Abstract Background Cancer requires interdisciplinary intersectoral care. The Care Coordination Instrument (CCI) captures patients’ perspectives on cancer care coordination. We aimed to translate, adapt, and validate the CCI for Germany (CCI German version). Methods The original English version contains 29 items in three domains, measured on a 4-point Likert scale (strongly disagree to strongly agree). Validation was conducted in three phases (mixed methods): (I) translation; (II) adaptation: pilot testing and revision in an iterative process using semi-structured, cognitive interviews with patients and professionals (physicians specializing in cancer), with interviews transcribed and qualitatively analyzed by inductive coding; and (III) validation: quantitative validation performed online (LimeSurvey), of at least 80 German patients, each with common cancer (breast, prostate) and rare cancer (different entities), with examination of factor structure (factor analysis) and determination of internal consistency (Cronbach's α) as well as potential influencing factors such as gender, education, or migration background (multivariable regression). Results Six patients and six professionals tested the translated instrument for comprehensibility, readability, and acceptability. Two items were consistently problematic for interviewees. A 31-item version (29 items + 2 alternative items) was validated in 192 patients. The alternative items had a higher variance in response behavior and were better understood; therefore, they replaced the two problematic items. However, the three original domains could not be confirmed statistically. Exploratively, a two-factorial structure (with cross-loadings) emerged, which can be interpreted as “communication/information” (16 items) and “need-based navigation” (17 items). Overall, the instrument had a high internal consistency (total score α = 0.931, M = 47.16, SD = 14.25; communication/information α = 0.924, M = 30.14, SD = 8.93; need-based navigation α = 0.868, M = 23.99, SD = 8.37). Significant factors on the care coordination score are treatment location (hospital vs. private practice oncologist M = -9.83 score points, p = 0.011) and gender (women vs. men M = 8.92 score points, p = 0.002). Conclusion The CCI German version is a valid instrument for measuring patients’ perceptions of cancer care coordination. Both domains reflect important aspects of care. The sensitivity of the CCI should be examined in future studies involving different cancer entities.

For Diabetic polyneuropathy, the most prevalent form of polyneuropathy, there is a lack of evidence-based treatment options. Current approaches include pain management, alpha-lipoic acid, and antidepressants. Physical interventions, such as electrical stimulation (four-chamber galvanic bath) have been suggested but have limited supporting evidence. Heated granular stone therapy is another option to consider. An unblinded randomized controlled trials was conducted in 68 diabetic patients with distal sensorimotor polyneuropathy undergoing rehabilitation for diabetes mellitus as a primary or secondary diagnosis in the Paracelsus-Harz-Clinic (Quedlinburg, Germany). Patients were randomized into either the intervention group receiving heated granulated stone footbaths, or the control group receiving four-chamber galvanic baths. The primary endpoint was the assessment of any change in polyneuropathy using a vibration sensation test (Rydel-Seiffer scale, 8/8) from admission to discharge, analyzed by t-test and multivariable regression. Additionally, serum TNF-α and IL-6 as potential markers for polyneuropathy were compared over time using paired t-test. The mean age of the patients was 66.8 ± 7.8 years; 63.2

Propensity scores (PS) have been established as a valid alternative to conventional regression models when evaluating non-randomized treatment studies. The PS describes the probability for an individual to receive a treatment, conditional on a set of observed covariates. PS analyses are performed in two steps. In the first step, the PS is generally estimated via logistic regression. In the second step, the actual treatment effect is estimated. The quality of a PS analysis depends on whether it is possible to achieve a sufficient balance of the patient characteristics in the treatment groups in the first step. This is the only way to ensure that these patient characteristics do not bias the estimate of the treatment effect. Various measures have been proposed to measure this balance, e.g. the standardized difference or the z-difference. Closely related to the balance of patient characteristics (and thus also a measure of the quality for a PS model) is the overlap, i.e. the similarity in the distribution of the estimated propensity scores in the two treatment groups. A valid comparison of the treatments is only possible in regions of sufficient overlap. In this article, the two concepts of balance and overlap are presented and discussed using an example from cardiac surgery.

INTRODUCTION:Hidradenitis suppurativa (HS) is a chronic inflammatory disorder of the pilosebaceous unit, often affecting and deforming intimate regions. HS is associated with severe pain, pruritus, and constant, purulent, malodorous discharge expected to impair sexual health of patients.METHODS:We performed a cross-sectional, multicentric study involving 199 German patients from the health services research project "Epidemiology and Care in Acne inversa (EpiCAi)." The sexual health, HS severity, and quality of life of the studied group were evaluated using a specially designed questionnaire.RESULTS:Regardless of gender, HS has an enormous impact on patients' sexual health. The patients scored, on average, 28.8 ± 5.3 points on the Relation and Sexuality Scale (RSS). Multiple linear regression revealed that females and patients with Hurley III stage had higher sexual dysfunction (p = 0.012). Sexual dysfunction is associated with pain (β = 0.25), the number of active lesions, the affected areas (β = 0.14), and psychosocial aspects, including low quality of life (β = 0.404), stigmatization (β = 0.411), depression (β = 0.413), and anxiety (β = 0.300). Patients already see a substantial decrease in sexual frequency in the early stages of HS, while functional impairment and fear increase with the severity of the disease.CONCLUSION:Sexual health and management of its dysfunctions should be part of a holistic approach to HS patients.

Hintergrund und ZieleHidradenitis suppurativa (HS)/Acne inversa (Ai) ist eine chronische, stark beeintr & auml;chtigende Erkrankung mit begrenzten Therapiem & ouml;glichkeiten. Die ger & auml;tebasierte LAight-Therapie wurde 2017 in Europa zugelassen. Ziel dieser Studie war es, die Auswirkungen einer Real-World-Versorgung mit der LAight-Therapie auf die Krankheitsaktivit & auml;t und -belastung von 3437 Patienten zu analysieren. Patienten und MethodikIn die Analyse wurden alle Patienten aufgenommen, die eine HS-Diagnose und mindestens eine LAight-Behandlung erhalten hatten. Die Endpunkte Hidradenitis Suppurativa Severity Score System (IHS4), Schmerz auf der numerischen Ratingskala (pain-NRS) und der Dermatologische-Lebensqualit & auml;ts-Index (DLQI) wurden mit Hilfe eines linearen gemischten Modells f & uuml;r wiederholte Messungen (MMRM) & uuml;ber 26 Wochen Versorgung mit der LAight-Therapie analysiert. Dar & uuml;ber hinaus wurden die Responderraten f & uuml;r alle Endpunkte berechnet und das Sicherheitsprofil der Therapie sowie die Patientenzufriedenheit eingehend untersucht. ErgebnisseW & auml;hrend der 26-w & ouml;chigen Versorgung mit LAight wurde ein signifikanter R & uuml;ckgang des IHS4, Schmerz-NRS und DLQI erreicht. Der BMI hatbei Therapiestart hatte einen signifikant negativen Einfluss auf das Therapieansprechen hinsichtlich Schmerz-NRS und DLQI. SchlussfolgerungenDiese Studie best & auml;tigt, dass die LAight-Therapie zu einer & uuml;berzeugenden Krankheitskontrolle in allen Schweregraden f & uuml;hrt und eine wertvolle Erg & auml;nzung des therapeutischen Repertoires bei HS darstellt.

BACKGROUND:Propensity score matching has become a popular method for estimating causal treatment effects in non-randomized studies. However, for time-to-event outcomes, the estimation of hazard ratios based on propensity scores can be challenging if omitted or unobserved covariates are present. Not accounting for such covariates could lead to treatment estimates, differing from the estimate of interest. However, researchers often do not know whether (and, if so, which) covariates will cause this divergence. METHODS:To address this issue, we extended a previously described method, Dynamic Landmarking, which was originally developed for randomized trials. The method is based on successively deletion of sorted observations and gradually fitting univariable Cox models. In addition, the balance of observed, but omitted covariates can be measured by the sum of squared z-differences. RESULTS:By simulation we show, that Dynamic Landmarking provides a good visual tool for detecting and distinguishing treatment effect estimates underlying built-in selection or confounding bias. We illustrate the approach with a data set from cardiac surgery and provide some recommendations on how to use and interpret Dynamic Landmarking in propensity score matched studies. CONCLUSION:Dynamic Landmarking is a useful post-hoc diagnosis tool for visualizing whether an estimated hazard ratio could be distorted by confounding or built-in selection bias.

Sexual health, a critical aspect of overall well-being, is often compromised in individuals with chronic disorders. Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that mainly affects intertriginous areas, potentially impacting sexual health as a result of its specific symptoms and psychosocial burden. This cross-sectional study utilized data from the EpiCAi project, focusing on 199 patients with HS. Participants completed digital questionnaires assessing sexual health via sex-specific instruments: the Female Sexual Function Index (FSFI) for women and the International Index of Erectile Function (IIEF) for men, alongside different psychosocial scales. The disease severity was assessed using the Hurley stage and the Lesion Identification Scheme for Acne Inversa (LISAI). The majority of the participants reported impaired sexual health, with significant clinical sexual dysfunctions noted in 71.8

SummaryBackground and objectivesHidradenitis suppurativa (HS)/Acne inversa (Ai) is a chronic debilitating disease with limited therapy options. The device‐based LAight therapy was approved in Europe in 2017. The aim of this study was to evaluate the effect of real‐world care with at least one treatment with LAight therapy on disease activity and burden in 3,437 patients.Patients and MethodsPatients were included in the analysis if they had a diagnosis of HS and received at least one treatment. The endpoints Hidradenitis Suppurativa Severity Score System (IHS4), pain on the numeric rating scale (pain‐NRS) and Dermatology Life Quality Index (DLQI) were analyzed using a linear mixed model for repeated measures (MMRM) over 26 weeks of care with LAight therapy. Furthermore, responder rates were calculated for all endpoints, and the therapy's safety profile and patient satisfaction were thoroughly examined.ResultsA significant decrease in IHS4, pain‐NRS, and DLQI was achieved during 26 weeks of care with LAight. The BMI at baseline had a significant negative effect on therapy response for pain‐NRS and DLQI.ConclusionsThis study confirms that LAight therapy leads to satisfactory disease control in all stages of severity and is a valuable addition to the therapeutic repertoire of HS.

Background Hidradenitis suppurativa (HS) is an inflammatory disease of the inverse skin regions that occurs in young women, in particular, and affects approximately 1% of the population. Outpatient care is often inadequate and usually cannot prevent progression. Objectives To evaluate in the EsmAiL ('Evaluation eines strukturierten und leitlinienbasierten multmodalen Versorgungskonzepts fur Menschen mit Akne inversa') trial whether an innovative care concept can decrease disease activity and burden, and improve patient satisfaction. Methods EsmAiL was conducted as a two-arm, multicentre, prospective, randomized controlled trial that included 553 adults with HS. Inclusion criteria were a minimum of three inflammatory lesions and at least a moderate impact of the disease on quality of life. The control group (CG) remained under standard care, while patients in the intervention group (IG) were treated according to a trial-specific, multimodal concept. The primary endpoint was the absolute change in International Hidradenitis Suppurativa Severity Score System (IHS4). Results In total, 274 patients were randomized to the IG and 279 to the CG. Altogether, 377 attended the final assessment after 12 months of intervention. Participants in the IG (n = 203) achieved a mean improvement in IHS4 of 9.3 points, while the average decrease in IHS4 in patients in the CG (n = 174) was 5.7 points (P = 0.003). Patients treated under the new care concept also reported a statistically significantly higher decrease in pain, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale scores compared with those in the CG (P < 0.001). Patient satisfaction was also statistically significantly higher in the IG compared with the CG (P < 0.001). Conclusions The establishment of standardized treatment algorithms in so-called 'acne inversa centres' in the ambulatory setting has a substantial, positive impact on the course of HS and significantly improves patient satisfaction. Hidradenitis suppurativa (HS) is a debilitating, complex disease. The current structure of outpatient care for patients with HS is inadequate. Access to HS specialists is limited, and although therapeutic options exist, they do not always fit patients' needs. There is a need to improve outpatient care for HS. The establishment of standardized treatment algorithms in so-called 'acne inversa centres' in the ambulatory setting has a substantial, positive impact on disease course and significantly improves patient satisfaction.

Rationale and Objectives: To evaluate the impact of low skeletal muscle mass in patients with COVID-19 on relevant outcomes like 30-day mortality, need for intubation and need for intensive care unit admission.Materials and Methods: For this study, data from six centers were acquired. The acquired sample comprises 1138 patients. There were 547 women (48.1%) and 591 men (51.9%) with a mean age of 54.5 +/- 18.8 years; median age, 55 years; range, 18-84 years). In every case, thoracic CT without intravenous application of contrast medium was performed. The following parameters of the pectoralis muscles were estimated: muscle area as a sum of the bilateral areas of the pectoralis major and minor muscles, muscle density, muscle index (PMI) (pectoralis muscle area divided by the patient's body height square) as a ratio pectoralis major and minor muscles divided by the patient's body height2, and muscle gauge as PMI x muscle density. Results: Overall, 220 patients (19.33%) were admitted to the intensive care unit. In 171 patients (15.03%), mechanical lung ventilation was performed. Finally, 154 patients (13.53%) died within the observation time of 30-day. All investigated parameters of pectoralis muscle were lower in the patients with unfavorable courses of Covid-19. All pectoralis muscle parameters were associated with 30-day mortality in multivariate analyses adjusted for age and sex: pectoralis muscle area, HR = 0.93 CI 95% (0.91-0.95) p < 0.001; pectoralis muscle den-sity, HR = 0.94 CI 95% (0.93-0.96) p < 0.001; pectoralis muscle index, HR = 0.79 CI 95% (0.75-0.85) p < 0.001, pectoralis muscle gauge, HR = 0.995 CI 95% (0.99-0.996) p < 0.001.Conclusion: in COVID-19, survivors have larger areas and higher index, gauge and density of the pectoralis muscles in comparison to nonsurvivors. However, the analyzed muscle parameters cannot be used for prediction of disease courses.

Body composition assessment derived from cross-sectional imaging has shown promising results as a prognostic biomarker in several tumor entities. Our aim was to analyze the role of low skeletal muscle mass (LSMM) and fat areas for prognosis of dose-limiting toxicity (DLT) and treatment response in patients with primary central nervous system lymphoma (PCNSL). Overall, 61 patients (29 female patients, 47.5

BACKGROUND:Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease affecting approximately 1% of the population. The patient journey through the German health care system leads to high disease burden and substantial treatment costs. The EsmAiL study showed that an innovative, interprofessional, multimodal care-concept reduces disease activity and burden of HS compared to standard care. This paper examines the costs of treating HS in Germany and compares them with those of the innovative care concept implemented in EsmAiL. METHODS:EsmAiL was a two-arm, multicenter, prospective randomized controlled trial including 553 adults with HS. The study was registered in the German Clinical Trials Registry (DRKS00022135). The control group (CG) remained in standard care, whereas the intervention group (IG) was referred to specialized so-called 'acne-inversa-centres (AiZ)' where patients were treated with a structured, interdisciplinary approach. The present paper analyses the treatment costs for a subpopulation based on health insurance cost data from the two largest German health insurers. Quality-Adjusted Life Years (QALY) was assessed based on Dermatology Life Quality Index (DLQI). RESULTS:Total annual treatment costs per patient were €3,966.07 in standard care (n = 89) and €3,974.37 in the innovative care (n = 93). The costs per additional QALY amounted to €12,698.72 in the IG. Given the conventional and established threshold of €22,600 to €33,900 per QALY, the innovative treatment in AiZ proved to be cost-effective. CONCLUSION:Treatment costs of HS are substantial and increase with disease severity. The new form of care is cost-effective and is expected to decrease costs in the long run.

The use of hazard ratios as the standard treatment effect estimators for randomized trials with time-to-event outcomes has been the subject of repeated criticisms in recent years, e.g., for its non-collapsibility or with respect to (causal) interpretation. Another important issue is the built-in selection bias, which arises when the treatment is effective and when there are unobserved or not included prognostic factors that influence time-to-event. In these cases, the hazard ratio has even been termed "hazardous" because it is estimated from groups that increasingly differ in their (unobserved or omitted) baseline characteristics, yielding biased treatment estimates. We therefore adapt the Landmarking approach to assess the effect of ignoring a gradually increasing proportion of early events on the estimated hazard ratio. We propose an extension called "Dynamic Landmarking". This approach is based on successive deletion of observations, refitting Cox models and balance checking of omitted but observed prognostic factors, to obtain a visualization that can indicate built-in selection bias. In a small proof-of-concept simulation, we show that our approach is valid under the given assumptions. We further use "Dynamic Landmarking" to assess the suspected selection bias in the individual patient data sets of 27 large randomized clinical trials (RCTs). Surprisingly, we find no empirical evidence of selection bias in these RCTs and thus conclude that the supposed bias of the hazard ratio is of little practical relevance in most cases. This is mainly due to treatment effects in RCTs being small and the patient populations being homogeneous, e.g., due to inclusion and exclusion criteria.

Low skeletal muscle mass (LSMM) predicts relevant clinical outcomes in oncologic patients. The purpose of this study was to perform a meta-analysis of data regarding associations between LSMM and treatment response (TR) in oncology. MEDLINE, Cochrane, and SCOPUS databases were screened for relationships between LSMM and TR in oncologic patients up to November 2022. Overall, 35 studies met the inclusion criteria. The meta-analysis was performed using RevMan 5.4 software. The collected 35 studies comprised 3858 patients. In 1682 patients (43.6 • Low skeletal muscle mass (LSMM) predicts treatment response (TR) to chemotherapy in the adjuvant and/or neoadjuvant setting. • LSMM predicts TR in immunotherapy. • LSMM does not influence TR in palliative chemotherapy.

Abstract Background/Aim: Body composition assessment has shown promising results as a prognostic biomarker as depicted by cross-sectional imaging of several tumor entities including lymphomas. The present study sought to elucidate the prognostic relevance of subcutaneous and visceral fat tissue (SAT and VAT) in patients with primary central nervous system lymphoma (PCNSL). Patients and Methods: Overall, 74 patients (36 female patients, 46.7%) with a mean age of 64.2±12.8 years (range=23-81 years) were identified in the database with sufficient clinical and imaging data and included into this retrospective study. Fat area assessment was performed on one axial slide on L3-height derived from staging computed tomography (CT) images. Subcutaneous, visceral, and intramuscular adipose tissues (SAT, VAT, IMAT) were estimated. Also, density of SAT, VAT, and IMAT were estimated. Finally, the ratio VAT/SAT (VSR) was calculated. Overall and progression-free survival (OS and PFS) were used as study end points. Results: In the observation period, overall, 47 patients (63.5%) died. Mean OS was 33.8±45.4 months and mean PFS was 26.6±42.7 months. The mean VAT value was 162±99.5 cm2, the mean SAT was 202.4±103.3 cm2, the mean VSR was 0.92±0.69. The hazard ratios (HRs) for overall survival were 0.87 for high VAT, 1.52 for SAT, and 0.73 for VSR in univariable analysis. For PFS it was 0.24 for VAT, 1.11 for SAT, and 1.07 for VSR. No values achieved statistical significance. Similar results were shown in Kaplan-Meier analysis for OS and PFS, respectively. Conclusion: Parameters of adipose tissue are not associated with OS and PFS in patients with PCNSL.

BACKGROUND:Low-skeletal muscle mass (LSMM) is defined as skeletal muscle loss, which can be assessed by imaging. Our aim was to establish the effect of LSMM on overall survival (OS) in metastasized colorectal cancer patients based on a large patient sample. PATIENTS AND METHODS:MEDLINE library, EMBASE, and SCOPUS databases were screened for the associations between LSMM and mortality in metastasized colorectal cancer patients up to March 2022. The primary aim of the systematic review was to investigate the influence of LSMM on overall survival (OS) by means of the effect of measure hazard ratio. Fifteen studies were included into the present analysis. RESULTS:The included studies comprised 1744 patients. The frequency of LSMM was 46.2%. Associations between LSMM and OS were as follows: hazard ratio (HR) = 1.34 (95% confidence interval [CI] 0.94-1.91), P = .10 in univariable analysis and HR = 2.05 (95% CI 1.18-3.56), P = .01 in multivariable analysis. LSMM influenced OS in patients undergoing first-line chemotherapy, HR = 1.51 (95% CI 1.20-1.89), P = .0004. In patients undergoing second- and third-line chemotherapy, LSMM was not associated with OS, HR = 1.43 (95% CI 0.65-3.14), P = .37 Also, LSMM did not affect OS in patients with resection of hepatic metastases, HR = 0.93 (95% CI 0.70-1.24), P = .63. LSMM tended to affect progression-free survival, HR = 1.49 (95% CI 0.94-2.35), P = .09. LSMM did not predict treatment toxicity, odds ratio (OR) = 1.52 (95% CI 0.84-2.72), P = .16. CONCLUSION:LSMM occurs in 46.2% of patients with metastasized colorectal cancers. LSMM is associated with OS in patients undergoing first-line chemotherapy. LSMM does not affect OS in second- and third-line chemotherapy and in patients undergoing resection of hepatic metastases. LSMM is not associated with progression-free survival and treatment toxicity.

Purpose To assess the influence of low skeletal muscle mass (LSMM) on post-operative complications in patients with hepatic malignancies grade (Clavien Dindo ≥ 3) undergoing resection. Methods MEDLINE, Cochrane, and SCOPUS databases were screened for associations between sarcopenia and major post-operative complications (≥ grade 3 according to Clavien-Dindo classification) after resection of different malignant liver tumors. RevMan 5.3 software was used to perform the meta-analysis. The methodological quality of the included studies was assessed according to the QUIPS instrument. Results The analysis included 17 studies comprising 3157 patients. Subgroup analyses were performed for cholangiocarcinoma (CCC), colorectal cancer (CRC) liver metastases, and hepatocellular carcinoma (HCC). LSMM as identified on CT was present in 1260 patients (39.9%). Analysis of the overall sample showed that LSMM was associated with higher post-operative complications grade Clavien Dindo ≥ 3 ( OR 1.56, 95% CI 1.25–1.95, p < 0.001). In the subgroup analysis, LSMM was associated with post-operative complications in CRC metastases ( OR 1.60, 95% CI 1.11–2.32, p = 0.01). In HCC and CCC sub-analyses, LSMM was not associated with post-operative complications in simple regression analysis. Conclusion LSMM is associated with major post-operative complications in patients undergoing surgery for hepatic metastases and it does not influence major post-operative complications in patients with HCC and CCC.