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OBJECTIVE: This study was conducted with the objective of exploring the usage of health-related quality of life (HRQOL) outcomes and willingness of health technology assessment (HTA) and public health stakeholders to use the EQ-5D-5L instrument in healthcare decision-making processes in Vietnam. METHOD: In this qualitative study, 11 interviews were held with key stakeholders involved in healthcare decision-making for HTA between June 2021 and June 2022. The interviewees included members of the Vietnamese pharmacoeconomic council and public-health professionals from a diverse array of regions of Vietnam. The data collection involved obtaining verbal consent, warm-up discussions and interviews conducted via Zoom, with subsequent verification by interviewees. The analysis employed a theoretical thematic approach, adopting a deductive methodology to identify and analyse underlying ideas and meanings within the empirical data. RESULTS: This study highlights the general importance and viability of HRQOL measures, and more particularly the EQ-5D-5L instrument, in healthcare decision-making in Vietnam. Challenges have been identified, including insufficient recognition, interpretation, standardisation and educational initiatives relating to HRQOL measurements. This study advocates for official training programmes on HRQOL measurements, guidelines for the application of the EQ-5D-5L and an open HRQOL database in Vietnam. Concerns regarding validity and outcome variation in HRQOL measurements underline the necessity for continuous psychometric properties assessments and regular updates to national HRQOL data in the Vietnamese context. CONCLUSION: HRQOL outcomes are important, and Vietnamese stakeholders express a readiness to employ the EQ-5D-5L in healthcare decision-making, especially HTA. Nevertheless, HRQOL measurements, including the EQ-5D-5L, are currently inadequately used in Vietnam, and further efforts are required to improve utilisation.
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Tomada de Decisões , Pesquisa Qualitativa , Qualidade de Vida , Avaliação da Tecnologia Biomédica , Humanos , Vietnã , Masculino , FemininoRESUMO
BACKGROUND: Rheumatic heart disease (RHD) is a devastating yet preventable condition that disproportionately affects low-middle-income countries and indigenous populations in some high-income countries. Various preventive interventions have been implemented across the globe, but evidence for the effectiveness of these measures in reducing the incidence or prevalence of acute rheumatic fever and RHD is scattered. This systematic review aims to assess the effectiveness of preventive interventions and identify the strategies used to reduce the burden of RHD. METHODS AND RESULTS: A comprehensive search was conducted to identify relevant studies on RHD prevention interventions including interventions for primordial, primary, and secondary prevention. Effectiveness measures for the interventions were gathered when available. The findings indicate that school-based primary prevention services targeting the early detection and treatment of Group A Streptococcus pharyngitis infection with penicillin have the potential to reduce the incidence of Group A Streptococcus pharyngitis and acute rheumatic fever. Community-based programs using various prevention strategies also reduced the burden of RHD. However, there is limited evidence from low-middle-income countries and a lack of rigorous evaluations reporting the true impact of the interventions. Narrative synthesis was performed, and the methodological quality appraisal was done using the Joanna Briggs Institute critical appraisal tools. CONCLUSIONS: This systematic review underscores the importance of various preventive interventions in reducing the incidence and burden of Group A Streptococcus pharyngitis, acute rheumatic fever, and RHD. Rigorous evaluations and comprehensive analyses of interventions are necessary for guiding effective strategies and informing public health policies to prevent and reduce the burden of these diseases in diverse populations. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42020170503.
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Faringite , Febre Reumática , Cardiopatia Reumática , Infecções Estreptocócicas , Humanos , Cardiopatia Reumática/diagnóstico , Cardiopatia Reumática/epidemiologia , Cardiopatia Reumática/prevenção & controle , Febre Reumática/diagnóstico , Febre Reumática/epidemiologia , Febre Reumática/prevenção & controle , Infecções Estreptocócicas/epidemiologia , Infecções Estreptocócicas/prevenção & controle , Faringite/epidemiologia , Faringite/prevenção & controle , Faringite/complicações , Fatores de RiscoRESUMO
Several literature review studies have been conducted on cost-effectiveness threshold values. However, only a few are systematic literature reviews, and most did not investigate the different methods, especially in-depth reviews of directly eliciting WTP per QALY. Our study aimed to 1) describe the different direct approach methods to elicit WTP/QALY; 2) investigate factors that contribute the most to the level of WTP/QALY value; and 3) investigate the relation between the value of WTP/QALY and GDP per capita and give some recommendations on feasible methods for eliciting WTP/QALY in low- and middle-income countries (LMICs). A systematic review concerning select studies estimating WTP/QALY from a direct approach was carried out in seven databases, with a cut off date of 03/2022. The conversion of monetary values into 2021 international dollars (i$) was performed via CPI and PPP indexes. The influential factors were evaluated with Bayesian model averaging. Criteria for recommendation for feasible methods in LMICs are made based on empirical evidence from the systematic review and given the resource limitation in LMICs. A total of 12,196 records were identified; 64 articles were included for full-text review. The WTP/QALY method and values varied widely across countries with a median WTP/QALY value of i$16,647.6 and WTP/QALY per GDP per capita of 0.53. A total of 11 factors were most influential, in which the discrete-choice experiment method had a posterior probability of 100%. Methods for deriving WTP/QALY vary largely across studies. Eleven influential factors contribute most to the level of values of WTP/QALY, in which the discrete-choice experiment method was the greatest affected. We also found that in most countries, values for WTP/QALY were below 1 x GDP per capita. Some important principles are addressed related to what LMICs may be concerned with when conducting studies to estimate WTP/QALY.
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Análise Custo-Benefício , Países em Desenvolvimento , Análise Custo-Benefício/métodos , Países em Desenvolvimento/economia , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Produto Interno Bruto , Teorema de Bayes , RendaRESUMO
BACKGROUND: The SF-6D index can be used to calculate quality-adjusted life years in economic evaluations, which is required by reimbursement agencies and national advisory bodies, including the Swedish ones. However, despite that SF-36 has been largely applied among patients undergoing bariatric surgery, almost no study has accessed the short form six-dimensions (SF-6D) after bariatric surgery. AIM: To establish normative values for the SF-6D index among patients undergoing bariatric surgery. MATERIALS AND METHODS: All patients who received bariatric surgery in Sweden between 2011-01-01 and 2019-03-31 were obtained from the Scandinavian Obesity Surgery Registry (SOReg). Information includes patients' sociodemographic characteristics, details regarding the procedure, and postsurgical conditions. The SF-36 is applied at baseline and at follow-up years 1, 2, and 5. The multiple sequential imputation method was applied to handle missingness on SF-6D items. Based on the UK tariff, the SF-6D preference scores were calculated. The normative values for the mean (SD) SF-6D index were reported by timepoint and surgical complications for men and women, respectively. Multivariate analyses were applied to investigate how the SF-6D index is associated with timepoint, controlling for age, sex, BMI, and comorbidities in a stepwise manner. RESULTS: The SF-6D index increased at 1 year relative to baseline and was roughly maintained at the same level at 2 years. The normative value of the SF-6D index can be used in economic evaluations for bariatric surgery.
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Cirurgia Bariátrica , Obesidade Mórbida , Masculino , Humanos , Feminino , Qualidade de Vida , Obesidade Mórbida/cirurgia , Comorbidade , Sistema de Registros , Inquéritos e QuestionáriosRESUMO
PURPOSE: Our aim was to elicit a value set for Capability-Adjusted Life Years Sweden (CALY-SWE); a capability-grounded quality of life instrument intended for use in economic evaluations of social interventions with broad consequences beyond health. METHODS: Building on methods commonly used in the quality-adjusted life years EQ-5D context, we collected time-trade off (TTO) and discrete choice experiment (DCE) data through an online survey from a general population sample of 1697 Swedish participants. We assessed data quality using a score based on the severity of inconsistencies. For generating the value set, we compared different model features, including hybrid modeling of DCE and TTO versus TTO data only, censoring of TTO answers, varying intercept, and accommodating for heteroskedasticity. We also assessed the models' DCE logit fidelity to measure agreement with potentially less-biased DCE data. To anchor the best capability state to 1 on the 0 to 1 scale, we included a multiplicative scaling factor. RESULTS: We excluded 20% of the TTO answers of participants with the largest inconsistencies to improve data quality. A hybrid model with an anchor scale and censoring was chosen to generate the value set; models with heteroskedasticity considerations or individually varying intercepts did not offer substantial improvement. The lowest capability weight was 0.114. Health, social relations, and finance and housing attributes contributed the largest capability gains, followed by occupation, security, and political and civil rights. CONCLUSION: We elicited a value set for CALY-SWE for use in economic evaluations of interventions with broad social consequences.
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Nível de Saúde , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Anos de Vida Ajustados por Qualidade de Vida , Suécia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Breast cancer represents the most prevalent cancer among Swedish women. Although considerable research has investigated the cost-effectiveness of emerging innovative medical treatments for breast cancer, studies addressing existing surgical procedures remain scant. Therefore, this study aimed to evaluate the cost-effectiveness of three surgical procedures for in situ breast cancer treatment in Sweden: mastectomy, lumpectomy without irradiation, and lumpectomy with irradiation. METHODS: A six-state Markov model with a 30-year time horizon was used to compare the cost-effectiveness of the three alternatives. Transition probabilities were based on a targeted literature review focusing on available evidence in Sweden and comparable contexts. Costs were estimated from both healthcare and societal perspectives, using patient data from the Swedish National Cancer Registry in 2020 (Cancerregistret). Health outcomes were quantified in terms of quality-adjusted life years (QALYs). Cost and health outcomes were then summarised into an incremental cost-effectiveness ratio (ICER) between competing strategies. A probabilistic sensitivity analysis (PSA) was conducted to address the uncertainties in the input parameters. RESULTS: The results showed that compared to lumpectomy without irradiation, lumpectomy with irradiation yielded a "moderate" ICER per QALY gained of 402,994 Swedish Krona (SEK) from a healthcare perspective and a "high" ICER of 575,833 SEK from a societal perspective. Mastectomy proved to be the costliest and least effective of the three alternatives over a 30-year period. The PSA results further substantiated these findings. CONCLUSIONS: Our study demonstrated that lumpectomy with irradiation is "moderately" cost-effective compared with lumpectomy without irradiation. Nevertheless, extending this study by conducting a comprehensive budget impact analysis to account for the prevalence of in situ breast cancer in Sweden is prudent. These results imply that a costlier and less effective mastectomy should only be considered when lumpectomy options are infeasible. Further studies are needed to obtain more reliable parameters relevant to Sweden and to increase the consistency of the findings.
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BACKGROUND: The per capita health expenditure (HE) and share of gross domestic product (GDP) spending on elderly healthcare are expected to increase. The gap between health needs and available resources for elderly healthcare is widening in many developing countries, like Tanzania, leaving the elderly in poor health. These conditions lead to catastrophic HEs for the elderly. This study aimed to analyse the association between measures of health, wealth, and medical expenditure in rural residents aged 60 years and above in Tanzania. METHODS: The data of this study were collected through a cross-sectional household survey to residents aged 60 years and above living in Nzega and Igunga districts using a standardised World Health Organization (WHO) Study on Global Ageing and Adult Health (SAGE) and European Quality of Life Five Dimension (EQ-5D) questionnaires. The quality of life (QoL) was estimated using EQ-5D weights. The wealth index was generated from principal component analysis (PCA). The linear regression analyses (outpatient/inpatient) were performed to analyse the association between measures of health, wealth, medical expenditure, and socio-demographic variables. RESULTS: This study found a negative and statistically significant association between QoL and HE, whereby HE increases with the decrease of QoL. We could not find any significant relationship between HE and social gradients. In addition, age influences HE such that as age increases, the HE for both outpatient and inpatient care also increases. CONCLUSION: The health system in these districts allocate resources mainly according to needs, and social position is not important. We thus conclude that the elderly of lower socio-economic status (SES) was subjected to similar health expenditure as those of higher socio-economic status. Health, not wealth, determines the use of medical expenditures.
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Gastos em Saúde , Qualidade de Vida , Adulto , Idoso , Humanos , Tanzânia , Estudos Transversais , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Rheumatic Heart Disease (RHD) causes high morbidity and mortality rates among children and young adults, impacting negatively on their health-related quality of life (HRQoL). This study aimed to evaluate the HRQoL and healthcare consultations of adult patients with RHD in Namibia. METHODS: From June 2019 to March 2020, a questionnaire was administered to 83 RHD patients during routine follow-ups. The EQ-5D-5L instrument was used to assess the health-related quality of life before diagnosis and at the time of the survey. The Ethiopian value set for EQ-5D-5L was used to calculate Quality-Adjusted Life Years (QALY). RESULTS: Most respondents were women (77%), young adults below the age of 30 years (42%), and individuals who grew up in rural areas (87%). The mean QALY statistically significantly improved from 0.773 pre-diagnosis to 0.942 in the last 12 months (p < 0.001). Sixty-six patients who had surgery reported a better QALY. Healthcare visits statistically significantly increased from on average 1.6 pre-diagnosis to 2.7 days in the last 12 months (p < 0.001). The mean distance to the nearest facility was 55 km, mean cost of transport was N$65, and mean time spent at the clinic was 3.6 h. The median time from diagnosis to the survey was 7 years (quartiles 4 and 14 years). CONCLUSION: Treatment and surgery can improve HRQoL substantially among RHD patients. Being diagnosed with RHD affects patients living in socioeconomically disadvantaged rural areas through cost and time for healthcare visits. It would be valuable with further research to understand differences between disease severities.
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Qualidade de Vida , Cardiopatia Reumática , Adulto , Feminino , Humanos , Masculino , Instituições de Assistência Ambulatorial , Namíbia/epidemiologia , Cardiopatia Reumática/diagnóstico , Cardiopatia Reumática/epidemiologia , Cardiopatia Reumática/terapiaRESUMO
PURPOSE: To investigate whether the quality-adjusted life years (QALYs) of the patients who underwent bariatric surgery could be predicted using their baseline information. MATERIALS AND METHODS: All patients who received bariatric surgery in Sweden between January 1, 2011 and March 31, 2019 were obtained from the Scandinavian Obesity Surgery Registry (SOReg). Baseline information included patients' sociodemographic characteristics, details regarding the procedure, and postsurgical conditions. QALYs were assessed by the SF-6D at follow-up years 1 and 2. The general and regularized linear regression models were used to predict postoperative QALYs. RESULTS: All regression models demonstrated satisfactory and comparable performance in predicting QALYs at follow-up year 1, with R2 and relative root mean squared error (RRMSE) values of about 0.57 and 9.6%, respectively. The performance of the general linear regression model increased with the number of variables; however, the improvement was ignorable when the number of variables was more than 30 and 50 for follow-up years 1 and 2, respectively. Although minor L1 and L2 regularization provided better prediction ability, the improvement was negligible when the number of variables was more than 20. All the models showed poorer performance for predicting QALYs at follow-up year 2. CONCLUSIONS: Patient characteristics before bariatric surgery including health related quality of life, age, sex, BMI, postoperative complications within six weeks, and smoking status, may be adequate in predicting their postoperative QALYs after one year. Understanding these factors can help identify individuals who require more personalized and intensive support before, during, and after surgery.
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Cirurgia Bariátrica , Obesidade Mórbida , Humanos , Lactente , Anos de Vida Ajustados por Qualidade de Vida , Suécia/epidemiologia , Obesidade Mórbida/cirurgia , Qualidade de Vida , Modelos LinearesRESUMO
BACKGROUND: Functional abdominal pain disorders (FAPDs) affect children worldwide, being more prevalent among girls. The individual and societal burdens of the disease are substantial, and evidence-based interventions are needed. Non-pharmacological treatments have generally produced promising results, with dance and yoga specifically having potential as an effective treatment option. Beside efficacy, the cost-effectiveness of interventions is important when prioritizing and allocating public resources. OBJECTIVE: This study evaluated the cost-effectiveness of an 8-month dance and yoga intervention for girls with functional abdominal pain or irritable bowel syndrome, based on a randomized control trial called 'Just in TIME'. METHODS: The intervention, performed in Sweden, was studied using a decision analysis tool, i.e., a decision tree within the trial followed by a Markov model with a time horizon of 10 years. The base case considered healthcare costs as well as productivity losses, measuring the effects in gained quality-adjusted life-years (QALYs) and presenting an incremental cost-effectiveness ratio (ICER). RESULTS: The base case results show that the intervention, compared with current practice, was the dominant strategy from both the 12-month and long-term perspectives. The sensitivity analyses indicated that the long-term, but not the short-term, findings were robust for different assumptions and changes in parameter estimates, resulting in ICERs similar to those of the base case scenario. CONCLUSIONS: Offering dance and yoga to young girls with FAPDs generates small QALY gains and monetary savings compared with standard healthcare and is likely cost-effective. These findings make a valuable contribution to an area where evidence-based and cost-effective treatment interventions are needed. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02920268; Name: Just in TIME-Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain.
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BACKGROUND: Obesity Problem Scale (OP) is a widely applied instrument for obesity, however currently calculation of health utility based on OP is not feasible as it is not a preference-based measure. Using data from the Scandinavian Obesity Surgery Registry (SOReg), we sought to develop a mapping algorithm to estimate SF-6D utility from OP. Furthermore, to test whether the mapping algorithm is robust to the effect of surgery. METHOD: The source data SOReg (n = 36 706) contains both OP and SF-36, collected at pre-surgery and at 1, 2 and 5 years post-surgery. The Ordinary Least Square (OLS), beta-regression and Tobit regression were used to predict the SF-6D utility for different time points respectively. Besides the main effect model, different combinations of patient characteristics (age, sex, Body Mass Index, obesity-related comorbidities) were tested. Both internal validation (split-sample validation) and validation with testing the mapping algorithm on a dataset from other time points were carried out. A multi-stage model selection process was used, accessing model consistency, parsimony, goodness-of-fit and predictive accuracy. Models with the best performance were selected as the final mapping algorithms. RESULTS: The final mapping algorithms were based on OP summary score using OLS models, for pre- and post-surgery respectively. Mapping algorithms with different combinations of patients' characteristics were presented, to satisfy the user with a different need. CONCLUSION: This study makes available algorithms enabling crosswalk from the Obesity Problem Scale to the SF-6D utility. Different mapping algorithms are recommended for the mapping of pre- and post-operative data.
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Obesidade , Qualidade de Vida , Humanos , Inquéritos e Questionários , AlgoritmosRESUMO
OBJECTIVE: Knowledge of the effectiveness and limits of the suitability of brief interventions in suicide prevention is greatly needed. We investigated subgroup differences and predictors for suicide re-attempts within a clinical trial population recruited for a brief intervention to prevent re-attempts. METHODS: Consenting adult patients receiving treatment for a suicide attempt in Helsinki City general hospital emergency rooms in 2016-2017 (n = 239) were randomly allocated to (a) the Attempted Suicide Short Intervention Program (ASSIP) or (b) Crisis Counseling (CC). Participants also received their usual treatment. Information on primary outcome repeat attempts and secondary outcomes was collected via telephone and from medical and psychiatric records for 2 years. As proportions of re-attempts did not differ significantly between ASSIP and CC (29.2 vs. 35.2%), patients were pooled and predictors for suicide re-attempts were analyzed using Kaplan-Meier and logistic regression analyses. RESULTS: Re-attempts were predicted by participants' younger age (OR 0.965 [0.933-0.998]), previous suicide attempts (OR 2.437 [1.106-5.370]), psychiatric hospitalization in the year preceding baseline (OR 3.256 [1.422-7.458]), and clinical diagnosis of a personality disorder (OR 4.244 [1.923-9.370]), especially borderline personality disorder (OR 5.922 [2.558-13.709]). CONCLUSIONS: Within a population of suicide attempters consenting to a brief intervention trial, the risk of re-attempt was strongly predicted by subjects' young age, history of previous attempts, psychiatric hospitalizations, and personality disorder, particularly borderline personality disorder. The composition of treated populations with regard to these characteristics may strongly influence the observed success of brief interventions. Their potential as moderators of treatment effectiveness and as indicators of the utility of brief interventions warrants further investigation.HIGHLIGHTSDuring the 2-year follow-up, 32% of trial participants reattempted suicide.Rates of reattempts varied and were strongly predicted by clinical subgroup.Subgroup composition may strongly influence brief interventions' observed outcome.
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BACKGROUND: The study aims to elicit a value set based on the EQ-VT for the EQ-5D-5L that can be used to support decision-making in Sweden. METHODS: Participants were recruited from the general population based on age, sex and urban/rural area quota sampling from five regions across Sweden. In total, 785 interviews were conducted from February 2020 to April 2021 using the EQVT 2.1 protocol, and both composite time trade-off (c-TTO) and discrete choice experiments (DCE) were used to elicit health preferences. A variety of models have been tested for the c-TTO data (generalized least square, Tobit, heteroskedastic models) and DCE data (conditional logit model), as well as the combined c-TTO and DCE data (hybrid modelling). Model selection was based on theoretical considerations, logical consistency of the parameter estimates, and significance of the parameters (p = 0.05). Model goodness-of-fit was assessed by AIC and BIC, and prediction accuracy was assessed in terms of mean absolute error. The predictions for the EQ-5D-5L health states between models were compared using scatterplots. RESULTS: The preferred model for generating the value set was the heteroskedastic model based on the c-TTO data, with the health utilities ranging from -0.31 for the worst (55,555) to 1 for the best (11111) EQ-5D-5L states. CONCLUSION: This is the first c-TTO-based social value set for the EQ-5D-5L in Sweden. It can be used to support the health utility estimation in economic evaluations for reimbursement decision making in Sweden.
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Qualidade de Vida , Humanos , Suécia , Valores Sociais , Inquéritos e QuestionáriosRESUMO
One of the main challenges for the successful implementation of health-related quality of life (HRQoL) assessments is missing data. The current study examined the feasibility and validity of a sequential multiple imputation (MI) method to deal with missing values in the longitudinal HRQoL data from the Scandinavian Obesity Surgery Registry. All patients in the SOReg who received bariatric surgery between 1 January 2011 and 31 March 2019 (n = 47,653) were included for the descriptive analysis and missingness pattern exploration. The patients who had completed the short-form 36 (SF-36) at baseline (year 0), and one-, two-, and five-year follow-ups were included (n = 3957) for the missingness pattern simulation and the sequential MI analysis. Eleven items of the SF-36 were selected to create the six domains of SF-6D, and the SF-6D utility index of each patient was calculated accordingly. The multiply-imputed variables in previous year were used as input to impute the missing values in later years. The performance of the sequential MI was evaluated by comparing the actual values with the imputed values of the selected SF-36 items and index at all four time points. At the baseline and year 1, where missing proportions were about 20% and 40%, respectively, there were no statistically significant discrepancies between the distributions of the actual and imputed responses (all p-values > 0.05). In year 2, where the missing proportion was about 60%, distributions of the actual and imputed responses were consistent in 9 of the 11 SF-36 items. However, in year 5, where the missing proportion was about 80%, no consistency was found between the actual and imputed responses in any of the SF-36 items. Relatively high missing proportions in HRQoL data are common in clinical registries, which brings a challenge to analyzing the HRQoL of longitudinal cohorts. The experimental sequential multiple imputation method adopted in the current study might be an ideal strategy for handling missing data (even though the follow-up survey had a missing proportion of 60%), avoiding significant information waste in the multivariate analysis. However, the imputations for data with higher missing proportions warrant more research.
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Cirurgia Bariátrica , Qualidade de Vida , Interpretação Estatística de Dados , Humanos , Projetos de Pesquisa , Inquéritos e QuestionáriosRESUMO
BACKGROUND: People with severe psychiatric disabilities and impaired autonomy, living in sheltered or supported housing facilities, often lead sedentary, solitary lives indoors and have significantly poorer health than others in the population. Meaningful everyday activities are important for the recovery towards an enrichening, agentic, social, and hopeful everyday life. The Everyday Life Rehabilitation (ELR) model-a person-centred activity- and recovery-oriented intervention-has shown positive outcomes in feasibility studies, and thus a randomised controlled trial (RCT) is required to establish the effectiveness of ELR, along with calculations of cost-effectiveness. METHODS: The ELR-RCT is a pragmatic, two-parallel-armed cluster RCT evaluating the effect and cost-effectiveness of using ELR from two measurement points over 6 months (pre-post intervention) and in three waves over 3 years. The primary outcome is recovering quality of life (ReQoL) at 6 months, and the secondary outcome is self-perceived recovery and daily functioning (RAS-DS) at 6 months. Additionally, Goal Attainment Scaling (GAS) will be used for the intervention group. Power analysis has been conducted for primary outcome measure. The first wave will include an internal pilot, to be evaluated after 6 months, used as basis for decisions on updating the required sample size and any other need for adaptations before continuing with the full-scale RCT in the second and third wave. All municipalities within a geographic area in northern Sweden, with a minimum of one sheltered or supported housing facility for people with severe psychiatric or neuropsychiatric disability, including access to occupational therapy, will be enrolled. Participants will be block-randomised to receive ELR plus treatment as usual (TAU) or TAU alone for a control period. The control group will thereafter receive delayed ELR. Occupational therapists and housing staff will receive an educational package, manuals, and tools, as well as reflections with colleagues during the intervention period. Housing managers will receive questions for monthly follow-up and coaching with staff. DISCUSSION: This is a protocol for both an internal pilot and full trial of the first RCT study using the ELR intervention model in sheltered or supported housing facilities, evaluating the effects together with cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT05056415. Registered on 24 September 2021.
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Habitação , Terapia Ocupacional , Análise Custo-Benefício , Estudos de Viabilidade , Humanos , Ensaios Clínicos Pragmáticos como Assunto , Qualidade de Vida/psicologia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: ASSIP (Attempted Suicide Short Intervention Program) is a brief psychotherapeutic intervention found remarkably effective in reducing rate of suicide attempt repetition in the pivotal study in Bern, Switzerland. We compared effectiveness of the ASSIP to usual crisis counselling (CC) in a randomized trial (ISRCTN13464512). METHODS: Adult patients receiving somatic treatment for a suicide attempt at the Helsinki City general hospital emergency rooms in 2016-2017 were requested to participate. Psychotic or likely nonadherent substance abusing or dependent patients were excluded. Consenting, eligible patients (N = 239) were randomly allocated to two interventions. (a) The ASSIP comprised three visits, including a videotaped first visit, a case formulation, individualized safety plan, plus letters from their therapist every 3 months for 1 year and then every 6 months for the next year. (b) The CC involved on average four face-to-face individual sessions. In addition, all participants received treatments as usual. One and two years after the baseline, the participants' suicidal thoughts and attempts and psychiatric treatments received during the follow-up were investigated by telephone and from psychiatric records. RESULTS: Of patients randomized, two thirds initiated either ASSIP (n = 89) or CC (n = 72), with 73 (82%) completing the ASSIP and 58 (81%) the CC. There was no significant difference between the ASSIP vs. the CC patients having at least one suicide attempt during the 2-year follow-up (29.2% (26/89) vs. 35.2% (25/71), χ21 = 0.654, p = 0.419). CONCLUSION: We found no evidence for a difference in effectiveness of the two active interventions in preventing the repetition of suicide attempts.
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INTRODUCTION: Capability-adjusted life years Sweden (CALY-SWE) are a new Swedish questionnaire-based measure for quality of life based on the capability approach. CALY-SWE are targeted towards use in cost-effectiveness evaluations of social welfare consequences. Here, we first motivate the measure both from a theoretical and from a Swedish policy-making perspective. Then, we outline the core principles of the measure, namely the relation to the capability approach, embedded equity considerations inspired by the fair-innings approach, and the bases for which capabilities should be considered. The aims were to 1) the most vital capabilities for individuals in Sweden, 2) to define a sufficient level of each identified capability to lead a flourishing life, and to 3) develop a complete questionnaire for the measurement of the identified capabilities. MATERIAL AND METHODS: For the selection of capabilities, we used a Delphi process with Swedish civil society representants. To inform the questionnaire development, we conducted a web survey in three versions, with each Swedish 500 participants, to assess the distribution of capabilities that resulted from the Delphi process in the Swedish population. Each version was formulated with different strictness so that less strict wordings of a capability level would apply to a larger share of participants. All versions also included questions on inequality aversion regarding financial, educational, and health capabilities. RESULTS: The Delphi process resulted in the following six capabilities: Financial situation & housing, health, social relations, occupations, security, and political & civil rights. We formulated the final phrasing for the questionnaire based on normative reasons and the distribution of capabilities in the population while taking into account inequality aversion. CONCLUSION: We developed a capability-based model for cost effectiveness economic evaluations of broader social consequences, specific to the Swedish context.
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Qualidade de Vida/psicologia , Validade Social em Pesquisa/métodos , Inquéritos e Questionários/normas , Análise Custo-Benefício , Humanos , Avaliação de Programas e Projetos de Saúde/métodos , Anos de Vida Ajustados por Qualidade de Vida , Reprodutibilidade dos Testes , Seguridade Social , Inquéritos e Questionários/economia , Suécia/epidemiologiaRESUMO
PURPOSE: Education and feedback on hypertension management has been associated with improved hypertension control. This study aimed to assess the effectiveness of such interventions to reduce the risk of stroke and cardiovascular events. MATERIALS AND METHODS: Individuals ≥18 years with a blood pressure (BP) recording in Västerbotten or Södermanland County during the study period 2001 to 2009 were included in 108 serial cohort studies, each with 24 months follow-up. The primary outcome was risk of first-ever stroke in Västerbotten County (intervention) compared with Södermanland County (control). Secondary outcomes were first-ever major adverse cardiovascular event (MACE), myocardial infarction, and heart failure, as well as all-cause and cardiovascular mortality. All outcomes were analysed using time-to-event data included in a Cox proportional hazards model adjusted for age, sex, hypertension, diabetes, coronary artery disease, atrial fibrillation, systolic BP at inclusion, marital status, and disposable income. RESULTS: A total of 121 365 individuals (mean [SD] age at inclusion 61.7 [16.3] years; 59.9% female; mean inclusion BP 142.3/82.6 mmHg) in the intervention county were compared to 131 924 individuals (63.6 [16.2] years; 61.2% female; 144.1/81.1 mmHg) in the control county. A first-ever stroke occurred in 2 823 (2.3%) individuals in the intervention county, and 3 584 (2.7%) individuals in the control county (adjusted hazard ratio 0.96, 95% CI 0.90 to 1.03). No differences were observed for MACE, myocardial infarction or heart failure, whereas all-cause mortality (HR 0.91, 95% CI 0.87 to 0.95) and cardiovascular mortality (HR 0.91, 95% CI 0.85 to 0.98) were lower in the intervention county. CONCLUSIONS: This study does not support an association between education and feedback on hypertension management to primary care physicians and the risk for stroke or cardiovascular outcomes. The observed differences for mortality outcomes should be interpreted with caution.
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Doenças Cardiovasculares , Insuficiência Cardíaca , Hipertensão , Infarto do Miocárdio , Acidente Vascular Cerebral , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Retroalimentação , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Hipertensão/tratamento farmacológico , Masculino , Infarto do Miocárdio/etiologia , Fatores de Risco , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/etiologiaRESUMO
INTRODUCTION: The Attempted Suicide Short Intervention Program (ASSIP) is a brief psychotherapeutic intervention, and a pivotal study found it to be remarkably effective in reducing repeat suicide attempts. OBJECTIVE: To compare the effectiveness of ASSIP to crisis counseling (CC) in a randomized clinical trial (ISRCTN13464512). METHODS: Adult patients receiving treatment for a suicide attempt in a Helsinki City general hospital emergency room in 2016-2017 were eligible to participate. We excluded psychotic or likely non-adherent substance-abusing or substance-dependent patients. Eligible patients (n = 239) were randomly allocated to one of two interventions. (a) ASSIP comprised three visits, including a videotaped first visit, a case formulation, and an individualized safety plan, plus letters from the therapist every 3 months for 1 year, and then, every 6 months for the next year. (b) CC typically involved 2-5 (median 3) face-to-face individual sessions. In addition, all participants received their usual treatment. One and 2 years after baseline, information related to participants' suicidal thoughts and attempts, and psychiatric treatment received was collected via telephone and from medical and psychiatric records. RESULTS: Among randomized patients, two-thirds initiated either ASSIP (n = 89) or CC (n = 72), with 73 (82%) completing ASSIP and 58 (81%) CC. The proportion of patients who attempted suicide during the 2-year follow-up did not differ significantly between ASSIP and CC (29.2% [26/89] vs. 35.2% [25/71], OR 0.755 [95% Cl 0.379-1.504]). CONCLUSIONS: We found no difference in the effectiveness of the two brief interventions to prevent repeat suicide attempts.
Assuntos
Intervenção em Crise , Tentativa de Suicídio , Adulto , Aconselhamento , Seguimentos , Humanos , Ideação Suicida , Tentativa de Suicídio/prevenção & controleRESUMO
PURPOSE: This study aims to provide EQ-5D-5L population norms among the general population in Vietnam and to test EQ-5D-5L' construction validity among people living with hypertension there. METHODS: Descriptive statistics of the five dimensions and five levels, EQ-VAS and EQ-5D-5L indexes were categorised into gender and age groups for the EQ-5D-5L population norms. Known-groups testing was set for lower EQ-5D-5L outcomes among people who were aware of their hypertensive status, females, people with more comorbidities, less education, older ages, and higher body mass indexes. Level of confident interval was 95%. RESULTS: The mean EQ-VAS and EQ-5D-5L indexes were 81.10 (SD: 13.35) and 0.94 (SD: 0.09) among the general population. The EQ-5D-5L outcomes were better among younger people, males, people with more education, employees, and single people. Respondents reported fewer problems with self-care and usual activities and tend to have problems at higher levels across older ages. The known-group testing showed statistically significant results. The mean EQ-VAS and EQ-5D-5L indexes of people in the diagnosed hypertensive group (71.48 and 0.94, respectively) were statistically significantly smaller than they were in the non-hypertensive and undiagnosed hypertensive group (76.65 and 0.97; 76.95 and 0.96 accordingly). Statistically significant associations of lower EQ-5D-5L indexes and EQ-VAS were found among people diagnosed for hypertension, people suffering from an incremental comorbidity, and obese people. CONCLUSION: This study has provided EQ-5D-5L population norms for the general population and evidence for known-groups validity of the EQ-5D-5L instrument among hypertensive people in Vietnam.