Prospective Nonrandomized Controlled Study Research Articles

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Objective: To investigate the effect of closed-system vs. open endotracheal suctioning on the frequency of ventilator-associated pneumonia and outcome in a pediatric intensive care unit in a developing country. Design: Prospective observational and nonrandomized controlled clinical study. Setting: A 20-bed pediatric intensive care unit in a tertiary pediatric hospital. Patients: Infants and children mechanically ventilated for >24 hrs. Intervention: Pediatric intensive care unit suctioning systems were alternated monthly. An 8-month interim analysis was planned with a priori efficacy and futility study termination boundaries set at p < .006 and p > .52, respectively. Measurements and Main Results: Demographic, clinical, and laboratory data were prospectively recorded. Ventilator-associated pneumonia was diagnosed using the Clinical Pulmonary Infection Score, and the results were confirmed retrospectively using Centers for Disease Control criteria. A total of 250 patients (median [interquartile range] age of 3.8 [1.2–15.0] months) in 263 pediatric intensive care unit admissions were included. Fifty-nine admissions developed ventilator-associated pneumonia, with a calculated rate of 45.1 infections per 1000 ventilated days. There was no difference in characteristics or outcome between patients on closed-system suctioning (n = 83) and those on open endotracheal suctioning (n = 180). The frequencies of ventilator-associated pneumonia for patients on closed-system suctioning and open endotracheal suctioning were 20.5% and 23.3%, respectively (p = .6), reaching the a priori set limit of futility. Patients who developed ventilator-associated pneumonia spent a median (interquartile range) of 22 (13–37) and 11 (8–16) days in the hospital and pediatric intensive care unit, respectively, compared to 14.5 (10–24) and 6 (4–8) days for those without ventilator-associated pneumonia (p < .001). A 22% proportion of patients who developed ventilator-associated pneumonia died compared to 11.3% of those without ventilator-associated pneumonia (p = .03). Risk factors for ventilator-associated pneumonia identified on multiple logistic regression were duration of mechanical ventilation, transport out of the pediatric intensive care unit, and blood transfusion. Conclusion: Closed-system suctioning did not affect the frequency of ventilator-associated pneumonia or patient outcome in this setting.

Transoral robotic resection and reconstruction for head and neck cancer

To evaluate the patterns of failure, survival, and functional outcomes for patients treated with transoral robotic surgery (TORS) and compare these results with those from a cohort of patients treated with concurrent chemoradiation (CRT). Prospective non-randomized case control study. Between April 2007 and April 2009, 30 patients with head and neck squamous cell carcinoma were treated with primary TORS and adjuvant therapy as indicated on an institutional review board-approved protocol. Patients were evaluated before treatment, after treatment, and at subsequent 3-month intervals after completing treatment to determine their disease and head and neck-specific functional status using the Performance Status Scale for Head and Neck Cancer and the Functional Oral Intake Score (FOIS). Functional scores were compared to a matched group of head and neck patients treated with primary CRT. The TORS patient population included 73% stage III-IV and 23% nonsmokers. The median follow-up was 20.4 months (range, 12.8-39.6 months). The 18-month locoregional control, distant control, disease-free survival, and overall survival were 91%, 93%, 78%, and 90%, respectively. Compared to the primary CRT group, TORS was associated with better short-term eating ability (72 vs. 43, P = .008), diet (43 vs. 25, P = .01), and FOIS (5.5 vs. 3.3, P < .001) at 2 weeks after completion of treatment. In contrast to TORS patients who returned to baseline, the CRT group continued to have decreased diet (P = .03) and FOIS (P = .02) at 12 months. Our early experience in treating selected head and neck cancers with TORS is associated with excellent oncologic and functional outcomes that compare favorably to primary CRT.

Feldenkrais Method Balance Classes Improve Balance in Older Adults: A Controlled Trial

The objective of this study was to investigate the effects of Feldenkrais Method balance classes on balance and mobility in older adults. This was a prospective non-randomized controlled study with pre/post measures. The setting for this study was the general community. A convenience sample of 26 community-dwelling older adults (median age 75 years) attending Feldenkrais Method balance classes formed the Intervention group. Thirty-seven volunteers were recruited for the Control group (median age 76.5 years). A series of Feldenkrais Method balance classes (the 33312Getting Grounded Gracefully33313 series), two classes per week for 10 weeks, were conducted. Main outcome measures were Activities-Specific Balance Confidence (ABC) questionnaire, Four Square Step Test (FSST), self-selected gait speed (using GAITRite instrumented gait mat). At re-testing, the Intervention group showed significant improvement on all of the measures (ABC, P = .016, FSST, P = .001, gait speed, P < .001). The Control group improved significantly on one measure (FSST, P < .001). Compared to the Control group, the Intervention group made a significant improvement in their ABC score (P = .005), gait speed (P = .017) and FSST time (P = .022). These findings suggest that Feldenkrais Method balance classes may improve mobility and balance in older adults.

Securing Feeding Tubes in Head and Neck Surgery: Septal Suture or Bridle Technique

Results Discussion References Securing Feeding Tubes in Head and Neck Surgery: Septal Suture or Bridle Technique Samer Al-Khudari1 MD, Daniel Clayburgh2 MD PhD, Lisa Morris2 MD, Tammara Watts2 MD PhD, Mark K. Wax2 MD, Tamer A. Ghanem1 MD PhD 1Department of Otolaryngology-Head & Neck Surgery Henry Ford Health System, Detroit, Michigan 2Departmet of Otolaryngology –Head & Neck Surgery Oregon Health & Science University, Portland, Oregon Objectives: To compare use of the anterior septal suture (SS) technique versus the septal bridle technique (BT) in securing nasogastric feeding tubes in head and neck surgery patients. Study Design: A multicenter prospective nonrandomized controlled study was conducted on patients undergoing head and neck surgery with postoperative need for a nasogastric feeding tube. Methods: Patients underwent either a septal suture or a bridle technique to secure the feeding tube intraoperatively. They were assessed by a standard questionnaire and physical exam administered at three time points postoperatively: days 1-5 (time-1), 6-9 (time-2), and day 10 or greater (time-3). The following factors were assessed: subjective assessment of overall pain, pain due to securing mechanism, route of pain control, local complications, and tube dislodgement secondary to securing method. To analyze pain at each time point a nonparametric two sample Wilcoxon test was used. To analyze the change in pain from time 1 to time 2 a Wilcoxon matched pairs signed rank test was used. Results: 74 patients were enrolled in the study. 29 patients underwent a septal suture technique and 45 underwent the bridle technique. No local complications were reported secondary to either securing method. No tube dislodgments occurred directly as a result of either securing technique. Overall pain did not significantly differ in both cohorts at each time point (p=0.196, 0.808, 0.469). Pain due to the tube securing method was significantly less for the bridle technique at time points 1 and 2 but not at time 3 (p=0.037, 0.021, 0.722). Overall pain and pain due to securing method did not significantly differ in patients primarily controlled on PO or IV medication at time 1 (p=0.744, p=0.909). When analyzing the change in overall pain from time 1 to time 2 in both cohorts there was a significant decrease in pain (p=0.001, p=0.001). When analyzing the change in mean pain due to the securing mechanism from time 1 to time 2 it was found to be significant in the SS patients (p=0.036) and approaching significance in the BT patients (p=0.078). Conclusions: The septal suture and bridle technique are both effective methods in securing feeding tubes postoperatively in head and neck surgery patients. In both cohorts no local complications were directly attributed to securing method and no tube dislodgments were reported directly related to the securing method.

Review of a Large Clinical Series: The Value of Routinely Obtained Chest Radiographs on Admission to a Mixed Medical—Surgical Intensive Care Unit

The efficacy of routinely obtained chest radiographs (CXRs) on admission to the intensive care unit (ICU) is largely unknown. The current study investigated the efficacy of routinely obtained admission CXRs and determined whether the value of this diagnostic test was dependent on patient category. Prospective nonrandomized controlled study. including 1081 admission CXRs of 1330 patients admitted to a 28-bed mixed medical-surgical university-affiliated ICU, over a 10-month period. To determine the value of admission CXRs, 2 categories of efficacy were used: diagnostic efficacy (the number of CXRs with a new or progressive major finding divided by the total number of CXRs) and therapeutic efficacy (the number of CXRs resulting in a change in clinical management divided by the total number of CXRs). Efficacy <15% was considered low. Patients were subclassified into subcategories on the basis of type of admission. Of all admission CXRs, 227 were clinically indicated and 854 were routinely obtained to establish a baseline prior to admission to ICU. Diagnostic efficacy of routinely obtained admission CXRs was 11%. The majority of abnormalities were malposition of invasive devices and severe pulmonary congestion. Therapeutic efficacy of routinely obtained admission CXRs was only 5%. Subgroup analysis showed highest efficacy in nonsurgical patients. In our mixed medical-surgical ICU the diagnostic and therapeutic efficacy of routinely obtained admission CXRs is low, though not completely negligible. Highest efficacy of CXRs was found in nonsurgical patients. Prospective studies are needed to determine whether abolishing this diagnostic test is a safe strategy.

Patellofemoral Chondral Defects Treated with 2nd Generation ACI: A Clinical Review at 6 Years (SS-60)

Patellofemoral lesions are difficult to treat, however, authors hypothesized that Second generation ACI could be a viable treatment for patellofemoral Grade III-IV chondral lesions. The aim of this study was to test the efficacy of Second generation ACI in treating full-thickness patellofemoral defects and report results at six years. In this prospective non-randomized controlled study, 34 patients with patellofemoral chondral lesions, mean size of 4.45 cm2, were followed up. Lesions were classified as ICRS grade IV A or B (76.47%), grade IIIC (14.70%) and secondary to OCD (8.82%). Grafts were implanted through a mini-incision approach (25) or arthroscopically (9). Results were evaluated using the ICRS IKDC 2000 subjective and objective scores, EuroQol VAS, and Tegner scores at pre-op, 2 and 6 yrs. Statistical analysis was performed using the paired T test and Wilcoxon signed rank test. All scores demonstrated a statistically significant improvement (P < .0001) at 6 years from pre-op. Objective preoperative data improved from 8/34 (23.52%) with IKDC A or B scores to 30/34 (88.22%) IKDC A or B scores at 6 years. Mean IKDC subjective scores improved from 46.09 points preoperatively to 70.39 points 6 years after implantation. Tegner improved from 2.56 to 4.68. EQ VAS scores improved from 54.81 to 78.24. Second generation ACI can be a viable treatment for patellofemoral chondral lesions. Long-term investigations (10 years) are needed to determine the durability of the repair produced with this technique.

Efficacy of intraoperative wound irrigation for preventing shunt infection

Although a cerebrospinal fluid shunt procedure is one of the most frequently performed operations in pediatric neurosurgery, the infection rate due to the procedure is not low. The authors have hypothesized that the key to reducing surgical shunt infections is to reduce bacteria from the operating field and wound. This hypothesis has been tested in a prospective nonrandomized controlled study at the authors' department. Beginning in August 2006, during shunt procedures the authors began routinely irrigating the operating field and wound with amikacin containing saline, using a jet of fluid from a syringe. Prior to this new routine no irrigation techniques were used, providing an adequate control group for comparing the effect of the irrigation technique. Data obtained in all patients undergoing shunt insertions or revisions for hydrocephalus performed between October 1, 2003, and November 30, 2007, were reviewed. A total of 101 shunt procedures were performed in 63 patients (34 females and 29 males) during the study period. The mean age of all patients was 48.2 +/- 61.8 months. A total of 61 shunt procedures were performed before August 2006, and 40 were performed after August 2006. There was no statistical difference between the ages of patients in the 2 groups (p = 0.64). Eight total infections occurred during the 90 days of the postoperative period (7.9% overall infection rate). All 8 infections occurred before implementation of the irrigation technique (13.1% infection rate), but no infections were noted after beginning use of the irrigation procedure (0% infection rate). There was a statistically significant difference in the infection rate between the 2 groups (p = 0.021). Use of an irrigation strategy aimed at reducing bacteria from the operating field and wound can be considered an effective procedure for preventing shunt infection.

Impact of case management by advanced practice nurses in primary care on unplanned hospital admissions: a controlled intervention study

BackgroundIncreasing unplanned hospital admissions disrupt planned health care, lead to additional morbidity and are expensive. A recent review found only weak evidence for case management preventing unplanned admissions, yet case management of older people is being implemented widely in the UK. We aimed to study the effect of advanced practice nurse case management on unplanned medical and geriatric hospital admission rates in patients 50 years and over, and on admission risk in a 'higher risk' sub-group of patients in the UK.MethodsCase management by advanced practice nurses in NHS primary care practices in the Swansea Local Health Board area, Wales, UK. We conducted a prospective non-randomized controlled intervention study comparing unplanned medical and geriatric patient admissions between five intervention and thirty non-intervention practices during a pre-intervention year and an intervention year.ResultsFor all lengths of stay, comparing intervention (n = 5) with non-intervention practices (n = 30) from pre-intervention to intervention year, we found that the unplanned medical and geriatric admission rate was significantly lower in the intervention group – adjusted relative risk of 0.909; relative risk reduction 9.1% (95% credible limit 0.840 to 0.984, p = 0.018); absolute risk reduction 0.99 admissions per 100 patients (95% credible limit 0.17 to 1.86, p = 0.018). For lengths of stay of one night or more we observed a stronger effect – adjusted relative risk 0.896; relative risk reduction 10.41% (95%, credible limit 0.820 to 0.979, p = 0.015). Most of the rate reduction was due to a reduction in the number of new admissions but much less so for admissions of lengths of stay of at least one night, compared to all lengths of stay. We did not find a statistically significant effect on re-admission or multiple re-admission rates in 'higher risk' patients previously admitted one or more times – adjusted relative risk of further multiple admissions per previously admitted patient 0.908 (95% credible limit 0.765, 1.077); relative risk reduction 9.3%; adjusted relative risk of total admissions per multiple admitter 0.995 (95% credible limit 0.940, 1.053) relative risk reduction 0.6%.ConclusionAlthough this study reports a reduction in unplanned admission rates in the intervention practices, this appears to be only in part directly due to nurse case management: most of the reduction did not occur in multipe admitters whom were case managed. Further research is needed to explain this finding, to elucidate how best to target the attention of case managers and to examine the complexity of potential outcomes in terms of the nature and necessity of admissions and most suitable lengths-of-stay in terms of acute care or rehabilittion need.

Treatment of Painful Osteoporotic or Traumatic Vertebral Compression Fractures by Percutaneous Vertebral Augmentation Procedures

Vertebroplasty (PV) and balloon kyphoplasty (KP) are minimally invasive vertebral augmentation procedures involving injection of polymethyl methacrylate cement under radiologic control into a fractured vertebral body. They strengthen the bone and improve the intense pain caused by fracture secondary to osteoporosis, metastasis, or trauma and refractory to conservative therapies such as analgesic use, bed rest, and bracing. Aim of the study is to investigate and compare safety and efficacy of KP and PV on pain and mobility in patients with vertebral fractures due to osteoporosis or trauma. Twenty-one patients have been enrolled in a prospective nonrandomized controlled study with painful vertebral compression fractures resistant to common therapies. Patients underwent KP or PV. A Visual Analog Scale has been used to measure pain status at different time up to 6 months; the Oswestry Disability Index (ODI) was chosen to evaluate functional activity before procedure and 6 months later. Mean pain scores decreased significantly from pretreatment to posttreatment with KP and PV as did the ODI scores. No significant differences could be found between both groups for the mean VAS and ODI scores preprocedure and postprocedure. Cement extravasation occurred only during PV. No other adverse events correlated to both techniques have been reported. Our results suggest that both PV and KP offer therapeutic benefit significantly reducing pain and improving mobility in patients with vertebral fracture without significant differences between groups in term of quality. The leakage of cement has been observed only during PV.

Evaluation of tumor oxygenation by color duplex sonography: A new approach

Description of a new noninvasive method for the evaluation of tissue oxygenation in head and neck cancer. Prospective nonrandomized controlled study in an academic medical center on 20 patients with neck metastases of head and neck cancer. Metastases were investigated using color duplex sonography and pO2 histography. The vascularization in sonography was quantitatively evaluated by color pixel density and compared to the pO2 values of the same nodes. The correlation between vascularization and flow velocity was 0.71. For the mean/median pO2 -values and for the pO2 readings <10.0 mmHg correlations were r = 0.65 / 0.76 and 0.71. This sonographic method allows a safe and reliable evaluation of oxygenation in metastases of head and neck cancer. The new approach is an alternative to pO2 histography and may play a future role in the planning of radiotherapy in the neck.

Laparoscopic Tenckhoff Catheter Implantation in Children

To assess the suitability of a laparoscopic Tenckhoff catheter implantation (TCI) technique in children. Prospective nonrandomized controlled study. Laparoscopic and conventional TCIs in children were performed in a tertiary-care hospital. Between 1998 and 2001, 25 laparoscopic and 23 conventional TCIs were performed in 42 children. Patients in unstable clinical conditions were excluded. The laparoscope was inserted via transumbilical incision, and a forceps by percutaneous puncture. After catheter insertion, the tip was positioned in the Douglas space, and the inner cuff placed adjacent to the peritoneum, without sutures. Peritoneal dialysis was initiated immediately after surgery. Catheter-related complications during the first 4 weeks after TCI. After laparoscopic TCI, dialysate leakage occurred in 2 of 25 cases, one of which could be managed conservatively. In 1 patient in whom dwell volume was increased immediately after laparoscopic TCI, subcutaneous leakage occurred at the site of forceps insertion. In 2 patients with severe pre-existing intra-abdominal adhesions, outflow obstruction persisted after laparoscopic TCI. Simultaneous herniotomy was performed in 2 male infants. After conventional TCI, dialysate leakage occurred in 5 of 23 cases, 1 of which could be managed conservatively. Outflow obstruction occurred in 2 cases. Laparoscopic TCI is feasible in children of all age groups, with at least equivalent functional results compared to conventional TCI. An additional advantage is the option to identify and eliminate anatomical risk factors, such as intra-abdominal adhesions or preformed inguinal hernias in male infants.

Obstructive Sleep Apnea Syndrome: A Comparison Between Far‐East Asian and White Men

To investigate the possible differences between Far-East Asian men and white men in obstructive sleep apnea syndrome (OSAS). Prospective nonrandomized controlled study. This study compared consecutive Far-East Asian men with OSAS (n = 50) with two selected groups of White men with OSAS (n = 50 in each group). One group of white men was controlled for age, respiratory disturbance index (RDI), and minimum oxygenation saturation (LSAT). Another group was controlled for age and body mass index (BMI). Cephalometric analysis was performed on all subjects. The majority of the Far-East Asian men were found to be nonobese (mean BMI, 26.7 +/- 3.8) but had severe OSAS (mean RDI, 55.1 +/- 35.1). When controlled for age, RDI, and LSAT, the white men were substantially more obese (mean BMI, 29.7 +/- 5.8, P = .0055). When controlled for age and BMI, the white men had less severe illness (RDI, 34.1 +/- 17.9, P = .0001). Although the posterior airway space and the distance from the mandibular plane to hyoid bone were less abnormal in the Far-East Asian men, the cranial base dimensions were significantly decreased. The majority of the Far-East Asian men in this study were found to be nonobese, despite the presence of severe OSAS. When compared with white men, Far-East Asian men were less obese but had greater severity of OSAS. There may be differences in obesity and craniofacial anatomy as risk factors in these two groups.

A pilot urban church‐based programme to reduce risk factors for diabetes among Western Samoans in New Zealand

We have assessed the impact of a 2-year pilot church-base diabetes risk reduction programme on major lifestyle predictors of future Type 2 diabetes mellitus: exercise and weight control in a prospective non-randomized controlled study of a modular lifestyle and diabetes awareness intervention programme using a community development model. The study involved two complete church congregations from an ethnic group at high risk of diabetes (Western Samoans) (intervention church n = 78; control church n = 144). Weight remained stable (0 ± 4.8 kg) in the intervention church but increased by 3.1 ± 9.8 kg in the control church (p = 0.05). In the intervention church, there was an associated reduction in waist circumference (−4 ± 10 cm vs +2 ± 7 cm in control, p < 0.001), an increase in diabetes knowledge (46 ± 26 % vs 4 ± 17 % in control, p < 0.001) and an increase in the proportion exercising regularly (+22 % vs −8 % in control, p < 0.05). Consumption of key fatty foods was also reduced in the intervention church. We conclude that diabetes risk reduction programmes based upon lifestyle change, diabetes awareness, and empowerment of high risk communities can significantly reduce risk factors for future Type 2 diabetes. © 1998 John Wiley & Sons, Ltd.

Assessment of endothelial function during oral contraception in women with insulin-dependent diabetes mellitus

The effects of contraceptive steroids on the expression of endothelial homeostasis were examined by direct and indirect measures in women with insulin-dependent diabetes mellitus (IDDM) in a prospective nonrandomized controlled study. Study subjects were 13 women with uncomplicated IDDM treated with a monophasic combination of 30 μg ethinyl estradiol and 75 μg gestodene for 12 consecutive cycles and 13 women of comparable diabetic status as control. During the study period, none of the participants developed increased renal albumin excretion, which was used as a direct measure of endothelial function. In the indirect assessment of endothelial function, we found a proportionate increase in plasma levels of thrombin-antithrombin III (TAT) complexes and D-dimer during treatment. Hormonal intake was followed by decreased antigen concentrations of tissue plasminogen activator (t-PA) and plasminogen activator inhibitor (type 1 [PAI-1]), whereas the activities of t-PA and PAI-1 were unchanged. Plasma levels of plasminogen and histidine-rich glycoprotein (HRG) increased and decreased, respectively, whereas an increase in von Willebrand factor was observed in the treatment group. No significant changes in direct or indirect measures were observed in the control group during the observation period of 12 months. In conclusion, no adverse effect on endothelial function was demonstrated by direct measures, but our findings suggest that a procoagulant state, compensated by enhanced activity of the fibrinolytic system, is induced by hormonal treatment. Clinical and metabolic monitoring is recommended if the use of oral contraceptives in women with IDDM is extended.