scholarly journals Graphing Each Individual's Data over Time

2018 ◽  
Vol 18 (3) ◽  
pp. 503-516
Author(s):  
Mark D. Chatfield
Keyword(s):  
Clinical Trials ◽  
Single Variable ◽  
Tips And Tricks ◽  
Time Points ◽  
Several Variables ◽  
Multiple Variables ◽  
Insight Into ◽  
Administrative Datasets ◽  
Over Time

Graphing each individual's data over time (in separate graphs) can be a worthwhile approach in exploring longitudinal and panel datasets. This especially applies for datasets where several variables change over time and where there are many possible time points, for example, administrative datasets and patient safety profiles in clinical trials. Studying a few individuals’ graphs closely can provide insight into the nature and quality of the data, generate hypotheses, and inform data analysis. Selecting a few typical or unusual graphs can make for powerful presentations at meetings. I give examples of graphing a single variable and multiple variables over time for each individual, and I detail associated Stata coding tips and tricks.

scholarly journals Health-related quality of life in children with Duchenne muscular dystrophy: a follow-up study

2015 ◽  
Vol 42 (S1) ◽  
pp. S8-S8
Author(s):  
Y Wei ◽  
K Speechley ◽  
C Campbell
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Health Related Quality ◽  
Parent Reports ◽  
Related Quality ◽  
Health Related ◽  
Over Time

Background: Improvement of health-related quality of life (HRQOL) is a major goal in chronic disease management and HRQOL has become an important outcome in clinical trials. Longitudinal data on HRQOL are needed to elucidate change over time and to assess effectiveness of interventions; such research is lacking in the paediatric Duchenne Muscular Dystrophy (DMD) population. Methods: We followed up participants from our initial HRQOL study in 2013 a year and a half later. Multidimensional generic and disease-specific measures from the Pediatric Quality of Life Inventory were used to assess HRQOL from child and parent perspectives. Mean changes in HRQOL were calculated. Results: Data collection is ongoing and currently, data from 16 families (out of the initial 98) are available. Preliminary results indicated that by both child and parent reports, there were declines in all domains of HRQOL except for social function, in which there was a slight improvement. Mean decline in HRQOL scores ranged from 1.6 to 8.6 for child reports; and 3.3 to 7.7 for parent reports. Conclusion: HRQOL of boys with DMD deteriorates over time. Our results may be helpful in interpreting patient reported outcomes in forthcoming clinical trials and determining minimally clinically important changes in this population.

Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries

2017 ◽  
Vol 45 (4) ◽  
pp. 875-883 ◽  
Author(s):  
Devon E. Anderson ◽  
Riley J. Williams ◽  
Thomas M. DeBerardino ◽  
Dean C. Taylor ◽  
C. Benjamin Ma ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Clinical Trials ◽  
Magnetic Resonance ◽  
Resonance Imaging ◽  
Repair Tissue ◽  
Time Points ◽  
Cartilage Lesions ◽  
Articular Cartilage Lesions ◽  
Over Time

Background: Autologous cartilage tissue implants, including the NeoCart implant, are intended to repair focal articular cartilage lesions. Short-term results from United States Food and Drug Administration (FDA) phase I and phase II clinical trials indicated that the NeoCart implant was safe when surgically applied as a cell-based therapy and efficacious compared with microfracture. Hypothesis: Quantitative magnetic resonance imaging (MRI) analysis would reveal NeoCart tissue maturation through to 60-month follow-up. Study Design: Case series; Level of evidence, 4. Methods: Patients with symptomatic full-thickness cartilage lesions of the distal femoral condyle were treated with NeoCart in FDA clinical trials. Safety and efficacy were evaluated prospectively by MRI and clinical patient-reported outcomes (PROs) through to 60-month follow-up. Qualitative MRI metrics were quantified according to modified MOCART (magnetic resonance observation of cartilage repair tissue) criteria, with an independent evaluation of repair tissue signal intensity. Subjective PROs and objective range of motion (ROM) were obtained at baseline and through to 60 months. Results: Twenty-nine patients treated with NeoCart were observed over a mean of 52.0 ± 15.5 months (median, 60 months). MOCART analyses indicated significant improvement ( P < .001) in cartilage quality from 3 to 24 months, with stabilization from 24 to 60 months. Signal intensity of the repair tissue evolved from hyperintense at early follow-up to isointense after 6 months and to hypointense after 24 months. The temporal progression toward hypointense T2 signals at later time points observed here indicated a further reorganization of the repair tissue toward a dense tissue that was less similar to the surrounding native tissue. However, 80% of patients showed evidence of subchondral bone changes on MRI at all time points; 4 patients (14%) showed no improvement of MRI criteria. Compared with baseline values, significant improvement ( P < .001) was seen in PROs (mean [±SD] baseline to mean [±SD] final follow-up), including the International Knee Documentation Committee score (47.9 ± 17.4 to 75.5 ± 22.1), physical component summary of the Short Form–36 (40.5 ± 7.2 to 51.4 ± 8.1), and all 5 domains of the Knee injury and Osteoarthritis Outcome Score (Pain: 64.8 ± 12.1 to 86.1 ± 17.3; Activities of Daily Living: 75.5 ± 14.8 to 91.6 ± 13.8; Quality of Life: 28.6 ± 15.5 to 69.4 ± 28.0; Symptoms: 65.8 ± 13.8 to 86.6 ± 13.4; Sports and Recreation: 41.4 ± 24.3 to 72.4 ± 28.8). Significant ( P < .0001) decreases from baseline scores for the visual analog scale for pain (34.6 ± 22.5) were seen by 6 months and sustained at final follow-up (14.3 ± 18.4). ROM significantly ( P < .0001) improved from baseline (131.5° ± 7.9°) to final follow-up (140.7° ± 6.3°). Conclusion: Longitudinal MRI analysis demonstrated that NeoCart-based repair tissue is durable and evolves over time. For a majority of patients, this progression trended from an initial hyperintense signal to a hypointense signal at later follow-ups. Changes in radiographic measures over time corresponded with improvement in clinical measures, with maximum benefits experienced at 24-month follow-up. Similarly, clinical efficacy for the total cohort, determined by clinical outcome scores, reached a maximum at 24 months without decline to 60 months. Results from safety and exploratory clinical trials indicate that NeoCart is a safe and effective treatment for articular cartilage lesions through to 5-year follow-up. Registration: NCT00548119 ( ClinicalTrials.gov identifier).

scholarly journals Objectively Monitoring Amyotrophic Lateral Sclerosis Patient Symptoms During Clinical Trials With Sensors: Observational Study

10.2196/13433 ◽  
2019 ◽  
Vol 7 (12) ◽  
pp. e13433 ◽  
Author(s):  
Luis Garcia-Gancedo ◽  
Madeline L Kelly ◽  
Arseniy Lavrov ◽  
Jim Parr ◽  
Rob Hart ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Home Monitoring ◽  
Home Setting ◽  
Time Points ◽  
Speech Data ◽  
The Impact ◽  
Lateral Sclerosis

Background Objective symptom monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) has the potential to provide an important source of information to evaluate the impact of the disease on aspects of real-world functional capacity and activities of daily living in the home setting, providing useful objective outcome measures for clinical trials. Objective This study aimed to investigate the feasibility of a novel digital platform for remote data collection of multiple symptoms—physical activity, heart rate variability (HRV), and digital speech characteristics—in 25 patients with ALS in an observational clinical trial setting to explore the impact of the devices on patients’ everyday life and to record tolerability related to the devices and study procedures over 48 weeks. Methods In this exploratory, noncontrolled, nondrug study, patients attended a clinical site visit every 3 months to perform activity reference tasks while wearing a sensor, to conduct digital speech tests and for conventional ALS monitoring. In addition, patients wore the sensor in their daily life for approximately 3 days every month for the duration of the study. Results The amount and quality of digital speech data captured at the clinical sites were as intended, and there were no significant issues. All the home monitoring sensor data available were propagated through the system and were received as expected. However, the amount and quality of physical activity home monitoring data were lower than anticipated. A total of 3 or more days (or partial days) of data were recorded for 65% of protocol time points, with no data collected for 24% of time points. At baseline, 24 of 25 patients provided data, reduced to 13 of 18 patients at Week 48. Lower-than-expected quality HRV data were obtained, likely because of poor contact between the sensor and the skin. In total, 6 of 25 patients had mild or moderate adverse events (AEs) in the skin and subcutaneous tissue disorders category because of skin irritation caused by the electrode patch. There were no reports of serious AEs or deaths. Most patients found the sensor comfortable, with no or minimal impact on daily activities. Conclusions The platform can measure physical activity in patients with ALS in their home environment; patients used the equipment successfully, and it was generally well tolerated. The quantity of home monitoring physical activity data was lower than expected, although it was sufficient to allow investigation of novel physical activity end points. Good-quality in-clinic speech data were successfully captured for analysis. Future studies using objective patient monitoring approaches, combined with the most current technological advances, may be useful to elucidate novel digital biomarkers of disease progression.

scholarly journals Utilization of Patient-Reported Outcomes in Myeloproliferative Neoplasm Clinical Trials Registered at Clinicaltrials.Gov

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5469-5469
Author(s):  
Blake T. Langlais ◽  
Gina Mazza ◽  
Crystal S. Langlais ◽  
Heidi E. Kosiorek ◽  
Holly L. Geyer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Funding ◽  
Patient Reported Outcomes ◽  
Outcome Data ◽  
Patient Reported ◽  
Secondary Endpoints ◽  
Secondary Outcomes ◽  
Line P ◽  
Over Time

Abstract Introduction Patients with myeloproliferative neoplasms (MPN) typically experience debilitating symptom profiles and profound quality of life (QoL) decrements. Characterizing symptom burden in MPN clinical trials is vital to inform efficacy analyses. Previous studies have shown clinicians and researchers depend on patient-reported outcomes (PROs) to glean disease-related symptoms and signs of QoL decline. The current literature also shows that integrating PROs into the routine care of patients with cancer is associated with increased survival compared with usual care. However, the extent to which PROs are employed in MPN clinical trials is undescribed. ClincalTrials.gov is a registry of clinical trials mandated by the US Congress and implemented in 2000 by the National Institutes of Health. This study used data from ClinicalTrials.gov to evaluate the characteristics of MPN clinical trials over time and their use of PROs as primary and secondary outcomes. Methods The statistical software R and the rclinicaltrials package were used to download data from ClinicalTrials.gov. Trial data were included in this study if the following criteria were met: (1) the words essential thrombocythemia, polycythemia vera, myelofibrosis, or myeloproliferativeneoplasm (MPN) were used in the registered primary disease condition or official trial title; (2) the trial start date was between January 1, 2000 - July 1, 2018; (3) primary/secondary outcome data were available. Trial outcome data were then parsed for PRO text phrases including MPN-Symptom Assessment Form, quality of life, questionnaire, patient-reportedoutcome, and more specific PRO items (e.g., bone pain, concentration problems, and depression). Descriptive statistics and regression analysis were used to assess rates of primary/secondary outcomes over time. Results Clinical trial characteristics There were 535 trials satisfying the inclusion criteria. Since 2000, the number of registered MPN-related clinical trials ranged from 11 to 36 trials per year with 28 trials registered annually on average (Figure 1). Of the 535 trials, 470 (88%) were interventional and 65 (12%) observational. Trials often employed multiple intervention types including: drug (77%); procedure (28%); biological (19%); radiation (13%); genetic (3%); behavioral (2%); device (2%); dietary supplement (1%); other (24%) [percentages do not sum to 100% as categories are not mutually exclusive]. Eligibility criteria varied widely, though most used 18 years old as the minimum age requirement (71%; 379/535) and nearly all included both genders (>99%; 533/535). PRO outcomes over time Of the 535 MPN trials, the number of primary outcomes within MPN trials did not change over time (p=.50) with an average of 1.6 per trial. Around 8% of MPN clinical trials had PRO-related primary outcomes; this rate also did not change over time (Figure 1: solid red line; p=.97). However, the total number of secondary outcomes per trial has increased since 2000 (p<.001). From 2000-2005, 2006-2011, and 2012-2018 there was an average of 2.8, 3.3, and 5.2 secondary outcomes per trial, respectively. Also, the proportion of MPN clinical trials with PRO-related secondary outcomes has increased steadily over time (Figure 1: dashed blue line; p<.001). On average, from 2000-2005, 2006-2011, and 2012-2018 the proportion of MPN clinical trials with PRO-related secondary outcomes increased from 8% to 23%, to 33%. Conclusion Analysis of ClinicalTrials.gov data suggest that patient-reported outcomes are being implemented into MPN clinical trials at increasing rates. While this suggests that MPN trials are becoming more patient-centered, PROs are included more often as secondary endpoints than primary endpoints. This analysis also suggests an increase in the number of secondary endpoints in recent years in MPN clinical trials, consistent with observed trends of growing complexity and increasing amount of data captured in clinical trials in general. Disclosures Mesa: Ariad: Consultancy; Galena: Consultancy; Gilead: Research Funding; Promedior: Research Funding; Incyte: Research Funding; Novartis: Consultancy; CTI: Research Funding; Celgene: Research Funding. Scherber:Orphan Pharmaceuticals: Honoraria; Incyte: Consultancy. Dueck:Bayer: Employment; Phytogine: Employment; Pfizer: Honoraria.

scholarly journals Co-researchers in motion: a journey of evolving relationships. A critical reflection on the co-operation between two older adults and a nurse researcher

2021 ◽  
Vol 11 (1) ◽  
pp. 1-9
Author(s):  
Jan S. Jukema ◽  
◽  
Jacqueline van Alphen ◽  
Jopie Jorritsma ◽  
Miranda Snoeren ◽  
...  
Keyword(s):  
Older Adults ◽  
Critical Reflection ◽  
Lessons Learned ◽  
Dynamic Search ◽  
Critical Understanding ◽  
The Individual ◽  
The Relationship ◽  
Insight Into ◽  
Over Time

Background: There is a growing amount of research in which older adults contribute as co-researchers. The quality of this research depends, among other factors, on the nature of relationships between professional researchers and co-researchers. Reflections on these relationships can offer structured insight into this form of research. Aim: Our reflection on the co-operation between two older adults and a nurse researcher aims to share the lessons learned based on a critical understanding of our journey. Our main questions are: 1. How has the relationship developed over time, including in terms of mutuality and equality? 2. Which moments have been decisive in this development? Conclusion: We regard our co-operative relationship as a ‘dynamic search’. The meaning of mutuality and equality may change over time and so enrich the relationships. There is a need for further understanding into how these values can be nurtured in different configurations of researchers and co-researchers. Implications for practice: Evolving relations can be nurtured through deliberative sharing of the perceptions, expectations and experiences of the researchers and co-researchers Combining a formal working atmosphere with informal moments helps the research team respond to the individual needs of its members To enhance equality and mutuality, it is important to appreciate and value everyone’s contribution rather than concentrating on ‘what ’or ‘how ’individuals contribute

scholarly journals Development and persistence of depressive symptoms in adolescents with CHD

2015 ◽  
Vol 26 (6) ◽  
pp. 1115-1122 ◽  
Author(s):  
Koen Luyckx ◽  
Jessica Rassart ◽  
Eva Goossens ◽  
Silke Apers ◽  
Leen Oris ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Heart Surgery ◽  
Depression Scale ◽  
Time Points ◽  
Cardiac Symptoms ◽  
Patient Reported ◽  
Reported Health ◽  
Over Time

AbstractPatients with CHD are vulnerable to psychiatric disorders. The present study compared baseline depressive symptoms between adolescents with CHD and community adolescents, and also assessed the development and persistence of depressive symptoms in patients. We examined the implications of persistent depressive symptoms towards quality of life and patient-reported health. In total, 296 adolescents with CHD participated in a four-wave longitudinal study, with 9-month intervals, and completed measures of depressive symptoms – Center for Epidemiologic Studies Depression Scale (CES-D) – at time points one to four and of quality of life – linear analogue scale (LAS) – and patient-reported health – LAS and Pediatric Quality of Life Inventory – at T (time) 4. Information about diagnosis, disease complexity, and previous heart surgery was collected from medical records. At T1, 278 patients were matched 1:1 with community adolescents, based on sex and age. The findings of this study indicate that patients scored significantly lower on depressive symptoms compared with community adolescents. Depressive symptoms in the total patient sample were stable over time and were unrelated to disease complexity. Based on conventional cut-off scores of the CES-D, substantial individual differences existed in the extent to which depressive symptoms persisted over time: 12.2% of the patients reported elevated depressive symptoms at minimally three out of the four time points. Especially physical functioning, cardiac symptoms, and patient-reported health at T4 were predicted by persistent depressive symptoms, even when controlling for the level of depressive symptoms at T4. Our findings indicate that those involved in the care of adolescents with CHD should remain vigilant to persistent depressive symptoms and arrange timely referral to mental healthcare services.

Mūsdienu latviešu terminu vārdnīcas: izdevēju pieredze

2020 ◽  
pp. 379-389
Author(s):  
Elīna Peina
Keyword(s):  
Significant Source ◽  
Scientific Quality ◽  
Marketing Policy ◽  
Publishing Houses ◽  
Publishing Practice ◽  
Insight Into ◽  
Over Time

Unified and precise terminology in any field of specialization ensures the scientific quality of the text. Dictionaries should be considered a particularly significant source of terminology due to having authority criterion. The present research examines 450 Latvian terminological dictionaries that have been published between 1990 and 2020. The article intends to highlight the path of Latvian terminography by giving insight into publishing practice; for this article, three publishing houses have been selected – Zinātne, Avots, Zvaigzne ABC. The interview of three editors provides an insight into several questions that have emerged over time, during the study of terminological dictionaries. The article’s main goal is to reveal several practical aspects of publishing terminological dictionaries in Latvia – marketing policy of dictionary publishing, lack of dictionary users’ feedback and review deficiency, the relevance of officially approved terminological dictionaries, etc. The conclusion of the research is that regularly issued official terminological dictionaries and updated terminological databases should provide a milestone for fields’ specialists and other dictionary users. It would greatly facilitate the work of translators and specialists in the field and reduce the publishing of low-quality resources.

Quality of Clinical Trials — A Concern of Three Decades

1982 ◽  
Vol 21 (02) ◽  
pp. 81-85 ◽  
Author(s):  
Elina Hemminki
Keyword(s):  
Clinical Trials ◽  
The Other ◽  
Controlled Trials ◽  
Change Over Time ◽  
Over Time

The purpose of this article is to summarize reviews on the quality of clinical trials. Altogether 29 reviews were found. Most clinical trials were judged to be uncontrolled or poorly controlled and/or otherwise poor. To study any change over time, reviews based on reports published 1943—1959, 1960—67, and 1968—77 were considered. The proportion of controlled trials was higher in 1943—59 than in 1968—77. The proportion of trials defined as »good« was lowest in the period 1960—1967. Since the material and definitions varied from one review to the other, the results should be interpreted to reflect the reviewers’ concern about quality rather than the actual quality of the trials themselves. In fact, in most reviews, in which the criteria and material used over time were comparable, the quality of trials had improved. But various factors guarantee that worries about the quality of clinical trials will continue.

scholarly journals A longitudinal evaluation of the impact of the COVID-19 pandemic on patients with pre-existing anxiety disorders

2021 ◽  
pp. 1-21
Author(s):  
K Hennigan ◽  
M McGovern ◽  
R Plunkett ◽  
S Costello ◽  
C McDonald ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Anxiety Disorders ◽  
Social Isolation ◽  
Social Impact ◽  
Rating Scales ◽  
Structured Interviews ◽  
Time Points ◽  
The Impact ◽  
Over Time

Abstract Objectives: To examine if the Covid-19 pandemic is associated with a differential effect over time in relation to its’ psychological and social impact on patients with established anxiety disorders. Methods: Semi-structured interviews were conducted with 24 individuals attending the Galway-Roscommon Mental Health Services with an ICD-10 diagnosis of an anxiety disorder at two-time points (six-months apart) to determine the impact of the Covid-19 restrictions on anxiety and depressive symptoms, social and occupational functioning and quality of life. Results: No statistical difference in symptomatology was noted between the two time points in relation to anxiety symptoms as measured utilising psychometric rating scales (BAI, HARS) or utilising a Likert Scale. The greatest impact of COVID-19 at both time points related to social functioning and quality of life. Significant variability was noted for individual participants. Qualitative analysis noted social isolation, concern for the participants’ future and increased difficulty managing anxiety with ongoing restrictions. Conclusions: No significant overall change in symptomatology or functioning over time was noted for individuals with pre-existing anxiety disorders. Variability was however demonstrated between individuals, with some individuals describing ongoing anxiety, social isolation and concern for their future. Identifying those with ongoing symptoms or distress and providing multidisciplinary support to this cohort is suggested.

scholarly journals Assessing Health-Related Quality of Life in Patients with Migraine

2002 ◽  
Vol 29 (S2) ◽  
pp. S16-S22 ◽  
Author(s):  
W.J. Becker
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Current Status ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Changes Over Time ◽  
Over Time

Background:The place of health-related quality of life (HRQoL) instruments in clinical research trials and clinical practice as compared to more traditional clinical outcome measures such as headache intensity and frequency is unclear.Objectives:To review the current status of HRQoL measurement in migraine.Methods:A literature search was done for HRQoL and migraine. Selected articles dealing with migraine and commonly used HRQoL instruments and HRQoL measures used in recent clinical trials were reviewed.Results:Several general and migraine specific HRQoLinstruments can detect changes over time in response to at least major changes in migraine therapy. Both also show a correlation with clinical headache features. However, their sensitivity to detect clinically significant changes over time is not clear.Conclusion:The SF-36, a general HRQoLmeasure and several migraine-specific HRQoL instruments are useful endpoints for migraine clinical trials. Their role in clinical practice is yet to be established.

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