Prospective Single-arm Cohort Study Research Articles

B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single-arm cohort study of telitacicept.

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease associated with B-cell hyperactivity. Telitacicept is a transmembrane activator, calcium modulator, and cyclophilin ligand interactor-Fc fusion protein, which can neutralize both B-cell lymphocyte stimulator and a proliferation-inducing ligand. Patients with active SLE who received telitacicept were prospectively followed at month 1, 3, 6, 9, and 12 after telitacicept initiation. Thirty-seven participants were involved and followed for 6.00 [3.00, 6.00] months. SRI-4 rate at month 6 was 44.7%. The median dosage of prednisone was decreased by 43.8% (from 10 to 5.62mg/d) at month 6. The anti-dsDNA level was significantly decreased, while complement levels were significantly increased at month 6 from baseline. Continuously significant reductions in serum immunoglobin (Ig)G IgA, and IgM levels were also observed. Patients experienced significant decreases in the numbers of total and naive B cells, whereas memory B cells and T cell populations did not change. The number of NK cells was significantly increased during the follow-up. At month 6, 58.3% (14 out of 24) patients experienced improved fatigue accessed by FACIT-Fatigue score exceeding the minimum clinically important difference of 4. Most adverse events were mild, but one each case of severe hypogammaglobulinemia, psychosis with suicidal behavior, and B-cell lymphoma were occurred. In our first prospective real-world study, telitacicept treatment led to a significant clinical and laboratory improvement of disease activity, as well as fatigue amelioration in patients with SLE. Safety profile was favorable overall, but more studies are greatly needed.

Role of laparoscopic lumbar sympathectomy in chronic limb-threatening ischemia due to nonreconstructable peripheral arterial disease

Background Lumbar sympathectomy (LS) was traditionally performed for intermittent claudication but is now eclipsed by revascularization for that indication. However, it retains a role in the management of chronic limb-threatening ischemia and other conditions causing lower limb pain with or without ischemia. In this study, we identify its role in the management of chronic limb-threatening ischemia in cases of nonreconstructable peripheral arterial disease. Aim The main aim of this study is to determine if LS procedure has an effective role in limb salvage and pain control for patients with nonreconstructable peripheral limb ischemia. The primary endpoint was limb salvage in the target limb, while the secondary endpoint targeted assessment of pain improvement in the same limb. Patients and methods This study is a prospective single-arm cohort study conducted using 21 patients between the January 1, 2021 and the January 1, 2023 at two hospitals, Ain Shams University Hospital and Nasser Institute Hospital. Patients complained of nonreconstructable peripheral arterial disease and there was no chance for revascularization either endovascular or surgical bypass. Results This study included 60 patients; one patient was excluded due to being lost to follow-up, and presented with nonconstructable critical limb ischemia between the January 1, 2021 and the January 1, 2023. There were 42 (70%) males and 18 (30%) females. Follow-up for all patients was subjected to measurement of ankle brachial pressure index, digital pulse oximetry, toe pressure and numerical rating scale for pain scoring preoperative and postoperative. On follow-up we noticed that there was no change in either ankle brachial pressure index or toe pressure immediately postoperatively and after 12 months. However, the digital pulse oximetry showed significant improvement immediately postoperatively from 68.40±7.36 to 81.15±12.23 with a P value of 0.001. The most remarkable improvement was found in pain scoring immediately, 1, 3, 6, and 12 months postoperatively with P values showing statistical significance. As for limb salvage, there was a 100% limb survival for 3 months. After 6 months, only nine cases underwent above-knee amputation, one of them was due to severe limb infection, and three cases had minor amputation ‘toe amputation.’ We noticed that three out of the nine cases suffering major amputations had femoropopliteal disease. Of the patients, 80% suffered no minor or major amputation, while 15% had major amputations beyond the tarsometatarsal joint and only 5% underwent minor toe amputation or debridement. Fortunately, there was no mortality among the studied cases. Conclusion Retroperitoneoscopic LS is significantly less invasive than open surgical technique with fewer wound complications and less hospital stay period and offers a longer duration of pain relief and less incidence of recurrence of manifestations.

Hysteroscopy-assisted suction curettage for early pregnancy loss: does it reduce retained products of conception and postoperative intrauterine adhesions?

To describe the feasibility of hysteroscopy-assisted suction curettage for early pregnancy loss and to investigate whether it reduces the rates of retained products of conception (RPOC) and intrauterine adhesions (IUA). Prospective single-arm cohort study. University-affiliated Department of Obstetrics and Gynecology. Women admitted for surgical evacuation of early pregnancy loss were invited to participate in the study. Vaginal misoprostol was administered for cervical ripening preoperatively. Under general anesthesia, a diagnostic hysteroscopy was performed to identify the pregnancy's implantation wall, followed by ultrasound-guided suction and curettage directed to the implantation wall, and then diagnostic hysteroscopy to verify complete uterine cavity emptying. Postoperative IUA were evaluated by follow-up office hysteroscopy. Identification of the pregnancy's implantation wall on hysteroscopy, and intra-, and postoperative complications associated with the procedure. The evaluation of postoperative IUA was limited due to the COVID-19 pandemic-related restrictions on elective procedures. Forty patients were included in the study group. Their mean age was 34.0 ± 6.6years, and their mean gestational age was 8.9 ± 1.6weeks. The implantation wall was clearly visualized on hysteroscopy in 33 out of 40 cases (82.5%). The mean operative time was 17.2 ± 8.8min, and no intraoperative complications occurred. Suspected RPOC were diagnosed intraoperatively by hysteroscopy and removed in 4 cases, and the histologic examination confirmed the presence of RPOC in three of them. Follow-up office hysteroscopy was performed in nine women: mild IUA was diagnosed in one case and a normal cavity was confirmed in eight cases. A new pregnancy was reported at the time of follow-up in 15 cases, while 12 women declined to attend the follow-up hysteroscopy and four were lost to follow-up. Hysteroscopy-assisted suction curettage for early pregnancy loss is a safe, short, and inexpensive procedure, which allows the identification of the pregnancy's wall in most cases and may reduce the rates of RPOC.

Development of Gambling Behaviour and Its Relationship with Perceived Social Support: A Longitudinal Study of Young Adult Male Gamblers

Young adult men who gamble frequently face an elevated risk of developing gambling-related problems. So far, little is known about how changing levels of perceived social support interact with the course of gambling behaviour and gambling-related problems in this population. Using data from a prospective single-arm cohort study (Munich Leisure Time Study), we applied hierarchical linear models to investigate the longitudinal association of changes in perceived emotional and social support (hereafter PESS; operationalized as ENRICHD Social Support Instrument score) with gambling intensity, gambling frequency, and fulfilled criteria for gambling disorder. Pooling data from three time points (baseline, 12-month and 24-month follow-ups) to assess two 1-year intervals, these models disentangle the associations of (a) “level of PESS” (cross-sectional, between participants) and (b) “changes in individual PESS” (longitudinally, within-participants). Among the 169 study participants, higher levels of PESS were associated with fewer gambling-related problems (− 0.12 criteria met; p = 0.014). Furthermore, increasing individual PESS was associated with lower gambling frequency (− 0.25 gambling days; p = 0.060) and intensity (− 0.11 gambling hours; p = 0.006), and fewer gambling-related problems (− 0.19 problems; p < 0.001). The results suggest a mitigating influence of PESS on gambling behaviour and gambling-related problems. Increasing individual PESS appears more decisive for this pathway than high initial levels of PESS. Treatment and prevention strategies that activate and reinforce beneficial social resources in people with gambling-related problems are recommended and promising.

The arterial input function: Spatial dependence within the imaging volume and its influence on 3D quantitative dynamic contrast-enhanced MRI for head and neck cancer

PurposeTo evaluate the dependence of the arterial input function (AIF) on the imaging z-axis and its effect on 3D DCE MRI pharmacokinetic parameters as mediated by the SPGR signal equation and Extended Tofts-Kermode model. TheoryFor SPGR-based 3D DCE MRI acquisition of the head and neck, inflow effects within vessels violate the assumptions underlying the SPGR signal model. Errors in the SPGR-based AIF estimate propagate through the Extended Tofts-Kermode model to affect the output pharmacokinetic parameters. Materials and methods3D DCE-MRI data were acquired for six newly diagnosed HNC patients in a prospective single arm cohort study. AIF were selected within the carotid arteries at each z-axis location. A region of interest (ROI) was placed in normal paravertebral muscle and the Extended Tofts-Kermode model solved for each pixel within the ROI for each AIF. Results were compared to those obtained with a published population average AIF. ResultsDue to inflow effect, the AIF showed extreme variation in their temporal shapes. Ktrans was most sensitive to the initial bolus concentration and showed more variation over the muscle ROI with AIF taken from the upstream portion of the carotid. kep was less sensitive to the peak bolus concentration and showed less variation for AIF taken from the upstream portion of the carotid. ConclusionInflow effects may introduce an unknown bias to SPGR-based 3D DCE pharmacokinetic parameters. Variation in the computed parameters depends on the selected AIF location. In the context of high flow, measurements may be limited to relative rather than absolute quantitative parameters.

Abstract OT1-12-02: Preliminary report of the PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer

Abstract Background: Breast conserving surgery (BCS) is typically followed by adjuvant radiotherapy (RT) based on several landmark trials demonstrating improvements in disease control and survival. Since completion of these historical trials, the advent of molecular subtyping has revealed that breast cancer is not a single disease entity, but rather a class of cancers with differential risk profiles. We evaluated whether RT could be safely omitted following BCS for patients with the most favorable subtype as defined by the Prosigna PAM50 assay. Methods: We conducted a multicenter prospective single-arm cohort study with IRB approval and an FDA investigational device exemption (IDE). Eligible patients were women 50 to 75 years of age (inclusive) who had undergone BCS revealing tumors ≤2cm in size, that were estrogen or progesterone receptor positive (HR+), HER2 negative, grade 1-2, node negative (N0), with negative excision margins (no ink on tumor). Intent to take endocrine therapy was required. Upon registration, tumors were submitted for central Prosigna testing and those with Risk of Recurrence (ROR) score ≤40 were deemed eligible for the investigational omission of RT. The primary endpoint was the 5-year locoregional recurrence rate (LRR). Anticipating a total of 345 RT-omitting patients to enroll over 3.5 years, the study was designed with 90% power to exclude a 5-year LRR of 5% using a one-sample exponential test with one-sided type I error of 0.025. Results: From 2016 to 2020, 671 patients were registered from 13 centers, inclusive of affiliated regional network sites. Of these, 382 patients had a ROR Score ≤40 and opted to forego RT, comprising the main intention-to-treat (ITT) study population. Median age was 65 years (range 50 to 75), and median tumor size was 0.9 cm (range 0.1 to 2.0 cm). At a median follow-up of 26.9 months, 12 events were observed: 4 patients had ipsilateral in-breast recurrences, 7 had contralateral breast cancers, and 1 developed an unrelated melanoma. There were no regional-nodal or distant recurrences. The 2-year cumulative rate of LRR was 0.3% (95% CI: 0 – 1.0%). Of the 4 ipsilateral breast recurrences, 2 were in the same quadrant as the original primary tumor. Conclusion: In this preliminary report of the PRECISION trial, patients 50-75 years of age undergoing BCS and endocrine therapy for pT1N0 HR+ HER2-negative breast cancer with ROR score ≤40 had exceedingly low rates of LRR in the absence of adjuvant RT at a median follow-up of 26.9 months. Additional follow-up is required to determine whether these favorable results are durable. Citation Format: Lior Z. Braunstein, Julia Wong, Deborah A. Dillon, Yu-Hui Chen, Paul Catalano, Oren Cahlon, Mahmoud B. El-Tamer, Rachel Jimenez, Atif Khan, Carmen Perez, Rinaa Punglia, Ron Shiloh, Laura Warren, David Wazer, Jean Wright, Elizabeth Buckley, Tari King, Simon Powell, Eric Winer, Jennifer Bellon. Preliminary report of the PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-12-02.

Abstract P4-07-54: Health related quality of life of patients treated with bevacizumab and paclitaxel as first-line treatment for HER2 negative metastatic breast cancer: impact of clinical factors

Abstract Background: Advances in screening and treatment have led to increase in breast cancer (BC) survival in recent years but prognoses for metastatic BC remain poor with poorer outcomes as health-related quality of life (HRQOL). Treatment as bevacizumab and paclitaxel for metastatic BC, although that can increase time to progression of disease, often carry toxicity and is not curative but rather palliative in intent with the goal to improve or maintain HRQOL. The aim of this work was to assess impact of clinical factors such as disease progression, toxicity on HRQOL. Methods: COMET study is a multicenter prospective single-arm cohort study in France whose main objective was to identify biological factor that could predict the clinical benefit of bevacizumab-paclitaxel combination therapy as first treatment in HER2 negative metastatic BC. HRQOL was assessed at baseline, at every cycle (every for 4 weeks) until progression and then every 3 months up to death using the EORTC QLQ-C30 questionnaire and its BC specific module, the EORTC QLQ-BR23. In this ancillary study, we targeted 5 dimensions HRQOL for the primary analyses: Global health status (GHS), physical functioning (PF), Emotional functioning (EF), fatigue (FA) and pain (PA). The primary endpoint was time until definitive deterioration (TUDD) in HRQOL scales that defined as time between inclusion and the first decrease HRQOL score ≥ 5 points compared to baseline score, with no further improvement of at least 5 points. Multivariable Cox model with time dependent covariate was performed to assess clinical factors associated with TUDD for each of the 5 target dimensions HRQOL. We performed 3 models for each dimension: model 1 including all covariate with p&amp;lt; 0.10 in univariable; model 2 including model 1 and adjusted on cancer subtype and model 3 included model 1 stratified by cancer subtype. P value &amp;lt; 0.01 were considered statistically significant. Results: Out of 510 patients included in COMET study, 432 patients with available HRQOL data were analyzed in this study. Median age at inclusion was 58 years (range: 29-83), and 24.4% of patients had triple negative tumor subtype. About 79 % of cancers were invasive ductal carcinoma and 43 % patients had least 3 metastasis sites at baseline. At baseline, patients reported a mean score for GHS of 57.6 (SD=22.7), for PF of 75.8 (23.2), for EF of 62.2 (25.8), for FA of 42.2 (29.60) and for PA of 38.1 (31.5). The Median TUDDs for the 5 targeted dimensions was 10.1 months [7.5-16.9] for GHS, 6.1 months [4.1-8.9] for PF, 21.6 [18.7-31.2] for EF, 10.8 [6.2-16.6] for FA and 13.6[10.1-22.5] months for PA. In multivariable analyses, Disease Progression was associated with TUDD of GHS (HR [99%CI] =2.4 [1.2-4.9] and TUDD of PF (2.1 [1.1-3.7]). After adjusted on cancer subtype, association persisted with TUDD of GHS (p=0.009). Performance Status was associated with TUDD of PF (1.6 [1.2-2.3]), and TUDD of Pain (1.6 [1.1-2.3]). Performance Status association with TUDD of PF continued after adjustment on cancer subtype (p=0.0003). Prior endocrine therapy was associated with TUDD of pain in patients with tumor with positive hormone receptor (HR+) (2.4 [1.2-4.7]). There was no factor associated with TUDD of EF and TUDD of FA. Conclusion: Results of this study have shown that among the 5 targeted dimensions HRQOL, Physical Functioning was deteriorated in the shortest time. Disease progression, base line performance status and prior endocrine therapy for HR+ subtype, are clinical factors that could influence HRQOL in HER2 negative metastatic BC treated with first line chemotherapy. Citation Format: Oumar Billa, Sandrine Dabakuyo, Marion Chevrier, Franck Bonnetain, Isabelle Desmoulins, William Jacot, Olivier Trédan, Marc Debled, Christelle Levy, Anthony Gonçalves, Jean-Marc Ferrero, Florence Dalenc, Christelle Jouannaud, Marie-Ange Mouret-Reynier, Mireille Mousseau, Julien Grenier, Jean-Philippe Jacquin, Fatima-Zohra Toumi, Frédérique Berger, Jérôme Lemonnier, Jean-Yves Pierga. Health related quality of life of patients treated with bevacizumab and paclitaxel as first-line treatment for HER2 negative metastatic breast cancer: impact of clinical factors [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-54.

An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis.

Aim: Osteoarthritis(OA) prevalence is increased in ageing and obese populations. This prospective single-arm cohort study aimed to investigate the efficacy of autologous microfragmented adipose tissuetreatment of severe knee or shoulder OA. Materials & methods: Participants received an intra-articular microfragmented adipose tissue injection to the affected joint(s). Multiple patient reported outcome measures (PROMS) were recorded from 0 to 52weeks for 63 consecutive joints. Results: Compared with baseline, there were significant improvements in all PROMS from 2 to12weeks and maintained at 52weeks. Regression analysis revealed an inverse correlation with BMI and change in PROMS for knee joints. Conclusion: Our observed findings suggest this approach represents a safe, effective treatment for moderate-to-severe knee and shoulder OA, although efficacy may be reduced with increasing obesity.

Predictive value of DCE-MRI and IVIM-DWI in osteosarcoma patients with neoadjuvant chemotherapy.

ObjectiveTo investigate the predictive value of dynamic contrast enhanced MRI (DCE-MRI) and intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI) for clinical outcomes of osteosarcoma patients with neoadjuvant chemotherapy.MethodsThe present prospective single-arm cohort study enrolled 163 patients of osteosarcoma during July 2017 to July 2022. All patients received the same treatment strategy of neoadjuvant chemotherapy. Both DCE-MRI and IVIM-DWI were conducted for the patients before the chemotherapy, as well as after one or two chemotherapy treatment cycles. The imaging parameters of contrast agent transfer rate between blood and tissue (Ktrans ), contrast agent back-flux rate constant (Kep ), extravascular extracellular fractional volume (Ve ), as well as pure diffusion coefficient (D value), pseudo-diffusion coefficient (D* value), apparent diffusion coefficient (ADC) and the perfusion fraction (f value) were recorded. RECIST standard [complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)] was used as the main clinical outcome.ResultsAfter two treatment cycles, 112 (68.71%) cases were with CR and PR, 31 (19.02%) cases were with SD and 20 cases (12.27%) were with PD. After 1~2 treatment cycles, patients with CR/PR showed significantly markedly lower Ktrans , Kep , Ve values, while higher D, ADC and f values compared with SD or PD patients. Alkaline phosphatase (ALP) and lactate dehydrogenase (LDH) were positively correlated with values of Ktrans , Kep , and Ve , while negative correlation was observed between ALP and values of D, ADC and f, as well as between LDH and D and ADC after the whole treatment. D and Kep values after two treatment cycles showed the best predictive value for diagnosis of PD. The values of Ktran , Kep , ADC as well as ALP and LDH were all risk factors for PD after neoadjuvant chemotherapy.ConclusionDCE-MRI and IVIM-DWI have the potential to predict clinical outcomes of osteosarcoma patients with neoadjuvant chemotherapy.

Effects of orthodontic treatment on body mass index, food habits and self-esteem of patients: A prospective single-arm cohort study

ObjectivesDuring orthodontic treatment, patients are often apprehensive about reduced food intake and loss of body weight. Body mass index (BMI) assessment is an inexpensive, easy method for screening and studying changes in weight categories. This research aimed to determine whether long-term changes in BMI, self-esteem, and food habits occur in patients during the first year of orthodontic treatment. MethodsBMI was calculated for 120 patients undergoing orthodontic treatment. Data were collected at baseline, and after the end of the first, second, third, sixth, and twelfth months. Rosenberg's self-esteem scale was used for scoring self-esteem. The Food Habit Assessment Scale was used to study changes in eating habits. Statistical analysis was performed with repeated measures ANOVA followed by Tukey HSD post-hoc test for BMI scores and Kruskal–Wallis test followed by Dunn's multiple comparison post-hoc tests for the Rosenberg scale and food habits questionnaire. ResultsAt the end of 12 months, 43.4% of patients had a decrease in BMI, 45.8% had a mild to moderate increase in BMI, and 10.8% of patients maintained their BMI levels. The changes were not statistically significant. Self-esteem changes were statistically significant for both genders. Changes in food habits were also significant. ConclusionBMI decreased for the first 3 months and gradually recovered by the end of the first year of treatment. Self-esteem scores showed a significant improvement in both genders. Patients reverted to pre-treatment food habits by the end of the year.

Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: cuttIng ballooN angioplaSTy combined wITh paclitaxel drUg-coaTed balloon angioplasty, an observatIONal study (INSTITUTION Study).

To study the safety and efficacy of cutting balloon angioplasty (CBA) followed by paclitaxel drug-coated balloon (PCB) angioplasty for recurrent venous lesions in arteriovenous fistulas (AVFs). We conducted a prospective single-arm cohort study of CBA followed by PCB angioplasty for recurrent AVF stenoses between September 2017 and April 2019. In total, 44 participants were recruited. Target lesions were included if they had recurred within 12months post-angioplasty, were > = 0.5cm upstream from the arteriovenous anastomosis, and did not involve the central veins. Up to two non-target lesions per circuit/participant with the same definition were allowed. Lesions were considered separate when there was an intervening 2-cm segment of normal vessel. Technical success was defined as complete lesion effacement on angioplasty. End-points of target and circuit patency were evaluated clinically at 3, 6, and 12months post-procedure. Technical success was 96% (42/44): Two participants were excluded from analysis due to the need for high-pressure balloon angioplasty as the target lesions did not efface with CBA. The median follow-up duration was 337.5days. Mean stenosis pre- and post-angioplasty was 69.0% (51.6-84.8) and 20.8% (0-44.8), respectively. The target lesion primary, primary assisted and circuit patency for the entire study population (n = 42) were 61.6 ± 7.8%, 92.7 ± 4.0%, and 54.7 ± 7.9%, respectively, at 12months. For participants without non-target lesions (n = 22), the rates were 77.3 ± 8.9%, 90.9 ± 6.1%, and 60.7 ± 11.0%, respectively, at 12months. CBA followed by PCB angioplasty appears safe and feasible for treatment of recurrent venous lesions in dysfunctional AVFs.

Effectiveness and Safety of 9-Month Treatment Regimen for Multidrug-Resistant Tuberculosis in the Philippines

Background: The Philippines has a burden of drug-resistant tuberculosis (DR-TB). One of the key challenges in the programmatic management of DR-TB (PMDT) is the high rate of loss to follow-up (38% in the 2010 cohort). An urgent need for a shorter, more tolerable, less expensive treatment regimen exists. The aim of the operational study is to determine the efficacy and safety of the short treatment regimen among drug resistant TB. Methods: This is a prospective single-arm cohort study evaluating the effectiveness and safety of a shorter 9 - 11-month treatment regimen (9MTR) for rifampicin-resistant/multi-drug resistant TB (RR/MDR-TB) in 10 PMDT facilities. All eligible consenting adult patients with rifampicin-resistant TB were enrolled and received the standardized 9-month treatment regimen (9MTR), including injectables, with a follow-up after 12 months of treatment completion. Results: A total of 329 patients were enrolled from July 2015 to December 2016. At the 6th month post-enrollment, 256 (77.8%) of them had culture-negative test results. The end-of-treatment success rate was 74.1% (224 [68.0%] were cured and 20 [6.1%] completed the treatment). On the other hand, 10 (3.0%) died, 41 (12.5%) lost to follow-up, 33 (10.0%) withdrawn, 1 (0.3%) treatment failure. In the 12th month after 9MTR completion, among the 244 patients with successful treatment, 198 (81.1%) had culture-negative results, while there were 46 patients whose culture tests were not done. One patient developed TB relapse with fluoroquinolone resistance. The majority of the adverse events were mild that occurred mostly during the first 6 months of treatment. Conclusion: The 9-month treatment regimen had a high treatment success rate with a favorable safety profile. The loss to follow-up was reduced; however, it was still a challenge. The introduction of the 9MTR via operational research had a major impact on building national capacity and infrastructure for the programmatic adoption of a new regimen. Ten PMDT centers received training and experience, created diagnostic pathways, and active drug safety monitoring and management were built.

Hysteroscopy Assisted Suction Curettage for Early Miscarriage: Does It Reduce Rpocn and Postoperative Intrauterine Adhesions?

<h3>Study Objective</h3> To describe the feasibility of hysteroscopy assisted suction curettage for early pregnancy loss and to investigate whether it reduces the rates of retained products of conception (RPOC) and intrauterine adhesions (IUA). <h3>Design</h3> Prospective single-arm cohort study. <h3>Setting</h3> University-affiliated department of Obstetrics and Gynecology. <h3>Patients or Participants</h3> Women admitted for surgical evacuation in cases of early pregnancy loss. <h3>Interventions</h3> Vaginal misoprostol was administered for cervical ripening preoperatively. Under general anesthesia, hysteroscopy was performed to identify the pregnancy's implantation wall, followed by ultrasound-guided suction and curettage directed to the implantation wall, and hysteroscopy to verify uterine cavity emptying. Postoperative IUA were evaluated by follow-up hysteroscopy. <h3>Measurements and Main Results</h3> Identification of the pregnancy's implantation wall on hysteroscopy, and intra- and postoperative complications associated with the procedure. The evaluation of postoperative IUA was limited due to the COVID-19 pandemic restrictions. Main Results: 40 patients, with early pregnancy loss were studied. In 33 out of 40 cases (82.5%), the implantation wall was clearly visualized on hysteroscopy. In 4 cases, suspected RPOC were diagnosed intraoperatively by hysteroscopy and removed. The histology examination confirmed the presence of RPOC in 3 out of 4 cases. Follow-up office hysteroscopy was performed in 9 women, diagnosing mild IUA in one out of 9 cases. In 15 cases, a new pregnancy was reported at time of follow-up. <h3>Conclusion</h3> Hysteroscopy assisted suction curettage for early pregnancy loss is safe procedure, which allows the identification of the pregnancy's implantation wall in most cases and may reduce the rates of RPOC and IUA. By identification of uterine anomalies, the procedure may offer a potential benefit in terms of reproductive outcomes for hypo-fertile patients.

Trigger point injection for post-mastectomy pain: a simple intervention with high rate of long-term relief

Post-mastectomy pain syndrome (PMPS) is a common and often debilitating condition. The syndrome is defined by chest wall pain unresponsive to standard pain medications and the presence of exquisite point tenderness along the inframammary fold at the site of the T4 and T5 cutaneous intercostal nerve branches as they exit from the chest wall. Pressure at the site triggers and reproduces the patient’s spontaneous or motion-evoked pain. The likely pathogenesis is neuroma formation after injury to the T4 and T5 intercostal nerves during breast surgery. We assessed the rate of long-term resolution of post-mastectomy pain after trigger point injections (2 mL of 1:1 mixture of 0.5% bupivacaine and 4 mg/mL dexamethasone) to relieve neuropathic pain in a prospective single-arm cohort study. Fifty-two women (aged 31–92) who underwent partial mastectomy with reduction mammoplasty or mastectomy with or without reconstruction, and who presented with PMPS were enrolled at the University of California San Francisco Breast Care Center from August 2010 through April 2018. The primary outcome was a long-term resolution of pain, defined as significant or complete relief of pain for greater than 3 months. A total of 91 trigger points were treated with mean follow-up 43.9 months with a 91.2% (83/91) success rate. Among those with a long-term resolution of pain, 60 trigger points (72.3%) required a single injection to achieve long-lasting relief. Perineural infiltration with bupivacaine and dexamethasone is a safe, simple, and effective treatment for PMPS presenting as trigger point pain along the inframammary fold.

Outcomes of a 1-Year Prospective Single-Arm Cohort Study Using a Novel Macro-Hybrid Implant Design in Extraction Sockets: Part 1.

A novel macro-hybrid implant design was introduced to afford high apical primary stability and more coronal space to preserve the circumferential extraction socket architecture. This study presents 1-year data from a prospective single-arm cohort study. The data was distilled based on the following criteria: (1) single-tooth immediate tooth replacement therapy (ITRT) in the maxillary anterior and premolar regions in intact (Type 1) extraction sockets that were (2) treated with the dual-zone grafting technique. The clinical and radiographic outcomes of 48 ITRT implants were evaluated. The mean ± SD labial plate dimension changes were 0.33 ± 0.41 mm at the implant abutment interface (L1) and 0.34 ± 0.40 mm at 5.0 mm below (L2). The mean labial plate dimension (thickness) at the 1-year recall was 2.27 ± 0.88 mm (L1) and 1.95 ± 0.95 mm (L2). At ITRT, the ridge contour at the free gingival margin and 3.0 mm below it were 7.54 ± 0.93 mm and 9.44 ± 2.36 mm, respectively; after final restoration delivery, the corresponding values were 7.45 ± 0.95 mm and 10.23 ± 2.30 mm, respectively. The peri-implant soft tissue thickness (PISTT) at the time of implant-level impression-making was 3.29 ± 0.73 mm, with an average Pink Esthetic Score of 12.79. A macro-hybrid implant design showed high levels of primary stability (~60 Ncm), stable ridge contour at 1 year, a labial plate dimension between 1.5 and 2.0 mm, and PISTT > 3.0 mm, which may be a critical factor in providing stable, long-term esthetic outcomes.

Evaluation of Alt-RAMEC With Facemask in Patients With Unilateral Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT) and Finite Element Modeling-A Clinical Prospective Study.

Evaluate the effects of alternate rapid maxillary expansion and constriction (Alt-RAMEC) protocol on patients with unilateral cleft lip and palate (UCLP) along with maxillary protraction using cone beam computed tomography (CBCT) records and a finite element modeling (FEM) model. Twenty-five patients (aged 9-13 years) with UCLP having a GOSLON score 3 were selected for this prospective single-arm cohort study after obtaining necessary informed consent. A 9-week Alt-RAMEC protocol using a custom-made fan-shaped expansion screw was initiated, which was followed by 6-month facemask wear. Pre (T1) and posttreatment (T2) records including CBCT were taken and were evaluated for treatment changes in all 3 dimensions using paired t test. Additionally, a FEM model (ANSYS 15.0) using the Alt-RAMEC protocol was also analyzed for the displacement and stress on various craniofacial structures. Significant forward movement of the maxilla along with clockwise rotation of mandible along with statistically significant increase in lower molar height and upper incisor proclination (P < .05) was observed. CBCT evaluation showed a statistical significant decrease in buccal alveolar bone thickness and increase in molar inclination (P < .05). Finite element modeling analysis highlighted that the maximum displacement occurred at the anterior region with stresses radiating till the anterior nasal spine, zygomatic arch, and sphenoid bone. Alt- RAMEC protocol combined with facemask protraction can lead to significant maxillary advancement, with some transient decrease in buccal bone thickness noted thereby warranting long-term studies to further assess its effect on the dentofacial apparatus.

Prospective Determination of Airway Response to Upper Airway Stimulation: A New Opportunity for Advanced Device Titration.

Response to upper airway stimulation (UAS) is associated with the degree of airway opening during stimulation. UAS programming may affect this opening. The objective of this study was to examine airway changes in response to five different electrode configurations programmable within the Inspire UAS system. Prospective single-arm cohort study. Subjects who underwent UAS implantation were recruited for a prospective single-arm cohort study during UAS device activation. Functional thresholds were recorded for all settings. Awake nasopharyngoscopy was performed to examine the retropalatal (RP) and retroglossal (RG) regions at rest and during activation with all settings at their functional thresholds. Cross-sectional measurements were made by two blinded reviewers and reported as percent change in airway size. Sixteen patients were included. The standard setting (+-+) resulted in the greatest change in RP area in 43.8% of patients. An alternative setting resulted in greatest change in 56.2% of patients (--- and o-o in 18.8% each, -o- in 12.5%, and -+- in 6.3% of patients). Average response to all five settings was utilized to classify degree of palatoglossal coupling. Most patients had some enlargement (20%-70% change in RP area, 43.8%) or no enlargement (<20% change, 43.8%), whereas a minority of patients (12.5%) had marked enlargement (>70% change). RP and RG expansion were not correlated. Degree of RP expansion varied among patients and settings. Although the standard setting resulted in greatest RP change in a plurality of patients, over half had a greater response to an alternative setting. Future studies should address whether choice of setting based on RP expansion results in improved outcomes. 4 Laryngoscope, 131:218-223, 2021.

Safety of Gastrointestinal Endoscopy with Monitored Anesthesia Care in Patients with Obstructive Sleep Apnea

Introduction: Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for cardiopulmonary complications. The aim of the present study was to evaluate the safety of monitored anesthesia care (MAC) in patients with OSA undergoing gastrointestinal endoscopy. Methods: We performed a prospective single arm cohort study at the James A. Haley VA Hospital which was IRB-approved. All consecutive adult patients with OSA confirmed using polysomnography undergoing endoscopy with MAC were eligible for inclusion. Cardiopulmonary variables such as heart rate, level of blood oxygen saturation and blood pressure were recorded continuously throughout the endoscopic procedures. Additionally, anesthesia maneuvers such as the use of suction, head tilt, nasal trumpet, and laryngeal mask airway (LMA) were recorded. Other variables such as the use of CPAP, bronchodilators, robinol, and lidocaine either as vein analgesia or for arrhythmia were also recorded. Event rates were assessed using descriptive statistics. All analyses were performed using SPSS v22 statistical analysis software. Results: A total of 76 with confirmed moderate or severe OSA met the inclusion criteria. Heart rate remained stable in 96.1% (n=73/76), blood pressure remained stable in 100% (n=76/76), and O2 saturation remained stable in 96% (n=72/76) of patients. Changes in heart rate and O2 saturation were transitory and recovered spontaneously without any additional intervention. In our cohort suction was only needed in 21.1% (n=16/76), head tilt was performed in 28.9% (n=22/76), nasal trumpet was used in 7.9% (n=6/76), LMA was used in 1.3% (n=1/76), 97.4% (n=74/76) of the patients maintained a normal pCO2 and none required the use of CPAP. IV lidocaine was used in 68.4% (n=52/76) of patients for vein analgesia and none required IV lidocaine for arrhythmia control. Bronchodilators were used in 2.6% (n=2/76) and robinol was used in 14.5% (n=11/76) of patients to inhibit intestinal motility. None of the cases required advanced anesthesia care such as general endotracheal intubation nor was there a procedure aborted. Conclusion: Despite the presumed increased risk of cardiopulmonary complications, patients with OSA who undergo endoscopy with monitored anesthesia care have clinically insignificant variations in cardiopulmonary parameters as suggested by this prospective study. Additionally, the anesthesia-related interventions were clinically insignificant.

Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi.

Introduction:Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi.Methods:A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering.Results:Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4–14.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1–10) were 2 (interquartile range, 2–4) during application and removal, and 0 (interquartile range, 0–2) at all other time points.Conclusions:Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision.

Long-term follow-up of a large active surveillance cohort of patients with prostate cancer.

Active surveillance is increasingly accepted as a treatment option for favorable-risk prostate cancer. Long-term follow-up has been lacking. In this study, we report the long-term outcome of a large active surveillance protocol in men with favorable-risk prostate cancer. In a prospective single-arm cohort study carried out at a single academic health sciences center, 993 men with favorable- or intermediate-risk prostate cancer were managed with an initial expectant approach. Intervention was offered for a prostate-specific antigen (PSA) doubling time of less than 3 years, Gleason score progression, or unequivocal clinical progression. Main outcome measures were overall and disease-specific survival, rate of treatment, and PSA failure rate in the treated patients. Among the 819 survivors, the median follow-up time from the first biopsy is 6.4 years (range, 0.2 to 19.8 years). One hundred forty-nine (15%) of 993 patients died, and 844 patients are alive (censored rate, 85.0%). There were 15 deaths (1.5%) from prostate cancer. The 10- and 15-year actuarial cause-specific survival rates were 98.1% and 94.3%, respectively. An additional 13 patients (1.3%) developed metastatic disease and are alive with confirmed metastases (n = 9) or have died of other causes (n = 4). At 5, 10, and 15 years, 75.7%, 63.5%, and 55.0% of patients remained untreated and on surveillance. The cumulative hazard ratio for nonprostate-to-prostate cancer mortality was 9.2:1. Active surveillance for favorable-risk prostate cancer is feasible and seems safe in the 15-year time frame. In our cohort, 2.8% of patients have developed metastatic disease, and 1.5% have died of prostate cancer. This mortality rate is consistent with expected mortality in favorable-risk patients managed with initial definitive intervention.