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Effectiveness of Varenicline as an Aid to Smoking Cessation in Primary Care: An Observational Study
(2012)
Aims: Although varenicline is commonly prescribed in primary care, information on smoking-related comorbidities and the effectiveness of varenicline in this context in Germany is scarce. This study assessed the efficacy and safety of varenicline in a large sample of patients seeking smoking cessation treatment through their general practitioners. The frequency of comorbidities was also evaluated. Methods: This was a 12-week, prospective, observational, non-comparative phase IV trial conducted in Germany. Abstinence rates at week 12 were evaluated by verbal reporting using the nicotine use inventory. Results: Overall, 1,391 subjects were enrolled; 1,177 received study medication and were evaluated for effectiveness and safety. At the end of the study, 71.1% (95% confidence interval 68.5–73.7) of subjects were abstinent. There were a total of 205 all-causality adverse events; 2.2% were classified as serious or severe. There were no fatal adverse events. At inclusion, 66.7% of participants had at least 1 concurrent comorbidity, with chronic obstructive pulmonary disease (35.5%), hypertension (29.6%) and depression (10.4%) being the most commonly reported. Conclusion: These real-world data indicate that varenicline is an effective and well-tolerated smoking cessation treatment when used in the primary care setting including patients with smoking-related comorbidities.
Abstract
Purpose
This study aims to assess the implementation of published research, contraindications, and warnings on the prescription of dual renin‐angiotensin‐hormone system (RAS) blockade in ambulatory care in Germany.
Methods
Cohort study based on health claims data of 6.7 million subjects from 2008 to 2015. Yearly prevalence and incidence for dual RAS blockade with (a) angiotensin‐converting enzyme inhibitors and angiotensin‐receptor blockers (ACEI + ARB) and (b) aliskiren and ACEI or ARB (aliskiren + ACEI/ARB) were calculated. We assessed prescriber specialty and associations between discontinuing dual RAS blockade with specialist (internal medicine, cardiology, nephrology) visits and hospital discharge in the previous year.
Results
A total of 2 984 517 patients were included (age 51.4 ± SD 18.4 y, 48.5% male). Prescription rates for ACEI + ARB decreased from 0.6% (n = 17 907) to 0.4% (n = 12 237) and for aliskiren + ACEI/ARB from 0.23% (n = 6634) to 0.03% (n = 818). Incident prescriptions decreased from 0.23% (n = 6705) to 0.19% (n = 5055) (ACE + ARB) and from 0.1% (n = 2796) to 0.005% (n = 142) (aliskiren + ACE/ARB); 59% of ACEI + ARB and 48% of aliskiren + ACE/ARB combinations were prescribed only by one physician. Of those, 73% (ACEI + ARB) and 58% (aliskiren + ACE/ARB) were primary care providers (PCPs). Discontinuing dual RAS blockade was associated with specialist care and hospital discharge in the previous year (specialist care: RR 1.4, 95% CI, 1.3‐1.6; hospital visit: RR 1.5, 95% CI, 1.3‐1.6).
Conclusions
Our results suggest a delayed uptake of treatment recommendation for ACEI + ARB and a higher impact of Dear Doctor letters addressing PCPs directly compared with published research, contraindications, and warnings. Targeted continuous medical education, practice software alerts, and stronger involvement of pharmacists might improve the implementation of medication safety recommendations in ambulatory care.
Introduction: The aim of this study was to test whether brief alcohol interventions at general hospitals work equally well for males and females and across age-groups.
Methods: The current study includes a reanalysis of data reported in the PECO study (testing delivery channels of individualized motivationally tailored alcohol interventions among general hospital patients: in PErson vs. COmputer-based) and is therefore of exploratory nature. At-risk drinking general hospital patients aged 18–64 years (N = 961) were randomized to in-person counseling, computer-generated individualized feedback letters, or assessment only. Both interventions were delivered on the ward and 1 and 3 months later. Follow-ups were conducted at months 6, 12, 18, and 24. The outcome was grams of alcohol/day. Study group × sex and study group × age interactions were tested as predictors of change in grams of alcohol/day over 24 months in latent growth models. If rescaled likelihood ratio tests indicated improved model fit due to the inclusion of interactions, moderator level-specific net changes were calculated.
Results: Model fit was not significantly improved due to the inclusion of interaction terms between study group and sex (χ2[6] = 5.9, p = 0.439) or age (χ2[6] = 5.5, p = 0.485).
Discussion: Both in-person counseling and computer-generated feedback letters may work equally well among males and females as well as among different age-groups. Therefore, widespread delivery of brief alcohol interventions at general hospitals may be unlikely to widen sex and age inequalities in alcohol-related harm.
Background
Few studies have assessed trajectories of alcohol use in the general population, and even fewer studies have assessed the impact of brief intervention on the trajectories. Especially for low-risk drinkers, it is unclear what trajectories occur, whether they benefit from intervention, and if so, when and how long. The aims were first, to identify alcohol use trajectories among at-risk and among low-risk drinkers, second, to explore potential effects of brief alcohol intervention and, third, to identify predictors of trajectories.
Methods
Adults aged 18-64 years were screened for alcohol use at a municipal registration office. Those with alcohol use in the past 12 months (N = 1646; participation rate: 67%) were randomized to assessment plus computer-generated individualized feedback letters or assessment only. Outcome was drinks/week assessed at months 3, 6, 12, and 36. Alcohol risk group (at-risk/low-risk) was determined using the Alcohol Use Disorders Identification Test–Consumption. Latent class growth models were estimated to identify alcohol use trajectories among each alcohol risk group. Sex, age, school education, employment status, self-reported health, and smoking status were tested as predictors.
Results
For at-risk drinkers, a light-stable class (46%), a medium-stable class (46%), and a high-decreasing class (8%) emerged. The light-stable class tended to benefit from intervention after 3 years (Incidence Rate Ratio, IRR=1.96; 95% Confidence Interval, CI: 1.14–3.37). Male sex, higher age, more years of school, and current smoking decreased the probability of belonging to the light-stable class (p-values<0.05). For low-risk drinkers, a very light-slightly increasing class (72%) and a light-increasing class (28%) emerged. The very light-slightly increasing class tended to benefit from intervention after 6 months (IRR=1.60; 95% CI: 1.12–2.28). Male sex and more years of school increased the probability of belonging to the light-increasing class (p-value < 0.05).
Conclusion
Most at-risk drinkers did not change, whereas the majority of low-risk drinkers increased alcohol use. There may be effects of alcohol feedback, with greater long-term benefits among persons with low drinking amounts. Our findings may help to identify refinements in the development of individualized interventions to reduce alcohol use.
Multivariate analysis of independent determinants of ADL/IADL and quality of life in the elderly
(2022)
Background
This study evaluated the determinants of disability and quality of life in elderly people who participated at the multi-centred RubiN project (Regional ununterbrochen betreut im Netz) in Germany.
Methods
Baseline data of the subjects aged 70 years and older of the RubiN project were used and only subjects with complete data sets were considered for the ensuing analysis (complete case analysis (CCA)).
Disability was examined using the concepts of ADL (activities of daily living) and IADL (instrumental activities of daily living). Subjects exhibiting one or more deficiencies in ADL respectively IADL were considered as ADL respectively IADL disabled. Quality of life was assessed using the WHOQOL-BREF and the WHOQOL-OLD. Applying multivariate analysis, sociodemographic factors, psychosocial characteristics as well as the functional, nutritional and cognitive status were explored as potential determinants of disability and quality of life in the elderly.
Results
One thousand three hundred seventy-five subjects from the RubiN project exhibited data completeness regarding baseline data. ADL and IADL disability were both associated with the respective other construct of disability, sex, a reduced cognitive and functional status as well as domains of the WHOQOL-BREF. Furthermore, ADL disability was related to social participation, while IADL disability was linked to age, education and social support. Sex, ADL and IADL disability, income, social support and social participation as well as the functional status were predictors of the domain ‘Physical Health’ (WHOQOL-BREF). The facet ‘Social Participation’ (WHOQOL-OLD) was affected by both ADL and IADL disability, income, social participation, the nutritional and also the functional status.
Conclusions
Several potential determinants of disability and quality of life were identified and confirmed in this study. Attention should be drawn to prevention schemes as many of these determinants appear to be at least partly modifiable.
Background
In the German health care system, parents with an acutely ill child can visit an emergency room (ER) 24 hours a day, seven days a week. At the ER, the patient receives a medical consultation. Many parents use these facilities as they do not know how urgently their child requires medical attention. In recent years, paediatric departments in smaller hospitals have been closed, particularly in rural regions. As a result of this, the distances that patients must travel to paediatric care facilities in these regions are increasing, causing more children to visit an ER for adults. However, paediatric expertise is often required in order to assess how quickly the patient requires treatment and select an adequate treatment. This decision is made by a doctor in German ERs. We have examined whether remote paediatricians can perform a standardised urgency assessment (triage) using a video conferencing system.
Methods
Only acutely ill patients who were brought to a paediatric emergency room (paedER) by their parents or carers, without prior medical consultation, have been included in this study. First, an on-site paediatrician assessed the urgency of each case using a standardised triage. In order to do this, the Paediatric Canadian Triage and Acuity Scale (PaedCTAS) was translated into German and adapted for use in a standardised IT-based data collection tool. After the initial on-site triage, a telemedicine paediatrician, based in a different hospital, repeated the triage using a video conferencing system. Both paediatricians used the same triage procedure. The primary outcome was the degree of concordance and interobserver agreement, measured using Cohen’s kappa, between the two paediatricians. We have also included patient and assessor demographics.
Results
A total of 266 patients were included in the study. Of these, 227 cases were eligible for the concordance analysis. In n = 154 cases (68%), there was concordance between the on-site paediatrician’s and telemedicine paediatrician’s urgency assessments. In n = 50 cases (22%), the telemedicine paediatrician rated the urgency of the patient’s condition higher (overtriage); in 23 cases (10%), the assessment indicated a lower urgency (undertriage). Nineteen medical doctors were included in the study, mostly trained paediatric specialists. Some of them acted as an on-site doctor and telemedicine doctor. Cohen’s weighted kappa was 0.64 (95% CI: 0.49–0.79), indicating a substantial agreement between the specialists.
Conclusions
Telemedical triage can assist in providing acute paediatric care in regions with a low density of paediatric care facilities. The next steps are further developing the triage tool and implementing telemedicine urgency assessment in a larger network of hospitals in order to improve the integration of telemedicine into hospitals’ organisational processes. The processes should include intensive training for the doctors involved in telemedical triage.
Background
The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The “COVID-19 Data Exchange Platform” (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing. All 34 participating university hospitals (NUM sites) work upon a harmonised infrastructural as well as legal basis for their data protection-compliant collection and transfer of their research dataset to the central CODEX platform. Each NUM site ensures that the exchanged consent information conforms to the already-balloted HL7 FHIR consent profiles and the interoperability concept of the MII Task Force “Consent Implementation” (TFCI). The Independent Trusted Third-Party (TTP) of the University Medicine Greifswald supports data protection-compliant data processing and provides the consent management solutions gICS.
Methods
Based on a stakeholder dialogue a required set of FHIR-functionalities was identified and technically specified supported by official FHIR experts. Next, a “TTP-FHIR Gateway” for the HL7 FHIR-compliant exchange of consent information using gICS was implemented. A last step included external integration tests and the development of a pre-configured consent template for the BC for the NUM sites.
Results
A FHIR-compliant gICS-release and a corresponding consent template for the BC were provided to all NUM sites in June 2021. All FHIR functionalities comply with the already-balloted FHIR consent profiles of the HL7 Working Group Consent Management. The consent template simplifies the technical BC rollout and the corresponding implementation of the TFCI interoperability concept at the NUM sites.
Conclusions
This article shows that a HL7 FHIR-compliant and interoperable nationwide exchange of consent information could be built using of the consent management software gICS and the provided TTP-FHIR Gateway. The initial functional scope of the solution covers the requirements identified in the NUM-CODEX setting. The semantic correctness of these functionalities was validated by project-partners from the Ludwig-Maximilian University in Munich. The production rollout of the solution package to all NUM sites has started successfully.
Background: A large body of research indicates that the cognitions individuals have
about their own age and aging, so called self-perceptions of aging (SPA), predict health and
wellbeing in later life. However, much less is known about associations of SPA with
developmental correlates such as personality. Some initial studies have found cross-sectional
and longitudinal associations of the Big Five traits (openness to experience,
conscientiousness, extraversion, agreeableness, and neuroticism) with SPA. Building on these
findings, this thesis aimed at advancing knowledge on associations of personality with SPA.
To this end, cross-sectional associations of the meta-traits of agency, i.e., a focus on the self,
and communion, i.e., a focus on others, with SPA were examined in study 1, and longitudinal
associations of agentic and communal personal values with SPA were examined in study 2.
Study 3 aimed at expanding findings of previous studies on associations of SPA with selfreported
physical function to an objective indicator of physical function, namely, gait pattern.
In all studies, SPA were treated as a multidimensional construct comprising gains and losses.
Methods: Study 1 was based on data of 154 adults aged 75 and older that were
recruited in hospital. Data was collected one month after recruitment. In regression analyses,
associations of agentic and communal traits with SPA beyond health were examined. Study 2
was based on data of 6,089 adults aged 40 and older enrolled in the German Ageing Survey
(DEAS). Multiple regression analyses were used to test whether personal value priority
predicted change in SPA over three years beyond age stereotypes. For study 3, latent profile
analysis was employed to detect gait patterns based on data of 150 adults aged 70 and older
collected via an automated walkway at participants’ regular speed and individual maximum
speed. In a next step, associations of SPA with gait patterns beyond personality traits were
investigated in binary logistic regressions.
Results: Agentic and communal personality traits were associated with gain-, but not
loss-related SPA when controlling for health (study 1). In study 2, the value priority of
openness to change (self-direction, stimulation) predicted more gain-related SPA three years
later, while the value priority of conservation (tradition, security) was negatively associated
with gain-related SPA. The value priority of self-enhancement (achievement, power) was
associated with more loss-related SPA three years later. Finally, the value priority of selftranscendence
(universalism, benevolence), i.e. a concern for the well-being of others, was
associated with more gain- and less loss-related SPA at follow-up. In study 3, latent profile
analyses distinguished two groups with different gait patterns in both gait speed conditions.
One group exhibited a slower and less well-coordinated gait pattern, which reflected
functional limitations. The other group exhibited a faster and well-coordinated gait pattern,
which reflected better physical function. More loss-, but not gain-related SPA were associated
with higher likelihood to exhibit a functionally limited gait pattern at regular speed.
Conversely, gain- but not loss-related SPA were associated with higher likelihood to exhibit a
fit gait pattern at individual maximum speed.
Conclusion: Results of this thesis have three main implications for research on SPA.
First, agency and communion may constitute useful dimensions for further investigating SPA
domains, as both were associated with SPA in study 1. Second, findings of study 2 point to
the role of motivation for SPA that needs to be further explored. Third, findings of study 3
indicate that SPA are not only associated with self-reported, but also objectively measured
physical function, which stresses the importance of SPA for health in later life. As a practical
implication, the findings presented here suggest that interventions on SPA should consider
participants’ personality, both on the level of traits and values.
Background
Numerous wearables are used in a research context to record cardiac activity although their validity and usability has not been fully investigated. The objectives of this study is the cross-model comparison of data quality at different realistic use cases (cognitive and physical tasks). The recording quality is expressed by the ability to accurately detect the QRS complex, the amount of noise in the data, and the quality of RR intervals.
Methods
Five ECG devices (eMotion Faros 360°, Hexoskin Hx1, NeXus-10 MKII, Polar RS800 Multi and SOMNOtouch NIBP) were attached and simultaneously tested in 13 participants. Used test conditions included: measurements during rest, treadmill walking/running, and a cognitive 2-back task. Signal quality was assessed by a new local morphological quality parameter morphSQ which is defined as a weighted peak noise-to-signal ratio on percentage scale. The QRS detection performance was evaluated with eplimited on synchronized data by comparison to ground truth annotations. A modification of the Smith-Waterman algorithm has been used to assess the RR interval quality and to classify incorrect beat annotations. Evaluation metrics includes the positive predictive value, false negative rates, and F1 scores for beat detection performance.
Results
All used devices achieved sufficient signal quality in non-movement conditions. Over all experimental phases, insufficient quality expressed by morphSQ values below 10% was only found in 1.22% of the recorded beats using eMotion Faros 360°whereas the rate was 8.67% with Hexoskin Hx1. Nevertheless, QRS detection performed well across all used devices with positive predictive values between 0.985 and 1.000. False negative rates are ranging between 0.003 and 0.017. eMotion Faros 360°achieved the most stable results among the tested devices with only 5 false positive and 19 misplaced beats across all recordings identified by the Smith-Waterman approach.
Conclusion
Data quality was assessed by two new approaches: analyzing the noise-to-signal ratio using morphSQ, and RR interval quality using Smith-Waterman. Both methods deliver comparable results. However the Smith-Waterman approach allows the direct comparison of RR intervals without the need for signal synchronization whereas morphSQ can be computed locally.
Abstract
The increasing global prevalence of dementia demands concrete actions that are aimed strategically at optimizing processes that drive clinical innovation. The first step in this direction requires outlining hurdles in the transition from research to practice. The different parties needed to support translational processes have communication mismatches; methodological gaps hamper evidence‐based decision‐making; and data are insufficient to provide reliable estimates of long‐term health benefits and costs in decisional models. Pilot projects are tackling some of these gaps, but appropriate methods often still need to be devised or adapted to the dementia field. A consistent implementation perspective along the whole translational continuum, explicitly defined and shared among the relevant stakeholders, should overcome the “research‐versus‐adoption” dichotomy, and tackle the implementation cliff early on. Concrete next steps may consist of providing tools that support the effective participation of heterogeneous stakeholders and agreeing on a definition of clinical significance that facilitates the selection of proper outcome measures.
Background
Vulnerable groups, e.g. persons with mental illness, neurological deficits or dementia, are often excluded as participants from research projects because obtaining informed consent can be difficult and tedious. This may have the consequence that vulnerable groups benefit less from medical progress. Vulnerable persons are often supported by a legal guardian in one or more demands of their daily life. We examined the attitudes of legal guardians and legally supervised persons towards medical research and the conditions and motivations to participate in studies.
Methods
We conducted a cross-sectional study with standardized surveys of legal guardians and legally supervised persons. Two separate questionnaires were developed for the legal guardians and the supervised persons to asses previous experiences with research projects and the reasons for participation or non-participation. The legal guardians were recruited through various guardianship organizations. The supervised persons were recruited through their legal guardian and from a previous study among psychiatric patients. The data were analysed descriptively.
Results
Alltogether, 82 legal guardians and 20 legally supervised persons could be recruited. Thereof 13 legal guardians (15.6%) and 13 legally supervised persons (65.0%) had previous experience with research projects. The majority of the guardians with experience in research projects had consented the participation of their supervised persons (n = 12 guardians, 60.0%; in total n = 16 approvals). The possible burden on the participating person was given as the most frequent reason not to participate both by the guardians (n = 44, 54.4%) and by the supervised persons (n = 3, 30.0%). The most frequent motivation to provide consent to participate in a research study was the desire to help other patients by gaining new scientific knowledge (guardians: n = 125, 78.1%; supervised persons: n = 10, 66.6%).
Conclusions
Overall, an open attitude towards medical research can be observed both among legal guardians and supervised persons. Perceived risks and no sense recognized in the study are reasons for not participating in medical research projects.
Background: Multimorbidity is a common issue in aging societies and is usually associated with dementia in older people. Physical activity (PA) may be a beneficial nonpharmacological strategy for patients with complex health needs. However, insufficient PA is predominant in this population. Thus, there is an evident need to expand the knowledge on potential determinants influencing PA engagement among elderly persons at risk of dementia and multimorbidity. Methods: We used baseline data from the multicenter, cluster-randomized controlled AgeWell.de study. The main aim was to describe PA engagement and identify potential PA determinants in a sample of community-dwelling Germans aged 60–77 years old with an increased risk of dementia and multimorbidity. Results: Of the 1030 included participants, approximately half (51.8%) engaged in PA ≥2 times/week for at least 30 min at baseline. We identified self-efficacy (beta = 0.202, (p < 0.001) and BMI (beta = −0.055, (p < 0.001) as potential PA determinants. Conclusions: The identified determinants, self-efficacy, and BMI are consistent with those reported in the literature. Specific knowledge on PA determinants and stages of change in persons with risk of dementia and multimorbidity might guide the development of effective future prevention measures and health services tailored to this population. Trial registration: German Clinical Trials Register (reference number: DRKS00013555).
This dynamic cohort was established to evaluate the targeted individual promotion of children affected by developmental risks as part of the German federal state law for child day-care and preschools in Mecklenburg-Western Pomerania. The project has been conducted in preschools in regions with a low socio-economic profile since 2011. Since 2017, the revision of the standardized Dortmund Developmental Screening for Preschools (DESK 3–6 R) has been applied. Developmental risks of 3 to 6-year-old children in the domains of motor, linguistic, cognitive and social competencies are monitored. The cohort is followed up annually. In 2020, n = 7,678 children from n = 152 preschools participated. At the baseline (2017), n = 8,439 children participated. Due to the defined age range of this screening, 3,000 to 4,000 5-6-year-old children leave the cohort annually. Simultaneously, an approximately equal number of 3-year-old children enters the cohort per survey wave. N = 702 children participated in all 4 survey waves. On the basis of DESK 3–6 R scores available from survey waves 2017 to 2019 it is possible to compute expected values for the survey wave 2020 and to compare those with the measured values to evaluate the effects of the COVID-19 pandemic (i.e. parental home care due to restrictions related to COVID-19).
Epidemiological data reveal that there is a need for prevention measures specifically targeted at children with low SES. In the German federal state Mecklenburg-Western Pomerania preschools in socially deprived regions can apply for additional funds to support children with developmental risks. Mandatory criteria for obtaining these funds involve an annual assessment of all children using the “Dortmunder Developmental Screening for Preschools (DESK 3–6 R).” This instrument can detect and monitor developmental risks in the domains fine motor skills, gross motor skills, language, cognition, and social development. In this study, we examine the domain “Attention and concentration,” which is included for the 5 to 6-year-old age group, using data from two consecutive survey waves (sw). Research questions: (1) Does the prevalence rate ratio (PRR) improve over time? (2) Is the rate of improvements (developmental risk at sw1, no developmental risk at sw2) higher than the rate of deteriorations (no developmental risk at sw1, developmental risk at sw2)? Prospective cohort analysis (n = 940). The prevalence rate of a developmental risk in this DESK domain decreases over time (PRR = 0.78; p = 0.019). The ratio of the rate of improvements is 8.47 times higher than the rate of deteriorations. The results provide evidence of the effectiveness of targeted intervention measures in preschools focusing on skills that improve attention and concentration. This is significant considering the small-time interval and the categorization method of DESK scores. Nevertheless, over the same time period, the DESK results of some children deteriorated. Therefore, preschools also have to be aware that it is natural for some children to show modest declines in their skills over time. German Clinical Trials Register, ID: DRKS00015134, Registered on 29 October 2018, retrospectively registered.
Discovery of novel eGFR-associated multiple independent signals using a quasi-adaptive method
(2022)
A decreased estimated glomerular filtration rate (eGFR) leading to chronic kidney disease is a significant public health problem. Kidney function is a heritable trait, and recent application of genome-wide association studies (GWAS) successfully identified multiple eGFR-associated genetic loci. To increase statistical power for detecting independent associations in GWAS loci, we improved our recently developed quasi-adaptive method estimating SNP-specific alpha levels for the conditional analysis, and applied it to the GWAS meta-analysis results of eGFR among 783,978 European-ancestry individuals. Among known eGFR loci, we revealed 19 new independent association signals that were subsequently replicated in the United Kingdom Biobank (n = 408,608). These associations have remained undetected by conditional analysis using the established conservative genome-wide significance level of 5 × 10–8. Functional characterization of known index SNPs and novel independent signals using colocalization of conditional eGFR association results and gene expression in cis across 51 human tissues identified two potentially causal genes across kidney tissues: TSPAN33 and TFDP2, and three candidate genes across other tissues: SLC22A2, LRP2, and CDKN1C. These colocalizations were not identified in the original GWAS. By applying our improved quasi-adaptive method, we successfully identified additional genetic variants associated with eGFR. Considering these signals in colocalization analyses can increase the precision of revealing potentially functional genes of GWAS loci.
Knowledge on differences in the severity and symptoms of infections with the SARS-CoV-2 Omicron variants BA.2 (Pango lineage B.1.529.2) and BA.5 (Pango lineage B.1.529.5) is still scarce. We investigated epidemiological data available from the public health authorities in Mecklenburg-Western Pomerania, Northeast Germany, between April and July 2022 retrospectively. Comparative analyses revealed significant differences between recorded symptoms of BA.2 and BA.5 infected individuals and found strong correlations of associations between symptoms. In particular, the symptoms ‘chills or sweating’, ‘freeze’ and ‘runny nose’ were more frequently reported in BA.2 infections. In contrast, ‘other clinical symptoms’ appeared more frequently in Omicron infections with BA.5. However, the results obtained in this study provide no evidence that BA.5 has a higher pathogenicity or causes a more severe course of infection than BA.2. To our knowledge, this is the first report on clinical differences between the current Omicron variants BA.2 and BA.5 using public health data. Our study highlights the value of timely investigations of data collected by public health authorities to gather detailed information on the clinical presentation of different SARS-CoV-2 subvariants at an early stage.
Quality of life (QoL) is a core patient-reported outcome in healthcare research, alongside primary clinical outcomes. A conceptual, operational, and psychometric elaboration of QoL in the context of TM is needed, because standardized instruments to assess QoL do not sufficiently represent essential aspects of intended outcomes of telemedical applications (TM). The overall aim is to develop an instrument that can adequately capture QoL in TM. For that purpose, an extended working model of QoL will be derived. Subsequently, an instrument will be developed and validated that captures those aspects of QoL that are influenced by TM. The initial exploratory study section includes (a) a systematic literature review, (b) a qualitative survey for concept elicitation, and (c) pre-testings using cognitive debriefings with patients and an expert workshop. The second quantitative section consists of an online expert survey and two patient surveys for piloting and validation of the newly developed instrument. The resulting questionnaire will assess central experiences of patients regarding telemedical applications and its impact on QoL more sensitively. Its use as adjunct instrument will lead to a more appropriate evaluation of TM and contribute to the improvement of care tailored to patients’ individual needs.
Copattern of depression and alcohol use in medical care patients: cross- sectional study in Germany
(2020)
Objective
To predict depressive symptom severity and presence of major depression along the full alcohol use continuum.
Design
Cross-sectional study.
Setting
Ambulatory practices and general hospitals from three sites in Germany.
Participants
Consecutive patients aged 18–64 years were proactively approached for an anonymous health screening (participation rate=87%, N=12 828). Four continuous alcohol use measures were derived from an expanded Alcohol Use Disorder Identification Test (AUDIT): alcohol consumption in grams per day and occasion, excessive consumption in days per months and the AUDIT sum score. Depressive symptoms were assessed for the worst 2-week period in the last 12 months using the Patient Health Questionnaire (PHQ-8). Negative binomial and logistic regression analyses were used to predict depressive symptom severity (PHQ-8 sum score) and presence of major depression (PHQ-8 sum score≥10) by the alcohol use measures.
Results
Analyses revealed that depressive symptom severity and presence of major depression were significantly predicted by all alcohol use measures after controlling for sociodemographics and health behaviours (p<0.05). The relationships were curvilinear: lowest depressive symptom severity and odds of major depression were found for alcohol consumptions of 1.1 g/day, 10.5 g/occasion, 1 excessive consumption day/month, and those with an AUDIT score of 2. Higher depressive symptom severity and odds of major depression were found for both abstinence from and higher levels of alcohol consumption. Interaction analyses revealed steeper risk increases in women and younger individuals for most alcohol use measures.
Conclusion
Findings indicate that alcohol use and depression in medical care patients are associated in a curvilinear manner and that moderation by gender and age is present.