Creating a best practice template for participant communication plans in global health clinical studies

Background Clinical trial participants have a right to be informed throughout the entire process of human subject research. As part of this pillar of research ethics, participants and other stakeholders should be made aware of research findings after a trial has been completed. Though participants have both a right, and a desire to be informed of research outcomes, studies show that they rarely receive communication about study findings. Our aim was (1) to understand what, if any, role communication plans play in current global health clinical research protocols and (2) to use our findings to develop a communication plan template tailored to clinical research carried out in low-and-middle-income countries (LMIC) while minimizing colonial assumptions. While the template was drafted in the LMIC context, the principles are universally applicable and should be considered best practices for all global health clinical trials. Methods We carried out a mixed-method study over a period of 6 months to understand the role of communication with study participants and other stakeholders in clinical trials. The semiquantitative analysis included mining publicly available clinical trial protocols for communication-related language. Qualitative interviews (n = 7) were used to gather knowledge and insight from clinical trial experts to inform the development of a communication plan template. Results None of the 48 mined clinical trial protocols included a communication plan. Of the 48, 21% (n = 21) protocols included communication-related language, and 10% (n = 5) described plans to share trial results with participants. Conclusion The use of communication plans in global health clinical trials is lacking. To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We recommend that researchers utilize the developed communication plan template throughout the entire research process to ensure a human-centered approach to participant communication. This communication plan should apply to all phases of a research trial, with a particular emphasis on plans to share results in an accessible and engaging manner once the trial has been completed

Machine learning uncovers the most robust self-report predictors of relationship quality across 43 longitudinal couples studies

Given the powerful implications of relationship quality for health and well-being, a central mission of relationship science is explaining why some romantic relationships thrive more than others. This large-scale project used machine learning (i.e., Random Forests) to 1) quantify the extent to which relationship quality is predictable and 2) identify which constructs reliably predict relationship quality. Across 43 dyadic longitudinal datasets from 29 laboratories, the top relationship-specific predictors of relationship quality were perceived-partner commitment, appreciation, sexual satisfaction, perceived-partner satisfaction, and conflict. The top individual-difference predictors were life satisfaction, negative affect, depression, attachment avoidance, and attachment anxiety. Overall, relationship-specific variables predicted up to 45% of variance at baseline, and up to 18% of variance at the end of each study. Individual differences also performed well (21% and 12%, respectively). Actor-reported variables (i.e., own relationship-specific and individual-difference variables) predicted two to four times more variance than partner-reported variables (i.e., the partner’s ratings on those variables). Importantly, individual differences and partner reports had no predictive effects beyond actor-reported relationship-specific variables alone. These findings imply that the sum of all individual differences and partner experiences exert their influence on relationship quality via a person’s own relationship-specific experiences, and effects due to moderation by individual differences and moderation by partner-reports may be quite small. Finally, relationship-quality change (i.e., increases or decreases in relationship quality over the course of a study) was largely unpredictable from any combination of self-report variables. This collective effort should guide future models of relationships

Setting the Standard for Challenge: Teaching English in Dimen, China

Travelling from Hong Kong to Dimen, China, requires a full day. The journey begins with a metro and high-speed train ride to a modern airport in the booming manufacturing center of Guangzhou. From there an Embraer jet shoots through oversized cumulus clouds and lands on the single runway at the Liping airport in Guizhou Province. A van navigates miles of bumpy switchbacks and finally arrives at the gateway to the 300-year-old village of Dimen and to the lives of the Dong ethnic minority. A few hundred wooden buildings line the river banks and then crawl up hillsides carpeted with bamboo, cascading rice paddies, and pine forests. From sunup to sundown, seven days a week, people young and old traverse the winding streets on foot, bicycle, ox-drawn cart, and motorcycle. They are on their way to shop, attend school, fish, or cultivate their rice or vegetable fields. The afternoon might bring a mahjong match, a swim in the river, or a chance to chat with friends in a drum tower or on a bridge. Many then return to the fields. Students in University of the Pacific’s Powell Scholars Program came to this “village on the edge of time,” as the writer Amy Tan has described it, to teach elementary school children. In return they gained a rare glimpse of a place and its people that are simultaneously a part of, and apart from, China’s transformation

sj-docx-1-cjo-10.1177_00084174221129941 - Supplemental material for Integrated Occupational Therapy Camp for Children with Regulation/Sensory Processing Differences: Preliminary Evaluation

Supplemental material, sj-docx-1-cjo-10.1177_00084174221129941 for Integrated Occupational Therapy Camp for Children with Regulation/Sensory Processing Differences: Preliminary Evaluation by Tracy M. Stackhouse, Hannah K. Burke, Colleen G. Hacker, Lynette M. Burke, Caroline E. Hui, Beth Osten and Shelly J. Lane in Canadian Journal of Occupational Therapy</p

One-Unit versus Two-Unit Cord-Blood Transplantation for Hematologic Cancers

BackgroundUmbilical-cord blood has been used as the source of hematopoietic stem cells in an estimated 30,000 transplants. The limited number of hematopoietic cells in a single cord-blood unit prevents its use in recipients with larger body mass and results in delayed hematopoietic recovery and higher mortality. Therefore, we hypothesized that the greater numbers of hematopoietic cells in two units of cord blood would be associated with improved outcomes after transplantation.MethodsBetween December 1, 2006, and February 24, 2012, a total of 224 patients 1 to 21 years of age with hematologic cancer were randomly assigned to undergo double-unit (111 patients) or single-unit (113 patients) cord-blood transplantation after a uniform myeloablative conditioning regimen and immunoprophylaxis for graft-versus-host disease (GVHD). The primary end point was 1-year overall survival.ResultsTreatment groups were matched for age, sex, self-reported race (white vs. nonwhite), performance status, degree of donor-recipient HLA matching, and disease type and status at transplantation. The 1-year overall survival rate was 65% (95% confidence interval [CI], 56 to 74) and 73% (95% CI, 63 to 80) among recipients of double and single cord-blood units, respectively (P=0.17). Similar outcomes in the two groups were also observed with respect to the rates of disease-free survival, neutrophil recovery, transplantation-related death, relapse, infections, immunologic reconstitution, and grade II-IV acute GVHD. However, improved platelet recovery and lower incidences of grade III and IV acute and extensive chronic GVHD were observed among recipients of a single cord-blood unit.ConclusionsWe found that among children and adolescents with hematologic cancer, survival rates were similar after single-unit and double-unit cord-blood transplantation; however, a single-unit cord-blood transplant was associated with better platelet recovery and a lower risk of GVHD. (Funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute; ClinicalTrials.gov number, NCT00412360.)

One-Unit versus Two-Unit Cord-Blood Transplantation for Hematologic Cancers

BACKGROUND: Umbilical-cord blood has been used as the source of hematopoietic stem cells in an estimated 30,000 transplants. The limited number of hematopoietic cells in a single cord-blood unit prevents its use in recipients with larger body mass and results in delayed hematopoietic recovery and higher mortality. Therefore, we hypothesized that the greater numbers of hematopoietic cells in two units of cord blood would be associated with improved outcomes after transplantation. METHODS: Between December 1, 2006, and February 24, 2012, a total of 224 patients 1 to 21 years of age with hematologic cancer were randomly assigned to undergo double-unit (111 patients) or single-unit (113 patients) cord-blood transplantation after a uniform myeloablative conditioning regimen and immunoprophylaxis for graft-versus-host disease (GVHD). The primary end point was 1-year overall survival. RESULTS: Treatment groups were matched for age, sex, self-reported race (white vs. nonwhite), performance status, degree of donor–recipient HLA matching, and disease type and status at transplantation. The 1-year overall survival rate was 65% (95% confidence interval [CI], 56 to 74) and 73% (95% CI, 63 to 80) among recipients of double and single cord-blood units, respectively (P = 0.17). Similar outcomes in the two groups were also observed with respect to the rates of disease-free survival, neutrophil recovery, transplantation-related death, relapse, infections, immunologic reconstitution, and grade II–IV acute GVHD. However, improved platelet recovery and lower incidences of grade III and IV acute and extensive chronic GVHD were observed among recipients of a single cord-blood unit. CONCLUSIONS: We found that among children and adolescents with hematologic cancer, survival rates were similar after single-unit and double-unit cord-blood transplantation; however, a single-unit cord-blood transplant was associated with better platelet recovery and a lower risk of GVHD

Synthesis of a Tris(phosphaalkene)phosphine Ligand and Fundamental Organometallic Reactions on Its Sterically Shielded Metal Complexes

A new tris­(phosphaalkene)­phosphine ligand (<b>1</b>) was synthesized via phospha-Wittig methodology. Metalation of <b>1</b> with [RhCl­(C₂H₄)₂]₂ and [IrCl­(COE)₂]₂ (COE = cyclooctene) produced trigonal bipyramidal metal chlorides <b>2a</b> (M = Rh) and <b>2b</b> (M = Ir) in which the ligand coordinates in a tetradentate fashion. X-ray crystallographic studies on <b>1</b>·1.5THF, <b>2a</b>·5CHCl₃, and <b>2b</b>·2.5CHCl₃ combined with DFT calculations revealed a pronounced change in hybridization of the phosphaalkene phosphorus atoms upon coordination to the Rh/Ir centers, resulting in highly sterically congested metal complexes. Nucleophilic substitution on <b>2a</b> with NaN₃ afforded Rh–N₃ complex <b>3</b>; computational analysis, IR spectroscopy, and ¹⁵N­{¹H} NMR spectroscopy on isotopologue ^<b>15</b><b>N-3</b> provided additional structural insights. Halide abstraction of the chloride in <b>2b</b> with AgOTf in the presence of acetonitrile afforded cationic Ir–NCMe complex <b>4</b>. Evidence of the bound acetonitrile unit was obtained by 2D NMR spectroscopy and deuterium labeling studies