A consensus-based checklist for the critical appraisal of cost-of-illness (COI) studies.

OBJECTIVES: To develop a consensus-based checklist that can be used as a minimum standard to appraise the comprehensiveness, transparency and consistency of cost-of-illness (COI) studies. This is important when, for instance, reviewing and assessing COI studies as part of a systematic review or when building an economic model. METHODS: The development process of the consensus-based checklist involved six steps: (i) a scoping review, (ii) an assessment and comparison of the different checklists and their questions, (iii) the development of a (preliminary) checklist, (iv) expert interviews, (v) the finalization of the checklist, and (vi) the development of guidance statements explaining each question. RESULTS: The result was a consensus-based checklist for the critical appraisal of COI studies, comprising seventeen main questions (and some additional subquestions) across three domains: (i) study characteristics; (ii) methodology and cost analysis; and (iii) results and reporting. Guidance statements were developed describing the purpose and meaning behind each question and listing examples of best practice. The following answer categories were suggested to be applied when answering the questions in the checklist: Yes, Partially, No, Not Applicable, or Unclear. CONCLUSIONS: The consensus-based checklist for COI studies is a first step toward standardizing the critical appraisal of COI studies and is one that could be considered a minimum standard. The checklist can help to improve comprehensiveness, transparency and consistency in COI studies, to address heterogeneity, and to enable better comparability of methodological approaches across international studies.

Expert opinion on a consensus-based checklist for the critical appraisal of cost-of-illness (COI) studies: qualitative interviews.

OBJECTIVES: This study explored experts' views on the development of a proposed checklist for cost-of-illness (COI) studies. It also investigated experts' perspectives on the use of COI studies and quality/critical appraisal tools used for COI studies as well as their experiences with the use of these tools. METHODS: Semi-structured, open-ended interviews were conducted with health economists and other experts working with COI studies and with experience of developing health economic guidelines or checklists. Participants were selected purposively using network and snowball sampling. A framework approach was applied for the thematic data analysis. Findings were reported narratively. RESULTS: Twenty-one experts from eleven different countries were interviewed. COI studies were found to be relevant to estimate the overall burden of a disease, to draw attention to disease areas, to understand different cost components, to explain cost variability, to inform decision making, and to provide input for full economic evaluations. Experts reported a lack of a standardized critical appraisal tool for COI studies. Their experience related predominantly to guidelines and checklists designed for full economic evaluations to review and assess COI studies. The following themes emerged when discussing the checklist: (i) the need for a critical appraisal tool, (ii) format and practicality, (iii) assessing the questions, (iv) addressing subjectivity, and (v) guidance requirements. CONCLUSIONS: The interviews provided relevant input for the development of a checklist for COI studies that could be used as a minimum standard and for international application. The interviews confirmed the important need for a checklist for the critical appraisal of COI studies.

Are intersectoral costs considered in economic evaluations of interventions relating to sexually transmitted infections (STIs)? A systematic review.

BACKGROUND/OBJECTIVE: Sexually transmitted infections (STIs) not only have an impact on the health sector but also the private resources of those affected, their families and other sectors of society (i.e. labour, education). This study aimed to i) review and identify economic evaluations of interventions relating to STIs, which aimed to include a societal perspective; ii) analyse the intersectoral costs (i.e. costs broader than healthcare) included; iii) categorise these costs by sector; and iv) assess the impact of intersectoral costs on the overall study results. METHODS: Seven databases were searched: MEDLINE (PubMed), EMBASE (Ovid), Web of Science, CINAHL, PsycINFO, EconLit and NHS EED. Key search terms included terms for economic evaluation, STIs and specific infections. This review considered trial- and model-based economic evaluations conducted in an OECD member country. Studies were included that assessed intersectoral costs. Intersectoral costs were extracted and categorised by sector using Drummond's cost classification scheme (i.e. patient/family, productivity, costs in other sectors). A narrative synthesis was performed. RESULTS: Twenty-nine studies qualified for data extraction and narrative synthesis. Twenty-eight studies applied a societal perspective of which 8 additionally adopted a healthcare or payer perspective, or both. One study used a modified payer perspective. The following sectors were identified: patient/family, informal care, paid labour (productivity), non-paid opportunity costs, education, and consumption. Patient/family costs were captured in 11 studies and included patient time, travel expenses, out-of-pocket costs and premature burial costs. Informal caregiver support (non-family) and unpaid help by family/friends was captured in three studies. Paid labour losses were assessed in all but three studies. Three studies also captured the costs and inability to perform non-paid work. Educational costs and future non-health consumption costs were each captured in one study. The inclusion of intersectoral costs resulted in more favourable cost estimates. CONCLUSIONS: This systematic review suggests that economic evaluations of interventions relating to STIs that adopt a societal perspective tend to be limited in scope. There is an urgent need for economic evaluations to be more comprehensive in order to allow policy/decision-makers to make better-informed decisions.

Process Evaluation of Lumbar Interbody Fusion Surgeries in Five Dutch Hospitals: A Qualitative Analysis.

Background and Objectives: Only limited qualitative research concerning instrumented spine surgeries has been published, despite the increasing number of these surgeries and the evident importance of qualitative analysis of the processes surrounding these complex interventions. Current qualitative research is mainly limited to the experiences, emotions and expectations of patients. Insight into the full process, including experiences from the perspective of informal caregivers and healthcare professionals, remains scarce. Materials and Methods: Data were gathered by means of semi-structured face-to-face interviews. In total, there were 27 participants, including 11 patients, 7 informal caregivers and 9 healthcare professionals. The interview process was audiotaped, and each interview was transcribed verbatim. To systematically analyse the gathered data, software for qualitative analysis (NVivo) was used. After immersion in the raw data of transcripts and field notes, a list of broad categories for organising the data into meaningful clusters for analysis was developed. All interviews were coded by the first author, and 25% was independently assessed by the second author. Results: The results of our study describe several promoting and limiting factors concerning the process of lumbar fusion surgery from the perspective of patients, informal caregivers and healthcare providers. The most frequently mentioned promoting factors were: information and opportunities to ask questions during consultations; multidisciplinary consultations; good communication and guidance during hospitalization; and follow-up appointments. The most frequently mentioned limiting factors were: lack of educational material; lack of guidance and communication prior to, during and after hospitalisation. Conclusion: Overall, participants were satisfied with the current healthcare-process in lumbar fusion surgery. However, we found that lack of educational material and guidance during the process led to insecurity about complaints, surgery and recovery. To improve the process of lumbar interbody fusion and to increase patient satisfaction, healthcare providers should focus on guiding and educating patients and informal caregivers about the pre-operative trajectory, the surgery and the recovery. From the healthcare providers' perspective, the process could be improved by multidisciplinary consultations and a dedicated spine team in the operation room. Although this study focusses on lumbar fusion surgery, results could be translated to other fields of spine surgery and surgery in general.

Intersectoral costs of sexually transmitted infections (STIs) and HIV: a systematic review of cost-of-illness (COI) studies.

BACKGROUND: Sexually transmitted infections (STIs) and HIV can generate costs both within and outside the health sector (i.e. intersectoral costs). This systematic review aims (i) to explore the intersectoral costs associated with STIs and HIV considered in cost-of-illness (COI) studies, (ii) to categorise and analyse these costs according to cost sectors, and (iii) to illustrate the impact of intersectoral costs on the total cost burden. METHODS: Medline (PubMed), EMBASE (Ovid), Web of Science, CINAHL, PsycINFO, EconLit and NHS EED were searched between 2009 and 2019. Key search terms included terms for cost-of-illness, cost analysis and all terms for STIs including specific infections. Studies were included that assessed intersectoral costs. A standardised data extraction form was adopted. A cost component table was established based on pre-defined sector-specific classification schemes. Cost results for intersectoral costs were recorded. The quality of studies was assessed using a modified version of the CHEC-list. RESULTS: 75 COI studies were considered for title/abstract screening. Only six studies were available in full-text and eligible for data extraction and narrative synthesis. Intersectoral costs were captured in the following sectors: Patient & family, Informal care and Productivity (Paid Labour). Patient & family costs were addressed in four studies, including patient out-of-pocket payments/co-payments and travel costs. Informal care costs including unpaid (home) care support by family/friends and other caregiver costs were considered in three studies. All six studies estimated productivity costs for paid labour including costs in terms of absenteeism, disability, cease-to-work, presenteeism and premature death. Intersectoral costs largely contributed to the total economic cost burden of STIs and HIV. The quality assessment revealed methodological differences. CONCLUSIONS: It is evident that intersectoral costs associated with STIs and HIV are substantial. If relevant intersectoral costs are not included in cost analyses the total cost burden of STIs and HIV to society is severely underestimated. Therefore, intersectoral costs need to be addressed in order to ensure the total economic burden of STIs and HIV on society is assessed, and communicated to policy/decision-makers.

The broader societal impacts of COVID-19 and the growing importance of capturing these in health economic analyses.

AbstractThe rapid spread of the current COVID-19 pandemic has affected societies worldwide, leading to excess mortality, long-lasting health consequences, strained healthcare systems, and additional strains and spillover effects on other sectors outside health (i.e., intersectoral costs and benefits). In this perspective piece, we demonstrate the broader societal impacts of COVID-19 on other sectors outside the health sector and the growing importance of capturing these in health economic analyses. These broader impacts include, for instance, the effects on the labor market and productivity, education, criminal justice, housing, consumption, and environment. The current pandemic highlights the importance of adopting a societal perspective to consider these broader impacts of public health issues and interventions and only omit these where it can be clearly justified as appropriate to do so. Furthermore, we explain how the COVID-19 pandemic exposed and exacerbated existing deep-rooted structural inequalities that contribute to the wider societal impacts of the pandemic.

A new instrument to measure high value, cost-conscious care attitudes among healthcare stakeholders: development of the MHAQ.

BACKGROUND: Residents have to learn to provide high value, cost-conscious care (HVCCC) to counter the trend of excessive healthcare costs. Their learning is impacted by individuals from different stakeholder groups within the workplace environment. These individuals' attitudes toward HVCCC may influence how and what residents learn. This study was carried out to develop an instrument to reliably measure HVCCC attitudes among residents, staff physicians, administrators, and patients. The instrument can be used to assess the residency-training environment. METHOD: The Maastricht HVCCC Attitude Questionnaire (MHAQ) was developed in four phases. First, we conducted exploratory factor analyses using original data from a previously published survey. Next, we added nine items to strengthen subscales and tested the new questionnaire among the four stakeholder groups. We used exploratory factor analysis and Cronbach's alphas to define subscales, after which the final version of the MHAQ was constructed. Finally, we used generalizability theory to determine the number of respondents (residents or staff physicians) needed to reliably measure a specialty attitude score. RESULTS: Initial factor analysis identified three subscales. Thereafter, 301 residents, 297 staff physicians, 53 administrators and 792 patients completed the new questionnaire between June 2017 and July 2018. The best fitting subscale composition was a three-factor model. Subscales were defined as high-value care, cost incorporation, and perceived drawbacks. Cronbach's alphas were between 0.61 and 0.82 for all stakeholders on all subscales. Sufficient reliability for assessing national specialty attitude (G-coefficient > 0.6) could be achieved from 14 respondents. CONCLUSIONS: The MHAQ reliably measures individual attitudes toward HVCCC in different stakeholders in health care contexts. It addresses key dimensions of HVCCC, providing content validity evidence. The MHAQ can be used to identify frontrunners of HVCCC, pinpoint aspects of residency training that need improvement, and benchmark and compare across specialties, hospitals and regions.

Five pillars for societal perspective.

In economic evaluation, the healthcare perspective has gradually given way to use of the societal perspective, as this perspective is often advocated for support in making optimal societal decisions. In practice, economic evaluations conducted from the societal perspective ignore, fail to measure and/or fail to monetize many of the costs that fall outside of the healthcare sector. To limit bias and increase decision-supportive power, researchers could strengthen their evaluations by adhering to a few basic principles. Five "pillars for the societal perspective" are proposed. First, who bears the cost and who does not is irrelevant. Second, it is imperative to consider including costs for sectors outside the healthcare sector. Third, both high frequent costs and costs with high unit prices should be considered. Fourth, double counting should be avoided. And fifth, researchers should reflect on choices related to costs, i.e. cost omission and problems with identifying, measuring, and valuing costs.

Exploring the identification, validation, and categorization of the cost and benefits of criminal justice in mental health: the PECUNIA project.

BACKGROUND: Mental health disorders and their treatments produce significant costs and benefits in both healthcare and non-healthcare sectors. The latter are often referred to as intersectoral costs and benefits (ICBs). Little is known about healthcare-related ICBs in the criminal justice sector and how to include these in health economics research. OBJECTIVES: The triple aim of this study is (i) to identify healthcare-related ICBs in the criminal justice sector, (ii) to validate the list of healthcare-related ICBs in the criminal justice sector on a European level by sector-specific experts, and (iii) to classify the identified ICBs. METHODS: A scientific literature search in PubMed and an additional grey literature search, carried out in six European countries, were used to retrieve ICBs. In order to validate the international applicability of the ICBs, a survey was conducted with an international group of experts from the criminal justice sector. The list of criminal justice ICBs was categorized according to the PECUNIA conceptual framework. RESULTS: The full-text analysis of forty-five peer-reviewed journal articles and eleven grey literature sources resulted in a draft list of items. Input from the expert survey resulted in a final list of fourteen unique criminal justice ICBs, categorized according to the care atom. CONCLUSION: This study laid further foundations for the inclusion of important societal costs of mental health-related interventions within the criminal justice sector. More research is needed to facilitate the further and increased inclusion of ICBs in health economics research.

Intersectoral Costs and Benefits of Mental and Behavioural Disorders in the Education Sector: an Exploration of Costing Methods.

BACKGROUND: The inclusion of indirect spillover costs and benefits that occur in non-healthcare sectors of society is necessary to make optimal societal decisions when assessing the cost effectiveness of healthcare interventions. Education costs and benefits are relevant in the disease area of mental and behavioral disorders, but their inclusion in economic evaluations is largely neglected due to lack of methodological knowledge. AIM OF THE STUDY: This study aims to explore, using a scoping review, the identification, measurement, and valuation methods used to assess the impact of mental and behavioural disorders on education costs and benefits. METHODS: A scoping review was conducted to identify articles that were set in the education sector and assessed education costs and benefits. An adapted 5-step approach was used: (i) initating a scoping review; (ii) identifying component studies; (iii) data extraction; (iv) reporting results; (v) discussion and interpretation of findings. Results were summarized in a narrative synthesis per identification, measurement, and valuation method. RESULTS: 177 component articles were identified in the scoping review that reported 61 mutually exclusive education costs and benefits. The nomenclature used to describe the costs and benefits was poorly defined, heterogeneous in nature and largely context dependent. This was also reflected in the diverse number of measurement and valuation methods found in the component articles. DISCUSSION: This is the first study, which offers a classification of education costs and benefits and costing methods reported by studies set in the education sector. In conclusion, mental and behavioral disorders have a notable impact on a variety of different education costs and benefits. IMPLICATIONS FOR HEALTH POLICIES: The classification provided in the current study gives an indication of the wide-spread impact of mental and behavioral disorders on the education sector. Hence, the inclusion of relevant education costs and benefits in economic evaluations for mental and behavioral disorders is necessary to make optimal societal decisions. IMPLICATIONS FOR FURTHER RESEARCH: By exploring a new area of research from a sector-specific perspective, the current study adds to the existing intersectoral cost and benefit literature base. Future research should focus on standardizing costing methods in pharmacoeconomic guidelines and assessing the relative importance of individual education costs and benefits in economic evaluations for specific interventions and diseases.

Chronic Kidney Disease: Exploring Value-Based Healthcare as a Potential Viable Solution.

BACKGROUND: Increasing healthcare expenditures have triggered a trend from volume to value by linking patient outcome to costs. This concept first described as value-based healthcare (VBHC) by Michael Porter is especially applicable for chronic conditions. This article aims to explore the applicability of the VBHC framework to the chronic kidney disease (CKD) care area. METHODS: The 4 dimensions of VBHC (measure value; set and communicate value benchmarking; coordinate care; payment to reward value-add) were explored for the CKD care area. Available data was reviewed focusing on CKD initiatives in Europe to assess to what extent each of the 4 dimensions of VBHC have been applied in practice. RESULTS: Translating VBHC into value-based renal care (VBRC) seems to be initiated to a limited extent in European health systems. In most cases not all dimensions of VBHC have been utilized in the renal care initiatives. CONCLUSION: The translation of VBHC into VBRC is possible and even desirable if an optimal treatment pathway for CKD patients could be achieved. This would require an organizational change in health system set up and should include a strategy focusing on full care responsibility. The patient outcome perspective and health economic analysis need to be the centre of attention.

Household costs and time to treatment for children with severe febrile illness in rural Burkina Faso: the role of rectal artesunate.

BACKGROUND: Community health workers (CHWs) were trained to identify children with malaria who could not take oral medication, treat them with rectal artesunate (RA) and refer them to the closest healthcare facility to complete management. However, many children with such symptoms did not seek CHWs' care. The hypothesis was that the cost of referral to a health facility was a deterrent. The goal of this study was to compare the out-of-pocket costs and time to seek treatment for children who sought CHW care (and received RA) versus those who did not. METHODS: Children with symptoms of severe malaria receiving RA at CHWs and children with comparable disease symptoms who did not go to a CHW were identified and their parents were interviewed. Household out-of-pocket costs per illness episode and speed of treatment were evaluated and compared between RA-treated children vs. non-RA treated children and by central nervous symptoms (CNS: repeated convulsions, altered consciousness or coma). RESULTS: Among children with CNS symptoms, costs of RA-treated children were similar to those of non-RA treated children ($5.83 vs. $4.65; p = 0.52), despite higher transport costs ($2.74 vs. $0.91; p < 0.0001). However, among children without CNS symptoms, costs of RA-treated children were higher than the costs of non-RA treated children with similar symptoms ($5.62 vs. $2.59; p = 0.0001), and the main driver of the cost difference was transport. After illness onset, CNS children reached CHWs for RA an average of 9.0 h vs. 16.1 h for non-RA treated children reaching first treatment [difference 7.1 h (95% CI - 1.8 to 16.1), p = 0.11]. For non-CNS patients the average time to CHW-delivered RA treatment was 12.2 h vs. 20.1 h for those reaching first treatment [difference 7.9 h (95% CI 0.2-15.6), p = 0.04]. More non-RA treated children developed CNS symptoms before arrival at the health centre but the difference was not statistically significant (6% vs. 4%; p = 0.58). CONCLUSIONS: Community health worker-delivered RA does not affect the total out-of-pocket costs when used in children with CNS symptoms, but is associated with higher total out-of-pocket costs when used in children with less severe symptoms. RA-treated children sought treatment more quickly.

CONCEPTUALIZATIONS OF THE SOCIETAL PERSPECTIVE WITHIN ECONOMIC EVALUATIONS: A SYSTEMATIC REVIEW.

OBJECTIVES: The aim of this study was to investigate how the societal perspective is conceptualized in economic evaluations and to assess how intersectoral costs and benefits (ICBs), that is, the costs and benefits pertaining to sectors outside the healthcare sector, impact their results. METHODS: Based on a search in July 2015 using PubMed, Embase, CINAHL, and PsychINFO, a systematic literature review was performed for economic evaluations which were conducted from a societal perspective. Conceptualizations were assessed in NVivo version 11 using conventional and directed content analysis. Trial-based evaluations in the fields of musculoskeletal and mental disorders were analyzed further, focusing on the way ICBs impact the results of economic evaluations. RESULTS: A total of 107 studies were assessed, of which 74 (69.1 percent) provided conceptualizations of the societal perspective. These varied in types of costs included and in descriptions of cost bearers. Labor productivity costs were included in seventy-two studies (67.3 percent), while only thirty-eight studies (35.5 percent) included other ICBs, most of which entailed informal care and/or social care costs. ICBs within the educational and criminal justice sectors were each included five times. Most of the trial-based evaluations analyzed further (n = 21 of 28) reported productivity costs. In nine, these took up more than 50 percent of total costs. In several studies, criminal justice and informal care costs were also important. CONCLUSIONS: There is great variety in the way the societal perspective is conceptualized and interpreted within economic evaluations. Use of the term "societal perspective" is often related to including merely productivity costs, while other ICBs could be relevant as well.

Quantifying and Valuing Community Health Worker Time in Improving Access to Malaria Diagnosis and Treatment.

BACKGROUND: Community health workers (CHWs) are members of a community who are chosen by their communities as first-line, volunteer health workers. The time they spend providing healthcare and the value of this time are often not evaluated. Our aim was to quantify the time CHWs spent on providing healthcare before and during the implementation of an integrated program of diagnosis and treatment of febrile illness in 3 African countries. METHODS: In Burkina Faso, Nigeria, and Uganda, CHWs were trained to assess and manage febrile patients in keeping with Integrated Management of Childhood Illness recommendations to use rapid diagnostic tests, artemisinin-based combination therapy, and rectal artesunate for malaria treatment. All CHWs provided healthcare only to young children usually <5 years of age, and hence daily time allocation of their time to child healthcare was documented for 1 day (in the high malaria season) before the intervention and at several time points following the implementation of the intervention. Time spent in providing child healthcare was valued in earnings of persons with similar experience. RESULTS: During the high malaria season of the intervention, CHWs spent nearly 50 minutes more in daily healthcare provision (average daily time, 30.2 minutes before the intervention vs 79.5 minutes during the intervention; test for difference in means P < .01). On average, the daily time spent providing healthcare during the intervention was 55.8 minutes (Burkina Faso), 77.4 minutes (Nigeria), and 72.2 minutes (Uganda). Using the country minimum monthly salary, CHWs' time allocated to child healthcare for 1 year was valued at US Dollars (USD) $52 in Burkina Faso, USD $295 in Nigeria, and USD $141 in Uganda. CONCLUSIONS: CHWs spend up to an hour and a half daily on child healthcare in their communities. These data are informative in designing reward systems to motivate CHWs to continue providing good-quality services. CLINICAL TRIALS REGISTRATION: ISRCTN13858170.

Impact of Improving Community-Based Access to Malaria Diagnosis and Treatment on Household Costs.

BACKGROUND: Community health workers (CHWs) were trained in Burkina Faso, Nigeria, and Uganda to diagnose febrile children using malaria rapid diagnostic tests, and treat positive malaria cases with artemisinin-based combination therapy (ACT) and those who could not take oral medicines with rectal artesunate. We quantified the impact of this intervention on private household costs for childhood febrile illness. METHODS: Households with recent febrile illness in a young child in previous 2 weeks were selected randomly before and during the intervention and data obtained on household costs for the illness episode. Household costs included consultation fees, registration costs, user fees, diagnosis, bed, drugs, food, and transport costs. Private household costs per episode before and during the intervention were compared. The intervention's impact on household costs per episode was calculated and projected to districtwide impacts on household costs. RESULTS: Use of CHWs increased from 35% of illness episodes before the intervention to 50% during the intervention (P < .0001), and total household costs per episode decreased significantly in each country: from US Dollars (USD) $4.36 to USD $1.54 in Burkina Faso, from USD $3.90 to USD $2.04 in Nigeria, and from USD $4.46 to USD $1.42 in Uganda (all P < .0001). There was no difference in the time used by the child's caregiver to care for a sick child (59% before intervention vs 51% during intervention spent ≤2 days). Using the most recent population figures for each study district, we estimate that the intervention could save households a total of USD $29 965, USD $254 268, and USD $303 467, respectively, in the study districts in Burkina Faso, Nigeria, and Uganda. CONCLUSIONS: Improving access to malaria diagnostics and treatments in malaria-endemic areas substantially reduces private household costs. The key challenge is to develop and strengthen community human resources to deliver the intervention, and ensure adequate supplies of commodities and supervision. We demonstrate feasibility and benefit to populations living in difficult circumstances. CLINICAL TRIALS REGISTRATION: ISRCTN13858170.

Cost-effectiveness of preventive case management for parents with a mental illness: a randomized controlled trial from three economic perspectives.

BACKGROUND: The children of parents with a mental illness (COPMI) are at increased risk for developing costly psychiatric disorders because of multiple risk factors which threaten parenting quality and thereby child development. Preventive basic care management (PBCM) is an intervention aimed at reducing risk factors and addressing the needs of COPMI-families in different domains. The intervention may lead to financial consequences in the healthcare sector and in other sectors, also known as inter-sectoral costs and benefits (ICBs). The objective of this study was to assess the cost-effectiveness of PBCM from three perspectives: a narrow healthcare perspective, a social care perspective (including childcare costs) and a broad societal perspective (including all ICBs). METHODS: Effects on parenting quality (as measured by the HOME) and costs during an 18-month period were studied in in a randomized controlled trial. Families received PBCM (n = 49) or care as usual (CAU) (n = 50). For all three perspectives, incremental cost-effectiveness ratios (ICERs) were calculated. Stochastic uncertainty in the data was dealt with using non-parametric bootstraps. Sensitivity analyses included calculating ICERs excluding cost outliers, and making an adjustment for baseline cost differences. RESULTS: Parenting quality improved in the PBCM group and declined in the CAU group, and PBCM was shown to be more costly than CAU. ICERs differ from 461 Euros (healthcare perspective) to 215 Euros (social care perspective) to 175 Euros (societal perspective) per one point improvement on the HOME T-score. The results of the sensitivity analyses, based on complete cases and excluding cost outliers, support the finding that the ICER is lower when adopting a broader perspective. The subgroup analysis and the analysis with baseline adjustments resulted in higher ICERs. CONCLUSIONS: This study is the first economic evaluation of family-focused preventive basic care management for COPMI in psychiatric and family services. The effects of the chosen perspective on determining the cost-effectiveness of PBCM underscore the importance of economic studies of interdepartmental policies. Future studies focusing on the cost-effectiveness of programs like PBCM in other sites and studies with more power are encouraged as this may improve the quality of information used in supporting decision making. TRIAL REGISTRATION: NTR2569 , date of registration 2010-10-12.

A Web-Based Computer-Tailored Alcohol Prevention Program for Adolescents: Cost-Effectiveness and Intersectoral Costs and Benefits.

BACKGROUND: Preventing excessive alcohol use among adolescents is important not only to foster individual and public health, but also to reduce alcohol-related costs inside and outside the health care sector. Computer tailoring can be both effective and cost-effective for working with many lifestyle behaviors, yet the available information on the cost-effectiveness of computer tailoring for reducing alcohol use by adolescents is limited as is information on the costs and benefits pertaining to sectors outside the health care sector, also known as intersectoral costs and benefits (ICBs). OBJECTIVE: The aim was to assess the cost-effectiveness of a Web-based computer-tailored intervention for reducing alcohol use and binge drinking by adolescents from a health care perspective (excluding ICBs) and from a societal perspective (including ICBs). METHODS: Data used were from the Alcoholic Alert study, a cluster randomized controlled trial with randomization at the level of schools into two conditions. Participants either played a game with tailored feedback on alcohol awareness after the baseline assessment (intervention condition) or received care as usual (CAU), meaning that they had the opportunity to play the game subsequent to the final measurement (waiting list control condition). Data were recorded at baseline (T0=January/February 2014) and after 4 months (T1=May/June 2014) and were used to calculate incremental cost-effectiveness ratios (ICERs), both from a health care perspective and a societal perspective. Stochastic uncertainty in the data was dealt with by using nonparametric bootstraps (5000 simulated replications). Additional sensitivity analyses were conducted based on excluding cost outliers. Subgroup cost-effectiveness analyses were conducted based on several background variables, including gender, age, educational level, religion, and ethnicity. RESULTS: From both the health care perspective and the societal perspective for both outcome measures, the intervention was more costly and more effective in comparison with CAU. ICERs differed for both perspectives, namely €40 and €79 from the health care perspective to €62 and €144 for the societal perspective per incremental reduction of one glass of alcohol per week and one binge drinking occasion per 30 days, respectively. Subgroup analyses showed, from both perspectives and for both outcome measures, that the intervention was cost-effective for older adolescents (aged 17-19 years) and those at a lower educational level and, from a health care perspective, the male and nonreligious adolescent subgroups. CONCLUSIONS: Computer-tailored feedback could be a cost-effective way to target alcohol use and binge drinking among adolescents. Including ICBs in the economic evaluation had an impact on the cost-effectiveness results of the analysis. It could be worthwhile to aim the intervention specifically at specific subgroups. TRIAL REGISTRATION: Nederlands Trial Register: NTR4048; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4048 (Archived by Webcite at http://www.webcitation.org/6c7omN8wG).

An Online Health Prevention Intervention for Youth with Addicted or Mentally Ill Parents: Experiences and Perspectives of Participants and Providers from a Randomized Controlled Trial.

BACKGROUND: Mental illnesses affect many people around the world, either directly or indirectly. Families of persons suffering from mental illness or addiction suffer too, especially their children. In the Netherlands, 864,000 parents meet the diagnostic criteria for a mental illness or addiction. Evidence shows that offspring of mentally ill or addicted parents are at risk for developing mental disorders or illnesses themselves. The Kopstoring course is an online 8-week group course with supervision by 2 trained psychologists or social workers, aimed to prevent behavioral and psychological problems for children (aged 16 to 25 years) of parents with mental health problems or addictions. The course addresses themes such as roles in the family and mastery skills. An online randomized controlled trial (RCT) was conducted to assess the effectiveness of the Kopstoring course. OBJECTIVE: The aim was to gain knowledge about expectations, experiences, and perspectives of participants and providers of the online Kopstoring course. METHODS: A process evaluation was performed to evaluate the online delivery of Kopstoring and the experiences and perspectives of participants and providers of Kopstoring. Interviews were performed with members from both groups. Participants were drawn from a sample from the Kopstoring RCT. RESULTS: Thirteen participants and 4 providers were interviewed. Five main themes emerged from these interviews: background, the requirements for the intervention, experience with the intervention, technical aspects, and research aspects. Overall, participants and providers found the intervention to be valuable because it was online; therefore, protecting their anonymity was considered a key component. Most barriers existed in the technical sphere. Additional barriers existed with conducting the RCT, namely gathering informed consent and gathering parental consent in the case of minors. CONCLUSIONS: This study provides valuable insight into participants' and providers' experiences and expectations with the online preventive intervention Kopstoring. It also sheds light on the process of the online provision of Kopstoring and the accompanying RCT. The findings of this study may partly explain dropout rates when delivering online interventions. The change in the (financial) structure of the youth mental health care system in the Netherlands has financial implications for the delivery of prevention programs for youth. Lastly, there are few RCTs that assess the effectiveness and cost-effectiveness of online prevention programs in the field of (youth) mental health care and not many process evaluations of these programs exist. This hampers a good comparison between online interventions and the expectations and experiences of the participants and providers. TRIAL REGISTRATION: Nederlands Trial Register: NTR1982; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1982 (Archived by WebCite® at http://www.webcitation.org/6d8xYDQbB).

Pelvic floor dysfunction: women's sexual concerns unraveled.

INTRODUCTION: Sexual function of women suffering from pelvic organ prolapse (POP) and/or urinary incontinence (UI) is adversely affected. However, our current understanding of the exact relationship between female sexual dysfunction and POP and/or UI is incomplete. A qualitative study can improve our understanding by describing what women themselves perceive as the real problem. AIM: To gain a more in-depth understanding of the impact of POP and/or UI on the different categories of female sexual dysfunction by way of a qualitative study. METHODS: Qualitative semistructured interviews were conducted in 37 women scheduled for pelvic floor surgery, and one was excluded from analysis due to incomplete recordings. MAIN OUTCOME MEASURES: The impact of POP and/or UI on female sexual function. RESULTS: Only 17% of women were completely positive about their sex life. Both POP and UI had a negative effect on body image. Women with POP had a negative image of their vagina, which caused them to be insecure about their partner's sexual experience, while women with UI were embarrassed about their incontinence and pad use, and feared smelling of urine. Worries about the presence of POP during sexual activity, discomfort from POP, and reduced genital sensations were the most important reasons for decreased desire, arousal, and difficulty reaching an orgasm in women with POP. Fear of incontinence during intercourse affected desire, arousal, and orgasm and could be a cause for dyspareunia in women with UI. Desire was divided into two main elements: "drive" and "motivation." Although "drive," i.e., spontaneous sexual interest, was not commonly affected by POP and/or UI, a decrease in "motivation" or the willingness to engage in sexual activity was the most common sexual dysfunction mentioned. CONCLUSIONS: Body image plays a key role in the sexual functioning of women with POP and/or UI with the biggest impact on women's "motivation."

Sexual experiences of male partners before and after female pelvic floor surgery: a qualitative study.

INTRODUCTION AND HYPOTHESIS: To obtain a precise idea of the partner's thoughts and experiences with regard to the effect of female pelvic floor disorders and surgery on his sexual life. METHODS: Qualitative semi-structured interviews were conducted in 8 partners of women undergoing pelvic floor surgery prior to, and in 6 partners at a median of 18 weeks after surgery. The data gathered were systematically analysed using data matrices. RESULTS: Although most men evaluated their sex life prior to surgery in a positive way, one or more changes in the sexual life of our participants as a result of the female pelvic floor disorder were common. This was a result of changes in the man's physical sensations and behaviour during sex (direct changes), and changes in the female partner's sexual behaviour and reduced body confidence (indirect changes). The cure of the pelvic floor disorder and changes in vaginal tightness following surgery caused direct improvements in the man's physical sensations, as well as indirect improvements in his sexual experience as a result of positive changes in the woman's sexual behaviour and body confidence. CONCLUSIONS: As only a small group of men participated in this study, the results should be interpreted with caution. The information gathered in our study can provide guidance to clinicians on possible aspects to explore with their patients prior to and after pelvic floor surgery, and can form the basis of disease-specific male sexual function questionnaires that can be used in quantitative studies on this topic.