Standardized Follow-up Procedures Research Articles

FRI488 The Effect Of Thyroid Stimulating Hormone On Brown Adipose Tissue In Humans

Abstract Disclosure: L. Salej: None. S.D. Kodani: None. N. Chaves: None. K.N. Youssef: None. R. Monahan-Earley: None. H. Halle: None. H. Shaelah: None. P. Annie: None. J.A. Parker: None. A.M. Cypess: None. G. Kolodny: None. Y. Tseng: None. B.C. James: None. A. Gavrila-Filip: None. Obesity and diabetes are two main public health concerns due to their high impact on global morbidity and mortality. In an effort to find new treatment strategies, highly active metabolic tissues such as brown adipose tissue (BAT) have been studied as potential targets. Animal studies have shown that TSH may have a direct local effect on BAT mass and activity by stimulating local T3 production via increased deiodinase-2 (DIO2) expression and also by increasing the expression of uncoupling protein-1 (UCP-1), the key molecule in BAT thermogenesis. We hypothesized that high circulating TSH levels could increase BAT activity by increasing local T3 production and generating a local tissue "thyrotoxicosis". We studied 7 patients with thyroid cancer who underwent thyroid surgery and required recombinant TSH (rhTSH) administration for standard follow-up procedures. Each patient underwent 2 PET-CT scans for assessment of BAT volume and activity, first one day after the rhTSH administration (high TSH state) and then 1-3 months later on suppressive thyroid hormone (TH) treatment (low TSH state). Indirect calorimetry and serum thyroid function tests, fasting glucose, insulin, HbA1c, and lipid panel were measured. Our results show that there was a statistically significant difference in TSH levels (p = 0.0095), with stable circulating T4 and T3 between the low and high TSH states. There was no statistically significant difference in the BAT volume and activity (SUVmax) between the high TSH and low TSH states. Age was a significant predictor of BAT SUVmax (p = 0.008; coeff = -0.39, CI = -0.65-0.13), while BMI was a significant predictor for resting energy expenditure (REE) (p = 0.04; coeff = -203.95, CI = -396.12 - -10.78). Based on these findings, along with those from our previous study[1] showing that circulating TH levels may not be directly correlated with BAT function, we have extended our study to assess the intracellular thyroid hormone status in BAT. We have collected deep peri-thyroidal adipose tissue and subcutaneous white adipose tissue (WAT) as a control group from patients undergoing thyroid surgery. In these samples, we will measure mRNA expression of TSH receptors, TH receptors, β-adrenergic receptors, DIO2 and UCP-1 and evaluate for correlations with circulating TSH and TH levels as well as different metabolic parameters to get a deeper insight into BAT function in humans. Reference: 1. Gavrila A et al. Variable Cold-Induced Brown Adipose Tissue Response to Thyroid Hormone Status. Thyroid. 2017 Jan 1;27(1):1-10. Presentation: Friday, June 16, 2023

Impact of the COVID-19 pandemic on positive airway pressure adherence and patients' perspectives in Greece: the role of telemedicine.

To analyze the impact of national lockdowns in Greece on positive airway pressure adherence, patients' perspectives regarding COVID-19 pandemic and the role of telemedicine. 872 obstructive sleep apnea patients from southern and 673 from northern Greece, under positive airway pressure treatment, were evaluated with adherence data available 12 months prior to and 3 months after the first and second lockdown. Telemedicine, locally available as part of a research protocol, was used for patient's follow-up in southern Greece and standard follow-up procedures were implemented in northern Greece. We analyzed the impact of COVID-19 lockdown on positive airway pressure adherence and patients' concerns regarding COVID-19 infection. Significant difference was noted in positive airway pressure adherence as measured by the hours of use at 12 months prior to and at the 3 months after the first lockdown in southern (5.6 vs 6.6, P = .003) and northern Greece (5.3 vs 6.0, P = .03). The proportion of patients with optimal adherence (≥ 6 hours) increased by 18% (P = .004) in southern and by 9% (P = .20) in northern Greece after the first lockdown and remained steady after the second lockdown in both groups. In southern Greece, 23% of patients reported that they were concerned about getting COVID-19 due to obstructive sleep apnea diagnosis, while only 3% reported decreased sleep duration. Moreover, 9% were concerned that the presence of obstructive sleep apnea would make them more susceptible for worse outcome in case of COVID-19 infection. Our results suggest that maintaining follow-up using telemedicine had a positive influence pointing out the potential role of digital health. Bouloukaki I, Pataka A, Mauroudi E, Moniaki V, Fanaridis M, Schiza SE. Impact of the COVID-19 pandemic on positive airway pressure adherence and patients' perspectives in Greece: the role of telemedicine. J Clin Sleep Med. 2023;19(10):1743-1751.

Cone beam computed tomography for detecting residual stones in percutaneous nephrolithotomy, a randomized controlled trial (CAPTURE) protocol

IntroductionPercutaneous nephrolithotomy (PCNL) is the standard surgical treatment method for large kidney stones. Its aim is to achieve a stone-free status, since any residual fragments (RFs) after PCNL are likely to cause additional morbidity or stone growth. Enhancing intraoperative detectability of RFs could lead to increased stone-free rates and decreased re-intervention rates. Cone beam computed tomography (CBCT) has recently been introduced in urology as a feasible method for intraoperatively imaging RFs. The aim of this trial is to determine the added value of CBCT in percutaneous nephrolithotomy, by measuring differences in stone-related morbidity for patients with procedures in which a CBCT is used versus patients with procedures without the use of CBCT.MethodsThe CAPTURE trial is an investigator-initiated single-center, randomized controlled trial (RCT) in adult patients who have an indication for percutaneous nephrolithotomy. A contemporary percutaneous nephrolithotomy is performed. Once the surgeon is convinced of a stone-free status by means of fluoroscopy and nephroscopy, randomization allocates patients to either the study group in whom an intraoperative CBCT scan is performed or to the control group in whom no intraoperative CBCT scan is performed. The main endpoint is the stone-free status as assessed four weeks postoperatively by low-dose non-contrast abdominal CT, as a standard follow-up procedure. Secondary endpoints include the number of PCNL procedures required and the number of stone-related events (SREs) registered. The total study population will consist of 320 patients that undergo PCNL and are eligible for randomization for an intraoperative CBCT scan.DiscussionWe deem a randomized controlled trial to be the most effective and reliable method to assess the efficacy of CBCT in PCNL. Though some bias may occur due to the impossibility of blinding the urologist at randomization, we estimate that the pragmatic nature of the study, standardized circumstances, and follow-up methods with pre-defined outcome measures will result in a high level of evidence.Trial registrationNetherlands Trial Register (NTR) NL8168, ABR NL70728.042.19. Registered on 15 October 2019. Prospectively registered.

Screening for Psychiatric Comorbidities and Psychotherapeutic Assessment in Inpatient Epilepsy Care: Preliminary Results of an Implementation Study.

Background: Anxiety and depression remain underdiagnosed in routine clinical practice in up to two thirds of epilepsy patients despite significant impact on medical and psychosocial outcome. Barriers to adequate mental health care for epilepsy and/or psychogenic non-epileptic seizures (PNES) include a lack of integrated mental health specialists and standardized procedures. This naturalistic study outlines the procedures and outcome of a recently established psychotherapeutic service.Methods: Routine screening included the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E, cut-off value > 13) and Generalized Anxiety Disorder scale (GAD-7, cut-off value > 5). Positively (above cut-off in at least one questionnaire) screened patients were seen for a standardized interview for mental health disorders and the development of a personalized treatment plan. PNES patients were seen irrespective of their screening score. Resources were provided to support self-help and access to psychotherapy. Patients were contacted 1 month after discharge to evaluate adherence to therapeutic recommendations.Results: 120 patients were screened. Overall, 56 of 77 positively screened patients (77%) were found to have a psychiatric diagnosis through standardized interview. More epilepsy patients with an anxiety disorder had previously been undiagnosed compared to those with a depressive episode (63% vs. 30%); 24 epilepsy patients (62%) with a psychiatric comorbidity and 10 PNES patients (59%) were not receiving any mental health care. At follow-up, 16/17 (94%) epilepsy patients and 7/7 PNES patients without prior psychiatric treatment were adhering to therapeutic recommendations.Conclusion: Integrating mental health specialists and establishing standardized screening and follow-up procedures improve adherence to mental health care recommendations in epilepsy and PNES patients.

Diffusion-weighted MRI improves response assessment after definitive radiotherapy in patients with NSCLC

BackgroundComputed tomography (CT) is the standard procedure for follow-up of non-small-cell lung cancer (NSCLC) after radiochemotherapy. CT has difficulties differentiating between tumor, atelectasis and radiation induced lung toxicity (RILT). Diffusion-weighted imaging (DWI) may enable a more accurate detection of vital tumor tissue. The aim of this study was to determine the diagnostic value of MRI versus CT in the follow-up of NSCLC.MethodsTwelve patients with NSCLC stages I-III scheduled for radiochemotherapy were enrolled in this prospective study. CT with i.v. contrast agent and non enhanced MRI were performed before and 3, 6 and 12 months after treatment. Standardized ROIs were used to determine the apparent diffusion weighted coefficient (ADC) within the tumor. Tumor size was assessed by the longest longitudinal diameter (LD) and tumor volume on DWI and CT. RILT was assessed on a 4-point-score in breath-triggered T2-TSE and CT.ResultsThere was no significant difference regarding LD and tumor volume between MRI and CT (p ≥ 0.6221, respectively p ≥ 0.25). Evaluation of RILT showed a very high correlation between MRI and CT at 3 (r = 0.8750) and 12 months (r = 0.903). Assessment of the ADC values suggested that patients with a good tumor response have higher ADC values than non-responders.ConclusionsDWI is equivalent to CT for tumor volume determination in patients with NSCLC during follow up. The extent of RILT can be reliably determined by MRI. DWI could become a beneficial method to assess tumor response more accurately. ADC values may be useful as a prognostic marker.

Shared care follow-up of patients with B-cell neoplasms based on nurse-led telephone consultations and PRO-data: a feasibility study from the North Denmark Region

BackgroundPatients with B-cell neoplasms in remission are monitored with regular physician visits at the hospital. The current standard follow-up procedure is not evidence-based or individualized to patient needs. To improve and individualize the follow-up, we investigated the feasibility of a shared care follow-up initiative, with alternating physician visits and nurse-led telephone consultations and assessments based on patient-reported outcome (PRO) data.MethodsPatients ≥18 years diagnosed with B-cell neoplasms were eligible for the study when they were in remission and stable without treatment for at least 6 months. Patients were assigned to alternating visits with physicians and nurse-led telephone consultations. The nurse-led telephone consultations were based on PROs, which were collected with the European Organization for Research and Treatment of Cancer questionnaire (EORTC-QLQ-C30), the Myeloproliferative Neoplasm – Symptom Assessment Form, and the Hospital Anxiety and Depression Scale. Patients completed questionnaires before every nurse-led consultation. We also applied the Patient Feedback Form to survey patient acceptance of the requirement of questionnaire completion. We applied descriptive statistics, in terms of counts (n) and proportions (%), to describe the study population and all endpoints.ResultsBetween February 2017 and December 2018, 80 patients were enrolled. Adherence, measured as the recruitment rate, was 96% (80/83), and the drop-out rate was 6% (5/80). During the study period, 3/80 (4%) patients relapsed, and 5/80 (6%) patients returned to the standard follow-up, because they required closer medical observation. Relapses were diagnosed based on unscheduled visits requested by patients (n = 2) and patient-reported symptoms reviewed by the nurse (n = 1). The response rate to questionnaires was 98% (335/341). A total of 58/79 (74%) patients completed the Patient Feedback Form; 51/57 (89%) patients reported improved communication with health care professionals; and 50/57 (88%) patients reported improved recollection of symptoms as a result of completing questionnaires.ConclusionBased on patient adherence, a low relapse rate, and positive patient attitudes towards completing questionnaires, we concluded that a shared care follow-up, supported by PROs, was a feasible alternative to the standard follow-up for patients with B-cell disease in remission.

Diagnostic value of probe-based confocal laser endomicroscopy versus conventional endoscopic biopsies of non-muscle invasive bladder tumors: a pilot study

Purpose The standard procedure for diagnostics and follow-up for non-muscle invasive bladder cancer (NMIBC) is cystoscopy in the outpatient clinic. Suspicious lesions are biopsied for histopathological assessment. This pilot study aimed to evaluate the ability of Confocal Laser Endomicroscopy (CLE) to rule out High Grade Urothelial Carcinoma (HGUC) to select patients for in-office fulguration. Materials and methods We performed a prospective non-randomized, single surgeon study. Intraoperative CLE was performed independently by the surgeon and a blinded on-site uropathologist. Following the procedure, a CLE evaluation was performed by another blinded urologist. Lesions were classified as normal/inflammatory, Low Grade Urothelial Carcinoma (LGUC) or HGUC. With the histological evaluations as the gold standard we calculated sensitivity, specificity, PPV and NPV for HGUC and the accuracy for each CLE assessor. The primary outcome was the NPV for HGUC for the surgeon. Results Twelve patients with a total of 34 lesions were included. Six lesions were flat and 28 were exophytic. On histopathology, 25 lesions were classified as normal/inflammatory or LGUC, while nine were classified as HGUC. For the surgeon, the uropathologist and the second urologist, the sensitivity was 44%, 78% and 22%, respectively. Specificities for the three observers were 84%, 68% and 96%. This corresponded to PPVs for HGUC of 50%, 47% and 67% and NPV for HGUC of 81%, 89% and 77%. Conclusions In our hands the NPV of CLE is not high enough for it to be considered an alternative to histopathological assessment of bladder lesions.

Role of ultrasound in the detection of recurrent ovarian cancer: a review of the literature.

Nowadays, no standard approaches for follow up in ovarian cancer (OC) patients exist. While the role of ultrasound (US) is well defined in primary diagnosis of OC, it is still controversial during follow-up of surgically treated OC. The aim of this narrative review is to evaluate the role described in literature of US imaging in the early detection of OC recurrences. A review of the English literature present in PubMed and SCOPUS of the past 30 years regarding the use of US in recurrent ovarian cancer (ROC) has been performed. The following keywords were searched: "ultrasound and recurrent ovarian cancer" and "intraoperative ultrasound and recurrent ovarian cancer". A total of 15 articles were selected. US was mainly adopted in the detection of recurrent pelvic disease after debulking surgery, after fertility sparing surgery (FSS) and as an intraoperative tool for localization of OC recurrences. If introduced as a standard follow-up procedure, US may have a central role in the early detection of pelvic OC recurrence, in ovarian localization of relapses of borderline ovarian tumor (BOT) and early stages disease treated with FSS; it may also play an important role in the intraoperative localization of previously suspected secondary lesions.

Differences in gait analysis and clinical outcome after TightRope\xae or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study

BackgroundAnkle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected.A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA).The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®).MethodsThis prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or “TightRope®”). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up.The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis.DiscussionThe results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00013562. Registered on July, 12, 2017.

Validation of a Novel, Sensitive, and Specific Urine-Based Test for Recurrence Surveillance of Patients With Non-Muscle-Invasive Bladder Cancer in a Comprehensive Multicenter Study.

Bladder cancer (BC), the most frequent malignancy of the urinary system, is ranked the sixth most prevalent cancer worldwide. Of all newly diagnosed patients with BC, 70–75% will present disease confined to the mucosa or submucosa, the non-muscle-invasive BC (NMIBC) subtype. Of those, approximately 70% will recur after transurethral resection (TUR). Due to high rate of recurrence, patients are submitted to an intensive follow-up program maintained throughout many years, or even throughout life, resulting in an expensive follow-up, with cystoscopy being the most cost-effective procedure for NMIBC screening. Currently, the gold standard procedure for detection and follow-up of NMIBC is based on the association of cystoscopy and urine cytology. As cystoscopy is a very invasive approach, over the years, many different noninvasive assays (both based in serum and urine samples) have been developed in order to search genetic and protein alterations related to the development, progression, and recurrence of BC. TERT promoter mutations and FGFR3 hotspot mutations are the most frequent somatic alterations in BC and constitute the most reliable biomarkers for BC. Based on these, we developed an ultra-sensitive, urine-based assay called Uromonitor®, capable of detecting trace amounts of TERT promoter (c.1-124C > T and c.1-146C > T) and FGFR3 (p.R248C and p.S249C) hotspot mutations, in tumor cells exfoliated to urine samples. Cells present in urine were concentrated by the filtration of urine through filters where tumor cells are trapped and stored until analysis, presenting long-term stability. Detection of the alterations was achieved through a custom-made, robust, and highly sensitive multiplex competitive allele-specific discrimination PCR allowing clear interpretation of results. In this study, we validate a test for NMIBC recurrence detection, using for technical validation a total of 331 urine samples and 41 formalin-fixed paraffin-embedded tissues of the primary tumor and recurrence lesions from a large cluster of urology centers. In the clinical validation, we used 185 samples to assess sensitivity/specificity in the detection of NMIBC recurrence vs. cystoscopy/cytology and in a smaller cohort its potential as a primary diagnostic tool for NMIBC. Our results show this test to be highly sensitive (73.5%) and specific (93.2%) in detecting recurrence of BC in patients under surveillance of NMIBC.

Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial

BackgroundTreatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, we plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect.Methods/designThis randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2–5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery.DiscussionThe results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.Trial registrationGerman Clinical Trials Register (DRKS), ID: DRKS00013882. Registered on 22 January 2018.

Endovascular treatment of post-thrombotic and non-thrombotic iliofemoral venous outflow obstructions with self-expanding nitinol stents.

The aim of the study was to investigate venous patency and clinical outcomes for endovascular treatment of iliofemoral venous obstruction in patients with post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) with dedicated self-expanding nitinol stents. Data were collected from the prospective Swiss Venous Stent Registry, enrolling consecutive patients with a standardized follow-up procedure since January 2008. Patency was evaluated by duplex sonography and clinical outcome by various scores including the Villalta score at baseline, three, six, and 12 months, and then annually after endovascular therapy. Overall, 93 patients (64 PTS, 29 NIVL) were analysed. Mean follow-up time was 20 ± 16 (range 3-70) months. A total of 11 (12 %) patients had a stent occlusion, all of which occurred in the PTS group, and 13 (14 %) patients had a symptomatic stent stenosis. Primary patency was 79 % (95 % CI 68-87 %) at 12 months and 72 % (95 % CI 59-82 %) at 24 months. In PTS patients, primary patency at 12 months was 75 % (95 % CI 61-84 %) vs. 89 % (95 % CI 63-97 %) in NIVL patients (p = 0.10). Secondary patency at 24 months was 94 % (95 % CI 84-98 %) in PTS and 100 % in NIVL, p = 0.19). Overall, 62 (67 %) patients were free from PTS at the latest follow-up with a Villalta score < 5 points. Predictive factors for the loss of primary patency were stents placed below the inguinal ligament (OR 2.59, 95 % CI, 0.99-6.84, p = 0.05). In symptomatic patients with chronic iliofemoral vein obstruction, endovascular therapy with self-expanding nitinol stents was associated with favourable patency rates and clinical improvement in the majority of patients.

Mobile Health in Oncology: A Patient Survey About App-Assisted Cancer Care.

BackgroundIn the last decade, the health care sector has been enriched by numerous innovations such as apps and connected devices that assist users in weight reduction and diabetes management. However, only a few native apps in the oncological context exist, which support patients during treatment and aftercare.ObjectiveThe objective of this study was to analyze patients’ acceptance regarding app use and to investigate the functions of an oncological app that are most required, and the primary reasons for patients to refuse app-assisted cancer care.MethodsWe designed and conducted a survey with 23 questions, inquiring patients about their technical knowledge and equipment, as well as the possible advantages and disadvantages, data transfer, and general functionality of an app.ResultsA total of 375 patients participated; the participation rate was 60.7% (375/618). Gender distribution was about 3:4 (female:male) with a median age of 59 years (range 18-92 years). Whereas 69.6% (261/375) of patients used mobile devices, 16.3% (61/375) did not own one, and 9.1% (34/375) only used a personal computer (PC). About half of the patients rated their usability skills as very good and good (18.9% 71/375; 35.2% 132/375), 23.5% (88/375) described their skills as intermediate, and 14.4% (54/375) as bad. Of all patients, 182 (48.5%, 182/375) were willing to send data to their treating clinic via an app, that is, to a server (61.0% 111/182) or as email (33.5%, 61/182). About two-thirds (68.7%, 125/182) believed that additional and regularly sent data would be an ideal complement to the standard follow-up procedure. Additionally, 86.8% (158/182) wished to be contacted by a physician when entered data showed irregularities. Because of lack of skills (34.4%, 56/163), concerns about the use of data (35.0%, 57/163), lack of capable devices (25.8%, 42/163), and the wish for personal contact with the treating physician (47.2%, 77/163), a total of 163 (43.5%, 163/375) patients refused to use an app. Pearson correlation showed a significant but mild relationship between age and app use (P=.03, r=−.12), favoring younger age; male gender correlated as well (P=.04; r=−.11).ConclusionsThe results show that the introduction of mobile apps needs to follow different strategies depending on the patients’ attitude. Age and gender seem to be the strongest predictive factors. For oncology patients, our survey showed that about half of the patients were willing to send data via an app supporting their treatment. In the future, clinical data such as quality of life and treatment satisfaction recorded by mobile health (mHealth) devices could be used to evaluate and improve therapy workflow. Furthermore, apps could support classical visits, document adverse effects, and remind patients of treatment dates or drug intake.

Postoperative monitoring with a mobile application after ambulatory lumbar discectomy: an effective tool for spine surgeons.

The rise of eHealth, with the increasing use of a Mobile application provides a new perspective for outpatient spine surgery follow-up. Assess the feasibility of Mobile app for postoperative monitoring after outpatient lumbar discectomy. Sixty consecutive patients, who underwent an ambulatory lumbar discectomy, were proposed the use of Mobile app to optimize their home monitoring for 15days. Contact was maintained with the clinic based on the level of symptom severity: pain, temperature, deficit, bleeding, to provide a suitable solution. Use of Mobile app compared to the standard follow-up procedure was evaluated daily and a satisfaction survey was carried-out 3months after surgery. Thirty-six patients (60.0%) completed the initial checklist within 48h, with no triggered severity. Five patients (8.3%) triggered a non-response alarm; no action was required in the follow-up of 41 patients. However, 19 patients (31.7%) triggered a total of 29 alarms, automatically resulting in a neurosurgeon contact for: postoperative pain management and optimization of analgesics, 21 cases (72.4%), low-grade fever <38.5°, 4 cases (13.8%), voiding delay, 2 cases (6.9%) and a problem related to dressing, 2 cases (6.9%). The scale ranged from 1 (poor) to 4 (excellent), with a 3.5/4 overall satisfaction mean score for the mobile handheld-device. Most patients (91.6%) responded that they would agree to repeat the postoperative experience. Overall patient satisfaction was excellent. Mobile app provides an effective useful tool for outpatient spine surgery monitoring and minimizes the need for in-person visits for postoperative patients.

Data monitoring committees for pragmatic clinical trials.

In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical trials require careful consideration when developing interim data monitoring plans, and trial sponsors, investigators, and data monitoring committees should agree on a plan before trial inception. Finally, special expertise, such as an informatics, may be helpful on data monitoring committees for some pragmatic clinical trials. Patient representatives may provide particularly valuable insights in the monitoring process.

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom

Background Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants’ awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly.Purpose Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher.Methods Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures.Results Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88–1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98.Conclusions In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

Effect of a French experiment of team work between general practitioners and nurses on efficacy and cost of type 2 diabetes patients care

To assess the efficacy and the cost of a French team work experiment between nurses and GPs for managing type 2 diabetes patients. Based on a case control study design we compare the evolution of process (standard follow-up procedures) and final (glycemic control) outcomes, and of cost, between two consecutive periods between type 2 diabetes patients followed within the team work experiment (intervention group) or by "standard" GPs (controlled group). After a 11 months of follow-up, patients in the intervention group, compared with those in the controlled group, have more chances to remain or to become: correctly followed-up (with OR comprise between 2.1 and 6.8, p≤5%) and under glycemic control (with OR comprise between 1.8 and 2.7, p≤5%). The latter result is obtained only when a visit for education and counselling has been delivered by a nurse in supplement to systematic electronic patient registry and electronic clinical GPs reminder. All these results are obtained without difference in costs between the intervention and the controlled group. This experimentation of team working can be considered both effective and efficient. Our findings may have implications in the design of future larger primary care team work experiment to be launched by French health authorities.

Vascular Risk Profiles for Dementia and Alzheimer's Disease in Very Old People: A Population-Based Longitudinal Study

Numerous studies have linked individual vascular factors to dementia including Alzheimer's disease (AD). We investigated different vascular risk profiles in relation to dementia and AD among very old people. A standardized follow-up procedure was applied three times to a dementia-free cohort (n=1270, age >or= 75) over a nine-year period to detect dementia and AD cases using the DSM-III-R criteria. We examined two vascular risk profiles, which were scored by counting the number of corresponding vascular factors: 1) atherosclerotic profile included systolic pressure >or= 160 mmHg, diabetes/prediabetes, and stroke; and 2) cerebral hypoperfusion profile constituted diastolic pressure < 70 mmHg, pulse pressure < 70 mmHg, and heart failure. Data were analyzed with Cox proportional-hazards models controlling for major potential confounders. During the 6406 person-years of follow-up, 428 subjects developed dementia, including 328 AD cases. All components of vascular profiles were significantly or marginally associated with increased dementia risk. The risk of dementias was increased with increasing score of both risk profiles (p for trend <or= 0.001); subjects with a score >or= 2 in either profile had an approximately twofold-increased risk for dementia and AD. These data suggest that aggregation of atherosclerotic- and hypoperfusion-related vascular factors increases the risk of dementia in very old people. Severe cerebral atherosclerosis and insufficient perfusion are involved in the development of dementia including AD.

RECANALIZATION AFTER INTRAVENOUS THROMBOLYSIS: DOES A RECANALIZATION TIME WINDOW EXIST?

Background: To evaluate the time course of major vessel recanalization under IV thrombolysis in relation to functional outcome in acute ischemic stroke. Methods: A total of 99 patients with an acute anterior circulation vessel occlusion who underwent IV thrombolysis were included. All patients had a standardized admission and follow-up procedure. Color-coded duplex sonography was performed on admission, 30 minutes after thrombolysis, and at 6 and 24 hours after onset of symptoms. Recanalization was classified as complete, partial, and absent. Functional outcome was rated with the modified Rankin Scale on day 30. Results: Complete recanalization occurred significantly more frequently in patients with multiple branch occlusions compared to those with mainstem occlusion (OR 5.33; 95% CI, 2.18 to 13.05; p p p = 0.002) was significantly associated with a favorable outcome. Multivariate analysis revealed recanalization at any time within 24 hours and NIHSS scores on days 1 and 7 together explaining 75% of the functional outcome variance 30 days after stroke. Conclusions: Complete recanalization up to 24 hours after stroke onset is significantly associated with the short-term clinical course and functional outcome 30 days after acute stroke.

Recanalization after intravenous thrombolysis

To evaluate the time course of major vessel recanalization under IV thrombolysis in relation to functional outcome in acute ischemic stroke. A total of 99 patients with an acute anterior circulation vessel occlusion who underwent IV thrombolysis were included. All patients had a standardized admission and follow-up procedure. Color-coded duplex sonography was performed on admission, 30 minutes after thrombolysis, and at 6 and 24 hours after onset of symptoms. Recanalization was classified as complete, partial, and absent. Functional outcome was rated with the modified Rankin Scale on day 30. Complete recanalization occurred significantly more frequently in patients with multiple branch occlusions compared to those with mainstem occlusion (OR 5.33; 95% CI, 2.18 to 13.05; p < 0.0001) and was associated with lower NIH Stroke Scale (NIHSS) scores (p < 0.001). Not the specific time point of recanalization at 6 or 24 hours after stroke onset, but recanalization per se within 24 hours (OR 7.8; 95% CI 2.2 to 28.2; p = 0.002) was significantly associated with a favorable outcome. Multivariate analysis revealed recanalization at any time within 24 hours and NIHSS scores on days 1 and 7 together explaining 75% of the functional outcome variance 30 days after stroke. Complete recanalization up to 24 hours after stroke onset is significantly associated with the short-term clinical course and functional outcome 30 days after acute stroke.