REDCap on FHIR: Clinical Data Interoperability Services.

BACKGROUND: Despite widespread use of electronic data capture (EDC) systems for research and electronic health records (EHR), most transfer of data between EHR and EDC systems is manual and error prone. Increased adoption of Health Level Seven Fast Healthcare Interoperability Resource (FHIR) application programming interfaces (APIs) in recent years by EHR systems has increased the availability of patient data for external applications such as REDCap. OBJECTIVE: Describe the development of the REDCap Clinical Data Interoperability Services (CDIS) module that provides seamless data exchange between the REDCap research EDC and any EHR system with a FHIR API. CDIS enables end users to independently set up their data collection projects, map EHR data to fields, and adjudicate data transfer without project-by-project involvement from Health Information Technology staff. METHODS: We identified two use cases for EHR data transfer into REDCap. Clinical Data Pull (CDP) automatically pulls EHR data into user-defined REDCap fields and replaces the workflow of having to transcribe or copy and paste data from the EHR. Clinical Data Mart (CDM) collects all specified data for a patient over a given time period and replaces the process of importing EHR data for registries from research databases. With an iterative process, we designed our access control, authentication, variable selection, and mapping interfaces in such a way that end users could easily set up and use CDIS. RESULTS: Since its release, the REDCap CDIS has been used to pull over 19.5 million data points for 82 projects at Vanderbilt University Medical Center. Software and documentation are available through the REDCap Consortium. CONCLUSIONS: The new REDCap Clinical Data and Interoperability Services (CDIS) module leverages the FHIR standard to enable real-time and direct data extraction from the EHR. Researchers can self-service the mapping and adjudication of EHR data into REDCap. The uptake of CDIS at VUMC and other REDCap consortium sites is improving the accuracy and efficiency of EHR data collection by reducing the need for manual transcription and flat file uploads.

Radioimmunoguided surgery in colorectal cancer using a genetically engineered anti-CEA single-chain Fv antibody.

In radioimmunoguided surgery (RIGS), a radiolabeled antibody is given i.v. before surgery and a hand-held gamma-detecting probe is used to locate tumor in the operative field. The rapid blood clearance and good tumor penetration of single-chain Fv antibodies (scFv) offer potential advantages over larger antibody molecules used previously for RIGS. A Phase I clinical trial is reported on RIGS with scFv (MFE-23-his) to carcinoembryonic antigen (CEA). Thirty-four patients undergoing surgery for colorectal carcinoma (17 primary tumors, 16 liver metastases, and 1 anastomotic recurrence) and 1 patient with liver metastases of pancreatic carcinoma received 125I-labeled MFE-23-his scFv (125I-MFE-23-his) 24, 48, 72, or 96 h before operation. 125I-MFE-23-his showed biexponential blood clearance with alpha and beta half-lives of 0.32 and 10.95 h, respectively. The abdomen was scanned during surgery with a hand-held gamma detecting probe (Neoprobe Corp.). 125I-MFE-23-his showed good tumor localization; comparison with histology showed overall accuracy of 84%. Highest median ratios for tumor:normal tissue and tumor:blood were recorded 72 or 96 h after scFv injection for patients undergoing resection of liver metastases. High levels of radioactivity were found in the kidneys. Five patients had grade 1 fever, and three had a grade 1 rise in blood pressure according to the Common Toxicity Criteria. There was a significant correlation between these ratios and those measured in excised tissues using a laboratory gamma counter (P < 0.001). MFE-23-his scFv antibody localizes in CEA-producing carcinomas. The short interval between injection and operation, the lack of significant toxicity, and the relatively simple production in bacteria make MFE-23-his scFv suitable for RIGS.

Colostomy or ileostomy after colorectal anastomosis?: a randomised trial.

Sixty one patients were entered in a randomised trial to compare transverse loop colostomy with loop ileostomy after a colorectal anastomosis thought to be at risk of dehiscence. Radiologically proven breakdown of the colorectal anastomosis occurred in 13% of these selected patients and most frequently in the colostomy group. Ileostomies functioned earlier than colostomies (P less than 0.001) but there was no other significant difference in outcome between the groups. In 52 patients intestinal continuity was restored by excision of the stoma within a month of construction with no difference in morbidity between the two groups. A loop ileostomy, closed as soon as the colorectal anastomosis has healed, is recommended as an alternative to transverse colostomy.

Compartment syndrome following pelvic surgery in the lithotomy position.

We report the cases of two patients who developed compartment syndrome following pelvic surgery in the lithotomy position. These cases highlight this important and potentially devastating complication.

Outpatient surgery in a developing country.

233 outpatient operations were performed under general anaesthesia on Nigerian patients whose selection was not influenced by adverse social circumstances. The complication-rate was similar to that found in comparable series from the United Kingdom. The incidence of wound infection was related to the age and social circumstances of the patient and was not affected by the type of hospital in which the operation was performed.

Resection for colorectal cancer in the very old: are the risks too high?

Altogether 277 consecutive patients aged 70 or more who were admitted for resection of colorectal cancer between 1975 and 1985 were studied. The postoperative complications and mortality in the 175 patients aged 70-79 were compared with those in the 102 patients aged 80 or more. The overall mortality was 11%. Mortality was significantly higher after resection in the older age group even when deaths from widespread malignancy were excluded from the analysis. After curative resection mortality was 2% (2/120) in the younger group and 7% (4/60) in the older group, but after palliative resection of tumours with local or distant spread mortality was significantly higher, at 21% (9/44) and 38% (12/32), respectively. An equal but high proportion of patients in both age groups suffered major complications, but complications caused significantly more deaths in the older group. The length of stay in hospital was not significantly different between the age groups. Patients should not be denied resection of a colorectal cancer because of age alone, especially if a curative operation is possible. The increased risk of death from major complications, particularly after palliative resection, should, however, be taken into account when an operation on patients over 80 is being considered.

Trial of maximal anal dilatation, cryotherapy and elastic band ligation as alternatives to haemorrhoidectomy in the treatment of large prolapsing haemorroids.

A selected group of 112 patients with prolapsing haemorrhoids which had failed to respond to injections of phenol in oil or which required manual replacement after defecation, were randomly allocated treatment by haemorrhoidectomy, maximal anal dilation, elastic band ligation or cryotherapy. When results were assessed 5 weeks after treatment, haemorrhoidectomy and maximal anal dilatation were equally effective in reducing symptoms, although more physical signs remained after maximal anal dilatation; cryotherapy and elastic band ligation were less effective in both respects. When patients were followed up between 6 months and 5 years haemorrhoidectomy was found to be the most effective method. Patients in the other three groups developed recurrent symptoms requiring haemorrhoidectomy.

Cell kinetics of mouse kidney using bromodeoxyuridine incorporation and flow cytometry: preparation and staining.

The kidney is recognized as a dose-limiting tissue by certain radiation treatments. The relationship between the onset of compensatory proliferation in response to irradiation and the expression of functional damage is difficult to study because of the low cell turnover in slowly proliferating tissues. We report on a method to obtain a suitable cell preparation from mouse kidney for study by flow cytometry using the recently developed staining techniques for bromodeoxyuridine incorporation. The labelling index of 0.3% in untreated mouse kidney was easily measured because large numbers of cells could be analysed rapidly. We show that compensatory proliferation after unilateral nephrectomy remains elevated for up to 3 weeks after surgery. Using the BrdU/FCM technique we were able to measure the duration of the S phase in normal and nephrectomized kidneys which we found to be 8.5 hr in both cases. The estimates of potential doubling time were similar to the time scale observed to elapse before functional damage is observed in normal kidneys and those in which damage is precipitated by surgery.

Side-to-side stapled anastomosis may delay recurrence in Crohn's disease.

PURPOSE: Perianastomotic recurrence after resection in Crohn's disease may be related to ischemia and subacute obstruction at the anastomosis. A technique designed to minimize these factors currently is being evaluated. METHODS: From 1984 to 1997 69 patients underwent resection and primary anastomosis for symptomatic Crohn's disease (17 jejunal or ileal, 72 ileocolic, and 7 colocolic resections). Of these, 42 patients underwent functional end-to-end anastomoses with the use of linear cutting staplers (Proximate 75 mm or GIA 228 80 mm) and 27 patients underwent end-to-end sutured anastomoses. RESULTS: In the stapled anastomosis group one (2 percent) patient required reoperation for recurrent symptoms at 46 months. Complications occurred in four (8 percent) patients (one enterocutaneous fistula, one wound infection, one abscess, and one ileus). There were no anastomotic leaks. The median postoperative stay was seven (range, 5-26) days. In the sutured anastomosis group 14 (43 percent) patients required 15 further resections for symptomatic recurrence at a median of 46 (range, 4-91) months. Complications occurred in six (17 percent) patients (two anastomotic leaks, two fistulas, one stricture, and one pulmonary embolus). The median postoperative stay was 10 (range, 6-28) days. CONCLUSIONS: Functional end-to-end stapled anastomoses after resection for Crohn's disease may be associated with fewer complications than sutured anastomoses and may delay reoperation for symptomatic recurrence. Further evaluation of the technique is indicated.

Management of pelvic sepsis after Ivalon rectopexy.

The consequences of pelvic sepsis after Ivalon rectopexy are described in four patients. Despite clear evidence of pelvic infection, reoperation was delayed by ineffective conservative measures and morbidity thereby prolonged. In three, the causative organism was Staphylococcus aureus and it is suggested that prophylactic antimicrobial regimens for intestinal organisms alone may be inadequate.

Long-term results of large-dose, single-session phenol injection sclerotherapy for hemorrhoids.

PURPOSE: The aim of our study was to assess the medium to long-term outcome following single session large dose injection sclerotherapy for symptomatic hemorrhoids. METHODS: One hundred eighty-nine patients (male = 106, female = 83, median age, 51; range, 20-85 years) were assessed following single-session, large-dose (3 x 5 ml) phenol injection therapy. The most frequent complaint was bleeding (100 percent). RESULTS: At four-year follow-up, 53 patients (28.0 percent) were cured, 26 (13.7 percent) were improved, 35 (18.5 percent) remained unchanged, 59 (31.2 percent) deteriorated, and 16 (8.5 percent) required surgical intervention. Among the patients who were not cured, symptoms were minimal in 50 percent. Sclerotherapy was associated with a reduced incidence of bleeding (P < 0.05) but an increase in difficulty in perineal cleaning was observed (P < 0.05). CONCLUSION: Large-dose, single-session sclerotherapy provides only short-term benefits in the majority of patients with symptomatic hemorrhoids.

Prospective randomized trial of Ivalon sponge versus sutured rectopexy for full-thickness rectal prolapse.

Ivalon sponge rectopexy is a safe reliable procedure in the management of rectal prolapse. Sutured rectopexy is simpler and avoids the use of foreign material. Sutured rectopexy is mandatory if synchronous resection is to be considered. Sixty-three patients (62 women) with full-thickness rectal prolapse were entered into a prospective randomized trial of Ivalon sponge rectopexy (31 patients) versus sutured rectopexy (32). Twenty patients (32 per cent) had coexistent incontinence (ten in each group). The operation was performed in the standard manner with a sutured rectangle of sponge or sutures alone placed along the length of the sacrum. Postoperative morbidity occurred in nine patients (14 per cent) of whom three underwent a sutured procedure and six Ivalon rectopexy: wound infection in three, chest infection in two, urinary tract infection in two and thromboembolism in two. There were no deaths within 30 days. At a median follow-up of 47 months prolapse had recurred in two patients (3 per cent), one in each group, 14 (22 per cent) suffered from incontinence (of whom five had undergone a sutured procedure), while 25 (40 per cent) had developed constipation (of whom 15 had received Ivalon rectopexy). The medium-term results of rectopexy by suture alone are equivalent to those obtained following the conventional Ivalon procedure. These data suggest that Ivalon rectopexy could now be abandoned.

A randomized trial to compare single with multiple phenol injection treatment for haemorrhoids.

One hundred and twenty consecutive patients were entered into a randomized trial of single versus multiple phenol injection for the treatment of haemorrhoids. Follow-up at 3 and 12 months was available in 105 patients (56 in the single group and 49 in the multiple group). The results have shown that injection therapy, whether this be single or multiple, is an extremely effective form of therapy for patients with first or second degree haemorrhoids.

Severe ulcerative colitis during successful pregnancy.

A 31-year-old patient presented with fulminant colitis during the 27th week of her first pregnancy. Despite failed medical treatment, colectomy was delayed because of the gravid uterus. A healthy child was delivered at 32 weeks by caesarian section, but a postoperative ileus appeared to induce transient colonic dilatation. A colectomy was performed 10 days post-partum. Both mother and child survived.

Prophylactic systemic antibiotics in colorectal surgery.

The prophylactic value of gentamicin combined with either lincomycin or metronidazole in 52 patients undergoing colorectal surgery was investigated. The results confirmed the value of this practice. In a control group, the sepsis-rate was 48% with 1 death attributable to sepsis, compared with a sepsis-rate of 4% in the treated group. The combination of gentamicin and lincomycin was effective against sepsis but pseudomembranous colitis developed in 2 of the 14 patients treated with this combination of drugs. Lincomycin was discontinued, and when metronidazole was substituted the results were equally good and there were no toxic side-effects.

Extramedullary haemopoiesis in the small bowel.

A patient with myelofibrosis developed repeated gastrointestinal haemorrhage from the small intestine, which was found to be infiltrated with extramedullary haemopoiesis. Nineteen months later he presented with subacute intestinal obstruction; radiology and laparotomy documented progressive infiltration of the small bowel. Histological examination of the resected terminal ileum showed patchy mucosal ulceration, with underlying submucosal and serosal extramedullary haemopoiesis.

Should air contrast computed tomography become the first investigation of the colon of frail or elderly patients?

OBJECTIVE: Air contrast computed tomography (ACCT) is an alternative test to barium enema or colonoscopy. We review our experience of this test as the first investigation of frail, elderly patients with lower gastrointestinal symptoms, and record the subsequent clinical course of these patients to evaluate the efficacy of the technique. PATIENTS AND METHODS: We performed 109 ACCT studies on frail patients aged 70 years or over with lower gastrointestinal symptoms. The findings were correlated with subsequent investigations and surgical findings. Patients with normal scans were followed up in out-patients or by their GP. Average follow up was 17 months. RESULTS: A good quality complete examination of the colon was achieved in 97% of patients. Of 109 examinations 34 (31%) were reported as normal, 65 (60%) as diverticular disease, nine (8%) as demonstrating a colonic malignancy and one (1%) showed a benign polyp. One sigmoid tumour was missed initially but diagnosed on a repeat ACCT study. CONCLUSION: ACCT is a reliable, well-tolerated technique in elderly frail patients.