Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings: Results from the TANDEM Study.

INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) and dolutegravir/rilpivirine (DTG/RPV) are fixed-dose, complete, single-tablet, two-drug regimens (2DRs) indicated for HIV-1. DTG/3TC is approved for antiretroviral therapy (ART)-naive people with HIV-1 and virologically suppressed individuals to replace current ART; DTG/RPV is indicated for virologically suppressed individuals as a switch option. Virologic efficacy and effectiveness of these DTG-based 2DRs have been demonstrated in phase 3 clinical trials and real-world cohorts, primarily from Europe. This study characterized real-world use of DTG-based 2DRs for HIV-1 treatment in the USA. METHODS: TANDEM was a retrospective medical chart review across 24 US sites. Individuals aged ≥ 18 years who initiated DTG/3TC or DTG/RPV before September 30, 2020, with ≥ 6 months of follow-up were included. One cohort included ART-naive people who initiated DTG/3TC (n = 126), and two other cohorts included virologically suppressed (HIV-1 RNA < 50 copies/mL) people on stable ART regimens for ≥ 3 months before switch to either DTG/3TC (n = 192) or DTG/RPV (n = 151). Clinical characteristics, treatment history, and outcomes are described. RESULTS: Virologically suppressed individuals were older than those who were ART-naive, and the ART-naive cohort had higher proportions of individuals assigned male at birth and of Hispanic ethnicity. The most common healthcare provider-reported reason for choosing a DTG-based 2DR was avoidance of long-term toxicities (25-33% across cohorts), followed by simplification/streamlining of treatment. Among ART-naive people on DTG/3TC, 94% achieved virologic suppression after initiation, and 83% maintained suppression at last follow-up; discontinuation rate was < 1%. Among cohorts who switched to DTG-based 2DRs, 96% maintained virologic suppression on DTG/3TC and 93% on DTG/RPV; 2% on DTG/3TC and 3% on DTG/RPV discontinued. CONCLUSION: Motivation for selecting DTG-based 2DRs was primarily driven by a desire to avoid or manage toxicities and simplify treatment. Results demonstrate that DTG/3TC and DTG/RPV are effective in real-world settings, with few discontinuations, reflecting data from clinical trials.

Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads: TANDEM Study Subgroup Analyses.

INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study. METHODS: TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. RESULTS: Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. CONCLUSIONS: Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads.

Addressing psychosocial needs in patients with Long-COVID (PsyLoCo-Study): study protocol of a pilot-study of a specialized modular intervention.

Introduction: After an acute infection with the corona virus 10-20% of those affected suffer from ongoing or new symptoms. A causal therapy for the phenomenon known as Long/Post-COVID is still lacking and specific therapies addressing psychosocial needs of these patients are imperatively needed. The aim of the PsyLoCo-study is developing and piloting a psychotherapeutic manual, which addresses Long/Post-COVID-related psychosocial needs and supports in coping with persistent bodily symptoms as well as depressive or anxiety symptoms. Methods and analysis: This pilot trial implements a multi-centre, 2-arm (N=120; allocation ratio: 1:1), parallel group, randomised controlled design. The pilot trial is designed to test the feasibility and estimate the effect of 1) a 12-session psychotherapeutic intervention compared to 2) a wait-list control condition on psychosocial needs as well as bodily and affective symptoms in patients suffering from Long/Post-COVID. The intervention uses an integrative, manualized, psychotherapeutic approach. The primary study outcome is health-related quality of life. Outcome variables will be assessed at three timepoints, pre-intervention (t1), post-intervention (t2) and three months after completed intervention (t3). To determine the primary outcome, changes from t1 to t2 are examined. The analysis will be used for the planning of the RCT to test the efficacy of the developed intervention. Discussion: The pilot study will evaluate a 12-session treatment manual for Long/Post-COVID sufferers and the therapy components it contains. The analysis will provide insights into the extent to which psychotherapeutic treatment approaches improve the symptoms of Long/Post-COVID sufferers. The treatment manual is designed to be carried out by psychotherapists as well as people with basic training in psychotherapeutic techniques. This approach was chosen to enable a larger number of practitioners to provide therapeutic support for Long/Post-COVID patients. After completion of the pilot study, it is planned to follow up with a randomized controlled study and to develop a treatment guideline for general practitioners and interested specialists. Trial registration: The pilot trial has been registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien; Trial-ID: DRKS00030866; URL: https://drks.de/search/de/trial/DRKS00030866) on March 7, 2023.

SARS-CoV-2 infection is associated with physical but not mental fatigue - Findings from a longitudinal controlled population-based study.

OBJECTIVE: Fatigue has been identified as the core symptom of long-Covid, however, putative pandemic-related influences remain largely unclear. We investigated trajectories of total, physical and mental fatigue and the factors associated with it in previously infected and non-infected individuals up to one year post- infection. METHODS: We used data from a longitudinal cohort study of German adults with two samples: A representative probability sample and a sample of individuals with proven SARS-CoV-2 infection. Surveys were conducted in spring 2020(T1), autumn 2020(T2) and summer 2021(T3). Fatigue was assessed using the FAS, distinguishes between physical and mental fatigue. Depression, anxiety and stress were assessed using PHQ-4 and PSQ. RESULTS: 1990 participants [mean age 47.2 (SD = 17.0), 30.5% previously infected] were included in the survey at T1 (n = 1118 at T2, n = 692 at T3). Total and physical fatigue, but not mental fatigue were significantly higher in the previously infected compared to the non-infected sample at T2, but this group difference disappeared at T3. We identified Covid-infection as a factor associated with transient total and physical fatigue at T2. Depression, anxiety and stress at T1 were associated with total, physical and mental fatigue at both follow-ups. CONCLUSIONS: Our results highlight the importance of considering physical and mental fatigue as separate entities, while suggesting a greater relevance of the physical signs of fatigue in understanding long-Covid. The results further showed that baseline mental health symptoms were the most strongly associated with fatigue trajectories.

Benefit of Prompt Vs Delayed Initiation of Triple Therapy Following an Exacerbation in Patients with COPD in Japan: A Retrospective Cohort Study.

Purpose: There is currently limited evidence for the optimal timing of triple therapy initiation in Japan, which is crucial for optimizing strategies for the effective treatment of chronic obstructive pulmonary disease (COPD). This study assessed the impact of prompt vs delayed initiation of triple therapy following a COPD exacerbation on clinical and economic outcomes in patients in Japan. Patients and Methods: Retrospective cohort study of patients in the Medical Data Vision Co., Ltd. database initiating triple therapy as single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol or budesonide/glycopyrronium/formoterol) or multiple-inhaler triple therapy within 180 days of a moderate-to-severe exacerbation (index). For the main analysis, patients were categorized as prompt or delayed initiators, initiating triple therapy within 0-30 days or 31-180 days of index, respectively. Inverse probability of treatment weighting based on propensity scores was used to adjust for measured confounders between prompt and delayed cohorts. Results: For the main analysis, 610 (60.3%) and 402 (39.7%) patients were prompt and delayed initiators, respectively. The rate of subsequent moderate-to-severe exacerbations following index exacerbation was numerically lower in prompt vs delayed initiators (weighted rate ratio 0.95, 95% confidence interval [CI]: 0.74-1.21; P = 0.6603). Time-to-first subsequent moderate-to-severe exacerbation increased significantly in prompt vs delayed initiators (weighted hazard ratio 0.77, 95% CI: 0.64-0.93; P = 0.0053). In patients indexed on a severe exacerbation, delayed initiation resulted in significantly higher 90-day all-cause readmissions vs prompt initiation (42.1% vs 30.6%; P = 0.0329 [weighted estimates]). Weighted healthcare resource utilization rates were numerically lower in prompt vs delayed initiators, and weighted direct costs (all cause and COPD-related) were significantly lower in prompt initiators. Conclusion: This real-world study demonstrated that earlier initiation of triple therapy resulted in several benefits in clinical outcomes for COPD and may also reduce the economic burden of COPD management in Japan.

Stress and Depressive and Anxiety Symptoms in the General Population and in SARS-CoV-2-Infected Patients-Findings from a Population-Based Three-Wave Study.

Objective: Understanding factors that impaired mental health during the COVID-19 pandemic is extremely relevant in order to mitigate long-term consequences of the pandemic and to promote resilience in future crises. Method: Data were collected in southern Germany in a population-based survey study (CoKoS) with three times of measurement in May 2020, November 2020 and July 2021. Predictors of depressive and anxiety symptoms were measured with a short version of the Patient Health Questionnaire (PHQ-4) in the general population (N = 758) and individuals who were infected with SARS-CoV-2 in the beginning of the pandemic (N = 412). We investigated differences between both samples and how stress components (worry, tension, demands and joy) measured with the Perceived Stress Questionnaire (PSQ) varied with depressive and anxiety symptoms over time. Three linear mixed models (GLMMs) were fitted to predict the PHQ-4 stepwise, including sociodemographic variables and stress (PSQ). Results: Depressive and anxiety symptoms increased from May 2020 to November 2020 and remained stable until July 2021. There were no differences between people with SARS-CoV-2 infection and the general population. Those with a pre-existing disease and lower education reported higher levels of depressive and anxiety symptoms. Stress explained a substantial fraction of variance in depressive and anxiety symptoms. The stress component worry emerged as the strongest predictor of depressive and anxiety symptoms, whereas joy seemed to buffer these symptoms. Conclusions: The results suggest that mitigating people's worry and increasing joy may promote resilience in future crises. Future studies should assess mental health interventions targeted at vulnerable groups, such as those with lower socioeconomic status and poorer health.

Quantifying The Burden of Persistent Musculoskeletal Pain in Employees at Rolls-Royce in The United Kingdom: A Real-World Cross-Sectional Survey.

OBJECTIVE: We aimed to investigate the burden of persistent musculoskeletal (MSK) pain in Rolls-Royce UK employees. METHODS: Employees with ( n = 298) and without ( n = 329) persistent MSK pain completed a cross-sectional survey. Weighted regression analyses were conducted to compare sickness absence, work ability, workplace accommodations/adaptations, and emotional well-being between these cohorts, controlling for confounders. RESULTS: Persistent MSK pain (particularly back pain) had a significant impact on physical work ability and was associated with increased sickness absence due to pain. Many employees (56%) had not disclosed their condition to their managers. Of these, 30% felt uncomfortable doing so, and 19% of employees reported insufficient support at work for their pain. CONCLUSIONS: These findings highlight the importance of creating a workplace culture that encourages the disclosure of work-relevant pain, enabling organizations to consider improved, tailored support for employees.

[A naturalistic study on the effects of antidepressants (e. g. SSRI) and acetyl salicylic acid (ASA) on the self-rated perception of the psychotherapeutic process of inpatient psychosomatic treatment and its results: Could ASA be beneficial?] / Eine naturalistische Untersuchung zur Auswirkung häufiger antidepressiver Medikationen (wie SSRI) und der Acetylsalicylsäure (ASS) auf die Selbstbeurteilungen der Wahrnehmung und des Ergebnisses stationärer Psychotherapie: Könnte ASS förderlich sein?

Objectives: Psychic perceptions are at the core of psychotherapeutic processes and modifiable by certain psychopharmacologic agents including antidepressants and cyclooxygenase (COX) inhibitors like acetylsalicylic acid (ASA). Methods: We analyzed the medical records of 208 participants, and used the weekly mean dosages and the number of weeks in therapy to predict ward experience (Stationserfahrungsbogen) and symptom burden (symptom-check list 90-R) by means of linear regression analyses and four repeated measures. Results: Time predicted symptom relief. ASA signified a more favorable ward experience and a trend towards less suffering. Antidepressants did not predict symptom burden or ward experience, except for amitriptyline's inverse relationship with process perception. Discussion: Regarding process perception and therapy outcome, amitriptyline might have unfavorable effects at dose reductions, whereas COX-inhibition could be beneficial at higher dosages. Similar findings have already been described with regard to COX-inhibition in depression and schizophrenia.

The role of face masks within in-patient psychotherapy: Results of a survey among inpatients and healthcare professionals.

Introduction: Face-to-face medical and psychotherapeutic treatments during the Corona pandemic often involve patients and health care providers wearing face masks. We performed a pilot survey assessing the subjective experience of wearing face masks during psychotherapy sessions regarding (i) feasibility, (ii) psychotherapeutic treatment and (iii) communication, emotion and working alliance in patients and healthcare professionals. Methods: A total of n = 62 inpatients (RR = 95.4%) and n = 33 healthcare professionals (RR = 86.8%) at an academic department of Psychosomatic Medicine and Psychotherapy participated in this survey anonymously. The items of the questionnaire were created by the interprofessional expert team and were based on existing instruments: (i) the Therapeutic Relationship Questionnaire and (ii) the German translation of Yalom's Questionnaire on Experiencing in Group Psychotherapy. Results: The majority of patients rate their psychotherapy as highly profitable despite the mask. In individual therapy, face masks seem to have a rather low impact on subjective experience of psychotherapy and the relationship to the psychotherapist. Most patients reported using alternative facial expressions and expressions. In the interactional group therapy, masks were rather hindering. On the healthcare professional side, there were more frequent negative associations of face masks in relation to (i) experiencing connectedness with colleagues, (ii) forming relationships, and (iii) therapeutic treatment. Discussion: Information should be given to patients about the possible effects of face masks on the recognition of emotions, possible misinterpretations and compensation possibilities through alternative stimuli (e.g., eye area) and they should be encouraged to ask for further information. Especially in group therapy, with patients from other cultural backgrounds and in cases of need for help (e.g., hearing impairment) or complex disorders, appropriate non-verbal gestures and body language should be used to match the intended emotional expression.

#Fighteverycrisis: A psychological perspective on motivators of the support of mitigation measures in the climate crisis and the COVID-19 pandemic.

Both crises, the climate crisis and the COVID-19 pandemic need collective mitigation support. In the context of COVID-19, the support of mitigation strategies has found its way to the forefront of debates. Our aim was to contribute empirical evidence to this debate by investigating mitigation behaviors across both crises and discussing similarities and differences. To this end, we drew on the Norm Activation Model and the concept of Social Identity to understand individuals' support of mitigation strategies in the climate crisis and their support of governmental strategies to mitigate the spread of the virus. Data were gathered within a Germany-wide survey (N = 3092) carried out in June and July 2020. Three predictors significantly explained the support of mitigation strategies in both crises: (1) The awareness that the entire society is affected by the pandemic emerged as the strongest predictor for support of COVID-19 mitigation strategies, whereas (2) social identification with others making efforts to mitigate the climate crisis was the strongest predictor for support of climate crisis mitigation strategies. (3) Efficacy expectations that together with others one can make a substantial contribution to mitigate the respective crisis predicted support of mitigation strategies in the COVID-19 pandemic and the climate crisis to similar proportions. The results point to the need for targeting the communication of mitigation strategies in a pandemic on raising awareness for the collective nature of the problem whereas strengthening efficacy expectations and feelings of belonging, e.g. through participation processes, could generally strengthen the support of mitigation strategies in both crises.

The Unhappy Shoulder: A Conceptual Review of the Psychosomatics of Shoulder Pain.

INTRODUCTION: Chronic pain is a multifaceted disorder genuinely entangled with psychic and psychosomatic symptoms, which are typically involved in the processes of chronification. The impingement syndrome of the shoulder is no exception to this rule, but several studies have shown respective peculiarities among those with pain and impingement of the shoulder. Notably, chronic pain is a lateralized experience, and, similarly, its psychosomatic correlates may be attached to the hemispheres functionally. AIM: The present review therefore gives an overview of the respective findings, with regard not only to psychopathology, but also to personality factors and psychologic trauma, since the latter are reportedly associated with chronic pain. Moreover, we acknowledge symmetry as a possible pathogenic factor. METHODS: This narrative review followed the current standards for conducting narrative studies. Based on prior findings, our research strategy included the relevance of psychotraumatologic and symmetrical aspects, as well as comorbidity. We retrieved the relevant literature reporting on the impact of psychopathology as well as personality features on shoulder pain, as published up to January 2022 from the Medline database (1966-2022). Study selecton: We included numerous studies, and considered the contextual relevance of studies referring to the neuropsychosomatics of chronic pain. RESULTS: Pain-specific fears, depression, and anxiety are important predictors of shoulder pain, and the latter is generally overrepresented in those with trauma and PTSD. Moreover, associations of shoulder pain with psychological variables are stronger as regards surgical therapies as compared to conservative ones. This may point to a specific and possibly trauma-related vulnerability for perioperative maladaptation. Additionally, functional hemispheric lateralization may explain some of those results given that limb pain is a naturally lateralized experience. Not least, psychosocial risk factors are shared between shoulder pain and its physical comorbidities (e.g., hypertension), and the incapacitated state of the shoulder is a massive threat to the function of the human body as a whole. CONCLUSIONS: This review suggests the involvement of psychosomatic and psychotraumatologic factors in shoulder impingement-related chronic pain, but the inconclusiveness and heterogeneity of the literature in the field is possibly suggestive of other determinants such as laterality.

How do appraisal as threat or challenge, efficacy, and environmental quality affect wellbeing in the COVID-19 pandemic?

Background: In crises, it is of great relevance to identify mechanisms that help people to maintain a certain level of wellbeing. This paper investigates whether appraising the COVID-19 pandemic as a threat vs. as a challenge has different effects on subjective wellbeing during the pandemic. Furthermore, we study the role of the perceived local environmental quality for individuals' subjective wellbeing. Methods: Via online survey study with two times of measurement (N = 758), we investigated (a) the prediction of participants' wellbeing in June 2020 and June 2021 through five variables and (b) how these five variables moderated within-participant differences in subjective wellbeing over time. Results: Results showed that a stronger perception of the pandemic as a threat (feeling worried) and a lower education in June 2020 predicted a lower subjective wellbeing in 2020 and 2021. A stronger challenge appraisal (feeling confident), higher efficacy expectations, and positive perceptions of the local environmental quality in June 2020 predicted a higher wellbeing in 2020 and 2021. There was no substantial change in participants' aggregated wellbeing over time. However, those who perceived the pandemic more as a threat in June 2020 struggled more with negative changes in their wellbeing, whereas those who perceived the pandemic more as a challenge reported a higher wellbeing. Conclusion: It seems key to support people in activating positive feelings to successfully cope with crises.

COVID-19 - A window of opportunity for the transition toward sustainable mobility?

The mobility sector was one of the sectors most affected by COVID-19 and its political restrictions, with, inter alia a huge drop in mobility behavior due to travel bans, lockdowns, and a reduced need to be mobile. The present study examined the potential of COVID-19 restrictions aiming at containing the spread of the virus to be a window of opportunity for the transition toward sustainable mobility by breaking up strongly habitualized daily and travel mobility behaviors through changes of behavioral contexts. We conducted an online survey in a sample representative for the German population (N = 3092) to study the consequences of the COVID-19 restrictions on Germans' daily and travel mode choices and on their wishes for future mobility. Furthermore, we examined the moderating effects of Germans' personal norms to protect the climate on changes in their mobility behavior toward sustainable mobility, both within and beyond the corona pandemic. In line with previous research, the present study shows an overall reduction of mobility across almost all modes of transport for daily and travel mobility during time periods of COVID-19 restrictions compared to pre-COVID-19-times, with different transport modes being affected differently. Our findings additionally point out the relevance of personal norms to protect the climate for the transition toward sustainable mobility behavior. Altogether, the present study provides first empirical evidence for the corona pandemic to represent a window of opportunity for the transition toward sustainable mobility. Furthermore, the study also points out relevant directions for further research.