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Kamboj, M., Blair, R., Bell, N., Son, C., Huang, Y.T., Dowling, M., . . . Sepkowitz, K. (2015). Use of disinfection cap to reduce central-line–associated bloodstream infection and blood culture contamination among hematology-oncology patients. Infection Control and Hospital Epidemiology, 36, 1401–1408. 

Study Purpose

To evaluate the impact of the routine use of a passive disinfection cap for catheter hub decontamination

Intervention Characteristics/Basic Study Process

Prior to the use of disinfection caps, the organization followed Centers for Disease Control and Prevention (CDC) recommendations for catheter care and routinely used chlorhexidine-impregnated dressings. The intervention was the routine use of disinfection caps with each central venous catheter (CVC) access rather than manual scrubbing of catheter hubs. The caps were changed after each access or every seven days on high-risk units. After implementation on high-risk units for six months, disinfection caps were introduced for routine use in general oncology units. Central line–associated bloodstream infection (CLABSI) rates were compared across all phases, preimplementation to full implementation. Data were compared to that from clinical units that did not use disinfection caps.

Sample Characteristics

  • N = 691 patients with 806 CLABSI episodes. Total patients with central lines was not reported.
  • AGE = Not provided
  • MALES: Not provided, FEMALES: Not provided
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: Not provided

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: New York

Study Design

  • Prospective observational

Measurement Instruments/Methods

  • Device utilization ratio—number of catheter days to patient days
  • Standardized incidence ratio—ratio of observed infections to expected number of infections, assuming incidence rates were the same as those for the reference period

Results

No significant decrease in CLABSI rates occurred when disinfection caps were used in high-risk units. CLABSI rates declined significantly when the caps were introduced among general oncology units that were at high-risk (p < 0.001); however, CLABSI rates did not change significantly within general oncology units that were not high-risk. The proportion of contaminated blood cultures from high-risk units declined after introducing the disinfection caps (p < 0.01). Substantial cost savings with reduction in CLABSI rates and contaminated specimens was estimated, assuming hospitalwide implementation results.

Conclusions

The use of catheter disinfection caps may help reduce CLABSI rates in high-risk patient groups and reduce the contamination of blood culture specimens obtained via catheters.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • No patient demographic information was provided, and whether patients were being actively treated in all areas was uknown; high-risk units included general medical-surgical intensive care, not oncology-specific populations
  • No information was provided on other relevant practices, such as antibiotic prophylaxis.
  • Whether all catheters were long-term indwelling catheters is unclear, particularly because general intensive care units were included.
  • No information regarding other factors that could influence results
  • Cost reduction estimates assumed hospitalwide implementation of disinfection caps; why this was done is unclear, because changes in CLABSI rates were seen only on high-risk units.

Nursing Implications

The findings suggest that the routine use of disinfection caps for CVCs may be helpful in reducing CLABSI rates among patients undergoing hematopoietic cell transplantation (HCT) and those with hematologic malignancies deemed to be at high-risk for infection. This is a relatively low-cost intervention that may be beneficial; however, this study does not provide strong evidence in support of this effect. Given the findings here, further research on the effects of this approach is warranted.

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Kamath, J., Feinn, R., & Winokur, A. (2012). Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study. Supportive Care in Cancer, 20, 1745–1753.

Study Purpose

To evaluate the efficacy and safety of thyrotropin-releasing hormone (TRH) compared with placebo to treat idiopathic cancer-related fatigue (CRF).

Intervention Characteristics/Basic Study Process

Patients received four study medication bolus infusions, once a week, over a four-week period. The infusions were separated by one week (plus/minus one day). Two of the infusions were TRH at doses of 0.5 and 1.5 mg (lower dose given first), and the other two infusions were placebo. Fatigue assessments were obtained at baseline.

Sample Characteristics

  • The sample was comprised of eight patients (one man, seven women). 
  • Mean age was 58 years (SD = 9.4 years).
  • Patients scored less than 34 on the Functional Assessment of Cancer Therapy–Fatigue (FACT-F) subscale and met the International Classification of Diseases, Tenth Revision (ICD-10) criteria.
  • All patients were at least 18 years of age and at least one month postchemotherapy.

Setting

  • Single site
  • Outpatient
  • University of Connecticut Health Center

Phase of Care and Clinical Applications

Patients were undergoing the transition phase after active treatment.

Study Design

The study used a pilot, phase II trial, double-blind, placebo-controlled, crossover design with two randomizations.

Measurement Instruments/Methods

  • Visual analog scale for energy level (VAS-E)
  • Profile of Mood States (POMS) scale 
  • Hospital Anxiety and Depression Scale (HADS)
  • 6-minute walk test (6MWT)
  • Leeds Sleep Evaluation Questionnaire (LSEQ)
  • Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)

Results

Improvements in energy level (p = 0.004 for 0.5 mg TRH and p = 0.002 for 1.5 mg TRH), vigor and fatigue, and sleep disturbance were markedly higher for both TRH doses compared with placebo (saline infusion) throughout the interval from baseline through 72 hours postinfusion. No significant difference existed in energy level between the two doses. The walking test scores and the anxiety and depression symptoms showed no statistically significant difference between TRH and placebo. Side effects included modest increases in blood pressure, heart rate, nausea, flushing, and bladder sensation or urge to urinate.

Conclusions

TRH was safe and well tolerated by the patients. The results suggested significant beneficial effects of intravenous TRH in the treatment of CRF.

Limitations

  • The study had a small sample size, with less than 30 patients.
  • The study had a risk of bias due to the sample characteristics.
  • Key sample group differences could have influenced the results.
  • The findings were not generalizable.
  • Patient withdrawals were 10% or greater. 

Nursing Implications

More data are needed to confirm these findings with a larger population. Nurses can encourage patients with prominent fatigue symptoms to enter a clinical trial testing the efficacy of TRH.

Print

Kaltenbaugh, D.J., Klem, M.L., Hu, L., Turi, E., Haines, A.J., & Hagerty Lingler, J. (2015). Using web-based interventions to support caregivers of patients with cancer: A systematic review. Oncology Nursing Forum, 42, 156–164. 

Purpose

STUDY PURPOSE: To survey literature focused on social, psychological, financial, technology, and nursing topics for evidence supporting web-based informational and supportive interventions to improve the health of the caregivers of patients with cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Inspec (Engineering Village), Ovid PsycINFO, PubMed, EBSCO, and CINAHL
 
KEYWORDS: Veb-based, caregivers, and cancer (primary topics)
 
INCLUSION CRITERIA: Published in English before February 1, 2014; focused on the caregivers of adult patients with cancer aged at leat 18 years; addressed web-based quantitative or mixed-methods assessment of interventions of informational or supportive nature
 
EXCLUSION CRITERIA: Primary qualitative studies, dissertations, conference proceedings, case studies, pediatric studies, and interventions delivered by telephone or telemedicine

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 795
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two reviewers independently assessed article eligibility for the study (included intervention outcomes, sample, and participant description). Each reviewer then assessed each article’s quality using the McMaster Quality Assessment Tool for Quantitative Studies. Resolution of reviewer disagreements about assessment processes were reached via consensus.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 6 
  • SAMPLE RANGE ACROSS STUDIES: 13–285 patients
  • KEY SAMPLE CHARACTERISTICS: Greater than half were females caring for a family member with cancer; half of caregivers focused on family member with lung cancer; included studies that addressed diverse types of patient cancers (early stage to stage 4); the majority of caregivers attended some college and believed they possessed intermediate computer and Internet experience; unknown caregiver ethnicity in four of six studies 

Phase of Care and Clinical Applications

PHASE OF CARE: Early-stage (breast cancer) to stage 4 (lung cancer)

Results

Three of the five articles used in the systematic review showed that web-based interventions decreased caregiver negative mood. One of the three studies showed that a multifaceted CHESS intervention had a moderate effect size (d = 0.387) to decrease caregiver burden and negative mood (d = 0.436) at six months. Another study using CHESS with a clinical report showed small to moderate effect reducing caregiver negative mood at six months and at one year (d = -0.592). A third study describing an informational intervention showed a large effect size (d = 0.88) on this variable. Two multifaceted interventions and one single-faceted intervention supported lower levels of caregiver stress and perceptions of broad social support. Only two of six studies presented usability score outcomes, and only one study addressed the feasibility of the web-based intervention.

Conclusions

Although only six of 581 initial literacy citations met the systematic review study criteria, those six indicated the successful use of web-based cancer caregiver interventions to meet social and psychological needs. The effect sizes of the six studies compared favorably to traditional interventions focused on caregiver burden, self-efficacy, and quality of life. The limited numbers of articles on web-based interventions that positively affected diverse groups of caregivers’ social, financial, and psychological outcomes support future exploration of the usefulness and feasibility of such interventions for cancer caregiver health.

Limitations

Studies showing significant effects of web-based cancer caregiver interventions may appear more often in the literature to affect article capturing for this systematic review. The lack of identification of caregiver ethnicity in 80% of the cited studies leaves a gap in understanding how non-Caucasian samples or male caregivers may respond to web-based interventions. Published studies after February 1, 2014 were absent from the review. Only six studies met the criteria for the review.

Nursing Implications

Increasing the use and success of technology to deliver health-related consumer interventions currently support initial evidence for web-based programs, aligned with traditional cancer care, to improve quality of life of patients with cancer and their caregivers. Additional research identify the dosing of Internet interventions and evidence of the efficacy of various forms of interventions is needed.

Print

Kahl, C., Sayer, H. G., Hinke, A., Freund, M., & Casper, J. (2012). Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation. Journal of Cancer Research and Clinical Oncology, 138, 513–517.

Study Purpose

To evaluate the optimal application time for pegfilgrastim in autologous hematopoietic stem cell transplant (AHSCT) recipients.

Intervention Characteristics/Basic Study Process

Within two institutions, patients were assigned to either receive pefilgrastim 6 mg subcutaneously on day 1 (Peg1) or pegfilgrastim 6 mg subcutaneously on day 4 (Peg4). Primary study endpoint was time between transplant and neutrophil recovery to greater than 500/µl.  A difference of less than 1 day was not considered clinically significant.

Sample Characteristics

  • Fifty-three patients (45.3% male, 54.7% female) were included.      
  • Mean age was 56.5 years (range 25–69).
  • The most common diagnosis was multiple myeloma.  
  • Most patients received high-dose melphalan.

Setting

  • Multi-site  
  • Inpatient

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.  

Study Design

This was an open-label, phase II study.

Measurement Instruments/Methods

  • Neutrophil engraftment >500 µl
  • Granulocyte greater than1,000 µl
  • Platelet recovery greater than 20,00 and greater than 50,000 Gpt/l
  • Incidence and duration of neutropenic fever
  • Incidence and duration of intravenous (IV) antibiotics
  • Transfusion requirement

Results

Both groups had a median of 10 days to neutrophil engraftment >500 µl and granulocyte engraftment greater than 1,000 µl, with no difference between groups.  There were no differences between groups in time to platelet engraftment, incidence of febrile neutropenia, incidence or duration of IV antibiotics, or transfusion requirements.

Conclusions

 Early administration of pegfilgrastim demonstrated no benefit versus administration on day 4 after AHSCT. No clear recommendation can be made with respect to an optimal time for pegfilgrastim use.

Limitations

  • Small sample (<100)
  • Risk of bias (no blinding)

Nursing Implications

The study findings suggest that early and late administration of pegfilgrastim are equally effective in terms of time to neutrophil, granulocyte, and platelet recovery after AHSCT, need for IV antibiotics, transfusion, and incidence of febrile neutropenia.

Print

Kahler, K.C., Hassel, J.C., Heinzerling, L., Loquai, C., Mossner, R., Ugurel, S., . . . \"Cutaneous Side Effects\" Committee of the Work Group Dermatological Oncology (ADO). (2016). Management of side effects of immune checkpoint blockade by anti-CTLA-4 and anti-PD-1 antibodies in metastatic melanoma. Journal of the German Society of Dermatology, 14, 662–681.

Purpose & Patient Population

PURPOSE: To review the mechanisms of action of immune checkpoint blockade as well as its clinical effects in metastatic melanoma with a focus on adverse events and management
 
TYPES OF PATIENTS ADDRESSED: Metastatic melanoma

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion  

PROCESS OF DEVELOPMENT: Clinical review

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care, palliative care 

Results Provided in the Reference

This article provides an overview of the mechanisms of action of immune checkpoint blockade and clinical effects in metastatic melanoma. The focus is the adverse effect profile and therapeutic management. The side effect profile includes a review of a meta-analysis of 1,265 patients from 22 clinical trials who received ipilimumab. Eighty-two to ninety-five percent of patients experienced treatment-related side effects. Incidence tables are provided as well as a checklist for important questions during patient visits, blood test recommendations, and organ-specific side effects. Diarrhea and colitis are described with a table of trade, treatment, and follow-up. Other organ-specific side effects are also reviewed. Recommendations for management algorithms are discussed.

Guidelines & Recommendations

Comprehensive clinical studies have shown a major benefit of anti-CTLA-4 antibody ipilimumab and two anti-PD-1 antibodies nivolumab and pembrolizumab in various tumors, including melanoma. These agents enhance an autoimmune phenomenon that affects various organs. Persistent diarrhea and colitis are evidenced early in treatment and can be serious adverse effects. The clinical significance is the debilitating effect they have on patients, with electrolyte disturbances and protracted weight loss. Intestinal perforation is a serious risk. Grade 1–2 diarrhea is treated with loperamide and electrolyte replacement. An endoscopy should be considered with persistent low-grade diarrhea because it diagnoses the true extent of the colitis. For grade 3–4 diarrhea/colitis, immunotherapy should be discontinued and high-dose corticosteroids initiated. Symptoms improve markedly with this regimen. Treatment with infliximab (5 mg/kg) is used in rare cases in which steroids do not induce a response. Colitis is associated with ocular inflammation, and observing for this side effect is imperative. Comprehensive study data identify that the timely and consistent use of corticosteroids allows for control and regression of symptoms in the majority of cases.

Limitations

This is an overview of a complex multidisciplinary side-effect management concern with new checkpoint inhibitors. Further study would be necessary for a nurse to acquire in-depth knowledge for patient care.

Nursing Implications

Immuno-oncology is becoming a mainstay of pharmacological cancer treatment. Knowledge of side effects of these checkpoint inhibitors, especially diarrhea and colitis, is essential to their prevention, treatment, and management. Early recognition and intervention can reduce sequelae for patients.

Print

Kahler, K.C., & Hauschild, A. (2011). Treatment and side effect management of CTLA-4 antibody therapy in metastatic melanoma. Journal of the German Society of Dermatology, 9, 277–286. 

Purpose & Patient Population

PURPOSE: To review the clinical use, mechanism of action, and side effects of CTLA-4 treatment, and to provide guidelines for side effect management
 
TYPES OF PATIENTS ADDRESSED: Adult patients with melanoma receiving CTLA-4 antibody treatment

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion

 

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results Provided in the Reference

N/A

Guidelines & Recommendations

Skin effects: Reports that 47%–68% reportedly develop maculopapular rash, which usually appears after about three weeks of therapy. Most cases are not severe, and treatment with topical steroids or urea-based topical treatment along with antipruritic agents.
 
Diarrhea: Provides an algorithm for management—for mild (grade 1–2) diarrhea, use symptomatic therapy and, if no improvement, corticosteroids (e.g., prednisolone 1mg/kg/day). For severe (grade 3–4) diarrhea, use high-dose steroids (e.g., meythlyprednisolone 2 mg/kg 1–2 times daily) and, if no improvement, possibly infliximab 5 mg/kg.

Limitations

Expert opinion level information

Nursing Implications

Currently, limited research evidence regarding interventions for the prevention and management of various side effects associated with immunotherapies exists. Corticosteroids are suggested to treat most side effects.

Print

Kachare, S.D., Sanders, C., Myatt, K., Fitzgerald, T.L., & Zervos, E.E. (2014). Toward eliminating catheter-associated urinary tract infections in an academic health center. The Journal of Surgical Research, 192, 280–285. 

Study Purpose

To determine if implementing two interventions would cause a reduction in catheter-associated urinary tract infections (CAUTIs) in an inpatient surgical oncology unit (The first intervention was designed to decrease the use of Foley catheters, and the second intervention was designed to initiate early removal while preventing reinsertion of the Foley catheter.)

Intervention Characteristics/Basic Study Process

The first intervention was the development of a hospital-wide guideline outlining the indications for Foley catheter use. There were six defined reasons for the use of a Foley catheter in a patient. If the patient did not meet one of these criteria, then Foley catheter use was not recommended. The second intervention included two measures. The first was aimed at the early removal of the catheter by designing a daily electronic query sent to the attending physician regarding continuing use of the Foley catheter, and the second was direct personal contact with the primary medical team to determine the medical necessity of continued Foley catheter use. They also focused on the prevention of catheter reinsertion by following a developed algorithm for the healthcare team.

Sample Characteristics

  • N = 2,843
  • KEY DISEASE CHARACTERISTICS: Cancer of the liver, pancreas, colon, head and neck, urologic, or gynecologic organs requiring inpatient surgery
  • OTHER KEY SAMPLE CHARACTERISTICS: CAUTIs were defined as the presence of symptomatic urinary tract infection (UTI) or asymptomatic bacteremic UTI in patients with an indwelling catheter in place for greater than 48 hours.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Vidant Medical Center, Greenville, NC

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

This study design was a pre/post design with preintervention data obtained in a retrospective manner followed by the authors obtaining postintervention data.

Measurement Instruments/Methods

  • The authors used total device days for Foley catheters, utilization rate, total number of CAUTI’s, and hand hygiene compliance pre- and postintervention as measurement instruments to determine the effectiveness of their interventions.

Results

There was a significant reduction in the use of Foley catheters after the interventions were put in place (P < 0.0001). There also was a significant reduction in CAUTI rates for patients who did require a Foley catheter after interventions were put into place, from 4.6 to 0 (P = 0.03). For patients who required a Foley catheter and had a diagnosed CAUTI during the postintervention time period, none of the Foley catheters were reinserted. The preintervention group had four patients with positive CAUTIs who had a Foley reinserted.

Conclusions

Even though the study was limited to one inpatient surgical oncology unit, the findings support other similar studies of best practice indicating use of Foley catheter insertion criteria as well as algorithm guidelines for care after catheter removal. Because infections can be detrimental in the oncology population, healthcare teams working with these patients should explore the literature surrounding the prevention of CAUTIs and ways of implementing best practices.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: Retrospective study; self-reporting of hand hygiene compliance; single-unit study

Nursing Implications

Oncology nurses need to be diligent with hand hygiene, not only among themselves but with other members of the healthcare team. They also need to adhere to Foley catheter bundles, including the daily verification of continuing need for the catheter, the use of catheter securement devices, keeping tubing below the level of the bladder, keeping the bag off of the floor, and providing perineal care at least twice per day. If the institution does not have a catheter bundle, nurses need to lead the initiative to implement one. This study demonstrated successful institutional approaches for protocol implementation and ongoing auditing and interventions with care providers.

Print

Julião, M., Oliveira, F., Nunes, B., Vaz Carneiro, A., & Barbosa, A. (2014). Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: A phase II randomized controlled trial. Journal of Palliative Medicine, 17, 688–695. 

Study Purpose

To determine the influence of dignity therapy on depression and anxiety in palliative care unit inpatients diagnosed with a terminal illness and experiencing high levels of distress

Intervention Characteristics/Basic Study Process

Dignity therapy (DT) is brief psychotherapy aimed at decreasing the loss of dignity for patients with a life-limiting illness. This nonblinded, phase II, randomized, controlled trial involved a control group receiving standard palliative care (SPC) and an intervention group receiving SPC plus DT. Participants received a baseline assessment of anxiety and depression, an explanation of DT, and a copy of the DT questions at T1 of the study. They were then randomized into two groups. Within two to three days, the intervention group received audio recorded 30–60-minute DT sessions that were transcribed verbatim within the next two to three days and transformed into a written narrative. The DT therapist read the narrative to the patient and received corrections, returning the final narrative to the patient. Follow-up measurements of depression and anxiety in both groups were conducted on days 4 (T2), 15 (T3), and 30 (T4). 

Sample Characteristics

  • N = 80  
  • AGE RANGE = 28–90 years
  • MALES: 46.25%, FEMALES: 53.75%
  • KEY DISEASE CHARACTERISTICS: Life-threatening terminal illness (cancer = 92.55%; noncancer = 7.5%) with a prognosis of six months or fewer
  • OTHER KEY SAMPLE CHARACTERISTICS: 95% Caucasian; 5% African American; two patients had Lou Gehrig disease; one patient had trigeminal neuralgia; inclusion criteria were no evidence of dementia or delirium and a Mini Mental State score of 20 or more; read and spoke Portuguese; written informed consent; available for four to five research encounters

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient  
  • LOCATION: S. Bento Menni’s 10-bed tertiary inpatient palliative medicine unit in Lisbon; recruitment took place over 36 months (May 2010 through May 2013)

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

This nonblinded, phase II, randomized, controlled trial involved a control group receiving SPC and an intervention group receiving SPC plus DT.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS): Symptoms of depression and anxiety were measured with HADS at T1, T2, T3, and T4 of follow-up. Scores for anxiety and depression subscales also were reported separately.

Results

There were no significant differences between the control and intervention groups at baseline. Between and within groups, results were similar. Intervention group scores showed a significant (p = 0.001) decrease in depression scores at T2 and T4, but not at T3, and a significant (p = 0.0001; p = 0.001; p = 0.013) decrease in anxiety scores at all time points. The SPC group showed a significant (p = 0.045; p = 0.004; p = 0.006) increase in depression scores between baseline and all assessment periods. The SPC group showed an insignificant increase in the HADS anxiety subscale between baseline and all measurement periods.

Conclusions

Terminally ill patients experience high levels of depression and anxiety. DT was suggested as a feasible offering to people with increased or severe psychological distress. Participants who received DT experienced depression and anxiety score reductions, suggesting psychological benefits at least to the 30-day measurement period.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: Relatively small sample size (N < 100) leaves findings nongeneralizable; specific training in the delivery of DT required

Nursing Implications

DT can be offered to patients with terminal conditions near the end of life (six-month prognosis). DT implementation requires careful training in the practice. Additional randomized, controlled trials testing DT against other psychological interventions in other populations of severely ill or terminally ill patients are needed.

Print

Jo, S.J., Shin, H., Jo, S., Kwon, O., & Myung, S.K. (2015). Prophylactic and therapeutic efficacy of pyridoxine supplements in the management of hand-foot syndrome during chemotherapy: A meta-analysis. Clinical and Experimental Dermatology, 40, 260–270. 

Purpose

STUDY PURPOSE: To measure the preventive and treatment efficacy of pyridoxine supplementation through a meta-analysis of hand-foot syndrome (HFS) incidence and improvement rates
 
TYPE OF STUDY: Meta-analysis

Search Strategy

DATABASES USED: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials
 
KEYWORDS: Hand-foot syndrome, acral erythema, palmar plantar erythrodysesthaesia, pyridoxine, vitamin B6
 
INCLUSION CRITERIA: Randomized, controlled trials (RCTs); prospective comparative trials; and retrospective studies that reported the efficacy of pyridoxine supplements to manage HFS compared to controls (placebo or no treatment)
 
EXCLUSION CRITERIA: Studies without a control group

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 238
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: All studies that were published in full-text, abstract, or poster form were eligible for inclusion. Excluded were duplicates, irrelevant studies, and studies with insufficient data or an identical population. Relative risk (RR) was calculated with a 95% confidence interval (CI) to evaluate the efficacy of pyridoxine supplements in the prevention of HFS. Treatment efficacy of pyridoxine supplements was evaluated by the number of patients with symptom improvement/the total number of patients with HFS. The methodological quality of RCTs was assessed by a validated five-point quality scale. Scores less than or equal to 2 were of low quality; scores 3 or greater were of high quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 9 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 890 patients, 441 assigned to intervention groups and 449 assigned to control groups
  • KEY SAMPLE CHARACTERISTICS: The mean age was 59 years (20–91), and 65.6% of patients were women. Cancer diagnoses included multiple myeloma, breast, metastatic breast, colorectal, ovarian, endometrial, and gastrointestinal tract cancers. Chemotherapy included (a) PLD/vincristine/capecitabine; (b) PLD/paclitaxel; (c) PLD 4; (d) capecitabine alone or in combination with cyclophosphamide; (e) capecitabine alone or in combination with cisplatin, or cisplatin with docetaxel; (f) capecitabine; (g) 5-fluorouracil; or (h) capecitabine alone or in combination with cisplatin, or cisplatin and docetaxel.

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Results

Eight studies (two retrospective, two prospective comparative trials, four RCTs) for preventive efficacy and three studies (one RCT and two non-RCTs) for treatment efficacy. Random-effects meta-analysis did not reveal any significant associations between ppx pyridoxine supplementation and HFS development (RR = 0.95%, 95% CI [0.87, 1.05]) or any significant preventive efficacy against HFS in subgroup meta-analyses of study design, chemotherapeutic agents, pyridoxine dose, HFS severity, publication year, or observation period. However, pyridoxine did show significant efficacy in treating HFS (RR = 1.75, 95% CI [1.09, 2.8]) but did not show efficacy in the only RCT (RR = 1.12, 95% CI [0.58, 2.14]).

Conclusions

No evidence to support the use of pyridoxine supplements to prevent HFS during chemotherapy exists.

Limitations

  • Only four RCTs
  • Chemotherapeutic agents included PLD or capecitabine

Nursing Implications

Further nursing research on the alternative uses of topical and oral therapies for HFS is warranted given that no evidence of clinical benefit was revealed.

Print

Van Meter, M.E., McKee, K.Y., & Kohlwes, R.J. (2011). Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: A systematic review. Journal of General Internal Medicine, 26(1), 70-76.

Purpose

The objective of this systematic review was to review published data on the efficacy and safety of tunneled indwelling pleural catheters (TIPCs).

Search Strategy

Databases searched were MEDLINE, EMBASE, and ISI Web of Science through 2009. A manual search was conducted of reference lists for relevant additional studies.

Search keywords were malignant pleural effusion (MPE), tunneled indwelling pleural catheter (TIPC), and palliative care.

Studies were included if they reported on

  • Adult patients
  • Patients with MPE
  • Patients treated with TIPCs.

Studies with and without control were included.

Studies were excluded if they reported on non-malignant effusions, empyema, chylothoras, long-bore chest tubes, or non-tunneled catheters. Studies in which all patients underwent thorascopy, video-assisted thorascopic surgery (VATS), or pleurodesis were excluded. Studies were excluded if they weren't published in English. Studies without primary data also were excluded.

Literature Evaluated

  • A total of 1,011 references were retrieved, which generated 25 eligible reports.
  • Data were abstracted independently by two authors, and discrepancies were resolved by discussion and consultation with a third author.
  • Abstractors were not blinded to any study details.
  • The GRADES system was used for evaluation of quality.
  • Case studies and one randomized controlled trial had low-level evidence.

This systematic review pertains to the dyspnea Putting Evidence Into Practice topic in that one outcome of the review evaluated “symptomatic improvement” with emphasis, although not exclusive focus, on dyspnea.
 

Sample Characteristics

  • The final number of studies included was 19.
  • The total sample size was 1,370 patients.
  • The sample range across studies was 8–263.
  • The average age was 63 years.
  • Of the sample, 50.5% were women.
  • Most patients had recurrent MPE with failed thoracentesis or other treatment.
  • The majority of the patients had a lung cancer diagnosis, but some also had breast cancer, mesothelioma, and a few other cancers.

Phase of Care and Clinical Applications

  • Patients were undergoing end-of-life care.
  • The study has clinical applicability for palliative care.

Results

Symptom relief was variably defined in the studies. Three studies reported symptom improvement without further delineation. One study rated dyspnea improvement on a three-point scale. The remaining studies reported symptomatic relief as “relief of dyspnea” or “improvement in respiratory performance,” “increased exercise tolerance,” “ improvement of pain,” and “catheter was useful.” When combined, 628 of the 657 patients (95.6%) experienced some degree of improvement in their symptoms, although the magnitude of improvement cannot be determined. Serious complications were rare. The most common complications were cellulitis (32 of 935, 3.4%) and obstruction or clogging (33 of 895, 3.7%) or unspecified malfunction of the catheter (11 of 121, 9.1%). The quality of the studies was low, as evaluated by the GRADES system.

Authors suggest that TIPC may improve symptoms for patients with MPE.

Conclusions

Based on the low-quality evidence in the form of the case studies, evidence is insufficient to demonstrate the effectiveness of TIPCs. 

Nursing Implications

More rigorous studies need to be conducted to establish evidence with respect to dyspnea.

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