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2.1. Study Design | obesity | OBESITY | An 8-month two-arm randomized pilot trial was conducted. Sixty African American women with obesity were assigned to receive the | PMC9859082 |
2.2. Participants | obesity | OBESITY | Participants included 60 insufficiently active AA women with obesity aged 24–49 years. Specific inclusion criteria included: (a) self-identifying as an AA woman; (b) being between the ages 24 and 49 years; (c) having a BMI ≥ 30 kg·m | PMC9859082 |
2.4. Cultural Tailoring of the Intervention | Cultural tailoring was achieved through a comprehensives synthesis of the literature [ | PMC9859082 |
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2.5. Description of the Smart Health Attention-Matched Wellness Comparison Intervention | Women assigned to the smartphone-delivered attention-matched wellness comparison condition received a surface-level culturally tailored health promotion intervention, entitled | PMC9859082 |
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2.6. Measures | PMC9859082 |
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2.6.1. Demographic Characteristics | Demographic characteristics (i.e., age, income, relationship status) were collected using a survey developed for the current study. | PMC9859082 |
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2.6.5. Social Cognitive Theory Outcomes | Social Cognitive Theory constructs targeted by the intervention were assessed using previously published and validated surveys, described elsewhere [ | PMC9859082 |
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2.7. Protocol | EVENTS, RECRUITMENT | Community-based strategies (i.e., email listservs, social media advertisements, in-person recruitment at community events) were used to recruit study participants. Interested individuals contacted the research team and were assessed for eligibility via a telephone interview or by completing an online eligibility screening survey. Eligible individuals were invited to attend an in-person orientation session to obtain more information about the study. At the orientation session, a trained member research team (i.e., either the study coordinator or research assistant) provided an in-depth description of all study activities, including information about the topical areas of both study arms, expectations associated with participation, study assessment procedures, and incentives for participation. At the conclusion of the orientation, written informed consent was obtained from women interested in enrolling in the study. Next, participants were given an ActiGraph GTX9 Link accelerometer to wear for 7 days. After this 7-day wear period, participants returned the accelerometer and completed an in-person study assessment where anthropometric, survey, and physiological data were collected. Participants were then randomized by the study statistician in a 1:1 allocation ratio. to receive either the | PMC9859082 |
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2.8. Statistical Design | PMC9859082 |
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2.8.1. Sample Size Considerations | The primary aim of this study was to examine acceptability and feasibility of the intervention, rather than to formally test the intervention’s efficacy. Accordingly, the choice of sample size was selected primarily to allow for testing and refinement of protocols and procedures (Aim 1), informal examination of between-arm differences in patterns of change (Aim 2), and estimation of variability in outcomes to be used in planning a subsequent fully powered efficacy trial. We selected our sample size (N = 60 total participants; n = 30 allocated to each arm) that, based on our previous work [ | PMC9859082 |
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2.8.2. Statistical Analyses | Univariate descriptive statistics (means, standard deviations, percentages, frequencies) were used to summarize demographic characteristics, To mitigate bias and the loss of statistical power due to attrition, we analyzed datasets created using multiple imputation (MI). We used a fully conditional specified imputation model for each outcome to generate 150 imputed datasets in Blimp [All analytic models were estimated in R [ | PMC9859082 |
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3. Results | PMC9859082 |
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3.1. Participant Characteristics | Participants (n = 60) had a mean age of 38.4 ( | PMC9859082 |
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3.2. Feasibility and Acceptability | PMC9859082 |
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3.3. Physical Activity | The intervention group demonstrated substantially greater increases in self-reported minutes/week of MVPA compared to the comparison group at both the 4-month (model-estimated between-arm difference in change [b ± SE(b)] = 43.3 ± 17.7 min/week, With respect to meeting national PA guidelines, at the 4-month follow-up, 6 of 24 (25%) intervention group participants, and 3 of 27 (11%) comparison group participants self-reported engaging in ≥150 min/week of MVPA (odds ratio [ | PMC9859082 |
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3.4. Cardiometabolic Risk Markers | Cardiometabolic risk outcomes are presented in | PMC9859082 |
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3.5. Social Cognitive Theory Outcomes | As illustrated in | PMC9859082 |
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4. Discussion | cardiometabolic disease | The current study examined the acceptability and feasibility of a smartphone-delivered PA intervention for AA women and explored between-group differences for patterns of change in cardiometabolic disease risk outcomes and hypothesized theoretical mediators. Overall, results for the feasibility and acceptability of the intervention were favorable, while also affording insight into how the intervention could be refined prior to implementation of a fully powered RCT. Observed patterns of change in self-reported MVPA and several cardiometabolic disease outcomes, including cardiorespiratory fitness and blood pressure, further demonstrate the promise of our smartphone-delivered PA intervention. These encouraging findings make an important contribution to the limited body of research examining the utility of mHealth approaches in increasing PA and improving cardiometabolic health among AA women. | PMC9859082 |
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4.1. Feasibility and Acceptability | RECRUITMENT, RECRUITMENT | Feasibility and acceptability of the intervention were supported by numerous indices, including participant recruitment and retention, results of the post-intervention satisfaction survey, and app use. Recruitment efforts yielded an enrollment rate of 7.5 women/month. Although comparison of this enrollment rate to other studies has limited utility due to the heterogeneity that exists across studies in regards to study populations, implementation settings, recruitment methods, and inclusion/exclusion criteria, this rate will be used to develop recruitment timelines for future intervention trials of the Participants expressed a high level of satisfaction for the multi-media modules, text message, and Fitbit components of the mHealth intervention, as well as for the intervention as a whole, with all participants who completed the intervention indicating they would recommend the smartphone-delivered PA intervention to a friend. These satisfaction results mirror those of an earlier iteration of the structured PA intervention (i.e., delivered through Facebook and text messages) [App use and Fitbit wear data revealed that engagement was high during the initial weeks of the intervention, but declined gradually over the course of the intervention. Although decreased engagement over time is commonly reported in e- and mHealth interventions [ | PMC9859082 |
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4.2. Physical Activity and Cardiometabolic Disease Risk Outcomes | weight loss, arterial stiffness | EVENTS, ARTERIAL STIFFNESS | Intervention participants self-reported greater MVPA increases than comparison group participants at both post-intervention assessments. Changes in self-reported energy expenditure followed a similar pattern. Self-reported MVPA changes from baseline to 4 months are comparable to improvements observed in a previous e- and mHealth PA intervention with AA women [Meaningful, though not statistically significant, improvements in cardiorespiratory fitness and blood pressure were observed among intervention participants. The descriptive increase in fitness among PA intervention participants (increase of 1.1 mL/kg/min vs. a decrease of 0.8 mL/kg/min in comparison group) corresponds to a 7–13% decrease in risk for premature mortality [Observed patterns of change for aortic pulse wave velocity, a measure of arterial stiffness and independent predictor of cardiovascular events and mortality [BMI was unchanged throughout the intervention. This outcome was not surprising, as weight loss from PA alone requires participants to engage in substantially more MVPA than levels promoted by the study (i.e., >225 min/week) [ | PMC9859082 |
4.3. Psychosocial Outcomes | Substantially greater improvement in behavioral capability for PA for intervention participants suggests that the intervention curriculum was successful in enhancing knowledge of national PA guidelines, the types of activities that constitute aerobic PA, and the health benefits of aerobic PA. We also observed small-to-moderate, albeit not statistically significant, baseline to 4-month increases in self-efficacy and self-regulation among intervention participants relative to comparison group participants. While promising, these finding highlight the need to further enhance the theoretical fidelity [ | PMC9859082 |
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4.4. Limitations, Strengths, and Future Directions | PA behaviors | RECRUITMENT, BLIND | The study’s findings are encouraging, but it is important to recognize potential limitations. The primary focus for this stage of intervention development was on feasibility and acceptability of the smartphone-delivered intervention, rather than efficacy testing. Accordingly, when interpreting PA, cardiometabolic, and psychosocial outcomes, we focused on examining magnitudes of effect, rather than statistical significance. Results for these outcomes (and our subsequent discussion of them) should be interpreted as suggestive, rather than definitive. Additionally, the multi-component nature of the intervention limits our ability to determine if one component of the intervention may have been more strongly related to changes in PA behavior than another. To properly address this type of question, a design that can examine component-specific effects is needed (e.g., factorial or multiphase optimization strategy [MOST] designs). A third limitation was that although efforts were made to blind research technicians conducting cardiorespiratory fitness tests to participants’ study group allocation at 4- and 8-month follow-up assessments, this was not always possible. Standardized testing procedures were used to limit this potential bias. Other limitations include recruiting participants from single geographical area (i.e., Phoenix, Arizona), using community-based recruitment methods, and providing compensation for participation (although this compensation was nominal compared to study time commitments). These considerations may limit generalizing results to AA women outside of the Phoenix metropolitan area and likely reflect a sample with increased motivation to adopt healthy lifestyle behaviors. Finally, restrictions on data collection related to the COVID-19 pandemic had serious impacts on conclusions that could be drawn from analyses of several 8-month outcomes. The lack of 8-month physiological study assessments for approximately 1/3 of our sample resulted in untrustworthy estimates from analyses of multiply imputed datasets, limiting us to complete-case analyses of cardiometabolic outcomes at 8 months. These restrictions also likely influenced PA behaviors and psychosocial outcomes among participants who were completing the study during the early stages of the pandemic.Despite limitations, numerous strengths of the study should also be noted. This is one of the first studies to examine the effects of a culturally tailored smartphone-delivered PA intervention among AA women, research necessary to advance e- and mHealth research on PA promotion. Second, we addressed several design limitations of previous studies [Future directions for this program of research include refining the | PMC9859082 |
5. Conclusions | obesity, cardiometabolic disease | OBESITY | This study demonstrated high acceptability and feasibility, and yielded promising findings regarding the intervention’s associations with increased PA and reduced cardiometabolic disease risk among insufficiently active AA women with obesity. | PMC9859082 |
Author Contributions | Conceptualization R.P.J., B.E.A., C.K. and M.A.A.; Supervision, R.P.J., Formal Analysis M.T.; Software, K.H.; Funding Acquisition, R.P.J., M.T., B.E.A., S.V.-L., M.A.A., G.A.G. and C.K.; Writing—orgininal draft, R.P.J.; Writing—review and editing, S.P.H. All authors have read and agreed to the published version of the manuscript. | PMC9859082 |
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Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of Arizona State University (STUDY00006163; Approved 4-24-2017). | PMC9859082 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9859082 |
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Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC9859082 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC9859082 |
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Purpose | ANTERIOR | Wii Fit exergames have been less commonly used for the rehabilitation of athletes after Anterior Cruciate Ligament Reconstruction (ACLR). This study aims to investigate the effects of an expert system using Wii Fit exergames compared to conventional rehabilitation following ACLR. A forward-chaining rule-based expert system was developed which proposed a rehabilitation program that included the number and type of exercise in terms of difficulty and ease and the duration of each exercise in a progressive manner according to the patient's physical condition. | PMC10386671 |
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Materials and methods | Twenty eligible athletes aged 20–30 who underwent ACLR were enrolled in this study and randomly assigned to two groups; and received 12 sessions of either Wii Fit exergames as Wii group ( | PMC10386671 |
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Results | knee flexion range, TG, knee effusion, pain | The main outcomes consisted of pain (Visual Analogue Scale (VAS)), knee effusion, knee flexion range (KFR), thigh girth (TG), single-leg hop for distance (SLHD), and for time (SLHT), static and dynamic balance tests. Both groups had considerable improvement in all outcomes, also there were significantly differences between Wii and CL groups as follows; VAS ( | PMC10386671 |
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Conclusions | post-ACLR, effusion, pain | EFFUSION | The findings showed that using Wii Fit exergames in post-ACLR patients reduced pain and effusion while also improving function and balance significantly. Iranian Registry of Clinical Trials registration number is IRCT20191013045090N1, and the registration date is 03-03-2020. | PMC10386671 |
Keywords | PMC10386671 |
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Introduction | knee flexion, knee effusion, pain | ANTERIOR | Anterior Cruciate Ligament (ACL) plays a crucial role in proper knee function and stability [Wii Fit™ is an exergaming video game released by Nintendo Wii™(Nintendo Co Ltd, Kyoto, Japan) with 48 exergames [The Nintendo Wii Balance Board (NWBB) is a unique accessory for the Wii console designed to train and also evaluate the center of balance [In the review of the use of NWBB in ACL rehabilitation, Karakoc et al. found no significant differences in pain, functionality, and balance between Wii Fit and control groups [Expert System (ES) has recently been introduced in rehabilitation with the capacity to replace the specialist. ES is used to solve problems with explicit knowledge but without any special algorithm [This research has focused on developing an ES for providing a rehabilitation program using NWBB exergames compared to the conventional rehabilitation on balance and physical function of ACL-reconstructed athletes.In summary, this study aims to develop an expert system (ES) for ACL rehabilitation using the Nintendo Wii Balance Board (NWBB) exergames and compare its effectiveness with conventional rehabilitation methods on ACL-reconstructed athletes' balance and physical function. The current literature suggests that the use of NWBB without an ES may not result in significant differences in rehabilitation outcomes compared to conventional methods. This study's original and innovative aspect is the development of an ES for ACL rehabilitation using NWBB exergames, which has not been extensively studied in physiotherapy. The study will enroll 20 ACL-reconstructed athletes, randomly assigned into two groups, one using the ES-based Wii Fit exergames program and the other using conventional rehabilitation. The study's outcomes will include pain, knee effusion, knee flexion range, thigh circumference, and single-leg hop for distance and time, as well as static and dynamic balance tests. The results of this study may contribute to improving ACL rehabilitation outcomes and provide a new approach to physiotherapy rehabilitation. | PMC10386671 |
Material and methods | bone-patellar tendon-bone | The study was designed as a pilot double-blinded randomized controlled trial carried out on 20 male athletes who underwent unilateral arthroscopic ACLR surgery with bone-patellar tendon-bone graft between March 2020 and March 2021. The Research Ethics Committee of Tarbiat Modares University approved the study (IR.MODARES.REC.1398.124) and all patients provided written informed consent. The study was carried out based on the latest version of the Declaration of Helsinki. Our study was also approved as a pilot randomized controlled trial study in the Iranian Registry of Clinical Trials with the ID of IRCT20191013045090N1 on 03-03-2020.Also, the patients signed a written Persian consent form and announced their agreement to participate in the study and for publication of the results with respect to the confidentiality of personal data. | PMC10386671 |
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Participants | knee ≤, traumatic injuries, lower extremity fractures, pain | DISEASES, NEUROMUSCULAR DISEASE | All participants were primarily checked for eligibility criteria before being referred to the physical therapy clinic. The inclusion criteria were as follows: (1) patient with ACLR surgery at least three months ago; (2) aged between 20 to 30 years; (3) BMI ≤ 30; (4) active ROM on reconstructed knee ≤ 90°; (5) normal mental state. The exclusion criteria were (1)previous or concomitant injury or surgery on the relevant knee and other joints; (2) history of lower extremity fractures surgery or traumatic injuries within the last six months; (3) neuromuscular disease; (4) bone implants; and (5) history of any diseases that restrict activities and any other conditions affecting the study; (6) usage of opioid analgesics or systemic corticosteroids within the last four weeks; (7) inability to do exercise; (8) any damages during the study; (9) unwillingness to participate in the study; (10) engagement in out-of-schedule exercises; (11)receiving any treatment other than the programs prescribed in this research; and (12) incomplete assessment/treatment programs. Before enrollment, the patients who were included in the study signed university-approved written informed consent forms and completed demographic datasheets. All participants were permitted to withdraw at any time if they did not wish to pursue the study. The sample size was calculated 10 in each group by considering type one (α) and type two errors (ß) of 0.05 and 0.20 (power = 80%), respectively, to detect the effect size of two scores in pain improvement scale (VAS). | PMC10386671 |
Randomized allocation | Initially, 29 patients were enrolled to study; five of them did not fulfill the inclusion criteria. The eligible participants were 23 patients who were randomly allocated into two groups: (1) Nintendo Wii Fit system (named Wii group) as an intervention group, and their exercise program was given by a proposed ES. (2) The control group received a conventional ACL rehabilitation program (named CL group). Three athletes were also excluded in the next stage (Fig. CONSORT Flow diagram of the participantsThe patients who met the inclusion criteria were randomly assigned to one of the groups in a 1:1 ratio using a computer-generated random allocation sequence using a stratified block randomization process. Patients were blinded to treatment. Also, assessors were blinded to the allocated group of patients. | PMC10386671 |
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Assessment procedures | Knee flexion, TG, knee effusion, pain | The patient underwent a baseline assessment including a demographic checklist, Visual Analog Scale (VAS) for pain, Knee flexion Range (KFR), Thigh Girth (TG), knee effusion, Balance Error Scoring System (BESS), Modified STAR Excursion Balance Test (MSEBT) and two functional tests of Single-Leg Hop for Distance (SLHD) and Time (SLHT). The outcomes were measured in two intervals; at the baseline or pre-intervention and at the 4th week or post-intervention in the physical therapy clinic by assessors. | PMC10386671 |
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Proposed expert system | TG, knee effusion, effusion, Tightrope | EFFUSION | The proposed ES (Fig. The flowchart of the proposed ESThe main sources of knowledge for rehabilitation after ACLR were obtained from sports medicine and physiotherapist through several interviews, debates, and surveys of the Wii Fit exergames. According to the experts’ responses, the most important assessment variables for optimal rehabilitation consisted of knee effusion, TG, KFR, BESS, and MSEBT used as ES inputs.After the exergames verifying, ten exercises were chosen including; Ski Slalom, Ski Jump, Table Tilt, Table Tilt Plus, Tightrope Walk, Balance Bubble, Balance Bubble Plus, Penguin Slide, Snowboard Slalom, and Skateboard Arena with three levels of difficulty; beginner, advanced, and expert.After collecting and analyzing data of the patients by ES, preliminary calculations were carried out to determine the differences of effusion, TG, and KFR between healthy and reconstructed knees.The BESS scores were checked, the differences of Double-Leg (DL), Single-Leg (SL), and Tandem (T) from stable and unstable positions were obtained and summed up, and finally, their means were calculated (Eq. The reach distances of the MSEBT test in three directions and their mean were calculated (Eq. The ES forward-chaining strategy is an inferential method that begins with a set of known facts and generates new facts using rules that are applied to the facts. This process continues until a rule can no longer be used in the inference process [Designed rules will select Wii Fit exergames according to the patient's condition. The output of the ES is a training program based on ten selected games with its level of difficulty and duration. The rules are planned to make it possible to exercises easier form while the patient is in a poor situation. The duration and difficulty of the rehabilitation program have gradually grown to ensure that treatment progresses.The UI is intended to communicate between the user and the ES and compare the patient's condition in different sessions using graphical charts. Through this reporting system, the patient can assess his condition during the rehabilitation. Another part of the UI was the scoring system to evaluate the progress of the patient's rehabilitation during 12 sessions.According to the experts' opinions, the patients were labeled in five categories; deterioration, unchanged, low, moderate, and excellent based on their improvement by the scoring system.The ES was developed by Python version 3.6 and graphical UI by Tkinter-toolbox. The Microsoft SQL Server was used to store the data. After preliminary evaluation of the proposed ES by an experienced orthopedic surgeon and a sports physician, they expressed their satisfaction with its performance and ensuring the system’s rules validity. | PMC10386671 |
Interventions | pain | STRETCHES | All participants participated in 12 supervised 90-min exercise sessions; three times a week consisting of 15-min warm-up plus lower limb stretches, 60-min of an ES-based protocol based on the Wii Fit or conventional protocol, 15-min lower limb stretches, and a cool-down period. The patients had the same warm-up schedule in both groups that consisted of a 10-min jogging warm-up program on a treadmill (Technogym, Italy) with 5-min gentle stretches of quadriceps, hamstring, hip adductor, and calf (3–5 stretches/muscle group; hold 30-s). Prior to the exercise-therapy, the patients in the Wii group were asked to read the instructions and the safety guidelines of the console. In the first, fourth, seventh, and tenth sessions, the ES progressed the Wii Fit program for each participant after analyzing their outcomes. The exercise programs for patients in the CL group included the following:Static exercises for quadriceps, hamstring, gluteal muscles, and SLR.Closed chain exercises (wall sit, mini squat, and leg press).Hip muscles strengthening exercises.Proprioceptive exercises.Walking and jogging on a treadmill.Before the exercise therapy, all participants received High TENS (Combined BTL-4825S Topline, UK) for 20-min. Also, all participants were asked to avoid taking pain killer one week before and during the intervention to unify the participants' medications. Acetaminophen was only prescribed with a maximum dose of 2g daily if they experienced pain. | PMC10386671 |
Statistical analysis | Statistical analyses were performed using SPSS version 25 (SPSS Inc., Chicago, IL, USA). The results were reported as mean ± Standard Deviation (SD) for quantitative variables and were summarized for categorical variables by frequency (percentage). Kolmogorov–Smirnov test was used to investigate the normal distribution of quantitative data. A paired-sample t-test was used to determine the within-group differences. An independent sample t-test was used to compare the mean of the two groups when they had a normal distribution. Fisher's exact test was used to compare the ratios in the two groups. The significance level was set at Ten patients with the same reconstructive surgery had repeated measurements seven days apart in a pilot study and the Intra-class Correlation Coefficients (ICC) for BESS, MSEBT, SLHD, and SLHT were 0.92, 0.95, 0.94, and 0.97, respectively, with a 95% level of confidence. | PMC10386671 |
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Discussion | ACL injuries, ACL, abnormal gait, muscle bulk atrophy, fibrosis, pain, muscular reflex, decreases its proprioceptive ability, knee effusion, effusion, TG | MUSCLE ATROPHY, FIBROSIS, NEUROMUSCULAR INHIBITION, JOINT EFFUSION, EFFUSION, COMPLICATIONS | Due to the growing number of people with ACL injuries and their urgent need for post-operative rehabilitation, numerous clinicians are seeking to develop new protocols to accelerate the rehabilitation process. With its board and exergames, Wii Fit could offer enjoyable training and accurate feedback to improve the outcomes. A new exergame protocol based on the expert system has been proposed to accelerate the ACLR rehabilitation process in the study.In the proposed ES, after entering the data and initial calculations, a proper rehabilitation program was presented in the format of ten Wii Fit exercises with their repetition, duration of each exercise, and difficulty level. Reducing waste of time is one of its most important advantage over conventional approaches. The patient could receive a training regimen from the ES without the need for constant attendance of therapists. With the ES increasing accessibility, the insights of the best experts are provided to the user anywhere and anytime through the computer. In the present research, the effectiveness of ES-based Wii Fit protocols on pain, knee effusion, TG, KFR, physical function, balances compared to the conventional rehabilitation outcomes in the patients following ACLR.Pain is one of the annoying complications after ACL reconstructive surgery that might be endured for months. Persistent pain often leads to neuromuscular inhibition, muscle atrophy, and reduction of knee ROM [Joint effusion is seen in most patients after ACLR which causes several complications loss of motion, neuromuscular inhibition, muscle atrophy, decreasing postural stability, and abnormal gait [The measurement of TG is commonly used to assess thigh muscle bulk atrophy. According to our findings, TG demonstrated no significant difference between the two groups similar to Karakoc et al. [Loss of mobility is one of the undesirables of ACL reconstructive surgery caused by pain, surgery, effusion, inactivity, periarticular tissue fibrosis, adaptive shortening of muscles, and so on [Hopping tests are among the most important functional assessments after ACLR with high validity and reproducibility in healthy and reconstructed knees [ACL plays a vital role as a sensory organ supplying proprioceptive data that initiates a protective muscular reflex. Reconstruction of ACL decreases its proprioceptive ability and impairs balance. ACL is responsible for the diagnosis of joint position, kinesthesia, and equilibrium. Equilibrium is a complex interaction between sensory perceptions and motor responses [Our findings revealed a significant improvement in the stability scores in the static BESS test in the Wii group. Karakoc et al. have gained no significant difference in the postural sways between the control and virtual rehabilitation group [This study applied the modified SEBT test in the anterior, posteromedial, and posterolateral directions to evaluate the dynamic balance. Significant differences exist between the groups in all directions of the modified SEBT test. So far, no scientific evidence supports the positive effect of exergames with Wii Fit on dynamic balance, especially after ACLR. However, based on our findings, it seems that exercise-therapy with Wii Fit using ES is an effective approach to improve the dynamic stability in ACL-reconstructed athletes.The finding of the present study also showed that the Wii Fit exergaming was very pleasant for the participants in the Wii group, and the patients' motivation to exercise was much higher and they participate eagerly in rehabilitation programs which were very encouraging for the researchers, besides, no dissatisfaction or side effects were reported by the patients. Wii Fit exergames therapy with an ES exclusively for use in rehabilitation clinics can improve patients' function, save time and resources. Besides, during COVID-19 pandemics, patients can receive their rehabilitation program by the ES and do it alone via Wii Fit. | PMC10386671 |
Limitations | Although our study investigated the effectiveness of ES-based Wii Fit protocols compared to conventional rehabilitation outcomes in patients following ACLR, it is important to acknowledge the limitations of our study. One such limitation is the small number of patients and the lack of follow-up due to the COVID-19 pandemic. Additionally, our study was conducted in a controlled environment, which may not accurately reflect real-world conditions where patients may face different challenges and experiences during their rehabilitation process.Another limitation of our study is that the duration was limited, and we were unable to assess the long-term effects of the ES-based Wii Fit protocols. While our research suggests that ES-based Wii Fit protocols may be a promising alternative to conventional rehabilitation outcomes, it is necessary to conduct research with larger sample sizes and longer durations to fully understand the potential benefits of this therapy.Furthermore, we did not use digital systems for balance assessment to evaluate postural stability parameters, which may have limited the accuracy of our findings. Also, scientific evidence is lacking to support ES for rehabilitation after ACLR, especially for neuromuscular training. | PMC10386671 |
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Acknowledgements | The authors express their gratitude to the participants for their precious time, consent, and excellent cooperation. The authors gratefully acknowledge the valuable assistance of the academic members of Sports Medicine department; Iran University of Medical Sciences. | PMC10386671 |
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Authors’ contributions | RECRUITMENT | AAb, AM, AK, and AAs conceived and designed the study. AAb and AM designed the expert system. AAb and AAs developed the expert system. AM assisted with the recruitment of participants. AAb and AM evaluated the patients and performed the rehabilitation programs. AAb and AK conducted the statistical analysis and interpretation of data. AAb wrote the paper. AM and AK prepared the paper for publication. All authors have read and approved the final manuscript. | PMC10386671 |
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Funding | No funding to declare. | PMC10386671 |
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Availability of data and materials | All data relevant to the study are included in the article. The datasets generated during and/or analyzed during the current study are available from the corresponding author, Arezoo Abasi, upon reasonable request. Please contact Arezoo Abasi at [email protected] for data requests. The data will be provided in a de-identified format and subject to any necessary ethical and legal approvals. Any materials used in this study are available upon request from the corresponding author. | PMC10386671 |
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Declarations | PMC10386671 |
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Ethics approval and consent to participate | The Research Ethics Committee of Tarbiat Modares University approved the study (IR.MODARES.REC.1398.124) and all patients provided written informed consent. The study was carried out based on the latest version of the Declaration of Helsinki. Our study was also approved as a Pilot controlled trial study in the Iranian Registry of Clinical Trials, Iranian Registry of Clinical Trials registration number is IRCT20191013045090N1 and the registration date is 03-03-2020. | PMC10386671 |
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Consent for publication | Not applicable. | PMC10386671 |
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Competing interests | The authors declare no competing interests. | PMC10386671 |
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References | PMC10386671 |
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Abstract | PMC10154847 |
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Introduction | Pharmacists are one of the most accessible health professionals in the United States, who, with training, may serve as gatekeepers who recognize suicide warning signs and refer at‐risk individuals to care. Our objective was to codesign a 30‐min online gatekeeper training module (Pharm‐SAVES) specifically for community pharmacy staff. | PMC10154847 |
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Methods | Over a period of 8 months, a nine‐member pharmacy staff stakeholder panel and the Finger Lakes (New York) Veterans Research Engagement Review Board each worked with the study team to codesign Pharm‐SAVES. Formative data from previous interviews with community pharmacists were presented to the panels and guided website development. | PMC10154847 |
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Results | Four key topics were identified for brief skills‐based modules that could be delivered asynchronously online. To help pharmacy staff understand their opportunities as gatekeepers in suicide prevention, statistics and statements from the Joint Commission and pharmacy professional organizations were highlighted in Module 1 (‘Why Me?’). Module 2 (‘What can I do?’) presents the five gatekeeping steps (SAVES): (1) Recognize suicide warning | PMC10154847 |
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Conclusion | communication behaviors | Pharm‐SAVES is a brief, online suicide prevention gatekeeper training program codesigned by researchers, community pharmacy and veteran stakeholders. By actively engaging stakeholders at each stage of the design process, we were able to create training content that was not only realistic but more relevant to the needs of pharmacy staff. Currently, Pharm‐SAVES is being evaluated in a pilot randomized controlled trial for changes in pharmacy staff suicide prevention communication behaviors. | PMC10154847 |
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Patient or Public Contribution | Stakeholder engagement was purposefully structured to engage pharmacy staff and pharmacy consumers, with multiple opportunities for study contribution. Likewise, the involvement of patient/public contribution was paramount in study design and overall development of our study team.
| PMC10154847 |
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INTRODUCTION | Suicide is a persistent public health problem in the United StatesPharmacists are one of the most accessible health professionals in the United StatesTherefore, our objective was to work with stakeholders to codesign a 30‐min online training module specifically for community pharmacy staff. A codesign approach to research involving stakeholders has the potential to enrich the development, implementation, and evaluation of health interventions.In this paper, we describe the process for working with stakeholders to prioritize training content and interactive elements. Interventions may provide better outcomes and be better received when a stakeholder codesign approach is used to develop them. | PMC10154847 |
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METHODS | A codesign approach was used to develop the suicide prevention training module. Vechakul and colleagues define codesign as a cooperative process bringing people and design professionals together to find new and innovative solutions for different problems of everyday life, this can include the innovation of technological products and/or management of complex social issues.Two stakeholder panels were involved in reviewing material developed for Pharm‐SAVES: a community pharmacy stakeholder panel including nine community pharmacy staff (i.e., pharmacists, pharmacy technicians, and a student pharmacist) and the Finger Lakes VA Veterans Research Engagement Board (VREB). The VREB consisted of 10 veterans from all branches, service periods, races, and genders, including officers and enlisted members. In addition to soliciting input from the pharmacy stakeholders and the VREB panel, a website development, educational design, two suicide prevention, and a patient‐provider communication expert, who attended the pharmacy panel meetings, provided input throughout the course of module development.Before meeting with all stakeholders, the research team, comprised of two primary investigators, a postdoctoral research assistant (postdoc) with previous experience in suicide prevention, and two study coordinators, met to discuss results from a previous formative study on pharmacy staff preferences for suicide prevention content. Data from the formative study showed that pharmacy staff preferred training that included: local suicide prevention referral resources, training that takes under 30‐min to complete, and incorporates three to four realistic role play scenarios, including a telephone interaction.Over the course of 8 months, 9 pharmacy stakeholder panel meetings were held in the late afternoon/evenings to accommodate busy pharmacy staff schedules (Table Stakeholder engagement meetings and content outline.
Reviewed the formative study outlining gatekeeper training needs of community pharmacy staffWatched existing videos modeling pharmacist‐ patient interactions of suicidal behaviorElicited specific feedback to determine if the interaction was realistic, an appropriate length, and needed to be adapted for pharmacy setting.Introduced VA SAVE, the suicide prevention gatekeeper training program developed by the VA Center of Excellence for Suicide Prevention (S.A.V.E. (Finalized regular meeting time
Reviewed scripts for the three proposed pharmacy video scenarios: (1) in‐person, (2) via telephone, and (3) drive‐through.VREB Panel Meeting 1
Reviewed proposed website contentReviewed scripts for the three proposed video scenarios, which take place: (1) in‐person, (2) via telephone and (3) at the pharmacy drive‐through.
Reviewed revised in‐person video scriptPresented written content for the training websiteFocused on structure of the websiteWebsite was divided into four key module topics: (1) Why me?, (2) What can I do? (Pharm‐SAVES), (3) How does it work? and (4) Referral resources.
Facilitated by the UNC MEDIA teamEvaluated website layout and design
Three different website mock‐ups with varying layouts and interactive features.VREB Panel Meeting 2
VREB reviewed the final drafts of video scripts and website mock‐up
MEDIA team presented revised website with training contentSolicited real‐time feedback on website modules for additional feedbackDrafted interactive cases
Presented the final version of the full training websiteReviewed the Introduction page and Module 1 ‘Why me?’ contentFeedback on Interactive Cases solicited, discussed the scripts and flow of content
Updated Introduction pageModule 2: ‘What can I do?’ (Pharm‐SAVES)Module 3: ‘How does it work?’Module 4: ResourcesSummary page
Module 2: ‘What can I do?’ (Pharm‐SAVES)Module 3: ‘How does it work?’Module 4: ResourcesSummary pageAdded section with credit for contributors and checked credentials
Study post‐doc presented Pharm‐SAVE websiteSolicited feedback on website content and structureAdvised to make ‘Set a reminder to follow‐up’ a separate step
Reviewed content proposed by suicide prevention expertUpdated acronym to ‘Pharm‐SAVES’ based on feedback from suicide prevention expertsReviewed resource referral toolThe pharmacy stakeholder group was provided with the video scripts before the meetings to provide written feedback and scripts were then reviewed over Zoom in real‐time as a group.The review of scripts was done via Zoom. The study post‐doc attended the meeting and took notes in real‐time which were typed and reviewed with the study team for integration into the revised scripts.The content was outlined by the postdoc and reviewed by the study investigators. A written outline of content was provided to the stakeholders for review prior to the meeting.Meeting minutes were recorded in a Word document in real‐time directly on the meeting agenda by either the study post‐doc or one of the study coordinators. Meeting minutes were reviewed weekly by the study team, where suggestions for website improvements, usability, module language, and content were extracted from meeting minutes. Any suggestions or edits related to website content (either written or video) were extracted and organized in a separate Word document. This Word document outlining website changes was then emailed to the UNC MEDIA team for incorporation into the course website.Due to the sensitive nature of the topic material, stakeholders and project staff were provided with mental health resources. The study post‐doc was also trained in mental health and suicide prevention protocols and was available for debriefing or to provide appropriate referral and local crisis resources. | PMC10154847 |
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RESULTS | buy‐in’, overdose, ’ | ABUSE | Twelve meetings occurred over the course of 8 months, during which there were nine meetings with an average of nine pharmacy stakeholders, two separate meetings with a veteran stakeholder (VREB) panel, and one separate meeting with two suicide prevention experts. Each meeting lasted roughly 1 h and was facilitated by the study post‐doctoral research assistant over Zoom. Using the written notes from the panel meetings, changes to website content were adopted iteratively and reviewed by the stakeholders over the course of the 8‐month meeting period.The overall structure of the website was divided into four main sections (or modules): (1) ‘Why me?’, (2) ‘What can I do?’ (Pharm‐SAVES), (3) ‘How does it work?’ and (4) Resources. Stakeholders wanted content that modeled realistic pharmacy interactions to increase the pharmacy staff member's confidence to engage in suicide prevention gatekeeping behaviors. Stakeholders wanted to know how they could integrate SAVES into their pharmacy workflow with minimal disruption to prescription filling, counseling, and other pharmacy services. The four modules were decided upon after the pharmacy stakeholder panel was provided with a summary of the formative data,One issue consistently raised by the pharmacy stakeholders was the importance of developing content that maximizes pharmacy staff ‘buy‐in’ and ‘relatability’. Therefore, the module starts with a section on ‘why me?’. Pharmacy stakeholders thought this section would help pharmacy staff (i.e., pharmacists and pharmacy technicians) understand the critical role they have in suicide prevention (Figure Pharm‐SAVES Module 1: Why Me?Module 2 presents the acronym ‘SAVES’, which stands for: (1) Recognize the warning Pharm‐SAVES Module 2: What Can I Do?Under the first ‘S’ tab (“The ‘E’ tab reinforces two key points: (1) Patients with warning signs of suicide should not be left alone, and (2) In addition to local resources, the NSPL is open 24/7, 365 days and is free and confidential. Finally, the second ‘S’, or ‘Video examples ground the ‘how does it work?’ section, modeling drive‐through, telephone, and in‐person cases. Each scenario models a ~3‐min initial interaction and a 30‐s follow‐up (set a reminder to follow‐up) interaction. The drive‐through interaction was deemed particularly important to model given the increased use of the drive‐through during the COVID‐19 pandemic.Summary of video scenarios.The pharmacy stakeholder panel felt it was important to keep users engaged and give opportunities to practice SAVES, which is why we developed the two interactive cases. The interactive cases allowed participants to practice SAVES in a controlled environment that provided feedback on their responses. One case depicts a white, middle‐aged male patient ‘Mr. Jones’ who is having difficulty sleeping. This demographic has a relatively high risk of suicide and is representative of the veteran population. A second case depicts an upbeat, female patient ‘Ms. Smith’ who asks about how much it would take to overdose on her medication. In each case, the trainee watches the video and types of responses to several questions, which are interspersed throughout the video. Example questions include: ‘Does Mr. Jones show any signs of suicide?’ or ‘How confident are you that you can ask Ms. Smith about suicide?’. Questions are a combination of free text response and multiple choice, where the participant is provided feedback after their response is submitted.In addition to the NSPL, the pharmacy stakeholder panel also wanted a resource referral tool that provided a list of local behavioral health, substance use, and other resources. Using online searchable databases, including the Substance Abuse and Mental Health Services Administration (SAMHSA) treatment locator and the Veterans Administration (VA) treatment locator, a list of mental health and substance use treatment facilities, providers, and other resources were compiled by zip code and county. Resources were classified based on services provided, current location, and contact information. This tool provides a consolidated list of local resources that can be sorted by county or zip code to provide pharmacy staff with suicide prevention or crisis resources (Figure Pharm‐SAVES Resources and Referral Tool. | PMC10154847 |
DISCUSSION | Codesign approaches that directly involve stakeholders, have previously been shown to enhance the development and implementation of health interventions to improve patient outcomes across healthcare settings. | PMC10154847 |
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Strengths and limitations | communication behaviors | There were several strengths in taking a codesign approach for the development of suicide prevention training for pharmacy staff. One such strength was that a codesign approach helped provide a framework in which feedback from one session guided and informed future meetings. Although a general meeting schedule and broad topic outline were created at the beginning of the project, allowing for adaptation of topic material based on participant feedback was useful in module development. Information gathered in each session, could be evaluated by the study team, and helped inform the development timeline, module content, and set benchmarks in the development process to reach the overall end‐goal. This is a similar approach taken by other codesign driven pharmacy interventionsSince meetings were conducted virtually, it allowed more stakeholders to attend despite their busy work schedules. Likewise, the pharmacy stakeholders were from different areas of NC and were able to participate, which allowed for a dynamic view of pharmacy experiences from across the state of NC. Furthermore, virtual meetings allowed for the inclusion of the VREB panel organized out of the VA in New York, which allowed us to gather veterans' perspectives. Additionally, Zoom teleconferencing afforded the study team an opportunity to interact with suicide prevention experts nationally who provided critical input about module content without the need for costly travel or delays due to COVID‐19. All these factors helped result in a more comprehensive product that included input from pharmacy stakeholders who represent the target user, considerations from the VREB panel who represent potential recipients of the intervention as pharmacy consumers, and expert guidance that improved content accuracy and best practices.Another key to success was having a consistently scheduled meeting time planned one month in advance. Pharmacy staff are quite busy, so the advanced scheduling promoted good attendance. At the first stakeholder meeting, a monthly meeting time was decided on. And the study postdoc sent a reminder 1 week before each meeting. Additionally, all stakeholders were emailed a meeting agenda in advance, and meetings were kept to 1 h. Having an agenda and a time limit helped keep the study team, and stakeholders focused and increased productivity.Despite the overall success of our approach, this process was not without challenges. One challenge was soliciting feedback on written documents via email. In general, stakeholders were more responsive during in‐person meetings. Overall, the amount of written feedback received on documents was low. Even when given multiple days or weeks to review documents, very few stakeholders provided written feedback to emailed documents. This usually resulted in review of documents during the virtual meetings. Given low engagement with emailed feedback, an alternative approach that may have been more successful would be to provide mock‐ups of these documents during virtual meetings. Although this may have increased the number of total meetings, it may have ultimately been more efficient.Another challenge we faced was receiving timely feedback. In addition to stakeholders, we also sought feedback from suicide research experts. Due to the time it takes to build a website and develop content, we did not seek outside expert input until near completion of the development process. This led to several iterations of edits that delayed website completion. In the future, including external suicide prevention education experts earlier and more frequently in the process would be beneficial.To further evaluate the impact of the codesign process and effectiveness of the suicide prevention training, the online module described here (Pharm‐SAVES) is currently being evaluated in a randomized controlled trial. The purpose of randomized control trial is to examine whether it improves the suicide prevention knowledge, gatekeeper self‐efficacy, and communication behaviors of pharmacy staff. Additionally, information from the results of this trial will be used to improve the training module and expand access to additional community pharmacy settings to continue to build a useable, up‐to‐date training resource. | PMC10154847 |
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CONCLUSIONS | Pharm‐SAVES is a brief, online suicide prevention gatekeeper training program for community pharmacy staff who were integral to its development. The module incorporates written, video, and interactive content to maximize the participant's learning experience. By engaging with stakeholders to compose this content, pharmacy staff may be more likely to identify with module content and find the information more relevant and useful to their daily workflow. Successful codesign of the module was facilitated using zoom meetings and integration of stakeholder feedback on module content. Future codesign projects aimed at suicide prevention in community pharmacy settings would benefit from examining the needs of pharmacy consumers both with and without lived experience in mental health and suicide. | PMC10154847 |
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AUTHOR CONTRIBUTIONS | PMC10154847 |
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CONFLICT OF INTEREST STATEMENT | The authors declare no conflict of interest. | PMC10154847 |
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ACKNOWLEDGEMENTS | CARPENTER | This project was supported by grant SRG‐0‐200‐17 award to Dr. Delesha Carpenter and Dr. Jill Lavigne by the American Foundation for Suicide Prevention. | PMC10154847 |
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DATA AVAILABILITY STATEMENT | Data are available on request from the authors. | PMC10154847 |
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REFERENCES | PMC10154847 |
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Abstract | F. Tanser and T. Bärnighausen are both senior authors. | PMC10440100 |
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Introduction | While it is widely acknowledged that family relationships can influence health outcomes, their impact on the uptake of individual health interventions is unclear. In this study, we quantified how the efficacy of a randomized health intervention is shaped by its pattern of distribution in the family network. | PMC10440100 |
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Methods | The “Home‐Based Intervention to Test and Start” (HITS) was a 2×2 factorial community‐randomized controlled trial in Umkhanyakude, KwaZulu‐Natal, South Africa, embedded in the Africa Health Research Institute's population‐based demographic and HIV surveillance platform (ClinicalTrials.gov # NCT03757104).The study investigated the impact of two interventions: a financial micro‐incentive and a male‐targeted HIV‐specific decision support programme. The surveillance area was divided into 45 community clusters. Individuals aged ≥15 years in 16 randomly selected communities were offered a micro‐incentive (R50 [$3] food voucher) for rapid HIV testing (intervention arm). Those living in the remaining 29 communities were offered testing only (control arm). Study data were collected between February and November 2018.Using routinely collected data on parents, conjugal partners, and co‐residents, a socio‐centric family network was constructed among HITS‐eligible individuals. Nodes in this network represent individuals and ties represent family relationships. We estimated the effect of offering the incentive to people with and without family members who also received the offer on the uptake of HIV testing. We fitted a linear probability model with robust standard errors, accounting for clustering at the community level. | PMC10440100 |
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Results | Overall, 15,675 people participated in the HITS trial. Among those with no family members who received the offer, the incentive's efficacy was a 6.5 percentage point increase (95% CI: 5.3−7.7). The efficacy was higher among those with at least one family member who received the offer (21.1 percentage point increase (95% CI: 19.9−22.3). The difference in efficacy was statistically significant (21.1–6.5 = 14.6%; 95% CI: 9.3−19.9). | PMC10440100 |
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Conclusions | Micro‐incentives appear to have synergistic effects when distributed within family networks. These effects support family network‐based approaches for the design of health interventions. | PMC10440100 |
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INTRODUCTION | Though family relationships crucially determine health and wellbeing, their role in shaping the uptake of individual health interventions is not well‐understood. Using family network data from a large population‐based cohort, we quantified the degree to which the efficacy of a randomized individual‐level health intervention—a financial incentive for HIV testing—is shaped by its pattern of distribution among family members.Improving testing programmes can increase access to anti‐retroviral therapy (ART) which effectively eliminates HIV transmission at the individual level [Through a post‐hoc analysis of Home‐Based Intervention to Test and Start (HITS) study data, we quantified how the effectiveness of a financial incentive for HIV testing changes depending on whether it is offered to an individual or offered to an individual along with family members. HITS, which was conducted in South Africa, investigated the effects on HIV testing and linkage to care of a ZAR 50 (USD 3) incentive and a male‐targeted HIV‐specific decision support programme. We previously reported that among men, the uptake of HIV testing increased from 17.1% in the standard of care to 27.5% in the financial incentives arm (risk ratio = 1.55, 95% CI: 1.31−1.82) [We build on this finding by testing the hypothesis that, for a given individual, the effectiveness of the financial incentive is augmented by offering incentives to family members prior to, or at the same time as, the individual. For many South Africans, resources are shared among extended family across different households [ | PMC10440100 |
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METHODS | PMC10440100 |
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Setting and participants | HITS is a community‐randomized controlled trial in the Hlabisa sub‐district of the uMkhanyakude district—a rural region of northern KwaZulu‐Natal with a high HIV burden and unemployment [Individuals were eligible for HITS if they were 15 years or older at the time of the surveillance visit, resided within the surveillance area, agreed to participate in annual HIV surveillance and provided written informed consent for trial participation. Individuals were not eligible to participate in the trial if they refused to participate in HIV surveillance, reported being already on ART or were mentally or physically unable to provide consent. The study is registered at the U.S. National Institute for Health's ClinicalTrials.gov (# NCT03757104). Further details are available in earlier publications [ | PMC10440100 |
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Randomization and masking | The HITS study investigated two interventions: a financial micro‐incentive for HIV testing and a male‐targeted HIV‐specific decision support programme [Flow diagram for HITS trial.The 45 communities were grouped into four strata based on baseline HIV incidence rates among women aged 15–30 years. The intervention arm consisted of four randomly selected communities from each of the four strata (16 communities total). The control arm consisted of the remainder of the communities in each stratum (29 communities total). The study was an open‐label trial. | PMC10440100 |
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Consent and intervention | Only residents who agreed to participate in annual AHRI HIV surveillance were eligible to participate in HITS. Residents were asked for their consent at the study visit. Those who consented to AHRI HIV surveillance were then asked for their consent to participate in the HITS study.Those who were eligible for and consented to participate in HITS were enrolled. Those who resided in control communities were offered rapid HIV testing per the HIV surveillance protocol. Those in intervention communities were offered a micro‐incentive conditional on undergoing home‐based rapid HIV testing during the study visit. The micro‐incentive was a food voucher valued at ZAR 50 (∼USD 3), which was redeemable at a local supermarket [ | PMC10440100 |
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Social network | A socio‐centric family network was constructed among HITS‐eligible individuals using routinely collected surveillance data. Nodes in this network represent individuals. Three kinds of ties were added between the nodes: first‐degree relatives (parents, children and all conjugal partners of each participant), second‐degree relatives (the first‐degree relatives of first‐degree relatives) and co‐resident relatives (individuals who ever resided in the same household as the participant and who were not tenants or domestic workers in that household). Below, we refer to members of each person's personal family network (i.e. the egocentric network) simply as “family members.”Family members of residents are only recorded if they ever resided in the surveillance area. For most individuals, it was possible to identify at least one family member—only 2.7% (424/15,675) of HITS participants were not linked with any other residents. Because surveillance began in 2000, older residents were less likely to be observed at the same time as their parents. Among the records of individuals aged 15–25, 15.0% (2321/15,458) were not linked to their mother's record and 48.3% (7471/15,458) were not linked to their father's. Among those over 55 years of age, these proportions were 87.9% (4795/5458) and 97.3% (5310/5458), respectively. Missing linkages between participants and their parents indicate that their parents were not eligible for the study. | PMC10440100 |
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Measures | The outcome of interest was individual uptake of rapid HIV testing at the study visit. Exposures of interest were individual offer of financial incentive (“individual offer”) and family offer of incentive (“family offer”). For each participant, family offer was defined as the count of family members who were offered the financial incentive prior to or on the same day as the participant's own study visit. Network size was defined as the count of family members. | PMC10440100 |
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Analysis | REGRESSION, SECONDARY | We calculated sample characteristics, examined patterns of network connections between communities and described the composition of network connections.For the primary analysis, we examined heterogeneity in the effect of the individual offer on HIV testing uptake across strata defined by the dichotomized family offer (≥1 vs. 0). We fitted a linear probability regression model with a two‐way interaction encoding the extent to which the causal effect of individual offer is modified by dichotomized family offer. (See Measures sub‐section for the definition of “family offer.”) In a secondary analysis, we examined heterogeneity across strata defined by ordinal family offer. We fitted a linear probability model with two‐way interaction terms encoding the extent to which the causal effect of individual offer is modified by family offer levels of zero, one, two, three, four and five or more. We conducted a linear trend test. Finally, we conducted sensitivity analyses which we report in a Supplementary Note.Models were fitted using robust standard errors, accounting for clustering at the community level. We did not formally adjust for multiple testing as we conducted only three hypothesis tests. | PMC10440100 |
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Missing data | REGRESSION | We conducted a complete case analysis as only 10/15,675 observations had missing outcome data. All other variables included in the regression models were complete. | PMC10440100 |
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Power and sample size | The HITS sample size was calculated to detect a relative reduction of 25% or more in HIV incidence among women aged 15–30 with power exceeding 80% and α = 0.05. Further details have been previously reported [ | PMC10440100 |
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Ethics statement | The Biomedical Research Ethics Committee of the University of KwaZulu‐Natal approved study protocols for the AHRI's population‐based HIV testing platform and HITS intervention (BE290/16 and BFC398/16) [ | PMC10440100 |
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RESULTS | PMC10440100 |
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Participants and network | Two‐thirds | Of 37,068 residents who met the inclusion criteria for the HITS study, 15,675 participated and 15,665 were included in the analysis (see Figure It was common for participants to have family members in different households (60.4%, 9468/15,675) and different communities (42.2%, 6613/15,675) (see Table Baseline characteristicsEach community had family connections with almost every other community (see Figure Family connections between communities in HITS study. The top part of the figure is a grid showing the number of family connections within each of the 45 randomization communities on the diagonal, and the number of family connections between each pair of communities below the diagonal. The size of the circles is proportional to the number of connections. Orange and blue bar graphs in the lower part of the diagram show the number of connections across communities but within the intervention arm and control arm, respectively. The grey bar graph shows the proportion of connections across communities in different study arms. The diagram shows that each community was connected to almost every other community through family ties.Two‐thirds (64.7%, 3647/5637) of participants in the intervention arm agreed to take an HIV rapid test, whereas half (50.7%, 5087/10,028) of participants in the control arm agreed, leading to an overall risk difference of 13.6 (95% CI: 12.0−15.3). Of the 8734 participants who consented for an HIV test, HIV test results were recorded for 8700. | PMC10440100 |
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Primary analysis | SECONDARY | We found support for the hypothesis that the effect of the incentive on an individual's HIV testing uptake is augmented by offering incentives to their family members prior to, or at the same time as, them (see Figure Effect heterogeneity of HITS intervention. The table shows results from the primary analysis (dichotomized family treatment) above and the secondary analysis (ordinal family treatment) below. Efficacy was calculated on the risk difference scale. | PMC10440100 |
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Secondary analysis | The strength of the effect of the individual offer increased as more family members received a prior or contemporaneous offer of the incentive, further supporting the main hypothesis. Effect sizes increased from 6.5% (95% CI: 5.3–7.7) among participants with no family members who received the offer to 26.3% (95% CI: 23.5–29.0) among participants with three family members who received it. The effect size of the individual incentive appeared not to change substantially when four (RD: 25.5, 95% CI: 20.2–30.7) or five or more (RD: 24.8, 95% CI: 20.7–28.9) family members received the offer. A linear trend test showed that for each additional family member who was offered the incentive, the risk difference for the effect of the incentive on testing uptake increased by 4.8% (95% CI: 2.4−7.2) on average. | PMC10440100 |
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Sensitivity analysis | In the Supplementary Note, we examined the potential impact of selection bias in study participation on the results of the primary analysis. Figure | PMC10440100 |
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DISCUSSION | The HITS study confirms that a modest community‐wide financial incentive increases the uptake of HIV testing. Our study establishes that an individual offered a financial incentive is more likely to take up testing when family members have received the same offer prior to or at the same time as them. The strength of the effect appears to increase with the count of family members in receipt of the offer.This finding adds to a growing body of evidence from randomized control trials demonstrating that economic incentives increase the uptake of HIV testing [Though prior studies are often not explicit about the causal mechanism through which incentives are hypothesized to shape behaviour, several explanations do appear in the epidemiologic literature. Incentives can change the structural environment in which behaviour unfolds (for instance by alleviating poverty); they can affect the price of some behaviour or good, or the income of the recipient in relation to that good or behaviour; and they can intervene on the psychological processes that shape behaviour [There are some notable exceptions. Several trials have shown that incentivizing close social contacts—most commonly romantic [Developing and applying theory that reflects the interdependence of individuals could enable the development of new interventions. For instance, family‐based intervention strategies might be effective at reaching groups which otherwise have low access to health services, such as young people [We make a novel contribution to the fields of study design and applied causal inference. Our results show empirical evidence for the violation of the assumption of “partial interference” in the context of a large‐scale cluster‐randomized trial [It is likely that there are important social relationships that are relevant to HIV testing that were not captured in population surveillance data. This is a limitation of our study. Further research should develop methods to account for missing network data and design new approaches to measuring socio‐centric networks. A further limitation is that we used the assumption of partial interference to calculate standard errors, though we show this assumption to be violated. This was motivated by the fact that network connections are much denser within clusters than they are across them; we do not expect this analytic decision to lead to anti‐conservative estimates of uncertainty. Finally, we did not adjust for multiple testing, though we note that using the Bonferroni correction (i.e. using a nominal Type I error rate of 0.05/3 = 0.017) would not have altered the main conclusions of this study.A major strength of our findings is that they are not susceptible to homophily bias—bias that arises because of the tendency for people with similar unmeasured characteristics to form relationships based on those characteristics [Understanding humans in the context of their relationships can lead to improvements in population health. There is an urgent need to cultivate robust social network data for epidemiologic analysis—whether by collecting them, constructing them from already collected study data as we did here or connecting passively collected information, such as social media data, with large public health datasets. | PMC10440100 |
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CONCLUSIONS | By combining family network data with data from a field experiment, we showed that network‐based financial incentive programmes for a behavioural health intervention might be more efficient than individual‐based programmes. While the field experiment was conducted in 2018, it is likely that our findings continue to apply in the current context since they are based on long‐standing social relationships among participants. Future HIV testing studies should assess interventions targeted at networks. More generally, public health studies should leverage data on participants’ social networks to generate new insights about population health and to spur on the development of new intervention approaches. | PMC10440100 |
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Role of the funding source | Study sponsors had no role in the design, data collection, analysis, interpretation or write‐up of this study, nor did they influence the decisions to submit the results for publication. | PMC10440100 |
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COMPETING INTERESTS | The authors declare no competing interests relating to this manuscript. | PMC10440100 |
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AUTHORS’ CONTRIBUTIONS | TB | KM conducted an analysis and drafted the manuscript. ETT, MTB and LB edited the manuscript. KM developed an analytic plan with ETT, HYK and TB. FT and TB accessed and verified all underlying data. All authors discussed and reviewed the manuscript. | PMC10440100 |
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Supporting information |
Click here for additional data file. | PMC10440100 |
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ACKNOWLEDGEMENTS | Our sincere thanks to the Africa Health Research Institute's population‐based demographic and HIV surveillance platform. We are grateful, also, to peer reviewers and editors whose thoughtful criticism led to improvements in the manuscript. | PMC10440100 |
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DATA AVAILABILITY STATEMENT | Study data, including de‐identified participant data and data dictionaries, are available for download from the AHRI Data Repository ( | PMC10440100 |
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REFERENCES | PMC10440100 |
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Abstract | active idiopathic intracranial hypertension | PAPILLOEDEMA, IDIOPATHIC INTRACRANIAL HYPERTENSION, MITCHELL, PRESSURE AREA | Therapeutics to reduce intracranial pressure are an unmet need. Preclinical data have demonstrated a novel strategy to lower intracranial pressure using glucagon-like peptide-1 (GLP-1) receptor signalling.Here, we translate these findings into patients by conducting a randomized, placebo-controlled, double-blind trial to assess the effect of exenatide, a GLP-1 receptor agonist, on intracranial pressure in idiopathic intracranial hypertension. Telemetric intracranial pressure catheters enabled long-term intracranial pressure monitoring. The trial enrolled adult women with active idiopathic intracranial hypertension (intracranial pressure >25 cmCSF and papilloedema) who receive subcutaneous exenatide or placebo. The three primary outcome measures were intracranial pressure at 2.5 h, 24 h and 12 weeks and alpha set Among the 16 women recruited, 15 completed the study (mean age 28 ± 9, body mass index 38.1 ± 6.2 kg/mThese data provide confidence to proceed to a phase 3 trial in idiopathic intracranial hypertension and highlight the potential to utilize GLP-1 receptor agonist in other conditions characterized by raised intracranial pressure.Mitchell | PMC10151178 |
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