Physical rehabilitation is frequently recommended in dogs recovering from acute thoracolumbar intervertebral disc extrusion (TL-IVDE), but protocols vary widely. The objective of this study was to evaluate the feasibility of incorporating sensory-integrated neurorehabilitation strategies into a post-operative rehabilitation protocol in dogs with TL-IVDE. Non-ambulatory dogs with acute TL-IVDE managed surgically were prospectively recruited to this unblinded cross-over feasibility study. Eligible dogs were randomized to start with tactile-enhanced  or auditory-enhanced (floor piano) basic rehabilitation exercises performed twice daily for the first 4 weeks before switching to the opposite surface for the subsequent 4 weeks. Neurologic examination, open field gait scoring, girth measurements and an owner-completed feasibility questionnaire were performed at baseline and 2, 4, 6, and 8 weeks post-operatively. Twenty-four dogs were enrolled, 12 randomized to each order of exercises. Gait scores did not differ between the two groups at baseline, 4 or 8 week visits. All modified exercises could be performed and compliance was high. Adverse events potentially attributable to the study surface were mild, self-limiting and occurred in 2/24 dogs. The most common surface-related limitations were that the piano was slippery and that both surfaces were too short. The artificial grass was preferred by owners and dogs compared to the floor piano surface, but this was influenced by which surface was utilized first. Auditory and tactile modifications were feasible and safe to incorporate into a standardized rehabilitation protocol. This pilot study could prompt larger efficacy studies investigating the benefit of sensory-integrated rehabilitation in dogs with TL-IVDE. Acute spinal cord injury (SCI) occurs frequently in dogs, commonly due to thoracolumbar intervertebral disc extrusion (TL-IVDE) , 2. A suSensory stimulation as a component of rehabilitation protocols in dogs is occasionally mentioned with descriptions of toe pinching, hair brushing, and utilizing different flooring surfaces , 16, 19.The objective of this study was to evaluate the feasibility of incorporating tactile- and auditory-enhanced exercises into a standardized, post-operative basic rehabilitation protocol in dogs with TL-IVDE. We hypothesized that sensory-enhanced exercises would be simple to perform and well-tolerated by dogs recovering from acute TL-IVDE.Client-owned dogs were prospectively recruited from the existing patient pool of the Purdue University Veterinary Hospital. Dogs had to have an acute SCI secondary to TL-IVDE resulting in non-ambulatory paraparesis or paraplegia with or without pain perception, be aged 1 to 10 years and weigh between 5 and 25 kg. The minimum weight limit was to ensure dogs were sufficiently large enough to produce sounds on the surface utilized for the auditory-enhanced exercises. The upper weight limit was chosen to facilitate adequate participation in exercises given length limitations of the study surfaces. Duration of neurologic signs had to be ≤7 days from onset of pain or pelvic limb deficits. Confirmation of TL-IVDE between the third thoracic and third lumbar vertebrae (T3-L3) was required based on computed tomography or magnetic resonance imaging. Decompressive hemilaminectomy was performed followed imaging confirmation of extruded disc material. The number of sites decompressed and whether durotomy or prophylactic fenestration were performed was at the discretion of the neurosurgeon.Exclusion criteria included deafness, severe orthopedic or systemic disease, signs consistent with progressive myelomalacia on presentation, temperament , or unwillingness to return for study rechecks. The study was approved by the Purdue Animal Care and Use Committee (protocol #201200210) and all owners provided informed consent at enrollment.This study was a prospective, randomized, unblinded, cross-over design clinical trial. At 48 h post-operatively, eligible dogs were enrolled, stratified based on whether or not they had deep pain perception (deep pain positive or deep pain negative) and then assigned to one of two treatment groups in a 1:1 ratio using block randomization (groups of 4) with a cross-over design. Stratification ensured an even distribution of the most severely affected dogs  between the treatment groups. Group 1 participated in tactile-enhanced neurorehabilitation for 4 weeks, then auditory-enhanced exercises for 4 weeks while group 2 participated in the opposite order of exercises. Dogs were evaluated at enrollment (baseline visit) and at 2-, 4-, 6-, and 8-weeks post-operatively.Touch  , 36. A Gt-test to look for any differences between groups. P < 0.05 was considered significant.As a pilot, feasibility study, a power analysis was not performed. A minimum sample size of 20 dogs was planned with the aim of providing sufficient preliminary data on our methods. Descriptive statistics were utilized to summarize enrollment and feasibility data acquired in this study. Triplicate girth measurements were averaged to provide a mean value for each dog at each visit. To account for dogs of varying size and conformation, these measurements were expressed as a percentage of the baseline values. Mean OFS scores and girth measurements at baseline, 4 and 8 weeks post-operatively were compared using a p = 0.04), but no significant differences were identified between groups with regard to age or duration of signs (p > 0.05).Twenty-four dogs were enrolled with a mean age of 4.4 years (SD 2.2) and mean body weight of 9.4 kg (SD 4.5) at baseline. Breeds included 12 dachshunds, four mixed breed dogs, three French bulldogs, and five breeds represented by two or fewer dogs. Mean duration of neurologic signs prior to enrollment was 3.2 days (SD 1.2), accounting for a 48-h interval from presentation and surgery to enrollment. Twelve dogs including twoparaplegic with absent pain perception were randomized to start with exercises incorporating the artificial grass (Group 1). This group had a mean age of 3.8 years (SD 2), mean body weight 11 kg (SD 4.9) of and mean duration of signs of 3.2 days (SD 1.1). Twelve dogs including 3 paraplegic with absent pain perception were randomized to start with the floor piano (Group 2). This group had a mean age of 5 years (SD 2.4), a mean body weight of 7.7 kg (SD 3.6) and a mean duration of signs of 3.2 days (SD 1.2). Group 1 was significantly heavier than group 2  and no physical rehabilitation exercises were performed (of any kind) until enrollment and randomization. Nineteen dogs completed all study visits , one dog completed three of the four rechecks (missed 6-week visit), two dogs completed two of four rechecks (missing 6- and 8-week rechecks), one dog completed only the 2-week recheck. One additional dog was euthanized within 1 week after the baseline visit (due to lack of neurologic improvement).p > 0.05).At baseline, seven dogs were non-ambulatory paraparetic , 12 were paraplegic with intact pain perception  and five were paraplegic with absent pain perception in their pelvic limb toes and tail base . Of the dogs with available follow-up data, 16 dogs were ambulatory by 2 weeks, 17 dogs were ambulatory by 4 weeks and 18 dogs were ambulatory by 8 weeks or sooner. At study completion, 4 dogs remained non-ambulatory, of which 3 had persistently absent pain perception with varying degrees of pelvic limb motor. Gait scores across study visits are outlined in p > 0.05).Proprioception (paw placing) was absent in all dogs at baseline. By study completion, proprioceptive placing had completely normalized in five dogs, including two dog from group 1 and three dogs in group 2, but remained delayed or absent in the remainder. Mean girth measurements expressed as a percentage of baseline values are outlined in Adverse events during the course of the study occurred in 5/24 (21%) dogs, including two dogs in which it was considered attributable to the tactile or auditory modifications. In one dog, the piano noise was noted to be particularly aversive and another dog developed a superficial abrasion on the dorsum of the right pelvic limb paw during the study period when using the artificial grass. Neither event required intervention and the exercises were continued by both owners. Additional adverse events reported by owners in three dogs were related to their neurologic status. This included one dog initially paraplegic deep pain negative that regained pain perception by discharge but was euthanized at 1 week post-operatively due to lack of recovery of function. Another dog initially recovered uneventfully but had a recurrence of paraplegia at 4.5 weeks post-operatively due to a presumptive re-herniation. This dog was managed conservatively and had regained independent ambulation by the next study visit. A third dog was noted by the owner to be intermittently, mildly painful when performing the daily exercises during the first 2 weeks post-operatively. No adjustments to the dog's analgesic protocol were required.In 20/24 (83%) dogs, all modified exercises were performed as instructed, while owners of four dogs reported that they were unable to perform all of the exercises twice daily at some point during the study period. In 3 dogs, this was reported for a single 2-week period while one owner reported incompletely performing the exercises over a duration of 4 weeks. The reasons cited included being busy or other scheduling conflict in 3 dogs and fear of worsening status in one dog that suffered a presumptive re-herniation.All exercises were able to be performed with the modifications. However, ease of use varied between dogs and surfaces. Summarizing owner-reported feasibility across all study visits in which data was available, 13/22 (59%) owners reported that the grass was easy to use while 9/22 (41%) owners reported at least once that use was associated with mild difficulty. Six of 20 (30%) dog owners reported that the piano was easy to use while 14/20 (70%) owners rated on at least one occasion that this surface was mildly difficult  or hard to use . No trends over time during the 8-week study period regarding ease of use for each surface were identified.Feedback relayed via the questionnaire could be subdivided into comments that were related vs. unrelated to the surfaces. Positive experiences related to the the artificial grass were reported in two dogs including one dog that ‘loved the grass' and another where it ‘reminded the dog of being outside.' Positive experiences related to the floor piano were also reported in two dogs including one dog that ‘liked making noises' and another where it ‘seemed like a game.' The most common surface-related limitations or negative experiences reported were that the piano was too slippery and both the grass and piano were too short, especially when performing the walking exercises. These were noted in ~25 and 15% of questionnaire responses, respectively. Less than 10% of responses indicated that dogs initially disliked or were scared of the artificial grass texture or the piano noises, though all were reported to get used to it on subsequent responses. One dog weighing 6.4 kg was noted to be too small to consistently make noise on the floor piano when performing the exercises, though this was not specifically reported in the seven other dogs weighing the same or less (5.4–6.4 kg) than this dog.There were non-surface related comments provided in about 27% of questionnaire responses and these were generally attributable to behavioral limitations associated with performing the exercises. The most commonly reported behavioral difficulties included that the dog got distracted or tried to move away from the owner and the designated surface/exercise area, that the dog was not cooperative when performing the exercises, that the dog became bored or frustrated during the 5-min sessions for each exercise, and that the duration of the exercises was too long. Owners also noted that these limitations became more frequent or problematic to overcome as their dogs improved and regained more pelvic limb function.Of the 20 dogs that completed an 8-week study visit, owners of 14 dogs preferred the grass, three preferred the piano, two indicated an equal preference for both and one did not provide an answer. Eleven owners indicated that their dog preferred the grass, two thought their dog preferred the piano, five indicated their dog liked both surfaces equally, 1 owner reported that their dog disliked both surfaces equally, and one owner did not provide an answer. The surface preferences varied by group . When stThis is the first study specifically investigating sensory-enhanced rehabilitation exercises in dogs recovering from acute TL-IVDE. Our results demonstrated that simple auditory and tactile modifications were feasible and safe to incorporate into a standardized rehabilitation protocol. While both surfaces were generally well-tolerated, dog behaviors independent of the surface contributed to challenges in performing the exercises during the study period. This preliminary information could be used to design larger efficacy studies investigating the benefit of sensory-enhanced neurorehabilitation and to continue to optimize rehabilitation protocols in this population.Incorporating two different, readily accessible surfaces, a piece of artificial grass or a child's floor piano, we provided a simple means to enhance sensory feedback as part of a basic post-operative rehabilitation protocol consisting of PROM, assisted weight shifting and assisted walking. There is very limited detail from prior studies in veterinary patients regarding how exercises with a sensory component are incorporated , 16, 19.Given the potential benefits demonstrated by human neurorehabilitation studies combined with the dearth of information in veterinary SCI patients, our rationale was to explore novel sensory stimulation integrated into a standardized rehabilitation protocol. We demonstrated that the tactile or auditory adaptations were simple to apply and that the modified exercises could be performed by veterinary professionals and owners with no specific training or skills. Additionally, the dogs of this study with severe SCI secondary to TL-IVDE were amenable to both the tactile and auditory sensory stimulation, regardless of their neurologic status or recovery trajectory. Patients who were paralyzed or severely paretic and also those who regained independent walking tolerated both types of sensory stimulation. In addition to feasibility, no substantial adverse events directly attributable to the surfaces or exercise modifications were encountered. Initiation of exercises at 48 h post-operatively was well-tolerated which is consistent with other clinical trials of post-operative physical rehabilitation .While this study was not designed to evaluate efficacy, we utilized open field gait scoring, proprioceptive placing and caudal trunk and thigh girth measurements to evaluate outcomes. No significant differences were identified in these measures between the two treatment groups at 4 or 8 weeks post-operatively, but there was no control group. In addition to incorporating controls and blinding evaluators, outcome measures that can quantify the potential influence of a sensory-integrated approach would help to evaluate the efficacy of our methods. For example, quantitative sensory thresholds have been established in dogs with acute SCI –45 and cWhile all modified exercises were feasible, owner feedback highlighted several limitations regarding ease of completion. The short length of both the artificial grass and floor piano as well as the slippery surface of the piano were recurrent comments. This suggests that additional refinement of our techniques for incorporating sensory modifications is needed to improve feasibility, ensure appropriate compliance and optimize the potential benefit. Future adjustments to the tactile-enhanced exercises could include using a textured surface of longer length or incorporating expanded tactile modifications, including taking advantage of natural outdoor surface variations on assisted walks. Providing varied terrain  has been mentioned for dogs with recovering from disc herniation , but speOwner reported compliance was generally high throughout the study, but owner feedback also commonly focused on non-surface related issues. This included things such as dog boredom, distractability or lack of cooperation for performing the exercises, which were reported to worsen as pelvic limb function improved. In prior studies in which at-home rehabilitation regimens are recommended –12, 17, At study completion, 70% of owners preferred the grass and 55% of owners thought their dogs also preferred the grass while just 15% of owners and 10% of dogs preferred the piano. While this might support a true preference for the artificial grass surface, there was a discrepancy based on whether dogs were randomized to group 1 (grass first) or group 2 (piano first). When rehabilitation exercises were initially performed on the piano, the vast majority of the dogs and owners preferred grass as compared to the piano. The opposite, however, was not the case; when dogs used grass for the first half of the study, owner preference for grass over the piano was less decisive and dog preference was essentially equally spread between the surfaces. Therefore, the role of the order of surfaces and the dogs' neurologic status during the recovery period must be considered as factors impacting this preference. Similar to previously published data on recovery rates , the majSimilarly, all owners whose dogs completed the study but did not regain ambulation during the 8 weeks of follow-up, preferred the grass to piano. In these more severely affected dogs, traction and support from the artificial grass might have facilitated more easily performing exercises compared to the smooth surface of the piano. While pelvic limb tone and ability to bear weight against gravity improved over the course of the study among the dogs that remained non-ambulatory, this might not have been enough to improve the ease of completion of exercises on the floor piano (relative to the grass) and influenced the owner's preferred surface.Overall, this pilot project demonstrated that sensory integrated rehabilitation was feasible in dogs recovering from severe SCI and provides a framework to continue to investigate multisensory rehabilitation protocols incorporating visual, auditory, tactile, or somatosensory stimulation, or a combination of approaches. These preliminary results will be useful to design future, larger scale efficacy studies on sensorimotor integration into intensive, staged rehabilitation protocols in dogs recovering from SCI.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The animal study was reviewed and approved by Purdue University Institutional Animal Care and Use Committee (protocol # 201200210). Written informed consent was obtained from the owners for the participation of their animals in this study.MJL and SAT participated in study design, data acquisition and analysis, manuscript preparation, and editing and review. JB, BL, NP, and RY participated in data acquisition and analysis and manuscript editing and review. All authors contributed to the article and approved the submitted version.This project was funded by a grant from the American Association of Rehabilitation Veterinarians (AARV) and the Purina Institute.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Continuous glucose monitors (CGMs) have been associated with improved glycemic control and diabetes-related quality of life in youth with type 1 diabetes (T1D), however use is lowest among youth from low-income households and racial/ethnic minorities. Shared medical appointments (SMAs) have been shown to improve glycemic control and reduce diabetes distress in adolescents with T1D, but a focus on marginalized youth has been lacking. This prospective cohort pilot study will assess feasibility and acceptability of the SMA intervention and impact on CGM uptake and sustained use, glycemic control, and diabetes distress in marginalized youth with elevated hemoglobin A1c (HbA1C).The pilot study will recruit 20 publicly insured youth with T1D aged 8–12 years who identify as non-Hispanic Black or Latinx and have had at least one HbA1C value > 8% in the past year and their primary caretaker. The trial will employ an enrollment visit, SMA visits every 3 months over a 12-month study period, and a 6-month follow-up observational period. Feasibility measures include proportion of eligible youth successfully recruited for participation, proportion initiating CGM, SMA attendance, and retention through study completion. Acceptability will be assessed using satisfaction surveys. Changes in glycemic control will be assessed using CGM metrics and A1c from baseline to completion of the 12-month SMA intervention, as well as 3 and 6-months after completion of the SMA intervention.Implementing SMAs for marginalized youth has the potential to address diabetes disparities by optimizing clinical and psychosocial outcomes for the most vulnerable youth living with T1D.https://clinicaltrials.gov/ct2/show/NCT05431686.Trial Registration:  Youth of color and those from the lowest socioeconomic statuses have worse long-term outcomes as compared to wealthier, non-Hispanic whites (NHW) in the U.S ,3.Unfortunately, these disparities in outcomes mirror the reality of access to emerging diabetes technologies in clinical care and research, and Non-Hispanic Black (NHB) and Latinx youth are woefully underrepresented in diabetes technology trials. Continuous glucose monitor (CGM) use has been associated with lower HbA1c values, less hypoglycemia, and improved quality of life . CGM hasShared medical appointments (SMAs), wherein small groups of individuals participate in group education sessions in place of traditional clinic visits, have been successfully employed in pediatric chronic disease management, and are well suited for diabetes care . SMA visThe primary aim of this pilot study is to assess the feasibility and acceptability of a 12-month SMA model employing interprofessional facilitator-mediated discussion to promote the uptake and sustained use of CGM, while also providing peer support, and fostering community to improve glycemic control and promote health equity among youth with T1D. Furthermore, this SMA intervention, focused on the needs of publicly insured NHB and Latinx youth with sub-optimally controlled T1D, will be the first specifically developed to support uptake and sustained use of diabetes technology. This SMA intervention will be designed specifically for younger youth, where the impact of SMAs has not been well studied. The SMA intervention is rooted in the tenets of social cognitive theory, which recognizes that knowledge, self-efficacy, and psychosocial factors all impact health behaviors . We hypo22.1This pilot trial will utilize a prospective cohort design. The study will include a single intervention group participating in the SMA visits (n = 20). In addition to assessing acceptability and feasibility, a goal of this pilot trial is to obtain effect size estimates to power a larger scale randomized controlled trial. The trial is registered with the Clinical Trials Registry (NCT05431686). Study approval was obtained from the Children's National Hospital Institutional Review Board (Pro00016268). The study will be conducted at Children's National Hospital, a pediatric tertiary care center in Washington, DC.2.2The study inclusion criteria are: (1) aged 8–12 years, (2) T1D duration of at least 1 year, (3) at least one HbA1C value > 8% in the past year, (4) self-reported NHB race and/or Latinx ethnicity, (5) public health insurance, which is used as a proxy measure of socioeconomic status, (6) English fluency in the youth and parent, and (7) participation of the primary diabetes caregiver. English fluency is a requirement as we currently do not have the ability to run the SMA intervention in other languages. Enrollment is open to youth that are currently using CGM, as well as those who will commit to using CGM for the duration of the study period. The study exclusion criteria are: (1) Use of insulin pump therapy for diabetes management at time of enrolment, (2) major illnesses other than T1D, (3) significant cognitive limitations and major psychiatric disorders in the child or parent, (4) concurrent use of any non-insulin diabetes medication to control blood glucose levels, and (5) concurrent participation in any other clinical studies during study period.2.3. If an email address is not on file, a letter will be sent via mail.All youth scheduled for routine clinical diabetes appointments at Children's National Specialty Care Locations will be screened through chart review by study team members to assess for eligibility after a HIPAA authorization waiver for recruitment is granted. Study team members will review upcoming clinic lists for eligibility criteria, and eligible youth will be approached to participate during routine clinical visits. For youth who cannot be approached in person at the time of the visit or are still considering enrollment after the clinic appointment, we will attempt to contact primary caregivers by email, phone, and/or text message. Text messages will not contain PHI and provide general information about the project and how to contact the study team if interestedOnce a potential participant has been identified, a study team member will give an IRB approved study information letter to the participant's primary diabetes caregiver and legal guardian. If the caregiver expresses interest in the study, a copy of the IRB approved consent will be provided. A research team member will review the informed consent form with the family and explain the study and answer all questions prior to obtaining informed consent from the parent and assent from the child. The informed consent will be signed by the caregiver and assent will be obtained from the patient at an in-person visit before any research interventions are done.For youth who cannot be approached in-person at the time of the visit, we will attempt to contact individuals by phone and obtain e-consent and/or e-assent with REDCap. The REDCap link of the IRB approved consent will be provided to the caregiver via text or email. A research team member will review the informed consent form with the family and explain the study and answer all questions prior to obtaining informed consent from the parent and assent from the child electronically. The informed consent will be electronically signed by the caregiver and assent will be obtained electronically from the patient.2.42.4.1This trial will employ SMA visits every 3 months over a 12-month study period, and a follow-up 6-month observational period to continue to evaluate outcomes once youth return to routine individual follow-up care. SMAs will consist of 4–6 youth with T1D and their primary diabetes caregiver. The SMA visits will be in place of the routine diabetes clinic visits. A new SMA group will be formed when enough parent-child dyads have enrolled, and these groups will remain the same across the intervention. All youth and caretakers will complete standard check-in procedures with the clinic medical staff, including vital sign assessments, anthropometric measurements , and point-of-care fingerstick HbA1c measurements. CGM data from 14 days prior to each SMA will be reviewed by the endocrinologist ahead of the group visit, and parent-child dyads will meet with the endocrinologist one-on-one for up to 10 min to review individual diabetes management plans and any content that the youth or parent would prefer to discuss outside of the group setting.During each visit, the facilitator role will be shared between a pediatric endocrinologist, certified diabetes care and education specialist (CDCES), nutritionist, and psychologist. Youth and caregivers will individually meet with the endocrinologist at different time points during the session to update personal management plans and goals of care. Each of the SMA sessions will be focused on one aspect of the content described in the International Society of Pediatric and Adolescent Diabetes (ISPAD) Clinical Practice Consensus Guidelines on delivery of ambulatory diabetes care and diabetes education ,27 with An overview of the 5 SMA sessions including content to be reviewed and key team members is outlined in 2.4.2The structure of the group visits will be reviewed with youth and families, and all members of the diabetes team will introduce themselves and explain their role in diabetes care. As some children will be CGM naïve before this visit, education will focus on insertion and removal of the CGM along with appropriate use of the CGM receiver, alerts and alarms, data sharing, and troubleshooting common CGM problems. Youth who are CGM naïve will be started on CGM technology at the initial SMA visit. Established sharing of CGM data between youth and the diabetes clinical care team by setting-up Dexcom Share and Follow applications will be confirmed before the end of the visit. The group visit will conclude with a review of the core concepts discussed, and youth and caregivers will set goals for the next SMA.2.4.3Four follow-up SMAs will be scheduled 3, 6, 9, and 12 months from the initial group visit. SMA 1 will focus on recognition and management of hyper- and hypo-glycemia. During the session the facilitator will aim to address common challenges with CGM use related to hyper- and hypo-glycemia, including how recurrent alerts and alarms can result in alarm fatigue , and falSMAs will also allow ample opportunity to jointly review de-identified CGM reports and how to effectively interpret data and make management changes in response to CGM data, empowering children and families to improve self-management and reduce distress related to CGM use. Active participation in discussions and group exercises will continue to strengthen the community feeling and social support network within the SMA group. After the 12-month SMA, participants will return to standard clinical care with individual patient-provider visits.2.4.4Survey measures and assessments of glycemic control will be repeated after 3 months and 6 months of routine clinical care to assess for long-lasting effects of the intervention. After the SMA visits have been completed, children will be scheduled for individual follow up visits with their primary endocrinologist 3-months and 6-months (±1 month) from the final SMA visit. Families will continue to be contacted ahead of their follow up visits to remind them to attend and the need to complete surveys at these visits.2.5We will look at differences in the following measures from baseline to completion of the SMA intervention, as well as 3- and 6-months after completion of the SMA intervention. We expect to obtain very complete data, as parent-child dyads will receive ClinCard vouchers and parking passes provided they attend the SMA study visit and complete all required surveys. Any surveys that have not been completed ahead of the visit will be completed in-person at the time of the SMA visit.2.5.1Given the novelty of the SMA approach for marginalized youth and focus on CGM technology uptake and sustained use, feasibility and acceptability of the intervention will serve as the primary outcome measure. Feasibility is of great importance with a focus on youth from historically underrepresented racial and ethnic backgrounds and income levels. We will track feasibility using a CONSORT table that will include the proportion of eligible youth successfully recruited for participation, proportion initiating CGM, SMA session attendance rates, and rates of retention to study completion. Attrition data and team feedback will help determine how recruitment rates may be improved.Acceptability will be assessed using focus groups and satisfaction surveys. The survey measures will include 5-point Likert scale items exploring participants’ satisfaction with participation, perceived utility of the intervention content, and perceived benefit from participation. During the final SMA parent-child dyads will participate in a semi-structured focus group to assess satisfaction with the SMAs. Focus groups will be led by a researcher not involved in the delivery of SMA visits to create an environment where respondents can feel comfortable being open and honest with their responses and minimize bias. Participants will be asked to share thoughts and opinions on the SMA model and how it compares to the routine individual clinic visit standard of care. To assess perceived benefits, participants will have the opportunity to speak freely about the impact that SMA has had on diabetes-related distress, quality of life, self-management skills, and glycemic control for both the caregiver and the child (if applicable). Participants will also be asked to assess how SMAs have influenced attitudes and behaviors related to CGM use and CGM reports.2.5.2CGMs will be prescribed for all participants, as they are covered by public health insurance. Locked smartphones will be supplied for the study duration so that CGM data can be shared. CGM metrics and chart review will be used to assess effects on glycemic control. (1) CGM time in range from 70 to 180 mg/dL (TIR), (2) time below range (<70 mg/dL) (TBR), (3) time above range (≥180 mg/dL) (TAR), (4) mean sensor glucose, (5) coefficient of variation (CV) of glucose, (6) CGM wear time, and (7) HbA1c. Glycemic indicators will be obtained from CGM downloads for the 14 days prior to follow-up data collection time point. As guided by published standardized CGM metrics , data wiCGM time in range (TIR) from 70 to 180 mg/dL has been correlated with HbA1c values, which have classically been used as primary outcomes in T1D studies because of their association with microvascular complications . We have2.5.3P-PAID-C) ; and Investigator Initiated Research funding from 10.13039/100015769Dexcom Inc.This work was supported by the The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.


To describe self-medication habits of patients with otorhinolaryngological disorders to characterize problematic aspects in order to manage and correct them.Descriptive.A multiple-choice questionnaire was used to obtain the data, consisting of 17 questions about self-medication habits. It was distributed to the patients assisted in our ENT clinic, in July/2003.Approximately 83% of the admitted patients have practiced self-medication . However, 73% of them stated that it wasn’t mandatory to present a prescription in order to obtain the medicine. The most utilized drugs were: analgesics/antipyretics (90%), cold and flu drugs (78%), and NSAIDs (69%); antibiotics were the 8th (11%). Among the reasons or diseases patients believed to suffer from that justified the self-medication practice, we observed: headaches (76%), cold/flu (74%) and nonspecific febrile illnesses (56%); otitis, in general, was the last (12%).This study demonstrates the need for continuous educational programs about the risks of self-medication, besides appropriate governmental regulation and inspection. Self-medication is a common habit in our country, mostly for patients with otolaryngological disorders, and it has always been a very controversial and debated issue in doctor-patient and pharmaceutical relationships. Especially in developing countries, such as Brazil, self-medication may be considered a need that complements our health care system. Thus, the World Health Organization published guidelines to assess the medications that could be bought over the counter, without a physician's prescriptionWe used a questionnaire with multiple choice questions to obtain our data (Attachment 1), with 17 questions about self medication habits, which was answered by the patient during his/her wait for the medical consult, after being duly informed about its aim. This questionnaire was prepared based on a paper from Arrais et al. (1997)Of the 150 questionnaires distributed, 72 (48%) were answered, and the rest was probably ignored by the patients. Of the 17 questions presented, we noticed a certain difficulty in answering only the one related to the amount of active agents present in the medication used, despite all the explanation provided. Over half of the patients (57%) did not answer that question. Age ranged between 15 and 72 years, with an average of 38 years. Gender distribution was of 58% women and 42% men. Almost 83% of the users had used or bought medication without a medical prescription. Notwithstanding, of this total, 73% answered the medication they used did not require a medical prescription to be bought. 62% of the time the medication was for their own use; 10% for family members; 25% for both situations and 3% bought it for other people. 72% took advice from the drug store pharmacist or sales person and 54% from third parties . Besides, 56% of the patients had suggestions from the drugstore attendant when buying the medication. Among those who could answer the question, 11.74% reported that there was only 1 active agent in the medication; 23% reported 2 active agents and 3% reported 3 or more. As to most used medications we obtained the following results: first and foremost analgesic and antipyretic (90%), followed by cold symptoms medication (78%) and anti-inflammatory (69%). Antibiotic agents came next to the last (11%). . As for Attachment 1Penido Burnier InstituteThis questionnaire is part of a study about self-medication. This study is being developed at the otolaryngology department of this institution and aims at listing the main medications used by the population without a medical prescription. The results of this paper, based on your answers will be presented in medical meetings and published in medical journals. Thus, if you agree with the terms of this survey, please answer the questionnaire below (you do not have to write your name) and hand it back to the receptionist. We thank you for your help.IdentificationGender: male  female Age:Marital status: single  married  widow (er)  Divorced/Separated  Other Questionnaire1) Have you ever used or bought medication without a medical prescription? YES NO2) Who was going to use the medication? yourself another family member both someone else3) Did you forget or lost the prescription at the time of purchase? YES NO4) Have you ever taken advice from the pharmacist or sales person in order to purchase medication? YES NO5) Have you ever received unsolicited advice (in the drugstore) ? YES NO6) Have you taken advice from third parties? YES NO7) If affirmative (previous question), from whom? neighbor  relative friend  someone else8) Have you ever used old medical prescriptions? YES  NO9) If affirmative, these past prescriptions were: yours  from someone else - who:10) The medication bought/used required a medical prescription by law? YES  NO11) How many active agents  were there in the drug? 01 active agent  02 active agents  03 or more12) Mark which medications you have already self-medicated with: analgesics/antipyretics anti-inflammatory agents cough syrups anti-asthma drugs antibiotics systemic steroids  nasal steroids  nasal decongestants/vasoconstrictors anti-allergic/anti-histaminic ear drops cold/flue control medications other - which:13) Which reasons/diseases below you believed you had? headache fever cold/flue throat inflammations / infections  ear infections/ inflammations (otitis) sinusitis rhinitis allergies oral lesions skin lesions other head and/or neck disorders reflux pulmonary diseases other - which:14) For how long did you use the medication? 01 day 02 days 03 to 05 days over 5 days – how many?15) Followed the label instructions? YES NO16) When was your last medical visit? less than 01 week ago between 01 week and 01 month ago between 01 and 03 months ago over 3 months ago - When: I don’t remember17) This space is for comments / criticism / suggestions that you may have:Our study showed that women self-medicated more than men, especially those in the third and fourth decades of life; and men had a more homogenous distribution in the different ages analyzed, according to results attained by Carlini5 and Paulo8. We noticed that most of the medication was for self use, and not for family members; such fact reduces the risk of crossed contamination of relatives by shared use of medication , as well as it reduces the risks of inadequate and/or incomplete for other family members. Such finding had already been reported by Arrais et al3. As for the problems that led the patients to self-medicate, most of them were self-limited diseases, and this does not justify the use of antibiotics. Notwithstanding, the use of analgesic, cold control medications and cough syrups, if properly used, would be justified when aiming at improving the patient's life quality and symptom relieving. Many of such medication still reflect the national market, characterized by the presence of many unnecessary products, or at least, products of questionable efficacy, intensely advertised, but without due public education. We also noticed a reasonably low number of medications that did require a medical prescription to be sold, and such fact may reflect a greater populational awareness in regards of regulations and the very dangers of wrong self-medication. Finally, we noticed that medications are incorporated in the very dynamics of a consumption society, and thus, subject to market interest and setting them away from their prime objective of prevention and treatment of human diseases.This paper shows the need to carry out educational campaigns to alert the population about the use of many medications available in the market. For that, it is paramount to have an active participation of health care professionals, specially physicians and pharmacists, besides the help from the pharmaceutical industry, government regulations and broad and continuous inspection by the competent authorities.


Two decades after the discovery of the hormone FGF23, we know more about phosphate homeostasis as it turned out that FGF23 is the central hormone that regulates this. Hereditary hypophosphatemic rickets and tumor-induced osteomalacia could by then be explained, by autonomous FGF23 production, and the nephrology field was excited by this new marker as it turned out to be independently associated with mortality in people treated by hemodialysis. This led to the development of several immunoassays to be able to measure FGF23 in blood. In the past years we learned that FGF23 is a rather stable peptide, the precision of the assays is acceptable but assays are not standardized and therefore not comparable. This means that reference values and cutoff values need to be assay specific. For several assays reference values have been established and gender and age did not seem of high importance. The phosphate content of the diet, which can be culturally dependent, however, should be taken into account when interpreting results, but to what extent is not totally clear. Currently, clinical application of the immunoassays is established in the diagnosis of hereditary hypophosphatemic rickets and diagnosis and follow-up of tumor-induced osteomalacia. Definite conclusions on the usefulness of the FGF23 measurement in people with CKD either as a marker for risk prediction or a as target for treatment remains to be determined. The latter applications would require dedicated prospective clinical trials, which may take years, before providing answers. To improve the standardization of the FGF23 assays and to shed light on the biological functions that fragments might have we might aim for an LC–MS/MS-based method to quantify both intact and fragmented FGF23. In this literature review we will summarize the current knowledge on the physiological role of FGF23, its quantification, and the clinical usefulness of its determination. More than 20 years ago Fibroblast Growth Factor 23 (FGF23) was identified for the first time . Althoug176-X-X-Arg179 into inactive C- and N- terminal fragments [178. This site-specific O-glycosylation inhibits the action of furin pro-protein convertase and enables secretion of intact active FGF23 [The 32-kDa peptide FGF23 is mainly synthesized in bone cells, specifically in the osteoblasts and osteocytes . FGF23 iragments –7. The eve FGF23 . In humave FGF23 .FGF23, PTH and 1.25 dihydroxyvitamin D (1.25diOHD), the active form of vitamin D, interact one with the other and play an important role in the regulation of phosphate homeostasis . In the In pathophysiological situations with a primary surplus of FGF23, such as the genetic diseases autosomal dominant hypophosphatemic rickets (ADHR), autosomal recessive hypophosphatemic rickets (ARHR) and X-linked hypophosphatemia (XLH), and tumor-induced osteomalacia (TIO), hypophosphatemia occurs, which may lead to rickets or osteomalacia . On the On the other hand, in people suffering from chronic kidney disease (CKD), FGF23 concentrations are increased. This can be explained by multiple reasons. First, since less phosphate is filtered by the glomerulus, serum phosphate concentrations tend to increase, inducing an adaptive increase of FGF23 and an increase of phosphaturia. In the first phase of the disease, this is sufficient to keep serum phosphate concentrations within normal ranges, but as the disease progresses, phosphate concentrations will increase further as does FGF23 . Second,High FGF23 concentrations are thought to induce left ventricular hypertrophy and other cardiovascular pathology although causality has not been proven yet , 26.Currently, circulating FGF23 can be measured using immunoassays. Both intact FGF23 (iFGF23) assays and so called C-terminal FGF23 (cFGF23) assays are available on the market , delayed centrifugation (centrifugation after 8 h), and delayed storage stability (after centrifugation), long-term stability in the freezer, and the stability after freeze–thaw cycles.The short-term stability has been extensively described in literature and summarized in 2019 by Dirks et al. . After Snd generation Immutopics assay) in 10 plasma samples stored at – 80 °C for 40–60 months and showed a small decline in concentrations [Long-term stability is studied less extensively. One study demonstrated the stability of iFGF23 (Kainos assay) and cFGF23  , 42, 43.p < 0.001), with the estimated acrophase at 08:30 h (relative clock time) and the nadir occurred at 20:30 h, although there was quite some inter-individual variation [FGF23 seems to have a diurnal variation in both women and men –46. One A high phosphate diet leads to higher iFGF23 and cFGF23 concentrations compared to a phosphate restricted diet in healthy subjects and a low phosphate diet seems to decrease iFGF23 (but not cFGF23) concentrations in people with chronic kidney disease (CKD) , 47. As Biological variation is the sum of the within-subject variation and the between-subject variation and important to calculate the reference change value . A reference change value can be used in the follow-up of patients to determine whether there is a significant increase or decrease of the biomarker, in this case of FGF23. Up to now three studies investigated the biological variation of FGF23 in healthy subjects. Two studies used the Liaison XL for iFGF23 measurement and both studies found a within-subject variation of 14% and a reference change value of ~ 40% , 51. AnoIn the past 20 years several groups conducted studies to determine references intervals for FGF23. Some laboratories might have established reference intervals that are only being used for internal purposes, while other published these results. We summarized the in literature available reference intervals including the sex, age, and other information about the subject and immunoassay that was used  a 92% sensitivity and the Immutopics iFGF23 assay (1st generation) a 38% sensitivity in detecting all hypophosphatemic patients with a confirmed TIO according to Imel et al. . In 2008In the last decades FGF23 has proven its worth in the diagnosis of TIO and hypophosphatemic rickets , 61. ForAlthough FGF23 is increased in CKD, with extremely high concentrations in people treated by dialysis, and these FGF23 concentrations are independently associated with mortality and related to cardiovascular events , to dateThe development of several FGF23 immunoassays improved the possibility for diagnosing and follow-up of people with hereditary hypophosphatemic rickets and TIO. Definite conclusions on the usefulness of the FGF23 measurement in people with CKD remains to be established and will only be answered when trials with FGF23 targeting interventions will be performed. Nevertheless, FGF23 immunoassays made it possible to study and firmly establish the association of  FGF23 concentrations with clinically relevant endpoints, such as mortality and cardiovascular events. This might lead to FGF23 as a biomarker for risk prediction to identify high-risk patients.The majority of the currently available immunoassays are ‘research only’ kits, thereby not allowed to use for patient care. Preferably, these assays should be marked for IVD use. From some of the CE-marked assays no analytical data are published, this information gap should be filled. An external quality assessment scheme for FGF23 and harmonization or standardization of the measurements would also help to improve the quality.The immunoassays that are currently used to measure FGF23 do not measure and quantify both the fragments and the intact hormone separately. In addition, regarding post-translational modification like phosphorylation and glycosylation of the FGF23 protein we are ignorant, both on its impact on assay performance and its clinical relevance. A step forward could therefore be the development of an LC–MS/MS method to quantify FGF23, both intact and fragmented and focusing on possible phosphorylation and glycosylation. Post-translational modifications might affect biological functionality in the physiological situation. A method able to separately detect intact FGF23 and its fragments would shed light on the differences in method comparisons that are observed and also shed light on the biological functions that fragments might have . In addi


Clinicians should consider the potential added value of task-specific fear assessment over the sole use of general kinesiophobia assessment. Kinematic data obtained during a movement task by individuals with chronic low back pain seem to be related to pain-related fear. General kinesiophobia assessments, such as Tampa Scale for Kinesiophobia, are often used to assess pain-related fear. However, these questionnaires could suffer from a lack of sensitivity and do not measure the fear of specific movements.The purpose of this study was to investigate whether the task-specific assessment of pain-related fear exhibits a closer association with trunk kinematics during lumbar flexion compared with the general kinesiophobia in individuals with chronic low back pain.2). We conducted a hierarchical multiple linear regression analysis to determine variance explained in lumbar flexion task performance by task-specific fear after controlling for demographic, pain, and general kinesiophobia.We assessed pain-related factors, task-specific fear, and Tampa Scale for Kinesiophobia-11 scores of 51 company employees. The lumbar angle during a lumbar flexion task was recorded by 2 wireless Axivity Ax3 accelerometers attached to the subject's spinous process (L3) and sacral spine (S2). Only task-specific fear was evaluated after the lumbar flexion task. We calculated the maximum lumbar flexion angle (°) and the peak angular velocity of lumbar flexion/return from flexion  and lumbar flexion .The results showed that task-specific fear was associated with the peak angular velocity of lumbar return from flexion (Our results suggest that clinicians should consider the potential added value of task-specific fear assessment over the sole use of conventional kinesiophobia assessment. Therefore, identifying the causes of these changes could be helpful in the treatment and prevention of CLBP.Many people (40%–85% of most populations) develop low back pain (LBP) at least once in their lives.13 The same has been reported for workers with CLBP, which is not indicative of definite tissue damage, and there is no clear relationship between the kinematics of the trunk and pain intensity of CLBP.8 Thus, these previous studies concluded that the factors involved in trunk kinematics are still unclear. In the “fear-avoidance model” of Vlaeyen and Linton,33 individuals undertake protective behaviors to avoid pain or to avoid movement(s) that might cause pain21; such behaviors could influence the development of the trunk kinematics in individuals with CLBP. Meulders et al. hypothesized that fear of movement-related pain influences trunk kinematics, although the movements themselves do not cause pain.22 Several studies have demonstrated that reduced speed of lumbar movement and hesitation of the movement were associated with the fear of movement as evaluated by self-reported questionnaires, such as the Tampa Scale for Kinesiophobia (TSK) and Pain Anxiety Symptoms Scale (PASS).29 However, such self-reported questionnaires could lack sensitivity because they do not measure the fear of specific movements or activities. The self-reported questionnaires administered before performing a particular movement may not reflect the “actual” fear during the movement because the questionnaires evaluate fear of general movement, not the target movement. The potential importance of task-specific fear has been highlighted in a review of the literature on the fear-avoidance model, which suggests the need to establish an assessment modality for the fear of specific movements.24Recent systematic reviews have reported no clear relationship between trunk kinematics and pain intensity in CLBP, and trunk kinematics were associated with pain-related fears and catastrophizing.12 In this FT task, a magnetic sensor was attached to the thumb and index finger of the patient to measure velocity and hesitation of movement. This task-specific assessment provided direct knowledge of the fear during a specific movement, rather than the more general fear of movement measured by general kinesiophobia. This study aimed to investigate whether the task-specific assessment of pain-related fear exhibits a closer association with trunk kinematics during lumbar flexion compared with the general kinesiophobia assessment in individuals with CLBP.Recently, a preliminary study reported that specific-fear after a finger-tapping (FT) task in patients with a distal radius fracture could be evaluated by a visual analogue scale.This cross-sectional study was conducted at a company in Izumisano, Japan, between February 14 and 21, 2020. The recruitment period was from January 23, 2019, to February 13, 2019. Flyers that stated the inclusion and exclusion criteria were distributed to a company in Izumisano, Japan, and volunteers were recruited. The inclusion criteria were as follows: full-time employment at the company; the age of 20 to 65 years; LBP duration of >6 months; a score of 1 or more on an 11-point numerical rating scale  for pain intensity; at least one previous visit to an orthopedic clinic due to LBP; and a diagnosis of LBP by the orthopedist. The exclusion criteria were as follows: part-time employment; previous spinal surgery; serious spinal pathology; pain at a site other than the lower back; acute lower back pain; psychiatric illness as diagnosed by a psychiatrist; or a diagnosis of neurological disease. Subjects with pain at a site other than the lower back and a diagnosis of neurological disease were excluded; therefore, we excluded subjects with sciatica . The study was intended to have 100 subjects, but 46 did not participate due to the influence of Covid-19; thus, a total 54 subjects  fulfilled these criteria and participated in the study. In addition, we conducted a preliminary study because we are considering a large-scale “low back pain examination” and intervention for chronic low back pain patients who have fear of movement in the future.34This study was approved by Osaka Kawasaki Rehabilitation University (no. OKRU19-A012) and conformed to the 2008 Helsinki Declaration of Human Rights guidelines. Before the study started, written informed consent to participate was obtained from each subject. In addition, we report this study following the STROBE guidelines.First, subjects completed a questionnaire regarding their age, gender, weight, and height. Each subject's body mass index (BMI) was calculated by dividing the body weight (in kilogram) by height squared (in square millimeters).23 We chose pain intensity during movement because movement-evoked pain appears to be more relevant to understanding its relationship with kinematic analysis than usual pain intensity at rest.14 Task-specific fear was assessed by another NRS (0 = no fear and 10 = the highest possible degree of fear) after the task.20 Both pain intensity and specific-task fear were assessed at the end of each type of movement pace. Subjects were asked the following questions: “Please indicate the pain intensity you experienced during lumbar flexion on a scale of 0 (no pain) to 10 (the highest possible degree of pain),” and “Please indicate the fear of movement you experienced during lumbar flexion on a scale of 0 (no fear) to 10 (the highest possible degree of fear).”Pain intensity (movement evoked pain) was assessed using an NRS scale (0 = no pain and 10 = the highest possible degree of pain) after the task.15 The TSK-11 is scored on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree). Low back pain disability was assessed by a Japanese version of the Roland Morris Disability Questionnaire.27The kinesiophobia of subjects was assessed using the TKS-11 Japanese version, which shows better internal reliability, identical construction, and known group validity compared with the 17‐item version.29 the subjects were asked to perform this lumbar flexion task at 2 paces—that is, at a speed that was comfortable for the subject and as fast as possible. In addition, the subjects were instructed to bend their lumbar spine forward until they had reached the maximum lumbar range of motion (ROM) and then to extend their lumbar spine backward and finally to return to an upright posture. The subjects practiced the tasks ahead of time so that they would not perform the task incorrectly and to check that the sensor attached to the subject would not come off. Each subject performed the lumbar movement task thrice, and a comfortable pace and the fastest possible pace were performed randomly. In addition, the subjects were allowed to take a 30-second break between the first and second task periods and between the second and third task periods. Among them, a 15-second rest was used for the kinematic analysis.For the lumbar flexion task, the subject stood upright in a natural posture and then bent forward at the start cue. As in previous studies,5 The 2 accelerometers were attached to the spinous process (L3) and sacral spine (S2)  the maximum lumbar flexion angle for lumbar flexion ; (2) the peak angular velocity of lumbar flexion (°/s2); and (3) return from flexion (°/s2). The maximum lumbar flexion angle (°) and peak angular velocity of lumbar flexion (°/s2) were calculated in phase 1. The peak angular velocity of lumbar return from flexion (°/s2) was calculated in phase 2. We used the average of the peak angular velocity for each trial. In addition, phase 1 was from the start cue to the time point at which the subject's lumbar flexion angle was maximum. Phase 2 was from the time point at which the subject's lumbar flexion angle was the maximum to the time point at which the subject returned from flexion. Subjects were in a natural posture with a neutral lumbar spine position at both the time point at the start cue and the subject's return from flexion. Thus, the maximum lumbar flexion angle was the same for phases 1 and 2.We recorded the lumbar angle of the subjects during the lumbar flexion task with the use of 2 wireless Axivity Ax3 accelerometers . The Ax3 is a small , 3-axis accelerometer capable of logging acceleration data at 100 Hz. This device has been validated for recording human movement at high resolution.We compared kinematic data  by performing a 1-way analysis of variance (ANOVA) and a post hoc test using Bonferroni correction.P values.1 In our study, a correlation analysis was conducted using 5 factors  for task-specific fear, TSK-11, and pain intensity. Therefore, the significance level of 0.05 was divided by 5, so the significance level was set at P = 0.01. In addition, Fisher z transformation was used to assess between-group differences of correlation coefficients.9 A z score outside the range of −1.96 ≤ z ≤ 1.96 indicated statistically significant differences between coefficients.We used Pearson correlation test to investigate whether the task-specific fear (NRS), and the TSK-11 results were related to the kinematic data. This correlation analysis was conducted to determine the objective variables and to investigate a correlation between task-specific fear and TSK-11. Because the significance level would change if the correlation analysis was repeated, Bonferroni correction was used to adjust the P = 0.05. If there was no correlation between fear, age, and BMI, step 1 was deleted, and step 2 was carried forward. In this case, step 1 regression used pain intensity and TSK-11, whereas step 2 added task-specific fear. The variance inflation factor (VIF) was calculated to investigate multicollinearity. Multicollinearity was deemed present if the variance inflation factor was more than 5 because a VIF limit of 5 is stricter than a VIF limit of 10.16To investigate whether the task-specific assessment of pain-related fear exhibits a closer association with trunk kinematics during lumbar flexion than the general kinesiophobia in individuals with CLBP, we conducted a hierarchical multiple linear regression analysis using SPSS ver. 27.0 . Step 1 regression used the subjects' basic information (age and BMI), and step 2 used the same information plus the pain intensity and TSK-11 data. Step 3 adds task-specific fear. The significance level was set at Four of the 54 subjects did not complete the evaluation. Thus, the final number of subjects for the analyses was 50 subjects. Tables r = −0.43, P = 0.001) at a comfortable pace, and the peak angular velocity of lumbar return from flexion at a comfortable pace significantly correlated with task-specific fear  , and the peak angular velocity of lumbar return from flexion significantly correlated with task-specific fear . Task-specific fear did not significantly correlate with the TSK-11  , and the peak angular velocity of lumbar return from flexion (comfortable pace) was associated with task-specific fear . In addition, we found that the peak angular velocity of lumbar flexion (fastest possible pace) was associated with task-specific fear , and the peak angular velocity of lumbar return from flexion (fastest possible pace) was associated with task-specific fear   was associated with task-specific fear .The major difference between general kinesiophobia assessment  and task-specific fear is whether trait or situational kinesiophobia is being evaluated. Because general kinesiophobia assessment  assesses beliefs related to the perceived harm and threat of experiencing LBP or performing physical activity while in pain, it cannot assess specific fears of movement. In addition, examples of specific activities  were not provided when patients responded to self-reported questionnaires, limiting their use in developing treatment programs. Conversely, we asked the subjects about the lumbar flexion task and assessed their fear after the task. Furthermore, because many patients have different fear behaviors, it may be better to use specific fears for an assessment to guide interventions. Thus, general kinesiophobia assessment  involves a trait assessment, and task-specific fear involves a situation assessment.35 Campbell et al.3 showed that situational catastrophizing was more strongly associated with experimental pain responses than dispositional Pain Catastrophizing Scale scores in healthy subjects and arthritis patients. In addition, higher levels of situational catastrophizing are associated with lower pain thresholds and higher pain ratings. Woznowski-Vu et al.35 reported that situational catastrophizing significantly correlated with self-reported disability and pain questionnaires, both cross-sectionally and at a 3-month follow-up. This finding is very useful for clinicians who perform psychologically informed physical therapy interventions, such as cognitive functional therapy, which seeks to expose and modify what is experienced during a task  in physical therapy settings where the therapist can choose the assessment (task-specific fear NRS vs TSK-11). However, because our study was a preliminary investigation, the results should be interpreted with caution.Our results are consistent with those of previous studies.13 Systematic reviews have shown an association between kinesiophobia and ROM.13 However, these systematic reviews did not include measures of angular velocity. A previous study showed that high pain-related fear was associated with angular velocity but not with joint angle.30 In addition, Fujii et al.10 reported that fear is associated with angular velocity. Recovery from an episode of low back pain follows a predictable course in which the recovery of normal lumbar angle is followed by recovery of normal peak angular velocity and finally angular acceleration.30 In the current study, the pain intensity and Roland Morris Disability Questionnaire scores were small, and the subjects were employed workers. Thus, because the subjects' pain was not intense nor was it interfering with their work, the angular velocity may have been affected without affecting the joint angle in our study. However, the practice trials completed before the lumbar movement task may have influenced the data.Our results did not show a significant correlation between kinesiophobia and maximum lumbar flexion angle, which is inconsistent with systematic reviews.29 our results are not consistent with those reports. Among patients with low back pain, it is unclear whether high pain intensity or kinesiophobia influences various movements or activities. To identify the movements or activities that are affected by pain or kinesiophobia, those movements or activities must be evaluated. Although some patients with CLBP may present with kinesiophobia of general movement, others might be fearful of specific activities only. Thus, CLBP patients who feel fear of specific activities may not show a high score on the general kinesiophobia, such as TSK or Fear Avoidance Belief Questionnaire. When asked about fear of general pain or fear of pain related to particular movements, patients will tend to imagine different contexts. Another reason may be that the self-reported questionnaires may lack sensitivity for measuring fear of a specific movement or activity. The potential importance of task-specific fear has been highlighted in a review of the literature on the fear-avoidance model, which suggests the need to establish a means of assessing fear of a specific movement.24Although other research groups have reported that the TSK was significantly correlated with kinematic data,31 Second, in the case of a longitudinal intervention, there is a need to assess fear before and after a movement or task so that fear-avoidance beliefs or expectations and the fear of the movement can be confirmed.25 In addition, kinesiophobia and pain factors related to the lumbar movement were not assessed after the practice trials. It is possible that failing to randomize subjects to different task orders and scale inquiries influenced the results in this study. It is possible that we were unable to create similar conditions in each trial using clear indicators. A previous study reported that the distinction between movement-evoked pain and resting or spontaneous pain is critically important.6 Our study did not distinguish between pain at rest and pain during a task or task-specific pain as possible confounding factors. Future research integrating sensory, psychological, and motor factors related to pain is required.14 Repeated full-range lumbar flexion may lead not only to the summation of pain but also to viscoelastic changes affecting the biomechanics of lumbar flexion movement through progressively reduced passive tissue resistance to movement. Third, adding a tool  to allow further investigation of objective muscle activity without the interference of psychological factors would be of additional value. Our study was a preliminary study, and the sample size was relatively small. Thus, the results may differ if the sample size is increased and the experiment is repeated. Therefore, the results of this study should be interpreted considering that it is a preliminary study. Thus, we believe that this study can be improved by increasing the sample size and recruiting individuals with high kinesiophobia levels.Our study has some limitations to consider. First, our results were obtained in a population with a moderate disability; therefore, they may not be applicable to all patients with CLBP. Compared with subjects of previous studies, the TSK-11 scores or pain intensity of our subjects were somewhat lower; therefore, all kinematic data might not be significantly correlated with the TSK-11 scores.We sought to determine which of the 2 measures, task-specific fear (task-specific assessment) and general kinesiophobia (TSK), was more closely associated with trunk kinematics in individuals with CLBP. We found that, compared with TSK-11, task-specific fear was significantly more related to the peak angular velocity of lumbar return from flexion (as fast as possible). Our results suggest that clinicians should consider the potential added value of task-specific fear assessment over the sole use of conventional kinesiophobia assessments.The authors have no conflict of interest to declare.


Background: National lockdowns have led to significant interruption to children’s education globally. In the Autumn term in 2020, school absence in England and Wales was almost five times higher than the same period in 2019. Transmission of SARS-CoV-2 in schools and ongoing interruption to education remains a concern. However, evaluation of rapid point of care (POC) polymerase chain reaction (PCR) testing in British schools has not been undertaken.Methods: This is a survey of secondary schools in England that implemented PCR-based rapid POC testing. The study aims to measure the prevalence of SARS-CoV-2 infection in schools, to assess the impact of this testing on school attendance and closures, and to describe schools experiences with testing. All schools utilised the SAMBA II SARS-CoV-2 testing platform.Results: 12 fee-paying secondary schools in England were included. Between September 1st 2020 and December 16th 2020, 697 on site rapid POC PCR tests were performed and 6.7% of these were positive for SARS-CoV-2 infection. There were five outbreaks in three schools during this time which were contained. Seven groups of close contacts within the school known as bubbles had to quarantine but there were no school closures. 84% of those tested were absent from school for less than one day whilst awaiting their test result. This potentially saved between 1047 and 1570 days off school in those testing negative compared to the NHS PCR laboratory test. Schools reported a positive impact of having a rapid testing platform as it allowed them to function as fully as possible during this pandemic.Conclusions: Rapid POC PCR testing platforms should be widely available and utilised in school settings. Reliable positive tests will prevent outbreaks and uncontrolled spread of infection within school settings. Reliable negative test results will reassure students, parents and staff and prevent disruption to education. Testing could reduce SARS-CoV-2 transmission in schools and mitigate against school closures and COVID-19 related absences. We evaluated the impact of rapid point of care PCR testing for SARS-COV-2 in schools and found it identified cases promptly and reduced school absence in non-cases.. National lockdowns have led to significant interruption to children’s education. Over the Autumn term in the 2020–2021 academic year, the average weekly absence from state-funded primary and secondary schools in England was 13% and this peaked at 28% in the last week of the Autumn term in December 2020 (school attendance during SARS-CoV-2 outbreak). This compared with an overall absence rate of 4.9% in Autumn 2019 before the COVID-19 pandemic. Attendance at state-funded secondary schools in 151 local authorities in England fell from 88% in the week of the 10th of September 2020 to 68% by the week of the 11th of December 2020 (English secondary school attendance). Further interruptions must be avoided.The COVID-19 pandemic has had an indelible impact on the education of children in the United Kingdom. However, less impressive results have been reported in community settings using antigen tests with lower sensitivity. Rapid, sensitive and specific SARS-CoV-2 POC testing could help to avoid school absence and school closures.The availability of rapid point of care (POC) diagnostic testing has been shown to facilitate timely diagnoses in hospitalshttps://doi.org/10.1128/JCM.01262-20).We conducted a survey of SARS-CoV-2 infection in secondary schools in England that had implemented PCR-based rapid POC testing for use in diagnosis and isolation of pupils and staff with SARS-CoV-2 infection on their school premises. All participating schools were fee-paying schools and boarding or mixed boarding/day schools. All schools utilised the SAMBA II SARS-CoV-2 testing platform. The tests were performed on combined nose and throat swab samples by a school nurse who had received training from the manufacturer. The limit of detection (LOD) of the SAMBA II SARS-CoV-2 test is 250 copies/ml .Schools were identified by convenience sampling either through the Independent Schools’ Bursars Association, who cascaded the invite to join the study to the headteachers of their member schools or through our working knowledge of schools that had purchased their own testing platform. The headteacher of the schools were sent an electronic letter inviting their school to participate. The letter included the participant information and consent forms. Informed consent was obtained from the headteacher in an electronic format. Following this, the school was enrolled in the study. A survey was sent out to the school electronically which was completed by the school nurse and returned weekly. Fully anonymised risk factor data were gathered along with the number and results of SARS-CoV-2 tests carried out in each school (see Extended data 1)school attendance in England).Data on new daily cases of COVID-19 stratified by age from South East, South West and East of England were downloaded from the Public Health England website. Data on state-funded school attendance during the COVID-19 was obtained from routinely published Department for Education data on attendance in education and early years settings during the COVID-19 outbreak  when continuous and as frequency and proportion (%) when categorical. The differences in continuous and categorical data were tested using the Mann-Whitney test and Chi-square test, respectively. Logistic regression was used to explore the association between a positive rapid POC result andWe initially planned to recruit 30 schools across the United Kingdom with the anticipation that the number of schools acquiring a testing platform will increase over the academic year. However, when schools reopened in March 2021, twice weekly lateral flow testing with an antigen test became the government recommendation. Therefore, all schools enrolled up to the end of the autumn term were included in this study. Ethics approval was granted by University of Cambridge Human Biology Research Ethics Committee- HRREC.202.0.39. st of September 2020 and the 16th of December 2020 (end of the Autumn term). The median age of those tested was 16 years (IQR 14-24), 44% (309/696) were male . Potentially, this cumulatively saves between 1,047 and 1,570 days off school . Participants reported that the use of an onsite rapid PCR tests helped the schools to function as fully as possible during the pandemic (Extended data 2).All infections occurred in eight out of the 12 schools. Two schools each had a single case and were able to limit transmission by identification and isolation of the infected individual. There were five outbreaks in three schools, defined as more than two cases diagnosed within two consecutive days. These outbreaks involved 16, five and four individuals in the affected schools. There were seven bubble closures and no school closures. The ability to exclude SARS-CoV-2 infection in symptomatic individuals was important in reducing school absence. The majority of individuals tested (84%) were absent from school for less than one day prior to receiving a rapid test result . This cord to the 19th of November 2020. The nationwide surveillance study included asymptomatic staff and students, which likely explains the difference in positivity rates between this survey population and the nationwide surveillance study. However, the incidence rates have been steadily increasing with the resultant increase in school absence and closure over the course of the Autumn term. 9-11% of children did not attend school for COVID-19 related reasons and up to 2% of state-funded schools were closed in the last week of the Autumn term (school attendance during SARS-CoV-2 outbreak). We estimate that having a rapid POC PCR-based test in these school saved between 1,047 and 1,570 days off school compared to the National Health Service / Public Health England PCR test and made a significant difference in the running of these schools.The proportional prevalence of SARS-CoV-2 in our study population is high at 6% as the majority of those tested had symptoms or were COVID-19 contacts. Despite this, there were no school closures and absence from school was minimal. A nationwide surveillance study of COVID-19 infection in students and staff in English schools (COVID-19 Schools Infection Survey) reported a prevalence of SARS-CoV-2 infection in secondary school students and staff of 1.48% and 1.47%, respectively, in the first half of the Autumn term from the 3. However, concerns have been raised about the ability of these lateral flow tests to accurately diagnose SARS-CoV-2 infection. Although the specificity of these test are high, sensitivity may be as low as 48% in asymptomatic and 58% in symptomatic individuals when self-administered. There is a trade-off between more expensive, highly accurate tests such as PCR tests and cheaper, less accurate, tests such as those based on lateral flow technology.New guidelines from the UK government to introduce mass testing in schools is welcome, if not overdueA limitation of the study is that the poplulation may not be representative of most schools in England in terms of being able to afford these tests, having staff capacity to implement a testing program, and the characteristics of the students attending these schools. Although a direct comparison has not been made between a POC testing platform sited on the school premises and one off-site, it is likely that the logistics required to facilitate an off-site test will add further delays to turn-around times. The success of this strategy may not be solely due to the testing platform. These populations are largely closed with limited mixing with the wider population as indicated by the low number of positive cases in these schools compared with the background prevalence in the geographical regions where these schools were based.Rapid diagnostic tests have a role to play in emerging infectious diseases as has been demonstrated in this study in schools, it can be rolled-out to assist in managing contacts, allowing prompt isolation of new cases and preventing absenteeism. We recommend that accurate, rapid POC PCR testing platforms should be widely available and utilised in school settings. We acknowledge that a barrier to implementing rapid POC PCR testing widely across all schools is cost. However, the cost to schools could be limited by government investment in these tests to support schools. We call for new research to develop cheaper but still accurate POC PCR tests. Furthermore, implementation could be managed by reserving more expensive POC PCR tests in higher risk settings like colleges and secondary schools whilst allowing for the use of cheaper but less accurate tests in younger ages where the risk of spreading infection is lower. Reliable positive tests will prevent outbreaks and uncontrolled spread of infection within school settings. Reliable negative test results will reassure students, parents and staff and prevent disruption of schooling.https://doi.org/10.5522/04/16764511.UCL Research Data Repository: Data underpinning Point of care SARS-CoV-2 nucleic acid testing in schools improves school attendance.https://doi.org/10.5522/04/16764535.UCL Research Data Repository: Extended data 1 for Point of care SARS-CoV-2 nucleic acid testing in schools improves school attendance.https://doi.org/10.5522/04/16766581.UCL Research Data Repository: Extended data 2 for Point of care SARS-CoV-2 nucleic acid testing in schools improves school attendance.Creative Commons Zero "No rights reserved" data waiver(CC0 1.0 Public domain dedication).Data are available under the terms of the I have reviewed the revised manuscript and tried to comment that I am happy with the edits.Is the work clearly and accurately presented and does it cite the current literature?PartlyIf applicable, is the statistical analysis and its interpretation appropriate?I cannot comment. A qualified statistician is required.Are all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:Clinician in ID and parent of 3 children, the lived experience of school absences/ closures on the whole family and medical workforce cannot be underestimated!I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. I approve this submission for indexing.Is the work clearly and accurately presented and does it cite the current literature?PartlyIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?PartlyAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:NAI confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Summary: Collier et al performed a retrospective survey-based analysis of school-based SARS-CoV-2 testing program using a point of care PCR assay, the SAMBA II. The authors analyzed data collected from September through December 2020 when SARS-CoV-2 prevalence was 6.7% in their schools. The majority of people were symptomatic and 84% of those tested with symptoms missed less than one day of school prior to being ruled out by the rapid PCR test. Compared to the testing program for the larger community, the authors estimate that the point of care PCR testing program saved between 1,047 and 1,570 days off from school.Major comments:The SARS-CoV-2 Omicron variant is much more transmissible than the viral lineages that were in circulation at the time of this study in the winter of 2020. Despite a much more established testing infrastructure, the Omicron variant spread widely, suggesting that diagnostic test performance regardless of assay type significantly declined. There are many possible reasons for this but it suggests that the efficacy of any testing program based on data from prior waves is at risk for being over-estimated if that program was implemented in the current environment.Key aspects of the testing programs, such as criteria for testing, frequency of testing and body sampling site by school (if available). Each school's definition of 'bubble' can also help readers understand how many people would be in quarantine with each positive case.Test characteristics of the SAMBA II including gene targets, limit of detection, turnaround time and literature supporting test performance.Surveillance data documenting the predominating variants in circulation at the time of the study (see #1 above).Generalizable conclusions are a bit challenging to draw from this study. Additional information that would be helpful for the community include:Similarly, would consider broadening the discussion to more critically examine the generalizability of results. Might an alternative explanation for the success of the testing program be due to the lack of mixing in the community, and not the characteristics of their point of care PCR testing strategy? Given that up to 90% of new infections occur from an asymptomatic index case, the fact that most  cases detected in this program were symptomatic suggests a highly insular environment, which again may not be the case in most other settings.et al. (2021)).Regarding the following statement: "However, concerns have been raised about the ability of these lateral flow tests to accurately diagnose SARS-CoV-2 infection" Would consider citing the more recent study by Deeks in BMJ  as a result of a deletion at nt207-212 (Δ69-70) in the Spike gene was recognised relatively early in our setting. Most assays use targets other than the S-gene and although a weak or absent signal would be seen in the S-gene, a positive signal will be seen in other regions such as ORF1 and N-gene in targeted RT-PCRs. Reviewer:Generalizable conclusions are a bit challenging to draw from this study. Additional information that would be helpful for the community include:  Key aspects of the testing programs, such as criteria for testing, frequency of testing and body sampling site by school (if available). Each school's definition of 'bubble' can also help readers understand how many people would be in quarantine with each positive case.  Author Response: This has now been included in the methods and references.https://doi.org/10.1128/JCM.01262-20).” “All schools utilised the SAMBA II SARS-CoV-2 testing platform, which amplifies two regions of the genome ORF1ab and nucleocapsid protein. The tests were performed on combined nose and throat swab samples by a school nurse who had received training from the manufacturer. The two regions of the genome (open reading frame 1ab [ORF1ab] and nucleocapsid protein [N]) limit of detection (LOD) of the SAMBA II SARS-CoV-2 test is 250 copies/ml .Author Response: This has now been included in the text. “The alpha variant was emerging as the dominant variant during this period and eventually replaced the preceding D614G wildtype variant .”Reviewer: Similarly, would consider broadening the discussion to more critically examine the generalizability of results. Might an alternative explanation for the success of the testing program be due to the lack of mixing in the community, and not the characteristics of their point of care PCR testing strategy? Given that up to 90% of new infections occur from an asymptomatic index case, the fact that most  cases detected in this program were symptomatic suggests a highly insular environment, which again may not be the case in most other settings.Author Response:  We agree and have broadened the discussion to include this. “A limitation of the study is that the sample may not be representative of most schools in England in terms of being able to afford these tests, having staff capacity to implement a testing program, and the characteristics of the students attending these schools. Although a direct comparison has not been made between a POC testing platform sited on the school premises and one off-site, it is likely that the logistics required to facilitate an off-site test will add further delays to turn-around times. The success of this strategy may not be solely due to the testing strategy. These populations are largely closed with limited mixing with the wider population as indicated by the low number of positives in these schools compared with the background prevalence in the geographical regions where these schools were based.”Reviewer: Regarding the following statement: "However, concerns have been raised about the ability of these lateral flow tests to accurately diagnose SARS-CoV-2 infection" Would consider citing the more recent study by Deeks in BMJ ).Author Response: This reference has been cited as suggested.et al. SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis BMJ 2022; 376 :e066871 doi:10.1136/bmj-2021-066871” “Deeks J J, Singanayagam A, Houston H, Sitch A J, Hakki S, Dunning JReviewer: References 6 and 9 appear to be duplicated.Author Response: Our apologies. This has been corrected. Reference 6 is:et al. Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study. Cell Rep Med. 2020;1(5):100062. Collier DA, Assennato SM, Warne B, Sithole N, Sharrocks K, Ritchie A, Reference 9 is:et al. Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant. Cell Rep Med. 2020;1(6):100099. Mlcochova P, Collier D, Ritchie A, Assennato SM, Hosmillo M, Goel N,Reviewer: A turnaround time of 1 to 3 days is assumed for PCR testing through Public Health England. While this makes sense for 2020, is that still the case in 2022?Author Response: The turnaround time for PCR testing has varied depending on the stage of the pandemic with longer turnaround times during periods of higher incidence which the resulting pressures of laboratories. The turnaround time quoted (supported by the reference) was the turnaround time at the time the study was conducted.Reviewer: Schools were selected through a convenience sample. Is there any data to support or refute the fact that these schools are representative of schools throughout the UK and beyond?Author Response: We stated in both the methods and references, these schools are fee-paying schools and so not representative of schools throughout the UK. “A limitation of the study is that the sample may not be representative of most schools in England in terms of being able to afford these tests, having staff capacity to implement a testing program, and the characteristics of the students attending these schools.” Reviewer:With regards to the following statement: "Data collected includes test performed from the 1st of September 2020 and will be collected up till the end of the academic year in August 2021. This initial report is based on data collected in the first term of the academic year up until the 16th of December 2020.", it has been nearly 8 months since the end of August 2021, therefore a reader would reasonably expect that that data should be included in this report. Is there a reason it has not yet been included? If it cannot be added, would suggest modifying this statement to just state the study ended in December 2020.Author response: We stated in the methods the study was stopped after the initial phase. “We initially planned to recruit 30 schools across the United Kingdom with the anticipation that the number of schools acquiring a testing platform will increase over the academic year. However, when schools reopened in March 2021, twice weekly lateral flow testing with an antigen test became the government recommendation. Therefore, all schools enrolled up to the end of the autumn term were included in this study.”    Reviewer:In the results, it states that 697 tests were performed, however the denominators for gender, staff vs student, and household members are 696, 692, and 692, respectively. What is the reason for the discrepancy?Author response: 697 tests were done, however when data are missing, we present the denominator as non-missing data. Please refer to table 1. *n/N is presented when data are missing.Reviewer: This statement could use further clarity: "No asymptomatic cases were identified amongst individuals tested for reasons such as asymptomatic screening, fitness to fly or other reasons."   The way it is currently written implies there are positive tests from asymptomatic cases tested for other indications. However, my understanding based on the manuscript is that this program did not pick up any asymptomatic cases.Author response: This sentence has been clarified and now reads.“Seven asymptomatic cases were identified who were contacts of known SARS-CoV-2 positive cases” For understandable reasons there is quite a delay in getting this to publication and the landscape has changed. Nonetheless the number of school days saved by deployment of a rapid POC PCR based test is sizeable and the impact of a sensitive diagnostic test can have on enabling school attendance is a key point to learn for future. More can be made in the discussion about the generalizability of this sort of approach in pandemics. Rapid roll out of diagnostics and evaluation of their impact over and above their PPV and NPV was a missing part of the approach to this pandemic. Therefore I do think that there is value in publication at this stage if the emphasis of the manuscript can be more on what can we learn and do better for next time.Is the work clearly and accurately presented and does it cite the current literature?PartlyIf applicable, is the statistical analysis and its interpretation appropriate?I cannot comment. A qualified statistician is required.Are all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:Clinician in ID and parent of 3 children, the lived experience of school absences/ closures on the whole family and medical workforce cannot be underestimated!I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Reviewer:For understandable reasons there is quite a delay in getting this to publication and the landscape has changed. Nonetheless the number of school days saved by deployment of a rapid POC PCR based test is sizeable and the impact of a sensitive diagnostic test can have on enabling school attendance is a key point to learn for future.Author Response: Many thanks to the reviewer for this comment. This is the main thrust of this article.Reviewer: More can be made in the discussion about the generalizability of this sort of approach in pandemics.Author Response: This has now been addressed in the discussion.Reviewer: “Rapid diagnostic tests have a role to play in emerging infectious diseases and as has been demonstrated in this study in schools, it can be rolled-out to assist in managing contacts, allowing prompt isolation of new cases and preventing absenteeism.” Rapid roll out of diagnostics and evaluation of their impact over and above their PPV and NPV was a missing part of the approach to this pandemic. Therefore I do think that there is value in publication at this stage if the emphasis of the manuscript can be more on what can we learn and do better for next time.Author Response: We wholeheartedly agree with this comment and indeed the landscape has changed since this study was conducted. We do believe that what this study shows is a workable option for managing COVID transmission in a closed setting. Its wider adoption may be limited by cost but early in an emerging epidemic when there isn’t widespread community transmission, highly accurate, rapid tests such as these certainly have a role. In light of the changed landscape of the pandemic we have removed the recommendation that rapid POC PCR testing platforms should be widely available and utilised in school settings from the discussion. “There is a trade-off between more expensive, highly accurate tests such as PCR tests and cheaper, less accurate, tests such as those based on lateral flow technology.” And highlight, where they could potentially have worked, had these technologies been adopted in the Autumn of 2020. “We call for new research to develop cheaper but still accurate POC PCR tests. Furthermore, implementation could be managed with more expensive POC PCR tests in higher risk settings and   like colleges and secondary schools whilst allowing for the use of cheaper but less accurate tests in younger ages where the risk of spreading infection is lower.”