Abstract Objective To illustrate and discuss current and proposed new concepts of effect size (ES) quantification and significance, with a focus on statistical and clinical/subjective interpretation ...and supported by empirical examples. Study Design and Settings Different methods for determining minimal clinically important differences (MCIDs) are reviewed, applied to practical examples (pain score differences in knee osteoarthritis), and further developed. Their characteristics, advantages, and disadvantages are illustrated and discussed. Results Empirical score differences between verum and placebo become statistically significant if sample sizes are sufficiently large. MCIDs, by contrast, are defined by patients' perceptions. MCIDs obtained by the most common “mean change method” can be expressed as absolute or relative scores, as different ES parameters, and as the optimal cutoff point on the receiver operating characteristic curve. They can further be modeled by linear and logistic regression, adjusting for potential confounders. Conclusion Absolute and relative MCIDs are easy to interpret and apply to data of investigative studies. MCIDs expressed as effect sizes reduce bias, which mainly results from dependency on the baseline score. Multivariate linear and logistic regression modeling further reduces bias. Anchor-based methods use clinical/subjective perception to define MCIDs and should be clearly differentiated from distribution-based methods that provide statistical significance only.
Research evaluating acute respiratory failure (ARF) survivors' outcomes after hospital discharge has substantial heterogeneity in terms of the measurement instruments used, creating barriers to ...synthesizing study data.
To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge.
We conducted a three-round modified Delphi consensus process with 77 participants (47% female, 55% outside the United States), including clinical researchers from more than 16 countries across six continents, patients/caregivers, clinicians, and research funders. Participants reviewed standardized information on measure instruments for seven consensus-derived outcomes plus one recommended outcome.
Response rates were 91 to 97% across the three rounds. Among 75 measurement instruments evaluated, the following met a priori consensus criteria: EQ-5D and 36-item Short Form Health Survey version 2 (optional) for the "satisfaction with life and personal enjoyment" and "pain" outcomes, and both the Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised for the "mental health" outcome. No measures reached consensus for the following outcomes: cognition, muscle and/or nerve function, physical function, and pulmonary function. All measures considered for pulmonary function met consensus criteria for exclusion. The following measures did not reach the threshold for consensus but achieved the highest scores for their respective outcomes: the Montreal Cognitive Assessment (cognition), manual muscle testing and handgrip dynamometry (muscle and/or nerve function), and 6-minute-walk test (physical function).
This Core Outcome Measurement Set is recommended for use in all clinical research evaluating ARF survivors after hospital discharge. In the future, researchers should evaluate measures for outcomes not reaching consensus.
Purpose
The Depression Anxiety Stress Scales (DASS)-21 measures emotional symptoms of depression, anxiety, and stress, is relatively short, and is freely available in the public domain, which has ...resulted in it being applied to various clinical and non-clinical populations in many countries. The aim of this study was to systematically review the measurement properties of the DASS-21.
Methods
The MEDLINE, Embase, and CINAHL databases were searched. The methodological quality of each identified study was assessed using the updated COSMIN Risk of Bias checklist. The quality of the measurement properties of the studies was rated using the updated criteria for good measurement properties. The quality of evidence was rated using a modified version of the GRADE approach.
Results
This study included 48 studies in its review. The content validity of the DASS-21 demonstrated sufficient moderate-quality evidence. The instrument exhibited sufficient high-quality evidence for bifactor structural validity and internal consistency. The instrument also showed sufficient high-quality evidence for hypothesis testing of construct validity. Regarding criterion validity, only the DASS-21 Depression subscale demonstrated sufficient high-quality evidence. The measurement invariance across gender demonstrated inconsistent moderate-quality evidence. There was insufficient low-quality evidence for the reliability of each subscale. For responsiveness there was sufficient low-quality evidence for depression and stress subscales, and insufficient very-low-quality evidence for anxiety subscale.
Conclusions
The DASS-21 demonstrated sufficient high-quality evidence for bifactor structural validity, internal consistency (bifactor), criterion validity (Depression subscale), and hypothesis testing for construct validity. Further studies are required to assess the other measurement properties of the DASS-21.
Inconsistent, poorly designed research on resilience in the human sciences has contributed to epistemological and ontological ambiguity which has fuelled claims that resilience as a concept is poorly ...theorized.
Building on research with abused and neglected children around the world, the objective of this paper is to show that studies of resilience must account for: (a) risk exposure (of relevance in different contexts); (b) promotive and protective processes (internal and external resources associated with resilience across systems); and (c) desired outcomes (as privileged by stakeholders in different cultures and contexts).
By identifying common aspects of resilience research from a purposeful selection of studies (ones with weak and strong methodologies), this paper identifies three dimensions of well-designed studies of childhood resilience.
Attention to all three dimensions enhances both the empirical validity (in the quantitative research paradigm) and phenomenological trustworthiness (in qualitative research) of resilience research with children and families. Challenges researching resilience can also be resolved by designing studies that account for all three dimensions. These challenges include the lack of systemic thinking to account for contextual factors and other external threats to child wellbeing, and the excessive generalization of findings.
This three-part model for resilience research reflects the very best practices among resilience researchers and has the potential to address the definitional and methodological ambiguity that plague studies of resilience.
The patient-reported outcomes measurement information system (PROMIS), created by the National institute of Health, is a reliable and valid survey for patients with lumbar spine pathology. ...Preoperative opioid use has been shown to be an important predictor variable of self-reported health status in legacy patient-reported outcome measures.
To investigate the impact of chronic preoperative opiate use on PROMIS survey scores.
Retrospective database analysis.
Between March 2019 and November 2021, 227 patients underwent lumbar decompression ± ≤ 2 level fusion. Fifty-seven patients (25.11%) had chronic preoperative opioid use.
Oswestry disability index (ODI) and PROMIS survey scores.
A retrospective analysis of a prospectively maintained single center patient-reported outcome database was performed with a minimum of 2 year follow-up. PROMIS Anxiety, Depression, Fatigue, Pain Interference (PI), Physical Function (PF), Sleep disturbance (SD), and Social Roles (SR) surveys were recorded at preoperative intake with subsequent follow-up at 6, 12, and 24 months postoperatively. Patients were grouped into chronic opioid users as defined by >6-month duration of use. Differences in mean survey scores were evaluated using Welch t-tests.
Two hundred and twenty-seven patients met our inclusion criteria of completed PROMIS surveys at the designated timepoints. A total of 57 (25.11%) were chronic opioid users (COU) prior to surgery. Analysis of patient-reported health outcomes shows that long term opioid use correlated with worse ODI and PROMIS scores at baseline compared to nonchronic users (NOU). At 1 and 2 year follow-up, the COU cohort continued to have significantly worse ODI, PROMIS Fatigue, PF, PI, SD, and SR scores. There is a statistical difference in the magnitude of change in health status between the 2 cohorts at 1 year follow-up in PROMIS Depression (-5.04±7.88 vs -2.49±8.73, p=.042), PF (6.25±7.11 vs 9.03±9.04, p=.019), and PI (-7.40±7.37 vs -10.58±9.87, p=.011) and 2 year follow-up in PROMIS PF (5.58±6.84 vs 7.99±9.64, p=.041) and PI (-6.71±8.32 vs -9.62±10.06, p=.032). Mean improvement in PROMIS scores for the COU cohort at 2 year follow-up exceeded minimal clinically important difference (MCID) in all domains except PROMIS Depression, SR and SD.
Patients with chronic opioid use status have worse baseline PROMIS scores compared with patients who had nonchronic use. However, patients in the COU cohort displayed clinically significant postoperative improvement in multiple PROMIS domains. These results show that patients with chronic opioid use can benefit greatly from surgical intervention and will allow physicians to better set expectations with their patients.
Purpose of Review
The current panorama of measurement tools for use in cancer rehabilitation is reviewed. For rehabilitation purposes, evaluating function is of the highest priority.
Recent Findings
...From a patient-reported outcome (PRO) standpoint, SF-36 and EORTC-QLQ-C30 are in most common use in cancer rehabilitation research; these are quality of life measures that contain functional subdomains. Newer tools which are based on item response theory and have options for both computer assisted or short form (SF) administration, including the Patient-Reported Outcomes Measurement Information System (PROMIS) and Activity Measure for Post-acute Care (AMPAC) instruments, show increasing use, especially PROMIS Physical Function SF, and, recently, PROMIS Cancer Function Brief 3D, which has been validated in the cancer population, with domains of physical function, fatigue, and social participation, to track clinical rehabilitation outcomes. Evaluating objective measures of function in cancer patients is also crucial.
Summary
Utilization of clinically feasible tools for cancer rehabilitation, to employ for both screening purposes and for monitoring of rehabilitation treatment efficacy, is an evolving area, much needed to promote further research and improved, consistent clinical care for cancer patients and survivors.
The Health of the Nation Outcome Scales (HoNOS) is a widely used clinical measure designed to rate and monitor the outcomes of service users accessing specialist mental healthcare. Since its ...development (in 1996), numerous research studies have confirmed the HoNOS captures the aspects of care that it purports to (validity), and that clinicians' ratings are consistent both over time, and between different raters (reliability).
In 2018, the HoNOS was reviewed with updates made to some terminology and other revisions intended to remove ambiguity in the guidance for raters. However, although the new version (HoNOS 2018) was accompanied by a recommendation that its validity and reliability be re-tested this was not undertaken. To our knowledge, this is the first study to re-assess the updated tool's reliability by measuring the level of agreement between different raters. Our findings confirm that there is an acceptable level of consistency between student mental health nurses that have been trained to use the (new) HoNOS 2018.
The HoNOS is nationally mandated for use by all specialist mental healthcare providers in the UK. Our findings provide some assurance that, with appropriate update training and monitoring of organisational-level data sets, the original HoNOS glossary can safely be replaced with the HoNOS 2018 to ensure more contemporary routine outcome measurement can occur.
INTRODUCTION: The Health of the Nation Outcome Scales (HoNOS) is a well-established clinician rated outcome measure for use in mental health services. Following an international review, an updated version (HoNOS 2018) was published with a recommendation that its psychometric properties be re-tested prior to widespread implementation. To date, only one such study has been published.
To test the inter-rater agreement levels for HoNOS 2018.
Third-year student mental health nurses received training to complete the HoNOS 2018. Following this timetabled session, they were each invited to independently rate two, randomly selected, videos of (simulated) patient interviews. The resulting data were then analysed to calculate the tool's internal consistency and inter-rater agreement levels.
The 55 participants provided 106 ratings from four vignettes. Cronbach's alphas and McDonalds omegas confirmed the revised tool's internal consistency was acceptable. Average measure intraclass correlation coefficients for the four patient vignettes indicated excellent reliability.
This study provides initial assurance that the HoNOS 2018 is a reliable clinician rated outcome measure suitable for use in routine clinical practice by relatively inexperienced mental health practitioners with limited training.
Purpose
This review sought to (a) describe definitions of long‐term opioid therapy (LTOT) outcome measures, and (b) identify the predictors associated with the transition from short‐term opioid use ...to LTOT for opioid‐naïve individuals.
Methods
We conducted a systematic review of the peer‐reviewed literature (January 2007 to July 2018). We included studies examining opioid use for more than 30 days. We classified operationalization of LTOT based on criteria used in the definitions. We extracted LTOT predictors from multivariate models in studies of opioid‐naïve individuals.
Results
The search retrieved 5,221 studies, and 34 studies were included. We extracted 41 unique variations of LTOT definitions. About 36% of definitions required a cumulative duration of opioid use of 3 months. Only 17% of definitions considered consecutive observation periods, 27% used days' supply, and no definitions considered dose.
We extracted 76 unique predictors of LTOT from seven studies of opioid‐naïve patients. Common predictors included pre‐existing comorbidities (21.1%), non‐opioid prescription medication use (13.2%), substance use disorders (10.5%), and mental health disorders (10.5%).
Conclusions
Most LTOT definitions aligned with the chronic pain definition (pain more than 3 months), and used cumulative duration of opioid use as a criterion, although most did not account for consistent use. Definitions were varied and rarely accounted for prescription characteristics, such as days' supply. Predictors of LTOT were similar to known risk factors of opioid abuse, misuse, and overdose. As LTOT becomes a central component of quality improvement efforts, researchers should incorporate criteria to identify consistent opioid use to build the evidence for safe and appropriate use of prescription opioids.
PDF
