High Therapy Adherence Research Articles

Effectiveness of time-limited eye movement desensitization reprocessing therapy for parents of children with a rare life-limiting illness: a randomized clinical trial

BackgroundParents of children with a rare progressive life-limiting illness are at risk for parental posttraumatic stress disorder (PTSD). Studies on the treatment of parental PTSD with eye movement and desensitization reprocessing (EMDR) therapy in pediatric practice are lacking. Therefore this study aims to evaluate the feasibility and effectiveness of time-limited EMDR therapy in reducing PTSD symptoms, comorbid psychological symptoms, distress, and parental stress.MethodsMono-center randomized clinical trial conducted between February 2020 and April 2021. Fourteen parents (N = 7 mothers, N = 7 fathers) of mucopolysaccharidosis type III patients reporting PTSD symptoms on a (sub)clinical level were assigned to EMDR or a wait-list control condition followed by EMDR. Four sessions of EMDR (each 90 min) divided over two half-days were offered. Measurements were conducted at baseline, post-treatment/post-waitlist, and 3-months post-treatment. The primary outcome was PTSD symptom severity (PTSD Check List for DSM-5). Secondary outcomes included comorbid psychological symptoms (Brief Symptom Inventory), distress (Distress Thermometer for Parents) and parenting stress (Parenting Stress Questionnaire). Between-group comparisons pre-to-post treatment (N = 7 EMDR vs. N = 7 wait-list) and within-group comparisons (EMDR, N = 14) from pre-to-post treatment and from pre-treatment to 3-months follow-up were carried out per intent-to-treat linear mixed model analyses.ResultsCompared to wait-list, EMDR resulted in a significant reduction on total PTSD symptom severity (d = 1.78) and on comorbid psychological symptoms, distress and parenting stress (d = .63–1.83). Within-group comparisons showed a significant effect on all outcomes at post-treatment (d = 1.04–2.21) and at 3-months follow-up (d = .96–2.30) compared to baseline. EMDR was well-tolerated, associated with a low drop-out rate, a high therapy adherence and no adverse events.ConclusionTime-limited EMDR reduces PTSD symptoms, psychological comorbidity, distress and parenting stress in parents of children with a rare progressive life-limiting illness. This treatment was feasible for these overburdened parents. Recurrent monitoring of PTSD symptoms, and, if needed, offering this time-limited type of trauma treatment should be introduced in everyday pediatric practice.Trial registration Netherlands Trial Register, NL8496. Registered 01-04-2020, https://trialsearch.who.int/Trial2.aspx?TrialID=NL8496.

A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt® Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension.

Background The aim of this study was to demonstrate the equivalence of generic dorzolamide 2% eye drops solution versus the innovator formulation (Trusopt® eye drops solution) in patients with open-angle glaucoma or ocular hypertension. Methods This prospective, monocentric, double-masked, active-controlled crossover phase III study included 32 patients. After washout, patients were randomized to reference product (Trusopt®) or test product (dorzolamide 2% eye drops, Rompharm Company SRL) for a 4-week period. Subsequent washout and crossover were performed. Drops were applied t.i.d. The primary efficacy endpoint was the difference in mean diurnal IOP. Goldmann applanation tonometry was performed at 8 am, 12 pm, and 4 pm at each visit, and safety was assessed by documentation of adverse events (AEs). Therapy adherence was documented by self-reporting and eye drop bottle weighing. An ANOVA with treatment, sequence, study period, and patient within the sequence as effects was performed and an additional post hoc ANCOVA including the baseline IOP was also performed. Results 34 patients were randomized and analyzed in the safety population. The per-protocol population included 32 patients. According to the self-report, all patients were >80% compliant. Under the ANCOVA model, the 90% confidence interval for the average change of the IOP −0.27 mmHg (−1.17 mmHg–0.64 mmHg) is included by the acceptance range −1.5 mmHg to +1.5 mmHg after excluding 2 patients, which had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments. Conclusions This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution. Trial Registration. This trial is registered with (ClinicalTrials.gov (identifier: NCT00878917) on April 9, 2009).

Smartphone Apps for Managing Antithrombotic Therapy: Scoping Literature Review.

BackgroundAntithrombotic therapy is complex and requires informed decisions and high therapy adherence. Several mobile phone apps exist to either support physicians in the management of antithrombotic therapies or to educate and support patients. For the majority of these apps, both their medical evidence and their development background are unknown.ObjectiveThis review aims to investigate the available literature describing high-quality apps for managing antithrombotic therapy based on professional scientific information.MethodsKeywords and Medical Subject Heading terms were used to search MEDLINE via PubMed and Ovid between December 2019 and January 2022. Inclusion criteria were the availability of full text and publications in the English language. Apps that solely focused on atrial fibrillation were excluded. Qualitative findings were thematically synthesized and reported narratively.ResultsOut of 149 identified records, 32 were classified as eligible. We identified four groups: (1) apps for patients supporting self-management of vitamin K antagonists, (2) apps for patients increasing therapy adherence, (3) educational apps for patients, and (4) apps for physicians in supporting guideline adherence.ConclusionsThroughout the evaluated data, patients from all age groups receiving antithrombotic drugs expressed the desire for a digital tool that could support their therapy management. In addition, physicians using mobile guideline-based apps may have contributed to decreased adverse event rates among their patients. In general, digital apps encompassing both user-friendly designs and scientific backgrounds may enhance the safety of antithrombotic therapies. However, our evaluation did not identify any apps that addressed all antithrombotic drugs in combination with perioperative stratification strategies. Currently, strict regulations for smartphone apps seem to negatively affect the development of new apps. Therefore, new legal policies for medical digital apps are urgently needed.

Skills Training in Affective and Interpersonal Regulation Narrative Therapy for women with ICD-11 complex PTSD related to childhood abuse in Japan: a pilot study

ABSTRACT Background: Skills Training in Affective and Interpersonal Regulation (STAIR) Narrative Therapy (SNT) has shown efficacy in alleviating symptoms of posttraumatic stress disorder (PTSD) and improving emotion regulation and interpersonal skills among individuals with complex trauma, such as childhood abuse. Although this therapy is expected to be effective for patients with complex PTSD (CPTSD), no study has directly assessed diagnostic and symptom outcomes. Moreover, the potential of therapy to achieve good outcomes in non-Western countries remains unclear. Objective: This pilot study examined the feasibility, safety, and outcomes of SNT for CPTSD among women with a history of childhood abuse in a Japanese clinical setting. Methods: Ten women aged 21–54 years (M = 29.1 years) with childhood-abuse-related ICD-11 CPTSD were enrolled in this study. The International Trauma Interview and International Trauma Questionnaire were administered to diagnose CPTSD and assess its severity. Symptoms of dissociation and depression, difficulties in emotion regulation and interpersonal relationships, quality of life, and negative cognitions were assessed pretreatment, midtreatment (after the STAIR phase), and immediately posttreatment (after the Narrative Therapy phase), in addition to 3 months after treatment. Results: Seven of the 10 participants completed the treatment. The therapists’ adherence to the therapy protocol was 96.4%, ranging from 93.6% to 100% across therapists. Serious adverse events were not observed. Among the seven completers, six at posttreatment and all at follow-up no longer met CPTSD diagnosis. Exploratory analyses using the linear mixed-effects model showed significant improvements at posttreatment and follow-up for almost all the variables. Conclusions: The results provide preliminary evidence for the feasibility and safety of SNT for CPTSD in a Japanese clinical setting. This study is the first to report the use of SNT for individuals diagnosed with ICD-11 CPTSD using reliable clinician and self-report measures. HIGHLIGHTS This study examined the feasibility and safety of STAIR Narrative Therapy for women with ICD-11 CPTSD related to childhood abuse in a Japanese clinical setting. High therapy adherence was observed. No serious adverse events occurred.

Clinical attributes and treatment characteristics are associated with work productivity and activity impairment in people with severe haemophilia A.

Few studies have examined the real-world impact of haemophilia on daily activities and work productivity in people with severe haemophilia A (PWSHA). To determine clinical attributes and treatment characteristics associated with impairment in daily activities and work among PWSHA using the patient-reported Work Productivity and Activity Impairment-General Health Questionnaire (WPAI-GH). PWSHA were asked to complete the WPAI-GH as part of the Cost of Haemophilia in Europe: A Socioeconomic Survey (CHESS) study. Outcomes were determined for activity impairment (AI), absenteeism, presenteeism and overall work productivity loss (WPL). Descriptive statistics and regression analyses were used to evaluate the association between these outcomes and clinical and treatment attributes. Overall, 376 participants completed the AI element of WPAI-GH; 175 were employed and thus also reported on work impact. Mean±standard deviation scores were as follows: AI=34.2%±25.8%; absenteeism=0.06% ±0.2%; presenteeism=26.8%±22.4%; WPL=28.6%±24.0%. Increased AI and WPL were associated with high haemophilia-related morbidity, measured both as chronic pain (p<.001 for both) and joint synovitis (AI: p<0.001; WPL: p=.017). In descriptive and multivariate analyses, lifelong prophylaxis was associated with reduced AI (p<.001 and p=.031, respectively); high therapy adherence was associated with reduced AI (p=.001 and p=.012, respectively) and with reduced WPL (p<.001 and p=.012, respectively). The WPAI-GH identified haemophilia-related morbidity and treatment characteristics, including therapy regimen and adherence, as key attributes impacting functional impairment and work contributions of PWSHA. Early prophylactic intervention and greater adherence to therapy may lead to lower AI and WPL in PWSHA.

Adherence to urate-lowering therapy while following the national guidelines for the management of patients with gout (preliminary evidence)

Low compliance in patients with gout is one of the reasons for inadequate disease control.Objective: to study treatment adherence in compliance with the national guidelines for the management of gout patients, which provide for the continuous use of urate-lowering drugs, a gradual increase in their dose until the target serum uric acid (UA) level is reached, prophylactic antiinflammatory therapy, and regular patient monitoring.Patients and methods. This was a prospective single-center study. By now, 60 of the 80 enrolled gout patients had completed the study. The follow-up period was at least 24 weeks, during which allopurinol or febuxostat was used at the final dose. During initiation of urate-lowering therapy, allopurinol 100 mg/day was prescribed, followed by dose titration to reach the target UA level (&lt;360 μmol/L) for all patients or &lt;300 μmol/L for those with severe tophaceous gout. Patients with ineffective allopurinol and/or in the presence of its associated adverse reactions were prescribed febuxostat (Azurix®) 80 mg/day; the dose was increased up to 120 mg/day as needed. To prevent acute arthritis attacks, all the patients received a nonsteroidal anti-inflammatory drug (NSAID) at minimal therapeutic doses or colchicine 0.5 mg/day, and in the presence of contraindications to their use, they took glucocorticoid (GC) 7.5 mg/day calculated with reference to prednisolone. The four-item Morisky–Green questionnaire was used to assess patient adherence to therapy.Results and discussion. At 24 weeks after the start of their follow-up, 53 (88%) of the 60 patients received urate-lowering therapy; 38 (72%) of these 53 patients achieved the target UA level. The dose of allopurinol was titrated in 19 patients; and 10 (53%) of them achieved the target serum UA levels. Due to its inefficacy, allopurinol was replaced by febuxostat in 24 patients. In this group, the target UA level was recorded in 16 (67%) patients. Seventeen patients were immediately prescribed febuxostat that could achieve the target UA level in 12 (71%) of them. All the patients enrolled in the study received prophylactic anti-inflammatory therapy: NSAIDs were used in 9 (15%) patients, colchicine and GC were given to 46 (77%) and 5 (8%), respectively. Twenty-six (49%) patients who had completed the investigation were ascertained to have a high adherence therapy. Moderate and low adherence was observed in 9 (17%) and 18 (34%) patients, respectively. High therapy adherence was noted in more than half of cases in the febuxostat group and in 40% in the allopurinol one.Conclusion. High compliance in gout patients can be achieved through the observance of the national guidelines for the treatment of this disease.

Use of the wearable cardioverter-defibrillator - the Swiss experience.

Sudden cardiac death caused by malignant arrhythmia can be prevented by the use of defibrillators. Although the wearable cardioverter defibrillator (WCD) can prevent such an event, its role in clinical practice is ill defined. We investigated the use of the WCD in Switzerland with emphasis on prescription rate, therapy adherence and treatment rate. The Swiss WCD Registry is a retrospective observational registry including patients using a WCD. Patients were included from the first WCD use in Switzerland until February 2018. Baseline characteristics and data on WCD usage were examined for the total study population, and separately for each hospital. From 1 December 2011 to 18 February 2018, a total of 456 patients (67.1% of all WCDs prescribed in Switzerland and 81.1% of all prescribed in the participating hospitals) were included in the registry. Up to 2017 there was a yearly increase in the number of prescribed WCDs to a maximum of 271 prescriptions per year. The mean age of patients was 57 years (&plusmn; 14), 81 (17.8%) were female and mean left ventricular ejection fraction (EF) was 32% (&plusmn; 13). The most common indications for WCD use were new-onset ischaemic cardiomyopathy (ICM) with EF &le;35% (206 patients, 45.2%), new-onset nonischaemic cardiomyopathy (NICM) with EF &le;35% (115 patients, 25.2%), unknown arrhythmic risk (83 patients, 18.2%), bridging to implantable cardioverter-defibrillator implantation or heart transplant (37 patients, 8.1%) and congenital/inherited heart disease (15 patients, 3.3%). Median wear duration was 58 days (interquartile range [IQR] 31&ndash;94) with a median average daily wear time of 22.6 hours (IQR 20&ndash;23.2). Seventeen appropriate therapies from the WCD were delivered in the whole population (treatment rate: 3.7%) to a total of 12 patients (2.6% of all patients). The most common underlying heart disease in patients with a treatment was ICM (13/17, 76.5%). There were no inappropriate treatments. The use of WCDs has increased in Switzerland over the years for a variety of indications. There is high therapy adherence to the WCD, and a treatment rate comparable to previously published registry data. &nbsp.

Navigated laser in diabetic macular edema: the impact of reduced injection burden on patients and physicians-who wins and who loses?

We inquired the impact of reduced therapy discontinuation in diabetic macular edema (DME) on physician's revenue considering anti-vascular endothelial growth factor (VEGF) monotherapy and its combination with Navilas treatment. Data were collected on injection frequency, treatment discontinuation and reimbursement fees for DME treatment with anti-VEGF compared to anti-VEGF in combination with navigated laser. Based on these data an economic model was built to compare physicians revenue over a 5y period using either therapy for 4 European countries and the USA. Due to patients' higher therapy adherence, physicians using navigated laser therapy with anti-VEGF generate similar or higher revenues compared to VEGF monotherapy in all analyzed countries. The use of Navilas decreases the patient's injection burden at the same clinical outcome, while the physician's revenue remained stable or increased. Therewith, therapy discontinuation in DME can be reduced using the combination therapy with Navilas.

High therapy adherence but substantial limitations to daily activities amongst members of the Dutch inflammatory bowel disease patients' organization: a patient empowerment study

Adherence is important for successful treatment in inflammatory bowel disease (IBD) patients. Previous studies demonstrated high prevalence of non-adherence. To assess IBD-patients' perceptions of therapy adherence and disease-related functional status in members of the Dutch patients' association of Crohn's disease and ulcerative colitis (CCUVN). Inflammatory bowel disease-patients completed anonymously a survey at the website of the CCUVN. Statistical analysis was performed using principal component analysis, univariate and multivariate logistic regression. The questionnaire was completed by 1067 patients [617 (58%) Crohn's disease (CD) and 450 (42%) ulcerative colitis (UC)]. Mean age was 43 years (s.d. 13.7); women (66%). Of 920 patients currently using medication, 797 (87%) were adherent. Of the patients using 5-ASA, 91% were adherent (527/582), vs. 96% using corticosteroids (316/330) and 97% (414/425) using immunosuppressives. CD patients (OR 1.54; 95% CI 1.05-2.27), patients with duration of disease <or=8 years (OR 2.25; 95% CI 1.49-3.39) were more adherent. Fifty percent of patients reported a low functional status and were limited in daily activities. This population-based study shows high therapy adherence, but low functional status in Dutch CCUVN-related IBD-patients. The high adherence rate in this present study could be an effect of CCUVN membership.

Older Age and the Response to and Tolerability of Antiretroviral Therapy

The unique health needs of a growing older adult population infected with human immunodeficiency virus (HIV) require study, especially in terms of the response to and tolerability of highly active antiretroviral therapy (HAART). Changes in HIV clinical markers after HAART initiation were compared among 2259 patients aged 18 to 39 years (reference group), 1834 patients aged 40 to 49 years, and 997 patients 50 years or older enrolled in an integrated health care system. Patients 50 years or older were more likely to achieve HIV RNA levels of less than 500 copies/mL within 1 year of HAART initiation (hazard ratio [HR], 1.15; P =.009), but adjustment for adherence attenuated this finding (HR, 1.03; P =.59). Subsequent HIV RNA level rebound (to > or =1000 copies/mL) was less likely among patients aged 40 to 49 years (HR, 0.81; P =.01), which persisted after adjustment for adherence (HR, 0.79; P =.004). In year 1 of HAART, younger patients had larger CD4 T-cell count increases (131.8, 121.3, and 111.8 CD4 T cells/microL per year among patients aged 18-39, 40-49, and > or =50 years, respectively; P =.046). In years 2 through 6, older patients had larger CD4 T-cell count increases (4.5, 11.6, and 9.7 CD4 T cells/microL per year among patients aged 18-39, 40-49, and > or =50 years, respectively; P =.04). After adjustment for adherence, age differences in CD4 T-cell count changes remained in year 1 (P =.02) but not in years 2 through 6 (P =.08). Other factors, including comorbidities, had no effect on study results. Metabolic (glucose and lipids), hematologic (absolute neutrophils and hemoglobin), and renal (creatinine) abnormalities were more likely among older patients. Despite a higher risk of adverse events, patients 50 years or older sustained high therapy adherence to maintain improved virological outcomes and to compensate for their early blunted CD4 T-cell count response compared with younger patients.