Routine Care Research Articles

Enthesitis in a European registry-based cohort of patients with psoriatic arthritis treated with tumour necrosis factor inhibitors: clinical burden, patient-reported outcomes, and treatment response.

To explore the registration of enthesitis among biologic-naïve patients with psoriatic arthritis (PsA) initiating tumour necrosis factor inhibitor (TNFi) treatment across 12 European registries, compare the disease burden and patient-reported outcomes (PROs) between patients with and without enthesitis, and assess the enthesitis treatment response. Demographics, clinical characteristics, and PROs at first TNFi (TNFi-1) initiation (baseline) were assessed in patients with PsA, diagnosed by a rheumatologist, with versus without assessment of entheses and between those with versus without enthesitis. Enthesitis scores and resolution frequency were identified at follow-up. Of 10547 patients in the European Spondyloarthritis (EuroSpA) Research Collaboration Network initiating TNFi, 1357 underwent evaluation for enthesitis. Eight registries included a validated scoring system for enthesitis. At baseline, 874 patients underwent entheses assessment [Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) 485 patients, Spondyloarthritis Research Consortium of Canada (SPARCC) 389 patients]. Enthesitis was detected by MASES in 170/485 (35%, mean score ± sd 3.1±2.4) and by SPARCC in 236/389 (61%, 4±3.4). Achilles enthesitis was most frequent, by both MASES (unilateral/bilateral 28%/9%) and SPARCC (48%/18%). MASES/SPARCC baseline and follow-up scores for TNFi-1 were available for 100/105 patients. Of these, 63 patients (63%) (MASES) and 46 (43.8%) (SPARCC) achieved resolution of enthesitis. The site-specific enthesitis resolution was overall lower at SPARCC sites (peripheral; 63-80%) than at MASES sites (mainly axial; 82-100%) following TNFi-1. Disease activity and PROs were worse in patients with versus without enthesitis. Entheseal assessments are only registered in a minority of patients with PsA in routine care. When assessed, enthesitis was common, and a substantial proportion demonstrated resolution following treatment with TNFi-1.

Dementia Care Nurses in the networked care of people with dementia: a qualitative evaluation study

Dementia Care Nurses in the networked care of people with dementia: A qualitative evaluation study Abstract: Background: To coordinate networked dementia care counselling concepts with case management (CM) structures are recommended. This approach has been explored and evaluated within the Dementia Care Nurse project in Saxony-Anhalt. Studies on the implementation of CM are mostly limited to cooperation between case managers and medical and nursing professional groups. Networking processes with all stakeholders involved in dementia care have hardly been described so far. Objective: The aim was to describe the experienced collaboration with Dementia Care Nurses (DCNs) from the perspective of the participating cooperation partners and to derive approaches for the continuation of the DCNs in routine care. Method: Eight semi-structured interviews were conducted with cooperation partners from the health and social care sector who participated in the DCN project. The interviews were analysed for content. Results: The interviews were evaluated by content analysis. Results: Overall, the interviewed cooperation partners rated the collaboration with the DCNs in the project as positive, especially the proactive approach and the continuous support of people with dementia. The continuation in routine care depends on the institutional location and the qualification of the DCNs. Conclusion: The commitment of DCNs enables a more demand-oriented involvement of relevant stakeholders in the individual planning of dementia care.

Comparing Mobile-Based to Group-Based Education for Weight Reduction in a Developing Country: A Randomized Study.

This study compared the impact of Short Message Service (SMS)-based education with traditional group-based education and the control group on body mass index, weight, and lifestyle in obese and overweight patients in a limited-resource country. It also compared the direct financial costs between the two intervention groups. In this controlled randomized educational study, 90 overweight or obese adults from four family physician clinics in Shiraz, Iran were randomly allocated to three training groups: SMS-based education, group-based education, and a control group. The participants' weight, body mass index (BMI), and waist circumference were measured at baseline, and the Physical Activity Scale questionnaire was completed. Group-based training was conducted in 1-hour weekly sessions. The SMS group received a text message each morning. The control group received routine care from a family physician. The intervention lasted 12 weeks. All participants were re-examined for the studied variables. Additionally, the direct costs were estimated, calculated, and compared. The mean weight, BMI, and waist circumference changed significantly after 3 months compared to baseline in each group. The mean weight change differed significantly among the three groups (P-value=0.04), and the mean BMI changes were near significant (P-value=0.06). A post hoc comparison of changes in weight and BMI showed a significant difference between the control and SMS groups. SMS education incurred much lower costs for patients and healthcare services than group-based education. The study showed that SMS is an effective and cost-saving educational method for weight loss compared to group-based education, especially in developing countries.

Survival Benefit Associated With Participation in Clinical Trials of Anticancer Drugs: A Systematic Review and Meta-analysis.

Many cancer clinical investigators view clinical trials as offering better care for patients than routine clinical care. However, definitive evidence of clinical benefit from trial participation (hereafter referred to as the participation effect) has yet to emerge. To conduct a systematic review and meta-analysis of the evidence examining whether patient participation in cancer trials was associated with greater survival benefit compared with routine care. Studies were found through PubMed and Embase (January 1, 2000, until August 31, 2022), as well as backward and forward citation searching. Studies were included that compared overall survival of trial participants and routine care patients. Data extraction and methodological quality assessment were completed by 2 independent coders using Covidence software. Data were pooled using a random-effects model and analyzed based on the quality of the comparison between trial participants and routine care patients (ie, extent to which studies controlled for bias and confounders). The hazard ratio (HR) for overall survival of trial participants vs routine care patients. Thirty-nine publications were included, comprising 85 comparisons of trial participants and routine care patients. The meta-analysis revealed a statistically significant overall survival benefit for trial participants (HR, 0.76 [95% CI, 0.69-0.82]) when all studies were pooled, regardless of design or quality. However, survival benefits diminished in study subsets that matched trial participants and routine care patients for eligibility criteria (HR, 0.85 [95% CI, 0.75-0.97]) and disappeared when only high-quality studies were pooled (HR, 0.91 [95% CI, 0.80-1.05]). They also disappeared when estimates were adjusted for potential publication bias (HR, 0.94 [95% CI, 0.86-1.03]). Many studies suggest a survival benefit for cancer trial participants. However, these benefits were not detected in studies using designs addressing important sources of bias and confounding. Pooled results of high-quality studies are not consistent with a beneficial effect of trial participation on its own.

Decision tree-Markov model of perinatal depression screening: a cost–utility analysis

BackgroundPerinatal depression affects the physical and mental health of pregnant women. It also has a negative effect on children, families, and society, and the incidence is high. We constructed a cost–utility analysis model for perinatal depression screening in China and evaluated the model from the perspective of health economics.MethodsWe constructed a Markov model that was consistent with the screening strategy for perinatal depression in China, and two screening strategies (screening and non-screening) were constructed. Each strategy was set as a cycle of 3 months, corresponding to the first trimester, second trimester, third trimester, and postpartum. The state outcome parameters required for the model were obtained based on data from the National Prospective Cohort Study on the Mental Health of Chinese Pregnant Women from August 2015 to October 2016. The cost parameters were obtained from a field investigation on costs and screening effects conducted in maternal and child health care institutions in 2020. The cost–utility ratio and incremental cost–utility ratio of different screening strategies were obtained by multiplicative analysis to evaluate the health economic value of the two screening strategies. Finally, deterministic and probabilistic sensitivity analyses were conducted on the uncertain parameters in the model to explore the sensitivity factors that affected the selection of screening strategies.ResultsThe cost–utility analysis showed that the per capita cost of the screening strategy was 129.54 yuan, 0.85 quality-adjusted life years (QALYs) could be obtained, and the average cost per QALY gained was 152.17 yuan. In the non-screening (routine health care) group, the average cost was 171.80 CNY per person, 0.84 QALYs could be obtained, and the average cost per QALY gained was 205.05 CNY. Using one gross domestic product per capita in 2021 as the willingness to pay threshold, the incremental cost–utility ratio of screening versus no screening (routine health care) was about −3,126.77 yuan, which was lower than one gross domestic product per capita. Therefore, the screening strategy was more cost-effective than no screening (routine health care). Sensitivity analysis was performed by adjusting the parameters in the model, and the results were stable and consistent, which did not affect the choice of the optimal strategy.ConclusionCompared with no screening (routine health care), the recommended perinatal depression screening strategy in China is cost-effective. In the future, it is necessary to continue to standardize screening and explore different screening modalities and tools suitable for specific regions.

Healthcare Providers’ and Pregnant People’s Preferences for a Preventive to Protect Infants from Serious Illness Due to Respiratory Syncytial Virus

We assessed the impact of respiratory syncytial virus (RSV) preventive characteristics on the intentions of pregnant people and healthcare providers (HCPs) to protect infants with a maternal vaccine or monoclonal antibodies (mAbs). Pregnant people and HCPs who treated pregnant people and/or infants were recruited via convenience sample from a general research panel to complete a cross-sectional, web-based survey, including a discrete choice experiment (DCE) wherein respondents chose between hypothetical RSV preventive profiles varying on five attributes (effectiveness, preventive type [maternal vaccine vs. mAb], injection recipient/timing, type of medical visit required to receive the injection, and duration of protection during RSV season) and a no-preventive option. A best–worst scaling (BWS) exercise was included to explore the impact of additional attributes on preventive preferences. Data were collected between October and November 2022. Attribute-level preference weights and relative importance (RI) were estimated. Overall, 992 pregnant people and 310 HCPs participated. A preventive (vs. none) was chosen 89.2% (pregnant people) and 96.0% (HCPs) of the time (DCE). Effectiveness was most important to preventive choice for pregnant people (RI = 48.0%) and HCPs (RI = 41.7%); all else equal, pregnant people (RI = 5.5%) and HCPs (RI = 7.2%) preferred the maternal vaccine over mAbs, although preventive type had limited influence on choice. Longer protection, protection starting at birth or the beginning of RSV season, and use for both pre-term and full-term babies were ranked highest in importance (BWS). Pregnant people and HCPs strongly preferred a preventive to protect infants against RSV (vs. none), underscoring the need to incorporate RSV preventives into routine care.

Effect of gradient pressure therapy on the prevention of chemotherapy-induced peripheral neuropathy in patients with breast cancer.

To investigate the effect of gradient pressure therapy on the prevention of chemotherapy-induced peripheral neuropathy (CIPN) and improvement in activities of daily living (ADL) in patients with breast cancer. Eighty female patients with breast cancer treated at Tangshan People's Hospital between October 2022 and July 2023 were selected as research participants and divided into control and intervention, with 40 patients in each group. The control group received routine treatment and care, whereas the intervention group received gradient pressure therapy based on routine treatment and care. Incidence of peripheral neuropathy and the degree of impact on ADL between the two groups were compared after the intervention for cycles 2, 4, and 6. There was no significant difference in the general information between the two groups (P > 0.05). After two intervention cycles, there was no significant difference in the incidence of CIPN, various dimensions of Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and total scores between the two groups (P > 0.05). After four intervention cycles, the two groups had a statistically significant difference in the incidence of CIPN, sensory dimension, general activity dimension, and total CIPNAT score (P < 0.05). After six intervention cycles, there was a significant difference in the incidence of CIPN, sensory dimension, fine activity dimension, general activity dimension, and total CIPNAT score between the two groups (P < 0.05), while there was no significant difference in the other dimensions (P > 0.05). Gradient pressure therapy can effectively prevent or alleviate peripheral neuropathy in patients with breast cancer undergoing chemotherapy and improve their ability to perform ADL. Thus, it is safe, effective, and worthy of clinical application. RMYY-LLKS-2022-054.

Epidemiology and Treatment of Patients With Primary Open Angle Glaucoma in Germany: A Health Claims Data Analysis.

Based on a large administrative database of German claims data, our study provides current estimates of the prevalence and incidence of primary open-angle glaucoma (POAG) in Germany and describes selected outcomes for prevalent POAG patients. To estimate the prevalence and incidence of POAG in Germany, to describe the patient population in terms of comorbidity burden, routine care, and overall healthcare resource utilization (HCRU) and associated costs, and to describe treatment patterns over time in patients undergoing relevant laser procedures. Based on anonymized German claims data, we carried out a retrospective, non-interventional study covering calendar years 2016 to 2021. For the adult German population (≥18y), we estimated a POAG one-year prevalence of 1.70% and a one-year incidence of 0.17% in 2018; both increased with age, peaking in 80-89 year-olds. Prevalence and incidence were lower in 2020 (1.65% and 0.16%, respectively), the first year of the SARS-CoV-2 pandemic. Most patients solely received topical treatment. Most surgically-treated patients underwent laser trabeculoplasty, followed by laser iridotomy, trabeculectomy, and filtration operations with implant. In patients undergoing laser trabeculoplasty, the treatment regimen was nearly unchanged in the second year after, compared to two years before the procedure. Multimorbidity was commonly observed; 75.5% of patients had arterial hypertension and 50.0% had disorders of lipoprotein metabolism and other lipidemias, compared to 60.1% and 39.2%, respectively, in an age- and sex-matched control sample. Our study provides insights into epidemiology and routine care of POAG in Germany and HCRU in prevalent patients. There was little change in treatment regimens in patients who underwent laser trabeculoplasty, two years after the procedure. Most patients were multimorbid highlighting the need for comprehensive care.

Effectiveness of two educational interventions based on the theory of planned behavior on oral cancer self-examination in adults: a randomized controlled trial.

The theory of planned behavior (TPB) is recognized as an effective theory for behavior change. The aim of the present study was to investigate the impact of two TPB-based educational interventions on oral self-examination (OSE) behavior and the related TPB constructs among adults in Tehran, Iran, in 2022. This randomized controlled trial involved 400 healthy individuals recruited from 20 urban comprehensive health centers in the southern part of Tehran, Iran. The health centers were randomly assigned to two control (PowerPoint) and intervention (WhatsApp) groups (200 individuals in each group). In the control group (the recipient of the routine care), participants received a 20-minute lecture through a PowerPoint presentation and a pamphlet. In the intervention group (the recipient of an additional intervention alongside the routine care), participants were educated through messages and images on WhatsApp along with having monthly group discussions. Data was collected at baseline, as well as at 1- and 3-month follow-ups using a structured questionnaire. The outcomes assessed included OSE behavior and the related TPB constructs: intention, attitude, subjective norm, and perceived behavioral control. Linear and logistic generalized estimating equations (GEE) regression models were used to evaluate the impact of the interventions with STATA version 17. Of the total participants, 151 (37.75%) were men. The mean ± standard deviation (SD) of ages in the PowerPoint and WhatsApp groups were 39.89 ± 13.72 and 39.45 ± 13.90, respectively. OSE and the related TPB constructs showed significant differences between the groups at the 1-month post-intervention assessment. The effect of PowerPoint was more significant in the short-term (one month), while both methods showed similar effectiveness after three months, specifically in relation to OSE and the TPB constructs. At the 3-month post-intervention assessment, there were significant increases in OSE (OR = 28.63), intention (β = 1.47), attitude (β = 0.66), subjective norm (β = 2.82), and perceived behavioral control (β = 1.19) in both groups (p < 0.001). The present study provides evidence of the effectiveness of both educational interventions in improving OSE and the TPB constructs after three months. Therefore, both TPB-based educational methods can be recommended for designing and implementing interventions aimed at preventing oral cancer. The trial protocol was registered in the Iranian Registry of Clinical Trials (IRCT) on 04/03/2022 (registration number: IRCT20220221054086N1).

Cost Effectiveness of Adding Fenfluramine to Standard of Care for Patients with Dravet Syndrome in Sweden.

This study evaluated, in a Swedish setting, the cost effectiveness of fenfluramine (FFA) as an add-on to standard of care (SoC) for reducing seizure frequency in Dravet syndrome, a severe developmental epileptic encephalopathy. Cost effectiveness of FFA+SoC compared with SoC only was evaluated using a patient-level simulation model with a lifetime horizon. Patient characteristics and treatment effects, including convulsive seizures, seizure-free days and mortality, were derived from FFA clinical trials. Resource use and costs included cost of drug acquisition, routine care and monitoring, as well as ongoing and emergency resources. Quality of life (QoL) estimates for patients and their caregivers were derived from clinical trial data. Robustness was evaluated by one-way sensitivity analysis, probabilistic sensitivity analysis and scenario analyses. Lifetime cost of FFA+SoC was ~3 million SEK per patient compared with ~1.5 million SEK for SoC only. FFA+SoC generated 15% more QALYs than SoC only (21.2 vs 18.5 over a lifetime), resulting in an incremental cost-effectiveness ratio (ICER) of ~540,000SEK. Moreover, FFA+SoC had a higher probability of being cost effective than SoC only from a willingness-to-pay threshold of 710,000SEK. Results remained generally consistent across scenario analyses, with only few exceptions (exclusions of carer utility or FFA effect on sudden unexpected death in epilepsy). Due to better seizure control, FFA is a clinically meaningful add-on therapy and was estimated to be a cost-effective addition to current SoC for patients with this rare disease in Sweden at a willingness-to-pay threshold of 1,000,000 SEK.

Social relationships and their impact on health-related quality of life in a long-term breast cancer survivor cohort.

Health-related quality of life (HRQOL) has become increasingly important for breast cancer survivors, but clinically relevant declines often persist for many years after treatment. This study aimed to investigate whether social relationships can mitigate or prevent this decline in HRQOL. Data were used from the German population-based Mamma Carcinoma Risk Factor Investigation (MARIE) cohort of 2022 breast cancer cases with follow-up information for more than 15 years after diagnosis. Correlations between social integration, social support, and global health status (GHS) as an overall measure of HRQOL were analyzed, and linear regression analysis was performed with structural equation modeling. The majority of participants reported high levels of social integration and social support and moderate levels of GHS. Social integration 5 years after diagnosis was associated with GHS 5 years after diagnosis (β=1.12; 95% CI,0.25-1.99), but no longitudinal effects were found. Social support 5 years after diagnosis was associated with better GHS 5 years (β=0.42; 95% CI,0.36-0.48) and 10 years after diagnosis (β=0.12; 95% CI,0.02-0.22), whereas social support 10 years after diagnosis was associated with GHS 10 years (β=0.29; 95% CI,0.20-0.39) and 15 years after diagnosis (β=0.10; 95% CI,0.01-0.21). These results confirm that social relationships positively influence HRQOL in long-term breast cancer survivors and that their association should receive more attention clinically and beyond routine care.

Characteristics, risk factors, and outcomes related to Zika virus infection during pregnancy in Northeastern Thailand: A prospective pregnancy cohort study, 2018-2020.

In response to the 2015-2016 Zika virus (ZIKV) outbreak and the causal relationship established between maternal ZIKV infection and adverse infant outcomes, we conducted a cohort study to estimate the incidence of ZIKV infection in pregnancy and assess its impacts in women and infants. From May 2018-January 2020, we prospectively followed pregnant women recruited from 134 participating hospitals in two non-adjacent provinces in northeastern Thailand. We collected demographic, clinical, and epidemiologic data and blood and urine at routine antenatal care visits until delivery. ZIKV infections were confirmed by real-time reverse transcriptase polymerase chain reaction (rRT-PCR). Specimens with confirmed ZIKV underwent whole genome sequencing. Among 3,312 women enrolled, 12 (0.36%) had ZIKV infections, of which two (17%) were detected at enrollment. Ten (83%, 3 in 2nd and 7 in 3rd trimester) ZIKV infections were detected during study follow-up, resulting in an infection rate of 0.15 per 1,000 person-weeks (95% CI: 0.07-0.28). The majority (11/12, 91.7%) of infections occurred in one province. Persistent ZIKV viremia (42 days) was found in only one woman. Six women with confirmed ZIKV infections were asymptomatic until delivery. Sequencing of 8 ZIKV isolates revealed all were of Asian lineage. All 12 ZIKV infected women gave birth to live, full-term infants; the only observed adverse birth outcome was low birth weight in one (8%) infant. Pregnancies in 3,300 ZIKV-rRT-PCR-negative women were complicated by 101 (3%) fetal deaths, of which 67 (66%) had miscarriages and 34 (34%) had stillbirths. There were no differences between adverse fetal or birth outcomes of live infants born to ZIKV-rRT-PCR-positive mothers compared to live infants born to ZIKV-rRT-PCR-negative mothers. Confirmed ZIKV infections occurred infrequently in this large pregnancy cohort and observed adverse maternal and birth outcomes did not differ between mothers with and without confirmed infections.

Risk factors for intensive care unit admission after cesarean hysterectomy for placenta accreta spectrum.

Placenta accreta spectrum (PAS) is a complex disorder of uterine wall disruption with significant morbidity and mortality, particularly at time of delivery. Both physician and physical hospital resource allocation/utilization remains a challenge in PAS cases including intensive care unit (ICU) beds. The primary objective of the present study was to identify preoperative risk factors for ICU admission and create an ICU admission prediction model for patient counseling and resource utilization decision making in an evidence-based manner. This was a case-control study of 145 patients at our PAS referral center undergoing cesarean hysterectomy for PAS. Final confirmation by histopathology was required for inclusion. Patient disposition after surgery (ICU vs post-anesthesia care unit) was our primary outcome and pre-/intra-/postoperative variables were obtained via electronic medical records with an emphasis on the predictive capabilities of the preoperative variables. Uni- and multivariate analysis was performed to identify independent predictive factors for ICU admission. In this large cohort of 145 patients who underwent cesarean hysterectomy for PAS, with histopathologic confirmation, 63 (43%) were admitted to the ICU following delivery. These patients were more likely to be delivered at an earlier gestational age (34 vs 35 weeks, P < 0.001), have had >2 episodes of vaginal bleeding and emergent delivery compared to patients admitted to patients with routine recovery care (44% vs 18.3%, P = 0.009). Uni- and multivariate logistic regression showed an area under the curve of 0.73 (95% CI: [0.63, 0.81], P < 0.001) for prediction of ICU admission with these three variables. Patients with all three predictors had 100% ICU admission rate. Resource prediction, utilization and allocation remains a challenge in PAS management. By identifying patients with preoperative risk factors for ICU admission, not only can patients be counseled but this resource can be requested preoperatively for staffing and utilization purposes.

Influence of continuous 4C nursing on quality of life and self-care ability of patients with diabetes retinopathy: An observational study.

This study aims to investigate the impact of continuous 4C nursing on patients with diabetes retinopathy (DR) and its influence on self-care ability. A total of 100 DR patients admitted to our hospital from October 2020 to October 2022 were randomly divided into a control group and an observation group, with 50 cases in each group. The control group received routine care, while the observation group received continuous 4C care. The nursing effects of both groups were compared. After nursing, the observation group showed a lower self-rating anxiety scale score and a higher self-care ability scale score compared to the control group (P < .05). The SQQL-VI scores for all social activities were also higher in the observation group (P < .05). Additionally, the observation group had lower levels of fasting blood glucose, 2-hour postprandial blood glucose, and glycated hemoglobin than the control group (P < .05). Moreover, the observation group had higher visual acuity and lower intraocular pressure than the control group (P < .05). The visual impairment rate was lower and the overall compliance rate was higher in the observation group compared to the control group (P < .05). After nursing, both groups showed improvements in symptoms, visual function, physical function, psychological and social activity scores, visual acuity, and patient satisfaction scores. The observation group showed greater improvements compared to the control group (P < .05). The application of continuous 4C nursing in DR patients has shown positive effects, including improved patient compliance and satisfaction, enhanced patient quality of life and visual acuity. These findings suggest that continuous 4C nursing should be widely promoted and applied in clinical practice.

Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany

BackgroundSystemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany.MethodsClaims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score–matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments.Results2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher.ConclusionsThe application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.

Impact of stage-specific limb function exercises guided by a self-management education model on arteriovenous fistula maturation status.

The exercise of limb function is the most economical and safe method to promote the maturation of arteriovenous fistula (AVF). However, due to the lack of a unified exercise standard in China, many patients have insufficient awareness of the importance of AVF, leading to poor effectiveness of limb function exercise. The self-management education model can effectively promote patients to take proactive health-related actions. This study focuses on the characteristics of patients during the peri-AVF period and conducts a phased limb function exercise under the guidance of the self-management education model to observe changes in factors such as the maturity of AVF. To assess the impact of stage-specific limb function exercises, directed by a self-management education model, on the maturation status of AVFs. This study is a randomized controlled trial involving 74 patients with forearm AVFs from the Nephrology Department of a tertiary hospital in Sichuan Province, China. Patients were randomly divided into an observation group and a control group using a random number table method. The observation group underwent tailored stage-specific limb function exercises, informed by a self-management education model which took into account the unique features of AVF at various stages, in conjunction with routine care. Conversely, the control group was given standard limb function exercises along with routine care. The assessment involves the maturity of AVFs post-intervention, postoperative complications, and the self-management level of the fistula in both groups patients. Analyses were conducted using SPSS version 23.0. Count data were represented by frequency and percentage and subjected to chi-square test comparisons. Measurement data adhering to a normal distribution were presented as mean ± SD. The independent samples t-test was utilized for inter-group comparisons, while the paired t-test was used for intra-group comparisons. For measurement data not fitting a normal distribution, the median and interquartile range were presented and analyzed using the Wilcoxon rank sum test. At the 8-wk postoperative mark, the observation group demonstrated significantly higher scores in AVF symptom recognition, symptom prevention, and self-management compared to the control group (P < 0.05). However, the variance in symptom management scores between the observation and control groups lacked statistical significance (P > 0.05). At 4 wk after the operation, the observation group displayed a superior vessel diameter and depth from the skin of the drainage vessels in comparison to the control group (P < 0.05). While the observation group did manifest elevated blood flow rates in the drainage vessels relative to the control group, this distinction was not statistically significant (P > 0.05). By the 8-wk postoperative interval, the observation group outperformed the control group with notable enhancements in blood flow rates, vessel diameter, and depth from the skin of drainage vessels (P < 0.01). Seven days following the procedure, the observation group manifested significantly diminished limb swelling and an overall reduced complication rate in contrast to the control group (P < 0.05). The evaluation of infection, thrombosis, embolism, arterial aneurysm stenosis, and incision bleeding showed no notable differences between the two groups (P > 0.05). By the 4-wk postoperative juncture, complications between the observation and control groups were statistically indistinguishable (P > 0.05). Stage-specific limb function exercises, under the guidance of a self-management education model, amplify the capacity of AVF patients to discern and prevent symptoms. Additionally, they expedite AVF maturation and mitigate postoperative limb edema, underscoring their efficacy as a valuable method for the care and upkeep of AVF in hemodialysis patients.

Opportunistic screening for osteoporosis using routine clinical care computed tomography brain studies.

Osteoporosis and falls are both prevalent in the elderly, and CT brain (CTB) is frequently performed post head-strike. We aim to validate the relationship between frontal bone density (Hounsfield unit) from routine CTB and bone mineral density from dual-energy X-ray absorptiometry (DEXA) scan for opportunistic osteoporosis screening. Patients who had a non-contrast CTB followed by a DEXA scan in the subsequent year were included in this multi-center retrospective study. The relationship between frontal bone density on CT and femoral neck T-score on DEXA was examined using ANOVA, Pearson's correlation, and receiver operating curve (ROC) analysis. Sensitivity, specificity, negative and positive predictive values, and area under the curve (AUC) were calculated. Three hundred twenty-six patients (205 females and 121 males) were analyzed. ANOVA analysis showed that frontal bone density was lower in patients with DEXA-defined osteoporosis (p < 0.001), while Pearson's correlation analysis demonstrated a fair correlation with femoral neck T-score (r = 0.3, p < 0.001). On subgroup analysis, these were true in females but not in males. On ROC analysis, frontal bone density weakly predicted osteoporosis (AUC 0.6, 95% CI 0.5-0.7) with no optimal threshold identified. HU < 610 was highly specific (87.5%) but poorly sensitive (18.9%). HU > 1200 in females had a strong negative predictive value for osteoporosis (92.6%, 95% CI 87.1-98.1%). Frontal bone density from routine CTB is significantly different between females with and without osteoporosis, but not between males. However, frontal bone density was a weak predictor for DEXA-defined osteoporosis. Further research is required to determine the role of CTB in opportunistic osteoporosis screening.

Process evaluation of a pragmatic feasibility trial on smokeless tobacco cessation intervention delivered in dental hospitals

BackgroundArticle 14 of the WHO ‘Framework Convention on Tobacco Control’ recommends, that all oral healthcare providers provide support for tobacco cessation, to all patients. Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, implementation remains low in most high-burden countries like Pakistan. A pragmatic pilot trial of a dentist-delivered behavioural support intervention for smokeless tobacco (ST) cessation, was conducted in dental hospitals in Pakistan. This paper presents the findings of the process evaluation of the trial.MethodsA mixed-method process evaluation of a multi-centre randomised control pilot trial of dentist-delivered behavioural support intervention ST cessation was conducted. The intervention included three sessions namely: pre-quit, quit and post-quit sessions. The process evaluation involved: semi-structured interviews with trial participants (n = 26, of which dental patients were n = 13 and participating dentists were n = 13 conducted from June-August 2022); and fidelity assessment of audio recordings of the intervention sessions (n = 29). The framework approach was used to thematically analyse the interview data.ResultsOverall the trial procedures were well accepted, however, young patients expressed uneasiness over revealing their ST use status. The intervention was received positively by dentists and patients. Dentists identified some challenges in delivering behavioural support to their patients. Of these, some were related to the contents of the intervention whereas, others were related to the logistics of delivering the intervention in a clinical setting (such as workload and space). Acceptability of the intervention resources was overall low amongst young patients as they did not take the intervention resources home due to fear of their family members finding out about their ST use. The intervention was successful in achieving the intended impact (in those who engaged with the intervention), i.e., change in the patients’ ST use behaviour. Giving up ST with the aid of behavioural support also had an unintended negative effect i.e., the use of harmful substances (cannabis, cigarettes) to give up ST use. Patients’ satisfaction with their dental treatment seemed to influence the intervention outcome.ConclusionWhile there are many variables to consider, but for the participants of this study, behavioural support for abstinence delivered through dentists during routine dental care, appears to be an acceptable and practical approach in helping patients give up ST use, in a country like Pakistan, where negligible support is offered to ST users.

INTERPOLAR-prospective, interventional studies as part of the Medical Informatics Initiative to improve medication therapy safety in healthcare

Medication analyses by ward pharmacists are an important measure of drug therapy safety (DTS). Medication-related problems (MRPs) are identified and resolved with the attending clinicians. However, staff resources for extended medication analyses and complete documentation are often limited. Until now, data required for the identification of risk patients and for an extended medication analysis often had to be collected from various parts of the institution's internal electronic medical record (EMR). This error-prone and time-consuming process is to be improved in the INTERPOLAR (INTERventional POLypharmacy-Drug interActions-Risks) project using an IT tool provided by the data integration centers (DIC).INTERPOLAR is ause case of the Medical Informatics Initiative (MII) that focuses on the topic of DTS. The planning phase took place in 2023, with routine implementation planned from 2024. DTS-relevant data from the EMR is to be presented and the documentation of MRPs in routine care is to be facilitated. The prospective multicenter, cluster-randomized INTERPOLAR‑1 study serves to evaluate the benefits of IT support in routine care. The aim is to show that more MRPs can be detected and resolved with the help of IT support. For this purpose, sixnormal wards will be selected at each of eightuniversity hospitals, so that 48clusters (with atotal of at least 70,000 cases) are available for randomization.

Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: A study protocol.

Episiotomy is associated with side effects, such as pain and wound infection. Additionally, discomfort after episiotomy affects the quality of life of both the mother and the baby. Medicinal herbs are one alternative method for the treatment of episiotomy wounds. This study will investigate the effectiveness of the combination of olive and black seed oil on pain intensity and the healing of episiotomy wounds in primiparous women. This randomized clinical trial will be conducted on primiparous women who have had a normal delivery with an episiotomy. There are 3 groups in this study: one group will receive a combination of olive oil and black seed oil, another group will receive olive oil alone, and the use of oils will start 24 hours after delivery. Ten drops will be applied topically 3 times a day for 10 days. The third group (control) will receive only routine care. Data will be collected through a demographic characteristics questionnaire, REEDA (Redness, Edema, Ecchymosis, Discharge, and Approximation) Scale, and Visual Analog Scale. To determine and compare the effects of pharmaceutical interventions on pain intensity and episiotomy wound healing in the groups, an analysis of variance (ANOVA) test with repeated measurements will be used with SPSS version 22. The results of this study will show the effects of a combination of olive and black seed oil, as well as olive oil alone, on pain intensity and episiotomy wound healing in primiparous women. The positive effects observed in this trial with these oils could be valuable for women who have undergone an episiotomy.