Investigate omega 3 fatty acids in reducing the incidence and severity of paclitaxel-induced peripheral neuropathy

Patients were randomly assigned to receive omega 3 fatty acid supplements at a dose of 640 mg three times daily, or an identical gelatin placebo capsule. All patients received the intervention throughout treatment and for one month after chemotherapy treatment. Patients were evaluated prior to chemotherapy and one month after completion of chemotherapy. Evaluations were done by a single neurologist.

• N = 57           
• MEAN AGE = 45.9
• FEMALES = 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving four courses of 175 mg/m² paclitaxel for positive node disease.

• SITE: Single site   
• SETTING TYPE: Outpatient  
• LOCATION: Iran

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled, randomized trial

• Total peripheral neuropathy score including sensory symptoms, pin sensibility, tendon reflexes, and nerve conduction studies of sural and peroneal nerves from scores for individual items of 0-4
• Unilateral nerve conduction studies
• Serum concentrations of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

70% of patients receiving omega 3 fatty acid supplements did not develop peripheral neuropathy, compared to 40% in the placebo group (odds ratio = 0.3, .95% CI = 0.10–0.88, p = .029). There was a non-significant trend toward lower severity of symptoms in those receiving omega 3 fatty acids. No significant differences existed between groups in individual nerve conduction study results. Significant differences did exist between groups in serum EPA and DHA concentrations (p < .005) with higher levels in the experimental group. No relationship existed between serum concentrations and peripheral neuropathy scores.

Findings suggest that oral supplementation with omega 3 fatty acids may have a protective effect for development of peripheral neuropathy in patients receiving paclitaxel.

• Small sample < 100
• Measurement/methods were not well described.
• Measurement validity/reliability was questionable.
• Findings were not generalizable.
• Study was underpowered by the authors’ report and calculations.
• The specific grading of findings to calculate the peripheral neuropathy score is not well defined and is not a commonly used and validated scoring approach.
• There was a limited timeframe of follow-up. 
• Findings may not be applicable in patients receiving different neurotoxic drugs.

Findings suggest a neuroprotective effect of omega 3 fatty acid supplementation. These are promising results, which warrant further research in well-powered studies and in the context of other types of neurotoxic chemotherapeutic agents.

To assess the effectiveness of palifermin in preventing mucositis in children with acute lymphocytic leukemia (ALL) undergoing chemotherapy

A clinical trial of 90 children with ALL who were randomized to receive chlorhexidine or palifermin. One group received 60 mcg/kg palifermin as an IV bolus once daily three days before and three days after chemotherapy. The other group received chlorhexidine mouthwash administered once daily three days before and three days after chemotherapy.

• N = 90   
• AGE = 5–18 years
• MALES: 44, FEMALES: 46
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: ALL 
• OTHER KEY SAMPLE CHARACTERISTICS: Induction chemotherapy protocol consisted of standard risk B-precursor ALL (COG)/dexamethasone, vincristine, L-asparaginase, intrathecal (MTN + Ara C + hydrocortisone). The intensification protocol was dexamethasone, vincristine, L-asparaginase/dexamethasone, cyclophosphamide/6-thioguanine + cytarabine + intrathecal MTX.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Tehran, Iran

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, palliative care 

Randomized, controlled trial

The World Health Organization (WHO) Oral Toxicity Scale was used for grading mucositis. The data were analyzed with two-way ANOVA.

The group that used the palifermin had a decreased incidence and severity of chemotherapy-induced mucositis.

Palifermin reduced oral mucositis in children with ALL.

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

In this study, palifermin has reduced the severity of mucositis in children with ALL who received induction and intensification chemotherapy.

To determine whether improved pain control and/or ulcer management of oral mucositis in patients with head and neck cancer receiving postoperative radiation therapy can be achieved with licorice mucoadhesive film or triamcinolone acetonide mucoadhesive film

When patients reached a World Health Organization (WHO) grade 2 or 3 mucositis rating, they were randomized according to a balanced block randomization to receive either triamcinolone (T) (.5 mg triamcinolone acetonide in film) or licorice (L) (.18 mg polyphenols as pyrogallol extracted from licorice root) in addition to the standard of care. The standard of care included frequent mouth rinses using boiled water, regular brushing and flossing, scaling, and the removal of plaque and tartar during radiation therapy. The films were applied to the upper lip four times per day. The intervention continued for four weeks or until the cessation of mucositis. The use of analgesics was not permitted before or during the study. Two investigators rated the severity of the mucositis, and data were collected on a weekly basis. Compliance was measured by counting unused films.

• N = 60  
• AVERAGE AGE = 57.93 years
• MALES: 60% (T group); 63.3% (L group), FEMALES: 40% (T group); 36.7% (L group)
• KEY DISEASE CHARACTERISTICS: This study included patients with head and neck cancer (documented histologically) undergoing radiation therapy with grades 2 and 3 oral mucositis as determined by the WHO scale.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were older than 18 years. The ability to continue throughout the entire study was required. The study included men and nonpregnant women. The study excluded patients undergoing chemotherapy and immunotherapy or taking investigational drugs. The study excluded patients with a significant history of drug or alcohol abuse and pregnant women.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Isfahan, Iran

• PHASE OF CARE: Active antitumor treatment

Double-blinded, prospective, randomized, controlled trial

• World Health Organization (WHO) mucositis scale
• Data forms
• Visual Analog Scale (VAS)

There was a significant difference in the mean value of the mucositis scores for the T and L interventions when compared to the control group (p < .05) although there was no difference between the two intervention groups. No statistically significant difference was achieved (p > .05) between interventions in reducing pain during radiation therapy. However, each was statistically significant (p < .05) in reducing pain during radiation therapy when compared to the standard of care alone. A slight additional reduction in pain was noted in the L group, but it was not significant.

Both triamcinolone acetonide mucoadhesive film and licorice mucoadhesive film reduced the mean mucositis score and the pain associated with mucositis during radiation therapy when compared to the group that only received standard of care. However, there was no significant difference between the two interventions for mucositis scores or pain scores when compared to each other.

• Small sample (< 100)
• Findings not generalizable
• Other limitations/explanation: State-run cancer center; convenience sampling; pre-existing oral complications

Although there is not enough evidence to recommended the use of this intervention, this study is a good starting point for nurse research to continue working toward finding additional, better ways to treat and prevent oral mucositis and its complications in patients undergoing cancer treatment.

To compare outcomes between patients with acute myeloid leukemia (AML) who did or did not receive prophylactic ciprofloxacin 500 mg twice per day for neutropenic fever

Administration of prophylactic ciprofloxacin 500 mg twice daily for the prevention of neutropenic fever

• N = 69   
• MEAN AGE = 41.3 years (SD = 14.3) ciprofloxacin group, 37.4 years (SD = 9) non-ciprofloxacin group
• MALES: 68.1%, FEMALES: 31.9%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: AML as diagnosed by bone marrow and peripheral blood smear showing greater than 20% blasts and meeting AML criteria on flow cytometry analysis (criteria for flow cytometry indications of AML not specified)
• OTHER KEY SAMPLE CHARACTERISTICS: Patients native to Tehran who had been treated from September 2009 to November 2010 for AML with idarubicin 12 mg/m²/day for three days and Ara-C 100–200 mg/m²/day as a continuous infusion for seven days were included.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Tehran, Iran

PHASE OF CARE: Active antitumor treatment

Retrospective, medical record, cross-sectional evaluation

Outcome measurements included rate of neutropenic fever episodes, microbiologic findings, patterns of resistance, and mortality. Independent variables included demographic data, type of AML, and administration or absence of the intervention (prophylactic ciprofloxacin). Administration of granulocyte–colony-stimulating factors were also included in the analyses.

No statistically significant differences were found in any of the outcome variables between patients who received prophylactic ciprofloxacin compared to patients who did not receive the prophylactic treatment. Specifically 80% of the treatment group and 82% of the control had neutropenic fevers. Although mortality rates were lower among those who received the prophylactic ciprofloxacin compared to those who did not, the differences were not statistically significant.

There is no benefit of prophylactic ciprofloxacin for the prevention of neutropenic fever among patients undergoing induction chemotherapy for AML. These findings aligned with other similar studies with the exception of one that the researchers found in the literature.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable

Understanding the ineffectiveness of prophylactic ciprofloxacin for the prevention of febrile neutropenia in patients undergoing induction chemotherapy for AML can aid in treatment decisions and promote the use of more effective interventions.

To determine the effectiveness and safety of the topical application of a combined 2% ketamine and 4% amitriptyline (KA) cream for reduction of chemotherapy-induced peripheral neuropathy (CIPN) in patients who have completed chemotherapy

One week prior to enrollment, subjects completed a seven-day daily pain, numbness, and tingling diary over the past 24 hours. Subjects answered the question for any of the three symptoms in either their hands or feet. At enrollment, subjects were instructed to use a measuring device for application of 4 g of either KA or placebo cream twice daily to each area of hands or feet with any pain, numbness, or tingling. The seven-day daily pain, numbness, and tingling diary for pain over the past 24 hours, by numeric rating scale (NRS), was completed at three and six weeks after enrollment. A secondary analysis for pain using NRS was done at baseline, three, and six weeks.

• N = 458
• AGE = 18 years or older; range not defined
• MALES: 29%, FEMALES: 71%
• KEY DISEASE CHARACTERISTICS: 40% breast cancer, 27% gastrointestinal cancer, 9% hematologic malignancy, 3% head and neck cancer, 8% lung cancer, 7% gynecologic cancer, 5% genitourinary cancer
• OTHER KEY SAMPLE CHARACTERISTICS: 100% had previous chemotherapy, 85% had previous surgery, 48% had previous radiation therapy, and 53% had prior taxanes; no statistical difference in sample characteristics between groups
• INCLUSION: One month post-completion of chemotherapy; subjects with average seven-day pain, numbness, and tingling ratings of greater than 4; 18 years or older; KPS greater than 60; pain medications allowed if the dose was stable for two weeks prior to enrollment
• EXCLUSION: Pre-existing peripheral neuropathy resulting from something other than chemotherapy; prior neurologic procedures or topical treatment; clinical depression; medications: monoamine oxidase inhibitors, barbiturates, anticholinergic agents, sympathomimetic drugs, inhibitors CP450 2D6; open skin lesions in the region of cream application; creatinine greater than 2 mg/dL within 30 days prior to screening

• SITE: Multi-site 
• SETTING TYPE: Outpatient    
• LOCATION: University of Rochester Cancer Center Community Clinical Oncology Program

• PHASE OF CARE: Transition phase after active treatment 
• APPLICATIONS:  Elder care, palliative care

• Multi-center, phase III, double-blind, randomized, placebo-controlled clinical trial
  • Stratified into two treatment regimen groups: prior taxanes and nontaxane

• NRS (0 = not at all to 10 = as bad as you could imagine) for evaluation of any pain, numbness, and tingling in hands or feet
• Secondary analysis for pain in hands or feet was evaluated with an NRS  (0 = no pain to 10 = worst pain you can imagine) adapted from the MD Anderson Symptom Inventory.

No therapeutic effect was observed with the application of KA cream to the affected areas on hands or feet for reduction of pain, numbness, and tingling (p = 0.363). Secondary analysis for pain alone did not show a statistically significant difference between groups comparing means at 95% CI (KA cream, 4.64; placebo, 4.68). Patients in the treatment regimen group of prior taxanes, regardless of receiving study treatment with either KA or placebo, reported a reduction in pain, numbness, and tingling at six weeks (p = 0.042). No statistically significant adverse events were reported for the KA treatment group compared to the placebo group.

This study showed no therapeutic benefit for the topical application of KA cream for CIPN.

• Measurement validity/reliability questionable
• No separation for measurement of pain, numbness, or tingling in the primary analysis
• No standardized scale for symptom assessment of peripheral neuropathy was used (i.e., National Cancer Institute Common Toxicity Criteria) in the primary analysis
• Other limitations/explanation: Unknown type of prior chemotherapy for sample population other than taxanes; unknown surgical and radiation therapy anatomic sites; unknown patient sample age range and comorbidities

Further studies need to be done to investigate if any combination or separate topical compound targeting specific nociceptive pathways has a therapeutic benefit for CIPN.

To investigate the efficacy of a surveillance method for the diagnosis and management of subclinical lymphedema in patients with early-stage breast cancer

Diagnostic criteria for lymphedema included a volume increase of 3% in the affected upper limb compared with the patient’s preoperative measurement and with consideration of the contralateral limb volume changes. When lymphedema was diagnosed, garments were prescribed for daily wear. No activity limitations were placed for the duration of the intervention. At follow-up, when limb volume decreased, women were advised to continue wearing the garment only when completing strenuous exercise or activity, during air travel, with symptoms of heaviness, or if visible swelling appeared. Time points of evaluation were the preoperative visit and 1, 3, 6, 9, 12, and 18 months postoperatively.

• The study sample (N = 86) was comprised of a subclinical lymphedema (n = 43) group and control group (n = 43).
• Mean age was 55.3 and 53.4 years for the subclinical lymphedema and control groups, respectively. 
• All patients were female with newly diagnosed, unilateral, early-stage breast cancer (stage I–III).
• Patients were excluded if they had a previous history of breast cancer, bilateral breast cancer, or severe trauma or surgery of the affected upper limb.

The study took place at the National Naval Medical Center Breast Care Center in Bethesda, MD.

The study used a case-control design.

• Measurements for both upper limbs were taken using a Perometer.
• Upper-limb volume was calculated by using 80% of the total limb length, which was measured from the ulnar styloid process to the tip of the acromion for standardization.
• Body weight was recorded at each visit to control for weight change.

The time to onset of lymphedema averaged 6.9 months postoperatively. The subclinical lymphedema group had significantly higher upper-limb volume than the control group when the compression intervention was introduced. After the intervention, a statistically significant mean 48 ml volume decrease was realized (p < 0.0001) in the subclinical lymphedema group with activity-related garment wear only compared with 2.3 ml decrease in the control group. The mean duration of the intervention was 4.4 weeks. Volume reduction was maintained at an average follow-up of 4.8 months after the intervention.

Preoperative assessment in the context of a prospective surveillance model enables the early detection and management of subclinical lymphedema. An early intervention protocol reduces the affected limb volume to near baseline measures and prevents progression to a more advanced stage of lymphedema for at least the first year postoperatively.

The study does not use a randomized controlled design.

Preoperative baseline measurement is vital to successfully diagnosing subclinical lymphedema. However, currently, physical therapists in clinical practice rely on an impairment-based model for diagnosing and treating lymphedema. The paradigm is inadequate and a shift in the current practice pattern in favor of surveillance models is necessary. Further research is warranted to confirm the long-term clinical and cost effectiveness of this surveillance model compared with a traditional impairment-based model in treating breast cancer-related lymphedema.

To compare the effectiveness of three established rash-management strategies in EGFR-inhibitor (EGFRI) associated rash development

Rash severity was assessed during the initial presentation to clinic by applying the EGFR-Induced Rash Severity Score (ERSS). Three different EGFRI rash-management strategies were compared, and each targeted the inflammatory and/or the infectious characteristics of the rash. In stage 1 of the study, 21 patients (ERSS 10.3 to 77.9) were treated topically with mometasone furoate cream (a topical anti-inflammatory) twice daily. In stage 2 of the study, 23 patients (ERSS 12.5 to 67.1)  were treated topically with nadifloxacin 1% cream (a potent topical fluoroquinolone antibiotic) once daily in the morning, in combination with prednicarbate 0.25% cream (a topical glucocorticosteroid) once daily in the evening. In stage 3 of the study, five patients (ERSS > 50) received topical nadifloxacin and prednicarbate 0.25% cream in combination with the systemic retinoid isotretinoin 10–20 mg/day. Rash severity was reassessed after three weeks of specific therapy to manage the dermatologic reaction.

• N = 49            
• AGE = Not reported
• MALES: Not reported, FEMALES: Not reported
• KEY DISEASE CHARACTERISTICS: Not reported
• OTHER KEY SAMPLE CHARACTERISTICS: (1) DRUG: Patients who were treated with either cetuximab (a monoclonal anti-EGFR antibody) or erlotinib (a small molecule EGFR tyrosine kinase inhibitor), and who developed an EGFRI-associated rash at the time of referral to the physician’s clinic. (2) TIMING: Selection was limited to initial patients, and their follow-up visits were made in the timeframe of March 2007 to October 2009. (3) RASH SEVERITY: Patients who presented with ERSS of 10 or higher.  

• SITE: Multi-site      
• SETTING TYPE: Outpatient          
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

Retrospective, uncontrolled, comparative study

Patients' EGFRI-associated rash severity improved significantly with all three dermatological treatments, which are aligned with recent expert recommendations: topical mometasone furoate cream (p = 0.00009); nadifloxacin 1% cream and prednicarbate 0.25% cream (p = 0.03); and nadifloxacin 1% cream and prednicarbate 0.25% cream plus systemic isotretinoin (p = 0.015).

In summary, the results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions, including topical glucocorticosteroids, topical antiseptics/antibiotics, and systemic retinoids. Topical mometasone furoate cream was the only therapy that resulted in a complete resolution of all rash symptoms in one patient.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Other limitations/explanation
  • For the sample population, age, sex, and diagnosis were not reported.
  • Statistical comparison of different therapy regimens is limited due to variations in patient numbers and rash severity in each of the three test groups before therapy. Specifically, group 3 had only five patients and the rash severity in all five patients was ERSS > 50 (severe).
  • The study design did not include a control group, which would have been a subgroup of patients with EGFRI rash that was left untreated for the study period (three weeks).
  • In the abstract, the authors state that mild to moderate rashes should be treated with basic measures in combination with other dermatologic treatments. In the discussion section, the authors state, “Notably, all approaches that were analyzed in this study are in line with recent expert recommendations that suggest an escalating strategy for the management of the EGFRI rash with a succession of treatments, as indicated, summarized as follows: intensive skin care in combination with mild cleansers ... .”   The components of “basic measures” or “intensive skin care” were not described, and whether intensive skin care and mild cleansers were included with the other interventions is not delineated in the article.
  • The ERSS system was designed with a non-linear affected area scale emphasizing minor variations in mild patients with face involvement only.   

Nurses should consider treating mild to moderate EGFRI skin rashes with basic skin care measures in combination with topical glucocorticosteroids or combined regimens using glucocorticosteroids and antiseptics/antibiotics. Nurses should be aware that more severe or therapy-resistant rashes may respond with the addition of systemic retinoids.

To assess the effect of primary prophylaxis with posaconazole and levofloxacin on the incidence of invasive fungal infections (IFI) and bacteremia

This was a retrospective, single-center study that evaluated two groups of adult patients with acute myeloid leukemia/acute promyelocytic leukemia (AML/APL) and high-grade myelodysplastic syndrome (MDS) receiving intensive chemotherapy. The primary endpoint was IFI and bacteremia with secondary endpoints of overall survival at day 100 and at two years, time from the initiation of chemotherapy to the onset of IFI, the use of intravenous and oral antifungal and antibacterial therapy, and total duration of antifungal and antibacterial medication.

• N = 88 (43 no prophylaxis and 45 prophylaxis)
• AVERAGE AGE = 49.8 years (no prophylaxis); 53.5 years (prophylaxis)
• MALES: 51.2% (no prophylaxis); 51.1% (prophylaxis)
• KEY DISEASE CHARACTERISTICS: Patients with AML, APL, or high-grade MDS receiving intensive chemotherapy

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital Zurich

• PHASE OF CARE: Active antitumor treatment

Retrospective 

• Radiologic diagnosis of IFI determined by two independent evaluators
• Possible or proven IFI defined according to European Organisation for Research and Treatment of Cancer and ​Mycoses Study Group (EORTC/MSG) criteria

IFIs were significantly less common in the prophylaxis group after the first chemotherapy cycle (33.3% versus 65.8%; p = 0.0088). IFIs were significantly less common in the prophylaxis group after the last chemotherapy cycle (53.9% versus 88.9%; p = 0.0021). Chemotherapy cycles that were complicated with bacteremia occurred at a rate of 34.6% with prophylaxis and 32.3% in the nonprophylaxis group; p = 0.8. Positive blood cultures were 50 and 43, respectively, with a nonsignificant trend to more gram-negative infections in the nonprophylaxis group (42% versus 14%; p = 0.073) and to more gram-positive infection in the prophylaxis group (86% versus 58%; p = 0.092). Overall survival at 100 days and at two years, as well as the use of antiviral medications, did not differ between the two arms. Fewer fever days (5.6 versus 9.2;  p = 0.00032) and less cytarabine toxicity (18.3% versus 35%; p = 0.025) were observed in the prophylaxis arm.

This single-center retrospective study of posaconazole prophylaxis was efficient in reducing the possible IFIs with a number needed to treat to prevent one IFI of only three. This institution had a relatively high rate of IFIs when compared to published data. Posaconazole for prophylaxis was cost-effective. There was no benefit seen in the use of levofloxacin in preventing bacteremia.

• Small sample (< 100)
• Measurement/methods not well described
• Findings not generalizable
• Other limitations/explanation: The rate of IFIs in this institution was higher compared to other published data, and the inclusion of possible IFIs may have led to an overdiagnosis of IFIs, which might not reflect the true outcomes of IFI.

Oncology nurses should be aware of facility policies relating to the use of prophylaxis for IFI and bacteremia and should understand the local climate that may affect the rate of IFIs. This facility used posaconazole and levofloxacin as prophylaxis agents. Other agents exist and are currently in use that may produce different outcomes.

The study evaluated the efficacy of transdermal estrogen in men in moderating hot flashes after hormonal therapy for prostate cancer.

• Intervention: Estrogen patch
  • Low dose (0.05 mg)
  • High dose (0.5 mg)
• Description of protocol:
  • Daily log maintained
  • Participants randomized to low-dose or high-dose of transdermal estrogen, then switched after four week washout to other dose

The study enrolled 12 men with advanced prostate cancer who were receiving leuprolide injections every one or three months. They were experiencing at least three hot flush episodes daily for at least three months.

This was a randomized, multi-dose, crossover trial.

Treatment response was assessed indaily logs. Questionnaires were completed every four weeks, including visual analog assessment. Serum luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone, and estradiol levels were taken every four weeks.

Key outcomes of the study included:

• Significant reduction in overall severity of hot flushes with both the low-dose and high-dose patches in 10 of the 12 men (83%) 
• Significant decrease in daily frequency of hot flushes with high-dose patch 
• Overall moderate to major improvement in symptoms at both doses (p = 0.04)
• FSH levels decreased significantly with both doses; estradiol levels increased with both doses. No significant change in serum testosterone or LH.

Study limitations included small sample size, absence of placebo arm, short duration.

To evaluate whether use of a checklist dedicated to pain management-related practices would improve pain control in inpatient settings

A checklist (38Checkpain) was developed by a group of patient management experts identifying practices related to pain management outlined in Italian law. The checklist consisted of seven items to remind practitioners of correct steps for assessment, monitoring, management, and treatment of pain. Healthcare centers participating in the program collected information on these aspects of pain management, adverse of effects, and episodes of breakthrough pain for all patients hospitalized that day on the unit for seven days. After, healthcare centers were randomized to use the checklist or to continue current practice without use of the checklist. Checklist items were measuring intensity of pain, checking if pain was 3 or less, modifying therapy if pain intensity was greater than 3, assessing the presence of adverse events with pain treatment, setting a specific therapy of adverse event management, checking for presence of factors that increase acute pain, and setting a specific therapy for treatment of factors that cause acute pain. The checklist was applied in patients with pain twice daily by providers. Data were collected for 21 days.

• N = 92 organizations, 895 patients   
• AGE: Not provided
• MALES: Not provided, FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: Not provided
• OTHER KEY SAMPLE CHARACTERISTICS: Not provided

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

• Prospective, randomized cohort

• 1–10 numeric pain rating scale 
• Proportion of patients with controlled pain, defined as intensity of 3 or less on numeric scale
• Incidence of adverse events
• Number and severity of breakthrough pain episodes

Mean pain intensity declined in the checklist group over the study period from 3.8–2.7. Mean pain intensity did not decline steadily in the no checklist group and overall was consistently higher. The proportion of patients with effective control of pain increased from 20.1% to 67.6% in the checklist group. In the no checklist group, control of pain increased by 13.8%. The incidence of breakthrough pain episodes decreased by 21.4% in the checklist group but increased by 6.6% in the other group. Compliance with checklist use was reported as at least once daily.

The use of a checklist to remind healthcare providers to make specific assessments and intervention plans for patients with pain appeared helpful in improving overall pain-related patient outcomes.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable
• Very little information to describe the patients is provided. 
• No statistical analysis was done. 
• The control group was about half the number of sites as the checklist cohort.
• Patients of whom data were collected from week to week were different patients, so it is unclear if outcomes differed based on the intervention examined here or on other patient conditions.

This study has multiple limitations; however, it does suggest that at least daily use of a checklist reminder for assessment and intervention practices for patients with pain may improve overall pain management and related patient outcomes. Checklists have been used in multiple ways in health care and may be an effective tool in reminding practices to improve various types of patient outcomes.