Health economic evaluation of a randomized controlled trial (EMBLA study), an internet-based treatment for provoked vulvodynia.
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ABSTRACT:
SUBMITTER: Hess Engstrom A
PROVIDER: S-EPMC10110522 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
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Health economic evaluation of a randomized controlled trial (EMBLA study), an internet-based treatment for provoked vulvodynia.
Hess Engström A A Bohm-Starke N N Buhrman M M Högberg U U Skalkidou A A Lagenskiöld S S
Scientific reports 20230417 1
Internet-based treatment (IBT) for provoked vulvodynia (PVD) may reduce pain during intercourse and increases pain acceptance. However, a there is still a knowledge gap regarding the cost-effectiveness of IBT for PVD. The aim of this study was to perform a health economic evaluation of guided internet-based intervention for PVD as an addition to standard treatment. The sample consisted of 99 women with a PVD diagnosis. Healthcare related costs, health-related quality of life, and quality-adjuste ...[more]
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Project description:BackgroundDepressive disorders often remain undiagnosed or are treated inadequately. Online-based programs may reduce the present treatment gap for depressive disorders and reduce disease-related costs. This study aimed to examine the potential of the internet intervention "deprexis" to reduce the total costs of statutory health insurance. Changes in depression severity, health-related quality of life and impairment in functioning were also examined.MethodA total of 3805 participants with, at minimum, mild depressive symptoms were randomized to either a 12-week online intervention (deprexis) or a control condition. The primary outcome measure was statutory health insurance costs, estimated using health insurers' administrative data. Secondary outcomes were: depression severity, health-related quality of life, and impairment in functioning; assessed on patient's self-report at baseline, post-treatment, and three-months' and nine-months' follow-up.ResultsIn both groups, total costs of statutory health insurance decreased during the study period, but changes from baseline differed significantly. In the intervention group total costs decreased by 32% from 3139€ per year at baseline to 2119€ in the study year (vs. a mean reduction in total costs of 13% in the control group). In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life.ConclusionThe study underlines the potential of innovative internet intervention programs in treating depressive disorders. The results suggest that the use of deprexis over a period of 12 weeks leads to a significant improvement in symptoms with a simultaneous reduction in the costs of statutory health insurance.
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Project description:ObjectiveTo evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia.MethodsIn a multicenter double-blind, placebo-controlled randomized crossover trial, gabapentin (1,200-3,000 mg/d) was compared with a placebo. The primary outcome was mean pain intensity (0, no pain at all to 10, worst pain ever) on the tampon test (a standardized tampon insertion and removal test used as a surrogate marker for dyspareunia) during the last 7 days of the maintenance phase. Secondary outcomes included sexual intercourse pain and daily pain. A sample size of 53 provided 90% power to detect a 1-point reduction on the tampon test (.05 level, two-sided) between the two treatment phases.ResultsFrom August 2012 to January 2016, 230 women were screened at three academic institutions and 89 (mean age 37 years; 65% black) were randomized: 45 to gabapentin first and then placebo and 44 to placebo first and then gabapentin. Tampon test pain with gabapentin was not different compared with the placebo (adjusted mean 4.0, 95% CI 3.0-4.9 vs 4.3, 95% CI 3.4-5.2, difference -0.3, 95% CI -0.7 to 0.0; P=.07). Gabapentin also did not improve pain over placebo for sexual intercourse pain (adjusted mean 3.9, 95% CI 2.4-5.3 vs 4.0, 95% CI 2.5-5.4, difference -0.1, 95% CI -0.9 to 0.6; P=.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference -0.2, 95% CI -0.5 to -0.2; P=.36). Subset analyses found that longer pain duration and oral contraceptive nonuse were associated with minimal improvement in tampon test pain with gabapentin.ConclusionIn this cohort, extended-release gabapentin, as compared with a placebo, did not reduce tampon test pain. These data do not support the recommendation of gabapentin alone as treatment for vulvodynia.Clinical trial registrationClinicalTrials.gov, NCT01301001.
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Project description:PurposeProvoked vulvodynia (PV) is the most common cause of vulvar pain and dyspareunia. Although its etiology is unknown, it has been associated with musculoskeletal dysfunction. The inability of the lax uterosacral ligaments (USLs) to support the adjoining T11/L2 and S2-4 nerve plexuses is considered to cause PV. This study aimed to determine whether providing mechanical support to the USLs would improve PV.Patients and methodsPV patients were randomly divided into two groups. The participants in each group underwent sham manipulation (inserting a wide swab in the vagina without applying pressure) and trial manipulation (supporting the posterior fornix with a wide swab sufficiently broad to mechanically support the USLs). This was a cross-over trial, and the participants alternated between the sham and trial manipulation. Using a 0-10 visual analog pain scale (VAS), PV-associated pain levels experienced by participants were recorded during each manipulation, and the results were compared with baseline levels.ResultsThe pain level significantly reduced with USL support compared with the baseline value and the sham manipulation pain level (P = 0.003). Pain during sham manipulation was not significantly different from that recorded at baseline. The average reduction in pain with USL support was 18.4% ± 2.2%. The manipulation order did not affect changes in the pain level during trial manipulation (P = 0.512).ConclusionApplying mechanical support to the posterior fornix temporarily alleviates provoked vulvar pain in some women.
| S-EPMC8141612 | biostudies-literature
Project description:BackgroundWork-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant.ObjectiveThe aim of this study was to assess the cost-effectiveness of a guided iSMI for employees.MethodsA sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale≥22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000).ResultsWhen the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained.ConclusionsOffering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC.Trial registrationGerman Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749.International registered report identifier (irrid)RR2-10.1186/1471-2458-13-655.
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Project description:BackgroundThe evidence base for internet-based cognitive behavioral therapy for insomnia (iCBT-I) is firm; however, little is known about iCBT-I's health-economic effects.ObjectiveThis study aimed to evaluate the cost-effectiveness and cost-utility of iCBT-I in reducing insomnia among schoolteachers.MethodsSchoolteachers (N=128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a wait list control group, both with unrestricted access to treatment as usual. Health care use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and a public health care perspective. Costs were related to symptom-free status (score <8 on the insomnia severity index) and quality-adjusted life years (QALYs) gained. Sampling error was handled using nonparametric bootstrapping.ResultsStatistically significant differences favoring the intervention group were found for both health outcomes (symptom-free status yes or no: β=.30; 95% CI 0.16-0.43; QALYs: β=.019, 95% CI 0.01-0.03). From a societal perspective, iCBT-I had a 94% probability of dominating the wait list control for both health outcomes. From a public health care perspective, iCBT-I was more effective but also more expensive than the wait list control, resulting in an incremental cost-effectiveness ratio of €650 per symptom-free individual. In terms of QALYs, the incremental cost-effectiveness ratio was €11,285. At a willingness-to-pay threshold of €20,000 per QALY gained, the intervention's probability of being cost-effective was 89%.ConclusionsOur trial indicates that iCBT could be considered as a good value-for-money intervention for insomnia.Trial registrationGerman Clinical Trial Registry: DRKS00004700; https://tinyurl.com/2nnk57jm.International registered report identifier (irrid)RR2-10.1186/1745-6215-14-169.
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| S-EPMC6288594 | biostudies-literature
Project description:ObjectiveTo estimate the efficacy of common treatments for vulvodynia: topical lidocaine monotherapy, oral desipramine monotherapy, and lidocaine-desipramine combined therapy.MethodsA 12-week randomized, double-blinded, placebo-controlled trial was conducted on 133 vulvodynia-afflicted women assigned to four treatment arms: placebo tablets-placebo cream, desipramine tablets-placebo cream, placebo tablets-lidocaine cream, and desipramine tablets-lidocaine cream. The tampon test was selected as primary end point using a modified intention-to-treat analysis. Twelve secondary end points were also examined. At completion of the 12-week randomized phase, women were examined "open label" through 52 weeks postrandomization.ResultsAll treatment arms reported substantial tampon-test pain reduction: 33% reduction placebo cream-placebo tablet, 20% reduction lidocaine cream-placebo tablet, 24% reduction placebo cream-desipramine tablet, and 36% reduction lidocaine cream-desipramine tablet. Compared with placebo, we found no significant difference in tampon-test pain reduction with desipramine (t=0.90; P=.37) or lidocaine (t=1.27; P=.21). Of the remaining 12 outcome measures, only the Index of Sexual Satisfaction, improved with desipramine compared with placebo (t=-2.81; P=.006). During the open-label phase, women undergoing vestibulectomy surgery reported significantly improved pain as measured by cotton swab test and the McGill Pain Scale compared with nonsurgical alternatives.ConclusionOral desipramine and topical lidocaine, as monotherapy or in combination, failed to reduce vulvodynia pain more than placebo. Placebo or placebo-independent effects are behind the substantial pain improvement seen in all treatment allocations.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068.Level of evidenceI.
| S-EPMC6545923 | biostudies-literature
Project description:IntroductionAn economic evaluation (EE) was conducted alongside a randomized controlled trial (the Protecting Teeth @ 3 Study [PT@3]), exploring the additional preventive value of fluoride varnish (FV) application at 6-monthly intervals in nursery schools compared to treatment as usual (TAU) in the same nurseries. TAU represented a multicomponent national child oral health improvement intervention, the Childsmile program, apart from nursery FV.MethodsThe EE was a within-trial cost-utility analysis (CUA) comparing the FV and TAU groups. The CUA was conducted from a National Health Service perspective and followed relevant methods guidance. Within-trial costs included intervention costs and health care resource use costs. Health outcomes were expressed in quality-adjusted life years (QALYs) accrued over the 2-y follow-up period. The Child Health Utility 9 Dimensions questionnaire was used to obtain utility scores. National reference costs were used, a discount rate of 1.5% for public health interventions was adopted, multiple imputation methods for missing data were employed, sensitivity analyses were conducted, and incremental cost-utility ratios were calculated.ResultsData from 534 participants from the 2014-2015 PT@3 intake were used in the EE analyses, n = 265 (50%) in the FV arm and n = 269 (50%) in the TAU arm. Mean incremental cost per child in the FV arm was £68.37 (P = 0.382; 95% confidence interval [CI], -£18.04 to £143.82). Mean incremental QALY was -0.004 (P = 0.636; 95% CI, -0.016 to 0.007). The probability that the FV intervention was cost-effective at the UK £20,000 threshold was 11.3%.ConclusionThe results indicate that applying FV in nurseries in addition to TAU (all other components of Childsmile, apart from nursery FV) would not be deemed cost-effective given current UK thresholds. In view of previously proven clinical effectiveness and economic worthiness of the universal nursery toothbrushing component of Childsmile, continuation of the additional, targeted nursery FV component in its pre-COVID-19 form should be reviewed given its low probability of cost-effectiveness.Knowledge transfer statementThe results of this study can be used by child oral health policy makers and dental public health professionals. They can form part of the evidence to inform the Scottish, UK, and international guidance on community-based child oral health promotion programs.
| S-EPMC10285425 | biostudies-literature
Project description:ObjectiveThis study aims at evaluating the cost-effectiveness and cost-utility of a guided and unguided internet-based intervention for chronic pain patients (ACTonPainguided and ACTonPainunguided) compared with a waitlist control group (CG) as well as the comparative cost-effectiveness of the guided and the unguided version.DesignThis is a health economic evaluation alongside a three-arm randomised controlled trial from a societal perspective. Assessments were conducted at baseline, 9 weeks and 6 months after randomisation.SettingParticipants were recruited through online and offline strategies and in collaboration with a health insurance company.Participants302 adults (≥18 years, pain for at least 6 months) were randomly allocated to one of the three groups (ACTonPainguided, ACTonPainunguided, CG).InterventionsACTonPain consists of seven modules and is based on Acceptance and Commitment Therapy. ACTonPainguided and ACTonPainunguided only differ in provision of human support.Primary and secondary outcome measuresMain outcomes of the cost-effectiveness and the cost-utility analyses were meaningful change in pain interference (treatment response) and quality-adjusted life years (QALYs), respectively. Economic evaluation estimates were the incremental cost-effectiveness and cost-utility ratio (ICER/ICUR).ResultsAt 6-month follow-up, treatment response and QALYs were highest in ACTonPainguided (44% and 0.280; mean costs = €6,945), followed by ACTonPainunguided (28% and 0.266; mean costs = €6,560) and the CG (16% and 0.244; mean costs = €6,908). ACTonPainguided vs CG revealed an ICER of €45 and an ICUR of €604.ACTonPainunguided dominated CG. At a willingness-to-pay of €0 the probability of being cost-effective was 50% for ACTonPainguided (vs CG, for both treatment response and QALY gained) and 67% for ACTonPainunguided (vs CG, for both treatment response and QALY gained). These probabilities rose to 95% when society's willingness-to-pay is €91,000 (ACTonPainguided) and €127,000 (ACTonPainunguided) per QALY gained. ACTonPainguided vs ACTonPainunguided revealed an ICER of €2,374 and an ICUR of €45,993.ConclusionsDepending on society's willingness-to-pay, ACTonPain is a potentially cost-effective adjunct to established pain treatment. ACTonPainunguided (vs CG) revealed lower costs at better health outcomes. However, uncertainty has to be considered. Direct comparison of the two interventions does not indicate a preference for ACTonPainguided.Trial registration numberDRKS00006183.
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