To compare and evaluate the efficacy, safety, acceptance, and one-year outcome of two laxatives, polyethylene glycol (PEG) without electrolytes and milk of magnesia (MOM).

Patients were randomly assigned to intervention with PEG 3350 without electrolytes (Miralax^®) or MOM by drawing a sealed envelope. Patients initially received 0.7 g/kg of PEG or 2 ml/kg of MOM daily.

• A total of 117 children were asked to participate; 79 were enrolled and randomized.
• The PEG group comprised 39 patients (31 boys and 8 girls), whereas the MOM group comprised 40 patients (34 boys and 6 girls).
• Patients were included in the study if they were new referrals (more than one per week), were aged four years or older, and had presence of functional constipation with fecal incontinence.
• Patients were excluded if they had stool toileting refusal, fecal incontinence without constipation, previously refused one of the study medications, Hirschsprung disease, previous surgery involving the colon, chronic intestinal pseudo-obstruction, or come for a second opinion.

Children’s Hospital of Iowa

Randomized controlled trial

• Improvement was defined as three or more bowel movements (BMs) per week and two or fewer episodes of fecal incontinence per month with no abdominal pain, with or without laxative.
• Recovery was defined as three or more BMs per week and two or fewer episodes of fecal incontinence per month with no abdominal pain, without laxative treament for at least one month.
• Children who received additional senna were counted as not improved or recovered.

• Baseline characteristics were not significant (p > 0.07).
• Compliance rates were significant at 95% for the PEG group and 65% for the MOM group.
• After 12 months, 62% of the PEG group and 43% of the MOM group exhibited improvement and 33% of the PEG group and 23% of the MOM group recovered (not significant).

PEG and MOM are effective and safe in long-term treatment, with PEG having better acceptance.

• The study had a high drop-out rate (loss to follow-up).
• The study did not measure biochemical profiles for all children.

Placebo versus two treatment arms of recombinant coagulation factor VIIa: 20 mcg/kg and 80 mcg/kg

• N = 204
• OTHER KEY SAMPLE CHARACTERISTICS: Noncirrhotic adults undergoing partial hepatectomy for cancer and/or benign tumors

• Placebo-controlled RCT

• Designed for 50% relative reduction
• Outcome measures included erythrocyte transfusion during or 48 hours after surgery
• Amount of erythrocytes transfused
• Change in hematocrit
• Requirement of fresh frozen plasma
• Surgery time
   

Perioperative transfusion difference approached significance (P = 0.09). Mean requirements decreased with rFVIIa (P = 0.78). Blood loss during surgery decreased (P = 0.07).





 

• 80% power
• Significance level 5%
• Exceeded 180 sample size
• No statistically significant results
• Larger trial needed for better evaluation

A larger trial is needed for better evaluation.

Patients were given a 5-mg pilocarpine tablet or placebo starting the day before the conditioning regimen, every 4 hours, for a total of 4 tablets per day. Patients continued taking tablets until absolute neutrophil count (ANC) was greater than 500 for 48 hours, discharge from hospital, or mucosal recovery.

• The study reported on 36 patients with 20 receiving pilocarpine and 16 receiving placebo.
• Patients were undergoing autologous stem cell transplant (SCT) with multiple (not all hemotologic) malignancies.

This was a prospective, double-blind, randomized, placebo-controlled trial. Patients were stratified by diagnosis and randomized by a computer-generated numbering scheme.

• The World Health Organization (WHO) mucositis scale and CMC outcome measures toxicity criteria were used.
• Numerous outcomes were measured.

• No statistically significant differences were found in the incidence, severity, or duration of mucositis.
• Pain at rest and with swallowing and the use of systemic narcotics were not significantly different.
   

Despite prior small trials that showed a benefit, this study clearly did not.  The intervention was not effective.

A standardized scoring system is needed.

1. Six sessions (50 minutes) of cognitive rehabilitation focused on purpose of a memory notebook and a calendar with a specific format as an external aid to compensate for cognitive symptoms.   
2. Six sessions of problem-solving therapy over two weeks focused on the ABC method of constructive thinking and problem solving.

• Enrolled: 7 control and 12 Tx
• Completed CRP: 6 control and 8 Tx
• Three-month F/U: 5 control and 8 Tx

*Withdrawals were due to tumor progression; new onset seizures; time commitment; caregiver issues; and fatigue.

• Tx group: 7 men, 5 women
• Controls: 4 men, 3 women

1. Newly diagnosed PBT prior to or during XRT
2. 18 years of age or older
3. Mild or moderate cognitive impairment based on neuropsych testing from the clinical assessment of the neuropsychologist
4. Prognosis of at least six months
5. Ability to attend sessions at the institution for two weeks
6. Designated caregiver must attend all sessions.

• SITE: Single site  
• LOCATION: Mayo Clinic

Randomized controlled trial; longitudinal

1. Baseline cognitive function (R-BANS) showed that control group scored lower than intervention group for memory.
2. Baseline cognitive function was used only as a comparison for those who completed all time points in the study as compared to those who did not.

1. Implementation of compensation strategies was used by 88% of subjects several times/week to several times/day after intervention completion; reduced to 50% at three-month follow-up (88% used at least once/week at three months).
2. 88% found intervention somewhat helpful to very helpful; 50% found cognitive intervention helpful, whereas 25% found problem-solving most helpful and 25% found both equally helpful; 88% would recommend to another PBT patient; caregivers had similar feedback about the program.

1. Study demonstrated feasibility of patient participation and satisfaction with cognitive rehabilitation and problem-solving therapies; despite low accrual, most completed program.
2. Most intervention subjects reported continued use of compensation strategies to some degree at three months.
3. This sample reported relative stable measures for QOL.
4. Recommend targeting patients reporting poor QOL, poor day-to-day functional performance, or emotional distress for the intervention.
5. Recommend larger stratified study to control for varying tumor characteristics and treatment differences (chemotherapy).

1. Small sample size with low accrual over two years. This altered randomization with the last three dyads placed into the intervention group.
2. Low accrual may have occurred due to the definition used for cognitive impairment as 38% of potential subjects referred for enrollment were not eligible.
3. Intervention occurred concurrently during radiation therapy treatments for two consecutive weeks, which most likely contributed to low accrual and can increase burden (especially for some who may have continued to work).
4. Cognitive measure (R-BANS) was utilized for a comprehensive assessment of cognitive function only at baseline. Long-term follow-up was not performed as originally planned with study design.
5. No educational level was reported for subjects.

To determine if a focused narrative-interview intervention can alleviate symptoms of suffering, anxiety, and depression in patients with advanced cancer

Patients in a hospice day unit were randomized to one of two groups. In one, patients received the study intervention; in the other, usual care. The intervention was a single focused narrative interview in which a patient was encouraged to discuss his or her perspectives; sense of meaning; sense of suffering; and psychological, physical, and spiritual well-being. The emphasis was on enabling each patient to tell his or her story. Study assessments were done at baseline and at two, four, and eight weeks after the intervention.

• The sample was composed of 100 participants.
• Mean patient age was 66 years. The age range was 31–89 years.
• Of all participants, 32% were male and 68% were female.
• All patients had advanced disease, and the sample included various tumor types. Of types of cancer represented in the sample, breast, lung, and colon cancer were the most common.
• Of all participants, 55% were married or cohabiting; 33.3% had been diagnosed with cancer within the last 12 months; and approximately 33.3% had, before cancer diagnosis, disorders related to depression or stress.

• Single site
• Outpatient
• United Kingdom

• Phase of care: end-of-life care
• Clinical applications: eldercare, palliative care

 Randomized controlled trial

• Brief Edinburgh Depression Scale (BEDS)
• Edmonton Symptom Assessment Scale (ESAS)
   

Baseline scores indicated, on average, probable depression. At four weeks investigators noted a slight, but nonsignificant improvement in the depression score. Authors noted no other changes or differences between groups.

As result of narrative interview intervention in a hospice day program, findings did not show any substantial improvement in measures of depression or other symptoms.

• The study had a small sample size, with fewer than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Authors did not describe usual care. Although the authors noted no significant differences as a result of the intervention, authors concluded that the intervention was effective.

Findings do not suggest that narrative interview, used as an intervention for depression and other symptoms, had any effect in this study.

To observe the longitudinal effects of antidepressant medication in a cohort of patients with advanced cancer

Of the 628 patients with advanced cancer in the study, 25% were receiving antidepressants for a median of 9.5 weeks. Patients were followed for six months or until death. Consecutive patients in the daycare unit were eligible for inclusion. Patients completed study assessments at baseline and at eight, 16, and 24 weeks. A patient self-report was used to identify patients taking antidepressants.

• N = 628  
• AVERAGE AGE = 66
• MALES: 33%, FEMALES: 67%
• KEY DISEASE CHARACTERISTICS: Advanced cancer; any tumor type
• OTHER KEY SAMPLE CHARACTERISTICS: Enrolled in hospice

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Hospice day units, northwest England

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Elder care and palliative care 

Observational

• Patient Health Questionnaire (PHQ-9) 
• Edinburgh Depression Scale (EDS)

Patients who stated that they took antidepressants had significantly higher depression scores on both measures. A subgroup analysis was completed for those with the highest PHQ-9 scores, assuming that effects might be seen in those with greater depression levels. However, there were no differences in results between those taking and not taking antidepressants.

The observational findings of this study suggest that antidepressant medication had little impact in reducing depression scores for patients attending Hospice daycare service.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: Hospice day treatment; other treatments in use as well as antidepressants; difficult to determine what was the cause of change; patient self-report only used to identify those taking antidepressants and was not corroborated with medical records or any other source information

This observational study did not show that antidepressants reduced depression among patients receiving Hospice care. However, there were several study design and measurement limitations. The role and effectiveness of antidepressants may vary among patients at different phases in the trajectory of cancer.

To update previous recommendations (released in 1995 and last updated in 1999) for vaccinations in pediatric and adult hematopoietic stem cell transplantation (HSCT) recipients.

This resource was classified as a guideline.  

Recommendations for 18 vaccinations were drawn from published data, most of which were specific to stem cell transplantation recipients. The strength of each recommendation and the quality of evidence supporting it are noted in a summary table, using grading standards endorsed by the Centers for Disease Control and Prevention (CDC).

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for late effects and survivorship, as well as pediatrics.

Patients undergoing HSCT are advised to be vaccinated against bacterial and viral infections beginning six to 12 months after transplantation, with the exception of meningococcal vaccine. Because polysaccharide pneumococcal vaccines are ineffective in patients with chronic graft-versus-host disease (GVHD), antibiotic prophylaxis should be given to patients with GVHD in addition to the pneumococcal vaccine. Three doses of Haemophilus influenzae type B (Hib) conjugate vaccine, tetanus toxoid vaccine, and diphtheria toxoid vaccine should be given beginning six months posttransplantation and spaced one to three months apart. Routine vaccination against pertussis was not recommended. Bacillus Calmette-Guerin vaccine was specifically contraindicated in this population.

Inactivated influenza vaccine was recommended for all patients undergoing HSCT, beginning no earlier than four to six months posttransplantation.  For patients undergoing allogeneic HSCT, influenza vaccination should be given annually (prior to influenza season) and continue at least as long as the patient remains immunocompromised. For patients undergoing autologous HSCT, the duration of yearly influenza vaccination should be assessed individually. Patients undergoing HSCT and those in close contact with them (e.g., family members and hospital staff who care for these patients) should be vaccinated against polio using the inactivated poliovirus vaccine only.

Patients undergoing HSCT should receive three doses of the inactivated vaccine, beginning six to 12 months following transplantation, with subsequent doses one to three months apart. Hepatitis B vaccination (HBV) is recommended for patients undergoing HSCT living in countries where HBV is recommended for the general public and should be given six to 12 months following HSCT. Vaccination with two doses of hepatitis A may be considered for patients who live or plan to travel to areas where the disease is endemic. The measles, mumps, and rubella (MMR) vaccine is generally recommended to begin no sooner that 24 months after HSCT but may be considered earlier if there is a high risk of measles. MMR is contraindicated in patients with chronic GVHD or ongoing immunosuppression. To prevent varicella, seronegative family members should be immunized with the varicella-zoster virus (VZV) vaccine. Seronegative patients undergoing HSCT may be considered for the VZV vaccine two years following transplantation, provided they are free of GVHD or ongoing immunosuppression. Vaccination of seropositive patients undergoing HSCT is not recommended.

Vaccination against yellow fever should only be considered in patients undergoing HSCT who must travel to areas of the world where yellow fever is endemic. Guidelines for serological testing of immune status are also included, again following the CDC grading standards. Immunity testing before vaccination is not necessary for tetanus toxoid, diphtheria toxoid, polio, influenza, pneumococcal, and Hib but is recommended for HBV, measles, mumps, and rubella (MMR), and varicella-zoster virus (VZV). Postvaccination testing to assess immune response is not recommended for tetanus toxoid, diphtheria toxoid, polio, Hib, or influenza. It is recommended for hepatitis B, MMR, and VZV and also may be considered for pneumococcal vaccine for patients at increased risk of poor response.

This article provided a concise summary for providers to use when considering the vaccination needs of HSCT recipients. It rated the strength of each recommendation using CDC guidelines. The article was extensively referenced to aid readers who wish to delve more deeply into the studies supporting each recommendation.

To evaluate the efficacy of a protocol including topical heparin therapy for hand-foot skin reactions (HFSR) during multikinase (MKI) treatment

Heparin Z ointment contains 500 IU unfractionated heparin sodium in each 1 g. Heparin, a member of the glycosaminoglycan family, has anti-inflammatory properties and is effective in the treatment of ulcerative wounds. All patients experiencing HFSR received mutifaceted care, including thick socks, shock-absorbing shoes, and topical treatment with heparin Z ointment (Zeria Pharmaceutical Co., Ltd., Japan), twice daily, integrated with urea-containing cream twice daily. Treatment with heparin Z ointment continued daily until grade of toxicity was downgraded to 0. All patients were seen monthly, and those with HFSR were seen weekly. Patients whose grade was downgraded to 0 were considered cured of HFSR. Treatment responders were recorded as the sum of cured and improved patients.

• N = 73 patients, 56 with metastatic renal cell carcinoma (MRCC) and 17 with castration-resistant prostate cancer (CRPC)  
• AGE = 26–86 years
• MALES: 80% of MRCC, 100% CRPC, FEMALES: 20% MRCC, 0% CRPC
• KEY DISEASE CHARACTERISTICS: CRPC and MRCC in patients eligible for MKI therapies
• OTHER KEY SAMPLE CHARACTERISTICS: Twenty-six patients developed HFSR, 16 developed MRCC, and 10 developed CRPC.

• SITE: Single site  
• SETTING TYPE: Not specified    
• LOCATION: Unclear, likely outpatient

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Intent-to-treat study design of patients on MKI therapy

• Percentages reported of four groups of patients experiencing HFSR
• Analysis statistics not clearly defined

Of patients whose grading was downgraded to 0, the highest percentage was in the axitinib group (50%), while 31.8% of the sunitinib group were downgraded to 0, which equated to the cure of HFSR. Patients with CRPC had a higher response rate on sunitinib therapy (80% to MRCC of 66.7%). A higher rate of HFSR was seen in patients with CRPC treated with sunitinib than those with MRCC treated with sunitinib. Only four patients required MKI dose reduction, and none of the 26 patients who experienced HFSR dropped out.

This study provides a new protocol for the treatment of HFSR in patients on MKI therapies who experience HFSR. It would appear beneficial for keeping patients on treatment with minimal need to decrease the dose.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement/methods not well described
• Findings not generalizable
• The use of heparin Z ointment as an added intervention appears to improve outcomes, but no control existed to separate the intervention.
• The sample is too small for an intergroup analysis.
• No data on skin pathology or exclusion prior to initiated therapies exist.

Nurses are aware of the need for supportive care to decrease the incidence and severity of skin toxicities with MKI therapies. The use of heparin Z ointment as an additive intervention seems appropriate, particularly in light of heparin use in burned skin and wound healing. However, this study does not allow for inclusion as a new guideline intervention. More investigation with better designed trials is needed.

To discuss the affect of 0.1% VitK1 cream on cetuximab-induced skin toxicity in patients with colorectal cancer

Routine nursing was implemented for all patients. The experimental group also received VitK1 cream smeared on the face, neck, chest, back, and nail edges three times on the day of cetuximab infusion at 9 am, 3 pm, and 9 pm.

• N = 60 (30 experimental, 30 control)  
• AGE = 20 years or older
• MALES: 86.7% (experimental), 66.7% (control); FEMALES: 13.3% (experimental), 33.3% (control)
• KEY DISEASE CHARACTERISTICS: Patients with colorectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients who were hospitalized and receiving cetuximab-containing therapy for the first time. No one with prior skin disease or diabetes was included.

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: The First Affiliated Hospital of Zhengzhou University (January 2013–October 2014)

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Randomized, controlled clinical trial

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

Dry skin, itchy skin, acne-like rash, skin dehiscence, and paronychia were evaluated in both groups after four cycles of cetuximab therapy (56 days) using the Common Toxicity Criteria, version 3.0, assessment scale. No grade 4 results were observed in either group. No significant differences existed in acne-like rash, paronychia, or dehiscence in either group. A significant difference existed in skin dryness and itch, favoring the experimental group. All patients had skin toxicities. No reports of discomfort were received from the experimental group, receiving VitK1 cream.

The VitK1 cream appeared to reduce skin dryness and itching.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable
• Convenience sampling
• Results consistent with studies from outside of China where VitK1 cream was available
• Need further discussion

Reducing or improving the existence of skin toxicities from cetuximab therapies allows patients to stay on therapies without an extreme decrease in quality of life. VitK1 cream had not been available in China; therefore, this study used the compounding of this cream with specific directions. Safeguarding the production of emollients and creams from compounding pharmacies has met recent scrutiny. Nurses need to ensure consistency with medical interventions when able. Providing for symptom management options, such as VitK1 cream, should promote patient adherence to therapy and improve outcomes. Few interventions have been shown effective for the prevention and management of skin toxicities. Further research is needed.

To investigate whether paravertebral block (PVB) implemented immediately before breast cancer surgery can affect pain and emesis and improve the quality of life of patients after breast cancer surgery

Consecutive patients received general anesthesia or PVB plus anesthesia before breast cancer surgery. Researchers compared the pain scores of both groups of patients at one hour and at six hours postoperatively and at midmorning of postoperative day 1 (POD1). At one hour, patients were observed in the postanesthesia care unit for one hour, where they were provided with analgesics to achieve a pain score of less than 4 on the Numeric Rating Scale (NRS). Choices of analgesic for patients with moderate to severe pain included intravenous morphine, 3–6 mg, and intravenous ketorolac, 30 mg. Patients with mild to moderate pain (a score of 4–7) received acetaminophen, 500–1000 mg, at the patient’s request. At six hours after surgery and on POD1, pain scores were recorded with patients at rest and during movement. Movement consisted of moving the arm until the arm and body were at a 90-degree angle. The amount of postoperative narcotics and the time to first request for pain medication was recorded.

• The sample was composed of 40 patients; presurgery, 25 received general anesthesia only and 15 received general anesthesia and a PVB.
• In the general anesthesia group, mean patient age was 50.4 years. In the group that received general anesthesia and PVB, mean patient age was 54.2.
• All patients were female.
• All patients had breast cancer. In the group that received general anesthesia only, four patients underwent modified radical mastectomy and 21 underwent a breast-conserving procedure. Of patients that received PVBs, one underwent modified radical mastectomy and 14 underwent a breast-conserving procedure.

• Single site
• Inpatient
• Taiwan
   

• Phase of care: active treatment
• Clinical applications: end of life and palliative care

Intervention study

• Quality-of-recovery (QoR) tool, 0–18 scale
• Numeric Rating Scale for pain, 0–10 scale
• Apfel risk score for postoperative nausea and vomiting (PONV)
• American Society of Anesthesiologists (ASA) physical status classification

• Compared to pain scores in the general anesthesia (GA) group, pain scores were significantly lower in the GA + PVB group at one hour (p < 0.0001), six hours (p < 0.0001), and at midmorning on POD1 (p = 0.041). SImilarly, in the GA + PVB group, pain scores with movement were lower at all three time points: one hour and six hours, p < 0.0001; POD1, p = 0.0012.
• The median QoR scores were higher in the GA + PVB group than in the GA group. At six hours, the median QoR score in the GA group was 12; in the GA + PVB group, 18, (p < 0.0001). At 10 a.m. on POD1 the mean QoR score in the GA group was 16; in the GA + PVB group, 18 (p = 0.0079).
• In the GA group, median cumulative postoperative analgesic consumption was four doses; in the GA + PVG group, 1 dose (p < 0.0001).
• In the GA group, median cumulative postoperative narcotic consumption was 1 dose; in the GA + PVB group, 0 dose (p = 0.001).
• Median time from the end of the operation to the first request for analgesia differed significantly between the two groups. In the GA group, the median time was 30 minutes; in the GA + PVB group, 435 minutes (p = 0.0002).
• Incidence of PONV was higher in the GA group (64%) than in the GA + PVB group (6.67%) (p < 0.001). 
• Patients in the GA group had significantly greater (p < 0.00001) antiemetic use overall than did patients in the GA + PVB group.

After breast cancer surgery, PVB plus GA may provide better pain relief than does GA alone. The researchers observed higher QoR scores and less antiemetic use in the GA + PVB than in the GA group.

• The study had a small sample size, with fewer than 100 patients.
• The study was conducted at a single site.
• Only 15 patients received the intervention.
• The study contained no randomization.
• At baseline, patients in the GA group used more antiemetic than did patients in the other group, a fact that makes results difficult to interpret.
   

PVB may be a useful tool to decrease pain after breast cancer surgery and to reduce PONV, but more research is needed before researchers can draw definitive conclusions.