Differences In Change Scores Research Articles

From Office-Based Treatment to Telehealth: Comparing Clinical Outcomes and Patient Participation in a Psychiatric Intensive Outpatient Program with a Large Transdiagnostic Sample.

Introduction: Patient participation and clinical outcomes of a precoronavirus disease 2019 (COVID-19) office-based transdiagnostic psychiatric intensive outpatient program (IOP) were compared with those of telehealth IOP during COVID-19. Materials and Methods: Weeks of enrollment, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) assessments, and sociodemographic and clinical factors (including group track and diagnosis) were collected during pre-COVID-19 (n = 191) and during COVID-19 (n = 200). Continuous and categorical measures of GAD-7 and PHQ-9 were analyzed; potential sociodemographic and clinical covariates to scores were also explored. Results: There were no statistically significant differences in participation between time periods. Associations were observed between PHQ-9/GAD-7 score improvement and number of assessments. Significant score reductions occurred in both periods, and differences in change scores were not significant. Sociodemographic and clinical factors were not significantly different between time periods. Patients with commercial insurance had significantly higher improvement in both mean and categorical PHQ-9 scores (t = 2.77, p = 0.006; χ2 = 10.47, df = 1, p = 0.001) and GAD-7 scores (t = 2.29, p = 0.023; χ2 = 8.58, df = 1, p = 0.003) than those with public insurance. Patients with anxiety disorders had significantly greater improvements (F = 4.49, p = 0.004; χ2 = 9.15, df = 3, p = 0.027) in GAD-7 during COVID-19. Discussion: Significant improvements in PHQ-9/GAD-7 scores and measures of participation were not significantly different between telehealth and office-based IOP, nor were they greatly influenced by clinical or sociodemographic factors. Further study is needed of possible care disparities for publicly insured patients. Conclusion: Despite some limitations, telehealth IOP appears to be a clinically appropriate option for a diverse sociodemographic and diagnostically heterogeneous psychiatric population.

Effect of Care Coordination Using an Allied Health Liaison Officer for Chronic Noncomplex Medical Conditions in Children

There is a paucity of high-quality evidence on the effect of care coordination on health-related quality of life among children with chronic noncomplex medical conditions (non-CMCs). To examine whether care coordination delivered by an Allied Health Liaison Officer results in improved quality-of-life (QOL) outcomes for children with chronic non-CMCs and their families. This multicenter, open label, randomized clinical trial was conducted in pediatric outpatient clinics at 3 Australian hospitals with tertiary- and secondary-level pediatric care facilities. A total of 81 children with chronic non-CMCs and their families participated in the trial for a period of up to 12 months between October 2017 to October 2020. Primary care reviews were offered at 1 week, 3 months, and 6 months after diagnosis. Eligible children were randomized 1:1 to receive care coordination or standard care. Families of children receiving care coordination were provided access to an Allied Health Liaison Officer, who was responsible for facilitation of health care access across hospital, education, primary care, and community sectors. The primary outcomes were scores on the Pediatric Quality of Life Inventory (PedsQL), version 4.0, and the PedsQL Family Impact Module, version 2.0, measured at 6 and 12 months. An intent-to-treat approach was used to analyze the data. Of 81 children (mean [SD] age, 8.2 [3.5] years; 55 [67.9%] male), 42 (51.9%) were randomized to care coordination and 39 (48.1%) to standard care. Compared with standard care, care coordination resulted in greater improvements in overall PedsQL scores (difference in score changes between groups, 7.10; 95% CI, 0.44-13.76; P = .04), overall PedsQL Family Impact Module scores (difference in score changes between groups, 8.62; 95% CI, 1.07-16.16; P = .03), and family functioning QOL (difference in score changes between groups, 15.83; 95% CI, 5.05-26.62; P = .004) at 12 months after diagnosis. In this randomized clinical trial, care coordination improved the quality of life of children with chronic non-CMCs and their families. Further studies should explore specific non-CMCs that may benefit most from care coordination and whether an orientation among health services to provide such a coordination model could lead to longer-term improved clinical outcomes. http://anzctr.org.au Identifier: ACTRN12617001188325.

Effects of Iron Supplementation on Attention Deficit Hyperactivity Disorder in Children Treated with Methylphenidate.

ObjectiveTo evaluate the effect of iron on the attention deficit hyperactivity disorder, treated with methylphenidate.MethodsThis double-blind, randomized placebo-controlled clinical trial was performed on 50 children with attention deficit hyperactivity disorder under the treatment of methylphenidate, with ferritin levels below 30 ng/ml and absence of anemia. They were randomly assigned into two groups of ferrous sulfate and placebo, for 12 weeks. Conners' Parent Rating Scale (CPRS) was used to assess the outcome in the first, sixth, and twelfth weeks.ResultsAlmost all CPRS subscales improved in the ferrous sulfate group from the baseline to the endpoint, although only the changes in conduct subscale scores were significant (p = 0.003). There was no significant difference in score changes between two groups in intergroup comparison. Also, the score of learning problems (p = 0.007) in the first six weeks, and conduct (p = 0.023) and psychosomatic (p = 0.018) subscales in the second six weeks were improved in the ferrous sulfate group compared with the placebo group.ConclusionOur study showed promising effects of iron supplementation in the improvement of subscales of the CPRS.

Abstract 10320: Feasibility of the Telehealth Assessment and Skill-Building Kit for Stroke Family Caregivers

Introduction: Existing stroke family caregiver interventions are limited in the use of technology and lack focus on caregiver health. The Telehealth Assessment and Skill-Building Kit (TASK III) was optimized based on caregiver preferences for technology and goal setting to improve caregiver health. The purpose of this study was to test feasibility of the TASK III program compared with an Information, Support, and Referral group (ISR) for improving caregiver depressive symptoms, life changes, and unhealthy days. Methods: Using randomized control trial design and an intent-to-treat analysis, 74 stroke family caregivers were randomized to TASK III (n=36) or ISR (n=38). The TASK III Resource Guide was provided by hard copy, website, eBook, and USB drive. TASK III and ISR groups received an American Stroke Association (ASA) pamphlet, access to the ASA website, and 8 weekly calls from a nurse (telephone/videoconferencing), with a booster call a month later. Data trends from baseline to 8 and 12 weeks were explored for depressive symptoms (PHQ-9), life changes (Bakas Caregiving Outcomes Scale), and unhealthy days. Minutes on calls with the nurse were controlled in analyses. Results: Among caregivers with mild to severe depressive symptoms at baseline (PHQ-9 > 5) (n=31), TASK III showed a greater reduction in depressive symptoms relative to ISR from baseline to 8 and 12 weeks (Mean group difference in change scores -3.7, p=.02 at 8 weeks; -3.7, p=.04 at 12 weeks). Using the full sample (N=74), life changes improved for TASK III relative to ISR from baseline to 8 and 12 weeks (Mean 8.1, p=.03; 14.9, p<.01), and for specific life changes of emotional well-being (Mean 0.8, p=.05; 1.4, p=.01) and physical health (0.7, p=.07; 1.2, p<.01). No significant differences in rate ratios were found for unhealthy physical (Rate ratio 1.7, p=.17; 1.1, p=.74) and mental days (Rate ratio 1.4 p=.22; 1.4, p=.25). Conclusions: Data trends supported feasibility of TASK III relative to ISR for improving depressive symptoms and life changes, including changes in emotional well-being and physical health. Unhealthy days were highly skewed and not sensitive to change. Testing efficacy of TASK III relative to ISR is warranted in a future, well-powered trial.

Educating Crisis Supporters About Self-Harm and Suicide in Older Adults

ObjectivesThis study aimed to describe existing knowledge of crisis supporters (volunteers responding to crisis calls/texts/messages) regarding self-harm and suicide in older adults and investigate knowledge translation through use of a novel online adaptive learning tool. MethodsThe online educational tool was tested in an Australian national sample of crisis supporters (trained volunteers) aged 18+. Knowledge Transfer was evaluated utilizing a pre/post intervention methodology for data collection. The collaboratively developed online educational tool comprised a pre-test (10 questions), middle learning module (individualised for participant's incorrect pre-test responses) and post-test (10 questions) on suicidal behaviours in older adults. Data analysed included the demographic characteristics of the participants, individual question scores, and summed pre- and post-tests scores. Group differences in change scores were assessed with either one-way between subjects ANOVA or independent samples t-test, depending on the number of groups within each variable. Pre-post education comparisons on individual change in scores were made using a paired samples t-test. Statistical significance was defined as p <0.05. Results104 crisis supporters completed the tool (pre-test, middle lesson and post-test). There was significant improvement in knowledge of crisis supporters after the intervention (pre-test scores Mean (M) = 4.56, SD = 1.62 and post-test scores M = 7.61, SD = 1.60; t (103) = 17.242, p <0.001.). ConclusionDedicated training about suicidal behaviors in older adults is needed given their high rates of suicide and differing underlying reasons and needs compared to younger adults.

The impact of resistance training on strength and correlates of physical activity in youth

ABSTRACT Resistance training (RT) may have a positive impact on specific correlates of physical activity (PA) in inactive and/or obese youth, with strength as a possible underlying mechanism. The aim of this study was to investigate this. Twelve participants (aged 8.9 ± 1.0 years) were assigned to an experimental group (EG) or control group (CG). Pre and post intervention assessments for strength, physical self-perceptions (PSPs), weight status, fundamental movement skills (FMS), and PA levels were completed. The EG participated in a twice-weekly 10-week RT programme. There were significant group x time interactions for FMS (CAMSA total P = 0.016, CAMSA skill score P = 0.036) and stretch stature (P = 0.002) (EG larges changes than the CG). Large effect sizes for the differences in change scores between the EG and CG were evident for CAMSA total score (Hedges’ g = 0.830, P = 0.138), CAMSA skill score (Hedges’ g = 0.895, P = 0.112) and relative strength (Hedges’ g = 0.825, P = 0.140). This study demonstrated that a 10-week RT intervention has a positive effect on strength and FMS, and may also benefit weight status and PSPs. This study supports the development of RT interventions to develop these correlates, and increase PA levels.

Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials

BackgroundThe aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer.MethodsWe used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians’ input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated.ResultsTwo clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and − 13 to − 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and − 10 to − 5 for deterioration.ConclusionsOur findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

PD23-07 WATER VS WATER II: THREE YEAR COMPARISON OF AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV (PD23)1 Sep 2021PD23-07 WATER VS WATER II: THREE YEAR COMPARISON OF AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA David-Dan Nguyen, Kevin C. Zorn, and Naeem Bhojani David-Dan NguyenDavid-Dan Nguyen More articles by this author , Kevin C. ZornKevin C. Zorn More articles by this author , and Naeem BhojaniNaeem Bhojani More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002016.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Surgical options are limited when treating large (>80cc) prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Open simple prostatectomy remains the most common procedure performed for large prostates. As such, there is a need for novel surgical approaches with shorter learning curves and effective treatment. Aquablation (AquaBeam System, PROCEPT BioRobotics, Inc., USA), an ultrasound-guided, robotically executed waterjet ablative procedure, could fill this gap. This analysis compares the 3-year outcomes of Aquablation in 30cc to 80cc prostates with the outcomes in 80cc to 150cc prostates. METHODS: WATER (NCT02505919) is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45 to 80 years old with a prostate between 30cc and 80cc. WATER II (NCT03123250) is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate between 80cc and 150cc. We compare 36-month outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation. Students’ t-test or Wilcoxon tests were used for continuous variables and Fisher’s test for binary variables. RESULTS: International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.4 at 36 months, with 36-month reductions of 14.4 and 16.7 points, respectively (p=.07 for difference in change scores). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 19.0 cc/sec, respectively (p=.70 for difference in change scores) at 36 months. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. Change in IPSS, Qmax, and post-void residual (PVR) can be found in Figure 1. CONCLUSIONS: Aquablation clinically normalizes outcomes between patients with a 30cc to 80cc prostate and patients with an 80cc to 150cc prostate treated for LUTS/BPH. It is effective in patients with large prostate glands (>80cc) with acceptable complications out to three years. Source of Funding: The WATER and WATER II clinical trials are funded by PROCEPT BioRobotics. This abstract is submitted on behalf of all WATER and WATER II investigators © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e422-e423 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information David-Dan Nguyen More articles by this author Kevin C. Zorn More articles by this author Naeem Bhojani More articles by this author Expand All Advertisement Loading ...

The short-term impact of remote instruction on achievement in children with ADHD during the COVID-19 pandemic.

There is nationwide concern that the abrupt transition to remote instruction in response to the Coronavirus disease (COVID-19) pandemic will have detrimental impacts on student learning. As a uniquely vulnerable group within schools, students with disabilities like attention deficit hyperactivity disorder (ADHD) may be at enhanced risk for these negative outcomes. The present study features a unique examination of achievement scores, collected for two Cohorts (2018-2019, 2019-2020) of students with ADHD. By collecting achievement data in both the fall and spring for each Cohort, direct comparisons between changes in achievement for Cohort One (2018-2019) can be made to those in Cohort Two (2019-2020). Analyses summarized remote learning practices, within-group changes in achievement data over time for Cohort Two, and between-group differences in score changes over time for Cohorts One and Two. Teachers used a variety of remote learning approaches, including videoconferencing and independently completed assignments. Student achievement scores in both Cohorts significantly improved from fall to spring. No significant differences were found in score growth between the Cohorts, indicating that the move to remote instruction did not have a differentially negative impact on Cohort Two. Implications focus on the promise of well-delivered remote instruction, and the need to examine individual factors (such as poor internet access) that may exacerbate the risk of students with disabilities receiving remote instruction. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Therapeutic Horticulture as a Therapeutic Intervention in Patients Receiving Electroconvulsive Therapy (ECT) Treatment for Major Depressive Disorder.

This study explored the effect of a structured therapeutic horticulture (TH) program on depression symptoms and quality of life indicators for individuals receiving inpatient electroconvulsive therapy (ECT) for major depressive disorders (MDD). Self-reported measures of depressive symptomatology (PHQ9, BDI-II) and quality of life (SF-36) were employed to compare intervention (n = 25) and control groups (n = 27), with the intervention group attending TH sessions for one-hour periods, twice per week, in addition to standard inpatient care associated with ECT received by both groups. All patients were assessed at admission, and after two weeks’ time or prior to discharge, during which the intervention group participated in a minimum of four TH sessions. Sessions were led by a horticultural therapist in an accessible on-campus greenhouse. Both groups improved significantly between assessment times one and two on both measures of depression, with a statistically significant difference in change scores for the BDI-II only, favoring the control over the intervention group (16.5, s.d. 12.78 versus 9.6, s.d. 10.15; p = 0.36). Both groups improved significantly on four of eight SF-36 subscales during the same period. A statistically significant difference in change scores was found for the Role Limitations-Physical Health (RLPH) subscale, where the intervention group improved between assessment periods, whereas the control group worsened (16.0, s.d.48.8 versus -9.3, s.d. 33.4; p = .033). Although quantifying group changes or improvement for individuals receiving intensive treatment for major depressive disorders (ECT) by the addition of an adjunct therapy is difficult, this study provides a basic premise for the consideration of various therapeutic horticulture settings to achieve therapeutic benefits through TH.

Key concepts in clinical epidemiology: Responsiveness, the longitudinal aspect of validity

ObjectivesResponsiveness is one of nine measurement properties that reflect the quality of outcome measurement instruments. MethodsIn this article, we explain that responsiveness is considered longitudinal validity, which refers to the degree to which an instrument is able to measure change in the construct to be measured. ResultsResponsiveness should be assessed in a longitudinal design, where hypotheses are tested about (1) the expected direction and magnitude of correlations between change scores on the instrument of interest and change scores of other instruments; (2) expected differences in change scores between different subgroups (i.e. known groups); or (3) the magnitude of the change in score that is expected on the construct of interest after a treatment with known efficacy. ConclusionResponsiveness cannot be proven, though, it is an ongoing process of testing hypotheses.

Community-based short-term integrated palliative and supportive care reduces symptom distress for older people with chronic noncancer conditions compared with usual care: A randomised controlled single-blind mixed method trial

BackgroundGlobally, a rising number of people live into advanced age and die with multimorbidity and frailty. Palliative care is advocated as a person-centred approach to reduce health-related suffering and promote quality of life. However, no evidence-based interventions exist to deliver community-based palliative care for this population. AimTo evaluate the impact of the short-term integrated palliative and supportive care intervention for older people living with chronic noncancer conditions and frailty on clinical and economic outcomes and perceptions of care. DesignSingle-blind trial with random block assignment to usual care or the intervention and usual care. The intervention comprised integrated person-centred palliative care delivered by multidisciplinary palliative care teams working with general practitioners and community nurses. Main outcome was change in five key palliative care symptoms from baseline to 12-weeks. Data analysis used intention to treat and complete cases to examine the mean difference in change scores and effect size between the trial arms. Economic evaluation used cost-effectiveness planes and qualitative interviews explored perceptions of the intervention. Setting/participantsFour National Health Service general practices in England with recruitment of patients aged ≥75 years, with moderate to severe frailty, chronic noncancer condition(s) and ≥2 symptoms or concerns, and family caregivers when available. Results50 patients were randomly assigned to receive usual care (n = 26, mean age 86.0 years) or the intervention and usual care (n = 24, mean age 85.3 years), and 26 caregivers (control n = 16, mean age 77.0 years; intervention n = 10, mean age 77.3 years). Participants lived at home (n = 48) or care home (n = 2). Complete case analysis (n = 48) on the main outcome showed reduced symptom distress between the intervention compared with usual care (mean difference -1.20, 95% confidence interval -2.37 to -0.027) and medium effect size (omega squared = 0.071). Symptom distress reduced with decreased costs from the intervention compared with usual care, demonstrating cost-effectiveness. Patient (n = 19) and caregiver (n = 9) interviews generated themes about the intervention of ‘Little things make a big difference’ with optimal management of symptoms and ‘Care beyond medicines’ of psychosocial support to accommodate decline and maintain independence. ConclusionsThis palliative and supportive care intervention is an effective and cost-effective approach to reduce symptom distress for older people severely affected by chronic noncancer conditions. It is a clinically effective way to integrate specialist palliative care with primary and community care for older people with chronic conditions. Further research is indicated to examine its implementation more widely for people at home and in care homes.Trial registration: Controlled-Trials.com ISRCTN 45837097Tweetable abstract: Specialist palliative care integrated with district nurses and GPs is cost-effective to reduce symptom distress for older people severely affected by chronic conditions.

Aerobic, Resistance, and Combination Training on Health-Related Quality of Life: The STRRIDE-AT/RT Randomized Trial.

Purpose: The main purpose of this study was to determine the differential effects of aerobic training (AT), resistance training (RT), and a combination of aerobic and resistance training (AT/RT) on changes in self-rated HrQoL measures, including the Short-Form 36 (SF-36) survey and Satisfaction with Physical Function and Appearance survey. We also sought to determine if combination training (AT/RT) has a more or less additive effect compared to AT or RT alone on self-rated HrQoL measures.Materials and Methods: Participants (n = 137) completed one of three 8-month exercise interventions: (1) AT: 14 kcal exercise expenditure per kg of body weight per week (KKW; equivalent to roughly 12 miles/week) at 65–80% of peak oxygen consumption; (2) RT: 3 days per week, 8 exercises, 3 sets per exercise, 8–12 repetitions per set; (3) AT/RT: full combination of the AT and RT interventions. The SF-36 survey, Satisfaction with Physical Function and Appearance survey, physical fitness, and anthropometrics were assessed at baseline and post-intervention. Paired t-tests determined significant pre- vs. post-intervention scores within groups (p < 0.05). Analyses of covariance determined differences in change scores among groups (p < 0.05).Results: On average, participants were 49.0 ± 10.6 years old, obese (BMI: 30.6 ± 3.2 kg/m2), female (57.7%), and Caucasian (84.7%). Following the 8-month intervention, exercise groups improved peak VO2 (all groups), strength (RT and AT/RT), and anthropometric measures (AT and AT/RT). For the SF-36, RT (p = 0.03) and AT/RT (p < 0.001) significantly improved their physical component score; only AT/RT (p < 0.001) significantly improved their mental component score. Notably, all groups significantly improved both their satisfaction with physical function and appearance scores (All Groups: p < 0.001 for both outcomes).Conclusions: We found that aerobic, resistance, or combination exercise training improves several components of self-rated HrQoL, including physical function, appearance, and mental well-being.Clinical Trial Registration: No. NCT00275145.

The Combination of Exercise and Manual Therapy Versus Exercise Alone in Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Clinical Trial.

Total knee arthroplasty (TKA) is one of the most commonly performed orthopedic surgeries in the lower extremity. However, patient dissatisfaction and functional disability are mostly experienced because of pain and limited range of motion (ROM). Although manual therapy is commonly implemented to improve ROM and modulate pain in the management of musculoskeletal disorders, there is a lack of evidence about its clinical effectiveness on postoperative TKA rehabilitation. To investigate the effectiveness of an exercise program combined with manual therapy compared with an exercise program only for pain, ROM, function, quality of life, and patient satisfaction outcomes. A randomized controlled clinical trial. Rehabilitation unit of a university hospital. Forty-two patients (68.45 ± 6.3 years) scheduled for unilateral TKA as a treatment of severe osteoarthritis. Joint and soft tissue mobilizations in addition to exercise therapy were provided to the mobilization group (n = 21) while the control group received exercise therapy only (n = 21). The outcome measures were numeric pain-rating scale, knee ROMs, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, 10-meter walk test (10MWT), 5-times sit to stand test (5SST), and Short Form-12 (SF-12). Improvements in pain outcomes were significantly higher in the mobilization group than in the control group (P = .001, F [3, 33] = 7.06) and the between-group difference in change score was 1.3 points (P = .001). Although the between-group difference in change score was 12.8° for knee flexion at 2 months (P = .001), the overall group-by-time interactions were not significant for flexion and extension ROMs (P = .175, F [3, 33] = 1.75 and P = .57, F [2, 34] = 0.56, respectively). Additionally, there were statistically meaningful group-by-time interactions on total WOMAC score (P = .006, F [2, 34] = 5.29), 10MWT (P = .002, F [3, 33] = 5.98), and SF-12 mental component summary (P = .01, F [2, 34] = 4.92) favoring the mobilization group. Also, patient satisfaction was higher in the mobilization group (P = .02). A structured exercise program combined with manual therapy can be more beneficial in improving pain, function, and patient satisfaction compared to exercise program alone for postoperative TKA patients.

The Impact of Preoperative Mental Health and Depression on Outcomes After Total Ankle Arthroplasty.

Preoperative mental health and depression have been shown to negatively impact patient-reported outcome measures after a broad array of orthopaedic procedures including total ankle arthroplasty. The hypothesis for this study was that decreased Short Form (SF)-36 Mental Component Summary (MCS) scores will modulate the impact of depression on patient-reported outcome measures after total ankle arthroplasty. All patients undergoing primary total ankle arthroplasty between January 2007 and December 2016 who were enrolled into a prospective outcomes study and who had at least 1-year minimum study follow-up were retrospectively reviewed. Patients were separated into 4 groups based on the presence or absence of an SF-36 MCS score of <35 points and diagnosis of depression. SF-36 Physical Component Summary (PCS) and MCS scores, Short Musculoskeletal Function Assessment (SMFA) function and bother components, and visual analog scale (VAS) pain were collected preoperatively and in the 1 to 2-year follow-up. The Wilcoxon rank sum was used to assess differences in outcomes by depression and low preoperative MCS scores. Multivariable models were then constructed to evaluate between-group differences in change scores according to preoperative SF-36 MCS scores and a diagnosis of depression, with adjustment for baseline patient and treatment characteristics. Patients with depression and those with low preoperative MCS scores had significantly worse final outcome scores along with reduced improvement in SF-36 PCS and VAS pain scores compared with patients without these risk factors. Among patients with depression, low preoperative MCS scores helped to differentiate patients with poor final outcome scores. Similarly, in patients with low preoperative MCS scores, depression helped to differentiate patients with poor final outcome scores. Although patients achieved significant improvements in functional outcomes regardless of cohort, decreased preoperative mental health modulated the impact of depression on outcomes. Patients with diminished preoperative mental health and depression are at an increased risk for sustaining smaller improvements in outcomes. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

CTNI-50. NEUROCOGNITIVE FUNCTION (NCF) OF THE PHOTON COHORT IN NRG-BN001

Abstract NRG BN001 is an ongoing randomized phase II trial of dose-intense (DI-RT) versus standard dose photon-based radiation therapy (SD-RT) with temozolomide (TMZ) for newly diagnosed glioblastoma. We report preliminary results of Group 1, DI-RT delivered with IMRT while SD-RT could be 3DCRT or IMRT. Group 2, DI-RT delivered with proton therapy, continues to accrue. From 10/2014 to 7/2018, 229 patients were eligible and randomized. Differences in overall survival following DI-RT versus SD-RT were not significant. Patients were scheduled to complete NCF testing at baseline, cycle 3 (within 7 days of cycle 4), and cycle 12 (day 22–28 of cycle 12, or 60 weeks from completion of chemoradiation). At baseline, 93–94% of eligible patients completed NCF testing. Compliance for evaluable patients at cycle 3 and cycle 12 was 66–68% and 51–54%, respectively, across the battery of NCF tests. The most common reasons for missing data were patient refusal (cycle 3: 14%, cycle 12: 22–23%) and institutional error (cycle 3: 9–10%, cycle 12: 14–15%). A prespecified secondary endpoint analysis was conducted to evaluate differences in NCF between SD-RT and DI-RT based on the Clinical Trial Battery Composite (CTB COMP), which is the mean of the standardized scores from the NCF test battery (HVLT-R, TMT, COWA). There was no statistically significant between arm difference in change from baseline on the CTB COMP at cycle 3 (DI-RT vs SD-RT mean/SD, 0.0 +/- 1.3 vs -0.3 +/- 1.5, p=0.370, Cohen’s d=0.22) or cycle 12 (DI-RT vs SD-RT mean/SD, 0.2 +/- 1.7 vs 0.2 +/- 1.1, p=0.977, Cohen’s d=0.01). A mixed effects longitudinal model of the CTB COMP yielded a non-significant time by treatment effect interaction (p=0.216). There were no significant differences in change scores between arms on any NCF test at cycles 3 or 12. NCF outcomes were similar for photon-based SD-RT and DI-RT.

Responsiveness of the PROMIS-29 Scales in Individuals With Chronic Low Back Pain.

Prospective cohort study. To evaluate responsiveness and estimate the minimal clinically important differences (MCIDs) for the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) scales in individuals with chronic low back pain. The PROMIS-29 questionnaire assesses seven health-related quality-of-life domains. However, research to evaluate the responsiveness and MCIDs of the PROMS-29 scores in individuals with low back pain is limited. The study was conducted in physical therapy clinics in Thailand, using validated Thai versions of the study measures. One hundred and eighty-three individuals with chronic low back pain completed the PROMIS-29 at baseline and at 4-weeks follow-up. Perceived change in each domain assessed by the PROMIS-29 scales was assessed at 4 weeks using a 7-point measure of Global Perceived Effect (GPE). Responsiveness of the PROMIS-29 scale scores was evaluated by examining the effect sizes, the standardized response means (SRMs) for change over time, and examining these as a function of the GPE ratings. MCIDs for the scales were estimated by computing a half a standard deviation (SD) and standard error of measurement statistic for each scale. The mean change scores, effect sizes, and SRMs increased as a function of the GPE ratings. Significant differences in change scores between those who reported that they were very much improved and those who did not improve were found for the PROMIS-29 Pain Intensity, Physical Function, and Anxiety scales. The correlations between changes scores and GPE ratings were mostly weak in magnitude. The MCID estimates computed as 0.50 of a SD unit and as a standard error of measurement showed similar values. The PROMIS-29 scale scores assessing pain intensity, physical function, and anxiety evidenced the most responsivity in the study sample. The results, when considered in light of the findings from other investigators, support 5.0 points as a reasonable MCID for most of the PROMIS-29 scales. Further studies are needed to determine the generalizability of the findings.Level of Evidence: 2.

Addendum to ‘A comparison of electronically-delivered and face to face cognitive behavioural therapies in depressive disorders: A systematic review and meta-analysis’ [EClinicalMedicine 24 (2020) 100442

Following the publication of the systematic review, we became aware of an oversight in the interpretation of Fig. 3 in the paper related to the comparison of electronically delivered cognitive behavioural therapy (eCBT) versus face to face CBT leading to incorrect interpretation of the figure. We provide an updated figure and an explanation of the source of error in the original manuscript. The quantitative analysis of the depressive symptoms scores was based on the change in the score between pre and post intervention as described in the methods. However, when using this calculated value in the statistical analysis program, the output label is set as the standardized mean difference and the results favoured the less mean score. The oversight occurred by not recognizing that the appropriate label should be “standardized mean difference in change scores”. This oversight led to misinterpretation of the finding and the confusion of the axes stating “favouring” one intervention or the other. The correct interpretation is that the average amount of change was less for eCBT compared to face to face CBT. The text related to this figure should read: we found an estimated mean change of −1.73 (95% CI −2.72, −0.74) showing the average amount of change is less for eCBT compared to face to face CBT. Both models of therapy showed a reduction in depressive symptoms however the reduction was less for eCBT. Sensitivity analysis removing an outlier as presented in the original manuscript supplementary material showed no significant difference in the amount of reduction in symptoms severity between the 2 models (standardized mean difference in change scores SMD −0.79, 95% CI −1.60, 0.02). Post publication comments from readers asked about using post intervention scores and not the change score. We conducted this analysis that shows no significant difference between the 2 models of CBT delivery (SMD 0.21, 95%CI −0.05, 0.46). The overall conclusions are essentially the same stating that eCBT and face to face CBT are effective in reducing depressive symptoms, no differences were seen between the 2 models of delivery in other outcomes including global function, quality of life, participants satisfaction or drop out rates while one study showed eCBT to be less costly. Considering all factors and limitations, eCBT is as effective as face to face CBT and should be considered as a treatment option if preferred by patients and therapists as originally stated. A comparison of electronically-delivered and face to face cognitive behavioural therapies in depressive disorders: A systematic review and meta-analysisAlthough we found eCBT to have moderate evidence of effectiveness in reducing symptoms of depression, high heterogeneity among studies precludes definitive conclusions for all outcomes. With the current reliance and accessibility of technology to increasing number of people worldwide, serious consideration in utilizing technology should be given to maximize accessibility for depression treatments. Our results found eCBT is at least as effective as face to face CBT, thus eCBT should be offered if preferred by patients and therapists. Full-Text PDF Open Access

Randomized control trial of advanced cancer patients at a private hospital in Kenya and the impact of dignity therapy on quality of life

BackgroundPalliative care is a modality of treatment that addresses physical, psychological and spiritual symptoms. Dignity therapy, a form of psychotherapy, was developed by Professor Harvey Chochinov, MD in 2005.The aim of the study was to assess the effect of one session of dignity therapy on quality of life in advanced cancer patients.MethodsThis was a randomized control trial of 144 patients (72 in each arm) randomized into group 1 (intervention arm) and group 2 (control arm). Baseline ESAS scores were determined in both arms following which group 1 received Dignity therapy while Group 2 received usual care only. Data collected was presented as printed (Legacy) documents to group 1 participants. These documents were a summary of previous discussions held. Post intervention ESAS scores were obtained in both groups after 6 weeks. Analysis was based on the intention to treat principle and descriptive statistics computed. The main outcome was symptom distress scores on the ESAS (summated out of 100 and symptom specific scores out of 10). The student T-test was used to test for difference in ESAS scores at follow up and graphs were computed for common cancers and comorbidities.ResultsOf the 144 (72 patients in each arm) patients randomized, 70%were female while 30% were male with a mean age of 50 years. At 6 weeks, 11 patients were lost to follow up, seven died and 126 completed the study. The commonly encountered cancers were gastrointestinal cancers (43%, p = 0.29), breast cancer (27.27% p = 0.71) and gynaecologic cancers (23% p = 0.35). Majority of the patients i.e. 64.3% had no comorbidities.The primary analysis results showed higher scores for the DT group (change in mean = 1.57) compared to the UC group (change in mean = − 0.74) yielding a non-statistically significant difference in change scores of 1.44 (p = 0.670; 95% CI − 5.20 to 8.06). After adjusting for baseline scores, the mean (summated) symptom distress score was not significant (GLM p = 0.78). Dignity therapy group showed a trend towards statistical improvement in anxiety (p = 0.059). The largest effects seen were in improvement of appetite, lower anxiety and improved wellbeing (Cohen effect size 0.3, 0.5 and 0.31 respectively).ConclusionDignity therapy showed no statistical improvement in overall quality of life. Symptom improvement was seen in anxiety and this was a trend towards statistical significance (p = 0.059).Trial registrationTrial registration number PACTR201604001447244 retrospectively registered with Pan African Clinical trials on 28th January 2016.

The Feasibility and Efficacy of an Israeli Lifestyle Redesign®-Based Program for Well Older Adults: A Pilot Study.

The Israeli Lifestyle Program (ILP) was adapted from the original Lifestyle Redesign® intervention, aiming to enhance health, functioning, and quality of life (QoL) of older adults. The purpose of this study was to examine the feasibility and effectiveness of the ILP. The design of the study entailed a non-randomized trial with a 3-month follow-up including 18 women aged 65 to 81 recruited from a community center. The research group (n = 9) participated in 15 weekly group meetings and three individual sessions. The control group (n = 9) received an information booklet based on the ILP content. Between-group comparisons revealed significant differences in change scores in favor of the research group for occupational performance (U = 19.0, p = .03), environmental (U = 21.5, p = .04), and social (U = 20.5, p = .03) QoL factors. Findings also revealed reduction in depressive symptoms (U = 24.0, p = .07). These findings suggest community group programs for improving occupational performance and QoL.