Core Outcome Measures Research Articles

Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol

IntroductionThe introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently...

Uptake of core outcome sets by clinical trialists in China: a protocol

Background The concept of core outcome sets (COS) has been introduced in China for about 10 years. In recent years, some Chinese researchers also committed to developing COS, though the majority of COS are ongoing. However, there were more than 500 published COS for research in the COMET database by 2020. The extent of availability of COS for the top 25 diseases with the highest burden in China is unknown. In addition, the uptake of COS in clinical trials for these diseases is unknown, along with the knowledge, perceptions, and views of the clinical trialist community in China on the use of COS in relation to choosing outcomes for their research. Methods The main burden of disease in China will be identified. Then we will search the COMET database to identify if there are ongoing or completed relevant COS research A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. We will extract scopes of published eligible COS, including condition, population, interventions, and core outcomes. Then we will search the Chinese Clinical Trial Registry using disease names for each disease that has a published COS. We will assess the overlap in scope between clinical trials and COS. Then we will conduct an online survey and semi-structured interviews to identify the knowledge and perceptions of COS among primary investigators of included clinical trials. Discussion This research will fill in gaps between COS and the burden of disease in China. Understanding clinical trialists’knowledge and perceptions of COS may help dissemination and application of COS in the future. Trial registration This research is registered in Core Outcome Measures in Effectiveness: https://www.comet-initiative.org/Studies/Details/2563.

Performance of successful ambulatory cervical spine surgery: safety, efficacy, and early experiences of first 100 cases in Poland

Background Ambulatory anterior cervical discectomy and fusion (ACDF) is a promising method, but not common in Poland. Objective That is why the purpose of this study was to demonstrate the experience of performing ACDF in patients with degenerative spinal diseases. Methods This study at the Spine Centre involved a single-center, multi-surgeon evaluation of 100 patients undergoing ACDF. Results Outcomes assessed included pain severity, measured by the visual analogue scale, which improved from 4.28 ± 0.76 preoperatively to 1.11 ± 0.59 one month postoperatively. The Core Outcome Measures Index-neck (COMI-neck) scale also showed significant improvement: before surgery, 30% of patients scored their condition severity between 4-6, and 70% scored 7-10; 6 months postoperatively, the scores were 0-3 for 55% of patients, 4-6 for 45%, and 7-10 for none. Only 2% of patients experienced moderate, temporary complications, with no serious complications or postoperative hematomas observed. Conclusion The study supports the feasibility, safety, and efficacy of performing ACDF in an ambulatory setting, suggesting that with appropriate patient selection and surgical protocols, ambulatory ACDF can be more broadly implemented.

Connecting Practice to Data: Implementation Strategies to Increase Collection of Core Outcome Measures in an Inpatient Rehabilitation Facility.

To describe a quality improvement project aimed at increasing collection of a "Core Set" of functional outcome measures in an inpatient rehabilitation facility (IRF), characterize implementation strategies used across 4 study phases, and evaluate program adoption and maintenance. A 30-bed brain injury unit of a 132-bed IRF. Participants included physical therapists (5 full-time, 2 part-time, and 30 hourly as needed) and 764 individuals with traumatic brain injury (TBI) who received care during the project period. In this descriptive observational study, we operationalize implementation strategies selected for 4 project phases: Exploration, Preparation, Implementation, and Sustainment. We define each implementation strategy using the Expert Recommendations for Implementing Change and report on program adoption and maintenance. Adoption (proportion of TBI-related admissions with completed outcome measures) and maintenance (adoption over 4years). Preparation phase strategies focused on local adaptations, education, environmental preparation, and collaboration with informatics. Implementation phase strategies included reminders, feedback, champions, and iterative adjustments. Sustainment strategies focused on integration into standard practice. Adoption increased postinitiation for all measures except one. Despite improvements, a notable portion of measures remained incomplete. Increases in outcome measure collection were maintained for 2 to 4years, but a significant decline in paired admission and discharge scores suggests a reduced ability to monitor change over time. This study provides an example of a clinically driven quality improvement project and selected implementation strategies used to increase the collection of standard outcome measures in IRF. By leveraging the Expert Recommendations for Implementing Change framework, we aim to enhance comparability with similar efforts elsewhere. The results demonstrate the program's successes and challenges, highlighting the need for interdisciplinary clinical and research collaboration to support the translation of knowledge between research and clinical practice and inform meaningful improvements in care across TBI rehabilitation.

Value-Based Healthcare: A Primer for the Dermatologist.

Value-based healthcare (VBHC) is an increasingly employed strategy to transform healthcare organizations into economically sustainable systems that deliver high-value care. In dermatology, the need for VBHC is evident as chronic skin diseases require long-term, often expensive treatments. This narrative review aims to introduce dermatologists to the principles and implementation of VBHC. VBHC emphasizes maximizing outcomes that are directly relevant to patients. Key components of VBHC include a systematic assessment of standardized patient-relevant outcomes by using core outcome sets and measurement of healthcare cost for the individual patient. Systematic reporting and comparing of risk-adjusted outcomes across the full cycle of care for a specific condition provide benchmarked feedback and actionable insights to promote high-value care and reduce low-value care. VBHC aims to organize care around the patient in condition-specific and team-based integrated practice units with multidisciplinary collaboration, utilize information technology platforms to enable digital data monitoring, reduce cost, and eventually reform payment systems to support bundled payments for the overall care cycle. VBHC implementation in practice necessitates the establishment of a systematic framework for outcome-based quality improvement, the incorporation of value and outcomes in shared decision-making practices, and the cultivation of a value-centric culture among healthcare professionals through continuous training. Dermatologists can benefit from implementing VBHC principles in their practice. An essential step toward value-driven dermatological care is to start measuring outcomes relevant for patients for each patient, which is lacking partly due to the absence of core outcome sets developed for clinical practice. By reducing low-value care and emphasizing optimal patient-centered outcomes, VBHC has the potential to improve the quality of care and ensure cost containment. Efforts are needed to enhance the development and uptake of VBHC in dermatological clinical practice to realize these benefits.

Toward a core outcome set for faecal incontinence-A systematic review of outcomes reported in the literature.

Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient's quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a core outcome set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. Through several steps outlined by COMET 'what' to measure will be determined prior to determining 'how' to measure these outcomes. This systematic review aims to identify 'what' outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI. Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development. A total of 109 studies were included, which revealed 51 unique outcomes classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1-11). The most commonly reported outcomes were "severity of FI" (83%), "quality of life" (64%), "number of FI episodes" (40%), "anorectal motor function" (39%), and "frequency of bowel movements" (16%). This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasizes the need for standardizing outcome reporting which can be established through the creation of a COS.

Fifteen years of engine-driven nickel-titanium reciprocating instruments, what do we know so far? An umbrella review.

Numerous systematic reviews (SRs) have produced conflicting findings on engine-driven nickel-titanium reciprocating instruments (reciprocating instruments) since Yared's seminal study 15 years ago. This umbrella review analysed SRs examining the clinical and laboratory evidence regarding reciprocating instruments for root canal treatment. SRs that evaluated qualitatively and/or quantitatively the outcomes postoperative pain, oral health-related quality of life (OHRQoL), shaping ability, debris extrusion, microbial load, endotoxins reduction, cyclic fatigue, file fracture, dentinal cracks and root canal filling removal were included. The AMSTAR 2 tool was used to evaluate SRs quality, while the ROBIS tool to assess risk of bias (RoB). Forty SRs were included. The SRs revealed predominantly 'high' RoB and 'critically low' quality. Most focused on technical outcomes, exhibiting significant methodological and statistical heterogeneity. Findings suggest comparable efficacy between reciprocating and rotary instruments. However, due to the scarcity of high-quality evidence, future well-designed studies and reviews considering core outcome measures are needed.

Comparable results in total knee arthroplasty using the ROSA knee system versus the conventional technique:Aretrospective propensity-matched cohort study.

Robotic-assisted total knee arthroplasty (RA-TKA) is an increasingly popular alternative that may increase the accuracy of conventional TKA techniques. This study aims to evaluate RA-TKA accuracy and compare its radiographic and clinical outcomes to conventional TKA (cTKA). A retrospective examination of patients with bi- or tricompartmental knee osteoarthritis who underwent RA-TKA (RObotic Surgical Assistant system) or cTKA and were prospectively documented in the TKA registry. Accuracy was assessed using standardized radiographic implant position evaluations, namely femoral and tibial coronal angles and femoral and tibial sagittal angles. Baseline demographics, surgery details and 6- and 12-month post-TKA patient-reported outcomes (PROMs; e.g., Oxford Knee Score [OKS] and Core Outcome Measures Index) were compared between RA-TKA and propensity score-matched cTKA patients. Overall correlation between preset and 6-week postoperative angle measurements for RA-TKA was low with significant differences noted only for mean tibial sagittal angles (84.6° [RA-TKA] vs. 82.3° [cTKA]) (p < 0.001). The study groups were demographically similar, although RA-TKA patients had slightly longer operative times and higher blood loss but shorter inpatient stays. There were sustainable improvements in all PROMs already at 6 months, yet RA-TKA patients had significantly higher OKS values over their conventional counterparts at this time point. Radiological and clinical outcomes were comparable between RA-TKA and cTKA. The robotic-assisted system demonstrated higher accuracy in the coronal than sagittal plane and RA-TKA patients achieved better short-term outcomes for pain and disability. While both methods are similar in the hands of a skilled surgeon, long-term studies are necessary to establish clear method superiority. Therapeutic, Level III.

Surgical Handover Core Outcome Measures (SH-CORE): a protocol for the development of a core outcome set for trials in surgical handover

BackgroundSurgical handover is associated with a significant risk of care failures. Existing research displays methodological deficiencies and little consensus on the outcomes that should be used to evaluate interventions in this area. This paper reports a protocol to develop a core outcome set (COS) to support standardisation, comparability, and evidence synthesis in future studies of surgical handover between doctors.MethodsThis study adheres to the Core Outcome Measures in Effectiveness Trials (COMET) initiative guidance for COS development, including the COS-Standards for Development (COS-STAD) and Reporting (COS-STAR) recommendations. It has been registered prospectively on the COMET database and will be led by an international steering group that includes surgical healthcare professionals, researchers, and patient and public partners. An initial list of reported outcomes was generated through a systematic review of interventions to improve surgical handover (PROSPERO: CRD42022363198). Findings of a qualitative evidence synthesis of patient and public perspectives on handover will augment this list, followed by a real-time Delphi survey involving all stakeholder groups. Each Delphi participant will then be invited to take part in at least one online consensus meeting to finalise the COS.Ethics and disseminationThis study was approved by the Royal College of Surgeons in Ireland (RCSI) Research Ethics Committee (202309015, 7th November 2023). Results will be presented at surgical scientific meetings and submitted to a peer-reviewed journal. A plain English summary will be disseminated through national websites and social media. The authors aim to integrate the COS into the handover curriculum of the Irish national surgical training body and ensure it is shared internationally with other postgraduate surgical training programmes. Collaborators will be encouraged to share the findings with relevant national health service functions and national bodies.DiscussionThis study will represent the first published COS for interventions to improve surgical handover, the first use of a real-time Delphi survey in a surgical context, and will support the generation of better-quality evidence to inform best practice.Trial registrationCore Outcome Measures in Effectiveness Trials (COMET) initiative 2675. http://www.comet-initiative.org/Studies/Details/2675.

Developing a core outcome set for acetabular fractures: a systematic review protocol

BackgroundClinical trials investigating acetabular fractures are heterogeneous in their investigated outcomes and their corresponding measurements. Standardization may facilitate comparability and pooling of research results, which would lead to an increase in knowledge about the optimal treatment of acetabular fractures, resulting in long-term evidence-based treatment decisions and improvements in patient care. The aim of this systematic review is to identify the reported outcomes and their measurements from studies on treatments for acetabular fractures to develop a core outcome set which contains the most relevant outcome measures to be included in future studies.MethodsStudies published in English and German including patients aged 16 years and older, with a surgically treated acetabular fracture, will be included. Studies with nonsurgical treatment, pathologic fractures, polytraumatized patients, and patients younger than 16 years of age will be excluded because other outcomes may be of interest in these cases. Any prospective and retrospective study will be included. Systematic reviews will be excluded, but their included studies will be screened for eligibility. The literature will be searched on MEDLINE, CENTRAL, Web of Science, ClinicalTrials.gov, and WHO ICTRP. Risk of selective reporting of outcomes will be assessed using the Outcome Reporting Bias in Trials classification system. Heterogeneously defined outcomes that measure the same outcome will be grouped and subsequently categorized into outcome domains using the taxonomy of the Core Outcome Measures in Effectiveness Trials Initiative.DiscussionIt is expected that a high number of studies will be included, and many outcomes will be identified using different definitions and measurement instruments. A limitation of this systematic review is that only previously investigated outcomes will be detected, thus disregarding potentially relevant outcomes.Systematic review registrationPROSPERO CRD42022357644

Development of a core outcome set for cardiac rehabilitation in patients with myocardial infarction: a study protocol

IntroductionHeterogeneous outcome reporting is common in clinical trials focused on cardiac rehabilitation for myocardial infarction (MI); this practice often results in the exclusion of data from clinical trials in systematic...

Patients’ and carers’ views on research priorities in prehabilitation for cancer surgery

IntroductionThe views of patients and carers are important for the development of research priorities. This study aimed to determine and compare the top research priorities of cancer patients and carers with those of multidisciplinary clinicians with expertise in prehabilitation.Materials and methodsThis cross-sectional study surveyed patients recovering from cancer surgery at a major tertiary hospital in Sydney, Australia, and/or their carers between March and July 2023. Consenting patients and carers were provided a list of research priorities according to clinicians with expertise in prehabilitation, as determined in a recent International Delphi study. Participants were asked to rate the importance of each research priority using a 5-item Likert scale (ranging from 1 = very high research priority to 5 = very low research priority).ResultsA total of 101 patients and 50 carers participated in this study. Four areas were identified as research priorities, achieving consensus of highest importance (> 70% rated as “high” or “very high” priority) by patients, carers, and clinical experts. These were “optimal composition of prehabilitation programs” (77% vs. 82% vs. 88%), “effect of prehabilitation on surgical outcomes” (85% vs. 90% vs. 95%), “effect of prehabilitation on functional outcomes” (83% vs. 86% vs. 79%), and “effect of prehabilitation on patient reported outcomes” (78% vs. 84% vs. 79%). Priorities that did not reach consensus of high importance by patients despite reaching consensus of highest importance by experts included “identifying populations most likely to benefit from prehabilitation” (70% vs. 76% vs. 90%) and “defining prehabilitation core outcome measures” (66% vs. 74% vs. 87%). “Prehabilitation during neoadjuvant therapies” reached consensus of high importance by patients but not by experts or carers (81% vs. 68% vs. 69%).ConclusionThis study delineated the primary prehabilitation research priorities as determined by patients and carers, against those previously identified by clinicians with expertise in prehabilitation. It is recommended that subsequent high-quality research and resource allocation be directed towards these highlighted areas of importance.

Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) in Chile

Objective To examine the psychometric properties of the Spanish version of the 34-item Clinical Outcomes in Routine Evaluation—Outcome Measure questionnaire (CORE-OM). Method Psychometric exploration was conducted in two samples: non-clinical (n = 706) and clinical (n = 420) participants. The non-clinical sample comprised a subgroup of community members (n = 308) and students (n = 398). The clinical sample consisted of self-reported patients (n = 209) and outpatients (n = 211). The analysis included both internal and test-retest reliability, convergent validity, and principal component analysis. A reliable change index and clinical cut-off scores were established for assessing clinically significant change. Results The Spanish CORE-OM demonstrated good internal consistency and test-retest reliability, along with satisfactory convergent validity against the 45-item Outcome Questionnaire (OQ-45.2). There were strong differentiations between the clinical and non-clinical samples and the four sample subsets. The outpatient group reported the highest scores, while the community group exhibited the lowest scores. There were no marked gender effects. All observed patterns aligned closely with the established Spanish referential data. Conclusion Our findings provide support for the utilization of the Spanish CORE-OM as a measure for tracking psychotherapeutic progress in the context of Chile.

An investigation into the quality of life improvements after vertebral osteomyelitis depending on the status of pathogen detection.

This study aimed to compare clinical characteristics and quality of life (QoL) after vertebral osteomyelitis (VO) based on the status of pathogen detection in microbiological sampling. We conducted a post hoc data analysis from a prospective single-center study in a tertiary referral hospital, including VO patients from 2008 to 2020. Data were collected preoperatively (T0) and 1-year post surgery (T1). The primary outcome was QoL, assessed with the Oswestry Disability Index and Core Outcome Measures Index. Data from 133 patients with surgically treated thoracic or lumbar VO were evaluated. The pathogen was detected from cultured intraoperative samples in 100 (75.2%) patients (group 1). Culture remained negative in 33 (24.8%) patients (group 2). Quality of life did not differ significantly between the groups at T1. We observed higher preoperative C-reactive protein values and higher rates of spinal empyema at T0 in group 1. Quality of life improved significantly for all patients at T1, but scores remained comparable to those reported by patients with chronic back pain. Quality of life was not affected by pathogen detection. However, attempts to detect pathogens are still indicated due to the concomitant findings, including bacteremia and epidural abscesses, along with the advantages of targeted antibiotic therapy. The most critical step for detection may be avoiding pre-sampling antibiotic administration. Cite this article as: Beyer F, Wenk B, Jung N, Bredow J, Eysel P, Yagdiran A. An investigation into quality of life improvements after vertebral osteomyelitis depending on the status of pathogen detection. Acta Orthop Traumatol Turc., 2024; 10.5152/j.aott.2024.23073 [Epub Ahead of Print].

Factors influencing use and choice of Core Outcome Sets and outcome measurement instruments in trials of interventions to prevent childhood obesity: A survey protocol

Background Two core outcome sets for childhood obesity prevention have been developed; standardised sets of outcome measurement instruments for these core outcome sets are currently being developed. Core outcome sets and standardised measurement sets can reduce heterogeneity and improve evidence syntheses for trials of interventions to prevent childhood obesity and/or interventions to improve child health behaviours related to childhood obesity. Such benefits are only realised if core outcome sets and standardised measurement sets are used in trials. The aims of this study are 1) to examine trialists’ awareness and attitudes towards the two existing core outcome sets and factors influencing their use; 2) to explore the characteristics of outcome measurement instruments that trialists currently use; and 3) to better understand how trialists choose outcome measurement instruments and the factors that influence those choices. Methods A cross-sectional online survey will be conducted with researchers involved in the design and/or conduct of trials of interventions to prevent childhood obesity and/or to improve child health behaviours related to childhood obesity, in children aged 0 to 5 years (trialists). Trialists will be recruited using purposive sampling, and will complete a 22-item survey examining trialist characteristics, awareness of the existing core outcome sets, factors influencing use of the existing core outcome sets, characteristics of measurement instruments, how trialists choose measurement instruments, and factors influencing choice of measurement instrument. Quantitative data will be analysed descriptively; responses to open-ended questions will be analysed using qualitative content analysis. Conclusions Findings from this study will inform approaches to maximising use of core outcome sets and standardised measurement sets for childhood obesity prevention. Use of standardised approaches to what and how outcomes are measured in this area will reduce heterogeneity and research waste and enhance evidence syntheses to better determine intervention effects.

The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID

BackgroundIndividuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID. MethodsThe PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir. Participants are recruited via patient groups, cultural ambassadors, and social media platforms. Medical records are reviewed through a platform facilitating participant-mediated data acquisition from electronic health records nationwide. During the drug treatment, participants complete daily digital diaries using a web-based application. Blood draws for eligibility and safety assessments are conducted at or near participants' homes. The study drug is shipped directly to participants' homes. The primary endpoint is the PROMIS-29 Physical Health Summary Score difference between baseline and Day 28, evaluated by a mixed model repeated measure analysis. Secondary endpoints include PROMIS-29 (Mental Health Summary Score and all items), Modified GSQ-30 with supplemental symptoms questionnaire, COVID Core Outcome Measures for Recovery, EQ-5D-5L (Utility Score and all items), PGIS 1 and 2, PGIC 1 and 2, and healthcare utilization. The trial incorporates immunophenotyping to identify long COVID biomarkers and treatment responders. ConclusionThe PAX LC trial uses a novel decentralized design and a participant-centric approach to test a 15-day regimen of nirmatrelvir/ritonavir for long COVID.

COS-PPA: protocol to develop a core outcome set for primary progressive aphasia

IntroductionThe term primary progressive aphasia (PPA) describes a group of language-led dementias. Disease-modifying treatments that delay, slow or reverse progression of PPA are currently lacking, though a number of interventions...

Mid-term results of autologous matrix-induced chondrogenesis for large chondral defects in hips with femoroacetabular impingement syndrome.

The purpose of this study was to evaluate the mid-term outcomes of autologous matrix-induced chondrogenesis (AMIC) for the treatment of larger cartilage lesions and deformity correction in hips suffering from symptomatic femoroacetabular impingement (FAI). This single-centre study focused on a cohort of 24 patients with cam- or pincer-type FAI, full-thickness femoral or acetabular chondral lesions, or osteochondral lesions ≥ 2 cm2, who underwent surgical hip dislocation for FAI correction in combination with AMIC between March 2009 and February 2016. Baseline data were retrospectively obtained from patient files. Mid-term outcomes were prospectively collected at a follow-up in 2020: cartilage repair tissue quality was evaluated by MRI using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. Patient-reported outcome measures (PROMs) included the Oxford Hip Score (OHS) and Core Outcome Measure Index (COMI). Clinical examination included range of motion, impingement tests, and pain. A total of 12 hips from 11 patients were included (ten males, one female, mean age 26.8 years (SD 5.0), mean follow-up 6.2 years (SD 5.2 months)). The mean postoperative MOCART score was 66.3 (SD 16.3). None of the patients required conversion to total hip arthroplasty. Two patients had anterior impingement. External hip rotation was moderately limited in four patients. There was a correlation between MOCART and follow-up time (rs = -0.61; p = 0.035), but not with initial cartilage damage, age, BMI, or imaging time delay before surgery. PROMs improved significantly: OHS from 37.4 to 42.7 (p = 0.014) and COMI from 4.1 to 1.6 (p = 0.025). There was no correlation between MOCART and PROMs. Based on the reported mid-term results, we consider AMIC as an encouraging treatment option for large cartilage lesions of the hip. Nonetheless, the clinical evidence of AMIC in FAI patients remains to be determined, ideally in the context of randomized controlled trials.

Construct validation of the Japanese Core Outcome Measures Index and the impact of diseases on patient-reported outcome measures in preoperative patients with lumbar spinal stenosis and disk herniation: a single-center observational study

PurposeThe primary objective was to validate the construct validity of the Japanese Core Outcome Measures Index (COMI) in preoperative patients aged 60 years or older undergoing lumbar spine surgery for lumbar spinal stenosis (LSS) and lumbar disk herniation (LDH). Additionally, as a secondary aim, we explored the impact of these diseases on quality of life (QOL).MethodsThe analysis included 199 preoperative patients aged 60 and above who were scheduled for lumbar spine surgery. To assess QOL, Japanese versions of the COMI, Oswestry Disability Index (ODI), EuroQol-5 Dimension-3 Level (EQ-5D-3L), and SF-12v2 were employed. The study assessed the validity of the COMI and compared demographic and clinical characteristics between the LSS (147 cases) and LDH (52 cases) groups. It used multivariate covariance analysis (MANCOVA) to examine the impact of diseases (LSS and LDH) on each patient-reported outcome measure while considering covariates.ResultsCompared to the LSS group, the LDH group showed more difficulty with the COMI summary score (LSS/LDH [mean]: 6.9/8.1, p < 0.001), ODI score (46.8/57.4, p < 0.001), and EQ-5D utility (0.53/0.43, p < 0.001). The LDH group also reported more difficulties in the COMI-function, COMI-symptom-specific well-being, COMI-disability, ODI-personal care, ODI-social life, and SF-12v2-bodily pain subscales. MANCOVA demonstrated that these results were not influenced by covariates such as gender and medical history.ConclusionsThis study highlights the distinct impact of LSS and LDH on preoperative QOL in older patients undergoing lumbar spinal surgery. Tailored interventions are essential to address the specific challenges posed by these conditions and improve patient-centered outcomes and postoperative recovery.

Report of the Standardized Outcomes in Nephrology-transplant Consensus Workshop on Establishing a Core Outcome Measure for Infection in Kidney Transplant Recipients: Erratum.

Report of the Standardized Outcomes in Nephrology-transplant Consensus Workshop on Establishing a Core Outcome Measure for Infection in Kidney Transplant Recipients: Erratum.