Intervention Arm Research Articles

Predictors associated with an increase in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention

BackgroundThis study aimed to explore predictors associated with intermediate (six months) and post-intervention (24 months) increases in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention.MethodsA secondary analysis was conducted based on data from people with prediabetes or type 2 diabetes from two intervention arms of the randomised controlled trial Sophia Step Study. Daily steps were measured with an ActiGraph GT1M accelerometer. Participants were divided into two groups based on their response to the intervention: Group 1) ≥ 500 increase in daily steps or Group 2) a decrease or < 500 increase in daily steps. Data from baseline and from six- and 24-month follow-ups were used for analysis. The response groups were used as outcomes in a multiple logistic regression together with baseline predictors including self-efficacy, social support, health-related variables, intervention group, demographics and steps at baseline. Predictors were included in the regression if they had a p-value < 0.2 from bivariate analyses.ResultsIn total, 83 participants were included. The mean ± SD age was 65.2 ± 6.8 years and 33% were female. At six months, a lower number of steps at baseline was a significant predictor for increasing ≥ 500 steps per day (OR = 0.82, 95% CI 0.69–0.98). At 24 months, women had 79% lower odds of increasing ≥ 500 steps per day (OR = 0.21, 95% CI 0.05–0.88), compared to men. For every year of increase in age, the odds of increasing ≥ 500 steps per day decreased by 13% (OR = 0.87, 95% CI 0.78–0.97). Also, for every step increase in baseline self-efficacy, measured with the Self-Efficacy for Exercise Scale, the odds of increasing ≥ 500 steps per day increased by 14% (OR = 1.14, 95% CI 1.02–1.27).ConclusionsIn the Sophia Step Study pedometer intervention, participants with a lower number of steps at baseline, male gender, lower age or higher baseline self-efficacy were more likely to respond to the intervention with a step increase above 500 steps per day. More knowledge is needed about factors that influence response to pedometer interventions.Trial registrationClinicalTrials.gov, NCT02374788.

Influence of grandchildren on COVID-19 vaccination uptake among older adults in China: a parallel-group, cluster-randomized controlled trial.

The uptake of COVID-19 booster vaccination among older adults in China is suboptimal. Here, we report the results of a parallel-group cluster-randomized controlled trial evaluating the efficacy of promoting COVID-19 booster vaccination among grandparents (≥60 years) through a health education intervention delivered to their grandchildren (aged ≥16 years) in a Chinese cohort (Chinese Clinical Trial Registry: ChiCTR2200063240 ). The primary outcome was the uptake rate of COVID-19 booster dose among grandparents. Secondary outcomes include grandparents' attitude and intention to get a COVID-19 booster dose. A total of 202 college students were randomized 1:1 to either the intervention arm of web-based health education and 14 daily reminders (n = 188 grandparents) or control arm (n = 187 grandparents) and reported their grandparents' COVID-19 booster vaccination status at baseline and 21 days. Grandparents in the intervention arm were more likely to receive COVID-19 booster vaccination compared to control cohort (intervention, 30.6%; control, 16.9%; risk ratio = 2.00 (95% CI, 1.09 to 3.66)). Grandparents in the intervention arm also had greater attitude change (β = 0.28 (95% CI, 0.04 to 0.52)) and intention change (β = 0.32 (95% CI, 0.12 to 0.52)) to receive a COVID-19 booster dose. Our results show that an educational intervention targeting college students increased COVID-19 booster vaccination uptake among grandparents in China.

An Age-Progression Intervention for Smoking Cessation: A Pilot Study Investigating the Influence of Two Sets of Instructions on Intervention Efficacy

Abstract Background Research on age-progression facial morphing interventions for smoking cessation has not investigated the effect of different instructions for intervention delivery. The objective of this pilot study was to investigate the influence of two instruction types used to deliver the intervention on efficacy of the intervention. Method Women were recruited and randomly allocated to an age-progression intervention session with (i) neutral instructions; (ii) instructions designed to reassure; or (iii) a condition that controlled for participant engagement (“control”). The conditions were delivered in a one-time procedure, after which primary (quitting intentions) and secondary (cigarettes/week, quit attempts) outcomes were measured immediately post-intervention, and at 1 and 3 months. Results Seventy-two women (M = 25.7; SD = 0.9) were recruited and randomly allocated to condition (Neutral n = 27, Reassuring n = 22, Control n = 23). Quitting intentions were higher in the Reassuring versus Control arm (3 months post-intervention, F = 4.37, p = 0.016, 95% CI [0.231, 2.539], eta2 = 0.11); quit attempts were greater in the two intervention arms (58%) versus Control (1-month post-intervention, 15%) (χ2 = 9.83, p &lt; 0.05, OR 1.00 [0.28, 3.63]). Conclusions Findings highlight the importance of optimising instructions to enhance intervention efficacy. Trial Registration clinicaltrials.gov Record: NCT03749382.

Cost-effectiveness of left atrial appendage occlusion during cardiac surgery in France: An economic evaluation based on the LAAOS III study

Objectives Left atrial appendage occlusion during cardiac surgery is a therapeutic option for stroke prevention in patients with atrial fibrillation. The effectiveness and safety of left atrial appendage occlusion have been evaluated in several studies, including the LAAOS-III trial. While these studies have demonstrated efficacy and safety, the long-term economic impact of this surgical technique has not yet been assessed. Here, we aimed to evaluate the cost-effectiveness and cost-utility of left atrial appendage occlusion during cardiac surgery over a long-term time horizon. Methods Our study was based on a model representing an hypothetical cohort with the same characteristics as LAAOS-III trial patients. We modelled the incidence of ischemic strokes and systemic embolisms in each intervention arm: "occlusion" and "no-occlusion," using a one-month cycle length with a 20-year time horizon. Regarding occlusion devices, sutures, staples, or an approved surgical occlusion device (AtriClip™—AtriCure, Ohio, USA) could be used. Results Our model generated an average cost savings of 607 euros per patient and an incremental gain of 0.062 quality-adjusted life years (QALYs), resulting an incremental cost-utility ratio (ICUR) of €-9,775/QALY. The scenario analysis in which occlusion was systematically performed using the AtriClip™ device generated an ICUR of €3,952/QALY gained. Conclusions In the base-case analysis, the strategy proved to be more effective and less costly, confirming left atrial appendage occlusion during cardiac surgery as an economically dominant strategy. The scenario analysis also appeared cost-effective, although it did not result in cost savings. This study provides a new perspective on the assessment of the cost-effectiveness of these techniques.

Evaluating and Enhancing an Educational Intervention to Reduce Smallholder Farmers' Exposure to Pesticides in Uganda Through a Digital, Systematic Approach to Behavior Change: Protocol for a Cluster-Randomized Controlled Trial.

Smallholder farmers receive educational interventions on safe pesticide handling by governmental agencies, industries, or nongovernmental organizations to reduce exposure risks. However, existing educational interventions have limited effects on changing behaviors. Targeting psychosocial determinants of behavior change in educational interventions through theory- and evidence-based approaches may enhance their effectiveness. We aim at describing the intervention development and study design of a 3-arm cluster-randomized controlled trial to assess the effects in improving safe pesticide handling and reducing pesticide exposure of (1) an existing educational intervention and (2) a newly developed SMS text messaging intervention based on the Risks, Attitudes, Norms, Abilities, and Self-regulation (RANAS) behavior change approach. We enrolled 539 Ugandan smallholder farmers in 12 clusters (subcounties). The clusters, each with 45 farmers, were randomly allocated to one of the three arms: (1) educational intervention, (2) educational intervention+RANAS-based SMS text messages, or (3) control group. The educational intervention comprised a 2-day workshop that targeted multiple aspects of safe pesticide handling, whereas the SMS text messages targeted the use of personal protective equipment (PPE) and were based on the RANAS approach. For intervention development in this study, this approach includes identifying psychosocial determinants of PPE use at baseline and selecting behavior change techniques to target them in SMS text messages. The primary outcomes of the study are (1) pesticide knowledge, attitude, and practice scores indicating performance throughout the educational intervention; and (2) frequency of PPE use. Secondary outcomes are the RANAS-based behavioral determinants of PPE use, the frequency of glove use, algorithm-based pesticide exposure intensity scores, and signs and symptoms of pesticide poisoning. The outcomes were assessed in structured interviews before the intervention (baseline) and at the 12-month follow-up. The effect of the interventions among the arms will be analyzed using the intervention arms and baseline measures as predictors and the follow-up measures as outcomes in linear multivariable mixed models including the clusters as random effects. The mediating psychosocial determinants of the interventions will be assessed in multiple mediation models. The study was conducted from 2020 to 2021-baseline interviews were conducted in October 2020, and the educational intervention was delivered in November 2020. The RANAS-based SMS text messages were developed based on the baseline data for relevant behavioral determinants of PPE use and sent between February 2021 and September 2021. Follow-up interviews were conducted in October 2021. Overall, 539 farmers were enrolled in the study at baseline; 8.3% (45/539) were lost to follow-up by the end of the study. This study will contribute to a better understanding of the effectiveness and behavior change mechanisms of educational interventions by using an experimental, cluster-randomized study design to improve pesticide handling among smallholder farmers. International Standard Randomised Controlled Trial Number (ISRCTN) 18237656; https://doi.org/10.1186/ISRCTN18237656. DERR1-10.2196/55238.

Effectiveness of School-based Substance abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills among adolescents in selected public schools of Pokhara, Nepal–A cluster randomized trial protocol

ObjectiveEarly substance use has been linked to various adverse outcomes and escalates quickly during adolescence. Delaying the onset of substance use among adolescents is a primary public priority as it is associated with severe effects. The objective of the study is to develop and determine the effectiveness of a School-based Substance Abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards preventing substance abuse among adolescents. MethodPhase I of the study is a qualitative approach, where a focus group discussion (FGD) will be conducted among different stakeholders to explore their perceptions regarding the prevention of substance use among adolescents. The anticipated sample size is 38. Thematic analysis will be done by using ATLAS.ti software. The inputs given by the stakeholders will be incorporated in developing the intervention (SSPP). Phase II is a cluster randomized controlled trial. A minimum of 210 adolescents (105 each in the intervention and control groups) between the age group of 13 to 15 years from 8th and 9th grade will be recruited for the study. In this study, the school will be the cluster and will be randomly assigned either to an intervention or control arm. The data will be collected at pre, post, 3-month, and 6-month intervals. The ethical approval was obtained from the Nepal Health Research Council Committee, Nepal (NHRC 276/2023). The trial was also registered under the Clinical Trial Registry of USA-Clinical Trials.gov (CTRI 06004726/2023/08/22/). Descriptive and inferential statistics will be used to analyze the data. Expected resultsImplementation of the SSPP module will improve the awareness, attitude, peer pressure, and life skills of adolescents toward preventing substance use behavior. Overall, the study aims to achieve Sustainable Development Goal (SDG) 3.5- ‘Good Health and Well-being; strengthen the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol.’ ConclusionThe present study protocol will help to develop a unique training module (SSPP) focused on preventing substance use behaviour among adolescents in Nepal.

Indirect calorimetry directed feeding and cycling in the older ICU population: a pilot randomised controlled trial

BackgroundOlder critically ill patients experience rapid muscle loss during stay in an intensive care unit (ICU) due to physiological stress and increased catabolism. This may lead to increased ICU length of stay, delayed weaning from ventilation and persistent functional limitations. We hypothesized that with optimal nutrition and early physical therapy acting in synergism, we can reduce muscle mass loss and improve functional outcomes.MethodsThis was a prospective, single blinded randomized, controlled single-center pilot study to compare the lean muscle mass (measured at bilateral quadriceps femoris using ultrasound) of older ICU patients at 4 time points over 14 days between the control and intervention groups. The control group received standard weight-based empiric feeding and standard ICU physiotherapy. The intervention group received indirect calorimetry directed feeding adjusted daily and 60 min per day of cycle ergometry. 21 patients were recruited and randomized with 11 patients in the control arm and 10 patients in the intervention arm. Secondary outcome measures included ICU and hospital mortality, length of stay, functional assessments of mobility and assessment of strength.ResultsMedian age was 64 in the control group and 66 in the intervention group. Median calories achieved was 24.5 kcal/kg per day in the control group and 23.3 kcal/kg per day in the intervention group. Cycle ergometry was applied to patients in the intervention group for a median of 60 min a day and a patient had a median of 8.5 sessions in 14 days. Muscle mass decreased by a median of 4.7cm2 in the right quadriceps femoris in the control group and 1.8cm2 in the intervention group (p = 0.19), while the left quadriceps femoris decreased by 1.9cm2 in the control group and 0.1cm2 in the intervention group (p = 0.51).ConclusionIn this pilot study, we found a trend towards decrease muscle loss in bilateral quadriceps femoris with our combined interventions. However, it did not reach statistical significance likely due to small number of patients recruited in the study. However, we conclude that the intervention is feasible and potentially beneficial and may warrant a larger scale study to achieve statistical significance.Trial RegistrationThis study was registered on Clinicaltrials.gov on 30th May 2018 with identifier NCT03540732.

Management of Chronic Fissure in Ano: A Case Study on Conservative vs. Surgical Treatment Approaches

The conservative treatment arm includes dietary modifications, stool softeners, topical analgesics, and sitz baths. This approach focuses on symptom relief, promoting healing, and preventing recurrence. In contrast, the surgical intervention arm involves procedures like lateral internal sphincterotomy (LIS) or advancement flap repair. These techniques aim to address the underlying sphincter hypertonicity or poor blood supply to the fissure site. The case study will present two patient profiles: one managed conservatively and the other surgically. Parameters such as pain scores, healing rates, time to symptom resolution, and recurrence rates will be compared between the two groups. Additionally, quality of life metrics and patient satisfaction will be assessed. Insights from this case study can aid clinicians in selecting the most appropriate treatment modality for chronic anal fissures, considering factors such as severity, patient preference, and potential risks. Ultimately, the study seeks to contribute valuable evidence to the ongoing debate surrounding the optimal management strategy for this prevalent colorectal condition. Furthermore, the impact on the patient's quality of life and satisfaction with the chosen treatment approach is examined. Through a multidisciplinary approach involving gastroenterologists, colorectal surgeons, and the patient, this case study highlights the importance of individualized care and shared decision-making in managing chronic fissure in ano.

An Opportunity for Management of Fatigue, Physical Condition, and Quality of Life Through Asynchronous Telerehabilitation in Patients After Acute Coronavirus Disease 2019: A Randomized Controlled Pilot Study

ObjectiveTo compare the preliminary efficacy of asynchronous telerehabilitation in patients after acute coronavirus disease 2019 (COVID-19) on fatigue, physical condition, quality of life, and feasibility of this pilot study with that of a booklet format. DesignRandomized pilot study with 2 intervention arms: asynchronous telerehabilitation group and booklet-based rehabilitation group, with 2 follow-ups at 3 and 6 months. SettingHospital. ParticipantsPatients discharged after COVID-19 were recruited and evaluated (N=35). InterventionsThe intervention consisted of a 12-week multimodal rehabilitation program via telerehabilitation or by a booklet. Main Outcome MeasuresFatigue as the main outcome and functional status, quality of life, and feasibility as secondary outcomes were evaluated. ResultsAfter the intervention, there was no significant difference between groups in fatigue, but there were significant differences in favor of the asynchronous telerehabilitation group for the 6-Minute Walk Test (p=.008), the 30-Second Sit-to-Stand Test (p=.019), and physical quality of life (p=.035). These improvements were maintained throughout the 6-month follow-up. Telerehabilitation was shown to be a viable option, without incidents and with a higher adhesion (p=.028) than the booklet format. ConclusionsA multimodal rehabilitation program by means of asynchronous telerehabilitation appears as a more effective option than traditional formats in improving post–acute COVID-19 sequelae.

Abstract PO1-19-03: The T-REX trial: a randomized international non-inferiority trial on Tailored Regional EXternal beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases

Abstract Background: Modern systemic treatment has reduced the incidence of regional recurrences and improved survival in breast cancer (BC). It is thus questionable whether regional radiotherapy (RT) is still indicated in patients with sentinel lymph node (SLN) macrometastases. Postoperative regional RT is associated with an increased risk of arm morbidity, pneumonitis, cardiac disease, and secondary cancer. Therefore, there is a need to individualize the indication for regional RT in relation to risk of recurrence. Trial design: In this multicenter, prospective randomized phase 3 trial, eligible patients have a clinically node-negative, estrogen receptor-positive, HER2-negative BC with 1-2 SLN macrometastases, and have not undergone completion axillary lymph node dissection. Participants are randomly assigned to receive regional RT (standard arm) or not (intervention arm). Regional RT includes the axillary levels I-III and the supraclavicular fossa. Internal mammary nodes are targeted in selected patients. After breast-conserving surgery (BCS), RT to the remaining breast is given in both groups while after mastectomy, chest-wall RT is only given in the standard arm. In the intervention arm, chest wall RT may be indicated in selected cases with extensive multifocality, according to national guidelines. RT quality assurance is an integral part of the trial. In addition, material from the primary tumor, SLN metastases and any recurrences is subjected to gene expression analysis to identify both prognostic markers for locoregional recurrence and predictive markers for the benefit of regional RT. After confirmation of eligibility and written informed consent, patients are randomized 1:1 between the treatment arms. Allocation is stratified by trial site and breast surgery (BCS vs. mastectomy). Participation in T-REX should not affect decisions on systemic adjuvant treatment. Eligibility criteria: Trial inclusion and exclusion criteria are given in Table 1. Specific aims: The main aim of the trial is to investigate if the omission of regional RT is non-inferior to routine regional RT in clinically node-negative BC patients with estrogen receptor-positive, HER2-negative T1-2 tumors with 1-2 SLN macrometastases not receiving axillary lymph node dissection. Secondary aims are to investigate whether refraining from regional RT reduces arm morbidity and late RT side effects, and improves short- and long-term health-related quality of life. In addition, the use of genomic classifiers for the prognostication of locoregional recurrences and the prediction of a benefit from regional RT will be investigated. Statistical methods: Primary outcome is recurrence free survival (RFS) at five years. Non-inferiority will be declared if the outcome in the intervention arm is not more than 4.5 percentage units below the standard arm, corresponding to a hazard ratio of 1.41 assuming 88% 5-year RFS with standard treatment. Secondary outcomes include locoregional recurrence, overall survival, patient-reported arm morbidity, and health-related quality of life. Accrual: The trial will include 1350 patients in Sweden, Norway and Finland from April 2023 to December 2028. First sites have been opened in April 2023. Contact information: Primary Investigator: Sara Alkner, Skåne University Hospital, Lund University, sara.alkner@med.lu.se. Responsible for the biobank: Per Karlsson, Sahlgrenska University Hospital, Gothenburg University, per.karlsson@oncology.gu.se. Inclusion and exclusion criteria Citation Format: Sara Alkner, Jana de Boniface, Dan Lundstedt, Ingvil Mjaaland, Lisa Rydén, Johan vikström, Pär-Ola Bendahl, Erik Holmberg, Helena Sackey, Elinore Wieslander, Per Karlsson. The T-REX trial: a randomized international non-inferiority trial on Tailored Regional EXternal beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-19-03.

Food is Medicine for HIV: Improved health and hospitalizations in the Changing Health through Food Support (CHEFS-HIV) pragmatic randomized trial.

Policy support for "Food is Medicine"-medically tailored meals or groceries to improve health-is rapidly growing. No randomized trials have heretofore investigated the benefits of medically tailored food programs for people living with HIV (PLHIV). The CHEFS-HIV pragmatic randomized trial included PLHIV who were clients of Project Open Hand (POH), a San Francisco-based nonprofit food organization. The intervention arm (n = 93) received comprehensive medically tailored meals, groceries, and nutritional education. Control participants (n = 98) received less intensive (POH "standard of care") food services. Health, nutrition, and behavioral outcomes were assessed at baseline and 6 months later. Primary outcomes measured were viral non-suppression and health related quality of life. Mixed models estimated treatment effects as differences-in-differences between arms. The intervention arm had lower odds of hospitalization (odds ratio [OR] = 0.11), food insecurity (OR = 0.23), depressive symptoms (OR = 0.32), antiretroviral therapy adherence <90% (OR = 0.18), and unprotected sex (OR = 0.18), and less fatty food consumption (β= -0.170 servings/day) over 6 months, compared to the control arm. There was no difference between study arms in viral non-suppression and health-related quality of life over 6 months. A "Food-is-Medicine" intervention reduced hospitalizations and improved mental and physical health among PLHIV, despite no impact on viral suppression. NCT03191253.

Abstract PO1-03-07: Revisiting the potential of pathological complete response as a surrogate for long-term survival outcomes in triple-negative breast cancer at the trial-level

Abstract Background: Pathological complete response (pCR) has been used as a primary endpoint in neoadjuvant clinical trials for non-metastatic breast cancer and as a surrogate endpoint for long-term survival outcomes. The U.S. Food and Drug Administration (FDA) accepted pCR as a surrogate endpoint for the approval of new drugs in the neoadjuvant setting in high-risk early-stage breast cancer. However, though the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) pooled analysis in 2014 showed that at the patient level achieving pCR was associated with longer overall survival (OS) and event-free survival (EFS), at the trial-level the association between high pCR rate and better OS and EFS outcomes was weak (coefficient of difference [R2]; 0.03 and 0.24, respectively) among all subtypes of breast cancer. A recent study reported that this association at the trial-level was similarly weak among Human Epidermal Growth Factor Receptor-2 (HER-2) positive breast cancer (R2; 0.02 and 0.23, respectively). However, the potential surrogacy of pCR rate for OS and EFS in triple-negative breast cancer (TNBC) in the neoadjuvant setting has not been well studied in a comprehensive manner. Moreover, because of significant advances in systemic treatment strategies in TNBC over the past decade including a combination of immune checkpoint inhibitors (ICIs) with conventional cytotoxic agents, the trial-level surrogacy needs to be reassessed in recently published neoadjuvant clinical trials for TNBC. Our primary objective is to assess the association between pCR rate and survival outcomes in neoadjuvant clinical trials for TNBC by collecting data from articles published after the CTNeoBC article in 2014. Methods: We performed a systematic literature search based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in the PubMed, Cochrane Library, and Web of Science databases. Articles published between January 1, 2014, and March 31, 2023, were searched. We included only randomized control trials of neoadjuvant treatments for clinical stage I-III TNBC that compared two or more regimens followed by curative intent breast surgery. The selected trials had data for odds ratio (OR) for pCR and hazard ratios (HRs) either for OS or for EFS or disease-free survival (DFS). We excluded trials including estrogen receptor positive, progesterone receptor-positive, or HER-2 positive diseases, and those without data enough to obtain ORs for pCR, HRs for OS, EFS, or DFS. Unpublished data as a full article was also excluded. If EFS could not be obtained from the articles, DFS was used in place of EFS. Two independent investigators (TY and TF) searched and extracted data. Any disagreement was resolved by discussion with the third author (ZZ). A linear regression model on a logarithmic scale weighted by the sample size of each trial was performed and the R2 was used to assess the trial-level association between OR for pCR and HRs for OS or EFS. Results: We identified eight trials with a total of 2,926 patients. Three of the eight trials used ICIs in the intervention arm. One trial did not provide OS data and was not included in the OS analysis. In four trials, EFS was not available and DFS was used for EFS analysis. The R2 was 0.191 (95% confidence interval [CI], 0.165 to 0.218) for OS and 0.193 (95% CI, 0.167 to 0.219) for EFS. Conclusions: Similarly to the previous reports, our findings suggest that the surrogacy of the pCR rate for OS and EFS in recent neoadjuvant clinical trials for TNBC is weak. At this moment, there is no strong evidence to support using pCR as a surrogate for long-term survival outcomes in neoadjuvant clinical trials for TNBC. Citation Format: Toru Yoshino, Zao Zhang, Ryota Sato, Stanley Lipkowitz, Takeo Fujii. Revisiting the potential of pathological complete response as a surrogate for long-term survival outcomes in triple-negative breast cancer at the trial-level [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-03-07.

Abstract PS03-06: Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: saving costs and time (the CONFIDENT-B trial)

Abstract Background Metastases in sentinel lymph nodes (SN) of breast cancer (BC) patients are strongly associated with a worse survival and consequently guide treatment. If metastases are absent upon pathologist’ assessment of the regular hematoxylin and eosin (HE)-slide, additional immunohistochemistry (IHC)-stains are performed to ensure that no metastases are missed. However, these stains come at high additional costs, which may exceed specimen reimbursement. Fortunately, digital pathology is becoming more common, thereby creating an avenue of opportunities for artificial intelligence (AI) assistance. Although the number of studies on (promising) AI-algorithms increases exponentially, studies on actual clinical implementation are lacking. In this single-center prospective trial, we investigated to which extent an artificial intelligence (AI)-assisted clinical workflow for the detection of SN-metastases reduces IHC-use, while maintaining current diagnostic safety standards. Methods We enrolled 190 SN-specimens of 182 patients with invasive or in situ BC from September 2022 to May 2023. SN-specimens were allocated bi-weekly to either the control-arm (n=90) or the intervention-arm (n=100). In the control-arm, SN-specimens were digitally assessed according to the current clinical workflow, while pathologists in the intervention-arm assessed the SN-specimen with the output the ‘Metastasis-Detection-App’ (Visiopharm©) available. In both groups, IHC was performed in all morphologically negative cases. Main outcome was the relative risk (RR) of IHC-use per detected case of SN-metastases. Case-mix adjustment was performed by log-binomial regression. Results Overall, 59 SN-specimens contained metastases (31.1%). AI-assistance resulted in a significantly lower risk of IHC-use per detected case of SN-metastases (adjusted RR: 0.680, 95% CI: 0.347-0.878). Besides preventing IHC-use, thereby reducing costs, AI-assisted pathologists also spent significantly less time on their assessment of the SN-specimen (3m:41s vs. 6m:04s, p = 0.028). Furthermore, the sensitivity of AI-assisted pathologists was up to 30% higher. The AI-assisted pathologists missed two cases of micro-metastases in the intervention arm, one of which was in retrospect highlighted by the algorithm, while in the other case the tumor cells were located in a heavily cauterized area of the HE-slide and therefore only visible on the (serial) IHC-slides. In the control arm, the algorithm in retrospect picked up all micro- and macro-metastases and nearly half of the isolated tumor cells (ITC). In addition, all participating pathologists stated that AI was easy to use, that they felt confident using AI, and that besides saving them time, AI made their work more enjoyable. Cost reductions on IHC by AI-assistance depend on laboratory policy (i.e. when and on how many levels IHC is performed), but, at a cost of €25,- per IHC-stain, range from €1.500 to €3.500 per 100 SN’s in a scenario where IHC is performed in all morphologically negative cases. In a scenario where IHC is only performed in patients in whom finding ITC has clinical consequences (i.e. patients who received neoadjuvant treatment), cost savings on IHC range from €7.500-€12.500 per 100 SNs, depending on laboratory policy. Conclusion AI-implementation for the detection of SN-metastases in BC-patients leads to a significant reduction of IHC-use and subsequent costs, while saving pathologists time and making their work more enjoyable. Importantly, AI-implementation during this trial was safe and patients were not at risk of an inferior diagnosis. By doing this trial alone, an estimated €3,000 on IHC-use was saved. Such tangible cost savings are crucial to build a viable business case for AI implementation in diagnostic pathology. Citation Format: Carmen van Dooijeweert, Rachel Flach, Natalie ter Hoeve, Celien Vreuls, Roel Goldschmeding, Jan-Erik Freund, Paul Pham, Tri Nguyen, Elsken Van der Wall, Geert Frederix, Nikolas Stathonikos, Paul Van Diest. Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: saving costs and time (the CONFIDENT-B trial) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS03-06.

Comparative evaluation of intensified short course regimen and standard regimen for adults TB meningitis: a protocol for an open label, multi-center, parallel arms, randomized controlled superiority trial (INSHORT trial)

BackgroundDespite several incremental improvements in the management of tuberculous meningitis (TBM), the mortality rates remain high. In spite of national and international guidelines, variation in the choice, dose, and duration of drugs exist between countries and clinicians. We propose to evaluate a shorter and more effective regimen containing agents with augmented intracerebral drug exposure and anti-inflammatory approaches to improve disability-free survival among patients with TBM. Our strategy incorporates the various developments in the field of TBM over the last two decades and only few trials have evaluated a composite of these strategies in the overall outcomes of TBM.MethodsAn open label, parallel arms, randomized controlled superiority trial will be conducted among 372 participants across 6 sites in India. Eligible participants will be randomly allocated in 1:1:1 ratio into one of the three arms. The intervention arm consists of 2 months of high-dose rifampicin (25 mg/kg), moxifloxacin (400 mg), pyrazinamide, isoniazid, aspirin (150 mg), and steroids followed by rifampicin, isoniazid, and pyrazinamide for 4 months. The second intervention arm includes all the drugs as per the first arm except aspirin and the patients in the control arm will receive treatment according to the National TB Elimination Program guidelines. All participants will be followed up for 1 year after the treatment. DiscussionCurrent WHO regimens have agents with poor central nervous system drug exposure and is too long. It does not reflect the accumulating evidence in the field. We propose a comprehensive clinical trial incorporating the emerging evidence accrued over the last two decades to shorten the duration and improve the treatment outcomes. This multi-centric trial may generate crucial evidence with policy and practice implications in the treatment of TBM.Trial registrationClinical Trial Registry India CTRI/2023/05/053314. Registered on 31 May 2023 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODYzMzg=&Enc=&userName=CTRI/2023/05/053314). ClinicalTrials.gov NCT05917340. Registered on 6 August 2023 (https://classic.clinicaltrials.gov/ct2/show/NCT05917340).Protocol versionVersion 1.3 dated 12 July 2023.

Abstract PO5-11-09: Participants’ experience with an online mindfulness-based stress reduction intervention for anxiety management in breast cancer survivors: A secondary analysis of a randomized trial

Abstract Background Breast cancer (BC) diagnosis and treatment can lead to multiple symptoms with a negative impact on the quality of life of survivors. Mindfulness-based stress reduction (MBSR) interventions have shown to improve anxiety, depression, and stress in patients with cancer across multiple settings. However, the effectiveness of an online MBSR program has not been studied. Methods This is an explanatory qualitative sub-study of a randomized trial of an online MBSR intervention versus a waitlist control. Participants were Mexican women aged ≥18 years diagnosed with stage 0-III BC 1-5 years prior to inclusion, not currently undergoing chemotherapy or radiotherapy, with moderate to severe anxiety (baseline GAD-7 score ≥10). The intervention consisted of 8 weekly 2-hour Zoom sessions with body scan meditation and yoga practice led by a certified instructor. Participants received a digital manual with exercises, audio for guided practice, and a video of postures for balance and flexibility. The primary outcome of the trial was anxiety at 2, 5, and 8 months after the intervention. Two focus groups were conducted via Zoom; 21 participants from the intervention arm were selected and invited according to the difference in GAD-7 scores between baseline and 8 months. The first group consisted of 7 participants (median age 53 years, range 39-62) with a decrease in GAD-7 score of ≥4 points (mean -9.1, SD 3.7); the second group consisted of 7 participants (median age 54 years, range 44-64) with a decrease of &amp;lt; 4 points or an increase in GAD-7 score (mean -1.2, SD 1.9). Each focus group was conducted 14 and 9 months after the MBSR intervention, respectively, and had a duration of 110 and 113 minutes, respectively. Audio and video were recorded and transcribed verbatim. Transcripts were analyzed and themes were developed, focusing on participants’ experience with the online intervention and its perceived benefits. Results The weekly sessions and at-home practice functioned as a “personal haven” for participants. At-home deliberate practice and the additional audio and video materials were considered essential for the effectiveness of the intervention. Participants no longer needed to consciously follow step-by-step directions, as the practices had become a part of who they were, even several months after the intervention. Breathing exercises were frequently used by participants on a day- to-day basis. Regarding the mindfulness practice itself, some participants indicated that they noticed positive changes in their character and demeanor, and in their reactions to everyday and BC-related stressors, including situations such as medical consultations and possible news regarding their treatment. In that sense, they mentioned that all they learned is useful for their life in general, and not exclusive to BC survivors. Despite differences in improvement of anxiety by GAD-7 scores between the focus groups, most participants in both groups referred to the intervention as “life-changing”. Most participants in both groups perceived the online format of the intervention as positive: it allowed them to join in from any location and fit the program into their daily routine with less time commitment. Likewise, the privacy of their homes made them feel more comfortable expressing themselves during the weekly sessions. A high level of recognition, appreciation and gratitude towards the instructor was observed. Some participants noted that contact with the instructor and other participants was limited due to the online format, preventing them from forming friendships or a sense of community. Conclusion BC survivors’ opinion of an online MBSR program was largely positive regarding the benefits of the intervention and its delivery format. Moreover, the intervention was successful at facilitating participants’ adoption of mindfulness practice in their daily lives and at improving other aspects of their lives beyond BC. Citation Format: Haydee Cristina Verduzco-Aguirre, Maura Pompa Mansilla, Misael Salazar-Alejo, Javier Gutierrez Ornelas, Fernanda Mesa-Chavez, Ana Ferrigno Guajardo, Cynthia Villarreal-Garza. Participants’ experience with an online mindfulness-based stress reduction intervention for anxiety management in breast cancer survivors: A secondary analysis of a randomized trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-11-09.

Abstract PO1-23-04: The IBRAnet localisation study; a UK National multi-centre cohort study comparing the safety and effectiveness of guidewire, RFID, and magnetic seed- guided localisation for impalpable breast lesions

Abstract Background Wire-guided localisations (WGL) of breast cancers have been the gold-standard for pre-operative localisation of non-palpable breast cancers for many years but have significant limitations. Newer localisation techniques have been introduced including Radio Frequency ID tags (RFID) and magnetic seeds which aim to overcome these limitations. The UK iBRA-net group have designed a multi-centre platform study aiming to compare the safety and effectiveness of wire, RFID, magnetic seeds, and radar-based localisation. A second aim was the qualitative assessment of shared learning as users gained experience. Methods A UK national multi-centre prospective observational platform study was designed to compare a control arm of WGL for women undergoing breast conserving surgery with two interventional arms of RFID tags and magnetic seeds. Patient data were collected between August 2018 and July 2022 in UK centres. The primary outcome was accurate excision of the index lesion at the time of surgery. Secondary outcomes were defined as; resection margins, breast reoperation rate (planned and unplanned), complications, cancellation rate on day of surgery, and duration of the surgery. To account for lesion size in the assessment of excision weight, we used size as a denominator over two dimensions, reporting this as weight/size2, in g/mm2. Data was collected prospectively on a secure REDcap database following approval from local audit departments. To calculate the sample size a power calculation was employed, with n=950 patients per group the upper limit of the observed one-sided 95% confidence interval for the difference between identification rates (intervention vs WGL) is expected to be less than 0.9% with 80% power, assuming the two methods both have an expected identification rate of 99.4%. Simple summary statistics were calculated for each outcome and data were tested for distribution and differences between groups using unpaired t-tests, Mann-Whitney U tests, and Chi squared tests as appropriate. Analyses were conducted using Stata® IC version 14 (StataCorp, College Station, Texas, USA). Results Data were accrued from 3484 patients in 55 units. This included 1293 patients having WGL, 1188 RFID tags, and 1003 magnetic seeds. RFID had a lower rate of identification of the index lesion compared to magnetic seed and wire (97.9% vs. 99.8% vs. 99.1% respectively). When comparing the reasons behind failure of the primary outcome, the majority were not thought to be related to the modality of localisation. Data from 1560 patients with unifocal, unilateral breast lesions were included in subgroup analysis, excluding those having neo-adjuvant chemotherapy and those having therapeutic mammoplasty. Positive margins were lower in RFID excisions compared to wire (11.2% vs. 15% respectively, p&amp;lt; 0.05), whereas magnetic seed were equivalent (11.2 % vs 13.3%, P=0.22). Routine cavity shaves were performed in 64.5% of WGL vs 48.3% of RFID vs 64.3% of magnetic guided excisions. There was no difference in specimen weight/size2 (0.138 WGL vs. 0.131 RFID vs. 0.15 magnetic seed). Re-excision (for positive or close margins) was equivalent across the three groups (13.2% of wire vs 15% of RFID vs 12.3% of magnetic seed guided excisions, p=0.3). There have been four shared learning educational events focussing on three key themes relating to preoperative, intraoperative, and postoperative learning outcomes in addition to 130 database shared learning entries. This may aid other surgeons as they adopt these techniques. Conclusions All three localisation devices demonstrate high levels of localisation accuracy. There was a higher rate of device dislodgement in the RFID group, which was also identified in the shared learning events. However, re-excision rates were equivalent across the three groups. This study has demonstrated a robust platform for the comparative evaluation of new localisation technologies and of sharing learning and experience. Citation Format: Rachel Foster, James Harvey, Rajiv Dave, Anthony Maxwell, Senthurun Mylvaganam, Matthew Gardiner, Sue Down, Nicola Barnes, Mihir Chandarana, Shelley Potter, Yazan Masannat, Chris Holcombe, Tahir Masudi, Amtul Carmichael, Robert Milligan, Jenna Morgan. The IBRAnet localisation study; a UK National multi-centre cohort study comparing the safety and effectiveness of guidewire, RFID, and magnetic seed- guided localisation for impalpable breast lesions [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-23-04.

Abstract PO2-20-01: The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients with HER2+ Metastatic Breast Cancer (TBCRC 062)

Abstract BACKGROUND: Anti-HER2 therapies have transformed the trajectory for patients with HER2-positive (HER2+) MBC. A subset of patients with HER2+ MBC do exceptionally well and remain on maintenance anti-HER2 therapy for many years. However, current therapy is non-curative and patients are treated indefinitely. While these therapies often are well-tolerated, they may cause significant toxicities, are expensive, and typically require frequent infusion and provider visits. Case reports and retrospective series demonstrate that some patients may do well after stopping anti-HER2 treatment. We currently lack prospective data on the likelihood of clinical impact of successful treatment discontinuation, outcomes among patients who progress and restart HER2-directed therapy, and tools to predict who may safely stop therapy. In this study, we will enroll pts with an exceptional response to anti-HER2 therapy. Pts may elect to either continue or stop anti-HER2 therapy and will be followed clinically and radiographically on a protocol-specified schedule. Considering the central role of patients in choosing the study intervention arm, and the unique nature of stopping therapy as a treatment intervention, patient advocates have been deeply involved in the study design to ensure patient concerns are being heard and addressed. We will retrospectively assess minimal residual disease (MRD), measured in plasma, as a biomarker of ongoing response, in a step toward shifting the treatment paradigm for pts with HER2+ MBC. METHODS: STOP-HER2 is a prospective, non-randomized, phase II, multicenter study of either continuation (cohort 1) or cessation (cohort 2) of anti-HER2 therapy in exceptional responders with HER2+ MBC. Eligible patients must have biopsy-proven HER2+ MBC by ASCO/CAP guidelines and must have been receiving first-line anti-HER2 therapy for MBC for at least 3 years without evidence of progressive disease (PD) as determined by the treating investigator. Patients with prior brain-only PD or oligo-PD outside the brain are eligible at least 2 years after local treatment to the central nervous system (CNS) and in absence of subsequent PD. Up to fifty-two participants will be enrolled into cohort 2, and an additional thirty participants enrolled into the cohort 1, at 10 US sites within the Translational Breast Cancer Research Consortium. Co-primary endpoints are the 1-year progression-free survival (PFS) in cohorts 2 and 1, separately. Secondary endpoints include the clinical benefit rate upon re-initiation of anti-HER2 therapy for patients in cohort 2 experiencing PD after treatment discontinuation; and 3-year overall survival in both cohorts. Correlative endpoints include MRD status at baseline and the correlation between MRD dynamics and outcomes. Patient-reported outcomes will be collected and analyzed, including quality of life, illness intrusiveness, financial toxicity, anxiety, and decision regret. The study will use a two-stage design to assess the primary objective of estimating the rate of participants who are free of progression at one year after discontinuing anti-HER2 therapy. If 50% or less are free of progression at one year, stopping HER2 therapy would not be considered a viable treatment plan (null hypothesis). The study is designed to have 80% power to reject the null hypothesis at the 10% type I error rate when 68% of exceptional responders are free of progression at one year after stopping HER2 therapy. STOP-HER2 began enrollment in Q2 2023 (NCT05721248). Citation Format: Heather Parsons, Kathryn Ruddy, Stefania Morganti, Karen Smith, Victoria Attaya, Eliza Kallfelz, Michelle DeMeo, Jamie LaScala, Shirley Mertz, Teri Pollastro, Patricia Spears, Adam Brufsky, Chau Dang, Susan Dent, Ahmed Elkhanany, WIlliam Gwin, Ciara O'Sullivan, Kathy Miller, Sara Nunnery, Elaine Walsh, Anna Maria Storniolo, Sara Tolaney, Nabihah Tayob, Antonio Wolff, Eric Winer, Mothaffar Rimawi, Ian Krop, Nancy Lin. The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients with HER2+ Metastatic Breast Cancer (TBCRC 062) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-20-01.

Abstract PO3-19-02: White Button Mushroom and Biomarkers of Immune Cell and Inflammatory Responses in Obese Postmenopausal Women at High Risk of Breast Cancer

Abstract Background: White Button Mushroom (WBM), Agaricus bisporus, has anti-tumor and anti-inflammatory effects. Oral WBM mitigated the effects of a high fat diet on hepatic steatosis and insulin resistance in ovariectomized mice. A Phase I trial of WBM in men with prostate cancer demonstrated decreased myeloid derived suppressor cells (MDSC) in those with decreased PSA; MDSC have been linked to different cancers, including breast, and conditions of chronic inflammation. Design: This is a preliminary evidence trail in postmenopausal, obese women at high risk of breast cancer with a single intervention arm of 14g of WBM taken as 28 tablets daily for 3 months to assess effects on inflammation. Participants undergo a physical exam, measuring height, weight, and waist circumference, an optional fine needle aspiration (FNA) of breast tissue, a blood draw, a food frequency questionnaire and a 24-hour food recall at baseline and final visits. Participants are contacted monthly for tolerance and adherence. Blood samples and FNA adipose are used for metabolic measurements and processed for biomarkers of inflammation and immune response. Peripheral blood mononuclear cells (PBMC) will be used for RNA single-cell analysis to assess for immune cell profiles and expression with an interest in evaluating MDSC. Red blood cells will be assessed for fatty acid profiles. Eligibility: Postmenopausal, obese (BMI ≥30, Asian ≥25) women with high risk for breast cancer who can swallow pills are eligible. Patients are high risk if their relative risk of breast cancer is ≥2 times that of the general population; this includes women with a strong family history, a genetic mutation associated with hereditary breast cancer, a high-risk breast histology, Gail model 5-year risk &amp;gt;1.67, or a previous history of stage I-II breast cancer. Participants are excluded for an active malignancy within 5 years, ongoing active or preventative cancer treatment, or lab abnormalities of serum creatinine and total bilirubin &amp;gt;1.5 the upper limit of normal, hemoglobin of &amp;lt; 9.0 g/dL, platelets of &amp;lt; 100,000/mm3, or a total white blood cell count of &amp;lt; 3,500/mm3. Participants cannot be taking mushroom supplements, immunosuppressants, or non-steroidal anti-inflammatories. Specific Aims: This study aims to evaluate the effects of WBM on regulating immune response and inflammation in obese women at high risk for breast cancer. Our primary objective is the assessment of PBMC, specifically MDSC immune profiles before and after treatment. Our secondary objective is to evaluate changes in biomarkers of inflammation, immune cell profiles in breast adipose tissue, BMI, waist circumference, and metabolic biomarkers. Additionally, the study aims to assess tolerability of the WBM dose and effects on diet quality. Statistical Methods: 26 patients will provide 80% power to detect a change in %MDSC of -0.67, assuming a standard deviation of 1.15, and a 2-sided type I error of 5%. We will have similar power to evaluate changes in other immune subsets, inflammatory markers, metabolic markers, anthropometric measurements, and diet quality. FNA adipose tissue analysis will be used as a safety signal to evaluate the potential for unwanted inflammation with taking WBM. 13 patients with FNA will provide 80% power to detect a change of 85% of the standard deviation of the difference in the measure of biomarkers such as Interleukin-6 with a 2-sided type I error of 5%. As a safety signal, the signal will be reported without adjustment for multiple comparisons. Any conclusions based on such secondary endpoints will make note of the multiple comparison issue. Accrual: The accrual target is 26 evaluable patients with an estimated need to enroll 31. The study has enrolled 27 patients, 14 completed the study and 5 are currently on treatment. 8 participants were removed; 3 never started treatment, 1 was diagnosed with breast cancer, and 4 had other medical issues preventing continuation. Contact: Jessica Dzubnar, MD: jdzubnar@coh.org Citation Format: Jessica Dzubnar, Lisa Yee, Shiuan Chen. White Button Mushroom and Biomarkers of Immune Cell and Inflammatory Responses in Obese Postmenopausal Women at High Risk of Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-02.

Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial

IntroductionBlinding is a methodologically important aspect in randomised controlled trials yet frequently overlooked in trials of spinal manual therapy interventions for back pain. To help inform the blinding methods of a future, double-placebo-controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain, we set four objectives: (1) to assess the feasibility of blinding participants, randomly allocated to an active or placebo-control spinal manual therapy intervention protocol, (2) to assess the feasibility of blinding outcome assessors within the trial, (3) to explore the influence of spinal manual therapy experience and low back pain on blinding, and (4) to explore factors contributing to perceptions about intervention assignment among participants and outcome assessors.Methods and analysisTwo-parallel-group, single-centre, placebo-controlled, methodological blinding feasibility randomised trial. We will recruit between 60 and 100 adults with or without back pain and with or without experience of spinal manual therapy from Zurich, Switzerland. Participants will be randomised to either an active spinal manual therapy or a placebo-control spinal manual therapy protocol—both interventions delivered over two study visits, up to two weeks apart. The primary outcome is participant blinding using the Bang blinding index within each intervention arm immediately after each of the two study visits. Secondary outcomes are participant blinding using the James blinding index, outcome assessor blinding (Bang and James blinding indices), self-reported factors influencing perceived intervention assignment among participants and outcome assessors, and participant-reported credibility and expectancy of study interventions. Other outcomes—included to blind the study objective from participants—are lumbar spine range of motion, self-rated general health, satisfaction with care, pain intensity, and function. Intervention provider outcomes include intervention component fidelity and quality of intervention delivery.Ethics and disseminationThe independent ethics commission of Canton Zurich granted ethical approval for this study (KEK 2023–00381). Written informed consent will be obtained from all participants. Findings will be disseminated in scientific conferences and a peer-reviewed publication and inform the blinding methods of a future double-placebo controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain—the SALuBRITY trial.Trial registrationNCT05778396.

Crowdsourced Partner Services Among Men Who Have Sex With Men Living With HIV: A Pilot Randomized Controlled Trial in China.

This study aimed to assess the acceptability, feasibility, and preliminary effectiveness of a crowdsourced HIV partner services (PS) intervention among men who have sex with men living with HIV (MLWH) in China. A pilot 2-arm randomized controlled trial was conducted in 3 HIV testing clinics in China. The control arm received conventional HIV PS, whereas the intervention arm received a crowdsourced intervention, including HIV self-testing kits for secondary distribution (HIVST-SD), digital education materials, and assisted PS. The intervention was developed through 2-phase crowdsourcing events including an open call and a Designathon. The primary outcomes were measured by the 3-month follow-up rate (i.e., the proportion of participants who completed the follow-up survey to report HIV PS outcomes 3 months after enrollment) and the frequency of using intervention components (feasibility), index evaluation of intervention components (acceptability), and the proportion of partners getting HIV testing (preliminary effectiveness). The study enrolled 121 newly diagnosed MLWH between July 2021 and May 2022. The 3-month follow-up rates were 93% (75 of 81) and 83% (33 of 40) in the intervention and control arms, respectively. Crowdsourced intervention components demonstrated feasibility, with all indexes using digital educational materials, 23 successfully using HIVST-SD, and 6 employing provider-referral to notify 9 sexual partners. Acceptability was high, with HIVST-SD and digital educational materials rated 4.4 and 4.1 out of 5. The proportion of partners receiving HIV testing was 11% higher in the intervention arm than in the control arm (marginal significance with 95% confidence interval, -2% to 24%; 38% vs. 27%). The crowdsourced HIV PS intervention was acceptable and feasible, suggesting the potential to facilitate partner HIV testing among Chinese MLWH. Further implementation research is recommended to expand HIV PS among key populations in low- and middle-income countries. NCT04971967 (Protocol ID: 19-0496).