12-month Prospective Study Research Articles

P0344 Comparative analysis of a simple POPSIL score with Lémann Index to define the burden of organ damage in Crohn’s disease

Abstract Background Uncontrolled inflammation in Crohn’s disease (CD) can lead to progressive bowel damage such as strictures, fistulae and abscesses. There is currently no practical measure for organ damage that is available for clinicians to use. Presently, the Lémann Index(LI) incorporates analysis of multiple bowel segments and complication coefficient multiplication (with minimum 60 data points) that is difficult to apply in real-world clinical setting(1). We designed a simple score derived from LI to capture risk factors of Penetrating, Organ Involvement, Perianal, Stricturing, Inflammation and Length (POPSIL) that can track the evolution of organ damage in CD and that can be universally applied to routine clinical data (Table 1). Methods We applied the LI and POPSIL score to CD patients from the MUSIC and GI-DAMPs IBD study(www.musicstudy.uk); a prospective 12-month longitudinal study and cross-sectional study following active IBD patients in response to current drug treatment respectively. All participants undergo endoscopic evaluation at baseline and again at 3-6 months for mucosal assessment; and MRI small bowel where clinically indicated. We calculated Pearson correlation coefficients to compare the LI results with the POPSIL score. In addition, we analysed organ damage scores with patient-reported outcomes of wellbeing (CUCQ32) in particular, pain, fatigue and psycho-social welfare. Results In total, of 312 CD patients with complete data, 72 (23.1%) patients had small bowel MRI and colonoscopy data within 60 days (median time between two tests was 26.5 days; IQR 5.75-44.25 days) of recruitment to enable both LI/POPSIL scores to be calculated. In this cohort, median age was 31 years (IQR 26-42), 36 female (50%). A total of 20.8% (n=15) patients were current smokers. The median BMI was 25 (IQR 21.4-29.4). Overall, median LI was 19.5 (IQR 8.3-26.4). Median POPSIL score was 6 (IQR 5-8) where in our cohort POPSIL scores were classified according to severity (Table 1): Mild 3.2% (n=2), Moderate 41.2% (n=26), Severe 49.2% (n=31) and Very Severe 6.4% (n=4). POPSIL score is significantly correlated with LI (r=0.6, p<0.001). CUCQ32 were not correlated with neither LI and POPSIL scores. The time taken to calculate the scores for LI and POPSIL per patient were 3 minutes and 1 minute respectively. Conclusion The POPSIL score has comparable effectiveness to the LI in assessing global bowel damage. Its ease of calculation suggests that it may be a more practical method to assess burden of organ damage over time, response to drug therapy and prognostic determination of disease course. To develop the POPSIL score, we will incorporate patient-reported outcomes and larger scale validation of this approach. References 1)Pariente B, Torres J, Burisch J, et al. Validation and Update of the Lémann Index to Measure Cumulative Structural Bowel Damage in Crohn’s Disease. Gastroenterology. 2021 Sep;161(3):853-864.e13

Modifiable factors for somatic symptom persistence in patients with somatic symptom disorder: study protocol for a longitudinal cohort with an embedded ecologically momentary assessment (SOMA.SSD)

IntroductionSomatic symptom disorder (SSD) is a distressing mental disorder characterised by the presence of at least one persistent somatic symptom and a significant psychological burden due to the symptom(s), as well as excessive thoughts, feelings or behaviours related to them or associated health concerns. The primary aim of our study is to deepen the understanding of risk factors and mechanisms for somatic symptom persistence. Specifically, we will investigate the role of patients’ expectations and somatic comorbidity regarding symptom persistence.Methods and analysisIn a prospective 12-month cohort study, n=240 patients with SSD will be recruited from the outpatient clinics of the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center Hamburg-Eppendorf. The roles of two hypothesised predictors (ie, expectations and comorbidity) will be analysed together with known predisposing and maintaining factors of persistent somatic symptoms. The study entails macrolevel and microlevel assessments to investigate symptom severity over different timespans. Assessments at the macrolevel take place at baseline, 6 and 12 months. At the microlevel, a 10-day ecological momentary assessment study will be implemented to elucidate patients’ dynamic experience with somatic symptoms in their natural environments. In order to elicit possible framing effects on the 10-day course of symptom severity, participants are randomised to either a positive or a negative expectation framing group. Cross-lagged panel models will be used to analyse data at the macrolevel. At the microlevel, multivariate latent growth curve models will be conducted to relate temporal changes in predictor and outcome variables to one another.Ethics and disseminationThe study was approved by the Ethics Committee of the Medical Associations Hamburg, Germany (2020-10197-BO-ff). The results will enable us to draw conclusions regarding the role of expectations for future targeted treatment options and regarding the utility of somatic comorbidity as a potential diagnostic specifier of SSD. Dissemination of our results will be achieved through scientific publications, and lay summaries for study participants, patient advocacy groups and the general public.Trial registration numberISRCTN36251388.

Internet-based enrollment of a myositis patient cohort-a national experience.

Recruitment for idiopathic inflammatory myopathies (IIM) research is a challenge due to the rarity of the disease and the scarcity of specialized myositis centers. Online recruitment may be a feasible alternative to reach rare disease patients. We evaluated various online recruitment methods in a large longitudinal IIM cohort. The "Myositis Patient Centered Tele-Research" (My Pacer) is a prospective 6-month observational study of IIM, recruited online and through traditional clinic visits. We utilized diverse recruitment methods, such as physician referrals, social media, websites, direct emails, and partnerships with patient-support organizations. Participants self-enrolled and completed pre-screening, e-consenting, and release of medical information via the study-specific app or website. We compared the effectiveness of various recruitment and enrollment methods and the characteristics of the population recruited. A total of 841 participants completed the pre-screening; 408 completed e-consent and registration. From those, 353 (86.5%) were remotely recruited. Email (201; 49.26%) and social media (77; 18.87%) were important recruitment tools. Patient-support organizations were responsible for disseminating the study to 312 (75.46%) participants. The study app was used by 232 (65.72%) individuals for enrollment, with app users being slightly younger than website users (p = 0.001). Participants were mostly female 317 (77.76%), mean age of 54.84 years, White 328 (80.42%), Black 49 (12%), Asian 13 (3.26%), and non-Hispanic 378 (92.65%). Our study reached all U.S. regions and 45 (90%) U.S. states. Social media and partnerships with patient-support organizations lead to a high rate of recruitment, with a wide reach, and a reasonably diverse population.

Oral Health-Related Quality of Life of Hong Kong Kindergarten Children Receiving Silver Diamine Fluoride Therapy.

The objective of this prospective 12-month observational study is to examine the oral health-related quality of life (OHRQoL) among Hong Kong young children aged 3-4 years old receiving silver diamine fluoride (SDF) therapy for carious upper anterior primary teeth. A parental questionnaire was used to collect each child's sociodemographic background and oral health habits at baseline. Data on parents' satisfaction with their child's dental aesthetics were collected at baseline and during a 12-month visit. The Chinese Early Childhood Oral Health Impact Scale (C-ECOHIS) was used to measure OHRQoL. A trained dentist performed examinations and recorded caries experience (dmft) and oral hygiene (visible plaque index) at baseline and 12 months. SDF was applied to the carious lesions. Out of 286 invited children, 248 (87%, 248/286) participated, and 211 (85%, 211/248) attended the 12-month examination. All SDF-treated carious lesions were discoloured at the 12-month examination. Regression analysis showed that the baseline C-ECOHIS score was associated with dmft (p < 0.001). The baseline and 12-month C-ECOHIS scores were 4.6 ± 5.5 and 5.0 ± 5.6, respectively (p = 0.42). The scores for parental satisfaction with dental aesthetics at baseline and 12 months were 59% to 46% (p < 0.001). Satisfaction was negatively associated with the number of discoloured upper anterior teeth (p < 0.001). In conclusion, SDF discoloured the carious upper anterior teeth of the Hong Kong kindergarten children. However, the discoloured lesions had no significant effects on the OHRQoL of these children. However, more parents became dissatisfied with their child's dental aesthetics after SDF therapy. Hence, clinicians should inform parents well before they perform SDF therapy on children.

Impulsivity as a predictor of clinical and psychological outcomes in a naturalistic prospective cohort of subjects at ultra-high risk (UHR) for psychosis from Tunisia

BackgroundImpulsivity is associated with serious detrimental consequences on physical, mental, behavioral and social aspects of health among patients with psychosis. The present prospective 12-month follow-up study aimed to determine the prevalence of highly impulsive individuals among Ultra High Risk (UHR) patients, how impulsivity evolves over the follow-up period, and whether impulsivity impacts clinical, psychological and functional outcomes in this population. MethodUHR patients were invited to complete a battery of measurements at three-time points: at baseline, and at 6 and 12 months of follow-up. Impulsivity was assessed using both behavioral (the Wisconsin Card Sorting Test, WCST) and self-report (the Barratt Impulsiveness Scale, BIS-11) measures. ResultsFindings showed that at 6 months of follow-up, higher 6-month BIS-11 attentional and motor impulsivity were significantly associated with lower quality of life and greater general psychological distress. In addition, higher baseline BIS-11 motor impulsivity significantly predicted more severe positive psychotic symptoms at 12 months of follow-up. However, WCST scores did not show any significant associations with study variables at the different times of follow-up. ConclusionInterventions targeting impulsivity in UHR individuals could help decrease psychological distress and positive psychotic symptoms’ severity, as well as improve quality of life in UHR individuals.

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial

BackgroundCigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.ObjectiveTo investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.MethodsA prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.DiscussionAs tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial.Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.

Psychosocial outcomes following emergency laparotomy (POLO) study: a study protocol for a multicentre mixed-methods prospective cohort study assessing the psycho-social outcomes following emergency laparotomy in adults

IntroductionMorbidity from an emergency laparotomy (EmLap) is difficult to define and poorly understood. Morbidity is a holistic concept, reliant upon an interplay of bio-psychosocial outcomes that evolve long after discharge....

Arthroscopic and open reconstruction of the posterolateral corner of the knee have equally good clinical results: first results of a prospective 12-month follow-up study

PurposeArthroscopic reconstruction techniques for higher-grade posterolateral corner (PLC) injuries (Fanelli Type B, PoLIS LI-B) have not yet been validated in clinical studies. The open reconstruction technique described by Arciero is well-established and showed good restoration of joint stability in previous studies. This study aimed to compare clinical outcomes of this established open surgery technique to a newly developed arthroscopic technique in a prospective randomized clinical trial.MethodsBetween 2019 and 2021, this study focused on chronic high-grade PLC injuries (Fanelli Type B, PoLIS LI-B). Group A consisted of patients treated with conventional open surgery following Arciero’s technique, while Group B included patients treated with Arciero’s arthroscopic technique. All cases underwent additional PCL reconstruction. After a minimum 12-month follow-up, clinical scores and objective stability assessments were compared between the groups.ResultsIn total, 26 (group A 12, group B 14) eligible patients with a mean follow-up of 14.9 ± 7.2 months were evaluated in the present study. Knee stability and patient-reported outcome scores (PROMS) were significantly improved when comparing pre- and post-operative values (p < 0.0001). No clinically relevant differences in PROMS (Lysholm: A 83.9 ± 11.4 vs. B 85.3 ± 13.8; IKDC: A 76.91 ± 12.6 vs. B 76.8 ± 15.7) were shown in both groups. Additionally, no statistically significant differences were detected between groups with respect to external rotation, range of motion and instrumental stability testing. Arthroscopic reconstruction showed significantly shorter operation time (p = 0.0109). There were no clinical failures or neurovascular complications of the surgical procedures.ConclusionBoth surgical techniques for isolated chronic PLC Fanelli Type B injuries significantly improved the knee stability, were equivalent with respect to PROMs and led to good clinical results. However, arthroscopic PLC reconstruction was associated with a shorter surgery time compared to open PLC reconstruction. Therefore, arthroscopic PLC reconstruction may be a viable option in the hands of an experienced surgeon.Level of evidenceProspective cohort study, II.

Prevalence and presence of sarcopenia and sarcopenic obesity in female breast cancer patients

Objective: This study aimed to evaluate prevalence and clinical correlates of sarcopenia and sarcopenic obesity in breast cancer patients Methods: A total of 50 female patients with histopathological diagnosis of breast cancer were included in this prospective 6-month observational study. Data on patient age, anthropometrics, bioelectrical impedance analysis, physical activity level and blood biochemistry were recorded. Sarcopenia was assessed using preoperative computed tomography (CT) findings, while obesity in sarcopenic patients was identified based on BMI (Body mass index) and fat percentage values. Results: Obesity, sarcopenia and sarcopenic obesity was evident in 50%, 50% and 20% of patients, respectively. None of the parameters studied, including age, laboratory results, BIA (bioelectrical impedance analysis), or anthropometric findings, showed a significant correlation with the degree of sarcopenia in the overall study population, as well as in patients with sarcopenia and those with sarcopenic obesity. Conclusion: The findings suggest that sarcopenia is prevalent in half of breast cancer patients before radiotherapy, with concomitant obesity in 40% of sarcopenic patients. Therefore, assessing body composition using CT imaging is essential to recognize sarcopenic obesity earlier and prevent the combined hazards of obesity and depleted muscle mass in breast cancer patients.

Efficacy and safety of the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus (results of a 6-month study)

Objective: to evaluate the efficacy and safety of the type I interferon (IFN) receptor inhibitor anifrolumab (AFM, Safnelo®) in patients with systemic lupus erythematosus (SLE) in real-life clinical practice over an observation period of 6 months.Material and methods. The prospective 6-month study included 21 patients with SLE fulfilling the 2012 SLICC criteria, predominantly women (n=17,81%), median age – 31 [27; 46] years, disease duration – 9 [6.0; 11.0] years. Standard laboratory values and immunological markers of SLE were examined in all patients. The SLEDAI-2K index was used to determine the activity of SLE, and the severity of the mucocutaneous syndrome was assessed using the Cutaneous Lupus Disease Area and Severity Index (CLASI) index. Organ damage was assessed using the SLICC/ACR Damage Index (DI). After 6 months, the achievement of low activity was assessed according to the Lupus Low Disease Activity State (LLDAS) indexResults and discussion. At the time of inclusion in the study, the mean SLEDAI-2K activity index for the group was 8 [6.0; 10.0] points, the median CLASI index – 8.6±8.2 points, 81% of patients had skin and mucosal lesions, 66% had non-erosive polyarthritis, and high immunological activity was observed in all cases. Various irreversible organ damage was observed in 86 of patients. The average DI was 2.2±1.5 points. At the start of AFM therapy, all patients received glucocorticoids (GCs) at a mean dose of 10.7±5.6 mg/day, 52% of patients received a dose above 10 mg/day, 76% of patients continued to take hydroxychloroquine, and 33% of patients took immunosuppressants. Significant positive dynamics were observed with AFM therapy. The average CLASI index for the group after 3 months of treatment was 1.2±4.1 points, after 6 months – 0.3±1.2 points (p&lt;0.0001). The SLEDAI-2K index fell significantly in the group on average from 8 [6.0; 10.0] to 2 [2.0; 4.0] points from the 3rd month of treatment (p&lt;0.0001) and remained at the same level after 6 months. At month 6 of treatment, 13 (62%) of 21 patients met the LLDAS criteria for low disease activity. After the 3rd month of treatment, a significant decrease in antibodies against dsDNA was observed, which persisted for 6 months after the start of treatment. In the group as a whole, there were no significant changes in complement fractions values during the observation period. There was no increase in irreversible organ damage (DI – mean 2.2±1.5 points). The mean daily dose of GCs was significantly reduced from 10.7±5.6 mg/day to 7.5±4.0 mg/day (p&lt;0.01) by the 3rd month and to 5.2±2.1 (p&lt;0.001) by the 6th month of treatment. No infusion reactions were observed in any case. Adverse events occurred in 9 (42%) out of 21 patients, mainly herpes infections of varying severity, mainly after the 1st to 3rd infusions. In one case, severe herpes zoster was observed, so the drug was discontinued.Conclusion. At a dose of 300 mg intravenously monthly AFM is a highly effective drug with a relatively good safety profile in patients with active SLE in whom autoantibodies are present and who do not respond adequately to standard therapy.

(105) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in North Africa and the Middle East

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt; 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt; 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality-of-life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

Postoperative Pain in the General Surgery Department of Fousseyni Daou Hospital in Kayes

Goal: To study the management of postoperative pain in the general surgery department of the Fousseyni DAOU hospital in Kayes. Patients and Method: We conducted a prospective 6-month study from November 2022 to May 2023, involving 107 surgical patients, aged 15 to 81 years, who met the inclusion criteria. We assessed pain using the Visual Analogue Scale (VAS) at patient admission, at the second hour, and then every eight hours until seventy- second hours after analgesic use. Multimodal analgesia was the most widely used in the study. Administration of paracetamol alone and/or in combination with nefopam and/or ketoprofen and/or morphine. The evolution of pain as well as adverse effects after administration of analgesics were investigated. Results: The mean age of our patients was 35.9 years with extremes of 15 and 81 years. Male sex was the most represented at 64.5% with a sex ratio of 1.82 and the majority of patients were classified as ASA 1 (82.2%). VAS less than 3 (VAS≤ 4) was most observed during the first 2 hours postoperatively, i.e. 41.1% for VAS 0-2 and 28.9% VAS 3-4 at rest, respectively, and respectively 33.6% and 30.8% for no pain and mild pain. At 24 hours postoperatively, 87.2% of patients did not feel pain after the resting assessment, this figure increased from 89.8% at the 48th postoperative hour at rest, still after the use of analgesics. At the 72nd hour, we observed cases of pain, i.e. 0.9% of patients, which was related to a postoperative complication. The average cost of pain management was estimated at 23580 FCFA. Side effects observed were vomiting in 3 patients and drowsiness in one patient. Conclusion: Postoperative pain is still understudied, the evaluation with the visual analogue scale of patients before and after the use of analgesics has allowed us to better understand patients' pain and to improve pain management in the surgical department.

Relative deficiency in interferon-γ-secreting CD4+ T cells is strongly associated with poorer COVID-19 vaccination responses in older adults.

Although the two-dose mRNA vaccination regime provides protection against SARS-CoV-2, older adults have been shown to exhibit poorer vaccination responses. In addition, the role of vaccine-induced T-cell responses is not well characterised. We aim to assess the impact of age on immune responses after two doses of the BNT162b2 mRNA vaccine, focussing on antigen-specific T-cells. A prospective 3-month study was conducted on 15 young (median age 31 years, interquartile range (IQR) 25-35 years) and 14 older adults (median age 72 years, IQR 70-73 years). We assessed functional, neutralising antibody responses against SARS-CoV-2 variants using ACE-2 inhibition assays, and changes in B and T-cell subsets by high-dimensional flow cytometry. Antigen-specific T-cell responses were also quantified by intracellular cytokine staining and flow cytometry. Older adults had attenuated T-helper (Th) response to vaccination, which was associated with weaker antibody responses and decreased SARS-CoV-2 neutralisation. Antigen-specific interferon-γ (IFNγ)-secreting CD4+ T-cells to wild-type and Omicron antigens increased in young adults, which was strongly positively correlated with their neutralising antibody responses. Conversely, this relationship was negative in older adults. Hence, older adults' relative IFNγ-secreting CD4+ T cell deficiency might explain their poorer COVID-19 vaccination responses. Further exploration into the aetiology is needed and would be integral in developing novel vaccination strategies and improving infection outcomes in older adults.

(388) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in the Middle East and North Africa

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt; 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt; 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality of life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

PET-CT guided characterisation of progressive, preclinical tuberculous infection and its association with low-level circulating Mycobacterium tuberculosis DNA in household contacts in Leicester, UK: a prospective cohort study

Incipient tuberculosis, a progressive state of Mycobacterium tuberculosis infection with an increased risk of developing into tuberculosis disease, remains poorly characterised. Animal models suggest an association of progressive infection with bacteraemia. Circulating M tuberculosis DNA has previously been detected in pulmonary tuberculosis by use of Actiphage, a bacteriophage-based real-time PCR assay. We aimed to investigate whether serial [18F]fluorodeoxyglucose ([18F]FDG)-PET-CT could be used to characterise the state and progressive trajectory of incipient tuberculosis, and examine whether these PET-CT findings are associated with Actiphage-based detection of circulating M tuberculosis DNA. We did a prospective 12-month cohort study in healthy, asymptomatic adults (aged ≥16 years) who were household contacts of patients with pulmonary tuberculosis, and who had a clinical phenotype of latent tuberculosis infection, in Leicester, UK. Actiphage testing of participants' blood samples was done at baseline, and [18F]FDG PET-CT at baseline and after 3 months. Baseline PET-CT features were classified as positive, indeterminate, or negative, on the basis of the quantitation (maximum standardised uptake value [SUVmax]) and distribution of [18F]FDG uptake. Microbiological sampling was done at amenable sites of [18F]FDG uptake. Changes in [18F]FDG uptake after 3 months were quantitatively categorised as progressive, stable, or resolving. Participants received treatment if features of incipient tuberculosis, defined as microbiological detection of Mtuberculosis or progressive PET-CT change, were identified. 20 contacts were recruited between Aug 5 and Nov 5, 2020; 16 of these participants had a positive result on IFNγ release assay (QuantiFERON-TB Gold Plus [QFT]) indicating tuberculosis infection. Baseline PET-CT scans were positive in ten contacts (all QFT positive), indeterminate in six contacts (three QFT positive), and negative in four contacts (three QFT positive). Four of eight PET-CT-positive contacts sampled had M tuberculosis identified (three through culture, one through Xpert MTB/RIF Ultra test) from intrathoracic lymph nodes or bronchial wash and received full antituberculosis treatment. Two further unsampled PET-CT-positive contacts were also treated: one with [18F]FDG uptake in the lung (SUVmax 9·4) received empirical antituberculosis treatment and one who showed progressive [18F]FDG uptake received preventive treatment. The ten untreated contacts with [18F]FDG uptake at baseline (seven QFT positive) had stable or resolving changes at follow-up and remained free of tuberculosis disease after 12 months. A positive baseline Actiphage test was associated with the presence of features of incipient tuberculosis requiring treatment (p=0·018). Microbiological and inflammatory features of incipient tuberculosis can be visualised on PET-CT and are associated with M tuberculosis detection in the blood, supporting the development of pathogen-directed blood biomarkers of tuberculosis risk. MRC Confidence in Concept.

Portrait of a patient with systemic lupus erythematosus for the prescription of the type I interferon inhibitor anifrolumab

In recent years the use of monoclonal antibodies that block activity of type I interferon (IFN) or its receptors has become the new approach in the pharmacotherapy of systemic lupus erythematosus (SLE).Objective: to characterize patients with SLE treated with the type I IFN receptor inhibitor anifrolumab (AFM, Saphnelo®).Material and methods. The prospective 12-month study included 21 patients with SLE who met the 2012 SLICC criteria. Standard laboratory and immunological markers for SLE were examined in all patients. The SLEDAI-2K index was used to determine the activity of SLE and the CLASI index was used to determine the severity of the mucocutaneous syndrome. Organ damage was assessed using the SLICC/ACR Damage Index (DI). The LupusQol and FACIT-Fatigue questionnaires were used to analyze health-related quality of life (HRQoL).Results and discussion. Female patients prevailed in the study, female/male ratio – 17 (81%)/4 (19%), median age – 31 [27; 46] years, disease duration – 9 [6.0; 11.0] years. The majority of patients (86%) had moderate or high disease activity according to the SLEDAI-2K index. Among the clinical manifestations of SLE, skin and mucous membranes lesions predominated (81%). Non-erosive polyarthritis of varying severity was observed in 66% of cases. Serositis showed 24% of patients (pleurisy, pericarditis), 43% had hematological abnormalities (hemolytic anemia, leukopenia, lymphopenia) and 14% - urinary syndrome (daily proteinuria up to 0.5 g/l and/or urinary sediment – leukocytes/erythrocytes/cylinders up to 5 in the field of view in the absence of urinary tract infection). All patients had immunological disorders. 14% of them were diagnosed with antiphospholipid syndrome (APS) and 43% with Sjögren's syndrome.All patients received hydroxychloroquine, 95% received glucocorticoids (GC) from 5 to 60 mg/day, 66% received immunosuppressants (cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate). 33% of patients had anamnesis of treatment with biologic disease modifying antirheumatic drugs (rituximab, belimumab, dual anti-B-cell therapy) and Janus kinase inhibitor baricitinib. All patients experienced a significant deterioration in HRQoL.Conclusion. The indications for prescribing AFM to 21 patients with SLE were: active SLE according to SLEDAI-2K and/or CLASI with predominant involvement of skin, its appendages and development of polyarthritis with immunological disorders, intolerance/ineffectiveness of previous standard therapy and inability to achieve low average daily doses of oral GCs. Other clinical manifestations in some patients were: serositis, mild hematological disorders (Coombs-positive anemia, leukopenia), urinary syndrome. AFM could be prescribed for a combination of SLE with secondary APS and Sjögren's syndrome as well as for a high DI SLICC.

Effects of aromatase inhibitor therapy on adiposity and cardiometabolic health in postmenopausal women: a controlled cohort extension study.

We previously demonstrated that 12 months of aromatase inhibitor (AI) treatment was not associated with a difference in body composition or other markers of cardiometabolic health when compared to controls. Here we report on the pre-planned extension of the study. The pre-specified primary hypothesis was that AI therapy for 24 months would lead to increased visceral adipose tissue (VAT) area when compared to controls. We completed a 12-month extension to our prospective 12-month cohort study of 52 women commencing AI treatment (median age 64.5 years) and 52 women with breast pathology not requiring endocrine therapy (63.5 years). Our primary outcome of interest was VAT area. Secondary and exploratory outcomes included other measures of body composition, hepatic steatosis, measures of atherosclerosis and vascular reactivity. Using mixed models and the addition of a fourth time point, we increased the number of study observations by 79 and were able to rigorously determine the treatment effect. Among study completers (AI = 39, controls = 40), VAT area was comparable between groups over 24 months, the mean-adjusted difference was -1.54 cm2 (95% CI: -14.9; 11.9, P = 0.79). Both groups demonstrated parallel and continuous increases in VAT area over the observation period that did not diverge or change between groups. No statistically significant difference in our secondary and exploratory outcomes was observed between groups. While these findings provide reassurance that short-to-medium-term exposure to AI therapy is not associated with metabolically adverse changes when compared to controls, risk evolution should be less focussed on the AI-associated effect and more on the general development of cardiovascular risk over time.

Severe acute respiratory syndrome coronavirus 2 infection does not worsen the course of inflammatory bowel disease in the long term.

The long-term outcome of inflammatory bowel disease (IBD) patients after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is under investigation. To assess, in a prospective study, whether a recent SARS-CoV-2 infection increases the risk of IBD relapse within 12 months. From March to April 2021, all IBD patients with recent (<2 months) SARS-CoV-2 infection (Cases) were enrolled. For each enrolled Case, four IBD Controls with no history of infection were considered. Clinical course of IBD was recorded for 12 months. Inclusion criteria: well defined diagnosis of IBD; age ≥18 and ≤85 years; 12-month follow-up; consent. Exclusion criteria: incomplete data; SARS-CoV-2 infection after enrollment. Additional inclusion criteria: recent SARS-CoV-2 infection for Cases; no history of SARS-CoV-2 infection for Controls. Data expressed as median [range]. Statistical analysis: Student-t-Test, Mann-Whitney U-test, χ2 test, multivariate logistic regression model [odds ratio (95% confidence interval)], Kaplan-Meier curves. One hundred forty-three IBD patients were enrolled. The analysis included 118 patients (22 met the exclusion criteria, three lost at follow-up): 29 (24.6%) Cases and 89 (75.4%) Controls. Demographic and clinical characteristics were comparable between groups. During the 12-month study, the frequency of IBD relapse was comparable between Cases and Controls [8 (27%) vs 19 (21%); P = 0.65]. At univariate analysis, SARS-CoV-2 infection was not a risk factor for IBD relapse within 12 months [1.5 (0.6-3.9); P = 0.34]. At multivariate analysis, IBD activity at baseline was the only risk factor for relapse [3.2 (1.1-9.1); P = 0.03]. Kaplan-Meier curves showed that survival from IBD relapse was comparable between Cases and Controls (P = 0.33). In a prospective 12-month study, a recent SARS-CoV-2 infection did not increase the risk of clinical relapse of IBD in the long term.

(472) The AM-EDITS: A New Tool for Evaluating the Arab Patient and Partner Satisfaction Following Penile Prosthesis Implantation

Abstract Introduction The Modified Erectile Dysfunction Inventory of Treatment Satisfaction (M-EDITS) is recognized as a useful tool in English language to assess post penile prosthetic implantation (PPI) satisfaction. Nevertheless, a more global questionnaire remains to be introduced for the Arab population, where malleable PPI (MPPI) remains more popular, compared to the inflatable types. Due to the sensitivity of the topic and the conservative nature of the Middle East and North Africa (MENA) region, a scarce body of related research is available. Objective Our primary goal was to develop a validated Arabic version of the M-EDITS adapted to the Arabic culture and introduce it as the AM-EDITS. Our secondary goal was to utilize it to investigate the levels of Arab patient and partner satisfaction after MPPI and its sustainability during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing MPPI at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). For our study, we developed a validated Arabic version of the M-EDITS, coined as the AM-EDITS. The first encounter covered general patient perioperative experience, beginning from preoperative counseling till early after surgery. The second and third encounters focused on patient and partner satisfaction regarding implant utilization. Results The mean ages for the men and their spouses were 54.7±8.4 and 32.9±4.6 years, respectively. Over 82% of the patients in our study showed a decreased level of anxiety after preoperative counseling. 96% of the patients reported a positive experience regarding their early PO days with above half exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied wives at 3 months, 78.5% were highly satisfied. Feeling sexually desirable by their husbands was reported in 93.4%. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt;0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt;0.001), respectively, compared to the 3 months follow up. Conclusions The AM-EDITS may expand the global application of the original M-EDITS. MPPI represents a good quality of life treatment option for middle to low-income countries. Time has a positive effect on the Arab men’s PO satisfaction as opposed to their partners’. These findings should be considered during perioperative counseling of both parties to ensure sustainable satisfaction. Extended studies are necessary to confirm our findings as well as assess long-term PO satisfaction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder

The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.