Recommended for Practice

Adherence to Guidelines

for Chemotherapy-Induced Nausea and Vomiting—Adult

Adherence to guidelines is the provision of care according to specific established professional guidelines for the topic under consideration.

Research Evidence Summaries

Abunahlah, N., Sancar, M., Dane, F., Özyavuz, M., & Özyavuz, M. . (2016). Impact of adherence to antiemetic guidelines on the incidence of chemotherapy-induced nausea and vomiting and quality of life. International Journal of Clinical Pharmacy, 38, 1464–1476. 

Study Purpose

To evaluate how adherence to Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology (MASCC/ESMO) 2014 guidelines affect chemotherapy-induced nausea and vomiting (CINV) and quality of life in chemotherapy-naïve patients

Intervention Characteristics/Basic Study Process

The chemotherapy regimens of chemotherapy-naïve participants were assessed to determine which MASCC/ESMO 2014 guideline was appropriate for their antiemetic regimen. The research team then evaluated the antiemetic regimen prescribed and compared it to the MASCC/ESMO 2014 guideline recommended for adherence or non-adherence.

Sample Characteristics

  • N = 100   
  • MEDIAN AGE = 53 years
  • MALES: 48%, FEMALES: 52%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Established malignancy
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients who were chemotherapy naïve or who received low emetogenic chemotherapy

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Marmara University Pendik Training and Research Hospital in Turkey

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, observational, longitudinal

Measurement Instruments/Methods

  • Daily diary of episodes of emesis, nausea severity (seven-item Likert-type scale), and rescue medications for five days
  • Modified Turkish version of the Functional Living Index-Emesis (FLI-E) questionnaire to record quality of life before and after chemotherapy
  • Side-effects questionnaire to record existence and severity of side effects

Results

Guideline nonadherence was most often related to overprescription, underprescription, and inappropriate dose or inappropriate prescription. Patients who had antiemetic regimens adherent to the MASCC/ESMO 2014 guidelines had significantly higher complete control of nausea (no emetic episodes, rescue therapy, or nausea) and fewer reported side effects compared to the nonadherent group. Physician compliance with the antiemetics guidelines was observed during the acute phase of CINV, not in the delayed phase.

Conclusions

Patients with antiemetic regimens that adhered to MASCC/ESMO 2014 guidelines reported improved control over CINV and enhanced quality of life related to the reduction of side effects.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Generalizability of the results to other hospitals

Nursing Implications

When determining an antiemetic regimen for patients receiving chemotherapy, healthcare professionals should adhere to antiemetic guidelines.

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Gilmore, J.W., Peacock, N.W., Gu, A., Szabo, S., Rammage, M., Sharpe, J., . . . Burke, T.A. (2013). Antiemetic Guideline Consistency and Incidence of Chemotherapy-Induced Nausea and Vomiting in US Community Oncology Practice: INSPIRE Study. Journal of Oncology Practice, 10, 68–74. 

Study Purpose

To evaluate the effectiveness of guideline-consistent versus guideline-inconsistent chemotherapy-induced nausea and vomiting (CINV) prophylaxis on the incidence of CINV in chemotherapy-naïve patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) for the first cycle of treatment

Intervention Characteristics/Basic Study Process

Patients who received HEC or MEC were followed for one chemotherapy cycle. Data were collected from electronic health records for 120 hours postchemotherapy and on days 5–8 during routine follow-up visits.

Sample Characteristics

  • N = 1,295
  • MEAN AGE = 59.3 years
  • MALES: 30%, FEMALES: 70%
  • KEY DISEASE CHARACTERISTICS: Breast, lung, lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Southeast United States, normal to obese weight, chemotherapy-naïve patients; one-third received HEC, two-thirds received MEC.

Setting

SITE: Multi-site  

SETTING TYPE: Outpatient  

LOCATION: Southeast United States

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Elder care, palliative care

Study Design

Prospective observational study

Measurement Instruments/Methods

  • Patient demographics
  • Baseline clinical characteristics
  • Multinational Association of Supportive Care in Cancer Antemesis Tool (MAT)

Results

The guideline-consistent (GC) group experienced fewer symptoms of CINV than the guideline-inconsistent (GI) group. Significant differences between the GC group and the GI group were found for no CINV (p < 0.001), no emesis (p = 0.027), and no clinically significant nausea (p = 0.001). Of the patients who received HEC, those in the GC group experienced no CINV (p = 0.024) and no clinically significant nausea (p = 0.033). Of the patients who received MEC, those in the GC group experienced significantly less emesis than those in the GI group (p = 0.02).

Conclusions

Adherence to the National Comprehensive Cancer Network (NCCN) guidelines was associated with a reduction of CINV over five days after cycle 1 of chemotherapy. Adherence to NCCN guidelines was low for patients receiving HEC because of omission of corticosteroids in the delayed phase. Adherence in MEC was higher, but would have increased to 98% if a NK1 receptor antagonist had been prescribed.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

This is one among other recent studies that have validated the use of guidelines. Patients who received prophylactic treatment per the guidelines had less CINV than patients who did not receive treatment per the guidelines, showing the need to educate oncology nurses on the value of guidelines and the need to collaborate with other healthcare providers. This study did not address low emetogenic potential regimens. This article also showed the helpfulness of extracting data from electronic health records to measure outcomes.

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Inoue, M., Shoji, M., Shindo, N., Otsuka, K., Miura, M., & Shibata, H. (2015). Cohort study of consistency between the compliance with guidelines for chemotherapy-induced nausea and vomiting and patient outcome. BMC Pharmacology and Toxicology, 16, 5-015-0005-1. 

Study Purpose

To assess compliance with chemotherapy-induced nausea and vomiting (CINV) guidelines and effects on patient outcomes

Intervention Characteristics/Basic Study Process

Patients were assessed for early and delayed CINV using the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). Chemotherapy and anti-emetic agents used were extracted from medical records, along with MAT results. Comparison was made between agents used and current practice guidelines used in the organization. Guidelines were dexamethasone for lowly emetogenic chemotherapy (LEC), either triple drug or doublet antiemetics for moderately emetogenic chemotherapy (MEC), and triple drug antiemetics for highly emetogenic chemotherapy (HEC).

Sample Characteristics

  • N = 73   
  • MEDIAN AGE = 62 years
  • AGE RANGE = 28-79 years
  • MALES: 49.3%, FEMALES: 49.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Varied tumor types; colorectal, breast, and lung were most common.
  • OTHER KEY SAMPLE CHARACTERISTICS: About 50% were on LEC, 23% on MEC, and 15% on LEC.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective cohort

Measurement Instruments/Methods

  • MASCC MAT
  • Complete response (not defined)

Results

Overall compliance with guidelines was 87.7%-98.6% for early phase CINV prophylaxis and 87% for delayed phase. Delayed phase compliance with LEC was 97.4%, with MEC was 82.4%, and with HEC was 54.5%. In the LEC group, CINV was not prevented in 11.3%, where guidelines were used, and 29% in the undertreated group. In the MEC group, it was not prevented in 11.8% with guidelines and 14.3% in the undertreated group. In the HEC group, CINV was not prevented in 45.5% with guidelines and 50% in the undertreated group.

Conclusions

Adherence to CINV prophylaxis guidelines was associated with better CINV prevention compared to undertreated patients; however, adherence to HEC guidelines was low, adherence was particularly low for delayed phase prevention, and guidelines based on emetogenicity of chemotherapy alone appear to be insufficient for CINV prophylaxis, particularly with HEC regimens.

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Other risk factors not described or used in analysis
  • Reports CINV grade but no mention of grading measure used.
  • The authors stated that HEC guidelines were effective; however, 45% in whom guidelines were followed had lack of CINV control.

Nursing Implications

The findings suggest that following professional CINV prophylaxis guidelines may be helpful for CINV control, although insufficient for control with HEC chemotherapy. Adherence to preventive guidelines for delayed phase CINV and HEC appears to be more problematic. Guideline adherence alone based on emetogenicity of chemotherapy appears to be insufficient to achieve complete control of CINV. Nurses need to advocate for consideration of individual risk factors in planning CINV prevention and ensure care planning for delayed phase interventions. Lack of delayed phase effectiveness also points to the need to ensure that patients have medication for any breakthrough CINV and that patients are adherent to medication regimens for prevention.

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Patil, V.M., Noronha, V., Joshi, A., Ramaswamy, A., Gupta, S., Sahu, A., . . . Prabhash, K. (2017). Adherence to and implementation of ASCO antiemetic guidelines in routine practice in a tertiary cancer center in India. Journal of Oncology Practice, 13, e574–e581.

Study Purpose

To evaluate adherence to ASCO guidelines and to improve quality of antiemetic prescriptions.

Intervention Characteristics/Basic Study Process

An initial audit of 1,211 consecutive prescriptions for adult patients with solid tumors receiving outpatient chemotherapy were characterized based on consistency with ASCO guidelines.  

  • Adherent to CINV prophylaxis
  • Overadherent to guideline with addition of an additional antiemetic.  
  • Nonadherent with two criteria identified: major deviation if the regimen had omitted an antiemetic either totally or in part, minor deviation if all appropriate medications utilized, but at lower than recommended dosing.

If a patient vomited, they were classified as having CINV if this occurred within five days after completion of chemotherapy and there was no other causation. Education was offered to clinicians regarding results of the audit. Review of the antiemetic policy was revised according to ASCO guidelines. A second audit occurred and included 201 patients.

Sample Characteristics

  • N: 1,211 prescriptions for antiemetics for adult patients with solid tumors between July and August 2015. This was repeated with another 201 prescriptions between September and October 2016.
  • AGE: 18 to older than 60
  • MALES: 49.5%  
  • FEMALES: 50.5%
  • CURRENT TREATMENT: Chemotherapy, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer, 183 (15.1%); ovarian, 197 (16.3%); lung, 132 (10.9%); gall bladder, 128 (10.6%); rectum, 124 (10.3%); cervix, 100 (8.2%); stomach, 77 (6.3%); colon, 57 (4.7%); esophagus, 27 (2.2%); prostate, 25 (2.1%); urinary bladder, 17 (1.4%); sarcoma, 11 (0.9%); endometrium, 10 (0.8%); and other, 123 (10.2%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Antiemetic potential: High, 404 (33.4%); moderate, 586 (48.4%); low, 220 (18.2%); minimal, 1 (0.1%). Chemotherapy regimen: only chemotherapy, 1,005 (83%); single drug, 223 (35.4%); combination, 782 (64.6%). Chemotherapy: concurrent with radiation, 206 (17%); single drug, 183 (15.1%); combination, 23 (1.9%).

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Tertiary Cancer Center in India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Retrospective study

Measurement Instruments/Methods

Measuring incidence of vomiting, emergency visits, and hospitalizations using Descriptive statistics and Fisher exact test

Results

Patient incidence of CINV with adherence to guidelines had a lower rate of vomiting, 6.6% versus 21.9% (p < 0.001), emergency visits, 2.6% versus 5.8%, p = 0.006 and hospitalization for emesis, 0.9% versus 4.9%, p < 0.001. In ASCO adherent guidelines, the proportion of prescriptions at initial audit was 63.6% and at reassessment was 98.5% (p < 0.001). Proportion of overuse was 41.3% at re-audit, and 68.3% before the intervention (p = 0.001). Post-audit intervention included education of providers regarding guideline and policy.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

Nursing Implications

Use of guidelines enhances patient outcomes by significantly reducing the occurrence of CINV. Use of semi-rigid corrective actions lead to substantial improvement in adherence rates at this institution. This study demonstrates the importance of using guidelines in clinical care.

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Tamura, K., Aiba, K., Saeki, T., Nakanishi, Y., Kamura, T., Baba, H., . . . CINV Study Group of Japan. (2015). Testing the effectiveness of antiemetic guidelines: Results of a prospective registry by the CINV Study Group of Japan. International Journal of Clinical Oncology, 20, 855–865.

Study Purpose

  • Studied the incidence of CINV in Japan, also evaluating risk factors and acute versus delayed CINV
  • Assessed staff estimation of incidence of CINV

Intervention Characteristics/Basic Study Process

Patients were provided with seven-day diaries before the start of therapy with either highly emetogenic or moderately emetogenic chemotherapy. The patient must be receiving this type of therapy for the first time. Recording of digestive symptoms including severity of nausea, oral intake, and vomiting were measured using a visual analog scale. Investigators/colleagues recorded background information including date of birth, treatment history, use of anxiolytics, and use of opioids. Other risk factors including alcohol use, history of motion sickness or morning sickness, performance status, chemotherapy regimen, and clinical lab reports were collected in a case report, corresponding to the patient’s diary.

Sample Characteristics

  • N: 2,068 registered, 1,939 patients evaluated with case reports  
  • AGE: 19-87 years, with a mean of 62 years
  • MALES: 45.7%  
  • FEMALES: 54.3%
  • CURRENT TREATMENT: Chemotherapy, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage II, 20.6%; III, 24.2%; IV, 34.5%; PS-ECOG), 0, 70.8%; 1, 26.3%; 2, 2.5%; 3, 0.3%; 4, 0.1%. Cancer type: breast, hematologic, gynecologic, lung, gastric, colorectal, esophageal, HCC, other gastrointestinal. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Multiple types of chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

This was a multicenter prospective cohort study, including university hospitals, cancer centers, and cancer treatment centers. One hundred eight institutions throughout Japan participated.

Measurement Instruments/Methods

Diaries and visual analog scales have long been utilized in CINV research, although several other instruments are available and reliable. Descriptive statistics were used as were univariate analysis and multivariate analysis (Wald's test) to evaluate risk factors for both acute and delayed nausea, and acute and vomiting. Fisher’s exact test was used to measure differences of occurrence between risk factors and HEC, MEC types of chemotherapy. There was no mention how providers gauged emetogenic risk for the patients, so it was difficult to tell if this was using a reliable instrument.

Results

Multiple cancers and multiple chemotherapy regimens were evaluated. Acute nausea and vomiting with HEC was 20.8% and 5.7%; with MEC, it was 6.7% and 1.7%, respectively. There was a high incidence of delayed nausea, 49.4% with HEC, and 41.7% with MEC. Delayed vomiting was low at 11.2% with HEC and 15.9% with MEC, which was notably higher; however, if the patient received a three-drug antiemetic regimen, it was then significantly lower. Motion sickness was associated with a higher risk for acute nausea, with men being more susceptible than women. A history of morning sickness was also a risk factor in women. HEC was associated with the highest risk in both genders. Prophylactic use of  three drug regimens was associated with reduced risk in men. Risk factor analysis also revealed that women were more susceptible to CINV in every aspect. Estimation of CINV by providers overestimated emetogenic risk.

Conclusions

A high compliance with guidelines was associated with a decreased incidence of CINV, particularly in the MEC group receiving three drugs. The authors recommend to study CINV for at least seven days. Mechanisms of acute CINV require further study to develop newer agents to target this symptom

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • Other limitations/explanation: Sample was too expansive with multiple disease states, all stages of disease and various chemotherapies. Inclusion criteria with previous treatments could be problematic. Lack of consistent chemotherapy regimens makes generalizing results difficult.

Nursing Implications

Implications for nurses indicates that knowledge and adherence to guidelines assist in managing CINV. As nurses, we must be advocates for patients, and ensure that the patient receives the best supportive care to prevent CINV and avoid breakthrough symptoms. Nurses should be aware of ONS guidelines to guide their practice.

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