scholarly journals Use of In-Game Rewards to Motivate Daily Self-Report Compliance: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Sara Taylor ◽  
Craig Ferguson ◽  
Fengjiao Peng ◽  
Magdalena Schoeneich ◽  
Rosalind W Picard
Keyword(s):  
Controlled Trial ◽  
Daily Diary ◽  
Self Report ◽  
Completion Rates ◽  
Daily Diaries ◽  
Disease Symptoms ◽  
System Usability Scale ◽  
Significant Difference ◽  
Patient Reported ◽  
Reported Data

BACKGROUND Encouraging individuals to report daily information such as unpleasant disease symptoms, daily activities and behaviors, or aspects of their physical and emotional state is difficult but necessary for many studies and clinical trials that rely on patient-reported data as primary outcomes. Use of paper diaries is the traditional method of completing daily diaries, but digital surveys are becoming the new standard because of their increased compliance; however, they still fall short of desired compliance levels. OBJECTIVE Mobile games using in-game rewards offer the opportunity to increase compliance above the rates of digital diaries and paper diaries. We conducted a 5-week randomized control trial to compare the completion rates of a daily diary across 3 conditions: a paper-based participant-reported outcome diary (Paper PRO), an electronic-based participant-reported outcome diary (ePRO), and a novel ePRO diary with in-game rewards (Game-Motivated ePRO). METHODS We developed a novel mobile game that is a combination of the idle and pet collection genres to reward individuals who complete a daily diary with an in-game reward. Overall, 197 individuals aged 6 to 24 years (male: 100 and female: 97) were enrolled in a 5-week study after being randomized into 1 of the 3 methods of daily diary completion. Moreover, 157 participants (male: 84 and female: 69) completed at least one diary and were subsequently included in analysis of compliance rates. RESULTS We observed a significant difference (F2,124=6.341; P=.002) in compliance to filling out daily diaries, with the Game-Motivated ePRO group having the highest compliance (mean completion 86.4%, SD 19.6%), followed by the ePRO group (mean completion 77.7%, SD 24.1%), and finally, the Paper PRO group (mean completion 70.6%, SD 23.4%). The Game-Motivated ePRO (P=.002) significantly improved compliance rates above the Paper PRO. In addition, the Game-Motivated ePRO resulted in higher compliance rates than the rates of ePRO alone (P=.09). Equally important, even though we observed significant differences in completion of daily diaries between groups, we did not observe any statistically significant differences in association between the responses to a daily mood question and study group, the average diary completion time (P=.52), or the System Usability Scale score (P=.88). CONCLUSIONS The Game-Motivated ePRO system encouraged individuals to complete the daily diaries above the compliance rates of the Paper PRO and ePRO without altering the participants’ responses. CLINICALTRIAL ClinicalTrials.gov NCT03738254; http://clinicaltrials.gov/ct2/show/NCT03738254 (Archived by WebCite at http://www.webcitation.org/74T1p8u52)

scholarly journals Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

2011 ◽  
Vol 29 (8) ◽  
pp. 1029-1035 ◽  
Author(s):  
Donna L. Berry ◽  
Brent A. Blumenstein ◽  
Barbara Halpenny ◽  
Seth Wolpin ◽  
Jesse R. Fann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Cancer Symptoms ◽  
Patient Reported ◽  
Life Issues ◽  
Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

scholarly journals Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241704
Author(s):  
Jennifer Wild ◽  
Shama El-Salahi ◽  
Michelle Degli Esposti ◽  
Graham R. Thew
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Report ◽  
Post Traumatic Stress ◽  
Emergency Responders ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

The Rationale for Collecting Patient-Reported Symptoms during Routine Chemotherapy

2014 ◽  
pp. 161-165 ◽  
Author(s):  
Ethan Basch
Keyword(s):  
Clinical Practice ◽  
Symptom Control ◽  
Data Interpretation ◽  
Data Representation ◽  
Routine Care ◽  
Self Report ◽  
Multiple Systems ◽  
Patient Reported ◽  
American Society ◽  
Reported Data

Patient-reported outcomes (PROs) such as symptoms and functional status are commonly measured in clinical trials. There is increasing interest to integrate PROs into routine clinical practice, for example during chemotherapy or postoperatively. There are several rationales for this. First, patient self-reporting improves patient-clinic communication, symptom detection, and symptom control. Second, patient-reported data may be used for quality assessment. Third, aggregated patient-reported data can be informative in comparative-effectiveness research (CER). Of particular interest is an approach that employs electronic collection of PROs with interfaces to the electronic health record (EHR) and clinician alerts for concerning symptoms. Multiple systems have been developed in oncology with these characteristics. Barriers to implementation exist, such as cost, logistics, EHR interfacing, data representation, and data interpretation, but have been largely overcome. Missing data remain a concern, but backup data collection strategies can bring self-report compliance rates up to about 85% in unselected routine care patients with advanced cancers. Overall, including patient self-reporting in routine care enhances quality of care and patient satisfaction, and is expected to become more common in the future. American Society for Clinical Oncology (ASCO) has several ongoing initiatives to develop standards and clinical practice tools in this area.

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

scholarly journals The effectiveness of game-based meditation therapy for traumatized adolescents in residential care: a randomized controlled trial (PREPRINT)

2021 ◽  
Author(s):  
Angela Schuurmans ◽  
Karin Nijhof ◽  
Arne Popma ◽  
Ron Scholte ◽  
Roy Otten
Keyword(s):  
Posttraumatic Stress ◽  
Residential Care ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Treatment As Usual ◽  
Posttraumatic Symptoms ◽  
Significant Difference ◽  
Evidence Based Treatments ◽  
Anxiety Depression

Aim: Many adolescents in residential care have experienced traumatic events and suffer from posttraumatic stress. This study examined the effectiveness of Muse, a game-based meditation intervention, as an addition to treatment as usual (TAU) for traumatized adolescents in residential care.Methods: Seventy-seven traumatized adolescents (10 – 18 years old) received either Muse and TAU (n = 37) or treatment as usual alone (n = 40). TAU consisted of evidence-based treatments that did not specifically target posttraumatic symptoms. Outcomes were measured at T1, T2, and two-months follow-up (FU). Primary outcomes were posttraumatic symptoms (self-report and mentor-report) and stress (self-report) at T2. Secondary outcomes included anxiety, depression, and aggression at T2, and all outcomes at follow-up.Results: The Muse group showed significantly greater improvements than the control group at T2 regarding self-reported posttraumatic symptoms, stress, anxiety, depression, and aggression. Mentor reports showed marginally significant decreases in posttraumatic stress at T2. There were no differences between the groups at FU, except for a marginally significant difference in self-reported posttraumatic symptoms, where the Muse participants showed larger decreases.Conclusions: Game-based meditation therapy is a promising intervention that is more effective than treatment as usual alone. Implications of these findings for the role of game-based meditation interventions for traumatized adolescents in residential care are discussed.

Changes in patient-reported outcomes in women with breast cancer in a multicenter double-blind randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor-induced musculoskeletal symptoms (AIMSS).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9103-9103
Author(s):  
Ting Bao ◽  
Kelly Betts ◽  
Karineh Tarpinian ◽  
Ling Cai ◽  
Jeff Gould ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Depression Scale ◽  
Sham Acupuncture ◽  
Menopausal Symptoms ◽  
Musculoskeletal Symptoms ◽  
Double Blind ◽  
Hot Flash ◽  
Significant Difference ◽  
Patient Reported

9103 Background: Aromatase Inhibitors (AIs) have been associated with worsening of patient related outcomes (PROs) such as AIMSS, menopausal symptoms and depression. Acupuncture has been reported to alleviate such symptoms. We hypothesized that real acupuncture (RA) would improve PROs more than sham acupuncture (SA). Methods: We collected PROs at baseline, 4, 8, and 12 weeks (wks), from women enrolled in a multi-center double blind RCT designed to assess the effect of acupuncture in reducing PROs. Patients were randomized to 8 wkly RA or SA. PROs were measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression Scale (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQoL survey. We measured estrogen and cytokines concentrations at baseline and wk 8. We used Wilcoxon rank sum and signed-rank tests to make comparisons between and within group, respectively. Results: We included 23 patients from RA and 24 from SA arms in the intent-to-treat analysis. We have previously reported no significant difference in reduction of AIMSS between two arms. RA caused reduction of CESD scores compared to SA (median: -2 vs 0, p = 0.057). When compared to baseline, there were statistically significant improvements at wk 8 in hot flash severity score (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022) scores in RA arm; for EuroQoL (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005) scores in SA arm. The majority of patients’ estradiol concentrations were undetectable at baseline and wk 8. Changes in other time points, data and analysis of cytokines changes will be presented at the meeting. Conclusions: Real and sham acupuncture were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference in the change of PROs between real and sham acupuncture, except for CESD.

Abstract 15892: Symptom Diary Use Improves Outcomes for Heart Failure Patients

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Linda G Park ◽  
Kathleen Dracup ◽  
Mary A Whooley ◽  
Michele M Pelter ◽  
Debra K Moser ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cox Regression ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Analysis ◽  
Daily Diary ◽  
Daily Diaries ◽  
Cox Regression Analysis ◽  
Cardiac Symptoms ◽  
Phone Calls

Introduction: Attention to symptoms of weight gain and dyspnea are central tenets in heart failure (HF) patient education. Daily diary use can be one method for HF patients to acknowledge and attend to their symptoms. However, it is not known whether diary use improves patient outcomes. We aimed to compare mortality among rural HF patients who did versus did not complete a daily diary of weight and symptom self-assessment. Methods: This study was a secondary analysis of a 3-arm randomized controlled trial with two intervention groups (Fluid Watchers LITE and PLUS) and usual care. The two intervention groups were given daily diaries for 2 years to track daily weight, HF symptoms, and response to symptom changes. Intervention group patients received self-care education and a script to call their health care provider, but the 2 groups varied on the number of follow-up phone calls received. Patient groups were categorized by duration of adherence to diary use: None, Low (1-3 months), Medium (4-12 months), and High (13-24 months). Cox regression analysis assessed survival from cardiac and non-cardiac death for 2 years while controlling for age and depression. Results: The mean age was 66 ± 13, 58% (n=227) were male, and 67% (264/393) completed diaries with no difference in diary use between the 2 intervention groups. As compared with the 129 patients with no diary use, the 117 patients with High diary use had fewer non-cardiac (p=0.001) and cardiac (p=0.01) deaths; the 89 patients with Medium diary use had fewer non-cardiac deaths (p=0.007) but similar cardiac deaths (p=0.79). Conclusions: This is the largest trial to examine daily diary use in HF patients over 2 years. Improved non-cardiac survival was associated with at least 4 months of diary use, while cardiac survival was associated with at least 12 months of diary use. It is unclear why non-cardiac survival improved, but it is speculated that attention to cardiac symptoms may have increased attention to non-cardiac symptoms.

scholarly journals Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate

2019 ◽  
Vol 78 (5) ◽  
pp. 610-616 ◽  
Author(s):  
Leonieke J J van Mens ◽  
Henriëtte M de Jong ◽  
Inka Fluri ◽  
Michael T Nurmohamed ◽  
Marleen G H van de Sande ◽  
...  
Keyword(s):  
Adverse Event ◽  
Psoriatic Arthritis ◽  
Controlled Trial ◽  
Early Initiation ◽  
Controlled Study ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Double Blind ◽  
Significant Difference ◽  
Patient Reported

ObjectivesEarly initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA.MethodsThis investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study.ResultsThe primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms.ConclusionsIn patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission.Trial registration numberNCT01871649.

scholarly journals Evaluating the Quality of Supportive Oncology Using Patient-Reported Data

2014 ◽  
Vol 10 (4) ◽  
pp. e223-e230 ◽  
Author(s):  
Sydney M. Dy ◽  
Anne M. Walling ◽  
Jennifer W. Mack ◽  
Jennifer L. Malin ◽  
Philip Pantoja ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Medical Record ◽  
Self Report ◽  
Medical Record Data ◽  
Patient Reported ◽  
Record Data ◽  
Supportive Oncology ◽  
Reported Data

Quality of care for symptoms measured using patient self-report was higher than when including medical record data.

scholarly journals An App With Brief Behavioural Support to Promote Physical Activity After a Cancer Diagnosis (APPROACH): Study Protocol for a Pilot Randomised Controlled Trial

2021 ◽  
Author(s):  
Phillippa Lally ◽  
Natalie Miller ◽  
Anna Roberts ◽  
Rebecca J Beeken ◽  
Diana M Greenfield ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Cancer Diagnosis ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Self Report ◽  
Brisk Walking ◽  
Behavioural Support ◽  
Patient Reported ◽  
Randomised Controlled

Abstract BackgroundThere are multiple health benefits from participating in physical activity after a cancer diagnosis, but many people living with and beyond cancer (LWBC) are not meeting physical activity guidelines. App-based interventions offer a promising platform for intervention delivery. This trial aims to pilot a theory-driven, app-based intervention that promotes brisk walking among people living with and beyond cancer. The primary aim is to investigate the feasibility and acceptability of study procedures before conducting a larger randomised controlled trial (RCT).MethodsThis is an individually randomised, two-armed pilot RCT. Patients with localised or metastatic breast, prostate or colorectal cancer, who are aged 16 years or over, will be recruited from a single hospital site in South Yorkshire in the UK. The intervention includes an app designed to encourage brisk walking (Active 10) supplemented with habit-based behavioural support in the form of two brief telephone/video calls, an information leaflet and walking planners. The primary outcomes will be feasibility and acceptability of the study procedures. Demographic and medical characteristics will be collected at baseline, through self-report and hospital records. Secondary outcomes for the pilot (assessed at 0 and 3 months) will be accelerometer measured and self-reported physical activity, body mass index (BMI) and waist circumference, and patient reported outcomes of quality of life, fatigue, sleep, anxiety, depression, self-efficacy, and habit strength for walking. Qualitative interviews will explore experiences of participating or reasons for declining to participate. Parameters for the intended primary outcome measure (accelerometer measured average daily minutes of brisk walking (>100 steps/minute)) will inform a sample size calculation for the future RCT and a preliminary economic evaluation will be conducted. DiscussionThis pilot study will inform the design of a larger RCT to investigate the efficacy and cost-effectiveness of this intervention in people LWBC. Trial registrationISRCTN registry, ISRCTN18063498. Registered 16 April 2021. http://isrctn.com/ISRCTN18063498

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