The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis.

BACKGROUND: The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) is a standardized severity assessment for use in clinical trials and registries for atopic dermatitis (AD). OBJECTIVES: To investigate the reliability, validity, responsiveness and within-patient meaningful change of the vIGA-AD. METHODS: Data were analysed from adult patients with moderate-to-severe AD in the BREEZE-AD1 (N = 624 patients; NCT03334396), BREEZE-AD2 (N = 615; NCT03334422) and BREEZE-AD5 (N = 440; NCT03435081) phase III baricitinib clinical studies. RESULTS: Across studies, test-retest reliability for stable patients showed moderate-to-good agreement [range of Kappa values for Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD), 0·516-0·639; for Eczema Area and Severity Index (EASI), 0·658-0·778]. Moderate-to-large correlations between vIGA-AD and EASI or body surface area (range at baseline, 0·497-0·736; Week 16, 0·716-0·893) supported convergent validity. Known-groups validity was demonstrated vs. EASI and PGI-S-AD (vIGA-AD for severe vs. moderate EASI categories at baseline, P < 0·001). Responsiveness was demonstrated vs. EASI (P < 0·001 for much improved vs. improved and improved vs. stable). Anchor- and distribution-based methods supported a vIGA-AD change of -1·0 as clinically meaningful. These findings are limited to populations defined by the studies' inclusion and exclusion criteria. CONCLUSIONS: The vIGA-AD demonstrated sufficient reliability, validity, responsiveness and interpretation standards for use in clinical trials. What is already known about this topic? A description of the development of the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) has been published previously. What does this study add? The current study validates the vIGA-AD by demonstrating appropriate test-retest reliability, convergent validity, known-groups validity and responsiveness across three baricitinib clinical studies. In addition, a 1-point change was identified as a clinically meaningful patient-perceived change minimal clinically important difference in the vIGA-AD. What are the clinical implications of the work? The vIGA-AD is a measure for investigator assessment of atopic dermatitis suitable for use in clinical research.

Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies.

BACKGROUND: To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily Bleeding Diary (UF-DBD). Test-retest reliability, criterion, construct validity, responsiveness, missingness and comparability of the MP SAP-c v3 and UF-DBD versus the alkaline hematin (AH) method and a patient global impression of severity (PGI-S) were analyzed in post hoc trial analyses. RESULTS: Analyses were based on data from up to 756 patients. The full range of MP SAP-c v3 and UF-DBD response options were used, with score distributions reflecting the cyclic character of the disease. Test-retest reliability of MP SAP-c v3 and UF-DBD scores was supported by acceptable intraclass correlation coefficients when stability was defined by the AH method and Patient Global Impression of Severity (PGI-S) scores (0.80-0.96 and 0.42-0.94, respectively). MP SAP-c v3 and UF-DBD scores demonstrated strong and moderate-to-strong correlations with menstrual blood loss assessed by the AH method. Scores increased in monotonic fashion, with greater disease severities, defined by the AH method and PGI-S scores; differences between groups were mostly statistically significant (P < 0.05). MP SAP-c v3 and UF-DBD were sensitive to changes in disease severity, defined by the AH method and PGI-S. MP SAP-c v3 and UF-DBD showed a lower frequency of missing patient data versus the AH method, and good agreement with the AH method. CONCLUSIONS: This evidence supports the use of the MP SAP-c v3 and UF-DBD to assess clinical efficacy endpoints in UF phase III studies replacing the AH method.

Elicitation of health state utilities associated with the mode of administration of drugs acting on the prostacyclin pathway in pulmonary arterial hypertension.

INTRODUCTION: Pulmonary arterial hypertension (PAH) is a rare, incurable disease associated with decreased life expectancy and a marked impact on quality of life (QoL). There are three classes of drugs available for treatment: endothelin receptor antagonists (ERA), drugs acting on nitric oxide pathway (riociguat and phosphodiesterase type 5 inhibitors [PDE5i]), and drugs acting on prostacyclin pathway. The latter have widely different modes of administration - continuous intravenous infusion, continuous subcutaneous infusion, inhaled, and oral - each associated with variable treatment burden, and implications for health economic assessment. This study aimed to establish utility values associated with different modes of administration of drugs acting on the prostacyclin pathway for use in economic evaluations of PAH treatments. METHODS: A UK general public sample completed the EQ-5D-5L and valued four health states in time trade-off interviews. The health states drafted from literature and interviews with PAH experts (n=3) contained identical descriptions of PAH and ERA/PDE5i treatment, but differed in description of administration including oral (tablets), inhaled (nebulizer), continuous subcutaneous infusion, and continuous intravenous infusion. RESULTS: A total of 150 participants (63% female; mean age 37 years) completed interviews. Utilities are presented as values between 0 and 1, with 0 representing the state of being dead and 1 representing being in full health. The mean (SD) utility for oral health state was 0.85 (0.16), while all other health states were significantly lower at 0.74 (0.27) for inhaled (p=0.001), 0.59 (0.31) for subcutaneous (p<0.001) and 0.54 (0.32) for intravenous (p<0.001), indicating that there are disutilities (negative differences) associated with non-oral health states. Disutilities were -0.11 for inhaled, -0.26 for subcutaneous, and -0.31 for intravenous administration. CONCLUSION: The results demonstrate quantifiable QoL differences between modes of administration of drugs acting on the prostacyclin pathway. QoL burden should be considered for economic evaluation of drugs for PAH treatment.

Evaluation and quantification of treatment preferences for patients with asthma or COPD using discrete choice experiment surveys.

INTRODUCTION: To investigate treatment preferences of patients with asthma or chronic obstructive pulmonary disease (COPD), previously identified influential treatment factors were used to develop a discrete choice experiment (DCE) survey. METHODS: An internet-based survey was conducted with UK-resident adults (recruited using a commercial panel) who were currently receiving asthma/COPD treatment and had not taken part in the previous phase of this study (qualitative interviews to understand patient burden, life impact and treatment preferences). Participants ranked treatment attributes from 0 (extremely important) to 8 (not at all important) and chose between hypothetical treatments for asthma/COPD with differing attributes. Preferences for each condition were assessed separately using a mixed logit regression model. RESULTS: Most of the 302 participants had not well-controlled asthma (Asthma Control Test™ scores ≤19/25) or experienced a high impact of COPD (COPD Assessment Test™ scores >20/40). Participant views were generally similar for both conditions; having well-controlled symptoms all day was considered most important. All treatment attributes significantly influenced preferences; the most preferred were no sleep disturbance (versus waking up often) and low cost. Subsequent preferences (with some variation between asthma/COPD) were for treatments with easy/convenient use, no flare ups/exacerbations, that enabled desired physical activities, well-controlled symptoms all day, that enabled desired social activities, and low medication frequency. CONCLUSIONS: These eight treatment attributes, valued by patients with asthma or COPD, are important for healthcare professionals to consider regarding treatment options and for future therapy development. Our DCE results broadly reinforce the findings from qualitative interviews in the first study phase.

Early discharge hospital at home.

BACKGROUND: Early discharge hospital at home is a service that provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care. This is an update of a Cochrane review. OBJECTIVES: To determine the effectiveness and cost of managing patients with early discharge hospital at home compared with inpatient hospital care. SEARCH METHODS: We searched the following databases to 9 January 2017: the Cochrane Effective Practice and Organisation of Care Group (EPOC) register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and EconLit. We searched clinical trials registries. SELECTION CRITERIA: Randomised trials comparing early discharge hospital at home with acute hospital inpatient care for adults. We excluded obstetric, paediatric and mental health hospital at home schemes.   DATA COLLECTION AND ANALYSIS: We followed the standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the body of evidence for the most important outcomes. MAIN RESULTS: We included 32 trials (N = 4746), six of them new for this update, mainly conducted in high-income countries. We judged most of the studies to have a low or unclear risk of bias. The intervention was delivered by hospital outreach services (17 trials), community-based services (11 trials), and was co-ordinated by a hospital-based stroke team or physician in conjunction with community-based services in four trials.Studies recruiting people recovering from strokeEarly discharge hospital at home probably makes little or no difference to mortality at three to six months (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.57 to 1.48, N = 1114, 11 trials, moderate-certainty evidence) and may make little or no difference to the risk of hospital readmission (RR 1.09, 95% CI 0.71 to 1.66, N = 345, 5 trials, low-certainty evidence). Hospital at home may lower the risk of living in institutional setting at six months (RR 0.63, 96% CI 0.40 to 0.98; N = 574, 4 trials, low-certainty evidence) and might slightly improve patient satisfaction (N = 795, low-certainty evidence). Hospital at home probably reduces hospital length of stay, as moderate-certainty evidence found that people assigned to hospital at home are discharged from the intervention about seven days earlier than people receiving inpatient care (95% CI 10.19 to 3.17 days earlier, N = 528, 4 trials). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).Studies recruiting people with a mix of medical conditionsEarly discharge hospital at home probably makes little or no difference to mortality (RR 1.07, 95% CI 0.76 to 1.49; N = 1247, 8 trials, moderate-certainty evidence). In people with chronic obstructive pulmonary disease (COPD) there was insufficient information to determine the effect of these two approaches on mortality (RR 0.53, 95% CI 0.25 to 1.12, N = 496, 5 trials, low-certainty evidence). The intervention probably increases the risk of hospital readmission in a mix of medical conditions, although the results are also compatible with no difference and a relatively large increase in the risk of readmission (RR 1.25, 95% CI 0.98 to 1.58, N = 1276, 9 trials, moderate-certainty evidence). Early discharge hospital at home may decrease the risk of readmission for people with COPD (RR 0.86, 95% CI 0.66 to 1.13, N = 496, 5 trials low-certainty evidence). Hospital at home may lower the risk of living in an institutional setting (RR 0.69, 0.48 to 0.99; N = 484, 3 trials, low-certainty evidence). The intervention might slightly improve patient satisfaction (N = 900, low-certainty evidence). The effect of early discharge hospital at home on hospital length of stay for older patients with a mix of conditions ranged from a reduction of 20 days to a reduction of less than half a day (moderate-certainty evidence, N = 767). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).Studies recruiting people undergoing elective surgeryThree studies did not report higher rates of mortality with hospital at home compared with inpatient care (data not pooled, N = 856, low-certainty evidence; mainly orthopaedic surgery). Hospital at home may lead to little or no difference in readmission to hospital for people who were mainly recovering from orthopaedic surgery (N = 1229, low-certainty evidence). We could not establish the effects of hospital at home on the risk of living in institutional care, due to a lack of data. The intervention might slightly improve patient satisfaction (N = 1229, low-certainty evidence). People recovering from orthopaedic surgery allocated to early discharge hospital at home were discharged from the intervention on average four days earlier than people allocated to usual inpatient care (4.44 days earlier, 95% CI 6.37 to 2.51 days earlier, , N = 411, 4 trials, moderate-certainty evidence). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence). AUTHORS' CONCLUSIONS: Despite increasing interest in the potential of early discharge hospital at home services as a less expensive alternative to inpatient care, this review provides insufficient evidence of economic benefit (through a reduction in hospital length of stay) or improved health outcomes.

The Hand-Foot Skin Reaction and Quality of Life Questionnaire: An Assessment Tool for Oncology.

BACKGROUND: Skin toxicity (hand-foot syndrome/hand-foot skin reaction, HFS/R) related to antineoplastic therapy is a significant issue in oncology practice, with potentially large impacts on health-related quality of life (HRQL). MATERIALS AND METHODS: A patient-reported questionnaire, the hand-foot skin reaction and quality of life (HF-QoL) questionnaire was developed to measure the HFS/R symptoms associated with cancer therapeutic agents and their effect on daily activities. The validity and reliability of the HF-QoL questionnaire was tested in a randomized trial of capecitabine with sorafenib/placebo in 223 patients with locally advanced/metastatic breast cancer. Other measures completed included patient ratings of condition severity, the Functional Assessment of Cancer Therapy-Breast cancer (FACT-B), and the clinician-rated National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0, hand-foot skin reaction grade. The psychometric properties of the HF-QoL tested included structural validity, internal consistency, construct validity, discriminant validity, and responsiveness. Finally, the minimal clinically important difference (MCID) was estimated. RESULTS: The HF-QoL instrument comprises a 20-item symptom scale and an 18-item daily activity scale. Each scale demonstrated excellent measurement properties and discriminated between NCI-CTCAE grade and patient-rated condition severity with large effect sizes. The daily activity scale had excellent internal consistency and correlated with the FACT-B and HF-QoL symptom scores. Both HF-QoL scale scores increased linearly with increasing patient-rated condition severity. The MCIDs were estimated as 5 units for daily activities and 8 units for symptoms mean scores. CONCLUSION: The HF-QoL was sensitive to symptoms and HRQL issues associated with HFS/R among participants treated with capecitabine with and without sorafenib. The HF-QoL appears suitable for assessing the HRQL impairment associated with HFS/R to cancer therapies. IMPLICATIONS FOR PRACTICE: Skin toxicity related to anticancer therapies is a significant issue in oncology practice. Several newer agents, as well as older therapies, are associated with the skin toxicity known as hand-foot skin reaction (HFSR) or hand-foot syndrome (HFS). This study describes the development and validation of a brief, patient-reported questionnaire (the hand-foot skin reaction and quality of life questionnaire) supporting its suitability for use in clinical research to aid in early recognition of symptoms, to evaluate the effectiveness of agents for HFS/R treatment within clinical trials, and to evaluate the impact of these treatments on HFS/R-associated patients' health-related quality of life.

Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial.

PURPOSE OF THE STUDY: to examine the costs and cost-effectiveness of 'second-generation' telecare, in addition to standard support and care that could include 'first-generation' forms of telecare, compared with standard support and care that could include 'first-generation' forms of telecare. DESIGN AND METHODS: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care. PRIMARY OUTCOME MEASURE: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective. RESULTS: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY. IMPLICATIONS: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs. TRIAL REGISTRATION NUMBER: ISRCTN 43002091.

The effect of telecare on the quality of life and psychological well-being of elderly recipients of social care over a 12-month period: the Whole Systems Demonstrator cluster randomised trial.

BACKGROUND: home-based telecare (TC) is utilised to manage risks of independent living and provide prompt emergency responses. This study examined the effect of TC on health-related quality of life (HRQoL), anxiety and depressive symptoms over 12 months in patients receiving social care. DESIGN: a study of participant-reported outcomes [the Whole Systems Demonstrator (WSD) Telecare Questionnaire Study; baseline n = 1,189] was nested in a pragmatic cluster-randomised trial of TC (the WSD Telecare trial), held across three English Local Authorities. General practice (GP) was the unit of randomisation and TC was compared with usual care (UC). METHODS: participant-reported outcome measures were collected at baseline, short-term (4 months) and long-term (12 months) follow-up, assessing generic HRQoL, anxiety and depressive symptoms. Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed questionnaire measures at baseline assessment plus at least one other assessment (n = 873). RESULTS: analyses found significant differences between TC and UC on Short Form-12 mental component scores (P < 0.05), with parameter estimates indicating being a member of the TC trial-arm increases mental component scores (UC-adjusted mean = 40.52; TC-adjusted mean = 43.69). Additional significant analyses revealed, time effects on EQ5D (decreasing over time) and depressive symptoms (increasing over time). CONCLUSIONS: TC potentially contributes to the amelioration in the decline in users' mental HRQoL over a 12-month period. TC may not transform the lives of its users, but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC. International Standard Randomised Controlled Trial Number Register: ISRCTN 43002091.

Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial.

BACKGROUND: In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology.The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis. METHODS/DESIGN: The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ.We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247.

Carer quality of life and experiences of health services: a cross-sectional survey across three neurological conditions.

BACKGROUND: Neurological conditions have a substantial impact on carers, with carer well-being having been shown to be influenced by a number of demographic, patient and caregiving factors. Support given to carers can lead to better coping. This study investigated the relationship between carer well-being and experiences with health and social services. METHODS: A cross-sectional survey was conducted of 1910 (37.4%) of carers of 5109 people with motor neuron disease (MND) (n=434, 54.9%), multiple sclerosis (MS) (n=721, 30.7%) and Parkinson's disease (PD) (n=755, 38.2%). Carers completed a generic health status measure (SF-12), a carer strain measure (Carer Strain Index- CSI) and a newly developed questionnaire on health and social care experiences. Data were analysed by analysis of variance with p set at <0.05. RESULTS: Carer well-being was found to be compromised and differed significantly between the three conditions. Furthermore, a considerable number of carers experienced problems with aspects of health and social care, although there was no clear pattern according to the condition that was cared for. The total number of problems reported did not differ significantly between conditions but was significantly (all p<0.001) associated with carer quality of life (both physical and mental health) and strain, even when other influencing factors (demographic and caregiving variables) were corrected for. The association was particularly strong for carer strain, and less strong (but still significant) for quality of life. CONCLUSIONS: The results show that carer well-being is compromised, in line with previous studies. Furthermore, the link of carer well-being to the number of problems reported suggests that minimizing problems experienced could improve carer well-being. This stresses the importance of health and social services appropriately supporting carers.

Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial.

OBJECTIVE: To examine the costs and cost effectiveness of telehealth in addition to standard support and treatment, compared with standard support and treatment. DESIGN: Economic evaluation nested in a pragmatic, cluster randomised controlled trial. SETTING: Community based telehealth intervention in three local authority areas in England. PARTICIPANTS: 3230 people with a long term condition (heart failure, chronic obstructive pulmonary disease, or diabetes) were recruited into the Whole Systems Demonstrator telehealth trial between May 2008 and December 2009. Of participants taking part in the Whole Systems Demonstrator telehealth questionnaire study examining acceptability, effectiveness, and cost effectiveness, 845 were randomised to telehealth and 728 to usual care. INTERVENTIONS: Intervention participants received a package of telehealth equipment and monitoring services for 12 months, in addition to the standard health and social care services available in their area. Controls received usual health and social care. MAIN OUTCOME MEASURE: Primary outcome for the cost effectiveness analysis was incremental cost per quality adjusted life year (QALY) gained. RESULTS: We undertook net benefit analyses of costs and outcomes for 965 patients (534 receiving telehealth; 431 usual care). The adjusted mean difference in QALY gain between groups at 12 months was 0.012. Total health and social care costs (including direct costs of the intervention) for the three months before 12 month interview were £1390 (€1610; $2150) and £1596 for the usual care and telehealth groups, respectively. Cost effectiveness acceptability curves were generated to examine decision uncertainty in the analysis surrounding the value of the cost effectiveness threshold. The incremental cost per QALY of telehealth when added to usual care was £92 000. With this amount, the probability of cost effectiveness was low (11% at willingness to pay threshold of £30 000; >50% only if the threshold exceeded about £90 000). In sensitivity analyses, telehealth costs remained slightly (non-significantly) higher than usual care costs, even after assuming that equipment prices fell by 80% or telehealth services operated at maximum capacity. However, the most optimistic scenario (combining reduced equipment prices with maximum operating capacity) eliminated this group difference (cost effectiveness ratio £12 000 per QALY). CONCLUSIONS: The QALY gain by patients using telehealth in addition to usual care was similar to that by patients receiving usual care only, and total costs associated with the telehealth intervention were higher. Telehealth does not seem to be a cost effective addition to standard support and treatment. TRIAL REGISTRATION: ISRCTN43002091.

Effect of telecare on use of health and social care services: findings from the Whole Systems Demonstrator cluster randomised trial.

OBJECTIVE: to assess the impact of telecare on the use of social and health care. Part of the evaluation of the Whole Systems Demonstrator trial. PARTICIPANTS AND SETTING: a total of 2,600 people with social care needs were recruited from 217 general practices in three areas in England. DESIGN: a cluster randomised trial comparing telecare with usual care, general practice being the unit of randomisation. Participants were followed up for 12 months and analyses were conducted as intention-to-treat. DATA SOURCES: trial data were linked at the person level to administrative data sets on care funded at least in part by local authorities or the National Health Service. MAIN OUTCOME MEASURES: the proportion of people admitted to hospital within 12 months. Secondary endpoints included mortality, rates of secondary care use (seven different metrics), contacts with general practitioners and practice nurses, proportion of people admitted to permanent residential or nursing care, weeks in domiciliary social care and notional costs. RESULTS: 46.8% of intervention participants were admitted to hospital, compared with 49.2% of controls. Unadjusted differences were not statistically significant (odds ratio: 0.90, 95% CI: 0.75-1.07, P = 0.211). They reached statistical significance after adjusting for baseline covariates, but this was not replicated when adjusting for the predictive risk score. Secondary metrics including impacts on social care use were not statistically significant. CONCLUSIONS: telecare as implemented in the Whole Systems Demonstrator trial did not lead to significant reductions in service use, at least in terms of results assessed over 12 months.

Use of risk assessment instruments to predict violence and antisocial behaviour in 73 samples involving 24 827 people: systematic review and meta-analysis.

OBJECTIVE: To investigate the predictive validity of tools commonly used to assess the risk of violence, sexual, and criminal behaviour. DESIGN: Systematic review and tabular meta-analysis of replication studies following PRISMA guidelines. DATA SOURCES: PsycINFO, Embase, Medline, and United States Criminal Justice Reference Service Abstracts. REVIEW METHODS: We included replication studies from 1 January 1995 to 1 January 2011 if they provided contingency data for the offending outcome that the tools were designed to predict. We calculated the diagnostic odds ratio, sensitivity, specificity, area under the curve, positive predictive value, negative predictive value, the number needed to detain to prevent one offence, as well as a novel performance indicator-the number safely discharged. We investigated potential sources of heterogeneity using metaregression and subgroup analyses. RESULTS: Risk assessments were conducted on 73 samples comprising 24,847 participants from 13 countries, of whom 5879 (23.7%) offended over an average of 49.6 months. When used to predict violent offending, risk assessment tools produced low to moderate positive predictive values (median 41%, interquartile range 27-60%) and higher negative predictive values (91%, 81-95%), and a corresponding median number needed to detain of 2 (2-4) and number safely discharged of 10 (4-18). Instruments designed to predict violent offending performed better than those aimed at predicting sexual or general crime. CONCLUSIONS: Although risk assessment tools are widely used in clinical and criminal justice settings, their predictive accuracy varies depending on how they are used. They seem to identify low risk individuals with high levels of accuracy, but their use as sole determinants of detention, sentencing, and release is not supported by the current evidence. Further research is needed to examine their contribution to treatment and management.

A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial.

BACKGROUND: It is expected that increased demands on services will result from expanding numbers of older people with long-term conditions and social care needs. There is significant interest in the potential for technology to reduce utilisation of health services in these patient populations, including telecare (the remote, automatic and passive monitoring of changes in an individual's condition or lifestyle) and telehealth (the remote exchange of data between a patient and health care professional). The potential of telehealth and telecare technology to improve care and reduce costs is limited by a lack of rigorous evidence of actual impact. METHODS/DESIGN: We are conducting a large scale, multi-site study of the implementation, impact and acceptability of these new technologies. A major part of the evaluation is a cluster-randomised controlled trial of telehealth and telecare versus usual care in patients with long-term conditions or social care needs. The trial involves a number of outcomes, including health care utilisation and quality of life. We describe the broad evaluation and the methods of the cluster randomised trial DISCUSSION: If telehealth and telecare technology proves effective, it will provide additional options for health services worldwide to deliver care for populations with high levels of need. TRIAL REGISTRATION: Current Controlled Trials ISRCTN43002091.

Comparative value of NYHA functional class and quality-of-life questionnaire scores in assessing heart failure.

PURPOSE: To assess the relationships between New York Heart Association (NYHA) functional class, quality of life, aerobic capacity (peak oxygen uptake, (.)VO2), ventilatory efficiency (minute ventilation/carbon dioxide production slope, VE/(.)VCO2 slope), and brain natriuretic peptide (BNP) in creating a model for predicting peak (.)VO2). METHODS: Cardiopulmonary exercise testing was performed in 62 patients. A baseline blood sample was taken to measure the N-terminal prohormone BNP (NT-proBNP). Patients also completed the Minnesota Living with Heart Failure Questionnaire (MLHF) and the Specific Activity Questionnaire (SAQ), and NYHA functional class was determined. RESULTS: NYHA functional class correlated more strongly with SAQ score than with MLHF score. Peak (.)VO2 and VE/(.)VCO2 slope had stronger associations with NYHA functional class and SAQ score than with MLHF score. NT-proBNP plasma levels correlated more significantly with NYHA functional class and SAQ score (both P < .001) than with MLHF score. Using multiple linear regression analysis adjusted for age and sex, SAQ score, NT-proBNP, and etiology of heart failure had significant independent relationships with peak (.)VO2, explaining 63% of its variability (adjusted R(2) = 0.596). CONCLUSIONS: Cardiopulmonary exercise variables and plasma NT-proBNP are associated more with NYHA functional class and SAQ score than with MLHF score. When combined, SAQ score, NT-proBNP, and etiology of heart failure can satisfactorily predict peak oxygen uptake.

Early discharge hospital at home.

BACKGROUND: 'Early discharge hospital at home' is a service that provides active treatment by health care professionals in the patient's home for a condition that otherwise would require acute hospital in-patient care. If hospital at home were not available then the patient would remain in an acute hospital ward. OBJECTIVES: To determine, in the context of a systematic review and meta-analysis, the effectiveness and cost of managing patients with early discharge hospital at home compared with in-patient hospital care. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Register , MEDLINE (1950 to 2008), EMBASE (1980 to 2008), CINAHL (1982 to 2008) and EconLit through to January 2008. We checked the reference lists of articles identified for potentially relevant articles. SELECTION CRITERIA: Randomised controlled trials recruiting patients aged 18 years and over. Studies comparing early discharge hospital at home with acute hospital in-patient care. Evaluations of obstetric, paediatric and mental health hospital at home schemes are excluded from this review. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed study quality. Our statistical analyses were done on an intention-to-treat basis. We requested individual patient data (IPD) from trialists, and relied on published data when we did not receive trial data sets or the IPD did not include the relevant outcomes. For the IPD meta-analysis, where at least one event was reported in both study groups in a trial, Cox regression models were used to calculate the log hazard ratio and its standard error for mortality and readmission separately for each data set. The calculated log hazard ratios were combined using fixed-effect inverse variance meta-analysis. MAIN RESULTS: Twenty-six trials were included in this review [n = 3967]; 21 were eligible for the IPD meta-analysis and 13 of the 21 trials contributed data [1899/2872; 66%]. For patients recovering from a stroke and elderly patients with a mix of conditions there was insufficient evidence of a difference in mortality between groups (adjusted HR 0.79, 95% CI 0.32 to 1.91; N = 494; and adjusted HR 1.06, 95% CI 0.69 to 1.61; N = 978). Readmission rates were significantly increased for elderly patients with a mix of conditions allocated to hospital at home (adjusted HR 1.57; 95% CI 1.10 to 2.24; N = 705). For patients recovering from a stroke and elderly patients with a mix of conditions respectively, significantly fewer people allocated to hospital at home were in residential care at follow up (RR 0.63; 95% CI 0.40 to 0.98; N = 4 trials; RR 0.69, 95% CI 0.48 to 0.99; N =3 trials). Patients reported increased satisfaction with early discharge hospital at home. There was insufficient evidence of a difference for readmission between groups in trials recruiting patients recovering from surgery. Evidence on cost savings was mixed. AUTHORS' CONCLUSIONS: Despite increasing interest in the potential of early discharge hospital at home services as a cheaper alternative to in-patient care, this review provides insufficient objective evidence of economic benefit or improved health outcomes.

Outcome measures used in forensic mental health research: a structured review.

BACKGROUND: The evidence base for forensic mental health (FMH) services has been developing since the late 1990s. Are outcome measures sound enough for the evaluation tasks? AIMS: To identify, from published literature, outcome measures used in FMH research and, where feasible, assess their quality. METHOD: A structured review was undertaken of trials and intervention studies published between 1990 and 2006. Details of outcome variables and measures were abstracted. Evidence regarding most frequently occurring outcome measures was assessed. RESULTS: Four hundred and fifty different instruments were used to assess outcomes, incorporating 1038 distinct variables. Very little evidence could be found to support the measurement properties of commonly used instruments. CONCLUSIONS: and implications for practice There is little consistency in the use of outcome measure in FMH research. Effort is required to reach consensus on validated outcome measures in this field in order to better inform practice.

Avoiding hospital admission through provision of hospital care at home: a systematic review and meta-analysis of individual patient data.

BACKGROUND: Avoidance of admission through provision of hospital care at home is a scheme whereby health care professionals provide active treatment in the patient's home for a condition that would otherwise require inpatient treatment in an acute care hospital. We sought to compare the effectiveness of this method of caring for patients with that type of in-hospital care. METHODS: We searched the MEDLINE, EMBASE, CINAHL and EconLit databases and the Cochrane Effective Practice and Organisation of Care Group register from the earliest date in each database until January 2008. We included randomized controlled trials that evaluated a service providing an alternative to admission to an acute care hospital. We excluded trials in which the program did not offer a substitute for inpatient care. We performed meta-analyses for trials for which the study populations had similar characteristics and for which common outcomes had been measured. RESULTS: We included 10 randomized trials (with a total of 1327 patients) in our systematic review. Seven of these trials (with a total of 969 patients) were deemed eligible for meta-analysis of individual patient data, but we were able to obtain data for only 5 of these trials (with a total of 844 patients [87%]). There was no significant difference in mortality at 3 months for patients who received hospital care at home (adjusted hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.54-1.09, p = 0.15). However, at 6 months, mortality was significantly lower for these patients (adjusted HR 0.62, 95% CI 0.45-0.87, p = 0.005). Admissions to hospital were greater, but not significantly so, for patients receiving hospital care at home (adjusted HR 1.49, 95% CI 0.96-2.33, p = 0.08). Patients receiving hospital care at home reported greater satisfaction than those receiving inpatient care. These programs were less expensive than admission to an acute care hospital ward when the analysis was restricted to treatment actually received and when the costs of informal care were excluded. INTERPRETATION: For selected patients, avoiding admission through provision of hospital care at home yielded similar outcomes to inpatient care, at a similar or lower cost.

Admission avoidance hospital at home.

BACKGROUND: Admission avoidance hospital at home is a service that provides active treatment by health care professionals in the patient's home for a condition that otherwise would require acute hospital in-patient care, and always for a limited time period. In particular, hospital at home has to offer a specific service to patients in their home requiring health care professionals to take an active part in the patients' care. If hospital at home were not available then the patient would be admitted to an acute hospital ward. Many countries are adopting this type of care in an attempt to reduce the demand for acute hospital admission. OBJECTIVES: To determine, in the context of a systematic review and meta analysis, the effectiveness and cost of managing patients with admission avoidance hospital at home compared with in-patient hospital care. SEARCH STRATEGY: The following databases were searched through to January 2008: MEDLINE, EMBASE, CINAHL, EconLit and the Cochrane Effective Practice and Organisation of Care Group (EPOC) register. We checked the reference lists of articles identified electronically for evaluations of hospital at home and obtained potentially relevant articles. Unpublished studies were sought by contacting providers and researchers who were known to be involved in this field. SELECTION CRITERIA: Randomised controlled trials recruiting patients aged 18 years and over. Studies comparing admission avoidance hospital at home with acute hospital in-patient care. The admission avoidance hospital at home interventions may admit patients directly from the community thereby avoiding physical contact with the hospital, or may admit from the emergency room. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed study quality. Our statistical analyses sought to include all randomised patients and were done on an intention to treat basis. We requested individual patient data (IPD) from trialists, and relied on published data when we did not receive trial data sets or the IPD did not include the relevant outcomes. When combining outcome data was not possible because of differences in the reporting of outcomes we have presented the data in narrative summary tables.For the IPD meta-analysis, where at least one event was reported in both study groups in a trial, Cox regression models were used to calculate the log hazard ratio and its standard error for mortality and readmission separately for each data set (where both outcomes were available). We included randomisation group (admission avoidance hospital at home versus control), age (above or below the median), and gender in the models. The calculated log hazard ratios were combined using fixed effects inverse variance meta analysis. If there were no events in one group we used the Peto odds ratio method to calculate a log odds ratio from the sum of the log-rank test 'O-E' statistics from a Kaplan Meier survival analysis. Statistical significance throughout was taken at the two-sided 5% level (p<0.05) and data are presented as the estimated effect with 95% confidence intervals. For each comparison using published data for dichotomous outcomes we calculated risk ratios using a fixed effects model to combine data. MAIN RESULTS: We included 10 RCTs (n=1333), 7 of which were eligible for the IPD. Five out of these seven trials contributed to the IPD meta-analysis (n=850/975; 87%). There was a non significant reduction in mortality at three months for the admission avoidance hospital at home group (adjusted HR 0.77, 95% CI 0.54 to 1.09; p=0.15), which reached significance at six months follow-up (adjusted HR 0.62, 95% CI 0.45 to 0.87; p=0.005). A non significant increase in admissions was observed for patients allocated to hospital at home (adjusted HR 1.49, 95% CI 0.96 to 2.33; p=0.08). Few differences were reported for functional ability, quality of life or cognitive ability. Patients reported increased satisfaction with admission avoidance hospital at home. Two trials conducted a full economic analysis, when the costs of informal care were excluded admission avoidance hospital at home was less expensive than admission to an acute hospital ward. AUTHORS' CONCLUSIONS: We performed meta-analyses where there was sufficient similarity among the trials and where common outcomes had been measured. There is no evidence from the analysis to suggest that admission avoidance hospital at home leads to outcomes that differ from inpatient hospital care.

Comparison of two patient-based outcome measures for shoulder instability after nonoperative treatment.

This study compared the responsiveness and minimal clinically important differences of the Oxford Instability Shoulder Score (OISS) and Shoulder Rating Questionnaire (SRQ). Ninety-three patients referred to physiotherapy with shoulder instability (100 shoulders) completed the questionnaires at the initial appointment and at 1 and 9 months later. A subjective rating of change was also obtained. Both questionnaires were able to detect change (effect sizes 1.16 OISS and 0.99 SRQ). The OISS change scores correlated more consistently with patients' subjective responses. The minimal detectable change (MDC90) scores were 16% (7 points) for the OISS and 17% (8 unweighted points) for the SRQ. The minimal clinically important difference (MCID) was between 9%, 4.5 points ("slightly better" and "much better") and 13.5%, 6.5 points ("much better") for the OISS, dependent on the subjective descriptors used, and 11% (4 unweighted points) for SRQ. The MCID change scores varied in relation to the baseline level of function.