected. Management by extraction of premolars is a better treatment modality than functional treatment for managing skeletal Class II division 1 malocclusion in Class II subjects with moderate skeletal discrepancy, increased overjet, protruded maxillary incisors and protruded lip... | PMC10202449 |
REFERENCES | PMC10202449 | |||
Supplementary Information | psychiatric, violent | Preventing dropout (attrition) from clinical trials is vital for improving study validity. Dropout is particularly important in justice-involved populations as they can be very challenging to engage and recruit in the first instance. This study identifies factors associated with dropout in a double-blind, placebo-contr... | PMC10657031 | |
Keywords | anger, violent offenders, violent crimes, learning disability, alcohol abuse, violent offending [, impulsivity, depression | In 2016, 2.2 million adults in Australia were estimated to have been victims of domestic violence by age 15 [Randomised control trials (RCT) represent the gold standard in medical research [One reason proposed to account for the lack of RCTs with offenders is that they fall into a group dubbed “hard to treat” by many r... | PMC10657031 | |
Methods | PMC10657031 | |||
Data source | The study design, which has been extensively described in previous publications [ | PMC10657031 | ||
Ethics | This study has received ethical approval from the University of New South Wales (HC17771), Aboriginal Health & Medical Research Council (AHMRC; 822/11), Corrective Services NSW (09/26576) and the NSW Justice Health (G8/14) and the ReINVEST study is registered with the Australian and New Zealand Clinical Trials Registry... | PMC10657031 | ||
Participants | psychiatric | RECRUITMENT | The study population is comprised of 628 (After screening, eligible participants then underwent a comprehensive psychiatric assessment and medical examination, administration of a number of behavioural measures, and collection of demographic data. A detailed list of all study assessments (including abbreviations) used ... | PMC10657031 |
Outcome and definitions | death | ADVERSE EVENTS, SECONDARY, ATTRITION | The primary outcome of interest in this study was time to attrition post-randomisation from the ReINVEST trial. The secondary outcomes were socio-demographic, justice-related and mental health factors associated with attrition from ReINVEST trial. Attrition was defined as the termination of a participant's involvement ... | PMC10657031 |
Covariates | juvenile violent, psychiatric, violent offences within 5 | The following covariates were included in the present analysis: randomisation status (main exposure), age, Aboriginal status, relationship status, accommodation type, number of children, highest educational level, requiring educational support during school, being expelled from school, history of juvenile violent offen... | PMC10657031 | |
Statistical analysis | death, Death | REGRESSION, EVENTS | Descriptive statistics were used to summarise participant characteristics at randomisation (baseline). The time at risk was calculated as the duration from randomisation until the earliest of the following events: attrition, death, or 24 months post-randomisation. Kaplan–Meier method was used to estimate the cumulative... | PMC10657031 |
Discussion | anger, psychiatric, alcohol abuse, impulsivity, irritability, violent | ADVERSE EFFECTS, DISORDERS | The current study explored factors associated with attrition from a clinical trial involving pharmacotherapy aimed at treating impulsive individuals with a history of violent offending. Specifically, we investigated whether attrition from the ReINVEST trial could be predicted by demographic and psychosocial factors ide... | PMC10657031 |
Limitations | anger, psychiatric, alcohol abuse, impulsivity, irritability | A limitation of this study is it is based on a sample of highly impulsive repeat-violent offenders. Additionally, reliance on self-report to ascertain the impact of some of the variables on attrition (e.g. relationship status, number of dependents, accommodation type, impulsivity, anger, irritability, and alcohol abuse... | PMC10657031 | |
Conclusions | violent crimes | The problem of offender attrition from clinical trials and programmes is ongoing and a serious concern given it is linked to recidivism. Identifying ways to reduce the attrition from clinical trials of offenders who commit violent crimes is vital. This study identified a number of risk factors that support researchers ... | PMC10657031 | |
Acknowledgements | Not applicable. | PMC10657031 | ||
Authors’ contributions | PWS, TB | ND, YIW, TGB, and PWS conceived and designed the study and/or acquired the funding. TB, PWS, LK, and BT obtained ethics approval. ND, YIW, TGB, EA, MG, LK, and CK drafted and revised the manuscript. EA, ND, YIW, and TGB. All authors read and approved the final manuscript. | PMC10657031 | |
Funding | Initial funding for ReINVEST was provided from an Australian National Health and Medical Research Council partnership grant in 2009 (NHMRC; No. 533559). From 2018, subsequent funding has been provided by the NSW Department of Communities and Justice. | PMC10657031 | ||
Availability of data and materials | Records management is guided by systems implemented by the NHMRC Clinical Trials Centre, in line with requirements for record keeping in the NSW private sector, medico-legal requirements and the NSW State Records Act 1998. Trial documents are stored under medical records conditions for 15 years post publication in the ... | PMC10657031 | ||
Declarations | PMC10657031 | |||
Ethics approval and consent to participate | This study has received ethical approval from the University of New South Wales (HC17771), Aboriginal Health & Medical Research Council (AHMRC; 822/11), Corrective Services NSW (09/26576) and the NSW Justice Health (G8/14)and the ReINVEST study is registered with the Australian and New Zealand Clinical Trials Registry ... | PMC10657031 | ||
Consent for publication | Not applicable. | PMC10657031 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10657031 | ||
References | PMC10657031 | |||
Background | Provision of small-quantity lipid-based nutrient supplements (SQ-LNSs) during early life improves growth and development. In the International Lipid-Based Nutrient Supplements DYAD–Ghana trial, prenatal and postnatal SQ-LNS reduced social–emotional difficulties at age 5 y, with greater effects among children in less-en... | PMC10447494 | ||
Objectives | We aimed to investigate the effect of prenatal and postnatal SQ-LNS on children's social–emotional problems at age 9–11 y. | PMC10447494 | ||
Methods | In 2009–2011, 1320 pregnant women ≤20 wk gestation were randomly assigned to receive the following daily until 6 mo postpartum: | PMC10447494 | ||
Results | We assessed outcomes in 966 children, comprising 79.4% of 1217 participants eligible for re-enrolment. No significant differences were found between the SQ-LNS and control (non-LNS groups combined) groups. Few children (<2%) experienced high parent-reported social–emotional difficulties at 9–11 y, in contrast to the hi... | PMC10447494 | ||
Conclusions | Overall positive effects of SQ-LNS on social–emotional development previously found at age 5 y are not sustained to age 9–11 y; however, there is some evidence of positive effects among children in less-enriched environments. The lack of effects may be owing to low prevalence of social–emotional problems at preadolesce... | PMC10447494 | ||
Keywords | PMC10447494 | |||
Abbreviations used | Brief Problem Monitor–ParentChildren’s Emotion Management ScalesEarly Adolescent Temperament Questionnaire–ParentEarly Childhood Home Observation for the Measurement of the Environmentiron and folic acidInternational Lipid-Based Nutrient Supplementslipid-based nutrient supplementMiddle Childhood Home Observation for th... | PMC10447494 | ||
Introduction | wasting, −0.12, anemia, micronutrient deficiencies, breast milk | WASTING, ANEMIA | Millions of pregnant women and children globally consume inadequate diets, resulting in conditions among children such as stunting, wasting, anemia, micronutrient deficiencies, and poor cognitive, motor, and social-emotional development [Meta-analyses of data from a large number of randomized trials and children (7 to ... | PMC10447494 |
Methods | PMC10447494 | |||
Objectives and hypotheses | Our objective was to investigate the effect of prenatal and postnatal SQ-LNS on social–emotional problems and self-regulation at age 9–11 y and in the context of children’s home environments. Our first hypothesis was that, compared with children who were not exposed to SQ-LNS in early life, those exposed to SQ-LNS woul... | PMC10447494 | ||
Participants and procedure | 9–11 y. | The methods of the International Lipid-Based Nutrient Supplements-DYAD–Ghana randomized controlled trial (RCT), performed in 2009–2014 [Nutrient and energy contents of the dietary supplements.IFA, iron and folic acid capsule; MMN, multiple micronutrient supplement capsule; SQ-LNS, small-quantity lipid-based nutrient su... | PMC10447494 | |
Assessment of background characteristics and home environment | Depression, depressive symptoms | At enrolment into the parent trial, maternal and household information, such as maternal age, parity, education, and household assets, was collected by trained field workers using a questionnaire. Trained laboratory personnel measured maternal blood hemoglobin concentration at a clinic visit using a digital Hemocue (He... | PMC10447494 | |
Assessment of outcomes | ’s behavior | We assessed children social–emotional problems through the following tools: We administered the strengths and difficulties questionnaire (SDQ) by parent report, teacher report, and child self-report. A set of 20 questions rate children’s behavior during the past 6 mo in 4 subscales: emotional symptoms, conduct problems... | PMC10447494 | |
Statistical analyses | A statistical analysis plan was posted to Open Science Framework before performing analyses ( | PMC10447494 | ||
Group characteristic comparisons | We examined whether children in the SQ-LNS and control groups were similar in key baseline characteristics by presenting descriptive statistics for each intervention group. To evaluate potential bias in the sample, we compared baseline characteristics between the sample included in the analysis and the sample enrolled ... | PMC10447494 | ||
Effect of SQ-LNS | We conducted a complete case intention-to-treat analysis. To test hypothesis 1, for each of the 8 outcomes described earlier (SDQ-Child, SDQ-Parent, SDQ-Teacher, BPM-P, MFQ, SCARED, EATQ-P, and CEMS), we examined the difference between the intervention (SQ-LNS) and control (non-LNS) groups using multivariate analysis o... | PMC10447494 | ||
Effect modifiers | In exploratory analyses, we evaluated potential effect modification by 5 additional variables: baseline household asset index, maternal education, prepregnancy BMI, primiparity, and child sex. We tested the interaction between each potential effect modifier and intervention groups. Significant interactions ( | PMC10447494 | ||
Results | REGRESSION | We successfully reenrolled 979 children at the home visit and collected data from 966 children at the project office visit, representing 107% of our target sample size (900), 73.2% of the 1320 pregnant women enrolled in the parent trial, and 79.4% of the 1217 children eligible for re-enrolment (excluding those known no... | PMC10447494 | |
Effects of SQ-LNS on child social–emotional problems and self-regulation (hypothesis 1) | Children in the SQ-LNS group did not significantly differ from those in the combined control group in any outcome score, with mean differences ranging from −0.3 to 0.5 points and Effect of SQ-LNS on each outcome score.Control refers to iron and folic acid + multiple micronutrient groups. Results based on MANCOVA. For a... | PMC10447494 | ||
Association of home environment with children social–emotional problems and self-regulation (hypothesis 2) | Children with higher EC-HOME scores, indicating higher responsive care and learning opportunities in the home environment during early childhood, showed lower SDQ conduct problems (by parent and teacher reports) and lower SDQ hyperactivity/inattention (by parent report). They also demonstrated lower BPM-P externalizing... | PMC10447494 | ||
Interaction of SQ-LNS with home environment (hypothesis 3) and other potential effect modifiers | The interaction between the intervention group and EC-HOME score was significant for self-report SDQ conduct problems (Association of SQ-LNS with self-reported SDQ conduct problems by Early Childhood Home Observation for the Measurement of the Environment (EC-HOME) scores. Among children with low EC-HOME scores (<23), ... | PMC10447494 | ||
Discussion | EARLY PREGNANCY | In this long-term follow-up study of an RCT that provided a comprehensive daily nutritional supplement during most of the first 1000 d, from early pregnancy to 18 mo postpartum, we did not find effects on social–emotional problems at age 9–11 y. Thus, the previous finding showing reduced social–emotional difficulties i... | PMC10447494 | |
Acknowledgments | CDA | We thank the families, teachers, and schools who participated in and supported this follow-up study and the Assistant Data Manager, Richard Azumah, for his contribution to data collection and cleaning. The authors’ responsibilities were as follows—KGD, SAA, ELP, PDH, AEG, AM, BMO: designed the research; SAA, EA, HB, MM... | PMC10447494 | |
Funding | This publication is based on research funded by grants to the | PMC10447494 | ||
Data availability | Deidentified individual participant data (such as data dictionaries) will be made available on request to researchers who provide a methodologically sound proposal and statistical analysis plan contingent on approval by the principal investigators. Proposals should be submitted to the corresponding author. | PMC10447494 | ||
References | PMC10447494 |
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