Non-Inferiority Trials: A Systematic Review on Methodological Quality and Reporting Standards.

BACKGROUND: Non-inferiority (NI) trials require unique trial design and methods, which pose challenges in their interpretation and applicability, risking introduction of inferior therapies in clinical practice. With the abundance of novel therapies, NI trials are increasing in publication. Prior studies found inadequate quality of reporting of NI studies, but were limited to certain specialties/journals, lacked NI margin evaluation, and did not examine temporal changes in quality. We conducted a systematic review without restriction to journal type, journal impact factor, disease state or intervention to evaluate the quality of NI trials, including a comprehensive risk of bias assessment and comparison of quality over time. METHODOLOGY: We searched PubMed and Cochrane Library databases for NI trials published in English in 2014 and 2019. They were assessed for: study design and NI margin characteristics, primary results, and risk of bias for blinding, concealment, analysis method and missing outcome data. RESULTS: We included 823 studies. Between 2014 and 2019, a shift from publication in specialty to general journals (15% vs 28%, p < 0.001) and from pharmacological to non-pharmacological interventions (25% vs 38%, p = 0.025) was observed. The NI margin was specified in most trials for both years (94% vs 95%). Rationale for the NI margin increased (36% vs 57%, p < 0.001), but remained low, with clinical judgement the most common rationale (30% vs 23%), but more 2019 articles incorporating patient values (0.3% vs 21%, p < 0.001). Over 50% of studies were open-label for both years. Gold standard method of analyses (both per protocol + (modified) intention to treat) declined over time (43% vs 36%, p < 0.001). DISCUSSION: The methodological quality and reporting of NI trials remains inadequate although improving in some areas. Improved methods for NI margin justification, blinding, and analysis method are warranted to facilitate clinical decision-making.

A Bibliometric Analysis on Adherence to Reporting Standards for Endovascular Treatment of Chronic Lower Extremity Peripheral Artery Disease.

OBJECTIVE: The treatment of chronic limb threatening ischemia (CLTI) involves a broad spectrum of therapies including many new and emerging techniques. To standardize results of studies examining this pathology and to allow critical analysis and comparison between studies, the Society for Vascular Surgery recommended reporting standard guidelines for the endovascular management of CLTI in 2016. Research studies that do not adhere to complete reporting standards are often more ambiguous in impact and external validity, leading to bias and misinformation that has potentially damaging effects on clinical decision making. We thus sought to examine adherence to, and factors associated with non-compliance with these recommended guidelines. METHODS: A literature database search was conducted to include all clinical trials, randomized controlled trials, and retrospective comparative studies written in English examining the endovascular treatment of PAD/CLTI from January 2020 to August 2022. Systematic reviews, case reports and meta-analysis were excluded. The manuscripts were reviewed for adherence with the SVS guidelines (overall and by guideline subcategories based on demographics, treatment methods and outcomes), and factors associated with this adherence were determined. This data was used to calculate descriptive and comparative statistics. RESULTS: 54 manuscripts were identified from this timeframe. On average, articles reviewed reported on 42.0% of the SVS reporting standards (range 25.0-65.2%, Fig 1) with 74.1% of articles (n=40) not adhering to at least 50.0% of the standards. Manuscripts most completely followed guidelines regarding "Patient Factors" and were least likely to demonstrate adherence to description of CLTI and study complications. Within the guideline subcategories, complete adherence to guidelines was not demonstrated in any manuscript in stent trials, disease outcome measures, technical outcome measures, patient factors and critical limb ischemia description, and complete adherence rates within the other subcategories was low (range 5.6-18.6%). Studies conducted within the United States and those with industry sponsorship were more likely to adhere to >50% of the reporting standards (p<0.05). Journal impact factor, year of publication, and number of authors had no correlation to the percent adherence to guidelines in specific categories or adherence overall. CONCLUSIONS: Adherence to reporting standard guidelines for endovascular treatment of lower extremity PAD specifically outlined by the SVS is suboptimal regardless of the quality of the journal the research is published in. Increasing adherence to reporting standards to provide a framework for comparison of studies across techniques used should be prioritized by authors, journal editors, and vascular societies.

Current data processing methods and reporting standards for untargeted analysis of volatile organic compounds using direct mass spectrometry: a systematic review.

INTRODUCTION: Untargeted direct mass spectrometric analysis of volatile organic compounds has many potential applications across fields such as healthcare and food safety. However, robust data processing protocols must be employed to ensure that research is replicable and practical applications can be realised. User-friendly data processing and statistical tools are becoming increasingly available; however, the use of these tools have neither been analysed, nor are they necessarily suited for every data type. OBJECTIVES: This review aims to analyse data processing and analytic workflows currently in use and examine whether methodological reporting is sufficient to enable replication. METHODS: Studies identified from Web of Science and Scopus databases were systematically examined against the inclusion criteria. The experimental, data processing, and data analysis workflows were reviewed for the relevant studies. RESULTS: From 459 studies identified from the databases, a total of 110 met the inclusion criteria. Very few papers provided enough detail to allow all aspects of the methodology to be replicated accurately, with only three meeting previous guidelines for reporting experimental methods. A wide range of data processing methods were used, with only eight papers (7.3%) employing a largely similar workflow where direct comparability was achievable. CONCLUSIONS: Standardised workflows and reporting systems need to be developed to ensure research in this area is replicable, comparable, and held to a high standard. Thus, allowing the wide-ranging potential applications to be realised.

Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review.

OBJECTIVE: Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD). DATA SOURCES AND REVIEW METHODS: A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials. RESULTS: After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored. CONCLUSION: The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported. PROSPERO registration number: CRD42022288214.

Around the EQUATOR with Clin-STAR: Prediction modeling opportunities and challenges in aging research.

The 2015 Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Statement was published to improve reporting transparency for prediction modeling studies. The objective of this review is to highlight methodologic challenges that aging-focused researchers will encounter when designing and reporting studies involving prediction models for older adults and provide guidance for addressing these challenges. In following the 22-item TRIPOD checklist, researchers must consider the representativeness of cohorts used (e.g., whether older adults with frailty, cognitive impairment, and social isolation were included), strategies for incorporating common geriatric predictors (e.g., age, comorbidities, functional status, and frailty), methods for handling missing data and competing risk of death, and assessment of model performance heterogeneity across important subgroups (e.g., age, sex, race, and ethnicity). We provide guidance to help aging-focused researchers develop, validate, and report models that can inform and improve patient care, which we label "TRIPOD-65."

Systematic Development of Standards for Mixed Methods Reporting in Rehabilitation Health Sciences Research.

OBJECTIVE: Mixed methods research (MMR) integrates quantitative and qualitative methods throughout the research process to answer complex research questions. MMR designs align with the guiding frameworks of patient-centered care and social determinants of health by effectively examining the role of contextual factors and human experiences in influencing health and rehabilitation outcomes. Reporting standards and critical appraisal tools ensure the quality and transparency of the research process. MMR standards exist; yet, there is a need for reporting guidelines and an appraisal tool that meets field standards, is applicable across rehabilitation fields of study, and can accommodate the range of possibilities for combining research approaches and methods. METHODS: Mixed Methods Reporting in Rehabilitation & Health Sciences (MMR-RHS) was developed using a systematic consensus-building process in accordance with published guidance and was preregistered with the Enhancing the Quality and Transparency of Health Research Network. MMR-RHS evolved through a sequence of steps, including extensive literature review, expert consultation, stakeholder feedback, pilot testing, and tool refinement. RESULTS: MMR-RHS consists of 20 criteria that align with field standards for rigor and transparency, with an emphasis on integration throughout the research process, a key component of MMR. CONCLUSIONS: A systematic process was utilized to develop the reporting standards and an appraisal tool for MMR in rehabilitation and health science. The tool is comprehensive, includes a set of criteria grounded in MMR literature, and is flexible for application to a range of MMR designs commonly seen in rehabilitation research. IMPACT: The MMR-RHS may improve the quality and transparency of MMR by supporting investigators, authors, reviewers, and editors during project development, manuscript preparation, and critical review. The tool may assist readers in critical appraisal, knowledge translation, and application of published MMR findings. Ultimately, the MMR-RHS may help legitimize mixed methods in rehabilitation and health research, an important step toward understanding the complexities of health care, patient outcomes, and evolving societal health needs.

Measurement of radiologist reporting times: Assessment of precision, comparison of three different measurement techniques and review of potential applications.

INTRODUCTION: Radiologist reporting times are a key component of radiology department workload assessment, but reliable measurement remains challenging. Currently, there are three contenders for this task: median reporting times (MRTs), extracted directly from a department's radiology information system (RIS); study-ascribed times (SATs), using published tables of individual descriptors derived from a combination of measurement and consensus; and radiology reporting figures (RRFs), using published tables of measured times based on modality and numbers of anatomical areas. METHODS: We review these techniques, their possible uses and some potential pitfalls. We discuss the level of precision that can realistically be attained in measuring reporting times, and list the strengths and weaknesses of each technique, comparing them in relation to each of eight potential applications. RESULTS: We believe that SATs are challenging for practical use due to their static nature, absent common descriptors and large number. RRFs are more user-friendly but are also static and require ongoing updates; currently, they do not include ultrasound. MRTs cannot currently be extracted from every RIS, but where available they are easy to use and their dynamic nature provides the most objective data. They underestimate the unmeasurable components of a radiologist's work and therefore the total time spent in a reporting session. CONCLUSION: MRTs are superior to the other methods in flexibility, precision and ease of use. All institutions should have access to this data and we call on vendors of Radiology Information Systems which are currently not capable of providing it to make the necessary modifications.

Minimal reporting guideline for research involving eye tracking (2023 edition).

A guideline is proposed that comprises the minimum items to be reported in research studies involving an eye tracker and human or non-human primate participant(s). This guideline was developed over a 3-year period using a consensus-based process via an open invitation to the international eye tracking community. This guideline will be reviewed at maximum intervals of 4 years.

Participant diversity in Psychophysiology.

The Society for Psychophysiological Research and accompanying journal, Psychophysiology, have increasingly incorporated diversity and inclusion into their posted values, conference programming, and science. Much of this focus on equity, diversity, and inclusion work has occurred since 2010. The current review content analyzed the articles published in Psychophysiology from 2010 through 2020 to determine if SPR and Psychophysiology's commitment to diversity and inclusion has resulted in changes to reporting and analysis of participant demographics. Demographic reporting practices were compared to APA reporting standards and the use of demographic variables assessed according to the guidance proffered in the introduction to Psychophysiology's 2016 Special Issue on Diversity and Representation. Results of the content analysis indicated near perfect reporting of biological sex and frequent reporting of average age. Age range and educational attainment were reported in over half of studies, while race or ethnicity were reported in only 17%. Socioeconomic status, income, gender identity, and sexual orientation were almost never reported. In over 60% of studies at least one major demographic variable was reported, but was not used in preliminary, main, or supplementary analyses as a covariate, moderator, or otherwise. SPR and Psychophysiology should continue advocating for increased reporting of major demographic variables and ethical analysis of demographic modulation of various psychophysiological mechanisms. We provide a preliminary template of reporting standards and call for the inclusion of more open science practices by psychophysiologists.

Incidence, Risk Factors, and Prognostic Impact of Type Ib Endoleak Following Endovascular Repair for Abdominal Aortic Aneurysm: Scoping Review.

OBJECTIVE: The primary objectives of this scoping review were to assess the rate of and risk factors for type Ib endoleak and to evaluate the extent of the evidence base that links type Ib endoleak to short and long term outcomes in patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). METHODS: Potentially eligible studies were searched in the Cochrane Central Register of Controlled Trials, MEDLINE, Web of Science Core Collection, SciELO Citation Index, Russian Science Citation Index, and KCI-Korean Journal Database. A scoping review was performed according to PRISMA extension for Scoping Reviews. RESULTS: A total of 27 articles (four prospective registries and 23 retrospective cohort studies) dealing with type Ib endoleak were included in the final analysis. The number of patients reported on was 7 197, with follow up ranging between 12 months and 93 months. The reported frequency of type Ib endoleak in patients treated with EVAR ranged from 0% to 8%, Patient and or procedure related factors associated with risk of type Ib endoleak were (1) common iliac artery (CIA) diameter ˃ 18 mm requiring use of flared stent graft limbs (FLs) ˃ 20 mm, (2) length of CIA landing zone ˂ 20 mm, (3) marked iliac tortuosity, and (4) large initial AAA diameter. Depending on the study, 50 - 100% of type Ib endoleaks were corrected by endovascular means, with a reported immediate technical success of 100% in the studies providing this information. CONCLUSION: Type Ib endoleak after EVAR has been reported to occur in 0 - 8% of cases. Several anatomical features, including CIA diameter ˃ 18 mm or requiring the use of FLs ˃ 20 mm, length of CIA landing zone ˂ 20 mm, marked iliac tortuosity, and large initial AAA diameter, could increase the risk of type Ib endoleak and may require alternative therapeutic options and or more stringent follow up. Therefore, this updated scoping review provides a comprehensive summary of the frequency, risk factors, prognosis, and treatment of type Ib endoleaks, and has identified knowledge gaps in the literature to guide further studies.

Implementing Reporting Standards for Polygenic Risk Scores for Atherosclerotic Cardiovascular Disease.

PURPOSE OF REVIEW: There is considerable interest in using polygenic risk scores (PRSs) for assessing risk of atherosclerotic cardiovascular disease (ASCVD). A barrier to the clinical use of PRSs is heterogeneity in how PRS studies are reported. In this review, we summarize approaches to establish a uniform reporting framework for PRSs for coronary heart disease (CHD), the most common form of ASCVD. RECENT FINDINGS: Reporting standards for PRSs need to be contextualized for disease specific applications. In addition to metrics of predictive performance, reporting standards for PRSs for CHD should include how cases/control were ascertained, degree of adjustment for conventional CHD risk factors, portability to diverse genetic ancestry groups and admixed individuals, and quality control measures for clinical deployment. Such a framework will enable PRSs to be optimized and benchmarked for clinical use.

iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

BACKGROUND: Implementation of digital health technologies has grown rapidly, but many remain limited to pilot studies due to challenges, such as a lack of evidence or barriers to implementation. Overcoming these challenges requires learning from previous implementations and systematically documenting implementation processes to better understand the real-world impact of a technology and identify effective strategies for future implementation. OBJECTIVE: A group of global experts, facilitated by the Geneva Digital Health Hub, developed the Guidelines and Checklist for the Reporting on Digital Health Implementations (iCHECK-DH, pronounced "I checked") to improve the completeness of reporting on digital health implementations. METHODS: A guideline development group was convened to define key considerations and criteria for reporting on digital health implementations. To ensure the practicality and effectiveness of the checklist, it was pilot-tested by applying it to several real-world digital health implementations, and adjustments were made based on the feedback received. The guiding principle for the development of iCHECK-DH was to identify the minimum set of information needed to comprehensively define a digital health implementation, to support the identification of key factors for success and failure, and to enable others to replicate it in different settings. RESULTS: The result was a 20-item checklist with detailed explanations and examples in this paper. The authors anticipate that widespread adoption will standardize the quality of reporting and, indirectly, improve implementation standards and best practices. CONCLUSIONS: Guidelines for reporting on digital health implementations are important to ensure the accuracy, completeness, and consistency of reported information. This allows for meaningful comparison and evaluation of results, transparency, and accountability and informs stakeholder decision-making. i-CHECK-DH facilitates standardization of the way information is collected and reported, improving systematic documentation and knowledge transfer that can lead to the development of more effective digital health interventions and better health outcomes.

Adverse Effects of Virtual and Augmented Reality Interventions in Psychiatry: Systematic Review.

BACKGROUND: Virtual reality (VR) and augmented reality (AR) are emerging treatment modalities in psychiatry, which are capable of producing clinical outcomes broadly comparable to those achieved with standard psychotherapies. OBJECTIVE: Because the side effect profile associated with the clinical use of VR and AR remains largely unknown, we systematically reviewed available evidence of their adverse effects. METHODS: A systematic review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework across 3 mental health databases (PubMed, PsycINFO, and Embase) to identify VR and AR interventions targeting mental health diagnoses. RESULTS: Of 73 studies meeting the inclusion criteria, 7 reported worsening clinical symptoms or an increased fall risk. Another 21 studies reported "no adverse effects" but failed to identify obvious adverse effects, mainly cybersickness, documented in their results. More concerningly, 45 of the 73 studies made no mention of adverse effects whatsoever. CONCLUSIONS: An appropriate screening tool would help ensure that VR adverse effects are correctly identified and reported.

Systematic Review of Descriptions and Justifications Provided for Single-Case Quantification Techniques.

There are currently a multitude of quantification techniques that have been developed for use with single-case designs. As a result, choosing an appropriate quantification technique can be overwhelming and it can be difficult for researchers to properly describe and justify their use of quantification techniques. However, providing clear descriptions and justifications is important for enhancing the credibility of single-case research, and allowing others to evaluate the appropriateness of the quantification technique used. The aim of this systematic literature review is to provide an overview of the quantification techniques that are used to analyze single-case designs, with a focus on the descriptions and justifications that are provided. A total of 290 quantifications occurred across 218 articles, and the descriptions and justifications that were provided for the quantification techniques that were used are systematically examined. Results show that certain quantification techniques, such as the non-overlap indices, are more commonly used. Descriptions and justifications provided for using the quantification techniques are sometimes vague or subjective. Single-case researchers are encouraged to complement visual analysis with the use of quantification techniques for which they can provide objective and appropriate descriptions and justifications, and are encouraged to use tools to guide their choice of quantification techniques.

Reporting guidelines used varying methodology to develop recommendations.

BACKGROUND AND OBJECTIVES: We investigated the developing methods of reporting guidelines in the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network's database. METHODS: In October 2018, we screened all records and excluded those not describing reporting guidelines from further investigation. Twelve researchers performed duplicate data extraction on bibliometrics, scope, development methods, presentation, and dissemination of all publications. Descriptive statistics were used to summarize the findings. RESULTS: Of the 405 screened records, 262 described a reporting guidelines development. The number of reporting guidelines increased over the past 3 decades, from 5 in the 1990s and 63 in the 2000s to 157 in the 2010s. Development groups included 2-151 people. Literature appraisal was performed during the development of 56% of the reporting guidelines; 33% used surveys to gather external opinion on items to report; and 42% piloted or sought external feedback on their recommendations. Examples of good reporting for all reporting items were presented in 30% of the reporting guidelines. Eighteen percent of the reviewed publications included some level of spin. CONCLUSION: Reporting guidelines have been developed with varying methodology. Reporting guideline developers should use existing guidance and take an evidence-based approach, rather than base their recommendations on expert opinion of limited groups of individuals.

SMART: A data reporting standard for mass spectrometry imaging.

Mass spectrometry imaging (MSI) is an important analytical technique that simultaneously reports the spatial location and abundance of detected ions in biological, chemical, clinical, and pharmaceutical studies. As MSI grows in popularity, it has become evident that data reporting varies among different research groups and between techniques. The lack of consistency in data reporting inherently creates additional challenges in comparing intra- and inter-laboratory MSI data. In this tutorial, we propose a unified data reporting system, SMART, based on the common features shared between techniques. While there are limitations to any reporting system, SMART was decided upon after significant discussion to more easily understand and benchmark MSI data. SMART is not intended to be comprehensive but rather capture essential baseline information for a given MSI study; this could be within a study (e.g., effect of spot size on the measured ion signals) or between two studies (e.g., different MSI platform technologies applied to the same tissue type). This tutorial does not attempt to address the confidence with which annotations are made nor does it deny the importance of other parameters that are not included in the current SMART format. Ultimately, the goal of this tutorial is to discuss the necessity of establishing a uniform reporting system to communicate MSI data in publications and presentations in a simple format to readily interpret the parameters and baseline outcomes of the data.

Protocol for a systematic review of reporting standards of lower limb endovascular interventions in peripheral arterial disease.

INTRODUCTION: Techniques and devices for the endovascular treatment of peripheral arterial disease (PAD) are continuously evolving. High-quality clinical trials limit the variation in how endovascular interventions are described, performed and reported. The aim of this systematic review is to assess the quality of reporting standards in randomised controlled trials (RCTs) of endovascular lower limb interventions against the Consolidated Standards of Reporting Trials for Non-Pharmacologic Treatments (CONSORT-NPT) and template for intervention description and replication (TIDieR) framework. METHODS: Randomised trials including participants with peripheral arterial disease undergoing any infra-inguinal lower limb endovascular arterial intervention, searched from Medline, Embase and Cochrane Library databases from inception to December 2021, will be included. All study data, including details of the procedure investigated, will be extracted in keeping with the CONSORT-NPT and TIDieR checklist. Descriptive statistics will be used to summarise general study details and reporting standards of the trials. DISCUSSION: The results will be used to inform the design of future RCTs in this area by optimising the way the interventions are described, standardised, and monitored. The systematic review will be disseminated via peer-reviewed manuscripts and presentations at relevant conferences. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022288214.

Is thematic analysis used well in health psychology? A critical review of published research, with recommendations for quality practice and reporting.

Despite the persistent dominance of a 'scientific psychology' paradigm in health psychology, the use of qualitative research continues to grow. Qualitative approaches are often based on fundamentally different values from (post)positivistempiricism, raising important considerations for quality, and whether qualitative work adheres to, and is judged by, appropriate publication standards. Thematic analysis (TA) has become a particularly popular method in qualitative health psychology, but poor practice is widespread. To support high quality, methodologically coherent TA practice and reporting, we critically reviewed 100 systematically selected papers reporting TA, published in five prominent health psychology journals. Our review assessed reported practice, and considered this in relation to methodological and quality recommendations. We identified 10 common areas of problematic practice in the reviewed papers, the majority citing reflexive TA. Considering the role of three 'arbiters of quality' in a peer review publication system - authors, reviewers, and editors - we developed 20 recommendations for authors, to support them in conducting and reporting high quality TA research, with associated questions for reviewers and editors to consider when evaluating TA manuscripts for publication. We end with considerations for facilitating better qualitative research, and enriching the understandings and knowledge base from which health psychology is practiced.

Longitudinal validity of self-rated health: the presence and impact of response shift.

Objective: This paper aimed to examine the longitudinal validity of self-rated health (SRH) and whether it would be affected by possible changes in evaluation standards (i.e., response shift) over time.Design: Data are from a longitudinal survey of a nationally representative sample in China. Analytical sample was restricted to respondents aged 45 and above (n = 15,893). Individual fixed effects models were used to analyze changes in ratings on health anchoring vignettes and self-rated health over time.Main outcome measures: SRH at two time points with a -two-year span.Results: Both SRH and anchoring vignettes ratings displayed changes over a two-year span for all the studied age groups. Compared with the self-assessed change in health ("How would you rate your health as compared to that of last year?"), changes in SRH reported over time displayed a more stable and optimistic pattern. SRH responded to doctor diagnosed chronic disease and changes in functional limitation, before and after adjusting for evaluation standards.Conclusion: SRH is responsive to the newly diagnosed chronic disease and functional limitation, regardless of whether we consider response shift within the same respondents over time.