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Evidence-based Complementary and... 2015Background. While therapeutic acupuncture perception (deqi) has recently been investigated only for the subject's perception, classical acupuncture discussed acupuncture...
Background. While therapeutic acupuncture perception (deqi) has recently been investigated only for the subject's perception, classical acupuncture discussed acupuncture perception for both the practitioner and the subject. The aim of this study was to explore the practitioner's and the subject's acupuncture perception during acupuncture. Methods. Explorative crossover study to quantitatively document acupuncture perception of both the practitioner and the subject. Eighty-one participants acted as a practitioner or a subject. The practitioner's and the subject's acupuncture perceptions were collected using self-report type checklists. Acupuncture needles were inserted to LI4 or ST36, adopting a four-phase method: insertion into shallow, middle, and deep depths, followed by twirling manipulation. Pain, transmission, dullness, and soreness feelings of the subject and thick, tangled, solid, and empty feelings of the practitioner were analyzed for their correlation. Results. The practitioner's and the subject's perception showed a significant correlation. Acupuncture perception varied over four phases of needling, with a tendency to be rated higher when inserted deep. Perception for LI4 was generally higher than those for ST36. Conclusion. The practitioner's acupuncture perception was successfully documented and analyzed in relation to the subject's acupuncture perception and different needling conditions.
PubMed: 26689128
DOI: 10.1155/2015/635089 -
Proceedings of SPIE--the International... Feb 2018The subarachnoid space is a layer in the meninges that surrounds the brain and is filled with trabeculae and cerebrospinal fluid. Quantifying the volume and thickness of...
The subarachnoid space is a layer in the meninges that surrounds the brain and is filled with trabeculae and cerebrospinal fluid. Quantifying the volume and thickness of the subarachnoid space is of interest in order to study the pathogenesis of neurodegenerative diseases and compare with healthy subjects. We present an automatic method to reconstruct the subarachnoid space with subvoxel accuracy using a nested deformable model. The method initializes the deformable model using the convex hull of the union of the outer surfaces of the cerebrum, cerebellum and brainstem. A region force is derived from the subject's Tl-weighted and T2-weighted MRI to drive the deformable model to the outer surface of the subarachnoid space. The proposed method is compared to a semi-automatic delineation from the subject's T2-weighted MRI and an existing multi-atlas-based method. A small pilot study comparing the volume and thickness measurements in a set of age-matched subjects with normal pressure hydrocephalus and healthy controls is presented to show the efficacy of the proposed method.
PubMed: 31043764
DOI: 10.1117/12.2293633 -
Frontiers in Psychology 2021Resilience has been defined as the maintenance or quick recovery of mental health during and after times of adversity. How to operationalize resilience and to determine... (Review)
Review
The Frequent Stressor and Mental Health Monitoring-Paradigm: A Proposal for the Operationalization and Measurement of Resilience and the Identification of Resilience Processes in Longitudinal Observational Studies.
Resilience has been defined as the maintenance or quick recovery of mental health during and after times of adversity. How to operationalize resilience and to determine the factors and processes that lead to good long-term mental health outcomes in stressor-exposed individuals is a matter of ongoing debate and of critical importance for the advancement of the field. One of the biggest challenges for implementing an outcome-based definition of resilience in longitudinal observational study designs lies in the fact that real-life adversity is usually unpredictable and that its substantial qualitative as well as temporal variability between subjects often precludes defining circumscribed time windows of inter-individually comparable stressor exposure relative to which the maintenance or recovery of mental health can be determined. To address this pertinent issue, we propose to frequently and regularly monitor stressor exposure (E) and mental health problems (P) throughout a study's observation period [Frequent Stressor and Mental Health Monitoring (FRESHMO)-paradigm]. On this basis, a subject's deviation at any single monitoring time point from the study sample's normative E-P relationship (the regression residual) can be used to calculate that subject's current mental health reactivity to stressor exposure ("stressor reactivity," SR). The SR score takes into account the individual extent of experienced adversity and is comparable between and within subjects. Individual SR time courses across monitoring time points reflect intra-individual temporal variability in SR, where periods of under-reactivity (negative SR score) are associated with accumulation of fewer mental health problems than is normal for the sample. If FRESHMO is accompanied by regular measurement of potential resilience factors, temporal changes in resilience factors can be used to predict SR time courses. An increase in a resilience factor measurement explaining a lagged decrease in SR can then be considered to index a process of adaptation to stressor exposure that promotes a resilient outcome (an allostatic resilience process). This design principle allows resilience research to move beyond merely determining baseline predictors of resilience outcomes, which cannot inform about how individuals successfully adjust and adapt when confronted with adversity. Hence, FRESHMO plus regular resilience factor monitoring incorporates a dynamic-systems perspective into resilience research.
PubMed: 34539510
DOI: 10.3389/fpsyg.2021.710493 -
Frontiers in Psychology 2016The present study examines the processing of subject-verb (SV) number agreement with coordinate subjects in pre-verbal and post-verbal positions in Greek. Greek is a...
The present study examines the processing of subject-verb (SV) number agreement with coordinate subjects in pre-verbal and post-verbal positions in Greek. Greek is a language with morphological number marked on nominal and verbal elements. Coordinate SV agreement, however, is special in Greek as it is sensitive to the coordinate subject's position: when pre-verbal, the verb is marked for plural while when post-verbal the verb can be in the singular. We conducted two experiments, an acceptability judgment task with adult monolinguals as a pre-study (Experiment 1) and a self-paced reading task as the main study (Experiment 2) in order to obtain acceptance as well as processing data. Forty adult monolingual speakers of Greek participated in Experiment 1 and a hundred and forty one in Experiment 2. Seventy one children participated in Experiment 2: 30 Albanian-Greek sequential bilingual children and 41 Greek monolingual children aged 10-12 years. The adult data in Experiment 1 establish the difference in acceptability between singular VPs in SV and VS constructions reaffirming our hypothesis. Meanwhile, the adult data in Experiment 2 show that plural verbs accelerate processing regardless of subject position. The child online data show that sequential bilingual children have longer reading times (RTs) compared to the age-matched monolingual control group. However, both child groups follow a similar processing pattern in both pre-verbal and post-verbal constructions showing longer RTs immediately after a singular verb when the subject was pre-verbal indicating a grammaticality effect. In the post-verbal coordinate subject sentences, both child groups showed longer RTs on the first subject following the plural verb due to the temporary number mismatch between the verb and the first subject. This effect was resolved in monolingual children but was still present at the end of the sentence for bilingual children indicating difficulties to reanalyze and integrate information. Taken together, these findings demonstrate that (a) 10-12 year-old sequential bilingual children are sensitive to number agreement in SV coordinate constructions parsing sentences in the same way as monolingual children even though their vocabulary abilities are lower than that of age-matched monolingual peers and (b) bilinguals are slower in processing overall.
PubMed: 27242577
DOI: 10.3389/fpsyg.2016.00648 -
BMC Medical Research Methodology Oct 2021Accuracy can be improved by taking multiple synchronous samples from each subject in a study to estimate the endpoint of interest if sample values are not highly...
BACKGROUND
Accuracy can be improved by taking multiple synchronous samples from each subject in a study to estimate the endpoint of interest if sample values are not highly correlated. If feasible, it is useful to assess the value of this cluster approach when planning studies. Multiple assessments may be the only method to increase power to an acceptable level if the number of subjects is limited.
METHODS
The main aim is to estimate the difference in outcome between groups of subjects by taking one or more synchronous primary outcome samples or measurements. A summary statistic from multiple samples per subject will typically have a lower sampling error. The number of subjects can be balanced against the number of synchronous samples to minimize the sampling error, subject to design constraints. This approach can include estimating the optimum number of samples given the cost per subject and the cost per sample.
RESULTS
The accuracy improvement achieved by taking multiple samples depends on the intra-class correlation (ICC). The lower the ICC, the greater the benefit that can accrue. If the ICC is high, then a second sample will provide little additional information about the subject's true value. If the ICC is very low, adding a sample can be equivalent to adding an extra subject. Benefits of multiple samples include the ability to reduce the number of subjects in a study and increase both the power and the available alpha. If, for example, the ICC is 35%, adding a second measurement can be equivalent to adding 48% more subjects to a single measurement study.
CONCLUSION
A study's design can sometimes be improved by taking multiple synchronous samples. It is useful to evaluate this strategy as an extension of a single sample design. An Excel workbook is provided to allow researchers to explore the most appropriate number of samples to take in a given setting.
Topics: Humans; Research Design
PubMed: 34657591
DOI: 10.1186/s12874-021-01414-7 -
BMC Medical Ethics Aug 2022The twenty-first century has witnessed an exponential increase in healthcare quality research. As such activities become more prevalent, physicians are increasingly...
BACKGROUND
The twenty-first century has witnessed an exponential increase in healthcare quality research. As such activities become more prevalent, physicians are increasingly needed to participate as subjects in research and quality improvement (QI) projects. This raises an important ethical question: how should physicians be remunerated for participating as research and/or QI subjects?
FINANCIAL VERSUS NON-MONETARY INCENTIVES FOR PARTICIPATION
Research suggests participation in research and QI is often driven by conditional altruism, the idea that although initial interest in enrolling in research is altruistic or prosocial, decisions to actually perform study tasks are cost-benefit driven. Thus, the three models commonly employed to appropriately compensate participants (in-kind compensation such as travel reimbursement, paying market rates for the subject's time, and paying market rates for the activity asked of the participant) are a poor fit when the participant is a clinician, largely due to the asymmetry between cost and benefit or value to the participant. Non-monetary alternatives such as protected time for participation, continuing education or maintenance of certification credit, or professional development materials, can provide viable avenues for reducing this asymmetry.
CONCLUSION
Research and QI are integral to the betterment of medicine and healthcare. To increase physician participation in these activities as the subject of study, new models are needed that clarify the physician's role in research and QI as a subject. Non-monetary approaches are recommended to successfully and ethically encourage research and QI participation, and thus incorporate these activities as a normal part of the ethical clinician's and successful learning healthcare system's world view.
Topics: Certification; Health Services Research; Humans; Physicians; Quality Improvement; Quality of Health Care
PubMed: 35964081
DOI: 10.1186/s12910-022-00817-5 -
Neural Regeneration Research Mar 2015The residual consciousness of unconscious patients can be detected by studying the P300, a wave among event-related potentials. Previous studies have applied tones, the...
The residual consciousness of unconscious patients can be detected by studying the P300, a wave among event-related potentials. Previous studies have applied tones, the subject's name and other names as stimuli. However, the results were not satisfactory. In this study, we changed the constituent order of subjects' two-character names to create derived names. The subject's derived names, together with tones and their own names, were used as auditory stimuli in event-related potential experiments. Healthy controls and unconscious patients were included in this study and made to listen to these auditory stimuli. In the two paradigms, a sine tone followed by the subject's own name and the subject's derived name followed by the subject's own name were used as standard and deviant stimuli, respectively. The results showed that all healthy controls had the P300 using both paradigms, and that the P300 in the second paradigm had a longer latency and two peaks. All minimally conscious state patients had the P300 in the first paradigm and the majority of them had the P300 in the second paradigm. Most vegetative state patients had no P300. Patients who showed the P300 in the two paradigms had more residual consciousness, and patients with the two-peak P300 had a higher probability of awakening within a short time. Our experimental findings suggest that the P300 event-related potential could reflect the conscious state of unconscious patients.
PubMed: 25878599
DOI: 10.4103/1673-5374.153699 -
The Journal of Clinical and Aesthetic... Aug 2020Dry, flaky skin remains one of the most common and vexing of human disorders. The anterior shin is a challenging area to treat in women with scaly skin. We sought to...
Dry, flaky skin remains one of the most common and vexing of human disorders. The anterior shin is a challenging area to treat in women with scaly skin. We sought to investigate whether a lactic acid/ceramide lotion improves the texture and appearance of dry skin through moisturization and desquamation. This was a randomized, single-center, controlled, evaluator-blinded, within-subject comparison of a lactic acid/ceramide lotion versus no treatment. The lotion was applied twice daily for 14 days, with evaluations performed on Days 1, 2, and 14. A total of 56 healthy female subjects, older than 50 years of age, with Fitzpatrick Skin Types I through VI and dry, rough skin on the anterior shins (defined as Grades 3-4 by investigator evaluation) were included in the study. Assessments of change in skin appearance following desquamation and moisturization by D-SQUAME® analysis and an investigator assessment on the Dry Skin Scale were performed on Days 1, 2, and 14. Additionally, subjects completed a self-assessment questionnaire on Day 1 and Day 14. Safety was assessed via spontaneous reporting and review of subject diaries. Clinical and statistically significant superiority to no treatment in terms of enhancing moisturization and desquamation per D-SQUAME® analysis at Day 2 and Day 14 (-2.51 and -3.07 from baseline, respectively; <0.0001) was achieved. Treatment success as assessed by the investigator (via the Dry Skin Scale) and subject's self-assessment also indicated statistically significant improvements were achieved with the lactic acid/ceramide lotion (<0.0001). No adverse events were reported during the study. The lactic acid/ceramide lotion provided a statistically significant and clinically meaningful improvement in moisturization and desquamation. NCT04085809.
PubMed: 33178384
DOI: No ID Found -
Perspectives in Clinical Research 2016Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during...
BACKGROUND
Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during conduct of trial affects conclusive results.
OBJECTIVE
To assess the level of challenges faced by Indian investigators in recruitment and retention of trial subjects.
METHODS
We developed a survey questionnaire on challenges encountered by investigators in subject recruitment and retention which was hosted on a web portal.
RESULTS
Seventy-three investigators from India participated in the survey. The frequently encountered challenges in subject recruitment were complexity of study protocol (38%), lack of awareness about clinical trials in patients (37%), and sociocultural issues related to trial participation (37%). About 63% of participants strongly agreed that creating a positive awareness about clinical trials among people through press and media, having a dedicated clinical research coordinator for trial (50.7%), and designing a recruitment strategy prior to study initiation (46.6%) would enhance recruitment. Almost 50.7% of participants agreed that interacting with medical community in vicinity of the study site and educating patients about clinical trials during routine outpatient department visits (46.6%) would enhance recruitment. Experiencing a serious adverse event, subject's fear for study procedures (47%) and side effects (44%) were thought to have a moderate effect on subject retention.
CONCLUSION
Our survey has put forth factors related to negative publicity by media, lack of patient education about clinical trials; complex study designs are barriers to clinical trial recruitment in India. It is essential to devise innovative and effective strategies focusing on education of public and mass media about clinical research in India.
PubMed: 27453831
DOI: 10.4103/2229-3485.184820 -
Biometrics Sep 2019The assumption that no subject's exposure affects another subject's outcome, known as the no-interference assumption, has long held a foundational position in the study...
The assumption that no subject's exposure affects another subject's outcome, known as the no-interference assumption, has long held a foundational position in the study of causal inference. However, this assumption may be violated in many settings, and in recent years has been relaxed considerably. Often this has been achieved with either the aid of a known underlying network, or the assumption that the population can be partitioned into separate groups, between which there is no interference, and within which each subject's outcome may be affected by all the other subjects in the group via the proportion exposed (the stratified interference assumption). In this article, we instead consider a complete interference setting, in which each subject affects every other subject's outcome. In particular, we make the stratified interference assumption for a single group consisting of the entire sample. We show that a targeted maximum likelihood estimator for the i.i.d. setting can be used to estimate a class of causal parameters that includes direct effects and overall effects under certain interventions. This estimator remains doubly-robust, semiparametric efficient, and continues to allow for incorporation of machine learning under our model. We conduct a simulation study, and present results from a data application where we study the effect of a nurse-based triage system on the outcomes of patients receiving HIV care in Kenyan health clinics.
Topics: Causality; Computer Simulation; HIV Infections; Humans; Kenya; Likelihood Functions; Machine Learning; Treatment Outcome; Triage
PubMed: 30714118
DOI: 10.1111/biom.13034