Perception and Impact of COVID-19 Pandemic in Psoriasis Patients: Data from the German PsoBest and the CoronaBest Registries.

Background: Limited data are available characterizing the impact of the SARS-CoV-2 pandemic on psoriasis care for patients in Germany. Objective: To analyze patient perception and impact of the pandemic on well-being and psoriasis management of German patients with moderate-to-severe psoriasis or psoriasis arthritis under systemic therapies. Methods: The CoronaBest registry captures events of SARS-CoV-2 infections and analyzes the impact of the pandemic on patients with psoriasis or psoriasis arthritis. In June 2020, and independently in February 2022, patients with psoriasis or psoriasis arthritis received a standardized questionnaire for current treatment, protective measures, well-being, and individual risks for COVID-19, among others. Results: Included were 4,194 patients in 2020 (mean age of 47.7 years and 41.8% women) and 4,818 patients in 2022 (mean age of 56.4 and 42.9% women). Treatment discontinuations were observed in 2.7% and 1.7% of patients in 2020 and 2022, respectively. In the vast majority of the cases (>92%), no additional measures were taken concerning the management of psoriasis treatments in either 2020 or 2022. Those patients with changes reported most frequently: telephone calls instead of face-to-face visits (80.2%, in 2020 vs 40.5% in 2022) or more frequent controls (27.1%, 2020 vs 22.0%, 2022). A majority (66.7%, 2020, and 70.6%, 2022) did not perceive the virus as a considerable threat. The proportion of patients feeling well informed about COVID-19 by physicians increased from 42.6% in 2020 to 51.8% in 2022. About 81.1% of patients in 2020 and 67.5% in 2022 stated that their overall personal condition was not affected due to the pandemic. Physicians attributed no special risk of contracting SARS-CoV-2 in most of the patients. Conclusion: A high rate of systemic treatment persistence and awareness of risks and protective measures indicate that health care for psoriasis largely followed current national and international recommendations during the COVID-19 pandemic.

Which factors influence the participation in statutory skin cancer screenings in Germany?

BACKGROUND AND OBJECTIVES: Due to increasing skin cancer incidence, Germany implemented a statutory nationwide routine skin cancer screening (rSCS) in 2008. The present study aims (1) to analyze which patient factors are associated with the participation in rSCS in Germany and (2) to investigate reasons for nonparticipation. PATIENTS AND METHODS: Participants and nonparticipants of rSCS (≥ 35 years) were recruited in routine care in nine dermatological outpatient clinics. Reasons for (non-)participation, knowledge about skin cancer as well as clinical and socioeconomic data were obtained. Stratified by groups, descriptive analyses and binary logistic regression analyses for associations with participation were performed. RESULTS: Of the 294 rSCS participants and 162 non-participants, 46.5% were male with a mean age of 54.5 ± 12.7 years. In total, 87.1% had sunburns in childhood and 47.1% used sunbeds before. Higher age, female gender, previous sunbed use, and concern for and knowledge of skin cancer were significantly associated with previous rSCS participation. Of the non-participants, 46% were unaware of the option for free rSCS and 40% justified their nonparticipation on the basis of feeling healthy. CONCLUSIONS: The reasons for nonparticipation in rSCS, such as sociodemographic characteristics and risk behavior, should be known in order to optimize rSCS programs.

Tricuspid Regurgitation and TAVR: Outcomes, Risk Factors and Biomarkers.

Background. The significance of concomitant tricuspid regurgitation (TR) in the context of transcatheter aortic valve replacement (TAVR) remains unclear. This study aimed to analyze the severity of TR before and after TAVR with regard to short- and long-term survival and to analyze the influencing factors. Methods. In our retrospective analysis, TR before and after TAVR was examined and patients were classified into groups accordingly. Special attention was paid to patients with post-interventional changes in TR. Mortality after TAVR was considered the primary endpoint of the analysis and major complications according to the Valve Academic Research Consortium 3 (VARC3) were compared. Moreover, biomarkers and risk factors for worsening or improvement of TR through TAVR were analyzed. Results. Among 775 patients who underwent TAVR in our center between January 2009 and December 2019, 686 patients (89%) featured low- and 89 patients (11%) high-grade TR. High-grade pre-TAVR TR was associated with worse short- (30-day), mid- (2-year) and long-term survival up to 8 years. Even though in nearly half of the patients with high-grade TR the regurgitation improved within seven days after TAVR (n = 42/89), this did not result in a survival benefit for this subgroup. On the other hand, a worsening of low-grade TR was seen in more than 10% of the patients (n = 73/686), which was also associated with a worse prognosis. Predictors of worsening of TR after TAVR were adipositas, impaired right ventricular function and the presence of mild TR. Age, atrial fibrillation, COPD, impaired renal function and elevated cardiac biomarkers were risk factors for mortality after TAVR independent from the grade of TR. Conclusions. Not only pre-interventional, but also post-TAVR high-grade TR is associated with a worse prognosis after TAVR. TAVR can change concomitant tricuspid regurgitation, but improvement does not have any impact on short- and long-term survival. Worsening of TR after TAVR is possible and impairs the prognosis.

Moral Distress in Radiation Oncology: Insights From Residents in Germany.

Purpose: Being challenged by circumstances that force one to act in discordance with one's moral compass can lead to moral distress. The phenomenon has been widely investigated among nurses. This study was designed to shed some light on the situation of resident physicians in radiation oncology. Methods and Materials: To gain insight into moral distress among residents in radiation oncology, a web-based questionnaire was developed and distributed throughout Germany. Participants were asked to evaluate possible burdensome situations and different options for relief. To outline the main issues of moral distress, an exploratory factor analysis was conducted. Relief options were examined by frequencies. Results: The factor analysis yielded lack of time, contradiction between patient request and indication, nonmedical interests, and decisions between curative treatment and best supportive care as main issues for the 84 participants. Support from supervisors and senior physicians, as well as exchanges with resident colleagues were indicated as forms of relief. Professional support, such as ethics consultations, structured conversation groups (Balint), or psychological case supervisions, were rated as less helpful, although most participants reported a lack of experience with these. Conclusions: The results are in accordance with existing assumptions that moral distress among physicians is mainly due to uncertainty. Regarding radiation oncology residents in particular, moral distress seems to be related to uncertainty in decisions and conflicts about treatment options. Although senior physicians and supervisors present important role models in dealing with moral distress, professional services such as ethics consultations offer an opportunity for relief that can still be expanded.

Sociodemographic and Environmental Determinants of Regional Prevalence of Psoriasis in Germany: A Spatiotemporal Study of Ambulatory Claims Data.

There are regional differences in the prevalence of psoriasis between countries, as well as within countries. However, regional determinants of differences in prevalence are not yet understood. The aim of this study was to identify sociodemographic and environmental determinants of regional prevalence rates for psoriasis. Analyses were based on German outpatient billing data from statutory health insurance, together with data from databases on sociodemographic and environment factors at the county level (N = 402) for 2015-2017. Descriptive statistics were calculated for all variables. To identify determinants for prevalence at the county level, spatiotemporal regression analysis was performed, with prevalence as the dependent variable, and the number of physicians, mean age, mean precipitation, sunshine hours, mean temperature, level of urbanity, and the German Index of Socioeconomic Deprivation (GISD) as independent variables. Mean prevalence of psoriasis increased from 168.63 per 10,000 in 2015 to 173.54 per 10,000 in 2017 for Germany as a whole, with high regional variation. Five determinants were detected (p < 0.05). The prevalence increased by 4.18 per 10,000 persons with SHI with each GISD unit, and by 3.76 per 10,000 with each year increase in age. Each additional hour of sunshine resulted in a decrease of 0.04 and each °C increase in mean temperature resulted in an increase of 4.22. Each additional dermatologist per 10,000 inhabitants resulted in a decrease of 0.07. In conclusion, sociodemographic and environmental factors result in significant differences in prevalence of psoriasis, even within-country.

Evaluation of skin cancer screening in Germany - Spatiotemporal associations between skin cancer screening and skin cancer mortality based on ambulatory claims data.

BACKGROUND: There are regional differences in skin cancer screening uptake in Germany. So far, it is unclear whether a high uptake of screening services leads to a reduction in mortality. This article presents study results on the investigation of spatiotemporal associations between skin cancer screening and mortality. The methods used are discussed regarding their suitability. MATERIAL AND METHODS: The basis is ambulatory claims data on the utilization of early skin cancer detection as well as data on skin cancer mortality from the cause-of-death statistics of the years 2011-2015 at county level in Germany. In addition to a descriptive evaluation, spatiotemporal cluster analyses and regression models were used to investigate the relationship between the uptake of early detection and mortality. In addition to age, adjustments were also made for other selected socio-economic and socio-graphical variables. RESULTS: The descriptive results show striking spatial patterns of skin cancer screening and mortality. Cluster analyses identified regions with significantly higher and lower cases of early detection and skin cancer mortality. The spatiotemporal regression analyses show no clear association. Only early detection by a dermatologist, adjusted for age, shows an association with mortality. CONCLUSIONS: No clear association between early skin cancer detection and mortality can be derived from the results. However, the study design used with a spatiotemporal cluster and regression analysis has shown that these methods allow in-depth statements about the relationship between early skin cancer detection and mortality.

Evaluation of early skin cancer detection in Germany with cancer registry data - challenges, solutions and current trends.

BACKGROUND AND AIMS: The evidence for the benefit of the skin cancer screening introduced in Germany in 2008 is weak. We investigate to what extent data from the German epidemiological cancer registries are suitable to contribute to the evaluation of skin cancer screening and report these evaluation results. MATERIAL AND METHODS: Skin cancer-related cancer registry data from 1999-2019 were described in terms of completeness and comprehensiveness. Regional pools with data of different validity were defined, missing data were multiply imputed where appropriate, and temporal trends were analyzed. In addition, data from the cause of death statistics were used. RESULTS: Reliable estimates of completeness are only available for malignant melanoma (ICD-10: C43). Based on a regional data pool covering approximately 21% of the German population, melanoma-related incidence can be validly described since 2005. Sufficient information for multiple imputation is available for T-stage and localization. The trend analyses show incidence changes that can be expected in the short term in the temporal context of the introduction of early detection, which changes into a long-lasting high incidence. The rate of advanced stages does not decrease significantly. From 2014 onwards, the melanoma mortality rate, which had been rising until then, decreases. CONCLUSIONS: Adequately selected and processed cancer registry data are suitable for population-based evaluation of skin cancer screening. An explanation of the persistently high incidence level is not possible based on the cancer registry data. Overdiagnosis or an increase in the background incidence can be considered. The benefit of skin cancer screening remains open.

Evaluation of skin cancer screening in Germany - participation, tumor detection and interval tumors based on SHI data.

BACKGROUND AND GOALS: The rising incidence of skin cancer in Germany has increased the need for secondary prevention measures. For this purpose, a statutory skin cancer screening for insured persons aged 35 and older was introduced on 1 June 2008. The aim of this work package in the Innovation Fund project "Perspectives of a multimodal evaluation of early skin cancer detection" (Pertimo) was to test an evaluation of skin cancer screening using secondary data. PATIENTS AND METHODS: The data basis was statutory insured persons of the DAK Health from the age of 35 who were insured as of 31 December 2010 and were followed up until the end of 2015. The rates of participation, skin tumors detected in skin cancer screening (tumor detections), and interval tumors that occurred within two years after a finding-free skin cancer screening were calculated. RESULTS: The biennial skin cancer screening take-up rate in 2014 and 2015 was 33.6% for women and 32.6% for men. Of those screened, 4.2% had a skin cancer finding (tumor detection) in the course of skin cancer screening. Of all incident skin cancer diagnoses (2012-2015), 50.1% were detected in skin cancer screening. In 1.5% of the insured persons with skin cancer screening without findings, an incidental skin tumor was diagnosed in the following two years (interval tumor). CONCLUSIONS: The data from the statutory health insurance mapped the skin cancer screening occurrence in Germany and highlighted the importance of dermatologists in the screening process. The analysis provided important new insights.

Genetic and geographic influence on phenotypic variation in European sarcoidosis patients.

Introduction: Sarcoidosis is a highly variable disease in terms of organ involvement, type of onset and course. Associations of genetic polymorphisms with sarcoidosis phenotypes have been observed and suggest genetic signatures. Methods: After obtaining a positive vote of the competent ethics committee we genotyped 1909 patients of the deeply phenotyped Genetic-Phenotype Relationship in Sarcoidosis (GenPhenReSa) cohort of 31 European centers in 12 countries with 116 potentially disease-relevant single-nucleotide polymorphisms (SNPs). Using a meta-analysis, we investigated the association of relevant phenotypes (acute vs. sub-acute onset, phenotypes of organ involvement, specific organ involvements, and specific symptoms) with genetic markers. Subgroups were built on the basis of geographical, clinical and hospital provision considerations. Results: In the meta-analysis of the full cohort, there was no significant genetic association with any considered phenotype after correcting for multiple testing. In the largest sub-cohort (Serbia), we confirmed the known association of acute onset with TNF and reported a new association of acute onset an HLA polymorphism. Multi-locus models with sets of three SNPs in different genes showed strong associations with the acute onset phenotype in Serbia and Lublin (Poland) demonstrating potential region-specific genetic links with clinical features, including recently described phenotypes of organ involvement. Discussion: The observed associations between genetic variants and sarcoidosis phenotypes in subgroups suggest that gene-environment-interactions may influence the clinical phenotype. In addition, we show that two different sets of genetic variants are permissive for the same phenotype of acute disease only in two geographic subcohorts pointing to interactions of genetic signatures with different local environmental factors. Our results represent an important step towards understanding the genetic architecture of sarcoidosis.

Genome-wide case-only analysis of gene-gene interactions with known Parkinson's disease risk variants reveals link between LRRK2 and SYT10.

The effects of one genetic factor upon Parkinson's disease (PD) risk may be modified by other genetic factors. Such gene-gene interaction (G×G) could explain some of the 'missing heritability' of PD and the reduced penetrance of known PD risk variants. Using the largest single nucleotide polymorphism (SNP) genotype data set currently available for PD (18,688 patients), provided by the International Parkinson's Disease Genomics Consortium, we studied G×G with a case-only (CO) design. To this end, we paired each of 90 SNPs previously reported to be associated with PD with one of 7.8 million quality-controlled SNPs from a genome-wide panel. Support of any putative G×G interactions found was sought by the analysis of independent genotype-phenotype and experimental data. A total of 116 significant pairwise SNP genotype associations were identified in PD cases, pointing towards G×G. The most prominent associations involved a region on chromosome 12q containing SNP rs76904798, which is a non-coding variant of the LRRK2 gene. It yielded the lowest interaction p-value overall with SNP rs1007709 in the promoter region of the SYT10 gene (interaction OR = 1.80, 95% CI: 1.65-1.95, p = 2.7 × 10-43). SNPs around SYT10 were also associated with the age-at-onset of PD in an independent cohort of carriers of LRRK2 mutation p.G2019S. Moreover, SYT10 gene expression during neuronal development was found to differ between cells from affected and non-affected p.G2019S carriers. G×G interaction on PD risk, involving the LRRK2 and SYT10 gene regions, is biologically plausible owing to the known link between PD and LRRK2, its involvement in neural plasticity, and the contribution of SYT10 to the exocytosis of secretory vesicles in neurons.

Effect of operators' proficiency level and patients' related factors on possible complications, using a high frequency polyamide sonic intracanal irrigation device: A prospective clinical cohort study.

OBJECTIVES: Sonic/ultrasonic devices are essential tools in today's endodontics. This prospective trial evaluated for the first time the impact of practitioners' proficiency levels and patient-related factors on complications associated with a high frequency polyamide sonic irrigant activation device. METHODS: In total 334 patients (females:158, males:176; age:18-95 years) received in the course of their endodontic therapy an intracanal irrigation, using a high frequency polyamide sonic irrigant activation device, by practitioners of different proficiency levels (undergraduate students, general practitioners or endodontists). Intracanal bleeding (yes/no), postoperative pain (0-10 scale), emphysema (yes/no) and polyamide tip fractures (yes/no) were recorded and related to proficiency levels, age, gender, tooth type, smoking-status, systemic conditions affecting healing ability, baseline pain, swelling, fistula, sensitivity to percussion and diagnosis. RESULTS: Intracanal bleeding was associated with patients' age (p<0.05), baseline pain level (OR = 1.14, 95%CI = 0.91-1.22) and baseline swelling (OR = 2.73, 95%CI = 0.14-0.99; p<0.05) but not proficiency level, gender, tooth type, smoking, systemic conditions, baseline fistula or sensitivity to percussion (p>0.05). Postoperative pain development was related to proficiency level (p<0.05) and baseline pain level (p<0.001), with no influence of age, gender, tooth type, smoking, systemic conditions, baseline fistula, swelling or sensitivity to percussion (p>0.05). Emphysema and polyamide tip fractures were not reported. CONCLUSIONS: Within the current study's limitations, younger patients with higher baseline pain and swelling, were associated with higher intracanal bleeding. Apart from higher postoperative pain observed with less experienced practitioners, proficiency level had no influence on bleeding, polyamide tip fracture or emphysema, endorsing the high frequency polyamide sonic irrigation device as a safe therapeutic device.

Spatial Distribution of COVID-19 Hospitalizations and Associated Risk Factors in Health Insurance Data Using Bayesian Spatial Modelling.

The onset of COVID-19 across the world has elevated interest in geographic information systems (GIS) for pandemic management. In Germany, however, most spatial analyses remain at the relatively coarse level of counties. In this study, we explored the spatial distribution of COVID-19 hospitalizations in health insurance data of the AOK Nordost health insurance. Additionally, we explored sociodemographic and pre-existing medical conditions associated with hospitalizations for COVID-19. Our results clearly show strong spatial dynamics of COVID-19 hospitalizations. The main risk factors for hospitalization were male sex, being unemployed, foreign citizenship, and living in a nursing home. The main pre-existing diseases associated with hospitalization were certain infectious and parasitic diseases, diseases of the blood and blood-forming organs, endocrine, nutritional and metabolic diseases, diseases of the nervous system, diseases of the circulatory system, diseases of the respiratory system, diseases of the genitourinary and symptoms, and signs and findings not classified elsewhere.

Health services in older psoriasis patients before and after nursing home admission : A retrospective analysis of health insurance data.

BACKGROUND AND OBJECTIVE: Demographic change confers significance to healthcare management of chronic diseases like psoriasis. There are few studies on the care of older people with psoriasis, particularly for the nursing home setting. It was investigated whether the number of psoriasis patients with specialist contact changes before vs. after nursing home admission. MATERIAL AND METHODS: We analyzed claims data of a German health insurance company including a cohort of newly admitted nursing home residents aged 65 years and older between 2011 and 2014, who received a diagnosis of psoriasis 1 year before nursing home admission. Outpatient care was compared between the years before vs. after nursing home admission. We conducted a multivariate regression analysis for identifying predictors for dermatological care. RESULTS: The study cohort included 718 insured persons (Ø83 years). Proportion of patients who had contact to a dermatologist significantly decreased after nursing home entry (44.6% before vs. 40.1% after nursing home entry). Strongest predictors for dermatological care after entry were a previously existing dermatological contact (odds ratio, OR 3.87, 95% confidence interval, CI 2.70-5.54) and prescription for topical steroids (OR 1.61, 95% CI 1.14-2.28). CONCLUSION: The analysis of health insurance data showed a pertinent decrease in the use of outpatient dermatological care after institutionalization. The evaluation of the adequacy of care is difficult due to the used database without clinical information. As long as no further investigations of this vulnerable patient group are available, the care of psoriasis patients of old age should be closely monitored. Dermatological knowledge of the skin in old age is an essential prerequisite for this.

[Further Development of Maturity Levels of Quality and Risk Management System at the University Hospital Schleswig-Holstein]. / Weiterentwicklung der Reifegrade des Qualitäts ­ und Risikomanagementsystems am Universitätsklinikum Schleswig-Holstein.

INTRODUCTION: Following upon our publication "Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein" in 2018, we present the further development of the maturity model. Quality and risk management in hospitals is not only required by law but also plays a significant role in an optimized patient- and process-oriented health care. METHODS: A questionnaire-based self-assessment was carried out by 46 clinical units of the UKSH (location Kiel and Lübeck) for the analysis of nine quality criteria overall. Four of these criteria (quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM)) were already analysed in 2016 and were extended to the five new aspects, namely audits and on-site inspections, responsibilities, morbidity and mortality conferences, hygiene training and surgical safety checklist. Every quality item was graded into four categories from "A" (fully implemented) to "D" (not implemented at all). RESULTS: The comparison of the results for quality criteria QS, CIRS, BM, PM and the overall maturity level between 2016 and 2020 demonstrated statistically significant improvements in 2020 concerning the criteria QS (p=0.013), CIRS (p=0.026), PM (p=0.000) and the overall maturity levels (p=0.019). The criteria BM did not show any statistically significant improvement. The five newly added quality criteria demonstrated maturity levels "A" (fully implemented) and "B" (largely implemented) the following: audits and on-site inspections (100%), responsibilities (95.6%), morbidity and mortality conferences (65.2%), hygiene training (95.6%), and surgical safety checklist (100%). CONCLUSION: An integrated quality and risk management has already been a firm element of UKSH for years. Nevertheless, review of effectiveness of the initiated targeted measures is still a challenge. This is the reason why it is necessary to develop effective and resource-saving approaches for the evaluation of measures and the identification of potential for improvement. The recognised potential for improvement should be risk-prioritized and completely exploited using sustainable measures. Following this principle, we designed a qualitative model of maturity levels for the evaluation of our quality and risk management system at the UKSH in 2016, whose further development we demonstrate here.

Case-only design identifies interactions of genetic risk variants at SIGLEC5 and PLG with the lncRNA CTD-2353F22.1 implying the importance of periodontal wound healing for disease aetiology.

AIM: The basis of phenotypic variation of periodontitis is genetic variability. Disease relevant effects of individual risk alleles are considered to result from genetic interactions. We investigated gene × gene (G×G) interactions of suggestive periodontitis susceptibility alleles. MATERIALS AND METHODS: We used the case-only design and investigated single-nucleotide polymorphism (SNPs) that showed associations in our recent genome-wide association study (GWAS) and GWAS meta-analysis with p < 5 × 10-6 . CRISPR-dCas9 gene activation followed by RNA-sequencing and gene-set enrichment analyses elucidated differentially expressed genes and gene networks. With the databases of SNPInspector and Transfac professional, luciferase reporter gene assays and antibody electrophoretic mobility shift experiments, we analysed allele-specific effects on transcription factor binding. RESULTS: SNPs at the genes sialic acid binding Ig-like lectin 5 (SIGLEC5) and plasminogen (PLG) showed G×G interactions with rs1122900 at the long non-coding RNA (lncRNA) CTD-2353F22. Associated chromatin cis-activated CTD-2353F22.1 6.5-fold (p = .003), indicating CTD-2353F22.1 as target gene of this interaction. CTD-2353F22.1 regulated GADD45A (padj < 4.9 × 10-11 , log2 fold change (FC) = -0.55), THBS1, SERPINE1 and Tissue Factor F3 (padj < 5 × 10-7 , log2 FC ≥ -0.35) and the gene set "angiogenesis" (area under the curve = 0.71, padj  = 8.2 × 10-5 ). rs1122900 effect C-allele decreased reporter gene activity (5.5-fold, p = .0003) and PRDM14 binding (76%). CONCLUSIONS: CTD-2353F22.1 mediates interaction of SIGLEC5 and PLG, together with genes that function in periodontal wound healing.

Medicinal Treatment of Elderly Psoriasis Patients before and after Entering a Nursing Home.

Psoriasis (PS) is a chronic inflammatory skin disease, and it increasingly appears also in the elderly population. There is a rising interest in drug therapy for PS, especially for people receiving care in nursing homes (NH). Which PS-related drugs are prescribed in the time before nursing home admission (NHA), and to what extent does the supply of drugs change after NHA? Which specialties prescribe PS-related drugs? Statutory health insurance data were examined for people with PS, aged ≥ 65 years, who were newly admitted to a NH in the period 2011-2014 and observed for one year before and after NHA. Changes in prescription prevalence (pre-post comparison) were examined for significant differences. Prescriptions of PS-relevant drugs were measured by defined daily dose and stratified according to the prescribing specialist group. The analysis included 718 insured persons with PS (76.2% female, mean age 83.3 years). Systemic therapeutics played a minor role (pre: 2.6% vs. post: 2.1%) in drug therapy. Topical steroids had a high share of about 40% in the pre-post comparison. Overall, the proportion of people with PS who received treatment remained at a comparable level before and after NHA. A structured assessment of the skin is crucial, specifically in people with cognitive impairment.

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy: A Systematic Review.

Importance: Approximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications. Objective: To investigate the use and reporting of PROs in clinical trials of palliative radiotherapy. Evidence Review: This preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines. Findings: Among 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score. Conclusions and Relevance: In this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.