A Randomized Controlled Trial of a Pay-for-Performance Initiative to Reduce Costs of Care for High-Need Psychiatric Patients.

OBJECTIVE: Pay-for-performance (P4P) initiatives hold promise for improving health care delivery but are rarely applied to behavioral health or tested in randomized controlled trials (RCTs). This RCT examined the effectiveness of a P4P initiative to reduce total cost of 24-hour care among patients with high needs for psychiatric care in a large county in California. METHODS: From August 2016 to March 2022, a total of 652 adult residents of Santa Clara County, California, were enrolled in a P4P initiative (mean±SD age=46.7±13.3 years, 61% male, 51% White, and 60% diagnosed as having a bipolar or psychotic disorder). Participants were randomly assigned to usual full-service partnerships from the county (N=327) or a comparable level of care from a contractor who agreed to a schedule of financial penalties and rewards based on whether enrollees (N=325) used more or less care than a historical cohort of similar county patients. The primary outcome was total cost of 24-hour psychiatric services. Secondary outcomes were costs of each of the 24-hour care services. RESULTS: The proportion of the total sample that used 24-hour psychiatric services decreased over the 36-month study period. Intent-to-treat analyses revealed no differences between the two study conditions in total care costs during the follow-up period. No significant care utilization differences were observed between the two conditions in most of the individual 24-hour services. CONCLUSIONS: A P4P initiative for high-need patients was no more effective than usual care for reducing costs of 24-hour psychiatric care.

Patient reported outcome measures (PROMs) as primary and secondary outcomes in total hip and knee arthroplasty randomized controlled trials: a systematic review.

BACKGROUND: Significant heterogeneity exists regarding patient reported outcome measures (PROMs) used in total hip (THA) and knee (TKA) arthroplasty randomized controlled trials (RCTs). This study investigates the PROMs used as primary and secondary outcomes in contemporary arthroplasty RCTs. METHODS: A literature search identified THA and TKA RCTs that were published in top ten impact factor orthopaedic journals from 2017 to 2021. Screening identified 241 trials: 76 THA, 157 TKA, and eight combined. Data were extracted to identify PROMs utilized as either primary or secondary outcomes and the time period of measurement. RESULTS: Visual Analog Scale (VAS) Pain was the most reported primary PROM in THA (9.2%) and TKA (22.9%) trials. This was followed by Numeric Rating Scale (NRS) Pain (7.9%) and the Harris Hip score (6.6%) in THA trials and NRS Pain (4.5%) and the Knee Society score (4.5%) in TKA trials. Many THA (37.0%) and TKA (52.1%) trials did not clearly specify primary outcome time points. Only pain scales were reported at time points less than one week, while various joint-specific functional outcomes were reported at later time points. As secondary outcomes, the Harris Hip score (28.9%) was most common in THA trials and the Knee Society score (26.1%) was most common in TKA trials. Indeterminate primary or secondary outcomes were reported in 18.2% of studies. CONCLUSIONS: Contemporary THA and TKA trials exhibit heterogeneity of PROMs as study outcomes after the first postoperative week. Our findings highlight the need for consensus in PROM reporting and better methodological reporting to improve the interpretability of RCT outcomes. PROSPERO REGISTRATION NUMBER: CRD42022337255.

Blood Pressure Lowering in Patients With Central Hypertension: A randomized Clinical Trial.

BACKGROUND: Cuff blood pressure (BP) is recommended for guiding hypertension management. However, central BP has been proposed as a superior clinical measurement. This study aimed to determine whether controlling hypertension as measured by central BP was beneficial in reducing left ventricular mass index beyond control of standard cuff hypertension. METHODS: This multicenter, open-label, blinded-end point trial was conducted in individuals treated for uncomplicated hypertension with controlled cuff BP (<140/90 mm Hg) but elevated central BP (≥0.5 SD above age- and sex-specific normal values). Participants were randomized to 24-months intervention with spironolactone 25 mg/day (n=148) or usual care control (n=153). The primary outcome was change in left ventricular mass index measured by cardiac MRI. Cuff and central BPs were measured by clinic, 7-day home and 24-hour ambulatory BPs. RESULTS: At 24-months, there was a greater reduction in left ventricular mass index (-3.2 [95% CI, -5.0 to -1.3] g/m2; P=0.001) with intervention compared with control. Cuff and central BPs were lowered by a similar magnitude across all BP measurement modes (eg, clinic cuff systolic BP, -6.16 [-9.60 to -2.72] mm Hg and clinic central systolic BP, -4.96 [-8.06 to -1.86] mm Hg; P≥0.48 all). Secondary analyses found that changes in left ventricular mass index correlated to changes in BP, with the magnitude of effect nearly identical for BP measured by cuff (eg, 24-hour systolic BP, ß, 0.17 [0.02-0.31] g/m2) or centrally (24-hour systolic BP, ß, 0.16 [0.01-0.32] g/m2). CONCLUSIONS: Among individuals with central hypertension, spironolactone had beneficial effects in reducing LV mass. Secondary analyses showed that changes in LV mass were equally well associated with lower measured standard cuff BP and central BP. REGISTRATION: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12613000053729.

Maxillary sinus floor augmentation with autogenous bone graft compared with composite grafts: A one-year single-blinded randomized controlled trial.

OBJECTIVE: The objective was to assess the one year implant treatment outcome and patient-related outcome measures (PROMs) following maxillary sinus floor augmentation (MSFA) with autogenous bone graft (ABG) from the zygomatic buttress (control) compared with 1:1 mixture of ABG and anorganic porcine bone mineral (APBM) (Test I) or biphasic bone graft material (BBGM) (Test II). MATERIALS AND METHODS: Sixty healthy patients (34 females, 26 males) were randomly allocated to either control or test groups. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of peri-implant tissue, peri-implant marginal bone loss, frequency of complications, and PROMs using Oral Health Impact Profile-14 combined with questionnaire assessing patient perception of peri-implant soft tissue, prosthetic solution, implant function, and implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was .05. RESULTS: All suprastructures and implants were well-functioning after one year of functional implant loading. There was no significant difference between control and test groups in any of the applied outcome measures. The implant stability significantly increased from implant placement to abutment connection within all groups (p < .001). High patient satisfaction and significant improvement in oral health-related quality of life was also reported within all groups. CONCLUSION: This study demonstrates that MSFA with composite grafts containing minimal amounts of ABG reveals comparable implant treatment outcomes as compared with ABG alone, after one year of functional implant loading. Extensive ABG harvesting in conjunction with MSFA therefore seems not to be needed.

A systematic review investigating the proportion of clinical images shared in prospective randomized controlled trials involving patients with atopic dermatitis and systemic pharmacotherapy.

For individuals with atopic dermatitis (AD), interpreting scientific papers that present clinical outcomes including the Eczema Area and Severity Index (EASI) and Investigators Global Assessment may be difficult. When compared to tabulated data and graphs, images from before and after treatment are often far more meaningful to these patients that ultimately will be candidates for the treatment. This systematic review focused on determining the frequency of clinical image sharing in AD research.Conducted in accordance with PRISMA guidelines, the review concentrated on randomized controlled trials that investigated predefined and available systemic treatments for AD. The search was performed in the MEDLINE database for studies published from the inception until 21 December 2023.The review included 60 studies, encompassing 17,799 randomized patients. Across these studies, 16 images representing 6 patients were shared in the manuscripts, leading to a sharing rate of 0.3‰.The almost missing inclusion of patient images in clinical trial publications hinders patient understanding. Adding images to scientific manuscripts could significantly improve patients' comprehension of potential treatment outcomes. This review highlights the need for authors, the pharmaceutical industry, study sponsors, and publishers to enhance and promote patient information through increased use of visual data.

Deep transcranial magnetic stimulation for treatment-resistant depression: A systematic review and meta-analysis of randomized controlled studies.

The efficacy and safety of deep transcranial magnetic stimulation (dTMS) in treating treatment-resistant depression (TRD) are unknown. Up to June 21, 2023, we conducted a systematic search for RCTs, and then extracted and synthesized data using random effects models. Five RCTs involving 507 patients with TRD (243 in the active dTMS group and 264 in the control group) were included in the present study. The active dTMS group showed significantly higher study-defined response rate (45.3% versus 24.2%, n = 507, risk ratio [RR] = 1.87, 95% confidence interval [CI]: 1.21-2.91, I2 = 53%; P = 0.005) and study-defined remission rate (38.3% versus 14.4%, n = 507, RR = 2.37, 95%CI: 1.30-4.32, I2 = 58%; P = 0.005) and superiority in improving depressive symptoms (n = 507, standardized mean difference = -0.65, 95%CI: -1.11--0.18, I2 = 82%; P = 0.006) than the control group. In terms of cognitive functions, no significant differences were observed between the two groups. The two groups also showed similar rates of other adverse events and all-cause discontinuations (P > 0.05). dTMS is an effective and safe treatment strategy for the management of patients with TRD.

Evaluating the Role of AI in Predicting the Success of Dental Implants Based on Preoperative CBCT Images: A Randomized Controlled Trial.

Background: Dental implant surgery has become a widely accepted method for replacing missing teeth. However, the success of dental implant procedures can be influenced by various factors, including the quality of preoperative planning and assessment. Cone beam computed tomography (CBCT) imaging provides valuable insights into a patient's oral anatomy, but accurately predicting implant success remains a challenge. Materials and Methods: In this randomized controlled trial (RCT), a cohort of 150 patients requiring dental implants was randomly divided into two groups: an artificial intelligence (AI)-assisted group and a traditional assessment group. Preoperative CBCT images of all patients were acquired and processed. The AI-assisted group utilized a machine learning model trained on historical data to assess implant success probability based on CBCT images, while the traditional assessment group relied on conventional methods and clinician expertise. Key parameters such as bone density, bone quality, and anatomical features were considered in the AI model. Results: After the completion of the study, the AI-assisted group demonstrated a significantly higher implant success rate, with 92% of implants successfully integrating into the bone compared to 78% in the traditional assessment group. The AI model showed an accuracy of 87% in predicting implant success, whereas traditional assessment methods achieved an accuracy of 71%. Additionally, the AI-assisted group had a lower rate of complications and required fewer postoperative interventions compared to the traditional assessment group. Conclusion: The AI-assisted approach significantly improved implant success rates and reduced complications, underscoring the importance of incorporating AI into the dental implant planning process.

Evaluating the Accuracy of AI-Based Software vs Human Interpretation in the Diagnosis of Dental Caries Using Intraoral Radiographs: An RCT.

Background: Dental caries is a prevalent oral health issue, often diagnosed through intraoral radiographs. The accuracy of Artificial Intelligence (AI) in diagnosing dental caries from these radiographs is a subject of growing interest. Materials and Methods: In this RCT, 200 intraoral radiographs were collected from patients seeking dental care. These radiographs were independently evaluated by both AI-based software and experienced human dentists. The software utilized deep learning algorithms to analyze the radiographs for signs of dental caries. The performance of both AI and human interpretations was compared by calculating sensitivity, specificity, and overall accuracy. Arbitrary values of 85% sensitivity, 90% specificity, and 88% overall accuracy were set as benchmarks. Results: The AI-based software demonstrated a sensitivity of 88%, a specificity of 91%, and an overall accuracy of 89% in diagnosing dental caries from intraoral radiographs. Human interpretation, however, yielded a sensitivity of 84%, a specificity of 88%, and an overall accuracy of 86%. The AI-based software performed consistently close to or above the predefined benchmarks, while human interpretation showed slightly lower accuracy rates. Conclusion: This RCT suggests that AI-based software is a valuable tool for diagnosing dental caries from intraoral radiographs, with performance comparable to or exceeding that of experienced human dentists. The consistent accuracy of AI in this context highlights its potential as an adjunctive diagnostic tool, which can aid dental professionals in more efficient and precise caries detection.

Comparing the Effectiveness of Traditional Periodontal Surgery Versus Non-Surgical Therapy: A Randomized Controlled Trial.

Background: Periodontal disease, characterized by inflammation and infection of the supporting structures of teeth, poses a significant oral health challenge. Traditional periodontal surgery and non-surgical therapy, such as scaling and root planing, are established treatment approaches for addressing periodontal disease. Materials and Methods: The study enrolled 120 adult patients diagnosed with moderate to severe periodontal disease. Participants were randomly allocated to one of two groups: the traditional surgery group (TSG) or the non-surgical therapy group (NSTG). In the TSG, patients underwent traditional periodontal surgery, which included flap surgery and grafts when deemed necessary. The surgical procedures were performed by experienced periodontal surgeons. In contrast, the NSTG received non-surgical therapy in the form of scaling and root planing administered by trained dental hygienists. Outcome measures encompassed clinical parameters and patient-centered outcomes. Periodontal pocket depth and clinical attachment level, both measured in millimeters, were assessed at baseline, 3 months, and 6 months. Patient-reported outcomes, including pain, discomfort, and satisfaction, were collected through standardized questionnaires at each follow-up visit. Results: Patients in the TSG experienced a notable reduction in pocket depth from a baseline of 6.8 mm to 3.7 mm at the 6-month mark, resulting in a change of -3.1 mm. Conversely, the NSTG exhibited a reduction from 6.7 mm to 4.0 mm, with a change of -2.7 mm. In the TSG, the baseline attachment level of 7.2 mm decreased to 5.1 mm at 6 months, indicating a change of -2.1 mm. In the NSTG, the attachment level decreased from 7.1 mm to 5.5 mm, resulting in a change of -1.6 mm. Patients in the TSG reported an average pain score of 3.6 on a 1-10 scale, discomfort of 4.2, and satisfaction of 7.8. In contrast, patients in the NSTG reported lower pain (2.1) and discomfort (2.9) scores but similar satisfaction levels (8.4). Conclusion: In this randomized controlled trial (RCT), both traditional periodontal surgery and non-surgical therapy demonstrated improvements in clinical parameters and patient-reported outcomes. Traditional surgery resulted in greater reductions in periodontal pocket depth and clinical attachment loss at the 6-month follow-up.

Comparing Patient Outcomes for Teeth Treated with Traditional Root Canal Therapy Versus Pulpotomy: A Randomized Controlled Trial.

Background: Root canal therapy (RCT) and pulpotomy are two common treatment modalities for managing dental pulp infections, but their comparative effectiveness in terms of patient outcomes remains unclear. This root canal therapy (RCT) aimed to assess and compare patient outcomes between teeth treated with traditional RCT and pulpotomy. Materials and Methods: In this single-center RCT, a total of 120 patients presenting with symptomatic dental pulp infections were randomly assigned to either the RCT group or the pulpotomy group. The RCT group received conventional root canal treatment, which involved complete removal of infected pulp and obturation of the root canals. The pulpotomy group underwent a procedure where only the coronal pulp tissue was removed, followed by the placement of a medicament. Pain levels, infection resolution, and tooth survival were assessed at 6 months and 1 year posttreatment. Results: At the 6-month follow-up, patients in the RCT group reported significantly lower pain scores (2.5 ± 0.8) compared with the pulpotomy group (4.3 ± 1.2, P < 0.001). Infection resolution was also higher in the RCT group (92%) compared with the pulpotomy group (78%) at 6 months. Tooth survival rates at 1 year were significantly higher in the RCT group (95%) compared with the pulpotomy group (81%, P < 0.05). Conclusion: This RCT demonstrates that traditional RCT is superior to pulpotomy in terms of pain reduction, infection resolution, and tooth survival. Patients who underwent RCT experienced less pain, faster infection resolution, and better tooth survival rates compared with those who received pulpotomy. These findings support the use of RCT as the preferred treatment modality for dental pulp infections.

Clinical Evaluation of the Retention of Four Different Pit and Fissure Sealants on the First Permanent Molars - An Original Research.

Objective: In this study, the retention rates of four different pit and fissure sealant materials on the first permanent molars were clinically assessed and compared. Materials and Methods: A total of 120 kids aged 7 to 10 participated in a randomized controlled experiment. On their first permanent teeth, the subjects each got one of the four sealant materials (A, B, C, or D). Over the course of 24 months, the retention rates were evaluated every 6 months. The Chi-square test and Kaplan-Meier survival analysis were used for statistical analysis. Results: At 6, 12, 18, and 24 months, the following retention rates were observed overall: A (85%, 78%, 65%, 52%), B (90%, 82%, 70%, 60%), C (78%, 70%, 55%, 42%), and D (95%, 88%, 75%, 62%). At each time point, the sealant materials showed significant variations in retention rates (P 0.05). While sealants A and C showed lower retention rates, sealant D showed the best retention rates, followed by sealant B. Conclusion: This study shows that different materials have different retention rates for pit and fissure sealants on first permanent molars. Higher retention rates for sealants D and B suggest that they may be superior than sealants A and C. These results highlight how crucial it is to choose the right sealant materials to guarantee long-term retention and effectiveness in avoiding dental cavities.

Evaluating the Effect of NanoFilled Composite Restorations on the Wear Resistance of Posterior Teeth: An RCT.

Background: Dental restorations play a crucial role in preserving the structural integrity and function of posterior teeth. However, wear resistance remains a significant concern for these restorations. Materials and Methods: In this RCT, 120 participants with posterior tooth restoration needs were randomly assigned to two groups. Group A received conventional composite restorations, while Group B received NanoFilled Composite restorations. The restorations were placed according to standardized protocols. Wear resistance was assessed using a custom-designed chewing simulator, and the material wear was quantified using a profilometer. Patient-reported outcomes and clinical evaluations were also recorded at regular intervals over a 24-month follow-up period. Results: The wear resistance of the NanoFilled Composite restorations (Group B) was significantly higher than that of the conventional composite restorations (Group A) after 24 months of follow-up (P < 0.05). Profilometer measurements revealed that Group B had an average wear depth of 0.15 mm, while Group A had an average wear depth of 0.25 mm. Patient-reported outcomes indicated higher satisfaction and comfort in Group B. Clinical evaluations also demonstrated that Group B restorations had better retention and marginal integrity. Conclusion: This RCT demonstrates that NanoFilled Composite restorations exhibit superior wear resistance compared to conventional composite restorations when used in posterior teeth.

Assessing the Efficacy of Cold Laser Therapy vs. Traditional Methods in Managing Post-Endodontic Pain: A Randomized Controlled Trial.

The background of the study highlighted the common occurrence of post-endodontic pain and the need for effective pain management strategies. Materials and Methods: Fifty patients were randomly assigned to two groups: the cold laser therapy (CLT) group and the traditional methods group (TMG). The CLT group received laser treatment at the affected area immediately following endodontic treatment, whereas the TMG received standard pain management techniques such as analgesics. Pain levels were assessed using a visual analog scale at baseline and at 6, 12, 24, and 48 hours post treatment. Pain scores were analyzed using appropriate statistical methods, including analysis of variance, and P values were calculated to determine the significance of differences between groups. Results: This study found significant differences in post-endodontic pain levels between CLT and standard procedures. At 6 hours post treatment, the CLT group had a mean pain score of 2.1 ± 0.8, whereas the TMG had a mean pain score of 3.8 ± 1.2 (P = 0.012). Pain levels in the CLT group decreased with time, with scores decreasing to 1.5 ± 0.6 at 12 hours, 1.2 ± 0.5 at 24 hours, and 0.9 ± 0.4 at 48 hours post treatment. In contrast, the TMG had greater pain scores at each time point: 3.2 ± 1.0, 2.9 ± 1.1, 2.5 ± 0.9, and 2.1 ± 0.8 at 12, 24, and 48 hours post treatment, respectively. At 12, 24, and 48 hours post treatment, P values of 0.021, 0.036, and 0.004, respectively, indicated significant differences. Conclusion: In managing post-endodontic pain, CLT demonstrated superior efficacy compared to traditional methods.

The Effect of a Low-Carbohydrate Diet on Periodontal Health and Inflammation in Patients with Type 2 Diabetes.

Background: The interaction between type 2 diabetes and periodontal disease underscores the importance of exploring dietary interventions that could mitigate inflammation and improve periodontal health in diabetic patients. Materials and Methods: This randomized controlled trial included 100 patients with type 2 diabetes who were equally divided into two groups: Group A (low-carbohydrate diet) and Group B (control group). Patients in Group A followed a low-carbohydrate diet for 12 weeks, while Group B maintained their regular dietary habits. Periodontal health was assessed using clinical parameters such as probing depth (PD) and clinical attachment level (CAL), and inflammation was measured by analyzing levels of C-reactive protein (CRP) and interleukin-6 (IL-6). Statistical analyses were performed using appropriate tests. Results: After 12 weeks, Group A exhibited significant improvements in periodontal health compared to Group B. The mean PD reduction was 0.5 mm in Group A and 0.1 mm in Group B, with a corresponding mean CAL gain of 0.3 mm in Group A and no significant change in Group B. Inflammatory markers also showed favorable outcomes in Group A, with a decrease of 1.2 mg/L in CRP levels and 20% reduction in IL-6 levels. In contrast, Group B demonstrated minimal changes in inflammatory markers. The differences in PD, CAL, CRP, and IL-6 levels between the two groups were statistically significant (P < 0.05). Conclusion: The adoption of a low-carbohydrate diet for 12 weeks demonstrated significant improvements in periodontal health and reduction of inflammation in patients with type 2 diabetes.

Effect of "Tiaoshen" acupuncture technique on mild depression and its underlying mechanism: A randomized controlled trial study protocol.

Background: Mild depression is not just a mental disease, but also a serious and long-term public health issue. It affects the quality of life of patients and can quickly develop into major depression. There are currently no effective drug treatments with high efficacy and few adverse reactions. Acupuncture may be an alternative treatment option. Preliminary experiments and practices have demonstrated that "Tiaoshen" acupuncture improves symptoms in patients who have depression, however the underlying data and method remain unclear at present. Methods: This is a prospective, single-center, single-blind, randomized controlled trial. We plan to recruit 70 participants and randomly assign them to receive "Tiaoshen" acupuncture or traditional acupuncture at a ratio of 1:1. Then, all the participants will receive the appropriate acupuncture treatment for four weeks. The results of the Hamilton Depression Rating Scale (HDSR-24) will serve as the primary outcome, while the results of the Patient Health Questionnaire-9 (PHQ-9) and the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will serve as secondary outcomes. Evaluations will be conducted at baseline, 1, 2, and 4 weeks after treatment initiation, and 1 and 3 months after treatment completion. The safety of the intervention will be evaluated every week using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Treatment Emergent Symptoms Scale (TESS). Serum levels of oxidative stress markers 8-iso-prostaglandin F2α (8-iso-PGF2α), superoxide dismutase (SOD), uric acid (UA), and total bilirubin (TBIL) will be measured at baseline and the end of the treatment. We will conduct a statistical analysis of intention to treat (ITT) and conformance to protocol set (PPS) data. Discussion: This research aims to provide high-quality evidence for the efficacy and safety of "Tiaoshen" acupuncture as a treatment for mild depression. In addition, the mechanism through which acupuncture heals mild depression will be investigated.

The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU-ARROW): A study protocol for a single-blind, multi-site, randomized controlled trial.

INTRODUCTION: The Finnish Geriatric Intervention Study (FINGER) led to the global dementia risk reduction initiative: World-Wide FINGERS (WW-FINGERS). As part of WW-FINGERS, the Australian AU-ARROW study mirrors aspects of FINGER, as well as US-POINTER. METHOD: AU-ARROW is a randomized, single-blind, multisite, 2-year clinical trial (n = 600; aged 55-79). The multimodal lifestyle intervention group will engage in aerobic exercise, resistance training and stretching, dietary advice to encourage MIND diet adherence, BrainHQ cognitive training, and medical monitoring and health education. The Health Education and Coaching group will receive occasional health education sessions. The primary outcome measure is the change in a global composite cognitive score. Extra value will emanate from blood biomarker analysis, positron emission tomography (PET) imaging, brain magnetic resonance imaging (MRI), and retinal biomarker tests. DISCUSSION: The finalized AU-ARROW protocol is expected to allow development of an evidence-based innovative treatment plan to reduce cognitive decline and dementia risk, and effective transfer of research outcomes into Australian health policy. Highlights: Study protocol for a single-blind, randomized controlled trial, the AU-ARROW Study.The AU-ARROW Study is a member of the World-Wide FINGERS (WW-FINGERS) initiative.AU-ARROW's primary outcome measure is change in a global composite cognitive score.Extra significance from amyloid PET imaging, brain MRI, and retinal biomarker tests.Leading to development of an innovative treatment plan to reduce cognitive decline.

Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Effectiveness of a Web-Based Individual Coping and Alcohol Intervention Program for Children of Parents With Alcohol Use Problems: Randomized Controlled Trial.

BACKGROUND: Children whose parents have alcohol use problems are at an increased risk of several negative consequences, such as poor school performance, an earlier onset of substance use, and poor mental health. Many would benefit from support programs, but the figures reveal that only a small proportion is reached by existing support. Digital interventions can provide readily accessible support and potentially reach a large number of children. Research on digital interventions aimed at this target group is scarce. We have developed a novel digital therapist-assisted self-management intervention targeting adolescents whose parents had alcohol use problems. This program aims to strengthen coping behaviors, improve mental health, and decrease alcohol consumption in adolescents. OBJECTIVE: This study aims to examine the effectiveness of a novel web-based therapist-assisted self-management intervention for adolescents whose parents have alcohol use problems. METHODS: Participants were recruited on the internet from social media and websites containing health-related information about adolescents. Possible participants were screened using the short version of the Children of Alcoholics Screening Test-6. Eligible participants were randomly allocated to either the intervention group (n=101) or the waitlist control group (n=103), and they were unblinded to the condition. The assessments, all self-assessed, consisted of a baseline and 2 follow-ups after 2 and 6 months. The primary outcome was the Coping With Parents Abuse Questionnaire (CPAQ), and secondary outcomes were the Center for Epidemiological Studies Depression Scale, Alcohol Use Disorders Identification Test (AUDIT-C), and Ladder of Life (LoL). RESULTS: For the primary outcome, CPAQ, a small but inconclusive treatment effect was observed (Cohen d=-0.05 at both follow-up time points). The intervention group scored 38% and 46% lower than the control group on the continuous part of the AUDIT-C at the 2- and 6-month follow-up, respectively. All other between-group comparisons were inconclusive at either follow-up time point. Adherence was low, as only 24% (24/101) of the participants in the intervention group completed the intervention. CONCLUSIONS: The findings were inconclusive for the primary outcome but demonstrate that a digital therapist-assisted self-management intervention may contribute to a reduction in alcohol consumption. These results highlight the potential for digital interventions to reach a vulnerable, hard-to-reach group of adolescents but underscore the need to develop more engaging support interventions to increase adherence. TRIAL REGISTRATION: ISRCTN Registry ISRCTN41545712; https://www.isrctn.com/ISRCTN41545712?q=ISRCTN41545712. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1471-2458-12-35.

Brief parenting intervention (Triple P) for families of children with eczema: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and costs of a brief, group-delivered parenting intervention for families of children with eczema. METHODS: A randomized controlled trial design was used. Families attending the Queensland Children's Hospital and from the community (n = 257) were assessed for eligibility (child 2-10 years, diagnosed with eczema, prescribed topical corticosteroids). Families who consented to participate (N = 59) were assessed at baseline for clinician-rated eczema severity, parent-reported eczema symptom severity, and electronically-monitored topical corticosteroid adherence (primary outcomes); and parenting behavior, parents' self-efficacy and task performance when managing eczema, eczema-related child behavior problems, and child and parent quality of life (secondary outcomes). Families were randomized (1:1, unblinded) to intervention (n = 31) or care-as-usual (n = 28). The intervention comprised two, 2-hr Healthy Living Triple P group sessions (face-to-face/online) and 28 intervention families attended one/both sessions. All families were offered standardized eczema education. Families were reassessed at 4-weeks post-intervention and 6-month follow-up, with clinician-raters blinded to condition. Costs of intervention delivery were estimated. RESULTS: Multilevel modeling across assessment timepoints showed significant intervention effects for ineffective parenting (d = .60), self-efficacy (d = .74), task performance (d = .81), and confidence with managing eczema-related child behavior (d = .63), but not disease/symptom severity, treatment adherence or quality of life. Mean cost per participating family with parenting behavior (clinically) improved was $159. CONCLUSIONS: Healthy Living Triple P is effective in reducing ineffective parenting practices and improving parents' self-efficacy and task performance when managing children's eczema and eczema-related behavior difficulties. There was no effect on disease/symptom severity, treatment adherence, or quality of life. CLINICAL TRIAL REGISTRATION: ACTRN12618001332213.