Dataset Information

Monitoring of adherence to headache treatments by means of hair analysis.

ABSTRACT:

Purpose

The aim of this study was to evaluate the potential of hair analysis to monitor medication adherence in headache patients undergoing chronic therapy. For this purpose, the following parameters were analyzed: the detection rate of 23 therapeutic drugs in headache patients' hair, the degree of agreement between the self-reported drug and the drug found in hair, and whether the levels found in hair reflected the drug intake reported by the patients.

Methods

The study included 93 patients suffering from primary headaches declaring their daily intake of at least one of the following drugs during the 3 months before the hair sampling: alprazolam, amitriptyline, citalopram, clomipramine, clonazepam, delorazepam, diazepam, duloxetine, fluoxetine, flurazepam, levomepromazine, levosulpiride, lorazepam, lormetazepam, mirtazapine, paroxetine, quetiapine, sertraline, topiramate, trazodone, triazolam, venlafaxine, and zolpidem. A detailed pharmacological history and a sample of hair were collected for each patient. Hair samples were analyzed by liquid chromatography-electrospray tandem mass spectrometry, using a previously developed method.

Results

All 23 drugs were detected in the examined hair samples. The agreement between the self-reported drug and the drug found in hair was excellent for most analytes (P < 0.001, Cohen's kappa); a statistically significant relationship (P < 0.05, linear regression analysis) between dose and hair level was found for amitriptyline, citalopram, delorazepam, duloxetine, lorazepam, and venlafaxine.

Conclusions

Hair analysis proved to be a unique matrix to document chronic drug use in headache patients, and the level found for each individual drug can represent a reliable marker of adherence to pharmacological treatments.

SUBMITTER: Ferrari A

PROVIDER: S-EPMC5226977 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description: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.

Project description:ObjectiveTo evaluate factors associated naturalistically with adherence to a mobile headache diary.BackgroundSelf-monitoring (keeping a headache diary) is commonly used in headache to enhance diagnostic accuracy and evaluate the effectiveness of headache therapies. Mobile applications are increasingly used to facilitate keeping a headache diary. Little is known about the factors associated with adherence to mobile headache diaries.MethodsIn this naturalistic longitudinal cohort study, people with headache (n = 1561) registered to use Curelator Headache® (now called N1-Headache®), an application that includes a mobile headache diary, through their physician (coupon), or directly through the website or app store using either a paid or free version of the application. Participants completed baseline questionnaires and were asked to complete daily recordings of headache symptoms and other factors for at least 90 days. Baseline questionnaires included headache characteristics and migraine disability. Daily recordings included headache symptoms and anxiety ratings. Adherence to keeping the headache diary was conceptualized as completion (kept the headache diary for 90 days), adherence rate (proportion of diary days completed 90 days after registration), and completion delay (the number of days past 90 days after registration required to complete 90 days of headache diary).ResultsThe majority of participants reported migraine as the most common headache type (90.0%), and reported an average of 30.8 headache days/90 days (SD = 24.2). One-third of participants completed 90 days of headache diary (32.4%). Endorsing higher daily anxiety scores (8/10 OR = 0.97 [95% CI = 0.96, 0.99]; 10/10 OR = 0.96 [95% CI = 0.91, 0.99]) was associated with lower odds of completion, whereas higher age (OR = 1.04 [95% CI = 1.03, 1.05]), and downloading the app paid vs free (OR = 4.27 [95% CI = 2.62, 7.06]), paid vs coupon (OR = 2.43, 95% CI = 1.41, 4.26]), or through a physician coupon vs free (OR = 1.75 [95% CI = 1.27, 2.42]) were associated with higher odds of completion. The median adherence rate at 90 days was 0.34 (IQR = 0.10-0.88), indicating that half of participants kept 34 or fewer days 90 diary days after registration. Endorsing high daily anxiety scores (5/10 OR = 0.98 [95% CI = 0.97, 1.00]; 8/10 OR = 0.96 [95% CI = 0.94, 0.98]; 10/10 OR = 0.96 [9% CI = 0.92, 0.98]) and higher age (OR = 1.05 [95% CI = 1.04, 1.07]) were associated with lower odds of adhering at 90 days, whereas downloading the app paid vs free (OR = 9.63 [95% CI = 4.61, 25.51]), paid vs coupon (OR = 2.39, 95% CI = 1.27, 5.10]), or through a physician coupon vs free (OR = 4.01 [95% CI = 2.54, 7.26]) were associated with higher odds of adhering at 90 days. Among completers, the median completion delay was 6.0 days (IQR = 2.0-15.0). Among completers, endorsing high daily anxiety scores (9/10 OR = 1/06 [95% CI = 1.01, 1.12]) and younger age (OR = 0.98 [95% CI = 0.97, 1.00]) was associated with completion delay; downloading the app through physician coupon vs free (OR = 0.40 [95% CI = 0.22, 0.71]) or paid vs free (OR = 0.38 [95% CI = 0.20, 0.72]) was associated with lower odds of completing 90 diary days in 90 calendar days.ConclusionThis naturalistic observational study confirmed evidence from clinical observation and research: adherence to mobile headache diaries is a challenge for a significant proportion of people with headache. Endorsing higher levels of daily anxiety, younger age, and downloading the app for free (vs either paying for the self-monitoring app or receiving a physician referral coupon) were associated with poorer adherence to keeping a mobile headache diary.

Project description:BackgroundOsmophobia, is common among primary headaches, with prevalence of migraine. The study aimed to evaluate prevalence and clinical characteristics of patients with osmophobia in a cohort of primary headache patients selected at a tertiary headache center. The second aim was to verify the possible predicting role of osmophobia in preventive treatment response in a sub cohort of migraine patients.MethodsThis was an observational retrospective cohort study based on data collected in a tertiary headache center. We selected patients aged 18-65 years, diagnosed as migraine without aura (MO), migraine with aura (MA) or Chronic Migraine (CM), Tension-Type Headache (TTH); and Cluster Headache (CH). We also selected a sub-cohort of migraine patients who were prescribed preventive treatment, according to Italian Guidelines, visited after 3 months follow up. Patients were considered osmophobic, if reported this symptom in at least the 20% of headache episodes. Other considered variables were: headache frequeny, the migraine disability assessment (MIDAS), Allodynia Symptom Checklist, Self-rating Depression scale, Self-rating Anxiety scale, Pain intensity evaluated by Numerical Rating Scale-NRS- form 0 to 10.ResultsThe 37,9% of patients reported osmophobia (444 patients with osmophobia, 726 without osmophobia). Osmophobia prevailed in patients with the different migraine subtypes, and was absent in patients with episodic tension type headache and cluster headache (chi square 68.7 DF 7 p < 0.0001). Headache patients with osmophobia, presented with longer hedache duration (F 4.91 p 0.027; more severe anxiety (F 7.56 0.007), depression (F 5.3 p 0.019), allodynia (F 6 p 0.014), headache intensity (F 8.67 p 0.003). Tension type headache patients with osmophobia (n° 21), presented with more frequent headache and anxiety. A total of 711 migraine patients was visited after 3 months treatment. The change of main migraine features was similar between patients with and without osmophobia.ConclusionsWhile the present study confirmed prevalence of osmophobia in migraine patients, it also indicated its presence among chronic tension type headache cases, marking those with chronic headache and anxiety. Osmophobia was associated to symptoms of central sensitization, as allodynia. It was not relevant to predict migraine evolution after first line preventive approach.

Project description:Although the placement of an intraventricular catheter remains the gold standard method for the diagnosis of intracranial hypertension (ICH), the technique has several limitations including but not limited to its invasiveness. Current noninvasive methods, however, still lack robust evidence to support their clinical use. We aimed to estimate, as an exploratory hypothesis generating analysis, the discriminative power of four noninvasive methods to diagnose ICH. We prospectively collected data from adult intensive care unit (ICU) patients with subarachnoid hemorrhage (SAH), intraparenchymal hemorrhage (IPH), and ischemic stroke (IS) in whom invasive intracranial pressure (ICP) monitoring had been placed. Measures were simultaneously collected from the following noninvasive methods: optic nerve sheath diameter (ONSD), pulsatility index (PI) using transcranial Doppler (TCD), a 5-point visual scale designed for brain Computed Tomography (CT), and two parameters (time-to-peak [TTP] and P2/P1 ratio) of a noninvasive ICP wave morphology monitor (Brain4Care[B4c]). ICH was defined as a sustained ICP > 20 mmHg for at least 5 min. We studied 18 patients (SAH = 14; ICH = 3; IS = 1) on 60 occasions with a mean age of 52 ± 14.3 years. All methods were recorded simultaneously, except for the CT, which was performed within 24 h of the other methods. The median ICP was 13 [9.8-16.2] mmHg, and intracranial hypertension was present on 18 occasions (30%). Median values from the noninvasive techniques were ONSD 4.9 [4.40-5.41] mm, PI 1.22 [1.04-1.43], CT scale 3 points [IQR: 3.0], P2/P1 ratio 1.16 [1.09-1.23], and TTP 0.215 [0.193-0.237]. There was a significant statistical correlation between all the noninvasive techniques and invasive ICP (ONSD, r = 0.29; PI, r = 0.62; CT, r = 0.21; P2/P1 ratio, r = 0.35; TTP, r = 0.35, p < 0.001 for all comparisons). The area under the curve (AUC) to estimate intracranial hypertension was 0.69 [CIs = 0.62-0.78] for the ONSD, 0.75 [95% CIs 0.69-0.83] for the PI, 0.64 [95%Cis 0.59-069] for CT, 0.79 [95% CIs 0.72-0.93] for P2/P1 ratio, and 0.69 [95% CIs 0.60-0.74] for TTP. When the various techniques were combined, an AUC of 0.86 [0.76-0.93]) was obtained. The best pair of methods was the TCD and B4cth an AUC of 0.80 (0.72-0.88). Noninvasive technique measurements correlate with ICP and have an acceptable discrimination ability in diagnosing ICH. The multimodal combination of PI (TCD) and wave morphology monitor may improve the ability of the noninvasive methods to diagnose ICH. The observed variability in non-invasive ICP estimations underscores the need for comprehensive investigations to elucidate the optimal method-application alignment across distinct clinical scenarios.

Project description:IntroductionElectronic adherence monitoring (EAM) is increasingly used to improve adherence. However, there is limited evidence on the effect of EAM in across chronic conditions and on patient acceptability. We aimed to assess the effect of EAM on adherence and clinical outcomes, across all ages and all chronic conditions, and examine acceptability in this systematic review and meta-analysis.MethodsA systematic search of Ovid MEDLINE, EMBASE, Social Work Abstracts, PsycINFO, International Pharmaceutical Abstracts and CINAHL databases was performed from database inception to December 31, 2020. Randomised controlled trials (RCTs) that evaluated the effect of EAM on medication adherence as part of an adherence intervention in chronic conditions were included. Study characteristics, differences in adherence and clinical outcomes between intervention and control were extracted from each study. Estimates were pooled using random-effects meta-analysis, and presented as mean differences, standardised mean differences (SMD) or risk ratios depending on the data. Differences by study-level characteristics were estimated using subgroup meta-analysis to identify intervention characteristics associated with improved adherence. Effects on adherence and clinical outcomes which could not be meta-analysed, and patient acceptability, were synthesised narratively. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline was followed, and Risk of bias (RoB) assessed using the Cochrane Collaboration's RoB tool for RCTs. The review is registered with PROSPERO CRD42017084231.FindingsOur search identified 365 studies, of which 47 studies involving 6194 patients were included. Data from 27 studies (n = 2584) were extracted for the adherence outcome. The intervention group (n = 1267) had significantly better adherence compared to control (n = 1317), (SMD = 0.93, CI:0.69 to 1.17, p<0.0001) with high heterogeneity across studies (I2 = 86%). There was a significant difference in effect according to intervention complexity (p = 0.01); EAM only improved adherence when used with a reminder and/or health provider support. Clinical outcomes were measured in 38/47 (81%) of studies; of these data from 14 studies were included in a meta-analysis of clinical outcomes for HIV, hypertension and asthma. In total, 13/47 (28%) studies assessed acceptability; patient perceptions were mixed.InterpretationPatients receiving an EAM intervention had significantly better adherence than those who did not, but improved adherence did not consistently translate into clinical benefits. Acceptability data were mixed. Further research measuring effects on clinical outcomes and patient acceptability are needed.