Variations of a group coaching intervention to support early-career biomedical researchers in Grant proposal development: a pragmatic, four-arm, group-randomized trial

Background Funded grant proposals provide biomedical researchers with the resources needed to build their research programs, support trainees, and advance public health. Studies using National Institutes of Health (NIH) data have found that investigators from underrepresented groups in the biomedical workforce are awarded NIH research grants at disproportionately lower rates. Grant writing training initiatives are available, but there is a dearth of rigorous research to determine the effectiveness of such interventions and to discern their essential features. Methods This 2 × 2, unblinded, group-randomized study compares the effectiveness of variations of an NIH-focused, grant writing, group coaching intervention for biomedical postdoctoral fellows and early-career faculty. The key study outcomes are proposal submission rates and funding rates. Participants, drawn from across the United States, are enrolled as dyads with a self-selected scientific advisor in their content area, then placed into coaching groups led by senior NIH-funded investigators who are trained in the intervention’s coaching practices. Target enrollment is 72 coaching groups of 4–5 dyads each. Groups are randomized to one of four intervention arms that differ on two factors: [1] duration of coaching support (regular dose = 5 months of group coaching, versus extended dose = regular dose plus an additional 18 months of one-on-one coaching); and [2] mode of engaging scientific advisors with the regular dose group coaching process (unstructured versus structured engagement). Intervention variations were informed by programs previously offered by the NIH National Research Mentoring Network. Participant data are collected via written surveys (baseline and 6, 12, 18, and 24 months after start of the regular dose) and semi-structured interviews (end of regular dose and 24 months). Quantitative analyses will be intention-to-treat, using a 2-sided test of equality of the effects of each factor. An inductive, constant comparison analysis of interview transcripts will be used to identify contextual factors -- associated with individual participants, their engagement with the coaching intervention, and their institutional setting – that influence intervention effectiveness. Discussion Results of this study will provide an empirical basis for a readily translatable coaching approach to supporting the essential grant writing activities of faculty, fellows, and other research trainees, including those from underrepresented groups.

Influential methods reports for group-randomized trials and related designs

Background. This article identifies the most influential methods reports for group-randomized trials and related designs published through 2020. Many interventions are delivered to participants in real or virtual groups or in groups defined by a shared interventionist so that there is an expectation for positive correlation among observations taken on participants in the same group. These interventions are typically evaluated using a group- or cluster-randomized trial, an individually randomized group treatment trial, or a stepped wedge group- or cluster-randomized trial. These trials face methodological issues beyond those encountered in the more familiar individually randomized controlled trial. Methods. PubMed was searched to identify candidate methods reports; that search was supplemented by reports known to the author. Candidate reports were reviewed by the author to include only those focused on the designs of interest. Citation counts and the relative citation ratio, a new bibliometric tool developed at the National Institutes of Health, were used to identify influential reports. The relative citation ratio measures influence at the article level by comparing the citation rate of the reference article to the citation rates of the articles cited by other articles that also cite the reference article. Results. In total, 1043 reports were identified that were published through 2020. However, 55 were deemed to be the most influential based on their relative citation ratio or their citation count using criteria specific to each of the three designs, with 32 group-randomized trial reports, 7 individually randomized group treatment trial reports, and 16 stepped wedge group-randomized trial reports. Many of the influential reports were early publications that drew attention to the issues that distinguish these designs from the more familiar individually randomized controlled trial. Others were textbooks that covered a wide range of issues for these designs. Others were “first reports” on analytic methods appropriate for a specific type of data (e.g. binary data, ordinal data), for features commonly encountered in these studies (e.g. unequal cluster size, attrition), or for important variations in study design (e.g. repeated measures, cohort versus cross-section). Many presented methods for sample size calculations. Others described how these designs could be applied to a new area (e.g. dissemination and implementation research). Among the reports with the highest relative citation ratios were the CONSORT statements for each design. Conclusions. Collectively, the influential reports address topics of great interest to investigators who might consider using one of these designs and need guidance on selecting the most appropriate design for their research question and on the best methods for design, analysis, and sample size.

Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial

Background Completion rates among adolescents who initiate the human papillomavirus (HPV) vaccine 3-dose series are low. SMS text message vaccine reminders are effective, but less is known about the best types for HPV series completion or the ability to assess and target vaccine decision-making stage. Objective The aim of this study is to compare the effectiveness of HPV vaccine series completion in minority adolescents who received precision and educational versus conventional SMS text message reminders. Methods Enrolled parents of adolescents aged 9-17 years who received the first HPV vaccine dose at 1 of the 4 academic-affiliated community health clinics in New York City were randomized 1:1 to 1 of the 2 parallel, unblinded arms: precision SMS text messages (which included stage-targeted educational information, next dose due date, and site-specific walk-in hours) or conventional SMS text messages without educational information. Randomization was stratified according to gender, age, and language. The primary outcome was series completion within 12 months. In post hoc analysis, enrollees were compared with concurrent nonenrollees and historical controls. Results Overall, 956 parents were enrolled in the study. The precision (475 families) and conventional (481 families) SMS text message arms had similarly high series completion rates (344/475, 72.4% vs 364/481, 75.7%). A total of 42 days after the first dose, two-thirds of families, not initially in the preparation stage, moved to preparation or vaccinated stage. Those in either SMS text message arm had significantly higher completion rates than nonenrollees (708/1503, 47.1% vs 679/1503, 45.17%; P<.001). Even after removing those needing only 2 HPV doses, adolescents receiving any SMS text messages had higher completion rates than historical controls (337/2823, 11.93% vs 981/2823, 34.75%; P<.001). A population-wide effect was seen from 2014 to 2016, above historical trends. Conclusions SMS text message reminders led to timely HPV vaccine series completion in a low-income, urban, minority study population and also led to population-wide effects. Educational information did not provide an added benefit to this population. Trial Registration ClinicalTrials.gov NCT02236273; https://clinicaltrials.gov/ct2/show/NCT02236273

Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer

Background Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer. Methods Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes. Discussion Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT. Trial registration ClinicalTrials.gov NCT03741335. Registered on November 18, 2018.

Exercise in the Park or Gym? The Physiological and Mental Responses of Obese People Walking in Different Settings at Different Speeds: A Parallel Group Randomized Trial

Evidence shows that physical activity has multiple health benefits for the body and mind of oneself, but little is known about the impacts of the setting and the intensity on exercise experience, especially for obese people. This study investigated the physiological and psychological effects of four walking conditions with different settings (park vs. gym) and intensity (slow vs. fast) on young obese adults. Subjects were 18–21 years old Chinese university students (N = 77), who were diagnosed as obese. They were randomly assigned to participate in one of the four activities in the field: slow walk in the park (2.8 km/h), fast walk in the park (5.5 km/h), slow walk in the gym, and fast walk in the gym. Physiological indices, including blood pressure and heart rate, were measured before and after the walk. Psychological responses were measured by the Symbol Digit Modalities Test, the mood states scale, and the semantic differential scale. This study of obese people aged 18–21 years confirmed the previous findings that exercising in natural environments better relieved stress and restored attentional level than indoor activities. The results suggested that the mood states of the participants and their environmental perceptions may be influenced by the walking conditions with different setting and speed. The findings can be used in planning and designing urban green spaces for promoting physical activity and making exercise plans for obese people.

Remote Relaxation and Acceptance Training for the Management of Stress in Cancer Patients: A Study Protocol

Background: Cancer patients are now facing a double distinctive challenge of survival against both the disease and fear of contracting COVID-19. This challenge has resulted in the forced adoption of social distancing measures and reorganization of the delivery of medical and psychological treatments. The perceived loneliness and uncertainty increased distress and symptoms burden. In the current period, eHealth interventions might provide valuable benefits in the field of cancer care.Objective: The overall goal of the study protocol will be to provide an innovative intervention for cancer patients based on an online platform, to help them manage and prevent psychological problems related to social isolation. Specifically, the efficacy of two web-based interventions aimed at lowering stress in cancer patients will be tested and compared.Methods: One hundred and fifty participants (75 per group) will be enrolled in a two-group randomized trial. The two interventions will be composed either by exercises on relaxation and meditation practices, presented in both automated online content and interactive group sessions or by fixed psychoeducational online content. Stress, anxiety, and depressive symptoms, distress, resilience, and perceived social isolation will be measured before the start of the interventions (T0), 2 weeks (T1), 4 weeks (T2), and 2 months (T3) after the beginning of the interventions in both groups. A repeated measures ANOVA will be performed to test differences in the questionnaires' scores between groups across the four-time points.Expected Results: We hypothesized greater improvement in the specific domain of stress symptoms (IES-R) assessed in the group receiving the interactive intervention, compared to the group which will receive only fully automated psychoeducational content. Secondarily, we expect the same trend of improvement across all the psychological variables in the blended intervention group.Conclusions: Implementing these practices on people who are forced into mandatory social isolation may help them become more aware of their mind-body condition and reduce negative effects. Moreover, relaxation techniques help individuals in achieving a greater state of well-being, increasing the ability to cope with stressful situations (resilience), and strengthening the immune system.

Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer

Background Most cancer survivors are married, and cancer strains the physical and mental health of each partner and their intimate relationship. We created a partnered strength training program, Exercising Together©, where the survivor and his/her partner exercise as a team in order to improve physical and mental health of both members of the couple as well as the quality of their relationship. We have not yet determined if Exercising Together© is similarly effective in couples coping with different types of cancer nor if training as a team has unique and added benefits over those derived from supervised group training and/or shared behavior change. The purpose of this study is to determine the unique benefits of Exercising Together© on physical, mental, and relational health in couples coping with breast, prostate, or colorectal cancer. Methods Survivors of prostate, breast and colorectal cancer (N = 294, 98 per cancer site) and their intimate, co-residing partners are recruited to participate in a single-blind, parallel group, randomized trial comparing three exercise groups that train twice per week for 6 months. Couples are randomized to one of three groups: (1) Exercising Together© where partners train as a team in a supervised group setting; (2) separate supervised group exercise classes for survivors or partners, respectively; (3) unsupervised home exercise program provided to each partner. The primary outcome is relationship quality (dyadic coping by the Dyadic Coping scale, emotional intimacy by the Dyadic Adjustment Scale, physical intimacy by the Physical Intimacy Behavior Scale, and symptom incongruence). Secondary outcomes are physical health (% body fat by DXA, serum fasting lipids (triglycerides, HDL, and LDL cholesterol), insulin resistance (HOMA-IR), resting blood pressure, C-reactive protein, TNF alpha, and physical functioning by the short Physical Performance Battery and SF-36) and mental health (depressive symptoms, anxiety, fear of recurrence) of each partner. Outcomes are collected at baseline, mid (3 months), post-intervention (6 months), and follow-up (12 months). Discussion Exercising Together© could shift the paradigm of survivorship care toward novel couple-based approaches that could optimize outcomes for each partner because their health is interdependent on each other and their relationship. Trial registration ClinicalTrials.govNCT03630354. Registered August 14, 2018

Effect of Nucart VG (Boswellia serrata in combination with veg glucosamine sulphate) in comparison with glucosamine sulphate to improve quality of life of knee osteoarthritis patients: a randomized controlled trial

<p class="abstract"><strong>Background:</strong> <em>Boswellia serrata</em> has been proved to be an effective and safe herb for the treatment of osteoarthritis (OA). This study aims at assessing the synergistic effect of this herb with vegetarian glucosamine sulphate, a nutritional supplement, on knee osteoarthritis using quality of life indicators.</p><p class="abstract"><strong>Methods:</strong> This<strong> </strong>was an open label, parallel group randomized trial of 12-week duration. Sixty-six subjects were equally randomized to two treatment arms: <em>Boswellia serrata</em> extract (600 mg) and glucosamine (750 mg) [Nucart VG]; and glucosamine sulphate (market comparator) 750 mg. Patients were administered 1 tablet twice-a-day post-meal for three months. Efficacy of treatment was measured on primary end-points like EuroQol-5D (EQ-5D) (health status indicator), visual analogue scale (VAS) and Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scale (pain indicators), while safety was measured in terms of vital parameters. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed for comparing scores between the two groups.<strong></strong></p><p class="abstract"><strong>Results:</strong> The baseline characteristics of patients between two groups were insignificantly different (p&gt;0.05). In ITT analysis, the health status (EQ-5D score) of patients in Nucart VG group improved significantly than the comparator group at follow up 2 (p=0.037) and showed further improvement at follow up 3 (p=0.012). The pain indicators i.e. VAS and WOMAC scores were significantly lower in Nucart VG group right from follow up 1 till follow up 3 (p&lt;0.05). Similar were the observations during PP analysis.</p><p class="abstract"><strong>Conclusions:</strong> Nucart VG is beneficial for the treatment of mild to moderate knee OA, as inferred from the functional and health status assessment.</p>