Real-world evaluation of an acceptance and commitment therapy-based group programme for breast cancer survivors with fear of cancer recurrence.

PURPOSE: To evaluate the effectiveness and acceptability of a 6-week acceptance and commitment therapy (ACT)-based group programme on participants' fear of cancer recurrence (FCR), quality of life (QoL), psychological distress and psychological flexibility at the end of the programme and 12-week follow-up. METHODS: A one-group, post-test service evaluation of a real-world psychological programme was carried out to evaluate collected outcome measures and attendance for a total of 21 groups facilitated between 2017 and 2019. Participants were breast cancer survivors who attended a 6-week group programme led by NHS clinicians. Descriptive statistics and repeated measures ANOVA analyses were carried out for each outcome measure. Attendance levels were examined to assess acceptability. RESULTS: A total of 97 group participants who had completed curative treatment for breast cancer took part. Of whom, 89% completed at least 4 of the 6 weekly group sessions and 76% attended the 12-week follow-up session. Eighty-four (87%) participants returned outcome measures at all three time points relative to group participation (T1 = pre, T2 = post T3 = 12-week follow-up). Group participants were female, mean age 51.9 years. FCR was highest at T1 (mean 25.2, SD 4.7), reduced T2 (mean 21.2, SD 5.4) and further lowered T3 (mean 19.5, SD 6.2). This difference was statistically significant (p < 0.001). QoL was lowest at T1 (mean 62.4, SD 15.7), increased T2 (mean 71.7, SD 18.1) and further increased at T3 (mean 75.9, SD 17.5). This difference was statistically significant (p < 0.001). Psychological distress measures were shown to reduce, and psychological flexibility increased. CONCLUSIONS: This real-world evaluation of an ACT-based group programme led to improvements in FCR, QoL, psychological distress and psychological flexibility in this population. This evaluation provides basis for further investigation to determine if these results can be replicated by controlled research design across diverse populations.

Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism.

BACKGROUND: The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group trial involving 737 adults who were at least 65 years of age and who had persisting subclinical hypothyroidism (thyrotropin level, 4.60 to 19.99 mIU per liter; free thyroxine level within the reference range). A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 µg daily, or 25 µg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). RESULTS: The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. The mean (±SD) thyrotropin level was 6.40±2.01 mIU per liter at baseline; at 1 year, this level had decreased to 5.48 mIU per liter in the placebo group, as compared with 3.63 mIU per liter in the levothyroxine group (P<0.001), at a median dose of 50 µg. We found no differences in the mean change at 1 year in the Hypothyroid Symptoms score (0.2±15.3 in the placebo group and 0.2±14.4 in the levothyroxine group; between-group difference, 0.0; 95% confidence interval [CI], -2.0 to 2.1) or the Tiredness score (3.2±17.7 and 3.8±18.4, respectively; between-group difference, 0.4; 95% CI, -2.1 to 2.9). No beneficial effects of levothyroxine were seen on secondary-outcome measures. There was no significant excess of serious adverse events prespecified as being of special interest. CONCLUSIONS: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. (Funded by European Union FP7 and others; TRUST ClinicalTrials.gov number, NCT01660126 .).

AD-8 for detection of dementia across a variety of healthcare settings.

BACKGROUND: Dementia assessment often involves initial screening, using a brief tool, followed by more detailed assessment where required. The AD-8 is a short questionnaire, completed by a suitable 'informant' who knows the person well. AD-8 is designed to assess change in functional performance secondary to cognitive change. OBJECTIVES: To determine the diagnostic accuracy of the informant-based AD-8 questionnaire, in detection of all-cause (undifferentiated) dementia in adults. Where data were available, we described the following: the diagnostic accuracy of the AD-8 at various predefined threshold scores; the diagnostic accuracy of the AD-8 for each healthcare setting and the effects of heterogeneity on the reported diagnostic accuracy of the AD-8. SEARCH METHODS: We searched the following sources on 27 May 2014, with an update to 7 June 2018: ALOIS (Cochrane Dementia and Cognitive Improvement Group), MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), BIOSIS Previews (Thomson Reuters Web of Science), Web of Science Core Collection (includes Conference Proceedings Citation Index) (Thomson Reuters Web of Science), CINAHL (EBSCOhost) and LILACS (BIREME). We checked reference lists of relevant studies and reviews, used searches of known relevant studies in PubMed to track related articles, and contacted research groups conducting work on the AD-8 to try to find additional studies. We developed a sensitive search strategy and used standardised database subject headings as appropriate. Foreign language publications were translated. SELECTION CRITERIA: We selected those studies which included the AD-8 to assess for the presence of dementia and where dementia diagnosis was confirmed with clinical assessment. We only included those studies where the AD-8 was used as an informant assessment. We made no exclusions in relation to healthcare setting, language of AD-8 or the AD-8 score used to define a 'test positive' case. DATA COLLECTION AND ANALYSIS: We screened all titles generated by electronic database searches, and reviewed abstracts of potentially relevant studies. Two independent assessors checked full papers for eligibility and extracted data. We extracted data into two-by-two tables to allow calculation of accuracy metrics for individual studies. We then created summary estimates of sensitivity, specificity and likelihood ratios using the bivariate approach and plotting results in receiver operating characteristic (ROC) space. We determined quality assessment (risk of bias and applicability) using the QUADAS-2 tool. MAIN RESULTS: From 36 papers describing AD-8 test accuracy, we included 10 papers. We utilised data from nine papers with 4045 individuals, 1107 of whom (27%) had a clinical diagnosis of dementia. Pooled analysis of seven studies, using an AD-8 informant cut-off score of two, indicated that sensitivity was 0.92 (95% confidence interval (CI) 0.86 to 0.96); specificity was 0.64 (95% CI 0.39 to 0.82); the positive likelihood ratio was 2.53 (95% CI 1.38 to 4.64); and the negative likelihood ratio was 0.12 (95% CI 0.07 to 0.21). Pooled analysis of five studies, using an AD-8 informant cut-off score of three, indicated that sensitivity was 0.91 (95% CI 0.80 to 0.96); specificity was 0.76 (95% CI 0.57 to 0.89); the positive likelihood ratio was 3.86 (95% CI 2.03 to 7.34); and the negative likelihood ratio was 0.12 (95% CI 0.06 to 0.24).Four studies were conducted in community settings; four were in secondary care (one in the acute hospital); and one study was in primary care. The AD-8 has a higher relative sensitivity (1.11, 95% CI 1.02 to 1.21), but lower relative specificity (0.51, 95% CI 0.23 to 1.09) in secondary care compared to community care settings.There was heterogeneity across the included studies. Dementia prevalence rate varied from 12% to 90% of included participants. The tool was also used in various different languages. Among all the included studies there was evidence of risk of bias. Issues included the selection of participants, conduct of index test, and flow of assessment procedures. AUTHORS' CONCLUSIONS: The high sensitivity of the AD-8 suggests it can be used to identify adults who may benefit from further specialist assessment and diagnosis, but is not a diagnostic test in itself. This pattern of high sensitivity and lower specificity is often suited to a screening test. Test accuracy varies by setting, however data in primary care and acute hospital settings are limited. This review identified significant heterogeneity and risk of bias, which may affect the validity of its summary findings.

Diagnostic test accuracy of a novel smartphone application for the assessment of attention deficits in delirium in older hospitalised patients: a prospective cohort study protocol.

BACKGROUND: Delirium is a common and serious clinical syndrome which is often missed in routine clinical care. The core cognitive feature is inattention. We developed a novel bedside neuropsychological test for assessing inattention in delirium implemented on a smartphone platform (DelApp). We aim to evaluate the diagnostic performance of the DelApp in a representative cohort of older hospitalised patients. METHODS: This is a prospective study of older non-scheduled hospitalised patients (target n = 500, age ≥ 65), recruited from elderly care and acute orthopaedic wards. Exclusion criteria are: non-English speakers; severe vision or hearing impairment; photosensitive epilepsy. A structured reference standard delirium assessment based on DSM-5 criteria will be used, which includes a cognitive test battery administered by a trained assessor (Orientation-Memory-Concentration Test, Abbreviated Mental Test-10, Delirium Rating Severity Scale-Revised-98, digit span, months and days backwards, Vigilance A' test) and assessment of arousal (Observational Scale of Level of Arousal, Richmond Agitation Sedation Scale). Prior change in cognition will be documented using the Informant Questionnaire on Cognitive Decline in the Elderly. Patients will be categorized as delirium (with/without dementia), possible delirium, dementia, no cognitive impairment, or undetermined. A separate assessor (blinded to diagnosis and assessments) will administer the DelApp index test within 3 h of the reference standard assessment. The DelApp comprises assessment of arousal (score 0-4) and sustained attention (score 0-6), yielding a total score between 0 and 10 (higher score = better performance). Outcomes (length of stay, mortality and discharge location) will be collected at 12 weeks. We will evaluate a priori cutpoints derived from a previous case-control study. Measures of the accuracy of DelApp will include sensitivity, specificity, positive and negative predictive values, and area under the ROC curve. We plan repeat assessments on up to 4 occasions in a purposive subsample of 30 patients (15 delirium, 15 no delirium) to examine changes over time. DISCUSSION: This study evaluates the diagnostic test accuracy of a novel smartphone test for delirium in a representative cohort of older hospitalised patients, including those with dementia. DelApp has the potential to be a convenient, objective method of improving delirium assessment for older people in acute care. TRIAL REGISTRATION: Clinical trials.gov, NCT02590796 . Registered on 29 Oct 2015. Protocol version 5, dated 25 July 2016.

A Novel Computerized Test for Detecting and Monitoring Visual Attentional Deficits and Delirium in the ICU.

OBJECTIVES: Delirium in the ICU is associated with poor outcomes but is under-detected. Here we evaluated performance of a novel, graded test for objectively detecting inattention in delirium, implemented on a custom-built computerized device (Edinburgh Delirium Test Box-ICU). DESIGN: A pilot study was conducted, followed by a prospective case-control study. SETTING: Royal Infirmary of Edinburgh General ICU. PATIENTS: A pilot study was conducted in an opportunistic sample of 20 patients. This was followed by a validation study in 30 selected patients with and without delirium (median age, 63 yr; range, 23-84) who were assessed with the Edinburgh Delirium Test Box-ICU on up to 5 separate days. Presence of delirium was assessed using the Confusion Assessment Method for the ICU. MEASUREMENTS AND MAIN RESULTS: The Edinburgh Delirium Test Box-ICU involves a behavioral assessment and a computerized test of attention, requiring patients to count slowly presented lights. Thirty patients were assessed a total of 79 times (n = 31, 23, 15, 8, and 2 for subsequent assessments; 38% delirious). Edinburgh Delirium Test Box-ICU scores (range, 0-11) were lower for patients with delirium than those without at the first (median, 0 vs 9.5), second (median, 3.5 vs 9), and third (median, 0 vs 10.5) assessments (all p < 0.001). An Edinburgh Delirium Test Box-ICU score less than or equal to 5 was 100% sensitive and 92% specific to delirium across assessments. Longitudinally, participants' Edinburgh Delirium Test Box-ICU performance was associated with delirium status. CONCLUSIONS: These findings suggest that the Edinburgh Delirium Test Box-ICU has diagnostic utility in detecting ICU delirium in patients with Richmond Agitation and Sedation Scale Score greater than -3. The Edinburgh Delirium Test Box-ICU has potential additional value in longitudinally tracking attentional deficits because it provides a range of scores and is sensitive to change.

Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).

BACKGROUND: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. METHODS: Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. DISCUSSION: This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. TRIAL REGISTRATION: Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.

Evaluation of delirium screening tools in geriatric medical inpatients: a diagnostic test accuracy study.

INTRODUCTION: screening all unscheduled older adults for delirium is recommended in national guidelines, but there is no consensus on how to perform initial assessment. AIM: to evaluate the test accuracy of five brief cognitive assessment tools for delirium diagnosis in routine clinical practice. METHODS: a consecutive cohort of non-elective, elderly care (older than 65 years) hospital inpatients admitted to a geriatric medical assessment unit of an urban teaching hospital. Reference assessments were clinical diagnosis of delirium performed by elderly care physicians. Routine screening tests were: Abbreviated Mental Test (AMT-10, AMT-4), 4 A's Test (4AT), brief Confusion Assessment Method (bCAM), months of the year backwards (MOTYB) and informant Single Question in Delirium (SQiD). RESULTS: we assessed 500 patients, mean age 83 years (range = 66-101). Clinical diagnoses were: 93 of 500 (18.6%) definite delirium, 104 of 500 (20.8%) possible delirium and 277 of 500 (55.4%) no delirium; 266 of 500 (53.2%) were identified as definite or possible dementia. For diagnosis of definite delirium, AMT-4 (cut-point < 3/4) had a sensitivity of 92.7% (95% confidence interval (CI): 84.8-97.3), with a specificity of 53.7% (95% CI: 48.1-59.2); AMT-10 (<4/10), MOTYB (<4/12) and SQiD showed similar performance. bCAM had a sensitivity of 70.3% (95% CI: 58.5-80.3) with a specificity of 91.4% (95% CI: 87.7-94.3). 4AT (>4/12) had a sensitivity of 86.7% (95% CI: 77.5-93.2) and specificity of 69.5% (95% CI: 64.4-74.3). CONCLUSIONS: short screening tools such as AMT-4 or MOTYB have good sensitivity for definite delirium, but poor specificity; these tools may be reasonable as a first stage in assessment for delirium. The 4AT is feasible and appears to perform well with good sensitivity and reasonable specificity.

Single screening questions for cognitive impairment in older people: a systematic review.

BACKGROUND AND OBJECTIVE: Single-item screening questions may be a practical first step in screening for cognitive problems in older people. A form of single-item cognitive assessment is proposed in the NHS England and Wales dementia strategy. We aimed to provide a review and synthesis of the evidence regarding the performance of single-item tests for detection of cognitive impairment. DESIGN: This review used Cochrane diagnostic test accuracy procedures. Two independent researchers searched for relevant papers across multiple, cross-disciplinary electronic databases using previously validated search strings. Our index test was any single screening question for cognitive impairment, including factor analysis of multi-item tools. Our reference standards included clinical diagnosis and multi-domain cognitive assessments. RESULTS: From 884 titles, 11 studies were identified as eligible for inclusion. Four studies were graded low risk of bias and recruited a representative patient sample. Five papers described a single screening question for cognitive impairment with each using a different question. Sensitivity ranged from 26 to 96% and specificity from 45 to 100%. Six papers described the component analysis of multiple item tools with broadly worded single questions ('decline in memory function', 'changes in ability to think and reason' or 'learning new things') performing best. CONCLUSION: Informant-based, single-item screening questions show promise for detecting cognitive impairment. However, there was substantial heterogeneity in format and application of single-item screens, and several studies were of poor methodological quality. Currently, there is insufficient evidence to support routine screening using a single-item approach.

Informant single screening questions for delirium and dementia in acute care--a cross-sectional test accuracy pilot study.

BACKGROUND: Cognitive impairment often goes undetected in older people in hospital. Efficient screening tools are required to improve detection. To determine diagnostic properties of two separate informant-based single screening questions for cognitive impairment (dementia and delirium) in hospitalised older people. METHODS: Patients over 65 years non-electively admitted to medical or geriatric wards within a teaching hospital. Our index tests were single screening questions (SSQ), one for dementia ("How has your relative/friend's memory changed over the past 5 years (up to just before their current illness)?") and one for delirium ("How has your relative/friend's memory changed with his/her current illness?"), which were assessed with informant response given on a five point Likert scale. Any deterioration on our index tests of SSQ-dementia and SSQ-delirium was accepted as a positive screen for cognitive impairment. Scores were compared to the Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) >3.38 accepted as dementia, and Confusion Assessment Method (CAM) diagnosis of delirium. We also collected direct cognitive screening data using Mini Mental Status Examination (MMSE). RESULTS: Informant responses were obtained in 70/161 (43.5%) patients, median age 80.8 (range:67-97) years; mean MMSE score 18.5 (SD: 8.1). The SSQ-dementia when compared to the IQCODE had a sensitivity of 83.3% and specificity of 93.1%. The SSQ-delirium when compared to CAM diagnosis had sensitivity of 76.9% and a specificity of 56.1%. CONCLUSIONS: These findings show promise for use of an informant single screening question tool as the first step in detection of dementia in older people in acute hospital care, although this approach appears to be less accurate in screening for delirium.

A smartphone-based test for the assessment of attention deficits in delirium: A case-control diagnostic test accuracy study in older hospitalised patients.

BACKGROUND: Delirium is a common and serious acute neuropsychiatric syndrome which is often missed in routine clinical care. Inattention is the core cognitive feature. Diagnostic test accuracy (including cut-points) of a smartphone Delirium App (DelApp) for assessing attention deficits was assessed in older hospital inpatients. METHODS: This was a case-control study of hospitalised patients aged ≥65 years with delirium (with or without pre-existing cognitive impairment), who were compared to patients with dementia without delirium, and patients without cognitive impairment. Reference standard delirium assessment, which included a neuropsychological test battery, was based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria. A separate blinded assessor administered the DelApp arousal assessment (score 0-4) and attention task (0-6) yielding an overall score of 0 to 10 (lower scores indicate poorer performance). Analyses included receiver operating characteristic curves and sensitivity and specificity. Optimal cut-points for delirium detection were determined using Youden's index. RESULTS: A total of 187 patients were recruited, mean age 83.8 (range 67-98) years, 152 (81%) women; n = 61 with delirium; n = 61 with dementia without delirium; and n = 65 without cognitive impairment. Patients with delirium performed poorly on the DelApp (median score = 4/10; inter-quartile range 3.0, 5.5) compared to patients with dementia (9.0; 5.5, 10.0) and those without cognitive impairment (10.0; 10.0, 10.0). Area under the curve for detecting delirium was 0.89 (95% Confidence Interval 0.84, 0.94). At an optimal cut-point of ≤8, sensitivity was 91.7% (84.7%, 98.7%) and specificity 74.2% (66.5%, 81.9%) for discriminating delirium from the other groups. Specificity was 68.3% (56.6%, 80.1%) for discriminating delirium from dementia (cut-point ≤6). CONCLUSION: Patients with delirium (with or without pre-existing cognitive impairment) perform poorly on the DelApp compared to patients with dementia and those without cognitive impairment. A cut-point of ≤8/10 is suggested as having optimal sensitivity and specificity. The DelApp is a promising tool for assessment of attention deficits associated with delirium in older hospitalised adults, many of whom have prior cognitive impairment, and should be further validated in representative patient cohorts.