Design and participant
The total details of the study are reported elsewhere (12, 13). In short, this study is designed with two parallel cancer, DBT and tau to be practical, single blind, random, controlled multi -center test, and cost and effects at the baseline (T)0), Late 6 months (t6) And 12 months follow -up (T12).
Participants were recruited from six Dutch mental health services between September 2018 and December 2022. The eligibility participants were adults who treated ASDs with suicidal actions that were diagnosed with ASD from the entry of all national guidelines (15). The diagnostic state was confirmed by autism-spectrum index (AQ-Short) 16. Suicide behavior was evaluated by suicide idea properties score (SIDAS score ≥ 21) and lifetime parasite count (LPC) 18. The exclusion criteria were evaluated as WAIS-IV only if IQ <80 was difficult to test the baseline due to an intellectual deficit (19); (2) Pharmaceutical addiction and clinical detoxification; (3) Inadequate commands in the Dutch language.
Eligible participants (N = 123) signed a preliminary consent and was randomly assigned to DBT.N= 63))Or number (N= 60). Parnassia Psychiatric Institute’s Independent Random Random Random Arts www.randomizer.org. The evaluator is hidden randomly. This study was registered in ISRCTN.com (ISRCTN96632579) and approved by the Medical Ethics Committee of the VRIJE Universityititeit Medical Center (NL59497.029.17).
arbitration
Dbt
DBT has been provided as a time limit mediation for up to six months. Intervention is based on four components of a comprehensive DBT, A) Weekly 45-minute individual cognitive-Haral psychological therapy session and primary therapist, b) Weekly 2 H15 technical training groups, C) access to telephone coaching with individual therapists when necessary, D) Counseling by week 1-Therapist consultation (14). Participants who were randomly assigned to the DBT group received two pre -processing sessions and two pretreatment sessions and prepared for the demands and expectations of the DBT. This process included learning the structure, components and goals of treatment to customers. Individual psychological therapy is conducted every week and focuses on motivation problems, including motivation to survive and maintain treatment. NEACSIU (2014) Emotional Control Technology Training (20) The group’s group technology training was introduced for two weeks. This format provides a wide range of opportunities for feedback, rehearsal and practice, ultimately improving technical learning that suits the needs of autism (21). During the follow -up period, participants continued to use various health services provided by the general opening, social and other medical service providers.
Acquire
The control group was treated as usual and included at least 45 -minute sessions with psychotherapists or social workers. Tau covered the general form of treatment of autism suicidal behavior in the Dutch mental health system, ensuring the realistic reflection of the current clinical practice in terms of form and intensity (eg, psychological education, social technical training, emotional regulatory therapy, cognitive behavioral therapy, trauma therapy, group, group and individual forms). Tau was not a time limited intervention, but it lasted a long time as long as customers and therapists were needed.
Therapist
Treatment was treated by mental health experts who worked in professional services for autism. All experts in both conditions had a great experience in autism, and were psychologists, psychiatrists or social psychiatric nurses.
result
Quality adjusted life
Quality adjustment life (QALYS) was the main result of CUA (cost utility analysis). QALYS was calculated as a participant’s response to the EQ-5D-3L questionnaire 22.0), (t6) And subsequent measures (T12). EQ-5D-3L has five domains (mobility, self-management, general activity, pain/inconvenience and anxiety/depression), and each level has three levels (no problem, some problems, serious problems).5= 243 You can define your health. The EQ-5D-3L health status has been converted to the utility (weight of life) with the Dutch tariff 23. Utility is fixed in 0 (death) and 1 (full health), but negative utility scores may occur in health conditions that are considered worse than death. The utility was obtained from the three measurement points, and the QALY gain was calculated using the area under the curved method over the 12 -month trace time.
Therapeutic reaction
The influence of cost efficiency (CEA) was measured in terms of suicide ideas for 12 months using SIDAS 17, a suicide idea properties scale. SIDAS is composed of five items and aims to affect the properties of suicide thoughts, that is, the frequency, control possibilities, intimacy with attempts, pain levels related to thoughts, and everyday functions. The score of ≥ 21 increases the risk of suicide thoughts and the higher the score, the worse the suicide. For clinical and health economic interpretations, SIDAS has been converted into a ‘therapeutic response’ defined as a reduction in SIDAS symptoms.0 -T12 Time spacing plus SIDAS scores are lower than 20 in T.12That is, less than SIDAS critical value for suicide.
Resource use and cost calculation
Medical use was evaluated using the Trimbos Institute and Institute of Medical Technology Assessment questionnaire using a questionnaire on the cost related to the mental illness (TIC-P) questionnaire using a reliable scales for the test-based economy evaluation of the Netherlands Health Care (24, 25). Data was collected from T0t6And t12, We report medical use and drug use for 3 months with participants.
Medical costs were calculated in the latest Dutch guidelines for medical units (for example, GP visits, sessions with psychologists, and hospital stays) for 2023 standard cost prices, medical unit costs and health care (26) (online resource table S1). The cost of drugs per standard daily daily daily dose was obtained from the Dutch FarmacotherApeutisch Kompas (27) and added to the number of prescription days and added to the pharmacist’s distribution fee to € 7 (online resource table S1) per 90 -day prescription period.
The cost of patients and family comes from travel expenses related to medical visit and informal treatment of patient families. Travel costs were estimated using the average distance (KM) between the address and health service multiplied by the KM price (online resource table S2) of public transportation. Unofficial treatment was evaluated as € 18,80 per hour according to the method of replacing the Dutch guidelines for cost calculation and economic evaluation of medical 26 (online resource table S1).
Productivity loss occurs in absenteeism (work loss date) and presentation (less productively at work) (28). The latter was estimated by multiplying the number of time reported to be less productive by factors that reflect the level of non -efficiency during that time. The total cost of productivity loss was determined by multiplying 39,88 euros in paid tasks and multiplied by 39,88 euros and 18,80 euros in the unpaid work time, based on the method of cost calculation (26) (online resource table S1).
The supervision cost of the therapist who provides DBT is included in the analysis as part of the medical cost. The director is essential to maintain a well -established and effective treatment program. The supervision cost is € 123 per 45 -minute session, based on a total of 16 sessions for 12 hours each year, and each of the 6 therapist teams is an average of 10 patients. As a result, the annual supervision cost per patient is € 32,80.
Social costs are the sum of medical, patients and family costs and costs due to productivity loss.
analyze
Health economy evaluation was carried out in accordance with the Integrated Health Economy Evaluation Report Standard (29) (online Resource Table S3) for economic evaluation. The purchase power of € 1.00 was reported in the Netherlands in 2023, which corresponds to US $ 1.7299 (30). Since the subsequent time of the test did not exceed 12 months, the discount was not applied to the cost and effect. Economic evaluation was carried out from a medical and social point of view.
With N= 64 ARM, the study was driven to detect the standardized average difference of statistically D 0.50, which was statistically significant in the central clinical results (SIDA), but no power was supplied to test the cost difference. Therefore, inferences on group costs and effect differences and incremental cost efficiency ratios are based on probability medical decision -making approach using 2,500 boot strap replications without statistical hypothesis test.
The data from the outing of the study was transferred using a regression confrontation for analysis of treatment intentions. The regression confrontation is used to obtain the exact estimates of Y, the predictor of the predictor of the two types of prediction variable: 1) the predictor of the result y and 2) the predictor of the missing, and the prediction variable set of M. is used to obtain the exact estimates of Y. The latter is used to be completely randomly estimated, and when there is a psychological or economic characteristic, the latter is used to meet the MAR assumption. This approach is recommended by Demirtas (2004) 31. For individuals who were killed by suicide, QALY was set to 0 (ie, “death”) and treatment reactions (ie, “failed”). During the one -year period of the test, the cumulative cost and QALY gain were obtained in the area according to the curve method between T.0t6And t12. The difference in reference costs was not statistically adjusted to use the standard cost as a covenant, but it was considered to be allowed if it focused on changes in Zalys in QALYS over time. Thus, the potential impact of the standard cost imbalance on comparison between groups was considered limited. The 2,500 times boot straps, which are not associated with the unclear regression equation (of course), were used to simultaneously evaluate the group cost and effectiveness and to plot the effective efficiency ratio (ICERS) simulated in the cost efficiency plane. The ICER plane is divided into four four quadrants. If the bulk (> 50%) of the simulated ICER can be found in the southeast (SE) quadrant, it is understood that DBT generates more health at a low cost than TAU. From a point of view of cost efficiency, this is the most advantageous result. Then arbitration is called ‘dominant’ because it is a preferred treatment option.
If the masses of the simulated ICER are concentrated in the northeast (NE) quadrant, it indicates that more health is increased by intervention despite additional costs. This ‘more payment, get more’ rule is a general result in health and economic evaluation, and decision makers should decide whether to pay more to get more health. As a tool for decision makers, cost efficiency acceptance curves (CEAC) have been created. The CEACS evaluates the probability that intervention will be cost -effective throughout the ceiling to obtain one additional QALY or one additional treatment. In the Netherlands, the ceiling is willing to obtain one Qaly, depending on the severity of the state, from € 20,000 to € 80,000 (32). ASDs with suicide can be considered serious, but we have applied existing WTP thresholds of 50,000 euros per qaly per qaly because we have no documentary weight on suicide adult ASD (33).
All analysis was performed as Stata 17.0 (Statacorp, 2021).
Sensitivity analysis
In the preliminary planned sensitivity analysis, the basic case analysis was repeated using the confrontation of LOCF (Last Observation) to assess the robustness of the results in other confrontation strategies (12).
