Chronic thoracic pain after cardiac surgery is prevalent (11 to 56%) and may affect patients’ physical and mental health status. Despite its favorable pharmacokinetic and pharmacodynamic properties, high doses of remifentanil administered during surgery are reported to cause acute postoperative pain and increased requirements for analgesics. Recently, an association between remifentanil use and the incidence of chronic thoracic pain in the long term was also reported. Our objective is to investigate the influence of the intraoperative remifentanil on chronic postoperative pain in a prospective randomized controlled trial.-1kgIBW-1 min-1) or additional fentanyl (200 to 500 μg) as needed during surgery.In this prospective, randomized, single-blind clinical trial, all patients (N =126) between 18 and 85 years undergoing cardiac surgery via sternotomy receive a continuous infusion of propofol together with intermittent intravenous fentanyl at predetermined times perioperatively. Patients are randomized to receive either an additional continuous infusion of remifentanil  at 3, 6 and 12 months after surgery; work productivity; and use of health care. In addition, thermal detection and pain thresholds are measured preoperatively, 3 days after surgery and 12 months after surgery using quantitative sensory testing (QST). Finally, the influence of several genetic variances on the different outcomes will be measured.Chronic thoracic pain is prevalent after cardiac surgery, and research is needed to minimize the risk of chronic persistent postoperative pain, which is an invalidating, long-term complication of surgery. The objective of this trial is to determine the influence of perioperative remifentanil on long-term pain outcomes for cardiac patients in a prospective randomized trial. The results may be used to optimize perioperative analgesia techniques and, thereby, improve quality of life after cardiac surgery.NCT02031016 on 13 December 2013.Clinicaltrials.gov Remifentanil is a pain-relieving drug frequently used during surgery due to its favorable pharmacokinetic and pharmacodynamic properties. It is characterized by rapid onset, predictable rapid recovery profile and dosing reliability. Its useLittle is known about a possible association between the intraoperative use of remifentanil and the development of chronic pain. A dose-dependent relationship was shown in 90 cardiac patients one year after surgery. Also a In our hospital, about 60% of cardiac surgery patients receive remifentanil next to fentanyl intraoperatively, depending on the anesthetist’s preference. We wondSo far, however, no prospective randomized controlled trials designed to evaluate the influence of intraoperative remifentanil on the incidence of chronic thoracic pain are available. The current prospective randomized trial is designed to investigate the influence of perioperative additional remifentanil or additional fentanyl on the development of chronic thoracic pain at 3, 6 and 12 months after surgery. In addition, changes in thermal detection thresholds and pain thresholds and the influence of genetic variances will be investigated.This study is a prospective, randomized, single-blind clinical trial carried out in the St. Antonius Hospital, Nieuwegein, the Netherlands Figure . The stuThe study was approved by the local Ethics Committee of this hospital (Verenigde Commissies Mensgebonden Onderzoek (VCMO) R13.013). The study was registered on the Clinical Trials register on 13 December 2013 . The research coordinator will obtain written informed consent from each participant.2 (7) prior cardiac surgery (re-operations); and (8) patients with chronic pain conditions.The following inclusion criteria are being applied: (1) patients undergoing cardiac surgery via sternotomy ; and (2) age between 18 and 85 years; (3) weight between 45 and 140 kg. Exclusion criteria are: (1) pregnancy or breastfeeding; (2) language barrier; (3) history of drug abuse; (4) neurologic condition such as peripheral neuropathy and fibromyalgia; (5) known remifentanil, fentanyl, morphine or paracetamol allergy; (6) a body mass index (BMI) above 35 kg/mAnesthesia will be induced with midazolam (2.5 to 5.0 mg) followed by a propofol bolus (1 to 2 mg/kg), fentanyl (250 to 500 ug) and pancuronium (0.05-2 mg/kg). After tracheal intubation, patients will be ventilated to normocapnia with oxygen enriched air (50 to 100% oxygen). No nitrous oxide will be used. Sevoflurane will be used as needed. Both groups receive a continuous infusion of propofol (starting dose 200 to 300 mg/hour) and intermittent intravenous fentanyl at predetermined times .Patients in the remifentanil group will receive a continuous infusion of remifentanil /min) on top of this propofol-fentanyl anesthetic regimen. Patients in the fentanyl group will receive additional boluses of fentanyl 200 to 500 μg as needed instead of the remifentanil infusion.Patients in both groups will receive 5 to 10 mg of intravenous morphine 30 minutes before the anticipated end of surgery. After surgery, patients will either go to the Intensive Care Unit (ICU) or to the Post-Anesthesia Care Unit (PACU).One day before surgery, three days after surgery and one year after surgery quantitative sensory testing (QST) will be performed. Cold and warm detection thresholds and pain thresholds will be measured, using the ‘method of limits’ with the Thermal Sensory Analyzer (TSA) II 2001 , 19. ThePatients in both groups will receive the same postoperative treatment. In both the ICU and the PACU, a pain management protocol is in place as part of standard care, consisting of a continuous infusion of morphine (starting dose of 2 mg/hour), which is adapted depending on Numerical Rating Scale (NRS) pain scores, as well as paracetamol four times a day . Any perAfter discharge from the hospital, patients will be asked to complete questionnaires 3, 6 and 12 months after surgery. This questionnaire contains questions about pain  based on the Brief Pain Inventory and was The primary end point is the percentage of patients with chronic thoracic pain (NRS >0) one year after cardiac surgery.Secondary end points are mean daily acute postoperative NRS scores (0 to 10) and analgesic consumption until discharge from the hospital. Also chronic pain (NRS), Quality of Life, analgesic consumption, work productivity, and use of health care 3, 6 and 12 months after surgery are assessed. In addition, warm/cold detection and pain thresholds ) using quantitative sensory testing (QST) are considered. The length of ICU, PACU and hospital stay will be calculated.In addition to primary and secondary endpoints, an exploratory screening of different genes in this population will be investigated. The possible influence of different genetic variances that are involved in pain sensitivity , WDFY family member 4 (WDFY4), Zinc Finger gene Family (ZNF), Melanocortin 1 Receptor (MC1R)) and the pharmacokinetics and pharmacodynamics of opiates , Multidrug Resistance-associated Protein (MRP), mu-opioid receptor gene 1 (OPRM1), Catechol-O-methyltransferase (COMT)) will be explored.Statistical analyses will be done with The SPSS statistical package . Patient demographics, baseline characteristics and clinical observations are compared between patients receiving remifentanil versus fentanyl during cardiac surgery. Nonparametric data will be expressed as median (range) and analyzed by chi-square. Parametric data will be expressed as mean ± SD and analyzed by Student’s t-tests or ranks tests.The effect of intraoperative use of remifentanil on chronic pain one year after cardiac surgery is analyzed using univariate logistic regression analysis. If baseline characteristics are not balanced, multivariable techniques will be applied. To evaluate the effect of remifentanil versus fentanyl during cardiac surgery on pain thresholds, paired t-tests will be used.To estimate the effect of the genotype on the outcome variables, each gene is examined to determine the appropriate model. The gene variants will be coded based on the observed distribution. The outcome parameters are compared between genotypes by a linear mixed model analysis based on the maximum likelihood ratio with the patient genotype status as fixed factors and the time point of outcome parameters as repeated measurement.In a previous study of 90 patients on chronic thoracic pain after cardiac surgery, 15 of the 52 patients who received remifentanil developed chronic thoracic pain (29%) versus 3 of the 38 patients who did not receive remifentanil (8%); resulting in an odds ratio of 4.7[Rounding numbers, the sample size calculation is made on the assumption that in this prospective study, approximately 30% of the patients receiving remifentanil will develop chronic thoracic pain and that approximately 10% of the patients receiving fentanyl will develop chronic thoracic pain.The sample size is calculated with a power of 0.80 and an alpha of 0.05; two sided. A total number of 117 patients are needed. According to previous reports, mortality thirty days after cardiac surgery is approximately 2 to 13.3%, 23. In This is the first randomized trial that prospectively evaluates the influence of intraoperative remifentanil on the incidence of chronic thoracic pain. Studies in healthy volunteers indicate that remifentanil increases the occurrence of secondary hyperalgesia in experimental pain models–28. OtheThe putative biological mechanism by which remifentanil would cause chronic pain is unclear. Opioid-induced hyperalgesia is well described in animal studies but the occurrence in patients is still under debate. Animal Ideally, the study design should be double blind and contain no other opioid besides remifentanil. As a study arm without opioids during surgery is obviously unethical, fentanyl was selected for the other arm. The current design, where intermittent fentanyl at predetermined times is combined with continuous propofol as the basis for standardized Total Intravenous Anesthesia (TIVA) in both arms, is based on the design of a previous study investigating risk factors for chronic thoracic pain in our hospital. With onIn the current study, all patients will be evaluated for their sensory detection and pain thresholds using QST preoperatively, 3 days and 1 year after surgery. This randomized trial in which chronic thoracic pain after cardiac surgery is studied in the remifentanil and control arm is not only an opportunity to investigate the influence of remifentanil on sensory thresholds, but also to explore the influence of cardiac surgery and chronic pain on sensory modalities. Ideally, for this purpose, a pain battery with more than one stimulus  should be used; however, in our opinion, use of a large number of pain thresholds measurements is not feasible in patients prior to and 3 days after invasive cardiac surgery.The results of this randomized trial may be used to optimize intraoperative analgesia techniques and thereby improve the quality of life of patients after cardiac surgery.The trial is currently enrolling patients. To date, 90% of the patients have been enrolled in the study. The expected average enrollment rate is three to five patients every week. Data collection will stop one year after the last patient is included.


Background Context. Products that can reduce development of epidural fibrosis may reduce risk for ongoing pain associated with development of scar tissue and make subsequent epidural reexploration easier. Purpose. To evaluate the use of dehydrated human amnion/chorion membrane (dHACM) on the formation of soft tissue scarring in the epidural space. Study Design. Case series. Patient Sample. Five patients having transforaminal lumbar interbody lumbar fusion (TLIF) with posterior instrumentation and implantation of dHACM in the epidural space and subsequent epidural reexploration. Outcome Measures. Degree of scar tissue adjacent to the epidural space at reexploration. Intraoperative and postoperative complications related to dHACM and patient reported outcomes. Methods. The degree of scar tissue adjacent to the epidural space was assessed during the reexploration surgery. Patients' outcomes were collected using standard validated questionnaires. Results. Four of 5 cases had easily detachable tissue during epidural reexploration. Angiolipoma of 10% was noted in 1 case and 5% in 2 cases. Significant improvements in patient reported outcomes were observed. No intraoperative or postoperative complications occurred. Conclusions. Our findings suggest that dHACM implant during TLIF may have favorable effects on epidural fibrosis and is well tolerated. Further studies with larger cohorts are required to prove our results. Epidural fibrosis results from the surgical intervention in the epidural space. The scar tissue envelops the nerve roots and covers the exposed portion of the dura within the spinal canal. Although this process is normal and an expected result of healing of the surgical site or wound, actual formation of scar tissue and adhesions may lead to a less than optimal clinical outcome. Specifically, epidural fibrosis has been associated with the persistence or recurrence of back pain after discectomy –5. EpiduA variety of methods have been used in an attempt to prevent and reduce epidural fibrosis. The most notable method may be the ADCON-L , a carbohydrate polymer gel designed to provide a mechanical barrier to inhibit fibroblast migration and adhesion. While the early results of the ADCON-L showed reduced scar tissue formation and improved outcomes , 9, the Another antiadhesion gel , composed of carboxymethylcellulose and polyethylene oxide, has been shown to improve some outcomes and reduce the rate of reoperation , 14. TheThe use of human amniotic membrane based products has also been considered for the prevention of epidural fibrosis. Amniotic membrane, comprised of both amnion and chorion membranes, is metabolically active tissue which continually remodels the extracellular matrix through processes controlled by paracrine growth factors . Amnion β1, EGF, VEGF, and PlGF [Dehydrated human amnion/chorion membrane (dHACM) is a dehydrated human allograft comprised of laminated amnion and chorion membranes derived from donated human placentas according to the American Association of Tissue Banks (AATB) standards and is considered a tissue product under Section 361 of the Public Health Service Act. PURION processed dHACM has been shown to retain the growth factors in natural amniotic membrane including PDGF-AA, PDGF-BB, bFGF, TGF-and PlGF . In addiand PlGF .Our primary objective was to evaluate the use of dehydrated human amnion/chorion membrane (dHACM) allograft  and the formation of soft tissue scarring in the epidural space, in patients having transforaminal lumbar interbody lumbar fusion (TLIF) with posterior instrumentation and subsequent reexploration with instrumentation removal. Secondary outcomes included intraoperative and postoperative complications related to dHACM and patient outcomes relative to disability, pain, and functional health.NCT01357187) were approved by the local Institutional Review Board . All participants gave full informed consent to participate in the study. Patients were eligible to receive dHACM implantation if they had no history of previous spinal surgery and were scheduled for transforaminal lumbar interbody fusion (TLIF) with posterior instrumentation. Included were those patients that underwent a secondary surgery to remove the posterior segmental instrumentation and required exploration of the appropriate nerve roots after having achieved solid bony fusion.The study design, protocol, and consent forms  was oriented with the appropriate side up, cut to fit the dura exposed by the decompression, and placed in the epidural space. Meticulous hemostasis was achieved and a hemovac drain placed prior to routine closure.After radiological studies had been performed to document adequate fusion, as evidenced by bridging bone within the interbody space and adjacent intertransverse region, the patient was scheduled for instrumentation removal with exploration of the epidural space. After exposure, the hardware was removed and the pedicles reconstructed with crushed cancellous allograft. The ease of dissection/extent of adhesions in the epidural space was determined by the surgeon and a piece of tissue adjacent to the epidural space was sent for histopathologic analysis.During the instrumentation removal surgery, the spine surgeon assessed the degree of scar formation adjacent to the epidural space using a 4-level scoring system ranging from “no adhesion” to “sharp dissection required” .2 section of the lumbar tissue was removed with a small scalpel blade, clearly marking the surface adjacent to the dura. The tissue sample was treated with H & E staining. The slides were evaluated for the presence and extent of scar tissue (mm of fibrosis and percent of fat infiltration).During the instrumentation removal surgery, a small sample of the scar tissue adjacent to the epidural space was collected for histological analysis. A 1-cmIntraoperative and postoperative complications were recorded. Patients were evaluated at three weeks, three months, six months, and twelve months after the TLIF surgery and again after the instrumentation removal surgery. Patients' outcomes were collected using standard validated questionnaires including Oswestry Disability Index (ODI), Numerical Rating Pain Scales, and SF-36. The average change in patient outcomes was assessed with repeated-measures analysis  with alpha = 0.05.During the study period a total of 5 patients  without history of prior spinal surgery underwent TLIF with dHACM and subsequent reexploration. Patient diagnosis, levels of TLIF, adhesion score assessed at reexploration, and histological analysis of fibrosis and fat infiltration are reported in There were no intraoperative complications, specifically no durotomy/cerebrospinal fluid leaks.Similarly, there were no postoperative complications, specifically no wound infections/dehiscence.Individual patient outcomes are reported in While there is also an improvement in physical well-being (PCS), it is not statistically significant .Both back and leg pain decreased on average. The decrease was significant for back pain but not leg pain .Patients exhibited individual variation in their responses to treatment: half the patients reported minimal to no disability and pain while half the patients improved but experienced persistent pain and disability. Patient 2 underwent a sacroiliac joint fusion to further help with back pain. Patient 4 underwent an unrelated cervical fusion for cervical myelopathy.Supplemental instrumentation is widely used in spinal fusion surgery. Biomechanical studies have demonstrated that supplemental instrumentation enhances the stability of the target motion segment . A subseThis pilot study investigated the use of a dHACM barrier in reducing epidural fibrosis and facilitating dissection in revision spinal surgery. Although the small sample size of the study limits the ability to generalize our results, we believe the use of a dHACM barrier was clearly useful in limiting epidural fibrosis and promoting dissection in revision spinal surgery. Furthermore, the dHACM did not lead to any adverse events such as infection or spinal fluid leak.Compared to other barriers that we have utilized, the dHACM performed better in revision surgery. In the past, we have used ADCON-L gel  but no longer utilize the product given the reports in the literature of associated radiculitis and spinal fluid leak. We have also used DuraSeal Xact  but contrary to Fransen study , we did Although this study is too small to properly evaluate the effectiveness of dHACM in preventing epidural fibrosis and facilitating dissection in revision spinal surgery, it clearly shows promise in achieving these goals. These results and the impact of the dHACM barrier on patient outcomes need to be confirmed with larger studies with longer term follow-up, before more definitive conclusions may be drawn.


Ebola survivors experience a range of medical conditions. Thousands of persons have survived Ebola virus disease. Almost all survivors describe symptoms that persist or develop after hospital discharge. A cross-sectional survey of the symptoms of all survivors from the Ebola treatment unit (ETU) at 34th Regimental Military Hospital, Freetown, Sierra Leone (MH34), was conducted after discharge at their initial follow-up appointment within 3 weeks after their second negative PCR result. From its opening on December 1, 2014, through March 31, 2015, the MH34 ETU treated 84 persons (8–70 years of age) with PCR-confirmed Ebola virus disease, of whom 44 survived. Survivors reported musculoskeletal pain (70%), headache (48%), and ocular problems (14%). Those who reported headache had had lower admission cycle threshold Ebola PCR than did those who did not (p<0.03). This complete survivor cohort from 1 ETU enables analysis of the proportion of symptoms of post-Ebola syndrome. The Ebola epidemic is waning, but the effects of the disease will remain. Thousands of persons have now survived Ebola virus disease (EVD). During efforts to control the current Ebola-Zaire outbreak, attention has focused on containing spread of infection and improving survival. In Sierra Leone, 4,051–5,115 persons are confirmed to have survived from among 8,704 confirmed cases and 3,589 confirmed deaths  at the 34th Regimental Military Hospital, (MH34), Wilberforce Barracks, Freetown, Sierra Leone, were all followed up in an outpatient clinic within 2 weeks after discharge. Although resources to care for survivors, including basic equipment , were scarce, each survivor was seen by a physician who made contemporaneous structured notes, which afforded an opportunity to document post-Ebola syndrome during these first weeks.What proportion of Ebola survivors have sequelae is not clear. Little is known about post-Ebola syndrome or whether it is an entity distinct from an appropriate response to the traumatic events of EVD. Abdominal pain, vision loss, hearing loss, impotence, bleeding, psychological problems, and general weakness were listed qualitatively as symptoms of post-Ebola syndrome after the Ebola-Sudan outbreak in Uganda in 2000  and discharged 44 survivors during December 2014–March 2015. The area for persons with confirmed EVD is a permanent building with several 1–4-bed rooms that have electric lighting and ceiling fans. Three hot meals per day are provided, generally rice with protein, such as fish or chicken; each meal is provided with 2 bags of water, and more water is freely available. Staff members of this small ETU are all permanent Sierra Leonean healthcare workers.t) result also was available. Although Ct results were not standardized between PCR platforms or between laboratories, a low Ct reflects a high viral load. Patients were staged on arrival to the ETU, as follows:Patients were admitted to the confirmed Ebola ward when Ebola virus (EBOV) infection was confirmed by real-time PCR. For some patients, a cycle threshold .Stage 2: multisystem features, including “wet” gastrointestinal symptoms , neurologic symptoms , vascular symptoms and signs , rash.Stage 3: internal and external bleeding, multiorgan failure.Patients were treated for Ebola with supportive care  continuous outcomes (Mann-Whitney U) and analyzed them using Stata version 9 . Graphics were produced by using Stata version 9 and R version 3.1.1 .During December 1, 2014–March 30, 2015, the MH34 ETU treated 84 persons with PCR-confirmed EVD. Of these, 44 (52%) survived; 23 were female, and patient ages were 8–70 years ; age was not documented for 1 patient ; Table 1t results were available, median Ct at ETU admission (admission Ct) was 28 . Two patients were admitted in clinical stage 1 and 9 in clinical stage 2. Information about the acute EVD episode was available for 12 (27%) of the 44 survivors. Sex and ages of these 12 survivors did not differ significantly from those of the full set. For these 12 persons, median length of ETU stay was 15.5 days . For the 11 survivors for whom CTwenty-three (52%) survivors received CWB. Ages of survivors receiving transfusions did not differ significantly from those of survivors who did not (p = 0.8). The frequencies of symptoms did not differ significantly between survivors who received CWB and those who did not (p = 0.5). Our study was not designed to assess efficacy or toxicity of CWB.>1 post-Ebola complaint . A total of 117 separate complaints were reported: 31 (70% [95% CI 55%–83%]) patients had musculoskeletal pain, 21 (48% [95% CI 32%–63%]) had headaches, and 6 (14% [95% CI 5%–27%]) had ocular problems.At the time of data extraction, each survivor had attended at least 2 appointments. All survivors had t results that were significantly lower  than those who did not subsequently report headache   . There w did not . One patient died after deteriorating respiratory symptoms and left-sided pleural effusion. He was a 25-year-old man in whom EVD was diagnosed on January 26; he received supportive care and 1 unit of CWB. His first negative PCR result was on February 8 and his confirmatory negative test on February 11; he was discharged home. At his 14-day follow-up visit, he had weight loss, cough, and dyspnea on exertion. At his second outpatient appointment, he was admitted to the general medical ward of MH34 on March 3 with left-sided pleural effusion. A pleural tap yielded only a small quantity of blood-stained fluid that was insufficient for analysis. He died on March 8, 2015, one month after his recovery from acute EVD. In adherence to safe-burial policy, a postmortem examination was not performed. His diagnosis remains unclear, but postviral effusion is possible, with tuberculosis pleural effusion a differential diagnosis.Because in our experience and in the local context the distinction between myalgia and arthralgia can be physician-dependent, we merged these complaints. However, for the purpose of comparisons with other studies, we determined that 12 (27% [95% CI 15%–42%]) of the 44 survivors had arthralgia, 15 (34% [95% CI 20%–50%]) had myalgia, and 4 (9% [95% CI 3%–22%]) had both . We founPatients described musculoskeletal pain variously as problems with walking or moving or pain specific to 1 area  or generalized musculoskeletal pain. (21%–52%). Most often, patients characterized their musculoskeletal pain as a general pain rather than pain in a specific joint or area, as reflected in the recorded symptoms. Unspecified joint pain accounted for 14 of the 19 times joint pain was recorded (73% [95% CI 49%–90%]) and generalized body pain for 8 of the 19 times body pain was recorded (42% [95% CI 20%–67%]). Some patients recorded >1 symptom.Examination indicated no joint inflammation or effusion, such as might be expected in a reactive condition, and patients retained full range of movement. Functional disability ranged from mild to moderate. For example, 1 man in his 20s continues to play football but now takes acetaminophen to facilitate this activity. A woman in her 40s requires assistance to step into a bath and cannot continue normal household work; she walked unaided into the clinic but needed assistance to step up into the clinic room and to sit and stand. Most of her musculoskeletal symptoms are relieved by simple analgesics.2 test). Headache was generally described as affecting the full head, with no diurnal pattern and being constant. Ocular symptoms might coincide, but no visual phenomena, such as might be found in migraines, were reported.Of the 21 (48% [95% CI 32%–63%]) survivors who reported having headache, 2 (10% [95% CI 1%–30%]) were girls 8 and 11 years of age. The proportion of male and female survivors reporting headaches did not differ significantly (p = 1 by χAmong the 6 (14% [95% CI 5%–27%]) survivors who reported ocular problems, symptoms were eye pain, clear discharge, red eyes, and blurred vision . These sMusculoskeletal pain and headache overlapped substantially. Eighteen (58% [95% CI 40%–75%]) of the 31 survivors with musculoskeletal pain reported headache, and 18 (86% [95% CI 64%–97%]) of the 21 survivors with headache reported musculoskeletal pain. Two (6% [95% CI 1%–21%]) survivors with musculoskeletal pain reported ocular problems, and 2 (33% [95% CI 4%–78%]) with ocular problems reported musculoskeletal pain. Two (6 % [95% CI 1%–30%]) survivors with headache reported ocular problems. One survivor had all 3 complaints  .Twenty-six (59% [95% CI 43%–74%]) of the 44 survivors reported other symptoms. Five (11% [95% CI 4%–25%]) reported cough; 4 (9% [95% CI 3%–22%]) each reported abdominal pain, chest pain, or itching; 3 (7% [95% CI 1%–19%]) each reported insomnia, fever, or loss of appetite; 2 (5% [95% CI 1%–15%]) each reported labored speech, epigastric pain, or rash; and 1 (2% [95% CI 0%–12%]) reported weight loss, hiccups, increased appetite, chest pain, sneezing, diarrhea, vomiting, left sided weakness with facial nerve palsy, breathlessness, rash, dry flaky skin, earache, fever blister/cold sore, left scrotal swelling, nasal congestion, and tremors .We documented symptoms of EVD survivors in the initial 3 weeks after negative Ebola virus PCR results and 2 weeks after ETU discharge. The dominant clinical features of this survivor cohort were musculoskeletal pain, headache, and ocular problems. Symptoms did not differ by survivor sex or age. Symptoms did not appear to be affected by use of CWB to manage acute EVD; however, this finding should be interpreted with caution because this report is not a prospective study and not designed to consider the effect of CWB on post-Ebola syndrome. Whether this collection of signs and symptoms after acute EVD constitutes a separate syndrome might be semantic. Because experience of survivors in the weeks after EVD, although varied, has common features, we propose that the term post-Ebola syndrome is useful to describe these phenomena.Our findings are consistent with some aspects of previous reports (We hypothesize that the pathogenesis of pain, particularly muscle pain, is a sequelae of widespread myositis or rhabdomyolysis during acute EVD. This hypothesis would be consistent with laboratory data reporting raised transaminases and disseminated intravascular coagulation from a previous outbreak of Ebola (Post-Ebola syndrome includes, but is not restricted to, musculoskeletal pain, headache, and ocular problems. Because some complications occur weeks or months after acute onset of EVD, some symptoms might be underestimated in this cohort (t results than did those who did not. Although patients with higher initial viral loads might be more likely to have central nervous system involvement, and then have a higher probability of headache as a post-Ebola sequelae; Ct values are not standardized among platforms or laboratories. This intertest variability, together with the small sample sizes in this data extraction, suggests any association should be interpreted with caution. We propose that this association warrants further investigation. Headaches could also represent ongoing tension headaches or might result from underlying undiagnosed changes in vision.Survivors who reported headache had had lower CWe would expect the criteria and definition of post-Ebola syndrome to continue to develop and that the survivors will continue to face fresh challenges. During the height of the Ebola epidemic, when these consultations took place, resources and equipment for assessing survivors were limited. Our survey documents symptoms only in the first 3 weeks after ETU discharge. Subsequent follow-up might be more detailed and benefit from increased resources, and symptoms continue to develop with time. Indeed, Ebola virus can cross the blood–brain barrier during the acute illness (Because musculoskeletal pain is a common complaint in the general population in Sierra Leone, a community-controlled comparison is needed. In survivors of the Kikwit Ebola-Zaire outbreak in 1995, Rowe et al. reported that their key features—arthralgia, myalgia, abdominal pain, fatigue, and anorexia—were more common in survivors than in household contacts, whereas fever, headache, diarrhea, dyspnea, hiccups, and hemorrhage were the same in both groups (


In Italy, the nsLTP (Pru p 3) has been identified as the most frequent cause of food allergy and anaphylaxis. In order to estimate the risk assessment in peach allergy, we investigated the presence of correlations between the levels of sIgE to Pru p 3 with the severity of the clinical symptoms in two Pru p 3 positive populations from two different areas of Italy.133 consecutively Pru p 3 positive patients were recruited from South Italy, where the prevalence of PR-10 and profilin sensitization is low, and from North-East Italy, where the sensitization to pathogenesis related protein -10 (PR-10) and profilin is higher. Skin prick test (SPT) to peach extract and sIgE to peach panallergens were performed.All 133 patients were positive to SPT to peach extract and to sIgE to Pru p 3. The North-East population was simultaneously positive to Pru p 1 (42.8 %) and Pru p 4 (12.7 %), while no Southern patients were positive to PR-10 or to profilin. A significant difference in the levels of sIgE to Pru p 3 was found only in South Italy Pru p 3 + patients vs. asymptomatic patients (p = 0.01) and in mild reactions vs. severe reactions (p = 0.0008). In South Italy patients, it was also found a significant correlation between the severity of the clinical reaction and the levels of sIgE to Pru p 3 (p = 0.001).Level of sIgE to Pru p 3 indicates the possibility of development a severe food allergic reaction. Pru p 3 positive patients from different geographical areas and with different co-sensitizations to Pru p 1 and/or Pru p 4 could have a different risk assessment in peach allergy. The possibility to predict, by in vitro approaches, the development of symptoms related to food allergy (FA) has been studied by different research groups and several data have been published focusing on this point. Interestingly, some results have demonstrated that the levels of specific IgE (sIgE) for food allergens can be considered a reliable marker of a positive “in vivo” challenge test. –3. CurreIn FA, the molecular allergy based diagnosis has the peculiarity of identify different type of sensitizations depending on the geographical area. For example, it has been shown that the sensitization to the panallergen non-specific lipid transfer protein (nsLTP) increases from North Europe to the Mediterranean area, while the sensitization to the pathogenesis related protein-10 (PR-10) increases in the opposite direction. By contrast, the frequency of sensitization to profilin is almost invariable.Several studies showed that Pru p 3, the peach nsLTP, is the more frequent cause of food-induced allergy and anaphylaxis in Italy –6. The cThe sensitization to this heat and proteolytic digestion resistant protein is potentially very dangerous . Cross rThe relationship between the levels of sIgE, the severity of the clinical reactions and the presence of symptoms with foods containing nsLTP different from peach, is presently controversial –23.In consideration of the potential hazard of the sensitization to Pru p 3, it is evident how important is to identify a biomarker able to predict both the severity of an allergic reaction and the potential cross reactions with other nsLTP foods.The aim of this study was to investigate a possible correlation between an anaphylactic biomarker, such as sIgE to Pru p 3, with the severity of symptoms in two Pru p 3 sensitized populations from different geographical areas of Italy. In addition, we performed the ROC curve analysis of the sIgE to Pru p 3 in order to identify patients at a higher risk of anaphylaxis and compare our results with the data published in literature.133 consecutively allergic patients who attended the observation were recruited. A common selection criteria was used in all participating center: (a) clear history of an allergic reaction after being in contact with/or after the consumption of peach, (b) skin prick test (SPT) positive to peach extract, (c) positive sIgE to Pru p 3, (d) positive oral open food challenge or in case the challenge could not been performed, a well-documented severe allergy had been exhibited, e) patients positive to SPT to peach and to sIgE to Pru p 3 but asymptomatic. None of the patients were under oral corticosteroid or antihistamine.All 71 patients who attended the outpatient Allergy Unit of C.N.R. and Buccheri La Ferla Hospital were born and live in Palermo . All 62 patients who attended the outpatient Allergy Unit of Santa Maria degli Angeli Hospital were born and live in Pordenone .Patients were divided into four groups based on severity of symptoms: asymptomatic, OAS, mild systemic reactions (Mueller classification grade 1–2), and severe systemic reactions (Mueller classification grade 3–4)  were performed consecutively by the same investigator in the South population and by another investigator in the North-East population, on the volar surface of the forearm by using a standard l mm tip lancet, according to the recommendations of the European Academy of Allergy and Clinical Immunology group. Histamine hydrochloride (10 mg/mL) and saline , respectively, were used as positive and negative controls.The SPT results were considered positive if the difference between the mean diameter of the wheal and the negative control was at least of 3 mm.sIgE anti-rPru p 1, anti-rPru p 3, and anti-rPru p 4 were consecutively determined using the ImmunoCAP system . Results were expressed in kUA/L and a value >0.15 kUA/L was considered positive.All serum samples were consecutively analysis by both Buccheri La Ferla and Maria degli Angeli laboratories. The calibration test was done when the ImmunoCAP 250 required. Every day, new reagents were used due to the high number of samples analysed by both laboratories. During every single session, two control curves and one quality control (given by Thermofisher/Phadia Diagnostics) were performed. In addition, measurements of sIgE to peach and to Pru p 3 were done using a “house control” (obtained from a serum pool frozen at −80 °C).Both laboratories have been participated to external VEQ specific allergy programs: Buccheri La Ferla laboratory has been participated to the Sicilian Region CRQ and the laboratory from Pordenone, to the NEQAS UK.To be sure the results were reproducible, all 133 serum samples were analysed by Buccheri La Ferla laboratory, during a single session, using the same batch of reagents.Patients with OAS reintroduced peaches under our supervision and experienced local symptoms of OAS. In view of the observational nature of the study and of the fear of several patients of a possibly severe adverse reaction, patients with systemic reactions were not challenged because of documented severe peach allergy .The study was performed with the approval of the ethics committee of Policlinico—Giaccone Hospital—Palermo Italy (7/2013–12.06.2013) and was in agreement with the Helsinki Declaration. Written consent form was obtained from the patients.The association between levels of sIgE to Pru p 3 in asymptomatic vs. symptomatic patients with local and systemic reactions were analyzed by Mann–Whitney test.The ROC analysis was carried out to determine the optimal cut-off value of sIgE to Pru p 3 to distinguish asymptomatic from symptomatic patients both in South and North-East Italian populations.Correlations between sIgE levels and symptom severity were assessed using Spearman rank correlation (rho). In addition, the odds ratio of sIgE levels to Pru p 3 was calculated to assess the risk of severe reactions. The latest test was not done in the North-East group due to the low number of patients with severe reactions.p value of <0.05 was considered significant.Medcalc 11.4.4.0 was used for the statistical analyses. A All South and North-East Italian patients were positive (mean diameter > 3 mm) to SPT to peach extract and to sIgE to Pru p 3. The sensitization to other panallergens differs according to the geographical area: the North-East population was simultaneously positive to Pru p 1 42.8 %) and Pru p 4 (12.7 %), while no Southern patients were positive to PR-10 or to profilin  vs. asymptomatic patients (p = 0.01), and between patients with mild systemic reactions compare with patients with severe systemic reactions (p = 0.0008). On the other hand, in the North-East population, not significant differences were found in the levels of sIgE to Pru p 3 between symptomatic  vs. asymptomatic patients (p = 0.08) and between patients with mild systemic reactions compared with patients with severe systemic reactions (p = 0.09).Interestingly, in the South population was found a correlation between the severity of the clinical reactions and the levels of sIgE to Pru p 3 . Unfortunately, in the North-East population, not correlation test was done due to the low number of patients with severe allergic reactions.The ROC curve analysis from all South Pru p 3 positive patients identified a value of sIgE toPru p 3 of 2.87 kUA/L as the best value discriminating asymptomatic from symptomatic  patients . Due to the low number of severe reactions in the North-East population, it was not possible identify a value of sIgE to Pru p 3 able to discriminate severe reactions from other clinical reactions  of symptomatic  vs. asymptomatic patients living in South Italy and North-East Italy were 0.873 and 0.631 , respectively. AUC of patients with clinical severe reaction vs. all other reactions were 0.819 and 0.755 , respectively.The risk assessment of severe allergic reactions was the following: for a value of sIgE to Pru p 3 >7.5 kUA/L, the odds ratio 95 % CI was 69  and >10 kUA/L, the odds ratio 95 % CI was 225 .For the first time, a study evaluates the usefulness of an anaphylactic biomarker in the risk assessment of Pru p 3 positive patients from different geographical areas of the same country.In this study, we investigated the presence of correlations between the levels of sIgE to Pru p 3 with the severity of the clinical reactions in a South Italian population and compared them, with the results from a Nord-East Italian population, where the prevalence of sensitization to birch pollen is similar to North Europe.All patients were assigned to one of the four groups according to their clinical manifestations: asymptomatic, OAS, mild systemic reactions and severe systemic reactions. We found that levels of sIgE to Pru p 3 (Mann–Whitney test) in the South population was significantly different between asymptomatic vs. symptomatic  Pru p 3 positive patients and between patients with mild systemic reactions in comparison to those with severe systemic reactions. Surprising, we could not found any significant differences in the levels of sIgE to Pru p 3 (Mann–Whitney test) in none of the groups from North-East Italy.Few studies have assessed the relationship between the levels of sIgE to Pru p 3 and the severity of the clinical reactions, and taken all together provided contradictory results. Gaier et al.  have repAn important result of this study was the determination of a cut-off level for sIgE to Pru p 3 values that can better discriminate asymptomatic patients from those symptomatic  and within this group, identify those patients at a higher risk for developing severe allergic reactions.Pastorello et al.  have ideInterestingly, we found a value of sIgE to Pru p 3 higher than 10.2 kUA/L  that was present in 70 % of the patients with severe systemic reactions from South Italy. In the North-East group, with the same value of sIgE to Pru p 3, we have a higher specificity but a lower sensitivity. However, we cannot exclude that these results are probably affected by a bias due to the low numbers of patients with severe allergic reactions included in this population.Although it has been shown that panallergens differ according to the geographical areas –6, up toThe different clinical manifestations present in the two Italian populations could be attributed not only to the existence of different co-sensitization to the panallergens but also to the levels of sIgE to Pru p 3. Therefore, lower levels of sIgE to Pru p 3 and the co-existence of positivity to Pru p1 and/or Pru p 4 could explain the minor frequency of severe reactions in the North-East patients with respect to the South patients, monosensitized and with higher level of sIgE to Pru p 3. On a speculative level, this fact supports the hypothesis that patients positive to Pru p 3 and simultaneously positive to Pru p 1 and/or Pru p 4, have a sort of ‘protective’ effect against the development of severe symptoms induced by Pru p 3 .Our results show that the level of an anaphylactic biomarker like sIgE to Pru p 3, indicates the possibility of development a severe food allergic reaction. In addition, Pru p 3 positive patients from different geographical areas and with different co-sensitizations could have a different risk assessment in peach allergy.This study could be a model to extrapolate to other geographical areas with different co-sensitizations to identify probably high risk group in food allergy.Further studies, including multicentre studies are necessary to confirm and expand these results.


There is a need for tools addressing gender inequality in the everyday clinical work in health care. The aim of our paper was to develop a tool for increasing the awareness of gendered and intersectional processes in clinical assessment of patients, based on a study of pain rehabilitation.In the overarching project named “Equal care in rehabilitation” we used multiple methods  in five sub studies. With a novel approach we used Grounded Theory in order to synthesize the results from our sub studies, in order to develop the gender equality tool. The gender equality tool described and developed in this article is thus based on results from sub studies about the processes of assessment and selection of patients in pain rehabilitation. Inspired by some questions in earlier tools, we posed open ended questions and inductively searched for findings and concepts relating to gendered and social selection processes in pain rehabilitation, in each of our sub studies. Through this process, the actual gender equality tool was developed as 15 questions about the process of assessing and selecting patients to pain rehabilitation. As a more comprehensive way of understanding the tool, we performed a final step of the GT analyses. Here we synthesized the results of the tool into a comprehensive model with two dimensions in relation to several possible discrimination axes.The process of assessing and selecting patients was visualized as a funnel, a top down process governed by gendered attitudes, rules and structures. We found that the clinicians judged inner and outer characteristics and status of patients in a gendered and intersectional way in the process of clinical decision-making which thus can be regarded as  biased with regard to gender, socio-economic status, ethnicity and age.The clinical implications of our tool are that the tool can be included in the systematic routine of clinical assessment of patients for both awareness raising and as a base for avoiding gender bias in clinical decision-making. The tool could also be used in team education for health professionals as an instrument for critical reflection on gender bias.Thus, tools for clinical assessment can be developed from empirical studies in various clinical settings. However, such a micro-level approach must be understood from a broader societal perspective including gender relations on both the macro- and the meso-level. Women’s subordinated position in society including in health care has received increasing attention around the world and has highlighted the need to emphasize gender equity and gender equality in health care , 2. As aThe terms gender equality and gender equity have different meanings but are sometimes used interchangeable. In this paper we use gender equality to define the absence of discrimination between women and men . On the There are a large number of studies indicating that there is gender bias, i.e. an unintended and systematic neglect of one gender, in health care –13. WomeThere is a lack of scientific publications about strategies to combat gender and social bias in health care. Many tools have been developed in order to analyze gender equality in health policies on the macro-level . The tooA WHO report has reviewed 17 widely used gender tools and their usefulness in gender analyzes in health . The repThus, there is a need for developing tools which address gender and social inequality in the everyday clinical work in health care. One clinical study in the field is the so-called “laundry bag project” which discovered gendered standards for dermatological treatment of common diagnoses. The study showed that among patients referred to a dermatological clinic with diagnoses of psoriasis or eczema  men receOur paper takes its point of departure in such detailed investigation in own sub studies which synthesize the results of our overarching research-project “Equal care in pain rehabilitation” about gendered and social processes in the case of pain rehabilitation. The aim of our paper was to develop a tool for increasing the awareness of gendered and intersectional processes in clinical assessment of patients, based on the case of pain rehabilitation.The tool is aimed at professionals of pain rehabilitation in both primary and specialist care for avoidance of gender bias in their assessment and selection of which patients with chronic pain that should be referred to multimodal rehabilitation programmes.We designed a research project “Equal care in pain rehabilitation” aiming at developing a tool for critically scrutinizing and increasing awareness about gender equality, which could be used by professionals in daily health care. In the overarching project we used multiple methods  includinWritten and signed informed consent was obtained from all participants of the sub studies. The whole project was approved by the Regional Ethics Vetting Board in Umeå, Sweden.The study was conducted at the Pain Rehabilitation Clinic at Umeå University Hospital as well as at a Primary Health Center in Umeå, Sweden. Patients with chronic pain were referred from primary health care to the Pain Rehabilitation Clinic. Individual plans for rehabilitation were based on two days assessment of the patients by interdisciplinary teams  and information about the patient from self-administered questionnaires. Individuals who were recommended multidisciplinary rehabilitation were offered enrolment in a 4-week inpatient multidisciplinary pain rehabilitation programme at the Pain Rehabilitation Clinic. The program focused on pain management and education about pain and its consequences. Almost everyone, who was selected to the rehabilitation programs, participated . Patienti) disabling, non-malignant, chronic and complex musculoskeletal pain (on sick leave or experiencing major interference in daily life due to chronic pain); (ii) age 18–65 years; (iii) no further medical investigations needed; (iv) written consent to participate in and attend the multidisciplinary programme; (v) agreement not to have parallel contacts with therapists such as physiotherapists while attending the multidisciplinary pain rehabilitation programme.Inclusion criteria for referral to the multidisciplinary rehabilitation programme were  referred mainly from primary health care centers to the Pain Rehabilitation Clinic and assessed between 5 November 2007 and 13 December 2010.The population of the qualitative analyzes consisted of patients referred to the Pain Rehabilitation Clinic. A strategic selection (n = 10) was made in relation to gender, age and country of birth. A purposeful sampling was also performed, consisting of health care professionals at the Pain Rehabilitation Clinic (n = 7) as well as general practitioners and their trainees working at one primary health care center in Umeå (n = 8).For the quantitative analyzes, patient data were collected from the Swedish Quality Registry for Pain Rehabilitation  and linkFor the qualitative analyzes, individual semi-structured interviews were performed with patients as well as with health care professionals at the Pain Rehabilitation Clinic. A focus-group discussion was performed with general practitioners with focus on experiences of possible in/equalities in health care.The co-authors worked together during the whole project period with various responsibilities for the sub studies. For this paper all authors contributed from their various disciplinary, theoretical and methodological backgrounds in a step-wise process throughout the time of the project.To develop our gender equality tool we took inspiration from earlier tools, especially the following questions from the Victorian lens :How will women and men from diverse backgrounds be meaningfully consulted about the issue?Are there particular cultural protocols to consider?Are under-represented groups being considered?What are the ‘non-negotiables’ for consultation?How will expectations and conflicting interests be managed?Are under-represented groups being considered? was posed and we found the importance of education in one quantitative )Our tool could also be discussed within a gender theoretical framework. Our social constructivist perspective on gender and health is based on the belief that we live in historical, social and cultural contexts that influence the way we write, think and talk about gender and health , 43. ThuFor example, the laundry bag project shows how personnel within healthcare continuously reconstruct what is seen as masculine or feminine in society through treating men and women differently . This isOur results can be seen as constructions of various masculinities and femininities in process of clinical assessment of patients in pain rehabilitation. In this process, gendered attitudes and judgements take place. Our gender theoretical approach goes beyond a dichotomous view on gender as we bring in other power dimensions, such as social class and ethnicity in their interaction with gender. The various axes of power do not necessarily act in unison—but operate in complex ways–upon health. One category, such as ‘class’, takes its meaning from another, such as ‘gender’, and a ‘new uniquely hybrid creation’ emerges at the intersection which becomes the unit of analysis .The strength of our paper is the width and depth of our study–both in relation to data , methods  and contents (the whole chain of rehabilitation). Our approach is a novel way of synthesizing the findings from empirical studies in the field into a clinically relevant tool. Triangulation between researchers, from perspectives of physiotherapy , rehabilitation medicine (BMS), and general practice  was used to increase the credibility in the data analysis . The emeA methodological challenge was the lack of established methods for synthesis of earlier findings. With only quantitative papers we could have performed a meta-analysis and with only qualitative papers we could have done a meta-synthesis. However, we wanted to use all our data and therefore chose GT to support the step-wise analytical process of synthesizing and abstracting empirical findings from different sources. GT also proved to be suitable as it has the potential to capture and theorize social processes .In the overarching project we used multiple methods as we had both quantitative and qualitative approaches attached to an overall inductively derived aim . In contThe empirical data of our sub studies were collected from one region in Sweden. During the three-year inclusion period of patients for the quantitative studies, the procedures for multidisciplinary team assessments did not change, thus enhancing the reliability of the data. In addition the team assessment was performed by experienced professionals with high staff continuity during the data collection period. Further, patient data were collected from a national register for pain rehabilitation which includes approximately 80% of pain management programs in Sweden . The proThe prevalence of pain is systematically higher among women than in men  and as aDespite a relatively small sample of interviews, we believe that the results of our qualitative study about staff experiences reflect crucial aspects of perceived inequalities, which can be further deepened and discussed in relation to other rehabilitation contexts in future studies.The main clinical implication of our study is that our tool can be included in the systematic routine work of clinical assessment of patients as well as in decisions about criteria for inclusion and exclusion to rehabilitation programmes. The tool questions to the workplace could be asked in the systematic evaluation of the work environment, which for example according to Swedish law must be performed regularly at work places. These evaluations include surveys of the work place activities, such as consultations of patients, with the aim of providing gender equal care. The tool questions to professionals could be asked for each patient by both those who make the clinical assessment and those who treat the patients. The tool could also be used in team education for health professionals as an instrument for reflection of gender bias.Gender equality tools for clinical assessment can be developed from empirical studies in various clinical settings. Such a micro-level approach must be understood from a broader societal perspective including gender relations on both the macro- and the meso-level.


Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient  may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the ‘Trialist’ mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain.A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome  is pain-related interference with daily functioning at 26 weeks.Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach.NCT02116621, first registered 15 April 2014.ClinicalTrials.gov: The online version of this article (doi:10.1186/s13063-015-0590-8) contains supplementary material, which is available to authorized users. Chronic pain is highly prevalent  costly , and cliDrug therapy is a mainstay of chronic pain management in primary care. Current drug treatment strategies for chronic painful conditions convey a mix of benefits and hazards. In usual practice, clinicians often begin with acetaminophen or a non-steroidal anti-inflammatory drug (NSAID), prescribing opioids when pain is severe or unresponsive ,8. When N-of-1 trials are single-subject crossover experiments  in whichN-of-1 trials are the most direct way to estimate individual treatment effects . HoweverN-of-1 trials have the potential to expand patient involvement and promote more personalized, patient-centered health care. From the population perspective, if mHealth-based n-of-1 trials can help patients and clinicians achieve therapeutic success faster and with greater confidence, patients may require fewer subsequent office visits, tests, emergency room visits, and after-hours telephone support, thus lessening the burden on health systems and saving money.The goal of the PREEMPT  study is to make n-of-1 trials easier to accomplish, to provide patients and clinicians with tools for individualizing treatments for chronic pain, and to evaluate this approach in terms of patient outcomes. A smartphone app called the ‘Trialist’ has been developed in collaboration with Open mHealth, a non-profit mobile health developer. The feasibility and efficacy of the ‘Trialist’ smartphone app is being assessed in a RCT to compare the effects of participating in a mobile n-of-1 trial versus usual care on patient outcomes including pain-related interference with daily functioning, pain intensity, participatory decision-making, medication adherence, and general health-related quality of life. Achieving these aims will set the stage for broader uptake of mHealth n-of-1 trials in chronic pain as well as other chronic health conditions.PREEMPT is a RCT with a planned total of 244 participants randomized to the Trialist app intervention or a usual care control group.The study is located in Northern California with recruitment occurring within the University of California, Davis (UC Davis) Primary Care Network, UC Davis Family Medicine Clinic, UC Davis General Internal Medicine Clinic, and the Veterans Affairs Northern California Health Care System (VANCHS). These networks are located within the greater metropolitan areas of Sacramento and Yolo counties.The primary study hypothesis is that, compared to usual care, patients randomized to the Trialist will experience less pain interference  at 26 weeks follow-up. Secondary hypotheses are: compared to usual care, patients randomized to the Trialist will experience less pain interference, less pain intensity, better general health-related quality of life, improved participatory decision-making, greater satisfaction with pain treatment, better adherence to prescribed therapy, and a better patient experience with care, each measured as longitudinal change from baseline up to 52-weeks follow-up.Study participants include patients as well as their regular treating clinicians. Clinicians are recruited first, and must have completed residencies in internal medicine, family medicine, or pain medicine or be practicing nurse practitioners or physician assistants. Patients, recruited from the practices of consenting clinicians, are required to meet the following criteria: English speaking adults between 18 and 75 years old who have experienced ongoing musculoskeletal pain for 6 weeks or longer; own an eligible iOS or Android smartphone or tablet; have a pain score of 4 or higher  on at least 1 of 3 items from the PEG pain scale ,31; and Clinicians are recruited via flyers, Emails, letters and presentations. Once clinicians indicate interest, informed consent is obtained detailing their responsibilities and soliciting their consent to have their patients recruited into the study. Clinicians receive a $100 gift card for each patient who is enrolled and guided through the study.Two methods are used for patient recruitment. First, clinicians can ask patients directly if they are interested in the study. Clinicians provide interested patients with a study flyer that provides research staff contact information. Second, patients of enrolled clinicians who have been seen within the past 2 to 12 months for a chronic painful condition  codes) are sent an informational letter informing them about the study and inviting them to contact research staff if interested in learning more. Both patient recruitment methods rely on patients initiating contact with PREEMPT study research staff.  authorization form. Informed consent will be obtained from all participants included in this study.Patients are randomized to Trialist versus usual care. Randomization is stratified by clinician; each clinician’s patients are randomized in blocks of size 4 (90% of blocks) or 6 (10% of blocks) in order to balance the numbers of participants per clinician and to minimize selection bias. Patients assigned to usual care will receive the usual course of care as prescribed by their clinician. The allocation sequence are generated by the study statisticians (CS and JS) and provided to the study coordinator (MM) in a format that allows for clinician block size to be masked until the study is completed and for patient randomization allocation to be masked until completion of the enrollment procedures.The enrollment interview is conducted by research staff and occurs just prior to the patient’s outpatient appointment in the clinic waiting room. If the signed consent form and HIPAA authorization form  have not been received prior to the enrollment interview, these documents are obtained first for each patient. Then the patient’s randomization assignment to either the Trialist app or usual care is revealed, and the patient completes a baseline questionnaire. At this visit, all patients receive a pain self-management booklet .Patients assigned to the intervention arm undergo a ‘Treatment Planning Visit’ with their clinician during a regularly scheduled appointment to design the patient’s n-of-1 trial. Clinicians and patients use the desktop interface of the Trialist together to select two treatment regimens for comparison. The customized option allows patients and clinicians to select from among acetaminophen; any NSAID ; an opioid combination product containing codeine, hydrocodone or oxycodone; tramadol; or complementary/alternative treatments such as massage, meditation or physical exercise. The participating provider’s clinical judgment and discussion with the patient determines which specific regimens to compare. Treatment regimens for comparison can be single agents  or combinations . Thus, the design of n-of-1 trials may range from simple  to complex (low-dose acetaminophen/hydrocodone plus music therapy versus naproxen plus tramadol). If a clinician attempts to select combinations that are clinically inappropriate , the Trialist will disallow that selection. The desktop interface also provides links to current prescribing standards and recommendations for the available drug treatment options. . Research staff also provide patients with ongoing technical support.After an n-of-1 trial is set up, patients are provided login credentials for the Trialist smartphone app. The app is available free on Google Play and Apple’s App Store. Research staff provide patients with information on how to use the Trialist app, including a help guide and an online video tutorial . Example daily questions include: ‘What number best describes your pain on average during the past 24 hours?’ on a 0 to 10 scale; ‘I felt fatigued during the past 24 hours’ on a 5-point scale from ‘not at all’ to ‘very much’; and ‘How often did you feel drowsy or sleepy today?’ on a 6-point response scale from ‘not at all’ to ‘very much’. The raw data are not included in the patient’s medical record, and are not available to other applications outside of the Trialist infrastructure. Patients receive notifications on their device to change treatments after 7 or 14 days and to complete daily and weekly questionnaires, and they also receive motivational messages keying off their progress in the trial. Patients can also view a graph of their own data to date, which displays scores from the questionnaires in chronological order . Study patients receive up to $50  for completing all the questionnaires.www.nihpromis.org.Pain interference is assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) adult Short Form v1.0 - Pain Interference 8a. The scale includes 8 items answered on a 5-point response scale . Questions include: ‘How much did pain interfere with your day-to-day activities?’ and ‘How much did pain interfere with your family life?’ Further information on the PROMIS scales and measures are available from Pain intensity is assessed using the PROMIS adult scale v1.0 - Pain Intensity 3a. The scale includes 3 items on a 5-point response scale from ‘no pain’ to ‘very severe’. Questions include: ‘In the past 7 days, how intense was your pain at its worst?’ ‘In the past 7 days, how intense was your average pain?’ and ‘What is your level of pain right now?’et al. [et al. [Self-reported adherence to pain treatment is assessed using the four-item Analgesic Adherence Scale developed to assess general medication adherence. The scale was developed by Rosser et al. , who rep [et al. . The scaFour items drawn from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Patient-Centered Medical Home Survey assessing shared decision-making are included. The scale includes 2 items on a 4-point response scale , and 2 ‘yes/no’ questions. Questions include: ‘In the last 12 months, did you and this provider talk about starting or stopping a prescription medicine?’ and ‘When you talked about starting or stopping a prescription medicine, how much did this provider talk about the reasons you might want to take a medicine?’ -37.et al. [Satisfaction with pain treatment is assessed using 22 items from the 61-item Pain Treatment Satisfaction Scale developed by Evans et al. . Questioet al. [The patient-provider relationship is assessed using an adapted version of the 11-item Trust in Physician Scale developed by Thom et al. , where tGeneral HRQL is assessed using the 10-item PROMIS global health scale v.1.0/1.1 . The scaDemographic data will be gathered on age, gender, marital status, race, ethnicity, employment and educational attainment. All demographic questions will be asked at baseline; marital status will be also re-assessed at 26 weeks, and employment status will be assessed at 13-, 26- and 52 weeks.Smartphone usage will be assessed at baseline using a six-item scale to determine familiarity and frequency with smartphones and apps. Questions include: ‘How long have you been using a smartphone?’ , and ‘Do you have any health-related Apps on your smartphone?’ . Two questions are adapted from the smartphone and medical related app use questionnaire created by Payne .Patient and clinician relationship length is assessed using 2 questions (items 3 and 4) from the 34-item CAHPS 12-month Clinician & Group Visit Survey. The questions assess how long the patient has been going to the provider and the number of visits to the provider in the last 12 months .Participants randomized to the Trialist app intervention group complete a Patient Expectations and Patient Experiences Questionnaire administered at the Treatment Planning Visit  and at the Result Review Visit . The purpose of this questionnaire is to evaluate intervention patient expectations and experiences with treatment and the extent to which patient expectations were met. Questions are asked on a five-point response scale.Intervention patients also complete the Trialist Acceptability and Satisfaction Questionnaire to provide feedback on the use of the Trialist app. The survey is sent to participants after the n-of-1 trial is completed. Questions contained in the survey are based upon adaptations of the System Usability Scale , and theAt baseline, clinicians answer a 19-item questionnaire on their clinical specialty, clinical practice workload, clinical trial experience, smartphone usage and demographic characteristics. Questions include: ‘What is the average number of patients you see during a typical half-day of practice?’ and ‘During your training, residency or fellowship, how much clinical research experience did you have?’t-test with a 0.05 2-sided significance level. Approximately 50 to 60 clinicians will be enrolled with each clinician being asked to enroll four to eight patients each. This reduces the burden required on any one clinician by ensuring that the maximum number of intervention patients for each clinician is two to four.The sample size required for the proposed RCT is based on the primary outcome: change from baseline to 26 weeks on the PROMIS pain interference scale. Assuming that the minimally important difference is 0.4 SD difference (4 points) and that 10% of those who enter the study will not complete an endpoint and will therefore be assigned a change of 0, the full sample (endpoint completers plus non-completers) would need to show a 3.6-point difference in order for the completers to show a minimally important difference. Assuming a common standard deviation of 10 points, each group  would need to include 122 patients  in order to have 80% power to detect a 3.6-point difference in means using a 2-group t-test for continuous outcomes and chi-square test for binary outcomes. Longitudinal outcomes will use mixed models with a fixed effect of treatment and a random effect of time and a random time by treatment interaction using the appropriate generalized linear model link function and distribution . Additional exploratory analyses will examine: potential interactions of treatment with covariates such as age, gender, type of intervention, dosage, time on treatment, physician and clinic.The primary analysis will be intent-to-treat which uses all participants as randomized. Outcomes will be analyzed both as changes from baseline to a single time point and as longitudinal evolutions in time. Changes at a single point  between the groups will be compared by a When no endpoint is available , we will use different approaches. In one, we will assume that no change has occurred and impute a change of zero. This will permit simple conservative assessments of single time point analyses. Longitudinal models can accommodate missing outcomes by ignoring them under the assumption that data are missing at random. We will also use multiple imputation to permit comprehensive analyses with missing covariates and interactions.As noted earlier, patients assigned to the Trialist are prompted to enter data on a daily basis. At the end of each person’s n-of-1 trial, statistical analysis is performed in order to compare results on the two treatments. Each n-of-1 trial requires a separate analysis and the analysis is automated to run in the background once each n-of-1 trial is completed. The analysis consists of running different Bayesian models that make different assumptions about the nature of the data . The results of these models are automatically compared as to which best fits the data, and the simplest model that accurately fits the data is chosen. The goal of the model checking is to assure that the model that can provide the most accurate and precise treatment effect is chosen. Automated model choice is checked manually by the study statisticians for all initial n-of-1 trials and then periodically thereafter to ensure that reasonable models are being selected. Robust models are preferred. Patients and clinicians are provided with an estimate of the treatment difference, represented as the estimated percentage that one treatment is superior to the other and a measure of its uncertainty  as well as the probability that each treatment is the best for each outcome. Results are portrayed numerically and graphically  survey or pen-and-paper. Data will be entered into RedCap databases . All datEthical approval was obtained from Institutional Review Boards at the University of California, Davis (496804) and the VANCHS (13-12-00717).The Trialist app allows chronic pain patients and their clinicians to jointly set up and conduct personalized n-of-1 trials. Patients with chronic pain are at risk for both over-treatment and under-treatment. Thus the need for new approaches to chronic pain management is urgent, not least because of accumulating evidence that traditional approaches such as trial-and-error are often ineffective , prescriFor patients who are uncertain about which of two therapies to choose, or who have concerns about the relative benefits or about the side effects of various treatment options, or who have been on a treatment for a long time and simply do not know whether that treatment is working, n-of-1 trials can support more confident decision-making. N-of-1 trials encourage greater patient involvement with care, which has been associated with better health outcomes . One reaN-of-1 trials have not gained traction in the research community, and one issue has been the difficulty of bringing n-of-1 trials to scale. The integration of smartphones and mHealth technology offers a possible solution, facilitating patient participation in n-of-1 trials and in turn, realizing benefit from increased therapeutic precision. With mHealth n-of-1 trials, clinical practice incorporates elements of research by bringing rigorous research design, outcomes assessment, and statistical analysis to the clinic. A successful demonstration of mHealth n-of-1 trials could pave the way for broader use of n-of-1 trials in chronic pain management and other chronic conditions.At the time of manuscript submission 43 clinicians and 64 patients have been enrolled, and 23 patients have been randomized.


Nutrition risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) are widely used screening tools but have not been compared in a Chinese population. We conducted secondary data analysis of a cross-sectional study which included 332 hospitalized gastrointestinal disease patients, collected by the Gastrointestinal department of Peking Union Medical College Hospital (PUMCH) in 2008. Results of NRS-2002 and SGA screening tools, complications, length of stay (LOS), cost, and death were measured. The agreement between the tools was assessed via Kappa (κ) statistics. The performance of NRS-2002 and SGA in predicting LOS and cost was assessed via linear regression. The complications and death prediction of tools was assessed using receiver operating characteristic (ROC) curves. NRS-2002 and SGA identified nutrition risk at 59.0% and 45.2% respectively. Moderate agreement (κ >0.50) between the two tools was found among all age groups except individuals aged ≤ 20, which only slight agreement was found (κ = 0.087). NRS-2002 (R square 0.130) and SGA (R square 0.140) did not perform differently in LOS prediction. The cost prediction of NRS-2002 (R square 0.198) and SGA (R square 0.190) were not significantly different. There was no difference between NRS-2002 (infectious complications: area under ROC (AUROC) = 0.615, death: AUROC = 0.810) and SGA  in predicting infectious complication and death, but NRS-2002 (0.738) seemed to perform better than SGA (0.552) in predicting non-infectious complications. The risk of malnutrition among patients was high. NRS-2002 and SGA have similar capacity to predict LOS, cost, infectious complications and death, but NRS-2002 performed better in predicting non-infectious complications. Malnutrition occurs when energy imbalance either results from overnutrition or undernutrition. Undernutrition results from nutrients and energy deficiencies due to decreased intake or increased demand. Undernutrition is a common problem in hospitals and other health care centers, with prevalence ranging from 10% to 60% among patients . In gastNRS-2002 and SGA are two screening tools in wide spread use. They assess a patient’s risk of malnutrition depending upon weight and dietary changes, current disease state, and physical examination . NRS-2002, introduced by the European Society for Parenteral and Enteral Nutrition (ESPEN), has been applied and reported among Chinese patients . SGA appThe purpose of this study is to assess prevalence of nutrition risk determined by NRS-2002 and SGA among patients in a Chinese gastrointestinal ward, and then compare the agreement between these two screening tools. Additionally, this study examines the clinical outcome predicting capacity of NRS-2002 and SGA for the outcomes of cost, LOS, complication, and death. Findings could benefit health care providers to choose the most appropriate screening tool for gastrointestinal inpatients.The clinical investigation was carried out in the gastrointestinal ward. The original data were collected by clinical dietitians in Peking Union Medical College Hospital (PUMCH), a referral and teaching hospital including more than 2000 beds.Patients were included in the study if they met the following criteria: 1) gastroenterology patients aged between 18 and 90 years old; 2) scheduled to stay at least one night in hospital; 3) no surgery planned before 8 a.m. on the following day; 4) voluntary participation; 5) capable to communicate for interviewing. Patients with less than one day LOS and surgery planned for the following day were excluded due to the limited time for screening. Patients who were sent to the intensive care unit directly or had a critical illness were not included in the study because the patients could not be interviewed for nutrition screening. Women who were pregnant, provided breast feeding, or had given birth within the past six months were also excluded.In 2008, 334 participants admitted to the GI department met the inclusion criteria and were included in the study (350 patients were invited to participate). Two subjects were excluded from data analysis due to missing data. For convenience, age groups were broken down into cohorts of 15 years starting from the age of 20, i.e. ≤20, 21–35, 36–50, 51–65, 66–80, and ≥81 year old groups.Nutrition risk screening was performed within 24 hours of admission using both NRS-2002 and SGA conducted by the same dietitian. Simultaneously, anthropometric parameters , age, and the diagnosis were recorded for each patient. After screening, participants with malnutrition or at risk of malnutrition determined by either NRS-2002 or SGA were referred to clinical dietitians for further nutritional care using the NCP.NRS-2002 classifies patients as at risk of malnutrition on a scale of 1–6. SGA classifies patients as nourished (A), mildly and moderately malnourished (B), or severely malnourished (C) relying on the evaluation about weight and dietary changes, gastrointestinal symptoms and functional problems. Patients were classified as at nutrition risk with a score of 3 or above by the NRS-2002 and with a score of B  or C  by SGA.LOS, incidence of complications, cost, and death were selected as indicators of clinical outcomes because they are influenced by nutrition status, and reflect the effectiveness and efficiency of medical and nutritional intervention . InfectiThe prevalence of nutrition risk detected by NRS-2002 and SGA was calculated for the total patient population and for categorized age groups. Cohen’s kappa (κ) was run to assess the chance-corrected agreement between NRS-2002 and SGA for classifying nutrition risk with 95% confidence intervals (CI). The results were interpreted as follows: <0, no agreement; 0 to 0.19, poor agreement; 0.20 to 0.39, fair agreement; 0.40 to 0.59, moderate agreement; 0.60 to 0.79, substantial agreement; and 0.80 to 1.00, almost perfect agreement .Linear regression was used to assess the performance of NRS-2002 and SGA in predicting LOS and cost. NRS-2002 and SGA were included in the regressions as a linear variable. Five patients who died during hospitalization were excluded from LOS analysis, so LOS was assessed for 327 subjects. LOS and cost were not normally distributed, so the outcomes were log-transformed. Due to a limited number of subjects aged ≤20 and ≥81, age was categorized as four groups: ≤35, 36–50, 51–65, ≥ 66. Age was regarded as a categorical variable because the relationship between age and the outcomes was assumed to be nonlinear. Gender and presence of infectious and non-infectious complications were included as covariates. To determine differences in the predicting capacity of NRS-2002 or SGA for different age groups, a global f-test was used to compare a full model for LOS and cost with a saturated model including the interaction between NRS-2002/ SGA and categorized age. This test compares the log likelihood of the full model (no interaction between screening tool and age) to the log likelihood of the saturated model (interaction between screening tool and age. The accuracy of NRS-2002 and SGA was compared through R-square for each model.Receiver operating characteristic (ROC) curves ,13 were P≤0.05. Adjustment was not made for the number of hypothesis tests, which could potentially inflate the probability of type 1 error. Data was analyzed by the statistical package IBM SPSS Statistics  version 20 for Windows. The Peking University Medical College Hospital Institutional Review Board approved the study protocol in 2008 (Registration No. S-203), and all participants were provided written informed consent. The present secondary data analysis was deemed exempt by the Institutional Review Board of Syracuse University in 2013 (IRB# 13–283). Data are available in For all analyses, statistical significance was set at A total of 332 patients  were analyzed in the study. Of these patients, 141 (42.5%) were female and 191 (57.5%) were male. Ages ranged from 18 to 86 years old. The mean age was 53 years (SD 18 years), and median age was 47 years. Among patients, 14 subjects were aged ≤ 20, 54 subjects were aged 21–35, 68 subjects were aged 36–50, 94 subjects were aged 51–65, 90 subjects were aged 66–80, and 12 subjects were aged ≥ 80 years.Five patients died (1.5%) during the hospitalization and were removed from the LOS analysis, resulting in 327 patients. The mean LOS from admission to discharge was 23.6 days (SD 19.4 days). The mean cost of hospitalization was 25,106.00 CNY  . Detailed clinical outcome data for different age groups are shown in The prevalence of nutrition risk among all subjects was 59.0% according to NRS-2002, and 45.2% relying on SGA. Among the different age groups upon admission, the highest prevalence of nutrition risk was in the ≥ 81 years group detected either by NRS-2002 or SGA, and the lowest prevalence of nutrition risk was in 51–65 years group .There was moderate agreement between the two screening tools, κ = 0.514 , p<0.0005. When stratifying by age, moderate agreement was observed for all age groups with the exception of individuals aged ≤20 .A one-step increase in malnutrition risk as measured through NRS-2002 or SGA was associated with an increase of 12.7% or 29.6%, respectively in hospitalization cost after adjusting for age and sex of the patient . There wThe results of the area under ROC curve analysis showed that the complication and death predicting capacity of NRS-2002 and SGA was generally better than random guessing , Table 5We conducted a secondary data analysis of nutrition risk as measured through NRS-2002 and SGA as well as the association between the measurements and clinical outcomes, such as LOS, cost, complications and death in a sample of gastrointestinal inpatients at PUMCH. Nutrition risk among patients was high, measured at 59.0% by NRS-2002 and 45.2% by SGA, which was consistent with other studies, but in the upper level of the nutrition risk ranges of 10–60% –19. A poA higher prevalence of nutrition risk was observed in elder patients (>66 years), which was in agreement with previous studies –23. Age The nutrition risk prevalence detected by NRS-2002 was higher than that detected by SGA for all age groups. SGA focuses more on chronic or established nutrition risk rather than acute nutritional changes compared to NRS-2002, which may explain the discrepancy. For example, the changes of subcutaneous fat and muscles upon physical examination of SGA are long term results of malnutrition, hence acute cases of nutrition risk may not be recognized by SGA .In contradiction to some misgivings about the difficulties in implementing routine use of SGA , nearly et al. [et al. [Moderate agreement was observed between NRS-2002 and SGA for the total population , which was similar to results of previous studies conducted by Kyle et al.  and Vela [et al.  with κ sThe objective of nutrition screening is to accurately identify patients who have higher risk of malnutrition and who could benefit from nutrition therapy. In this study, positive relationships were observed among nutrition risk and clinical outcomes. Patients with higher nutrition risk were more likely to experience more infectious and non-infectious complications, longer LOS, higher cost, and higher mortality. There was no significant interaction between age and NRS-2002 and SGA, suggesting that NRS-2002 or SGA did not perform much differently according to ages. However, the R-square of each model was small, so it was possible the relationship between NRS-2002 or SGA and clinical outcomes was non-linear. The relationships between nutritional status, LOS, and cost are not necessarily causal; rather LOS and cost might be a reflection of the severity of the underlying diseases, economic and even educational status of the patients and their families. In this analysis disease severity was not explicitly included, which may have explained the relatively poor explanatory power of the regression models. The NRS-2002 indirectly includes a measure of disease severity which is one of the parameters used to determine nutrition risk. The explicit inclusion of disease severity greatly complicates modeling approaches with many independent variables all at great risk of colinearity and requiring much larger sample sizes. Some researchers have taken the severity of disease into account, by classifying disease into different levels , or justThe linear regression measuring the association among screening tools and LOS and cost showed that there were not large differences in the predictive capacity of the models with NRS-2002 or SGA for either LOS or cost. Even though compared to NRS-2002, a one-step increase in SGA was associated with a relatively larger increase in cost, the difference was due to having fewer categories in the SGA classification compared to the NRS-2002 classification.The area under ROC revealed that both NRS-2002 and SGA had generally good predictive capacity for complications (>0.500), especially for death (>0.800). The two screening tools did not perform differently for predicting infectious complications and death, but NRS-2002 was more accurate than SGA to predict non-infectious complications.et al. [It is worth noting that NRS-2002 had identified a higher portion of patients with nutrition risk compared to SGA (59.0%:45.2%), and NRS-2002 was also more efficient than SGA in predicting non-infectious complication. Previous studies conducted by Raslan et al.  and Kyleet al.  indicateThis study is one of the few studies to include hospitalized adult patients with a variety of conditions that were treated both non-surgically and surgically. To our knowledge, this is the first study to evaluate the application of SGA among Chinese hospitalized patients. All the data was collected by clinical dietitians trained in PUMCH.Selection bias in this study might lead to an underestimate of the prevalence of nutrition risk among patients in gastrointestinal department of PUMCH. Patients with critical illness, or those who were incommunicable were excluded from the present study because there was limited opportunity for interviewing. Critically ill patients might not experience the symptoms of malnutrition at the moment of assessment, but could be at a high risk of malnourishment because of the increased energy and nutrient requirements of the diseases. As a result, the high prevalence of nutrition risk demonstrated the need for including nutrition screening as a part of the admission process in Chinese hospitals, particularly among GI disease patients.There are many factors associated with the prevalence of nutrition risk, such as social segregation, psychological factors, economic status, and lack of medical awareness ,18, whicBecause of the influences of inflammation on nutrition risk and the response to nutrition intervention and clinical outcomes –30, the The prevalence of risk of malnutrition was found to be high in gastrointestinal patients, which demonstrated the importance of including nutrition risk screening as admission evaluation.Both NRS-2002 and SGA worked well among GI patients, and they did not perform differently for patients of different ages. There was a significant association between risk of malnutrition and clinical outcomes, but the relationship should be further explored, since many other factors including social factors, severity of diseases and nutrition intervention, influence the clinical outcomes. There was no significant difference of LOS, cost, infectious complications and death predicting capacity of NRS-2002 and SGA, however NRS-2002 performed better in predicting non-infectious complications.S1 Dataset(XLS)Click here for additional data file.