Assessing Costs Using the Treatment Inventory Cost in Psychiatric Patients (TIC-P), TIC-P Mini and TIC-P Midi.

BACKGROUND: The Treatment Inventory Cost in Psychiatric patients (TIC-P) instrument is designed to measure societal costs in patients with psychiatric disorders and to be applied in economic evaluations. Efforts have been made to minimize respondents' burden by reducing the number of questions and meanwhile retaining the comprehensiveness of the instrument. Previously, a TIC-P Mini version and a TIC-P Midi version were developed and tested in a predominantly inpatient patient population. AIMS OF THE STUDY: The aims of this study are to examine the comprehensiveness of the abridged questionnaires in estimating the societal costs for patients with anxiety or depressive disorders and to assess the impact of productivity costs on the total costs. METHODS: The comprehensiveness of the abridged versions of the TIC-P was assessed in four populations: a group of primary care patients with anxiety disorders (n=175) and three groups of patients with major depressive disorders in various outpatient settings (n=140; n=125; and n=79). Comprehensiveness was measured using the proportion of total health care costs and productivity costs covered by the abridged versions compared to the full-length TIC-P. Costs were calculated according to the guidelines for costing studies using the Dutch costing manual. RESULTS: Our results showed that the TIC-P Mini covered 26%-64% of health care costs and the TIC-P Midi captured 54%-79% of health care costs. Health care costs in these populations were predominantly dispersed over primary care, outpatient hospital care, outpatient specialist care and inpatient hospital care. The TIC-P Midi and TIC-P Mini captured 22% and 0% of primary care costs respectively. In contrast, inpatient hospital care costs and outpatient specialist mental health care costs were almost fully included in the abridged versions. Costs due to lost productivity as measured by the full-length TIC-P were substantial, representing 38% to 92% of total costs. DISCUSSION: A reduction of the number of items resulted in a substantial loss in the ability to measure health care costs compared to the full-length TIC-P, because these outpatient populations consumed health care from a variety of health care providers. Two limitations of the study need to be stressed. Firstly, the number of patients in each of the four studies was relatively small. However, results were consistent over the four studies despite the small number of patients. Secondly, we did not take costs of medication into account. IMPLICATIONS FOR HEALTH POLICIES: In developing mental health policy, it is important to include considerations on cost-effectiveness. Increasing the evidence on instruments to measure costs from a societal perspective may support policymakers to adopt a broader perspective. IMPLICATIONS FOR FURTHER RESEARCH: The TIC-P Mini is not suitable to capture health care costs in outpatients with anxiety or depressive disorders. The comprehensiveness of TIC-P Midi compared to the full-length TIC-P varied. The TIC-P Midi should therefore be revised in order to better capture costs in all patient groups.

Cost-effectiveness of the treatments for critical limb ischemia in the elderly population.

OBJECTIVE: The treatment of critical limb ischemia (CLI), with the intention to prevent limb loss, is often an intensive and expensive therapy. The aim of this study was to examine the cost-effectiveness of endovascular and conservative treatment of elderly CLI patients unsuitable for surgery. METHODS: In this prospective observational cohort study, data were gathered in two Dutch peripheral hospitals. CLI patients aged 70 years or older were included in the outpatient clinic. Exclusion criteria were malignant disease, lack of language skills, and cognitive impairment; 195 patients were included and 192 patients were excluded. After a multidisciplinary vascular conference, patients were divided into three treatment groups (endovascular revascularization, surgical revascularization, or conservative therapy). Subanalyses based on age were made (70-79 years and ≥80 years). The follow-up period was 2 years. Cost-effectiveness of endovascular and conservative treatment was quantified using incremental cost-effectiveness ratios (ICERs) in euros per quality-adjusted life-years (QALYs). RESULTS: At baseline, patients allocated to surgical revascularization had better health states, but the health states of endovascular revascularization and conservative therapy patients were comparable. With an ICER of €38,247.41/QALY (∼$50,869/QALY), endovascular revascularization was cost-effective compared with conservative therapy. This is favorable compared with the Dutch applicable threshold of €80,000/QALY (∼$106,400/QALY). The subanalyses also established that endovascular revascularization is a cost-effective alternative for conservative treatment both in patients aged 70 to 79 years (ICER €29,898.36/QALY; ∼$39,765/QALY) and in octogenarians (ICER €56,810.14/QALY; ∼$75,557/QALY). CONCLUSIONS: Our study has shown that endovascular revascularization is cost-effective compared with conservative treatment of CLI patients older than 70 years and also in octogenarians. Given the small absolute differences in costs and effects, physicians should also consider individual circumstances that can alter the outcome of the intervention. Cost-effectiveness remains one of the aspects to take into consideration in making a clinical decision.

Development and Validation of the Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) Questionnaire.

Health-related quality of life (HRQoL) is important in the management of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Disease-specific questionnaires exist, but with important shortcomings. The aim of this study was to develop and validate a questionnaire suitable for use in all patients with BCC and those with SCC. In a 4-phase trajectory, a preliminary questionnaire was created and population-based testing (1,173 patients) carried out. The questionnaire was reduced using exploratory factor analysis and item response theory. Individual item performance was assessed using classical test theory. A total of 721 patients completed the questionnaire. The number of items was reduced to 16, covering 5 scales. Confirmatory factor analysis showed a good fit. Cronbach�s ?s (range 0.67�0.82) were reasonable to high with good internal consistency. In conclusion, the Basal and Squamous Cell Carcinoma Quality of Life questionnaire has good face, content and construct validity. It is useful in the wide range of BCC and SCC patients and captures HRQoL impact over different time-frames.

Does non-adherence to DMARDs influence hospital-related healthcare costs for early arthritis in the first year of treatment?

INTRODUCTION: Non-adherence to disease-modifying antirheumatic drugs (DMARDs) is suspected to relate to health care costs. In this study we investigated this relation in the first year of treatment. METHODS: In a multi-center cohort study with a one year follow up, non-adherence was continuously measured using electronic monitored medication jars. Non-adherence was defined as the number of days with a negative difference between expected and observed opening of the container. Cost measurement focused on hospital costs in the first year: consultations, emergency room visits, hospitalization, medical procedures, imaging modalities, medication costs, and laboratory tests. Cost volumes were registered from patient medical files. We applied multivariate regression analyses for the association between non-adherence and costs, and other variables (age, sex, center, baseline disease activity, diagnosis, socioeconomic status, anxiety and depression) and costs. RESULTS: Of the 275 invited patients, 206 were willing to participate. 74.2% had rheumatoid arthritis, 20.9% had psoriatic arthritis and 4.9% undifferentiated arthritis. 23.7% of the patients were more than 20% non-adherent over the follow-up period. Mean costs are € 2117.25 (SD € 3020.32). Non-adherence was positively related to costs in addition to baseline anxiety. CONCLUSION: Non-adherence is associated with health care costs in the first year of treatment for arthritis. This suggests that improving adherence is not only associated with better outcome, but also with savings.

Burden of Keloid Disease: A Cross-sectional Health-related Quality of Life Assessment.

Keloid scars may be painful, itch severely and be cosmetically disturbing. The burden of keloid disease, however, has not yet been determined. This study evaluated the association of keloid disease with health-related quality of life (HRQL) and identified indicators of burden using a cross-sectional survey study, with one disease-specific HRQL measure (Skindex-29) and 2 generic HRQL measures (SF-36 and EQ-5D-5L). A total of 106 keloid patients with no other skin diseases participated in the study. Having keloid disease was associated with a considerable impairment of emotional wellbeing, with most impairment on the emotional and mental HRQL. Pain and itch were the strongest indicators of HRQL impairment in keloid patients. Having painful or itchy keloids was related to low mental and emotional HRQL, implying that patients with keloids require access to effective treatment aimed at alleviating physical symptoms.

Validation, test-retest reliability and norm scores for the Dutch Catquest-9SF.

PURPOSE: The Catquest-9SF questionnaire is a unidimensional, reliable, valid and short patient-reported outcome measure for quantifying benefits in visual functioning from cataract surgery. Our aim was to develop a formal Dutch translation, calculate norm scores, assess its validity and test-retest reliability and provide an easy way for use in clinical practice. METHODS: Translation of the questionnaire was performed according to guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Catquest-9SF was obtained in 657 patients pre- and postcataract surgery. We applied Rasch and classical analyses to determine the questionnaire performance with characteristics such as unidimensionality, reliability, separation and differential item functioning. Test-retest reliability was assessed in another group of 145 patients. A cut-off value to discriminate between people with and without cataract, norm scores and a reliable change index (RCI) were calculated using data from a sample of 916 'healthy' persons from the normal population. RESULTS: The Dutch Catquest-9SF was unidimensional, and both person and item reliability were high; 0.87 and 0.99, respectively. Cronbach's alpha was 0.94, test-retest reliability was 0.85 and the intraclass correlation coefficient was 0.93. Catquest-9SF showed to be responsive to the effect of cataract surgery (effect size = 1.27; p < 0.001). The cut-off value was -1.90, and RCI was 2.27. A quick-access table with norm scores and percentiles was established to facilitate clinical interpretation. CONCLUSION: This investigation provides validity and reliability of the Dutch Catquest-9SF as well as norm scores and a new tool to facilitate the clinical interpretation of patient scores. This makes Catquest-9SF suitable for routine use in clinical practice.

Development of the Treatment Inventory of Costs in Psychiatric Patients: TIC-P Mini and Midi.

BACKGROUND: Medical costs of (psychiatric) illness can be validly measured with patient report questionnaires. These questionnaires comprise many detailed items resulting in lengthy administrations. OBJECTIVES: We set out to find the minimal number of items needed to retrieve 80% and 90% of the costs as measured by the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P). METHODS: The TIC-P is a validated patient-reported outcome measure concerning the utilization of medical care and productivity losses. The present study focused on direct medical costs. We applied data of 7756 TIC-P administrations from three studies in patients with mental health care issues. Items that contribute least to the total cost were eliminated, providing that 80% and 90% of the total cost was retained. RESULTS: Average medical costs per patient were €658 over the last 4 weeks. The distribution of cost was highly skewed, and 5 of the 14 items of the TIC-P accounted for less than 10% of the total costs. The 80% Mini version of the TIC-P required five items: ambulatory services, private practice, day care, general hospital, and psychiatric clinic. The TIC-P Midi 90% inventory required eight items. Both had variance between the three samples in the optimal choice of the items. CONCLUSIONS: The number of items of the TIC-P can be reduced considerably while maintaining 80% and 90% of the medical costs estimated by the complete TIC-P. The reduced length makes the questionnaire more suitable for routine outcome monitoring.

Day hospital Mentalization-based treatment versus intensive outpatient Mentalization-based treatment for patients with severe borderline personality disorder: protocol of a multicentre randomized clinical trial.

BACKGROUND: Borderline personality disorder (BPD) is associated with a high socioeconomic burden. Although a number of evidence-based treatments for BPD are currently available, they are not widely disseminated; furthermore, there is a need for more research concerning their efficacy and cost-effectiveness. Such knowledge promises to lead to more efficient use of resources, which will facilitate the effective dissemination of these costly treatments. This study focuses on the efficacy and cost-effectiveness of Mentalization-Based Treatment (MBT), a manualized treatment for patients with BPD. Studies to date have either investigated MBT in a day hospitalization setting (MBT-DH) or MBT offered in an intensive outpatient setting (MBT-IOP). No trial has compared the efficacy and cost-effectiveness of these MBT programmes. As both interventions differ considerably in terms of intensity of treatment, and thus potentially in terms of efficacy and cost-effectiveness, there is a need for comparative trials. This study therefore sets out to investigate the efficacy and cost-effectiveness of MBT-DH versus MBT-IOP in patients with BPD. A secondary aim is to investigate the association between baseline measures and outcome, which might improve treatment selection and thus optimize efficacy and cost-effectiveness. METHODS/DESIGN: A multicentre randomized controlled trial comparing MBT-DH versus MBT-IOP in severe BPD patients. Patients are screened for BPD using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders, and are assessed before randomization, at the start of treatment and 6, 12, 18, 24, 30 and 36 months after the start of treatment. Patients who refuse to participate will be offered care as usual in the same treatment centre. The primary outcome measure is symptom severity as measured by the Brief Symptom Inventory. Secondary outcome measures include parasuicidal behaviour, depression, substance use, social, interpersonal, and personality functioning, attachment, mentalizing capacities, and quality of life. All analyses will be conducted based on the intention-to-treat principle. Cost-effectiveness will be calculated based on costs per quality-adjusted life-year. DISCUSSION: This multisite randomized trial will provide data to refine criteria for treatment selection for severe BPD patients and promises to optimize (cost-)effectiveness of the treatment of BPD patients. TRIAL REGISTRATION: NTR2292 . Registered 16 April 2010.

Assessment of surgery residents' operative skills in the operating theater using a modified Objective Structured Assessment of Technical Skills (OSATS): a prospective multicenter study.

BACKGROUND: With the implementation of competency-based curricula, Objective Structured Assessment of Technical Skills (OSATS) increasingly is being used for the assessment of operative skills. Although evidence for its usefulness has been demonstrated in experimental study designs, data supporting OSATS application in the operating room are limited. This study evaluates the validity and reliability of the OSATS instrument to assess the operative skills of surgery residents in the operating theater. METHODS: Twenty-four residents were recruited from seven hospitals within a general surgical training region and classified equally into three groups according to postgraduate training year (PGY). Each resident had to perform five different types of operations. Surgical performance was measured using a modified OSATS consisting of three scales: Global Rating Scale, Overall Performance Scale, and Alphabetic Summary Scale. Validity and reliability metrics included construct validity (Kruskal-Wallis test) and internal consistency reliability (Cronbach's α coefficient). Spearman's correlation coefficients were calculated to determine correlations between the different scales. RESULTS: Eighteen residents (PGY 1-2 [n = 7]; PGY 3-4 [n = 8]; PGY 5-6 [n = 3]) performed 249 operations. Comparisons of the performance scores revealed that evidence for construct validity depended on the difficulty level of the selected procedures. For individual operations, internal consistency reliability of the Global Rating Scale ranged from 0.93 to 0.95. Scores on the different scales correlated strongly (r = 0.62-0.76, P < .001). CONCLUSION: Assessment of operative skills in the operating theater using this modified OSATS instrument has the potential to establish learning curves, allowing adequate monitoring of residents' progress in achieving operative competence. The Alphabetic Summary Scale seems to be of additional value. Use of the Overall Performance Scale should be reconsidered.

Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P).

BACKGROUND: Patient self-report allows collecting comprehensive data for the purpose of performing economic evaluations. The aim of the current study was to assess the feasibility, reliability and a part of the construct validity of a commonly applied questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder (TiC-P). METHODS: Data were derived alongside two clinical trials performed in the Netherlands in patients with mental health problems. The response rate, average time of filling out the questionnaire and proportions of missing values were used as indicators of feasibility of the questionnaire. Test-retest analyses were performed including Cohen's kappa and intra class correlation coefficients to assess reliability of the data. The construct validity was assessed by comparing patient reported data on contacts with psychotherapists and reported data on long-term absence from work with data derived from registries. RESULTS: The response rate was 72%. The mean time needed for filling out the first TiC-P was 9.4 minutes. The time needed for filling out the questionnaire was 2.3 minutes less for follow up measurements. Proportions of missing values were limited (< 2.4%) except for medication for which in 10% of the cases costs could not be calculated. Cohen's kappa was satisfactory to almost perfect for most items related to healthcare consumption and satisfactory for items on absence from work and presenteeism. Comparable results were shown by the ICCs on variables measuring volumes of medical consumption and productivity losses indicating good reliability of the questionnaire.Absolute agreement between patient-reported data and data derived from medical registrations of the psychotherapists was satisfactory. Accepting a margin of +/- seven days, the agreement on reported and registered data on long-term absence from work was satisfactory. The validity of self-reported data using the TiC-P is promising. CONCLUSIONS: The results indicate that the TiC-P is a feasible and reliable instrument for collecting data on medical consumption and productivity losses in patients with mild to moderate mental health problems. Additionally, the construct validity of questions related to contacts with psychotherapist and long-term absence from work was satisfactory.

Somatic complaints and social competence predict success in childhood overweight treatment.

OBJECTIVE: To determine baseline predictors of treatment success in terms of Body Mass Index-Standard Deviation Scores (BMI-SDS) in a multidisciplinary family-based behavioural lifestyle intervention for overweight and obese children. METHODS: Overweight and obese children (N = 248; age 8-14 years) and their caregivers participated in a prospective study and attended a lifestyle intervention. Baseline data assessment included anthropometrics, demographics, breakfast behaviour, competence and behavioural problems (Child Behaviour Checklist [CBCL]), family functioning (Family Adaptability and Cohesion Evaluation Scales [FACES] III), and personality (Dutch Personality Questionnaire-Youth [NPV-J]). BMI-SDS was measured at start and after 3, 9, and 12 months of treatment. Mixed modelling was used for analysis. RESULTS: Greater BMI-SDS reductions over the course of one year were found in children with Caucasian parents, with lower baseline BMI-SDS, and higher CBCL-social competence scores. Furthermore, children with non-overweight parents, younger children, and children with lower CBCL-somatic scores were more successful in BMI-SDS reduction. No effects on treatment success were found for the number or position of siblings, having divorced parents or a working mother, educational level of the parents, breakfast behaviour, family functioning, and personality. CONCLUSIONS: These results suggest that screening for baseline characteristics in childhood obesity treatment could identify who will benefit most from a paediatric lifestyle intervention. Tailored programs should be developed and the treatment team should focus on children who are less successful in achieving weight reductions. Future research should study by which mechanisms somatic complaints and social competence influence treatment success.

Myotonic dystrophy: the burden for patients and their partners.

OBJECTIVE: Dystrophia myotonica is characterized by progressive muscular weakness, myotonia, mental slowness and lack of initiative, which causes problems in daily life both for patients and for their spouses. Some couples seem to deal with these problems satisfactorily, while for others they are quite burdensome. The aim of this study was to describe the relationship of severity of dystrophia myotonica and psychological wellbeing in patients and partners. METHODS: Sixty-nine couples, in whom one partner had dystrophia myotonica, completed questionnaires on severity of dystrophia myotonica, marital satisfaction, anxiety and depression (Hospital Anxiety and Depression Scale), hopelessness (Beck Hopelessness Scale) and general psychological health (General Health Questionnaire-12). RESULTS: For patients, a worse view of the future, worse general wellbeing, more anxiety and more depression was associated with a greater need for help. For partners, worse general wellbeing and more anxiety was associated with a lack of initiative of the patient and less marital satisfaction. It is noteworthy that 40% of patients and particularly female partners had Beck Hopelessness Scale scores suggestive of clinically relevant depression. CONCLUSION: Dystrophia myotonica places a heavy burden on patients, and especially on female partners. The need for help and dependency has more influence on the wellbeing of patients than the symptoms of dystrophia myotonica themselves. Marital satisfaction is a strong predictor of better wellbeing, both for patients and, even more so, for partners.

High satisfaction rates in women after DIEP flap breast reconstruction.

BACKGROUND: Breast reconstruction (BR) is aimed at improving quality of life (QoL) after mastectomy. Patient satisfaction is an important indicator to evaluate the success of BR. This study explored patient satisfaction and its determinants in women undergoing deep inferior epigastric artery perforator (DIEP) flap BR as well as the impact of the procedure on body image, sexuality and QoL. METHODS: Patient satisfaction and QoL were studied in 72 women who underwent DIEP flap BR using a study-specific questionnaire as well as the Short Form-36 (SF-36). RESULTS: Patient satisfaction was very high. Approximately 90% of the patients reported that they had been sufficiently informed about the procedure and its consequences, that their preoperative expectations had been met, that the reconstructed breast felt like their own and that they would choose the same procedure again and would recommend this procedure to a friend. Patient satisfaction was positively and significantly related to the reconstructed breast(s) feeling like their own. Women with secondary reconstructions were more positive about changes in sexuality and femininity than women with primary BRs. There were no clinically relevant differences in QoL between our study population and a random sample of Dutch females. CONCLUSIONS: Women with DIEP flap BRs reported high satisfaction rates. However, to compare these satisfaction rates with other forms of BR, prospective studies in comparable groups are necessary.

Behavioural problems in Huntington's disease using the Problem Behaviours Assessment.

OBJECTIVE: To investigate behavioural problems in Huntington's disease (HD). METHOD: In 152 HD mutation carriers and a control group of 56 noncarriers at initial 50% risk, the Dutch version of the Problem Behaviours Assessment (PBA) was administered. Mutation carriers were divided into three groups according to the motor section of the Unified Huntington's Disease Rating Scale (UHDRS): pre-(motor) symptomatic, early and advanced symptomatic subjects. The factor structure and interrater reliability of the PBA were investigated. RESULTS: The clinically relevant interrater reliability of the PBA was 0.82 for severity scores and 0.73 for frequency scores. The PBA showed a three-factor solution: apathy, depression and irritability. Mutation carriers, including presymptomatic subjects, portrayed more apathy, depression and irritability than noncarriers. Early symptomatic subjects had more apathy, but not more depression or irritability, compared to presymptomatic subjects. Advanced symptomatic subjects had more apathy than early symptomatic subjects. CONCLUSIONS: The PBA is a reliable and sensitive instrument. Behavioural problems occur in all stages of HD and arise before the onset of motor symptoms. Apathy is related to disease severity, whereas depression and irritability are not. The broad clinical phenotype of HD therefore requires adequate service delivery with integrated and multidisciplinary patient care.

Assessment of the burden of disease among inpatients in specialized units that provide psychotherapy.

The burden of disease of 1,651 inpatients in the Netherlands who had complex personality problems and personality disorders and who were treated in specialized units that provide psychotherapy was compared with the burden of disease of patients with other mental and physical conditions. Patients completed the EuroQol EQ-5D, a generic quality-of-life questionnaire. The mean EQ-5D index score was .54 (possible scores range from -.59 to 1.00, with higher scores indicating fewer problems). This score reflects a burden of disease comparable with the burden in severe illnesses, such as Parkinson's disease (.58) or rheumatic disease (.53).