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Sandra D Boxum,1,2,* Sabien H van Exter,3,* Jan-Jaap Reinders,1,4,5 Niek Koenders,6 Hans Drenth,1,7,8 Manon GA van den Berg,3 Michael Tieland,9,10 Sophie LW Spoorenberg,11 Evelyn J Finnema,12– 14 Philip J van der Wees,2,6 Harriët Jager-Wittenaar1,3,15 1Research Group Healthy Ageing, Allied Health Care and Nursing, Hanze University of Applied Sciences, Groningen, the Netherlands; 2Science Department IQ Health, Radboud university medical center, Nijmegen, the Netherlands; 3Department of Gastroenterology and Hepatology, Dietetics, Radboud university medical center, Nijmegen, 6500 HB, the Netherlands; 4Center for Dentistry and Dental Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; 5Research Group Interprofessional Education (IPE), Lifelong Learning, Education and Assessment Research Network (LEARN), Research Institute SHARE, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; 6Department of Rehabilitation, Radboud university medical center, Nijmegen, the Netherlands; 7ZuidOostZorg, Organization for Elderly Care, Drachten, the Netherlands; 8Department of Primary and Long-Term Care, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 9Center of Expertise Urban Vitality, Faculty of Sports and Nutrition, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands; 10School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, VIC, Australia; 11Primary care group ‘Dokter Drenthe’, Assen, the Netherlands; 12Health Science-Nursing Science and Education, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 13Research Group Living, Wellbeing and Care for Older People, NHL Stenden University of Applied Sciences, Leeuwarden, the Netherlands; 14Research Group Nursing Diagnostics, Hanze University of Applied Sciences, Groningen, the Netherlands; 15Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Research Unit Experimental Anatomy, Vrije Universiteit Brussel, Brussels, Belgium*These authors contributed equally to this workCorrespondence: Sandra D Boxum, Hanze University of Applied Sciences, Petrus Driessenstraat 3, 9714 CA, Groningen, the Netherlands, Email s.d.boxum@pl.hanze.nlBackground: As our global population ages, malnutrition and sarcopenia are increasingly prevalent. Given the multifactorial nature of these conditions, effective management of (risk of) malnutrition and sarcopenia necessitates interprofessional collaboration (IPC). This study aimed to understand primary and social care professionals’ barriers, facilitators, preferences, and needs regarding interprofessional management of (risk of) malnutrition and sarcopenia in community-dwelling older adults.Methods: We conducted a qualitative, Straussian, grounded theory study. We collected data using online semi-structured focus group interviews. A grounded theory data analysis was performed using open, axial, and selective coding, followed by developing a conceptual model.Results: We conducted five online focus groups with 28 professionals from the primary and social care setting. We identified five selective codes: 1) Information exchange between professionals must be smooth, 2) Regular consultation on the tasks, responsibilities, and extent of IPC is needed; 3) Thorough involvement of older adults in IPC is preferred; 4) Coordination of interprofessional care around the older adult is needed; and 5) IPC must move beyond healthcare systems. Our conceptual model illustrates three interconnected dimensions in interprofessional collaboration: professionals, infrastructure, and older adults.Conclusion: Based on insights from professionals, interprofessional collaboration requires synergy between professionals, infrastructure, and older adults. Professionals need both infrastructure elements and the engagement of older adults for successful interprofessional collaboration.Keywords: malnutrition, sarcopenia, interprofessional, older adults

Background and aimsENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-δ (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).Approach and resultsPatients were randomized 1:1:1 to oral seladelpar 5 mg (n=89), 10 mg (n=89), placebo (n=87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67×upper limit of normal (ULN), ≥15% ALP decrease from baseline, and total bilirubin ≤ ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score ≥4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial. While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10 mg: 78.2%) versus placebo (12.5%) ( p < 0.0001). ALP normalization occurred in 5.4% ( p =0.08) and 27.3% ( p < 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: -3.14 ( p =0.02); placebo: -1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% ( p =0.0008); 10 mg: 16.7% ( p =0.03); placebo: 4%]. There were no serious treatment-related adverse events.ConclusionsPatients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.

BackgroundPatients with occupational injuries often receive multidisciplinary rehabilitation for a rapid return to work. Rehabilitation aftercare programs give patients the opportunity to help patients apply the progress they have made during the rehabilitation to their everyday activities. Telerehabilitation aftercare programs can help reduce barriers, such as lack of time due to other commitments, because they can be used regardless of time or location. Careful identification of barriers, facilitators, and design requirements with key stakeholders is a critical step in developing a telerehabilitation aftercare program. ObjectiveThis study aims to identify barriers, facilitators, and design requirements for a future telerehabilitation aftercare program for patients with occupational injuries from the perspective of the key stakeholders. MethodsWe used a literature review and expert recommendations to identify key stakeholders. We conducted semistructured interviews in person and via real-time video calls with 27 key stakeholders to collect data. Interviews were transcribed verbatim, and thematic analysis was applied. We selected key stakeholder statements about facilitators and barriers and categorized them as individual, technical, environmental, and organizational facilitators and barriers. We identified expressions that captured aspects that the telerehabilitation aftercare program should fulfill and clustered them into attributes and overarching values. We translated the attributes into one or more requirements and grouped them into content, functional, service, user experience, and work context requirements. ResultsThe key stakeholders identified can be grouped into the following categories: patients, health care professionals, administrative personnel, and members of the telerehabilitation program design and development team. The most frequently reported facilitators of a future telerehabilitation aftercare program were time savings for patients, high motivation of the patients to participate in telerehabilitation aftercare program, high usability of the program, and regular in-person therapy meetings during the telerehabilitation aftercare program. The most frequently reported barriers were low digital affinity and skills of the patients and personnel, patients’ lack of trust and acceptance of the telerehabilitation aftercare program, slow internet speed, program functionality problems (eg, application crashes or freezes), and inability of telerehabilitation to deliver certain elements of in-person rehabilitation aftercare such as monitoring exercise performance. In our study, the most common design requirements were reducing barriers and implementing facilitators. The 2 most frequently discussed overarching values were tailoring of telerehabilitation, such as a tailored exercise plan and tailored injury-related information, and social interaction, such as real-time psychotherapy and digital and in-person rehabilitation aftercare in a blended care approach. ConclusionsKey stakeholders reported on facilitators, barriers, and design requirements that should be considered throughout the development process. Tailoring telerehabilitation content was the key value for stakeholders to ensure the program could meet the needs of patients with different types of occupational injuries.

Introduction and Objectives: Autoimmune liver diseases (AILD) are rare causes hepatocellular carcinoma (HCC), and data on the efficacy and tolerability of anti-tumor therapies are scarce. This pan-European study aimed to assess outcomes in AILD-HCC patients treated with tyrosine kinase inhibitors (TKIs) or transarterial chemoembolization (TACE) compared with patients with more common HCC etiologies, including viral, alcoholic or non-alcoholic fatty liver disease. Materials and Methods: 107 patients with HCC-AILD (AIH:55; PBC:52) treated at 13 European centres between 1996 and 2020 were included. 65 received TACE and 28 received TKI therapy. 43 (66 %) were female (median age 73 years) with HCC tumor stage BCLC A (34 %), B (46 %), C (9 %) or D (11 %). For each treatment type, propensity score matching was used to match AILD to non-AILD-HCC on a 1:1 basis, yielding in a final cohort of 130 TACE and 56 TKI patients for comparative analyses of median overall survival (mOS) and treatment tolerability. Results: HCC-AILD patients showed comparable mOS to controls for both TACE (19.5 vs. 22.1 months, p = 0.9) and TKI (15.4 vs. 15.1 months, p = 0.5). Adverse events were less frequent in AILD-HCC patients than controls (33 % % vs. 62 %, p = 0.003). For TKIs, there were no significant differences in adverse events (73% vs. 86%, p = 0.2) or interruption rates (44% vs. 36 %, p = 0.7). Conclusions: In summary, this study demonstrates comparable mOS for AILD-HCC patients undergoing local and systemic treatments, with better tolerability than HCC of other causes. TKIs remain important therapeutic options for AILD-HCC patients, particularly given their exclusion from recent immunotherapy trials.

Background & Aims: Although primary biliary cholangitis (PBC) is considered a rare disorder, accurate determination of its incidence and prevalence remains challenging due to limited comprehensive population-based registries. We aimed to assess the incidence and prevalence of PBC in the Netherlands over time through the nationwide Dutch PBC Cohort Study (DPCS). Methods: DPCS retrospectively included every identifiable patient with PBC in the Netherlands from 1990 onwards in all 71 Dutch hospitals. Incidence and prevalence were assessed between 2008-2018 by Poisson regression between sex and age groups over time. Results: On the 1st of January 2008, there were 1,458 patients with PBC in the Netherlands. Between 2008-2018, 2,187 individuals were newly diagnosed, 46 were transplanted and 468 died. The yearly incidence of PBC in 2008 was 1.38, increasing to 1.74 per 100,000 persons in 2018. When compared to those aged

Background & Aims: Autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) can co-exist in AIH-PBC, requiring combined treatment with immunosuppression and ursodeoxycholic acid (UDCA). The Paris criteria are commonly used to identify these patients; however, the optimal diagnostic criteria are unknown. We aimed to evaluate the use and clinical relevance of both Paris and Zhang criteria. Methods: Eighty-three patients with a clinical suspicion of AIH-PBC who were treated with combination therapy were included. Histology was re-evaluated. Characteristics and long-term outcomes were retrospectively compared to patients with AIH and PBC. Results: Seventeen (24%) patients treated with combination therapy fulfilled the Paris criteria. Fifty-two patients (70%) fulfilled the Zhang criteria. Patients who met Paris and Zhang criteria more often had inflammation and fibrosis on histology compared to patients only meeting the Zhang criteria. Ten-year liver transplant (LT)-free survival was 87.3% (95% CI 78.9–95.7%) in patients with AIH-PBC. This did not differ in patients in or outside the Paris or Zhang criteria (p = 0.46 and p = 0.40, respectively) or from AIH (p = 0.086). LT-free survival was significantly lower in patients with PBC and severe hepatic inflammation – not receiving immunosuppression – compared to those with AIH-PBC (65%; 95% CI 52.2–77.8% vs. 87%; 95% CI 83.2–90.8%; hazard ratio 0.52; p = 0.043). Conclusions: In this study, patients with AIH-PBC outside Paris or Zhang criteria were frequently labeled as having AIH-PBC and were successfully treated with combination therapy with similar outcomes. LT-free survival was worse in patients with PBC and hepatic inflammation than in those treated as having AIH-PBC. More patients may benefit from combination therapy. Impact and implications: This study demonstrated that patients with AIH-PBC variant syndrome treated with combined therapy consisting of immunosuppressants and ursodeoxycholic acid often do not fulfill the Paris criteria. They do however have comparable response to therapy and long-term outcomes as patients who do fulfill the diagnostic criteria. Additionally, patients with PBC and additional signs of hepatic inflammation have poorer long-term outcomes compared to patients treated as having AIH-PBC. These results implicate that a larger group of patients with features of both AIH and PBC may benefit from combined treatment. With our results, we call for improved consensus among experts in the field on the diagnosis and management of AIH-PBC variant syndrome.

Abstract Background Nowadays, large benign lateral spreading lesions (LSLs) and sessile polyps in the colorectum are mostly resected by endoscopic mucosal resection (EMR). A major drawback of EMR is the polyp recurrence rate of up to 20%. Snare tip soft coagulation (STSC) is considered an effective technique to reduce recurrence rates. However, clinical trials on STSC have mainly been conducted in expert referral centers. In these studies, polyp recurrence was assessed optically, and additional adjunctive techniques were excluded. In the current trial, we will evaluate the efficacy and safety of STSC in daily practice, by allowing adjunctive techniques during EMR and the use of both optical and histological polyp recurrence to assess recurrences during follow-up. Methods The RESPECT study is a multicenter, parallel-group, international single blinded randomized controlled superiority trial performed in the Netherlands and Germany. A total of 306 patients undergoing piecemeal EMR for LSLs or sessile colorectal polyps sized 20–60 mm will be randomized during the procedure after endoscopic complete polyp resection to the intervention or control group. Post-EMR defects allocated to the intervention group will be treated with thermal ablation with STSC of the entire resection margin. Primary outcome will be polyp recurrence by optical and histological confirmation at the first surveillance colonoscopy after 6 months. Secondary outcomes include technical success and complication rates. Discussion The RESPECT study will evaluate if STSC is effective in reducing recurrence rates after piecemeal EMR of large colorectal lesions in daily clinical practice performed by expert and non-expert endoscopists. Moreover, endoscopists will be allowed to use adjunctive techniques to remove remaining adenomatous tissue during the procedure. Finally, adenomatous polyp recurrence during follow-up will be defined by histologic identification. Trial registration ClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025.

Abstract Background Autoimmune hepatitis (AIH) is a rare, chronic inflammatory disease of the liver. The treatment goal is reaching complete biochemical response (CR), defined as the normalisation of aspartate and alanine aminotransferases and immunoglobulin gamma. Ongoing AIH activity can lead to fibrosis and (decompensated) cirrhosis. Incomplete biochemical response is the most important risk factor for liver transplantation or liver-related mortality. First-line treatment consists of a combination of azathioprine and prednisolone. If CR is not reached, tacrolimus (TAC) or mycophenolate mofetil (MMF) can be used as second-line therapy. Both products are registered for the prevention of graft rejection in solid organ transplant recipients. The aim of this study is to compare the effectiveness and safety of TAC and MMF as second-line treatment for AIH. Methods The TAILOR study is a phase IIIB, multicentre, open-label, parallel-group, randomised (1:1) controlled trial performed in large teaching and university hospitals in the Netherlands. We will enrol 86 patients with AIH who have not reached CR after at least 6 months of treatment with first-line therapy. Patients are randomised to TAC (0.07 mg/kg/day initially and adjusted by trough levels) or MMF (max 2000 mg/day), stratified by the presence of cirrhosis at inclusion. The primary endpoint is the difference in the proportion of patients reaching CR after 12 months. Secondary endpoints include the difference in the proportion of patients reaching CR after 6 months, adverse effects, difference in fibrogenesis, quality of life and cost-effectiveness. Discussion This is the first randomised controlled trial comparing two second-line therapies for AIH. Currently, second-line treatment is based on retrospective cohort studies. The rarity of AIH is the main issue in clinical research for alternative treatment options. The results of this trial can be implemented in existing international clinical guidelines. Trial registration ClinicalTrials.gov NCT05221411 . Retrospectively registered on 3 February 2022; EudraCT number 2021–003420-33. Prospectively registered on 16 June 2021.

The Ralstonia solanacearum species complex is a group of globally important plant pathogens. Bacteria in this very large and genetically diverse group all colonize the xylem elements of angiosperm plants and cause high-impact wilting diseases of many crops. Because they threaten economic and food security, several R. solanacearum species complex subgroups are strictly regulated as quarantine pests. Biologically meaningful and consistent nomenclature is essential for organisms that have major economic and regulatory importance, such as plant-pathogenic Ralstonia. There are currently three species of Ralstonia wilt pathogens: R. pseudosolanacearum (corresponding to two phylogenetic groups that are described in the literature as phylotypes I and III), R. solanacearum (phylotypes IIA, IIB, and IIC), and R. syzygii (phylotype IV, containing three subspecies: subsp. syzygii, subsp. celebensis, and subsp. indonesiensis). A recent paper proposed reclassifying phylotype I as a new species named “Ralstonia nicotianae.” The purpose of this commentary is to register our objection to the taxon “Ralstonia nicotianae.” [Figure: see text] Copyright © 2023 The Author(s). This is an open access article distributed under the CC BY 4.0 International license.

Abstract Background Frailty and multimorbidity are common among patients in geriatric rehabilitation care (GRC). Proper care of these patients involves multiple professionals which requires optimal interprofessional collaboration to provide the best possible support. Interprofessional collaboration (IPC) goes beyond multi-professional collaboration. It requires professionals to think beyond the expertise of their own discipline and work on joint outcomes in which the patient is actively involved. This study describes the development of the GRC teams of an elderly care organization towards the IPC. Methods Mixed method pre-post study of 15 months. The interprofessional training program comprised team trainings, webinars, and online team sessions. Data was aggregated by administering the Extended Professional Identity Scale (EPIS) and QuickScan Interprofessional Collaboration (QS) measurements to GRC staff and by observations of the multi-professional team consultation (MPC) meetings of six GRC teams of an organization for elderly care in Drachten and Dokkum in the Netherlands. ADL independence (Barthel Index) and number of inpatient days were analyzed before and after the project. Results Pretest healthcare professional response was 106, patients for analyses was 181; posttest response was 84, patients was 170. The EPIS shows improvement on “interprofessional belonging” (P = .001, 95%CI: 0.57–2.21), “interprofessional commitment” (P = .027, 95%CI: 0.12–1.90), and overall “interprofessional identity” (P = .013, 95%CI: 0.62 − 5.20). On the QS, all domains improved; “shared values” (P = .009, 95%CI: 0.07 − 0.47), “context” (P = .005, 95%CI: 0.08 − 0.44), “structure & organization” (P = .001, 95%CI: 0.14 − 0.56), “group dynamics & interaction” (P

Background: Palliative care patients desire more symptom management interventions that are complementary to their medical treatment. Within the multi-professional team, nurses could help support pain management with non-pharmacological interventions feasible for their practice and adaptable to palliative care patients’ needs. Objectives: The objective was to identify non-pharmacological interventions feasible in the nursing scope of practice affecting pain in palliative care patients. Design: A systematic review. Data sources and methods: A defined search strategy was used in PubMed, CINAHL, PsycINFO, and Embase. Search results were screened double-blinded. Methodological quality was double-appraised with the Joanna Briggs Institute Critical Appraisal Tools. Data were extracted from selected studies and the findings were summarized. The methodological quality, quantity of studies evaluating the same intervention, and consistency in the findings were synthesized in a best-evidence synthesis to rank evidence as strong, moderate, limited, mixed, or insufficient. Results: Out of 2385 articles, 22 studies highlighted non-pharmacological interventions in the nursing scope of practice. Interventions using massage therapy and virtual reality demonstrated most evidentiary support for pain management, while art therapy lacked sufficient evidence. Mindful breathing intervention showed no significant reduction in pain. Hypnosis, progressive muscle-relaxation-interactive-guided imagery, cognitive-behavioral audiotapes, wrapped warm footbath, reflexology, and music therapy exhibited promising results in pain reduction, whereas mindfulness-based stress reduction program, aromatherapy, and aroma-massage therapy did not. Conclusion: Despite not all studies reaching significant changes in pain scores, non-pharmacological interventions can be clinically relevant to palliative care patients. Its use should be discussed for its potential value and nurses to be trained for safe practice. Methodologically rigorous research for non-pharmacological interventions in nursing scope of practice for pain relief in palliative care patients is necessary. Trial registration: The protocol for this study is registered in the International Prospective Register of Systematic Review (PROSPERO registration number: CRD42020196781).

Background: People with dementia have a yearly risk of falling of 60 to 80 percent. Therefore, a walker is often recommended. However, the use of a walker in people with dementia is associated with a threefold increased odds of falls compared to their healthy peers. Better advice and training could reduce fall risk. Therefore, a tool to assess functional walking skills with a walker is needed. The SUMAC was developed to fill this gap. So far, there is no Dutch instrument available that can assess functional walking skills with a walker in people with dementia. Methods: Reliability was evaluated by scoring videos of people with dementia (n = 9) using a walker performing the SUMAC-NL. ICC was used to assess inter-rater and test-retest reliability. An expert panel (n = 8) evaluated the content validity using the content validity index (CVI) and the content validity ratio (CVR). Results: Inter-rater reliability of the SUMAC-NL was statistically significant for the PF domain (ICC = 0.94, 95%CI (0.84, 0.98, p < 0.001) and for the EQ domain (ICC = 0.79, 95%CI (0.49 – 0.95), p < 0.001). Test-retest reliability was statistically significant for both the PF domain (ICC = 0.95, 95%CI (0.89, 0.99), p < 0.001) and EQ domain (ICC = 0.92, 95%CI (0.82, 0.98), p < 0.001). The SUMAC-NL shows content validity with a CVI >0.79 for both domains and a CVR of 0.53 on the PF domain and 0.78 on the EQ domain. Conclusions: The SUMAC-NL shows good to excellent reliability and content validity for both the PF and the EQ domain. The SUMAC-NL seems to be a promising tool to assess walking with a walker in people with dementia in the Netherlands.

Phytophthora root rot (PRR) of chickpea (Cicer arietinum) caused by Phytophthora medicaginis is an important disease. Partial resistance to PRR is sourced from Cicer echinospermum. In this study, we evaluated if lines with low levels of PRR foliage symptoms in two contrasting recombinant inbred line (RIL) populations parented by chickpea cultivars (Yorker and Rupali) and 04067-81-2-1-1 (C. echinospermum, interspecific breeding line) had a significant drag on yield parameters. For the Yorker × 04067-81-2-1-1 population with the highest level of PRR resistance, in the absence of PRR, low foliage symptom RIL had significantly later flowering and podding, lower grain yields, and lighter seed and shorter plant phenotypes than high foliage symptom RIL. A quantitative trait locus analysis identified significant QTL for flowering, height, 100-seed weight, and yield, and there was a significantly higher frequency of alleles for the negative agronomic traits (i.e., drag) from the 04067-81-2-1-1 parent in low foliage symptom RIL than in high foliage symptom RIL. For the Rupali × 04067-81-2-1-1 population with lower levels of PRR resistance, in the absence of PRR, low foliage symptom RIL had significantly lighter seed and shorter plants than high foliage symptom RIL. Significant QTL were detected, the majority were for the timing of flowering and podding (n = 18), others were for plant height, yield, and 100-seed weight. For this second population, the frequency of alleles for the negative agronomic traits from the 04067-81-2-1-1 parent did not differ between low and high foliage symptom RIL. The 100 seed weight of RIL under moderate PRR disease pressure showed some promise as a yield component trait to identify phenotypes with both high levels of PRR resistance and grain yield potential for further seed number evaluations. We identified that large population sizes are required to enable selection among chickpea × C. echinospermum crosses for high levels of PRR resistance without a significant drag on yield.

The origin of cancer-associated fibroblasts (CAFs) in cancer remains to be identified. Here, single-cell transcriptomics, in vivo and in vitro studies suggest that CD26+ and CD26- normal fibroblasts transform into distinct CAF subpopulations in mouse models of breast cancer.

Abstract Background Currently, the standard therapy for autoimmune hepatitis (AIH) consists of a combination of prednisolone and azathioprine. However, 15% of patients are intolerant to azathioprine which necessitates cessation of azathioprine or changes in therapy. In addition, not all patients achieve complete biochemical response (CR). Uncontrolled data indicate that mycophenolate mofetil (MMF) can induce CR in a majority of patients. Better understanding of first-line treatment and robust evidence from randomised clinical trials are needed. The aim of this study was to explore the potential benefits of MMF as compared to azathioprine, both combined with prednisolone, as induction therapy in a randomised controlled trial in patients with treatment-naive AIH. Methods CAMARO is a randomised (1:1), open-label, parallel-group, multicentre superiority trial. All patients with AIH are screened for eligibility. Seventy adult patients with AIH from fourteen centres in the Netherlands and Belgium will be randomised to receive MMF or azathioprine. Both treatment arms will start with prednisolone as induction therapy. The primary outcome is biochemical remission, defined as serum levels of alanine aminotransferase and immunoglobulin G below the upper limit of normal. Secondary outcomes include safety and tolerability of MMF and azathioprine, time to remission, changes in Model For End-Stage Liver Disease (MELD)-score, adverse events, and aspects of quality of life. The study period will last for 24 weeks. Discussion The CAMARO trial investigates whether treatment with MMF and prednisolone increases the proportion of patients in remission compared with azathioprine and prednisolone as the current standard treatment strategy. In addition, we reflect on the challenges of conducting a randomized trial in rare diseases. Trial registration EudraCT 2016-001038-91 . Prospectively registered on 18 April 2016. Graphical Abstract