Patient-specific affect-abdominal pain interactions in endometriosis: an experience sampling method (ESM) study.

OBJECTIVES: Cross-sectional studies show that endometriosis-related pain is associated with affect. Measuring these symptoms in real-time in a longitudinal perspective yields the ability to analyze the temporal relationship between variables. The aim was to evaluate the association between affect and abdominal pain, using the Experience Sampling Method (ESM) as a real-time, randomly repeated assessment. METHODS: Thirty-four endometriosis patients and 31 healthy subjects completed up to 10 real-time self-assessments concerning abdominal pain and affective symptoms during seven consecutive days. RESULTS: Endometriosis patients experienced more abdominal pain and negative affective symptoms, and scored lower on positive affect compared to healthy controls. A significant association was found between abdominal pain and both positive and negative affect in endometriosis patients. For healthy controls, less strong or non-significant associations were found. When looking at abdominal pain as a predictor for affect and vice versa, we found that only in endometriosis patients, pain was subsequently accompanied by negative affect, and positive affect may alleviate pain in these patients. CONCLUSIONS: This study confirms a concurrent and temporal relationship between affect and abdominal pain in endometriosis patients and supports the use of real-time symptom assessment to interpret potential influencers of abdominal complaints in patients with endometriosis.

SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study.

STUDY QUESTIONS: The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (-30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY: Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN SIZE DURATION: This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS SETTING METHODS: Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTERESTS: This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER: Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE: 2 January 2019. DATE OF FIRST PATIENT'S ENROLMENT: First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

Risk sharing between competing health plans and sponsors.

In many countries, competing health plans receive capitation payments from a sponsor, whether government or a private employer. All capitation payment methods are far from perfect and have raised concerns about risk selection. Paying health plans partly on the basis of capitation and partly on the basis of actual costs ("risk sharing") reduces plans' incentives for selection but sacrifices some incentives for efficiency. This paper summarizes our empirical research on Dutch health plans with respect to various forms of risk sharing. All sponsors can improve their payment systems by either implementing or changing their form of risk sharing.

Costs in the last year of life in The Netherlands.

The costs of health care in the last year of life are a subject of debate and myth. Expensive interventions at the end of life often are blamed for the rapid increase in health care spending, but evidence about the existence of such exceptionally high expenditures at the end of life is rare and faulty. This investigation examines the development and composition of health care costs at the end of life for all age groups in The Netherlands. In contrast with earlier studies, this research analyzes both acute care (cure) and long-term care (care) costs. As an alternative for the frequently used concept of calendar years, we employed the concept of life years for calculating the costs at the end of life. We found that when life approaches its end, health care expenditures indeed rise sharply, especially in the last months. However, when we compared total cure costs in the last year of life to the total cure costs for the entire population, we concluded that the end-of-life share was only about 10%. Results of this study show that interventions to reduce costs in the last year of life will have only a modest impact compared to the total health care budget.

Risk sharing as a supplement to imperfect capitation: a tradeoff between selection and efficiency.

This paper describes forms of risk sharing between insurers and the regulator in a competitive individual health insurance market with imperfectly risk-adjusted capitation payments. Risk sharing implies a reduction of an insurer's incentives for selection as well as for efficiency. In a theoretical analysis, we show how the optimal extent of risk sharing may depend on the weights the regulator assigns to these effects. Some countries employ outlier or proportional risk sharing as a supplement to demographic capitation payments. Our empirical results strongly suggest that other forms of risk sharing yield better tradeoffs between selection and efficiency.

Access to coverage for high-risks in a competitive individual health insurance market: via premium rate restrictions or risk-adjusted premium subsidies?

A competitive market for individual health insurance tends to risk-adjusted premiums. Premium rate restrictions are often considered a tool to increase access to coverage for high-risk individuals in such a market. However, such regulation induces selection which may have several adverse effects. As an alternative approach we consider risk-adjusted premium subsidies. Empirical results of simulated premium models and subsidy formulae are presented. It is shown that sufficiently adjusted subsidies eliminate the need for premium rate restrictions and consequently avoid their adverse effects. Therefore, the subsidy approach is the preferred strategy to increase access to coverage for high-risk individuals.

Ignoring small predictable profits and losses: a new approach for measuring incentives for cream skimming.

Under inadequate capitation formulae competing health insurers have an incentive for cream skimming, i.e., the selection of enrollees whom the insurer expects to be profitable. When evaluating different capitation formulae, previous studies used various indicators of incentives for cream skimming. These conventional indicators are based on all actual profits and losses or on all predictable profits and losses. For the latter type of indicators, this paper proposes, as a new approach, to ignore the small predictable profits and losses. We assume that this new approach provides a better indication of the size of the cream skimming problem than the conventional one, because an insurer has to take into account its costs of cream skimming and the (statistical) uncertainties about the net benefits of cream skimming. Both approaches are applied in theoretical and empirical analyses. The results show that, if our assumption is right, the problem of cream skimming is overestimated by the conventional ways of measuring incentives for cream skimming, especially in the case of relatively good capitation formulae.

Mandatory pooling as a supplement to risk-adjusted capitation payments in a competitive health insurance market.

Risk-adjusted capitation payments (RACPs) to competing health insurers are an essential element of market-oriented health care reforms in many countries. RACPs based on demographic variables only are insufficient, because they leave ample room for cream skimming. However, the implementation of improved RACPs does not appear to be straightforward. A solution might be to supplement imperfect RACPs with a form of mandatory pooling that reduces the incentives for cream skimming. In a previous paper it was concluded that high-risk pooling (HRP), is a promising supplement to RACPs. The purpose of this paper is to compare HRP with two other main variants of mandatory pooling. These variants are called excess-of-loss (EOL) and proportional pooling (PP). Each variant includes ex post compensations to insurers for some members which depend to various degrees on actually incurred costs. Therefore, these pooling variants reduce the incentives for cream skimming which are inherent in imperfect RACPs, but they also reduce the incentives for efficiency and cost containment. As a rough measure of the latter incentives we use the percentage of total costs for which an insurer is at risk. This paper analyzes which of the three main pooling variants yields the greatest reduction of incentives for cream skimming given such a percentage. The results show that HRP is the most effective of the three pooling variants.

Risk-adjusted capitation payments for catastrophic risks based on multi-year prior costs.

In many countries regulated competition among health insurance companies has recently been proposed or implemented. A crucial issue is whether or not the benefits package offered by competing insurers should also cover catastrophic risks (like several forms of expensive long-term care) in addition to non-catastrophic risks (like hospital care and physician services). In 1988 the Dutch government proposed compulsory national health insurance based on regulated competition among insurer as well as among providers of care. The competing insurers should offer a benefits package covering both non-catastrophic risks and catastrophic risks. The insurers would be largely financed via risk-adjusted capitation payments. The government intended to use a capitation formula that is, besides some demographic variables, based on multi-year prior costs. This paper presents the results of an explorative empirical analysis of the possible consequences of such a capitation formula for catastrophic risks. The main conclusion is that this formula would be inadequate because it would leave ample room for cream skimming.

Mandatory high-risk pooling: an approach to reducing incentives for cream skimming.

Risk-adjusted capitation payments (RACPs) to competing health insurers are an essential element of market-oriented health care reforms in The Netherlands. Crude RACPs are inadequate, especially because they encourage insurers to select against people expected to be unprofitable--a practice called cream skimming. However, implementing improved RACPs does not appear to be straightforward. This paper analyzes an approach that, given a system of crude RACPs, reduces insurers' incentives for cream skimming in the market for individual health insurance, while preserving incentives for efficiency and cost containment. Under the proposed system of Mandatory High-Risk Pooling (MHRP), each insurer would be allowed to periodically predetermine a small fraction of its members whose costs would be (partially) pooled. The pool would be financed with mandatory, flat-rate contributions. The results suggest that MHRP is a promising supplement to RACPs.

Risk-adjusted capitation: recent experiences in The Netherlands.

The market-oriented health care reforms taking place in the Netherlands show a clear resemblance to the proposals for managed competition in U.S. health care. In both countries good risk adjustment mechanisms that prevent cream skimming--that is, that prevent plans from selecting the best health risks--are critical to the success of the reforms. In this paper we present an overview of the Dutch reforms and of our research concerning risk-adjusted capitation payments. Although we are optimistic about the technical possibilities for solving the problem of cream skimming, the implementation of good risk-adjusted capitation is a long-term challenge.