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.

Assessing the costs and outcomes of control programmes for sexually transmitted infections: a systematic review of economic evaluations.

OBJECTIVE: To identify economic evaluations of interventions to control STIs and HIV targeting young people, and to assess how costs and outcomes are measured in these studies. DESIGN: Systematic review. DATA SOURCES: Seven databases were searched (Medline (Ovid), EMBASE (Ovid), Web of Science, PsycINFO, NHS Economic Evaluation Database, NHS Health Technology Assessment and Database of Abstracts of Reviews of Effects) from January 1999 to April 2019. Key search terms were STIs (chlamydia, gonorrhoea, syphilis) and HIV, cost benefit, cost utility, economic evaluation, public health, screening, testing and control. REVIEW METHODS: Studies were included that measured costs and outcomes to inform an economic evaluation of any programme to control STIs and HIV targeting individuals predominantly below 30 years of age at risk of, or affected by, one or multiple STIs and/or HIV in Organisation for Economic Co-operation and Development countries. Data were extracted and tabulated and included study results and characteristics of economic evaluations. Study quality was assessed using the Philips and BMJ checklists. Results were synthesised narratively. RESULTS: 9530 records were screened and categorised. Of these, 31 were included for data extraction and critical appraisal. The majority of studies assessed the cost-effectiveness or cost-utility of screening interventions for chlamydia from a provider perspective. The main outcome measures were major outcomes averted and quality-adjusted life years. Studies evaluated direct medical costs, for example, programme costs and 11 included indirect costs, such as productivity losses. The study designs were predominantly model-based with significant heterogeneity between the models. DISCUSSION/CONCLUSION: None of the economic evaluations encompassed aspects of equity or context, which are highly relevant to sexual health decision-makers. The review demonstrated heterogeneity in approaches to evaluate costs and outcomes for STI/HIV control programmes. The low quality of available studies along with the limited focus, that is, almost all studies relate to chlamydia, highlight the need for high-quality economic evaluations to inform the commissioning of sexual health services.

Cost-effectiveness of a weaning food safety and hygiene programme in rural Gambia.

OBJECTIVE: The main objective of the economic evaluation was to determine the cost-effectiveness of a weaning food safety and hygiene programme in reducing rates of diarrhoea compared with the control in rural Gambia. METHODS: The public health intervention, using critical control points and motivational drivers, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up. An economic evaluation was undertaken alongside the RCT with data collected prospectively from a societal perspective. Decision-analytic modelling was used to explore cost-effectiveness over a longer time period (4 years). RESULTS: Direct out-of-pocket healthcare expenditure for households due to diarrhoea was large. The intervention significantly reduced reported childhood diarrhoeal episodes after 6 months (incident risk ratio = 0.40, 95% CI 0.33, 0.49) and 2 years after the intervention (incident risk ratio = 0.68, 95% CI 0.46, 1.02). The within-trial analysis found that the intervention led to total savings of 8064 dalasi 6 months after the intervention and 4224 dalasi 2 years after the intervention. Based on the model results, if the intervention is successful in maintaining the reduction in the risk of diarrhoea, the ICER is US$ 814 per DALY avoided over 4 years. This is cost-effective. CONCLUSIONS: This study suggests that there are substantial household costs associated with diarrhoeal episodes in children. The within-trial analysis and model results suggest that the community-based approach to improving weaning food hygiene and safety is likely to be cost-effective compared with control.

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.

Identifying and assessing the benefits of interventions for postnatal depression: a systematic review of economic evaluations.

BACKGROUND: Economic evaluations of interventions for postnatal depression (PND) are essential to ensure optimal healthcare decision-making. Due to the wide-ranging effects of PND on the mother, baby and whole family, there is a need to include outcomes for all those affected and to include health and non-health outcomes for accurate estimates of cost-effectiveness. This study aimed to identify interventions to prevent or treat PND for which an economic evaluation had been conducted and to evaluate the health and non-health outcomes included. METHODS: A systematic review was conducted applying a comprehensive search strategy across eight electronic databases and other sources. Full or partial economic evaluations of interventions involving preventive strategies (including screening), and any treatments for women with or at-risk of PND, conducted in OECD countries were included. We excluded epidemiological studies and those focussing on costs only. The included studies underwent a quality appraisal to inform the analysis. RESULTS: Seventeen economic evaluations met the inclusion criteria, the majority focused on psychological /psychosocial interventions. The interventions ranged from additional support from health professionals, peer support, to combined screening and treatment strategies. Maternal health outcomes were measured in all studies; however child health outcomes were included in only four of them. Across studies, the maternal health outcomes included were quality-adjusted-life-years gained, improvement in depressive symptoms, PND cases detected or recovered, whereas the child health outcomes included were cognitive functioning, depression, sleep and temperament. Non-health outcomes such as couples' relationships and parent-infant interaction were rarely included. Other methodological issues such as limitations in the time horizon and perspective(s) adopted were identified, that were likely to result in imprecise estimates of benefits. CONCLUSIONS: The exclusion of relevant health and non-health outcomes may mean that only a partial assessment of cost-effectiveness is undertaken, leading to sub-optimal resource allocation decisions. Future research should seek ways to expand the evaluative space of economic evaluations and explore approaches to integrate health and non-health outcomes for all individuals affected by this condition. There is a need to ensure that the time horizon adopted in studies is appropriate to allow true estimation of the long-term benefits and costs of PND interventions.

A Systematic Review of the Techniques Used to Value Temporary Health States.

BACKGROUND: A broad literature on health state utility values exists, but compared with chronic health states (HSs), issues surrounding the valuation of temporary health states (THSs) have been poorly explored. OBJECTIVES: To assess the methods used by previous studies to value HSs that are considered temporary so as to determine the strengths and limitations associated with various approaches and to inform future study designs. METHODS: A systematic review was undertaken to explore the methods used, assess how the valuation was conducted for diseases that might lead to HSs deemed as temporary, and identify the challenges encountered in the valuation of THSs. RESULTS: Of the 36 relevant studies, 22 were explicit that the HS being valued was temporary. Most of the studies used more than one technique (often incorporating both conventional and adapted approaches). In using adapted techniques, the primary challenge was identifying an appropriate intermediate "anchor" HS and the possibility of negative utilities. CONCLUSIONS: There is no agreement on the most methodologically robust approach to THS valuation. Valuation is complex and important issues relating to the validity, practicality, and reliability of the techniques used were not adequately covered by most of the studies identified.

Measuring Health and Quality of Life for Women Undergoing Testing and Screening for Chlamydia: A Systematic Review.

BACKGROUND: Most economic evaluations of interventions to prevent or control curable sexually transmitted infections (STIs), such as chlamydia, have focused on the longer-term health impacts avoided. However, there is a range of qualitative evidence suggesting that those who think that they might have an STI and/or undergo testing can experience impacts on their quality of life (QoL) at the testing and diagnosis stage. A systematic review was undertaken to identify and evaluate studies that have measured QoL and sexual health for women undergoing testing and screening for chlamydia. METHODS: A systematic review was conducted, with searches of 5 electronic databases up to the end of August 2013. Data on study characteristics, methods, and results were extracted using a standard template, and a narrative synthesis was undertaken. RESULTS: Eight studies measuring QoL and sexual health were included. The included studies measured a variety of aspects of QoL and sexual health, with a focus on psychosocial well-being. A range of validated tools were used to measure health and QoL, and "bespoke" questions were also developed. Few significant differences were found with comparator groups using generic instruments, but some impacts were found using bespoke questions. CONCLUSIONS: Although researchers have begun to examine the relationships between QoL and sexual health, there are limitations associated with the evidence available. There is, thus, a need for further research exploring sexual health and QoL for patients undergoing testing and screening for curable STIs, with a focus on analyzing the most appropriate methodological approaches in this context.

Developing and testing accelerated partner therapy for partner notification for people with genital Chlamydia trachomatis diagnosed in primary care: a pilot randomised controlled trial.

BACKGROUND: Accelerated partner therapy (APT) is a promising partner notification (PN) intervention in specialist sexual health clinic attenders. To address its applicability in primary care, we undertook a pilot randomised controlled trial (RCT) of two APT models in community settings. METHODS: Three-arm pilot RCT of two adjunct APT interventions: APTHotline (telephone assessment of partner(s) plus standard PN) and APTPharmacy (community pharmacist assessment of partner(s) plus routine PN), versus standard PN alone (patient referral). Index patients were women diagnosed with genital chlamydia in 12 general practices and three community contraception and sexual health (CASH) services in London and south coast of England, randomised between 1 September 2011 and 31 July 2013. RESULTS: 199 women described 339 male partners, of whom 313 were reported by the index as contactable. The proportions of contactable partners considered treated within 6 weeks of index diagnosis were APTHotline 39/111 (35%), APTPharmacy 46/100 (46%), standard patient referral 46/102 (45%). Among treated partners, 8/39 (21%) in APTHotline arm were treated via hotline and 14/46 (30%) in APTPharmacy arm were treated via pharmacy. CONCLUSIONS: The two novel primary care APT models were acceptable, feasible, compliant with regulations and capable of achieving acceptable outcomes within a pilot RCT but intervention uptake was low. Although addition of these interventions to standard PN did not result in a difference between arms, overall PN uptake was higher than previously reported in similar settings, probably as a result of introducing a formal evaluation. Recruitment to an individually randomised trial proved challenging and full evaluation will likely require service-level randomisation. TRIAL REGISTRATION NUMBER: Registered UK Clinical Research Network Study Portfolio id number 10123.

Exploring the costs and outcomes of sexually transmitted infection (STI) screening interventions targeting men in football club settings: preliminary cost-consequence analysis of the SPORTSMART pilot randomised controlled trial.

BACKGROUND: The objective of this study was to compare the costs and outcomes of two sexually transmitted infection (STI) screening interventions targeted at men in football club settings in England, including screening promoted by team captains. METHODS: A comparison of costs and outcomes was undertaken alongside a pilot cluster randomised control trial involving three trial arms: (1) captain-led and poster STI screening promotion; (2) sexual health advisor-led and poster STI screening promotion and (3) poster-only STI screening promotion (control/comparator). For all study arms, resource use and cost data were collected prospectively. RESULTS: There was considerable variation in uptake rates between clubs, but results were broadly comparable across study arms with 50% of men accepting the screening offer in the captain-led arm, 67% in the sexual health advisor-led arm and 61% in the poster-only control arm. The overall costs associated with the intervention arms were similar. The average cost per player tested was comparable, with the average cost per player tested for the captain-led promotion estimated to be £88.99 compared with £88.33 for the sexual health advisor-led promotion and £81.87 for the poster-only (control) arm. CONCLUSIONS: Costs and outcomes were similar across intervention arms. The target sample size was not achieved, and we found a greater than anticipated variability between clubs in the acceptability of screening, which limited our ability to estimate acceptability for intervention arms. Further evidence is needed about the public health benefits associated with screening interventions in non-clinical settings so that their cost-effectiveness can be fully evaluated.

The SPORTSMART study: a pilot randomised controlled trial of sexually transmitted infection screening interventions targeting men in football club settings.

BACKGROUND: Uptake of chlamydia screening by men in England has been substantially lower than by women. Non-traditional settings such as sports clubs offer opportunities to widen access. Involving people who are not medically trained to promote screening could optimise acceptability. METHODS: We developed two interventions to explore the acceptability and feasibility of urine-based sexually transmitted infection (STI) screening interventions targeting men in football clubs. We tested these interventions in a pilot cluster randomised control trial. Six clubs were randomly allocated, two to each of three trial arms: team captain-led and poster STI screening promotion; sexual health adviser-led and poster STI screening promotion; and poster-only STI screening promotion (control/comparator). Primary outcome was test uptake. RESULTS: Across the three arms, 153 men participated in the trial and 90 accepted the offer of screening (59%, 95% CI 35% to 79%). Acceptance rates were broadly comparable across the arms: captain-led: 28/56 (50%); health professional-led: 31/46 (67%); and control: 31/51 (61%). However, rates varied appreciably by club, precluding formal comparison of arms. No infections were identified. Process evaluation confirmed that interventions were delivered in a standardised way but the control arm was unintentionally 'enhanced' by some team captains actively publicising screening events. CONCLUSIONS: Compared with other UK-based community screening models, uptake was high but gaining access to clubs was not always easy. Use of sexual health advisers and team captains to promote screening did not appear to confer additional benefit over a poster-promoted approach. Although the interventions show potential, the broader implications of this strategy for UK male STI screening policy require further investigation.

Exploring the intangible economic costs of stillbirth.

BACKGROUND: Compared to other pregnancy-related events, the full cost of stillbirth remains poorly described. In the UK one in every 200 births ends in stillbirth. As a follow-up to a recent study which explored the direct costs of stillbirth, this study aimed to explore the intangible costs of stillbirth in terms of their duration and economic implication. METHODS: Systematic searches identified relevant papers on the psychological consequences of stillbirth. A narrative review of the quantitative studies was undertaken. This was followed by a qualitative synthesis using meta-ethnography to identify over-arching themes common to the papers. Finally, the themes were used to generate questions proposed for use in a questionnaire to capture the intangible costs of stillbirth. RESULTS: The narrative review revealed a higher level of anxiety and depression in couples with stillbirth compared to those without stillbirth. The qualitative synthesis identified a range of psychological effects common to families that have experienced stillbirth. Both methods revealed the persistent nature of these effects and the subsequent economic burden. CONCLUSIONS: The psychological effects of stillbirth adversely impacts on the daily functioning, relationships and employment of those affected with far-reaching economic implications. Knowledge of the intangible costs of stillbirth is therefore important to accurately estimate the size of the impact on families and health services and to inform policy and decision making.

Valuing the health states associated with Chlamydia trachomatis infections and their sequelae: a systematic review of economic evaluations and primary studies.

OBJECTIVES: Economic evaluations of interventions to prevent and control sexually transmitted infections such as Chlamydia trachomatis are increasingly required to present their outcomes in terms of quality-adjusted life-years using preference-based measurements of relevant health states. The objectives of this study were to critically evaluate how published cost-effectiveness studies have conceptualized and valued health states associated with chlamydia and to examine the primary evidence available to inform health state utility values (HSUVs). METHODS: A systematic review was conducted, with searches of six electronic databases up to December 2012. Data on study characteristics, methods, and main results were extracted by using a standard template. RESULTS: Nineteen economic evaluations of relevant interventions were included. Individual studies considered different health states and assigned different values and durations. Eleven studies cited the same source for HSUVs. Only five primary studies valued relevant health states. The methods and viewpoints adopted varied, and different values for health states were generated. CONCLUSIONS: Limitations in the information available about HSUVs associated with chlamydia and its complications have implications for the robustness of economic evaluations in this area. None of the primary studies could be used without reservation to inform cost-effectiveness analyses in the United Kingdom. Future debate should consider appropriate methods for valuing health states for infectious diseases, because recommended approaches may not be suitable. Unless we adequately tackle the challenges associated with measuring and valuing health-related quality of life for patients with chlamydia and other infectious diseases, evaluating the cost-effectiveness of interventions in this area will remain problematic.

Exploring the wider societal impacts of sexual health issues and interventions to build a framework for research and policy: a qualitative study based on in-depth semi-structured interviews with experts in OECD member countries.

OBJECTIVES: Sexual health is a complex public health challenge and can generate wide-ranging health, social and economic impacts both within and beyond the health sector (ie, intersectoral costs and benefits). Methods are needed to capture these intersectoral impacts in economic studies to optimally inform policy/decision-making. The objectives of this study were (1) to explore the different intersectoral costs and benefits associated with sexual health issues and interventions, (2) to categorise these into sectors and (3) to develop a preliminary framework to better understand these impacts and to guide future research and policy. DESIGN: A qualitative study based on in-depth semi-structured online interviews. SETTING: OECD (Organisation for Economic Co-operation and Development) member countries. PARTICIPANTS: Professionals with expertise in the field of sexual health including clinicians, medical practitioners, sexologists, researchers, professionals working for international governmental or non-governmental health (policy) organisations and professionals involved in implementation and/or evaluation of sexual health interventions/programmes. METHODS: Sampling of participants was undertaken purposively. We conducted in-depth semi-structured online interviews to allow for a systemic coverage of key topics and for new ideas to emerge. We applied a Framework approach for thematic data analysis. RESULTS: 28 experts were interviewed. Six themes emerged from the interviews: (1) Interconnections to other areas of health (ie, reproductive health, mental health), (2) Relationships and family, (3) Productivity and labour, (4) Education, (5) Criminal justice/sexual violence, (6) Housing, addiction and other sectors. The findings confirm that sexual health is complex and can generate wide-ranging impacts on other areas of health and other non-health sectors of society. CONCLUSION: These different sectors need to be considered when evaluating interventions and making policy decisions. The preliminary framework can help guide future research and policy/decision-making. Future research could explore additional sectors not covered in this study and expand the preliminary framework.

An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed--a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. OBJECTIVE: This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. METHODS: A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. RESULTS: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. CONCLUSIONS: This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43645.

The cost of primary care consultations associated with long COVID in non-hospitalised adults: a retrospective cohort study using UK primary care data.

BACKGROUND: The economic impact of managing long COVID in primary care is unknown. We estimated the costs of primary care consultations associated with long COVID and explored the relationship between risk factors and costs. METHODS: Data were obtained on non-hospitalised adults from the Clinical Practice Research Datalink Aurum primary care database. We used propensity score matching with an incremental cost method to estimate additional primary care consultation costs associated with long COVID (12 weeks after COVID-19) at an individual and UK national level. We applied multivariable regression models to estimate the association between risk factors and consultations costs beyond 12 weeks from acute COVID-19. RESULTS: Based on an analysis of 472,173 patients with COVID-19 and 472,173 unexposed individuals, the annual incremental cost of primary care consultations associated with long COVID was £2.44 per patient and £23,382,452 at the national level. Among patients with COVID-19, a long COVID diagnosis and reporting of longer-term symptoms were associated with a 43% and 44% increase in primary care consultation costs respectively, compared to patients without long COVID symptoms. Older age, female sex, obesity, being from a white ethnic group, comorbidities and prior consultation frequency were all associated with increased primary care consultation costs. CONCLUSIONS: The costs of primary care consultations associated with long COVID in non-hospitalised adults are substantial. Costs are significantly higher among those diagnosed with long COVID, those with long COVID symptoms, older adults, females, and those with obesity and comorbidities.

Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial.

BACKGROUND: Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain. METHODS: We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference. DISCUSSION: This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE. TRIAL REGISTRATION: ISRCTN registry ISRCTN27244948. Registered 6 April 2021.

Planning human resources and facilities to achieve Sustainable Development Goals: a decision-analytical modelling approach to predict cancer control requirements in Indonesia.

OBJECTIVES: Indonesia aims to achieve universal health coverage (UHC) and Sustainable Development Goals (SDGs), including SDG 3 target 4, which focuses on cancer control, by 2030. This study aimed to forecast the human resources for health (HRH) and facilities required for cancer control in Indonesia over an 11-year period to support these goals. DESIGN: A two-stage Markov model was developed to forecast the demand side of facilities and HRH requirements for cancer control in Indonesia over an 11-year period. SETTING: Data sources used include the Indonesia Health Profile Report (2019), the Indonesian Radiation Oncology Society Database and National Cancer Control Committee documents (2019). METHODS: The study involved modelling the current availability of HRH and healthcare facilities in Indonesia and predicting future requirements. The gap between the current and the required HRH and facilities related to oncology, and the costs associated with meeting these requirements, were analysed. RESULTS: Results indicate the need to increase the number of healthcare facilities and HRH to achieve SDG targets. However, UHC for cancer care still may not be achieved, as eastern Indonesia is predicted to have no tertiary hospital until 2030. The forecast shows that Indonesia had a median of only 39% of the HRH requirements in 2019. Closing the HRH gap requires around a 47.6% increase in salary expenditure. CONCLUSION: This study demonstrates the application of decision-analytical modelling approach to planning HRH and facilities in the context of a low-to-middle-income country. Scaling up oncology services in Indonesia to attain the SDG targets will require expansion of the number and capability of healthcare facilities and HRH. This work allows an in-depth understanding of the resources needed to achieve UHC and SDGs and could be utilised in other disease areas and contexts.