The effect of minimum volume standards in hospitals (MIVOS) - protocol of a systematic review.

BACKGROUND: The volume-outcome relationship, i.e., higher hospital volume results in better health outcomes, has been established for different surgical procedures as well as for certain nonsurgical medical interventions. Accordingly, many countries such as Germany, the USA, Canada, the UK, and Switzerland have established minimum volume standards. To date, there is a lack of systematically summarized evidence regarding the effects of such regulations. METHODS: To be included in the review, studies must measure any effects connected to minimum volume standards. Outcomes of interest include the following: (1) patient-related outcomes, (2) process-related outcomes, and (3) health system-related outcomes. We will include (cluster) randomized controlled trials ([C]RCTs), non-randomized controlled trials (nRCTs), controlled before-after studies (CBAs), and interrupted time-series studies (ITSs). We will apply no restrictions regarding language, publication date, and publication status. We will search MEDLINE (via PubMed), Embase (via Embase), CENTRAL (via Cochrane Library), CINHAL (via EBSCO), EconLit (via EBSCO), PDQ evidence for informed health policymaking, health systems evidence, OpenGrey, and also trial registries for relevant studies. We will further search manually for additional studies by cross-checking the reference lists of all included primary studies as well as cross-checking the reference lists of relevant systematic reviews. To evaluate the risk of bias, we will use the ROBINS-I and RoB 2 risk-of-bias tools for the corresponding study designs. For data synthesis and statistical analyses, we will follow the guidance published by the EPOC Cochrane group (Cochrane Effective Practice and Organisation of Care (EPOC), EPOC Resources for review authors, 2019). DISCUSSION: This systematic review focuses on minimum volume standards and the outcomes used to measure their effects. It is designed to provide thorough and encompassing evidence-based information on this topic. Thus, it will inform decision-makers and policymakers with respect to the effects of minimum volume standards and inform further studies in regard to research gaps. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022318883.

Protocol for the development of a core outcome set for studies on centralisation of healthcare services.

INTRODUCTION: Centralisation defined as the reorganisation of healthcare services into fewer specialised units serving a higher volume of patients is a potential measure for healthcare reforms aiming at reducing costs while improving quality. Research on centralisation of healthcare services is thus essential to inform decision-makers. However, so far studies on centralisation report a variability of outcomes, often neglecting outcomes at the health system level. Therefore, this study aims at developing a core outcome set (COS) for studies on centralisation of hospital procedures, which is intended for use in observational as well as in experimental studies. METHODS AND ANALYSIS: We propose a five-stage study design: (1) systematic review, (2) focus group, (3) interview studies, (4) online survey, (5) Delphi survey. The study will be conducted from March 2022 to November 2023. First, an initial list of outcomes will be identified through a systematic review on reported outcomes in studies on minimum volume regulations. We will search MEDLINE, EMBASE, CENTRAL, CINHAL, EconLIT, PDQ-Evidence for Informed Health Policymaking, Health Systems Evidence, Open Grey and also trial registries. This will be supplemented with relevant outcomes from published studies on centralisation of hospital procedures. Second, we will conduct a focus group with representatives of patient advocacy groups for which minimum volume regulations are currently in effect in Germany or are likely to come into effect to identify outcomes important to patients. Furthermore, two interview studies, one with representatives of the German medical societies and one with representatives of statutory health insurance funds, as well as an online survey with health services researchers will be conducted. In our analyses of the suggested outcomes, we will largely follow the categorisation scheme developed by the Cochrane EPOC group. Finally, a two-round online Delphi survey with all stakeholder groups using predefined score criteria for consensus will be employed to first prioritise outcomes and then agree on the final COS. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committee at the Brandenburg Medical School Theodor Fontane (MHB). The final COS will be disseminated to all stakeholders involved and through peer-reviewed publications and conferences.

Development and Evaluation of a Multimodal Supportive Intervention for Promoting Physical Function in Older Patients with Cancer.

Physical function (PF) in older patients with cancer may decline during and after oncologic therapy. This study aimed to develop and pilot test an individually tailored unsupervised physical activity (PA) program and dietary recommendations to promote PF in older patients with cancer. Following development and pretest, the intervention was pilot tested to explore feasibility, acceptance, adherence and potential benefit. Patients ≥60 years, with heterogeneous cancer diagnoses, starting outpatient radiotherapy were randomized in two study arms: paper-based vs. video-based instructions. Based on assessments of PF, PA, nutrition, cognition, mental health, social support, HRQOL and personal goals, participants received individual recommendations for PA and nutrition. After 12 weeks of intervention (T1), reassessments were performed. The postal 4-week follow-up questionnaire included PA, nutrition and HRQOL. Participants (n = 24, 14 female, mean age 70 ± 7 years) showed comparable characteristics in both study arms. The majority rated the program as helpful. Facilitators and barriers to PA adherence were collected. Both modes of instructions were appreciated equally. PF (EORTC QLQ-C30) declined slightly (not clinically relevant >10 pts.) at group level T0: 76 ± 16, T1: 68 ± 21, T2: 69 ± 24. The intervention was feasible, well accepted, showing potential benefit for the maintenance of PF during outpatient radiotherapy, and should be further tested in a larger sample.