Internet-delivered exposure-based cognitive behaviour therapy (ICBT) has been shown to be effective in the treatment of severe health anxiety. The health economic effects of the treatment have, however, been insufficiently studied and no prior study has investigated the effect of ICBT compared with an active psychological treatment. The aim of the present study was to investigate the cost effectiveness of ICBT compared with internet-delivered behavioural stress management (IBSM) for adults with severe health anxiety defined as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) hypochondriasis. ICBT was hypothesised to be the more cost-effective treatment.
This was a cost-effectiveness study within the context of a randomised controlled trial conducted in a primary care/university setting. Participants from all of Sweden could apply to participate.
Self-referred adults (N=158) with a principal diagnosis of DSM-IV hypochondriasis, of whom 151 (96%) provided baseline and post-treatment data.
ICBT or IBSM for 12 weeks.
The primary outcome was the Health Anxiety Inventory. The secondary outcome was the EQ-5D. Other secondary measures were used in the main outcome study but were not relevant for the present health economic analysis.
Both treatments led to significant reductions in gross total costs, costs of healthcare visits, direct non-medical costs and costs of domestic work cutback (p=0.000-0.035). The incremental cost-effectiveness ratio (ICER) indicated that the cost of one additional case of clinically significant improvement in ICBT compared with IBSM was $2214. The cost-utility ICER, that is, the cost of one additional quality-adjusted life year, was estimated to be $10,000.
ICBT is a cost-effective treatment compared with IBSM and treatment costs are offset by societal net cost reductions in a short time. A cost-benefit analysis speaks for ICBT to play an important role in increasing access to effective treatment for severe health anxiety.
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The goal of this study was to validate an instrument measuring the clinical burden of several medical problems in the same patient (multimorbidity), in a family practice context and, more specifically, to verify if trained nurses can score the Cumulative Illness Rating Scale (CIRS) from chart review.
A convenience sample of 40 patients was selected. The attending physicians scored the CIRS during clinical interview (CIRS-MD/I), then three nurses scored the CIRS during clinical interview (CIRS-NUR/I) and three other nurses scored the CIRS from chart review (CIRS-NUR/C) (interrater reliability). Two of these nurses scored the CIRS-NUR/C again 2 months later (intrarater reliability).
For interrater reliability, the intraclass correlation coefficients were 0.81 (0.70-0.89) for the CIRS-NUR/I and 0.78 (0.66-0.87) for the CIRS-NUR/C. The intrarater reliability of the CIRS-NUR/C was 0.89 (0.80-0.94) for one of the nurses and 0.80 (0.65-0.89) for the other. Concomitant validity of these two forms of CIRS with the CIRS-MD/I ranged from 0.73 to 0.84.
The CIRS appears to be a reliable and valid instrument in a primary care context and trained nurses can score the CIRS from chart review.
Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial.
Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed. Recently, the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms. The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes, but had fewer manic symptoms during the trial. It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage, social activity, physical activity, and mobility. The Monsenso system, for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial.
The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the control group during the trial. Ethical permission has been obtained. Positive, neutral and negative findings will be published.
If the system is effective in reducing depressive and/or manic symptoms (and other symptoms of bipolar disorder) and the rate of episodes, there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale.
ClinicalTrials.gov NCT02221336. Registered 26th of September 2014.
Cites: Lancet. 2002 Feb 16;359(9306):614-811867132
An instrument of assessing the cognitive status of the severely demented is needed.
To validate the Danish version of the cognitive part of the Baylor Profound Mental State Examination (BPMSE-cog).
Participants were residents in dementia care units. The Mini-Mental State Examination (MMSE), the Severe Impairment Battery (SIB), the Geriatric Deterioration Scale (GDS) and the Disability Assessment of Dementia (DAD) were co-administered. Three assessments were performed: at baseline, 1 week and 6 months later. At visits 1 and 3, participants were assessed blinded by a geriatric psychiatrist (GDS, MMSE and diagnosis) and by a registered nurse (BPMSE-cog, SIB, DAD). At visit 2, assessments were made by the RN only. Test-retest and inter-rater reliabilities were calculated. External validity was assessed in terms of correlation to MMSE, SIB, GDS and DAD; internal validity was assessed using Cronbach's alpha, Mokken/Loevinger coefficients and the item response analysis.
Inter-rater reliability and test-retest reliability were very high for total scale as well as for the subscales. The external validity was satisfactory with correlation coefficients: MMSE: 0.74; SIB: 0.89; the GDS 0.83; DAD: 0.67 (P
Liver biopsy is the primary method of assessing liver injury in hepatitis C patients. FIBROSpect II (FS), a diagnostic panel of three extracellular matrix remodelling markers, may be useful as a noninvasive alternative to this procedure. The purpose of this study was to correlate FS results with liver fibrosis scores to determine if this test is sufficiently accurate to be a viable alternative to liver biopsy. A total of 142 serum specimens were evaluated for fibrosis with FS and were compared with Knodell and Ishak fibrosis scores. FS reports an index score ranging from 0.1 to 1.0, which corresponds to the probability of progressive liver fibrosis. Using a FS index cut-off of 0.42, 50 of 54 patients with Ishak 3-6 were classified as having advanced fibrosis (METAVIR F2-F4) and 58 of 88 patients with Ishak 0-2 as having no/mild fibrosis (METAVIR F0-F1), resulting in a sensitivity of 93%, specificity of 66%, and an overall test accuracy of 76%. With a 38% prevalence of advanced fibrosis, the negative predictive value was 94% and positive predictive value was 63%. A biopsy length of > or = 2 cm was associated with higher concordance between FS results and liver fibrosis scores (P = 0.01). FS was clinically useful in ruling out advanced fibrosis in hepatitis C by identifying patients with mild disease in whom treatment could be deferred. The limitation of this test is its decreased sensitivity and specificity in the middle of the test's reporting range between scores of 0.42 and 0.80.
The aim was to determine the effect of one weekly hour of specific strength training within working hours, performed with the same total training volume but with different training frequencies and durations, or with different levels of supervision, on compliance, muscle health and performance, behavior and work performance. In total, 573 office workers were cluster-randomized to: 1 WS: one 60-min supervised session/week, 3 WS: three 20-min supervised sessions/week, 9 WS: nine 7-min supervised sessions/week, 3 MS: three 20-min sessions/week with minimal supervision, or REF: a reference group without training. Outcomes were diary-based compliance, total training volume, muscle performance and questionnaire-based health, behavior and work performance. Comparisons were made among the WS training groups and between 3 WS and 3 MS. If no difference, training groups were collapsed (TG) and compared with REF. Results demonstrated similar degrees of compliance, mean(range) of 39(33-44)%, and total training volume, 13.266(11.977-15.096)kg. Musculoskeletal pain in neck and shoulders were reduced with approx. 50% in TG, which was significant compared with REF. Only the training groups improved significantly their muscle strength 8(4-13)% and endurance 27(12-37)%, both being significant compared with REF. No change in workability, productivity or self-rated health was demonstrated. Secondary analysis showed exercise self-efficacy to be a significant predictor of compliance. Regardless of training schedule and supervision, similar degrees of compliance were shown together with reduced musculoskeletal pain and improved muscle performance. These findings provide evidence that a great degree of flexibility is legitimate for companies in planning future implementation of physical exercise programs at the workplace. ClinicalTrials.gov, number NCT01027390.
Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents.
This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months.
This study is designed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy. If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective, it may serve as a basis for optimising the clinical pathway for those suffering from the condition, where specific emphasis can be placed on early diagnosis and early treatment.
clinicaltrials.gov reference: NCT01438762.
Cites: Am J Physiol Heart Circ Physiol. 2000 Jun;278(6):H2039-4910843903
To investigate the clinical performance and safety of a new silver-containing wound-contact layer, Physiotulle -Ag (Coloplast), in the treatment of chronic venous leg ulcers with delayed healing and signs of critical colonisation.
This was an open prospective non-comparative multicentre clinical study. Patients were treated for four weeks with Physiotulle -Ag, which was covered by Alione Hydrocapillary Dressing (Coloplast).
Thirty patients were recruited into the study. One ulcer healed after three weeks of treatment. The mean relative ulcer area reduced by 55% after four weeks. Over the study period the mean amount of healthy granulation tissue increased from 26% to 62%, and the mean amount of fibrin decreased from 63% to 32%. The ratio of malodorous wounds was 50% at inclusion, 20% after one week and 3% after four weeks. The dressing was considered easy or very easy to apply in 100% and easy to remove in 89% of dressing evaluations. The dressing combination showed good exudate-management properties. Incidence and severity of maceration, erythema and eczema decreased during the study and no device-related adverse events were recorded.
Physiotulle -Ag is safe and easy to use in chronic venous leg ulcers in which healing is delayed and with signs of critical colonisation.
This study investigated effects of physical exercise on musculoskeletal pain symptoms in all regions of the body, as well as on other musculoskeletal pain in association with neck pain. A single blind randomized controlled trial testing a one-year exercise intervention was performed among 549 office workers; specific neck/shoulder resistance training, all-round physical exercise, or a reference intervention. Pain symptoms were determined by questionnaire screening of twelve selected body regions. Case individuals were identified for each body region as those reporting pain intensities at baseline of 3 or more (scale of 0-9) during the last three months. For neck cases specifically, the additional number of pain regions was counted. Intensity of pain decreased significantly more in the neck, low back, right elbow and right hand in cases of the two exercise groups compared with the reference group (P
The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial).
Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis.
One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life.
These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load, pain and physical function in people with mild to moderate knee osteoarthritis.