To investigate whether a multidisciplinary, best practice central line maintenance care bundle reduces central line-associated blood stream infection (CLABSI) rates in hospitalized pediatric oncology patients and to further delineate the epidemiology of CLABSIs in this population.

The organization joined an effort to improve quality, focusing on CLABSI elimination through the implementation of best practice central line care bundles. The care bundle used was based on relevant Centers for Disease Control and Prevention (CDC) guidelines, including daily site assessment and dressings based on CDC recommendations; procedures for cap, tubing, dressing, and needle changes; catheter site care; and catheter hub, cap, and tubing care. Education on the Children’s Hospital Association (CHA) central line care bundle of reduction of line entries, aseptic entries into the line, and aseptic procedures when changing line components was performed. Nursing self-practice audits were performed prospectively, with a one day per week random nursing shift sampling for all patients with central lines. Targeted interventions were performed to improve compliance, including staff feedback of CLABSI rates, discussion in daily rounds, and mini root cause analysis in cases of CLABSI development. Ongoing individual and group education was performed based on the findings.

• Thirty patients (64% male, 36% female) were included.
• There were 14,059 central line days.
• Average age was 10.5 years.
• Key disease characteristics were hematologic and solid tumors and bone marrow transplantation (BMT).

• Single site 
• Inpatient 
• University-affiliated pediatric hospital in Maryland

• Patients were undergoing the active antitumor treatment phase of care. 
• The study has clinical applicability for pediatrics.

This study was a prospective, interupted time series.

• Anonymous nursing self-practice audits were performed on a randomly chosen nursing shift, one day every week, as a sampling strategy for all unit patients with central lines. Nursing practice was only recorded as compliant with one of the bundle elements if every part of that bundle was documented as completed appropriately.
• The CLABSI rate was defined as CLABSIs per 1,000 central line days.

The unit experienced a 20% decrease in CLABSI rates after the implementation of the intervention (p = 0.58). Secondary analyses indicated that the second year of the intervention had a 64% decline in CLABSI rates below baseline (p = 0.091), suggesting that a long ramp-up period may be necessary to achieve effective change. At the end of 24 months of continuous improvement efforts, 35% of patients were not receiving all bundle elements.

Although the implementation of best practices for central line care to decrease CLABSIs is a viable intervention, the long time to significant results should be seriously considered ongoing education, and monitoring would be required, potentially increasing costs and decreasing staff interest in the intervention.

• Small sample size (<100 patients)
• Findings were not generalizable.
• It is unclear if the results from a single-institution study can be generalized to nontertiary care inpatient pediatric oncology units that do not care for a large number of BMT recipients.
• Strategies described here for improvement activities included some but not all of those strategies shown by evidence to be effective. Staff did not adhere to bundle care 35% of the time, but there is no information about the causes of the lack of adherence.
• Various patient types and types of central lines were included, with a varied risk of infection.
• The heterogeneity of the sample and lack of sufficient sample size for related subgroup analysis limited the ability to draw firm conclusions. 
• The relationship between bundle adherence and infection development were not fully discussed.

CLABSI prevention efforts focusing on central line maintenance are difficult, rely directly on front-line staff participation, and require patience for culture change but also have a profound effect on each nurse who has worked to prevent an infection from occurring.  Nurses need to be aware of the evidence regarding effective approaches to improve guideline adherence and performance of evidence-based practice and use known effective strategies.  Causes of nonadherence to guidelines need to be identified in order for ongoing improvement.  With bundle approaches, it might be useful to analyze which bundle items are truly critical to the outcome.

To evaluate influenza vaccination in patients with cancer

DATABASES USED: PubMed from 1992–2002, using influenza, vaccination, immunization, cancer, and malignancy as search terms; no restrictions were placed on the language of the publications. Additional data were acquired by direct communication with vaccine manufacturers.

FINAL NUMBER STUDIES INCLUDED = 11 studies measuring seroconversion after influenza vaccination

KEY SAMPLE CHARACTERISTICS: No comments existed regarding the research design of the studies, but five studies included a control group.

Seroconversion rates following influenza vaccination ranged from 10%–78% in patients with cancer as compared with 56%–94% in healthy controls. Seroconversion rates following influenza vaccination ranged from 37%–52% in patients with cancer on chemotherapy as compared with 76%–92% of patients with cancer not receiving chemotherapy. One study of 42 adult patients with hematologic or oncologic disorders found that the seroconversion rate following influenza vaccination was 50% if the vaccine was given at the time of chemotherapy, compared with 93% if the vaccine was given between cycles.

• The studies found in the literature search were characterized by small sample sizes and an absence of stratification for tumor type, stage, chemotherapy schedule, vaccination type, or immune function.

STUDY PURPOSE: To evaluate the evidence to assess the effects of oral cryotherapy for the prevention of oral mucositis (OM)

• DATABASES USED: MEDLINE, EMBASE, CINAHL, CANCERLIT, Cochrane Collaboration, National Institutes of Health (NIH) health trials registry, World Health Organization (WHO) clinical trials registry
• KEYWORDS: Explicit search terms per database are provided.
• INCLUSION CRITERIA: Randomized controlled trails comparing oral cryotherapy against any other treatment or no treatment; OM caused by chemotherapy, radiotherapy, or combination therapy
• EXCLUSION CRITERIA: Crossover design trials, interventions involving other approaches in addition to cryotherapy

• FINAL NUMBER STUDIES INCLUDED = 14 in qualitative review, 11 in meta-analysis
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,316
• SAMPLE RANGE ACROSS STUDIES: 20–206 patients
• KEY SAMPLE CHARACTERISTICS: One study included a small number of children, one study involved patients with head and neck cancer receiving radiation therapy, and the rest involved patients receiving chemotherapy. Five studies involved treatment with high-dose melphalan.

PHASE OF CARE: Active antitumor treatment

Insufficient evidence exists to evaluate the effect of cryotherapy in patients receiving radiation therapy alone for head and neck cancer. Five studies in which 5-fluorouracil (5-FU) was administered showed that oral cryotherapy reduced the risk of OM development (RR = 0.61; 95% CI [0.52, 0.72]; p < 0.00001). Five studies involving treatment with high-dose melphalan risk of OM was also reduced (RR = 0.59; 95% CI [0.35, 1.01]; p = 0.05). OM risk was reduced in mild, moderate, and severe OM cases. Insufficient evidence existed to determine whether 30 minutes or 60 minutes of cryotherapy was more effective. One study with a high risk of bias showed no difference between oral cryotherapy and the use of prophylactic chlorhexidine.

Oral cryotherapy is effective in reducing OM in patients receiving 5-FU and high-dose melphalan.

Studies were of moderate quality based on the risk of bias assessment.

Strong evidence existed in support of effectiveness of oral cryotherapy to reduce the OM risk in patients receiving 5-FU treatment and moderately strong evidence of efficacy in patients given high-dose melphalan. Very limited evidence existed in children. This intervention is very low risk, so nurses can advocate for the use of oral cryotherapy for patients receiving chemotherapeutic agents with a short half-life. Ice chips could create a potential choking hazard for children; therefore, the use of iced drinks or popsicles may be better approaches to use in this population. Future research of head and neck trials of cryotherapy versus other effective interventions would be useful to further inform clinical practice.

To compare time to absolute neutrophil count (ANC) recovery for patients treated with filgrastim versus pegfilgrastim.  

Patients were randomized to Arm A, pegfilgrastim 6 mg subcutaneously on day 1 after autologous peripheral blood stem cell transplant (PBSCT), or Arm B, weight-based dose of filgrastim subcutaneously from day 1 until either the third consecutive day of ANC greater than 5,000/mm³ or one day of ANC greater than 10,000/mm³ after PBSCT.  Duration of treatment was not to be more than 21 days.

• Ninety-two patients (64% male, 36% female) with non-Hodgkin lymphoma (NHL) were included.
• Age range was 23.4 to 73 years.
• Patients had previously undergone PBSCT.

Multi-site

Patients were undergoing the active treatment phase of care.

This was a randomized, phase II study.

• Until engraftment:  brief daily history, physical examination, and laboratory work
• After engraftment as clinically indicated:  daily history, physical examination, weekly Eastern Cooperative Oncology Group Performance Status (ECOG PS), complete blood count (CBC) at least 3 times a week, and comprehensive metabolic panel at least twice a week
• Test hypotheses:  H0 (MEANarm A - MEANarmB >2 days) versus H1 (MEANarm A - MEANarmB  <2 days), where MEANarm A represents the mean time to ANC recovery in patients treated with pegfilgrastim and MEANarmB represents the mean time to ANC recovery in patients treated with filgrastim.
• Equivalence of pegfilgrastim to filgrastim would be accepted if time to recovery with pegfilgrastim was different by less than 2 days when compared to filgrastim.
• Similar methods were used for secondary objectives. Febrile neutropenia, intravenous (IV) antibiotics, positive blood cultures, and red blood cell transfusion.  
   

• Forty-eight patients in arm A and 44 patients in arm B completed treatment.
• Mean ANC recovery time was 9.3 days for pegfilgrastim (Arm A) compared to 9.8 days for filgrastim (Arm B), resulting in statistically significant finding (p < 0.01).

In the posttransplant setting, pegfilgrastim is preferred over filgrastim based on faster neutrophil recovery, less patient discomfort, and comparable cost.

Small sample size

Pegfilgrastim is favored over filgrastim in patiens undergong NHL posttransplantation due to faster ANC recovery with less patient discomfort at cost that is comparable.

The primary aim of the study was to describe the practice of palliative sedation for patients with cancer and compare patients who were sedated prior to death with patients who were not sedated. The secondary aim was to explore clinical implications of palliative sedation for symptom management at the end of life.

• Medical and nursing records of 157 (of the 753 admitted) patients with cancer who died at an acute palliative care unit (PCU) were analyzed.
• For patients who underwent palliative sedation, “continuous deep sedation” was warranted and titrated until the “cessation of symptoms.\"
• Records of patients’ characteristics and decision-making process (i.e., discussion with patient, relative, and other caregiver; indication for initiating palliative sedation; sedatives used and duration of sedation) were analyzed.
• Patients who received palliative sedation were compared with patients who hadn’t based on sex, age, primary tumor site, survival after admission, survival after identification of primary tumor, and survival after identification of metastases.

• The study reported on a sample of 157 patients.
• The mean age of sedated patients was 55 years, and the mean age of nonsedated patients was 59 years.
• Of the sample, 86 were females [37 (54%) were sedated, and 49 (55%) were nonsedated]. Seventy-one were males [31 (46%) were sedated, and 40 (45%) were nonsedated].
• The cancer types in the sample were lung (35%), gastrointestinal (27%), breast (41%), genitourinary (29%), head and neck (13%), melanoma (19%), sarcoma (15%), and other (21%).
• Patients with cancer who died at the acute PCU between 2001 and 2005 were included.
• Versed, often combined with propofol, was the commonly utilized sedative.

The single-site study was conducted on an inpatient PCU in the Netherlands.

Patients were undergoing end-of-life and palliative care.

Retrospective, descriptive study

Checklist for data retrieval from medical records

Sixty-eight patients (43%) had received palliative sedation. Palliative sedation for the majority of patients (68%) started on the last day before death, with an average duration of 19 hours (range of 1–125 hours). No difference was seen between sedated and nonsedated patients with regards to sex or survival after admission to the acute PCU (mean of 8 and 7 days respectively, P = 0.12). Within 48–25 hours prior to death, sedation was initiated in 13 patients, while 45 patients received sedation 24–0 hours before death. The experience of pain, dyspnea, and delirium during the interval 48–25 hours before death in both sedated and nonsedated groups had decreased during the interval 24–0 hours before death (P = 0.54). Midazolam, sometimes combined with propofol, was the most commonly used sedating drug.

• Findings suggest that palliative sedation does not hasten death when used for patients with limited life expectancy.
• Use of sedation did not appear to be associated with differences in symptom severity shortly before death.

• To what degree nursing and medical records are reflective of clinical practice and how thoroughly they were filled out are questionable.
• No insight was provided into the severity of symptoms or decision-making process regarding palliative sedation because data reviewed were in summary format.
• Generizability of data to other palliative care settings is questionable.
• Validity of patients’ experiences of symptoms is questionable because patients are under palliative sedation.

• Delirium and dyspnea in the last few days of life are common and should be anticipated early, especially at the onset of sedation, so that they can be appropriately managed.
• This retrospective analysis suggests that palliative sedation does not hasten death.

To evaluate evidence of lymphedema self-care through a systematic review

Databases searched were PubMed, CINAHL, Cochrane Collaboration, PapersFirst, ProceedingsFirst, Worldcat, PEDro, National Guidelines Clearing House, ACP Journal Club, and Database of Abstracts of Reviews of Effects. Best Practice for the Management of Lymphoedema (Lymphedema Framework, 2006) terms were used as well as additional terms that were not stated. Inclusion criteria were not specified. Qualitats, grey literature, dissertations, live studies, and case reports were excluded.

The total references received was 47. Literature was evaluated and commented on using categories of PEP levels of evidence.

• The final number of studies included was 16.
• The sample range across studies was 10–1,449.
• Most studies were of breast cancer survivors.
• Only single therapies done via self-care were included. 

• Late effects
• Survivorship

Reviewed findings related to self-care interventions. No interventions met criteria for Recommended for Practice. Interventions that were Likely to Be Effective included full-body exercise and phase 2 complete decongestive therapy (CDT). Pneumatic compression devices, compression garments, infection management, self-monitoring, skin care, simple manual decongestive therapy, and weight reduction were categorized as Effectiveness Not Established. Aromatherapy was categorized as Effectiveness Unlikely.

Strongest evidence for effect is found for exercise and phase 2 CDT.

There were relatively few studies in the area of self-care interventions.

Findings suggested that self-care using exercise and CDT are likely to be effective for lymphedema self-management. Further research in other potential self-care interventions are needed.

To compare advanced pneumatic truncal, chest, and arm treatment to arm only treatment to determine which therapy provides a larger reduction in lymphedema in post-operative patients with breast cancer

Participants were randomly assigned to receive truncal, chest, and arm compression or arm compression only. The compression was performed for one-hour, once per day for 30 days.

• The study reported on 42 patients.
• The mean age of patients was 56.9 years (SD = 8.1 years) with a range of 38–71.
• The sample was 100% female.
• Patients had breast cancer and were diagnosed with lymphedema stage II (2 cm circumference difference or a lymphedema index ratio of 1.163 with dominant arm affected or 1.109 when the nondominant arm was affected).
• Patients were at least 6 months postsurgery or postradiation treatment.

The study was conducted in Nashville, TN. The site and setting were not stated.

Patients were undergoing active lymphedema treatment.

This was a randomized control trial.

Demographic and medical data was collected via nurse interviews. The participants completed a Lymphedema Symptom Intensity and Distress Survey—Arm (LSIDS-A) and a functional assessment screening questionnaire (FASQ).

A statistically significant reduction was found in the number of symptoms and overall burden from the symptoms in both groups (p < 0.01). However, no statistical significance was found in the number of symptoms between groups (p = 0.145). No statistically significant change was found in functioning from baseline to the end of the study for either group, and no difference was found between the control and intervention group. The physical arm measurements indicated a significant reduction in bioelectrical impedance within both groups at the end of the study compared to baseline (p = 0.004 for arm only and p = 0.023 for truncal, chest, and arm). The combined groups were found to have a significant reduction at p = 0.018.

Both groups experienced a significant improvement but no difference was found based on treatment of arm alone or of truncal, chest, and arm. Some differences were noted between the intervention and control group that may have led to these conclusions. For example, the participants in the experimental group had more symptoms at baseline than the control group; whether these patients would have benefited equally from the arm-only treatment was not clear. Another variable that may have affected results is that the experimental group developed lymphedema more quickly after surgery and at a younger age. Researchers have hypothesized that opening truncal lymph channels is necessary to promote volume reduction, but this study suggested that the procedure may not play as a big of a role as originally thought. Repeating this study with a larger sample size, while holding these possible confounding variables constant, would be worthwhile.

• The sample size was small with fewer than 100 patients.
• Important baseline sample differences exist, such as the fact that the patients in the experimental group developed lymphedema more quickly after surgery and at a younger age.
• A risk of bias exists because of the lack of blinding and the particular sample characteristics.

This study suggested that truncal, chest, and arm pneumatic compression therapy is not significantly better than arm pneumatic compression alone. Differences between the control group and the experimental group could have contributed to these findings. Repeating the study with more rigorous inclusion and exclusion criteria is needed to ensure that these variables did not affect the results of the study.

To examine the impact of advanced practice nurse (APN)-administered low-level laser therapy (LLLT) as a stand-alone and complementary treatment for arm volume, symptoms, and quality of life (QOL) in women with breast cancer–related lymphedema

Three interventions were used, including LLLT alone, manual lympatic drainage (MLD) alone, and combined MLD and LLLT. LLLT alone used a RianCorp LTU 904, FAD-approved, class I laser. Grids for the areas to be treated were identified. The laser was applied, and exposure was limited to 20–30 seconds per point in each grid. Time for each session using this procedure was about 20 minutes. MLD alone included treatment that followed international standards. A standard number of strokes was used at each anatomical location. Each MLD session took about 40 minutes. Combined MLD and LLLT included participants receiving 20 minutes of LLLT, followed by 20 minutes of MLD. In addition, compression bandaging was applied after each treatment regardless of group assignment. Baseline and outcome data were collected pretreatment and on the last day of treatment after therapy was concluded.

• N =  46   
• MEAN AGE = 66.6 years (SD = 10.4 years)
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors with treatment-related lymphedema
• OTHER KEY SAMPLE CHARACTERISTICS:  95.7% Caucasian

• SITE:  Single site 
• SETTING TYPE:  Other 
• LOCATION:  Private medical practice in Florida

• PHASE OF CARE: Late effects and survivorship

• A pilot, randomized clinical trial

• Extracellular fluid with bioelectrical impedance
• Arm volume with circumferential measurement
• Height and weight
• Skin assessment checklist
• Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A)
• Brief Fatigue Inventory (BFI)
• Profile of Mood States-Short Form (POMS)
• Center for Epidemiologic Studies-Depression (CES-D)
• Upper Limb Lymphedema-27 (ULL27)
• Functional Assessment of Cancer Therapy-Breast (FACT-B)

All groups had clinically and statistically significant reduction in volume (p < 0.05); however, no statistically significant between-group differences were found in volume reduction. Treatment-related improvements were noted in symptom burden within all groups; however, no group differences were noted in psychological and physical symptoms or QOL. Skin improvement was noted in each group that received LLLT.

LLLT with compression bandaging may offer a time-saving therapeutic option to conventional MLD.

• Small sample (< 100)
• Risk of bias (no blinding)
• Other limitations/explanation: The dose of each intervention varied by individual patient because current reimbursement does not cover lymphedema therapy once reduction has slowed or stopped.

The study demonstrates that a trained APN could implement lymphedema therapy in clinical practice. LLLT with bandaging may offer a time-saving therapeutic option to conventional MLD. Studies with a larger sample size are needed to compare MLD and LLLT.

To examine potential efficacy of the Flexitouch system (compression garment) for self-care home use in patients with breast cancer who had truncal lymphedema

The system examined includes compression garments for the trunk, chest, and arm and applies variable dynamic pressure to affected areas, controlled by software programming. It uses multi-chambered inflatable and stretchable fabric garments. Patients were fitted for the garments. Patients completed one-hour daily treatments for 10 days. Patient symptoms and cirumferential measurements were done at baseline, after the fifth treatment, and at the end of the study. Patients were trained in use and, after the initial treatment, were instructed in use for home treatment. Research staff observed the first home treatment, then patients completed the rest on their own at home.

• The study sample (N = 12) was comprised of female patients with breast cancer.
• Mean age was 55.3 years, with a range of 43–79 years.
• Patients had an average of 5.4 years since diagnosis and an average of 52.6 months duration of lymphedema.
• Of patients in the study, 75% were married or partnered and 50% were employed full-time.

The study took place in home settings in the United States.

The study has clinical applicability for late effects and survivorship.

The study used a quasi-experimental pre-post design.

• Patients took the Lymphedema Symptom Intensity and Distress Survey-Arm and Trunk (LSIDS-AT).
• Patients took the Functional Assessment Screening Questionnaire.
• Trunk circumference was measured using Gulick II tape.

There were significant reductions in symptoms of truncal heaviness (x² = 15.07, p = 0.0001), swelling (x²=14.73, p = 0.0001), tightness (x² = 12.63, p = 0.0002) and itchiness (x²= 12.0, p = 0.0002). There were no significant changes in truncal measurements; however, there was a general non-significant trend of reduced circumference in all areas measured. There was also significant reduction in difficulty sleeping (p = 0.008).  All significant changes occurred after the fifth treatment and then remained stable at the end of the study. There was a general trend of increasing reports of skin conditions over the course of the study.

The system may be an effective device to relieve lymphedema symptoms with home self-care treatment.

• The sample size was small, with less than 30 participants.
• The study design had a risk of bias because of no control group, no blinding, no random assignment, and no appropriate attentional control condition. Risk of bias (no control group) 
• The study duration was short, and it is not clear what the longer-term effects would be, particularly given the trend of increasing skin condition reporting.

The device may be helpful to reduce symptoms of lymphedema with an approach that patients can use at home for self-care. Larger controlled studies are warranted and longer term use should be evaluated.

To compare the safety and efficacy of a once-daily dose of a new formulation of morphine sulfate—abuse-deterrent, prolonged-release erodible-matrix (ADPREM) morphine sulfate—to the safety and efficacy of a twice-daily dose of standard controlled-release morphine

During a run-in period of three days, clinicians determined each patient's effective dose of the study drug. Throughout the study, immediate-release morphine was available for breakthrough pain. The study drug was titrated to provide a level of pain relief characterized by four or fewer episodes of breakthrough pain per day and a level of pain intensity that was acceptable (this level was undefined). Treatment periods were two weeks long. In a crossover trial, patients received either the study drug, once daily, or controlled-release morphine twice daily. In diaries patients recorded daily all medications used, number of breakthrough episodes, and pain ratings. Clinicians evaluated adverse events.

• The sample was composed of 34 patients.
• Mean patient age was 57.5 years. Age range was 42–81 years.
• Of all patients, 36.8% were female and 63.2% were male.
• The most common cancer types in the sample were lung, breast, and rectal cancer.

• Multisite
• Outpatient
• Italy

Randomized phase 2 double-blind crossover study

• Eleven-point numeric rating scale, to measure pain intensity
• Drug-metabolite concentration in plasma

The pattern of treatment-related adverse events was the same for both treatments. The fixed dose determined during the run-in period was 30–210 mg/day. Authors noted no differences between treatments in regard to breakthrough pain episodes or use of rescue medication. Average pain intensity ratings were similar for both treatments.

The efficacy and side effects associated with a once-daily dose of ADPREM morphine sulfate were similar to those associated with twice-daily doses of controlled-release morphine. Studies that include larger samples are warranted.

• The study had a small sample, with fewer than 100 participants.
• Authors did not provide a standard definition of the term acceptable pain.

For some patients, the ability to control pain by using fewer pills daily may be a significant consideration. This study provides evidence that supports the efficacy and safety of a once-daily ADPREM formulation of morphine.