Increased device thresholds with subsequent improvement status post-systemic therapy in a patient with multiple myeloma.
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ABSTRACT:
SUBMITTER: Martinez JC
PROVIDER: S-EPMC8602117 | biostudies-literature | 2021 Nov
REPOSITORIES: biostudies-literature
Publications
Increased device thresholds with subsequent improvement status post-systemic therapy in a patient with multiple myeloma.
Martinez Jake Cordell JC Khiatah Bashar B Jazayeri Sam S Oregel Karlos Z KZ Dukes Jonathan Walter JW
HeartRhythm case reports 20210518 11
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| S-EPMC11612371 | biostudies-literature
Project description:Over the past 13 years, there have been advances in characterizing the patient experience in oncology trials, primarily using patient-reported outcomes (PROs). This review aims to provide details on the PRO measures and analyses used in multiple myeloma (MM) registrational trials. We identified registrational trials supporting MM indications from 2007 to 2020 from FDA databases. Trial protocols, statistical analysis plans, and clinical study reports were reviewed for PRO measures used, collection methods, statistical analyses, baseline and instrument completion definitions, and thresholds for clinical meaningfulness. Twenty-five trials supporting 20 MM indications were identified; 17 (68%) contained submitted PRO data. Of the 17 trials, 14 were randomized controlled trials and the remainder were single-arm trials. All but one trial were open label trials. Seven trials collected data electronically and five in paper format. The majority of trials evaluated at least two PRO measures (82%) with two trials (12%) utilizing four measures. Nine unique PRO measures were used, most commonly the EORTC QLQ-30 (87%), EQ-5D (65%), and QLQ-MY20 (47%). All 17 (100%) trials provided descriptive summaries, 10 (59%) carried out longitudinal mixed model analysis, 9 (53%) conducted responder analysis, and 2 (12%) did a basic inferential test. We noted substantial heterogeneity in terms of PRO collection methods, measures, definitions, and analyses, which may hinder the ability to effectively capture and interpret patient experience in future MM clinical trials. Further research is needed to determine the most appropriate approaches for statistical and analytical methodologies for PRO data in MM trials.
| S-EPMC8408214 | biostudies-literature
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| S-EPMC8924210 | biostudies-literature
Project description:Systemic right ventricular failure is a common finding in patients with transposition of the great arteries. Some of these patients require ventricular assist device implantation. We describe the feasibility of HeartMate 3 [Abbott, Illinois, United States] implantation in a patient with transposition of the great arteries, high human leukocyte antigen sensitization, and severe pectus excavatum using a two-stage approach.Learning objectives1.To notice the challenges faced while implanting HeartMate 3 [Abbott, Illinois, United States] in patients with congenital heart disease and anatomical limitations.2.To understand that despite the difficulties, HeartMate 3 implantation is possible, worthwhile, and sometimes the only choice in a patient with end-stage heart failure and congenital heart disease.
| S-EPMC9352421 | biostudies-literature
Project description:ObjectiveWe examined whether nonadherence to hydroxychloroquine (HCQ) or immunosuppressive medications (ISMs) was associated with higher subsequent acute care utilization among Medicaid beneficiaries with systemic lupus erythematosus (SLE).MethodsWe utilized US Medicaid data from 2000-2006 to identify adults ages 18-64 years with SLE who were new users of HCQ or ISMs. We defined the index date as receipt of HCQ or ISMs without use in the prior 6 months. We measured adherence using the medication possession ratio (MPR), the proportion of days covered by total days' supply dispensed, for the 1-year post-index date. Our outcomes were all-cause and SLE-related emergency department (ED) visits and hospitalizations in the subsequent year. We used multivariable Poisson regression models to examine the association between nonadherence (MPR <80%) and acute care utilization, adjusting for sociodemographics and comorbidities.ResultsWe identified 9,600 HCQ new users and 3,829 ISM new users with SLE. The mean ± SD MPR for HCQ was 47.8% ± 30.3% and for ISMs was 42.7% ± 30.7%. Seventy-nine percent of HCQ users and 83% of ISM users were nonadherent (MPR <80%). In multivariable models, among HCQ users, the incidence rate ratio (IRR) of ED visits was 1.55 (95% confidence interval [95% CI] 1.43-1.69) and the IRR of hospitalizations was 1.37 (95% CI 1.25-1.50), comparing nonadherers to adherers. For ISM users, the IRR of ED visits was 1.64 (95% CI 1.42-1.89) and of hospitalizations was 1.67 (95% CI 1.41-1.96) for nonadherers versus adherers.ConclusionIn this cohort, nonadherence to HCQ and ISMs was common and was associated with significantly higher subsequent acute care utilization.
| S-EPMC4684806 | biostudies-literature
Project description:BackgroundAs disease-modifying therapies do not reverse the course of multiple sclerosis (MS), assessment of therapeutic success involves documenting patient-reported outcomes (PROs) concerning health-related quality of life, disease and treatment-related symptoms, and the impact of symptoms on function. Interpreting PRO data involves going beyond statistical significance to calculate within-patient meaningful change scores. These thresholds are needed for each PRO in order to fully interpret the PRO data. This analysis of PRO data from the PROMiS AUBAGIO study, which utilized 8 PRO instruments in teriflunomide-treated relapsing-remitting MS (RRMS) patients, was designed to estimate clinically meaningful within-individual improvement thresholds in the same manner, for 8 PRO instruments.ResultsThe analytical approach followed a triangulation exercise that considered results from anchor- and distribution-based methods and graphical representations of empirical cumulative distribution functions in PRO scores in groups defined by anchor variables. Data from 8 PRO instruments (MSIS-29 v2, FSMC, MSPS, MSNQ, TSQM v1.4, PDDS, HRPQ-MS v2, and HADS) were assessed from 434 RRMS patients. For MSIS-29 v2, FSMC, MSPS, and MSNQ total scores, available anchor variables enabled both anchor- and distribution-based methods to be applied. For instruments with no appropriate anchor available, distribution-based methods were applied. A recommended value for meaningful within-individual improvement was defined by comparing mean change in PRO scores between participants showing improvement of one or two categories in the anchor variable or those showing no change. A "lower bound" estimate was calculated using distribution-based methods. An improvement greater than the lower-bound estimate was considered "clinically meaningful".ConclusionThis analysis produced estimates for assessing meaningful within-individual improvements for 8 PRO instruments used in MS studies. These estimates should be useful for interpreting scores and communicating study results and should facilitate decision-making by regulatory and healthcare authorities where these 8 PROs are commonly employed.
| S-EPMC10319693 | biostudies-literature
Project description:PurposePatients with multiple myeloma suffer from disease-related complications such as bone destruction, toxicities from repeated therapies and age-related co-morbidities. With improved treatment options, patients are living longer and have specific survivorship needs such as low exercise levels that need to be addressed. In this study, we designed, implemented and evaluated a multidisciplinary team (MDT) myeloma clinic that provided participants with tailored exercise and lifestyle advice.MethodsThe Promoting Individualised Self-Management and Survivorship (PrISMS) clinic was set up in two UK myeloma centres. This remote MDT clinic comprised of a doctor, a nurse specialist and a physiotherapist. Patients were required to complete blood tests and a questionnaire about their symptoms and concerns before each consultation. Patient-reported outcome measures were captured using validated questionnaires. Patient feedback was collected using a specially designed survey and structured telephone interviews.ResultsSixty-one patients were enrolled in the pilot clinic with 210 consultations held during the study period. Nine patients had disease progression and were referred safely back to face-to-face clinics. There was a significant improvement in patients' exercise score (p = 0.02) after PrISMS clinic. Patient satisfaction was high, with 83% feeling more confident in self-managing myeloma after PrISMS clinic.ConclusionPrISMS clinic is safe and feasible, with high patient compliant and acceptability. It empowers patients to self-manage their condition and encourages physical activity, which is associated with improved quality of life and fatigue level. Future randomised controlled trials will help to confirm its benefits on patient clinical outcomes and cost-effectiveness.
| S-EPMC9860216 | biostudies-literature
Project description:BackgroundBreast Implant Illness (BII) describes a variety of symptoms reported by patients with breast implants. Biospecimens data revealed minimal statistical differences between BII and non-BII cohorts. Baseline analysis of PROMIS data demonstrated significant differences between the BII cohort and the 2 control cohorts.ObjectivesThis study was designed to determine if patients in the BII cohort obtained any symptom improvement after explantation, whether symptom improvement was related to the type of capsulectomy, and which symptoms improved.MethodsA prospective blinded study enrolled 150 consecutive patients divided equally into 3 cohorts. Baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, were obtained at baseline, 3 to 6 weeks, 6 months, and 1 year.ResultsA total of 150 patients were enrolled between 2019 and 2021. Follow-up at 1 year included 94% of the BII cohort and 77% of non-BII and mastopexy cohorts. At 1 year, 88% of patients showed at least partial symptom improvement, with a reduction of 2 to 20 symptoms. The PROMIS score in the BII cohort decreased at 1 year for anxiety, sleep disturbances, and fatigue. Systemic symptom improvement was noted out to 1 year in the BII cohort regardless of the type of capsulectomy performed.ConclusionsParts 1-3 in this series concluded that there were no consistent differences in biospecimen results between the cohorts. Unlike the data observed in the biospecimen analysis, BII patients had heightened symptoms and poorer PROMIS scores at baseline compared to the control cohorts. The reduction of negative expectations and a potential nocebo effect could contribute to this improvement.Level of evidence: 4
| S-EPMC10501748 | biostudies-literature
Project description:BackgroundBreast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. There currently exists a difference of opinion among clinicians and patients concerning the diagnosis and treatment of patients self-reporting BII.ObjectivesThe first aim of this study was to determine if there is a valid indication for "en bloc" capsulectomy in patients self-reporting BII and if the type of capsulectomy performed alters long-term symptom improvement. The second goal was to identify any clinical laboratory differences between the cohorts. This study was funded by the Aesthetic Surgery Education and Research Foundation (ASERF).MethodsA prospective blinded study enrolled 150 consecutive subjects divided equally into 3 cohorts: (A) women with systemic symptoms they attribute to their implants who requested implant removal; (B) women with breast implants requesting removal or exchange who do not have symptoms they attribute to their implants; and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. The subject's baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, was obtained before surgery and at 3-6 weeks, 6 months, and 1 year. Blood was collected from all 3 cohorts and implant capsules were collected from Cohorts A and B.Results150 patients were enrolled between 2019-2021. Follow-up at 3-6 weeks for all 3 cohorts was between 98%-100%, 78%-98% at 6-months, and 1 year data is currently at 80%. The type of capsulectomy; intact total, total, or partial all showed similar symptom improvement with no statistical difference in the reduction of symptoms based on the type of capsulectomy.ConclusionsThis study addresses one of the most discussed questions by plastic surgeons, patients, their advocates, and social media. The findings show that patients who self-report BII demonstrate a statistically significant improvement in their symptoms after explantation and that this improvement persists for at least 6 months. This improvement in self-reported systemic symptoms was seen regardless of the type of capsulectomy performed.Level of evidence: 2
| S-EPMC9208825 | biostudies-literature
Project description:Video 1Colonic abnormalities observed in the course of systemic multiple myeloma.
| S-EPMC10422100 | biostudies-literature