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Acknowledgements | RECRUITMENT | We are grateful to all participants of the study and the staff at the Taiwan Adventist Hospital who assisted in the recruitment and implementation process. | PMC10388457 | |
Funding | The authors’ contributions in the following manner:Study design: W.L.P. and L.C.L.Data collection and data analysis: W.L.P., M.J.C., and P.Y.L.Manuscript writing and revisions for important intellectual content: W.L.P., L.C.L., and L.Y.K.This study was supported by National Science and Technology Council, Taiwan. (Grant No: MOST 109-2314-B-227 -002 and NSTC 110-2314-B-227 -002 -MY2). The funding bodies played no role in the design of the study, collection, analysis, interpretation of data, or in writing the manuscript. | PMC10388457 | ||
Declarations | Data used and analyzed in the current study are available from the corresponding author upon reasonable request. | PMC10388457 | ||
Ethics approval and consent to participate | This study was approved by the Institutional Review Board of Taiwan Adventist Hospital (No. 108-E-14) with an approval date of December 16, 2020. All participants obtained their Oral and written informed consent. All methods were carried out in accordance with relevant guidelines and regulations. | PMC10388457 | ||
Consent for publication | Not applicable. | PMC10388457 | ||
Competing interests | The authors declare no competing interests. | PMC10388457 | ||
Abbreviations | depression, Perinatal mood | Perinatal mood and anxiety disorderMindfulness based childbirth and parentingEdinburgh postnatal depression scalePerceived stress scalePregnancy-related thoughts questionnairePostpartum bonding questionnaire | PMC10388457 | |
References | PMC10388457 | |||
Background | impairments in social cognition | Although potential links between oxytocin (OT), vasopressin (AVP), and social cognition are well-grounded theoretically, most studies have included all male samples, and few have demonstrated consistent effects of either neuropeptide on mentalizing (i.e. understanding the mental states of others). To understand the potential of either neuropeptide as a pharmacological treatment for individuals with impairments in social cognition, it is important to demonstrate the beneficial effects of OT and AVP on mentalizing in healthy individuals. | PMC10123837 | |
Methods | In the present randomized, double-blind, placebo-controlled study ( | PMC10123837 | ||
Results | alexithymia | Relative to placebo, neither drug showed an effect on task reaction time or accuracy, nor on whole-brain neural activation or functional connectivity observed within brain networks associated with mentalizing. Exploratory analyses included several variables previously shown to moderate OT's effects on social processes (e.g., self-reported empathy, alexithymia) but resulted in no significant interaction effects. | PMC10123837 | |
Conclusions | Results add to a growing literature demonstrating that intranasal administration of OT and AVP may have a more limited effect on social cognition, at both the behavioral and neural level, than initially assumed. Randomized controlled trial registrations: ClinicalTrials.gov; NCT02393443; NCT02393456; NCT02394054. | PMC10123837 | ||
Keywords | PMC10123837 | |||
Background | CORTEX | A number of oxytocin (OT) and vasopressin (AVP) administration studies point to a possible role for these neuropeptides in improving mentalizing (Brunnlieb, Münte, Tempelmann, & Heldmann, The majority of these studies include the Reading the Mind in the Eyes Test (RMET; Baron-Cohen, Wheelwright, Hill, Raste, & Plumb, A few studies have examined the effects of OT on other mentalizing tasks. In healthy control groups, one study (Although there is limited evidence for a behavioral effect of OT on mentalizing, it is possible that OT affects neural regions associated with mentalizing even in the absence of behavioral changes. The mentalizing network includes the temporoparietal junction (TPJ)/posterior superior temporal sulcus, the medial prefrontal cortex (mPFC), the inferior frontal gyrus (IFG), the temporal poles, and the posterior cingulate cortex (PCC)/precuneus (Mar, Compared to OT, even less research has examined the effects of AVP on mentalizing. In one study, AVP reduced mentalizing ability in the RMET (In the present study, we recruited a large sample ( | PMC10123837 | |
Methods | PMC10123837 | |||
Participants | All participants ( | PMC10123837 | ||
Procedure | Participants completed two sessions (see online Supplementary Fig. S2 for study timeline). In the first session, participants completed a series of self-report questionnaires. The measures relevant to the present study are described below. The second session occurred 7–145 days later (mean = 45.37, | PMC10123837 | ||
Why/How task | The Why/How task (Spunt & Lieberman, Description of Why/How Task. Following a fixation cross presented for an average of 9 s, each of the 16 experimental blocks began with a prompt question shown for 2.1 s followed by a blank screen lasting 0.15 s before presenting a sequence of eight trial images. Participants were given a max of 2.2 s to respond to each image, and a reminder prompt lasting 0.3 s was shown between each image. Each pre-block prompt began with ‘Is the person’ followed by a descriptive phrase specific to each question. This same phrase was then shown as a reminder between each trial. Recorded BOLD signal was analyzed in a variable epoch manner beginning from the onset of the first image to the offset of the final image of the block. The Why prompts described either intentions inferred from a person's bodily actions (e.g. ‘helping someone’) or emotional states inferred from facial expressions (e.g. ‘proud of themselves’). The How prompts described the physical mechanics of body actions (e.g. ‘lifting something’) or facial orientations (e.g. ‘opening their mouth’). The same set of images were used for both Why and How trials, and participants responded ‘yes’ or ‘no’ with their index or middle finger to indicate whether the person(s) in each image demonstrated that mental state or were performing the action stated in the prompt. On average, the task lasted approximately 4.9 min per person. See online Supplemental Information for additional prompt examples and task information. | PMC10123837 | ||
Self-report measures | As shown in online Supplementary Table S1, participants completed several self-report measures for exploratory moderation analyses of OT and AVP effects. | PMC10123837 | ||
fMRI image acquisition | BRAIN | We collected data on a Prisma 3-T MR system at the UCLA Ahmanson-Lovelace Brain Mapping Center. We collected 148 functional volumes using a T2* weighted gradient echo-planar sequence with the following parameters: matrix size = 64 × 64, 3.1 × 3.1 × 3 mm voxels, repetition time (TR) = 2.0 s, echo time (TE) = 24 ms, flip angle (FA) = 90°, FOV = 1200 mm, bandwidth = 2605 Hz/Px, 20-channel head coil, and no acceleration. Volumes consisted of 36.3 mm slices with a distance factor 33%, and slice orientation tilt of 22.5% relative to the AC/PC plane. At the end of the scanning session, a high-resolution structural volume (MPRAGE) was collected with the sequence parameters: 1.1 × 1.1 × 1.2 mm voxels, TR = 2.3 s, TE = 2.95 ms, FA = 9°, distance factor 50%, and parallel imaging implementation mode GRAPPA with an acceleration factor of 2. The first 96 participants were run with scans going from posterior to anterior. Since dropout of signal can depend on the direction of the scans, for optimal coverage of the ventral PFC, we ran the last 90 participants with scans going from anterior to posterior. Contrasting blood oxygen level-dependent (BOLD) activation for participants whose images had posterior to anterior | PMC10123837 | |
Statistical analysis | PMC10123837 | |||
Behavioral analysis | We examined the effects of either neuropeptide on reaction time and accuracy for the Why/How task using two-sided | PMC10123837 | ||
Results | PMC10123837 | |||
Oxytocin and vasopressin effects on accuracy and reaction time | We first examined the effect of either neuropeptide on accuracy and reaction time during Why trials (mentalizing) and How trials (action understanding). No significant differences between treatment groups were found in accuracy (Differences between OT, AVP, and placebo on accuracy and reaction time. (a) Accuracy for Why and How trials, (b) reaction time for Why and How trials. No significant behavioral differences in accuracy or reaction time were observed for OT and AVP | PMC10123837 | ||
Oxytocin and vasopressin effects on functional connectivity | We also examined functional connectivity while the participants were performing the task. First, we measured how changes in connectivity for the Why Twenty ROIs chosen from Spunt and Adolphs ( | PMC10123837 | ||
Exploratory analyses of gender | We further examined potential gender interaction effects with OT | PMC10123837 | ||
Exploratory moderation analyses | To explore potentially relevant moderators of OT or AVP effects, we separately averaged the activity observed within each of the mentalizing and mirror networks from Spunt and Adolphs ( | PMC10123837 | ||
Discussion | neurodevelopmental disorders | LUDWIG | In this large fMRI study, we found no effects of OT or AVP Meta-analyses have found evidence of beneficial effects of OT on theory of mind in studies of people with neurodevelopmental disorders (Bürkner, Williams, Simmons, & Woolley, The lack of results for OT or AVP suggests that these neuropeptides may not influence mentalizing in healthy individuals. This is consistent with the results from Geng et al. (It must be noted that there is still skepticism about the use of intranasal OT and AVP administration due to methodological issues, and in particular, the unclear pharmacokinetics (Leng & Ludwig, The present results may also differ from previous studies using the RMET because it is possible that OT may more strongly affect emotion recognition than mentalizing processes. Although mentalizing and emotion recognition networks show overlap in the mPFC (Lieberman, Straccia, Meyer, Du, & Tan, Another possibility for the present findings is that the main effects of the Why/How task are too strong to see drug effects. Indeed, one of the primary strengths of the Why/How task compared to other mentalizing paradigms, such as the RMET, is the tight control it offers in parsing neural effects related to mental state inference The present study has a number of strengths including the use of one of the most well-validated fMRI tasks for reliably dissociating the mentalizing and mirror networks, indicating the rare ability amongst fMRI tasks of distinguishing mental state representations from perceptual and motor representations. We also demonstrate null results of both main effects and interaction effects related to measures previously observed to moderate the effects of OT or AVP on social cognitive processes.Since the majority of human studies examining the effects of OT and AVP has relied on all male samples, our majority female sample can be viewed as a strength and represents an important contribution to the literature (Quintana et al., In addition, our results only relate to the effects of OT or AVP approximately 90 min post-administration. The current consensus for the optimal amount of time for incubation is approximately 35–50 min before beginning the task. Therefore, our results may not represent the peak increase in OT concentrations (Quintana et al., Another limitation is that our between-subjects design limited overall power (Quintana et al., Last, it is important to note that in our preregistration in 2015, the Why/How task was overlooked and not listed because it was initially intended as a localizer for use in a separate task in the same broader study (a task described as ‘learning for teaching’). In addition, unfortunately, for logistical purposes, the larger study was separated into three different preregistrations based on different funding mechanisms (NCT02393443; NCT02393456; NCT02394054). Information on the overall study design and the other tasks, including an empathy task, a deception detection task, and a task involving viewing images of participants' attachment figures, were listed in the original preregistrations. Null results that are not preregistered, such as those in the present study, may be subject to biases such as reverse In sum, in a majority female non-clinical sample, we found no effects of either OT or AVP administration compared to placebo on behavioral responses, neural activation, or functional connectivity related to mentalizing, a social cognitive process that is impaired in several clinical populations. Furthermore, of the relevant moderators we explored, no associations survived after correction for multiple comparisons. These results, based on the well-validated Why/How task, support previous research showing a lack of an association between OT and several social processes (Tabak et al., | PMC10123837 |
Acknowledgements | The authors thank Saskia Giebl, Shosuke Suzuki, Elizabeth Castle, and Natalie Saragosa-Harris for their assistant in data collection, and Eunji Kim, Zhixing Luo, and Maira Karan for their assistance in study management.The notes appear after the main text. | PMC10123837 | ||
Notes | Based on time and resources, we had the opportunity to include AVP administration for approximately 30 individuals. Given that we could only include this number, we chose to include only female participants in this condition because the vast majority of AVP administration studies have only included male participants (Brunnlieb et al., | PMC10123837 | ||
Supplementary material | For supplementary material accompanying this paper visit https://doi.org/10.1017/S0033291721004104.click here to view supplementary material | PMC10123837 | ||
Financial support | This research was supported by the Office of Naval Research (N00014-13-1-0082 – PI: M.D.L) and an NIMH postdoctoral training fellowship for B.A.T. in Biobehavioral Issues in Mental and Physical Health when he was at the University of California, Los Angeles (T32MH15750). | PMC10123837 | ||
Conflict of interest | None. | PMC10123837 | ||
References | PMC10123837 | |||
Materials and methods | Thirty-eight volunteer collegiate players (22 males; age = 21.1±1.9 years, height = 1.81± 0.06 m, weight = 73.4± 9.5 kg; 16 females; age = 21.3±1.5 years; height = 1.71± 0.07 m, weight = 67.8± 8.5 kg) underwent the 11+ and the Football+ in a randomized crossover design with a one-week washout. The Football+ starts with a self-estimated 40–50 percent running, followed by dynamic stretching of the hip muscles, shoulder contact, controlled lunge, Copenhagen exercise, and modified Nordic hamstring exercise. The second part involves roughly intensive small-sided games, followed by plyometric and anaerobic exercises in the third part. The warm ups’ effects on performance were determined by a linear sprinting test (20 m), countermovement jump performance (CMJ), Illinois agility (IA), and dribbling speed (DS) tests. Within-subject differences were reported as the means and SD. Pairwise t tests at the significance level of p<0.05 were used to calculate the significant differences. | PMC10118141 | ||
Results | Overall, except for the CMJ (mean = -0.43±3.20 cm, p = 0.21, d = -0.13), significant differences for the 20 m sprint (mean = 0.04±0.10 s, p = 0.005, d = 0.42), IA (mean = 0.65±0.45 s, p = 0.01, d = 1.43), and DS (mean = 0.60±1.58 s, p = 0.012, d = 0.38) were observed. In females, significant differences observed only for IA (mean difference = 0.52±0.42 s, p<0.001, d = 1.24) and DS (mean difference = 1.29±1,77 s, p = 0.005, d = 0.73), with the Football+ showing superiority. In males, significant differences were found only for 20 m sprinting (mean difference = 0.06±0.09, p = 0.005, d = 0.60) and IA (mean difference = 0.74±0.46, p<0.001, d = 1.62), with the Football+ having superiority. | PMC10118141 | ||
Discussion | Although practicable for injury prevention, the 11+ may not optimize acute performance and prepare players for high-intensity physical tasks as well as a well-structured, roughly intensive warm-up. Further gender-specific studies should evaluate the long-term effects of the Football+ on performance and injury prevention. | PMC10118141 | ||
Data Availability | All relevant data are within the paper and its | PMC10118141 | ||
Introduction | groin, knee injury | STRETCHES | Primarily designed as an injury prevention-oriented warm-up, the 11+ has been proven to reduce overall, hamstring, groin, and knee injury incidences by 40%, 66%, 48%, 46%, respectively [Regarding the acute effects of the 11+ on performance, however, the literature is tightly limited, sparse, and inconsistent. To date, only four studies including small samples (N<20) have been published [It is widely accepted that a practical warm-up should optimize motor performance. Several studies have addressed the advantages of dynamic warm-ups on acute performance and concluded that high-intensity warm-ups involving small-sided games and anaerobic exercises result in superior performance in intermittent-sprint running, reactive agility, countermovement jump, and 20-m sprinting [The weak effects of the 11+ on acute performance might result from a low intensity and suboptimal sequencing of the exercises embedded in this program. The 11+ starts with jogging exercises, dynamic stretches and controlled contacts followed by 10-minute strengthening exercises and ends with 2-min anaerobic exercises. Such a sequence is highly acknowledged for injury prevention [Taken together, the acute effects of the 11+ on performance and consequently its applicability for warming up before competitions and matches remain questionable. This is a prominent challenge considering that the acute effects of the 11+ on performance highly interact with the compliance and implementation of the program, which have shown a strong correlation to the success of each injury prevention protocol and to team success [ | PMC10118141 |
Methods | PMC10118141 | |||
Study design | The current study was conducted in accordance to the Helsinki declaration guidelines. The ethics committee of TU Dortmund University read and approved the study protocol. Participation was voluntary, and before study commencement, all participants signed a written informed consent letter. In a randomized crossover design, participants conducted two warm-up modalities with a 1-week washout phase in between. Following the application of each warm-up, participants’ performance was tested using a standardized test battery for performance assessment. To reach the best allocation concealment and avoid the learning effect from occasion to occasion, an ABBA approach was applied [ | PMC10118141 | ||
Inclusion/exclusion criteria | infection, collegiate, ill | INFECTION | This study included collegiate students who were actively playing football. Participants had to be at least 18 years old and participate in at least two training sessions per week. Those with a history of injury within the last four weeks were excluded. Participants were also excluded if they missed a measurement session, were engaged in intensive physical activities 24 hours before the test session, fell ill or contracted an infection during the study period. | PMC10118141 |
Participants | G*Power software [ | PMC10118141 | ||
Interventions | Both interventions consist of three parts lasting 25 minutes but differ in content. The 11+ aims to tackle modifiable injury risk factors such as neuromuscular control, static and dynamic balance, and the hamstring/quadriceps strength ratio [The 11+ exercises were described in detail by Soligard et al. [ | PMC10118141 | ||
Performance tests | The warm ups’ effects on performance were measured through a linear 5-, 10-, and 20-m sprint ( | PMC10118141 | ||
Sprinting test. | PMC10118141 | |||
Countermovement jump test. | PMC10118141 | |||
Illinois agility test. | PMC10118141 | |||
Dribbling test. | For linear sprinting, the players stood a meter behind the baseline and tried to run through the path with a maximal pace. The IA is performed in a rectangle of 10×5 m. The players start in a prone position, run toward the barrier at 10 m at maximum speed, return, and perform a zigzag run around four barriers, each 3.3 m apart. The test ends with another straight run to the end of the rectangle [ | PMC10118141 | ||
Statistical analyses | SE | Descriptive measures, such as the means, SD and mean standard error (SE), were calculated for each outcome measure. Normal distribution of the data was proven for all variables using the Shapiro‒Wilks test. Subsequently, the within-subject effects of the warm ups were analyzed by paired sample t tests. The level of significance was set at α < .05. Magnitudes of differences were assessed using Cohen´s d effect sizes and interpreted as small (.25), medium (.5), and large (1.0) [ | PMC10118141 | |
Mean values, standard deviation (SD) and mean standard error (mean SE) for the 11+ and Football+. | SD = standard deviation, SE = standard ErrorExcept for the CMJ (mean difference = -0.43±3.20 cm, p = 0.21, d = -0.13), the pairwise t test analyses revealed significant differences for the 20-m sprint (mean difference = 0.09±0.10 s, p = 0.005, d = 0.42), IA (mean difference = 0.65±0.45 s, p = 0.01, d = 1.43), and DS (mean difference = 0.60±1.58 s, p = 0.012, d = 0.38).According to gender, males outperformed females across all parameters regardless of the warm ups (p≤0.005). In females, although differences were observed in 20 m sprinting and CMJ, the pairwise t test revealed significant differences only for IA (mean difference = 0.52±0.42 s, p<0.001, d = 1.24) and DS (mean difference = 1.29±1,77 s, p = 0.005, d = 0.73), with the Football+ showing superiority. In males, although differences were observed in DS, the statistical analysis revealed significant differences only for 20 m sprinting (mean difference = 0.06±0.09, p = 0.005, d = 0.60) and IA (mean difference = 0.74±0.46, p<0.001, d = 1.62), with the Football+ having superiority. | PMC10118141 | ||
Discussion | amateur | The primary aim of this study was to compare the acute effects of the 11+ and Football+ on motor performance and address concerns regarding the use of the 11+ as an appropriate warm-up modality before high-intensity training and competitions. In general, the findings demonstrate that the Football+ program appropriately optimizes acute performance, leading to superior operation in sprinting, agility, and dribbling, but not in the vertical jump, compared to the 11+ program in collegiate players. Our outcomes strongly support Ayala et al. (2017), who found no acute impact on sprinting or vertical jump following the application of the 11+ compared to a dynamic warm-up among amateur male and female soccer players [There have been several studies assessing the effects of different warm-ups on acute performance, the majority of which reported the applicability of dynamic and intensive warm-ups to properly prepare athletes for high-level performance [It has been demonstrated that walking lunges and plyometric exercises improve jump height [The differences in agility and sprinting following application of the 11+ and Football+ warm-ups can be discussed based on their structure. The 11+ involves more static than dynamic exercises, with a focus on strengthening core and hip muscles. Although highly effective in terms of injury prevention, such a static structure, including high volume strength exercises, may not prepare the players for further intensive skilled tasks. Parameters such as agility and sprinting depend on the training features, including coordination, mobility, leg power, and speed [According to gender, males outperformed females across all parameters regardless of the warm-ups, which is entirely in line with previous studies [Although useful in injury prevention, the current findings highlight that the 11+ is not a proper warm-up for competitions and matches, as it may not prepare amateur players for subsequent skilled tasks and optimize their performance. Given that delivery of the 11+ to football administrations has remained challenging, such a lack of efficacy on acute performance potentially reduces the 11+ applicability for being used before competitions and consequently lowers the compliance and implementation of the program. Therefore, fundamental modifications on the 11+ aiming to link performance and injury prevention approaches appear to be intransitive and turn to the center of attention considering that the 11+ has not been updated since its launch in 2006. Trainers in amateur football are recommended to apply the Football+ program as a warm-up routine before competitions and high-load training sessions and benefit from its advantage in optimizing motor performance. | PMC10118141 | |
Conclusion | dribbling | A well-structured football-specific dynamic warm-up including dynamic stretching, roughly intensive running exercises, strengthening, small-sided games, and plyometrics properly optimizes acute performance and improves sprinting, agility, and dribbling compared to the 11+. Although practical in injury prevention, the 11+ may not optimize acute performance properly and should not be performed before competitions and high-demand training sessions. A new framework to incorporate both soccer-specific and injury prevention exercise into the program may justify the applicability of the 11+ as a warm-up routine and may potentially enhance the delivery and compliance of the program. This study provides empirical evidence behind the applicability of the Football+ program before matches and competitions in amateur football. Practitioners and trainers are highly recommended to apply the Football+ program and benefit from its advantage in performance optimization before competitions and matches. Further studies should evaluate the long-term effects of the Football+ on performance and injury prevention. | PMC10118141 | |
Limitations | This study involved no control group, and therefore, we could not compare the effects of two warm-up modalities with traditional warm-ups being used in amateur football. Further, given that the sample size was relatively small, dividing the players based on gender resulted in nonsignificant and contradictory results. Therefore, further gender-specific studies including larger samples are required to better identify the acute 11+ effects on different genders. | PMC10118141 | ||
Supporting information | (XLSX)Click here for additional data file. | PMC10118141 | ||
Mean values, standard deviation (SD) and mean standard error (mean SE) for the 11+ and Football+. | (DOCX)Click here for additional data file. | PMC10118141 | ||
The Football+ program. | (DOCX)Click here for additional data file.The authors would like to express their gratitude to Kevin Nolte for his support in data processing. | PMC10118141 | ||
Methods | SENSITIVITY | Activity-based costing (ABC) estimated the costs of post-VMMC care, including counselling, follow-ups, and tracing in $US dollars. Transportation for VMMC and follow-up was provided for rural clients in outreach settings but not for urban clients in static sites. Data were collected from National Department of Health VMMC forms, RCT databases, and time-and-motion surveys. Sensitivity analysis presents different follow-up scenarios. We hypothesized that 2wT would save per-client costs overall, with higher savings in rural settings. | PMC10653449 | |
Results | VMMC program costs were estimated from 1,084 RCT clients: 537 in routine care and 547 in 2wT. On average, 2wT saved $3.56 per client as compared to routine care. By location, 2wT saved $7.73 per rural client and increased urban costs by $0.59 per client. 2wT would save $2.16 and $7.02 in follow-up program costs if men attended one or two post-VMMC visits, respectively. | PMC10653449 | ||
Conclusion | COMPLICATIONS | Quality 2wT follow-up care reduces overall post-VMMC care costs by supporting most men to heal at home while triaging clients with potential complications to timely, in-person care. 2wT saves more in rural areas where 2wT offsets transportation costs. Minimal additional 2wT costs in urban areas reflect high care quality and client engagement, a worthy investment for improved VMMC service delivery. 2wT scale-up in South Africa could significantly reduce overall VMMC costs while maintaining service quality. | PMC10653449 | |
Data Availability | All relevant data are within the manuscript and its | PMC10653449 | ||
Introduction | Voluntary medical male circumcision (VMMC) is one of the most successful biomedical prevention strategies to reduce HIV transmission risk [Mobile health (mHealth) is used to describe the practice of healthcare and public health supported by mobile communication devices such as cellphones. mHealth interventions are recognized as more cost-effective compared to conventional interventions and may help address persistent challenges of healthcare worker (HCW) shortages and client difficulty in accessing healthcare facilities [In 2018, the International Training and Education Center for Health (I-TECH) in the Department of Global Health at the University of Washington (UW) and technology partner, Medic, conducted a randomized control trial (RCT) among VMMC clients in routine VMMC clinics in Zimbabwe using a two-way texting (2wT) telehealth approach between clients and nurses. 2wT is an mHealth platform for conversational messaging between VMMC clinicians and clients, providing short messaging service (SMS) for post-operative telehealth care in lieu of scheduled, in-person visits. In Zimbabwe, and likely in other VMMC programs operating at scale, in-person, post-operative visits may be burdensome for patients and providers, leading to poor attendance [South Africa, with reported mobile-cellular subscriptions of 161.8 per 100 population in 2020 [Costing of HIV prevention interventions is gaining recognition for its importance in informing policy and scale-up. In recent reviews of costing research on HIV prevention interventions in sub-Saharan Africa, 38 out of 159 studies (24%) were conducted in South Africa [ | PMC10653449 | ||
Materials and methods | We applied the activity-based costing (ABC) approach to estimate the costs associated with 2wT intervention. We focused on estimating the marginal cost of follow-up for an additional VMMC client using the 2wT or routine follow-up approach. | PMC10653449 | ||
Comparators | PMC10653449 | |||
Routine care | The VMMC implementing partner, Centre For HIV-AIDS Prevention Studies (CHAPS), followed all National Department of Health (NDoH) protocols [ | PMC10653449 | ||
Activities undertaken in the 2wT study. | PMC10653449 | |||
2wT intervention and specific 2wT RCT procedures | The 2wT approach for VMMC follow-up was described previously [An | PMC10653449 | ||
Data collection and assumptions | While exceptions do occur, in general, it is most common that VMMC clients self-paid transportation costs in urban sites and that the program paid for client transportation costs in rural areas. These transportation commonalities are reflected in the payer perspective, representing CHAPS costs as part of their overall VMMC program costs funded by the major VMMC donor, PEPFAR. This is the most prevalent model of VMMC funding and was assumed for the current approach.For the costing study, data were collected from three main sources: 1) RCT databases of routine VMMC data including client visits, AEs, and follow-up tracing; 2) the 2wT database; and 3) time-and-motion surveys designed for the costing component of the study. The first source, the RCT databases, included de-identified routine VMMC data on the number of visits attended, the number/type/severity of AEs, and the number of traced clients, by tracing method (phone and/or home visit). Visit costs associated with the study day 14 visit were excluded since it was specific to the RCT study and not considered routine VMMC follow-up care. The 2wT database contained enrolment data including transportation costs to the clinic. The 2wT database also included counts of inbound and outbound SMS. RCT-specific activities (e.g., additional consenting, RCT monitoring forms) were also not included in time-and-motion data.Based on Time and Motion Form (It is assumed that (1) all fixed costs related to post-operative follow-ups were in place, and hence we focus on analysing marginal costs in serving an additional VMMC client in the system; (2) that full-time employees worked a 40-hour workweek or 160 hours per month; (3) that nurse counselling time was 5 minutes in routine counselling and 10 minutes for 2wT counselling; (4) that the nurse spent one minute per SMS response on average, and (5) that the average phone call time with a VMMC client was 5 minutes. | PMC10653449 | ||
Hypotheses | We tested the following two hypotheses in our costing study:Hypothesis 1: 2wT reduces post-VMMC care costs by triaging only those in need of in-person review to care, allowing most men to heal safely at home without in-person follow-up visits.Hypothesis 2: 2wT saves more costs in rural VMMC program settings than in urban program settings. | PMC10653449 | ||
Data analysis: Activity-based costing | Using an ABC approach, we estimated the costs in the post-VMMC care continuum from the perspective of the payer–the VMMC program with donor support. There were four activity categories in costing: counselling on the day of male circumcision, SMS follow-ups, physical follow-up visits, and tracing. All activity-based costs were estimated for 2wT care and routine care to test the hypotheses of cost savings. We applied ranges of ±50% uncertainty interval for parameters presented in | PMC10653449 | ||
Summary statistics by activity category in rural and urban South Africa. | PMC10653449 | |||
Counselling | Each VMMC client had a counselling session directly following circumcision. The post-operative counselling cost was estimated by the average time in minutes for a counselling session and wage per minute for the nurse performing the counselling.Counselling cost = time * wage | PMC10653449 | ||
SMS follow-ups | There were three components in SMS follow-ups per client. The first component was the ‘Africa is Talking’ SMS aggregator monthly set-up costs. The second component was the SMS service cost, i.e., the product of SMS unit cost and average number of SMS per client. The third component was the associated personnel cost of sending a manual SMS.SMS cost = set-up cost + SMS service cost + manual SMS time cost | PMC10653449 | ||
Follow-up visits and AE management | The rural costing model included the estimation of transportation fuel cost, transportation time cost, and nurse review time cost per visit. In urban settings, we estimated reception time cost and nurse review time cost per visit. We used the average number of follow-up visits per client by location. Transportation cost was paid by the program in rural settings whereas patients paid for transportation in urban settings. In the rural setting, an enrolled nurse interacted with clients via 2wT and usually drove out to meet clients at their homes or workplaces to conduct any requested post-VMMC reviews. In urban settings, clients interacted with clients via 2wT and typically returned to the clinic on their own for visits when needed or desired. Reception time cost only applied to urban settings as the rural settings did not have reception.Cumulative moderate and severe AEs as defined by global VMMC standards [Rural visit cost = # of visits * (transportation fuel cost + transportation time cost + review time cost)Urban visit cost = # of visits * (reception time cost + review time cost)In rural settings, transportation fuel cost = Round trip distance to client home (km) * Litres of petrol (per km) * Price of petrol (per litre)AE management = probability of AE * AE material cost | PMC10653449 | ||
Tracing | In routine care, if the client missed both day 2 and day 7 visits, three phone calls were attempted to confirm healing. In the 2wT arm, if the client had no SMS contact by day 8, the client was actively traced via phone up to three attempts. Successful calls to clients in both arms took about 5 minutes If the client was not reachable by phone, up to three home visits were attempted for both study arms. The number of clients eligible for phone tracing and home tracing was reported in the RCT [Phone tracing cost = probability of phone tracing * (phone call time cost in up to 3attempts + phone call service cost of a successful completed call).For home tracing, transportation cost was estimated in the care model that the nurse drove to the client’s home to conduct the review. Transportation fuel cost, transportation time cost, and nurse review time cost were also included. We considered the least expensive model, in which the nurse also served as the driver. The urban tracing distance is 72% of the distance in rural settings according to the survey results in our RCT [Home tracing cost = probability of home tracing * (transportation time cost in all attempts + transportation fuel cost in all attempts + review time cost in successful attempt).For all tracing attempts, phone service costs and client review costs were only recorded for the successful attempt. For instance, if the nurse made three home visits and the client was reached in the last visit, the client review cost for only the one successful visit was included. | PMC10653449 | ||
Ethics | This Multiple Principal Investigators (MPI) study was approved by the Internal Review Boards of the University of Washington (Study 00009703, PI: Feldacker) and the University of the Witwatersrand, Human Research Ethics Committee (Ethics Reference No: 200204, PI: Setswe). All RCT participants provided written informed consent for use of individual-level data collected from both 2wT study specific sources and routine VMMC program data collection. All data obtained and utilized for the costing study was de-identified data from study databases and contained no identifying information. As part of the overall RCT IRB approvals, a waiver of consent was granted for healthcare worker observations from the time-motion study. | PMC10653449 | ||
Results | PMC10653449 | |||
VMMC clients | BLIND | A total of 1,460 VMMC clients were recruited for the RCT, and 141 (9.7%) clients were found ineligible for 2wT: 103 (45.2%) had no cell phones, 21 (5.7%) had a language barrier, 13 (3.5%) could not read or write, 2 (0.5%) were blind, and 2 (0.5%) were unfit to consent) [ | PMC10653449 | |
Costs in USD for routine care and 2wT per client (USD). | PMC10653449 | |||
Cost changes by implementing 2WT compared to the routine, rural vs. urban (USD). | PMC10653449 | |||
Unit cost for routine care (standard of care (SoC) and 2wT ($USD). | PMC10653449 | |||
Potential cost savings from 2wT (USD). | PMC10653449 | |||
Counselling | In both settings, an enrolled nurse with a monthly salary of $1,205 was assumed to spend 5 minutes in routine post-operative counselling and 10 minutes in 2wT counselling ( | PMC10653449 | ||
Follow-up visits and adverse event management | PMC10653449 | |||
Clinic visits | As previously reported in the RCT, and as expected per RCT intervention assignment, routine clients had more clinic follow-up visits than 2wT clients. Routine clients had 1.34 (0.67 to 2.01) visits on average between day 2 and day 13: 1.26 (0.63 to 1.89) in rural areas and 1.42 (0.71 to 2.13) in urban locations. 2wT clients had 0.22 (0.11 to 0.33) visits on average, with 0.14 (0.07 to 0.21) in rural areas and 0.3 (0.15 to 0.45) in urban clinics. Urban clients, in both routine and 2wT groups, had more visits than rural clients. Post-operative engagement in care was higher among 2wT arm than control: 94% of 2wT males responded to at least one 2wT message and 80.4% of control arm males attended at least 1 in-person, post-operative visit [ | PMC10653449 | ||
AE material cost | The study identified a total of 16 AEs across both arms. Among 719 visits in the routine arm, there were 5 AEs identified whereas 11 AEs were identified among 118 visits in 2wT arm. Material cost per AE, including bandage, paraffin gauze, and antiseptic ointment, was estimated at $5.28. | PMC10653449 | ||
Salary and time cost | In the rural setting, Enrolled Nurses with a monthly salary of $1,205 conducted the post-VMMC reviews with 3.79 (1.90 to 5.69) minutes per client. In urban settings, administrators with a monthly salary of $638 facilitated reception with 2.67 (1.34 to 4.01) minutes per client and a | PMC10653449 | ||
Transportation cost | In rural settings, routine VMMC teams drove to review clients or provided transport while urban clients were largely responsible for their own transportation. It was estimated that the round–trip distance to a client’s home on average was 39.64 (19.82–9.91) kilometers in rural areas. As indicated in the vehicle manual, the average fuel consumption of the vehicle that was used for tracing was 0.06L/km (From time-motion data, it was estimated that the program’s transportation time per client visit was 34 minutes in rural settings. No client transportation was provided by the program in urban settings over the observation period. | PMC10653449 | ||
Tracing | Among routine men, 29 clients did not attend any visit and were potentially lost-to-follow-up (LTFU). Potential LTFU were traced first by phone; 17/29 were not reached by phone and were traced by home visit. For the participants in the 2wT arm, 47 had no contact by day 8 post-VMMC; 46 were reached by phone and 1 was traced by home visit.The cost of phone call was $0.08 per minute. It was assumed that an Enrolled Nurse conducted the phone calls, and an average phone call time was 5 minutes. To trace potential LTFU clients, it was assumed that on average 3 phone calls were attempted in both routine group and 2wT group. In home tracing, the transportation fuel cost was the same as the clinic visit. The estimated tracing transportation costs on average, including fuel and personnel costs, were $0.64 and $0.04 in rural and urban areas, respectively. According to our time-motion study, it is important to note that home visits were costly both in terms of money and time, especially in rural areas. The average travel time to reach one client was 34 minutes (range: 17 to 51 minutes) and the average review time was 3.8 minutes (range: 1.9 to 5.7 minutes). On a typical day of rural tracing, the nurse spent 90% of the time driving. On average, 5 clients (range: 2.5 to 7.5 clients) would be traced in one day in rural settings. | PMC10653449 | ||
Discussion | In this costing analysis, we determined that 2wT-based VMMC follow-up saved an average of $3.56 per client across settings, with savings ranging from $2.16 to $7.02. 2wT improves the quality of post-VMMC follow-up care at lower overall cost by providing an SMS-based mHealth option for clients with access to cell phones, encouraging visits when needed instead of compulsory visits on day 2 and/or day 7. Savings using the 2wT approach were higher in rural as compared to urban areas–an important finding as the majority of VMMC program implementation occurs in rural areas [Cost savings from 2wT vary by adherence to required attendance at post-VMMC visits and by location. Given that moderate and severe AE rates in male circumcisions are low (1%-2%) [2wT may increase some costs that are likely offset by additional quality care benefits. Firstly, enhanced counselling incurred a minimal cost of $0.63, but enabled the clients to effectively identify and communicate AE concerns in daily SMS–a worthwhile cost. Second, daily SMS communication improved early detection of AEs and subsequent swift referral of those in need for in-person clinical visits. This triaging process led to identification of AEs earlier with less severity, likely averting costs of more severe AEs [Quality assurance likely also benefits from 2wT improvements in verification of, and supervision for, quality post-operative care. For NDoH, 2wT follow-up adhered to government regulations regarding client privacy and complied with required NDoH documentation for VMMC client follow-up. The 2wT system provides verification of timely, nurse-led, post-operative support in line with PEPFAR guidelines, facilitating quality follow-up regardless of client location. 2wT documentation also provides another layer of quality assurance to confirm program performance. Unique client verification via the 2wT system increases confidence in program productivity, providing another data source to prevent duplication in reporting. Although not formally considered in the costing analysis, supervision costs of 2wT may be lower than those for routine care. Routine monitoring of care quality via review of paper forms is time-consuming, requiring intensive efforts. However, 2wT dashboards and system-embedded hierarchies allow for remote client oversight and access to data for timely program monitoring. Supervisors can access 2wT messages, reports, tasks, and client records from multiple sites or remotely from a central location. Similarly, quality assurance activities can also take place virtually, allowing managers and program administrators to review data and provide clinical oversight, informing improvements. In future, calculation of these costs may demonstrate further benefit of the 2wT approach for routine VMMC follow-up. | PMC10653449 | ||
Limitations | pain | HOLIDAYS | There are several assumptions and limitations in this study. First, this study focuses on the cost of the activities to serve an average client presuming that 2wT is implemented within an existing routine VMMC service. Therefore, start-up costs (e.g., developing text message library, translation to local languages, adaptation to South Africa context) and fixed costs (e.g., full-time employment dedicated to 2wT, cell phones, computers, vehicle purchase, insurance, maintenance cost) were excluded. Second, we conducted costing from the perspective of the VMMC program and current guidelines to inform feasibility of adoption by the NDoH, assuming the existing VMMC donors would continue support for at least the 5-year time frame. However, with any payer (Ministry of Health, donor, or program), and evolving guidelines, 2wT costs and comparators could change over time. Third, we used the standard workweek in South Africa, i.e., 5 days per week, from Monday to Friday. In calculating hourly wage, we used the salary of the Enrolled Nurse cadre and did not take into account that some nurses work on weekends and public holidays or may have additional days off, such as annual leave or sick leave–considerations that could affect costs. For AE management, only costs related to reportable moderate and severe cases are documented and noted in this study. We did not measure the costs to manage mild AEs such as pain. Lastly, we explored will see savings (monetary cost) in reduced transportation fuel costs that the reduced staff time required for follow-up (an opportunity cost not a monetary cost savings) means that overall monetary costs to the program are likely to increase. | PMC10653449 |
Conclusion | Evidence from two RCTs in Zimbabwe and South Africa demonstrate that this 2wT approach provides high-quality VMMC follow-up as compared to required in-person reviews and lowers overall VMMC program costs. Rural savings using 2wT offset nominal increased costs in urban areas. Additional 2wT associated improvements in care quality, supervision, and verification also likely leading to longer-term savings. The health sector should invest in 2wT. In the context of National VMMC targets of 350,000 to 500,000 VMMCs per annum, employing 2wT could dramatically reduce the number of in-person post-operative reviews, resulting in concrete efficiency gains and significant annual program savings. Investing these resources back into the VMMC program could further expand VMMC access, improve care quality, and advance VMMC program goals of safe, efficient, and effective VMMC scale-up. | PMC10653449 | ||
Supporting information | PMC10653449 | |||
2wT costing study EpiCollect form. | Tool used for 2WT time-in-motion client follow-up data collection.(PDF)Click here for additional data file. | PMC10653449 | ||
Abbreviations | AIDS | AIDS, EMERGENCY | Modifiable Excel spreadsheet for 2wT scenario costing.(XLSX)Click here for additional data file.The authors would like to thank the following: the Departments of Health of the Gauteng and Northwest Provinces, Bojanala district and the Ekurhuleni Health District Research Committee (EHDRC) for allowing us to conduct the study in their districts; implementing partner, Right to Care and the CHAPS study implementation team. The authors would like to thank the Medic team and all study participants for their involvement in the study. The authors would like to thank Lingchao Mao and Ziwei He for independent replications of the results as well as thank Simon Ding and Emily Chu for their comments.Two-way textingadverse event(s)Centre For HIV-AIDS Prevention Studiesmale circumcisionNational Department of HealthPresident’s Emergency Plan for AIDS ReliefSouth AfricaWorld Health Organization | PMC10653449 |
Background | shoulder pain | Despite similar outcomes for surgery and physical therapy (PT), the number of surgeries to treat rotator cuff related shoulder pain (RCRSP) is increasing. Interventions designed to enhance treatment expectations for PT have been shown to improve patient expectations, but no studies have explored whether such interventions influence patient reports of having had surgery, or being scheduled for surgery. The purpose of this randomized clinical trial was to examine the effect of a cognitive behavioral intervention aimed at changing expectations for PT on patient-report of having had or being scheduled for surgery and on the outcomes of PT. | PMC10691016 | |
Methods | pain | SECONDARY | The Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention, was designed to change expectations regarding PT. PEERC was evaluated in a randomized, pragmatic “add-on” trial in by randomizing patients with RCRSP to receive either PT intervention alone (PT) or PT + PEERC. Fifty-four (54) individuals, recruited from an outpatient hospital-based orthopedic clinic, were enrolled in the trial (25 randomized to PT, 29 randomized to PT + PEERC). Outcomes assessed at enrollment, 6 weeks, discharge, and six months after discharge included the patient report of having had surgery, or being scheduled for surgery (primary) and satisfaction with PT outcome, pain, and function (secondary outcomes). | PMC10691016 |
Results | Chronicity, shoulder pain | The average age of the 54 participants was 51.81; SD = 12.54, and 63% were female. Chronicity of shoulder pain averaged 174.61 days; SD = 179.58. Study results showed that at the time of six months follow up, three (12%) of the participants in the PT alone group and one (3.4%) in the PT + PEERC group reported have had surgery or being scheduled for surgery ( | PMC10691016 | |
Conclusions | pain | In patients with RCRSP, PT plus the cognitive behavioral intervention aimed at changing expectations for PT provided no additional benefit compared to PT alone with regard to patient report of having had surgery, or being scheduled to have surgery, patient reported treatment satisfaction with the outcome of PT, or improvements in pain, or function. | PMC10691016 | |
Trial registration | The trial is registered on ClinicalTrials.gov: NCT 03353272 (27/11/2017). | PMC10691016 |
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