Effect of a novel telehealth device for dietary cognitive behavioral intervention in overweight or obesity care.

Obesity has become a major public health issue which relate to numerous physical problems and highly comorbid with depression and anxiety. Recently, some studies of technology-based interventions for weight reduction emerged to overcome the barriers from time, cost and distance. Mood component and eating behavior related to obesity are less discussed so far with technology-based intervention though. This pilot study was aimed to investigate the effect of telehealth assisted intervention on weight reduction, mood status, and eating behavior change under a smartphone application (app) with novel 3D food picture recognition and incorporated with cognitive behavioral training programs. Adult aged 30-60 years old with overweight were recruited and randomly assigned to control-first group and intervention-first group. In period 1, control-first group had regular life and intervention-first group underwent app intervention; in period 2, two groups went crossover. Body composition and psychological/behavioral questionnaires were collected at baseline, end of period 1, and end of period 2. Nonparametric statistics was performed for data analyzing. A total of 20 participants were enrolled. In control-first group, there were statistically significant reduction in body weight (- 0.55 kg, p = 0.02) and change of body weight percentage (- 0.6%, p = 0.02) after App use. In intervention-first group, the fat percentage decreased by 0.4% after App use in period 1, and increased by 0.05% in period 2. The integrated crossover data revealed that subjects of App group had significant improvements in mindful eating behavior. This pilot study showed the effectiveness in using CogniNU app for weight control and eating behavior. The difference of short-term and long-term effectiveness of technology-based weight control intervention deserves more investigation in the future.Clinical Trial Registration: ISRCTN16082909.

Left ventricular assist device exchange from HeartMate II to HeartMate 3 in an Asian patient-a case report and literature review.

BACKGROUND: Pump exchange surgery of left ventricular assist device (LVAD) has been demonstrated in several studies; however, information for Asian patients was limited. CASE PRESENTATION: A 63-year-old man underwent a pump upgrade from HeartMate II to HeartMate 3 for driveline damage through limited left anterior thoracotomy and lower partial sternotomy. He did not experience any hemodynamic adverse events or device malfunction during postoperative follow-ups of 12 months. We also reviewed all published cases with HeartMate II exchange to HeartMate 3. CONCLUSIONS: The case demonstrated that it was safe and feasible to perform HMII LVAD exchange to HM3 through a limited approach for Asian patients.

The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial.

BACKGROUND: Previous studies have reported that vitamin D supplement could improve fracture healing, but evidence regarding the role of vitamin D supplements in spinal fusion was limited. Thus, this study aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients undergoing lumbar spinal fusion. METHODS: This randomized, double-blind, parallel-designed, active-control trial included the patients who planned for elective lumbar spinal fusion. Eligible patients were randomly assigned to receive either daily vitamin D3 (cholecalciferol) 800 IU and daily calcium citrate 600 mg (experimental group) or only daily calcium citrate 600 mg (control group). All supplements were given from postoperative day 1 and lasted for 3 months. Primary outcome was postoperative 1-year fusion rate, and secondary outcomes included time to fusion, Oswestry Disability Index (ODI), and visual analogue scale (VAS) for pain. RESULTS: Among the included 34 patients (21 in the experimental group and 13 in the control group), baseline 25-hydroxyvitamin D (25[OHVitD) level was 26.7 (10.4) ng/ml. Preoperative prevalence of vitamin D deficiency and insufficiency were 23.5% and 47.1%, respectively. Postoperative 1-year fusion rate was not significantly different between the two groups (95.2% vs. 84.6%, P = 0.544). The experimental group had significantly shorter time to fusion (Kaplan-Meier estimated: 169 days vs. 185 days [interquartile range: 88-182 days vs. 176-324 days], log-rank test: P = 0.028), lower postoperative 6-month ODI (P < 0.001), and lower postoperative 6-month VAS (P < 0.001) than the control group. Time to fusion was significantly and negatively correlated with preoperative, postoperative 3-month, and 6-month 25(OH)VitD levels (all P < 0.01). CONCLUSION: The patient with vitamin D supplements had shorter time to fusion, better spinal function and less pain after elective spinal fusion. Further research is warranted to identify the patients who can benefit the most from vitamin D supplements and the appropriate dose of vitamin D supplements. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05023122. Registered 20 August 2021. Retrospectively registered, http://clinicaltrials.gov/ct2/show/NCT03793530 .

Intraoperative ECMO assistance during TAVI for aortic insufficiency in an Asian patient with LVAD support.

A 69-year-old male underwent concomitant left ventricular assist device (LVAD) implantation and aortic valve repair procedure for moderate aortic insufficiency (AI). Due to recurrence of symptomatic heart failure and post-repair AI deterioration from trivial to moderate-to-severe insufficiency 2 months later, transcatheter aortic valve implantation (TAVI) was arranged. During TAVI, intraoperative extracorporeal membrane oxygenation was used to maintain stable haemodynamics and to ensure a safe environment for prosthesis deployment. Postoperative 5 month follow-up revealed no AI and no paravalvular leakage.

Sex difference in the prognostic role of body composition parameters in Taiwanese patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Evidence on association between body composition and outcomes of transcatheter aortic valve implantation (TAVI) is limited for Asian patients. This study investigated the prognostic role of body composition parameters in Taiwanese patients undergoing TAVI. MATERIALS AND METHODS: Data of consecutive patients undergoing TAVI for severe aortic stenosis between May 1, 2010 and August 31, 2019 were prospectively collected in this observational study. The association between body composition parameters (body mass index [BMI], body surface area [BSA], lean body mass [LBM], and LBM index) and cumulative mortality was analyzed using Cox proportional hazard regression model. RESULTS: A total of 221 patients (mean age 81.4 years), including 125 (56.6%) males, were included with median follow-up duration of 23.8 months. In males, multivariate analysis revealed that higher BMI (P = 0.035), BMI ≥ 20 kg/m2 (P = 0.026), and higher LBM index (P = 0.023) significantly predicted lower overall all-cause cumulative mortality. In females, none of the body composition parameters was significantly associated with all-cause cumulative mortality. Paradoxical association between BMI and estimated all-cause cumulative mortality was only significant among male patients. CONCLUSION: In Taiwanese TAVI patients, the prognostic effects of BMI and LBM index on cumulative mortality were only observed in males, not in females. Sex differences must be considered when stratifying risk among patients undergoing TAVI.

Clinical feasibility of the augmented reality computer-assisted spine surgery system for percutaneous vertebroplasty.

PURPOSE: This study aimed to demonstrate that the augmented reality computer-assisted spine surgery (ARCASS) system is clinically feasible for percutaneous vertebroplasty (PVP). METHODS: This prospective case-control study included the patients undergoing PVP under the assistance of the ARCASS system between July 1, 2013, and October 31, 2014. The control group was the age- and gender-matched patients who underwent standard PVP and met the same eligible criteria as the case group. Primary outcome was the frequency of fluoroscopy. Secondary outcomes were the accuracy of bony entry point and operative time. RESULTS: Eighteen patients were included in this study: 9 patients with 11 levels of lesions in the ARCASS group and 9 patients with 10 levels of lesions in the control group. Compared with the control group, the ARCASS group had significantly less frequency of fluoroscopy (6 vs. 18, P < 0.001) and shorter operative time (78 vs. 205 s, P < 0.001) during the process of entry point identification and local anesthesia, which started from the registration of skin entry point at lesion site to the end of bony entry point identification. Regarding accuracy, the ARCASS group had significant greater proportion of 'good' entry point than the control group on lateral views (81.8% vs. 30.0%, P = 0.028) and anteroposterior views (72.7% vs. 20.0%, P = 0.020). CONCLUSION: This study revealed that the ARCASS system was clinically feasible for PVP. The guidance of ARCASS system provided more accurate bony entry point with reduced operative time and unnecessary radiation exposure.

The suction-assisted laryngoscopy assisted decontamination technique toward successful intubation during massive vomiting simulation: A pilot before-after study.

This study demonstrated a training program of the suction-assisted laryngoscopy assisted decontamination (S.A.L.A.D.) technique for emergency medical technician paramedic (EMT-P). The effectiveness of the training program on the improvements of skills and confidence in managing soiled airway was evaluated.In this pilot before-after study, 41 EMT-P participated in a training program which consisted of 1 training course and 3 evaluation scenarios. The training course included lectures, demonstration, and practice and focused on how to perform endotracheal intubation in soiled airway with the S.A.L.A.D technique. The first scenario was performed on standard airway mannequin head with clean airway (control scenario). The second scenario (pre-training scenario) and the third scenario (post-training scenario) were performed in airway with simulated massive vomiting. The post-training scenario was applied immediately after the training course. All trainees were requested to perform endotracheal intubation for 3 times in each scenario. The "pass" of a scenario was defined as more than twice successful intubation in a scenario. The intubation time, count of successful intubation, pass rate, and the confidence in endotracheal intubation were evaluated.The intubation time in the post-training scenario was significantly shorter than that in the pre-training scenario (P = .031). The pass rate of the control, pre-training, and post-training scenario was 100%, 82.9%, and 92.7%, respectively. The proportion of trainees reporting confident or very confident in endotracheal intubation in soiled airway increased from 22.0% to 97.6% after the training program. Kaplan-Meier analysis revealed that the adjusted hazard ratio of successful intubation for post-training versus pre-training scenario was 2.13 (95% confidence interval of 1.57-2.91).The S.A.L.A.D. technique training could efficiently help EMT-P performing endotracheal intubation during massive vomiting simulation.

Extra-articular endoscopic excision of symptomatic popliteal cyst with failed initial conservative treatment: A novel technique.

To reduce the damage to posteromedial knee capsule, we developed a direct extra-articular arthroscopic approach for excision of symptomatic popliteal cysts. This study aimed to demonstrate the surgical technique and present the 2-year follow-up results. Cystectomy is performed by extra-articular surgical approach through a high posteromedial portal. Twenty-one consecutive patients diagnosed of symptomatic popliteal cysts with failed initial conservative treatments were included. At a median follow-up of 29.4 months, all knees had improved clinical function assessed by Rauschning and Lindgren knee classification (p<0.001). The cysts were either disappeared (95.2%) or reduced in size (4.8%). Only one (4.8%) patient had recurrent cyst, which was solved after ultrasound-guided aspiration. This direct extra-articular arthroscopic technique could be a feasible alternative for treatment of symptomatic popliteal cysts.

The effectiveness of telemedicine on body mass index: A systematic review and meta-analysis.

OBJECT: The purpose of this study was to evaluate the clinical effectiveness of telemedicine on changes in body mass index for overweight and obese people as well as for diabetes and hypertension patients. METHODS: A systematic review of articles published before 31 August 2014, was conducted using searches of Medline, Cochrane Library, EMBASE, and CINAHL Plus. The inclusion criteria were randomised controlled trials that compared telemedicine interventions with usual care or standard treatment in adults and reported a change in body mass index. A meta-analysis was conducted for eligible studies, and the primary outcome was a change in body mass index. Subgroup analysis was performed for the type of telemedicine, main purpose of intervention, and length of intervention. RESULTS: Twenty-five randomised controlled trials comprising 6253 people were included in the qualitative and quantitative analyses. The length of intervention ranged from nine weeks to two years. The meta-analysis revealed significant differences in body mass index changes (pooled difference in means = -0.49, 95% confidence interval -0.63 to -0.34, p < 0.001) between the telemedicine and control groups. The subgroup analyses found that either Internet-based or telephone-based intervention was associated with greater changes in body mass index than in controls. Telemedicine intervention was effective in improving body mass index whether it was used for diabetes control, hypertension control, weight loss, or increasing physical activity and was also effective for people with and without diabetes or hypertension. However, only interventions with a duration ≥ 6 months significantly decreased body mass index compared to controls. CONCLUSION: Both patients with chronic disease and overweight/obese people could benefit from telemedicine interventions. We suggest that an effective telemedicine approach should be longer than six months and emphasise the importance of post-interventional follow-ups.

One-stage surgery for removal of intravascular leiomyomatosis extending to right ventricle.

RATIONALE: Intravascular leiomyomatosis (IVL) is a rare nonmalignant tumor that can be fatal if untreated. PATIENT CONCERNS: A 49-year-old nulliparous Asian woman who underwent hysterectomy and left salpingo-oophorectomy for multiple uterine leiomyomas 18 months prior presented complaining of intermittent palpitation and chest tightness for approximately 1 month. Echocardiography revealed a large mobile tumor mass extending from the inferior vena cava (IVC) to the right atrium that partially obstructed IVC flow and tricuspid inflow. Thoracicabdominopelvic computed tomography revealed a left adnexal tumor (4.8 × 2.5 cm) causing intravascular obstruction extending from the left internal iliac vein to the IVC, right atrium, and right ventricle. DIAGNOSIS: IVL with right heart involvement INTERVENTIONS:: Under cardiopulmonary bypass, a one-stage surgery combining sternotomy and laparotomy was performed. The tumor was approached and extracted via sternotomy, and tumor detachment and removal of residual tumors was accomplished via laparotomy. OUTCOMES: A firm, smooth, and regularly shape tumor 15.5 × 5.5 × 2.5 in size was completely removed and histopathologically confirmed as IVL. The patient tolerated the surgical procedure well and no postoperative complication was noted. LESSONS: We describe a one-stage surgical approach to completely remove an IVL extending to the right ventricle.

The Effect of Functional Movement Training After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.

OBJECTIVES: To evaluate the effect of functional movement screen (FMS)-based functional exercise in patients after anterior cruciate ligament reconstruction (ACLR). DESIGN: Randomized, controlled, single-blind trial. SETTING: Institutional, single center. PATIENTS: A total of 38 patients who underwent ACLR were recruited and randomly assigned to group 1 (n = 19) or group 2 (n = 19). INTERVENTIONS: Both groups received 6-month routine rehabilitation immediately after surgery. From the postoperative fourth to sixth month, group 1 received FMS-based functional exercise plus routine rehabilitation and group 2 received routine rehabilitation only. The FMS-based functional exercise was individualized and customized functional corrective exercise, which was designed based on the 3-month postoperative FMS results. The frequency of rehabilitation was 1 hour per session, twice a week, for a total duration of 6 months. MAIN OUTCOME MEASURES: At 3 and 6 months postoperatively, patients were evaluated by FMS scoring, Lysholm Knee Score, and International Knee Documentation Committee 2000 Score. RESULTS: After the intervention, both groups had significantly increased FMS, Lysholm Knee Score, and International Knee Documentation Committee 2000 score. Group 1 had significantly greater changes in FMS (median: 4 vs 3, P < .001), Lysholm Knee Score (median: 24 vs 16, P = .001), and International Knee Documentation Committee 2000 Score (median: 22 vs 8, P < .001) than group 2. CONCLUSION: The application of FMS-based functional exercise to patients after ACLR resulted in significant improvement in knee function and movements. The authors suggested integrating FMS evaluation and FMS-based training into routine post-ACLR rehabilitation programs.

Koebner phenomenon induced by failed revisional orthopedic surgery but remitted with bone union: A case report.

RATIONALE: Trauma or surgical incision might cause Koebner phenomenon (KP) in patients with cutaneous diseases, but seldom studies reported KP induced by repeated orthopedic surgery. PATIENT CONCERNS: The 22-year-old man did not have any prior histories of cutaneous diseases. Two months after the revision surgery for nonunion of the left femoral shaft fracture, KP was noted by psoriasis presented at the surgical scar, left thigh, scalp, and trunk. Phototherapy and topical treatments were prescribed but the effect was limited. DIAGNOSIS: KP induced by failed revisional orthopedic surgery. INTERVENTIONS: Because of implant failure, he underwent the second revision surgery, which was performed on the previous scar surrounded and covered by psoriatic plaques. OUTCOMES: After the second revision surgery successfully corrected the orthopedic problem, the psoriatic lesion remitted along with the bone union. LESSONS: In a patient having KP, to perform an operation on psoriatic lesion sites was safe and the surgical wound could heal well. The most important to treat KP induced by orthopedic surgery might be the underlying bone stability.

Cost-utility analysis of direct ventricular assist device vs double bridges to heart transplantation in patients with refractory heart failure.

OBJECT: This study compared the cost-utility of direct ventricular assist device (VAD) vs double bridges, extracorporeal membrane oxygenation (ECMO) before VAD, to heart transplantation in patients with refractory heart failure. MATERIALS AND METHODS: From a health payer perspective, a Markov model was developed. The cycle length was 1 month, and the time horizon was a lifetime. Probabilities and direct cost data were calculated from a nationwide claim database. Utility inputs were adopted from published sources. The utility was expressed as quality-adjusted life years (QALYs). Both costs and utility were discounted by an annual rate of 3%. Deterministic and probabilistic sensitivity analyses were performed to test the stability of the model. RESULTS: The direct VAD group had less lifetime costs (USD 95 910 vs USD 129 516) but higher lifetime QALYs than the double bridges group (1.73 vs 0.89). The sensitivity analysis revealed that the direct VAD group consistently had lower cost and higher QALYs during all variations in model parameters. The probability that direct VAD was cost-effective exceeded 75% at any levels of willing-to-pay. CONCLUSION: From a health insurance payer perspective, direct VAD bridge to heart transplantation appeared to be more cost-effective than double bridges in patients with refractory heart failure.

Using a pedicle pectoralis major musculocutaneous flap in head and neck reconstruction after modified radical mastectomy: A case report.

RATIONALE: A pedicle pectoralis major musculocutaneous (PMMC) flap is one of the strategies for head and neck reconstruction. Seldom studies reported the case in which the skin area of previous modified radical mastectomy (MRM) had been used as a PMMC flap in head and neck reconstruction. PATIENT CONCERNS: An 84-year-old female who had suffered from left breast cancer and undergone a left modified radical mastectomy (MRM) more than 20 years earlier. DIAGNOSES: She had squamous cell carcinoma of the tongue and had undergone partial glossection and left modified radial neck dissection. Four months later, a left submandibular mass was noted with progressive enlargement and the biopsy revealed recurrent carcinoma. INTERVENTIONS: Left marginal mandibulectomy with radical neck dissection was performed and the neck area was reconstructed by a left pedicle PMMC flap harvested from the left chest wall which had the previous MRM scar. OUTCOMES: The post-operative course was uneventful with complete survival of the flap. The patient received post-operative adjuvant radiotherapy at the left neck and no delayed wound disruption or flap necrosis was noted six months after surgery. LESSONS: A pedicle PMMC flap may be harvested to achieve a functionally as well as an aesthetically pleasing outcome without compromising its viability despite the previous MRM.

Transverse rectus abdominis myocutaneous flap for postpneumonectomy bronchopleural fistula: A case report.

RATIONALE: Numerous types of flap coverage have been reported to prevent or to repair bronchopleural fistulas. Most of the flaps were harvested from chest area. However, these pedicled flaps might not be optimal for the patient who has undergone previous radiotherapy on pulmonary parenchyma because the pedicle artery of the flap might have been injured by irradiation. Therefore, an alternative flap outside of the chest area is necessary. PATIENT CONCERNS: A 61-year-old male was diagnosed of squamous cell carcinoma in right upper lobe lung (cT3N2M0, stage IIIa). After completing the neoadjuvant chemoradiotherapy, he underwent video-assisted thoracoscopic surgery with right side intrapericardial pneumonectomy. DIAGNOSIS: Persistent air leak due to postpneumonectomy bronchopleural fistula. INTERVENTIONS: Pedicled transverse rectus abdominis myocutaneous (TRAM) flap was used to repair the bronchial stump. OUTCOMES: The bronchial stump was repaired successfully, the bronchopleural fistula was obliterated, and the patient was free from air leak after following for 12 months. LESSONS: This case demonstrated that pedicled TRAM flap is a feasible alternative to repair bronchopleural fistula.

Rural older people had lower mortality after accidental falls than non-rural older people.

OBJECTIVE: This study aimed to investigate the mortality rate after falls of rural and non-rural older people and to explore the risk factors of mortality after falls among older people. PATIENTS AND METHODS: This population-based case-control study identified two groups from a nationwide claim database (National Health Insurance Research Database in Taiwan): a rural group and a non-rural group, which included 3,897 and 5,541 older people, respectively, who were hospitalized for accidental falls (The International Classification of Diseases, Ninth Revision, Clinical Modification: E880-E888) during 2006-2009. Both groups were followed up for 4 years after falls. Four-year cumulative all-cause mortality rate after falls was calculated, and the demographic factor, comorbidity, and medications were considered as the potential risk factors of mortality after falls. RESULTS: The rural group had a significantly higher frequency of fall-related hospitalizations (7.4% vs 4.3%, P<0.001), but a lower 4-year cumulative all-cause mortality rate after falls than the non-rural group (8.8% vs 23.4%, P<0.001). After adjusting for age, gender, comorbidity, and medication use, the rural group had a significantly lower risk of mortality after falls than the non-rural group (adjusted odds ratio =0.32, 95% confidence interval =0.28-0.37, P<0.001). Age, gender, place of residence, comorbidity, number of medications, and inappropriate medication use were independent risk factors of mortality after falls. CONCLUSION: The rural older people had a higher frequency of fall-related hospitalizations but lower mortality after falls than the non-rural older people. Fall prevention programs should be adjusted for difference in place of residence.

Split renal function of both kidneys after robot-assisted partial nephrectomy for renal tumor larger than 4 cm.

PURPOSE: Relative few studies reported the changes in split renal function using renal scintigraphy for robot-assisted partial nephrectomy (RaPN) for renal tumor >4 cm. This study aimed at demonstrating that RaPN is safe for renal tumor >4 cm without damaging the renal function of ipsilateral and contralateral kidney. METHODS: Patients who underwent RaPN for single renal tumor from December 2009 to December 2013 were identified from a prospectively collected database. We compared demographic, perioperative, and postoperative outcomes between patients with renal tumor >4 cm (case group) and patients with renal tumor ≦4 cm (control group). Renal function was assessed by serum creatinine, estimated glomerular filtration rate, and effective renal plasma flow (ERPF). RESULTS: One hundred and three consecutive patients (45 in case group and 58 in control group) were identified. Case group had significantly longer operative time (P = 0.011), longer warm ischemia time (P < 0.001), and more estimated blood loss (P = 0.010) than control group. Only one patient in the case group had conversion surgery. There was no significant difference regarding hospital stay, blood transfusion, complications rate, and positive surgical margin. The changes in ipsilateral ERPF and contralateral ERPF were not significantly different between groups (ipsilateral kidney: -10.5 vs. -12.5%, P = 0.989; contralateral kidney: -3.6 vs. -5.2%, P = 0.611). CONCLUSIONS: RaPN is a safe and feasible modality of nephron-sparing surgery for renal tumor >4 cm, as it is for renal tumor ≦4 cm.

A novel endoscopic-assisted harvesting of pedicled freestyle fasciocutaneous flaps.

The endoscopy-assisted technique has been demonstrated in harvesting muscle flaps; however, for pedicled freestyle fasciocutaneous flaps, few studies have applied this technique. We present a surgical procedure utilizing endoscopic-assisted method to identify the perforators of pedicled freestyle fasciocutaneous flaps for the reconstruction of soft tissue defects. From August to December 2012, 9 consecutive patients underwent endoscopic-assisted harvesting of fasciocutaneous flaps for the reconstruction of soft tissue defects. All of the defects were caused by trauma with tendon or bone exposure. Postoperatively, all patients were requested to return for outpatient follow-up visits for at least 3 months. The age of the 9 patients (8 men and 1 woman) ranged from 20 to 79 years (median 59 years). The defects ranged in size from 2 × 2 to 6 × 8 cm2. Two patients received anterolateral thigh transmuscular perforator flaps, 5 patients received fibular septocutaneous perforator flaps, and 2 patients received medial gastrocnemius transmuscular perforator flaps. The median incision length was 10 cm, and the median operative time was 120 minutes. None of the patients had intraoperative complications, and intraoperative bleeding was minimal (<50 mL). At the end of the 3-month follow-up period, none of the patients had any complications on either recipient or donor site, including total or partial necrosis of the flaps, flap dehiscence, hematomas, seromas, wound infections, or any conditions that indicated additional unplanned operative procedures. All of the patients had surviving flaps. Our results demonstrated that the endoscopic-assisted method could be a valuable and reliable alternative in harvesting pedicled freestyle fasciocutaneous flaps.

Comparison of a semi-automatic annotation tool and a natural language processing application for the generation of clinical statement entries.

BACKGROUND AND OBJECTIVE: Electronic medical records with encoded entries should enhance the semantic interoperability of document exchange. However, it remains a challenge to encode the narrative concept and to transform the coded concepts into a standard entry-level document. This study aimed to use a novel approach for the generation of entry-level interoperable clinical documents. METHODS: Using HL7 clinical document architecture (CDA) as the example, we developed three pipelines to generate entry-level CDA documents. The first approach was a semi-automatic annotation pipeline (SAAP), the second was a natural language processing (NLP) pipeline, and the third merged the above two pipelines. We randomly selected 50 test documents from the i2b2 corpora to evaluate the performance of the three pipelines. RESULTS: The 50 randomly selected test documents contained 9365 words, including 588 Observation terms and 123 Procedure terms. For the Observation terms, the merged pipeline had a significantly higher F-measure than the NLP pipeline (0.89 vs 0.80, p<0.0001), but a similar F-measure to that of the SAAP (0.89 vs 0.87). For the Procedure terms, the F-measure was not significantly different among the three pipelines. CONCLUSIONS: The combination of a semi-automatic annotation approach and the NLP application seems to be a solution for generating entry-level interoperable clinical documents.

A multi-technique approach to bridge electronic case report form design and data standard adoption.

BACKGROUND AND OBJECTIVE: The importance of data standards when integrating clinical research data has been recognized. The common data element (CDE) is a consensus-based data element for data harmonization and sharing between clinical researchers, it can support data standards adoption and mapping. However, the lack of a suitable methodology has become a barrier to data standard adoption. Our aim was to demonstrate an approach that allowed clinical researchers to design electronic case report forms (eCRFs) that complied with the data standard. METHODS: We used a multi-technique approach, including information retrieval, natural language processing and an ontology-based knowledgebase to facilitate data standard adoption using the eCRF design. The approach took research questions as query texts with the aim of retrieving and associating relevant CDEs with the research questions. RESULTS: The approach was implemented using a CDE-based eCRF builder, which was evaluated using CDE- related questions from CRFs used in the Parkinson Disease Biomarker Program, as well as CDE-unrelated questions from a technique support website. Our approach had a precision of 0.84, a recall of 0.80, a F-measure of 0.82 and an error of 0.31. Using the 303 testing CDE-related questions, our approach responded and provided suggested CDEs for 88.8% (269/303) of the study questions with a 90.3% accuracy (243/269). The reason for any missed and failed responses was also analyzed. CONCLUSION: This study demonstrates an approach that helps to cross the barrier that inhibits data standard adoption in eCRF building and our evaluation reveals the approach has satisfactory performance. Our CDE-based form builder provides an alternative perspective regarding data standard compliant eCRF design.