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Efficacy of supervised home-based, real time, videoconferencing telerehabilitation in patients with type 2 diabetes: a single-blind randomized controlled trial

Eur J Phys Rehabil Med. 2023 Jun 23. doi: 10.23736/S1973-9087.23.07855-3. Online ahead of print.

ABSTRACT

BACKGROUND: Exercise-based interventions prevent or delay symptoms and complications of type 2 diabetes (T2D) and are highly recommended for T2D patients; though with very low participation rates. Τelerehabilitation (TR) could act as an alternative to overcome the barriers preventing the promotion of T2D patients’ well-being.

AIM: Determine the effects of a six-week TR program on glycemic control, functional capacity, muscle strength, PA, quality of life and body composition in patients with T2D.

DESIGN: A multicenter randomized, single-blind, parallel-group clinical study.

SETTING: Clinical trial.

POPULATION: Patients with T2D.

METHODS: Thirty T2D patients (75% male, 60.1±10.9 years) were randomly allocated to an intervention group (IG) and a control group (CG) with no exercise intervention. IG enrolled in a supervised, individualized exercise program (combination of aerobic and resistance exercises), 3 times/week for 6 weeks at home via a TR platform. Glycated hemoglobin (HbA1c), six-minute walk test (6MWT), muscle strength (Hand Grip Strength Test [HGS], 30-Second Chair Stand test [30CST] physical activity [IPAQ-SF]), quality of life (SF-36) and anthropometric variables were assessed.

RESULTS: Two-way repeated-ANOVA showed a statistically significant interaction between group, time and test differences (6MWT, muscle strength) (V=0.33, F [2.17]=4.14, P=0.03, partial η2=0.22). Paired samples t-test showed a statistically significant improvement in HbA1c (Z=-2.7), 6MWT (Μean ∆=-36.9±27.2 m, t=-4.5), muscle strength (Μean ∆=-1.5±1.4 kg, t=-2.22). Similarly, SF-36 (mental health [Μean ∆=-13.3±21.3%], general health [Μean ∆<inf>=</inf>-11.4±16.90%]) were statistically improved only in IG.

CONCLUSIONS: The findings of this study indicate that a 6-week supervised home-based TR exercise program induced significant benefits in patients with T2D, thus enabling telehealth implementation in rehabilitation practice as an alternative approach.

CLINICAL REHABILITATION IMPACT: Home-based exercise via the TR platform is a feasible and effective alternative approach that can help patients with T2D eliminate barriers and increase overall rehabilitation utilization.

PMID:37350165 | DOI:10.23736/S1973-9087.23.07855-3

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The impact of a pharmacist-led oral anticancer clinic on medication adherence and laboratory monitoring

J Oncol Pharm Pract. 2023 Jun 23:10781552231159870. doi: 10.1177/10781552231159870. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the impact that a pharmacist-managed oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

METHODS: A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib within the study time period. The primary outcome was assessing medication adherence by comparing the medication possession ratio (MPR) before (Phase 1) and after (Phase 2) initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome was assessing lab monitoring adherence by patients and providers in Phase 1 and Phase 2. This will be done by assessing whether labs were ordered at the appropriate time frame by oncology providers, as well as whether or not the patient came and got these labs drawn. This study will also examine outcomes related to the pharmacist-led oral anticancer therapy clinic (phase 2) for descriptive purposes.

RESULTS: A total of 189 charts were analyzed with 134 excluded and 55 included (25 patients in phase 1 and 30 patients in phase 2). Independent sample t-test analyses revealed a statistically significant increase (t(30.57) = -1.99; p = 0.027) in the MPR ratio between phase 1 (mean = 0.98, SD = 0.13) compared to phase 2 (mean = 1.04, SD = 0.08). For patient adherence to lab monitoring, there was a statistically significant improvement between phase 1 and phase 2 for patients on abiraterone (21.9% vs 67%; t(25) = -5.73; p < 0.001) and enzalutamide (35.7% vs. 90.5%; t(8) = -3.26; p = 0.006). However, for patients on ibrutinib, there was a slight decline in lab monitoring adherence between phase 1 and phase 2 but this effect was not statistically significant (56.2% vs. 51%; t(17) = 0.58; p = 0.283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had, on average, 6.7 encounters per patient with the majority being phone and face-to-face appointments.

CONCLUSIONS: Data from this study demonstrated that a pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer medication regimens. In addition, patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient and provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, relatively small sample size, and retrospective nature of this study. The results of this study support that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies that have shown similar benefits.

PMID:37350157 | DOI:10.1177/10781552231159870

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Predictors for the Development of Neurological Immune-related Adverse Events of Immune Checkpoint Inhibitors and Impact on Mortality

Eur J Neurol. 2023 Jun 23. doi: 10.1111/ene.15942. Online ahead of print.

ABSTRACT

BACKGROUND: Little is known about risk factors for developing neurological immunological adverse events (neuro-irAEs) from immune check point inhibitors (ICI). We report the incidence, predictors for development, impact on mortality of neuro-irAEs, and impact of ICI on pre-existing neurological conditions in a large clinical cohort.

METHODS: Patients who received ICI between January 2011 and December 2018 were identified from a tertiary cancer center registry. Descriptive statistics were used to summarize patient, cancer, and treatment data. Odds ratios from univariable and multivariable logistic regression models were calculated to identify potential predictors for developing a neuro-irAE. Impact of neuro-irAE on overall survival was estimated by Kaplan-Meier and Cox proportional-hazard models.

RESULTS: Overall frequency of neurological irAEs was 2.3%. Peripheral nervous system complications were most frequent (53.6%). Melanoma, younger age, prior chemotherapy, prior resection, CTLA-4 ICI exposure, and combination PD-1 and CTLA-4 ICI exposure had significantly higher odds for developing a neuro-irAE (p <0.05) on univariate but not multivariate models. Those with a neuro-irAE were less likely to die at 3 years compared to those without a neuro-irAE (69% vs 55%, p=0.004) in univariate but not multivariate model. Flare of pre-existing neurological condition after exposure to ICI was present (15.4%, 2 of 13 patients) but manageable. One patient was rechallenged with ICI without recurrent flare.

CONCLUSIONS: Neuro-irAEs are not associated with increase in overall mortality. Potential predictors for the development of neuro irAEs are younger age, melanoma, prior chemotherapy and resection, CTLA-4, or combination ICI exposure.

PMID:37350150 | DOI:10.1111/ene.15942

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Erectile dysfunction, depression, and anxiety in patients with functional anorectal pain: a case-control study

J Sex Med. 2023 Jun 22:qdad082. doi: 10.1093/jsxmed/qdad082. Online ahead of print.

ABSTRACT

BACKGROUND: Men with functional anorectal pain (FARP) report having erectile dysfunction (ED) and significant changes in psychological status.

AIM: The study sought to investigate the risk factors associated with FARP among male Chinese outpatients, alongside the impact of FARP on patients’ ED, depression, and anxiety.

METHODS: This case-control study included 406 male participants, divided into FARP (n = 323) and healthy control (n = 73) groups. Demographic and disease characteristics were collected from the patients, and the 5-item International Index of Erectile Function, Patient Health Questionnaire-9, and Generalized Anxiety Disorder 7 were used to assess erectile function, depression, and anxiety symptoms. Baseline characteristics were described using descriptive statistics, logistic regression analysis identified factors influencing FARP, and its association with ED, depression, and anxiety were analyzed using linear and ordinal logistic regression analyses. Validity was ensured through subgroup and sensitivity analyses.

OUTCOMES: The primary outcome was the association between FARP and ED, depression, and anxiety; the secondary outcome was the influencing factors of FARP such as lifestyle and work habits.

RESULTS: Men with FARP were likely to have more serious ED (59.8% vs 32.9%), depression (20.7% vs 4.1%), and anxiety(31.5% vs 12.3%); have lower 5-item International Index of Erectile Function scores; or have higher Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7 scores compared with unaffected participants. Alcohol intake, family relationship, high work pressure, and prolonged bowel movements were significantly associated with FARP severity. The association between FARP with ED, depression, and anxiety was statistically significant in both crude and adjusted models. FARP was associated with 2.47, 2.73, and 2.67 times higher risk for ED, depression, and anxiety, respectively. An increase pain severity increased the incidence of ED (moderate pain: 4.80 times, P < .000; severe pain: 3.49 times, P < .004), depression (moderate pain: 1.85 times, P < .017; severe pain: 2.04 times, P < .037), and anxiety (moderate pain: 1.86 times, P < .014).Clinical Implications: Changes in lifestyle and work habits can help prevent pain symptom exacerbation. Attention to erection and psychological issues in patients with FARP and interdisciplinary comprehensive treatment may improve the efficacy.

STRENGTHS AND LIMITATIONS: The study highlights a correlation between FARP and ED, depression, and anxiety, with pain severity being a contributing factor. However, the study’s limitations include a small sample size and potential recall bias, and other sexual functions were not thoroughly explored.

CONCLUSION: Patients with FARP have a higher prevalence of ED, depression, and anxiety, which increase with pain severity. Factors such as alcohol intake, work pressure, prolonged sitting, and longer defecation times are significantly correlated with FARP pain severity.

PMID:37350145 | DOI:10.1093/jsxmed/qdad082

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An investigation on cervical cancer and human papillomavirus vaccine knowledge, and analysis of influencing factors for choosing domestic or imported 2vHPV vaccine among females in Shenzhen, China

Hum Vaccin Immunother. 2023 Jun 23:2225389. doi: 10.1080/21645515.2023.2225389. Online ahead of print.

ABSTRACT

In 2020, the domestic (Chinese native) 2v human papillomavirus (HPV) vaccine was approved for use in females. At present, there are obvious differences in demand for different HPV vaccines. We aimed to investigate knowledge level of cervical cancer and HPV vaccine and its influencing factors among the eligible female recipients in Shenzhen, China, and to analyze the factors influencing choice of 2vHPV vaccine (domestic or imported) would be selected. A self-administered questionnaire was carried out on this investigation, and respondents were selected by random sampling method conducted by vaccination doctors. A total of 1197 valid questionnaires were collected, of which 729 (60.9%) were vaccinated with domestic vaccines and 468 (39.1%) were vaccinated with imported. Four hundred and fifty (61.7%) and 306 (65.4%) got a passing grade, respectively (χ2 = 1.637, P = .201). Logistic regression analysis showed that age (P = .002), ethnicity (P < .001), duration of residence in Shenzhen (P < .001), educational level (P < .001) and occupation (P < .001) were significant. It also showed that the manufacturers (P < .001), efficacy (P < .001), safety (P < .001), cognitive approach (P < .001), public opinion (P < .001), convenient acquisition (P < .001) and knowledge reserve (P = .035) were statistically significant. While price (P = .371) and doctor’s suggestion (P = .114) were not. In conclusion, eligible female recipients had a high degree of knowledge regarding cervical cancer and HPV vaccine, education level and occupation were the most important factors for scores. Domestic 2vHPV vaccine was more widely utilized than imported, manufacturer, efficacy, safety, cognitive approach, public opinion, convenient acquisition, and knowledge reserve had an impact on selection for recipients, while price and doctor’s suggestion did not.

PMID:37350143 | DOI:10.1080/21645515.2023.2225389

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The effect of blood pressure lowering medications on the prevention of episodic migraine: A systematic review and meta-analysis

Cephalalgia. 2023 Jun;43(6):3331024231183166. doi: 10.1177/03331024231183166.

ABSTRACT

BACKGROUND: Currently, only a few specific blood pressure-lowering medications are recommended for migraine prevention. Whether benefits extend to other classes or drugs is uncertain.

METHODS: Embase, MEDLINE, and the Cochrane Central Registry of Controlled Trials were searched for randomized control trials on the effect of blood pressure-lowering medications compared with placebo in participants with episodic migraine. Data were collected on four outcomes – monthly headache or migraine days, and monthly headache or migraine attacks, with a standardised mean difference calculated for overall. Random effect meta-analysis was performed.

RESULTS: In total, 50 trials (70% of which were crossover) were included, comprising 60 comparisons. Overall mean age was 39 years, and 79% were female. Monthly headache days were fewer in all classes compared to placebo, and this was statistically significant for all but one class: alpha-blockers -0.7 (95% CI: -1.2, -0.1), angiotensin-converting enzyme inhibitors -1.3 (95% CI: -2.9, 0.2), angiotensin II receptor blockers -0.9 (-1.6, -0.1), beta-blocker -0.4 (-0.8, -0.0) and calcium channel blockers -1.8 (-3.4, -0.2). Standardised mean difference was significantly reduced for all drug classes and was separately significant for numerous specific drugs: clonidine, candesartan, atenolol, bisoprolol, metoprolol, propranolol, timolol, nicardipine and verapamil.

CONCLUSION: Among people with episodic migraine, a broader number of blood pressure-lowering medication classes and drugs reduce headache frequency than those currently included in treatment guidelines.Trial Registration: The study was registered at PROSPERO (CRD42017079176).

PMID:37350141 | DOI:10.1177/03331024231183166

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How Does Being under the Influence Affect Willingness to Experience Overlapping Effects of Alcohol and Marijuana?

Subst Use Misuse. 2023 Jun 23:1-10. doi: 10.1080/10826084.2023.2223284. Online ahead of print.

ABSTRACT

OBJECTIVE: This study tested how individuals anticipate they will respond to opportunities to engage in simultaneous alcohol and marijuana (SAM) use.

METHODS: Two studies utilizing a within-subjects design were conducted. Study 1 was conducted in Spring 2021 and a replication (Study 2) was conducted in Fall 2021. Participants were presented with pairs of scenarios. One scenario pair compared how willing participants expected to be to get drunk if they were sober vs. high. Another pair compared how willing participants would be to take a hit of marijuana if they were sober vs. drunk. College attending young adults (Study 1: N = 173; female = 81%; Study 2: N = 212; female = 49.1%) with varying degrees of substance use experience were recruited.

RESULTS: In Study 1 participants reported greater willingness to get drunk when sober than when high. This was qualified by a statistically significant interaction whereby differences were greater among those who had more experience with past 30-day heavy drinking. Similar findings emerged for willingness to use marijuana. Participants anticipated greater willingness to use marijuana when sober than when drunk. This was also qualified by a statistically significant interaction whereby differences were greater among experimental or established users of marijuana than among abstainers. Study 2 findings replicated those from Study 1.

CONCLUSIONS: College attending young adults state greater willingness to remain under the influence of one substance than to engage in SAM use when opportunities arise. Simultaneous use of alcohol and marijuana among college students is likely an exception, not the rule. Implications for prevention are discussed.

PMID:37350140 | DOI:10.1080/10826084.2023.2223284

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Delivering Biopsychosocial Health Care Within Routine Care: Spotlight-AQ Pivotal Multicenter Randomized Controlled Trial Results

J Diabetes Sci Technol. 2023 Jun 23:19322968231183436. doi: 10.1177/19322968231183436. Online ahead of print.

ABSTRACT

BACKGROUND: Annual national diabetes audit data consistently shows most people with diabetes do not consistently achieve blood glucose targets for optimal health, despite the large range of treatment options available.

AIM: To explore the efficacy of a novel clinical intervention to address physical and mental health needs within routine diabetes consultations across health care settings.

METHODS: A multicenter, parallel group, individually randomized trial comparing consultation duration in adults diagnosed with T1D or T2D for ≥6 months using the Spotlight-AQ platform versus usual care. Secondary outcomes were HbA1c, depression, diabetes distress, anxiety, functional health status, and healthcare professional burnout. Machine learning models were utilized to analyze the data collected from the Spotlight-AQ platform to validate the reliability of question-concern association; as well as to identify key features that distinguish people with type 1 and type 2 diabetes, as well as important features that distinguish different levels of HbA1c.

RESULTS: n = 98 adults with T1D or T2D; any HbA1c and receiving any diabetes treatment participated (n = 49 intervention). Consultation duration for intervention participants was reduced in intervention consultations by 0.5 to 4.1 minutes (3%-14%) versus no change in the control group (-0.9 to +1.28 minutes). HbA1c improved in the intervention group by 6 mmol/mol (range 0-30) versus control group 3 mmol/mol (range 0-8). Moderate improvements in psychosocial outcomes were seen in the intervention group for functional health status; reduced anxiety, depression, and diabetes distress and improved well-being. None were statistically significant. HCPs reported improved communication and greater focus on patient priorities in consultations. Artificial Intelligence examination highlighted therapy and psychological burden were most important in predicting HbA1c levels. The Natural Language Processing semantic analysis confirmed the mapping relationship between questions and their corresponding concerns. Machine learning model revealed type 1 and type 2 patients have different concerns regarding psychological burden and knowledge. Moreover, the machine learning model emphasized that individuals with varying levels of HbA1c exhibit diverse levels of psychological burden and therapy-related concerns.

CONCLUSION: Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes. Results reflect the importance of a biopsychosocial approach to routine care visits. Spotlight-AQ is viable across health care settings for improved outcomes.

PMID:37350136 | DOI:10.1177/19322968231183436

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A combined multilevel factor analysis and covariance regression model with mixed effects in the mean and variance structure

Stat Med. 2023 Jun 23. doi: 10.1002/sim.9768. Online ahead of print.

ABSTRACT

Li et al developed a multilevel covariance regression (MCR) model as an extension of the covariance regression model of Hoff and Niu. This model assumes a hierarchical structure for the mean and the covariance matrix. Here, we propose the combined multilevel factor analysis and covariance regression model in a Bayesian framework, simultaneously modeling the MCR model and a multilevel factor analysis (MFA) model. The proposed model replaces the responses in the MCR part with the factor scores coming from an MFA model. Via a simulation study and the analysis of real data, we show that the proposed model is quite efficient when the responses of the MCR model are not measured directly but are latent variables such as the patient experience measurements in our motivating dataset.

PMID:37350103 | DOI:10.1002/sim.9768

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Understanding the resilience of children living on an American Indian reservation: A mixed methods participatory study

J Adv Nurs. 2023 Jun 22. doi: 10.1111/jan.15734. Online ahead of print.

ABSTRACT

AIM: To explore the resilience of children, six to thirteen years old, living on a Northern Plains American Indian Reservation using a situation specific nursing theory.

BACKGROUND: American Indian and Alaska Native children experience mental health inequities compared to their white peers, including substance use, suicide, depression, and anxiety. Resilience is a strength of children that can be leveraged to improve their mental health.

DESIGN: A parallel convergent mixed methods design.

METHODS: A community advisory board culturally adapted resilience instruments. During two weeks in summer 2022, forty-seven children/caregiver dyads completed surveys about the child’s resilience. Descriptive statistics gave the scores of each child’s personal, relational, and total resilience. A subset of 20 children participated in a semi-structured interview.

RESULTS: Children scored high on overall resilience, and higher on the relational subscale than the personal subscale. Caregiver survey scores were not significantly correlated with their child’s scores and were higher than the children’s scores. Qualitative coding revealed six themes of resilience. Integration of data showed a concordance and expansion of the quantitative data across themes.

CONCLUSION: The children reported high resilience supported by a strong ecosystem of relationships. Resilience, as explained through children’s voices, corroborated with findings from the surveys.

IMPLICATIONS FOR NURSING: Findings will help nurses across sectors of primary, secondary, and tertiary care create resilience-enhancing interventions and prevent mental health crises in this community.

IMPACT STATEMENT: This findings from this study will inform local mental health interventions on the Reservation. The study provides a reproducible design to adapt to other Indigenous communities.

PUBLIC CONTRIBUTION: A community advisory board was a partner in every stage of the study. Children and caregivers participated in data collection.

CONTRIBUTION TO THE WIDER CLINICAL COMMUNITY: This research provides knowledge that will further social justice efforts within nursing to promote health equity across diverse populations.

PMID:37350100 | DOI:10.1111/jan.15734