To evaluate the effect of lobeglitazone on renal disease progression in patients with type 2 diabetes mellitus using longitudinal real-world data.
Retrospective cohort study.
Hospital-based Common Data Model database.
A total of 14 712 adults with type 2 diabetes mellitus who visited the Diabetes Center of Ewha Womans University Mokdong Hospital between 2013 and 2019 were identified. A 1:2 propensity score matching was performed to compare patients treated with lobeglitazone plus metformin with those receiving metformin monotherapy, sulfonylurea plus metformin, or a dipeptidyl peptidase-4 (DPP4) inhibitor plus metformin.
Treatment with lobeglitazone plus metformin compared with metformin monotherapy, sulfonylurea plus metformin or DPP4 inhibitor plus metformin.
Renal progression, defined as initiation of renal replacement therapy, a sustained ≥30% decline in estimated glomerular filtration rate (eGFR) from baseline, or doubling of serum creatinine with a concurrent eGFR ≤45 mL/min/1.73 m².
The HR of renal progression was 0.84 (95% CI 0.58 to 1.21) in the lobeglitazone plus metformin compared with metformin monotherapy, 1.00 (95% CI 0.79 to 1.27) compared with sulfonylurea plus metformin group, 1.10 (95% CI 0.84 to 1.44) compared with DPP4 inhibitor plus metformin group after adjusting for multiple variables. Subgroup analyses demonstrated significant interactions by sex in the comparison with metformin monotherapy (P for interaction=0.0179) and by glycaemic control in the comparisons with sulfonylurea plus metformin (P for interaction=0.0161) and DPP4 inhibitor plus metformin (P for interaction=0.0006), suggesting potential heterogeneity in treatment effects.
Lobeglitazone showed renal outcomes comparable to those of other antidiabetic medications, with a possible heterogeneity in treatment effects according to sex and glycaemic control.
Pain, including phantom limb pain (PLP), residual limb pain (RLP) and low back pain (LBP), is highly prevalent after lower limb amputation (LLA) and compromises quality of life. Although both pain and function have been studied extensively, methods of assessment and reporting vary, limiting comparability. A clearer overview of how these domains are measured and interrelated is needed to guide research and practice.
To synthesise evidence on how postamputation pain and functional outcomes have been assessed and reported in adults with LLA, and to examine reported relationships between pain and mobility/function.
Scoping review guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
MEDLINE, Embase and PsycINFO (inception to 15 August 2025).
Quantitative studies that measured pain and functional outcome in adults with LLA.
Two reviewers independently extracted study characteristics, pain measures and functional outcomes in Covidence; findings were narratively synthesised.
Eighty-four studies were included. RLP (n=46), LBP (n=32) and PLP (n=28) were most frequently examined. Pain was mainly assessed by self-report scales; mobility was typically assessed by clinical tests and less often by biomechanical instrumentation. PLP was associated with altered gait and balance deficits; RLP with limited walking distance, asymmetric weight-bearing and reduced community participation; LBP with gait asymmetry, trunk–pelvis discoordination and increased energy cost of walking.
Postamputation pain is often linked to reduced mobility and functional limitations. However, heterogeneous definitions and inconsistent methodology hinder synthesis across studies. Future research should combine validated pain scales with objective analysis, wearable sensors and musculoskeletal modelling to clarify mechanisms and inform rehabilitation.
Acute pain following pulmonary surgery can affect the recovery process of patients. The use of intrathecal morphine (ITM) injections offers a long-lasting analgesic effect, but its clinical application remains controversial. This study aims to investigate the impact of combining bupivacaine with ITM injections on the quality of postoperative recovery in patients who have undergone pulmonary surgery.
This multicentre, randomised, double-blind, controlled trial will enrol 254 patients undergoing elective lung surgery, who will be randomly assigned in a 1:1 ratio to either group IT (receiving an intrathecal injection of 3 mg bupivacaine and 0.25 mg morphine before general anaesthesia induction) or the control group (C group). The primary outcome includes postoperative recovery quality on day 1 (quality of recovery, QoR-15), with secondary outcomes encompassing postoperative recovery quality on days 2 and 3 (QoR-15), pain scores within 72 hours postoperatively, analgesic rescue, intraoperative haemodynamic parameters, opioid consumption, postoperative adverse reactions, recovery metrics, complications, chronic pain incidence and sleep quality.
The results will be disseminated through peer-reviewed publications. This study protocol (V.2.0, 30 October 2024) involves human participants and has been approved by the Ethics Committee of Affiliated Hospital of Yangzhou University (number 2024-08-02-2), Taicang Hospital Affiliated to Soochow University (number 2025 SR-041) and Yichang Central People’s Hospital (number 2024-513-02). Each individual who agrees to participate in the research will provide written informed consent after the objectives and procedures of this study are explained to them.
ChiCTR2400092935. Registered on 26 November 2024.
Despite substantial research investments aiming to prevent cancer and develop therapeutic interventions, cancer remains a formidable challenge. In view of the persistent rise in cancer prevalence, the condition should also be recognised as a chronic disease. Such an approach can enhance the quality of life of patients with cancer, inhibit treatment-related adverse events and prevent recurrence via comprehensive post-treatment management. The core objective of this study is to investigate the association between dietary factors and treatment-related adverse events in patients with cancer, with the aim of providing individualised dietary recommendations to reduce adverse events and enhance quality of life.
The study cohort will include 600 participants aged ≥20 years. The participants will be assessed for dietary intake, cancer therapy-related adverse events and single-nucleotide polymorphisms using genomic DNA extracted from saliva. In addition, general and clinical information, lifestyle patterns and general/biochemical data of the blood will also be collected. The primary outcome is dietary factors that mitigate chemotherapeutic adverse events, and the secondary outcome is the association between nutritional status and survival in Korean patients with cancer. Considering the potential impact of dietary habits on the adverse events of cancer treatment, the findings of this study can be used as a basis for the establishment of new dietary guidelines for patients with cancer.
The Institutional Review Board of Severance Hospital, Yonsei University Health System, Seoul, Korea, approved the study protocol (4-2021-1110). Further, all participants provided a written informed consent prior to the study. The findings will be shared via publications.
The Swedish Prescribed Drugs and Health Cohort (SPREDH) is a population-based cohort based on merged data from four nationwide health data registers in Sweden. SPREDH provides opportunities to investigate how the use of various medications influences cancer risk, cancer prognosis and many other outcomes. The cohort was recently updated to include a longer follow-up, more patients and additional drugs.
SPREDH currently includes 9 454 340 users of selected medications, who have been followed up for a total of 138 015 003 person-years from 1 July 2005 to 31 December 2024, that is, for up to 191/2 years.
SPREDH includes data from the Swedish Prescribed Drug Register, Patient Register, Cancer Register and Cause of Death Register. Available data include participants’ characteristics, use of medication, healthcare utilisation, diagnoses (including detailed information on cancers), surgical procedures and dates and causes of death. The original version of SPREDH has been used for 10 original studies published in scientific journals, primarily in the fields of gastroenterology and oncology. The updated version of SPREDH includes 1 382 698 participants who have developed a cancer during the follow-up.
The newly updated and extended version of SPREDH enables studies with a wide range of study designs and hypotheses, especially pharmacoepidemiological studies evaluating how the use of certain medications affects the risk and prognosis of cancer and other diseases. It also allows for comparative research across classes of medications, as well as investigations of drug utilisation, safety and effectiveness.
The incidence of acute pain subsequent to modified radical mastectomy (MRM) for breast cancer approximates 40%, with more than half of these cases evolving into chronic pain. Currently, the commonly employed analgesic schemes in clinical practice still have inadequacies. Liposomal bupivacaine (LB) is bupivacaine encapsulated in liposomes, and it is reported that its duration of action can extend up to 72 hours. This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle plane (TTP) block and pectoral nerves (PECS) block after MRM for breast cancer.
In this prospective, randomised, controlled trial, we will enrol 80 female patients aged 30 to 65 years who are scheduled to undergo MRM under general anaesthesia in combination with nerve block. They will be randomly assigned in a 1:1 ratio to the LB+BHCl group (Group A) and the BHCl group (Group B). All patients will undergo ultrasound-guided TTP+PECS block prior to surgery. The primary outcomes are the cumulative pain visual analogue scale (VAS) scores from 6 to 72 hours post-surgery and the quality of recovery, assessed using the QoR-40 score at 72 hours post-surgery. The secondary outcomes include the time to first analgesic rescue, the consumption of analgesic drugs within 72 hours postoperatively, the occurrence of adverse events and the VAS scores at 6 and 12 months postoperatively.
Ethical approval was obtained from the Ethics Committee of the Affiliated Hospital of Yangzhou University (2024 Ke Lun Shen (2024-07-01)). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.
Chinese Clinical Trial Registry (ChiCTR2400089933).
Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.
This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.
Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.
Fear of cancer recurrence (FCR) is one of the most prevalent psychological concerns among young adult cancer survivors. Despite its clinical relevance, little is known about how survivors overcome this fear and the role of healthcare professionals in that process. This protocol outlines a systematic review and qualitative meta-synthesis to explore the coping mechanisms and support resources that facilitate overcoming FCR in young adult cancer survivors.
This study will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A comprehensive search will be conducted across five databases (PubMed, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Social Sciences Citation Index) and supplemented by hand-searching. Methodological quality will be assessed using the Critical Appraisal Skills Programme checklist. Data synthesis will follow Thomas and Harden’s thematic synthesis approach, guided by the post-traumatic growth theory. The review aims to identify key support systems and professional interventions that aid in coping with FCR, emphasising the unique developmental and psychosocial context of young adulthood. The final synthesis will inform targeted, resource-based interventions by healthcare providers.
As this study is a retrospective review involving secondary analysis of publicly available primary data, ethical approval is not required. The findings of this review will be disseminated through publication in peer-reviewed journals and presented at scholarly conferences and other relevant professional forums. This protocol has been registered with PROSPERO.
CRD420251029414.