Patient-reported Depression Research Articles

Efficacy and Safety of Yangxinshi versus Trimetazidine on Exercise Tolerance in Patients with Coronary Heart Disease after Percutaneous Coronary Intervention: Multicenter, Double-Blind Clinical Trial

BackgroundOptimizing medication to improve exercise tolerance in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) is limited. Yangxinshi tablets, an herbal-based oral medicine, relieve symptoms of angina might be that they can improve energy metabolism of the ischemic myocardium. We conducted a randomized trial to assess the efficacy and safety of Yangxinshi vs. trimetazidine in improving exercise tolerance in patients with CHD after PCI. MethodsThis prospective, randomized, double-blind, double-dummy, multicenter, non-inferiority study enrolled patients aged 18–75 years with CHD who underwent their first PCI within 2 months of diagnosis. Patients were randomized to Yangxinshi plus trimetazidine-placebo or trimetazidine plus Yangxinshi-placebo for 24 weeks. The primary endpoint was the change in metabolic equivalents (METs) assessed by cardiopulmonary exercise test (CPET) between 0 and 24 weeks. Secondary endpoints were comprehensive variables of the CPET, health status and adverse events. This study has been registered at ClinicalTrials. gov (NCT03809273). ResultsBetween August 1, 2019, and March 31, 2022, a total of 681 patients were randomized to Yangxinshi (n=341) or trimetazidine (n=340). After 24 weeks, the exercise tolerance of patients increased by 0.77±1.25 METs in the Yangxinshi group and 0.76±1.00 METs in the trimetazidine group (difference, 0.01; 95% confidence interval [CI], −0.17 to 0.19), meeting the predefined non-inferiority threshold. Better outcomes were observed in the Yangxinshi group compared with the trimetazidine group for patient-reported depression (PHQ-9; −1.88±3.32 vs. −0.93±3.68; P < 0.001) and anxiety (GAD-7; −1.70±3.26 vs. −0.39±3.29; P < 0.001). Adverse events were similar in both groups. ConclusionsIn patients with CHD after PCI, Yangxinshi was non-inferior to trimetazidine in improving exercise tolerance during the 24-week treatment period. Notably, patients in the Yangxinshi group showed a better mental health profile compared with trimetazidine recipients.

Sex Differences in Patient-Reported Depression Following Vascular Surgery Procedures

IntroductionFemale patients frequently experience worse clinical outcomes than male patients after undergoing vascular surgery procedures. However, it is unclear whether these sex-based disparities also impact mental health outcomes. This study was designed to investigate sex differences in patient-reported outcome measures of depression for patients undergoing vascular surgery. MethodsWe retrospectively analyzed 107 patients (73 males and 34 females) who underwent vascular surgery procedures between January 2016 and April 2023. These patients completed a Patient-Reported Outcome Measurement Information System (PROMIS) Item Bank v1.0-Depression assessment 90 d before surgery and at least once after surgery. After stratifying patients by sex, we analyzed changes in PROMIS depression scores using a multiple mixed-effects linear regression model. Then, logistic regression was used to compare the proportion of patients who achieved a clinically meaningful difference in PROMIS depression score within 15 mo after surgery. ResultsThere was no significant difference between female and male patients among rates of complications, length of hospital stay, or rates of nonhome discharge. However, female sex was associated with significantly improved PROMIS depression scores after surgery compared to male sex (P = 0.034). Furthermore, female patients were over 3-fold more likely than male patients to reach the minimal clinically important difference threshold for improvement in PROMIS depression scores (odds ratio 4.66, 95% confidence interval 1.39-15.61). ConclusionsThese results suggest that female sex is associated with improved patient-reported measures of depression after undergoing vascular surgery. Clinicians should consider these mental health benefits when evaluating female patients for vascular interventions.

Impact of SARS-CoV-2 Infection on Long-Term Depression Symptoms among Veterans

BackgroundPrior research demonstrates that SARS-COV-2 infection can be associated with a broad range of mental health outcomes including depression symptoms. Veterans, in particular, may be at elevated risk of increased depression following SARS-COV-2 infection given their high rates of pre-existing mental and physical health comorbidities. However, few studies have tried to isolate SARS-COV-2 infection associations with long term, patient-reported depression symptoms from other factors (e.g., physical health comorbidities, pandemic-related stress).ObjectiveTo evaluate the association between SARS-COV-2 infection and subsequent depression symptoms among United States Military Veterans.DesignSurvey-based non-randomized cohort study with matched comparators.ParticipantsA matched-dyadic sample from a larger, stratified random sample of participants with and without known to SARS-COV-2 infection were invited to participate in a survey evaluating mental health and wellness 18-months after their index infection date. Sampled participants were stratified by infection severity of the participant infected with SARS-COV-2 (hospitalized or not) and by month of index date. A total of 186 participants in each group agreed to participate in the survey and had sufficient data for inclusion in analyses. Those in the uninfected group who were later infected were excluded from analyses.Main MeasuresParticipants were administered the Patient Health Questionnaire-9 as part of a phone interview survey. Demographics, physical and mental health comorbidities were extracted from VHA administrative data.Key ResultsVeterans infected with SARS-COV-2 had significantly higher depression symptoms scores compared with those uninfected. In particular, psychological symptoms (e.g., low mood, suicidal ideation) scores were elevated relative to the comparator group (MInfected = 3.16, 95%CI: 2.5, 3.8; MUninfected = 1.96, 95%CI: 1.4, 2.5). Findings were similar regardless of history of depression.ConclusionSARS-COV-2 infection was associated with more depression symptoms among Veterans at 18-months post-infection. Routine evaluation of depression symptoms over time following SARS-COV-2 infection is important to facilitate adequate assessment and treatment.

Perceived COVID-19 pandemic impact and protective factors predicting patient-reported depression and anxiety in individuals living with cancer

BackgroundThe COVID-19 pandemic presents a unique, amplified threat to those living with a cancer diagnosis, but personal factors may play a role in how this affects well-being. This cross-sectional study (1) describes the impacts of COVID-19 on cancer patients’ lives, and (2) explores the extent to which specific impacts of COVID-19 and noted protective factors, hope and resilience, predict two crucial patient-reported outcomes, depression and anxiety, after controlling for relevant sociodemographic and clinical factors.Methods520 cancer patients and survivors in the U.S. completed an online survey during the first year of the pandemic and answered questions about COVID-19 areas of impact, psychological well-being, hope, and resilience. Hierarchical regression analyses were used to analyze the unique impact of each group of variables on patient-reported levels of depression and anxiety during the pandemic.ResultsParticipants strongly endorsed COVID-19 impact across several areas of life, especially social activity, well-being, and ability to acquire basic essentials. Regression models explained a substantial amount of variance in patient-reported depression (R2 = .50, p < .001) and anxiety (R2 = .44, p < .001), revealing COVID-19 financial impact as a significant predictor of depression (β = 0.07), and COVID-19 family impact as a significant predictor of anxiety (β = 0.14), even after controlling for the effects of relevant sociodemographic and clinical variables. Additionally, resilience and hope were the largest predictors of both depression (β = − 0.19 and − 0.37, respectively) and anxiety (β = − 0.18 and − 0.29), suggesting that they account for unique variance in patient-reported mental health during the COVID-19 pandemic and might serve as important protective factors.ConclusionsThe current results add to existing literature documenting the significant effect of COVID-19 on those living with cancer. COVID-19 impact, including financial and family well-being, as well as positive psychological constructs, hope and resilience, play a crucial role in levels of patient-reported depression and anxiety during the pandemic. As COVID-19 continues to evolve, health care providers should routinely assess psychological well-being and needs related to COVID-19 financial and family impact in an effort to appropriately align individuals with resources and support, and consider how hope and resilience can be fostered to serve as psychological buffers during this time.

Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life

BackgroundCOMP360 is a proprietary, synthetic formulation of psilocybin being developed for treatment-resistant depression (TRD), a burdensome, life-threatening illness with high global impact. Here, we expand upon the previous report of primary outcomes from a phase 2 study of COMP360 in individuals with TRD—the largest randomised controlled clinical trial of psilocybin—to discuss findings of the exploratory efficacy endpoints. MethodsIn this phase 2, double-blind trial, 233 participants with TRD were randomised to receive a single dose of psilocybin 25 mg, 10 mg, or 1 mg (control), administered alongside psychological support from trained therapists. Efficacy measures assessed patient-reported depression severity, anxiety, positive and negative affect, functioning and associated disability, quality of life, and cognitive function. ResultsAt Week 3, psilocybin 25 mg, compared with 1 mg, was associated with greater improvements from Baseline total scores in all measures. The 10 mg dose produced smaller effects across these measures. LimitationsInterpretation of this trial is limited by the absence of an active comparator and the possibility of functional unblinding in participants who received a low dose of psilocybin. ConclusionsThree weeks after dosing, psilocybin 25 mg and, to a lesser degree, 10 mg improved measures of patient-reported depression severity, anxiety, affect, and functioning. These results extend the primary findings from the largest randomised clinical trial of psilocybin for TRD to examine other outcomes that are of importance to patients.

A Community Partnership to Reduce Food Insecurity and Improve Patient-Reported Depression

Summary To address the growing prevalence of food insecurity and its adverse effects on health, health care organizations are partnering with community organizations to develop nutrition programs aimed at both reducing hunger and improving diet-related health. Although there has been little effort to document improvements in mental health outcomes among nutrition program recipients who receive support through a community–health care partnership, this study suggests a beneficial relationship. The Greater Boston Food Bank, a 501(c)3 organization that supplies food pantries and tracks food insecurity throughout eastern Massachusetts, has developed a mobile market (MM) intervention in partnership with community health centers (CHCs) and other community-based locations to provide free produce, dairy, and high-protein food to low-income residents of eastern Massachusetts in a farmers’ market–style environment, with the primary goal to reduce food insecurity. The data collected through the CHC partnership indicate that attendance at the MM was associated with improvement in depression score among CHC patients. All MM attendees experienced improvement in depression score with increased MM utilization, but the biggest effect was for patients with a diagnosis of depression at baseline. This partnership experience demonstrates that interventions developed by health care–community partnerships may have benefits for program participants beyond the primary goal of the program. During the study period of more than 3 years, for all patients in the study, each MM visit was associated with a 0.05-point decrease in the subsequent nine-item Patient Health Questionnaire (PHQ-9) score (95% confidence interval [CI], −0.08 to −0.02), which is a measure of depression on a scale of 0 to 27. Among those who had a diagnosis of moderate or severe depression before the MM intervention (PHQ-9 higher than 9), each MM visit was associated with a 0.27-point decrease in the subsequent PHQ-9 score (95% CI, −0.33 to −0.20). Mean attendance at the MM for patients with a diagnosis of depression was 6.7 visits, which translates to a predicted 1.8-point reduction in PHQ-9 score per patient during the study period.

Effects of Depression, Anxiety, and Pain Catastrophizing on Total Hip Arthroplasty Patient Activity Level

BackgroundImprovements in psychological factors are strongly associated with increased physical activity in the general population. The effects of depression, anxiety, and pain catastrophizing on activity level have not been thoroughly explored in patients undergoing total hip arthroplasty (THA). Mental health markedly influences patient perspectives on treatment success and quality of life. We hypothesized that improvements in screenings for depression, anxiety, and catastrophizing correlate with improvements in activity levels after THA. MethodsTwo hundred ninety two patients (313 hips) who underwent THA with a minimum 1-year (mean 615 ± 270 days) follow-up completed preoperative and postoperative surveys containing the University of California Los Angeles (UCLA) Activity Score, Hospital Anxiety Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and Depression Anxiety Stress Scale-21 (DASS). Wilcoxon signed-rank tests were performed between preoperative and postoperative times for outcome measures. Partial Spearman’s rank-order correlations were performed between the change in UCLA Score and the change in HADS, PCS, and DASS. ResultsThere were significant improvements in UCLA Score (P value < .0001) and every subscale of PCS, HADS, and DASS (P values < .0001). Significant negative correlations existed between change in UCLA Score and change in HADS-anxiety (rs = −0.21, P value < .001), change in HADS-depression (rs = −0.23, P value < .001), and change in DASS-anxiety (rs = −0.22, P value = .004) following THA. Weaker significant negative correlations existed between change in UCLA Score and change in the remaining PCS (P values = .006) and DASS-depression(P value = .037) subscales. ConclusionImprovements in patient-reported depression, anxiety, and pain catastrophizing screenings following THA were associated with increased activity levels. Patients who were screened for catastrophizing, depression, and anxiety achieved statistically and clinically meaningful improvements in symptoms following THA. Addressing patient mental health provides another avenue for holistic care of THA patients.

Assessment of Outcome-Based Measures of Depression Care Quality in Veterans Health Administration Facilities.

To inform the potential use of patient-reported depression symptom outcomes as measures of care quality, this study collected and analyzed longitudinal Patient Health Questionnaire (PHQ9) scores among 1,638 patients who screened positive for major depression according to a PHQ9 ≥ 10 across 29 Department of Veterans Affairs facilities. The study found baseline PHQ9, prior mental health visits, physical functioning, and treatment expectancy were consistently associated with subsequent PHQ9 outcomes. No facilities outperformed any others on PHQ9 scores at the 6-month primary endpoint, and the corresponding intra-class coefficient was ≤ .01 for the entire sample (n = 1,214) and 0.03 for the subgroup of patients with new depression episodes (n = 629). Measures of antidepressant receipt, psychotherapy, or treatment intensification were not associated with 6-month PHQ9 scores. PHQ9 outcomes are therefore unlikely to be useful as quality indicators for VA healthcare facilities due to low inter-facility variation, and new care process measures are needed to inform care for patients with chronic depression prevalent in this sample.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11414-022-09813-4.

Financial Hardship Impacts Depression and Anxiety Among U.S. Patients with Sinusitis.

Mental health conditions are common in the United States, and recent efforts have examined the development of mental health conditions among patients with sinusitis. The purpose of this study was to investigate the association between depression, anxiety, and financial hardship among patients with sinusitis. Cross-sectional study using the 2018 National Health Interview Survey (NHIS). Data regarding demographics, perceived financial hardship, self-reported depression and anxiety, mental healthcare utilization, and treatment compliance were obtained. Among patients with sinusitis (N = 28 million adults), 9% reported depression and 24% reported anxiety. Sinusitis patients with depression and anxiety reported an increased severity of financial insecurity (p < 0.001). On multivariable logistic regression, worsening financial insecurity increased the odds of depression and anxiety. Patients reporting the highest financial insecurity severity had the highest odds of depression (OR = 3.88, 95% CI = 3.84-3.93, p < 0.001) and anxiety (OR = 2.09, 95% CI = 2.08-2.10, p < 0.001) among measures of financial stress. Specific financial stressors were independently associated with patient-reported depression and anxiety. Sinusitis patients with increased financial insecurity were more likely to require mental health services and treatment (p < 0.001), but were also more likely to report cost-related treatment noncompliance (p < 0.001) and reduced access to mental healthcare due to costs (p < 0.001). Perceived financial hardship is associated with self-reported depression and anxiety among patients with sinusitis. Sinusitis patients with financial hardship also face challenges in accessing and maintaining mental health services and treatment due to costs. Understanding the burden of financial insecurity on mental health and access to treatment may improve quality of care through the development of screening tools and individualized treatment strategies.

504 - Pediatric Patient and Caregiver Reported Symptom Burden, Anxiety, Depression, and Quality of Life during CD19-CAR T-Cell Therapy

504 - Pediatric Patient and Caregiver Reported Symptom Burden, Anxiety, Depression, and Quality of Life during CD19-CAR T-Cell Therapy

Evaluation of the Pathways for Survivors Program to Address Breast Cancer Survivorship-Associated Distress: Survey Study.

BackgroundPatients with breast cancer frequently experience escalation of anxiety after completing curative treatment.ObjectiveThis study evaluated the acceptability and psychological impact of a 1-day workshop to emphasize behavioral strategies involving intention and self-efficacy.MethodsBreast cancer survivors who attended a 1-day Pathways for Survivors workshop provided feedback and completed electronic quality of life (QOL) questionnaires at baseline, 1 and 6 weeks, and 6 months after the workshop. Attendees’ baseline QOL scores were compared to follow-up (FUP) scores. Scores from patients receiving routine FUP care were also compiled as a reference population.ResultsIn total, 77 patients attended 1 of 9 workshops. The mean satisfaction score was 9.7 out of 10 for the workshop and 9.96 out of 10 for the moderator. Participants’ baseline mean Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scores were 57.8 (SD 6.9) and 55.3 (SD 7.5), respectively, which were significantly higher than those of patients receiving routine FUP care (49.1, SD 8.3 and 47.3 SD 8.0, respectively). PROMIS anxiety and depression scores decreased, and the Happiness Index Profile (HIP-10) score—measuring intention and resiliency—increased significantly at 1- and 6-week FUPs.ConclusionsThe Pathways for Survivors program was favorably received. Anxiety and depression decreased significantly at 1- and 6-weeks after the workshop and remained below baseline at 6 months. Increased HIP-10 scores suggest that patients acquired and implemented skills from the workshop. A 1-day workshop led by a lay moderator significantly improved several psychological measures, suggesting that it may be a useful and time-efficient strategy to improve QOL in breast cancer survivors. We are investigating whether an abbreviated “booster” of the intervention at a later date could further improve and maintain QOL gains.

Associations between diagnostic time intervals and health-related quality of life, clinical anxiety and depression in adolescents and young adults with cancer: cross-sectional analysis of the BRIGHTLIGHT cohort

BackgroundThe association of diagnostic intervals and outcomes is poorly understood in adolescents and young adults with cancer (AYA). We investigated associations between diagnostic intervals and health-related quality of life (HRQoL), anxiety and depression in a large AYA cohort.MethodsParticipants aged 12–24 completed interviews post-diagnosis, providing data on diagnostic experiences and the patient-reported outcomes (PROs) HRQoL, anxiety and depression. Demographic and cancer information were obtained from clinical and national records. Six diagnostic intervals were considered. Relationships between intervals and PROs were examined using regression models.ResultsEight hundred and thirty participants completed interviews. In adjusted models, across 28 of 30 associations, longer intervals were associated with poorer PROs. Patient intervals (symptom onset to first seeing a GP) of ≥1 month were associated with greater depression (adjusted odds ratio (aOR):1.7, 95% Confidence Interval (CI):1.1–2.5) compared to <1 month. ≥3 pre-referral GP consultations were associated with greater anxiety (aOR:1.6, CI:1.1–2.3) compared to 1–2 consultations. Symptom onset to first oncology appointment intervals of ≥2 months was associated with impaired HRQoL (aOR:1.8, CI:1.2–2.5) compared to <2 months.ConclusionsProlonged diagnostic intervals in AYA are associated with an increased risk of impaired HRQoL, anxiety and depression. Identifying and delivering interventions for this high-risk group is a priority.

Rotator cuff outcomes and mental health indices: Correlation or causation?

Psychological factors such as catastrophizing, anxiety, and depression influence clinical outcomes in many conditions. Our purpose was to examine trends and associations between these and outcomes of rotator cuff surgery. 148 patients (76 W:72 M, 55.1 ± 8.2 years) with unilateral symptomatic rotator cuff syndrome were followed for 1 year after surgery. The Western Ontario Rotator Cuff Score (WORC), the Pain Catastrophizing Score (PCS), and the Hospital Anxiety and Depression Score (HADS) were administered. Evolution and associations of WORC, HADS and PCS scores were examined using uni- and multivariate analyzes. At 1 year, PCS, HADS-A, and HADS-D scores negatively correlated with WORC score (R = -0.6, -0.61, -0.69). The strength of correlation was lower between baseline PCS, HADS-A, and HADS-D scores and 1-year WORC score (R = -0.38, -0.43, -0.42). Prior anxiety diagnosis was associated with higher HADS-A scores at 2- and 6- weeks post-op (p = 0.013, 0.011). 106 participants experienced an improving HADS-D over the year of follow-up. Worse pre-op pain, WORC, PCS, HADS-A, HADS-D, cardiovascular disease and current smoking were associated with non-improving HADS-D. Patient-reported outcomes of rotator cuff surgery are associated with patient-reported anxiety, depression, and pain catastrophizing. In many, all outcome scores improved over time suggesting a two-way association between shoulder condition and psychological parameters. II.

Anticipating mental health needs after chemotherapy in early-stage breast cancer using patient-reported symptom screening.

Many patients with breast cancer experience depression and anxiety for years after completing systemic chemotherapy, which negatively impact overall symptom burden, quality of life, and treatment outcomes. The objective of this study was to examine the utility of patient-reported outcome (PRO) measures to predict mental health needs in patients with breast cancer during post-chemotherapy follow-up care. In a sample of women with non-metastatic breast cancer, associations between patient-reported depression and anxiety at end of chemotherapy and post-chemotherapy mental health needs were evaluated using log-binomial regression adjusted for functional status, social activity limitations, and time from chemotherapy. In a sample of 149 women, 40% reported at least mild depressive symptoms and 52% reported at least mild anxiety at the end of chemotherapy. Over an average 3.2years post-chemotherapy (range: 0.7-5.6years), 23% received new psychiatric diagnoses, 21% engaged in mental health specialty care, and 62% were prescribed psychotropic medications. End of chemotherapy depression and anxiety were associated with future prescription of psychotropic medications (RR 1.52; 95% CI 1.14-2.03), as well as greater number of psychotropics. Associations were strongest with serotonin-norepinephrine reuptake inhibitors [(depression: RR 4.75; 95% CI 2.06-10.95); (anxiety: RR 3.68; 95% CI 1.62-8.36); (depression and anxiety: RR 2.98; 95% CI 1.65-5.36)]. Diagnosis of and treatment for depression and anxiety are common among women with breast cancer after completing chemotherapy. Prescriptions for psychotropic medications during the initial years after systemic chemotherapy can be anticipated by depression and anxiety screening at end of chemotherapy.

Association between antiseizure medications and quality of life in epilepsy: A mediation analysis.

The relationship between antiseizure medications (ASMs), which improve health outcomes by controlling seizures, and health-related quality of life (HRQOL) is poorly understood and may involve intermediate variables. We evaluated the potential mediators of the association between ASMs and HRQOL. Data are from an outpatient registry of adult patients with epilepsy seen at the Foothills Medical Center, Calgary, Alberta, Canada. Quality of life was measured using the 10-item Quality of Life in Epilepsy, and depression was measured using the Neurological Disorders Depression Inventory for Epilepsy. Propensity score matching was used to adjust for covariate imbalance between patients who received a single ASM (monotherapy) and those who received two or more ASMs (polytherapy) due to confounding. Mediation analysis was used to estimate the mediating effects of depression and ASM side effects on the association between patients' ASM polytherapy and HRQOL. Of 778 patients included in this analysis, 274 (35.2%) were on two or more ASMs. Patient-reported depression and ASM side effects jointly mediated the association between ASMs and HRQOL; these mediators accounted for 42% of the total average effect of ASM polytherapy ( =-13.6, 95% confidence interval = -18.2 to -8.6) on HRQOL. These findings highlight the importance of managing depression and ASM side effects for improving health outcomes of patients requiring treatment with ASMs. Intervention programs aimed at improving HRQOL of patients with epilepsy need to target these potential mediators.

A novel multidisciplinary approach to the management of end-stage macular disease

Introduction: In 2017, the Royal College of Ophthalmologists UK published ‘The Way Forward’ describing the effects of the ageing UK population on clinical demand for macular conditions. Although one-stop clinics have become accepted standard practice for combined assessment and injections, there is little guidance regarding eventual discharge of patients, and practice varies between clinicians. In 2018, NHS Lothian started a multidisciplinary one-stop clinic involving an Ophthalmologist, a Medical Photographer, a specialist Low Vision Optometrist, and a Low Vision Counsellor. We aimed to detail our experiences of this novel multidisciplinary discharge clinic for advanced macular disease patients. We also aimed to assess patient-reported anxiety and depression outcomes following this clinic. Retrospective data on 60 patients who attended the clinic from August 2018 to January 2019 were collected and included in analysis. Average age at presentation to the clinic was 85.76 ± 8.18 years old and patients had been followed up in the macula clinic for a mean of 4.80 ± 2.43 years prior to attending the clinic. In all, 31 patients responded to a survey on anxiety and depression using the Hospital Anxiety and Depression score (HADS). Three (10%) of the patients reported scores abnormal for anxiety, and there were no abnormal scores for depression. The clinic provides a holistic approach for end-stage macular disease patients and reduces unnecessary macular anti–vascular endothelial growth factor treatments and clinic review appointments. This is especially important now during the coronavirus SARS-CoV-2 global pandemic. This provides significant benefits to capacity for delivery of clinical services and facilitates a safe and supported discharge for patients.

Patient-reported anxiety and depression measures for use in Indian head and neck cancer populations: a psychometric evaluation

BackgroundHead and neck cancers (HNC) are one of the most traumatic forms of cancer because they affect essential aspects of life such as speech, swallowing, eating and disfigurement. HNCs are common in India, with over 100,000 cases being registered each year. HNC and treatment are both associated with considerable anxiety and depression. With increasing multinational research, no suitable measures in Indian languages are available to assess anxiety and depression in Indian HNC patients. This study evaluated the psychometric properties of cross-culturally adapted versions of Zung’s self-rating Anxiety Scale (SAS) and the Patient health questionnaire – 9 (PHQ-9) in Tamil, Telugu and Hindi speaking Indian HNC populations.MethodsHNC patients were recruited from three tertiary cancer centres in India. Patients completed the cross-culturally adapted versions of SAS and PHQ-9. We assessed targeting, scaling assumptions, construct validity (exploratory and confirmatory factor analyses), convergent validity, and internal consistency reliability.ResultsThe study sample included 205 Tamil, 216 Telugu and 200 Hindi speaking HNC patients. Exploratory and confirmatory factor analyses indicated a two-factor solution for PHQ-9 and four-factor solution for SAS in all three languages. Cronbach’s alpha coefficients ranged between 0.717 and 0.890 for PHQ-9 and between 0.803 and 0.868 for SAS, indicating good reliability. Correlations between hypothesized scales were as expected providing evidence towards convergent validity.ConclusionsThis first psychometric evaluation of the measurement properties of Tamil, Telugu and Hindi versions of the SAS and PHQ-9 in large, Indian HNC populations supported their use as severity and outcome measures across the disease and treatment continuum.

Cost-effectiveness of feedback-informed psychological treatment: Evidence from the IAPT-FIT trial

BackgroundFeedback-informed treatment (FIT) involves using computerized routine outcome monitoring technology to alert therapists to cases that are not responding well to psychotherapy, prompting them to identify and resolve obstacles to improvement. In this study, we present the first health economic evaluation of FIT, compared to usual care, to enable decision makers to judge whether this approach represents a good investment for health systems. MethodsThis randomised controlled trial included 2233 patients clustered within 77 therapists who were randomly assigned to a FIT group (n = 1176) or a usual care control group (n = 1057). Treatment response was monitored using patient-reported depression (PHQ-9) and anxiety (GAD-7) measures. Therapists in the FIT group had access to a computerized algorithm that alerted them to cases that were “not on track”, compared to normative clinical data. Health service costs included the cost of training therapists to use FIT and the cost of therapy sessions in each arm. The incremental cost-effectiveness of FIT was assessed relative to usual care, using multilevel modelling. ResultsFIT was associated with an increased probability of reliable symptomatic improvement by 8.09 percentage points (95% CI: 4.16%–12.03%) which was statistically significant. The incremental cost of FIT was £15.17 (95% CI: £6.95 to £37.29) per patient and was not statistically significant. The incremental cost-effectiveness ratio (ICER) per additional case of reliable improvement was £187.4 (95% CI: £126.7 to £501.5); this confidence interval shows that the relative cost-effectiveness is between FIT being a dominant strategy (i.e. more effective and also cost-saving) to FIT being more effective at a modest incremental cost to the health system. ConclusionsThe FIT strategy increases the probability of reliable improvement in routine clinical practice and may be associated with a small (but uncertain) incremental cost. FIT is likely to be a cost-effective strategy for mental health services.

Dynamic prediction of psychological treatment outcomes: development and validation of a prediction model using routinely collected symptom data

Common mental disorders can be effectively treated with psychotherapy, but some patients do not respond well and require timely identification to prevent treatment failure. We aimed to develop and validate a dynamic model to predict psychological treatment outcomes, and to compare the model with currently used methods, including expected treatment response models and machine learning models. In this prediction model development and validation study, we obtained data from two UK studies including patients who had accessed therapy via Improving Access to Psychological Therapies (IAPT) services managed by ten UK National Health Service (NHS) Trusts between March, 2012, and June, 2018, to predict treatment outcomes. In study 1, we used data on patient-reported depression (Patient Health Questionnaire 9 [PHQ-9]) and anxiety (Generalised Anxiety Disorder 7 [GAD-7]) symptom measures obtained on a session-by-session basis (Leeds Community Healthcare NHS Trust dataset; n=2317) to train the Oracle dynamic prediction model using iterative logistic regression analysis. The outcome of interest was reliable and clinically significant improvement in depression (PHQ-9) and anxiety (GAD-7) symptoms. The predictive accuracy of the model was assessed in an external test sample (Cumbria Northumberland Tyne and Wear NHS Foundation Trust dataset; n=2036) using the area under the curve (AUC), positive predictive values (PPVs), and negative predictive values (NPVs). In study 2, we retrained the Oracle algorithm using a multiservice sample (South West Yorkshire Partnership NHS Foundation Trust, North East London NHS Foundation Trust, Cheshire and Wirral Partnership NHS Foundation Trust, and Cambridgeshire and Peterborough NHS Foundation Trust; n=42 992) and compared its performance with an expected treatment response model and five machine learning models (Bayesian updating algorithm, elastic net regularisation, extreme gradient boosting, support vector machine, and neural networks based on a multilayer perceptron algorithm) in an external test sample (Whittington Health NHS Trust; Barnet Enfield and Haringey Mental Health Trust; Pennine Care NHS Foundation Trust; and Humber NHS Foundation Trust; n=30 026). The Oracle algorithm trained using iterative logistic regressions generalised well to external test samples, explaining up to 47·3% of variability in treatment outcomes. Prediction accuracy was modest at session one (AUC 0·59 [95% CI 0·55-0·62], PPV 0·63, NPV 0·61), but improved over time, reaching high prediction accuracy (AUC 0·81 [0·77-0·86], PPV 0·79, NPV 0·69) as early as session seven. The performance of the Oracle model was similar to complex (eg, including patient profiling variables) and computationally intensive machine learning models (eg, neural networks based on a multilayer perceptron algorithm, extreme gradient boosting). Furthermore, the predictive accuracy of a more simple dynamic algorithm including only baseline and index-session scores was comparable to more complex algorithms that included additional predictors modelling sample-level and individual-level variability. Overall, the Oracle algorithm significantly outperformed the expected treatment response model (mean AUC 0·80 vs 0·70, p<0·0001]). Dynamic prediction models using sparse and readily available symptom measures are capable of predicting psychotherapy outcomes with high accuracy. University of Sheffield.

Sleep Disruption, Fatigue, and Depression as Predictors of 6-Year Clinical Outcomes Following Allogeneic Hematopoietic Cell Transplantation.

Allogeneic hematopoietic cell transplantation (HCT) is a widely used treatment for hematologic cancers, with survival rates ranging from 25% to 78%. Known risk factors for chronic graft-versus-host disease (cGVHD), a serious and common long-term complication, disease relapse, and mortality following HCT have been identified, but much of the variability in HCT outcomes is unexplained. Biobehavioral symptoms including depression, sleep disruption, and fatigue are some of the most prevalent and distressing for patients; yet research on biobehavioral risk factors for HCT outcomes is limited. This study evaluated patient-reported depression, sleep disruption, and fatigue as risk factors for cGVHD, disease relapse, and mortality. Adults receiving allogeneic HCT for a hematologic malignancy (N = 241) completed self-report measures of depression symptoms, sleep quality, and fatigue (severity, interference) pre-HCT and 100 days post-HCT. Clinical outcomes were monitored for up to 6 years. Cox proportional hazard models (2-tailed) adjusting for patient demographic and medical characteristics revealed that high pre-HCT sleep disruption (Pittsburgh Sleep Quality Index >9; hazard ratio [HR] = 2.74, 95% confidence interval [CI] = 1.27 to 5.92) and greater post-HCT fatigue interference (HR = 1.32, 95% CI = 1.05 to 1.66) uniquely predicted increased risk of mortality. Moderate pre-HCT sleep disruption (Pittsburgh Sleep Quality Index 6-9) predicted increased risk of relapse (HR = 1.99, 95% CI = 1.02 to 3.87). Biobehavioral symptoms did not predict cGVHD incidence. Biobehavioral symptoms, particularly sleep disruption and fatigue interference, predicted an increased risk for 6-year relapse and mortality after HCT. Because these symptoms are amenable to treatment, they offer specific targets for intervention to improve HCT outcomes.