UK Medical Cannabis Registry: A two-year case series of clinical outcomes in depression.

Insomnia affects approximately 10% of adults globally. Current treatments have their limitations, and there is growing evidence on the therapeutic potential of cannabis-based medicinal products for insomnia. This study aimed to assess changes in sleep-specific and general patient-reported outcome measures (PROMs) in individuals prescribed cannabis-based medicinal products for insomnia and to assess the incidence of adverse events. A case series was analysed with patients diagnosed with primary insomnia from the UK Medical Cannabis Registry (UKMCR). The primary outcome examined changes in the Single-Item Sleep Quality Scale (SQS), Generalised Anxiety Disorder-7 (GAD-7), and EuroQol-5 Dimension-5 Level (EQ-5D-5L). Changes in PROMs were assessed from baseline to 1-, 3-, 6-, 12- and 18-months. Adverse events were classified according to the CTCAE version 4.0. The inclusion criteria were met by 124 participants. SQS scores showed improvement from baseline (2.66 ± 2.41) to 1- (5.67 ± 2.65; p < 0.001), 3- (5.41 ± 2.69; p < 0.001), 6- (4.80 ± 2.89; p < 0.001), 12- (4.24 ± 3.01; p < 0.001) and 18-months (3.81 ± 2.90; p < 0.001). GAD-7 scores improved from baseline to 1-, 3-, 6-, 12- and 18-months (p < 0.050). There were also improvements in EQ-5D-5L dimensions of usual activities, pain/discomfort, anxiety/depression, and index values (p < 0.001). Eleven (8.87%) participants reported a total of 112 (90.32%) adverse events, but none were disabling or life-threatening. The study demonstrated improvements in subjective sleep quality and other captured PROMs in insomnia patients treated with cannabis-based medicinal products. Although the treatment was generally well-tolerated, randomised controlled trials are needed to confirm the effectiveness and safety of cannabis-based medicinal products.

Fibromyalgia is a common condition characterised by widespread chronic pain, associated with comorbid mental health disorders and reduced quality of life. Preclinical data suggest cannabis-based medicinal products (CBMPs) may have potential benefits in fibromyalgia, but there is a paucity of high-quality clinical evidence. This study aims to assess the change in patient-reported outcome measures (PROMs) and incidence of adverse events (AEs) in patients treated with CBMPs for fibromyalgia. This case series analysed data from the UK Medical Cannabis Registry (UKMCR). The primary outcome was change in PROMs [Fibromyalgia Symptom Severity, Fibromyalgia Widespread Pain Index, EQ-5D-5L, Generalised Anxiety Disorder-7, and Single-Item Sleep Quality Scale] from baseline to follow-up at 1, 3, 6, 12, and 18months. Statistical significance was defined as p < 0.050. Four hundred ninety-seven patients were included. The mean age was 44.66 ± 12.02years, 341 patients (68.61%) were female, and the majority of patients were unemployed (n = 268, 53.92%). There was an improvement in all PROMs (p < 0.010) from baseline to all follow-up periods. Higher CBD doses (> 25.00mg/day) and previous cannabis use were associated with increased odds of improvement on fibromyalgia-specific scales (p < 0.050). 227 patients (45.67%) reported 2100 AEs (422.54%). Most AEs were mild-to-moderate (n = 1792, 85.33%). The most common AE was fatigue (n = 153, 30.78%). There was an association between treatment with CBMPs and improvements in pain, anxiety, sleep, and general quality of life. The high incidence of AEs in relation to other patient cohorts from the UKMCR may relate to the central sensitisation mechanism of fibromyalgia. Key Points • This study found that CBMPs were associated with short to medium-term improvements in pain, anxiety, sleep, and general quality-of-life in patients with fibromyalgia. • More randomised controlled trials are warranted to consolidate the literature, but this large analysis provides real-world data to inform their rollout.

There is uncertainty around the costs and health impacts of undiagnosed mental health problems. Using survey data, we aim to understand the costs and health-related quality-of-life decrements from undiagnosed anxiety/depression. We analysed survey data from two waves of the North West Coast Household Health Survey, which included questions on disease, medications, and Patient Health Questionnaire 9 (PHQ-9) and Generalised Anxiety Disorder 7 (GAD-7) scores (depression and anxiety scales). People were judged as having undiagnosed anxiety/depression problems if they scored ≥5 on the PHQ-9 or GAD-7, and did not declare a mental health issue or antidepressant prescription. Linear regression for EuroQol 5-Dimension 3-Level (EQ-5D-3L) index scores, and Tweedie regression for health and social care costs, were used to estimate the impact of undiagnosed mental health problems, controlling for age, gender, deprivation and other health conditions. Around 26.5% of participants had undiagnosed anxiety/depression. The presence of undiagnosed anxiety/depression was associated with reduced EQ-5D-3L index scores (0.040 lower on average) and increased costs (£250 ($310) per year on average). Using a higher cut-off score of 10 on the PHQ-9 and GAD-7 for undiagnosed anxiety/depression had similar increased costs but a greater reduction in EQ-5D-3L index scores (0.076 on average), indicating a larger impact on health-related quality of life. Having undiagnosed anxiety or depression increases costs and reduces health-related quality of life. Reducing stigma and increasing access to cost-effective treatments will have population health benefits.

Cancer pain (CP) is a prevalent condition with limited pharmacotherapeutic options. Cannabis-based medicinal products (CBMPs) have shown analgesic effects, but their efficacy in CP remains contentious. This study aims to evaluate the change in patient-reported outcome measures (PROMs) and adverse events (AEs) in CP patients treated with CBMPs. A case series was conducted using prospectively collected clinical data from the UK Medical Cannabis Registry. Primary outcomes were the changes in the Brief Pain Inventory (BPI), pain visual analogue scale (Pain-VAS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7), Patient Global Impression of Change (PGIC) and Single-Item Sleep Quality Scale (SQS) questionnaires from baseline to 1, 3, and 6 months. AEs were recorded and graded. p < 0.050 was considered statistically significant. One hundred and sixty-eight participants were included. CBMPs were associated with improvements in all pain-specific PROMs at all follow-up periods (p < 0.050). Improvements in GAD-7, SQS, and EQ-5D-5L index scores were also observed (p < 0.050). Twenty-nine AEs (17.26%) were reported by five patients (2.98%), mostly mild-to-moderate (72.41%). Although the observational design means causality cannot be established, the findings support the development of future randomized controlled trials into CP management with CBMPs.

A third of epilepsy patients fail to enter seizure remission despite optimal therapeutic management. Cannabis-based medicinal products (CBMPs) have shown promise as a potential therapy. However, a paucity of high-quality literature regarding CBMPs' efficacy and safety profile means further investigation is needed. The study aimed to examine changes in epilepsy-specific and general health-related quality of life (HRQoL) patient-reported outcome measures (PROMs) in individuals with treatment-resistant epilepsy. A case series of patients with epilepsy from the UK Medical Cannabis Registry analyzed changes in Quality of Life in Epilpesy-31 (QOILE-31), Single-Item Sleep Quality Score (SQS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) and Patient Global Impression of Change (PGIC) between baseline, one, three, and six months. Adverse events (AEs) were collected and classified by severity. p < 0.050 was considered statistically significant. There were 134 patients included. Improvements were recorded from baseline to one, three, and six months in QOILE-31 and all HRQoL PROMs (p < 0.050). Forty patients (29.85%) reported a minimal clinically important difference in Quality of Life in Epilepsy-31 (QOLIE-31) at six months. There were 18 (13.43%) AEs reported by 5 (3.73%) patients, mainly mild and moderate. The proportion of patients achieving a clinically significant change is similar to existing CBMPs in epilepsy literature. AE incidence was lower than similar studies although this may be due to the large proportion (67.16%) of individuals who were not cannabis naïve. Initiation of CBMPs was associated with an improvement across all PROMs. CBMPs were well tolerated across the cohort. However, randomized controlled trials are needed to help determine causality.

Background: CAD is a rare chronic autoimmune hemolytic anemia characterized by classical complement pathway (CP)-mediated hemolysis, anemia, fatigue, and poor quality of life (QOL). Sutimlimab is a first-in-class humanized monoclonal antibody that selectively inhibits C1s of the C1 complex, preventing CP activation, while leaving the alternative and lectin pathways intact. One-year interim follow-up from the CARDINAL study (NCT03347396) have previously demonstrated continuous classical CP inhibition with sutimlimab resulted in rapid, sustained improvements in all patient-reported outcomes (PROs) measures evaluated. Aims: To report sutimlimab effect on PROs at 2 years, from the CARDINAL Part B extension. Methods: CARDINAL was a Phase 3, open-label, single-arm study with a 26-week treatment period (Part A) and a 2-year extension (Part B) after the last patient finishes Part A. Sutimlimab was administered through intravenous infusions on Days 0 and 7, followed by biweekly dosing. PRO data through Week 135, the last data recording within the 2-year Part B time period, are reported here. Efficacy endpoints included hemolytic markers and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) as a measure of QOL. Exploratory QOL endpoints included mean change from baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) scores, 12-Item Short Form Health Survey (SF-12), Patient Global Impression of Change (PGIC) and Patient Global Impression of Fatigue Severity (PGIS). PRO measures were evaluated every 3 months and conducted in the following order: FACIT-Fatigue, PGIS, PGIC, SF-12 and EQ-5D-5L. Descriptive statistics, frequency, or percentage were used to analyze outcomes. Results: Overall, 24 patients enrolled and 22 finished Part A and entered Part B, with 19 (86.4%) patients completing Part B. The mean (SD) FACIT-Fatigue score at baseline was 32 (11) and improved by 7 (8) within 1 week of sutimlimab treatment; the mean change score from baseline remained ≥5 from Week 1 to Week 135 (minimum score of 38 (9) at Week 123, maximum score of 44 (5) at Week 7), consistent with a clinically meaningful improvement. Efficacy for the EQ-5D-5L visual analogue scale (VAS) was sustained over 2 years; the mean (SD) change from baseline in EQ-5D-5L visual analogue scale (VAS) score (n=15/22) at Week 135 was 17.1 (21.6) (Figure A). The majority of evaluable patients (n=13/15) indicated an improved disease state compared to baseline on the PGIC at Week 135. No or mild fatigue was reported in patients (80%, n=12/15) on completing PGIS at Week 135, compared with one-third at baseline (n=2/6). The mean increase in SF-12 physical and mental component scores (n=6/22) from baseline to Week 123 were 4.7 (6.9) and 3.8 (14.1) (Figure B), consistent with the clinically important changes of 3.9 and 2.8 respectively. Image:Summary/Conclusion: From this CARDINAL follow-up extension study, sutimlimab has shown to produce rapid and sustained improvements in FACIT-Fatigue and other PRO measures evaluated up to 2 years, demonstrating the continued meaningful impact of sutimlimab on patient QOL.

Effects of Depression and Anxiety Improvement on Adherence to Medication and Health Behaviors in Recently Hospitalized Cardiac Patients

Category:Midfoot/ForefootIntroduction/Purpose:First metatarsal phalangeal joint (MTPJ) arthrodesis is a well established procedure in the treatment of end-stage arthritis. Patient reported outcome measures (PROMs) are an important part of the modern healthcare system. The aim of surgery is to improve pain, function and health related quality of life (HRQoL). The Manchester-Oxford Foot Questionnaire (region-specific) and the Euro-QOL 5 dimension (generic) are both PROMs, known to be sensitive to change following foot/ ankle surgery at 6-months post-procedure (Maher & Kilmartin, J of Foot & Ankle Res, 5: 17, 2012). However we don’t know if baseline scores and the presence of comorbidities influence the change in these PROMs. This is important to understand so that we can identify which patients to offer MTPJ arthrodesis surgery to.Methods:Aims 1. To identify the change in two patient-reported outcome measures (PROMs) following MTPJ arthrodesis: The Manchester-Oxford Foot Questionnaire (MOxFQ) and the Euro-QOL 5 dimension tool. Do baseline scores make a difference to the change? 2. To describe the impact of co-morbidities on the change in both PROMs. Data was collected prospectively from patients who had undergone a first MTPJ arthrodesis. Patients with complete pre- and post-PROMs data were included in the analysis. PROMs data was collected on average 5.2 months post-operatively. Surgery notes were crosschecked with radiographic findings. A comparative analysis was done between pre and post-operative data using SPSS (version 20). The MOxFQ generates a total score, as well as 3 sub-domain scores for pain, walking/ standing and social interaction. The EQ5D generates a total score and a health today score (visual analogue scale: VAS from 0-100).Results:90 patients were identified, 52 had complete data. Mean (SD) age 56.9(17.8) years, 78% female. Comorbidities: diabetes 2%, hypertension 21%, rheumatoid arthritis (RA) 43%, current smokers 10%, average (SD) weekly units of alcohol 5.2 (9.1). Most cases were unilateral (94%) and fixed with two screws (87%). 37% had other foot procedures carried out concurrently.Table 1 shows the change in MoxFQ total, domain scores and the EQ5D total score, health today (VAS). The correlation between baseline EQ5D total and the change for this outcome was r=0.6 (p<0.001). The correlation between baseline MOxFQ total and the change for this outcome was r=0.5 (p<0.001). The only comorbidity to have an influence on PROMs was RA- the presence of RA significantly reduced change in EQ5D total (p<0.05).Conclusion:Following MTPJ arthrodesis, statistically and clinically significant changes were observed in EQ5D total score, MOxFQ total scores (and all sub-domains). The EQ5D VAS did not change. Baseline scores in both PROMs were correlated with the change scores following surgery- suggesting that we may be able to identify a baseline score which could predict the outcome in PROMs and target who we offer surgery to as a consequence. Comorbidities had little influence on the change in both PROMs following surgery, other than the presence of RA dampening the change in EQ5D total score. Again this is useful to inform pre- operative discussions.

This study aims to analyze changes in health-related quality of life (HRQoL) and safety in patients with generalized anxiety disorder (GAD) prescribed a homogenous selection of cannabis-based medicinal products (CBMPs). Patients prescribed Adven CBMPs (Curaleaf International, UK) for GAD were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in patient-reported outcome measures (PROMs) from baseline up to 12 months, including GAD-7, Single-Item Sleep Quality Scale (SQS), and EQ-5D-5L. Adverse events were recorded using CTCAE version 4.0. A total of 120 patients were identified for inclusion, of which 38 (31.67%), 52 (43.33%), and 30 (25.00%) were prescribed oils, dried flower, and both formulations of CBMP. Associated improvements in GAD-7, SQS, and EQ-5D-5L at 1, 3, 6, and 12 months were observed compared to baseline ( P < 0.010). There were 24 (20.00%) patients who reported 442 (368.33%) adverse events, most of which were mild (n = 184, 41.63%) and moderate (n = 197, 44.57%). This study reports an association between initiation of a homogeneous CBMP therapy and improvements in anxiety severity and HRQoL in individuals with GAD. Moreover, therapy was well-tolerated at 12 months follow-up. Further investigation through randomized controlled trials will ultimately be required to determine causation.

There is a paucity of high-quality evidence on the clinical efficacy of cannabis-based medicinal products (CBMPs). The objective of this study was to perform trajectory k-means clustering of health-related quality of life (HRQoL) outcomes in patients prescribed CBMPs to identify distinct response patterns and baseline predictors of treatment outcomes over 24 months. A cohort study of patients enrolled in the UK Medical Cannabis Registry with any qualifying indication was performed. Participants completed patient-reported outcome measures including EuroQol 5-Dimension 5-Level (EQ-5D-5L), Generalized Anxiety Disorder-7 (GAD-7), and Single-Item Sleep Quality Scale (SQS), at baseline, 1, 3, 6, 12, 18, and 24 months. Longitudinal k-means clustering was performed on EQ-5D-5L index values where the optimal number of clusters was selected via the gap statistic. Univariable and multivariable logistic regression analyses identified predictors of cluster membership. The 8945 patients were included in the analysis, from which 10 distinct trajectory clusters were identified, with eight demonstrating HRQoL improvements representing 77.72% of the cohort (n = 6952). Over 70% of participants reported improved EQ-5D-5L index values at each timepoint, whilst 54.21% (n = 4849) and 44.07% (n = 3942) achieved clinically significant improvements in GAD-7 and SQS at 24 months, respectively. Adverse events were reported by 13.65% (n = 1221) of patients, predominantly rated as mild (n = 4732; 42.31%) or moderate (n = 4860; 43.46%). Baseline patient characteristics, particularly treatment indication, severe anxiety, poor sleep quality, female sex, and cannabis-naïve status, were stronger predictors of favorable treatment response than product-specific factors.

BackgroundMigraine is associated with depression as well as negative impact on quality of life and work productivity. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa), selectively targets the calcitonin gene‐related peptide and has proven efficacy for the preventive treatment of migraine.ObjectiveIn this open‐label extension (OLE) of the phase 3b FOCUS study, we assessed patient‐reported outcomes (PROs) over time.MethodsPatients with episodic migraine (EM) and chronic migraine (CM) completing the 12‐week, double‐blind (DB) period of the FOCUS trial entered the 12‐week OLE and received three monthly doses of fremanezumab (225 mg). PROs included the Migraine‐Specific Quality of Life (MSQoL) questionnaire (role function—restrictive [RFR], role function—preventive [RFP], and emotional function [EF] domains), EuroQol‐5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire, Patient Global Impression of Change (PGIC) assessment, Work Productivity and Activity Impairment (WPAI) questionnaire, and 9‐Item Patient Health Questionnaire (PHQ‐9).ResultsA total of 838 patients were randomized in the DB period, 807 entered the OLE at 3 months, and 772 were still enrolled at 6 months. At 6 months, patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups, respectively, reported improvements in RFR (mean [standard deviation] change from baseline: 24.6 [21.9]; 22.9 [21.3]; 20.8 [26.5]), RFP (19.6 [20.0]; 18.3 [19.7]; 16.0 [19.9]), and EF (22.5 [24.2]; 19.1 [23.6]; 17.2 [24.7]) domains of the MSQoL questionnaire, the EQ‐5D‐5L questionnaire (8.0 [19.6]; 7.3 [21.1]; 6.6 [21.0]), all four domains of the WPAI questionnaire, and the PHQ‐9 (−2.4 [5.3]; −1.6 [5.5]; −2.0 [4.9]); 77.1% (209/271), 75.4% (205/272), and 68.8% (181/263) of patients were identified as PGIC responders.ConclusionAmong patients with EM or CM and prior inadequate response to multiple migraine‐preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6 months of fremanezumab treatment.

Hip arthroplasty (HA) and knee arthroplasty (KA) are high-volume procedures. However, there is a debate about the quality of indication; that is, whether surgery is truly indicated in all patients. Patient-reported outcome measures (PROMs) may be used to determine preoperative thresholds to differentiate patients who will likely benefit from surgery from those who will not. (1) What were the minimum clinically important differences (MCIDs) for three commonly used PROMs in a large population of patients undergoing HA or KA treated in a general orthopaedic practice? (2) Do patients who reach the MCID differ in important ways from those who do not? (3) What preoperative PROM score thresholds best distinguish patients who achieve a meaningful improvement 12 months postsurgery from those who do not? (4) Do patients with preoperative PROM scores below thresholds still experience gains after surgery? Between October 1, 2019, and December 31, 2020, 4182 patients undergoing HA and 3645 patients undergoing KA agreed to be part of the PROMoting Quality study and were hence included by study nurses in one of nine participating German hospitals. From a selected group of 1843 patients with HA and 1546 with KA, we derived MCIDs using the anchor-based change difference method to determine meaningful improvements. Second, we estimated which preoperative PROM score thresholds best distinguish patients who achieve an MCID from those who do not, using the preoperative PROM scores that maximized the Youden index. PROMs were Hip Disability and Osteoarthritis Outcome Score-Physical Function short form (HOOS-PS) (scored 0 to 100 points; lower indicates better health), Knee Injury and Osteoarthritis Outcome Score-Physical Function short form (KOOS-PS) (scored 0 to 100 points; lower indicates better health), EuroQol 5-Dimension 5-level (EQ-5D-5L) (scored -0.661 to 1 points; higher indicates better health), and a 10-point VAS for pain (perceived pain in the joint under consideration for surgery within the past 7 days) (scored 0 to 10 points; lower indicates better health). The performance of derived thresholds is reported using the Youden index, sensitivity, specificity, F1 score, geometric mean as a measure of central tendency, and area under the receiver operating characteristic curve. MCIDs for the EQ-5D-5L were 0.2 for HA and 0.2 for KA, with a maximum of 1 point, where higher values represented better health-related quality of life. For the pain scale, they were -0.9 for HA and -0.7 for KA, of 10 points (maximum), where lower scores represent lower pain. For the HOOS-PS, the MCID was -10, and for the KOOS-PS it was -5 of 100 points, where lower scores represent better functioning. Patients who reached the MCID differed from patients who did not reach the MCID with respect to baseline PROM scores across the evaluated PROMs and for both HA and KA. Patients who reached an MCID versus those who did not also differed regarding other aspects including education and comorbidities, but this was not consistent across PROMs and arthroplasty type. Preoperative PROM score thresholds for HA were 0.7 for EQ-5D-5L (Youden index: 0.55), 42 for HOOS-PS (Youden index: 0.27), and 3.5 for the pain scale (Youden index: 0.47). For KA, the thresholds were 0.6 for EQ-5D-5L (Youden index: 0.57), 39 for KOOS-PS (Youden index: 0.25), and 6.5 for the pain scale (Youden index: 0.40). A higher Youden index for EQ-5D-5L than for the other PROMs indicates that the thresholds for EQ-5D-5L were better for distinguishing patients who reached a meaningful improvement from those who did not. Patients who did not reach the thresholds could still achieve MCIDs, especially for functionality and the pain scale. We found that patients who experienced meaningful improvements (MCIDs) mainly differed from those who did not regarding their preoperative PROM scores. We further identified that patients undergoing HA or KA with a score above 0.7 or 0.6, respectively, on the EQ-5D-5L, below 42 or 39 on the HOOS-PS or KOOS-PS, or below 3.5 or 6.5 on a 10-point joint-specific pain scale presurgery had no meaningful benefit from surgery. The thresholds can support clinical decision-making. For example, when thresholds indicate that a meaningful improvement is not likely to be achieved after surgery, other treatment options may be prioritized. Although the thresholds can be used as support, patient preferences and medical expertise must supplement the decision. Future studies might evaluate the utility of using these thresholds in practice, examine how different thresholds can be combined as a multidimensional decision tool, and derive presurgery thresholds based on additional PROMs used in practice. Preoperative PROM score thresholds in this study will support clinicians in decision-making through objective measures that can improve the quality of the recommendation for surgery.

BackgroundPrevious studies showed that lumacaftor-ivacaftor (LUMA-IVA) provides meaningful clinical benefits in patients with cystic fibrosis who are homozygous for the Phe508del CFTR mutation. However, little is known about the patient...

Depression and anxiety are highly prevalent conditions in the United States. Despite the availability of suitable therapeutic options, limited access to high-quality psychiatrists represents a major barrier to treatment. Although telepsychiatry has the potential to improve access to psychiatrists, treatment efficacy in the telepsychiatry model remains unclear. Our primary objective was to determine whether there was a clinically meaningful change in 1 of 2 validated outcome measures of depression and anxiety-the Patient Health Questionnaire-8 (PHQ-8) or the Generalized Anxiety Disorder-7 (GAD-7)-after receiving at least 8 weeks of treatment in an outpatient telepsychiatry setting. We included treatment-seeking patients enrolled in a large outpatient telepsychiatry service that accepts commercial insurance. All analyzed patients completed the GAD-7 and PHQ-8 prior to their first appointment and at least once after 8 weeks of treatment. Treatments included comprehensive diagnostic evaluation, supportive psychotherapy, and medication management. In total, 1826 treatment-seeking patients were evaluated for clinically meaningful changes in GAD-7 and PHQ-8 scores during treatment. Mean treatment duration was 103 (SD 34) days. At baseline, 58.8% (1074/1826) and 60.1% (1097/1826) of patients exhibited at least moderate anxiety and depression, respectively. In response to treatment, mean change for GAD-7 was -6.71 (95% CI -7.03 to -6.40) and for PHQ-8 was -6.85 (95% CI -7.18 to -6.52). Patients with at least moderate symptoms at baseline showed a 45.7% reduction in GAD-7 scores and a 43.1% reduction in PHQ-8 scores. Effect sizes for GAD-7 and PHQ-8, as measured by Cohen d for paired samples, were d=1.30 (P<.001) and d=1.23 (P<.001), respectively. Changes in GAD-7 and PHQ-8 scores correlated with the type of insurance held by the patients. Greatest reductions in scores were observed among patients with commercial insurance (45% and 43.9% reductions in GAD-7 and PHQ-8 scores, respectively). Although patients with Medicare did exhibit statistically significant reductions in GAD-7 and PHQ-8 scores from baseline (P<.001), these improvements were attenuated compared to those in patients with commercial insurance (29.2% and 27.6% reduction in GAD-7 and PHQ-8 scores, respectively). Pairwise comparison tests revealed significant differences in treatment responses in patients with Medicare versus commercial insurance (P<.001). Responses were independent of patient geographic classification (urban vs rural; P=.48 for GAD-7 and P=.07 for PHQ-8). The finding that treatment efficacy was comparable among rural and urban patients indicated that telepsychiatry is a promising approach to overcome treatment disparities that stem from geographical constraints. In this large retrospective data analysis of treatment-seeking patients using a telepsychiatry platform, we found robust and clinically significant improvement in depression and anxiety symptoms during treatment. The results provide further evidence that telepsychiatry is highly effective and has the potential to improve access to psychiatric care.

PRODIAB: Perspectives on the use of patient-reported outcome measures among diabetic patients