Median Adherence Research Articles

Applicability of predictive models for 30-day unplanned hospital readmission risk in paediatrics: a systematic review

ObjectivesTo summarise multivariable predictive models for 30-day unplanned hospital readmissions (UHRs) in paediatrics, describe their performance and completeness in reporting, and determine their potential for application in practice.DesignSystematic review.Data sourceCINAHL,...

Effect of perindopril or leucine on physical performance in older people with sarcopenia: the LACE randomized controlled trial.

BackgroundThis trial aimed to determine the efficacy of leucine and/or perindopril in improving physical function in older people with sarcopenia.MethodsPlacebo‐controlled, parallel group, double‐blind, randomized two‐by‐two factorial trial. We recruited adults aged ≥ 70 years with sarcopenia, defined as low gait speed (<0.8 m/s on 4 m walk) and/or low handgrip strength (women < 20 kg, men < 30 kg) plus low muscle mass (using sex and body mass index category‐specific thresholds derived from normative UK BioBank data) from 14 UK centres. Eligible participants were randomized to perindopril 4 mg or placebo, and to oral leucine powder 2.5 g or placebo thrice daily. The primary outcome was the between‐group difference in the short physical performance battery (SPPB) score over 12‐month follow‐up by repeated‐measures mixed models. Results were combined with existing systematic reviews using random‐effects meta‐analysis to derive summary estimates of treatment efficacy.ResultsWe screened 320 people and randomized 145 participants compared with an original target of 440 participants. For perindopril [n = 73, mean age 79 (SD 6), female sex 39 (53%), mean SPPB 7.1 (SD 2.3)] versus no perindopril [n = 72, mean age 79 (SD 6), female sex 39 (54%), mean SPPB 6.9 (SD 2.4)], median adherence to perindopril was lower (76% vs. 96%; P < 0.001). Perindopril did not improve the primary outcome [adjusted treatment effect −0.1 points (95%CI −1.2 to 1.0), P = 0.89]. No significant treatment benefit was seen for any secondary outcome including muscle mass [adjusted treatment effect −0.4 kg (95%CI −1.1 to 0.3), P = 0.27]. More adverse events occurred in the perindopril group (218 vs. 165), but falls rates were similar. For leucine [n = 72, mean age 78 (SD 6), female sex 38 (53%), mean SPPB 7.0 (SD 2.1)] versus no leucine [n = 72, mean age 79 (SD 6), female sex 40 (55%), mean SPPB 7.0 (SD 2.5)], median adherence was the same in both groups (76% vs. 76%; P = 0.99). Leucine did not improve the primary outcome [adjusted treatment effect 0.1 point (95%CI −1.0 to 1.1), P = 0.90]. No significant treatment benefit was seen for any secondary outcome including muscle mass [adjusted treatment effect −0.3 kg (95%CI −1.0 to 0.4), P = 0.47]. Meta‐analysis of angiotensin converting enzyme inhibitor/angiotensin receptor blocker trials showed no clinically important treatment effect for the SPPB [between‐group difference −0.1 points (95%CI −0.4 to 0.2)].ConclusionsNeither perindopril nor leucine improved physical performance or muscle mass in this trial; meta‐analysis did not find evidence of efficacy of either ACE inhibitors or leucine as treatments to improve physical performance.

Effects of a 12-Week Multimodal Exercise Intervention Among Older Patients with Advanced Cancer: Results from a Randomized Controlled Trial.

Older patients with cancer are at risk of physical decline and impaired quality of life during oncological treatment. Exercise training has the potential to reduce these challenges. The study aim was to investigate the feasibility and effect of a multimodal exercise intervention in older patients with advanced cancer (stages III/IV). Eighty-four older adults (≥65 years) with advanced pancreatic, biliary tract, or non-small cell lung cancer who received systemic oncological treatment were randomized 1:1 to an intervention group or a control group. The intervention was a 12-week multimodal exercise-based program including supervised exercise twice weekly followed by a protein supplement, a home-based walking program, and nurse-led support and counseling. The primary endpoint was change in physical function (30-second chair stand test) at 13 weeks. Median age of the participants was 72 years (interquartile range [IQR] 68-75). Median adherence to the exercise sessions was 69% (IQR 21-88) and 75% (IQR 33-100) for the walking program. At 13 weeks, there was a significant difference in change scores of 2.4 repetitions in the chair stand test, favoring the intervention group (p < .0001). Furthermore, significant beneficial effects were seen for physical endurance (6-minute walk test), hand grip strength, physical activity, symptom burden, symptoms of depression and anxiety, global health status (quality of life), and lean body mass. No effects were seen for dose intensity, hospitalizations, or survival. A 12-week multimodal exercise intervention with targeted support proved effective in improving physical function in older patients with advanced cancer during oncological treatment.

Assessing the reporting quality of randomized controlled trials on COVID-19 vaccines: a systematic review

ABSTRACT This systematic review evaluated the reporting quality of COVID-19 vaccine randomized controlled trials (RCTs). Relevant RCTs published between July 20, 2020 and June 11, 2021 were identified in the PubMed database by two independent reviewers. Study quality was evaluated with the 2010 AND 2001 Consolidated Standards of Reporting Trials (CONSORT) adherence scores. A total of 22 RCTs were included. The median CONSORT adherence score according to the 2010 criteria was 21 (range, 12–25), thus indicating that 75% of the items in more than half of the RCTs had clear reports. Univariate analysis showed that CONSORT adherence scores were not predicted by category; analysis of variance also showed no significant difference between groups. Our results indicated that the overall quality of COVID-19 vaccine RCTs was very good. Current evidence indicates that a variety of COVID-19 vaccines are effective. No RCTs have reported serious adverse effects such as mortality.

Reporting Quality of Studies Developing and Validating Melanoma Prediction Models: An Assessment Based on the TRIPOD Statement.

Transparent and accurate reporting is essential to evaluate the validity and applicability of risk prediction models. Our aim was to evaluate the reporting quality of studies developing and validating risk prediction models for melanoma according to the TRIPOD (Transparent Reporting of a multivariate prediction model for Individual Prognosis Or Diagnosis) checklist. We included studies that were identified by a recent systematic review and updated the literature search to ensure that our TRIPOD rating included all relevant studies. Six reviewers assessed compliance with all 37 TRIPOD components for each study using the published “TRIPOD Adherence Assessment Form”. We further examined a potential temporal effect of the reporting quality. Altogether 42 studies were assessed including 35 studies reporting the development of a prediction model and seven studies reporting both development and validation. The median adherence to TRIPOD was 57% (range 29% to 78%). Study components that were least likely to be fully reported were related to model specification, title and abstract. Although the reporting quality has slightly increased over the past 35 years, there is still much room for improvement. Adherence to reporting guidelines such as TRIPOD in the publication of study results must be adopted as a matter of course to achieve a sufficient level of reporting quality necessary to foster the use of the prediction models in applications.

Accuracy of Machine Learning Assisted Detection of Keratoconus: A Systematic Review and Meta-Analysis.

(1) Background: The objective of this review was to synthesize available data on the use of machine learning to evaluate its accuracy (as determined by pooled sensitivity and specificity) in detecting keratoconus (KC), and measure reporting completeness of machine learning models in KC based on TRIPOD (the transparent reporting of multivariable prediction models for individual prognosis or diagnosis) statement. (2) Methods: Two independent reviewers searched the electronic databases for all potential articles on machine learning and KC published prior to 2021. The TRIPOD 29-item checklist was used to evaluate the adherence to reporting guidelines of the studies, and the adherence rate to each item was computed. We conducted a meta-analysis to determine the pooled sensitivity and specificity of machine learning models for detecting KC. (3) Results: Thirty-five studies were included in this review. Thirty studies evaluated machine learning models for detecting KC eyes from controls and 14 studies evaluated machine learning models for detecting early KC eyes from controls. The pooled sensitivity for detecting KC was 0.970 (95% CI 0.949–0.982), with a pooled specificity of 0.985 (95% CI 0.971–0.993), whereas the pooled sensitivity of detecting early KC was 0.882 (95% CI 0.822–0.923), with a pooled specificity of 0.947 (95% CI 0.914–0.967). Between 3% and 48% of TRIPOD items were adhered to in studies, and the average (median) adherence rate for a single TRIPOD item was 23% across all studies. (4) Conclusions: Application of machine learning model has the potential to make the diagnosis and monitoring of KC more efficient, resulting in reduced vision loss to the patients. This review provides current information on the machine learning models that have been developed for detecting KC and early KC. Presently, the machine learning models performed poorly in identifying early KC from control eyes and many of these research studies did not follow established reporting standards, thus resulting in the failure of these clinical translation of these machine learning models. We present possible approaches for future studies for improvement in studies related to both KC and early KC models to more efficiently and widely utilize machine learning models for diagnostic process.

The effects of physical exercise in the palliative care phase for people with advanced cancer: a systematic review with meta-analysis.

The purpose of this systematic review with meta-analysis was to evaluate the safety, feasibility and effectiveness of exercise in the palliative care phase for people with advanced cancer. Electronic databases were searched for exercise randomised controlled trials involving individuals with incurable cancer that were published prior to April 14, 2021. Meta-analyses were performed to evaluate the effects of exercise on health outcomes. Subgroup effects for exercise mode, supervision, intervention duration and cancer diagnosis were assessed. Twenty-two trials involving interventions ranging between 2weeks and 6months were included. Interventions comprised of aerobic (n = 3), resistance (n = 4), mixed-mode (n = 14) and other exercise (n = 1) modalities. Cancer types consisted of lung (n = 6), breast (n = 3), prostate (n = 2), multiple myeloma (n = 1) and mixed cancer types (n = 10). Meta-analysis of 20 RCTs involving 1840 participants showed no difference in the risk of a grade 2-4 adverse event between exercise and usual care (n = 110 adverse events (exercise: n = 66 events; usual care: n = 44 events), RD = - 0.01 (91% CI = - 0.01, 0.02); p = 0.24). Overall median recruitment, retention and adherence rates were 56%, 80% and 69%, respectively. Meta-analysis of health outcomes showed effects in favour of exercise for quality of life, fatigue, aerobic fitness and lower-body strength (SMD range = 0.27-0.48, all p < 0.05). Participants who engaged in exercise experienced an increase in quality of life, fitness and strength and a decrease in fatigue. Physical activity programs were found to be safe and feasible for people with advanced cancer in the palliative care phase.

Adherence, Efficacy, and Safety of Wearable Technology-Assisted Combined Home-Based Exercise in Chinese Patients With Ankylosing Spondylitis: Randomized Pilot Controlled Clinical Trial.

BackgroundClinical practice guidelines recommend that exercise is essential in the self-management of ankylosing spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be difficult and patients may decline participation, whereas effective home-based exercise interventions that do not require regular medical center visits are likely to be more accessible for AS patients.ObjectiveThe goal of the research was to investigate the adherence, efficacy, and safety of a wearable technology–assisted combined home-based exercise program in AS.MethodsThis was a 16-week investigator-initiated, assessor-blinded, randomized, pilot controlled trial conducted at Chinese People’s Liberation Army General Hospital. We enrolled patients with AS who had no regular exercise habits and had been stable in drug treatment for the preceding month. Patients were randomly assigned (1:1) using a computer algorithm. An exercise program consisting of moderate-intensity aerobic exercise and functional exercise was given to the patients in the intervention group. The exercise intensity was controlled by a Mio FUSE Heart Rate Monitor wristband, which uses photoplethysmography to measure heart rate. Patients in the control group received usual care. The primary outcome was the difference in the Ankylosing Spondylitis Disease Activity Score (ASDAS). The secondary outcomes were patient global assessment (PGA), physician global assessment (PhGA), total pain, nocturnal pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BAS Functional Index (BASFI), BAS Metrology Index (BASMI), Spondyloarthritis International Society Health Index (ASAS HI), 36-item Short Form Survey (SF-36), maximal oxygen uptake (VO2) max, body composition, range of motion of joints, and muscle endurance tests. Retention rate, adherence rate, barriers to being active, and adverse events were also assessed.ResultsA total of 77 patients were screened, of whom 55 (71%) patients were enrolled; 2% (1/55) withdrew without treatment after randomization. Patients were assigned to the intervention (n=26) or control group (n=28). The median adherence rate of the prescribed exercise protocol was 84.2% (IQR 48.7%-97.9%). For the primary outcome, between-group difference of ASDAS was significant, favoring the intervention (–0.2, 95% CI –0.4 to 0.02, P=.03). For the secondary outcomes, significant between-group differences at 16 weeks were detected in PGA, PhGA, total pain, BASDAI, BASDAI-fatigue, BASDAI–spinal pain, BASDAI–morning stiffness intensity, BASFI, and BASMI. Moreover, the frequency of difficulty in ASAS HI-motivation at 16 weeks was less in the intervention group (P=.03). Between-group difference for change from baseline were also detected in VO2 max, SF-36, back extensor endurance test, and the range of motion of cervical lateral flexion at 16 weeks. Lack of time, energy, and willpower were the most distinct barriers to being active. Incidences of adverse events were similar between groups (P=.11).ConclusionsOur pilot study suggests that this technology-assisted combined home-based exercise program can improve the clinical outcomes of patients with AS who have no exercise habit, with good adherence and safety profile.Trial RegistrationChinese Clinical Trial Registry ChiCTR1900024244; http://www.chictr.org.cn/showproj.aspx?proj=40176

Medication adherence in women with IBD of childbearing age likely associated with disease knowledge

Medication adherence in inflammatory bowel disease (IBD) is crucial, particularly during pregnancy. Unplanned pregnancies are common; therefore, efforts to maximise adherence should not be restricted to pregnant women. We aimed to assess medication adherence in women with IBD of childbearing age, regardless of their reproduction plans. We performed a multi-centre pilot questionnaire study of women with IBD age 18-45 years. Survey questions included patient demographics, disease history, and validated assessments of IBD and pregnancy knowledge, medication adherence and quality of life. The primary outcome was rates and predictors of medication adherence. In all, 72 women [58.3% Crohn's disease (CD) and 37.5% ulcerative colitis] completed the survey. The median patient age was 30 years [interquartile range (IQR): 24.8-36.0) and 37.5% had children. Medication adherence was high (84%; median Medication Adherence Report Scale: 19.0/20; IQR: 17.0-20.0). Knowledge scores were adequate for both the Crohn's and Colitis Knowledge (CCKnow; median: 15.5/30; IQR: 12.3-18.0) and Crohn's and Colitis Pregnancy Knowledge (CCPKnow; median: 8.0/17; IQR: 4.0-11.0). Disease knowledge was predictive of high medication adherence (CCPKnow: p = 0.02; CCKnow: p ⩽ 0.01). Higher adherence was significantly associated with a diagnosis of CD (p = 0.01), exposure to biological agents (p = 0.03) and immunomodulators (p = 0.04), childbearing after diagnosis with IBD (p = 0.03), and correctly understanding the importance of delivery modality (p = 0.02) and IBD activity in pregnancy (p = 0.01). Following dedicated education at the IBD clinic, medication adherence, disease-specific and pregnancy-specific knowledge in women with IBD of childbearing age tends to be high. Unplanned pregnancies are frequent; therefore, we should aim to maximise medication adherence in all women of childbearing age to optimise maternofoetal outcomes if unexpected pregnancies occur.

Adherence to the Mediterranean Diet of Pregnant Women in Central South Africa: The NuEMI Study.

Introduction:The Mediterranean diet (MeD) has been shown to have significant health benefits for adults and children. A mother’s diet during pregnancy directly impacts the health of her offspring. This study aimed to investigate the adherence to the MeD of pregnant women attending antenatal care at a Regional Hospital in Bloemfontein, South Africa (SA).Methods:A cross-sectional study was conducted on a consecutive sample of 681 pregnant women who attended the antenatal clinic of a Regional Hospital in Bloemfontein. Socio-demographics included: age, highest level of education, household income, employment status, and income stability. Food group intake was assessed with a quantitative food frequency questionnaire. The adapted Mediterranean Diet Adherence Screener (MeDAS) consisted of 13 of the original 14 questions that measured intake of key food groups (score of ⩽7 poor, 8-9 moderate, ⩾10 good) (wine intake was excluded for pregnant women).Results:A total of 681 pregnant women with a median age of 31.8 years (IQR: 26.8-36.5 years) and a median gestational age of 32.0 weeks at the time of the interview participated in the study. The vast majority showed poor adherence to the MeD (99.6%), with only 0.4% (n = 3) having moderate adherence and 0% good adherence. The median adherence score was 5 points and the maximum 8 points. Of those with poor adherence, only 11.5% had tertiary education, 43.2% earned less than R 3000 (<201 USD) per month, 52.5% were unemployed, and 42.0% did not have a stable income in the past 6 months. Of the 3 participants with moderate adherence, all had grade 11 to 12 education, 2 out of the 3 earned more than R3000 (201 USD), one was unemployed, and 2 had a stable income over the past 6 months. Compared to those with an income ⩽ R3000 (⩽201 USD), those with an income above R3000 were significantly more likely to eat nuts (including peanuts) (2.0% vs 4.6%, P = .05), and adhere to sofrito (similar to tomato and onion relish) intake (9.2% vs 15.6%, P = .02). Compared to those who only had a primary education level up to grade 10 (n = 229), those who had a secondary education level or more (grade 11 and higher, n = 452) were significantly more likely to consume enough olive oil per day (1.3% vs 5.0%, P = .01), and to consume sofrito (6.6% vs 18.0%, P = .02).Conclusion:Pregnant participants showed poor adherence to the MeD. Although almost all women fell in the poor adherence group, secondary education contributed to consuming recommended amounts of olive oil and sofrito and higher income was associated with an adequate intake of nuts and sofrito. Based on the findings, we recommend the development of a contextualized MeDAS tool that includes foods that are typically eaten by most South Africans for similar MeD benefits.

Blood eosinophils in managing preschool wheeze: Lessons learnt from a proof-of-concept trial.

Management of preschool wheeze is based predominantly on symptom patterns. To determine whether personalizing therapy using blood eosinophils or airway bacterial infection results in fewer attacks compared with standard care. A proof-of-concept, randomized trial to investigate whether the prescription of inhaled corticosteroids (ICS) guided by blood eosinophils, or targeted antibiotics for airway bacterial infection, results in fewer unscheduled healthcare visits (UHCVs) compared with standard care. Children aged 1-5years with ≥2 wheeze attacks in the previous year were categorized as episodic viral wheeze (EVW) or multiple trigger wheeze (MTW). The intervention group was prescribed ICS if blood eosinophils ≥3%, or targeted antibiotics if there is positive culture on induced sputum/cough swab. The control group received standard care. The primary outcome was UHCV at 4months. 60 children, with a median age of 36.5 (range 14-61) months, were randomized. Median blood eosinophils were 5.2 (range 0-21)%, 27 of 60 (45%) children were atopic, and 8 of 60 (13%) had airway bacterial infection. There was no relationship between EVW, MTW and either blood eosinophils, atopic status or infection. 67% in each group were prescribed ICS. 15 of 30 control subjects and 16 of 30 patients in the intervention group had UHCV over 4months (p=.8). The time to first UHCV was similar. 50% returned adherence monitors; in those, median ICS adherence was 67%. There were no differences in any parameter between those who did and did not have an UHCV. Clinical phenotype was unrelated to allergen sensitization or blood eosinophils. ICS treatment determined by blood eosinophils did not impact UHCV, but ICS adherence was poor.

Home-Based Exercise Program for Patients With Combined Advanced Chronic Cardiac and Pulmonary Diseases: Exploratory Study.

BackgroundAs chronic cardiac and pulmonary diseases often coexist, there is a need for combined physical home-based rehabilitation programs, specifically addressing older patients with advanced disease stages.ObjectiveThe primary aim of this study is to evaluate the completion and adherence rates of an 8-week, home-based exercise program for patients with advanced cardiopulmonary disease. The secondary end points include patient satisfaction; adverse events; and program efficacy in terms of change in functional capacity, level of dyspnea, and health-related quality of life.MethodsThe participants received a goal-oriented, home-based exercise program, and they used a wrist-worn activity tracker to record their exercise sessions. Activity tracker data were made visible on a digital platform, which was also equipped with several other features such as short instruction videos on how to perform specific exercises. The participants received weekly coaching by a physiotherapist and an occupational therapist through video communication.ResultsIn all, 10 patients with advanced combined cardiopulmonary disease participated (median age 71, IQR 63-75 years), and 50% (5/10) were men. Of the 10 participants, 9 (90%) completed the 8-week program. Median adherence to the exercise prescription was 75% (IQR 37%-88%), but it declined significantly when the program was divided into 2-week periods (first 2 weeks: 86%, IQR 51%-100%, and final 2 weeks: 57%, IQR 8%-75%; P=.03). The participants were highly satisfied with the program (Client Satisfaction Questionnaire: median score 29, IQR 26-32, and Purpose-Designed Questionnaire: median score 103, IQR 92-108); however, of the 9 participants, 4 (44%) experienced technical issues. The Patient-Specific Complaints Instrument scores declined, indicating functional improvement (from median 7.5, IQR 6.1-8.9, to median 5.7, IQR 3.8-6.7; P=.01). Other program efficacy metrics showed a trend toward improvement.ConclusionsHome-based cardiopulmonary telerehabilitation for patients with severe combined cardiopulmonary disease is feasible in terms of high completion and satisfaction rates. Nevertheless, a decrease in adherence during the program was observed, and some of the participants reported difficulties with the technology, indicating the importance of the integration of behavior change techniques, using appropriate technology.Trial RegistrationNetherlands Trial Register NL9182; https://www.trialregister.nl/trial/9182

Adding Hydroxyurea to Chronic Transfusion for Sickle Cell Anemia Reduces Transfusion Burden: Final Results of the HAT Prospective Trial

Background: Chronic red blood cell (RBC) transfusion is an established therapy to prevent stroke in patients with sickle cell anemia (SCA). Chronic transfusion, however, requires considerable blood resources and has risks so a strategy to decrease transfusion requirements is highly desirable especially given blood shortages. Chronic transfusion also can fail to prevent progressive cerebrovascular disease so further optimization of this therapy is needed. Hydroxyurea has been studied as an alternative to chronic transfusion, but alone it provides inadequate cerebrovascular protection for patients at highest risk for stroke. Combination therapy hydroxyurea and transfusion (HAT) may provide benefits over either therapy alone because each ameliorates the pathology of SCA via different mechanisms. To evaluate the feasibility and impact of HAT on transfusion requirements, we conducted a single-arm clinical trial (NCT03644953).Methods: Pediatric patients with SCA already receiving simple chronic transfusion for stroke prevention for at least one year were approached. Patients with poor adherence to chronic transfusion defined by having a hemoglobin (Hb) S >45% and a transfusion interval >5 weeks in the last year were excluded. Enrolled patients were started on hydroxyurea 20 mg/kg/day and continued on simple chronic transfusions with the same transfusion protocol. Transfusion volumes were based on the pre-transfusion Hb to achieve a target post-transfusion Hb of 11.5-12.0 g/dL. Hydroxyurea was dose escalated to achieve a HAT target dose (HAT-TD) defined by either an absolute neutrophil count <4000/µL, or a pre-transfusion Hb >10g/dL with HbS >30%. Transfusion volumes and pre-transfusion laboratory values were compared the year before HAT and the year after HAT-TD.Results: A total of 19 eligible patients were offered participation and 14 enrolled (74% recruitment ratio). The median age was 11.2 years (range 5.3-19.8). The primary indication for chronic transfusion was history of an abnormal transcranial Doppler ultrasound (n=7), overt stroke (n=6), and progression of cerebral vasculopathy (n=1). Five participants ended the study prematurely (care transferred to another hospital, nonadherence to transfusions, patient desire to not take medications, hair thinning, family concern after a hospitalization); none had a serious adverse event that was attributed to HAT. Among the 9 participants who completed the study, the median HAT-TD was 25 mg/kg/dose (range 20-30) and was achieved after a median of 18 weeks (range 0-26). The median hydroxyurea adherence ratio, measured by pill counts, was 91%. One patient with baseline splenomegaly developed splenic sequestration requiring hospitalization; there were no other serious adverse events attributed to HAT. One patient developed a pre-transfusion Hb >11 g/dL and HbS >45%. This patient had hydroxyurea held for 12 weeks and was changed to partial manual exchange transfusions. With HAT, patients had a significant increase in pre-transfusion total Hb, HbS, HbF, and MCV; and a significant decrease in ANC and LDH (Table). After HAT-TD, 8/9 participants received fewer RBCs with a significant median RBC volume reduction of 19.4 ml/kg/year (p=.02, Figure). The single patient who received more RBCs after HAT-TD had suspected nonadherence to hydroxyurea returning only 33% of dispensed hydroxyurea bottles. While receiving HAT 8/9 patients had brain magnetic resonance imaging for clinical monitoring after a median of 75 weeks (range 29-100), no patient had a new infarct or progressive vasculopathy.Conclusion: Hydroxyurea added to chronic transfusion therapy for patients with SCA is feasible. HAT effectively decreases transfusion volumes so can help conserve blood resources. While Hb S% increases with HAT, this increase is relatively small and markers of hemolysis improved. Most patients are able to safely continue simple transfusions when hydroxyurea is added, but a few may require exchange transfusions. The effect of HAT on cerebrovascular disease warrants further study. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Adherence of HIV clinics to guidelines for the delivery of TB screening among people living with HIV/AIDS in Ghana

BackgroundTuberculosis screening of people living with HIV (PLHIV) – an intervention to reduce the burden of TB among PLHIV – is being implemented at HIV clinics in Ghana since 2007, but TB screening coverage remains low. Facility adherence to intervention guidelines may be a factor but is missing in implementation science literature. This study assesses the level of HIV clinic adherence to the guidelines and related facility characteristics in selected district hospitals in Ghana.MethodsThis cross-sectional study was conducted in all 27 district hospitals with HIV clinics, X-ray and geneXpert machines in Ghana. These hospitals are in 27 districts representing about 27% of the 100 district hospitals with HIV clinics in Ghana. A data collection tool with 18-items (maximum score of 29) was developed from the TB/HIV collaborative guidelines to assess facility adherence to four interrelated components of the TB screening programme as stated in the guidelines: intensive TB case-finding among PLHIV (ITCF), Isoniazid preventive therapy initiation (IPT), TB infection control (TIC), and programme review meetings (PRM). Data were collected through record review and interviews with 27 key informants from each hospital. Adherence scores per component were summed to determine an overall adherence score per facility and summarized using medians and converted to proportions. Facility characteristics were assessed and compared across facilities with high (above median) versus low (below median) overall adherence scores, using nonparametric test statistics.ResultsFrom the 27 key interviews and facility records reviewed, the median adherence scores for ITCF, IPT, TIC, and PRM components were 85.7% (IQR: 85.5–100.0), 0% (IQR: 0–66.7), 33.3% (IQR: 33.3–50.0), and 90.0% (IQR: 70.0–90.0), respectively. The overall median adherence score was 62.1% (IQR: 58.6–65.1), and 17 clinics (63%) with overall adherence score above the median were categorized as high adherence. Compared to low adherence facilities, high adherence facilities had statistically significant lower PLHIV clinic attendees per month (256 (IQR: 60–904) vs. 900 (IQR: 609–2622); p = 0.042), and lower HIV provider workloads (28.6 (IQR: 8.6–113) vs. 90 (IQR: 66.7–263.5); p = 0.046), and most had screening guidelines (76%, p < 0.01) and questionnaire (80%, p < 0.01) available on-site.ConclusionPRM had highest score while the IPT component had the lowest score. Almost a third of the facilities implemented the TB screening programme activities with a high level of adherence to the guidelines. We suggest to ensure adherence to all four components, reducing staff workloads and making TB screening questionnaires and guidelines available on-site would increase facility adherence to the intervention and ultimately achieve intervention targets.

Feasibility of video observed therapy to support controller inhaler use among children in West Baltimore

Objective To assess feasibility of a novel video directly observed therapy (DOT)-based digital asthma program intended to support correct inhaled corticosteroid (ICS) use among children. Methods We conducted a 60-day pilot study among patients 2–18 years attending a primary care clinic with prescribed ICS and sub-optimally controlled asthma (recent hospitalization, ICS nonadherence, frequent rescue inhaler use, therapy escalation, or Asthma Control Test <20). Participants used a mobile application to receive reminders, submit videos of ICS doses (video DOT), and receive asynchronous feedback on adherence and inhaler technique. We assessed enrollment, engagement, program metrics, and user experience; adherence and inhaler errors were secondary outcomes. Results Of 26 eligible patients, 21 (81%) enrolled and submitted ≥1 video; median age was 11 years (8–15), 71% were male, 90% had Medicaid, and 62% experienced ≥1 exacerbation in the previous 6 months. Retention was 57% and 52% at week 5 and 8, respectively. Participants submitted 810 videos. Missed doses, inhaler errors (n = 247) and adherence issues (n = 107) prompted 543 communications; inadequate inspiration or holding breath were most common. Among 16 patients with engagement >7 days and >4 videos, median inhaler error rate (proportion of videos with ≥1 error) decreased from week 1 to week 2 (73% vs 8%, p ≤ 0.05) with median adherence >80%. Participants experienced the program as long, but easy to use; benefits included building routines, skill, and independence. Conclusions This pilot study suggests high program acceptability among our cohort. High engagement with improved inhaler technique over the first 14 days suggests shorter implementation. Supplemental data for this article is available online at at

Telemedicine Strategy to Rescue CPAP Therapy in Sleep Apnea Patients with Low Treatment Adherence: A Pilot Study.

Patients with sleep apnea are usually treated with continuous positive airway pressure (CPAP). This therapy is very effective if the patient′s adherence is satisfactory. However, although CPAP adherence is usually acceptable during the first months of therapy, it progressively decreases, with a considerable number of patients accepting average treatment duration below the effectiveness threshold (4 h/night). Herein, our aim was to describe and evaluate a novel telemedicine strategy for rescuing CPAP treatment in patients with low adherence after several months/years of treatment. This two-week intervention includes (1) patient support using a smartphone application, phone and voice recorder messages to be answered by a nurse, and (2) daily transmission and analysis of signals from the CPAP device and potential variation of nasal pressure if required. On average, at the end of the intervention, median CPAP adherence considerably increased by 2.17 h/night (from 3.07 to 5.24 h/night). Interestingly, the procedure was able to markedly rescue CPAP adherence: the number of patients with poor adherence (<4 h/night) was considerably reduced from 38 to 7. After one month, adherence improvement was maintained (median 5.09 h/night), and only 13 patients had poor adherence (<4 h/night). This telemedicine intervention (103€ per included patient) is a cost-effective tool for substantially increasing the number of patients with CPAP adherence above the minimum threshold for achieving positive therapeutic effects.

Evaluation of Technology-Enabled Monitoring of Patient-Reported Outcomes to Detect and Treat Toxic Effects Linked to Immune Checkpoint Inhibitors

Immune checkpoint inhibitors can produce distinct toxic effects that require prompt recognition and timely management. To develop a technology-enabled, dynamically adaptive protocol that can provide the accurate information needed to inform specific remedies for immune toxic effects in patients treated with immune checkpoint inhibitors. An open-label cohort study was conducted at a single tertiary referral center from September 6, 2019, to September 3, 2020. The median follow-up duration was 63 (interquartile range, 35.5-122) days. Fifty patients with genitourinary cancers treated with immune checkpoint inhibitors were enrolled. A fit-for-purpose electronic platform was developed to enable active patient and care team participation. A smartphone application downloaded onto patients' personal mobile devices prompted them to report their symptoms at least 3 times per week. The set of symptoms and associated queries were paired with alert thresholds for symptoms requiring clinical action. The primary end point of this interim analysis was feasibility, as measured by patient and care team adherence, and lack of increase in care team staffing. Operating characteristics were estimated for each symptom alert and used to dynamically adapt the alert thresholds to ensure sensitivity while reducing unnecessary alerts. Of the 50 patients enrolled, 47 had at least 1 follow-up visit and were included in the analysis. Median age was 65 years (range, 37-86), 39 patients (83%) were men, and 39 patients (83%) had metastatic cancer, with the most common being urothelial cell carcinoma and renal cell carcinoma (22 [47%] patients each). After initial onboarding, no further care team training or additional care team staffing was required. Patients had a median study adherence rate of 74% (interquartile range, 60%-86%) and 73% of automated alerts were reviewed within 3 days by the clinic team. Symptoms with the highest positive predictive value for adverse events requiring acute intervention included dizziness (21%), nausea/vomiting (26%), and shortness of breath (14%). The symptoms most likely to result in unnecessary alerts were arthralgia and myalgia, fatigue, and cough. The findings of this cohort study suggest an acceptable and fiscally sound method can be developed to create a dynamic learning system to detect and manage immune-related toxic effects.

Symptomatic response to CPAP in obstructive sleep apnea versus COPD- obstructive sleep apnea overlap syndrome: Insights from a large national registry.

BackgroundThe symptomatic response to continuous positive airway pressure (CPAP) therapy in COPD-obstructive sleep apnea overlap syndrome (OVS) compared to OSA syndrome (OSA) alone has not been well studied so far. The aim of this study is to explore main differences in the clinical response to CPAP treatment in OVS compared to OSA alone.Study design and methodsUsing prospective data from the French National Sleep Apnea Registry, we conducted an observational study among 6320 patients with moderate-to-severe OSA, available spirometry, and at least one follow-up visit under CPAP therapy.ResultsCPAP efficacy measured on the residual apnea-hypopnea index and median adherence were similar between OVS and OSA patients. In both groups, the overall burden of symptoms related to sleep apnea improved with CPAP treatment. In a multivariable model adjusted for age, gender, body mass index, adherence to treatment and residual apnea-hypopnea index, OVS was associated with higher odds for persistent morning headaches (OR: 1.37 [95% CI; 1.04; 1.79]; P = 0.02), morning tiredness (OR: 1.33 [95% CI: 1.12; 1.59]; P<0.01), daytime sleepiness (OR; 1.24 [95% CI: 1.4; 1.46]: P<0.01) and exertional dyspnea (OR: 1.26 [95% CI: 1.00;1.58]; P = 0.04) when compared with OSA alone.InterpretationCPAP therapy was effective in normalizing the apnea-hypopnea index and significantly improved OSA-related symptoms, regardless of COPD status. CPAP should be offered to patients with OVS on a trial basis as a significant improvement in OSA-related symptoms can be expected, although the range of response may be less dramatic than in OSA alone.

Patterns of Fitbit Use and Activity Levels Among African American Breast Cancer Survivors During an eHealth Weight Loss Randomized Controlled Trial.

This study examined adherence with a physical activity tracker and patterns of activity among different subgroups of African American/Black breast cancer survivors (AABCS). Secondary analysis of weight loss trial that used an activity tracker (FitBit) with or without a commercial eHealth program (SparkPeople) over 12 months. AABCS (N = 44) in New Jersey. Adherence with tracker use, steps per day, and active minutes per week were compared by demographic and clinical characteristics using nonparametric statistics. Median adherence was over 6 days per week throughout the 12-months. Adherence was significantly correlated with steps and active minutes (p < 0.015). Groups with lower adherence included: those with 5 or more conditions (p = 0.039), had higher number of household members (p = 0.008), and younger than 60 years (p = 0.044). Median number of steps per day remained consistently around 7000 throughout 12 months. Factors associated with lower activity included: age > 60; retirement; higher number of household members, comorbidity, or baseline BMI; and those in the SparkPeople + Fitbit group. Self-monitoring, goal setting, and self-efficacy were significantly correlated with activity levels (p < 0.05). Use of a physical activity tracker may help increase activity levels in AABCS. Certain subgroups, e.g. those older than age 60 years, retired, with BMI over 40, higher number of comorbidities or more household members, may require additional interventions.

Comparison of Medication Adherence Assessment Tools to Identify Glaucoma Medication Nonadherence

To assess the accuracy of 5 subjective self-assessment tools (3 adherence measures and 2 psychometric scales) and pharmacy refill data in predicting objective electronically monitored nonadherence. Prospective cohort study. Glaucoma patients (> 40 years old, >1 medication with poor self-reported adherence) were recruited from University of Michigan Kellogg Eye Center for a study assessing the impact of a personalized glaucoma coaching program on medication adherence. Participants completed an initial assessment including 5 self-assessment tools and a 3-month period of electronic monitoring of glaucoma medication adherence (AdhereTech); pharmacy refill data were obtained. Electronically monitored adherence was calculated monthly as the percentage of doses taken on time. The median of these adherence rates was designated as baseline adherence. Patients with adherence of ≤80% by electronic monitoring were considered nonadherent. Self-assessment tools were scored, and pharmacy refill data were summarized as the proportion of days covered. Correlation between measures of adherence was estimated with Pearson and Spearman correlation coefficients. Receiver operating characteristic curves, including estimation of area under the curve (AUC), sensitivity, specificity, and accuracy were used to compare measures of adherence with respect to predicting electronically monitored nonadherence. Accuracy of self-reported and pharmacy refill data adherence measures in predicting electronically monitored nonadherence. Ninety-five patients completed 3 months of electronic monitoring with a median monthly adherence of 74 (± 21%); 53 patients (56%) were nonadherent. Pharmacy refill data were not correlated significantly with electronically monitored medication adherence (r= 0.12; P= 0.2). Of all the measures, a single-item adherence question ("Over the past month, what percentage of your drops do you think you took correctly?") showed the largest correlation with median electronically monitored adherence (r= 0.47; P < 0.0001), largest AUC for predicting nonadherence (AUC = 0.76 [95% confidence interval [CI], 0.66-0.87]), best accuracy (71% [95% CI, 61%-82%]), and good sensitivity (84% [95% CI, 73%-96%]). The single-item question was the most accurate in predicting electronically monitored nonadherence among participants with poor self-reported adherence. In clinical practice, where alternatives are too resource intensive, this free single-item screening question can help to identify glaucoma patients at risk of poor medication adherence with reasonable accuracy.