A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans

This article reports the first randomized prospective multicenter evaluation of a bioabsorbable conduit for nerve repair. The study enrolled 98 subjects with 136 nerve transections in the hand and prospectively randomized the repair to two groups: standard repair, either end-to-end or with a nerve graft, or repair using a polyglycolic acid conduit. Two-point discrimination was measured by a blinded observer at 3, 6, 9, and 12 months after repair. There were 56 nerves repaired in the control group and 46 nerves repaired with a conduit available for follow-up. Three patients had a partial conduit extrusion as a result of loss of the initially crushed skin flap. The overall results showed no significant difference between the two groups as a whole. In the control group, excellent results were obtained in 43 percent of repairs, good results in 43 percent, and poor results in 14 percent. In those nerves repaired with a conduit, excellent results were obtained in 44 percent, good results in 30 percent, and poor results in 26 percent (p = 0.46). When the sensory recovery was examined with regard to length of nerve gap, however, nerves with gaps of 4 mm or less had better sensation when repaired with a conduit; the mean moving two-point discrimination was 3.7 +/- 1.4 mm for polyglycolic acid tube repair and 6.1 +/- 3.3 mm for end-to-end repairs (p = 0.03). All injured nerves with deficits of 8 mm or greater were reconstructed with either a nerve graft or a conduit. This subgroup also demonstrated a significant difference in favor of the polyglycolic acid tube. The mean moving two-point discrimination for the conduit was 6.8 +/- 3.8 mm, with excellent results obtained in 7 of 17 nerves, whereas the mean moving two-point discrimination for the graft repair was 12.9 +/- 2.4 mm, with excellent results obtained in none of the eight nerves (p < 0.001 and p = 0.06, respectively). This investigation demonstrates improved sensation when a conduit repair is used for nerve gaps of 4 mm or less, compared with end-to-end repair of digital nerves. Polyglycolic acid conduit repair also produces results superior to those of a nerve graft for larger nerve gaps and eliminates the donor-site morbidity associated with nerve-graft harvesting.     

A cluster randomized controlled trial comparing three methods of disseminating practice guidelines for children with croup [ISRCTN73394937]

Background

The optimal management of croup – a common respiratory illness in young children – is well established. In particular, treatment with corticosteroids has been shown to significantly reduce the rate and duration of intubation, hospitalization, and return to care for on-going croup symptoms. Furthermore treatment with a single dose of corticosteroids does not appear to result in any significant adverse outcomes, and yields overall cost-savings for both families and the health care system. However, as has been shown with many other diseases, there is a significant gap between what we know and what we do. The overall aim of this study is to identify, from a societal perspective, the costs and associated benefits of three strategies for implementing a practice guideline that addresses the management of croup.

Methods/designs

We propose to use a matched pair cluster trial in 24 Alberta hospitals randomized into three intervention groups. We will use mixed methods to assess outcomes including linkage and analysis of administrative databases obtained from Alberta Health and Wellness, retrospective medical chart audit, and prospective telephone surveys of the parents of children diagnosed to have croup. The intervention strategies to be compared will be mailing of printed educational materials (low intensity intervention), mailing plus a combination of interactive educational meetings, educational outreach visits, and reminders (intermediate intensity intervention), and a combination of mailing, interactive sessions, outreach visits, reminders plus identification of local opinion leaders and establishment of local consensus processes (high intensity intervention). The primary objective is to determine which of the three intervention strategies are most effective at lowering the rate of hospital days per 1,000 disease episodes. Secondary objectives are to determine which of the three dissemination strategies are most effective at increasing the use of therapies of known benefit. An economic analysis will be conducted to determine which of the three intervention strategies will most effectively reduce total societal costs including all health care costs, costs borne by the family, and costs stemming from the strategies for disseminating guidelines.     

An outcome analysis comparing the thoracodorsal and internal mammary vessels as recipient sites for microvascular breast reconstruction: a prospective study of 100 patients

The thoracodorsal vessels have been the standard recipient vessels for the majority of surgeons performing free transverse rectus abdominis musculocutaneous (TRAM) flap reconstructions. Recently, the internal mammary vessels have been recommended as the first-choice recipient vessels for microvascular breast reconstruction. This approach requires a shorter pedicle length, allows for central placement of flap tissue, and avoids axillary scarring. The use of the internal mammary vessels may provide for a shorter operative time and a higher-quality aesthetic reconstruction. The authors performed a prospective trial examining the differences in operative and aesthetic outcomes between each recipient site. A prospective trial of 108 consecutive free-tissue transfers was conducted in 100 patients. The first 60 TRAM flap patients were randomized so that 30 flaps were anastomosed to the internal mammary vessels and 30 were anastomosed to the thoracodorsal vessels, whereas the recipient vessels for the remaining 40 patients were left to the discretion of the surgeon. Of the 40 nonrandomized patients, 10 patients underwent reconstruction using the internal mammary vessels and 30 patients underwent reconstruction using the thoracodorsal vessels. The patients' medical history and hospital course were noted. To evaluate aesthetic outcome, a group of five blinded nonmedical observers and three blinded plastic surgeons graded the reconstructions in the 60 TRAM flap patients for symmetry and overall aesthetic result on a scale of 1 to 5. Blinded practitioners administered postoperative questionnaires to patients regarding recovery time and satisfaction with the aesthetic result. Forty-three flaps were transferred to the internal mammary vessels and 65 were transferred to the thoracodorsal vessels. No significant differences existed between groups with regard to age of preoperative risk factors. Average operative time was 6 hours in each group. Average hospital stay was 5.8 days in each group. Conversion from initial recipient vessel to a secondary recipient site occurred in 12.5 percent of internal mammary reconstructions and 7 percent of thoracodorsal reconstructions. All converted internal mammary cases occurred in left-sided reconstructions and were attributable to problems with the veins. Overall, 20 percent of left-sided internal mammary reconstructions were found to have an inadequate recipient vein. Unusable thoracodorsal vessels were found only in delayed reconstructions, at a rate of 15 percent in the delayed setting. All flaps from converted procedures survived without complications. Average follow-up was 20 months, during which time there was one flap loss in the thoracodorsal group. There were no significant differences in complication rates between groups. Average aesthetic grade was 3.6 in each group. Postoperative recovery time and overall patient satisfaction were not significantly different between groups. Either recipient site can provide for a safe and acceptable result; however, surgeons should be aware of conversion rates and plan appropriately if recipient vessels appear unusable for free-tissue transfer.     

Adjuvant chemotherapy for breast cancer: side effects and quality of life.

In a trial of postoperative adjuvant chemotherapy women with primary breast cancer and spread to one or more axillary nodes were randomised to receive a six-month course of either the single agent chlorambucil or the five-drug combination of chlorambucil, methotrexate, fluorouracil, vincristine, and adriamycin. On completing the treatment 47 patients were asked to fill in questionnaires at home on the side effects of treatment and its influence on the quality of their life. Side effects including nausea, vomiting, malaise, and alopecia had been severe enough to interfere with their lifestyle in 9 (42%) of the patients who had received the single agent and 19 (79%) of those who had received multiple-drug treatment. Various other side effects were reported by a few patients. Seven (29%) of the patients who had received the multiple-drug schedule voluntarily added that the treatment had been "unbearable" or "could never be gone though again." The proportion of patients who had experienced severe side effects while receiving the treatment was considerable; hence such adjuvant chemotherapy is justifiable only if it will substantially improve a patient''s prognosis.     

Reduction mammaplasty is a functional operation,improving quality of life in symptomatic women: a prospective,single-center breast reduction outcome study

Breast hypertrophy creates a functional disability, adversely affecting quality of life because of disproportionate upper body weight. No study to date has prospectively shown or statistically proved (using validated questionnaires) the functional benefits of breast reduction surgery. Moreover, no study has quantified the physical findings seen in these patients. A prospective trial was designed to illustrate objectively the functional benefits of breast reduction surgery and answer the question, Does surgically removing breast tissue in symptomatic patients (regardless of amount of tissue removed) improve their physical disabilities related to breast hypertrophy, and in turn, improve their quality of life? Fifty-five consecutive patients with an average age of 38 years (range, 18 to 73 years) undergoing breast reduction surgery by the senior surgeon (L.A.C.) were recruited for this study. The North American Spine Society (NASS) Lumbar Spine Outcome Assessment Instrument was used to assess patients' disability, expectations for treatment, and satisfaction with treatment. The visual analogue scale was used to quantify pain intensity. Muscle strengths of the pectoralis major, pectoralis minor, rhomboid, middle trapezius, and lower trapezius muscles and postural measures were obtained. Information was collected preoperatively and 6 months postoperatively for comparison. The mean cumulative preoperative NASS Lumbar Spine Outcome Assessment Instrument disability score was 1.94 +/- 0.68, and the mean cumulative postoperative disability score was 1.16 +/- 0.35 (p = 0.0001); 96.1 percent of patients met expectations to a certain degree and, of these patients, 96 percent were very satisfied with their surgery. The mean cumulative baseline preoperative visual analogue score for all participants was 6.2 +/- 2.06, and their mean cumulative postoperative score was 0.53 +/- 0.88 (p = 0.0001). There was statistically significant improvement of muscle strength in the rhomboids, middle trapezius, and lower trapezius muscles (p < 0.001). All postural measures showed improvement postoperatively, with head translation and cranial rotation showing statistical improvement (p < 0.05). This single-center, single-surgeon breast reduction outcome study showed that the signs and symptoms of breast hypertrophy are definable in a consistent manner. By standardizing and quantifying preoperative and postoperative evaluations with validated questionnaires, validated pain scoring, and standardized muscle and posture testing, it was shown that breast reduction for symptomatic breast hypertrophy can effect a statistically significant improvement in these objective measures of pain, disability, muscle weakness, and poor posture.     

Hospitalization-induced exacerbation of the ill effects of chemotherapy on rest-activity rhythm and quality of life of breast cancer patients: a prospective and comparative cross-sectional follow-up study

ABSTRACT

Chemotherapy administration may result in the disruption of circadian rhythms and impairment of quality of life (QoL) of cancer patients. Nevertheless, we have little knowledge on the long-term consequences of chemotherapy and the effects of hospitalization. In the present study, we employed the two-factor repeated-measure cross-sectional design to determine the effects of chemotherapy and hospitalization on rest-activity (RA) rhythm and QoL of breast cancer patients. Initially, we randomly selected 39 inpatients and 42 outpatients, scheduled to receive six cycles of chemotherapy, from the Regional Cancer Center (RCC), Raipur, India. Finally, 30 patients in each group were included in the current study. We monitored circadian RA rhythm and QoL using wrist actigraphy and QLQ-C30 and QLQ-BR23, respectively, during the 1st (C1), 3rd (C3) and 6th (C6) chemotherapy cycles. Results revealed that with the progression of chemotherapy cycles (from C1 to C6), all rhythm parameters, namely mesor, amplitude, acrophase, rhythm quotient (RQ), circadian quotient (CQ), peak activity (PA), dichotomy index and autocorrelation coefficient, significantly decreased in both cancer in- and outpatients. In both groups of patients and during C1–C6, all functional and global QoL measures of QLQ-C30 and QLQ-BR23 significantly decreased and the symptoms significantly increased, except constipation, body image, sexual functioning and future perspectives in outpatients. The hospitalization exacerbated the problems associated with the RA rhythm and the QoL of the patients. In conclusion, the current study highlighted the negative consequences of hospitalization among inpatients, irrespective of the stage of cancer. We, therefore, recommend that cancer patients should be administered with chemotherapy as outpatients. The proposed protocol might have a covert bearing on the expression of better physiological state leading to satisfactory treatment outcomes.     

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

Background

Quality improvement (QI) programs focused on mastery of content by individual staff members are the current standard to improve resident outcomes in nursing homes. However, complexity science suggests that learning is a social process that occurs within the context of relationships and interactions among individuals. Thus, QI programs will not result in optimal changes in staff behavior unless the context for social learning is present. Accordingly, we developed CONNECT, an intervention to foster systematic use of management practices, which we propose will enhance effectiveness of a nursing home Falls QI program by strengthening the staff-to-staff interactions necessary for clinical problem-solving about complex problems such as falls. The study aims are to compare the impact of the CONNECT intervention, plus a falls reduction QI intervention (CONNECT + FALLS), to the falls reduction QI intervention alone (FALLS), on fall-related process measures, fall rates, and staff interaction measures.

Methods/design

Sixteen nursing homes will be randomized to one of two study arms, CONNECT + FALLS or FALLS alone. Subjects (staff and residents) are clustered within nursing homes because the intervention addresses social processes and thus must be delivered within the social context, rather than to individuals. Nursing homes randomized to CONNECT + FALLS will receive three months of CONNECT first, followed by three months of FALLS. Nursing homes randomized to FALLS alone receive three months of FALLs QI and are offered CONNECT after data collection is completed. Complexity science measures, which reflect staff perceptions of communication, safety climate, and care quality, will be collected from staff at baseline, three months after, and six months after baseline to evaluate immediate and sustained impacts. FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the end of the intervention. Analysis will use a three-level mixed model.

Discussion

By focusing on improving local interactions, CONNECT is expected to maximize staff's ability to implement content learned in a falls QI program and integrate it into knowledge and action. Our previous pilot work shows that CONNECT is feasible, acceptable and appropriate.

Trial Registration

ClinicalTrials.gov: NCT00636675     

Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness

Background

Prolonged sedation is common in mechanically ventilated patients and is associated with increased morbidity and mortality. We sought to determine the diagnostic value of head computed tomography (CT) in mechanically ventilated patients who remain unresponsive after discontinuation of sedation.

Methods

A retrospective review of adult (age >18 years of age) patients consecutively admitted to the medical intensive care unit of a tertiary care medical center. Patients requiring mechanical ventilation for management of respiratory failure for longer than 72 hours were included in the study group. A group that did not have difficulty with awakening was included as a control.

Results

The median time after sedation was discontinued until a head CT was performed was 2 days (interquartile range 1.375–2 days). Majority (80%) of patients underwent head CT evaluation within the first 48 hours after discontinuation of sedation. Head CT was non-diagnostic in all but one patient who had a small subarachnoid hemorrhage. Twenty-five patients (60%) had a normal head CT. Head CT findings did not alter the management of any of the patients. The control group was similar to the experimental group with respect to demographics, etiology of respiratory failure and type of sedation used. However, while 37% of subjects in the control group had daily interruption of sedation, only 19% in the patient group had daily interruption of sedation (p < 0.05).

Conclusion

In patients on mechanical ventilation for at least 72 hours and who remain unresponsive after sedative discontinuation and with a non-focal neurologic examination, head CT is performed early and is of very limited diagnostic utility. Routine use of daily interruption of sedation is used in a minority of patients outside of a clinical trial setting though it may decrease the frequency of unresponsiveness from prolonged sedation and the need for head CT in patients mechanically ventilated for a prolonged period.