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Background and aimsChronic migraine is a common neurovascular brain disorder with substantial economic costs. We performed a systematic review to identify economic evaluations of pharmacological treatments for adults with chronic migraine.MethodsWe undertook systematic literature searches using terms for migraine/headache and prophylactic drug interventions, combined with economic/cost terms where appropriate. Using inclusion and exclusion criteria, two reviewers independently assessed the citations and abstracts, and full-text articles were retrieved. A review of study characteristics and methodological quality was assessed.ResultsSixteen citations met the inclusion criteria and were model-based cost-utility studies evaluating: Botox (n = 6); Erenumab (n = 8); Fremanezumab (n = 2); and Galcanezumab (n = 1) as the main treatment. They varied in their use of comparators, perspective, and model type. Botox was cost-effective compared to placebo with an incremental cost-effectiveness ratio (ICER) ranging between £15,028 (€17,720) and £16,598 (€19,572). Erenumab, Fremanezumab and Galcanezumab when compared to Botox, was associated with ICERs ranging between £59,712 ($81,080) and £182,128 (€218,870), with the ICERs above the most common willingness-to-pay thresholds (WTPs). But they were cost-effective within the commonly used WTPs among the population for whom the previous treatments including Botox were failed. Three studies compared the cost-effectiveness of Erenumab against the placebo and found that Erenumab was dominant. All studies performed sensitivity analyses to check the robustness of their results. None of the findings from the included articles were generalisable and none of the included studies fulfilled all the criteria mentioned in the CHEERS 2022 reporting checklist and Phillips’s checklist for economic models.ConclusionsEvidence to support the cost-effectiveness of pharmacological treatments of chronic migraine in the adult population using Botox and Erenumab were identified. Our findings suggest that both Botox and Erenumab, are cost-effective compared to placebo; although Erenumab had more incremental economic benefits compared to Botox, the ICERs were above the most common willingness-to-pay thresholds. Hence, Erenumab might be an acceptable treatment for chronic migraine for patients whom other treatments such as Botox do not work. Further research is needed to help characterise the data to adequately structure and parameterise an economic model to support decision-making for chronic migraine therapies.

BackgroundMigraine is the world’s second most common disabling disorder, affecting 15% of UK adults and costing the UK over £1.5 billion per year. Several costly new drugs have been approved by National Institute for Health and Care Excellence.AimTo assess the cost-effectiveness of drugs used to treat adults with chronic migraine.MethodsWe did a systematic review of placebo-controlled trials of preventive drugs for chronic migraine. We then assessed the cost-effectiveness of the currently prescribable drugs included in the review: Onabotulinum toxin A (BTA), Eptinezumab (100mg or 300mg), Fremanezumab (monthly or quarterly dose), Galcanezumab or Topiramate, each compared to placebo, and we evaluated them jointly. We developed a Markov (state-transition) model with a three-month cycle length to estimate the costs and quality-adjusted life years (QALYs) for the different medications from a UK NHS and Personal Social Services perspective. We used a two-year time horizon with a starting age of 30 years for the patient cohort. We estimated transition probabilities based on monthly headache days using a network meta-analysis (NMA) developed by us, and from published literature. We obtained costs from published sources and applied discount rates of 3.5% to both costs and outcomes.ResultsDeterministic results suggest Topiramate was the least costly option and generated slightly more QALYs than the placebo, whereas Eptinezumab 300mg was the more costly option and generated the most QALYs. After excluding dominated options, the incremental cost-effectiveness ratio (ICER) between BTA and Topiramate was £68,000 per QALY gained and the ICER between Eptinezumab 300mg and BTA was not within plausible cost-effectiveness thresholds. The cost-effectiveness acceptability frontier showed that Topiramate is the most cost-effective medication for any amount the decision maker is willing-to-pay per QALY.ConclusionsAmong the various prophylactic medications for managing chronic migraine, only Topiramate was within typical cost-effectiveness threshold ranges. Further research is needed, ideally an economic evaluation alongside a randomised trial, to compare these newer, expensive CGRP MAbs with the cheaper oral medications.

IntroductionHead and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.Methods and analysisGetting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.Ethics and disseminationThe trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.Trial registration numberISRCTN13855775.

BackgroundChronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication is the most effective. We present a network meta-analysis to determine the effectiveness and rank of preventive drugs for chronic migraine in adults.MethodsWe identified, reviewed, and extracted data from randomised controlled trials (RCTs) of preventive drugs for chronic migraine with at least 200 participants. Data were analysed using network meta-analysis.FindingsWe included 12 RCTs of six medications (Eptinezumab, Erenumab, Fremanezumab, Galcanezumab, Onabotulinumtoxin A, and Topiramate) compared to placebo or each other. All drugs effectively reduced monthly headache and migraine days compared with placebo. The most effective drug for monthly headache days was Eptinezumab 300mg, with a mean difference of -2.46 days, 95% Credible Interval (CrI): -3.23 to -1.69. On the Surface Under the Cumulative Ranking Area (SUCRA) analysis, the probability that Eptinezumab 300mg was ranked highest was 0.82. For monthly migraine days, the most effective medication was Fremanezumab-monthly, with a mean difference: -2.77 days, 95% CrI: -3.36 to -2.17, and 0.98 probability of being ranked the highest. All included drugs, except Topiramate, improved headache-related quality of life. No eligible studies were identified for the other common preventive oral medications such as Amitriptyline, Candesartan, and Propranolol. The main reasons were that the studies did not define chronic migraine, were undertaken before the definition of chronic migraine, or were too small.InterpretationAll six medications were more effective than the placebo on monthly headache and migraine days. The absolute differences in the number of headache/migraine days are, at best, modest. No evidence was found to determine the relative effectiveness of the six included drugs with other oral preventive medications.RegistrationPROSPERO (number CRD42021265990).

BackgroundAcute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN) was a large trial comparing the clinical and cost-effectiveness of two rehabilitation interventions in adults with a first-time traumatic shoulder dislocation. Participants were allocated to receive either a single session of advice (ARTISAN) or a single session of advice and a programme of physiotherapy (ARTISAN plus). Trial results illustrated that additional physiotherapy after an initial session was not superior in improving functional outcomes for participants.ObjectivesIn this study, we aim to explore the experiences of a purposive sample of participants from both the ARTISAN and ARTISAN plus groups regarding their rehabilitation journey.DesignThis is a semistructured interview-based study.SettingThe study was conducted in the United Kingdom.ParticipantsThirty-one participants of ARTISAN trial: 16 participants from ARTISAN group and 15 from ARTISAN plus group.Outcome measures and analysisThe study follows the consolidated criteria for reporting qualitative research. The framework analysis was used to synthesise the participants’ experiences. The interviews were coded through NVivo 12.6.1.ResultsThree dominant and interrelated topics emerged from the interview data: (1) feelings about their shoulder rehabilitation outcome, (2) judgement of ARTISAN rehabilitation materials, (3) assessment of shoulder rehabilitation service provision.ConclusionBoth forms of intervention have some merit for some individuals. Thus, it may be appropriate to look at the patients’ preference for offering treatment to them. Recognising and facilitating this will be of benefit to both the patients and healthcare as a whole.

BackgroundMigraine is the second most common prevalent disorder worldwide and is a top cause of disability with a substantial economic burden. Many preventive migraine medications have notable side effects that affect different body organs.MethodWe systematically searched for published randomised controlled trials (RCTs) using terms for migraine/headache and preventive medications. Using eligibility criteria, two reviewers independently assessed the articles. Cochrane risk-of-bias tool was applied to assess the quality of the studies. Data were classified by system organ class (SOC).ResultsThirty-two RCTs with 21 780 participants met the eligibility criteria for the incidence of adverse events (AEs). Additionally, 33 RCTs with 22 615 participants were included to synthesise the incidence of serious AEs (SAEs). The percentage of attributed AEs and SAEs to each SOC for 10 preventive drugs with different dosing regimens was calculated. Amitriptyline and topiramate had a higher incidence of nervous system disorders; Topiramate was also associated with a higher incidence of psychiatric disorders. All drugs showed a certain incidence of infections and infestations, with Onabotulinumtoxin A (BTA) having the lowest rate. BTA had a higher incidence of musculoskeletal disorders than the other drugs. Calcitonin gene-related peptide (CGRP) monoclonal antibodies (MAbs) such as fremanezumab and galcanezumab were linked to more general disorders and administration site conditions than other drugs.ConclusionNotably, the observed harm to SOCs varies among these preventive drugs. We suggest conducting head-to-head RCTs to evaluate the safety profile of oral medications, BTA, and CGRP MAbs in episodic and/or chronic migraine populations.PROSPERO registration numberCRD42021265993.

BackgroundAortic stenosis is a prevalent heart valvular disorder in Iran. Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) are two common procedures for treating the disease in the current clinical pathway. However, TAVI is an expensive procedure, and for Iran with severe limitations in financial resources, it is crucial to investigate the cost-effectiveness of the technology against other competing alternatives with the same purpose. This study aims to analyse the cost-effectiveness of TAVI vs SAVR in elderly patients who are at a higher risk of surgery.MethodsThis study is a decision economic evaluation modeling, with a lifetime horizon and a healthcare payer (health insurer) perspective. The utility values are from a previous study, transitional probabilities come from an established clinical trial called PARTNER-1, and the unit costs are from Iran’s national fee schedule for medical services. The probabilistic and one-way sensitivity analyses have been performed to mitigate the uncertainty.ResultsThe incremental cost, effectiveness, and cost-effectiveness ratio for the base case were: 368,180,101 Iranian Rial, (US$ 1,473), 0.37 QALY-per-patient, and, 995,081,354 Iranian Rial (US$ 3,980), respectively. The probabilistic sensitivity analysis yielded 981,765,302 I.R.I Rials (US$ 3,927) per patient for the ICER. The probability of being cost-effective at one and three times the country’s Gross Domestic Production (GDP) is 0.31 and 0.83, respectively.ConclusionsTAVI does not seem a cost-effective procedure in comparison with SAVR at the current willingness to pay thresholds of the country. However, by increasing the WTP threshold to 3 times the GDP per capita the probability of being cost-effective will raise to 83%.

Inequality in households' payments on food and health expenditures presents the accessibility and utilization patterns between them. This study investigated the Iranian rural and urban households' inequality in payments on food and Out-of-Pocket health expenditures from 1998 to 2012. This descriptive study was conducted through the analysis of Iranian Statistics Centre data on Iranian households' income and expenditures. The Gini Coefficients, Concentration and Kakwani indices have been calculated for Iranian rural and urban households' Out-of-Pocket health and food expenditures. The means of Iranian rural and urban total consumption expenditures inequality were 0.48 and 0.48, respectively. The means of concentration index of food expenditures for rural and urban regions were 0.35 and 0.34, respectively. The means of Out-of-Pocket payments for health services for rural and urban regions were 0.51 and 0.5, respectively. Finally the means of Kakwani index of Out-of-Pocket health payments in rural and urban households were -0.005 and -0.018, respectively. There are relative high levels of inequality in Iranian households' payments on food and Out-of-Pocket health expenditures.

The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care. In this open-label, randomised controlled phase 3 trial, women aged ≥18 years with a suspected LGA fetus (estimated fetal weight >90th customised percentile) as identified by ultrasound scan between 35 weeks and 0 days (35+0 weeks) of gestation and 38+0 weeks' gestation, recruited from 106 hospitals across England, Scotland, and Wales in the UK, were randomly assigned (1:1) by web app to standard care or induction of labour between 38+0 weeks' gestation and 38+4 weeks' gestation using minimisation, balancing site, estimated fetal weight percentile (≤95th EFW percentile or >95th EFW percentile), and maternal age (≤35 years or >35 years). Key exclusion criteria included drug-treated diabetes, gestational diabetes, and elective caesarean section or induction already planned or indicated for any reason. Our primary outcome was incidence of shoulder dystocia, assessed by a masked independent expert adjudication panel who reviewed participants' delivery notes. Induction of labour was anticipated to result in birth 10·5 days earlier with a 300 g lower birthweight on average than standard care. We did an intention-to-treat (ITT) analysis in all participants for whom we had primary outcome data, and a per-protocol analysis in participants in the induction group who went into labour or were induced at 38+0 to 38+4 weeks' gestation versus participants in the standard care group who had not started labour, been induced, or had an elective caesarean section before 38+4 weeks' gestation. This study was registered with ISRCTN (18229892) and is no longer recruiting. Between June 8, 2018, and Oct 25, 2022, 2893 women were randomly assigned to induction of labour (n=1447) or standard care (n=1446); the trial was terminated before the target of 4000 participants was reached on advice of the data monitoring committee following the lower-than-expected incidence of shoulder dystocia in the standard care group. Two participants in the induction group and seven in the standard care group had missing data for the primary outcome and were excluded from the ITT analysis. In the ITT analysis, 33 (2·3%) of 1445 babies in the induction group versus 44 (3·1%) of 1439 in the standard care group had shoulder dystocia (risk ratio [RR] 0·75 [95% CI 0·51–1·09]; p=0·14) with a mean difference of –6·0 days' (95% CI –6·3 to –5·6) gestation and –163·6 g (–190·0 to –137·1) birthweight between trial groups. 355 (24·6%) of 1446 mothers in the standard care group were induced, delivered, or went into labour at or before 38+4 weeks' gestation. In the per-protocol analysis, 27 (2·3%) of 1180 babies in the induction group versus 40 (3·7%) of 1074 in the standard care group had shoulder dystocia (RR 0·62 [0·41–0·92]; p=0·019), and there was a mean difference of –8·1 days' (–8·4 to –7·9) gestation and –213·3 g (–242·0 to –184·6) birthweight between trial groups. One neonatal death occurred from perinatal asphyxia after shoulder dystocia in the standard care group, and one neonatal death occurred following sepsis and congenital pneumonia in the induction group. 88 (6·1%) of 1447 mothers in the induction group had an adverse event versus 108 (7·5%) of 1446 in the standard care group (RR 0·81 [0·62 to 1·06]; p=0·13). Similar numbers of serious adverse events were reported in both groups. No significant difference in incidence of shoulder dystocia was found between trial groups in the ITT analysis, probably due to the high proportion of earlier-than-expected deliveries in the standard care group reducing the intended between-group differences in gestational age and birthweight. However, in the per-protocol analysis, compared with all deliveries after 38+4 weeks' gestation, induction of labour between 38+0 weeks' gestation and 38+4 weeks' gestation did show a significant reduction in shoulder dystocia. This study provides pregnant women with suspected LGA fetuses and their clinicians important information about choices and decision making for timing and mode of birth. National Institute for Health and Care Research Health Technology Assessment Programme.