Eppendorf (Germany)

Patients, as central actors in healthcare, should be enabled to actively participate in health services research processes. In addition, other stakeholders, such as professionals from healthcare practice, are also essential for a comprehensive participatory approach. This DNVF memorandum focuses on participatory approaches in the context of health services research. It begins by outlining the key characteristics of participatory health services research and describing its current development and institutionalization in Germany. The DNVF memorandum also highlights the potential and benefits of participatory research. Finally, it addresses two cross-cutting topics that are particularly relevant for further development in this field: the theoretical and conceptual foundations, and the investigation of effects and effectiveness of participatory approaches.

Primary cutaneous B‑cell lymphomas (PCBCL) belong to the group of extranodal non-Hodgkin lymphomas and by definition only manifest on the skin at the time of diagnosis. These lymphomas can be broadly classified into indolent and aggressive subtypes. Indolent PCBCLs include primary cutaneous marginal zone lymphoma, primary cutaneous follicular B‑cell lymphoma and Epstein-Barr virus-positive mucocutaneous ulcer, which present solitary or multifocal lesions and are associated with afavorable prognosis. Treatment usually involves excision or radiotherapy, although awatch-and-wait concept can also be discussed. Conversely, aggressive PCBCLs, such as primary cutaneous diffuse large B‑cell lymphoma, leg type, and primary cutaneous intravascular large B‑cell lymphoma, carry ahigh risk of systemic dissemination. Consequently, they require systemic treatment. The standard first-line therapy is typically the R‑CHOP regimen, which may be supplemented with radiotherapy.

The DIPLOMA trial showed comparable radical resection rates after minimally invasive left pancreatectomy (MILP) and open left pancreatectomy (OLP) in patients with upfront resectable pancreatic cancer. Data on long-term overall survival (OS) and disease-free survival (DFS) are currently lacking, but are required before the oncological efficacy of MILP can be confirmed. To determine the long-term oncological outcome, including OS and DFS, of MILP vs OLP in patients with upfront resectable left-sided pancreatic cancer in the DIPLOMA trial. The randomized, patient-blinded and pathologist-blinded DIPLOMA trial was conducted between 2018 and 2021, with a follow-up duration of at least 36 months. It was a multicenter international trial that took place in 35 centers in 12 countries worldwide. Patients with upfront resectable pancreatic ductal adenocarcinoma of the body or tail of the pancreas were included. Participants were randomly assigned to undergo MILP (laparoscopic and robotic) or OLP. Patients were blinded for the surgical approach. Main outcomes included OS and DFS. Other outcomes include receipt of adjuvant therapy and time to start of adjuvant therapy. Between May 2018 and May 2021, 258 patients were randomized to the MILP (131 patients) and OLP (127 patients) groups. After a median follow-up of 38 (IQR 36-46) months, 134 patients (52%) had died and 127 patients (55%) experienced disease recurrence. OS did not differ significantly between the MILP and OLP groups (median, 32 vs 34 months; stratified hazard ratio, 1.02; 95% CI, 0.72-1.44; P = .92). Also, DFS did not significantly differ between the MILP and OLP groups (median, 21 vs 17 months; stratified hazard ratio, 0.96; 95% CI, 0.68-1.35; P = .81). Adjuvant therapy was administered in 79 patients after MILP (79 of 113 [70%]) and 79 patients after OLP (79 of 110 [72%]) (P = .63). Time to adjuvant therapy was comparable between groups (median 59 vs 56 days; P = .92). In this long-term follow-up of the randomized DIPLOMA trial in patients with upfront resectable pancreatic cancer, oncological outcomes after MILP and OLP did not differ significantly, confirming the oncological safety of MILP. International Standard Registered Clinical/Social Study Number Registry Identifier: ISRCTN44897265.

Germany has one of the highest cancer incidence rates in Europe. Radiotherapy is essential for patients with cancer as 50% have an evidence‐based indication for radiotherapy. However, it is unknown how health‐related quality of life (HRQoL) of cancer patients undergoing radiotherapy compares to the general population in Germany. Therefore, we conducted a secondary analysis by pooling cross‐sectional individual‐level data from a multicenter cohort of cancer patients (n = 1052) undergoing radiotherapy across Germany and a normative sample from the German general population (n = 1006). We used the EORTC QLQ‐C30 to measure global HRQoL (range: 0–100). Higher scores indicate higher HRQoL. We used ANOVA for univariable and ANCOVA with predefined covariates for multivariable analyses. As per univariable analysis, cancer patients had significantly lower global HRQoL compared with the general population (mean [M] = 54.6 vs. M = 65.9; p < .001). This difference was smaller but persisted in the multivariable analysis (M = 56.5 vs. M = 63.5; p < .001). Multivariable analyses stratified by education showed that HRQoL was only lower in cancer patients with medium (M = 56.2 vs. M = 63.0; p < .001) or high education (M = 57.0 vs. M = 66.5; p < .001) compared with the general population. The minimal important difference threshold of seven points was only met in the group with high education. In conclusion, there may be a meaningful gap in HRQoL of cancer patients at the end of radiotherapy compared with the general population, mainly in patients with higher educational levels. Upon validation, this would highlight the need for supportive care and optimized radiotherapy strategies to eventually close the HRQoL gap.