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Results for “Adherence Interventions”

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PubMed2005

PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.

BACKGROUND: Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study. METHODS: The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months. RESULTS: We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%. CONCLUSIONS: The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.

Adult↗

PubMed2026

The effect of antiretroviral therapy adherence on viral load suppression rate among people living with HIV in Ethiopia: A systematic review and meta-analysis.

BACKGROUND: Antiretroviral therapy (ART) adherence is a key determinant of viral load suppression among people living with HIV (PLHIV). In Ethiopia, evidence on the magnitude of ART adherence and its effect on virological outcomes remains fragmented. This systematic review and meta-analysis aimed to estimate the pooled prevalence of ART adherence and viral load suppression, and to measure the association between adherence and viral suppression among PLHIV in Ethiopia. METHODS: This systematic review and meta-analysis used the PRISMA checklist for systematic reviews and meta-analyses. The review protocol has been registered onPROSPERO:(CRD420251125899). PubMed, ScienceDirect, Scopus, Epistemonikos, and Google Scholar were searched. The quality of included articles has been evaluated with a Newcastle-Ottawa Scale (NOS), adapted for observational studies. A random-effects model using restricted maximum likelihood (REML) with Knapp-Hartung adjustment was used to estimate pooled prevalence and odds ratio. Heterogeneity was assessed using I2, τ2, and Cochran's Q test. RESULTS: A total of 39 studies were included in the final analysis. The pooled prevalence of good ART adherence was 79.4% (95% CI: 74.8%-83.4%), while the pooled viral load suppression rate was 77.5% (95% CI: 72.5%-81.8%). The pooled odds ratio showed that good ART adherence was strongly associated with viral load suppression (OR = 6.30, 95% CI: 4.84-8.19). Substantial heterogeneity was observed across studies for both adherence and viral suppression outcomes (I2 > 90%). CONCLUSIONS: ART adherence and viral load suppression among PLHIV in Ethiopia are relatively high but remain below global targets. Good adherence was significantly associated with virologic suppression, highlighting adherence as a critical modifiable factor for achieving optimal treatment outcomes. Strengthening adherence support interventions is essential to improve virological success and advance progress toward HIV epidemic control.

Humans↗

PubMed2026

Digital Structured Education With Behavioral Nudge Tools for Adults With Type 2 Diabetes: Multicenter Randomized Controlled Trial.

BACKGROUND: Digital interventions offer scalable alternatives to traditional face-to-face diabetes education, but often face challenges related to inconsistent clinical effectiveness, and declining user engagement. However, whether a digital structured education program integrated with behavioral nudge tools can improve metabolic, behavioral, and psychological outcomes in adults with type 2 diabetes remains unclear. OBJECTIVE: This study aimed to evaluate the effectiveness of a digital structured education program integrated with behavioral nudge tools in improving metabolic, behavioral, and psychological outcomes among adults with type 2 diabetes. METHODS: This multicenter randomized controlled trial was conducted in the endocrinology departments of 4 hospitals in China. Adults with type 2 diabetes were randomly assigned to an intervention group receiving a digital structured education program integrated with behavioral nudge tools (n=146) or a control group receiving standard digital diabetes education (n=147). Assessments were conducted at baseline and 12-week follow-up. The primary outcome was hemoglobin A1c (HbA1c) at 12 weeks, adjusted for baseline HbA1c, and study center. Secondary outcomes included fasting blood glucose (FBG), weight, BMI, waist circumference, blood pressure, lipid profiles, self-management behaviors, self-efficacy, and habit strength. RESULTS: Among 293 participants (mean age 49.19, SD 10.02 y), 287 (97.9%) completed follow-up. At 12 weeks, the intervention group demonstrated significantly greater improvements than the control group in HbA1c (adjusted mean difference -0.38%, 95% CI -0.68% to -0.09%; P=.01), FBG (adjusted mean difference -0.75, 95% CI -1.27 to -0.44 mmol/L; P<.001), weight (adjusted mean difference -0.84, 95% CI -1.61 to -0.07 kg; P=.03), BMI (adjusted mean difference -0.38, 95% CI -0.65 to -0.11 kg/m²; P=.01), systolic blood pressure (adjusted mean difference -2.71, 95% CI -4.62 to -0.79 mm Hg; P=.01), diastolic blood pressure (adjusted mean difference -2.92, 95% CI -4.47 to -1.37 mm Hg; P<.001), and total cholesterol (adjusted mean difference -0.27, 95% CI -0.48 to -0.05 mmol/L; P=.02). The intervention was also associated with significantly greater improvements in self-management behaviors, self-efficacy, and habit strength (all P<.05). CONCLUSIONS: Digital structured education integrated with behavioral nudge tools improved metabolic outcomes and strengthened psychological and behavioral determinants of self-management among adults with type 2 diabetes over a 12-week period. These findings suggest that a digital structured education program integrated with behavioral nudge tools may enhance diabetes self-management beyond standard digital diabetes education. Further studies with longer follow-up and real-world implementation are warranted to evaluate the sustainability, generalizability, and long-term clinical impact of this integrated intervention.

Humans↗

PubMed2000

Efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol in children with elevated LDL cholesterol: the Dietary Intervention Study in Children.

BACKGROUND: Few studies have shown the efficacy and safety of lower-fat diets in children. OBJECTIVE: Our objective was to assess the efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol to decrease LDL-cholesterol concentrations in children. DESIGN: A 6-center, randomized controlled clinical trial was carried out in 663 children aged 8-10 y with LDL-cholesterol concentrations greater than the 80th and less than the 98th percentiles for age and sex. The children were randomly assigned to either an intervention group or a usual care group. Behavioral intervention promoted adherence to a diet providing 28% of energy from total fat, <8% from saturated fat, </=9% from polyunsaturated fat, and <0.018 mg cholesterol*kJ(-)(1)*d(-)(1) (not to exceed 150 mg/d). The primary efficacy measure was mean LDL cholesterol and the safety measures were mean height and serum ferritin concentration at 3 y. RESULTS: At 3 y, dietary total fat, saturated fat, and cholesterol were lower in the intervention group than in the usual care group (all P: < 0. 001). LDL cholesterol decreased in the intervention and usual care groups by 0.40 mmol/L (15.4 mg/dL) and 0.31 mmol/L (11.9 mg/dL), respectively. With adjustment for baseline concentration, sex, and missing data, the mean difference between groups was -0.08 mmol/L (95% CI: -0.15, -0.01), or -3.23 mg/dL (95% CI: -5.6, -0.5) (P: = 0. 016). There were no significant differences between groups in adjusted mean height or serum ferritin. CONCLUSION: Dietary changes are effective in achieving modest lowering of LDL cholesterol over 3 y while maintaining adequate growth, iron stores, nutritional adequacy, and psychological well-being during the critical growth period of adolescence.

Child↗

PubMed2004

Medication adherence in pediatric and adolescent liver transplant recipients.

OBJECTIVE: Nonadherence to medications is a leading cause of morbidity in children and adolescents who have had a transplant, yet there are no published data about the use of different methods for detecting whether these children are taking their medications. There are also no published data about the age of transition at which a child assumes responsibility over taking the medications. This information is important if interventions to improve adherence are contemplated. METHODS: We present an analysis of data obtained in the first year of the implementation of an adherence assessment protocol at a pediatric liver transplant clinic in a tertiary medical care center. Data were obtained for children and adolescents who had a liver transplant at least 1 year before the assessments took place. We used 5 adherence detection methods. The 4 subjective methods were self-reported, scaled questionnaires answered by nurses, physicians, caregivers, and patients. For the objective method, a standard deviation (SD) was calculated for tacrolimus blood levels obtained from each patient over time. A higher SD suggests increased variation among patients' blood levels and hence more erratic medication taking. We also asked the patients and caregivers who is responsible for taking the medications and what are the reasons for not taking them. The medical outcome measures were biopsy-proven rejection episodes, number of biopsies regardless of the results, number of hospital admissions, and number of in-patient days. RESULTS: An analysis of 81 cases (258 assessments) revealed that the only method that predicted the medical outcome variables (biopsy-proven rejection and number of biopsies) was the SD of medication blood levels. Patients', clinicians', and caregivers' reports were not predictive. Clinicians' ratings of adherence were not correlated with patients' or caregivers'. The transition of responsibility for medication taking occurred approximately at the age of 12 years. Forgetfulness was cited as the most common reason for nonadherence by patients and caregivers; medication side effects were not frequently cited. CONCLUSIONS: Our results indicate that clinical impression is not sufficient to determine whether children and adolescents are taking their medications after they have had a liver transplant. An objective assessment method should be used. Interventions targeting adherence should address the child's increasing role beginning in early adolescence. A clinical protocol incorporating objective assessments of adherence could potentially be implemented in other settings. It could form the basis for the evaluation of efficacy of interventions seeking to improve adherence to medications.

Adolescent↗

PubMed2004

Self-reported adherence to cholesterol-lowering medication in patients with familial hypercholesterolaemia: the role of illness perceptions.

BACKGROUND: The objectives of this study are to describe levels of adherence to cholesterol-lowering medication and to identify predictors of adherence in patients with familial hypercholesterolaemia (FH). DESIGN: Descriptive questionnaire study. METHODS: 336 adults patients with FH attending one of five outpatient lipid clinics in South East England underwent a clinical assessment by a nurse and completed a questionnaire. The questionnaire assessed self-reported adherence to cholesterol-lowering medication, anxiety, depression, and patient perceptions of heart disease. RESULTS: Overall, participants reported high levels of medication adherence, although 63% reported some level of non-adherence. Total medication adherence (never deviating from the regimen) was more likely to be reported by older participants, those with no formal educational qualifications, those with a personal history of cardiovascular disease, those with a lower total cholesterol level, and those with a greater difference between untreated cholesterol levels and current cholesterol levels. The illness perceptions associated with reported total adherence were lower perceived risk of raised cholesterol, perceiving greater control over FH, and perceiving genes and cholesterol to be important determinants of a heart attack. Emotional state was not associated with medication adherence. In logistic regression analysis, predictors of total medication adherence were having personal history of cardiovascular disease, having no formal qualifications, and perceiving genes to be important determinants of a heart attack. CONCLUSIONS: Both clinical factors and patients' illness perceptions were associated with self-reported cholesterol-lowering medication adherence. The association with illness perceptions was small and many of these associations may be a consequence, rather than a cause, of greater adherence. Given this, intervention strategies aimed at helping patients' to establish routines for medication taking may be more effective in increasing adherence than interventions designed to alter perceptions related to taking statins.

Anticholesteremic Agents↗

PubMed2003

Testing an intervention for preventing osteoporosis in postmenopausal breast cancer survivors.

PURPOSE: To test a 12-month multicomponent intervention for preventing or treating osteoporosis in 21 postmenopausal women who had completed treatment (except Tamoxifen) for breast cancer, and for whom hormone replacement therapy (HRT) was contraindicated. DESIGN: Pilot intervention study. METHODS: The intervention consisted of home-based strength and weight training exercises, 5 or 10 mg alendronate per day, 1500 mg calcium per day, 400 IU vitamin D per day, education on osteoporosis, and facilitative strategies to promote adherence to the intervention. Outcome measures were: adherence to the intervention, dynamic balance, muscle strength, and bone mineral density (BMD) of the hip, spine, and forearm. FINDINGS AND CONCLUSIONS: Adherence to calcium, vitamin D, and alendronate therapy was above 95%, and adherence to strength training exercises was above 85%. Over the 12 months, the 21 participants had significant improvements in dynamic balance, muscle strength for hip flexion, hip extension, and knee flexion, and BMD of the spine and hip. Participants had a significant decrease in BMD of the forearm. Three of the 21 women who had measurable bone loss at baseline had normal BMD after 12 months of the intervention.

Adult↗

PubMedDate not supplied

Evaluation of a Wellness-Based Mindfulness Stress Reduction intervention: a controlled trial.

PURPOSE: To determine if participation in a Wellness-Based Mindfulness Stress Reduction intervention decreases the effect of daily hassles, psychological distress, and medical symptoms. DESIGN: A randomized controlled trial of a stress reduction intervention with a 3-month follow-up. SETTING: A university setting in West Virginia. SUBJECTS: A total of 103 adults, with 59 in the intervention group and 44 in the control group. Eight-five percent of subjects completed the intervention. Fifty-nine percent and 61% of the intervention and control subjects completed the study, respectively. INTERVENTION: The intervention consisted of an 8-week group stress reduction program in which subjects learned, practiced, and applied "mindfulness meditation" to daily life situations. The control group received educational materials and were encouraged to use community resources for stress management. MEASURES: The Daily Stress Inventory assessed the effect of daily hassles, the Revised Hopkins Symptom Checklist measured psychological distress, the Medical Symptom Checklist measured number of medical symptoms, and a Follow-up Questionnaire measured program adherence. RESULTS: Intervention subjects reported significant decreases from baseline in effect of daily hassles (24%), psychological distress, (44%), and medical symptoms (46%) that were maintained at the 3-month follow-up compared to control subjects (repeated measures analysis of variance [ANOVA]; p < .05). CONCLUSIONS: Self-selected community residents can improve their mental and physical health by participating in a stress reduction intervention offered by a university wellness program.

Adult↗

PubMed2026

Behaviourally informed text message reminders to increase cervical screening attendance in people with severe mental illness: the OPTIMISE pilot randomised controlled trial.

OBJECTIVES: This study assessed the feasibility of both the delivery and evaluation of 'enhanced' (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening. DESIGN: A pilot randomised controlled trial (RCT). SETTING: 13 General Practice (GP) practices in London were recruited. PARTICIPANTS: GP practices identified people with SMI aged 24-64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials. INTERVENTION: In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder. PRIMARY AND SECONDARY OUTCOME MEASURES: 18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome). RESULTS: Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not. CONCLUSIONS: Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group. TRIAL REGISTRATION NUMBER: ISRCTN12558681.

Humans↗

PubMed2004

Modifiable risk factors for non-adherence to immunosuppressants in renal transplant recipients: a cross-sectional study.

BACKGROUND: Non-adherence to immunosuppressants is a major cause of renal transplant failure. Interventions to improve adherence need to target modifiable risk factors. METHODS: Adherence was measured using the 'gold standard' measure of electronic monitoring in 58 adult renal transplant recipients from a UK transplant unit. Subjects were identified from a stratified random sample of 153 recipients recruited to a larger cross-sectional study comparing different measures of adherence. Inclusion criteria included age over 18 years and a functioning renal transplant, transplanted 6-63 months previously. Exclusion criteria included residence outside the region served by the unit and inability to give informed consent. Health beliefs, depression and functional status were measured using standardized questionnaires (Beliefs about Medicines Questionnaire, Illness Perception Questionnaire, Revised Clinical Interview Schedule and SF-36) and semi-structured interview. Transplant and demographic details were collected from the notes. RESULTS: Seven [12%, 95% confidence interval (CI) 4-20%] subjects missed at least 20% of days medication and 15 (26%, 15-37%) missed at least 10% of days. Lower belief in the need for medication and having a transplant from a live donor were the major factors associated with non-adherence. Depression was common, although not strongly associated with non-adherence. CONCLUSIONS: Beliefs about medication are a promising target for interventions designed to improve adherence. The lower adherence in recipients of transplants from live donors needs confirming but may be clinically important in light of the drive to increase live donation.

Adult↗

PubMed2026

Care Navigation for Methamphetamine Use Disorder: A Randomized Clinical Trial.

IMPORTANCE: Stimulant-involved deaths continue to increase in the US, and methamphetamine use remains a weighty public health concern. Treating methamphetamine use disorders is complicated. Contingency management has demonstrated the best effectiveness but is not widely implemented. OBJECTIVE: To examine the effectiveness of dedicated care navigation in linking patients to treatment. DESIGN, SETTING, AND PARTICIPANTS: This prospective randomized clinical trial was conducted at an integrated safety-net health system in Denver, Colorado, between April 10, 2023, and December 31, 2024. Eligible participants were 18 years or older who had a methamphetamine-related encounter in an acute care setting; those with involuntary treatment holds, substance treatment in past 90 days or actively seeking treatment, and inability to provide consent were excluded. Participants completed baseline, 30-day, and 90-day study visits. INTERVENTION: Dedicated care navigation, incorporating contingency management principles, with a focus on addressing health-related social needs. MAIN OUTCOMES AND MEASURES: Linkage to treatment within 30 and 90 days of enrollment defined as a composite measure of at least 1 of the following: electronic health record data indicating a visit at the health system's substance treatment clinic, a behavioral health encounter at an outpatient clinic, temporary residential treatment, or self-reported treatment on the 30- and/or 90-day follow-up survey. RESULTS: Of 192 participants enrolled in the Beginning Early and Assertive Treatment for Methamphetamine Use trial, 156 (81.3%) were male, and the median age was 39 (IQR, 31-47) years. Most participants were unstably housed (163 [84.9%]), not currently employed (158 [82.3%]), and without regular access to a working phone (94 [49.0%]). Of the 96 participants randomized to the intervention, 60 (62.5%) engaged in 2 or more navigation sessions, 45 (46.9%) completed the 30-day study visit, and 47 (49.0%) completed the 90-day study visit compared with 44 (46.3%) and 37 (38.5%), respectively, of the 96 randomized to the control arm. No statistically significant differences in treatment linkage were observed at 30 days (24 participants [25.0%] in both arms; risk ratio, 1.00 [95% CI, 0.61-1.63]) or 90 days post enrollment, (32 [33.3%] in intervention vs 24 [25.0%] in control arms; risk ratio, 1.33 [95% CI, 0.85-2.09]). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, integrating principles of contingency management into the intervention may have increased engagement with a dedicated care navigator but did not increase likelihood of linkage to treatment for methamphetamine use disorder. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06033365.

Humans↗

PubMed2003

Impact of an antidepressant management program on medication adherence.

OBJECTIVE: To evaluate the impact of mail-based physician and member educational interventions on patient adherence to antidepressant medications. STUDY DESIGN: The randomized controlled prospective design included patients followed for 6 months after filling a new prescription for an antidepressant. A pharmacy claims database was used to identify patients and track medication adherence. PATIENTS AND METHODS: Patients receiving a new prescription for an antidepressant and their prescribers were included. Prescribers were randomly assigned to the intervention and control groups. Patient assignment was linked to their physician's assignment. The control group received no intervention. The educational intervention consisted of monthly letters to patients and prescribers regarding the Health Plan Employer Data and Information Set (HEDIS) standards or educational information regarding the importance of medication adherence. The primary outcome was adherence as measured by the medication possession ratio and measurement as specified by HEDIS. The Student's ttest, the chi2 test, and a logistic regression model were used to compare groups and the variables that affect adherence. Other secondary measurements of adherence were performed. RESULTS: A total of 9564 patients were included. Patients in the intervention group demonstrated greater adherence compared with the control group at 90 and 180 days (P < .05). After adjusting for variables, the intervention variable stood alone in its significant impact on adherence (P <.01; confidence interval, 1.003-1.197). Adherence in the total population was significantly higher for selective serotonin reuptake inhibitors than for other agents (P < .001). CONCLUSION: A monthly mail-based educational intervention program regarding antidepressant medications can positively influence patient adherence to therapy.

Adolescent↗

PubMed1994

Serological markers of cancer and their applications in clinical trials.

Strategies for the prevention of cancer include those aimed at reducing the incidence of cancer (primary prevention) and cancer mortality through early detection of tumors (secondary prevention). The efficacy of prevention interventions is evaluated by clinical trials. The conduct of clinical trials is aided by the use of serological indicators of the carcinogenic process measured using plasma or red or white blood cells. The accessibility and acceptability of obtaining blood samples for the measurement of serological markers of carcinogenesis permit widespread applications in the conduct of clinical trials. Serological markers must be shown to be valid and reliable before their use. Serological markers identify a variety of stages in the process of carcinogenesis such as inherited or acquired susceptibility to cancer, environmental exposures to carcinogens, biological effects of exposures, and the presence of preinvasive or invasive cancer. Serological markers may be used in clinical trials to select high risk but disease-free individuals for participation in clinical trials based on susceptibility factors or carcinogenic exposures. Other uses of serological markers include monitoring adherence to interventions and establishing trial outcomes of intermediate cancer end points or incident invasive disease. Examples of these applications are discussed. Serological markers of carcinogenesis have widespread applications in clinical research and potentially for clinical practice. Currently, the only limitation to their widespread use is the availability of validated serological markers. Because of the ease and acceptability of their use, research into the development of serological markers should continue. Methods for quickly validating serological markers should be developed in order to aid the transition to clinical applications.

Biomarkers, Tumor↗

PubMed2003

The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison.

BACKGROUND: The optimal treatment of ulcers with nonbleeding visible vessels and adherent clots is unclear. OBJECTIVE: To compare intravenous omeprazole infusion plus endoscopic therapy with intravenous omeprazole infusion alone for prevention of recurrent bleeding from ulcers with nonbleeding visible vessels or adherent clots. DESIGN: Single-blind randomized study with blinded evaluation of study end points. SETTING: An endoscopy center in a university hospital in Hong Kong. PATIENTS: 156 persons with upper gastrointestinal bleeding and ulcers showing nonbleeding visible vessels or adherent clots. INTERVENTION: Combination of endoscopic therapy and omeprazole infusion versus sham endoscopic therapy and omeprazole infusion. MEASUREMENTS: Recurrent ulcer bleeding before discharge and within 30 days. RESULTS: 78 patients were recruited in each group. Ulcer bleeding recurred before discharge in seven patients who received intravenous omeprazole alone (9%) and no patients who received combined therapy (difference, 9 percentage points [95% CI, 1.7 to 17.6 percentage points]; P = 0.01). The probability of recurrent bleeding within 30 days was 11.6% (9 patients) in the omeprazole-alone group and 1.1% (1 patient) in the combined therapy group (difference, 10.5 percentage points [CI, 1.7 to 19.8 percentage points]; P = 0.009). Patients in the combined therapy group required less transfusion (difference in median units of blood transfused, 1 unit [CI, 0 to 2 units]; P = 0.02). One patient in the combined therapy group had surgery for ulcer perforation. Four patients receiving omeprazole alone (5.1%) and two patients receiving combined therapy (2.6%) died within 30 days. CONCLUSION: The combination of endoscopic therapy and omeprazole infusion is superior to omeprazole infusion alone for preventing recurrent bleeding from ulcers with nonbleeding visible vessels and adherent clots.

Anti-Ulcer Agents↗

PubMed2026

Effect of a digitally augmented general health promotion intervention on abstinence from health-risk behaviors among emergency department discharge patients: A randomized controlled trial.

BACKGROUND: Noncommunicable diseases (NCDs) are the leading global cause of death and are driven by modifiable behaviors, such as tobacco use, harmful alcohol consumption, unhealthy diet, and physical inactivity. Recognizing that emergency department (ED) visits represent a unique opportunity to promote behavior change, this trial evaluated a digitally augmented, theory based general health promotion approach, combining a brief telephone-based intervention with mobile instant messaging support, to help discharged ED patients abstain from health risk behaviors. METHODS AND FINDINGS: This assessor-blinded randomized controlled trial was conducted in a major public hospital ED in Hong Kong. Adults (18-65 years) triaged as semi-urgent or non-urgent and with ≥1 health-risk behavior and smartphone access were randomized to receive a digitally augmented, theory‑based general health‑promotion intervention consisting of a brief telephone‑based AWARD‑model intervention (Ask, Warn, Advise, Refer, and Do-it-again) followed by weekly WhatsApp or WeChat messages for 6 months, or to a control group receiving brief telephone advice only. The primary outcome was self-report abstinence from ≥1 health-risk behavior at 6 months; secondary outcomes included the proportion of participants who achieved self-reported abstinence from ≥1 health-risk behavior at 12 months and reduction in the number of behaviors at 6 and 12 months. Of the 2,134 screened patients, 572 were enrolled (286 per group). At 6 months, 30.1% of the intervention participants versus 19.9% of the controls achieved self-reported abstinence (RR = 1.51; 95% CI, 1.13-2.02; P = 0.006). The intervention also significantly increased the likelihood of fewer risky behaviors at 6 (RR = 1.54; P = 0.01) and 12 (RR = 1.48; P = 0.02) months. Physical inactivity showed the greatest improvement at 6 months (31.7% versus 16.2%; P < 0.001). The effects attenuated after cessation of booster messaging. Limitations include reliance on self-reported outcomes, the single-center study design, and loss to follow-up, which may have affected the generalizability of the results. CONCLUSIONS: A digitally augmented, theory-based general health promotion strategy delivered at ED discharge through brief telephone intervention and mobile instant messaging support demonstrated short-term benefits in promoting self-reported abstinence and reducing health-risk behaviors at 6 months. However, the absence of a sustained effect at 12 months suggests that extended support or maintenance strategies may be required to maintain these improvements over time. Multicenter trials with longer follow-up are warranted to evaluate long-term effectiveness. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (Registration No: NCT06077565).

Humans↗

PubMed2006

Eating and feeding are not the same: caregivers' perceptions of gastrostomy feeding for children with cerebral palsy.

Using a semi-structured questionnaire, this descriptive study examined perceptions of feeding and adherence to feeding recommendations for caregivers (26 females; mean age 32y 7mo [SD 9.4y], range 20-59y) of children with cerebral palsy (CP) and a gastrostomy tube (GT). Children in the study (15 females, 11 males; mean age 4y 8mo [SD 3y 11mo], range 8mo-16y) had had a GT in place for at least 1 month and been assessed at Level II (n=2), Level III (n=2), Level IV (n=5), and Level V (n=17) of the Gross Motor Function Classification System. A negative response was reported by 18 caregivers when the GT was recommended; however, 21 caregivers reported improvement in the children following placement. All children received formula through the GT that was adequate for complete nutrition, yet 14 caregivers gave other foods through the GT (e.g. juice, cereal, soup, or table food). Of the 17 children receiving oral feedings, meals were an unpleasant experience for over half. Of the remaining nine children, in spite of a strict nil by mouth recommendation by physicians, five continued to receive some oral feedings. Generally, caregivers perceived GT feeding as 'unnatural'. Understanding these perceptions will help clinicians to develop effective, family-centered, patient-appropriate intervention and adherence strategies for GT-fed children with CP.

Adolescent↗

PubMed2005

Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance.

CONTEXT: Clinical practice guidelines (CPGs) have been developed to improve the quality of health care for many chronic conditions. Pay-for-performance initiatives assess physician adherence to interventions that may reflect CPG recommendations. OBJECTIVE: To evaluate the applicability of CPGs to the care of older individuals with several comorbid diseases. DATA SOURCES: The National Health Interview Survey and a nationally representative sample of Medicare beneficiaries (to identify the most prevalent chronic diseases in this population); the National Guideline Clearinghouse (for locating evidence-based CPGs for each chronic disease). STUDY SELECTION: Of the 15 most common chronic diseases, we selected hypertension, chronic heart failure, stable angina, atrial fibrillation, hypercholesterolemia, diabetes mellitus, osteoarthritis, chronic obstructive pulmonary disease, and osteoporosis, which are usually managed in primary care, choosing CPGs promulgated by national and international medical organizations for each. DATA EXTRACTION: Two investigators independently assessed whether each CPG addressed older patients with multiple comorbid diseases, goals of treatment, interactions between recommendations, burden to patients and caregivers, patient preferences, life expectancy, and quality of life. Differences were resolved by consensus. For a hypothetical 79-year-old woman with chronic obstructive pulmonary disease, type 2 diabetes, osteoporosis, hypertension, and osteoarthritis, we aggregated the recommendations from the relevant CPGs. DATA SYNTHESIS: Most CPGs did not modify or discuss the applicability of their recommendations for older patients with multiple comorbidities. Most also did not comment on burden, short- and long-term goals, and the quality of the underlying scientific evidence, nor give guidance for incorporating patient preferences into treatment plans. If the relevant CPGs were followed, the hypothetical patient would be prescribed 12 medications (costing her 406 dollars per month) and a complicated nonpharmacological regimen. Adverse interactions between drugs and diseases could result. CONCLUSIONS: This review suggests that adhering to current CPGs in caring for an older person with several comorbidities may have undesirable effects. Basing standards for quality of care and pay for performance on existing CPGs could lead to inappropriate judgment of the care provided to older individuals with complex comorbidities and could create perverse incentives that emphasize the wrong aspects of care for this population and diminish the quality of their care. Developing measures of the quality of the care needed by older patients with complex comorbidities is critical to improving their care.

Aged↗

PubMed2026

Ketamine assisted psychotherapy to reduce chronic neuropathic pain: A mixed-methods randomized pilot trial.

BACKGROUND: Intravenous ketamine can provide short-term analgesia in chronic neuropathic pain but benefits often wane after treatment. We conducted a randomized pilot trial to assess the feasibility of combining ketamine infusions with psychotherapy to inform future efficacy trials. METHODS: In this single-center, randomized, outcome-assessor-blinded pilot trial at a Canadian tertiary pain clinic, adults with moderate-to-severe chronic neuropathic pain were randomly assigned in 1:1:1 ratio to the ketamine, psychotherapy, or combined ketamine plus psychotherapy arm. Ketamine was delivered as three intravenous infusions over 16 weeks; psychotherapy consisted of 16 weekly cognitive behavioral therapy and mindfulness-based meditation sessions. The primary outcome was feasibility, assessed using prespecified progression criteria. Exploratory outcomes included changes in pain interference (PROMIS 6a T-score), pain intensity, mood, and qualitative interview findings at week 20 (ClinicalTrials.gov: NCT05639322). FINDINGS: Between October 23, 2023, and March 31, 2025, 30 participants were randomized, and 26 (87%) completed 20-week follow-up. Most feasibility criteria, including consent, retention, data completeness, and absence of study-related serious adverse events, were met; adherence targets were partially met. Exploratory pain outcomes showed numerical improvement across groups, with clinically meaningful reductions observed for pain interference and pain intensity. Sixty-four adverse events were recorded, mostly mild and in ketamine-containing groups; no serious study-related adverse events occurred. CONCLUSIONS: Combined ketamine and psychotherapy was feasible and acceptably safe in this pilot trial, supporting evaluation in a larger efficacy-powered study. FUNDING: The study was funded by the St. Michael's Hospital Innovation Fund, The Canadian Pain Society Early Investigator Award and the Physician Services Incorporation Early Career Researcher Award.

Humans↗