Generic Health Status Measure Research Articles

A systematic review of patient reported outcome measures in patients with anti-neutrophil cytoplasmic antibody associated vasculitis.

ANCA associated vasculitis (AAV) is associated with significant morbidity, fatigue, pain and poor health-related quality of life (HRQoL). This review aims to assess the comprehensiveness of existing patient reported outcome measures (PROMs) used in AAV and identify associations with poorer HRQoL outcomes. A literature review of studies using PROMs, including those labelled HRQoL in people with AAV as a primary or secondary study outcome were screened and reviewed up to July 2023. Quality was assessed using the Critical Appraisal Skills Programme. A total of 30 articles were included which utilised 22 different PROM tools. 76.7% (n = 23) used the SF-36 or a variation as a generic measure of health status and or HRQoL. Two studies developed a disease specific PROM. The AAV-PRO showed good psychometric properties but potential limitations in capturing all relevant aspects of the disease experience for AAV patients. Factors associated with poorer HRQoL included: neurological and sinonasal involvement, women and younger patients. 86.6% of studies showed no meaningful relationships between the SF-36 and BVAS, VDI or disease duration. Depression and anxiety were common and socioeconomic factors such as unemployment were significantly associated with poorer mental health outcomes. Glucocorticoids were found to be independently associated with worse SF-36 scores. Generic PROMs are useful in measuring significant changes but lack sensitivity to specific symptoms and unique AAV-related issues, while existing disease specific PROMs have limitations and may not fully capture AAV patient's perspective on disease and treatment burden.

PCR219 Hungarian Population Norms for the 15D Generic Preference-Accompanied Health Status Measure

PCR219 Hungarian Population Norms for the 15D Generic Preference-Accompanied Health Status Measure

The Influence of Comorbidities, General Health Status, and Self-Care Self-Efficacy on COVID-19 Symptoms During the Omicron Wave.

Background The emergence of the less virulent COVID-19 strains such as Omicron and its subvariants shifted the paradigm of COVID-19 treatment from inpatient treatment to regular outpatient care. The individual health determinants affecting COVID-19 disease severity among vulnerable adults treated in outpatient settings are an under-researched area. Methods This study conducted in an outpatient COVID-19 antibody infusion center employed a cross-sectional survey design to explore the impact of comorbidities, general health status, and self-care self-efficacy on COVID-19 symptom severity. We recruited 120 COVID-19-positive participants over 40 years of age, of which 117 completed the study with 87 providing complete data. After the screening and consenting process, the participants completed the following surveys in a secure REDCap survey software (Vanderbilt University, Nashville, USA)on an iPad (Apple Inc., Cupertino, USA): 1) sociodemographic questionnaire, 2) Charlson Comorbidity Index (CCI) to capture comorbidities, 3)Medical Outcomes Study Short-Form (SF-12) to assess general health including physical (PCS) and mental (MCS) health subscales, 4) Self-Care Self-Efficacy Scale (SCSES) to measure self-care self-efficacy, and 5) the COVID-19 Symptom rating scale (COVID-19 SRS). Statistical analysis used were Chi-square and Pearson correlations. Results As evidenced by CCI, the top five comorbidities were hypertension (42%), diabetes mellitus (31%), pulmonary disease (19%), depression (14%), and solid tumors (11%). Age was statistically significantly correlated to comorbidity burden(p<0.0001). Severe COVID-19 symptoms reported were fatigue, myalgia, cough, runny nose, and sore throat. The general health status measure (SF-12) subscales showed that the patient's mental component summary (MCS) was more statistically significant to COVID-19 symptom severity than the physical component summary (PCS). The MCS demonstrated a statistically significant correlation with fatigue and myalgia (p<0.0001), headache and breathing difficulties (p<0.001), nausea/vomiting (p<0.01), and abdominal pain/diarrhea (p<0.05). The PCS showed a lesser statistically significant correlation with fatigue, myalgia, headaches (p<0.01), fever/chills, cough, congestion/runny nose, night sweats, breathing difficulties, nausea/vomiting, and abdominal pain/diarrhea (p<0.05). Interestingly, the 'loss of smell' which is the hallmark symptom of COVID-19 was the only symptom that showed a statically significant correlation with the Charlson Comorbidity Index (p<0.05), and it did not show any association with either mental (SF-12 MCS) or physical (SF-12 PCS) health status. The SF-12 MCS also showed a statistically significant correlation with a diagnosis of depression (p< 0.01), validating it as a true measure of mental health among vulnerable adults. The SCSES was not correlated with any of the COVID-19 symptoms. Conclusions The patient's general health status, especially mental health was more statistically significant to COVID-19 symptoms. The COVID-19 hallmark symptom of 'loss of smell' was the only symptom that showed statistical significance with comorbidities. Within the limitations of a cross-sectional survey design and convenient sampling methods, this study calls to tailor general health status, especially mental health, and cumulative comorbidity burden to risk assessment/risk stratification of COVID-19 care.

Hungarian population norms for the 15D generic preference-accompanied health status measure

Objectives15D is a generic preference-accompanied health status measure covering a wide range of health areas, including sensory functions. The aim of this study was to establish population norms for the 15D instrument in Hungary.Methods2000 members of the Hungarian adult general population participated in an online cross-sectional survey in August 2021. The sample was broadly representative in terms of gender, age groups, highest level of education, geographical region, and settlement type. Index values were derived using the Norwegian 15D value set. In addition to providing population norms, mean index values were computed for 32 physical and 24 mental health condition groups.ResultsMost respondents (78.7%) reported problems in at least one 15D domain. The most problems were reported with sleeping (50.7%), followed by vitality (49.2%), distress (43.6%), discomfort and symptoms (31.2%), depression (31.1%), sexual activities (29.6%), breathing (28.1%), and vision (27.8%). The mean 15D index value was 0.810. With advancing age categories, the 15D index values showed an inverse U-shaped curve. Generally, mean index values in respondents with mental health conditions were lower [range 0.299 (post-traumatic stress disorder) to 0.757 (smoking addiction)] than those of respondents with physical conditions [range 0.557 (liver cirrhosis) to 0.764 (allergies)].ConclusionsThis study provided 15D population norms of the Hungarian general population; furthermore, this is the first study to provide population norms for the 15D in any country. The values established in this study can serve as benchmarks for evaluating efficacy outcomes in clinical trials, quantifying disease burden and identifying unmet needs.

Psychometric properties and general population reference values for PROMIS Global Health in Hungary

ObjectivesPatient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) is a widely used generic measure of health status. This study aimed to (1) assess the psychometric properties of the Hungarian PROMIS-GH and to (2) develop general population reference values in Hungary.MethodsAn online cross-sectional survey was conducted among the Hungarian adult general population (n = 1700). Respondents completed the PROMIS-GH v1.2. Unidimensionality (confirmatory factor analysis and bifactor model), local independence, monotonicity (Mokken scaling), graded response model fit, item characteristic curves and measurement invariance were examined. Spearman’s correlations were used to analyse convergent validity of PROMIS-GH subscales with SF-36v1 composites and subscales. Age- and gender-weighted T-scores were computed for the Global Physical Health (GPH) and Global Mental Health (GMH) subscales using the US item calibrations.ResultsThe item response theory assumptions of unidimensionality, local independence and monotonicity were met for both subscales. The graded response model showed acceptable fit indices for both subscales. No differential item functioning was detected for any sociodemographic characteristics. GMH T-scores showed a strong correlation with SF-36 mental health composite score (rs = 0.71) and GPH T-scores with SF-36 physical health composite score (rs = 0.83). Mean GPH and GMH T-scores of females were lower (47.8 and 46.4) compared to males (50.5 and 49.3) (p < 0.001), and both mean GPH and GMH T-scores decreased with age, suggesting worse health status (p < 0.05).ConclusionThis study established the validity and developed general population reference values for the PROMIS-GH in Hungary. Population reference values facilitate the interpretation of patients’ scores and allow inter-country comparisons.

Effects of an Exercise Program and Cold-Water Immersion Recovery in Patients with Rheumatoid Arthritis (RA): Feasibility Study.

Rheumatoid Arthritis (RA) patients present is an increased cardiovascular risk (CVR) linked to systemic inflammatory manifestations. A physical activity program with known positive effects on CVR, followed by cryotherapy because of its analgesic and anti-inflammatory effects, may be interesting. However, there are no reports in the literature of such a program. This study aimed to determine the feasibility (acceptability, safety, and effectiveness) of an individualized Intermittent Exercise Program followed by cold-water immersion as a recovery for RA patients. The program was conducted three times per week by eighteen RA patients (one man) with means of age and BMI of 55 (11.9) years and 25.5 (4.7) kg·m-2. Outcomes were assessed before and after nine and seventeen sessions and included evaluation of acceptability by perceived exertion (Borg) and water temperature (VAS) measures at each session; safety by a number of painful and swollen joints (echography); physical function (health assessment questionnaire); general health status (Short Form-36) measures; and effectiveness by arterial stiffness (pulse wave velocity, or PWV) measures. The results showed good acceptability of the program; no patient dropped out of the protocol or even presented difficulties or perceived pain. The HR and PWV values decreased significantly (70.2 ± 8.4 to 66 ± 5.5; p < 0.05 and 8.9 ± 1.2 to 7.0 ± 0.8; p < 0.001) after nine exercise sessions. No aggravation of symptoms has been noted. This program is acceptable, safe, and effective; consider tailoring it for supervised home-based use.

Association of Metformin, Dipeptidyl Dipeptidase-4 Inhibitors, and Insulin with Coronavirus Disease 2019–Related Hospital Outcomes in Patients with Type 2 Diabetes

ObjectiveThe effects of diabetes medications on COVID-19 hospitalization outcomes have not been consistent. We sought to determine the effect of metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), and insulin on admission to the intensive care unit (ICU), need for assisted ventilation, development of renal insufficiency, and mortality in patients admitted with COVID-19 infection after controlling for clinical variables and other relevant diabetes-related medications in patients with type 2 diabetes mellitus (DM). MethodsThis was a retrospective study of patients hospitalized with COVID-19 from a single hospital system. Univariate and multivariate analyses were performed that included demographic data, glycated hemoglobin, kidney function, smoking status, insurance, Charlson comorbidity index, number of diabetes medications, and use of angiotensin-converting enzyme inhibitors and statin prior to admission and glucocorticoids during admission. ResultsA total of 529 patients with type 2 DM were included in our final analysis. Neither metformin nor DPP4i prescription was associated with ICU admission, need for assisted ventilation, or mortality. Insulin prescription was associated with increased ICU admission but not with need for assisted ventilation or mortality. There was no association of any of these medications with development of renal insufficiency. ConclusionsIn this population, limited to type 2 DM and controlled for multiple variables that have not been consistently studied (such as a measure of general health, glycated hemoglobin, and insurance status), insulin prescription was associated with increased ICU admission. Metformin and DPP4i prescriptions did not have an association with the outcomes.

Generating EQ-5D-3L health utility scores from the Edinburgh Postnatal Depression Scale: a perinatal mapping study

BackgroundPerinatal depression (PND) describes depression experienced by parents during pregnancy or in the first year after a baby is born. The EQ-5D instrument (a generic measure of health status) is not often collected in perinatal research, however disease-specific measures, such as the Edinburgh Postnatal Depression Scale (EPDS) are widely used. Mapping can be used to estimate generic health utility index values from disease-specific measures like the EPDS.ObjectiveTo develop a mapping algorithm to estimate EQ-5D utility index values from the EPDS.MethodsPatient-level data from the BaBY PaNDA study (English observational cohort study) provided 1068 observations with paired EPDS and EQ-5D (3-level version; EQ-5D-3L) responses. We compared the performance of six alternative regression model types, each with four specifications of covariates (EPDS score and age: base, squared, and cubed). Model performance (ability to predict utility values) was assessed by ranking mean error, mean absolute error, and root mean square error. Algorithm performance in 3 external datasets was also evaluated.ResultsThere was moderate correlation between EPDS score and utility values (coefficient: – 0.42). The best performing model type was a two-part model, followed by ordinary least squared. Inclusion of squared and cubed covariates improved model performance. Based on graphs of observed and predicted utility values, the algorithm performed better when utility was above 0.6.ConclusionsThis direct mapping algorithm allows the estimation of health utility values from EPDS scores. The algorithm has good external validity but is likely to perform better in samples with higher health status.

The Increasing Salience of Health in Social Forces Research

Global life expectancy at birth approximately doubled during the 100-year history of Social Forces (Heuveline 2022; Riley 2005). As the average length of life of the individuals and their experiences in the communities and institutions studied in the journal increased, health became more salient to social and economic life. The increasing prominence of health, embodied by an individual’s continuing physical, emotional, mental, and social ability to cope with his or her environment over the life course, is reflected in the trend of health-related articles in Social Forces. A handful of health-related articles appeared during the decades from 1920 to 1960, followed by a small but steady flow of publications from 1970 to 2000, after which there has been more growth and diversity in health-related publications in the twentieth-first-century issues of Social Forces. The trend in health research within Social Forces has been driven by three factors: (1) the substantive relevance of health status, behavior, and healthcare (i) within societal structures and institutional contexts, (ii) in relation to social behavior, and (iii) as influenced by social stratification processes; (2) increasing availability of high-quality health data; and (3) increased attention to measurement of health. While much of the early health research published in Social Forces focused on mental health and mental health systems, over time as new surveys delivered a greater range of health measures, research soon included diverse measures of general health status, health behavior, and physical health indicators and change in them over time.

Botulinum Toxin A in the treatment of frostbite sequelae – results from a blinded, early-phase, comparative trial

ABSTRACT Introduction: Freezing Cold Injuries (FCI) have been associated with long-term sequelae including vasospasm. The aims of the pilot study are to explore the research methodology and investigate the tolerability and safety of treatment with Botulinum Toxin-A (BTX-A) in FCI Sequelae. Methodology: This pilot study tests the logistics, the treatment setting and the follow-up procedure in an early-phase, double-blinded, randomized, controlled trial study-design. The variables in the study were subjective symptoms, peripheral micro-vascularization/rewarming, somatosensory responsiveness, and generic measure of health status. Results: No major challenges or difficulties were noticed according to the protocol or the study methodology. The monitoring of tolerability and safety of treatment with BTX-A did not reveal any major unwanted and/or adverse reactions among the patients in the pilot study and no challenges occurred during data collection of endpoints. The study revealed an inaccuracy of the 2nd degree FCI diagnosis and uncover a need for relevant and sufficient clinical information for FCI classification. Conclusions: This pilot study showed the study methodology with minor adjustments is feasible in a future full-scale clinical trial. The recruitment process needs to be more refined to ensure that the eligible study participants are a homogenous group of FCI patients.

Validation of an Adapted Version of the Veterans RAND 12-Item Health Survey for Older Adults Living in Long-Term Care Homes.

The Veterans RAND 12-Item Health Survey (VR-12) is a generic patient-reported outcome measure of physical and mental health status. An adapted version of the VR-12 was developed for use with older adults living in long-term residential care (LTRC) homes in Canada: VR-12 (LTRC-C). This study aimed to evaluate the psychometric validity of the VR-12 (LTRC-C). Data for this validation study were collected via in-person interviews for a province-wide survey of adults living in LTRC homes across British Columbia (N = 8,657). Three analyses were conducted to evaluate validity and reliability: (1) confirmatory factor analyses were conducted to validate the measurement structure; (2) correlations with measures of depression, social engagement, and daily activities were examined to evaluate convergent and discriminant validity; and (3) Cronbach's alpha (r) statistics were obtained to evaluate internal consistency reliability. A measurement model with 2 correlated latent factors (representing physical health and mental health), 4 cross-loadings, and 4 correlated items resulted in an acceptable fit (root-mean-square error of approximation = 0.07; comparative fit index = 0.98). Physical and mental health were correlated in expected directions with measures of depression, social engagement, and daily activities, though the magnitudes of the correlations were quite small. Internal consistency reliability was acceptable for physical and mental health (r > 0.70). This study supports the use of the VR-12 (LTRC-C) to measure perceived physical and mental health among older adults living in LTRC homes.

A head-to-head comparison of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample

BackgroundThe EQ-5D-5L and 15D are generic preference-accompanied health status measures with similar dimensions. In this study, we aim to compare the measurement properties of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample.MethodsIn August 2021, an online cross-sectional survey was conducted in a representative adult general population sample (n = 1887). The EQ-5D-5L and 15D descriptive systems and index values were compared in terms of ceiling and floor, informativity (Shannon’s Evenness index), agreement, convergent and known-groups validity for 41 chronic physical and mental health conditions. Danish value sets were used to compute index values for both instruments. As a sensitivity analysis, index values were also estimated using the Hungarian EQ-5D-5L and Norwegian 15D value sets.ResultsOverall, 270 (8.6%) and 1030 (3.4*10−6%) unique profiles occurred on the EQ-5D-5L and 15D. The EQ-5D-5L dimensions (0.51–0.70) demonstrated better informativity than those of 15D (0.44–0.69). EQ-5D-5L and 15D dimensions capturing similar areas of health showed moderate or strong correlations (0.558–0.690). The vision, hearing, eating, speech, excretion and mental function 15D dimensions demonstrated very weak or weak correlations with all EQ-5D-5L dimensions, which may indicate potential room for EQ-5D-5L bolt-ons. The 15D index values showed lower ceiling than the EQ-5D-5L (21% vs. 36%). The mean index values were 0.86 for the Danish EQ-5D-5L, 0.87 for the Hungarian EQ-5D-5L, 0.91 for the Danish 15D and 0.81 for the Norwegian 15D. Strong correlations were found between the index values (Danish EQ-5D-5L vs. Danish 15D 0.671, Hungarian EQ-5D-5L vs. Norwegian 15D 0.638). Both instruments were able to discriminate between all chronic condition groups with moderate or large effect sizes (Danish EQ-5D-5L 0.688–3.810, Hungarian EQ-5D-5L 1.233–4.360, Danish 15D 0.623–3.018 and Norwegian 15D 1.064–3.816). Compared to the 15D, effect sizes were larger for the EQ-5D-5L in 88–93% of chronic condition groups.ConclusionsThis is the first study to compare the measurement properties of the EQ-5D-5L and 15D in a general population sample. Despite having 10 fewer dimensions, the EQ-5D-5L performed better than the 15D in many aspects. Our findings help to understand the differences between generic preference-accompanied measures and support resource allocation decisions.

Care delivery and self-management strategies for children with epilepsy.

Epilepsy is a neurological disorder affecting both children and adults. Epileptic seizures are the result of excessive and abnormal cortical cell electrical activity in the brain. In response to criticism that epilepsy care for children has little impact on long-term outcomes, healthcare professionals and administrators have developed various service models and strategies to address perceived inadequacies. This is an updated version of a Cochrane Review previously published in 2018. To assess the effects of any specialised or dedicated intervention for epilepsy versus usual care in children and adolescents with epilepsy and their families. We searched the following databases on 14 January 2020: the Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 13 January 2020), PsycINFO (1887 to 14 January 2020), CINAHL Plus (1937 to 14 January 2020), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Register of Studies (CRS Web) includes the Cochrane Epilepsy Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL). We also contacted experts in the field seeking information on unpublished and ongoing studies and checked the websites of epilepsy organisations and the reference lists of included studies. We included randomised controlled trials recruiting children and adolescents with epilepsy. Two review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 1. Seizure frequency and severity; 2. Appropriateness and volume of medication prescribed (including evidence of drug toxicity); 3. Participants' reported knowledge of information and advice received from professionals; 4. Participants' reports of health and quality of life; 5. Objective measures of general health status; 6. Objective measures of social or psychological functioning (including the number of days spent on sick leave/absence from school or work, and employment status); and 7. Costs of care or treatment. The results of the data extraction and quality assessment for each study were presented in structured tables and as a narrative summary. All summary statistics were extracted for each outcome. We included nine studies of eight interventions in the review, reporting on seven distinct self-management programmes for educating or counselling children with epilepsy and their parents, and one new model of care. Based largely on self-reported outcomes, each programme showed some benefits for the well-being of children with epilepsy; however, all of the included studies had methodological flaws. No single programme was evaluated with different study samples, and in no instance was the same outcome measured and reported in the same way across studies, precluding any possible meta-analysis, even if the interventions were considered sufficiently similar to include in meta-analysis. We chose the outcomes for which data might be important for decisions about the interventions as per guidance in the Cochrane Handbook for Systematic Reviews of Interventions. We found moderate certainty evidence that one of the educational interventions reduced seizure frequency. There was low certainty evidence that two other educational interventions reduced seizure severity, seizure control, and seizure cure rates. The evidence for all other outcomes (drug adherence, knowledge, self-efficacy and self-perception of epilepsy on quality of life) was mixed. Whilst each of the programmes evaluated in this review showed some benefit to children with epilepsy, their impact was extremely variable. No programme showed benefits across the full range of outcomes, and all studies had methodological problems. There is currently insufficient evidence in favour of any single programme. Further evidence from randomised controlled trials using validated measures and considering clinical meaningfulness as well as statistical significance of results is required.

POSB380 General Population Reference Values for the Promis Global Health in Hungary

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, also referred to as PROMIS Global-10, is a generic health status measure that has two subscales capturing physical and mental health. This study aimed to (1) develop Hungarian reference values for the PROMIS Global Health instrument and to (2) compare the results with the Dutch and US reference values.

Internal fixation versus hip arthroplasty in patients with nondisplaced femoral neck fractures: short-term results from a geriatric trauma registry

PurposeTo determine whether internal fixation (IF) or hip arthroplasty (HA) is associated with superior outcomes in geriatric nondisplaced femoral neck fracture (FNF) patients.MethodsData from the Registry for Geriatric Trauma of the German Trauma Society (ATR-DGU) were analyzed (IF Group 449 and HA Group 1278 patients). In-hospital care and a 120-day postoperative follow-up were conducted. Primary outcomes, including mobility, residential status, reoperation rate, and a generic health status measure (EQ-5D score), and the secondary outcome of mortality were compared between groups. Multivariable analyses were performed to assess independent treatment group associations (odds ratios, ORs) with the primary and secondary end points.ResultsPatients in the HA group were older (83 vs. 81 years, p < 0.001) and scored higher on the Identification of Seniors at Risk screening (3 vs. 2, p < 0.001). We observed no differences in residential status, reoperation rate, EQ-5D score, or mortality between groups. After adjusting for key covariates, including prefracture ambulatory capacity, the mobility of patients in the HA group was more frequently impaired at the 120-day follow-up (OR 2.28, 95% confidence interval = 1.11–4.74).ConclusionTreatment with HA compared to treatment with IF led to a more than twofold increase in the adjusted odds of impaired ambulation at the short-term follow-up, while no significant associations with residential status, reoperation rate, EQ-5D index score, or mortality were observed. Thus, IF for geriatric nondisplaced FNFs was associated with superior mobility 120 days after surgery. However, before definitive treatment recommendations can be made, prospective, randomized, long-term studies must be performed to confirm our findings.

Measurement properties of the 12-item Short Form Health Survey\xa0version 2 in Australians with lung cancer: a Rasch analysis

BackgroundThe 12-item Short-Form Health Survey version 2 (SF-12v2), a widely used, generic patient-reported measure of health status that provides summary scores of physical and mental health. No study to date has examined the measurement properties of the SF-12v2 in patients with lung cancer using Rasch analysis. The aim of this study was to extend the psychometric evaluations of the SF-12 within the lung cancer population to ensure its validity and reliability to assess the health status in this population.MethodsParticipants in the Victorian Lung Cancer Registry (VLCR) who completed the SF-12v2 between 2012 and 2016 were included in this study. The structural validity of the SF-12v2 was assessed using Rasch analysis. Overall fit to the Rasch measurement model was examined as well as five key measurement properties: uni-dimensionality, response thresholds, internal consistency, measurement invariance and targeting.ResultsA total of 342 participants completed the SF-12v2 three months following their lung cancer diagnosis. The SF-12 Physical Component Score (PCS-12) did not fit the overall Rasch measurement model (χ2 107.0; p < 0.001). Three items deviated significantly from the Rasch model (item fit residual beyond ± 2.5) with signs of dependency between item responses and disordered thresholds. Nevertheless, the PCS-12 was uni-dimensional with good internal consistency (person separation index [PSI] 0.83) and reasonable targeting. In contrast, the SF-12 Mental Component Score (MCS-12) had good overall model fit (χ2 35.1; p = 0.07), reasonable targeting and good internal consistency (PSI 0.81).ConclusionsRasch analysis suggests that there is general support for the reliability of the SF-12v2 as a measure of physical and mental health in people with lung cancer. However, the appropriateness of some items (e.g. pain) in the PCS-12 is questionable and further refinement of the scale including changing the response options may be required to improve the ability of the SF-12v2 to more appropriately assess the health status of this population.

Quality of life assessment in amyloid transthyretin (ATTR) amyloidosis.

BackgroundAmyloid transthyretin (ATTR) amyloidosis is caused by the systemic deposition of transthyretin molecules, either normal (wild‐type ATTR, ATTRwt) or mutated (variant ATTR, ATTRv). ATTR amyloidosis is a disease with a severe impact on patients’ quality of life (QoL). Nonetheless, limited attention has been paid to QoL so far, and no specific tools for QoL assessment in ATTR amyloidosis currently exist. QoL can be evaluated through patient‐reported outcome measures (PROMs), which are completed by patients, or through scales, which are compiled by clinicians. The scales investigate QoL either directly or indirectly, i.e., by assessing the degree of functional impairment and limitations imposed by the disease.DesignSearch for the measures of QoL evaluated in phase 2 and phase 3 clinical trials on ATTR amyloidosis.ResultsClinical trials on ATTR amyloidosis have used measures of general health status, such as the Short Form 36 Health Survey (SF‐36), or tools developed in other disease settings such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) or adaptations of other scales such as the modified Neuropathy Impairment Score +7 (mNIS+7).ConclusionsScales or PROMs for ATTR amyloidosis would be useful to better characterize newly diagnosed patients and to assess disease progression and response to treatment. The ongoing ITALY (Impact of Transthyretin Amyloidosis on Life qualitY) study aims to develop and validate 2 PROMs encompassing the whole phenotypic spectrum of ATTRwt and ATTRv amyloidosis, that might be helpful for patient management and may serve as surrogate endpoints for clinical trials.

COVID-19-related healthcare closures negatively affect patient health and postoperative recovery

ObjectiveTo determine how COVID-19-related healthcare closures affect the health, recovery and access to resources of preoperative and postoperative orthopaedic sport medicine patients.MethodsPatients whose orthopaedic restorative surgeries were postponed as well as those within 3 months postoperative completed electronic questionnaires assessing physical health, emotional health, virtual care and access to resources. The EuroQoL-five-dimensional-three level (EQ-5D-3L) was included as a quantitative and standardised measure of general health status. Data were descriptively analysed using means, SD and qualitative measures.ResultsA total of 115 patients whose surgeries were postponed completed the survey. Notable findings included that 41.7% of patients reported an increase in their symptoms during the COVID-19-related closures, and 68.7% described a negative impact on their physical health. Furthermore, 62.6% of patients reported that the postponement of their surgery would negatively affect their ability to return to work. A substantial percentage of patients (71.3%) reported that postponement of their surgery had an overall negative impact on their physical and/or emotional health. The mean health state on the EQ-5D-3L visual analogue scale (VAS) scale was 69.9 (SD=18.7). A total of 198 patients within 3 months postoperative completed the survey. A majority of patients (69.7%) indicated that COVID-19-related healthcare closures had an overall negative affect on their recovery. One-third of patients (35.4%) stated that they experienced increased symptoms as a direct result of limited postoperative follow-up. Less than half (41.4%) of patients accessed virtual physiotherapy, and only 42.9% of those that did found it to be helpful in some way. Virtual orthopaedic follow-up was deemed helpful by 61.3% of patients but many commented that it did not replace inperson visits. The mean health state reported on the EQ-5D-3L VAS scale was 76.9 (SD=15.6).ConclusionThis study highlighted the significant impact of COVID-19-related healthcare closures on preoperative and postoperative orthopaedic sport medicine patients. It revealed that restorative procedures play an important role in maintaining physical and emotional health, as well as returning individuals to work and leisure activities. It also showed that virtual care did not adequately replace the hands-on assessments of allied care and orthopaedic specialists.Level of EvidenceV.

General health status in young people with intellectual disabilities with and without Down syndrome in, and transitioning from, special education: findings from the National Longitudinal Transitions Study-2.

There has been little prior investigation of the general health of young people with intellectual disabilities across transition, nor separately for youth with intellectual disabilities with or without Down syndrome, despite general health being a strong predictor of subsequent health service use, hospital admissions and mortality in the general population. We aimed to investigate general health status in youth with intellectual disabilities with and without Down syndrome over the transitional period and quantify the extent to which personal characteristics, parental relationship and household income are associated with general health status. The National Longitudinal Transitions Study-2 includes a nationally representative sample of youth receiving special education services aged 13-17years at wave 1, followed up over 10years in five waves of data collection. Data on general health status of youth with intellectual disabilities with and without Down syndrome were obtained from parent reports. We summarised overall demographics and general health status and plotted general health status for those who had health data available for all five waves. We then used random-effects ordered logistic regression to investigate whether wave of data collection, age, sex, Down syndrome, ethnicity, parental relationship status and household income are associated with general health status. At wave 1, data on intellectual disabilities were available on 9008/9576 (94.1%) young people, and 871/9008 (9.7%) of them had intellectual disabilities, of whom 125/871 (14.4%) had Down syndrome. Youth with intellectual disabilities with or without Down syndrome had low rates of excellent or very good health. Across waves 1-5, there was a shallow gradient in the proportion of youth with intellectual disabilities reporting excellent/very good health, from 57.7% at 13-17years to 52.6% at 21-25years, being more marked for those without Down syndrome (57.8% at 13-17years to 51.8% at 21-25years). However, contrary to our expectations, an ordinal measure of general health status did not decline over this transitional period and did not differ between youth with and without Down syndrome. There was a gradient with higher income associated with better health, significantly so over $50001 (odds ratio=0.559, 95% confidence interval 0.366-0.854). Poorer health was experienced by youth with Hispanic, Latino or Spanish ethnicity (odds ratio=1.790, 95% confidence interval 1.051-3.048). Female sex and parental relationship status were not associated with health status. Young people with intellectual disabilities have bad health, and require support across all ages, including transition. Schools, teachers and staff in transitional services should consider health, and health care and support during transitional planning due to change in service provision and be aware of ethnicity and the stressful effects of low household income. This is important as interventions based on provision of greater support can prevent adverse consequences.

Towards patient-centred cancer care: cross-cultural validity and responsiveness of the Turkish Integrated Palliative care Outcome Scale

BackgroundA valid measure to describe the most important needs and concerns of people with life-threatening illnesses is missing in Cyprus. Our aim was to adapt and test the cross-cultural validity and responsiveness of the Integrated Palliative care Outcome Scale (IPOS) in a cohort of Turkish speaking cancer patients.MethodsThe IPOS (English) patient-reported measure was translated into Turkish following published guidelines including, 2 independent forward, 2 independent blind backward translations, expert panel review by 7 members and field testing with 11 cognitive interviews (5 patients and 6 specialists) and final approval of the copyright holder. Consecutive cancer patients (n = 234) seen by the community palliative care services were recruited from Help Those with Cancer Society (KHYD); of those 82 were followed-up. The instrument was administered by personal interview. Confirmatory Factor Analysis was used to validate the factor structure of Turkish IPOS. Internal consistency reliability of the subscales was evaluated by Cronbach’s alpha and Intraclass Correlation Coefficient respectively. Validity was assessed by calculating Pearson’s correlation coefficient (r) between Turkish IPOS scores and Turkish version of EQ-5D-3L - a validated generic measure of health status developed by the EuroQol Group.ResultsTurkish IPOS is conceptually and semantically equivalent to the English version and linguistically valid. The CFA was inconclusive for the three factor structure due to low sample size, as the SRMR and CFI tests only approached the defined minimums warranting further investigation. There were low levels of missing values, and no ceiling or floor effects. The Physical (α = 0.91) and the Social and Quality of Care Issues (α = 0.75) sub-scales showed good internal consistencies, however Emotional sub-scale showed poor internal consistency (α = 0.64). The reliability of the Physical (ICC = 0.51, 0.45–0.56 95% CI) and Social Quality of Care Issues (ICC = 0.50, 0.42–0.57 95% CI) were moderate. Poor internal consistency (α =0.64) and reliability (ICC = 0.31, 0.24–0.39, 95% CI) was obtained for Emotional Subscale. Construct validity was evidenced through significant correlations in the predicted directions and strength with EQ-5D. Turkish IPOS showed higher needs and concerns in participants at more advanced stages than those at earlier stages of cancer. The standardized response mean (SRM) of − 0.94 suggested large internal responsiveness to clinical change.ConclusionTurkish IPOS is a clear, relevant, acceptable measure and responsive to the needs and concerns of cancer patients, observing regional differences, it may have implications for use in other Turkish speaking communities. Future studies are needed to clarify the factor structure, assess its external responsiveness and to improve the properties of its Emotional subscale.