To measure the technical success of therapeutic bronchoscopy and its impact in improving dyspnea and quality of life among patients with malignant central airway obstruction

Data from the AQuIRE (American College of Chest Physicians Quality Improvement Registry) for 1,115 procedures on 947 patients undergoing therapeutic bronchoscopy from January 2009–February 2013 were used for this study. Primary outcome data were defined as greater than a 50% opening of airway lumen. A smaller subset (N = 187) of centers collected pre- and postprocedure (30 days) secondary outcome data looking at dyspnea improvement after bronchoscopy as measured via Borg scores and health-related quality of life (HRQOL) measured via the SF-6D.

• N = 947   
• AGE = 62.8 years
• MALES: 55.6%, FEMALES: 44.4%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Of all participants, 71.7% had primary lung cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: The sample size for clinical outcome data was 187.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Cleveland Clinic Foundation, Cleveland, OH; the Penn State Cancer Institute, Hershey, PA; the University of Illinois Hospital and Health Sciences Center, Chicago, IL; the Department of Pulmonary and Critical Care Medicine, Boston University, Boston, MA; the Department of Interventional Pulmonology, Chicago Chest Center, Chicago, IL; the Department of Pulmonary and Critical Care, Baylor College of Medicine, Houston, TX; the Department of Internal Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University Medical Center, Durham, NC; the Department of Pulmonary and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD; the Department of Pulmonary, Critical Care, and Sleep Medicine, University of Cincinnati, Cincinnati, OH; and the Department of Pulmonary and Critical Care Medicine, University of Calgary, Calgary, AB, Canada

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care

• Retrospective data analysis for technical outcomes
• Prospective trial to evaluate clinical outcomes

• SF-6D
• Borg Rating of Perceived Exertion Scale score 
• Technical success was based on anatomic criteria defined as a brochoscopically reopening of the airway lumen to greater than 50% of the normal diameter, and the airway had to connect to a viable area of distal lung. All clinical outcomes were assessed by the attending physician using standardized definitions from a code book developed by the American College of Chest Physicians Quality Improvement Registry, Evaluation and Education (AQuIRE) program, to evaluate therapeutic bronchoscopy for malignant central airway obstruction.

The use of therapeutic bronchoscopy for the treatment of malignant central airway obstruction had a high technical success rate. More importantly, patients showed significant improvement in their subjective rating of dyspnea and in HRQOL. Having clinical outcome data assists in the process of weighing potential risks versus benefits of this procedure. Given that some of the patients with the worst dyspnea at baseline ultimately had the greatest benefit, these patients should be considered for therapeutic bronchoscopy and not assumed to be too sick to benefit.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Findings not generalizable
• No standard method of patient selection or standardization of procedure, as all clinical decisions were at the discretion of the individual performing the therapeutic bronchoscopy
• Significant variations in practice patterns existed in different centers and locations of care.
• Technical success rates were determined by the individual performing the procedure, and bias may have existed.

To educate and advocate for patients undergoing therapeutic bronchoscopies, nurses must be knowledgeable about the different types, purpose, indications, and potential risks and benefits of each. The technical success of the procedure is not sufficient enough in measuring the overall benefit to the patient; quality of life and palliation of dyspnea outcomes must also be considered.

• FINAL NUMBER STUDIES INCLUDED = 21, and 19 in meta-analysis
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,007
• SAMPLE RANGE ACROSS STUDIES: 19-549
• KEY SAMPLE CHARACTERISTICS: Varied tumor types, ages ranged from 18-89 years

Antidepressants were effective in reducing distressing symptoms (SMD = -0.229, p = 0.018) and major depression or depressive symptoms (SMD = -0.285, p = 0.001).  All types of antidepressants showed some efficacy, although tricyclic antidepressants did not show efficacy across two small studies. SSRIs and manserin were effective. Quality of life measures were also improved. There was significant heterogeneity. Analysis showed significant efficacy was correlated with length of follow up (p < 0.001). Antidepressants did not differ from placebo in terms of acceptability, using drop-out rate as a proxy of acceptability.

Antidepressants of all types demonstrated overall efficacy for improvement in depressive symptoms as well as other distressing symptoms. SSRIs and manserin showed the best results

Overall quality of reports was graded as low to moderate. Several studies included funding by drug companies, suggesting sponsorship bias as the funder role was not described.  There was significant heterogeneity

Findings from this analysis show that antidepressants, particularly SSRIs and manserin, were tolerable and effective in reducing depressive symptoms in patients with cancer. Findings also suggest that efficacy may increase over time, pointing to the potential need for sufficient duration of treatment. It is important that nurses screen for symptoms of depression among patients with cancer, and facilitate relevant treatment.

STUDY PURPOSE: Assess effects of antidepressants among people with cancer for treatment of depression

There was no differences between antidepressants as a class and placebo in five RCTs, no difference between groups comparing different antidepressants, and no difference in drop-out rates between placebo and antidepressants

The findings did not provide strong evidence for efficacy of antidepressants.

Study quality was generally low with unclear risk of bias in multiple aspects of the study design and implementation. In five studies, risk of bias due to conflict of interest was questionable. There was no difference found between SSRIs and tricyclic antidepressants. Studies included were all conducted prior to 2009.

This particular analysis did not demonstrate efficacy of antidepressants in patients with cancer for management of depressive symptoms. There were multiple limitations in this analysis due to the low quality of the studies included.

To assess the effect of Lactobacillus and fiber supplementation on tolerability of treatment with chemotherapy containing 5-fluorouracil (5-FU) and to compare the tolerability and frequency of diarrhea with the Mayo regimen (bolus 5-FU) to that of the simplified de Gramont regiment (bolus plus continuous 5-FU)

Postoperative colorectal cancer (CRC) patients were randomly assigned to receive adjuvant chemotherapy monthly (Mayo regimen) or twice monthly (simplified de Gramont regimen) for 24 weeks. Further randomization determined whether patients received the probiotic Lactobacillus rhamnosus GG gelatin capsules twice daily and daily fiber on cycle days 7–14 for 8 days per month during the 24 weeks of chemotherapy. All patients received dietary counseling and kept nutrition diaries. Treatment-related adverse effects were assessed at every cycle.

• The study reported on 148 patients.
• Median age was 60 years, with a range of 31–75.
• The sample was 49% female and 51% male.
• Patients were scheduled to receive adjuvant chemotherapy after surgery for Dukes’ B or C CRC or chemotherapy following surgery for Dukes’ D CRC who were rendered free from metastases by the surgery.

The study was conducted at a single-site, outpatient setting in Finland.

All patients were undergoing the active treatment phase of care.

This was a prospective, randomized trial.

The National Cancer Institute of Canada Common Toxicity Criteria, version 2, was used.

• Less grade 3-4 diarrhea occurred in patients receiving Lactobacillus supplementation than in those not receiving it (22% versus 37%; p = 0.027). 
• Less abdominal discomfort (flatulence, borborygmi, or abdominal distention) of any grade occurred in patients receiving Lactobacillus than in those not receiving it (59% versus 75%; p = 0.058). 
• Only 21% of the patients receiving Lactobacillus had chemotherapy dose reductions due to bowel toxicity as compared to 47% of those who did not receive this supplement (p = 0.0008). 
• Lactobacillus supplementation had no significant effects on overall treatment toxicity or on the frequency of stomatitis or neutropenia.
• Fiber supplementation did not affect overall gastrointestinal (GI) toxicity (p = 0.13).

The frequency of grade 3 or 4 diarrhea and the frequency of abdominal discomfort may be decreased with the use of Lactobacillus rhamnosus supplementation for patients receiving 5-FU-based chemotherapy.

• Adjuvant chemotherapy for CRC now commonly includes irinotecan, capecitabine, or oxaliplatin.  5-FU was the only adjuvant chemotherapy given in this study.
• The study was neither placebo-controlled nor blinded to the administration of the fiber or Lactobacillus.
• Metoclopramide and 5-HT₃ inhibitors were used to treat nausea and vomiting. These medications could possibly have effected reported bowel toxicity.
• No mention was made regarding whether patients were instructed to avoid yogurts and other dairy products produced by fermentation.
• Use of antimicrobials was not mentioned as an exclusion criterion.

The administration of Lactobacilus rhamnosus GG may decrease the frequency and severity of diarrhea and abdominal discomfort with 5-FU-based chemotherapy. Further placebo-controlled, blinded studies are needed.

To determine the cumulative incidence of varicella-zoster virus (VZV) two years after transplant.

Following allogeneic hematopoietic stem cell transplant (HSCT), patients received low-dose valacyclovir (VCV) for prophylaxis against VZV.  Up to day 35, patients received oral acyclovir (ACV) 1,000 mg/day, and then from days 36 to 365, they received oral VCV 500 mg/day three days a week.  Patients were monitored for VZV for two years after HSCT.

• Forty adult patients (57% male, 43% female) were included.
• Median age was 43 years (range 18–61).    
• Diagnosis for transplant: ten patients had acute myeloblastic leukemia, eight had acute lymphoblastic leukemia, four had chronic myelogeneous leukemia, five had myelodysplastic syndrome, nine had Hodgkin lymphoma, one had multiple myeloma, and three had severe aplastic anemia.
• Patients were excluded if they had renal or liver dysfunction, antithymocyte globulin, T cell-depleted graft, cord blood, or a hematologic malignancy and were not in remission prior to HSCT.
• Patients from ages 16 to 70 who were seropositive for VZV-IgG antibody prior to allogeneic HSCT.  Those enrolled were not necessarily as young or as old as the eligibility criteria.

• Multi-site
• Hospitals participating in the Japan Hematological Oncology Clinical Study Group

• Patients were undergoing posttransplant care.
• The study has clinical applicability for antimicrobial prophylaxis in a transplant setting.

This was a prospective, nonrandomized study.

• Development of VZV    
• Dermal development of VZV (defined as generalized cutaneous distribution or characteristic vesicular skin lesions on an erythematous base within a dermatome)
• Visceral development of VZV
• Toxicities of VCV
• Postherpetic neuralgia
   

Breakthrough VZV occurred in two patients while receiving VCV.  After stopping VCV prophylaxis, an additional five patients developed VZV disease.  These seven patients had a favorable response to oral or intravenous VCV given at therapeutic doses.  Univariate analysis revealed no factors that significantly associated patients with incidence of VZV.

For patients undergoing allogeneic HSCT, one year of low-dose VCV is safe and effective for preventing VZV.

Small sample size

Patients undergoing allogeneic HSCT may benefit from the safe use of low-dose prophylactic VCV (500 mg/day three times a week) for VZV in the posttransplant setting.

To investigate the effects of cognitive behavioral therapy (CBT) and patient education on depression, anxiety, pain, physical functioning, and quality of life (QOL) in adult cancer survivors

The study involved searching MEDLINE, PsycINFO, and the Cochrane Database for the period 1993–2004.

The literature evaluated included 15 randomized controlled trials (RCTs), five of which measured depression and all of which had been published 1993–2004. Authors assessed quality of the RCTs by means of the Jadad scale.

The sample size was 1,492.

CBT is related to short-term effects on depression; individual interventions were more effective than group interventions. Neither CBT nor patient education produced significant long-term effects on depression.

To investigate the effects of cognitive behavioral therapy (CBT) and patient education (PE) on anxiety in adult cancer survivors

Databases searched were MEDLINE, PsycINFO, and the Cochrane Database (1993–2004).

Search keywords were cancer, anxiety, depression, quality of life (QOL), fatigue, stress, pain, physical function, social, self-management, evidence-based, interventions, and random/randomized.

Studies were included in the review if they

• Reported on adult patients with cancer (all types and stages)
• Had a control group, randomization, and measurable outcomes of interest (anxiety, depression, fatigue, QOL, physical function, and pain)
• Had at least one follow-up assessment beyond post-treatment, which allowed for examination of duration of effects.

Studies were excluded if they were not randomized or controlled, had a score of less than four on checklist, did not report follow-up data, or did not report data on targeted outcomes.

Dissertations were excluded.

• A total of 592 studies were evaluated, with only 19 studies meeting criteria. Comprehensive meta-analysis was used to determine effect size for each outcome.
• Quality was assessed by a modified version of Jadad’s six-item checklist (randomization, double blinding, descriptions of withdrawals and dropouts, statistical analyses, inclusion and exclusion criteria, and adverse effects).
• Longitudinal study: Times of measurement varied from one week to 14 months. Median follow-up was defined as short-term (less than eight months) and long-term (more than eight months).
• Four studies reviewed used CBT for anxiety.
  • CBT sessions varied from four weekly one-hour sessions to 55 weekly two-hour sessions.
  • CBT included stress management and problem-solving approaches.
• One study reviewed used PE for anxiety.
  • PE sessions varied from one 20-minute session to six weekly one-hour sessions.
  • PE included information about illness, symptom management, and discussion of treatment options using booklets, videos, and other educational materials.

• The review reported on 1,492 adult cancer survivors.
• All types and stages of cancer were represented.
• Survivor age range was 18–84 years.
• 790 survivors were assigned to interventions, and 702 were assigned to control (medical management only).

• CBT interventions on anxiety (four studies):
  • Large effect was noted for individual and group CBT (g = 1.99, p < 0.01; 95% CI 0.69–3.31).
  • Of these four studies, a sensitivity analysis revealed a large effect size for individual treatment (g = 2.41, p < 0.01; 95% CI 1.2–3.55) and no effect for group interventions (d = 0.03, p+0.82; 95% CI -0.20–0.25).
  • Forest plots representing the effect sizes of CBT on anxiety favor the intervention.
• The single trial using PE to decrease anxiety resulted in no short-term effect on anxiety and did not include long-term follow-up on anxiety (d= -0.02, p = 0.89; 95% CI -0.36–0.31).

• Analysis did not consider patient adherence to pharmacologic interventions, which is known to be modest in medical patients.
• No cost-benefit implications were noted.

CBT is effective for short-term management (less than 8 months) of anxiety. Individually based interventions were more effective than those delivered in a group format. Various CBT approaches provided in an individual format can assist cancer survivors in reducing the emotional distress of anxiety.

To determine whether itraconazole is superior to fluconazole in the prevention of invasive fungal infections, particularly invasive aspergillosis, in hematopoietic stem cell transplant (HSCT) recipients and patients with acute leukemia (AL).

Patients were stratified to either high or low risk based on type of therapy or disease.  High risk included patients undergoing allogeneic HSCT or patients with relapsed/resistant AL.  Low risk included patients undergoing autologous HSCT or newly diagnosed patients with AL receiving induction.  Patients were then randomized to receive either itraconazole or fluconazole prophylaxis in each risk stratum, using a random number generator, in blocks of four.  Intravenous (IV) preparations were used only if the patient could not tolerate oral medications and was switched back to oral as soon as the patient tolerated oral medications.  Antifungal prophylaxis was continued until the resolution of neutropenia, for a maximum of eight weeks. Antibacterial prophylaxis was not administered.  Fluconazole was given in a dose of 400 mg once daily, and itraconazole was given at 200 mg twice daily.

• One hundred ninety-five patients were included.
• Median patient age was 49 (range 18–73) in the fluconazole arm and 50 (range 17–75) in the itraconazole arm.
• In the fluconazole arm, 56% of patients were male and 43% were female.  In the intraconazole arm, 63% of patients were male and 33% were female.
• Patients received autologous HSCT (56% in the fluconazole group, 52% in the itraconazole group), allogeneic HSCT (19% in the fluconazole group, 18% in the itraconazole group), haploidentical HSCT (3% in the fluconazole group, 4% in the itraconazole group), or no transplant (21% in the fluconazole group, 22% in the itraconazole group).  Per the above criteria, patients were considered low-risk (74% in the fluconazole group, 72% in the itraconazole group) or high-risk (25% in the fluconazole group, 24% in the itraconazole group).  Mean duration of neutropenia for high-risk patients was 13.4 days (SD = 6.1) in the fluconazole arm and 15.4 days (SD = 9.7) in the itraconazole arm.  Mean duration of neutropenia in low-risk patients was 10.7 days (SD = 6.4) in the fluconazole arm and 10.8 days (SD = 7.0) in the itraconazole arm.  Patients receiving group 1 chemotherapy (consisting of standard induction and consolidation regimens for AL and chemotherapy-based conditioning regimens for autologous bone marrow transplant [BMT]) included 77% in the fluconazole arm and 76% in the itraconazole arm.  Patients receiving group 2 chemotherapy (consisting of total body irradiation-based conditioning regimens for autologous or allogeneic BMT) included 10% in the fluconazole arm and 8% in the itraconazole arm.  Patients receiving group 3 chemotherapy (consisting of reduced intensity or T cell depleted conditioning regimens, which included anti-thymocyte globulin and/or fludarabine for allogeneic or haploidentical BMT) included 12% in both groups.

• Single site  
• Inpatient 
• This study was conducted at a single hematology and BMT center, comprising a 15-bed BMT unit and an 11-bed hematology unit, on hospitalized patients in these two units, in a protected environment using a high-efficiency particulate absorption filtration system.

Patients were undergoing the active treatment phase of care.

This was a randomized trial comparing oral and IV itraconazole with oral and IV fluconazole.

Toxicity was graded from 0 to 4 according to the National Cancer Institute Common Toxicity Criteria.

Itraconazole was not found to be more effective than fluconazole in preventing invasive fungal infections (IFIs) in neutropenic patients after chemotherapy for AL or after HSCT.  Both drugs were successful in preventing invasive candidal infections.  Invasive aspergillosis (IA) was not as decreased in the itraconazole arm as expected, although the mortality from IA  was lower in the itraconazole arm.

Fungal prophylaxis is important in patients with AL and those undergoing HSCT.  Both itraconazole and fluconazole seem to be effective in preventing IFIs and IA, but neither appeared to be superior to the other in this study.  Itraconazole seems to be less well tolerated in the oral form due to gastrointestinal side effects, although none were significant.  Neither drug completely prevented IA, which causes significant morbidity and mortality; therefore, more research is needed for drugs that have better prophylaxis against IA.

This was a nonblinded study leading to bias in the assessment of efficacy and adverse events, as well as the evaluation of response and causes for adverse events.  There was a lack of itraconazole blood measurement.  Antifungal prophylaxis was only used during the early period at risk (during the neutropenic period), the high-risk patients, especially, are at risk for significantly more time than just the neutropenic period.  Antifungal prophylaxis should be continued for an extended period after engraftment, especially in patients undergoing allogeneic HSCT.  This information is useful for most hematologic malignancy but may not be generalizable for patients with solid tumors.

Education related to antifungal prophylaxis and the necessity of taking these medications is important.  Nurses can educate about the expected side effects, especially the GI side effects of itraconazole when given orally.

STUDY PURPOSE: To examine the effectiveness of conservative treatments for lymphedema

TYPE OF STUDY: Systematic review

DATABASES USED: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, AMED, and CINAHL 1990–January 2010

KEYWORDS: Search terms provided in online file

INCLUSION CRITERIA: RCT or observational study with comparison group, pediatric and adult patients with secondary lymphedema for any reason except filariasis infection

EXCLUSION CRITERIA: Pharmacologic or surgical treatment for lymphedema

TOTAL REFERENCES RETRIEVED: 6,814 articles were evaluated.

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Jadad scale used for RCTs; Newcastle-Ottawa Scale used  for observational studies

• FINAL NUMBER STUDIES INCLUDED = 44 (32 with cancer)
• SAMPLE RANGE ACROSS STUDIES: 21–150
• KEY SAMPLE CHARACTERISTICS: Cancer evidence was in patients with breast cancer.

PHASE OF CARE: Not provided

Six RCTs involving intermittent pneumatic compression (IPC) were used. Two showed IPC had benefit over CDT or self-massage, and three did not show IPC to be any better than massage, skin care, or elastic sleeve; one compared different IPC devices. Six RCTs using massage-based treatments were used, and five showed no benefit. Four studies of low-level laser were used. Three showed low-level laser was superior to exercise, sham laser, or usual care, and one shows that low-level laser was better than sham laser at some time points in the study. Dieting yielded conflicting findings. Equivocal results were seen for ultrasound, modified manual lymph drainage, and compression stockings.

This review provides limited evidence of effects of conservative treatments for lymphedema, and no conclusions about the most effective conservative approach are possible from this review.

Most studies had “fair” quality. Follow-up time frames in studies varied considerably. The majority of studies were among breast cancer patients only. It is surprising that this review did not include any studies involving CDT.

Findings from this review showed that most interventions reduced limb volume and were not associated with any significant patient harms. Dieting alone does not appear to be particularly effective for limb volume reduction. Patients may benefit from a variety of conservative approaches to manage lymphedema. Ongoing research is needed to determine comparative effects of various approaches.