scholarly journals Compliance in Ambulatory Assessment Studies: Investigating Study and Sample Characteristics as Predictors

Assessment ◽  
2021 ◽  
pp. 107319112110327
Author(s):  
Charlotte Ottenstein ◽  
Linda Werner
Keyword(s):  
Clinical Studies ◽  
Compliance Rate ◽  
Ambulatory Assessment ◽  
Healthy Controls ◽  
Study Protocols ◽  
Study Characteristics ◽  
Healthy Sample ◽  
Sample Characteristics ◽  
Study Designs ◽  
Do So

Ambulatory assessment (AA) studies are becoming more and more popular. However, it can be challenging to motivate participants to comply with study protocols. The aim of the present study was to investigate possible predictors of compliance in AA studies with diverse samples and study designs. To do so, we extracted compliance information, study characteristics, and sample characteristics from 488 previously published studies. The average compliance across the studies was rather high. The total number of measurement occasions and the number of study days were negatively related to the compliance rate. Moreover, a higher percentage of healthy controls in clinical studies was associated with a higher compliance rate. By contrast, other study characteristics (e.g., the amount of financial compensation) and sample characteristics (clinical vs. healthy sample) were not related to compliance. The findings have implications for the design of future AA studies.

scholarly journals Robust Step Detection from Different Waist-Worn Sensor Positions: Implications for Clinical Studies

2020 ◽  
Vol 4 (1) ◽  
pp. 50-58
Author(s):  
Matthias  Tietsch ◽  
Amir Muaremi ◽  
Ieuan Clay ◽  
Felix Kluge ◽  
Holger Hoefling ◽  
...  
Keyword(s):  
Clinical Study ◽  
Clinical Studies ◽  
Neurological Diseases ◽  
Human Gait ◽  
Robust Solution ◽  
Step Detection ◽  
Study Protocols ◽  
Study Results ◽  
Wide Range ◽  
The Impact

Analyzing human gait with inertial sensors provides valuable insights into a wide range of health impairments, including many musculoskeletal and neurological diseases. A representative and reliable assessment of gait requires continuous monitoring over long periods and ideally takes place in the subjects’ habitual environment (real-world). An inconsistent sensor wearing position can affect gait characterization and influence clinical study results, thus clinical study protocols are typically highly proscriptive, instructing all participants to wear the sensor in a uniform manner. This restrictive approach improves data quality but reduces overall adherence. In this work, we analyze the impact of altering the sensor wearing position around the waist on sensor signal and step detection. We demonstrate that an asymmetrically worn sensor leads to additional odd-harmonic frequency components in the frequency spectrum. We propose a robust solution for step detection based on autocorrelation to overcome sensor position variation (sensitivity = 0.99, precision = 0.99). The proposed solution reduces the impact of inconsistent sensor positioning on gait characterization in clinical studies, thus providing more flexibility to protocol implementation and more freedom to participants to wear the sensor in the position most comfortable to them. This work is a first step towards truly position-agnostic gait assessment in clinical settings.

scholarly journals Dopamine D1 receptor availability is not associated with delusional ideation measures of psychosis proneness

2018 ◽  
Author(s):  
Granville James Matheson ◽  
Pontus Plavén-Sigray ◽  
Anaïs Louzolo ◽  
Jacqueline Borg ◽  
Lars Farde ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Dopamine D1 Receptor ◽  
D1 Receptor ◽  
Psychotic Symptoms ◽  
Antipsychotic Treatment ◽  
Exact Nature ◽  
Healthy Controls ◽  
Psychosis Proneness ◽  
Delusional Ideation ◽  
Increased Risk

AbstractThe dopamine D1 receptor (D1R) is thought to play a role in psychosis and schizophrenia, however the exact nature of this involvement is not clear. Positron emission tomography studies comparing D1R between patients and control subjects have produced inconsistent results. An important confounding factor in most clinical studies is previous exposure to antipsychotic treatment, which is thought to influence the density of D1R. To circumvent some of the limitations of clinical studies, an alternative approach for studying the relationship between D1R and psychosis is to examine individuals at increased risk for psychotic disorders, or variation in subclinical psychotic symptoms such as delusional ideation within the general population, referred to as psychosis proneness traits. In this study, we investigated whether D1R availability is associated with delusional ideation in healthy controls using data from 76 individuals measured with PET using [11C]SCH23390 and 217 individuals who completed delusional ideation questionnaires, belonging to three different study cohorts. We first performed exploratory, hypothesis-generating, analyses by creating and evaluating a new measure of delusional ideation (n=132 and n=27), which was then found to show a negative association with D1R availability (n=24). Next, we performed confirmatory analyses using Bayesian statistical modelling, in which we first attempted to replicate this result (n=20), and then evaluated the association of Peters Delusion Inventory scores with D1R availability in two independent cohorts (n=41 and 20). Collectively, we found strong evidence that there is little to no linear association between delusional ideation and D1R availability in healthy controls. If differences in D1R can be confirmed in drug-naive schizophrenia patients compared to controls, further studies are needed to ascertain whether these changes occur at the onset of psychotic symptoms or if they are associated with specific behavioural or genetic aspects of psychosis proneness other than delusional ideation.

A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation

2010 ◽  
Vol 1 (1) ◽  
pp. 93-106 ◽  
Author(s):  
T. Tompkins ◽  
X. Xu ◽  
J. Ahmarani
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Clinical Findings ◽  
Chronic Diarrhoea ◽  
Helicobacter Pylori Eradication ◽  
Asian Populations ◽  
Post Market ◽  
Improve Compliance ◽  
Irritable Bowel ◽  
Study Designs

Probiotics as dietary supplements have been readily accepted by Asian populations. Use of certain probiotic preparations is widespread and the number of clinical trials undertaken with such products is unparalleled in western scientific literature. One such preparation, containing a combination of Enterococcus faecium R0026 and Bacillus subtilis R0179, has 23 publications on post-market clinical studies involving over 1,800 adults. The majority of these publications are printed in Chinese and Korean journals. This review examines the clinical findings with this probiotic combination. As mono-therapy, it has been used to overcome symptoms associated with chronic diarrhoea and irritable bowel syndrome. It has been used as co-adjuvant therapy with sulfasalazine and mesalazine to improve remission times in mild to moderate Ulcerative Colitis and to improve compliance with conventional triple therapy for Helicobacter pylori eradication. While the much of the data is preliminary and the study designs require refinement, the contribution of these trials should not be ignored. The information derived in this review will provide practitioners with practical information on appropriate applications for probiotic supplements, expected outcomes, dosing regimes, safety and reported adverse events. Furthermore, identification of problems in these trials should help researchers design better clinical trials when investigating probiotic products.

A Systematic Review of the Relationships Between Physical Activity and Sleep in Early Childhood

2021 ◽  
pp. 1-17
Author(s):  
Christine W. St. Laurent ◽  
Katrina Rodheim ◽  
Rebecca M.C. Spencer
Keyword(s):  
Physical Activity ◽  
Systematic Review ◽  
Evaluation Framework ◽  
Outcome Studies ◽  
Study Quality ◽  
Assessment Development ◽  
High Prevalence ◽  
Study Characteristics ◽  
Study Designs

The aim of this systematic review was to examine the associations between physical activity and sleep in children aged less than 6 years. Articles were included if participants were primarily aged less than 6 years and study designs were observational or experimental. Study characteristics were extracted, and the Grading Recommendations Assessment, Development and Evaluation framework was used to assess study quality. Thirty-six studies (16 sleep, 16 physical activity, and three fitness outcomes) from 18 countries reported in 29 articles were included. The majority of sleep and physical activity outcome studies reported mixed effects with very low to low quality of evidence. Fitness outcome studies were limited, and therefore, evidence was insufficient. The high prevalence of mixed and null results could be related to study limitations. Importantly, this review points to the critical need for higher quality studies of sleep and physical activity in young children, which would support health recommendations and intervention strategies for healthier child development.

scholarly journals A Systematic Review of the Effect of Expectancy on Treatment Responses to Acupuncture

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Ben Colagiuri ◽  
Caroline A. Smith
Keyword(s):  
Meta Analysis ◽  
Future Research ◽  
Placebo Acupuncture ◽  
Study Characteristics ◽  
Treatment Responses ◽  
Methodological Considerations ◽  
Randomised Controlled ◽  
Study Designs ◽  
The Relationship ◽  
Relevant Outcome

Randomised controlled trials (RCTs) of acupuncture often find equivalent responses to real and placebo acupuncture despite both appearing superior to no treatment. This raises questions regarding the mechanisms of acupuncture, especially the contribution of patient expectancies. We systematically reviewed previous research assessing the relationship between expectancy and treatment responses following acupuncture, whether real or placebo. To be included, studies needed to assess and/or manipulate expectancies about acupuncture and relate these to at least one health-relevant outcome. Nine such independent studies were identified through systematic searches of Medline, PsycInfo, PubMed, and Cochrane Clinical Trials Register. The methodology and reporting of these studies were quite heterogeneous, meaning that meta-analysis was not possible. A descriptive review revealed that five studies found statistically significant effects of expectancy on a least one outcome, with three also finding evidence suggestive of an interaction between expectancy and type of acupuncture (real or placebo). While there were some trends in significant effects in terms of study characteristics, their generality is limited by the heterogeneity of study designs. The differences in design across studies highlight some important methodological considerations for future research in this area, particularly regarding whether to assess or manipulate expectancies and how best to assess expectancies.

scholarly journals A Review of Study Designs and Outcomes of Phase I Clinical Studies of Nanoparticle Agents Compared with Small-Molecule Anticancer Agents

2013 ◽  
Vol 19 (12) ◽  
pp. 3309-3315 ◽  
Author(s):  
Whitney P. Caron ◽  
Katherine P. Morgan ◽  
Beth A. Zamboni ◽  
William C. Zamboni
Keyword(s):  
Phase I ◽  
Small Molecule ◽  
Anticancer Agents ◽  
Clinical Studies ◽  
Study Designs

scholarly journals Improving Reporting of Clinical Studies Using the POSEIDON Criteria: POSORT Guidelines

2021 ◽  
Vol 12 ◽  
Author(s):  
Sandro C. Esteves ◽  
Alessandro Conforti ◽  
Sesh K. Sunkara ◽  
Luigi Carbone ◽  
Silvia Picarelli ◽  
...  
Keyword(s):  
Assisted Reproductive Technology ◽  
Clinical Studies ◽  
Critical Analysis ◽  
Reproductive Technology ◽  
Therapeutic Strategies ◽  
Clinical Use ◽  
Quality Of Reporting ◽  
Study Designs

The POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) criteria were developed to help clinicians identify and classify low-prognosis patients undergoing assisted reproductive technology (ART) and provide guidance for possible therapeutic strategies to overcome infertility. Since its introduction, the number of published studies using the POSEIDON criteria has increased steadily. However, a critical analysis of existing evidence indicates inconsistent and incomplete reporting of critical outcomes. Therefore, we developed guidelines to help researchers improve the quality of reporting in studies applying the POSEIDON criteria. We also discuss the advantages of using the POSEIDON criteria in ART clinical studies and elaborate on possible study designs and critical endpoints. Our ultimate goal is to advance the knowledge concerning the clinical use of the POSEIDON criteria to patients, clinicians, and the infertility community.

scholarly journals HIS-based support of follow-up documentation – concept and implementation for clinical studies

2011 ◽  
Vol 02 (01) ◽  
pp. 1-17 ◽  
Author(s):  
F. Fritz ◽  
K. Rahbar ◽  
L. Stegger ◽  
M. Schäfers ◽  
M. Dugas ◽  
...  
Keyword(s):  
Clinical Study ◽  
Computer Tomography ◽  
Clinical Studies ◽  
Clinical Information System ◽  
Single Photon ◽  
Photon Emission ◽  
Additional Patient ◽  
Clinical Workflow ◽  
Study Protocols

Summary Objective: Follow-up data must be collected according to the protocol of each clinical study, i.e. at certain time points. Missing follow-up information is a critical problem and may impede or bias the analysis of study data and result in delays. Moreover, additional patient recruitment may be necessary due to incomplete follow-up data. Current electronic data capture (EDC) systems in clinical studies are usually separated from hospital information systems (HIS) and therefore can provide limited functionality to support clinical workflow. In two case studies, we assessed the feasibility of HIS-based support of follow-up documentation. Methods: We have developed a data model and a HIS-based workflow to provide follow-up forms according to clinical study protocols. If a follow-up form was due, a database procedure created a follow-up event which was translated by a communication server into an HL7 message and transferred to the import interface of the clinical information system (CIS). This procedure generated the required follow-up form and enqueued a link to it in a work list of the relating study nurses and study physicians, respectively. Results: A HIS-based follow-up system automatically generated follow-up forms as defined by a clinical study protocol. These forms were scheduled into work lists of study nurses and study physicians. This system was integrated into the clinical workflow of two clinical studies. In a study from nuclear medicine, each scenario from the test concept according to the protocol of the single photon emission computer tomography/computer tomography (SPECT/CT) study was simulated and each scenario passed the test. For a study in psychiatry, 128 follow-up forms were automatically generated within 27 weeks, on average five forms per week (maximum 12, minimum 1 form per week). Conclusion: HIS-based support of follow-up documentation in clinical studies is technically feasible and can support compliance with study protocols.

PP185 Clinical Papers: Which Are Ongoing Studies To Assess MHealth In 2020?

2019 ◽  
Vol 35 (S1) ◽  
pp. 71-72
Author(s):  
Cyril Olivier ◽  
Estelle Piotto ◽  
Corinne Collignon ◽  
Hubert Galmiche ◽  
Chantal Bélorgey
Keyword(s):  
Mobile Health ◽  
Medical Devices ◽  
Clinical Studies ◽  
Randomized Study ◽  
Clinical Development ◽  
Added Value ◽  
Mobile Health Systems ◽  
Major Criterion ◽  
Study Designs ◽  
Patient Use

IntroductionMobile health systems (MHS) are one of the more spreading technologies in the field of medicine. However, identification of useful MHS is rather challenging. Few of them are, or could be, connected medical devices (cMD). Like other medical devices, cMD must be assessed to validate claimed benefits for reimbursement purposes. Clinical added value demonstration is a major criterion used to satisfy administrative requirements. With the increase of clinical studies that are including MHS, study registries can be used for insight into the type of evidence expected to become available in the near future.MethodsIn 2018, the French National Authority for Health (HAS) performed a review of registered MHS clinical study designs. The Clinicaltrials.gov database was consulted for all studies indexed with the terms “mHealth” and “mobile health” for the search fields “study title”, “conditions” and “interventions”.ResultsFour hundred and fifteen clinical studies were registered. Three hundred and eighty studies were interventional with most comprised of a randomized study design (75 percent). Fifteen had a crossover design. Only few observational studies (n = 35) were registered. These mainly concerned (59 percent) patient use of an app on a smartphone without any other device.ConclusionsPatterns of clinical studies were not found to significantly differ between MHS and other medical devices. Most of the clinical studies were randomized and specific criteria to assess MHS could easily be identified. However, specific methodologies for clinical development are not used in practice for cMD health technology assessment. In the absence of validated and specific methodology for clinical development, current methods that are being used in these ongoing studies will nonetheless be generating evidence for the upcoming years.

56 Rapid review of dissemination strategies and activities as listed in published protocol papers

2018 ◽  
Vol 8 (3) ◽  
pp. 381.2-382
Author(s):  
Maria Giovanna Palmieri ◽  
Fiona Morgan ◽  
Mirella Longo ◽  
Clive Gregory ◽  
Annmarie Nelson ◽  
...  
Keyword(s):  
Research Process ◽  
Rapid Review ◽  
The Public ◽  
Additional Information ◽  
Study Protocols ◽  
Key Stakeholders ◽  
Specific Feedback ◽  
Dissemination Of Research ◽  
Study Participants ◽  
Study Designs

BackgroundDissemination of research results is now recognised as an important part of the research process. UK funding agencies and the Health Research Authority require that researchers have a clear plan about how findings should be reported back to patients and members of the public. Wider dissemination using a range of mechanisms specifically targeting the lay community enables the work to have impact outside its academic base and accelerate implementation. The study evolves over three stages: a review of the literature surveys of key stakeholders (research partners study participants members of the public and researchers) and a consensus meeting.AimTo present a literature review of dissemination activities planned by researchers as reported in published protocol papers.MethodologyThe MEDLINE electronic database was searched to identify study protocols published in 2017 and covering a range of study designs.Results138 papers published in 2017 were reviewed. Most papers lacked a clear and detailed dissemination plan. In general descriptions of dissemination plans were short and listed a very limited number of stakeholder groups targeted for dissemination and few dissemination channels. A few papers contained additional information on dissemination strategies and activities. Four papers mentioned specific feedback to participants by newsletter or other methods. A full and detailed dissemination plan was present in three protocol papers.ConclusionMost of the previous research has focused on the researchers’ perspective. The guidelines will embed the views of other stakeholders including the general public patient participants in research trials funding bodies and policy makers.

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