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Cited by 192Dementia and Cognitive Impairment ResearchFamily Caregiving in Mental IllnessNursing care and research

START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia

Open access
Livingston, Gill, Barber, Julie, Rapaport, Penny, Knapp, Martin, Griffin, Mark, Romeo, Renee, King, Derek, Livingston, Debbie +5 more·2014·Health Technology Assessment
DOI 10.3310/hta18610PMC PMC4781467
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Abstract

Background: Two-thirds of people with dementia live at home, receiving most care from family carers, about 40% of whom have clinically significant depression or anxiety. This impacts on the person with dementia, families and society, predicting care breakdown. There are currently no clinically effective and cost-effective NHS family carer interventions. Objectives: To assess the STrAtegies for RelaTives (START) intervention in the short (4 and 8 months) and long term (1 and 2 years) compared with treatment as usual (TAU). Design: Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2 : 1 (intervention to TAU) to allow for therapist clustering. Setting: Three UK mental health services and one neurological service. Participants: Family carers of people with dementia. Intervention: Eight-session manual-based coping intervention delivered by supervised psychology graduates to individuals. Main outcome measures: Affective symptoms [Hospital Anxiety and Depression Scale-total (HADS-T)] and cost-effectiveness. Secondary measures: anxiety and depression symptoms and caseness, quality of life (QoL), abusive behaviour and long-term care home admission. Results: Two hundred and sixty participants were randomised (173 intervention, 87 TAU). We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU). In the short term, the intervention group had lower HADS-T [mean difference –1.80, 95% confidence interval (CI) –3.29 to –0.31; p = 0.02] and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI –0.01 to 0.08). Costs were no different between groups [mean £252 (95% CI –£28 to £565) for intervention group]. The cost-effectiveness acceptability curve showed a greater than 99% chance of being cost-effectiveness at a £30,000/QALY willingness-to-pay threshold and a high probability of cost-effectiveness based on the HADS-T score. Carers in the intervention group had less case-level depression [odds ratio (OR) 0.24, 95% CI 0.07 to 0.76], a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05), lower Hospital Anxiety and Depression Scale-anxiety (HADS-A) (–0.91, 95% CI –1.76 to –0.07; p = 0.03) and Hospital Anxiety and Depression Scale-depression (HADS-D) (–0.91, 95% CI –1.71 to –0.10; p = 0.03) and higher Health Status Questionnaire (HSQ) QoL (mean difference 4.09, 95% CI 0.34 to 7.83). Group differences in abusive behaviour (OR 0.48, 95% CI 0.18 to 1.27) and the person with dementia’s quality of life-Alzheimer’s disease (QoL-AD) (mean increase 0.59, 95% CI –0.72 to 1.89) were not significant. In the long term, the intervention group had lower HADS-T (mean difference –2.58, 95% CI –4.26 to –0.90; p = 0.03) and higher QALYs (mean difference 0.03, 95% CI –0.01 to 0.06). Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53), a trend towards reduced case-level anxiety (OR 0.57, 95% CI 0.26 to 1.24), lower HADS-A (–1.16, 95% CI –2.15 to –0.18) and HADS-D (1.45, 95% CI –2.32 to –0.57), and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08). Thirty-two (18.7%) people with dementia in the intervention group and 17 (20.2%) in TAU were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p = 0.56). There were no significant differences between groups in abusive behaviour (OR 0.83, 95% CI 0.36 to 1.94), the person with dementia’s QoL-AD (0.17, 95% CI –1.37 to 1.70) or costs (£336, 95% CI –£223 to £895) for intervention group. The probability that the intervention would be seen as cost-effective at £30,000/QALY threshold and cost-effectiveness on the HADS-T remained high. Conclusions: The START intervention was clinically effective and cost-effective in the short and longer term. The results are robust to the sensitivity analyses performed. Future work is needed to consider mechanism of action; the effects on people with dementia in clinical terms (cognition, neuropsychiatric symptoms, longer-term care home admission); and on health and social care costs. In addition, we will explore the effects of carer abusive behaviour on the care recipient’s care home admission and if this then reduces abusive behaviour. We would also like to implement START and evaluate this implementation in clinical practice. Trial registration: Current Controlled Trials ISCTRN70017938. Funding: The National Institute for Health Research Health Technology Assessment programme.

AI snapshot

Written from the paper’s full text.

TL;DR

The START pragmatic RCT found that an eight-session manual-based coping intervention delivered by supervised psychology graduates to family carers of people with dementia improved carer affective symptoms and quality of life compared with treatment as usual in the short term (8 months) and long term (2 years). The intervention had a high probability of being cost-effective in the short term, with weaker evidence at 24 months, and did not significantly affect care home admission, abusive behaviour, or the care recipient’s quality of life.

Key findings

  • Among 260 randomised carers (173 intervention, 87 TAU), the intervention group had lower HADS-T scores at 8 months (adjusted mean difference –1.80, 95% CI –3.29 to –0.31; p=0.02) and at 24 months (–2.58, 95% CI –4.26 to –0.90).
  • Case-level depression was less likely in the intervention group at 8 months (OR 0.24, 95% CI 0.07 to 0.76) and at 24 months (OR 0.14, 95% CI 0.04 to 0.53); case-level anxiety showed a trend at both points (OR 0.30, 95% CI 0.08 to 1.05; OR 0.57, 95% CI 0.26 to 1.24).
  • Carer HSQ mental health scores were higher in the intervention group at 8 months (mean difference 4.09, 95% CI 0.34 to 7.83) and 24 months (7.47, 95% CI 2.87 to 12.08); QALY gains were 0.03 in both periods.
  • Costs did not differ significantly between groups (8 months: £252, 95% CI –£28 to £565; 24 months: £336, 95% CI –£223 to £895); the probability of cost-effectiveness at £30,000/QALY was >99% at 8 months and 75% at 24 months. Care home admission occurred in 32/171 (18.7%) intervention vs 17/84 (20.2%) TAU (HR 0.83, 95% CI 0.44 to 1.56; p=0.56).

Methods

  • Pragmatic, parallel-group, superiority randomised controlled trial with blinded outcome assessment, recruiting carers 2:1 to intervention versus treatment as usual to allow for therapist clustering; participants were family carers of people with dementia referred to three UK mental health services and one neurological service.
  • The intervention was an eight-session manual-based individual coping strategy programme adapted from the US “Coping with Caregiving” programme and delivered by supervised psychology graduates; adherence was defined as attending five or more sessions, achieved by 130/173 (75.1%).
  • Primary outcome was HADS-T; cost-effectiveness used CSRI and EQ-5D QALYs. Intention-to-treat analyses used multilevel mixed models accounting for repeated measures and therapist clustering, adjusted for baseline HADS-T, centre, carer age, sex, NPI and Zarit scores; economic analyses used ICERs, CEACs and net monetary benefit from a health and social care perspective, with 3.5% discounting.

Limitations

  • The paper states the study was powered for clinical effectiveness, not costs or cost-effectiveness; the economic evaluation took a health and social care perspective and did not measure costs of services used by people with dementia or attach monetary values to carers’ time.
  • The paper notes that translation of the manual was not fully resourced, making effects of delivery through translators difficult to determine; it could not assess how many sessions were necessary for change; and there were no data beyond 2 years.
  • The paper acknowledges possible bias because carers knew their allocation and the statistical team knew the intervention group was larger; TAU may have been improved by informing clinical teams about abusive behaviour in the control group. The text also makes evident that economic analyses used complete cases without imputation, and the trial was not powered for care home admission or abusive behaviour outcomes.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.3310/hta18610

Cites

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Statistics

Nothing to recompute.

Claims the paper makes

0 of 62 cited sources checked · 0 supported · 0 flagged

  • Findingown data
    § Abstract

    In the short term, there was a trend towards reduced case-level anxiety in the intervention group compared with TAU (OR 0.30, 95% CI 0.08 to 1.05).

    “a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05)”
    Quote in the paperNot a substantial claim
  • Findingown data
    § Abstract

    In the short term, there was a high probability of cost-effectiveness based on the HADS-T score.

    “and a high probability of cost-effectiveness based on the HADS-T score.”
    Quote in the paperSubstantial claim
  • Findingown data
    § Abstract

    In the short term, costs were no different between intervention and TAU groups (mean £252, 95% CI -£28 to £565 for intervention group).

    “Costs were no different between groups [mean £252 (95% CI –£28 to £565) for intervention group].”
    Quote in the paperSubstantial claim
  • Findingown data
    § Abstract

    In the short term, the intervention group had higher QALYs than TAU (mean difference 0.03, 95% CI -0.01 to 0.08).

    “and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI –0.01 to 0.08)”
    Quote in the paperSubstantial claim
  • Findingown data
    § Abstract

    In the short term (up to 8 months), the intervention group had lower HADS-T than TAU (mean difference -1.80, 95% CI -3.29 to -0.31; p=0.02).

    “In the short term, the intervention group had lower HADS-T [mean difference –1.80, 95% confidence interval (CI) –3.29 to –0.31; p= 0.02]”
    Quote in the paperSubstantial claim
  • May combine two claims. 117
  • The quote only partly states this claim. 27
  • Classified as probably not a substantial claim. 90

  • May combine two claims.

    Findingown data
    § Abstract

    In the long term, the probability that the intervention would be seen as cost-effective at £30,000/QALY threshold and cost-effectiveness on the HADS-T remained high.

    “The probability that the intervention would be seen as cost-effective at £30,000/QALY threshold and cost-effectiveness on the HADS-T remained high.”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data
    § Abstract

    In the long term, the intervention group had higher HSQ than TAU (mean difference 7.47, 95% CI 2.87 to 12.08).

    “and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08)”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data
    § Abstract

    In the long term, carers in the intervention group had less case-level depression than TAU (OR 0.14, 95% CI 0.04 to 0.53).

    “Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53)”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § Results

    260 (55%) of 472 referred carers were randomised.

    “We randomised 260 (55%) of 472 carers referred.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data
    § Results

    Adherence did not differ by age or work situation.

    “Adherence did not differ by age [aged < 60 years, 75 (77%) vs. 55 (73%)] or work situation [paid work 49 (78%) vs. other 81 (74%)].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § Results

    Adherence was better in male carers than in female carers (81% vs 72%).

    “in male carers than in female carers [46 (81%) vs. 84 (72%)]”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § Results

    Adherence was better in those with at least A-level education than in those with a lower level of education (80% vs 72%).

    “and in those with at least A-level education than in those with a lower level of education [56 (80%) vs. 74 (72%)].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data
    § Results

    173 (67%) participants were randomised to the intervention and 87 to TAU.

    “We randomised 173 (67%) participants to the intervention and 87 to TAU.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § Results

    Adherence was better in those of white ethnicity than in other ethnic groups (78% vs 61%).

    “Adherence was better in those of white ethnicity than in other ethnic groups [110 (78%) vs. 19 (61%)]”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § Results

    The intervention had an approximately 95% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.

    “The intervention had an approximately 95% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    The cost per QALY was £11,200 and the CEAC showed a 75% chance of cost-effectiveness at a willingness-to-pay threshold of £30,000 per QALY gained.

    “The cost per QALY was £11,200 and the CEAC showed a 75% chance of cost-effectiveness at a willingness-to-pay threshold of £30,000 per QALY gained.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    At the lower NICE threshold of £20,000, the START intervention had a 70% likelihood of being seen as cost-effective, rising to 80% at the £30,000 threshold.

    “At the lower NICE threshold of £20,000, the START intervention had a 70% likelihood of being seen as cost-effective, rising to 80% at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    The CEAC showed a >99% chance of cost-effectiveness at a willingness-to-pay threshold of £30,000 per QALY gained and a high probability of cost-effectiveness on the HADS-T.

    “The CEAC showed a > 99% chance of cost-effectiveness at a willingness-to-pay threshold of £30,000 per QALY gained and a high probability of cost-effectiveness on the HADS-T.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    The second sensitivity analysis adjusting for baseline imbalances gave similar results; mean ICER values were £5756 per additional QALY and £112 per 1-point difference in HADS-T score.

    “The second sensitivity analysis results, adjusting for baseline characteristics imbalances, were again similar. The mean ICER values were £5756 per additional QALY and £112 per 1-point difference in HADS-T score.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § Results

    In the analysis adjusting for baseline imbalances, mean ICER values were £8567 per additional QALY and £209 per 1-point difference in HADS-T score.

    “In the analysis adjusting for baseline imbalances, the mean ICER values were £8567 per additional QALY, and £209 per 1-point difference in HADS-T score.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    At the lower-bound NICE threshold of £20,000, the intervention has a 93% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.

    “At the lower-bound NICE threshold of £20,000, the intervention has a 93% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    The intervention had an approximately 67% likelihood of being seen as cost-effective, rising to 75% at the £30,000 threshold.

    “The intervention had an approximately 67% likelihood of being seen as cost-effective, rising to 75% at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    Sensitivity analyses adjusting for predictors of missingness gave similar results; mean ICER values were £5452 per additional QALY and £107 per 1-point difference in HADS-T score.

    “Sensitivity analyses adjusting for predictors of missingness gave similar results. The mean ICER values were now £5452 per additional QALY and £107 per 1-point difference in HADS-T score.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Results

    In the sensitivity analysis adjusting for missingness predictors, mean ICER values were £9767 per additional QALY and £125 per 1-point difference in HADS-T score.

    “In the sensitivity analysis adjusting for missingness predictors, the mean ICER values were £9767 per additional QALY and £125 per 1-point difference in HADS-T score.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § Results

    There was an indication of a decrease risk of admission to 24-hour care in the intervention group; 17 (20.2%) in TAU and 32 (18.7%) in intervention were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p=0.56).

    “There was an indication of a decrease risk of admission to 24-hour care in the intervention group. Seventeen participants (20.2%) in the TAU group and 32 (18.7%) in the intervention group were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p= 0.56).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § RESULTS

    Seven (4.0%) of those in the intervention group withdrew before taking part in any therapy sessions.

    “Seven (4.0%) of those in the intervention group withdrew before taking part in any therapy sessions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Those who consented were slightly more likely to be married to the care recipient than those who did not consent.

    “Those who consented were, however, slightly more likely to be married to the care recipient than those who did not consent.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § RESULTS

    Adherence was slightly better for male carers than female carers.

    “and slightly better for male carers [46 (80.7%) vs. 84 (72.4%) of female carers]”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 10 17 (9.8)

    The primary outcome (HADS-T score) was missing for 35 (13.5%) patients at 4 months and for 56 (21.5%) patients at 8 months, with a slightly higher proportion missing in the intervention group: 40 (23.0%) in the intervention group and 16 (18.0%) in the TAU group.

    “The primary outcome (HADS-T score) was missing for 35 (13.5%) patients at 4 months and for 56 (21.5%) patients at 8 months, with a slightly higher proportion missing in the intervention group: 40 (23.0%) in the intervention group and 16 (18.0%) in the TAU group.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 10 17 (9.8)

    Missingness of HADS-T score at 8 months was associated with having dependent children at home (p= 0.003), patient ethnicity (p= 0.013), patient living with carer (p= 0.002), patient relationship to carer (p= 0.011) and the COPE dysfunction score (p= 0.004).

    “for the 8-month outcome with having dependent children at home (p= 0.003), patient ethnicity (p= 0.013), patient living with carer (p= 0.002), patient relationship to carer (p= 0.011) and the COPE dysfunction score (p= 0.004).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Two hundred and sixty (55%) of the 472 carers referred were randomised to the trial.

    “Two hundred and sixty (55%) of the 472 carers referred were randomised (CIFT= 182, NELFT= 16, DRC= 35, NEPFT= 27) to the trial.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § RESULTS

    Adherence (attending five or more sessions) was better in those of white ethnicity than in those of other ethnicity.

    “Adherence (attending five or more sessions) was better in those of white ethnicity [110 (78.0%) vs. 19 (61.3%)] than in those of other ethnicity”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § RESULTS

    Adherence was slightly better for those with at least A-level education than those without.

    “and those with at least A-level education [56 (80.0%) vs. 74 (71.8%)].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § 10 17 (9.8)

    The mean fidelity score was 4.7 (SD 0.66).

    “The mean fidelity score was 4.7 (SD 0.66).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    The others declined to participate (n= 181; 38%), did not meet inclusion criteria (n= 22; 5%) or were uncontactable (n= 9; 2%).

    “The others declined to participate (n= 181; 38%), did not meet inclusion criteria (n= 22; 5%) or were uncontactable (n= 9; 2%).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data
    § RESULTS

    Adherence was similar by age group and work situation.

    “Adherence was similar by age group [aged < 60–75 years (77.3%) vs. 55 years (73.3%)] and work situation [in paid work 49 (77.8%) vs. other 81 (73.6%)].”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    Models including an interaction with time showed no evidence of a differential effect of the intervention between the 4- and 8-month time points or between the 12- and 24-month time points for HADS-A or HADS-D (p=0.99 and p=0.86, respectively).

    “Models including an interaction with time showed no evidence of a differential effect of the intervention between the 4- and 8-month time points or between the 12- and 24-month time points for HADS-A or HADS-D (p= 0.99 and p= 0.86, respectively).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 1500 2000 2500 3000 3500 4000 4500 5000

    At the lower-bound NICE threshold of £20,000, the START intervention has an approximately 95% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.

    “at the lower-bound NICE threshold of £20,000, the START intervention has an approximately 95% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § 1500 2000 2500 3000 3500 4000 4500 5000

    The mean ICER values from the second sensitivity analysis are £5756 per additional QALY and £112 per 1-point difference in HADS-T score.

    “The mean ICER values from this further analysis are £5756 per additional QALY, and £112 per 1-point difference in HADS-T score.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    Models including an interaction with time showed no evidence of a differential effect of the intervention between the 4- and 8-month time points or between the 12- and 24-month time points for HADS-T score (p=0.92) and indicated a similar long-term treatment effect.

    “Models including an interaction with time showed no evidence of a differential effect of the intervention between the 4- and 8-month time points or between the 12- and 24-month time points for HADS-T score (p= 0.92) and indicated a similar long-term treatment effect.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    Outpatient service costs over 9-12 months and 21-24 months were higher in the intervention group as participants in this group used outpatient services more frequently than those in the TAU group.

    “outpatient service costs over 9–12 months and 21–24 months were higher in the intervention group as participants in this group used outpatient services more frequently than those in the TAU group.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 28 (29.5)a

    The estimated hazard ratio for the effect of the intervention compared with TAU on time to care home admission was 0.83 (95% CI 0.44 to 1.56; p=0.56), showing no significant evidence of an effect.

    “The estimated hazard ratio (HR) was 0.83 with 95% CI 0.44 to 1.56 (p= 0.56), showing no significant evidence of an effect of the intervention compared with TAU.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: In the parametric shared frailty model for time to institutionalisation, the shared frailty follows a gamma distribution and survival times follow a Weibull distribution.

  • May combine two claims.

    Findingown data
    § 1500 2000 2500 3000 3500 4000 4500 5000

    At the lower-bound NICE threshold of £20,000, the START intervention has a 93% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.

    “At the lower-bound NICE threshold of £20,000, the START intervention has a 93% likelihood of being seen as cost-effective, rising to 98% at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data
    § 1500 2000 2500 3000 3500 4000 4500 5000

    The mean ICER values in the first sensitivity analysis were £5452 per additional QALY and £107 per 1-point difference in HADS-T score.

    “The mean ICER values are now £5452 per additional QALY and £107 per 1-point difference in HADS-T score.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § 28 (29.5)a

    Models including an interaction with time showed no evidence of a differential effect of the intervention between the 4- and 8-month time points or between the 12- and 24-month time points for either QoL-AD or HSQ mental health (p=0.24 and p=0.14, respectively).

    “Models including an interaction with time showed no evidence of a differential effect of the intervention between the 4- and 8-month time points or between the 12- and 24-month time points for either QoL-AD or HSQ mental health (p= 0.24 and p= 0.14, respectively).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 28 (29.5)a

    Of the remaining 84 in the TAU group, 17 (20.2%) were admitted to a care home, and in the intervention group, 32 (18.7%) of the remaining 171 were admitted, within the 24-month follow-up period.

    “Of the remaining 84 in the TAU group, 17 (20.2%) were admitted to a care home, and in the intervention group, 32 (18.7%) of the remaining 171 were admitted, within the 24-month follow-up period.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    Fourteen patients were admitted to a care home during the 8-month follow-up period: three (3.6%) in the TAU group and 11 (6.4%) in the intervention group.

    “Fourteen patients were admitted to a care home during the 8-month follow-up period (not included in Table 7): three (3.6%) in the TAU group and 11 (6.4%) in the intervention group.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The intervention produced significant improvements in depression and anxiety symptoms, QoL, and depression caseness.

    “This change was significant in terms of both depression and anxiety symptoms and also in QoL and depression caseness.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    There was an indication of possible reduction in the chances of being admitted to a care home but this was not significant.

    “There was an indication of possible reduction in the chances of being admitted to a care home but this was not significant.”
    Quote in the paperNot a substantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data
    § RESULTS

    In the second sensitivity analysis, at a threshold of £20,000, START had a likelihood of being seen as cost-effective of 70%, rising to 80% at £30,000.

    “At a threshold of £20,000, the START intervention has a likelihood of being seen as cost-effective of 70%, rising to 80% at the £30,000 threshold.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    Abusive behaviour reduced in both groups and there was no significant difference between them.

    “Abusive behaviour reduced in both groups and there was no significant difference between them.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    Over 24 months, carers who received the START intervention had slightly but not statistically significantly higher total costs and better, although not statistically significant, outcomes in health-related QoL (QALY) and affective symptoms (HADS-T) compared with TAU.

    “Over the 24 months, carers who received the START intervention had slightly, but not statistically significantly, higher total costs and better, although not statistically significant, differences in outcomes whether measured in terms of health-related QoL (QALY) or affective symptoms (HADS-T).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The study intervention was effective over time and acceptable to most participants.

    “Our study was effective over time and acceptable to most participants”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    In the second sensitivity analysis, START had an approximately 72% likelihood of being seen as cost-effective at £500 and remained above 82% if willingness to pay for a 1-point improvement was over £1000.

    “In this sensitivity analysis, the START intervention has an approximately 72% likelihood of being seen as cost-effective at £500 and remained above 82% if the willingness to pay for a 1-point improvement in outcome is over £1000.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    At 8 months, the intervention did not show a delay in care home admission, but at 2 years there was an indication that it may tend to delay care home admission.

    “The short-term follow-up over 8 months did not show this but at 2 years there was an indication that it may tend to delay care home admission”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    At the £20,000 per QALY threshold, the probability that START would be seen as cost-effective was 65%; at the £30,000 threshold it was 75%.

    “At the £20,000 per QALY threshold associated with NICE recommendations, the probability that the START intervention would be seen as cost-effective was 65%, and at the higher NICE threshold of £30,000 it was 75%.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    In the second sensitivity analysis, adjusting for imbalances in baseline characteristics, the findings were similar to the primary analyses; the mean ICER values were £8567 per additional QALY and £209 per 1-point difference in HADS-T score.

    “In the second sensitivity analysis adjusted for imbalances in baseline characteristics, the findings were similar to those from the primary analyses. The results are shown alongside those of the first sensitivity analysis in Table 16. The mean ICER values from this second sensitivity analysis are £8567 per additional QALY and £209 per 1-point difference in HADS-T score.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    At 8 months, those in the TAU group were four times more likely, and at 24 months five times more likely, to have clinically significant depression than the intervention group.

    “the ORs indicate that, at follow-up at 8 months, those in the TAU group were four times more likely, and at 24 months were five times more likely, to have clinically significant depression”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    In the first sensitivity analysis, START had an approximately 89% likelihood of being seen as cost-effective at £500, and the likelihood was above 95% if willingness to pay for a 1-point improvement was > £1000.

    “The START intervention has an approximately 89% likelihood of being seen as cost-effective at £500. The likelihood of cost-effectiveness is above 95% if the willingness to pay for a 1-point improvement in outcome is > £1000.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    In the first sensitivity analysis, adjusting for significant differences on demographic and clinical predictors of missing values did not alter the results; the mean ICER values were £9767 per additional QALY and £125 per 1-point difference in HADS-T score.

    “In the first sensitivity analysis, we adjusted for significant differences on demographic and clinical predictors of missing values. This analysis did not alter the results and is summarised in Table 16. The mean ICER values from this analysis are £9767 per additional QALY and £125 per 1-point difference in HADS-T score.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    This study found the minimally important difference in the HADS-T score to be 1.61 and 1.68 for the emotional function and mastery domains, respectively.

    “This study, based on consideration of an emotional function and mastery domain from a scale administered at the same times as the HADS, found the minimally important difference in the HADS-T score to be 1.61 and 1.68 for the former and latter domain, respectively.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The intervention was effective 8 months after randomisation and continued to work 2 years later.

    “The intervention was effective 8 months after randomisation and continued to work 2 years later.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    There is little evidence of harm, with withdrawal from treatment at a similar rate to withdrawal from TAU.

    “There is little evidence of harm with withdrawal from the treatment being at a similar rate to withdrawal from TAU arm”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    Incidence of clinical depression increased in the control group but not in the intervention group.

    “Incidence of clinical depression increased in the control group but not in the intervention group”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § RESULTS

    In the first sensitivity analysis, START had an approximately 67% likelihood of being seen as cost-effective at £20,000, rising to 75% at £30,000.

    “The START intervention has an approximately 67% likelihood of being seen as cost-effective at the lower bound of NICE threshold of £20,000, rising to 75% at the £30,000 threshold.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § DISCUSSION

    Most people did all the sessions, and so the numbers are small.

    “In addition, most people did all the sessions, and so the numbers are small.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation
    § DISCUSSION

    The levels of anxiety and depressive symptoms, case-level anxiety and depression, neuropsychiatric symptoms and carer abusive behaviour were slightly higher than in a recent cohort study of newly referred people with dementia.

    “The levels of anxiety and depressive symptoms, case-level anxiety and depression, neuropsychiatric symptoms and carer abusive behaviour, however, were slightly higher than in a recent cohort study of newly referred people with dementia”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [9] Cooper, 2009, The determinants of family carers’ abusive behaviour to people with dementia: results of the CARD study, J Affect Disord source

      Not checked in the free run.

    • cites [60] Cooper, 2008, The prevalence of elder abuse and neglect: a systematic review, Age Ageing source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given
    § DISCUSSION

    Carers' scores on outcome measures and burden at baseline ranged widely.

    “The carers' scores on the outcome measures and burden at baseline ranged widely.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § DISCUSSION

    High-fidelity ratings and lack of clustering by therapist were observed.

    “the high-fidelity ratings and lack of clustering by therapist”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § DISCUSSION

    The researchers saw 19 out of 173 participants in the evenings or out of hours for their intervention sessions.

    “The researchers saw 19 out of 173 participants in the evenings or out of hours for their intervention sessions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given
    § DISCUSSION

    It was difficult to deliver the therapy to people who did not speak English.

    “We found it difficult to deliver the therapy to people who did not speak English”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § DISCUSSION

    Participants were of either sex (31% male), throughout the adult age range (18-89 years) and from a range of ethnic and socioeconomic backgrounds.

    “The participants were of either sex (31% male), throughout the adult age range (18–89 years) and from a range of ethnic (around three-quarters white UK) and socioeconomic backgrounds.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § DISCUSSION

    Participants were in the main children (44%) or partners (42%) of the person with dementia.

    “Participants were in the main children (44%) or partners (42%) of the person with dementia”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, the incremental QALY gain at 24 months with 6% discounting was 0.03 (95% CI -0.01 to 0.06).

    “0.03 (–0.01 to 0.06)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, the incremental QALY gain at 24 months with 0% discounting was 0.03 (95% CI -0.01 to 0.07).

    “0.03 (–0.01 to 0.07)”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingnone given
    § DISCUSSION

    The START intervention was effective in the short and long term (2 years); there was no difference between the clinical effects at either time period.

    “The START intervention was effective in the short and long term (2 years); there was no difference between the clinical effects at either time period.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § DISCUSSION

    Neither of the hypothesized patterns (effect wearing off or increasing over time) seemed to be the case.

    “Neither of these seemed to be the case (at least alone)”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingnone given
    § DISCUSSION

    The START intervention is clinically effective in terms of carer impacts in the short term (8 months) and long term (2 years) both for mood and for QoL.

    “The START intervention is clinically effective in terms of carer impacts in the short term (8 months) and long term (2 years) both for mood and for QoL.”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    At the 24-month evaluation with 6% discounting, the incremental HADS-T change (reversed so higher scores show better outcomes) was 1.45 (95% CI -0.55 to 3.45).

    “1.45 (–0.55 to 3.45)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    At the 24-month evaluation, the incremental QALY gain was 0.03 (95% CI -0.01 to 0.06) at both 0% and 6% discounting.

    “0.03 (–0.01 to 0.06) 0.03 (–0.01 to 0.06)”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingreasoning
    § DISCUSSION

    The START intervention improved carer outcomes while not significantly increasing overall costs.

    “This cost-effectiveness advantage arises because the intervention improved carer outcomes while not significantly increasing overall costs, with the additional cost of the intervention being partly counterbalanced by a reduction in service-related costs.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § DISCUSSION

    There was no evidence of a change in the magnitude of effectiveness between 4 and 8 months, or at 12 months and 2 years.

    “This study reports carer outcomes and that there was no evidence of a change in the magnitude of effectiveness between 4 and 8 months, or at 12 months and 2 years, thus suggesting some lasting effect.”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    At the 24-month evaluation with 0% discounting, the ICER was £11,767 per QALY.

    “ICER (£ per QALY) £11,767 £10,833”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    At the 24-month evaluation with 6% discounting, the ICER was £10,833 per QALY.

    “ICER (£ per QALY) £11,767 £10,833”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    At the 24-month evaluation with 0% discounting, the incremental HADS-T change (reversed so higher scores show better outcomes) was 1.63 (95% CI -0.61 to 3.88).

    “1.63 (–0.61 to 3.88)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, at the 24-month evaluation with 6% discounting, the incremental health and social care cost with HADS-T as outcome (n=156) was £274 (95% CI -£262 to £810).

    “£274 (–£262 to £810)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, the ICER at 24 months with 0% discounting was £10,267 per QALY.

    “ICER (£ per QALY) £10,267 £9400”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the ICER at 24 months with 0% discounting was £9033 per QALY.

    “ICER (£ per QALY) £9033 £8267”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, at the 24-month evaluation with 0% discounting, the incremental health and social care cost with QALY as outcome (n=144) was £271 (95% CI -£336 to £877).

    “£271 (–£336 to £877)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the incremental HADS-T change (reversed so higher scores show better outcomes) at 24 months with 6% discounting was 1.28 (95% CI -0.90 to 3.45).

    “1.28 (–0.90 to 3.45)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the ICER at 24 months with 6% discounting was £214 per unit change on HADS-T.

    “ICER (£ per unit change on HADS-T) £203 £214”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, at the 24-month evaluation with 6% discounting, the incremental health and social care cost with HADS-T as outcome (n=156) was £245 (95% CI -£292 to £782).

    “£245 (–£292 to £782)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, the incremental HADS-T change (reversed so higher scores show better outcomes) at 24 months with 0% discounting was 2.15 (95% CI -0.06 to 4.38).

    “2.15 (–0.06 to 4.38)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the ICER at 24 months with 6% discounting was £8267 per QALY.

    “ICER (£ per QALY) £9033 £8267”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the incremental HADS-T change (reversed so higher scores show better outcomes) at 24 months with 0% discounting was 1.44 (95% CI -1.01 to 3.90).

    “1.44 (–1.01 to 3.90)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the incremental QALY gain at 24 months was 0.03 (95% CI -0.01 to 0.06) at both 0% and 6% discounting.

    “0.03 (–0.01 to 0.06) 0.03 (–0.01 to 0.06)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, at the 24-month evaluation with 0% discounting, the incremental health and social care cost with HADS-T as outcome (n=156) was £264 (95% CI -£298 to £825).

    “£264 (–£298 to £825)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, the ICER at 24 months with 6% discounting was £9400 per QALY.

    “ICER (£ per QALY) £10,267 £9400”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, at the 24-month evaluation with 0% discounting, the incremental health and social care cost with HADS-T as outcome (n=156) was £293 (95% CI -£269 to £855).

    “£293 (–£269 to £855)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for significant predictors of missing values, the incremental HADS-T change (reversed so higher scores show better outcomes) at 24 months with 6% discounting was 1.92 (95% CI -0.05 to 3.90).

    “1.92 (–0.05 to 3.90)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In the sensitivity analysis adjusting for baseline imbalances, the ICER at 24 months with 0% discounting was £203 per unit change on HADS-T.

    “ICER (£ per unit change on HADS-T) £203 £214”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § Methods

    Analyses were carried out on an intention-to-treat basis, excluding carers with missing data at both 4 and 8 months or long term.

    “Analyses were carried out on an intention-to-treat basis, but excluded carers for whom data were missing at both 4 and 8 months (short-term follow-up) or long term (12 and 24 months).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § ABSTRACT

    A computer program was used to decide randomly whether carers were in the intervention or the control group.

    “We compared it with usual treatment by using a computer program to decide randomly whether or not carers should be in the intervention or the control group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § Abstract

    The trial used intention-to-treat analysis in the short term and in the long term.

    “We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § Methods

    The trial used an online computer-generated randomisation system, stratified by trust using random permuted blocks.

    “We used an online computer-generated randomisation system, stratified by trust using random permuted blocks.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § Methods

    Sensitivity analyses were used to assess robustness of conclusions by adjusting for baseline characteristics, imbalances between randomised groups, and treatment by time interaction.

    “We used sensitivity analyses to assess our conclusions' robustness by adjusting for baseline characteristics, imbalances between randomised groups and differential effects of treatment over time (treatment by time interaction).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data
    § Abstract

    The trial was a randomised, parallel-group, superiority trial.

    “Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2 : 1 (intervention to TAU) to allow for therapist clustering.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data
    § Methods

    The analyses adjusted for baseline HADS-T score, centre, carer age, sex, burden, and care recipient neuropsychiatric symptoms.

    “We adjusted for baseline HADS-T score and centre (each trust was a centre), and for previously reported factors influencing affective symptoms (carer age, sex, burden and care recipient neuropsychiatric symptoms).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § Results

    Fidelity rating was scored for 128 out of 166 (77%) intervention participants, with mean score 4.70 (SD 0.66).

    “We scored fidelity rating for 128 out of 166 (77%) intervention participants. The mean score was 4.70 (SD 0.66).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data
    § INTRODUCTION

    Outcome assessors were blinded to randomisation status.

    “Outcome assessors were blinded to randomisation status, but it was not possible to blind study participants.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § Abstract

    The trial was registered (Current Controlled Trials ISCTRN70017938).

    “Trial registration: Current Controlled Trials ISCTRN70017938.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § Methods

    All statistical analyses followed a predefined analysis plan.

    “All statistical analyses followed a predefined analysis plan, using Stata version 11 (StataCorp LP, College Station, TX, USA) for clinical outcomes and Stata version 12 for cost-effectiveness.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Premisenone given
    § Background

    NICE recognises that quality dementia care should include psychological therapy for family carers, but recommends further research regarding cost-effectiveness.

    “The National Institute for Health and Care Excellence (NICE) recognises that quality dementia care should include psychological therapy for family carers, but recommends further research regarding cost-effectiveness.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given
    § INTRODUCTION

    The study was a randomised, parallel-group superiority trial with blinded outcome assessment, recruiting participants 2:1 to intervention and TAU to allow for therapist clustering.

    “The study is a randomised, parallel-group superiority trial, with blinded outcome assessment, recruiting participants 2 : 1 to intervention and TAU to allow for therapist clustering.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § Abstract

    Assessment was blinded.

    “Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2 : 1 (intervention to TAU) to allow for therapist clustering.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning
    § Abstract

    Participants were recruited 2:1 (intervention to TAU) to allow for therapist clustering.

    “Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2 : 1 (intervention to TAU) to allow for therapist clustering.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisenone given
    § Background

    Systematic reviews report that successful interventions to reduce carer depression have been individual rather than group, required active participation, and offered multicomponent strategies tailored to carers' individual needs.

    “Systematic reviews report successful interventions to reduce carer depression have been individual rather than group; required active participation; and offered multicomponent strategies to be tailored to carers' individual needs.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based).

    Premisenone given
    § Background

    Preliminary evidence suggests that interventions for anxiety might be effective if they include relaxation techniques and strategies to manage caring demands rather than reducing contact.

    “Preliminary evidence suggested that interventions for anxiety might be effective if they include relaxation techniques and strategies to manage caring demands rather than reducing contact.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationnone given
    § Discussion

    This was a pragmatic trial; participants were from NHS services and their diverse backgrounds suggest generalisability.

    “This was a pragmatic trial; participants were from NHS services and their diverse backgrounds suggest generalisability.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data
    § Discussion

    Although differences were small, they were clinically significant and sustained post intervention, as reflected in QoL improvements and possibly delayed care home admission.

    “Although differences were small, they were clinically significant and sustained post intervention, as reflected in QoL improvements and possibly delayed care home admission.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § Conclusion

    In the team's earlier systematic review, behavioural management and coping strategy-based interventions had been efficacious, interventions targeting individuals tended to work better than group interventions, and the minimum number of sessions of individual behaviour management shown efficacious was six.

    “We found that behavioural management and coping strategy-based interventions had been efficacious, that interventions targeting individuals tended to work better than group interventions and that the minimum number of sessions of individual behaviour management which had been shown to be efficacious was six.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [10] Selwood, 2007, Systematic review of the effect of psychological interventions on family caregivers of people with dementia, J Affective Disord source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data
    § Discussion

    The START intervention was clinically effective and cost-effective over 8 months and 2 years.

    “The START intervention was clinically effective and cost-effective over 8 months and 2 years.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: TAU from the several teaching trusts was based on NICE guidelines (good TAU).

  • May combine two claims.

    Premisecitation
    § Conclusion

    Carer psychological morbidity, in particular depression, predicts care breakdown and institutionalisation, as well as elder abuse.

    “carer psychological morbidity, in particular depression, predicts care breakdown and, therefore, institutionalisation,7,8 as well as elder abuse.9”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [7] Morris, 1988, The relationship between marital intimacy, perceived strain and depression in spouse caregivers of dementia sufferers, Br J Med Psychol source

      Not checked in the free run.

    • cites [8] Gallagher, 2011, Determinants of the desire to institutionalize in Alzheimer’s caregivers, Am J Alzheimers Dis Other Demen source

      Not checked in the free run.

    • cites [9] Cooper, 2009, The determinants of family carers’ abusive behaviour to people with dementia: results of the CARD study, J Affect Disord source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data
    § Results

    The CIs around NMB for these sensitivity analyses suggest that these findings are robust, although possibly less strong at the £30,000 threshold.

    “The CIs around NMB for these sensitivity analyses, taking into account uncertainty in the estimation, suggest that these findings are robust, although possibly less strong at the £30,000 threshold.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § Conclusion

    About 40% of family carers of people with dementia have clinically significant depression or anxiety, while others have significant psychological symptoms.

    “About 40% of family carers of people with dementia have clinically significant depression or anxiety, while others have significant psychological symptoms.5,6”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [5] Cooper, 2007, A systematic review of intervention studies about anxiety in caregivers of people with dementia, Int J Geriatr Psychiatry source

      Not checked in the free run.

    • cites [6] Mahoney, 2005, Anxiety and depression in family caregivers of people with Alzheimer disease: the LASER-AD study, Am J Geriatr Psychiatry source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Conclusion

    Specialist, individually tailored, psychological support to people with dementia and their family carers has been shown to reduce the rate of, although not necessarily the time to, care home admission in the USA, although there is no evidence in the UK.

    “Specialist, individually tailored, psychological support to people with dementia and their family carers has been shown to reduce the rate of, although not necessarily the time to, care home admission in the USA, although there is no evidence in the UK.10,11”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [10] Selwood, 2007, Systematic review of the effect of psychological interventions on family caregivers of people with dementia, J Affective Disord source

      Not checked in the free run.

    • cites [11] Spijker, 2008, Effectiveness of nonpharmacological interventions in delaying the institutionalization of patients with dementia: a meta-analysis, J Am Geriatr Soc source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § METHODS

    Researchers in the two groups carried out assessments on carers after receiving training in taking informed consent, good clinical practice and all the assessment tools being administered.

    “Researchers in the two groups carried out assessments on carers having received training in taking informed consent, good clinical practice and all the assessment tools being administered.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § METHODS

    Psychology graduates with no clinical training were employed and trained to deliver the intervention.

    “We employed and trained psychology graduates with no clinical training to deliver the intervention.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § INTRODUCTION

    There is evidence from systematic reviews that therapies individualised to the carer receiving them are most effective in delaying institutionalisation, and that individual behavioural therapies are more effective than group interventions in reducing carer morbidity.

    “There is evidence from systematic reviews that therapies individualised to the carer receiving them are most effective in delaying institutionalisation,11 and that individual behavioural therapies are more effective than group interventions in reducing carer morbidity.10”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [11] Spijker, 2008, Effectiveness of nonpharmacological interventions in delaying the institutionalization of patients with dementia: a meta-analysis, J Am Geriatr Soc source

      Not checked in the free run.

    • cites [10] Selwood, 2007, Systematic review of the effect of psychological interventions on family caregivers of people with dementia, J Affective Disord source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning
    § METHODS

    The psychology graduates were provided with specific training in how to respond to any risks disclosed by carers.

    “The psychology graduates were provided with specific training in how to respond to any risks disclosed by carers”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § METHODS

    The manual was piloted by the research assistants trying it with PR, GL, CC, DL and each other, and altered whenever it did not flow, or was unclear or repetitive.

    “We piloted the manual by the research assistants trying it with PR, GL, CC, DL and each other, and altered it whenever it did not flow, or was unclear or repetitive.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § Conclusion

    The Coping with Caregiving programme was developed in the USA as a group intervention; it is a manual-based psychological intervention delivered in weekly group sessions.

    “The Coping with Caregiving programme16,17 was developed in the USA as a group intervention. It is a manual-based, psychological intervention delivered in weekly group sessions.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [16] Coon, 2003, Anger and depression management: psychoeducational skill training interventions for women caregivers of a relative with dementia, Gerontologist source

      Not checked in the free run.

    • cites [17] Gallagher-Thompson, 2001, A psychoeducational intervention to reduce distress in Hispanic family caregivers, Clin Gerontol source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § METHODS

    The largest validation study of HADS in community samples included 6163 participants, more than five times the sum of the other validation studies, and includes random samples of adults throughout the age group and groups of people with psychiatric and physical illnesses.

    “The largest of these included 6163 participants, more than five times the sum of the other validation studies and includes random samples of adults throughout the age group and groups of people with psychiatric and physical illnesses.34”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [34] Spinhoven, 1997, A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects, Psychol Med source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisenone given
    § METHODS

    Individual therapy can be tailored to the specific problems faced by the carer.

    “Individual therapy also has the advantage that it can be tailored to the specific problems faced by the carer”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § Conclusion

    Education about dementia by itself, group behavioural therapy and supportive therapy were not effective carer interventions.

    “Education about dementia by itself, group behavioural therapy and supportive therapy were not effective carer interventions.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [10] Selwood, 2007, Systematic review of the effect of psychological interventions on family caregivers of people with dementia, J Affective Disord source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Conclusion

    There is some evidence that carer support can reduce institutionalisation and that therapies such as the Coping with Caregiving programme, which include problem-solving strategies and offer carers a choice of support strategies tailored to individual needs, are most effective.

    “a recent systematic review finds that there is some evidence that carer support can reduce institutionalisation and that therapies such as the Coping with Caregiving programme, which include problem-solving strategies and offer carers a choice of support strategies which can be tailored to their individual needs, are most effective.11”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] Spijker, 2008, Effectiveness of nonpharmacological interventions in delaying the institutionalization of patients with dementia: a meta-analysis, J Am Geriatr Soc source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § METHODS

    Fidelity scores were not high for 7 out of the 131 recorded sessions.

    “This was the case for 7 out of the 131 recorded sessions”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § METHODS

    Clinical supervision was provided by a clinical psychologist to each of the two teams for 1.5 hours of group supervision fortnightly.

    “Our clinical psychologist, PR, met with each of the two teams (of three or four psychology assistants) for 1.5 hours of group supervision a fortnight.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § METHODS

    Sessions were practised with each other to ensure that all researchers had the same understanding of how to deliver the therapy.

    “Sessions were practised with each other to ensure that all researchers had the same understanding of how to deliver the therapy.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data
    § INTRODUCTION

    The assessment team was not informed of the outcome of randomisation.

    “The trial manager told the intervention team (B if the assessment team was A or vice versa) the result, but the assessment team was not informed of the outcome of randomisation.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Premisereasoning
    § METHODS

    Individual therapies are quicker to deliver than group therapies because in groups time is needed for all group members' problems to be discussed.

    “Individual therapies are quicker to deliver, as, in groups, time is needed for all group members' problems to be discussed”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisenone given
    § Conclusion

    There are no manual-based therapies currently available for dementia carers in the NHS, nor an evidence base for delivering standardised psychological interventions within NHS services.

    “there are no manual-based therapies currently available for dementia carers in the NHS, nor is there an evidence base to demonstrate whether or not such standardised psychological interventions can be realistically, effectively and economically delivered to family carers within NHS services.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § Conclusion

    In the Resources for Enhancing Alzheimer's Caregiver Health project, depression scores were significantly decreased in treatment groups compared with controls in all of the studies and self-efficacy scores were increased.

    “depression scores were significantly decreased in treatment groups compared with controls in all of the studies16–19 and self-efficacy scores were increased.18”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [16] Coon, 2003, Anger and depression management: psychoeducational skill training interventions for women caregivers of a relative with dementia, Gerontologist source

      Not checked in the free run.

    • cites [17] Gallagher-Thompson, 2001, A psychoeducational intervention to reduce distress in Hispanic family caregivers, Clin Gerontol source

      Not checked in the free run.

    • cites [18] Steffen, 2000, Anger management for dementia caregivers: a preliminary study using video and telephone interventions, Behav Ther source

      Not checked in the free run.

    • cites [19] Gallagher-Thompson, 2003, Change in indices of distress among Latino and Anglo female caregivers of elderly relatives with dementia: site-specific results from the REACH national collaborative study, Gerontologist source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given
    § METHODS

    Therapists were trained to adhere to the manual and required to demonstrate, by role-play, competence in delivering each session of the intervention.

    “We trained therapists to adhere to the manual and required them to demonstrate, by role-play, competence in delivering each session of the intervention.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisenone given
    § METHODS

    Carers face difficulties in attending a group intervention because it can be impossible to make alternative care arrangements for their relative and to be available at a prespecified time.

    “Carers face difficulties in attending a group intervention, as it can be impossible to make alternative care arrangements for their relative and to be available at a prespecified time.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § METHODS

    The Hospital Anxiety and Depression Scale (HADS) is validated for all age groups and settings, in people who are physically well or ill, and in Asian and African ethnic groups.

    “The Hospital Anxiety and Depression Scale (HADS)32 is a self-complete scale, and is validated for all age groups and settings, in people who are physically well or ill, and in Asian and African ethnic groups.33”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [32] Zigmond, 1983, The hospital anxiety and depression scale, Acta Psychiatr Scand source

      Not checked in the free run.

    • cites [33] Bjelland, 2002, The validity of the Hospital Anxiety and Depression Scale. An updated literature review, J Psychosom Res source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § METHODS

    Fidelity to the manualised intervention was monitored by recording one randomly selected session per participant and rating it against a checklist by a therapist not involved in that participant's intervention.

    “The session to be recorded was selected at random by the trial manager using a Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) formula before any interventions were carried out. This session was rated for fidelity to the manual by a therapist in the same team who was not involved in that participant's intervention using the standard checklist.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § METHODS

    The Neuropsychiatric Inventory (NPI) is a validated instrument with 12 symptom domains that are scored for their severity and frequency and summarised as a single continuous score, with higher scores indicating worse symptoms.

    “The Neuropsychiatric Inventory (NPI).42 The NPI is a validated instrument with 12 symptom domains that are scored for their severity and frequency and summarised as a single continuous score (higher scores indicating worse symptoms).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [42] Cummings, 1994, The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia, Neurology source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    The study was originally powered for a primary outcome of HADS-A score based on data from a cross-sectional pilot study of family carers.

    “This study was originally powered for a primary outcome of HADS-A score based on data from a cross-sectional pilot study of family carers.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § METHODS

    The Health Status Questionnaire (HSQ) mental health domain measures health-related quality of life throughout the age range, is sensitive to change and has been validated in older and younger people.

    “The Health Status Questionnaire (HSQ)38 mental health domain measures health-related QoL throughout the age range, is sensitive to change and has been validated in older and younger people.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [38] Pettit, 2001, Validation and normative data of health status measures in older people: the Islington study, Int J Geriatr Psychiatry source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § METHODS

    The Zarit Burden Interview is the most consistently used measure of carer burden.

    “The Zarit Burden Interview is a 22-item self-report questionnaire and is the most consistently used measure of carer burden;35”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [35] Zarit, 1980, Relatives of the impaired elderly: correlates of feelings of burden, Gerontologist source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    All analyses were carried out by intention to treat, but carers with data missing at both 4- and 8-month follow-up were excluded from the short-term analysis.

    “All analyses were carried out by intention to treat, but we excluded. in the short term. carers who had data missing at both 4- and 8-month follow-up and, in the longer term, those with data missing at the 12- and 24-month follow-up.”
    Quote in the paperNot a substantial claim
    • The authors state this as an assumption: Missing outcome data are missing at random.

  • Classified as probably not a substantial claim.

    Premisenone given
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    A decrease of 2 points in mean HADS-A score and a 0.5 change in SD was considered to be clinically significant (expert consensus).

    “A decrease of 2 points in mean score and a 0.5 change in SD was considered to be clinically significant (expert consensus).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § METHODS

    The Modified Conflict Tactic Score (MCTS) has been validated for use in family carers of people with dementia.

    “This scale has been validated for use in family carers of people with dementia.37”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [37] Cooper, 2009, The sensitivity and specificity of the Modified Conflict Tactics Scale for detecting clinically significant elder abuse, Int Psychogeriatr source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductreasoning
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    To detect such a difference, with 90% power at 5% significance level, 75 participants per group were required.

    “To detect such a difference, with 90% power at 5% significance level, 75 participants per group were required.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Based on these calculations and inflating for 20% attrition, the planned recruitment was 90 participants in the TAU group and 168 participants in the intervention group.

    “Based on these calculations and inflating for 20% attrition, we planned to recruit 90 participants in the TAU group (no clustering) and 168 participants in the intervention group (clustering).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    With the available sample size, there is 80% power to detect a difference of 2.4 points on the HADS-T and 90% power to detect a 2.7-point difference.

    “Based on these values, with the available sample size we have 80% power to detect a difference of 2.4 points on the HADS-T and 90% power to detect a 2.7-point difference, both consistent with differences considered to be clinically important.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Model assumptions were examined by checking normality of residuals and plotting residuals against fitted values at individual and therapist cluster level, and these plots did not indicate concerns about model fit.

    “Model assumptions were examined by checking the normality of the residuals and also plotting the residuals compared with the fitted values both at the individual and therapist cluster level.”
    • Also stated in: § RESULTS · plain
      “These plots are shown in Figure 3 and do not indicate concerns about the model fit.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Two sensitivity analyses were conducted to assess the robustness of results.

    “Two sensitivity analyses were conducted to assess the robustness of our results.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    We did not collect service use data during the period between 12- and 21-month data collection time points; costs during this period were interpolated from 12- and 24-month data.

    “We did not collect service use data during the period between the 12- and 21-month data collection time points (on average 8 months). Costs during this period were interpolated from the 12- and 24-month data.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    All economic analyses were conducted on an intention-to-treat basis; carers were excluded if data were missing at both 4 and 8 months for the 1-8-month economic analysis, and for the 1-24-month economic analysis, carers were excluded if data were missing at 4, 8 and 24 months.

    “All analyses were conducted on an intention-to-treat basis; carers were excluded if data were missing at both 4 and 8 months for the 1–8-month economic analysis, and, for the 1–24-month economic analysis, carers were excluded if data were missing at 4, 8 and 24 months.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: Missing outcome data are missing at random.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Sensitivity analyses were used to reanalyse outcomes in various ways to assess robustness of conclusions.

    “Sensitivity analyses were used to reanalyse the outcomes in various ways to assess robustness of our conclusions.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductreasoning
    § 3. carer (HSQ mental health45) and care recipient (QoL-AD43) QoL

    Because estimation of QALYs requires data at each time point, only complete cases were included in the cost-effectiveness analysis, and no imputation was conducted.

    “Because the estimation of QALYs requires data at each time point, only complete cases were included in the cost-effectiveness analysis. No imputation was conducted.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: Missing outcome data are missing at random.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § RESULTS

    Fidelity rating was carried out for 128 (78%) of the 165 participants who received one or more intervention(s).

    “Fidelity rating was carried out for 128 (78%) of the 165 participants who received one or more intervention(s).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § 40 (33.3%)

    Treatment effect estimates (differences and odds ratios) are from models that take into account repeated measurements, therapist clustering in the intervention arm, and are adjusted for baseline characteristics.

    “Treatment effect estimates (differences and odds ratios) are from models which take into account the repeated measurements, therapist clustering in the intervention arm and which are adjusted for baseline characteristics.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data
    § RESULTS

    Double rating for the first 13 participants had a Cohen's kappa value of 0.77, which is substantial agreement.

    “Double rating was carried out for the first 13 participants; these had a Cohen's kappa value of 0.77, which is substantial agreement.52”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [52] Landis, 1977, The measurement of observer agreement for categorical data, Biometrics source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § RESULTS

    Model assumptions were examined by checking plots assessing the normality of residuals and plotting residuals versus fitted values at both individual and therapist cluster level; these plots did not indicate concerns about the model fit.

    “Model assumptions were examined by checking plots assessing the normality of the residuals and also plotting residuals versus fitted values. These were done for residuals at both the individual and the therapist cluster level. These plots did not indicate concerns about the model fit.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § RESULTS

    The therapist ICC at 12 months was 0.00 (95% CI 0.00 to 0.07) and at 24 months was 0.00 (95% CI 0.00 to 0.07).

    “The therapist ICC at 12 months was 0.00 (95% CI 0.00 to 0.07) and at 24 months was 0.00 (95% CI 0.00 to 0.07).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § 1500 2000 2500 3000 3500 4000 4500 5000

    The first sensitivity analysis adjusted for significant baseline differences on demographic and clinical predictors of missing values, and the results were similar to those from the primary analyses.

    “The first sensitivity analysis adjusted for significant baseline differences on demographic and clinical predictors of missing values. The results were similar to those from the primary analyses and are summarised in the first column of figures in Table 10.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § 1500 2000 2500 3000 3500 4000 4500 5000

    The second sensitivity analysis adjusted for imbalances in baseline characteristics, and the results were again quite similar to those from the primary analyses.

    “The second sensitivity analysis adjusted for imbalances in baseline characteristics. The results were again quite similar to those from the primary analyses and are summarised in the second column of figures in Table 11.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § RESULTS

    The primary outcome (HADS-T score) was missing for 55 (21.2%) patients at 12 months and for 64 (24.6%) patients at 24 months.

    “The primary outcome (HADS-T score) was missing for 55 (21.2%) patients at 12 months and for 64 (24.6%) patients at 24 months.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    Outcome measures were carefully considered for validity.

    “outcome measures were carefully considered for validity”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The study was designed as a pragmatic study with broad inclusion criteria and followed Medical Research Council guidance on the evaluation of a complex intervention.

    “This was designed as a pragmatic study with broad inclusion criteria and followed closely the Medical Research Council guidance on the evaluation of a complex intervention.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    An economic evaluation was conducted.

    “and an economic evaluation was conducted”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The clustering of therapists was accounted for in the analysis.

    “The clustering of therapists was accounted for by the analysis”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    Previous studies of information and advice to people with dementia and their families have suggested that this can improve the patient's QoL but not the carer's psychological symptoms, and an intervention targeted at the carer may not help the person with dementia to the same extent.

    “Previous studies of information and advice to people with dementia and their families have suggested this can improve the patient's QoL but not the carer's psychological symptoms and an intervention which is targeted at the carer may not help the person with dementia to the same extent.55”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [55] Corbett, 2012, Systematic review of services providing information and/or advice to people with dementia and/or their caregivers, Int J Geriatr Psychiatry source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The global QoL measure used, which considers finance, housing and physical health in addition to well-being, may have made it less likely to change.

    “However, QoL is a complex phenomenon and the measure we used is a global one, thus considering finance, housing and physical health in addition to well-being, and this may have made it less likely to change.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationcitation
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The effect size for total mean affective symptoms was small, but previous evidence suggests that treatment effects are in the range that is important to patients.

    “The effect size in terms of the total mean affective symptoms was small, but previous evidence from studies in which researchers set out to calculate what a clinically important difference in the HADS would be suggests that treatment effects are in the range that is important to patients.54”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [54] Puhan, 2008, The minimal important difference of the hospital anxiety and depression scale in patients with chronic obstructive pulmonary disease, Health Qual Life Outcomes source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    Family carers inevitably knew which group they were in.

    “the family carers inevitably knew which group they were in.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationreasoning
    § DISCUSSION

    Our intervention is more practical for many carers because we did not require them all to come to a group at the same time.

    “but we judge that our intervention is more practical for many carers as we did not require them all to come to a group at the same time.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § DISCUSSION

    Follow-up rate was 88.1% overall at 8 months with similar rates in both arms.

    “There was a very satisfactory follow-up rate of 88.1% overall at 8 months with similar rates in both arms.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning
    § DISCUSSION

    The study informed clinical teams about abusive behaviour of carers in the TAU group, which may have improved the outcome for TAU.

    “We did, however, inform the clinical teams about abusive behaviour of the carers in the TAU group when there was no intervention in place and, thus, may have improved the outcome for the TAU.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The impact of different numbers of sessions on carers' outcomes was not the focus of this study.

    “the impact that different numbers of sessions might have had on carers' outcomes was not the focus of this study.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The statistical team were aware that the intervention group was the larger group.

    “the statistical team were aware that the intervention group was the larger group.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § DISCUSSION

    The study from which START was derived used a similar intervention and also alleviated depressive symptoms in carers.

    “The study from which we derived START uses a similar intervention and it also alleviated depressive symptoms in carers”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17] Gallagher-Thompson, 2001, A psychoeducational intervention to reduce distress in Hispanic family caregivers, Clin Gerontol source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductreasoning
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The study did not measure the costs of treatment and care services used by the individuals with dementia, nor attach monetary values to carers' time.

    “We did not, therefore, measure the costs of treatment and care services used by the individuals with dementia who were being supported by these carers, nor did we attach monetary values to the time spent by carers in providing support to their relatives.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning
    § DISCUSSION

    The intervention is generally acceptable to and the results are generally applicable to family carers around the time people present to secondary care with dementia in the UK.

    “Thus, we think that the intervention is generally acceptable to and the results are generally applicable to the family carers around the time people present to secondary care with dementia in the UK.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § DISCUSSION

    The earliest study of the three used trained ex-carers in a voluntary sector befriending intervention and was not taken up by many carers.

    “The earliest study of the three used trained ex-carers in a voluntary sector befriending intervention and was not taken up by many carers.24”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [24] Charlesworth, 2008, Befriending carers of people with dementia: randomised controlled trial, BMJ source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

    Interpretationreasoning
    § DISCUSSION

    Acceptability, as well as the theoretical background, needs to be a major focus of any intervention.

    “This suggests that acceptability, as well as the theoretical background, needs to be a major focus of any intervention.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    The evaluation was conducted from a health and social care perspective and concentrated on carer outcomes.

    “The evaluation was conducted from a health and social care perspective, and concentrated on outcomes experienced by carers.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

    Data were entered and cleaned while blind to intervention status.

    “the data were entered and cleaned while blind to intervention status”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductnone given
    § DISCUSSION

    The intervention was manual based, standardised and supervised.

    “The intervention was manual based, standardised and supervised”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Study design and conductnone given
    § DISCUSSION

    The instruments were validated and standardised.

    “The instruments were validated and standardised.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § DISCUSSION

    Ten therapist-delivered sessions of CBT over the internet were effective in reducing depression at 4 and 8 months.

    “Ten therapist-delivered sessions of CBT over the internet were effective in reducing depression at 4 and 8 months (equivalent to our short-term measures).71”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [71] Kessler, 2009, Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial, Lancet source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § DISCUSSION

    A recent structured intervention in family carers of people with stroke did not improve their mood, QoL or burden, or improve patient outcome.

    “A recent structured intervention in family carers of people with stroke with care competencies taught and assessed by nurses did not improve their mood, QoL or burden, or improve patient outcome.15”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Thompson, 2007, Systematic review of information and support interventions for caregivers of people with dementia, BMC Geriatr source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § DISCUSSION

    CBT treatment for health anxiety was effective at 6 months, 1 and 2 years with no significant increase in costs for anxiety and depression, but was ineffective in increasing health-related QoL.

    “CBT treatment for health anxiety was effective at 6 months, 1 and 2 years with no significant increase in costs for anxiety and depression, but was ineffective in increasing health-related QoL.72”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [72] Tyrer, 2013, Clinical and cost-effectiveness of cognitive–behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial, Lancet source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § DISCUSSION

    Previous research in carers had shown that interventions continue to work for an average of 7-11 months.

    “Previous research in carers had shown that interventions continue to work for an average of 7–11 months.66”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [66] Sörensen, 2006, Dementia care: mental health effects, intervention strategies, and clinical implications, Lancet Neurol source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § DISCUSSION

    That study examined the cost-effectiveness of a modular multicomponent intervention delivered in carers' homes and found a significant difference over the 6-month study period, with carers in the intervention group having more time to dedicate to activities unrelated to caregiving.

    “It examined the cost-effectiveness of a modular multicomponent intervention delivered in carers' homes, with three sessions by telephone, supplemented by five group sessions (five or six carers in each) delivered by telephone. Focusing on hours of care-giving, the authors found a significant difference over the 6-month study period, with carers in the intervention group having more time to dedicat”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [21] Nichols, 2008, The cost-effectiveness of a behavior intervention with caregivers of patients with Alzheimer’s disease, J Am Geriatr Soc source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § DISCUSSION

    A RCT of CBT as an adjuvant therapy for treatment-resistant depression was effective at the 6- and 12-month follow-up.

    “In contrast, a RCT of CBT as an adjuvant therapy for treatment-resistant depression found that it was effective at the 6- and 12-month follow-up.70”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [70] Wiles, 2013, Cognitive–behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial, Lancet source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationreasoning
    § DISCUSSION

    The content of the intervention, as well as its acceptability in terms of take-up, is important.

    “This suggests that the content of the intervention, as well as its acceptability in terms of take-up, is also important.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § DISCUSSION

    A RCT of telephone-administered psychotherapy for depressive symptoms worked over the 16 weeks it was administered, but was no longer significantly efficacious at 1 year.

    “Previous work has found that a RCT of telephone-administered psychotherapy for depressive symptoms worked over the 16 weeks it was administered, but was no longer significantly efficacious at 1 year.68”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [68] Mohr, 2005, Telephone-administered psychotherapy for depression, Arch Gen Psychiatry source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning
    § DISCUSSION

    The cost-effectiveness advantage of the START intervention arises because it improved carer outcomes without significantly increasing overall costs, with additional intervention costs partly offset by reduced service-related costs.

    “This cost-effectiveness advantage arises because the intervention improved carer outcomes while not significantly increasing overall costs, with the additional cost of the intervention being partly counterbalanced by a reduction in service-related costs.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § DISCUSSION

    72% of participants in DAISY completed the intervention according to the study's definition.

    “In contrast to the former study, 72% of participants completed the intervention according to the study's definition (attending three or more of individual and educational sessions).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [61] Waldorff, 2012, Efficacy of psychosocial intervention in patients with mild Alzheimer’s disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY), BMJ source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § DISCUSSION

    Our earlier studies have found that family carers tend to become more anxious and depressed over time without intervention, and that this is associated with an increase in abusive behaviour.

    “Our earlier studies have found that family carers tend to become more anxious and depressed over time without intervention, and that this is associated with an increase in abusive behaviour”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [63] Cooper, 2008, Coping strategies, anxiety and depression in caregivers of people with Alzheimer’s disease, Int J Geriatr Psychiatry source

      Not checked in the free run.

    • cites [64] Cooper, 2009, Abuse of people with dementia by family carers: representative cross sectional survey, BMJ source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § DISCUSSION

    A RCT of a 'coping with depression' psychoeducational group programme was effective in reducing depression at 6 months but not at 12 months.

    “Similarly, a RCT of a 'coping with depression' psychoeducational group programme, with booster session up to 4 months after the intervention had finished, was effective in reducing depression at 6 months but not at 12 months.69”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [69] Ellison, 2009, Maintenance of gains following experiential therapies for depression, J Consult Clin Psychol source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § DISCUSSION

    A recent review found some evidence that psychosocial interventions for carers of people with dementia could lead to greater improvements in outcome and also generate cost savings.

    “A recent review found some evidence that such interventions could lead to greater improvements in outcome and also generate cost savings.20”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [20] Knapp, 2013, Dementia care costs and outcomes: a systematic review, Int J Geriatr Psychiatry source

      Not checked in the free run.

201 of 201

  • The paper relies on this without support.

    About 40% of family carers of people with dementia have clinically significant depression or anxiety.

    “about 40% of whom have clinically significant depression or anxiety.”
    “About 40% of those family carers of people with dementia have clinically significant depression or anxiety”

  • The paper relies on this without support.

    Carer psychological morbidity predicts care breakdown and institutionalisation.

    “This impacts on the person with dementia, families and society, predicting care breakdown.”
    “carer psychological morbidity predicts care breakdown and, therefore, institutionalisation, as well as elder abuse.”

  • The paper relies on this without support.

    There are currently no clinically effective and cost-effective NHS family carer interventions.

    “There are currently no clinically effective and cost-effective NHS family carer interventions.”

  • The paper relies on this without support.

    There are no manual-based therapies currently available for dementia carers in the NHS.

    “There are no manual-based therapies currently available for dementia carers in the NHS”

  • The paper relies on this without support.

    There is no evidence regarding whether or not standardised psychological interventions can be realistically, effectively and economically delivered to family carers within NHS services.

    “and no evidence regarding whether or not standardised psychological interventions can be realistically, effectively and economically delivered to family carers within NHS services.”

  • The paper relies on this without support.

    NICE recognises that quality dementia care should include psychological therapy for family carers.

    “The National Institute for Health and Care Excellence (NICE) recognises that quality dementia care should include psychological therapy for family carers”

  • The paper relies on this without support.

    Two-thirds of people with dementia live at home, receiving most care from family carers.

    “Two-thirds of people with dementia live at home, receiving most care from family carers”
    “Two-thirds of people with dementia live at home, with family providing most of their care.”

  • The paper relies on this without support.

    TAU from the several teaching trusts was based on NICE guidelines (good TAU).

    “We expected TAU from the several teaching trusts to be based on NICE guidelines, i.e. good 'TAU'.”

  • The paper relies on this without support.

    There are no manual-based therapies currently available for dementia carers in the NHS, nor an evidence base for delivering standardised psychological interventions within NHS services.

    “there are no manual-based therapies currently available for dementia carers in the NHS, nor is there an evidence base to demonstrate whether or not such standardised psychological interventions can be realistically, effectively and economically delivered to family carers within NHS services.”

  • The authors state this as an assumption.

    Treatment as usual (TAU) is similar to good TAU throughout the UK and based on the NICE guidelines.

    “As several teaching trusts were involved, we expected the TAU to be similar to good TAU throughout the UK and based on the NICE guidelines.31”

  • The paper relies on this without support.

    Neuropsychiatric symptoms are associated with carer psychological morbidity.

    “This was included as neuropsychiatric symptoms have been shown to be associated with carer psychological morbidity.”

  • The paper relies on this without support.

    Carers with more burden are expected to be more stressed.

    “We used it to adjust for the baseline burden on carers as those who have more burden may be expected to be more stressed.”

  • The authors state this as an assumption.

    Stress is the mismatch between primary appraisal (perceived demand) and secondary appraisal (perceived ability to cope and available resources and options).

    “In this, stress is seen as the mismatch between primary appraisal (perceived demand) and secondary appraisal (perceived ability to cope and available resources and options, and principles from CBT).”

  • The paper relies on this without support.

    Changes in the rate of admissions to 24-hour care may become more apparent over a longer time.

    “This is because changes in the rate of admissions may become more apparent over a longer time.”

  • The authors state this as an assumption.

    Missing outcome data are missing at random.

    “thus making missing at random assumptions more plausible.”

  • The authors state this as an assumption.

    In the parametric shared frailty model for time to institutionalisation, the shared frailty follows a gamma distribution and survival times follow a Weibull distribution.

    “A parametric shared frailty model assuming a gamma distribution for the shared frailty with a Weibull survival distribution was fitted for the time to institutionalisation.”

  • The paper relies on this without support.

    A minimally important clinical difference on the HADS-T is 1.6.

    “We can also refer to a previous suggestion that a minimally important clinical difference on the HADS-T is 1.6.”

  • The paper relies on this without support.

    There is no other rigorous study of an intervention delivered by psychology graduates without previous clinical training.

    “There is no other rigorous study of an intervention delivered by psychology graduates without previous clinical training, a group who are relatively available and inexpensive but with a background in understanding the concepts.”

  • The paper relies on this without support.

    We are not aware of any other interventions in this group for which health economic evaluations have been undertaken.

    “We are not aware of any other interventions in this group for which health economic evaluations have been undertaken and we discuss this below.”

  • The paper relies on this without support.

    There is a paucity of literature which considers how long it takes for a psychological intervention to work and the period for which it continues to work.

    “There is a paucity of literature which considers how long it takes for a psychological intervention to work and the period for which it continues to work.”

  • The paper relies on this without support.

    There is little previous evidence on the cost-effectiveness of psychosocial interventions for carers of people with dementia.

    “There is little previous evidence on the cost-effectiveness of psychosocial interventions for carers of people with dementia.”
21 of 21

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Five included RCTs implemented group activities; those with standard activities reduced mean agitation levels and decreased symptoms in care homes while they were in place.

    “Five of the included RCTs implemented group activities; those with standard activities reduced mean agitation levels, and decreased symptoms in care homes while they were in place. 22,23”

    From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [23]

    Split into 2 atoms — 0 confirmed, 0 partially supported, 1 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

  • In a recent trial, caregivers from the intervention group reported less but insignificant abusive behaviors toward care receipts.

    “In a recent trial, caregivers from the intervention group reported less but insignificant abusive behaviors toward care receipts [40].”

    From Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: A Study Protocol (2022) · cites this paper as [40]

  • There are no conclusive results for validation and reminiscence therapy, the effectiveness of light therapy is not clear, and aromatherapy is better than no treatment for behavioral and psychological symptoms of dementia.

    “In particular, there are no conclusive results for validation and reminiscence therapy, the effectiveness of light therapy is not clear, aromatherapy is better than no treatment.”

    From The Multidisciplinary Approach to Alzheimer’s Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment (2018) · cites this paper as [106]

  • Potential benefits of non-pharmacological treatments for behavioral and psychological symptoms of dementia have been documented, but the strength of evidence is overall low and heterogeneity in intervention type, follow-up duration, and outcome measures hampers comparison across studies.

    “Potential benefits of these interventions have been documented, but the strength of evidence is overall low and the great heterogeneity in terms of type of intervention, follow-up duration, type of outcome measures hamper comparison across studies.”

    From The Multidisciplinary Approach to Alzheimer’s Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment (2018) · cites this paper as [106]

  • The small body of evidence for massage and touch therapy suggests they could be viable treatment options, especially given the ease of implementation and minimal training involved.

    “The small body of evidence for other sensory interventions, such as massage and touch therapy, suggests they could be viable treatment options, especially given the ease of implementation and minimal training involved.”

    From The Multidisciplinary Approach to Alzheimer’s Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment (2018) · cites this paper as [106]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Table 13's 12-month outpatient percentage uses a different denominator

    Minor

    Table 13 lists 19 outpatient-service users among 67 TAU carers at 12 months, which is 28.36%, not the reported 24.7%. Other percentages in the table also do not match the stated group sizes.

    Reported 24.7 · recomputed 28.358209

  • Table 13's 24-month outpatient percentage does not match its group size

    Minor

    For the 24-month TAU group, 24 users among the stated 64 carers is 37.5%, rather than the reported 27.6%.

    Reported 27.6 · recomputed 37.5

  • Conflicting p-values for the adjusted long-term HADS-T effect

    Minor

    The abstract gives p=0.03 for the -2.58-point effect, whereas the detailed results give p=0.003 for the same estimate and confidence interval.

  • Long-term depression effect has the wrong sign in the abstract

    Minor

    The abstract reports a positive HADS-D difference of 1.45 while describing lower depression scores. The detailed results report the difference as -1.45, consistent with its entirely negative confidence interval.

  • Fidelity calculation accounts for only 118 of 128 ratings

    Minor

    The described calculation combines the first 13 participants with 105 remaining participants, accounting for 118 ratings. The section says fidelity ratings were available for 128 participants.

  • Fidelity-rating denominator differs between sections

    Minor

    The scientific summary says 166 intervention participants received sessions, while the detailed fidelity section calls this group 165. The latter section's 128 rated plus 38 not rated also totals 166.

  • Twelve-month TAU HADS-T sample size conflicts with missing-outcome count

    Minor

    Table 12 gives 64 TAU carers with a 12-month HADS-T score. Table 11 reports 20 missing among the 87 randomised TAU carers, implying 67 available scores; Table 12 also lists 67 for each HADS subscale.

  • The 78% HADS-T cost-effectiveness probability is assigned to different thresholds

    Minor

    The scientific summary assigns a 78% probability to willingness to pay of £50 per point, but the detailed results assign that probability to £500 per point. This tenfold difference changes the interpretation of the economic result.

8 of 8

Cites

Flagged first, then by citations

2 of the 68 references couldn’t be matched to a known paper.

Research works printed but not linked: 9

  1. Knapp, 2007, Dementia UK
  2. 2006, Dementia: Supporting People with Dementia and their Carers in Health and Social Care
  3. Radosevich, 1995, Twelve-Item Health Status Questionnaire: HSQ-12 Version 2.0
  4. Dolan, 1995, A Social Tariff for EuroQol: Results from a UK Population Survey
  5. 2010, National Schedule of Reference Costs 2008–09 for NHS Trusts and PCTs Combined
  6. Curtis, 2010, Unit Costs of Health and Social Care 2010
  7. 2004, Guide to the Methods of Technology Appraisal
  8. 2008, Guide to the Methods of Technology Appraisal
  9. 2008, Improving Access to Psychological Therapies Implementation Plan: National Guidelines for Regional Delivery

Cited by

Sorted by citations

Related

Authors
Livingston, G., Barber, J., Rapaport, P., Knapp, M., Griffin, M., Romeo, R., King, D., Livingston, D., Lewis-Holmes, E., Mummery, C., Walker, Z., Hoe, J., & Cooper, C.
Affiliations
  • University College London (GB)
  • King's College London (GB)
  • Institute of Psychiatry, King’s College London, London, UK
  • London School of Economics and Political Science (GB)
  • University College London Hospitals NHS Foundation Trust (GB)
Corresponding author
Livingston, Gill
ORCID
Venue
Health Technology Assessment
Publisher
National Institute for Health and Care Research
Published
2014-10
Volume
18
Issue
61
Pages
1-242
ISSN
  • 1366-5278 (ISSN-L)
  • 2046-4924
DOI
10.3310/hta18610
PMC
PMC4781467
OpenAlex
W1995140156
Semantic Scholar
23871b9bd0810a17340afc1d1e87e0646628a00a
Cited by
192
References
68
Citations by year
2026: 3 · 2025: 13 · 2024: 7 · 2023: 7 · 2022: 21 · 2021: 12 · 2020: 22 · 2019: 19 · 2018: 17 · 2017: 32 · 2016: 18 · 2015: 16 · 2014: 5
FWCI
18.06
Type
journal article
Language
en
Open access
Licence
Locations
  • Health Technology Assessment (publishedVersion, cc-by)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • London School of Economics and Political Science Research Online (London School of Economics and Political Science) (acceptedVersion)
  • City Research Online (City University London) (acceptedVersion)
  • London School of Economics and Political Science Theses Online (London School of Economics and Political Science) (acceptedVersion)
  • RePEc: Research Papers in Economics (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • UCL Discovery (University College London) (submittedVersion)
  • Research Portal (King's College London) (submittedVersion)
  • UWL Repository (University of West London) (submittedVersion)
Funders
National Institute for Health Research (08/14/06)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Social Sciences › Psychology › Clinical Psychology › Family Caregiving in Mental Illness
  • Health Sciences › Health Professions › Pharmacy › Nursing care and research
Keywords
family caregivers, dementia, coping interventions, depression, anxiety, cost-effectiveness, quality-adjusted life years, quality of life, abusive behavior
MeSH terms
Adaptation, Psychological, Aged, Aged, 80 and over, Anxiety Disorders, Cost-Benefit Analysis, Dementia, Depressive Disorder, Family, Female, United Kingdom, Humans, Male, Middle Aged, Psychotherapy, Regression Analysis, State Medicine, Caregivers, Health Care Costs, Outcome Assessment, Health Care, Quality-Adjusted Life Years

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-09.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-09.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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