Final Outcome Assessment Research Articles

Dilemma of managing asymptomatic children referred with ‘culture-confirmed’ drug-resistant tuberculosis

BackgroundThe diagnosis of drug-resistant tuberculosis (DR-TB) in children is challenging and treatment is associated with many adverse effects.ObjectiveWe aimed to assess if careful observation, without initiation of second-line treatment, is...

A comprehensive study of proximal humerus fractures and osteosynthesis in adult

Background: Proximal humerus fractures are one of the commonest fractures accounting approximately 4–5% of the fracture attendance at the hospital. They occur more commonly in elderly patients, after cancellous bone of the humeral neck has weakened by senility but these fractures are seen in patients of all ages & merge with epiphyseal separations. Because of increasing incidence of high velocity trauma, complicated fracture patterns are becoming increasingly common. It has been always enigma of management because of numerous muscles attachment and paucity of space for fixing implant. Preservation of function and prevention of complication is the goal of any surgery. A prospective study was done to understand the various patterns and displacements of proximal humerus fracture and how these fractures behave to different types of surgical modalities being offered. So at the end of the study, some tentative conclusions can be drawn: (A) Type of treatment options could be offered for various fracture patterns, taking in considering age, occupation, expectations and associated problems (B) Steps and care should be taken to minimize the complications (C) Ideal time of rehabilitation programMethods: In this study, 55 patients presented to the Orthopedic Unit C (Wednesday and Saturday), V. S. General Hospital and N.H.L. Medical College (Gujarat University, Ahmedabad) with proximal humerus fractures from April 2009 to March 2012 were included and treated with various surgical modalities. All patients were followed-up for minimum 2 years and final outcome assessment included all the complications, ASES and Neer’s scoring.Results: Type of fracture and mode of fixation are the two most important factors determining the results amongst all. In our study, we have fond that average chances of getting excellent to satisfactory results lies between 65–80%. Proper understanding of fracture pattern, appropriate mode of fixation and timely physiotherapy are the keys to achieve good results even in seemingly difficult cases.

Childhood facial vitiligo: how intractable is it?

Following the recent elucidation of its pathogenic mechanisms involving reactive oxygen species, use of vitamins, folic acid and antioxidants as adjuvant therapy has been suggested. To evaluate the long-term outcome of childhood facial vitiligo who were treated with nutritional education, vitamin E (α-tocopherol 100-400 IU/day), folic acid (1-2 mg/day) and multivitamin intake and antioxidant cosmetics as the mainstay of treatment as well as the conventional therapies including oral, topical and/or intralesional corticosteroid, topical macrolactam, Excimer laser and epidermal graft. Medical data and photographs of 111 paediatric facial vitiligo patients who had been followed up for longer than 1 year from March 1, 2003 to June 30, 2013 were extracted from data warehouse of electric medical records. Photographic evaluation and final visual outcome assessment was performed. By investigator's assessment, 9% of patients demonstrated no improvement regardless of treatment modality, whereas 91% showed improvement of lesions. Among the latter, 33.3% resulted in >75% improvement; 18% in 50%-75% improvement; 26.1% in 25%-50% improvement; and 13.5% in <25% improvement. In the final visual outcome assessment, 'Looking excellent' was seen in 42.3%; 'looking very good' in 30.6%; 'looking good' in 17.1%; 'looking fair' in 9.0%; and 'looking bad' in 0.9%. Although childhood facial vitiligo is quite refractory to treatment, the long-term outcome of this condition is not dismal with conventional vitiligo therapy along with basic nutritional therapeutic regimen.

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Protocol: A Randomized, Blinded, Efficacy Trial of Standard vs. Intensive Hyperglycemia Management in Acute Stroke

Patients with acute ischemic stroke and hyperglycemia have worse outcomes than those without hyperglycemia. Intensive glucose control during acute stroke is feasible and can be accomplished safely but has not been fully assessed for efficacy. The Stroke Hyperglycemia Insulin Network Effort trial aims to determine the safety and efficacy of standard vs. intensive glucose control with insulin in hyperglycemic acute ischemic stroke patients. This is a randomized, blinded, multicenter, phase III trial of approximately 1400 hyperglycemic patients who receive either standard sliding scale subcutaneous insulin (blood glucose range 80-179 mg/dL, 4·44-9·93 mmol/L) or continuous intravenous insulin (target blood glucose 80-130 mg/dL, 4·44-7·21 mmol/L) for up to 72 h, starting within 12 h of stroke symptom onset. The acute treatment phase is single blind (for the patients), but the final outcome assessment is double blind. The study is powered to detect a 7% absolute difference in favorable outcome at 90 days. The primary outcome is a baseline severity adjusted 90-day modified Rankin Scale score, defined as 0, 0-1, or 0-2, if the baseline National Institutes of Health Stroke Scale score is 3-7, 8-14, or 15-22, respectively. The primary safety outcome is the rate of severe hypoglycemia (<40 mg/dL, <2·22 mmol/L). This trial will provide important novel information about preferred management of acute ischemic stroke patients with hyperglycemia. It will determine the potential benefits and risks of intensive glucose control during acute stroke.

Comparing the Effectiveness of 1064 vs. 810 nm Wavelength Endovascular Laser for Chronic Venous Insufficiency (Varicose Veins)

The objective of this study was to compare the efficacy and safety of Endovenous Laser Photocoagulation (EVLP) at wavelengths of 1064 nm versus 810 nm for chronic venous insufficiency (varicose veins) in a large series of patients. A retrospective review was conducted of 108 patients with chronic venous insufficiency treated over a 8-year period. Subjects' ages ranged between 16 to 79 years; there were 83 females and 25 males, all of whom were Asian. Patients (n=54) received EVLP at wavelengths of 1064 nm (EVLP-1064 nm), Nd:YAG laser. Subsequent patients (n=54) received 810 nm (EVLP-810 nm), Diode laser. The primary efficacy measurement was the quantitative assessment of final outcome for 1064 nm versus 810 nm. Patients were monitored for adverse effects as well. Complications were observed at 3 weeks (early), 6 weeks (late) and 6 months after EVLP. In both groups, the commonest complication in early convalescence was swelling. This was followed by Local paraesthesia, pigmentation, superficial burns, superficial phlebitis, and localized hematomas. At 6 weeks postoperatively, local paraesthesia, persistent hyperpigmentation, and minimal scarring were presented. These problems all disappeared completely after the 6 months study period. Based on chi-squared analysis, there were clinical, and statistically significant differences in the severity score of final results favoring the EVLP-810 nm group. All patients achieved good or excellent improvement after EVLP-1064nm and EVLP-810nm. However, the difference of final outcome was significant, and indicates that improvement was greater in the Diode group. Further studies of different wavelengths and optimization of cryogen spray cooling (CSC) may lead to improved results in the eradication of varicose veins.

Significance of pregnancy-associated plasma protein a (PAPP-a) concentration determination in the assessment of final outcome of pregnancy

Pregnancy-associated plasma protein A (PAPP-A) is high molecular matrix metalloproteinase originally isolated in the serum of pregnant women. The aim of this study was to analyze the values of concentration of PAPP-A in assessment of progress and outcome of pregnancy in pregnant women diagnosed with threatening preterm delivery, preeclampsia and fetal growth restriction in relation to physiological pregnancy of the same gestational age. The study included 60 pregnant women that were divided into three groups according to gestational age and the diagnosis of imminent premature birth upon reception, preeclampsia and fetal growth restriction as follows: the group I from 28 to 32 weeks of gestation, a total of 25 pregnant women, the group II from 33 to 36 weeks of gestation, a total of 23 pregnant women, and the group III from 37 to 41 weeks of gestation, a total of 12 pregnant women. The control group consisted of 60 pregnant women without complications of pregnancy that were identically divided into three groups according to gestational age as in the sample. We performed quantitative determination of PAPP-A from the venous blood of patients by using commercial tests of the company Diagnostics Product Corporation (DPC), Los Angeles, California, USA. There was a statistically significant difference in PAPP-A values in the examined groups in all gestational ages (p < 0.01). The value of the PAPP-A concentration in different gestational ages with equal statistical significance indicated the possibility of complications, which was examined during pregnancy in relation to the control group of pregnant women with physiological pregnancies. This study confirmed that there was a statistically significant difference in fetal body weight at birth (p < 0.05), Apgar score in 5 min after birth (p < 0.05), and gestational age at birth (p < 0.05), as parameters of the outcome of pregnancy course, between the examined groups of pregnant women in relation to the value of PAPP-A concentration. The age of pregnant women was not statistically different in the examined groups (p > 0.05). Differences in PAPP-A concentration should point out to the obstetrician the need for more intensive antepartum fetal surveillance in order to increase the chances of favorable perinatal outcome, regardless gestational age.

Proximal Femoral Nailing: Technical Difficulties and Results in Trochanteric Fractures

Background: Proximal femoral nailing in communited intertrochanteric fractures is increasingly becoming popular in view of superior biomechanics and prevention of varus collapse associated with Dynamic hip screw. However, technical difficulties and implant related complications have been described with this technique, thus we need more studies to address these issues. Our study aims to understand technical difficulties involved in proximal femoral nailing, and specifically analyses neck shaft angle at follow-up indicating varus collapse and also to compare results of stable and unstable fractures. Materials and Methods: In this study, patients who presented to the Orthopedic Unit of Dr. TMA Pai Hospital (An associated hospital of Manipal University, Manipal) with trochanteric fractures included and treated with proximal femoral nailing. The technical difficulties involved with surgical procedure and techniques adapted to overcome such difficulties were recorded. All patients were followed up for a period of 2 years and final outcome assessment included the number of shortening, neck shaft angle and harris hip score. Results: 41 patients (mean age 71) who underwent proximal femoral nailing from January 2004 to December 2009 were included in the study, 38 patients completed 2-year follow-up. The technical difficulties we faced were divided into 3 categories, difficulties in securing entry point and guide wire placement especially when greater trochanter and piriform fossa were gathered, reduction was lost while passing nail, and finally difficulties faced during placement of hip screws. In all except one, neck shaft angle of more than 130 degrees was achieved, and this was also maintained in the final follow-up (Mean 131.9 degrees). All fractures were united, with mean shortening of 2 mm. Conclusions: Although PFN is technically required, with a proper technique PFN gives excellent clinical results with almost negligible varus collapse even in unstable trochanteric fractures. Regarding the techniques, reaming the proximal part of femur adequately and observing the nail passage with image carefully are important in placing the nail correctly, while, placement of lag screw in the inferior part of neck in anterior posterior projection and central in lateral projection reduces risk of implant failure.

Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria

ObjectiveTo determine the feasibility of introducing misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility. MethodsAn open-label prospective study was conducted in a secondary-level health facility in Nigeria. Eligible women diagnosed with incomplete abortion received 400-μg sublingual misoprostol as first-line treatment. Nurse–midwives took the lead in diagnosis, counseling, treatment, and assessment of final outcome. The primary outcome was the proportion of women who completed the abortion process. ResultsComplete evacuation was achieved in 83 of 90 (92.2%) eligible women. The most common adverse effects were abdominal pain/cramps (58 [64.4%]), heavy bleeding (21 [23.3%]), spotting (15 [16.7%]), and fever/chills (11 [12.2%]). More than 90% of women reported that the procedure was satisfactory, that pain and adverse effects were tolerable, and that bleeding was acceptable. Eighty-four (93.3%) and 86 (95.6%) women, respectively, would use the method in the future and recommend it to friends. ConclusionMisoprostol is an effective, safe, and acceptable method for treating incomplete abortion. It can be successfully used as first-line treatment by nurse–midwives. Success rates over 90% are consistent with findings from previous studies in which drug administration was controlled solely by physicians.Clinical trials.gov: NCT01539408.

Surgical management of ventral and ventrolateral foramen magnum meningiomas: report on a 64-case series and review of the literature

Foramen magnum meningioma poses a challenge for neurosurgeons. Prognosis has generally improved with diagnostic and surgical advances over the past two decades; however, it may ultimately depend more on the surgeon's ability to tailor the approach and interpret intraoperative risks in single cases. The series comprised 64 patients operated on for ventral and ventrolateral foramen magnum meningioma. All patients underwent preoperative magnetic resonance imaging and received surgery via the dorsolateral route, rendering the series homogeneous in neuroradiological workup and surgical treatment. Particular to this series was that the majority of patients were of advanced age (n = 29; age, >65 years), had serious functional impairment (n = 30, Karnofski score <70), and large tumors (mean diameter, 3.5 cm). Total tumor removal was achieved in 52 (81 %) patients; operative mortality was nil. Early outcome varied depending on difficulties encountered at surgery (cranial nerve position and type of involvement in particular) and type of preoperative dysfunction. Long-tract signs and cerebellar deficits improved in 74 and 77 % of cases, respectively, but only 27 % of cranial nerve deficits did so. Surgical complications most often involved the cranial nerves: cranial nerve impairment, especially of the 9th through the 12th cranial nerves, due to stretching or encasement was noted in 44 cases. At final outcome assessment, two thirds of the cranial nerve deficits cleared, and all but two patients returned to a normal productive life. One patient was reoperated on during the follow-up period. Foramen magnum meningiomas behave like clival or spinal tumors depending on their prevalent extension. A dorsolateral approach tailored to tumor position and extension and meticulous surgical technique allow for definitive control of surgical complications. Scrupulous postoperative care may prevent dysphagia, a major persistent complication of surgery. Long-term observation of indolent tumor behavior at follow-up suggests that incomplete resection may be a viable surgical treatment option.

Role of PET/CT in Staging and Evaluation of Treatment Response After 3 Cycles of Chemotherapy in Locally Advanced Retinoblastoma: A Prospective Study

The present study prospectively evaluated the role of (18)F-FDG PET/CT for staging, neoadjuvant chemotherapy response evaluation, and final outcome assessment in International Retinoblastoma Staging System (IRSS) stage III retinoblastoma. Twenty-five consecutive IRSS stage III patients, with a median age of 3 y, were prospectively enrolled after ethics approval. All patients received neoadjuvant chemotherapy followed by enucleation, radiotherapy, and adjuvant chemotherapy. PET/CT was performed at baseline (PET/CT-1) and after 3 cycles of neoadjuvant chemotherapy (PET/CT-2). All 25 patients underwent PET/CT-1, and 21 of 25 patients underwent PET/CT-2. PET/CT-1 was compared with routine staging, and response on PET/CT-2 was assessed by criteria from the European Organization for Research and Treatment of Cancer response. Event-free survival (EFS) and overall survival (OS) were calculated using Kaplan-Meier survival analysis, and differences between the groups were compared using log-rank test. A P value of 0.05 or less was considered significant. Increased (18)F-FDG uptake was noted in primary extraocular tumor in all patients, except 5 with bilateral retinoblastoma (one eye with advanced and the other eye with intraocular disease) in whom the intraocular tumor did not show (18)F-FDG uptake. Five of 22 IRSS stage IIIA patients with clinically negative cervical lymph node involvement were found to have uptake in cervical lymph nodes on PET/CT-1, and 2 of 3 IRSS stage IIIB patients with pathologically confirmed cervical lymph node involvement did not show any uptake in the involved lymph nodes. No significant difference in EFS and OS was seen between IRSS stage IIIA and IIIB patients using routine staging or PET/CT staging (P ≥ 0.05); however, there was a trend toward better OS in patients with IRSS stage IIIB disease on PET/CT (P = 0.065). There was no significant discordance between routine staging and PET/CT staging (P = 0.256). The 8 patients with optic nerve uptake had lower EFS (P = 0.0001) and OS (P = 0.0009) than did 17 patients without optic nerve uptake on PET/CT-1. The 17 patients with complete response or partial response had better EFS (P = 0.042) and OS (P = 0.026) than did the 4 patients with progressive disease on PET/CT-2. Optic nerve uptake at baseline on PET/CT and response after neoadjuvant chemotherapy according to criteria from the European Organization for Research and Treatment of Cancer are strong predictors of EFS and OS in IRSS stage III retinoblastoma.

The Early Prevention of Obesity in CHildren (EPOCH) Collaboration - an Individual Patient Data Prospective Meta-Analysis

BackgroundEfforts to prevent the development of overweight and obesity have increasingly focused early in the life course as we recognise that both metabolic and behavioural patterns are often established within the first few years of life. Randomised controlled trials (RCTs) of interventions are even more powerful when, with forethought, they are synthesised into an individual patient data (IPD) prospective meta-analysis (PMA). An IPD PMA is a unique research design where several trials are identified for inclusion in an analysis before any of the individual trial results become known and the data are provided for each randomised patient. This methodology minimises the publication and selection bias often associated with a retrospective meta-analysis by allowing hypotheses, analysis methods and selection criteria to be specified a priori.Methods/DesignThe Early Prevention of Obesity in CHildren (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine if early intervention for childhood obesity impacts on body mass index (BMI) z scores at age 18-24 months. Additional research questions will focus on whether early intervention has an impact on children's dietary quality, TV viewing time, duration of breastfeeding and parenting styles. This protocol includes the hypotheses, inclusion criteria and outcome measures to be used in the IPD PMA. The sample size of the combined dataset at final outcome assessment (approximately 1800 infants) will allow greater precision when exploring differences in the effect of early intervention with respect to pre-specified participant- and intervention-level characteristics.DiscussionFinalisation of the data collection procedures and analysis plans will be complete by the end of 2010. Data collection and analysis will occur during 2011-2012 and results should be available by 2013.Trial registration numberACTRN12610000789066

Diagnostic performance of Baveno IV criteria in cirrhotic patients with upper gastrointestinal bleeding: Analysis of the F7 liver-1288 study population

The definition of failure to control bleeding agreed upon at the Baveno IV consensus meeting, included the Adjusted Blood Requirement Index [ABRI: number of blood units/(final-initial hematocrit+0.01)]. ABRI ≥0.75 denotes failure. However, timing for hematocrit measurements was not defined. The aims of this study were: (1) to assess the Baveno IV criteria performance to classify treatment success or failure to control bleeding at 5 days, (2) to determine the appropriate timing for hematocrit. Two hundred and forty-two cirrhotic patients with gastrointestinal bleeding were independently classified by three clinical experts according to the Baveno IV criteria, by analysis of the database of a randomized trial. ABRI was calculated by using the closest hematocrit to the 5 day time point from the first trial product administration (ABRI-1) or after the latest transfusion within the 5-day period (ABRI-2). The gold standard for success/failure for 5-day control of bleeding was the clinical judgment of the three independent observers based on all the clinical and follow-up data. Inter-observer agreement for the final outcome assessment was 0.82 and a final consensus was obtained in 236/242 patients. Inter-observer agreement on patient classification with Baveno IV criteria was 0.70 with ABRI-1 and 0.84 with ABRI-2. c-statistics for correct patients classification were 0.86 for ABRI-1, 0.84 for ABRI-2, and 0.88 for Baveno IV criteria without ABRI. ABRI-1 caused misclassification of 27 patients and ABRI-2 of 39. Baveno IV criteria are accurate to assess outcome of patients with variceal bleeding. There is a substantial observer variability linked to timing of hematocrits for ABRI calculation. With the current definition ABRI does not add to the performance of the other criteria.

A postmarketing surveillance study of the safety and efficacy of ReFacto® (St Louis‐derived active substance) in patients with haemophilia A

This clinical trial evaluated the safety and efficacy of ReFacto (St Louis-derived active substance) in patients with severe or moderately severe haemophilia A over a period of 6 months or 50 exposure days (EDs), whichever occurred first. Sixty patients, 58 previously treated and two previously untreated, were enrolled into this study. This was an open-label, multicentre, postmarketing surveillance study in which patients received prophylaxis or on-demand treatment as determined by their doctor. Surgical prophylaxis was evaluated in seven patients requiring elective surgery. Thirty-two patients aged <1 to 66 years (median 19.5) received prophylaxis and 28 patients, aged 1-71 years (median 33.5), received on-demand treatment. The majority of patients had severe haemophilia A (FVIII:C < 2%): 84.4% in the prophylaxis group and 85.7% in the on-demand group. Prophylaxis with ReFacto was associated with a median of 6.7 bleeds per year (range: 0-37). The investigator's assessment of final outcome for prophylactic treatment was excellent or effective for 93.1% of patients. ReFacto resolved 92.8% of bleeds with one or two infusions. The investigator's assessment was excellent or good for 98.2% of bleeds treated with ReFacto. Haemostasis was achieved for all seven surgical cases and ReFacto gave an excellent or good response for each. The nature and incidence of adverse events was as expected and no new safety concerns emerged. One previously treated patient (PTP) developed a high-titre inhibitor (maximum 75 BU) and one minimally treated patient (MTP) developed a low-titre inhibitor while on the study but eventually achieved high titres (maximum 30 BU) after immune tolerance therapy was initiated with a plasma-derived FVIII product. One previously untreated patient (PUP) developed a transient low-titre inhibitor (0.4 BU). Other serious adverse events (SAEs) were unrelated to study treatment. There were no allergic events. The results of this study are consistent with the previously published ReFacto pivotal studies.

Neuropsychological progress during 14 years after severe traumatic brain injury in childhood and adolescence

Objective: To investigate the impact of time since injury on neuropsychological and psychosocial outcome after serious TBI in childhood or adolescence.Methods: The subjects were eight patients with serious TBI sustained at a mean age of 14 years who had been assessed neuropsychologically at 1, 7 and 14 years after TBI. A retrospective longitudinal design was chosen to describe the development in six neuropsychological domains on the basis of the assessments. Psychosocial data were gathered from clinical knowledge and a semi-structured interview 14 years after TBI.Results: Performance of verbal IQ shows a declining trend over the three assessments, that the performance of attention and working memory is low and that verbal learning is the cognitive domain which exhibits the largest impairments. The main psychosocial result is that three of the eight subjects went from a school situation with no adjustments to adult life with early retirement.Conclusions: Time since insult is an important factor when assessing outcome after TBI in childhood and adolescence and that assessment of final outcome should not be done before adulthood.

119th ENMC international workshop: Trial design in adult idiopathic inflammatory myopathies, with the exception of inclusion body myositis, 10–12 October 2003, Naarden, The Netherlands

Department of Neurology, University Medical Center, Heidelberg laan 100, Utrecht, CX 3584, The Netherlands Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA The Walton Centre for Neurology and Neurosurgery, Liverpool, UK Department of Rheumatology, King’s College Hospital, London, UK Rheumatology Unit, Department of Medicine, Karolinska Hospital, Karolinska Institute, Stockholm, Sweden King’s Neurosciences Centre, King’s College Hospital, London, UK Institute of Rheumatology, Prague, Czech Republic Department of Neurology, Academic Medical Centre, Amsterdam, The Netherlands Department of Clinical Neurosciences, Guy’s, King’s and Thomas’ School of Medicine, London, UK

OUTCOME RESULTS OF TRANSURETHRAL COLLAGEN INJECTION FOR FEMALE STRESS INCONTINENCE: : ASSESSMENT BY URINARY INCONTINENCE SCORE

We assessed the results of collagen injection for female sphincteric incontinence using strict subjective and objective criteria. We evaluated 63 consecutive women with sphincteric incontinence who underwent a total of 131 transurethral collagen injections. Sphincteric incontinence was confirmed by urodynamics. All patients were treated with 1 to 5 transurethral collagen injections and treatment outcome was classified according to a new outcome score. Cure was defined as no urinary loss due to urge or stress incontinence documented by a 24-hour diary and pad test, and patient assessment that cure was achieved. Failure was defined as poor objective results and patient assessment that treatment failed. Cases that did not fulfill these cure and failure criteria were considered improved and further classified as a good, fair or poor response. Mean patient age plus or minus standard deviation was 67.7 +/- 12.8 years. All women had a long history of severe stress urinary incontinence, 18 (29%) underwent previous anti-incontinence surgery, and 41% had combined stress and urge incontinence. Preoperatively diary and pad tests revealed a mean of 7.5 +/- 4.6 incontinence episodes and 152 +/- 172 gm. of urine lost per 24 hours. Overall 1 to 5 injections were given in 26, 17, 13, 3 and 4 patients, respectively. Mean interval between injections was 4.4 +/- 5.7 months, mean followup was 12 +/- 9.6 months, and mean interval between the final injection and outcome assessment was 6.4 +/- 4.9 months. There was a statistically significant decrease in the total number of incontinence episodes per 24-hour voiding diary after each injection session. Although there was a clear trend toward decreased urinary loss per 24-hour pad test, statistical significance was not established. Using the strict criteria of our outcome score overall 13% of procedures were classified as cure, 10%, 17% and 42% as good, fair and poor, respectively, and 18% as failure. As defined by strict subjective and objective criteria, we noted a low short-term cure rate after collagen injection in women with severe sphincteric incontinence. It remains to be determined how patients with less severe incontinence would fare using our outcome assessment instruments.

Microbial keratitis—a late complication of penetrating keratoplasty

A retrospective review of 323 penetrating keratoplasties performed in Taiwan between January 1993 and December 1997 revealed that late microbial keratitis developed in 39 eyes of 36 patients (12.1%). All patients were operated on by the same surgeon, and all were followed for at least 1 year. The mean interval between the corneal transplantation and the onset of graft infection was 8.6 ± 8.8 months (range 3 weeks–47 months). Predisposing risk factors for keratitis included chronic blepharitis with poor lid hygiene (43·6%), suture-related problems (38·5%), dry eyes (28·2%), epithelial defects (25.6%), and use of contact lenses (5·1 %). Infectious keratitis was diagnosed within 6 months after keratoplasty in 59 % of cases. Positive cultures were obtained in 100% of the ulcers; Pseudomonas aeruginosa and Staphylococcus aureus were the most common pathogens. In the final visual outcome assessment, 30·8% of cases had clear grafts, 20·5% had graft failures, and 10·3% had corneal perforations.

Clinical value of colonic irrigation in patients with continence disturbances.

Continence disturbances, especially fecal soiling, are difficult to treat. Irrigation of the distal part of the large bowel might be considered as a nonsurgical alternative for patients with impaired continence. This study is aimed at evaluating the clinical value of colonic irrigation. Thirty-two patients (16 females; median age, 47 (range, 23-72) years) were offered colonic irrigation on an ambulatory basis. Sixteen patients suffered from fecal soiling (Group I), whereas the other 16 patients were treated for fecal incontinence (Group II). Patients were instructed by enterostomal therapists how to use a conventional colostomy irrigation set to obtain sufficient irrigation of the distal part of their large bowel. Patients with continence disturbances during the daytime were instructed to introduce 500 to 1,000 ml of warm (38 degrees C) water within 5 to 10 minutes after they passed their first stool. In addition, they were advised to wait until the urge to defecate was felt. Patients with soiling during overnight sleep were advised to irrigate during the evening. To determine clinical outcome, a detailed questionnaire was used. Median duration of follow-up was 18 months. Ten patients discontinued irrigation within the first month of treatment. Symptoms resolved completely in two patients. They believed that there was no need to continue treatment any longer. Irrigation had no effect in two patients. Despite the fact that symptoms resolved, six patients discontinued treatment because they experienced pain (n = 2) or they considered the irrigation to be too time-consuming (n = 4). Twenty-two patients are still performing irrigations. Most patients irrigated the colon in the morning after the first stool was passed. Time needed for washout varied between 10 and 90 minutes. Frequency of irrigations varied from two times per day to two times per week. In Group I, irrigation was found to be beneficial in 92 percent of patients, whereas 60 percent of patients in Group II considered the treatment as a major improvement to the quality of their lives. If patients who discontinued treatment because of washout-related problems are included in the assessment of final outcome, the success rate is 79 and 38 percent respectively. Patients with fecal soiling benefit more from colonic irrigation than patients with incontinence for liquid or solid stools. If creation of a stoma is considered, especially in patients with intractable and disabling soiling, it might be worthwhile to treat these patients first by colonic irrigation.