Care Control Group Research Articles

Effect of goal-directed mobilisation versus standard care on physical functioning among medical inpatients: the GoMob-in randomised, controlled trial

ObjectiveTo assess the effect of goal-directed mobilisation (GDM) on physical functioning in medical inpatients.DesignRandomised, controlled, single-centre, parallel, superiority trial with a 3-month follow-up and blinded outcome assessment.SettingGeneral internal medicine wards...

Atrial fibrillation screening to prevent stroke in persons with low-normal thyrotropin

Abstract Background Screening for atrial fibrillation (AF) has been proposed as a method to prevent strokes in high-risk individuals. Recent trials were unable to prove efficacy for stroke prevention but suggested that a more refined approach may be beneficial. Low-normal thyroid-stimulating hormone (TSH) is a marker for AF and stroke risk and may be used to select individuals for AF screening. Purpose To explore TSH as a tool to select individuals for AF screening to prevent stroke. Methods Post hoc analysis of a clinical trial enrolling 6004 participants with stroke risk factors but no known AF randomized 1:3 to implantable loop recorder (ILR) screening for AF and initiation of oral anticoagulation (OAC) upon AF detection versus usual care (control group). The primary outcome was stroke or systemic embolism (SE). Secondary outcomes included the combination of stroke, SE, or cardiovascular (CV) death, all-cause death, AF diagnosis, and OAC initiation. All outcomes were adjudicated. Results Baseline TSH was measured in 6003 participants (99.98%); 1500 randomized to ILR vs 4503 to control. The mean age was 75±4 years, 2836 (47%) were women. The tertiles of TSH were at ≤1.2, 1.2-1.9, and >1.9 mIU/L. Participants in the first tertile had slightly higher levels of the thyroid hormones (T3, T4, and free T4), were slightly younger, had more smoking pack-years, and higher pulse rate compared to other tertiles. The median follow-up duration was 5.4 (4.9-5.8) years, and no participants were lost to follow-up. AF was diagnosed in 476 (31.7%) participants in the ILR group vs 550 (12.2%) in the control group and this difference was similar across tertiles (p-interaction=0.44). Similar patters were observed for OAC initiation. In the first TSH tertile, participants in the ILR group were significantly less likely to experience the primary outcome (hazard ratio 0.52 [0.30–0.90]; p=0.019) or the combination of stroke, SE, or CV death (hazard ratio 0.54 [0.35–0.84]; p=0.006, respectively) compared to control, while there was no effect in participants with higher TSH (p-interaction 0.029 and 0.014, respectively) and there was no effect on all-cause death in any tertile. When TSH was modelled as a continuous variable, the effect of ILR screening gradually increased with decreasing TSH, with the upper bound of the confidence interval reaching HR<1 at TSH<1.2-1.5 mIU/L. Sensitivity analyses excluding participants with baseline TSH outside reference range (0.3-4.0 mIU/L) and/or treated with thyroid hormone replacement or antithyroid agents yielded similar results. Conclusion In persons with stroke risk factors and TSH <1.2-1.5 mIU/L, ILR screening for AF and anticoagulation upon detection led to significantly decreased stroke risk. There was no effect in persons with higher TSH, though the yield of screening was similar across levels. This suggests that low-normal TSH may indicate benefit from AF screening while higher levels may lead to overdiagnosis.TableFigure

The cost-effectiveness of a digitally enabled telerehabilitation program delivered nationally to patients in Australia

Abstract Introduction Traditionally delivered cardiac rehabilitation (CR) programs have considerable benefits, yet access and participation remains low. Emerging digital health models offer promise in healthcare delivery, but their benefits and impact on healthcare utilization and cost-effectiveness are uncertain. We conducted a cost-effectiveness analysis of a telehealth program with a CR mobile app for post-hospitalization coronary heart disease (CHD) patients. Purpose To assess whether a digitally enabled CR program is cost-effective compared with a propensity matched usual care control group in the Australian health system. Methods Patients were recruited nationally, through a health insurer, following hospitalization for CHD. Participants received weekly telehealth consultations for up to 8 weeks, supplemented by use of an mHealth app. Using administrative private health insurance claims data, we assessed differences in hospital costs, mortality rates and bed days at 12-months post discharge. Incremental cost effectiveness ratios (ICERS) were calculated to determine the cost per deaths prevented and cost per bed days saved for the digital-CR group (n=133) compared with usual care (n=266). Results Among the cohort, 36% lived in regional/rural areas, 70% were male and the mean age was 68 years. The mean total hospital all cause readmission costs at 12-months were $1,488 AUD less in the digital-CR group ($16,411) compared to the usual care group ($17,899). Digital-CR had fewer total hospital days relative to the usual care group (median of 2 vs 3 days) and patients in the digital-CR group had a significantly lower mortality rate at 12-months post discharge. The ICERs were -$337 per 100 patient deaths prevented and -$3,033 per median bed days saved. Conclusion The implementation of a digital-CR program demonstrates cost-effectiveness for patients with CHD when compared to usual care. Thus, advocating for the widespread availability of digital-CR programs as an option for CHD patients following hospital discharge is warranted.

Safety and efficacy of fluoxetine in post-stroke anxiety-A pilot prospective randomized open blinded endpoint (PROBE) study.

The prevalence of post-stroke anxiety (PSA) is reported to be 20%-25%. There is insufficient evidence on the efficacy of antidepressants for treating anxiety in such patients. This Prospective Randomized Open Blinded Endpoint (PROBE) study was designed to assess the safety and efficacy of fluoxetine in PSA. In this single-center pilot study conducted in India, post-stroke patients (between 1 to 6months) were randomized to fluoxetine (intervention group: 20mg/day for 12weeks) or standard medical care (control group). The primary outcome was improvement in the Hamilton Anxiety Rating Scale (HAM-A) at 12weeks. The secondary outcomes were anxiety remission (>50% improvement in HAM-A), modified Rankin Scale (mRS), Barthel Index (BI), quality of life (SF-36), and Hamilton Depression Rating Scale (HAM-D). A linear regression analysis was done for determinants of HAM-A to account for baseline differences in the intervention and control groups. A total of 60 patients were randomized: (30: intervention, 30: control). The overall prevalence of post-stroke anxiety among participants in the study was 50.8%, and 31.5% experienced both anxiety and depression. The average HAM-A score at baseline was 11, and average follow-up score at study conclusion was 4. There was similar improvement in the HAM-A score at 12weeks post-randomization in the intervention and control groups [fluoxetine: -8.0 (95% CI = -11.0 to -4.0); control: -7.0 (95% CI = -9.5 to -4.0); P = 0.91]. Likewise, there was no significant difference between intervention and control groups at 12weeks post-randomization on the mRS, BI, SF-36, or HAM-D. There were no serious adverse events in either group during the study. Fluoxetine and standard medical care had comparable improvement in HAM-A in post-stroke patients with mild anxiety at 12weeks. Further study of the pharmacological treatment of post-stroke patients with more severe anxiety is needed. CTRI/2018/12/016568.

Effect of transcutaneous electrical acupoint stimulation at different frequencies on mild hypertension: A randomized controlled trial

BackgroundTranscutaneous electrical acupoint stimulation (TEAS) may contribute to blood pressure (BP) control, but the evidence remains insufficient. Our objectives were to evaluate the impact of TEAS on hypertension and determine the optimal frequency. MethodsA total of 120 hypertensive patients were randomly allocated to the TEAS-2Hz group, TEAS-10Hz group, or usual care control group in a 1:1:1 ratio. All patients were advised to continue their usual antihypertensive regimen. Additionally, patients in the TEAS groups received TEAS therapy 3 times per week for 4 weeks, with a 4-week follow-up. ResultsThe primary outcome was the change in systolic BP (SBP) from baseline to week 4. Secondary outcomes included changes in diastolic BP (DBP), mean arterial pressure (MAP), heart rate (HR), heart rate variability (HRV), and 12-item health survey (SF-12) at different time points. Both TEAS groups showed reductions in SBP relative to control (TEAS-2Hz group vs. control, −4.70 mmHg [95 % CI, −7.00 to −2.40 mmHg]; P < 0.001; TEAS-10Hz group vs. control, −8.66 mmHg [95 % CI, −10.97 to −6.36 mmHg]; P < 0.001). TEAS-10Hz provided a significant decrease in SBP than TEAS-2Hz (-3.96 mmHg [95 % CI, −1.66 to −6.26 mmHg]; P< 0.001). TEAS groups also exhibited reductions in DBP, MAP, HR, LF/HF ratio（LF/HF）, very low frequency (VLF), and normalized low frequency (LF norm), and an increase in normalized high frequency (HF norm) than control. No differences were observed among groups in low frequency (LF), high frequency (HF), total power (TP), very low frequency (VLF), and SF-12. ConclusionTEAS might be a promising adjunctive therapy for hypertension, and the recommended frequency is 10 Hz, which should be confirmed in larger trials.

Effect of multidisciplinary team-style continuity of care and nutritional nursing on lung cancer: randomized study.

Aim: The clinical efficacy of systemic chemotherapy is limited due to the nonspecific delivery of anticancer drugs and is associated with serious systemic adverse effects. Therefore, integrated treatment and comprehensive care are particularly important for postoperative chemotherapy patients with lung cancer.Materials & methods: This study aimed to ascertain the application effect of multidisciplinary team (MDT)-style continuity of care combined with whole-process nutritional nursing in postoperative chemotherapy patients with lung cancer. Nutritional indices, immune function, adverse emotions, self-efficacy, self-care ability, quality of life and toxic reactions during chemotherapy were recorded in postoperative chemotherapy patients with lung cancer receiving routine care (control group) and MDT-style continuity of care combined with whole-process nutritional care (intervention group).Results: After care, the intervention group performed higher BMI, PA, TP and ALB, CD3+, CD4+ and CD4+/CD8+, lower levels of CD8+, lower self-rating anxiety scale, self-rating depression scale and QLQ-C30 symptom domain scores and higher general self-efficacy scale, exercise of self-care agency scale and QLQ-C30 functional domain scores versus the control group (all p<0.05).Conclusion: MDT-style continuity of care combined with whole-process nutritional care can improve the nutritional status of postoperative chemotherapy patients with lung cancer, and in turn enhance their quality of life.

LUDT-ADHF trial: Lung ultrasound-guided diuretic therapy for hospitalized patients with acute decompensated heart failure: An open-label clinical trial

Background Acute Decompensated Heart Failure (ADHF) constitutes a major reason for hospital admissions and significantly contributes to increased morbidity and mortality. Limited research indicates that lung ultrasound (LUS) may enhance the care for patients with ADHF.Objectives The purpose of this study was to evaluate the impact of LUS-guided diuretic therapy on reducing length of hospital stay (LOS) and 90-day readmissions among patients with ADHF.Methods This open-label, non-randomized clinical trial included patients with ADHF managed with diuretics based on LUS findings of B-lines and pleural effusion (LUS group) compared to those receiving standard care (control group). The primary outcome was LOS during the index admission, and secondary outcomes included 90-day ADHF readmissions, all-cause readmissions, and safety parameters like acute kidney injury, hypokalemia, and hypotension.Results The study included a total of 77 patients, segregated into two groups: control and LUS. The median age of the patients was 68 years, with women slightly outnumbering men (53.25%, n=41). The most prevalent comorbidities were hypertension (88.31%, n=68), diabetes mellitus (59.74%, n=46), and chronic kidney disease (66.23%, n=51). The LUS group had a shorter LOS, though not statistically significant (4 vs five days, p= 0.175). Patients in the LUS group had significantly fewer 90-day ADHF readmissions compared to the control group (10.53% vs. 35.9%; p<0.01). Survival analysis demonstrated that the LUS group had a longer time to 90-day ADHF readmissions, with a hazard ratio (HR) of 0.24 (95% CI: 0.08–0.75, p=0.014). For 90-day all-cause readmissions, the LUS group also showed a longer time to readmission compared to controls, with an HR of 0.45 (95% CI: 0.200–1.005, p=0.046). For other safety measures, there was no significant difference in the incidence of adverse events, including acute kidney injury, hypokalaemia, or hypotension, between the LUS and control groups.Conclusion LUS might reduce in-hospital mortality and readmissions among adults with acute decompensated HF. However, further double-blinded randomized clinical trials are needed to confirm these preliminary results.

Effectiveness of Mobile Application Disease Self-Management Programme on Mental Health and Self-Management of Patients With Hypertension: A Randomised Controlled Trial.

Hypertension is a chronic disease that consumes considerable medical resources. The aim of this study is to evaluate a model able to develop and assess the effectiveness of a mobile application disease self-management programme regarding mental health and self-management for patients with hypertension. A randomised controlled trial and single-blind random assignment was employed to group the participants. A total of 100 patients were collected from the cardiology clinic of a teaching hospital in Taiwan. There were 50 participants in each group: the mobile application group (experimental group) and the routine care (control group). The primary outcome measures were mental health and self-management. This study discovered that the intervention improved the mental health and self-management of the experimental group. The results for the experimental group revealed significantly improved effects and outcomes superior to those of the control group. The study results verified that a mobile application disease self-management programme could improve the mental health and disease self-management of patients with hypertension.

Association between delay in diabetes development and mortality in people with obesity: Up to 33 years follow-up of the prospective Swedish Obese Subjects study.

Life expectancy is reduced in people with obesity and is further reduced in those with concomitant type 2 diabetes. The aim of the study was to assess whether a 2-year delay in diabetes development influences life expectancy in people with obesity. Participants from the Swedish Obese Subjects study without diabetes at baseline and known diabetes status at the 2-year follow-up were included: bariatric surgery (n = 1471) and usual obesity care (n = 1392). Median follow-up was 26.1 years (interquartile range: 22.7-28.7 years). The Swedish Cause of Death Register, case sheets and autopsy reports were assessed to determine the direct cause of death. Analyses were adjusted for preselected risk factors: inclusion year, sex, baseline age, body mass index (BMI) and smoking. Across both study arms, 146 participants were newly diagnosed with type 2 diabetes at the 2-year examination, whereas 2717 remained diabetes-free. Most participants diagnosed with diabetes (n = 140) were from the usual care control group. During the follow-up, there were 18.3 deaths per 1000 person-years (95% confidence interval [CI]:14.1-23.9) in the group with diagnosed diabetes at the 2-year follow-up and 10.9 deaths per 1000 person-years (95% CI:10.2-11.8) in the group that remained diabetes-free (adjusted hazard ratio [HRadj] 1.60, 95% CI: 1.19-2.15, p = 0.002). The adjusted median life expectancy in the diabetes group was 3.7 years (95% CI: 1.4-6.0, p = 0.002) shorter than in the diabetes-free group. Specifically, cardiovascular mortality was higher in the group with diabetes (adj sub-hazard ratio [sub-HR] 1.74 [95% CI: 1.09-2.77], p = 0.021). A 2-year delay in diabetes development may be linked to increased life expectancy, possibly due to a reduction in cardiovascular mortality. Future studies should confirm these findings.

The role of preoperative immunonutrition on morbidity and immune response after cystectomy: protocol of a multicenter randomized controlled trial (INCyst Trial)

IntroductionCancer, malnutrition, and surgery negatively impact patient’s immune system. Despite standardized surgical technique and the development of new perioperative care protocols, morbidity after cystectomy remains a serious challenge for urologists. Most common postoperative complications, such as infections and ileus, often lead to longer length of stay and worse survival. The immune system and its interaction with the gut microbiota play a pivotal role in cancer immunosurveillance and in patient’s response to surgical stress. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. Immunonutrition (IN) may improve the nutritional status, immunological function, and clinical outcome of surgical patients. Aims of the study are (1) to evaluate the impact of IN on morbidity and mortality at 30 and 90 days after cystectomy and (2) to determine immune and microbiota signature that would predict IN effect.MethodsThis is a randomized, multicentric, controlled, pragmatic, parallel-group comparative study, supported by the Swiss National Science Foundation. A total of 232 patients is planned to be enrolled between April 2023 and June 2026. Three participating centers (Lausanne, Bern, and Riviera-Chablais) have been selected. All patients undergoing elective radical and simple cystectomy will be randomly assigned to receive 7 days of preoperative IN (Oral Impact®, Nestlé, Switzerland) versus standard of care (control group) and followed for 90 days after surgery. For the exploratory outcomes, blood, serum, urine, and stool samples will be collected in patients treated at Lausanne. In order to determine the impact of IN on immune fitness, patients enrolled at Lausanne will be vaccinated against influenza and the establishment of the vaccine-specific immune response will be followed. Analysis of the microbiota and expression of argininosuccinate synthetase 1 as potential biomarker will also be performed.Discussion and conclusionStrengths of the INCyst study include the randomized, multicenter, prospective design, the large number of patients studied, and the translational investigation. This study will challenge the added value of preoperative IN in patients undergoing cystectomy, assessing the clinical effect of IN on the onset of postoperative morbidity and mortality after cystectomy. Furthermore, it will provide invaluable data on the host immune response and microbiota composition.Trial registrationClinicalTrials.gov NCT05726786. Registered on March 9, 2023.

A randomized-controlled trial of parent-administered interventions to improve short-term motor outcomes in hospitalized very low birthweight infants.

Premature infants are at increased risk for cerebral palsy (CP). Early interventions with a motor focus and administered by parents may improve motor outcomes. Secondary study evaluating the short-term motor outcomes and risk for CP in very low birthweight (VLBW) infants randomized to multimodal interventions with a motor focus provided by parents versus usual care. Randomized controlled trial (intervention vs. usual care (control group)). Infants (<32 weeks' gestational age (GA) and/or <1500 grams birthweight) born between March 2019 and October 2020. Short-term motor outcomes and risk for CP was evaluated using the Hammersmith Infant Neurological Evaluation (HINE, primary motor outcome), the General Movement Assessment (GMA) and the Test of Infant Motor Performance (TIMP) at 3 months' postmenstrual age (PMA). 70 participants were enrolled (GA 28.3±2.7 weeks, birthweight 1139.2±376.6 grams, 64.3% male). The in-person follow-up rate was 73%, lower than expected, in part due to COVID-19 restrictions, resulting in 25 infants (intervention) and 26 infants (control) with outcome data available for analysis. There was not a significant difference in the HINE, GMA or TIMP at 3 months' PMA between groups. Multimodal interventions with a motor focus and provided by parents need further investigation to determine if they can improve short-term motor outcomes in VLBW infants. These interventions are evidence-based and the evaluation of broader implementation into routine care is also needed.

Efficacy of combined hyperbaric oxygen therapy and topical haemoglobin spray in treating hard-to-heal sloughy wounds.

This study examined the effectiveness of a combination of hyperbaric oxygen therapy (HBOT) and topical haemoglobin spray in treating hard-to-heal, sloughy diabetic foot ulcers (DFUs). Patients with hard-to-heal DFUs at least 25% sloughy or necrotic were included in the study. We compared the results of patients who received standard of care and HBOT with topical haemoglobin spray (oxygen group) to an equal number of patients who only received standard personalised wound care (control group). The initial values of haemoglobin A1C and C-reactive protein, wound culture results and SINBAD (site, ischaemia, neuropathy, bacterial infection, area, depth) scores were documented. Wounds were considered healed when completely closed within 16 weeks. The oxygen group (n=21) had a mean SINBAD score of 5.00±0.89, while the control group (n=21) had a mean score of 4.62±0.80 (p=0.155). After 16 weeks, 85.7% of wounds in the oxygen group showed complete recovery, compared with 52.4% in the control group (p=0.02). In this study, a greater number of wounds in the oxygen group healed. Combining HBOT with topical haemoglobin spray provides oxygenation to the wound for longer, primarily because patients can receive 90 minutes of HBOT daily. This ensures that patients benefit from both systemic and local oxygen. This combination therapy may effectively address the problem of hypoxia and promote healing in hard-to-heal wounds.

A community health worker–led intervention to improve patient knowledge and receipt of precision medicine: Updated ALCANCE randomized clinical trial findings.

181 Background: Inequitable access to precision medicine limits its impact. To address disparities, we co-developed the Addressing Latinx Cancer Care Equity Study (NCT04843332), a multi-level intervention with community stakeholders. ALCANCE was designed for low-income and Latinx adults with cancer in rural Monterey County, California. We provided annual training for clinicians about testing guidelines and precision medicine disparities. Trained CHWs educated patients about precision medicine and encouraged them to raise the topic with their oncologist. We tested whether the intervention improved patient knowledge and receipt of precision medicine. Methods: Patients with newly diagnosed or recurrent cancer, age ≥ 18 years, able to consent in English or Spanish, and who self-identified as a racial and ethnic minority OR low-income status OR were insured by public or agricultural company insurance OR uninsured and receiving cancer care at Pacific Cancer Care, a rural community oncology practice in Monterey County, were randomized 1:1 to usual care (control group) or usual care augmented with the multi-level intervention for 12 months (intervention group). The primary outcome was whether the multilevel intervention could increase patient knowledge of precision medicine using a validated 6 question survey from time of enrollment (baseline) to 6-months post-enrollment between groups. A secondary outcome was receipt of precision medicine. CHWs and clinicians completed semi-structured interviews. Results: 110 participants were randomized; 70% (n = 67) reported Spanish as their primary language; 81% (n = 89) identified as Hispanic. Median age was 55 years (55.4 ± 14.3, mean± SD); majority had annual household incomes (USD) ≤ $34,999 (59.0%, n = 46); majority obtained a high school diploma/GED or less (67.3%, n = 74). Most had gastrointestinal (35.5%, n = 39) and breast (24.5%, n = 27) cancers and were diagnosed with stage 3 or 4 (64.5%, n = 71) disease. Precision medicine knowledge was low at baseline across both the control and intervention groups (23.5 ± 19.3 versus 23.0 ± 17.7, respectively). Intervention group participants had greater precision medicine knowledge at 6-months (39.2 ± 23.0) than control group participants (24.2 ± 20.0) with greater increase in knowledge overtime than control group participants (p &lt; 0.001). More intervention group participants (n=46, 79.3%) received precision medicine testing than control (n=34, 60.7%). Across both groups, 26 of those tested had an actionable mutation. Of those 26, 66.7% (n=6 of 9) in the control group and 94.1% (n=16 of 17) in the intervention group received targeted therapy (p=0.065). Interviews with the care team indicated the model was acceptable and has been sustained as part of usual care. Conclusions: CHW-facilitated interventions may reduce disparities in precision medicine cancer care. Clinical trial information: NCT04843332

Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial

IntroductionDespite several calls to deprescribe benzodiazepine receptor agonists (BZRA) in older adults, their use among nursing home residents (NHRs) remains high. Therefore, we developed an intervention targeting general practitioners’ and...

Integrated model of secondary fracture prevention in primary care (INTERCEPT): protocol for a cluster randomised controlled multicentre trial

BackgroundOsteoporotic fractures signal severely compromised bone strength and are associated with a greatly increased risk of refracture. Despite the availability of effective and safe medications that reduce fracture risk, 70–80% of patients are inadequately investigated or treated for osteoporosis following an initial fracture, constituting a significant ‘osteoporosis care gap’. Optimal methods of bridging this gap with primary care at the forefront of secondary fracture prevention remain undetermined. This protocol describes a cluster randomised controlled trial to evaluate the effectiveness of a novel integrated model of secondary fracture prevention and management in primary care.MethodsThe cluster randomised controlled trial involves multiple branches of a community-based radiology provider (CRP), a hospital-based secondary fracture prevention program (SFPP) and numerous primary care practices in metropolitan Sydney that refer to either the CRP or SFPP. Using natural language processing tools, patients diagnosed with a potential osteoporotic fracture will be identified by automatically screening radiology reports generated at the CRP or SFPP. The primary care practices that these patients attend will be randomised (1:1) to either the intervention or usual care. The intervention consists of (i) electronic and fax alerts informing the practice/primary care physician that their patient has been diagnosed with a potential osteoporotic fracture; (ii) provision of osteoporosis management guidelines and (iii) follow-up surveys at 4 weeks and 6 months. Practices in the usual care (control) group will receive no alerts and provide usual care. The primary outcome is the proportion of patients undergoing a bone density scan and/or filling a prescription for osteo-protective pharmacotherapy within 3 months of the initial diagnostic imaging report. Secondary outcomes are the proportion of patients: (i) undergoing an osteoporosis-related blood test within 3 months of the initial diagnostic imaging report; (ii) initiated on a chronic disease management plan within 3 months of the diagnostic report, and (iii) filling a second prescription for osteo-protective pharmacotherapy within 9 months post initial diagnostic imaging report. Outcomes will be obtained through de-identified linked data from Medical Benefits Schedule and Pharmaceutical Benefits Scheme held by the Australian Institute of Health and Welfare.DiscussionThis is the first randomised trial to integrate case-detection of potential osteoporotic fractures in a hospital and community setting with direct alerts to the patient’s primary care provider. This study will determine whether such an intervention is effective in improving investigation and/or treatment rates of osteoporosis in patients with a potential osteoporotic fracture.Trial registrationThis study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000658617p.

Brief psychological intervention for suicide prevention based on problem-solving applied in different formats to people over 50 years old: protocol for a randomized controlled trial

BackgroundSuicide is a major public health problem, especially among individuals over 50 years old. Despite the suitability of this life stage for prevention, research on the efficacy of psychological interventions is scarce and methodologically limited, affecting their clinical utility and efficacy. Brief, flexible interventions that can be applied both in-person and remotely are needed. This study aims to evaluate the efficacy of a brief problem-solving-based suicide prevention program applied through various modalities to individuals over 50 years old.MethodsA randomized controlled trial will be conducted. A sample of 212 adults aged 50 or older with suicidal ideation will be randomly assigned to a problem-solving-based psychological intervention administered face-to-face (PSPI-P; n = 53), by telephone multiconference (PSPI-M; n = 53), via a smartphone app (PSPI-A; n = 53), or to a usual care control group (UCCG; n = 53). The intervention will be delivered in 7 sessions or modules of 90 min each. Blind trained evaluators will conduct assessments at pre-intervention, post-intervention, and follow-ups at 3, 6, and 12 months. The primary outcome will be suicidal ideation evaluated using the Suicidal Ideation Scale (SSI) and the Columbia Suicide Severity Rating Scale (C-SSRS). Secondary outcomes will include hopelessness, anxiety and depression symptoms, reasons for living, impulsivity, problem-solving skills, social support, anger syndrome, gratitude, personality, dropouts, treatment adherence, and satisfaction with the intervention.DiscussionThis study will provide evidence of the efficacy of a brief problem-solving-based intervention for suicide prevention in individuals over 50 years old, administered face-to-face, by telephone multiconference, and via a smartphone app. If results are favorable, it will indicate that an effective, accessible, clinically and socially useful suicide prevention intervention has been developed for affected individuals, families, and communities.Trial registrationClinicalTrials.gov NCT06338904. Registered April 1, 2024.

Effects of a reminiscence therapy-involved program on anxiety, depression, and the quality of life in cancer patients: a meta-analysis of randomized controlled trials.

Reminiscence therapy is increasingly being utilized for cancer patients to address psychological pressure and enhance their quality of life. This meta-analysis aimed to comprehensively evaluate the effect of a reminiscence therapy-involved program (RTIP) on anxiety, depression, and quality of life in cancer patients. A systematic literature search was conducted in the Web of Science, PubMed, Embase, and Cochrane Library databases until December 2023 to screen randomized control trials (RCTs) comparing the effect of RTIP and control care. A total of 16 RCTs published from 2013 to 2023 were included, with 1,963 cancer patients undergoing RTIP with or without control care (RTIP group, N = 984) or control care (control group, N = 979). The results showed the the anxiety score [standardized mean differences (SMD) = -0.539; 95% confidence interval (CI) = -0.700, -0.378; P < 0.001], anxiety rate [relative risk (RR) = 0.736; 95% CI: 0.627, 0.865; P < 0.001], depression score (SMD = -0.664; 95% CI: -0.967, -0.361; P < 0.001), and depression rate (RR = 0.632; 95% CI = 0.532, 0.750; P < 0.001) were significantly reduced in the RTIP group compared to the control group. Furthermore, overall quality of life was increased in the RTIP group than in the control group (SMD = 0.501; 95% CI: 0.314, 0.689; P < 0.001). In digestive system cancer patients, anxiety/depression scores and rates were reduced, and the overall quality of life was elevated in the RTIP group in comparison with the control group (all P < 0.050). The quality of evidence was generally high, with a low risk of bias in most studies and no publication bias in any outcomes (all P > 0.050). RTIP attenuates anxiety and depression and improves the quality of life in cancer patients, benefitting their overall health condition. This meta-analysis was registered at PROSPERO with registration number CRD42024563266.

A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study)

BackgroundMulticomponent interventions based on a comprehensive geriatric assessment (CGA) could promote active aging and improve health status in older people with Noncommunicable Chronic Diseases (NCDs), but conflicting evidences are available.AimTo evaluate the efficacy of a CGA-based multicomponent personalized preventive program (PPP) in reducing unplanned hospitalization rates during 12-month follow-up in community-dwelling older people with NCDs.Materials and methodsIn this randomized clinical trial (RCT), 1216 older adults recruited by 33 general practitioners (GPs) will be randomly allocated to intervention group (IG) or usual care control group (CG). The IG will receive a multicomponent PPP developed on the findings of the CGA-based Multidimensional Prognostic Index short-form (Brief-MPI), including structured interventions to improve functional, physical, cognitive, and nutritional status, to monitor NCDs and vaccinations, and to prevent social isolation. Participants in the CG will receive usual care. Brief-MPI, resilience, and health-related quality of life will be assessed after 6 and 12 months. Moreover, saliva samples will be collected at baseline in IG to measure biomarkers of oxidative stress, inflammatory cytokines, and oral microbiome.Expected resultsThe CGA-based PPP might reduce unplanned hospitalization rates and potentially institutionalization rates, emergency department (ED) and unplanned GP visits, and mortality. Further outcomes explored in the IG will be the adherence to PPP, resilience, health-related quality of life, and multidimensional frailty as assessed by the Brief-MPI.ConclusionsResults will suggest whether the CGA-based multicomponent PPP is able to improve specific outcomes in a primary care setting.Trial registrationClinicalTrials.gov; identifier: NCT06224556; Registered January 25, 2024.

The cervico-ocular reflex changes following treatment in individuals with subclinical neck pain: a randomized control trial.

Individuals with subclinical neck pain (SCNP) exhibit altered cerebellar processing, likely due to disordered sensorimotor integration of inaccurate proprioceptive input. This association between proprioceptive feedback and SMI has been captured in cervico-ocular reflex (COR) differences where SCNP showed higher gain than healthy participants. Previous neurophysiological research demonstrated improved cerebellar processing in SCNP participants following a single treatment session, but it is unknown whether these neurophysiological changes transfer to cerebellar function. In a parallel group, randomized control trial conducted at Ontario Tech University, 27 right-hand dominant SCNP participants were allocated to the 8-week chiropractic care (n = 15; 7M & 8F) or 8-week control (n = 12; 6M & 6F) group. COR gain (ratio of eye movement to trunk movement) was assessed using an eye-tracking device at baseline and at post 8-weeks (treatment vs. no treatment). COR gain (10 trials): participants gazed at a circular target that disappeared after 3s, while a motorized chair rotated their trunk at a frequency of 0.04Hz, with an amplitude of 5º, for 2 minutes. A 2 × 2 repeated measures ANOVA was performed. COR gain was significantly reduced following 8-weeks of chiropractic care compared to the SCNP control (8-weeks of no treatment) group (p = 0.012, ηp2 = 0.237). The decrease in COR gain following treatment is likely due to normalized proprioceptive feedback from the neck, enabling improved processing and integration within the flocculonodular lobe of the cerebellum.

The sustainability of exercise following colorectal surgery: A qualitative study of participants in the PREPARE-ABC trial

Objective This study aimed to explore perceptions regarding the sustainability of exercise following participation in a pre- and post-colorectal surgery exercise intervention trial (PREPARE-ABC). Design Qualitative interview study. Data were analysed using framework analysis and independently coded by two researchers. Setting Six United Kingdom National Health Service Trusts. Participants Eighteen interviews (hospital-based exercise n = 9, home-based exercise n = 3, standard care n = 6) were conducted with patients 12–15 months after being randomised in the trial, after their 12 month appointment. Intervention Individuals who participated in one of two exercise intervention groups (hospital-supervised or home-supported exercise) or a standard care control group of the PREPARE-ABC trial were invited to interview. Results The exercise interventions were reported to influence participants’ recovery and future sustainability of exercise behaviour change. Several participants continued to engage in exercise over a year after their surgery. Reasons for this included being engaged with exercise prior to diagnosis, psychological benefits of exercise and wanting to be engaged with something to help recovery. Perceptions about the sustainability of active lifestyles were influenced by confidence to engage in structured exercise or physical activity and beliefs about its potential to promote future wellness. Conclusions Sustainability varies among individuals and early assessment of physical activity engagement could be beneficial. Physical activity interventions immediately following surgery may be important for future engagement.