scholarly journals An economic analysis of a wearable patient sensor for preventing hospital-acquired pressure injuries among the acutely ill patients

2021 ◽  
Author(s):  
Leo Nherera ◽  
Barrett Larson ◽  
Annemari Cooley ◽  
Patrick Reinhard
Keyword(s):  
Cost Saving ◽  
Clinical Outcomes ◽  
Standard Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
The United States ◽  
Patient Treatment ◽  
Decision Analytic Model ◽  
Wearable Sensor ◽  
Hospital Acquired

AbstractMore than 2.5 million people in the United States develop pressure injuries annually, which are one of the most common complications occurring in hospitals. Despite being common, hospital-acquired pressure injuries (HAPIs) are largely considered preventable by regular patient turning. Although current methodologies to prompt on-time repositioning have limited efficacy, a wearable patient sensor has been shown to optimize turning practices and improve clinical outcomes. The purpose of this study was to assess the cost-effectiveness of patient-wearable sensor in the prevention of HAPIs in acutely ill patients when compared to standard practice alone. A decision analytic model was developed to simulate the expected costs and outcomes from the payer’s perspective using data from published literature, including a recently published randomized controlled trial. Both univariate and probabilistic sensitivity analysis were conducted. The patient-wearable sensor was found to be cost saving (dominant). It resulted in better clinical outcomes (77% reduction in HAPIs) compared to standard care and an expected cost savings of $6,621 per patient over a one-year period. Applying the model to a cohort of 1,000 patients, an estimated 203 HAPIs would be avoided with annualized cost reduction of $6,222,884 through all patient treatment settings. The probabilistic analysis returned similar results. In conclusion, the patient-wearable sensor was found to be cost-effective in the prevention of HAPIs and cost-saving to payers and hospitals. These results suggest that patient-wearable sensors should be considered as a cost-effective alternative to standard care in the prevention of HAPIs.

Costs and Benefits of Hospital and Day Treatment with Community Care of Affective and Schizophrenic Disorders

1995 ◽  
Vol 166 (S27) ◽  
pp. 52-59 ◽  
Author(s):  
D. Wiersma ◽  
H. Kluiter ◽  
F. J. Nienhuis ◽  
M. Rüphan ◽  
R. Giel
Keyword(s):  
Community Care ◽  
Psychiatric Treatment ◽  
Day Treatment ◽  
Controlled Trial ◽  
Clinical Care ◽  
Cost Effective ◽  
Patient Treatment ◽  
Schizophrenic Disorder ◽  
Course Of Illness ◽  
Schizophrenic Patients

Background. A randomised controlled trial of day treatment with community care for patients with schizophrenic and affective disorders, referred for in-patient psychiatric treatment, was conducted to evaluate patterns of treatment and the course of illness with its psychosocial consequences over a period of two years.Method. Seventy patients, of whom 34 had affective and 36 had schizophrenic disorder, were assigned to the experimental condition (day treatment with ambulatory and domiciliary care), and 33 patients, of whom 16 had affective and 17 had schizophrenic disorder, were assigned to the control condition of standard clinical care.Results. Day treatment with community care was feasible for 40.6% of the affective patients and 33.3% of the schizophrenic patients. The direct treatment costs of both disorders, based on numbers of in- and day-patient days and out-patient contacts over two years, appeared more or less the same. Patients benefited equally from day treatment as from in-patient treatment, although there were some gains in self-care and in functioning in the household among experimentals. Although schizophrenics were socioeconomically worse off, and also suffered from more (severe) symptoms and social disabilities than the affective patients at entry into the study, they were similar at two years. This finding is unexpected, compared with other follow-up studies. Extra cost for patients and families were not observed. Patients and their families in the experimental condition were significantly more satisfied with the treatment. Experimental patients spent much more time at home during admission, remained much less time in secluded wards, and were more compliant with treatment.Conclusions. Day treatment could be considered a cost-effective alternative to in-patient treatment.

A multilayer polyurethane foam dressing for pressure ulcer prevention in older hip fracture patients: an economic evaluation

2020 ◽  
Vol 29 (2) ◽  
pp. 120-127
Author(s):  
Cristiana Forni ◽  
Richard Searle
Keyword(s):  
Economic Evaluation ◽  
Cost Saving ◽  
Polyurethane Foam ◽  
Negative Impact ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
Effective Strategy ◽  
Cost Effective Strategy ◽  
The Us

Objective: Hospital-acquired pressure ulcers (PU) have a substantial negative impact on patients and continue to impose a cost burden on hospital providers. Since the incidence of fragility fracture is growing, driven by the increase in the older population, it is expected that the overall incidence of associated complications will also increase accordingly. The aim of this economic evaluation was to determine whether the use of a multilayer, silicone-adhesive polyurethane foam dressing (ALLEVYN LIFE, Smith & Nephew, UK) alongside standard prevention (SP) for the prevention of PUs in older patients with hip fractures is a cost-effective strategy, compared with SP alone. Method: A decision-analytic model was constructed to determine the incremental cost and effectiveness of the foam dressing strategy from the perspectives of the Italian and US hospital systems. We also performed one-way and probabilistic sensitivity analyses. Results: The foam dressing intervention was found to be cost saving and more effective than SP in both Italy and the US. Switching to foam dressing and standard prevention would result in an expected cost saving of €733 per patient in Italy and $840 per patient in the US, reducing the per-patient cost of treating PUs by 37-69% and 36–68%, respectively. The one-way and probabilistic sensitivity analyses demonstrate that the strategy remains dominant over a range of values of the input variables. Conclusion: The foam dressing intervention is likely to be a cost-effective strategy compared with standard prevention alone.

Standardizing the Response to Category II Tracings during Induction with Oxytocin: A Cost-Effectiveness Analysis

2017 ◽  
Vol 34 (12) ◽  
pp. 1255-1263 ◽  
Author(s):  
Leah Savitsky ◽  
Blake Zwerling ◽  
Justin Williams ◽  
Alison Cahill ◽  
Aaron Caughey ◽  
...  
Keyword(s):  
Heart Rate ◽  
Cost Effectiveness ◽  
Fetal Heart Rate ◽  
Fetal Heart ◽  
Mode Of Delivery ◽  
Cost Effective ◽  
The United States ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
Cesarean Deliveries

Background Oxytocin is one of the most frequently used medications in obstetrics. It is generally considered to be safe and effective for induction and augmentation of labor but has been implicated in uterine hyperstimulation and adverse fetal outcomes. The management of labor with oxytocin in response to changes in fetal status remains an area of debate. Objective This study sought to assess the cost-effectiveness of reducing or ceasing oxytocin administration in response to Category II fetal heart rate tracings. Study Design A decision-analytic model was built using TreeAge 2016 software (TreeAge Software Inc.) with probabilities, costs, and utilities derived from the literature. Primary outcomes included cerebral palsy (CP), neonatal mortality, and mode of delivery. Secondary outcomes included cost per quality-adjusted life year (QALY; cost-effectiveness threshold set at $100,000/QALY), admission to the neonatal intensive care unit (NICU), and low 5-minute Apgar score (<7). Sensitivity analyses were performed to determine the robustness of our baseline assumptions. Results In a theoretical cohort of 900,000 women (estimated number of women undergoing induction at term in the United States), decreasing or stopping oxytocin in response to Category II tracings prevented 12,510 NICU admissions, 4,410 low Apgar scores, 204 neonatal deaths, and 126 cases of CP. However, there were 81,900 more cesarean deliveries. The strategy cost $356 million more, but was cost-effective with an ICER of $9,881.5 per QALY. Sensitivity analysis revealed that the intervention would be cost-effective up to a cesarean rate of 54%. Conclusion Decreasing or stopping oxytocin in response to Category II fetal heart rate tracings is cost-effective. This intervention increases the rate of cesarean deliveries but reduces neonatal morbidity and mortality. Further work on this guideline should be performed to ascertain how the approach using different aspects of the Category II tracing to guide care might lead to similar improved outcomes without increasing the cesarean delivery rate.

scholarly journals Cost-effectiveness of a community-delivered multicomponent intervention compared with enhanced standard care of obese adolescents: cost-utility analysis alongside a randomised controlled trial (the HELP trial)

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018640 ◽  
Author(s):  
Monica Panca ◽  
Deborah Christie ◽  
Tim J Cole ◽  
Silvia Costa ◽  
John Gregson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Resource Use ◽  
Standard Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Community Settings ◽  
Utility Analysis ◽  
Randomised Controlled

ObjectiveTo undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care.DesignCost-utility analysis alongside a randomised controlled trial.SettingCommunity settings in Greater London, England.Participants174 young people with obesity aged 12–19 years.InterventionsIntervention participants received 12 one-to-one sessions across 6 months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice.Main outcome measuresMean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC).ResultsMean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI −0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained.ConclusionsWe did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective.Trial registration numberISRCTN99840111.

scholarly journals A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial

2017 ◽  
Vol 5 (2) ◽  
pp. 1-290 ◽  
Author(s):  
Melanie J Davies ◽  
Laura J Gray ◽  
Dariush Ahrabian ◽  
Marian Carey ◽  
Azhar Farooqi ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Score ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Research Programme ◽  
Cost Effective ◽  
Cluster Randomised Controlled Trial ◽  
Education Programme ◽  
Structured Education

BackgroundPrevention of type 2 diabetes mellitus (T2DM) is a global priority; however, there is a lack of evidence investigating how to effectively translate prevention research into a primary care setting.Objectives(1) To develop and validate a risk score to identify individuals at high risk of T2DM in the UK; and (2) to establish whether or not a structured education programme targeting lifestyle and behaviour change was clinically effective and cost-effective at preventing progression to T2DM in people with prediabetes mellitus (PDM), identified through a risk score screening programme in primary care.DesignA targeted screening study followed by a cluster randomised controlled trial (RCT), with randomisation at practice level. Participants were followed up for 3 years.SettingA total of 44 general practices across Leicestershire, UK. The intervention took place in the community.ParticipantsA total of 17,972 individuals from 44 practices identified through the risk score as being at high risk of T2DM were invited for screening; of these, 3449 (19.2%) individuals attended. All received an oral glucose tolerance test. PDM was detected in 880 (25.5%) of those screened. Those with PDM were included in the trial; of these, 36% were female, the average age was 64 years and 16% were from an ethnic minority group.InterventionPractices were randomised to receive either standard care or the intervention. The intervention consisted of a 6-hour group structured education programme, with an annual refresher and regular telephone contact.Main outcome measuresThe primary outcome was progression to T2DM. The main secondary outcomes were changes in glycated haemoglobin concentrations, blood glucose levels, cardiovascular risk, the presence of metabolic syndrome, step count and the cost-effectiveness of the intervention.ResultsA total of 22.6% of the intervention group did not attend the education and 29.1% attended all sessions. A total of 131 participants developed T2DM (standard care,n = 67; intervention,n = 64). There was a 26% reduced risk of T2DM in the intervention arm compared with standard care, but this did not reach statistical significance (hazard ratio 0.74, 95% confidence interval 0.48 to 1.14;p = 0.18). There were statistically significant improvements in glycated haemoglobin concentrations, low-density lipoprotein cholesterol levels, psychosocial well-being, sedentary time and step count in the intervention group. The intervention was found to result in a net gain of 0.046 quality-adjusted life-years over 3 years at a cost of £168 per patient, with an incremental cost-effectiveness ratio of £3643 and a probability of 0.86 of being cost-effective at a willingness-to-pay threshold of £20,000.ConclusionsWe developed and validated a risk score for detecting those at high risk of undiagnosed PDM/T2DM. We screened > 3400 people using a two-stage screening programme. The RCT showed that a relatively low-resource pragmatic programme may lead to a reduction in T2DM and improved biomedical and psychosocial outcomes, and is cost-effective.LimitationsOnly 19% of those invited to screening attended, which may limit generalisability. The variation in cluster size in the RCT may have limited the power of the study.Future workFuture work should focus on increasing attendance to both screening and prevention programmes and offering the programme in different modalities, such as web-based modalities. A longer-term follow-up of the RCT participants would be valuable.Trial registrationCurrent Controlled Trials ISRCTN80605705.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

scholarly journals Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n84 ◽  
Author(s):  
Viviane C Veiga ◽  
João A G G Prats ◽  
Danielle L C Farias ◽  
Regis G Rosa ◽  
Leticia K Dourado ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Confidence Interval ◽  
Clinical Outcomes ◽  
Odds Ratio ◽  
Standard Care ◽  
Controlled Trial ◽  
Data Monitoring Committee ◽  
Ordinal Scale ◽  
Care Group ◽  
Standard Care Group

Abstract Objective To determine whether tocilizumab improves clinical outcomes for patients with severe or critical coronavirus disease 2019 (covid-19). Design Randomised, open label trial. Setting Nine hospitals in Brazil, 8 May to 17 July 2020. Participants Adults with confirmed covid-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). The data monitoring committee recommended stopping the trial early, after 129 patients had been enrolled, because of an increased number of deaths at 15 days in the tocilizumab group. Interventions Tocilizumab (single intravenous infusion of 8 mg/kg) plus standard care (n=65) versus standard care alone (n=64). Main outcome measure The primary outcome, clinical status measured at 15 days using a seven level ordinal scale, was analysed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met. Results A total of 129 patients were enrolled (mean age 57 (SD 14) years; 68% men) and all completed follow-up. All patients in the tocilizumab group and two in the standard care group received tocilizumab. 18 of 65 (28%) patients in the tocilizumab group and 13 of 64 (20%) in the standard care group were receiving mechanical ventilation or died at day 15 (odds ratio 1.54, 95% confidence interval 0.66 to 3.66; P=0.32). Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group (odds ratio 6.42, 95% confidence interval 1.59 to 43.2). Adverse events were reported in 29 of 67 (43%) patients who received tocilizumab and 21 of 62 (34%) who did not receive tocilizumab. Conclusions In patients with severe or critical covid-19, tocilizumab plus standard care was not superior to standard care alone in improving clinical outcomes at 15 days, and it might increase mortality. Trial registration ClinicalTrials.gov NCT04403685 .

scholarly journals Age of thawed plasma does not affect clinical outcomes or biomarker expression in patients receiving prehospital thawed plasma: a PAMPer secondary analysis

2021 ◽  
Vol 6 (1) ◽  
pp. e000648
Author(s):  
Katherine M Reitz ◽  
Danielle S Gruen ◽  
Frances Guyette ◽  
Joshua B Brown ◽  
Mark H Yazer ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Standard Care ◽  
Controlled Trial ◽  
Traumatic Injury ◽  
Secondary Analysis ◽  
Vital Signs ◽  
Study Cohort ◽  
Severely Injured ◽  
Post Injury ◽  
Level Of Evidence

BackgroundPrehospital plasma administration during air medical transport reduces the endotheliopathy of trauma, circulating pro-inflammatory cytokines, and 30-day mortality among traumatically injured patients at risk of hemorrhagic shock. No clinical data currently exists evaluating the age of thawed plasma and its association with clinical outcomes and biomarker expression post-injury.MethodsWe performed a secondary analysis from the prehospital plasma administration randomized controlled trial, PAMPer. We dichotomized the age of thawed plasma creating three groups: standard-care, YOUNG (day 0–1) plasma, and OLD (day 2–5) plasma. We generated HRs and 95% CIs for mortality. Among all patients randomized to plasma, we compared predicted biomarker values at hospital admission (T0) and 24 hours later (T24) controlling for key difference between groups with a multivariable linear regression. Analyses were repeated in a severely injured subgroup.ResultsTwo hundred and seventy-one patients were randomized to standard-care and 230 to plasma (40% YOUNG, 60% OLD). There were no clinically or statistically significant differences in demographics, injury, admission vital signs, or laboratory values including thromboelastography between YOUNG and OLD. Compared with standard-care, YOUNG (HR 0.66 (95% CI 0.41 to 1.07), p=0.09) and OLD (HR 0.64 (95% CI 0.42 to 0.96), p=0.03) plasma demonstrated reduced 30-day mortality. Among those randomized to plasma, plasma age did not affect mortality (HR 1.04 (95% CI 0.60 to 1.82), p=0.90) and/or adjusted serum markers by plasma age at T0 or T24 (p>0.05). However, among the severely injured subgroup, OLD plasma was significantly associated with increased adjusted inflammatory and decreased adjusted endothelial biomarkers at T0.DiscussionAge of thawed plasma does not result in clinical outcome or biomarker expression differences in the overall PAMPer study cohort. There were biomarker expression differences in those patients with severe injury. Definitive investigation is needed to determine if the age of thawed plasma is associated with biomarker expression and outcome differences following traumatic injury.Level of evidenceII.

scholarly journals Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

2017 ◽  
Vol 21 (16) ◽  
pp. 1-260 ◽  
Author(s):  
Kim S Thomas ◽  
Lucy E Bradshaw ◽  
Tracey H Sach ◽  
Fiona Cowdell ◽  
Jonathan M Batchelor ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Standard Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
Skin Infections ◽  
Observational Period ◽  
Treatment Allocation ◽  
Patient Reported ◽  
Randomised Controlled

BackgroundAtopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.ObjectivesTo assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.DesignParallel-group, observer-blind, randomised controlled trial of 6 months’ duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.SettingSecondary care and the community in five UK centres.ParticipantsChildren aged 1–15 years with moderate or severe AE.InterventionsParticipants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM(AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM(DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measuresPrimary outcome – AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes – patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility – 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes – number of skin infections and hospitalisations for AE.ResultsA total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07;p = 0.43). This confidence interval is equivalent to a difference of –1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds.LimitationsKnowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.ConclusionsThe addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making.Future workNon-pharmacological interventions for the management of AE remain a research priority among patients.Trial registrationCurrent Controlled Trials ISRCTN77261365.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

scholarly journals Cognitive–behaviour therapy for health anxiety in medical patients (CHAMP): a randomised controlled trial with outcomes to 5 years

2017 ◽  
Vol 21 (50) ◽  
pp. 1-58 ◽  
Author(s):  
Peter Tyrer ◽  
Paul Salkovskis ◽  
Helen Tyrer ◽  
Duolao Wang ◽  
Michael J Crawford ◽  
...  
Keyword(s):  
Cognitive Behaviour Therapy ◽  
Standard Care ◽  
Controlled Trial ◽  
Health Anxiety ◽  
Cost Effective ◽  
Health Technology ◽  
Anxiety And Depression ◽  
Behaviour Therapy ◽  
Cognitive Behaviour ◽  
Randomised Controlled

BackgroundHealth anxiety is an under-recognised but frequent cause of distress that is potentially treatable, but there are few studies in secondary care.ObjectiveTo determine the clinical effectiveness and cost-effectiveness of a modified form of cognitive–behaviour therapy (CBT) for health anxiety (CBT-HA) compared with standard care in medical outpatients.DesignRandomised controlled trial.SettingFive general hospitals in London, Middlesex and Nottinghamshire.ParticipantsA total of 444 patients aged 16–75 years seen in cardiology, endocrinology, gastroenterology, neurology and respiratory medicine clinics who scored ≥ 20 points on the Health Anxiety Inventory (HAI) and satisfied diagnostic requirements for hypochondriasis. Those with current psychiatric disorders were excluded, but those with concurrent medical illnesses were not.InterventionsCognitive–behaviour therapy for health anxiety – between 4 and 10 1-hour sessions of CBT-HA from a health professional or psychologist trained in the treatment. Standard care was normal practice in primary and secondary care.Main outcome measuresPrimary – researchers masked to allocation assessed patients at baseline, 3, 6, 12, 24 months and 5 years. The primary outcome was change in the HAI score between baseline and 12 months. Main secondary outcomes – costs of care in the two groups after 24 and 60 months, change in health anxiety (HAI), generalised anxiety and depression [Hospital Anxiety and Depression Scale (HADS)] scores, social functioning using the Social Functioning Questionnaire and quality of life using the EuroQol-5 Dimensions (EQ-5D), at 6, 12, 24 and 60 months, and deaths over 5 years.ResultsOf the 28,991 patients screened over 21 months, 5769 had HAI scores of ≥ 20 points. Improvement in HAI scores at 3 months was significantly greater in the CBT-HA group (mean number of sessions = 6) than in the standard care, and this was maintained over the 5-year period (overallp < 0.0001), with no loss of efficacy between 2 and 5 years. Differences in the generalised anxiety (p = 0.0018) and depression scores (p = 0.0065) on the HADS were similar in both groups over the 5-year period. Gastroenterology and cardiology patients showed the greatest CBT gains. The outcomes for nurses were superior to those of other therapists. Deaths (n = 24) were similar in both groups; those in standard care died earlier than those in CBT-HA. Patients with mild personality disturbance and higher dependence levels had the best outcome with CBT-HA. Total costs were similar in both groups over the 5-year period (£12,590.58 for CBT-HA; £13,334.94 for standard care). CBT-HA was not cost-effective in terms of quality-adjusted life-years, as measured using the EQ-5D, but was cost-effective in terms of HAI outcomes, and offset the cost of treatment.LimitationsMany eligible patients were not randomised and the population treated may not be representative.ConclusionsCBT-HA is a highly effective treatment for pathological health anxiety with lasting benefit over 5 years. It also improves generalised anxiety and depressive symptoms more than standard care. The presence of personality abnormality is not a bar to successful outcome. CBT-HA may also be cost-effective, but the high costs of concurrent medical illnesses obscure potential savings. This treatment deserves further research in medical settings.Trial registrationCurrent Controlled Trials ISRCTN14565822.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 50. See the NIHR Journals Library website for further project information.

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