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Gonella, S., di Pasquale, T., & Palese, A. (2015). Preventive measures for cyclophosphamide-related hemorrhagic cystitis in blood and bone marrow transplantation: An Italian multicenter retrospective study. Clinical Journal of Oncology Nursing, 19, E8–E14.

Study Purpose

To determine the incidence of early onset hemorrhagic cystitis (EOHC) and identify the effectiveness of preventive measures upon EOHC

Intervention Characteristics/Basic Study Process

This retrospective study evaluated the effects of hyperhydration, diuresis alkalization, mesna, fluoroquinolone antibiotic prophylaxis, urethral catheterization, and CBI on 158 patients in two centers undergoing BMT regime upon EOHC. EOHC was defined as HC occurring within the 21 days after transplantation.

Sample Characteristics

  • N = 158  
  • MEAN AGE = 41.9 years
  • MALES: 59%, FEMALES: 41%
  • KEY DISEASE CHARACTERISTICS: Patients receiving conditioning BMT regimes for either autologous (n = 5) or allogeneic (n = 153) BMT for hematologic malignancies  
  • OTHER KEY SAMPLE CHARACTERISTICS: 40% of patients had AML.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Italy

Phase of Care and Clinical Applications

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

Study Design

  • Retrospective study of patients receiving BMT regimes at two Italian centers

Measurement Instruments/Methods

Groups were compared using the Mann-Whitney U test (for continuous variables) and Yates’ correction (for categorical variables). Logistic regression was used to identify factors contributing to the development of EOHC, including gender, age, smoking habits, type of transplantation, stem-cell donor, Cytoxan dose, urethral catheterization, and CBI. A multivariate regression model using a backward stepwise selection algorithm was employed.

Results

Thirty-one patients (all allogeneic transplantations) developed EOHC. Female gender (p = 0.24) and the dose of cytoxan (p = 0.016) were identified as independent risk factors for EOHC. The daily dose of mesna was the only significant measure (p = 0.01) identified between those who developed EOHC (median = 4.463) and those who did not (3.701).

Conclusions

Univariate analysis does not support the current standard, prophylactic catheterization and CBI, for prevention of EOHC. The best practice includes hyperhydration association with diuresis alkalization and mesna infusions.

Limitations

  • Unintended interventions or applicable interventions that would influence results were not described.
  • This was a retrospective study.

Nursing Implications

Nurses caring for patients at risk of HC may need to reassess current standards for prophylactic treatment of HC.

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Gonella, S., Garrino, L., & Dimonte, V. (2014). Biofield therapies and cancer-related symptoms: A review. Clinical Journal of Oncology Nursing, 18, 568–576. 

Purpose

STUDY PURPOSE: To review the evidence regarding the effects of biofield therapies for relief of cancer-related symptoms
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, CINAHL, PsycINFO, Trip database, and Cochrane Collaboration
 
KEYWORDS: Not provided 
 
INCLUSION CRITERIA: Cancer diagnosis; age > 18 years old; undergoing biofield therapies (BT) to relieve cancer-related pain, anxiety, and fatigue, or to increase well-being and quality of life
 
EXCLUSION CRITERIA: Studies related to surgical pain were excluded

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 121
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Not stated

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 13 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,003
  • SAMPLE RANGE ACROSS STUDIES = 16–230 patients
  • KEY SAMPLE CHARACTERISTICS: Various tumor types, patients in active treatment undergoing chemotherapy or radiation therapy

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Palliative care

Results

Interventions considered to be BT were healing touch, Reiki, and therapeutic touch. The effect on pain was examined in seven studies. There were some mixed findings, but most showed a reduction in pain over short time periods. Fatigue was assessed in five studies. These demonstrated fatigue reduction post-treatment, but data were conflicting over a longer period of four to eight weeks. Anxiety and depression were examined in seven studies. All but one found a significant reduction in mood disorders, but a study comparing Reiki, sham Reiki, and usual care found no difference between the sham and actual Reiki groups. Most studies were of descriptive or quasi-experimental design; potential confounding variables were not examined, and placebo effects could not be ruled out.

Conclusions

Studies using biofield therapies for relief of pain, anxiety, fatigue, and depression generally showed benefit; however, the evidence is not strong due to the limitations of the studies included.

Limitations

Low-quality design studies and the short duration of study follow-up

Nursing Implications

BT therapies have not demonstrated effectiveness in well-designed clinical studies; however, though it is weak, evidence suggests potential benefit. There were no adverse effects of these interventions reported. Biofield therapies are not expensive and are low-risk, so they can be considered in the management of cancer-related symptoms. Well-designed clinical trials are needed to establish efficacy.

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Gomutbutra, P., O'Riordan, D.L., & Pantilat, S.Z. (2013). Management of moderate-to-severe dyspnea in hospitalized patients receiving palliative care. Journal of Pain and Symptom Management, 45, 885–891.

Study Purpose

To describe the management of moderate to severe dyspnea in patients receiving palliative care

Intervention Characteristics/Basic Study Process

A retrospective study was conducted using the records of patients who were consulted by a palliative care service over a five-year period. Information about medications prescribed was collected for patients who self-reported moderate to severe dyspnea at their initial evaluations by the palliative care service. Follow-up assessments of dyspnea were conducted by the palliative care service within 24 hours of the initial assessment. Data extraction was completed by a physician.

Sample Characteristics

  • N = 115  
  • MEAN AGE = 64 years (SD = 17 years)
  • MALES: 51% (n = 59), FEMALES: 49% (n = 56)
  • KEY DISEASE CHARACTERISTICS: Primary diagnoses were cancer (64%, n = 59), heart failure (8%, n = 9), and chronic obstructive pulmonary disease (5%, n = 6). 
  • OTHER KEY SAMPLE CHARACTERISTICS: Half of the sample was Caucasian (54%, n = 62). Pneumonia was diagnosed in 34% of patients (n = 39), and 30% of patients (n = 35) had a pleural or pericardial effusion. 

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Urban medical center

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

Retrospective chart review of patients with moderate or severe dyspnea

Measurement Instruments/Methods

  • Charleston Comorbidity Index (CCI) to assess the severity of illness through the classification of comorbidities to predict short- and long-term mortality
  • Dosages of opioids were converted into milligrams of oral morphine per day by equianalgesic dosing.
  • Plonk’s equation was used to convert methadone to morphine. 
  • Dyspnea, pain, and anxiety were measured using a four-point categorical scale based on patient self-reports.
  • Data from the chart review included the frequency and dose of opioids and benzodiazepines, age, sex, race, comorbidities, the presence of pneumonia, and pleural or pericardial effusion. 

Results

At baseline, most patients reported moderate dyspnea (73%, n = 31) or severe dyspnea (27%). In addition, 48% of patients reported pain, and 57% reported anxiety. 15% of patients reported nausea. There was no association between the severity of dyspnea at baseline and patients' reports of pain (P = 0.8), anxiety (P = 0.08), or nausea (P = 0.8). At the 24 hour follow-up assessment, 74% (n = 85) of patients reported an improvement in their dyspnea. 44% (n = 51) of patients reported mild dyspnea, 29% (n = 33) moderate, 9% (n = 10) severe, and 18% (n = 21) reported no dyspnea. Of the 74% of patients who reported an improvement in their dyspnea, 42% (n = 36) received opioids alone, 37% (n = 31) had benzodiazepines concurrent with opioids, 2% (n = 2) had benzodiazepines alone, and 19% (n = 16) had not received either medication. 
 
Patients prescribed a medication were significantly associated with improvements in dyspnea (p = 0.05). Logistical regression identified that patients who received benzodiazepines and opioids had increased odds of improving dyspnea (odds ratio = 5.5, 95% CI = 1.4, 21.3) compared to those receiving no medications. 

Conclusions

Most patients reported an improvement in dyspnea within of 24 hours after palliative care service consultation. Most patients with dyspnea received opioids but only the combination of benzodiazepines and opioids was independently associated to improve dyspnea.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no control group) 
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)  
  • Other limitations/explanation: The results were from a retrospective chart review. Conclusions cannot be drawn about the effectiveness of treatment or the causal relationships between medication and improvements in in dyspnea symptoms due to the study’s design. The study acknowledges potential confounding factors including patient factors, procedures, and psychological care that may impact the study’s findings. The results are reflective of the practices of one institution, which may limit generalizability. The population studied may not be generalizable to the broader palliative care population.
 

 

Nursing Implications

Because dyspnea is a common symptom in patients receiving palliative care, the authors conducted a study that reviewed the records of patients with moderate or severe dyspnea. The study found that opioids given with benzodiazepines were associated with improvements in dyspnea. Additional research to determine whether the use of benzodiazepines alone or in combination with opioids is more effective is necessary to to lead to improvements in dyspnea treatments.

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Gomez-Hernandez, J., Orozco-Alatorre, A.L., Dominguez-Contreras, M., Oceguera-Villanueva, A., Gomez-Romo, S., Alvarez Villaseñor, A.S., . . . Gonzalez-Ojeda, A. (2010). Preoperative dexamethasone reduces postoperative pain, nausea and vomiting following mastectomy for breast cancer. BMC Cancer, 10, 692.

Study Purpose

To evaluate the effectiveness of preoperative dexamethasone in reducing postoperative nausea, vomiting, and pain after mastectomy

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either IV dexamethasone 8 mg or placebo 60 minutes prior to skin incision. All patients had the same standardized general anesthesia. The same surgical team performed each surgery. Pain was assessed on entry to the recovery room and at 6, 12, and 24 hours postoperatively. Analgesia was ketorolac 30 mg every 8 hours and IV tramadol infusion 50 mg as backup medication. Patients were followed for up to 30 days after surgery.

Sample Characteristics

  • The sample was composed of 70 patients.
  • In the placebo group, mean patient age was 49.89 years (SD = 10.58 years). In the dexamethasone group, mean patient age was 50.11 years (SD = 12.37 years).
  • All patients were female.
  • All patients had breast cancer. In each group, more than 90% underwent radical mastectomy with axillary node dissection.

Setting

  • Single site
  • Inpatient
  • Guadalajara, Jalisco, Mexico

Study Design

Double-blinded placebo-controlled randomized trial

Measurement Instruments/Methods

  • Visual analog scale, to assess pain
  • Four-point ordinal scale (0 = no vomiting, 3 = vomiting), to assess postoperative nausea and vomiting

Results

Compared to patients in the placebo group, those receiving dexamethasone had significantly lower pain scale scores immediately after surgery (p = 0.004), at 6 hours (p < 0.0005), and at 12 hours (p = 0.04). Pain score differences between groups were approximately 1 point at these times. Authors noted no differences between groups at 24 hours after surgery. More patients in the placebo group than in the dexamethasone group required analgesics (p = 0.008), and the mean dose of IV tramadol was lower for those who received dexamethasone (p = 0.03). Incidence of nausea and vomiting was lower with dexamethasone; more patients in the placebo group required antiemetics (p = 0.01)

Conclusions

Compared to preoperative administration of placebo, preoperative administration of dexamethasone was associated with less short-term postoperative pain, nausea, and vomiting.

Limitations

  • The study had a small sample size, with fewer than 100 participants.
  • Patients with a history of motion sickness and other risk factors for nausea and vomiting were excluded from the study, so patients included were those at lower risk for these problems.
  • Authors did not report actual intake of opioid or analgesic.

Nursing Implications

Findings suggest that preoperative dexamethasone administration can reduce short-term postoperative pain, nausea, and vomiting. In this study patients received specific anesthesia regimens. Findings may not be the same with different anesthetics. Further study in this area should identify optimal management of postoperative symptoms. The administration of a single corticosteroid dose prior to surgery can be a relatively low-risk intervention that seems to improve the patient’s experience.

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Gomes, M.Z., Jiang, Y., Mulanovich, V.E., Lewis, R.E., & Kontoyiannis, D.P. (2014). Effectiveness of primary anti-Aspergillus prophylaxis during remission induction chemotherapy of acute myeloid leukemia. Antimicrobial Agents and Chemotherapy, 58, 2775–2780. 

Study Purpose

To analyze risk factors for breakthrough invasive fungal infection (IFI) in patients receiving remission-induction chemotherapy and evaluate effects of echinocandin versus triazole prophylaxis

Intervention Characteristics/Basic Study Process

Data were obtained from patients’ electronic medical records for antifungal use, documented IFI, type of chemotherapy, use of HEPA air filtration, duration of hospitalization, and neutropenia and mortality. Kaplan-Meier curves were used to estimate the probability of remaining IFI free based on prophylaxis strategy. Patient data were used up to IFI diagnosis, loss to follow-up, death, or completion of 120 days post-induction, whichever came first.

Sample Characteristics

  • N = 125
  • MEDIAN AGE = 64 years
  • AGE RANGE = 51–73 years
  • MALES: 55%, FEMALES: 45%
  • KEY DISEASE CHARACTERISTICS: AML undergoing remission induction. The majority were on cytarabine-based regimens.

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Texas

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Retrospective

Measurement Instruments/Methods

  • None—no definition of IFI provided

Results

Those receiving echinocandin versus mold active triazole had higher incidence of IFI (0% in the triazole group, 8% in the echinocandin group, p = 0.09). All cause mortality did not differ between groups. Regimens containing clofarabine for induction was also an independent predictor of IFI (p = 0.004). Patients who died within 120 days of beginning induction chemotherapy were more likely to be female, had prior chemotherapy-related AML, had lung disease or infection, or had cardiovascular disease as a comorbid condition. Those receiving echinocandin also had more breakthrough yeast infections.

Conclusions

Findings suggest that primary antifungal prophylaxis during remission induction with echinocandin may be less effective in preventing IFI than prophylaxis with mold-active triazoles.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no random assignment) 
  • There were very few fungal infections overall, and a much lower sample size that received echinocandin.

Nursing Implications

Patients with AML undergoing remission-induction chemotherapy are at high risk for developing IFIs, particularly mold infections. Findings from this study suggest that the class of antifungal prophylaxis agent used influences the patient’s risk of IFI. Nurses should be aware of the potential increased risk for fungal and yeast infections in patients getting echinocandin prophylaxis. Further research in this area is warranted given the limitations of this study.

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Gomes, B., Calanzani, N., Curiale, V., McCrone, P., & Higginson, I.J. (2013). Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database of Systematic Reviews, 6, CD007760.

Purpose

STUDY PURPOSE: To review the evidence regarding effectiveness of home palliative care services for patients and their caregivers

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: 12 electronice databases were searched up to November 2012—Cochrane Central Register of Controlled Trials (CENTRAL); EMBASE; MEDLINE; Cochrane Pain, Palliative, and Supportive Care (PaPaS) Trials Register; Cochrane Effective Practice and Organisation of Care (EPOC) Trials Register; CINAHL; EURONHEED; PsycINFO; Cochrane Database of Systematic Reviews (CDSR); Database of Abstracts of Reviews of Effectiveness (DARE); Health Technology Assessment (HTA) Database; and NHS Economic Evaluation Database (NHS EED)

KEYWORDS: An extensive listing of search strategies is provided.

INCLUSION CRITERIA: Randomized controlled trials, time series, and pre-post trials; patients older than 18 years and/or their caregivers

EXCLUSION CRITERIA: Services provided in settings other than the home

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 7,594
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Used the method outlined for Cochrane systematic reviews

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 23 (7 included in meta-analysis and 6 included in cost analysis)
  • SAMPLE RANGE ACROSS STUDIES: 42–747 in prospective studies; also included large analysis of retrospective data
  • KEY SAMPLE CHARACTERISTICS: Advanced disease including noncancer and cancer

Phase of Care and Clinical Applications

PHASE OF CARE: End-of-life care

APPLICATIONS: Palliative care

Results

Palliative care services provision results in statistically significant increased odds of dying at home (OR 2.21, p = .0003) and a significant but small reduction in patients’ symptom burden. Regarding effects for informal caregivers, evidence of the impact on caregiver physical outcomes was conflicting. Evidence was inconclusive regarding effect on caregiver psychosocial outcomes. Evidence regarding effects on caregiver burden was conflicting. Evidence regarding effects on caregiver severity of grief and satisfaction with care was conflicting. In two studies that examined the addition of specialized caregiver support to usual palliative care services, results showed an increase in caregivers who felt rewards from caregiving. Six studies reported decreased costs in intervention groups, but this was only significant in one study and significance was not analyzed in three.

Conclusions

Strong evidence suggests that home palliative care services increase the likelihood of patients dying at home and decrease symptom burden for patients. Evidence regarding effects for caregivers is conflicting and inconclusive. Evidence regarding cost and cost-effectiveness is insufficient to draw conclusions.

Limitations

  • Most studies were old, and most were done in high-income countries.  
  • Most studies had methodologic flaws and relatively high risk of bias.

Nursing Implications

Findings provide strong evidence that home palliative care services result in increased deaths at home and reduced symptom burden for patients. The effect for informal caregivers is uncertain. Caregiver burden can be higher in situations with more patient symptoms to manage, so one could expect that reducing patient symptom burden could have some benefit for the caregiver.

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Gollins, S., Gaffney, C., Slade, S., & Swindell, R. (2008). RCT on gentian violet versus a hydrogel dressing for radiotherapy-induced moist skin desquamation. Journal of Wound Care, 17, 268–275.

Study Purpose

To compare hydrogel dressing to gentian violet (GV) for healing moist desquamation

Intervention Characteristics/Basic Study Process

Patients were referred after a nurse or radiographer identified moist desquamation. They were randomly assigned to GV or hydrogel. Patients were given instruction on how to apply GV or hydrogel at home and were assessed by radiographers on alternate days until the healing occurred. Tracing of the moist desquamation area on to polythene sheets was done randomly on different days with different patients.

Sample Characteristics

  • The study sample (N = 30) was comprised of male (6.3%) and female (93.7%) patients with head and neck or breast cancer.
  • Mean age was 61.2 years for the GV group and 57.4 years hydrogel group.
  • Median dose was 50 Gy, with a range of 40–64.7 Gy.

Setting

The study took place at a single site in the United Kingdom.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • The end point was the time to healing.
  • The secondary end point was “area under the curve” of the plot of the median area of moist desquamation against time.
  • Tracing of the area of moist desquamation was used as the measure.

Results

  • Median healing time was 12 days in the hydrogel group and 30 days in GV group.
  • Ten of the 16 patients withdrew from the GV group, citing nonhealing and stinging.
  • Three of the 14 patients in the hydrogel group withdrew because of stinging and noncompliance.
  • Over the first seven days, there were no differences in the area of moist desquamation.
  • Over 14 days, the hydrogel group had a smaller area (p = 0.003), but the area of moist desquamation increased from baseline in both groups.

 

Conclusions

The study could not support or refute the value of hydrogel dressings.

Limitations

  • The sample size was small, with less than 50 patients.
  • There is no standard system to identify moist desquamation.
  • Many patients withdrew from the study.
  • The study was stopped because of the benefit seen in hydrogel.
  • The study had a risk of bias because it was unblinded.
  • There was no standard amount of GV applications (several times a day).
  • Patients with head and neck cancer often were not nutritionally sound, and patients with breast cancer may not have as many comorbidities.
  • No subgroup analysis was done.
  • The report did not mention if chemotherapy given.
  • Although time to healing was the main end point, no statistical analysis of differences in time to healing could be done.
  • There were no standard time points of skin evaluations.
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Goldschmidt, N., Ganzel, C., Attias, D., Gatt, M., Polliack, A., & Tadmor, T. (2014). Pegfilgrastim prophylaxis for cladribine-induced neutropenia in patients with hairy-cell leukemia. Acta Haematologica, 132, 118–121.

Study Purpose

To evaluate the efficacy of primary prophylactic pegfilgrastim compared to on-demand daily G-CSF after treatment with cladribine in patients with hairy-cell leukemia (HCL)

Intervention Characteristics/Basic Study Process

This was a retrospective chart review of 40 patients with HCL (1991–2012) treated with cladribine (0.1 mg/kg per day) for five to seven days either subcutaneously (SC) or IV, receiving a total of 40 courses of therapy treated with filgrastim (300 mcg per day) on demand until the patients' absolute neutrophil counts (ANCs) were > 2.0 x 109 compared to nine courses of therapy with primary pegfilgrastim prophylaxis (6 mg SC for 24 hours after the completion of chemotherapy).

Sample Characteristics

  • N = 40 (on-demand filgrastim arm had 31 patients; primary pegfilgrastim prophylaxis arm had nine patients)   
  • RANGE AGE = 23–76 years  
  • MALES: 80%, FEMALES: 20%
  • KEY DISEASE CHARACTERISTICS: HCL diagnosis confirmed by bone marrow biopsy and additional flow cytometry confirmation (after 2004); no significant difference in clinical and laboratory parameters between study populations before therapy including cytopenias, spleen size, ANC, platelet count, hemoglobin count, nadir duration, infections requiring hospitalization, and duration of hospitalization
  • OTHER KEY SAMPLE CHARACTERISTICS: The on-demand filgrastim arm included two patients who received three cycles because of relapsed disease, seven patients who were treated with two cycles, and 31 patients who received only one course of therapy. In the primary prophylaxis pegfilgrastim arm, nine consecutive courses were given to nine patients 24 hours after the completion of chemotherapy.

Setting

  • SITE: Medical centers
  • SETTING TYPE: Inpatient  
  • LOCATION: Haifa, Israel

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

Retrospective, historical control study of patients with HCL prescribed cladribine determining the effect of IV pegfilgrastim versus filgrastim on neutropenia, hospitalization, 20 FN, severity of infection, and ANC nadir

Measurement Instruments/Methods

  • The incidence of neutropenia (defined as an ANC < 1.0 x 109 /L)
  • Fever (defined as a temperature > 38.2 oC)
  • Number of days of hospitalization because of FN
  • Details of severity of infection
  • Number days from the last day of therapy until ANC recovery (defined as an ANC > 1.0 x 109 /L)

Results

The median follow-up was 94 months (range = 12–312 months). No significant difference was found between primary prophylaxis with pegfilgrastim versus on-demand filgrastim for patients with HCL treated with cladribine for the variables of incidence of neutropenia, number days of hospitalization because of FN, severity of infection, or the number of days from the last day therapy till ANC recovery.

Conclusions

This retrospective study demonstrated no difference in the clinical effectiveness of primary pegfilgrastim versus on-demand filgrastim after cladribine therapy for patients with HCL.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Questionable protocol fidelity
  • Other limitations/explanation: The majority of patients were in the filgrastim group (n = 31) compared to the pegfilgrastim group (n = 9). There may have been differences between the sites that were not disclosed. The grade of neutropenia not described. There were differences between the study groups (relapsed patients in the filgrastim on-demand arm). There were unknown comorbities in study population. Previous patient chemotherapy exposure was unknown. The details of the types and severity of infections post-treatment were not well-reported or described.
 
 

Nursing Implications

This study demonstrated no difference in the incidence of neutropenia, FN, or infections requiring hospitalization between the use of pegfilgrastim versus filgrastim after treatment with cladribine. Large, prospective, randomized trials need to be conducted to validate this study's results. Nurse-sensitive interventions remain critical in the prevention of infection for patients with HCL and prolonged neutropenia caused by disease and treatment.

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Goldberg, R.M., Loprinzi, C.L., O’Fallon, J.R., Veeder, M.H., Miser, A.W., Mailliard, J.A., … Burnham, N.L. (1994). Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. Journal of Clinical Oncology, 12, 155–158.

Study Purpose

The study evaluated transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer.

Intervention Characteristics/Basic Study Process

Four weeks of transdermal clonidine (equivalent to a daily oral dose of 0.1mg) was followed by four weeks of placebo patches or vice versa. Patches were changed weekly.

Sample Characteristics

The study enrolled 116 women with a mean age of 54 years who were receiving tamoxifen for breast cancer experiencing hot flashes and requesting intervention; experiencing hot flashes for longer than one month and at least seven per week. One hundred ten (110) of the 116 completed the study. Participants were stratified by age, duration of hot flash symptoms, and the average frequency and severity of hot flashes.

Study Design

This was a randomized, double-blind, crossover prospective study.

Measurement Instruments/Methods

The study employed the following measures:

  • Daily self-administered patient questionnaires
  • Weekly questionnaires
  • Nurse assessment every two to three weeks for compliance, toxicity profile, and standard questions
  • Hot flash severity and frequency measures and combined hot flash score

Results

The study showed a statistically significant decrease in hot flashes (frequency and severity) (p < .0001), and clinically moderate decreases in frequency (20%) and severity (10%). Toxicities included dry mouth (p < .001) and constipation (p < .02).

Limitations

Small study size limited the value of the outcomes.

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Goldberg, G.R., & Morrison, R.S. (2007). Pain management in hospitalized cancer patients: A systematic review. Journal of Clinical Oncology, 25, 1792–1801.

Purpose

To provide a systematic review of institutional interventions designed to improve management of pain in hospitalized patients with cancer

Search Strategy

Databases searched were MEDLINE, Cochrane Library, and authors’ personal libraries.

Search keywords were pain, pain measurement, outcomes assessment, or quality assurance.

Inclusion criteria was not specifically stated, other than that studies involved patients with cancer.

Exclusion criteria was not specifically stated.

Literature Evaluated

Total number of studies retrieved or initially evaluated is not provided.

Articles were reviewed and independently summarized by the authors, and any disagreements were discussed until consensus was achieved.

Sample Characteristics

Studies were not exclusively for patients with cancer, but all did involve some cancer care cases.

  • Four studies involving the effect of educational interventions for care providers, encompassing 939 nurses
  • Two studies involving patient education, encompassing 343 patients
  • Ten studies of interventions to improve assessment and documentation of pain, involving more than 2,876 cases
  • Three studies involving the use of auditing and feedback, involving more than 4,662 patients
  • Two studies and one meta-analysis involving use of pain specialty consultation
  • One study involving the use of a computerized decision support system (CDSS) to enhance physician prescribing and treatment of pain

Results

Nursing educational interventions improve knowledge and correct misconceptions but have not shown improved pain or patient satisfaction.

Studies suggest that patient education and tailored counseling sessions directed at patients can improve pain scores and negative beliefs and misconceptions.

Routine pain assessment has been shown to improve staff and patient satisfaction; however, interventions have not been shown to improve overall pain scores or pain severity.

Provision of audit and feedback of patient pain scores to nursing  staff improved pain assessment rates but had no effect on pain severity.

The study involving CDSS showed some improvement in prescribing practices, predominantly reducing use of meperidine, but did not demonstrate improved pain scores.

Meta-analysis of eight studies in the effect of a hospital-based palliative care team suggests that referral to such programs results in small but positive effects on pain, other symptoms, satisfaction, and reduction in length of stay compared to conventional care.

Conclusions

The major types of institution-wide interventions aimed at improving pain management include education, inclusion of pain assessment as a vital sign, auditing and staff feedback of pain scores, use of CDSS, and referral to palliative care specialists. Improved knowledge, assessment, and process of care measures have been demonstrated; however, no substantial effects on actual pain scores and severity have been demonstrated as a result of these interventions. From this review, the most promising interventions related to actual pain outcomes appear to be patient education and counseling and referral to palliative care specialists. The authors conclude that no generalizable interventions were identified.

Limitations

  • Findings are limited by the fact that studies had numerous methodological flaws and, in some cases, very small samples.
  • The search strategy was limited and not well-reported and may have missed reports of some quality improvement efforts that may have not been published or identified in this review.

Nursing Implications

Findings point to the difficulty of being able to demonstrate the effects of institutional interventions on patients’ measurable pain outcomes other than satisfaction with pain management. Most of these efforts are not necessarily appropriate in a randomized controlled trial type of design, leading to questions of methodological rigor in findings, and suggest that the patient’s experience of pain is complex and not readily determined by standardized processes.

Findings suggest that individual patient interventions including counseling and education are worth further investigation in order to have an effect on pain outcomes.

Involvement of palliative care specialists appears to be somewhat effective to improve pain outcomes; however, it is not clear that universal referrals to such groups for all pain management are practical. This raises the question of how such specialized knowledge, focus, and expertise might be shared and utilized in new ways to impact all patients. It is not clear that educational interventions for staff that have been studied are sufficient to improve knowledge of providers to the extent required to impact pain-related results.

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