Extra Visits Research Articles

PNEUMATIC RETINOPEXY FOR GIANT RETINAL TEAR ASSOCIATED RETINAL DETACHMENT: A Retrospective Cohort Study

Purpose: To report the technique and long-term outcomes of patients with giant retinal tear associated retinal detachment (GRT-RD) treated with pneumatic retinopexy (PnR). Methods: Retrospective cohort study. All patients presenting with GRT-RD with tears in the superior ten-clock hours who underwent primary PnR were included in this study. Results: 31 patients were included in the study. 61.2% (19/31) achieved PARR with PnR at 3 months and 58.0% (18/31) at the final follow-up. Patients included in this study had a median follow-up of 24 months (interquartile range 46.5). The absence of retinal tears elsewhere at baseline was associated with a final PARR of 80% (16/20) (p= 0.007). Thirteen eyes required PPV after a failed PnR. Two eyes required the intraoperative use of perfluorocarbon liquids (PFCL). No eyes required silicone oil (SO). Visual acuity improved significantly from baseline to the last follow-up. Final anatomic reattachment rate was 100% (31/31). Conclusion: For selected cases of GRT-RDs affecting the superior ten-clock hours, PnR could be a possible treatment option when patients consent to extra visits and the surgeon has substantial expertise. When lacking this extensive experience and comfort with PnR, PPV remains the treatment that is most likely to result in a primary anatomic reattachment. While this study provides guidance on PnR technique for GRT-RDs, it is essential to note that the reported PARR may be contingent on the expertise of the surgeon/center, and the authors recommend that those new to PnR first gain substantial experience in cases meeting clinical trial criteria.

Time Burdens for Participants With Advanced Cancer in Phase I Trials: A Cross-Sectional Study.

Participating in phase I cancer clinical trials often entails extra visits and procedures. We describe the planned time and procedures associated with phase I trial participation. We searched ClinicalTrials.gov for phase I cancer trials of new drugs with assessment schedules and results posted between 2020 and 2022. Trials were included if participants had advanced or metastatic disease. Our primary analysis measured the number of planned research days (PRDs; each day a clinic visit is required) per participant up to the first month of trial participation and for the entire trial duration. Secondarily, we estimated the number of research procedures. Our sample included 71 phase I trials comprising 302 cohorts. These trials enrolled 3,904 participants; the median participation duration was 2.5 months. During screening and up to the first month of participation, the median PRDs per participant was 7 (IQR, 7-10). Across the entire trial, the median PRDs per participant was 4.5 days per month (IQR, 3.30-6.20). Participants spent 15% of trial days attending planned appointments. Per trial cohort, participants were given a median of 8 (IQR, 7-11) physical examinations, 6 (IQR, 3-10) infusions, 6 (IQR, 3-12) electrocardiograms, and 1 (IQR, 1-3) biopsy. Participants commit a substantial amount of time to planned visits in phase I cancer trials, especially in the first month. Overall, they invest 15% of trial days attending planned research activities. These estimates provide a lower bound to the time participants in phase I trials donate to drug development, as our analysis excluded unplanned visits.

Pediatric Pneumococcal Conjugate Vaccine and Dosing Schedule Perceptions Among Health Care Providers and Caregivers in Germany, France, Spain, and Greece.

Most European infant national immunization programs (NIPs) recommend pneumococcal conjugate vaccines (PCVs), which currently cover 10-15 serotypes administered in a three-dose schedule (two primary plus one booster). Recently, a PCV covering 20 serotypes that is administered in a four-dose schedule (three primary plus one booster) was licensed. An online survey was administered to collect data from health care providers (HCPs) and caregivers of children aged 0-5 (including expectant mothers) in four European countries (Germany, France, Spain, and Greece). All caregiver respondents had a shared or full responsibility to make health decisions for their child. Data on opinions, perceptions, and openness to a change in childhood vaccination dosing schedules were collected, along with demographic information for HCPs as well as caregivers. A total of 601 HCPs and 1954 caregivers were recruited across the four countries. Nearly all HCPs (93%) agreed that broader serotype coverage against pneumococcal disease for children is a significant unmet need, and 92% had a "sense of urgency" to vaccinate children. Both HCPs and caregivers were supportive of an additional PCV dose and doctor visit, assuming it provided at least 20% more serotype coverage than what is currently available. Caregivers strongly agreed on the importance of full vaccination for pneumococcal disease, even if an extra dose and visit to the doctor was required. HCPs and caregivers were virtually unanimous in their support for a PCV with broader serotype coverage and showed a subsequent willingness to include an extra infant dose/visit. These results can help guide broader discussions regarding public health policy and vaccine administration in the context of important efforts to reduce the global disease burden associated with pneumococcal disease.

Evaluating two implant designs in patients undergoing primary total knee arthroplasty using a novel measure of early optimal recovery: a retrospective observational study.

Quality of care in total knee arthroplasty (TKA) between implants was assessed using a novel composite outcome measure, early optimal recovery (EOR), to indicate ideal clinical outcomes and minimal healthcare resource utilization. Patients that underwent primary TKA in the study group (ATTUNE® Knee System) or control group (LCS® COMPLETE Knee System) were included in this retrospective, single-center study. EOR was defined as no complications, no readmissions, no extra outpatient visits, ≤ 48h length of hospital stay (LOS), and restored range of motion and pain perception at 3-month follow-up. Multivariate logistic regression was used to compare EOR between the study and control groups. Results were adjusted for differences in baseline characteristics and are presented with 95% confidence intervals (CI). Data were collected from a specialized clinic for elective surgeries in the Netherlands, between January 2017 and December 2020. A total of 566 patients (62.4% female, mean age 67years) were included for analysis; 185 patients (32.7%) underwent TKA in the study group. Compared to the control group, patients in the study group had greater probability of achieving EOR (65.8% [95% CI: 55.1-75.2] vs. 38.9% [95% CI: 32.8-45.3]; p < 0.001), a LOS ≤ 48h (77.2% [95% CI: 67.7-84.5] vs. 61.4% [95% CI: 54.7-67.7]; p < 0.05), and ideal pain perception at 3-month follow-up (93.3% [95% CI: 85.7-97.0] vs. 78.2% [95% CI: 71.0-83.9]; p < 0.05). The study group was associated with a greater probability of achieving EOR versus the control group, suggesting improved quality of care.

Comparing Relative Value Units for Intramedullary Limb Lengthening Procedures to Common Pediatric Orthopaedic Surgeries to Determine Adequate Compensation.

Reimbursement for surgical procedures is determined by a computation of the relative value unit (RVU) associated with CPT codes. It is based on the amount of work required to provide a service, resources available, and level of expertise involved. Given the evolution of changes in the limb lengthening field, we wanted to evaluate whether the RVU values were comparable across different orthopaedic subspecialties. Consequently, this study compares the work relative value unit (wRVU) totals of 3 common pediatric orthopaedic surgeries-arthroscopic ACL reconstruction, spinal fusion for adolescent idiopathic scoliosis, and antegrade femoral intramedullary limb lengthening. This was an IRB-approved, multicenter, retrospective chart review. Charts of subjects who had ACL reconstructions, including meniscal repairs; spinal fusion surgeries for adolescent idiopathic scoliosis (7 to 12 levels), including Ponte osteotomies, and femoral antegrade internal limb lengthening procedures, each completed by fellowship-trained orthopaedic surgeons were reviewed. Comparisons were carried out between several parameters, including mean duration per procedure, number of CPT codes billed per procedure, number of postoperative visits in the 90-day global period, and the wRVU for each procedure. Fifty charts (25 per center) per procedure were reviewed. The wRVU per hour was lowest in the antegrade femur lengthening group ( P < 0.0001). The number of postoperative visits in the 90-day global postsurgery period was significantly higher in the antegrade femur lengthening group ( P < 0.0001). Intramedullary limb lengthening also had the least number of CPT codes billed. RVUs per time are statistically lowest in the limb lengthening group and highest in the scoliosis group. The limb lengthening patient also requires significantly more visits and time in the postoperative period compared with the other groups. These extra visits during the global period do not add any RVU value to the lengthening surgeon and occupy clinic spots that could be filled with new patients. Based on these data, a review of the RVU values assigned to the limb lengthening codes may be necessary. Level III-retrospective comparison study.

Worldwide Increasing Use of Nonfasting Rather Than Fasting Lipid Profiles.

Historically, lipids and lipoproteins were measured in the fasting state for cardiovascular risk prediction; however, since 2009 use of nonfasting lipid profiles has increased substantially worldwide. For patients, nonfasting lipid profiles are convenient and avoid any risk of hypoglycemia. For laboratories, blood sampling in the morning and extra visits for patients who have not fasted are avoided. For patients, clinicians, hospitals, and society, nonfasting sampling allows same-day visits with first blood sampling followed by a short wait for test results before clinical consultation. Therefore, nonfasting compared to fasting lipid profiles will save money and time and may improve patient compliance with cardiovascular prevention programs. We report on the progression of endorsement and implementation of nonfasting lipid profiles for cardiovascular risk prediction worldwide and summarize the recommendations from major medical societies and health authorities in different countries. We also describe practical advantages and disadvantages for using nonfasting lipid profiles. Further, we include a description of why fasting has been the standard historically, the barriers against implementation of nonfasting lipid profiles, and finally we suggest the optimal content of a nonfasting lipid profile. Lipid, lipoprotein, and apolipoprotein concentrations vary minimally in response to normal food intake and nonfasting lipid profiles are equal or superior to fasting profiles for cardiovascular risk prediction. Major guidelines and consensus statements in Europe, the United States, Canada, Brazil, Japan, India, and Australia now endorse use of nonfasting lipid profiles in some or all patients; however, there are still gaps in endorsement and implementation of nonfasting lipid profiles worldwide.

"I think my vagina is still there?": Women's perspectives on sexual function and dysfunction following radical cystectomy for bladder cancer, a qualitative study.

Women's sexual health after radical cystectomy is an important but poorly understood aspect of bladder cancer survivorship. Dedicated investigation is needed to elucidate patient perceptions on sexual function and dysfunction in this setting. In this study we sought to qualitatively examine women's perceptions and experiences of sexual health following radical cystectomy for bladder cancer. We conducted one-on-one qualitative telephone interviews with 40 women who underwent radical cystectomy in the past 6months to 5 years and signed a research consent form to be contacted for future studies. We examined women's experiences of engaging in sexual activity after surgery and their attitudes toward sex and body image. We audio recorded, transcribed, and coded the interviews using ATLAS.ti software and applied grounded theory methods for analysis. For data that emerged during the qualitative interviews that was related to lack of knowledge about how physical and psychological sexual health would be affected after surgery, we reviewed and discussed transcripts that enabled coding of the data into emerging topic areas. Our analysis yielded 4 main themes. (1) Women reported receiving little to no information from providers about female sexual dysfunction prior to or after radical cystectomy. Women wished they had been provided more information about female sexual dysfunction from their clinicians, including strategies for postoperative self-pleasure and nonintercourse methods of sexual pleasure with partners. (2) Women shared that they were not sexually active following surgery due to physical and mental barriers. (3) When women did try to engage in sex, they described feeling disappointed that it did not feel the same as prior to surgery. (4) Some women found that physical therapy helped them to physically and mentally recover their strength to engage in sexual activity again. Clinicians must directly address sexual health concerns with patients who undergo radical cystectomy. This study has several key strengths. Investigation into women's sexual function and dysfunction addresses a gap in understanding of this component of women's health-related quality of life after radical cystectomy, which represents an unmet need. The large number of interviews conducted as well as the in-depth information obtained through one-on-one interviews are additional strengths. This study also has limitations, including possible shortcomings of telephone interviews compared with in-person interviews. However, telephone interviews were beneficial because the interviews took place during the COVID-19 pandemic and spared patients from extra visits or from having to travel long distances to the respective medical centers. Other possible limitations were that patients may have been reluctant to share all of their experiences and that patients who underwent urostomies, also termed ileal conduits, were overrepresented in this study compared with women who underwent continent urine diversions, which allow greater control over urine output. Broadening the understanding of sexual health beyond sexual intercourse to encompass sexuality and self-pleasure can provide clinicians, patients, and their families with more effective preparation and strategies to care for an essential aspect of their wellbeing.

Single-use negative pressure wound therapy to prevent surgical site complications in high-risk patients undergoing caesarean sections: a real-world study

Abstract Surgical site complications (SSCs), including surgical site infection (SSI), are common following C-sections. Management of the post-operative incision with single-use negative pressure wound therapy (sNPWT) has been shown to reduce the risk of SSC in high-risk individuals. This study explored the outcomes of routine, real-world use of sNPWT in high-risk patients undergoing C-sections. An observational, retrospective in-service evaluation was conducted across eight obstetric centres in the Republic and Northern Ireland. Patients undergoing C-sections were stratified for their risk of developing SSC using commonly known risk factors, including BMI ≥30, smoking, diabetes, and whether the patients had undergone previous C-sections or had a previous history of wound dehiscence. Those at high-risk were treated with sNPWT post-operatively. Data relating to any SSC that developed post-operatively, for up to 30 days, were captured. Data were compared with original research previously published by Wloch et al. (2012). Of 1111 women considered high-risk, 106 (9.5%) went on to develop SSCs, predominantly superficial SSIs. SSCs were associated with extra visits with their general practitioner (GP), outpatient visits, or inpatient hospital stays in 5.7%, 2.4%, and 1.7% of the entire cohort, representing 59.4%, 25.5%, and 17.9% of the 106 patients with SSC. Patients needed on average 1.8 extra GP visits and 0.7 extra outpatient visits. Patients who needed to be readmitted to hospital had an average length of stay of 4 days. In comparison with a previously published cohort, in which sNPWT was not used, we observed a significant reduction in the incidence of SSCs across BMI groups 18.5–24.9 (P = 0.02), 25–29.9 (P = 0.003), and ≥35 kg/m2 (P = 0.04). In those patients who had undergone at least one previous C-section, the rates of complications also reduced (P = 0.006). This analysis provides further justification for using sNPWT to manage surgical incisions in patients considered at high risk of developing post-procedural SSCs, particularly those with a BMI ≥30 or a history of more than one C-section.

Consequences of a shortage and rationing: Evidence from a pediatric vaccine

Shortages and rationing are common in health care, yet we know little about the consequences. We examine an 18-month shortage of the pediatric Haemophilus Influenzae Type B (Hib) vaccine. Using insurance claims data and variation in shortage exposure across birth cohorts, we find that the shortage reduced uptake of high-value primary doses by 4 percentage points and low-value booster doses by 26 percentage points. This suggests providers largely complied with rationing recommendations. In the long-run, catch-up vaccination occurred but was incomplete: shortage-exposed cohorts were 4 percentage points less likely to have received the ir booster dose years later. We also find that the shortage and rationing caused provider switches, extra provider visits, and negative spillovers to other care.

Assessing Continuous Epidural Infusion and Programmed Intermittent Epidural Bolus for Their Effectiveness in Providing Labor Analgesia: A Mono-Centric Retrospective Comparative Study.

Background and Objectives: Local anesthetics administered via epidural catheters have evolved from intermittent top-ups to simultaneous administration of continuous epidural infusion (CEI) and patient-controlled epidural analgesia (PCEA) using the same device. The latest programmed intermittent epidural bolus (PIEB) model is believed to create a wider and more even distribution of analgesia inside the epidural space. The switch from CEI + PCEA to PIEB + PCEA in our department began in 2018; however, we received conflicting feedback regarding workload from the quality assurance team. This study aimed to investigate the benefits and drawbacks of this conversion, including the differences in acute pain service (APS) staff workload, maternal satisfaction, side effects, and complications before and after the changeover. Materials and Methods: Items from the APS records included total delivery time, average local anesthetic dosage, and the formerly mentioned items. The incidence of side effects, the association between the duration of delivery and total dosage, and hourly medication usage in the time subgroups of the CEI and PIEB groups were compared. The staff workload incurred from rescue bolus injection, catheter adjustment, and dosage adjustment was also analyzed. Results: The final analysis included 214 and 272 cases of CEI + PCEA and PIEB + PCEA for labor analgesia, respectively. The total amount of medication and average hourly dosage were significantly lower in the PIEB + PCEA group. The incidences of dosage change, manual bolus, extra visits per patient, and lidocaine use for rescue bolus were greater in the PIEB + PCEA group, indicating an increased staff workload. However, the two groups did not differ in CS rates, labor time, maternal satisfaction, and side effects. Conclusions: This study revealed that while PIEB + PCEA maintained the advantage of decreasing total drug doses, it inadvertently increased the staff burden. Increased workload might be a consideration in clinical settings when choosing between different methods of PCEA.

Does luteal phase progesterone supplementation affect physical and psychosocial well-being among women undergoing modified natural cycle-FET? A sub-study of a randomized controlled trial.

Are there any differences in physical and psychosocial well-being among women undergoing modified natural cycle frozen embryo transfer (mNC-FET) with or without vaginal progesterone as luteal phase support (LPS)? Women undergoing mNC-FET with vaginal progesterone supplementation were more likely to experience physical discomfort but there was no difference in psychosocial well-being between the two groups. mNC-FET can be carried out with or without vaginal progesterone as LPS, which has several side-effects. It is commonly known that fertility treatment can cause stress and psychosocial strain, however, most studies on this subject are conducted in fresh cycle regimes, which differ from NC-FET and results may not be comparable. This is a sub-study of an ongoing RCT investigating whether progesterone supplementation has a positive effect on live birth rate in mNC-FET. The RCT is conducted at eight fertility clinics in Denmark from 2019 and is planned to end primo 2024. The sub-study is based on two questionnaires on physical and psychosocial well-being added to the RCT in August 2019. On the time of data extraction 286 women had answered both questionnaires. Women who had answered both questionnaires were included in the sub-study. Participants were equally distributed, with 143 in each of the two groups. Participants in both groups received the same questionnaires at two time-points: on cycle day 2-5 (baseline) and after blastocyst transfer. Participants in the progesterone group had administered progesterone for 7 days upon answering the second questionnaire. All items in the questionnaires were validated. Items on psychosocial well-being originate from the Copenhagen Multi-Centre Psychosocial Infertility-Fertility Problem Stress Scale (COMPI-FPSS) and from the Mental Health Inventory-5. Women receiving progesterone experienced more vaginal itching and/or burning than women in the non-progesterone group (P < 0.001). Women in the progesterone group also experienced more self-reported vaginal yeast infection, this was, however, not significant after adjustment for multiple testing (P/adjusted P = 0.049/0.881). No differences regarding psychosocial well-being were found between the two groups. Within the progesterone group, a shift toward feeling less 'downhearted and blue' was found when comparing response distribution at baseline and after blastocyst transfer (P < 0.001). All items on physical symptoms were self-reported. The item on vaginal yeast infection was therefore not diagnosed by a doctor. Inclusion in the study required a few extra visits to the clinic, participants who felt more burdened by fertility treatment might have been more likely to decline participation. Women who experienced a lot of side-effects to progesterone prior to this FET cycle, might be less likely to participate. Our results are in line with previous known side-effects to progesterone. Physical side-effects of progesterone should be considered before administration. The RCT is fully supported by Rigshospitalet's Research Foundation and a grant from Gedeon Richter. Gedeon Richter were not involved in the design of protocol nor in the conduction of the study or analysis of results. A.P., L.P., and N.I.-C.F. report grants from Gedeon Richter, Ferring and Merck with no relations to this study. N.I.-C.F. has received travel support from Ferring, Merck A/S, & Gideon Richter, and is the head of the steering committee for the Danish Fertility Guidelines made by the members of from the Danish Fertility Society. A.P. reports consulting fees from Preglem, Novo Nordisk, Ferring, Gedeon Richter, Cryos, & Merck A/S, honoraria from Gedeon Richter, Ferring, Merck A/S, Theramex, and Organon, has received travel support from Gedeon Richter (payment to institution), participated on an advisory board for Preglem and was loaned an embryoscope from Gedeon Richter to their institution. A.L.S. has stock options for Novo Nordisk B A/S. B.A. have received unrestricted grant from Gedeon Richter Nordic and Merck and honoraria for lectures from Gedeon Richter, Merck, IBSA, and Marckyrl Pharma. The RCT is registered on ClinicalTrials. gov (NCT03795220) and in EudraCT (2018-002207-34).

Same-Day Bilateral Intravitreal Dexamethasone Implants for the Treatment of Diabetic Macular Edema

Introduction: The aim of this study was to evaluate the outcomes and complications associated with the use of same-day bilateral intravitreal dexamethasone (DEX) implants for the treatment of diabetic macular edema (DME). Methods: This retrospective analysis of an open-label, multicenter, consecutive case series included 130 eyes of 65 patients with bilateral DME who were treated with intravitreal DEX implants. The patients were divided into two groups: a control group (comprising 40 eyes treated with an alternating unilateral regimen) and a study group (comprising 90 eyes treated with concomitant bilateral DEX implants). All patients were followed up monthly after implantation. The changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to sixth month after implantation, and ocular adverse effects such as intraocular pressure, cataract, and tolerability of bilateral implantation were reviewed. The primary endpoint was to assess the safety of the same-day bilateral treatment protocol. The secondary endpoints focused on evaluating the functional and anatomical changes associated with bilateral simultaneous or alternating implantations. Results: At 6 months after implantation, mean BCVA increased and CRT decreased in both groups. Moreover, no serious ocular adverse effects were observed. In addition, no differences were observed between the two groups in the number of patients who required extra follow-up visits or the number of extra visits made in addition to the treatment schedule. Conclusions: Same-day bilateral intravitreal DEX implants are associated with a low complication rate and are well tolerated by patients. This safe practice may optimize efficiency and reduce the burden on both the health-care system and patients, when used to treat bilateral DME.

Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials.

Transcutaneous tibial nerve stimulation (TTNS) is a promising treatment for neurogenic lower urinary tract symptoms. However, the evidence is limited due to a general lack of randomised controlled trials (RCTs) and, also, inconsistency in the sham and blinding conditions. In the context of much-needed RCTs, we aimed to develop a suitable sham-control protocol for a clinical setting to maintain blinding but avoid meaningful stimulation of the tibial nerve. Three potential electrode positions (lateral malleolus/5th metatarsal/plantar calcaneus) and two electrode sizes (diameter: 2.5 cm/3.2 cm) were tested to determine which combination provided the optimal sham configuration for a TTNS approach, based on a visible motor response. Sixteen healthy volunteers underwent sensory and motor assessments for each sham configuration. Eight out of them came back for an extra TTNS visit. Sensory thresholds were present for all sham configurations, with linear regression models revealing a significant effect regarding electrode position (highest at plantar calcaneus) but not size. In addition, motor thresholds varied with the position-lowest for the 5th metatarsal. Only using this position and 3.2 cm electrodes attained a 100% response rate. Compared to TTNS, sensory and motor thresholds were generally higher for the sham configurations; meanwhile, perceived pain was only higher at the lateral malleolus. In conclusion, using the 5th metatarsal position and 3.2 cm electrodes proved to be the most suitable sham configuration. Implemented as a four-electrode setup with standardized procedures, this appears to be a suitable RCT protocol for maintaining blinding and controlling for nonspecific TTNS effects in a clinical setting.

Maternal satisfaction with reduced postnatal length of stay in Brussels: evidence from the KOZI&Home program

BackgroundReducing the length of stay (LOS) after childbirth is a trend, including cost savings, a more family-centered approach and lower risk for nosocomial infection. Evaluating the impact of reduced LOS is important to improve the outcomes of care, which include maternal satisfaction. The aim of this study was to compare the maternal satisfaction, before and after the reduced LOS.MethodsThis study was conducted in the University Hospital Brussels, before and after implementing the KOZI&Home program (intervention). This KOZI&Home program consisted of a reduced length of stay of at least one day for both vaginal delivery and caesarean section. It also included three extra antenatal visits with the midwife, preparing for discharge and postnatal home care by an independent midwife. Women completed a questionnaire, including the Maternity Satisfaction Questionnaire (MSQ) and Home Satisfaction Questionnaire (HSQ), respectively at discharge and two weeks postpartum. Satisfaction was split into five dimensions: ‘Midwives time investment’, ‘Provision of information’, ‘Physical environment’, ‘Privacy’ and ‘Readiness for discharge’. A combination of forward and backward model selection (both directions) was used for statistical analysis.ResultsIn total, 585 women were included in this study. 332 women in the non-intervention group and 253 women in the intervention group. Satisfaction with ‘provision of information’ at home had a higher mean score of 4.47/5 in the intervention group versus 4.08/5 in the non-intervention group (p < 0.001). Women in the KOZI&Home group were more satisfied regarding ‘privacy at home’ (mean 4.74/5 versus 4.48/5) (p < 0.001) and ‘readiness for discharge’ (p = 0.02).ConclusionThe intervention was associated with a higher score in some of dimensions of satisfaction. Our study concludes that this integrated care program is acceptable for postpartum women and associated with some favourable outcomes.

Economic evaluation of telemonitoring as a follow-up approach for patients with obstructive sleep apnea syndrome starting treatment with continuous positive airway pressure.

Telemonitoring of obstructive sleep apnea patients is increasingly being adopted though its cost-effectiveness evidence base is scanty. This study investigated whether telemonitoring is a cost-effective strategy compared with the standard follow-up in patients with obstructive sleep apnea who are starting continuous positive airway pressure treatment. In total, 167 obstructive sleep apnea patients were randomised into telemonitoring (n = 79) or standard follow-up (n = 88), initiated continuous positive airway pressure treatment, and were followed up for 6 months. The frequencies of healthcare contacts, related costs (in USD 2021 prices), treatment effect and compliance were compared between the follow-up approaches using generalised linear models. The cost effectiveness analysis was conducted from a healthcare perspective and the results presented as cost per avoided extra clinic visit. Additionally, patient satisfaction between the two approaches was explored. The analysis showed no baseline differences. At follow-up, there was no significant difference in treatment compliance, and the mean residual apnea-hypoapnea index. There was no difference in total visits, adjusted incidence rate ratio 0.87 (0.72-1.06). Participants in the telemonitoring arm made eight times more telephone visits, 8.10 (5.04-13.84), and about 73% fewer physical healthcare visits 0.27 (0.20-0.36). This translated into significantly lower total costs for the telemonitoring approach compared with standard follow-up, -192 USD (-346 to -41). The form of follow-up seemed to have no impact on the extent of patient satisfaction. These results demonstrate the telemonitoring of patients with obstructive sleep apnea initiating continuous positive airway pressure treatment as a cost saving strategy and can be argued as a potential worthy investment.

Identification of a methylation panel as an alternative triage to detect CIN3+ in hrHPV-positive self-samples from the population-based cervical cancer screening programme

BackgroundThe Dutch population-based cervical cancer screening programme (PBS) consists of primary high-risk human papilloma virus (hrHPV) testing with cytology as triage test. In addition to cervical scraping by a general practitioner (GP), women are offered self-sampling to increase participation. Because cytological examination on self-sampled material is not feasible, collection of cervical samples from hrHPV-positive women by a GP is required. This study aims to design a methylation marker panel to detect CIN3 or worse (CIN3+) in hrHPV-positive self-samples from the Dutch PBS as an alternative triage test for cytology.MethodsFifteen individual host DNA methylation markers with high sensitivity and specificity for CIN3+ were selected from literature and analysed using quantitative methylation-specific PCR (QMSP) on DNA from hrHPV-positive self-samples from 208 women with CIN2 or less (< CIN2) and 96 women with CIN3+. Diagnostic performance was determined by area under the curve (AUC) of receiver operating characteristic (ROC) analysis. Self-samples were divided into a train and test set. Hierarchical clustering analysis to identify input methylation markers, followed by model-based recursive partitioning and robustness analysis to construct a predictive model, was applied to design the best marker panel.ResultsQMSP analysis of the 15 individual methylation markers showed discriminative DNA methylation levels between < CIN2 and CIN3+ for all markers (p < 0.05). The diagnostic performance analysis for CIN3+ showed an AUC of ≥ 0.7 (p < 0.001) for nine markers. Hierarchical clustering analysis resulted in seven clusters with methylation markers with similar methylation patterns (Spearman correlation> 0.5). Decision tree modeling revealed the best and most robust panel to contain ANKRD18CP, LHX8 and EPB41L3 with an AUC of 0.83 in the training set and 0.84 in the test set. Sensitivity to detect CIN3+ was 82% in the training set and 84% in the test set, with a specificity of 74% and 71%, respectively. Furthermore, all cancer cases (n = 5) were identified.ConclusionThe combination of ANKRD18CP, LHX8 and EPB41L3 revealed good diagnostic performance in real-life self-sampled material. This panel shows clinical applicability to replace cytology in women using self-sampling in the Dutch PBS programme and avoids the extra GP visit after a hrHPV-positive self-sampling test.

Abstract #1413249: Acute Exacerbations of Chronic Obstructive Pulmonary Disease and its Association with Glycaemic Control

Hyperglycemia is associated with poor outcomes in patients with pneumonia, myocardial infarction, and stroke but the effect of hyperglycemia on outcomes during AECOPD has not been definitely established. This study was aimed to find out the relationship between the glycaemic status and AECOPD This real world, retrospective longitudinal study was carried out among 280 adults having T2DM with the co-morbidity of COPD who also visits OPD seeking consultation for AECOPD episodes. Study was carried on for a period of 2.5 years. The patients were divided into 3 Groups according to mean HbA1c status. (A<7%, B≥7% to ≤8% and C>8% to ≤9.5%). The follow up visits were scheduled once every 3 months, (extra OPD visits were encouraged for exacerbation of any respiratory symptom). 85 patients needed hospitalisation for episodes of AECOPD, out of which 26 patients needed admission in the ICU with 7 patients needing invasive ventilation. 3 patients out of these 7 died. Men weighed 89±24 kg, with a body mass index (BMI) of 31.5±9.1 kg/m2. Participants had a 65±43 pack-year smoking history. Highest percentage of AECOPD episodes (43%) were observed with Group A whereas group B it was 35% and Group C it was 40%. Exacerbations were characterised by increased dyspnoea (100%), wheeze (83%), chest tightness (72%) and cough (69%). Of the 85 patients needing hospitalisation, majority (84%) belonged to Group C (HbA1c >8%). This study showed that factors other than glycaemic control are also responsible for episodes of AECOPD in patients of T2DM, though a poor glycaemic control (Group C) has a greater risk of hospitalisation. Hence other factors like increasing age, longer duration of COPD, malnutrition, irregular inhalation therapy, etc. needs to be looked into details as aetiology, leading to episodes of AECOPD besides glycaemic control in patients of T2DM.

Identifying strategies for implementing a clinical guideline for cancer-related fatigue: a qualitative study

BackgroundClinical practice guidelines assist health professionals’ (HPs) decisions. Costly to develop, many guidelines are not implemented in clinical settings. This paper describes an evaluation of contextual factors to inform clinical guideline implementation strategies for the common and distressing problem of cancer-related fatigue (CRF) at an Australian cancer hospital.MethodsA qualitative inquiry involving interviews and focus groups with consumers and multidisciplinary HPs explored key Canadian CRF guideline recommendations. Four HP focus groups examined the feasibility of a specific recommendation, while a consumer focus group examined experiences and preferences for managing CRF. Audio recordings were analysed using a rapid method of content analysis designed to accelerate implementation research. Strategies for implementation were guided by the Consolidated Framework for Implementation Research.ResultsFive consumers and 31 multidisciplinary HPs participated in eight interviews and five focus groups. Key HP barriers to fatigue management were insufficient knowledge and time; and lack of accessible screening and management tools or referral pathways. Consumer barriers included priority for cancer control during short health consultations, limited stamina for extended or extra visits addressing fatigue, and HP attitudes towards fatigue. Enablers of optimal fatigue management were alignment with existing healthcare practices, increased HP knowledge of CRF guidelines and tools, and improved referral pathways. Consumers valued their HPs addressing fatigue as part of treatment, with a personal fatigue prevention or management plan including self-monitoring. Consumers preferred fatigue management outside clinic appointments and use of telehealth consultations.ConclusionsStrategies that reduce barriers and leverage enablers to guideline use should be trialled. Approaches should include (1) accessible knowledge and practice resources for busy HPs, (2) time efficient processes for patients and their HPs and (3) alignment of processes with existing practice. Funding for cancer care must enable best practice supportive care.

Unraveling the canine using labial auxiliary spring and unilateral distalisation using infra zygomatic crestal implants

Impacted canines are a matter of concern in the treatment of malocclusion. After the third molars, maxillary canines are considered the most commonly impacted teeth with a frequency of 0.27% among Japanese and 2.4% among Italians. Unilateral impactions are more prevalent than bilateral impactions. The impacted canine can be detected with palpation, and radiographic techniques such as IOPA (Tube shift technique), panoramic radiographs, occlusal radiographs, and CT. The mesiodistal position and angulation of the canine crown on a panoramic radiograph can possibly predict treatment success. Various treatment approaches are considered depending on the mesiodistal angulation and position of the impacted canine. An auxiliary spring in the buccal region of the impacted canine designed by Kornhauser Et al has advantages such as avoidance of usage of palatal arches, and additional lab work such as soldering thereby incurring at least an extra clinical visit. This case report showcases the treatment of a 13-year-old growing male patient with a palatally impacted right maxillary canine using a Labial auxiliary spring and correction of molar relation using an Infra Zygomatic Crestal Implant.

Clinically Manifest Infections Do Not Increase the Relapse Risk in People with Multiple Sclerosis Treated with Disease-Modifying Therapies: A Prospective Study.

Many factors are believed to be positively associated with the incidence of relapses in people with multiple sclerosis (MS), including infections. However, their role is still controversial. We aimed to investigate whether symptomatic infections in people with MS increase the risk of relapse in the short, medium, or long term. We enrolled consecutive patients with relapsing MS (RMS) from October to December 2018. From enrolment up to September 2020, an online questionnaire investigating the occurrence of infections was sent via WhatsApp® monthly to the enrolled patients, while in-person visits were performed every six months. When patients complained of symptoms compatible with relapses, they attended an extra in-person visit. We enrolled 155 patients with RMS, and 88.38% of patients were treated with disease-modifying therapies. In the dataset, 126,381 total patient days, 78 relapses, and 1202 infections were recorded over a period of about 2 years. No increased risk of relapse after clinically manifest infections was found in the short-, medium-, or long-term period. No correlation was found between all infections and the number of relapses (p = 0.212). The main analyses were repeated considering only those infections that had at least two of the following characteristics: duration of infection ≥ 4 days, body temperature > 37° Celsius, and the use of drugs (antibiotics and/or antivirals), and no significant associations were observed. No associations between infections and relapses were observed, likely suggesting that disease-modifying therapies may protect against the risk of relapse potentially triggered by infections.