An investigation into the psychometric performance of existing measures of health, quality of life and wellbeing in older adults

The UK population is ageing, with the proportion of the population aged over 65 continuing to rise. Old age is associated with increasing prevalence of frailty, characterised by a slow and steady decline in health and functioning. Older adults experiencing frailty often have complex needs, requiring complicated combinations of health and social care services over the long-term. This has led to a push for integration between health and social care services. Traditionally, the economic evaluation of health services has focussed on health-related quality of life (QoL) as the unit of benefit. However, current health measures may not be appropriate to evaluate the outcomes of social care or integrated health and social care interventions. Outcome measurement methods may need to be adapted to include broader assessment of QoL or wellbeing. This thesis aims to examine the psychometric performance of existing measures of health, QoL and wellbeing in older adults. First, the existing evidence of the psychometric performance of the EQ-5D-5L, SF-12v2, ASCOT, WEMWBS and ONS-4 was systematically reviewed. Then, item response theory (IRT) was used to examine the construct and structural validity and internal consistency of these measures in older adults aged 65+. Differential item functioning (DiF) analyses assessed whether older and younger adults with the same underlying health, QoL or wellbeing had different expected scores, indicating bias due to age. Lastly, the content validity of the EQ-5D-5L, SF-12v2, WEMWBS and ONS-4 was explored using cognitive interviews in older adults. This thesis identified some key findings which can inform the choice of measure in the evaluation of health and social care interventions aimed at older adults. In the IRT study, the ASCOT and EQ-5D-5L displayed ceiling effects, while the SF-12v2 and EQ-5D-5L exhibited DiF, both of which can bias the estimates of effectiveness obtained from these measures in an economic evaluation. The cognitive interviewing study provided insight into the way older adults conceptualise QoL and how this impacts the way they respond to items. Issues with response shift were broadly identified, which are the likely cause of DiF. Participants found the functional focused EQ-5D-5L items easier to answer and mostly relevant to their situation. The relevance of broader subjective wellbeing items on the WEMWBS and ONS-4 and negatively phrased mental health items across the measures were commonly questioned as these concepts were not prioritised in older adults’ conceptualisation of QoL. However, the coverage of any of the measures would need to be extended to include broader elements of QoL identified as important to older adults. This may be through adaptations to the EQ-5D-5L, such as bolt ons, or the development of a new measure, possibly based on the style of the EQ-5D-5L

Important methodological issues regarding the use of TMS to investigate interoceptive processing: a comment on Pollatos et al (2016)

Comment on: Changes in interoceptive processes following brain stimulation by Pollatos, Herbert, Mai & Kammer, 201

Associations between emotion recognition and autistic and callous-unemotional traits:differential effects of cueing to the eyes

BackgroundAlthough autism and callous-unemotional (CU) traits are distinct conditions, both are associated with difficulties in emotion recognition. However, it is unknown whether the emotion recognition difficulties characteristic of autism and CU traits are driven by comparable underpinning mechanisms.MethodsWe tested whether cueing to the eyes improved emotion recognition in relation to autistic and CU traits in a heterogeneous sample of children enhanced for social, emotional and behavioural difficulties. Participants were 171 (n = 75 male) children aged 10–16 years with and without a diagnosis of autism (n = 99 autistic), who completed assessments of emotion recognition with and without cueing to the eyes. Parents completed the assessment of autistic and CU traits.ResultsAssociations between autistic and CU traits and emotion recognition accuracy were dependent upon gaze cueing. CU traits were associated with an overall decrease in emotion recognition in the uncued condition, but better fear recognition when cued to the eyes. Conversely, autistic traits were associated with decreased emotion recognition in the cued condition only, and no interactions between autistic traits and emotion were found.ConclusionsThe differential effect of cueing to the eyes in autistic and CU traits suggests different mechanisms underpin emotion recognition abilities. Results suggest interventions designed to promote looking to the eyes may be beneficial for children with CU traits, but not for children with autistic characteristics. Future developmental studies of autism and CU characteristics are required to better understand how different pathways lead to overlapping socio-cognitive profiles

The effects of age at menarche and first sexual intercourse on reproductive and behavioural outcomes:A Mendelian randomization study

There is substantial variation in the timing of significant reproductive life events such as menarche and first sexual intercourse. Life history theory explains this variation as an adaptive response to an individual's environment and it is important to examine how traits within life history strategies affect each other. Here we applied Mendelian randomization (MR) methods to investigate whether there is a causal effect of variation in age at menarche and age at first sexual intercourse (markers or results of exposure to early life adversity) on outcomes related to reproduction, education and risky behaviour in UK Biobank (N = 114 883-181 255). Our results suggest that earlier age at menarche affects some traits that characterize life history strategies including earlier age at first and last birth, decreased educational attainment, and decreased age at leaving education (for example, we found evidence for a 0.26 year decrease in age at first birth per year decrease in age at menarche, 95% confidence interval: -0.34 to -0.17; p < 0.001). We find no clear evidence of effects of age at menarche on other outcomes, such as risk taking behaviour. Age at first sexual intercourse was also related to many life history outcomes, although there was evidence of horizontal pleiotropy which violates an assumption of MR and we therefore cannot infer causality from this analysis. Taken together, these results highlight how MR can be applied to test predictions of life history theory and to better understand determinants of health and social behaviour

Do Changes in the Pace of Events Affect One-Off Judgments of Duration?

Five experiments examined whether changes in the pace of external events influence people’s judgments of duration. In Experiments 1a–1c, participants heard pieces of music whose tempo accelerated, decelerated, or remained constant. In Experiment 2, participants completed a visuo-motor task in which the rate of stimulus presentation accelerated, decelerated, or remained constant. In Experiment 3, participants completed a reading task in which facts appeared on-screen at accelerating, decelerating, or constant rates. In all experiments, the physical duration of the to-be-judged interval was the same across conditions. We found no significant effects of temporal structure on duration judgments in any of the experiments, either when participants knew that a time estimate would be required (prospective judgments) or when they did not (retrospective judgments). These results provide a starting point for the investigation of how temporal structure affects one-off judgments of duration like those typically made in natural settings

Face, body and speech cues independently predict judgments of attractiveness

Research on human attraction frequently makes use of single-modality stimuli such as neutral-expression facial photographs as proxy indicators of an individual’s attractiveness. However, we know little about how judgments of these single-modality stimuli correspond to judgments of stimuli that incorporate multi-modal cues of face, body and speech. In the present study, ratings of attractiveness judged from videos of participants introducing themselves were independently predicted by judgments of the participant’s facial attractiveness (a neutral-expression facial photograph masked to conceal the hairstyle), body attractiveness (a photograph of the upper body), and speech attractiveness (the soundtrack to the video). We also found that ratings of the face, body and speech were positively related to each other. Our results support the assumption that the single-modality stimuli used in much attractiveness research are valid proxy indicators of overall attractiveness in ecologically valid contexts, and complement literature showing cross-modality concordance of trait attractiveness, but also recommend that research relying on assessments of individual attractiveness take account of both visual and vocal attractiveness where possible

A qualitative investigation of older adults’ conceptualisation of quality of life and a think-aloud content validation of the EQ-5D-5L, SF-12v2, WEMWBS and ONS-4

Objectives Old age is characterized by declining health, comorbidities, and increasing health and social care service use. Traditionally, patient-reported outcome measures (PROMs) including the EQ-5D-5L and SF-12v2 have focused on health. Nevertheless, aged care often aims to improve broader elements of quality of life (QoL), captured by well-being measures, such as the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) and Office of National Statistics-4 (ONS-4). This study investigates older adults’ conceptualization of QoL and the content validity of the EQ-5D-5L, SF-12v2, WEMWBS, and ONS-4 in measuring their QoL. Methods Qualitative cognitive think-aloud interviews were undertaken with older adults aged 75+, exploring their views on what was important to QoL and, for each measure, the relevance, acceptability, and interpretation of items; suitability of response options; and the comprehensiveness of the measure. Conceptualization of QoL was analyzed thematically and content validity using framework analysis. Results Twenty interviews were undertaken. Older adults’ conceptualization of QoL centered on health, ability to perform usual activities, social contact, and emotional functioning. Possible response shift was observed, as older adults assessed their health relative to lower health expectations at their age or to people in worse states. Participants questioned the relevance of negatively phrased mental items and often preferred the functioning-focused EQ-5D-5L to more subjective ONS-4 and WEMWBS items. Domains suggested to improve comprehensiveness included social contact, coping, security, dignity, and control. Conclusions These findings are useful to researchers developing new PROMs for older adults or for the developers of included PROMs considering permanently adapting or bolting-on domains to improve content validity in older adults

Regulatory and HTA early dialogues in medical devices

Abstract Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence. Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe. Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues. Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially. Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers

SeHCAT (tauroselcholic [75 selenium] acid) for the investigation of bile acid diarrhoea in adults: a systematic review and cost-effectiveness analysis

Background: Tauroselcholic [75 selenium] acid (SeHCAT™) (GE Healthcare, Chicago, IL, USA) is a radiopharmaceutical that may be useful in diagnosing bile acid diarrhoea. Objectives: To assess the clinical effectiveness and cost-effectiveness of SeHCAT for the investigation of adults with chronic unexplained diarrhoea, diarrhoea-predominant irritable bowel syndrome or functional diarrhoea (suspected primary bile acid diarrhoea), and adults with chronic diarrhoea and Crohn’s disease who have not undergone ileal resection (suspected secondary bile acid diarrhoea). Methods: Sixteen databases were searched to November 2020. The review process included measures to minimise error and bias. Results were summarised by primary or secondary bile acid diarrhoea and study quality was considered. The cost-effectiveness analysis combined a short-term (6-month) decision-analytic model (diagnosis and initial treatment response) and a lifetime Markov model comprising three health states (diarrhoea, no diarrhoea and death), with transitions determined by probabilities of response to treatment. Analyses were conducted from an NHS and Personal Social Services perspective. Results: Twenty-four studies were included in this review. Of these, 21 were observational studies, reporting some outcome data for patients treated with bile acid sequestrants, and in which only patients with a positive SeHCAT test were offered bile acid sequestrants. The median rate of response to bile acid sequestrants, among patients with a 7-day SeHCAT retention value of ≤ 15%, was 68% (range 38–86%) (eight studies). The estimated sensitivity of SeHCAT (≤ 15% threshold) to predict positive response to colestyramine was 100% (95% confidence interval 54.1% to 100%) and the specificity estimate was 91.2% (95% confidence interval 76.3% to 98.1%) (one study). The median proportion of treated patients who were intolerant/discontinued bile acid sequestrants was 15% (range 4–27%) (eight studies). There was insufficient information to determine whether or not intolerance varied between colestyramine, colestipol and colesevelam. For both populations, the SeHCAT 15% (i.e. a SeHCAT retention value of ≤ 15%) strategy dominated other strategies or resulted in incremental cost-effectiveness ratios of 15% could benefit from treatment with bile acid sequestrants. Although the results of the economic evaluation conducted for both populations indicated that the SeHCAT 15% strategy dominated the other two strategies or resulted in incremental cost-effectiveness ratios that were lower than the common thresholds of £20,000 or £30,000 per quality-adjusted life-year gained, the paucity and poor quality of evidence mean that uncertainty is high. Future work: The optimum study design would be a multiarm randomised controlled trial, in which participants meeting the inclusion criteria are randomised to receive colestyramine, colestipol, colesevelam or placebo, and all participants receive SeHCAT testing. Study registration: This study is registered as PROSPERO CRD42020223877