Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes

1. No differences were found in depressive symptoms and emotional well-being between various treatments for localized prostate cancer.

2. Patient demographic factors such as older age, having comorbidities, and having low income were significantly associated with worse mental health outcomes.

Evidence Rating Level: 2 (Good)

Currently, treatments for localized prostate cancer include active surveillance, radical prostatectomy, and radiotherapy with or without androgen deprivation therapy (ADT). Only small differences in cancer-specific and overall mortality have been found among these three treatment options, and so the tolerability of these treatments is an important consideration for patients and clinicians. Specifically, the association of mental health outcomes with these treatments is not well-known. Therefore, the current prospective cohort study examined the association of emotional well-being and depression, with the type of prostate cancer treatment selected. The study population consisted of 2,742 patients with localized prostate cancer (cT1-cT2): 13.7% had active surveillance as their primary treatment, 51.8% had surgery, 23.0% had radiation without ADT, and 11.7% had radiation with ADT. These patients filled out surveys at the time of enrollment, and 0.5, 1, 3, and 5 years thereafter. As well, depressive symptoms were measured using the validated Centers for Epidemiologic Studies Depression (CES-D) scale, and emotional well-being was measured using the validated Study 36-item Short Form survey (SF-36).  Overall, there was no association found between type of treatment and depressive symptoms. Also, the prevalence of depressive symptoms was low at baseline, with a median score of 4 (IQR 1-8) out of a maximum score of 60. There was also no association between type of treatment and emotional well-being or energy/fatigue, as measured by the SF-36. However, some baseline characteristics of patients were associated with worse depressive symptoms, such as old age (p = 0.001), comorbidity (p < 0.001), lower income (p = 0.002), but not race (p = 0.38). Similar results were seen for emotional well-being as well. In conclusion, no link was found between the type of prostate cancer treatment and mental health outcomes, but demographic patient factors were associated.


Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults

1. No difference in TSH levels were among patients who switched between different generic levothyroxine preparations and those who remained on the same generic preparation.

Evidence Rating Level: 2 (Good)

Levothyroxine sodium is a medication used to treat thyroid hormone deficiency, and is available as a generic or brand-name drug in the United States. When physicians prescribe a generic, there is a potential for patients to receive generics made from different manufacturers, over the course of their prescription. While the American Thyroid Association recommends avoiding switching between manufacturers, the Food and Drug Administration states that generic levothyroxine preparations are interchangeable. Therefore, this retrospective propensity-matched cohort study compared the effectiveness and safety for patients receiving generic levothyroxine from the same manufacturer and from various manufacturers. The main outcome measured was thyroid stimulating hormone (TSH) level between 6 weeks and 12 months after the index date, which was either the date of switching manufacturers in the cohort that switched, or a randomly assigned date 3 months after their prescription. The study population included 15,829 patients, 82.4% of which took generic levothyroxine from the same manufacturer, and 17.6% of which had switched after at least 3 months on the prescription. From this, there were 2780 propensity score-matched pairs were generated. The results showed that the proportion of patients with normal TSH levels (0.3-4.4 mIU/L) were not different between nonswitchers and switchers (82.7% and 84.5% respectively; risk difference -0.018, 95% CI -0.038 to 0.002, p = 0.07). As well, the proportion of patients with markedly abnormal TSH levels (<0.1 or >10 mIU/L) were not different between nonswitchers and switchers (3.1% and 2.5% respectively, RD 0.007, 95% CI -0.002 to 0.015, p = 0.14). Furthermore, mean [SD] levels of TSH were similar between nonswitchers and switchers (2.7 [2.3] mIU/L and 2.7 [3.3] mIU/L respectively, p = 0.94). Overall, this study demonstrated there were no differences in TSH levels between patients who switched between generic levothyroxine preparations and patients who stayed on the same generic preparation.


Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial

1. Combined individual and group schema therapy (IGST) was more effective at reducing severity in borderline personality disorder (BPD) patients, compared to predominantly group schema therapy (PGST) or treatment as usual (TAU).

Evidence Rating Level: 1 (Excellent)

Schema therapy (ST) has been shown to be an effective treatment for borderline personality disorder (BPD) when used as an adjunct to treatment as usual (TAU). However, the effectiveness of ST as a stand-alone treatment has not been examined, and it is also unknown whether combined individual and group ST (IGST) or predominantly group ST (PGST) is more effective. Therefore, this multi-centre randomized controlled trial compared BPD severity after 2 years in patients undergoing IGST, PGST, or TAU. The study population consisted of 494 adults diagnosed with BPD, recruited from 15 centres in Europe and Australia: Each site was randomized to deliver either IGST and TAU, or PGST and TAU. Patients at each site were randomized 1:1 to the treatment that each site delivered. For the IGST treatment, there was 1 individual and 1 group session per week for the 1st year, and for the PGST treatment, there were 2 group sessions per week in the 1st year (with 12 individual sessions maximum if requested by the patient). The number of sessions decreased in frequency gradually over the 2nd year. TAU was the optimal treatment available at each site, which was often dialectical behaviour therapy. The primary outcome was BPD severity, as measured by the BPD Severity Index (BPDSI-IV) total score, with measurements taken at 0, 6, 12, 18, 24, and 36 months after treatment. The results showed that IGST and PGST combined were more effective than TAU (Cohen d 0.73, 95% CI 0.29-1.18, p = 0.001). As well, this was significantly different at 1.5 years (mean [SE] difference, 2.38 [0.98], 95% CI 0.27-4.49, p = 0.03). Furthermore, IGST was more effective than PGST (Cohen d 0.84, 95% CI 0.09-1.59, p = 0.03) and TAU (Cohen d 1.14, 95% CI 0.57-1.71, p < 0.001). This was significantly different starting at 1 year of treatment compared to TAU (difference 2.59, 95% CI 0.05-5.13, p = 0.048), and starting at 2.5 years compared to PGST (difference 2.68, 95% CI 0.12-5.25, p = 0.04). PGST was not significantly different from TAU (Cohen d 0.30, 95% CI -0.29 to 0.89, p = 0.32). Overall, this trial demonstrated that a combination of individual and group schema therapy was more effective at reducing BPD severity than predominantly group schema therapy or treatment as usual.


Prospective Associations of Accelerometer‐Assessed Physical Activity With Mortality and Incidence of Cardiovascular Disease Among Adults With Hypertension: The UK Biobank Study

1. Patients with hypertension had lower risk of CVD incidence, CVD mortality, and all-cause mortality with higher levels of moderate-to-vigorous physical activity and total physical activity volume, as measured with accelerometers.

Evidence Rating Level: 2 (Good)

Hypertension (HTN) affects greater than 1 billion people worldwide and is the leading cause of cardiovascular disease (CVD). Although the benefits of exercise on lowering blood pressure in hypertensive patients is well-studied, there is less evidence on whether exercise reduces CVD mortality in patients with HTN. Furthermore, most of this evidence is based on self-reported physical activity, and the dose-response association of exercise on CVD mortality is unclear. Therefore, this prospective cohort study examined the dose-response association of accelerometer-measured physical activity with CVD incidence, CVD mortality, and all-cause mortality, among patients with HTN. The study population consisted of 39,294 patients with HTN between the ages of 40 and 69, taken from the UK Biobank study. For 7 days in a row, participants wore an Axivity AX3 accelerometer that measured acceleration in 3 axes. The total physical activity volume as well as time spent in moderate-to-vigorous activity (measured as >100 milligravities on the accelerometer) were measured and categorized into 4 categories, based on the 10th, 50th, and 90th percentiles. From a median follow-up of 6.25 years (241,418 person-years), the results showed that the relative risks for all-cause mortality decreased with each increasing category of moderate-to-vigorous physical activity, compared to the lowest category of activity, with hazards ratios of 0.53 (0.46-0.61), 0.41 (0.34-0.49), and 0.36 (0.26-0.49) respectively. This was also true for risk of all-cause mortality and increasing categories of total physical activity volume, with HRs of 0.56 (0.48-0.64), 0.41 (0.34-0.50), and 0.30 (0.21-0.41). The same trends were found for CVD mortality as well, although no associations were found between moderate-to-vigorous activity and stroke mortality specifically. Furthermore, after excluding participants with pre-existing CVD, the CVD incidence relative risk was lower for increasing categories of moderate-to-vigorous activity (with HRs of 0.77 (0.71-0.84), 0.65 (0.59-0.72), and 0.57 (0.49-0.67), and was lower for increasing categories of total physical activity volume (with HRs of 0.77 (0.70-0.84), 0.66 (0.59-0.74), and 0.61 (0.52-0.71). In conclusion, this study demonstrated that increased amounts of exercise, measured objectively, are correlated with improved CVD incidence, CVD mortality, and all-cause mortality in patients with HTN.


Differences in mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) SARS-CoV-2 vaccine immunogenicity among patients undergoing dialysis

1. Patients on hemodialysis had higher levels of anti-spike and anti-receptor binding domain antibodies, at 6-7 weeks and 12 weeks after receiving 2 doses of the mRNA-1273 (Moderna) SARS-CoV-2 vaccine compared to 2 doses of the BNT162b2 (Pfizer-BioNTech) vaccine.

Evidence Rating Level: 2 (Good)

Patients on hemodialysis (HD) living with end-stage kidney disease are at greater risk of mortality from COVID-19. However, studies evaluating the efficacy of vaccines in those with kidney disease are limited. This current prospective cohort study evaluated the humoral response following the 2nd dose of two mRNA SARS-CoV-2 vaccines: The 30 ug dose BNT162b2 (Pfizer BioNTech) and 100 ug dose mRNA-1273 (Moderna) vaccines. Specifically, the study measured the levels of anti-spike protein and anti-receptor binding domain (anti-RBD) antibodies, at 6-7 weeks and 12 weeks after the 2nd dose. The study population consisted of 224 patients on HD, 129 who received the BNT162b2 vaccine and 95 who received the mRNA-1273 vaccine. The results showed that at 6-7 weeks post-vaccination, the median anti-spike antibody levels were significantly higher for mRNA-1273 (relative ratio 1.72, IQR 1.68-1.79) compared to BNT162b2 (relative ratio 1.58, IQR 1.28-1.67, p < 0.001), but the anti-RBD levels were not significantly different (relative ratio 1.44, IQR 1.29-1.53 for mRNA-1273 and relative ratio 1.23, IQR 0.61-1.64 for BNT162b2, p = 0.2). The proportion of individuals with a robust antibody response was 95% for anti-spike and 79% for anti-RBD in mRNA-1273 patients, which was significantly higher than the 73% for anti-spike and 50% for anti-RBD responses in BNT162b2 patients (p < 0.001). At 12 weeks, anti-spike levels had declined in BNT162b2 but not in mRNA-1273 patients (relative ratio 1.45, IQR 1.09-1.58 for BNT162b2 and relative ratio 1.93, IQR 1.76-2.02 for mRNA-1273, p < 0.001). This was true for anti-RBD levels (relative ratio 0.89, IQR 1.76-2.02 for BNT162b2, relative ratio 1.32, IQR 1.04-1.47 for mRNA-1273, p < 0.001). As well, 57.4% of BNT162b2 patients had robust anti-spike responses at 12 weeks compared to 96% of mRNA-1273 patients (p < 0.001), but there was no difference in proportion of anti-RBD responses (38.5% in BNT162b2 patients, 63% in mRNA-1273 patients, p = 0.002). Overall, there was a greater and longer-lasting humoral response in patients on hemodialysis who received 2 doses of the mRNA-1273 (Moderna) vaccine compared to those who received the BNT162b2 (Pfizer-BioNTech) vaccine.

Image: PD

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