Participants In Intervention Group Research Articles

Combination of Antistaphylococcal β-Lactam With Standard Therapy Compared to Standard Therapy Alone for the Treatment of Methicillin-Resistant Staphylococcus aureus Bacteremia: A Post Hoc Analysis of the CAMERA2 Trial Using a Desirability of Outcome Ranking Approach.

Desirability of outcome ranking (DOOR) is an emerging approach to clinical trial outcome measurement using an ordinal scale to incorporate efficacy and safety endpoints. We applied a previously validated DOOR endpoint to a cohort of CAMERA2 trial participants with methicillin-resistant Staphylococcus aureus bacteremia (MRSAB). Participants were randomly assigned to standard therapy, or to standard therapy plus an antistaphylococcal β-lactam (combination therapy). Each participant was assigned a DOOR category, within which they were further ranked according to their hospital length of stay (LOS) and duration of intravenous antibiotic treatment. We calculated the probability and the generalized odds ratio of participants receiving combination therapy having worse outcomes than those receiving standard therapy. Participants assigned combination therapy had a 54.5% (95% confidence interval [CI], 48.9%-60.1%; P = .11) probability and a 1.2-fold odds (95% CI, .95-1.50; P = .12) of having a worse outcome than participants on standard therapy. When further ranked according to LOS and duration of antibiotic treatment, participants in the combination group had a 55.6% (95% CI, 49.5%-61.7%) and 55.3% (95% CI, 49.2%-61.4%) probability of having a worse outcome than participants in the standard treatment group, respectively. When considering both efficacy and safety, treatment of MRSAB with a combination of standard therapy and a β-lactam likely results in a worse clinical outcome than standard therapy. However, a small benefit of combination therapy cannot be excluded. Most likely the toxicity of combination therapy outweighed any benefit from faster clearance of bacteremia.

Improving the social communication skills of preschoolers with autism spectrum disorder: robot-based intervention on Picture Exchange Communication System use

Objectives Children diagnosed with autism spectrum disorder (ASD) often exhibit challenges in social communication. Picture Exchange Communication System (PECS) is effective in enhancing the social skills of children with ASD, and interventions using social robots are potentially beneficial training tools. However, it is uncertain whether robots can facilitate more effective training for children with ASD compared to human therapists. Methods In the present study, we compared the effectiveness of robot-based and human-based interventions on enhancing the social communication behaviors in young children diagnosed with ASD. The feasibility and efficacy of integrating the PECS in robotic systems were evaluated using a single-case design. Eight children with ASD were randomly assigned to either a robot-based group (N = 4) or a human-based group (N = 4). Participants in the two groups underwent phases I–III of the PECS protocol facilitated by either a human therapist or a robot therapist. Changes in social communication behaviors were assessed in each child after intervention using a single-case design. Results Half of the participants in the robot-based intervention group showed significant improvement in both verbal and nonverbal communication behaviors after a two-month PECS intervention. A higher proportion of children in the robot-based intervention group showed significantly enhanced social communication skills encompassing both verbal and nonverbal behaviors than in the human-based intervention group. Conclusions This study demonstrates the effectiveness of robot-based PECS intervention in enhancing verbal and nonverbal communication behaviors in young children with ASD. These findings present novel intervention tools for early intervention educators engaged in supporting children with ASD.

Effects of an individualized nutritional educational program in pregnant women: A randomized controlled trial in Japan.

To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30-min booklet-based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self-administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p = .051, 95% CI [-0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p = .040; F = 4.31; effect size = 0.36). The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face-to-face interventions for pregnant women in Japan.

Piloting co-developed behaviour change interventions to reduce exposure to air pollution and improve self-reported asthma-related health.

Exposure to air pollution can exacerbate asthma with immediate and long-term health consequences. Behaviour changes can reduce exposure to air pollution, yet its 'invisible' nature often leaves individuals unaware of their exposure, complicating the identification of appropriate behaviour modifications. Moreover, making health behaviour changes can be challenging, necessitating additional support from healthcare professionals. This pilot study used personal exposure monitoring, data feedback, and co-developed behaviour change interventions with individuals with asthma, with the goal of reducing personal exposure to PM2.5 and subsequently improving asthma-related health. Twenty-eight participants conducted baseline exposure monitoring for one-week, simultaneously keeping asthma symptom and medication diaries (previously published in McCarron et al., 2023). Participants were then randomised into control (n = 8) or intervention (n = 9) groups. Intervention participants received PM2.5 exposure feedback and worked with researchers to co-develop behaviour change interventions based on a health behaviour change programme which they implemented during the follow-up monitoring week. Control group participants received no feedback or intervention during the study. All interventions focused on the home environment. Intervention group participants reduced their at-home exposure by an average of 5.7 µg/m³ over the monitoring week (-23.0 to +3.2 µg/m³), whereas the control group had a reduction of 4.7 µg/m³ (-15.6 to +0.4 µg/m³). Furthermore, intervention group participants experienced a 4.6% decrease in participant-hours with reported asthma symptoms, while the control group saw a 0.5% increase. Similarly, the intervention group's asthma-related quality of life improved compared to the control group. This pilot study investigated a novel behaviour change intervention, utilising personal exposure monitoring, data feedback, and co-developed interventions guided by a health behaviour change programme. The study aimed to reduce personal exposure to fine particulate matter (PM2.5) and improve self-reported asthma-related health. Conducting a randomised controlled trial with 28 participants, co-developed intervention successfully targeted exposure peaks within participants' home microenvironments, resulting in a reduction in at-home personal exposure to PM2.5 and improving self-reported asthma-related health. The study contributes valuable insights into the environmental exposure-health relationship and highlights the potential of the intervention for individual-level decision-making to protect human health.

Can Dance Improve Turning in People With Parkinson's Disease?

Objective: To investigate the effects of a dance intervention on selected functional parameters during the 180° turning phase of the Timed Up & Go (TUG) test in people with Parkinson's Disease (PwPD). Methods: Fifteen adults clinically diagnosed with idiopathic PD were allocated into dance intervention (DIG; n = 7 ; age 73 ± 2 years) and control (CG; n = 8; age 64 ± 5 years) groups. The dance intervention lasted for 3 months (1 hour, twice a week). At baseline, all participants completed the Unified PD Rating Scale-part III, the International Physical Activity Questionnaire-short form, and the Hoehn & Yahr scale. Pre- and post-intervention, the primary outcomes were measured (number of steps and time to complete the 180° turning phase of the TUG test) at 2 speeds (comfortable walking and as quickly and safely speed) while using the Xsens® 3D motion suit. The secondary outcome (girdle dissociation) was assessed by calculating the difference between pelvis and affected shoulder orientation in the transverse plane (dissociation angles) at each data point during the TUG test's 180° turning phase. Results: At participant's comfortable walking speed, the functionality during the 180° turning remained unaffected following the dance intervention. However, at participant's fast speed, the dance intervention group significantly reduced the number of steps with a large effect size, and the total time taken to complete the 180° turning with a medium effect size. Post-intervention, most participants in the dance intervention group reduced the affected shoulder and pelvic girdle dissociation and turned more "en bloc." Conclusion: Dance can improve selected functional parameters during the 180° turning at fast speed in PwPD. The current results should be considered in rehabilitation programs.

Growing Resilience in Tough Times (GRITT): Development and Randomized Trial of a Farmer Mental Health Literacy Intervention

ABSTRACT Objectives Farmers in the United States (U.S.) are exposed to myriad stressors and experience their negative effects, including higher rates of suicide than individuals in some other occupations. However, interventions to address mental health amongst farmers have faced barriers, such as farmers’ perceived stigma regarding mental health, time constraints, and geographical isolation. Using text-messaging for intervention delivery may help to address some barriers, as text messages are private, delivered directly to one’s phone, and require no travel. Our objective was to develop and assess the feasibility, acceptability, and initial efficacy of a text-messaging mental health literacy intervention tailored to U.S. farmers: Growing Resiliency in Tough Times (GRITT). Methods U.S. farmers (N = 134) were randomly assigned to an intervention group, who received 12 weeks of text messages regarding mental health literacy, or a control group, who received no treatment. Online pre-test and post-test surveys assessed mental health knowledge, familiarity with relevant mental health resources, self-efficacy to manage stress, and perceived stress. Feasibility was assessed via recruitment and retention data, and intervention group participants completed post-test measures to assess acceptability. Results Results indicate that intervention group participants were highly satisfied with the intervention and had higher post-test scores on multiple facets of mental health literacy and self-efficacy to manage farm stress than control group participants. The intervention group experienced a significant drop in perceived stress from pre-test to post-test. Participant retention was relatively high (84%). However, recruitment difficulties call into question intervention feasibility. Conclusion Though the intervention was efficacious in enhancing mental health literacy, improving stress management self-efficacy, and reducing stress, difficulties with participant recruitment indicate the need for continued intervention research in this context.

A RCT to explore the effectiveness of supporting adherence to nebuliser medication in adults with cystic fibrosis: fidelity assessment of study interventions

BackgroundA multi-component self-management intervention ‘CFHealthHub’ was developed to reduce pulmonary exacerbations in adults with Cystic Fibrosis (CF) by supporting adherence to nebuliser medication. It was evaluated in a randomized controlled trial (RCT) involving 19 CF centres, with 32 interventionists, 305 participants in the intervention group, and 303 participants in the standard care arm. Ensuring treatment fidelity of intervention delivery was crucial to ensure that the intervention produced the expected outcomes.MethodsFidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform.ResultsDesign: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant.ConclusionsThe study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care.Trial registrationISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).

Usability and Feasibility of the Antipsychotic Medication Decision Aid in a Community Program for First-Episode Psychosis.

Although antipsychotic medications are considered first-line treatment for psychosis, rates of discontinuation and nonadherence are high, and debate persists about their use. This pilot study aimed to explore the usability, feasibility, and potential impact of a shared decision making (SDM) intervention, the Antipsychotic Medication Decision Aid (APM-DA), for decisions about use of antipsychotic medications. A pilot randomized controlled trial was conducted with 17 participants in a first-episode psychosis program. Nine participants received the APM-DA, and eight received usual care. After their appointments, intervention group participants had less decisional conflict and greater satisfaction with decisions than control group participants had. Use of the APM-DA did not increase appointment length. Comparison of the intervention outcomes with the control outcomes was limited because of the small sample. The results support the feasibility and usability of an SDM process via the use of the APM-DA in routine community psychosis care.

Structured lifestyle modification as an adjunct to obesity pharmacotherapy: there is much to learn.

We are at the start of an exciting new era of very effective pharmacotherapy for patients with obesity, with the latest generation of drugs approaching the efficacy of obesity surgery. Clinical trials of obesity drugs tend to emphasise the importance of participation in some form of structured lifestyle intervention for all trial participants. This usually consists of advice to reduce calorie intake and increase moderate to vigorous physical activity. There is strong evidence that structured lifestyle modification programmes improve health in patients with obesity and related disorders. However, there is no specific evidence that they improve the response to obesity medications. This is because of the way that drug trials for patients with obesity have traditionally been designed, with participants in the active drug treatment group being compared to participants on placebo drug treatment, but with both groups always receiving the same structured lifestyle intervention. While this approach is entirely reasonable, it makes it impossible to draw any inferences about the efficacy of structured lifestyle modification to augment the response to drug therapy. Given this genuine equipoise, a critical step in ensuring that our treatment of patients with obesity is robustly evidence-based is to determine whether "drug plus lifestyle" offer any advantage over "drug plus placebo" in large, well-designed and adequately powered clinical trials. We also need to determine the cost-effectiveness of these programmes.

COVID-19 Rebound After VV116 vs Nirmatrelvir-Ritonavir Treatment

With the widespread use of anti-SARS-CoV-2 drugs, accumulating data have revealed potential viral load rebound after treatment. To compare COVID-19 rebound after a standard 5-day course of antiviral treatment with VV116 vs nirmatrelvir-ritonavir. This is a single-center, investigator-blinded, randomized clinical trial conducted in Shanghai, China. Adult patients with mild-to-moderate COVID-19 and within 5 days of SARS-CoV-2 infection were enrolled between December 20, 2022, and January 19, 2023, and randomly allocated to receive either VV116 or nirmatrelvir-ritonavir. Participants in the VV116 treatment group received oral 600-mg VV116 tablets every 12 hours on day 1 and 300 mg every 12 hours on days 2 through 5. Participants in the nirmatrelvir-ritonavir treatment group received oral nirmatrelvir-ritonavir tablets with 300 mg of nirmatrelvir plus 100 mg of ritonavir every 12 hours for 5 days. Participants were followed up every other day until day 28 and every week until day 60. The primary outcome was viral load rebound (VLR), defined as a half-log increase in viral RNA copies per milliliter compared with treatment completion. Secondary outcomes included a reduction in the cycle threshold value of 1.5 or more, time until VLR, and symptom rebound, defined as an increase of more than 2 points in symptom score compared with treatment completion. The primary outcome and secondary outcomes were analyzed using the full analysis set. Sensitivity analyses were conducted using the per protocol set. Adverse events were analyzed using the safety analysis set. The full analysis set included 345 participants (mean [SD] age, 53.2 [16.8] years; 175 [50.7%] were men) who received VV116 (n = 165) or nirmatrelvir-ritonavir (n = 180). Viral load rebound occurred in 33 patients (20.0%) in the VV116 group and 39 patients (21.7%) in the nirmatrelvir-ritonavir group (P = .70). Symptom rebound occurred in 41 of 160 patients (25.6%) in the VV116 group and 40 of 163 patients (24.5%) in the nirmatrelvir-ritonavir group (P = .82). Viral whole-genome sequencing of 24 rebound cases revealed the same lineage at baseline and at viral load rebound in each case. In this randomized clinical trial of patients with mild-to-moderate COVID-19, viral load rebound and symptom rebound were both common after a standard 5-day course of treatment with either VV116 or nirmatrelvir-ritonavir. Prolongation of treatment duration might be investigated to reduce COVID-19 rebound. Chinese Clinical Trial Registry Identifier: ChiCTR2200066811.

Promoting physical activity in rheumatoid arthritis through a physiotherapist led behaviour change-based intervention (PIPPRA): a feasibility randomised trial

Physical activity (PA) is recommended as a key component in the management of people with rheumatoid arthritis (RA). The objective of this study was to examine the feasibility of a physiotherapist led, behaviour change (BC) theory-informed, intervention to promote PA in people with RA who have low levels of current PA. A feasibility randomised trial (ClinicalTrials.gov NCT03644160) of people with RA over 18 years recruited from outpatient rheumatology clinics and classified as insufficiently physically active using the Godin−Shephard Leisure Time Physical Activity Questionnaire. Participants were randomised to intervention group (4 BC physiotherapy sessions in 8 weeks) delivered in person/virtually or control group (PA information leaflet only). Feasibility targets (eligibility, recruitment, and refusal), protocol adherence and acceptability were measured. Health care professionals (HCPs) involved in the study and patients in the intervention and control arms were interviewed to determine acceptability. Descriptive statistics were used to analyse the data with SPSS (v27) with interviews analysed using content analysis using NVivo (v14). Three hundred and twenty participants were identified as potentially eligible, with n = 183 (57%) eligible to participate, of which n = 58 (32%) consented to participate. The recruitment rate was 6.4 per month. Due to the impact of COVID-19 on the study, recruitment took place over two separate phases in 2020 and 2021. Of the 25 participants completing the full study, 23 were female (mean age 60 years (SD 11.5)), with n = 11 allocated to intervention group and n = 14 to control. Intervention group participants completed 100% of sessions 1 & 2, 88% of session 3 and 81% of session 4. The study design and intervention were acceptable overall to participants, with enhancements suggested. The PIPPRA study to improve promote physical activity in people with RA who have low PA levels was feasible, acceptable and safe. Despite the impact of COVID-19 on the recruitment and retention of patients, the study provides preliminary evidence that this physiotherapist led BC intervention is feasible and a full definitive intervention should be undertaken. Health care professionals involved in the study delivery and the patient participants described a number of positive aspects to the study with some suggestions to enhance the design. These findings hence inform the design of a future efficacy-focused clinical trial.

Benefits of Collaboration Between the Wound, Ostomy, and Continence Nurse and Orthopedic Surgeon When Treating Skin Defects After Soft Tissue Sarcoma Resection: A Retrospective Case-Control Study.

The purpose of this study was to evaluate the benefits of collaborative management between orthopedic surgery and WOC nurses in patients undergoing resection of subcutaneous sarcomas. Retrospective case-control study. The sample comprised 25 patients who underwent wide resection for soft tissue sarcoma, followed by 2-stage split-thickness skin grafting. Data collection occurred between January 2015 and April 2021 in a university hospital based in Kagoshima, Japan. For comparison, we categorized these patients into 2 groups: intervention group participants were managed by an orthopedic surgeon and a WOC nurse; nonintervention group members were managed without WOC nurse participation. Patient background and treatment-related information was retrospectively collected from medical records and compared between the WOC nurse intervention group and the nonintervention group, including maximum tumor diameter, surgical time, maximum skin defect diameter, length of hospital stay, and time from surgery to complete wound healing. The average length of hospital stay was significantly shorter in the WOC nurse intervention group compared with the nonintervention group (38.3 days, SD = 8.0 vs 47.1 days, SD = 10.2; P = .023). Collaborative wound management with a WOC nurse resulted in a shorter hospital length of stay when compared to traditional management with WOC nurse involvement. Based on these findings, we assert that WOC nurses provide an important bridge between postoperative wound management in patients undergoing resection of subcutaneous sarcomas.

Motivational Interviewing as an Intervention to Improve Antiretroviral Treatment Initiation among People who Inject Drugs (PWID): A Pilot Study in Jakarta and Bandung, Indonesia.

Progress towards the 95-95-95 target among People Who Inject Drugs (PWID) with Human Immunodeficiency Virus (HIV) infection was considerably low. A behavioral approach, such as motivational interviewing (MI), has been recognized as an effective strategy for improving HIV treatment outcomes among PWID. This study aimed at assessing the impact of MI counselling to improve ARV initiation among HIV-positive PWID. A cohort design pilot study was performed, and participants were recruited using a convenience sampling technique. Participants were PWID with HIV who accessed healthcare facilities in two Indonesian cities. Selected participants were assigned to an intervention group and a control group. The intervention group followed MI counselling, while the control group received ART following the standard of care. The participants were assigned to each group based on their preferences. The data was collected between January 2018 and January 2019. In total, 115 PWID with HIV participated in this study in the intervention (n=30) and control (n=85) groups. All but one intervention group's participants started ART, while 68/85 in the control group did so. Receiving MI counselling significantly contributed to ART initiation. In addition, the participants were followed-up until 12 months after ARV initiation. During this period, we found that similar proportions of participants in both groups discontinued the treatment, and only a small number achieved HIV viral suppression. The positive effect of MI counselling on ART initiation provides insight into the possibility of its wider implementation. Further studies are needed to gain a deeper understanding of MI counselling and its effect on other outcomes of the HIV treatment cascade.

A mixed-method non-randomized pilot evaluation of a mentalization-informed motivational interviewing group intervention for concerned significant others of adolescents with excessive gaming behaviors

Existing interventions to address gaming disorder or excessive gaming primarily focus on individuals with the disorder. Little research has been undertaken regarding the development and evaluation of interventions tailored for concerned significant others (CSOs), who often feel distressed due to their loved ones’ excessive gaming. This pilot study adopts a mixed-method design to evaluate the impacts of four sessions of a mentalization-informed motivational interviewing group intervention for CSOs. For the quantitative evaluation, a non-randomized controlled design is used. The study involves 38 parents of adolescents who are experiencing excessive gaming in Hong Kong. The intervention group (n = 23) received the CSO intervention; the control group (n = 15) did not. A total of 12 qualitative interviews with the intervention group participants were also conducted to collect their views on the usefulness of the intervention. The quantitative findings show that the intervention group experienced significant improvements in mental health, emotion regulation, and gaming-related parent–child conflict from pre-test to post-test, compared with the control group. The qualitative data corroborates the quantitative findings and provides insights into potential reasons for these improvements. The findings contribute to the knowledge base regarding CSO interventions in the context of gaming disorder—an underexplored area of study.

The effect of a training program on family stress and life satisfaction: A randomized controlled study of mothers of children with disabilities

ObjectiveThis randomized controlled study focused on mothers of children with disabilities to determine the effect of a training program on family stress and life satisfaction. MethodThe sample consisted of 52 mothers of children with disabilities (intervention group = 26 and control group = 26). The intervention group participated in a five-session training program on coping mechanisms and life satisfaction. Data were collected using the Questionnaire On Resource And Stress (QRS-FT) and the Satisfaction with Life Scale (SWLS). ResultsAfter the intervention, the mean life satisfaction scores of the intervention group participants increased (p < 0.05), while their mean total score of family stress decreased (p > 0.05). In the control group, the mean life satisfaction scores decreased (p > 0.05), while the mean total score of family stress increased (p < 0.05). ConclusionThe intervention helped mothers of children with disabilities experience more satisfaction with life and less family stress. Authorities should consider the outcomes of educational intervention studies and formulate training programs for mothers of children with disabilities. Practical implicationsNurses can use interactive educational programs as nursing interventions to help mothers of children with disabilities experience less family stress and more life satisfaction.

Evaluation of an SMS Based Alcohol Intervention for Same Sex Attracted Women: A Randomized Controlled Trial to Examine Feasibility, Acceptability, and Efficacy

Purpose The purpose of this randomized controlled trial (Trial registration ID: redacted) was to examine the feasibility, acceptability, and efficacy of the Step One program, an SMS-based alcohol intervention for same-sex attracted women (SSAW). Methods Ninety-seven SSAW who scored ≥8 on the Alcohol Use Disorders Identification Test (AUDIT) were randomly allocated to receive the Step One program (n = 47; mean age = 36.79) or a weekly message containing a link to a website with health information and support services for LGBT individuals (n = 50; mean age = 34.08). Participants completed questionnaires on alcohol use, wellbeing, and help-seeking at baseline (T1), intervention completion (T2; 4 wk after baseline) and 12 wk post-intervention (T3). In addition, participants in the intervention condition completed feasibility and accessibility measures at T2, and a subsample (n = 10) was interviewed about acceptability at T3. Results Across conditions, participants significantly reduced their alcohol intake and improved their wellbeing and help-seeking over time. However, there were no significant differences between the intervention and control condition. Furthermore, frequency of help-seeking was low; only four intervention group participants and three control group participants began accessing support between T1 and T3. Overall, our findings indicate the intervention would benefit from revision prior to implementation. Conclusions Our approach was consistent with best practice in the development of an ecologically valid intervention; however, this intervention, in its current form, lacks the complexity desired by its users to optimally facilitate alcohol reduction among SSAW. Keywords: Alcohol intervention; Intervention mapping framework; Randomized controlled trial (RCT); Same-sex attracted women; Short-message service (SMS).

Who Benefited Most from the Internet-Based Conversational Engagement RCT (I-CONECT)? Application of the Personalized Medicine Approach to a Behavioral Intervention Study

BackgroundMany Alzheimer’s Disease (AD) clinical trials have failed to demonstrate treatment efficacy on cognition. It is conceivable that a complex disease like AD may not have the same treatment effect due to many heterogeneities of disease processes and individual traits.ObjectivesWe employed an individual-level treatment response (ITR) approach to determine the characteristics of treatment responders and estimated time saved in cognitive decline using the Internet-based Conversational Engagement Clinical Trial (I-CONECT) behavioral intervention study as a model.Design and SettingI-CONECT is a multi-site, single-blind, randomized controlled trial aimed to improve cognitive functions through frequent conversational interactions via internet/webcam. The experimental group engaged in video chats with study staff 4 times/week for 6 months; the control group received weekly 10-minute check-in phone calls.ParticipantsOut of 186 randomized participants, current study used 139 participants with complete information on both baseline and 6-month follow-up (73 with mild cognitive impairment (MCI), 66 with normal cognition; 64 in the experimental group, and 75 in the control group).MeasurementsITR scores were generated for the Montreal Cognitive Assessment (MoCA) (global cognition, primary outcome) and Category Fluency Animals (CFA) (semantic fluency, secondary outcome) that showed significant efficacy in the trial. ITR scores were generated through 300 iterations of 3-fold cross-validated random forest models. The average treatment difference (ATD) curve and the area between the curves (ABC) were estimated to measure the heterogeneity of treatment responses. Responder traits were identified using SHapley Additive exPlanations (SHAP) and decision tree models. The time saved in cognitive decline was explored to gauge clinical meaningfulness.ResultsABC statistics showed substantial heterogeneity in treatment response with MoCA but modest heterogeneity in treatment response with CFA. Age, cognitive status, time spent with family and friends, education, and personality were important characteristics that influenced treatment responses. Intervention group participants in the upper 30% of ITR scores demonstrated potential delays of 3 months in semantic fluency (CFA) and 6 months in global cognition (MoCA), assuming a 5-fold faster natural cognitive decline compared to the control group during the post-treatment period.ConclusionsITR-based analyses are valuable in profiling treatment responders for features that can inform future trial design and clinical practice. Reliably measuring time saved in cognitive decline is an area of ongoing research to gain insight into the clinical meaningfulness of treatment.

Assessing effectiveness of adding niosomal atorvastatin 1% ointment to topical calcineurin inhibitor treatment in non-segmental vitiligo.

Treatment of vitiligo is still a big challenge for dermatologists. The efficacy of statins in the treatment of vitiligo is controversial. We studied possible therapeutic effect of topical 1% niosomal atorvastatin ointment combined with topical 0.1% tacrolimus in treatment of non-segmental vitiligo. This is a triple blind, pilot, randomized placebo-controlled trial (RCT) that was performed in dermatology clinic. All the patients used topical 0.1% tacrolimus cream twice daily (BD). Moreover, the intervention group participants used topical 1% niosomal atorvastatin ointment, and control group participants were prescribed placebo ointment, BD. Patients were evaluated using vitiligo area surface index (VASI) score and patients' satisfaction at baseline and after 3 months treatment. The mean patient satisfaction in the intervention and control groups were 5 ± 1.4 and 3.5 ± 1.9; the difference between groups was not statistically significant (p = 0.9). We found statistically significant difference in VASI score before and after treatment in both intervention and control groups (p = 0.01 and p = 0.03, respectively). However, comparison of the VASI score between groups was not statistically significant (p = 0.62). We also found no significant correlation between VASI score and other variables. The result of this study indicates that adding of niosomal atorvastatin 1% ointment to topical calcineurin inhibitor has no additional effect on non-segmental type of vitiligo. Further large studies with different combinations are recommended before any conclusive result can be concluded on efficacy of statins in vitiligo.

Effect of cognitive training on cognitive function in community-dwelling older people with mild-to-moderate dementia: A single-blind randomised controlled trial.

The purpose of this assessor-blinded, randomised controlled trial was to determine the effect of computerised cognitive training (CT) on executive function, processing speed and working memory in 61 people with mild-to-moderate dementia. The primary outcomes were forward Digit Span and Trail Making Tests (TMT) at the completion of the 6-month intervention. Secondary outcomes included cognitive and physical performance, rate of falls, participant and caregiver's quality of life and usability and adherence to the CT program. The study was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12617000364370). Intervention group (n = 31) participants averaged 81 min of CT per week, and system usability scores were acceptable (participants: 68.8 ± 22.1; caregivers: 79.4 ± 23.5). There were no statistically significant differences in cognitive or physical performance outcomes between the intervention and control groups at 6- or 12-months (between-group differences [95% CI] for primary outcomes at 6-months: Forward Digit Span -0.3 [-0.8, 0.3]; TMT-A 2.7 s [-14.1, 19.5]; TMT-B -17.1 s [-79.3, 45.2]). At the 12-month follow-up reassessment, the intervention group reported significantly more depressive symptoms and had lower caregiver-rated participant quality of life and higher caregiver quality of life compared to control. This study showed no benefit of the CT program on working memory, processing speed and executive function. Future studies are required to better understand how CT can be used to improve cognitive and physical functioning in older people with mild-moderate dementia.

Effectiveness of Antenatal Exercises Program for the Management of Neck and Shoulder Pain

Background: Pregnancy is a significant period in a woman's life, often accompanied by various physical discomforts, including neck and shoulder pain. The management of these discomforts through non-pharmacological methods, particularly exercise, has gained attention due to its potential benefits for both maternal and fetal health. Objective: This study aimed to evaluate the effectiveness of a structured antenatal exercise program in reducing the severity of neck and shoulder pain, improving functional limitations, and enhancing the quality of life among pregnant women. Methods: A randomized control trial was conducted at the Jinnah College of Rehabilitation Sciences, Sohail University, Karachi, from June to December 2023. A total of 220 pregnant women between 14 to 30 weeks of gestation were recruited and randomly assigned to either an intervention group (n=110) or a control group (n=110). The intervention group participated in a structured antenatal exercise program designed by certified physiotherapists, which included stretching, strengthening, and relaxation exercises targeting the neck and shoulder muscles. The control group received standard prenatal care. Data on pain severity, functional limitations, and quality of life were collected at baseline, mid-intervention, and post-intervention. Statistical analysis was performed using SPSS version 25.0, with p-values less than 0.05 considered statistically significant. Results: The intervention group demonstrated a significant reduction in pain scores from a baseline of 6.0 to 3.0 post-intervention, compared to the control group, which saw a decrease from 6.0 to 5.0 (p&lt;0.01). Functional limitations were also significantly reduced in the intervention group, from 70% at baseline to 20% post-intervention, whereas the control group showed a reduction from 70% to 60% (p&lt;0.01). Positive feedback regarding pain relief, mobility, and empowerment was reported by participants in the intervention group. Conclusion: The structured antenatal exercise program was effective in significantly reducing neck and shoulder pain and improving functional limitations among pregnant women. These findings suggest that antenatal exercise programs can be a valuable component of prenatal care, enhancing the overall well-being of pregnant women.