scholarly journals Validation of a Digital Support App to Assess Inflammatory Disease Activity and Mental Health Patient-Reported Outcomes (PROs): A Pilot Investigation

2019 ◽  
Vol 2019 ◽  
pp. 1-9
Author(s):  
Kelly E. Tow ◽  
Claudia Rogge ◽  
Thomas Lee ◽  
Peter Caputi ◽  
Simon R. Knowles

Background. Real-time collection of mental health and disease activity patient-reported outcomes (PROs) are essential to assist clinicians in delivering optimal holistic health care. The aim of this pilot study was to validate a digital support tool (DST) delivered via a tablet device in an outpatient setting to assess IBD activity and psychological distress.Methods. 48 individuals (26 females; average age: 40.04) with IBD completed the DST and a paper-based survey in a hospital IBD outpatient setting. PROs for disease activity and psychological distress (Kessler K10) were compared to paper-based gold-standard measures of disease activity (Partial Mayo Index or Harvey Bradshaw Index completed by the clinician) and psychological distress (Depression Anxiety Stress Scale; completed by the patient). Patient feedback regarding usability and acceptance of the DST was also collected.Results. DST patient-derived disease activity scores were significantly correlated with clinician assessment of disease activity (p<0.01). Patient DST-derived psychological well-being scores were also significantly correlated with the gold-standard measure of psychological distress (p<0.05). Patients found the DST to be easy to use and identified a willingness to follow through with the recommendations provided by the DST in relation to their psychological distress scores.Conclusions. The pilot study demonstrates the value in collecting disease activity and psychological distress PROs via a DST in an outpatient setting. Disease activity and psychological distress PROs were found to correlate significantly with gold standard measures. The findings provide preliminary support for the value of embedding digital technology into clinical care to promote patient engagement and optimal holistic healthcare.

Lupus ◽  
2020 ◽  
Vol 29 (13) ◽  
pp. 1781-1789
Author(s):  
Suhas K Ganguli ◽  
Joyce S Hui-Yuen ◽  
Meenakshi Jolly ◽  
Jane Cerise ◽  
Barbara Anne Eberhard

Objective To evaluate the reliability, validity, feasibility and psychometric performance of the Lupus Impact Tracker (LIT) as a patient reported outcome (PRO) measure tool in pediatric systemic lupus erythematosus (pSLE). Methods This is a prospective, observational, pilot study where patients aged between 12 and 25 years, fulfilling the 1997 ACR classification criteria for SLE, were enrolled. Over 3 consecutive, routine, clinical visits, the patients completed the LIT alongside the Patient-Reported Outcomes Measurement Information System-Short Forms (PROMIS-SFs), Childhood Health Assessment Questionnaire (CHAQ). Rheumatologists completed the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC-ACR) Damage Index. Demographic, clinical and laboratory data were also collected. Results Of 46 patients enrolled, 38 patients completed 2 visits and 31 completed all 3 visits. Seventy-eight percent were female, 33% African American, 28% Asian, 15% Caucasian and 17% Hispanic. The mean (SD) age was 17.2 (2.7) years, with a mean (SD) disease duration of 4.6 (3.1) years. The mean (SD) SLEDAI-2K at enrollment was 3.54 (2.96). In the 38 patients who completed two or more visits, intra-class correlation coefficient and Cronbach alpha were calculated to be 0.70 and 0.91 respectively, signifying good reliability of LIT. The LIT showed positive correlation with CHAQ-Disability Index and majority of the PROMIS-SFs parameters. Construct validity was established against clinical disease activity (SLEDAI-2K). Conclusion The preliminary results indicate that the LIT is a reliable and valid instrument to capture PRO in p-SLE. Prospective validation with a larger, multicenter cohort is the next step.


BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021859
Author(s):  
Ilana N Ackerman ◽  
Richard S Page ◽  
Kathy Fotis ◽  
Peter Schoch ◽  
Nigel Broughton ◽  
...  

IntroductionPersistent musculoskeletal conditions can impact profoundly on younger people’s quality of life, psychological distress and capacity to work, as shown by previous research involving younger people with osteoarthritis. The personal impacts, in particular, work and parenting impacts, of other musculoskeletal conditions (such as persistent shoulder pain) on younger patient groups remain poorly understood. Furthermore, the personal financial burden associated with managing musculoskeletal conditions is rarely documented. This study aims to investigate well-being, work participation and productivity, shoulder-related parenting disability and out-of-pocket healthcare expenditure among younger people with shoulder pain and evaluate changes over 12 months.Methods and analysisOne hundred and fifty people aged 20–55 years with shoulder pain of more than 6 weeks’ duration (excluding those with recent history of fracture or dislocation) will be recruited for this cohort study. Participants will be recruited from three major public hospitals in Victoria, Australia, following screening of orthopaedic outpatient clinics lists and referrals. Participants will be asked to complete a baseline questionnaire and 2-week healthcare costs diary, with follow-up data collected at 12 months. Patient-reported outcomes will be collected, including health-related quality of life (HRQoL), shoulder pain and function, psychological distress, shoulder-related parenting disability and work productivity. Information on sociodemographics, employment, health services utilisation and shoulder-related healthcare expenditure will also be collected. Descriptive analysis of baseline data will provide a comprehensive snapshot of the personal burden of shoulder pain. Baseline HRQoL and psychological distress data will be compared with Australian population norms to provide context around well-being. Associations between sociodemographic factors and patient-reported outcomes will be evaluated using univariate and multivariate analyses. Changes in patient-reported outcomes from baseline to 12 months will be analysed using paired t-tests.Ethics and disseminationEthics approval has been obtained. The study findings will be submitted to peer-reviewed journals and presented at relevant scientific meetings.


RMD Open ◽  
2018 ◽  
Vol 4 (1) ◽  
pp. e000676 ◽  
Author(s):  
Katie Bechman ◽  
Fang En Sin ◽  
Fowzia Ibrahim ◽  
Sam Norton ◽  
Faith Matcham ◽  
...  

BackgroundTapering of anti-tumour necrosis factor (TNF) therapy appears feasible, safe and effective in selected patients with rheumatoid arthritis (RA). Depression is highly prevalent in RA and may impact on flare incidence through various mechanisms. This study aims to investigate if psychological states predict flare in patients’ dose tapering their anti-TNF therapy.MethodsThis study is a post-hoc analysis of the Optimizing TNF Tapering in RA trial, a multicentre, randomised, open-label study investigating anti-TNF tapering in RA patients with sustained low disease activity. Patient-reported outcomes (Health Assessment Questionnaire, EuroQol 5-dimension scale, Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F), 36-Item Short Form Survey (SF-36)) were collected at baseline. The primary outcome was flare, defined as an increase in 28-joint count Disease Activity Score (DAS28) ≥0.6 and ≥1 swollen joint. Discrete-time survival models were used to identify patient-reported outcomes that predict flare.ResultsNinety-seven patients were randomised to taper their anti-TNF dose by either 33% or 66%. Forty-one patients flared. Higher baseline DAS28 score was associated with flare (adjusted HR 1.96 (95% CI 1.18 to 3.24), p=0.01). Disability (SF-36 physical component score), fatigue (FACIT-F) and mental health (SF-36 mental health subscale (MH)) predicted flare in unadjusted models. In multivariate analyses, only SF-36 MH remained a statistically significant predictor of flare (adjusted HR per 10 units 0.74 (95% CI 0.60 to 0.93), p=0.01).ConclusionsBaseline DAS28 and mental health status are independently associated with flare in patients who taper their anti-TNF therapy. Fatigue and function also associate with flare but the effect disappears when adjusting for confounders. Given these findings, mental health and functional status should be considered in anti-TNF tapering decisions in order to optimise the likelihood of success.Trial registration numbersEudraCT Number: 2010-020738-24; ISRCTN28955701; Post-results.


2010 ◽  
Vol 30 (3) ◽  
pp. 148-149 ◽  
Author(s):  
J. Caron ◽  
A. Liu

Objective This descriptive study compares rates of high psychological distress and mental disorders between low-income and non-low-income populations in Canada. Methods Data were collected through the Canadian Community Health Survey – Mental Health and Well-being (CCHS 1.2), which surveyed 36 984 Canadians aged 15 or over; 17.9% (n = 6620) was classified within the low-income population using the Low Income Measure. The K-10 was used to measure psychological distress and the CIDI for assessing mental disorders. Results One out of 5 Canadians reported high psychological distress, and 1 out of 10 reported at least one of the five mental disorders surveyed or substance abuse. Women, single, separated or divorced respondents, non-immigrants and Aboriginal Canadians were more likely to report suffering from psychological distress or from mental disorders and substance abuse. Rates of reported psychological distress and of mental disorders and substance abuse were much higher in low-income populations, and these differences were statistically consistent in most of the sociodemographic strata. Conclusion This study helps determine the vulnerable groups in mental health for which prevention and promotion programs could be designed.


2019 ◽  
Vol 31 (2) ◽  
pp. 222-228 ◽  
Author(s):  
Joshua L. Golubovsky ◽  
Arbaz Momin ◽  
Nicolas R. Thompson ◽  
Michael P. Steinmetz

OBJECTIVEBertolotti syndrome is a rare spinal condition that causes low-back pain due to a lumbosacral transitional vertebra (LSTV), which is a pseudoarticulation between the fifth lumbar transverse process and the sacral ala. Bertolotti syndrome patients are rarely studied, particularly with regard to their quality of life. This study aimed to examine the quality of life and prior treatments in patients with Bertolotti syndrome at first presentation to the authors’ center in comparison with those with lumbosacral radiculopathy.METHODSThis study was a retrospective cohort analysis of patients with Bertolotti syndrome and lumbosacral radiculopathy due to disc herniation seen at the authors’ institution’s spine center from 2005 through 2018. Diagnoses were confirmed with provider notes and imaging. Variables collected included demographics, diagnostic history, prior treatment, patient-reported quality of life metrics, and whether or not they underwent surgery at the authors’ institution. Propensity score matching by age and sex was used to match lumbosacral radiculopathy patients to Bertolotti syndrome patients. Group comparisons were made using t-tests, Fisher’s exact test, Mann-Whitney U-tests, Cox proportional hazards models, and linear regression models where variables found to be different at the univariate level were included as covariates.RESULTSThe final cohort included 22 patients with Bertolotti syndrome who had patient-reported outcomes data available and 46 propensity score–matched patients who had confirmed radiculopathy due to disc herniation. The authors found that Bertolotti syndrome patients had significantly more prior epidural steroid injections (ESIs) and a longer time from symptom onset to their first visit. Univariate analysis showed that Bertolotti syndrome patients had significantly worse Patient-Reported Outcomes Measurement Information System (PROMIS) mental health T-scores. Adjustment for prior ESIs and time from symptom onset revealed that Bertolotti syndrome patients also had significantly worse PROMIS physical health T-scores. Time to surgery and other quality of life metrics did not differ between groups.CONCLUSIONSPatients with Bertolotti syndrome undergo significantly longer workup and more ESIs and have worse physical and mental health scores than age- and sex-matched patients with lumbosacral radiculopathy. However, both groups of patients had mild depression and clinically meaningful reduction in their quality of life according to all instruments. This study shows that Bertolotti syndrome patients have a condition that affects them potentially more significantly than those with lumbosacral radiculopathy, and increased attention should be paid to these patients to improve their workup, diagnosis, and treatment.


2020 ◽  
Vol 6 (1) ◽  
pp. e000965
Author(s):  
Natalie A Lowenstein ◽  
Peter J Ostergaard ◽  
Daniel B Haber ◽  
Kirsten D Garvey ◽  
Elizabeth G Matzkin

ObjectivesRisk factors for anterior shoulder dislocation include young age, contact activities and male sex. The influence of sex on patient-reported outcomes of arthroscopic Bankart repair (ABR) is unclear, with few studies reporting potential differences. This study’s purpose was to compare patient-reported outcomes of males and females following ABR.MethodsProspectively collected data was analysed for 281 patients (males: 206, females: 75) after ABR with preoperative, 1-year and 2-year follow-up responses. The Wilcoxon signed-rank and χ2 tests, preoperative, 1 year and 2 year follow-up results were examined to determine differences of scores in males versus females.ResultsNo statistically significant sex differences were observed in Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES), Visual Analogue Scale (VAS) or Single Assessment Numerical Evaluation (SANE) Scores at 1-year or 2-year follow-up. Females had lower Veterans RAND 12-item health survey (VR-12) mental health subscores at 2-year follow-up (females: 52.3±9.0, males: 55.8±7.6, p=0.0016). Females were more likely to report that treatment had ‘exceeded expectations’ at 2-year follow-up regarding motion, strength, function and normal sports activities.ConclusionResults of study demonstrate that ABR has similar outcomes for both males and females. There were no statistically significant sex-related differences in SST, ASES, VAS or SANE scores following ABR. VR-12 mental health subscores showed a minimal difference at 2-year follow-up, with lower scores in females.Level of evidenceRetrospective cohort study; level II.


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