Patient Diaries Research Articles

Clinically important change on the Unified Dyskinesia Rating Scale among patients with Parkinson's disease experiencing dyskinesia.

The Unified Dyskinesia Rating Scale (UDysRS) evaluates dyskinesia in patients with Parkinson's disease (PD). A minimal clinically important change (MCIC)-the smallest change in a treatment outcome that a patient considers important-remains undefined for the UDysRS. To utilize pivotal amantadine delayed-release/extended-release (DR/ER) trial data to derive MCICs for the UDysRS total score in patients with PD experiencing dyskinesia. Pivotal trials included PD patients with ≥1 h daily ON time with troublesome dyskinesia and baseline scores ≥2 on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, item 4.2. Patients randomized to amantadine DR/ER or placebo completed two consecutive 24-h diaries before each clinic visit and were evaluated during ON time with dyskinesia using the UDysRS, MDS-UPDRS, and Clinician Global Impression of Change (CGI-C). The UDysRS changes from baseline to week 12 were anchored to corresponding changes in MDS-UPDRS item 4.2 scores. A minimal clinically important improvement in the CGI-C and diary-reported ON time with troublesome dyskinesia (≥0.5 h) were supportive anchors. Receiver operating characteristic curves determined the UDysRS change values optimizing sensitivity and specificity to at least minimal improvement on each anchor. The analyses included 196 patients. Week 12 UDysRS total score reduction of ≥8 points corresponded to at least minimal MDS-UPDRS item 4.2 improvement. UDysRS reduction of ≥9 points corresponded to decreased ON time with troublesome dyskinesia of ≥0.5 h per patient diaries, and UDysRS reduction of ≥10 points corresponded to at least minimal improvement on the CGI-C. Anchored to the MDS-UPDRS Part IV, item 4.2, an 8-point reduction in the UDysRS total score can be considered an MCIC for PD patients with dyskinesia.

Modern opportunities to improve the effectiveness of eradication therapy on a clinical case

Today, one of the significant and urgent problems of gastroenterology is Helicobacter pylori infection, which is one of the most common causative agents of chronic infections in humans. The problems of its diagnosis, and to a greater extent therapy, continue to be the subject of numerous consensuses and recommendations. The effectiveness of Helicobacter pylori eradication therapy is quite acute, taking into account both the characteristics of the microorganism itself, the growing antibiotic resistance and the decrease in patients’ adherence to therapy. The choice of treatment regimen is determined by a number of regional characteristics, including indicators of H. pylori resistance to clarithromycin and nitroimidazole, as a result of which regional recommendations are being developed in a number of countries. At the same time, the summary data on the resistance of H. pylori to clarithromycin in Russia do not allow us to speak about high rates of this problem. Therefore, clarithromycin can be used in first-line therapy as an effective component of eradication therapy. At the same time, an important measure to improve the effectiveness of H. pylori eradication is to increase the adherence of patients to therapy, which consists in talking with the patient, providing complete information about the disease, its complications, the need to follow all recommendations and taking prescribed drugs, keeping a patient diary, and, if necessary, telephone contact with the patient. In addition, it is possible to influence compliance by increasing it by prescribing a fixed combination of drugs in one package. An example of this approach is the drug combination of omeprazole, clarithromycin and amoxicillin. This article presents a small review of the literature on the reasons for unsuccessful H. pylori eradication, considers possible ways to improve it, and analyzes a clinical case with a discussion of rational pharmacocorrection.

LEAP Virtual Visit Assessment (VIVA): a structured protocol for virtual visits for patients with heart failure.

Telemedicine may be of benefit in patients with heart failure (HF), although virtual visits are often carried out on an ad hoc basis. Herein, we discuss a structured protocol that defines all the steps needed for virtual visits, LEAP Virtual Visit, which includes guides and support kits for clinicians and patients. A working group of clinicians was established to develop a protocol for virtual visits. The virtual model for monitoring HF patients was based on measurement and sizing of patient flows, type of services, and critical organizational points. The process of virtual visits was broken down to identify the specific activities, players, roles, and support tools needed for implementation in daily practice. In the protocol developed, sections were included on patient eligibility, exams, supportive tools, and practical organizational aspects. IT requirements were also considered and the most widely used teleconference platforms were compared according to features that were considered to be priority for virtual visits. Protocols and support kits were developed, including guides for clinicians and patients, two questionnaires to assess the level of satisfaction, patient diary, disease awareness brochure, and template to monitor key performance indicators. The phases include an enrolment phase, document sharing phase, pre-evaluation phase, the virtual visit itself, and the post-visit phase. The protocol for the virtual visit was divided into 8 sequential steps to be carried out between the clinic and patient/caregiver. The protocol described can be expected to have a number of benefits for the patient, clinic, and healthcare structure.

The effect of postdural puncture headache on pre-existing and new-onset headaches after cesarean section: A retrospective study

BackgroundObstetric patients are at higher risk of postdural puncture headache (PDPH) than other age- and sex-matched individuals. The debate over the long-term effects of PDPH continues. In this study, we aimed to assess the development of new-onset headaches or worsening of pre-existing chronic headaches in patients who underwent cesarean section under spinal anesthesia and developed PDPH. MethodsForty patients who developed PDPH (Group P) after cesarean section surgery (post-cesarean section–PCS), 80 patients who underwent cesarean section under spinal anesthesia (Group S), and 80 patients who underwent cesarean section under general anesthesia (Group G) were evaluated in the study. Chronic headache and other related symptoms that were present before pregnancy (pre-gestational–PG) and within 12 months after cesarean section were assessed. ResultsEight of the 40 patients in Group P had a new-onset chronic headache after cesarean surgery, which was significantly higher than the rates in the other groups (p = 0.001). Of the patients whose pre-existing headache worsened during the PCS period, seven were in Group P, and four were in Group S (p = 0.020), while none was in Group G. According to the multiple logistic regression analysis, the risk of worsening headache increased by 1.51-fold for every 1 unit increase in the PG Numerical Rating Scale (NRS). ConclusionIn conclusion, patients who develop PDPH appear to be at higher risk of developing new-onset headaches or worsening of pre-existing headaches compared with those who do not. We believe that keeping a headache diary for patients who will undergo dural puncture for whatever purpose, and also long-term follow-up of these patients for the risk of chronic headaches may increase awareness of this issue.

Ragweed pollen concentration predicts seasonal rhino-conjunctivitis and asthma severity in patients allergic to ragweed

In this work, we investigate the correlation between ragweed pollen concentration and conjunctival, nasal, and asthma symptom severity in patients allergic to ragweed pollen using ambient pollen exposure in the Milan area during the 2014 ragweed season We calculate the pollen/symptom thresholds and we assess the effectiveness of ragweed allergen immunotherapy (AIT). A total of 66 participants allergic to ragweed (Amb a 1) were enrolled in the study and divided into two groups: AIT treated (24) and no AIT treated (42). Pollen counts and daily symptom/medication patient diaries were kept. Autoregressive distributed lag models were used to develop predictive models of daily symptoms and evaluate the short-term effects of temporal variations in pollen concentration on the onset of symptoms. We found significant correlations between ragweed pollen load and the intensity of symptoms for all three symptom categories, both in no AIT treated (τ = 0.341, 0.352, and 0.721; and ρ = 0.48, 0.432, and 0.881; p-value < 0.001) and in AIT treated patients (tau= 0.46, 0.610, and 0.66; and ρ = 0.692, 0.805, and 0.824; p-value < 0.001). In both groups, we observed a positive correlation between the number of symptoms reported and drug use. Mean symptom levels were significantly higher in no AIT treated than in AIT treated patients (p-value < 0.001) for all symptom categories. Pollen concentration thresholds for the four symptom severity levels (low, medium–low, medium–high and high) were calculated. Ragweed pollen concentration is predictive of symptom severity in patients with a ragweed (Amb a 1) allergy. Patients treated with AIT had significantly reduced mean symptom levels compared to those without AIT.

33238 Initial psychometric evaluation of the eczema symptom and impact diary in patients with moderate to severe atopic dermatitis from a phase 2 trial

Introduction: The Eczema Symptom and Impact Diary (ESID) is a novel, 9-item patient-reported outcome (PRO) diary for atopic dermatitis signs/symptoms (itching, red skin, dry skin, and pain) and impacts (sleep, clothes, avoiding activities, embarrassment, and effect on work). This study evaluated selected psychometric properties of ESID item-level weekly average scores.

SP7.8 The SUNRRISE Trial – Single Use Negative pRessure dressing for Reduction in Surgical site infection following Emergency laparotomy

Abstract Background Surgical Site Infections (SSI) are common after abdominal surgery, and more so after emergency laparotomy. Despite Single Use Negative Pressure Dressings (SUNPDs) having mixed evidence regarding effectiveness, they are recommended in the WHO SSI Prevention guidelines. SUNRRISE is an international, multi-centre, trainee devised, led and delivered randomised controlled trial, funded by the NIHR (UK) and MRFF (Australia). It investigates whether a SUNPD reduces the risk of SSI within 30 days of emergency laparotomy. Method Patients were randomised between SUNPD (PICO7©, Smith and Nephew) and surgeon's preference of dressing. Patients were eligible if they underwent an emergency laparotomy with an incision of at least 5cm that was primarily closed at the end of the operation. SSI was assessed at day 5–10, via a patient diary while the patient was at home and at day 30–44 by a blinded, trained wound assessor. Results 840 patients were randomised from 34 centres across the UK and Australia. Intention to treat analysis showed no difference in SSI between the two groups (SUNPD-28%, Control-27%, p=0.75). There was also no difference in all secondary outcomes- length of stay (9 vs 11, p=0.14), hospital readmission for wound related complications (3% vs 3%, p-0.96, rates of wound related complications (19% vs 18%, p-0.79), pain (1.8 vs 1.8, p-0.61) and quality of life (SF-12 &amp; EQ5D-5L). Conclusion SUNRRISE is a multicentre, assessor blinded, phase III RCT that provides robust evidence that single-use negative pressure dressings are not effective in reducing surgical site infections in patients undergoing an emergency laparotomy.

A Systematic Survey of Research Trends in Technology Usage for Parkinson's Disease.

Parkinson’s disease (PD) is a neurological disorder with complicated and disabling motor and non-motor symptoms. The complexity of PD pathology is amplified due to its dependency on patient diaries and the neurologist’s subjective assessment of clinical scales. A significant amount of recent research has explored new cost-effective and subjective assessment methods pertaining to PD symptoms to address this challenge. This article analyzes the application areas and use of mobile and wearable technology in PD research using the PRISMA methodology. Based on the published papers, we identify four significant fields of research: diagnosis, prognosis and monitoring, predicting response to treatment, and rehabilitation. Between January 2008 and December 2021, 31,718 articles were published in four databases: PubMed Central, Science Direct, IEEE Xplore, and MDPI. After removing unrelated articles, duplicate entries, non-English publications, and other articles that did not fulfill the selection criteria, we manually investigated 1559 articles in this review. Most of the articles (45%) were published during a recent four-year stretch (2018–2021), and 19% of the articles were published in 2021 alone. This trend reflects the research community’s growing interest in assessing PD with wearable devices, particularly in the last four years of the period under study. We conclude that there is a substantial and steady growth in the use of mobile technology in the PD contexts. We share our automated script and the detailed results with the public, making the review reproducible for future publications.

Comparing effect of definition of diurnal periods by diary, fixed periods, and actigraphy on ambulatory blood pressure parameters in a Chinese population.

Background:Reliable measurement of daytime and night-time blood pressure (BP), and degree of BP dipping during sleep during ambulatory blood pressure monitoring (ABPM) requires an accurate definition of sleep time (diurnal definition). However, superiority of any diurnal definition on ABPM remains unclear. The present study compared mean daytime and night-time SBP and DBP using different methods for diurnal definition: patient's diary, wide-defined and narrow-defined fixed periods, and actigraphy, in a Chinese population with diagnosed essential hypertension. We hypothesize that BP values from actigraphy are different from BP obtained by other methods and associated with end-organ damage (i.e. impaired renal function, proteinuria, left ventricular hypertrophy).Methods:From April 2017 to October 2019, 203 Chinese patients diagnosed with hypertension were recruited prospectively from Lek Yuen Clinic and 179 completed a 48-h ABPM study, wearing a validated actigraph and completed a sleep diary. Presence of end-organ damage was retrieved from the computerized clinical management system. The differences in the mean BP values provided by different diurnal definition were compared using paired t tests and Bland–Altman plots. The prevalence of elevated BP, dipping status categories, overall percentage agreement and the Kappa statistic were calculated by pairwise comparisons between different diurnal definitions. The reproducibility was also estimated and logistic regression was used to examine the relationship between BP values from different diurnal definitions and end-organ damage.Results:Mean daytime and night-time BP values were similar regardless of the definition used (mean difference <2 mmHg). Kappa statistics and overall percentage agreement found excellent agreement between different definitions to diagnose elevated daytime BP (Kappa ranged from 0.80 to 0.91) and night-time BP (Kappa ranged from 0.74 to 0.89). Good agreement to diagnose nondipping was also detected (Kappa ranged from 0.65 to 0.78). Furthermore, ABPM values were most reproducible when diurnal periods were defined by patient's diary (intra-class correlation coefficient = 0.82–0.93). Daytime and night-time BP values obtained using different diurnal definitions did not differ in their association to end-organ damage.Conclusion:Differing definitions of diurnal periods provide similar mean BP values among a Chinese hypertensive population and have good agreement for diagnosis of elevated BP and dipping status. In individual patients, clinicians should be aware that different definitions of diurnal periods can lead to a 3–5 mmHg difference in patient's BP values and may affect the diagnosis of elevated BP in patients with BP close to diagnostic thresholds. The current study supports using the patient's diary to define diurnal periods, which provided the best reproducibility.

Analysis of Daily Sleep Diary Measures From Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children and Adults With ADHD

Objective: To compare the effect of a once-daily extended-release methylphenidate formulation (PRC-063) versus placebo on sleep, measured via daily electronic diary in two clinical trials in pediatric (6–12 years) and adult (≥18 years) patients with attention deficit hyperactivity disorder (ADHD). Method: A diary was completed by adult patients or parents/caregivers of pediatric patients during two randomized, double-blind, placebo-controlled laboratory classroom studies. Following dose optimization of PRC-063, patients were randomized to 1 week of double-blind treatment with PRC-063 or placebo before attending a full-day laboratory classroom session. Results: In the studies, 148 pediatric patients and 239 adult patients were randomized to either PRC-063 or placebo. When compared with the diaries of placebo patients, the sleep diaries in both pediatric and adult patients showed no statistical difference in total sleep time, efficiency, or latency. Conclusion: PRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD.

Continuous partially hydrolyzed guar gum intake reduces cold-like symptoms: a randomized, placebo-controlled, double-blinded trial in healthy adults.

Partially hydrolyzed guar gum (PHGG), a water-soluble dietary fiber produced by the controlled partial enzymatic hydrolysis of guar gum beans, has various physiological roles. PHGG is expected to influence the immune function and prevent infections. The objective of this study was to examine the effect of continuous ingestion of PHGG for 12 weeks on the development of cold-like symptoms. A placebo-controlled, double blind, randomized, parallel-group comparative study was conducted. 96 healthy Japanese adults received 5.2 g PHGG or placebo daily for 12 weeks. Cold-like symptoms were assessed based on patient diary, and the levels of short-chain fatty acids (SCFAs) in stool and blood immune markers at baseline and at weeks 6 and 12. The cumulative number of "no symptoms" days for all symptoms was significantly larger in the PHGG than in the placebo group. The result of the analysis by severity of cold-like symptoms also showed significant differences, with the PHGG group having a lower severity of cold-like symptoms. Propionic acid at weeks 6 and 12 and n-butyric acid and total SCFAs at week 12 were significantly higher in the PHGG than in the placebo group. The Interferon-γ level was significantly lower at week 6 in the PHGG than in the placebo group. PHGG intake may affect immune function and suppress cold-like symptoms through the production of SCFAs in healthy adults.

A scoping review of nausea, vomiting and retching measurement methods in children with cancer.

Evaluation of chemotherapy-induced nausea and vomiting (CINV) in the pediatric population is subject to diverse approaches. This scoping review summarizes the methods used in clinical studies that assessed nausea, vomiting or retching in children with cancer. We conducted a literature search of studies indexed in EMBASE and Ovid MEDLINE after 2000. Studies were included if they involved patients ≤18 years of age diagnosed with cancer, and had nausea, vomiting or retching as a primary study outcome. We excluded studies that reported only parent- or clinician-proxy measures without including the child's self-reported NVR, and those without specifying the NVR data collection process. The literature search identified twenty-four studies evaluating pediatric nausea, vomiting or retching. In the assessment of NVR, structured surveys were the most commonly used instrument for NVR assessment (75%) and the use of patient diaries (50%). Nine studies (38%) relied solely on self-reports from children as the outcome measure, while fifteen studies (62%) solicited input from parents/ caregivers and healthcare providers in addition to children's self-reports. Almost all the studies reported the frequency (n = 24) and/or severity (n = 23) of NVR symptoms and the use of antiemetic therapy (n = 19). Fewer studies evaluated distress caused by the symptoms (n = 2) and the effects of symptoms on activities of daily living (n = 4). Incorporating NVR measurement tools as part of standard of care for pediatric patients undergoing chemotherapy is strongly advocated. Based on the age group, we recommend the use of such tools comprising Likert scale, pictorial scales and structured scripts to assess various dimensions of a child's NVR experience.

Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation

BackgroundApproximately 60% of patients with chronic constipation (CC) have a significantly higher rate of loss of defecation desire (LODD). Bile acids are expected to have a restorative effect on defecation desire (DD) because they lower the rectal sensory threshold, which is an objective index of DD. Elobixibat (EXB) specifically inhibits the ileal bile acid transporter/apical sodium-dependent bile acid transporter, which is a transporter involved in the reabsorption of bile acids in the terminal ileum. This study aims to investigate the LODD improvement rate in patients with CC after 4 weeks of EXB treatment. MethodsA total of 40 adult patients with CC who meet the eligibility criteria will be enrolled. Patients will receive oral EXB (10 mg/day) for 4 weeks. A patient diary will be provided daily at 4 weeks after treatment. The primary endpoint will be the percentage LODD improvement at week 4 of the treatment period from week 2 of the observation period using questionnaires. Ethics and disseminationEthical approval was obtained from the Yokohama City University Certified Institutional Review Board prior to participant enrolment (approval number: CRB21-008). The results of this study will be submitted for publication in international peer-reviewed journals, and key findings will be presented at international scientific conferences. Participants desiring the results of this study will be directly contacted for data dissemination. Trial registrationThis trial was registered at ClinicalTrials.gov (NCT05165199). Protocol version1.0, September 21, 2021.

S196: ROPEGINTERFERON ALFA-2B ACHIEVES PATIENT-SPECIFIC TREATMENT GOALS IN POLYCYTHEMIA VERA: FINAL RESULTS FROM THE PROUD-PV/CONTINUATION-PV STUDIES

Background: Treatment of polycythemia vera (PV) aims to prevent thromboembolic complications, reduce the risk of progression to acute leukemia or myelofibrosis - of particular concern to patients - and ameliorate the symptom burden; specifically, to improve quality of life, therapy should address the most clinically important symptoms while reducing phlebotomies to avoid iron-deficiency symptoms. Long-term efficacy and safety of ropeginterferon alfa-2b have been demonstrated in PROUD-PV/CONTINUATION-PV; the final analysis applied a patient-focused approach. Aims: To analyze the patient-relevant benefit of ropeginterferon alfa-2b versus hydroxyurea (HU)/best available treatment (BAT) over 6 years. Methods: Patients diagnosed with PV according to WHO 2008 criteria who were cytoreduction-naïve or hydroxyurea pre-treated and gave written informed consent were randomized 1:1 to ropeginterferon alpha-2b or control treatment (HU) for one year in PROUD-PV. In CONTINUATION-PV, control arm patients could switch from HU to BAT. Patient-reported PV symptom burden was assessed based on adverse events documented in the patient diary and recorded at each visit; items defined in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; fatigue, concentration problems, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) and medical synonyms were evaluated post-hoc. Efficacy assessments included Kaplan-Meier analysis of event-free survival, phlebotomy need and JAK2V617F allele burden. Analyses were conducted on the CONTINUATION-PV full analysis set over 6 years of treatment. Results: The full analysis set comprised 95 patients in the ropeginterferon alfa-2b arm and 74 in the control arm. Patient-reported symptoms defined in the MPN-SAF TSS were present in a small minority (9.5%) of patients per arm at baseline (up to Week 4 of treatment) in this early-stage PV population. Occurrence of the defined symptoms remained low over long-term treatment, reported in 15.7% of patients in the ropeginterferon alfa-2b arm and 20.7% in the control arm during the 6th year of treatment. No phlebotomies were required to maintain hematocrit <45% in the 6th year of treatment in 81.4% of patients receiving ropeginterferon alfa-2b compared with 60.0% of patients in the control arm (p=0.005). Depletion of the JAK2V617F alle burden, which may lower the risk of progression to myelofibrosis, was observed in ropeginterferon alfa-2b treated patients; JAK2V617F allele burden <1% at 6 years was achieved in 19/92 (20.7%) patients in the ropeginterferon alfa-2b arm with baseline allele burden >10%. One patient met this threshold in the control arm (1/70 [1.4%]; p=0.0001). Event-free survival (risk events: disease progression, death and thromboembolic events) over ≥6 years of treatment was significantly higher among ropeginterferon alfa-2b treated patients than the control group (risk events reported in 5/95 vs. 12/74 patients, respectively; p=0.04 [Log-Rank]; Fig 1). Image:Summary/Conclusion: Long-term ropeginterferon alfa-2b therapy fulfils treatment goals important to patients with PV: a good quality of life as indicated by a low symptom burden and phlebotomy requirement, the potential to influence myelofibrosis risk, and better event-free survival versus BAT.

Effect of Dewaxed Coffee on Gastroesophageal Symptoms in Patients with GERD: A Randomized Pilot Study.

Gastroesophageal Reflux Disease (GERD) is multifactorial pathogenesis characterized by the abnormal reflux of stomach contents into the esophagus. Symptoms are worse after the ingestion of certain foods, such as coffee. Hence, a randomized pilot study conducted on 40 Italian subjects was assessed to verify the effect of standard (SC) and dewaxed coffee (DC) consumption on gastroesophageal reflux symptoms and quality of life in patients with gastrointestinal diseases. The assessment of patient diaries highlighted a significant percentage reduction of symptoms frequency when consuming DC and a significant increase in both heartburn-free and regurgitation-free days. Consequentially, patients had a significant increase of antacid-free days during the DC assumption. Moreover, the polyphenolic profile of coffee pods was ascertained through UHPLC-Q-Orbitrap HRMS analysis. Chlorogenic acids (CGAs) were the most abundant investigated compounds with a concentration level ranging between 7.316 (DC) and 6.721 mg/g (SC). Apart from CGAs, caffeine was quantified at a concentration level of 5.691 mg/g and 11.091 for DC and SC, respectively. While still preliminary, data obtained from the present pilot study provide promising evidence for the efficacy of DC consumption in patients with GERD. Therefore, this treatment might represent a feasible way to make coffee more digestible and better tolerated.

Validation of the PD home diary for assessment of motor fluctuations in advanced Parkinson’s disease

The Parkinson’s disease (PD) home diary is frequently used in clinical trials to measure efficacy of medical treatments for motor fluctuations in advanced PD. This prospective study in fluctuating PD patients examines the validity of the diary for quantification of motor states in comparison to direct clinical observation. 51 patients (median age: 65 years, disease duration: 11 years) completed the diary half-hourly for two consecutive days and were simultaneously rated by an experienced observer, who independently evaluated motor states half-hourly throughout daytime. Overall agreement (Cohen’s kappa) between patient and observer diary entries was 59.8% (0.387). Patients documented more On without dyskinesia (52.3% vs. 38.9%, P < 0.001) and less On with dyskinesia (21.5% vs. 34.2%, P < 0.001), whereas proportions for Off intervals were not different between patient and observer diaries (26.2% vs. 27.0%, P = 0.97). Temporal agreement between diary ratings was unsatisfactory, particularly for On with dyskinesia. Taken together, our study suggests that the PD home diary only inadequately reflects actual motor states compared to direct clinical observation.

Bleeding patterns of women with heavy menstrual bleeding or dysmenorrhoea using the levonorgestrel-releasing intrauterine system: results from a real-world observational study in Japan (J-MIRAI)

Purpose To collect real-world safety and clinical outcome data on the levonorgestrel-releasing intrauterine system (LNG-IUS) for functional/organic heavy menstrual bleeding (HMB) and dysmenorrhoea in Japanese women (J-MIRAI). Materials and methods In this prospective, multicentre, single-cohort, open-label, post-authorisation study, we assessed menstrual blood loss after LNG-IUS insertion by changes from baseline in pictorial blood loss assessment chart (PBAC) scores. Scores for the menorrhagia multi-attribute scale (MMAS) were collected for 12 months to assess quality of life. Results We included 47 patients with complete PBAC score and patient diary data. The median PBAC score before LNG-IUS insertion was 159.0, which decreased significantly to 6.0 at 12 months post-insertion; for patients with adenomyosis (n = 20), PBAC score decreased from 174.5 pre-insertion to 19.5 at 12 months. The number of patient-reported bleeding days was correlated with PBAC score ≥5. The proportion of women with prolonged bleeding decreased from 85.7% to 34.6% by the study’s end. Some women reported no bleeding after the first 90-day reference period. The mean MMAS overall score significantly increased from 50.50 before insertion to 88.67 at 12 months. Conclusions Japanese women with functional/organic HMB experienced substantial reductions in bleeding symptoms and improvements in quality of life after 12-month use of the LNG-IUS.

Comparison of the Results of a Parkinson's Holter Monitor With Patient Diaries, in Real Conditions of Use: A Sub-analysis of the MoMoPa-EC Clinical Trial.

BackgroundFor specialists in charge of Parkinson's disease (PD), one of the most time-consuming tasks of the consultations is the assessment of symptoms and motor fluctuations. This task is complex and is usually based on the information provided by the patients themselves, which in most cases is complex and biased. In recent times, different tools have appeared on the market that allow automatic ambulatory monitoring. The MoMoPa-EC clinical trial (NCT04176302) investigates the effect of one of these tools—Sense4Care's STAT-ON—can have on routine clinical practice. In this sub-analysis the agreement between the Hauser diaries and the STAT-ON sensor is analyzed.MethodsEighty four patients from MoMoPa-EC cohort were included in this sub-analysis. The intraclass correlation coefficient was calculated between the patient diary entries and the sensor data.ResultsThe intraclass correlation coefficient of both methods was 0.57 (95% CI: 0.3–0.73) for the OFF time (%), 0.48 (95% CI: 0.17–0.68) for the time in ON (%), and 0.65 (95% CI%: 0.44–0.78) for the time with dyskinesias (%). Furthermore, the Spearman correlations with the UPDRS scale have been analyzed for different parameters of the two methods. The maximum correlation found was −0.63 (p < 0.001) between Mean Fluidity (one of the variables offered by the STAT-dON) and factor 1 of the UPDRS.ConclusionThis sub-analysis shows a moderate concordance between the two tools, it is clearly appreciated that the correlation between the different UPDRS indices is better with the STAT-ON than with the Hauser diary.Trial Registrationhttps://clinicaltrials.gov/show/NCT04176302 (NCT04176302).

Open-Label Placebo Administration Decreases Pain in Elderly Patients With Symptomatic Knee Osteoarthritis - A Randomized Controlled Trial.

BackgroundRecent studies indicate that the administration of open-label placebos (OLP) can improve symptoms in various medical conditions. The primary aim of this 3-week randomized controlled trial was to examine the effects of OLP treatments on pain, functional disability, and mobility in patients with arthritic knee pain.MethodsSixty patients (55% females; mean age, 66.9 ± 9.7 SD years) were randomized to one of two OLP treatments (n = 41) or no treatment (NT; n = 19). OLP treatments were accompanied by the verbal suggestion “to decrease pain” (OLP-pain, n = 20) or “to improve mood” (OLP-mood, n = 21). Pain and mood levels were monitored on 11-point Numeric Rating Scales (NRSs) in a patient diary, and global clinical improvement (CGI-I) was assessed at the end of the study. At baseline and after 21 days, patients filled in validated questionnaires to assess symptoms and functional disability of the knee (WOMAC), mental and physical quality of life (SF-36), state anxiety (STAI-state), perceived stress (PSQ-20), and self-efficacy (GSE). In addition, knee mobility (neutral zero-method), heart rate variability (HRV), and diurnal cortisol levels were evaluated before and after treatment.ResultsEvaluation of daily pain ratings indicated significant pain decrease in the OLP groups compared to NT (p = 0.013, d = 0.64), with no difference between the OLP-pain and the OLP-mood groups (p = 0.856, d = 0.05). OLP treatment also improved WOMAC pain (p = 0.036, d = 0.55), again with no difference between the two OLP groups (p = 0.65, d = 0.17). WOMAC function and stiffness, knee mobility, stress, state anxiety, quality of life, and self-efficacy did not change differently between groups.ConclusionOLP treatment improved knee pain in elderly patients with symptomatic knee osteoarthritis (OA), while functional disability and mobility of the knee did not change. The content of the verbal suggestion was of minor importance. OLP administration may be considered as supportive analgesic treatment in elderly patients with symptomatic knee OA.Trial RegistrationGerman Clinical Trials Register (https://www.drks.de/), DRKS00015191 (retrospectively registered).

Leveraging electronic patient diaries in SUDEP risk evaluation

ObjectiveOur aim was to describe the risk factors known to be related to sudden unexpected death in epilepsy (SUDEP) that can be extracted from patients that utilizes an online seizure diary tool (SeizureTracker™). MethodWe conducted a descriptive analysis of SeizureTracker™ users across factors relevant to SUDEP risk. We also compared our app-using cohort to published SUDEP case-control studies. ResultsWe report across seven risk factors from 30,813 users of SeizureTracker™ who had a median length of time using the app of 5.69 years (range from 1 month to 15 years). We found that they are at greater risk for SUDEP than groups from published studies (p < .00001) based on the risk factor of generalized tonic-clonic seizures. SignificanceWe demonstrated that the population using the SeizureTracker™ tool can be a valuable population for expanding investigation of SUDEP risk factors and is a first step towards establishing a large sample with a method to ascertain data prospectively that might be critical to developing a SUDEP risk algorithm.