Skip to main content

Tomlinson, D., Diorio, C., Beyene, J., & Sung, L. (2014). Effect of exercise on cancer-related fatigue: A meta-analysis. American Journal of Physical Medicine and Rehabilitation, 93, 675–686. 

Purpose

STUDY PURPOSE: To determine whether exercise reduces fatigue compared to usual care or a nonexercise control intervention in patients with cancer
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Ovid MEDLINE, EMBASE, PsycINFO, The Cochrane Central Register of Controlled Trials, and CINAHL
 
KEYWORDS: Fatigue, neoplasm, and exercise therapy
 
INCLUSION CRITERIA: Random assignment to intervention or control; diagnosed with cancer; in active treatment or follow-up; and fatigue as primary or secondary outcome
 
EXCLUSION CRITERIA: No random assignment; treatment arm not one of the interventions; no control arm or used as intervention; participants not diagnosed with cancer; fatigue not reported; duplicate publication; publication not in English; or publication was conference session or thesis

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,159
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Studies were reviewed by two people independently, and included studies were agreed upon by both using the Jadad scale. 

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 72
  • TOTAL PATIENTS INCLUDED IN REVIEW = 5,367 (2,740 in intervention, 2,627 control groups)
  • KEY SAMPLE CHARACTERISTICS: 19% aerobic, 26% walking, 12.5% yoga, 31% mixed-exercise, 63% supervised, 36% home-based, 63% mixed malignancy, 26% solid tumor, 11% hematologic; and most patients off treatment

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

There was a moderate effect on fatigue, sleep disturbance, and depression with exercise in the intervention groups (p < 0.001) compared to the control group. The benefits of exercise did not differ by type of exercise intervention (P = 0.85 for interaction). However, the effect of exercise on fatigue reduction may differ by underlying malignancy type with a stronger effect in solid tumors versus hematologic and mixed-malignancy types (P = 0.01 for interaction). There was a stronger effect on depression in females (p = 0.03). Patients with solid tumors seemed to experience a greater benefit.

Conclusions

Exercise can have an effect on fatigue despite the type of exercise and phase of care when delivered.

Limitations

The clinical effect of what is considered a significant reduction in Functional Assessment of Cancer Therapy - Fatigue was questioned. The terms physical activity and exercise were used interchangeably, and the meaning of structured exercise was not well-explained.

Nursing Implications

Patients may be given several options for kinds of exercise to improve fatigue based on their preference while still receiving the benefit of improved fatigue.

Print

Tomiska, M., Tomiskova, M., Salajka, F., Adam, Z., & Vorlicek, J. (2003). Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma, 50, 227–233.

Study Purpose

To evaluate the effect of different doses of oral suspension of megestrol acetate (MA) on appetite, quality of life, body weight, and anthropometric measures in patients with advanced cancer

Intervention Characteristics/Basic Study Process

Researchers evaluated a fixed dose of MA (480 mg) versus escalating doses of MA. Patients were evaluated at baseline, two, four, and eight weeks.

Sample Characteristics

  • The study included 22 patients with advanced, nonhormonally dependent cancer who were experiencing anorexia-related weight loss (at least 5% of usual body weight).
  • Patients had a life expectancy of more than three months, and a World Health Organization performance status of two or less.
  • Median patient age was 59 years.
  • A total of 19 patients were evaluated (2 died, 1 withdrew): 15 men and 4 women.
  • Patients were diagnosed with lung cancer (nine), gastrointestinal cancer (six), renal cancer (two), mesothelioma (one), and non-Hodgkin lymphoma (one).
  • At eight weeks, 12 patients were evaluated (eight patients died, one withdrew from study, and one stopped because of side effects).

Study Design

The study was a randomized, multicenter, blinded, two-arm trial.

Measurement Instruments/Methods

  • Visual analog scale using 0–100 mm to measure appetite (patient self-report)
  • Body weight
  • Anthropometric measures of mid-arm circumference and four skinfold thickness
  • Hand grip strength
  • Serum measure of albumin, prealbumin, c-reactive protein, and cortisol
  • European Organization for Research and Treatment Cancer Core Quality of Life questionnaire (EORTC QLQ-C30, version 1.0)

Results

Twelve patients were evaluated at eight weeks (eight patients died, one withdrew from study, and one stopped because of side effects). Therefore, the patients were evaluated as a single group regardless of whether they were receiving a fixed dose or an escalating dose of MA. There was statistically significant improvement in appetite over baseline in all patients at two weeks (p = 0.0001), four weeks (p = < 0.01), and eight weeks (p = 0.022). Overall quality of life improved in the majority of patients at two and eight weeks, but it was not statistically significant. There was no statistically significant improvement in body weight or other measures. In terms of side effects, 4 of 19 patients experienced clinically significant edema, resulting in 1 patient withdrawing from the study.

Conclusions

Original aims of the study could not be met because of the small sample size, so no conclusions can be drawn about the effectiveness of oral MA suspension or optimal or superior dose of MA.

Limitations

  • The study had a very small sample size, with significant attrition (36%).
  • The study had no placebo group; all patients were assessed compared to their baseline measures.
Print

Tomé-Pires, C., & Miró, J. (2012). Hypnosis for the management of chronic and cancer procedure-related pain in children. International Journal of Clinical and Experimental Hypnosis, 60, 432–457.

Purpose

STUDY PURPOSE: To review published trials of hypnotic treatments for children with chronic and cancer-related pain

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, PsycINFO, Cochrane Collaboration

KEYWORDS: Children, hypnosis, pain

INCLUSION CRITERIA: RCT; patients 18 years old or younger; Catalan, English, French, Portuguese, or Spanish languages; included patients with chronic pain or cancer procedure-related pain

EXCLUSION CRITERIA: Abstracts only, not published in full in peer-reviewed journals

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 81

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No study quality evaluation reported

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 12 (10 in cancer)
  • SAMPLE RANGE ACROSS STUDIES: 20–80
  • TOTAL PATIENTS INCLUDED IN REVIEW: Total in cancer studies = 394
  • KEY SAMPLE CHARACTERISTICS: Procedures involved were bone marrow aspiration, LP, or venipuncture

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Pediatrics

Results

All studies in children with cancer were related to acute procedure-related pain and anxiety. Hypnotic interventions were better at reducing pain than no treatment, standard care, placebo, and attention control. Compared to other psychological treatments, hypnosis had about the same effectiveness as cognitive behavioral therapy. Comparison of hypnosis to distraction showed mixed results. Younger patients had significantly better responses to hypnosis. Parents of those receiving hypnosis had lower anxiety. Results of hypnosis on anxiety were mixed. One study showed similar effects between hypnosis and play. Calculated effect sizes with hypnosis showed decrease in pain of 20%–80%. In four studies that included follow up at 3–12 months, therapeutic effects appeared to be long-lasting.

Conclusions

Hypnosis is effective in reducing acute procedure-related pain among children with cancer.

Limitations

Studies tended to have small samples, and many of these studies were done by the same group of researchers.

Nursing Implications

Findings of this systematic review support the use of hypnosis in children undergoing invasive procedures for reduction in pain. Nurses can advocate for availability of this intervention in pediatric settings.

Print

Tomblyn, M., Chiller, T., Einsele, H., Gress, R., Sepkowitz, K., Storek, J., . . . Centers for Disease Control and Prevention. (2009). Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biology of Blood and Marrow Transplantation, 15, 1143–1238.

Purpose & Patient Population

To update previously published guidelines from 2000 for the prevention of infection in patients receiving any type of hematopoietic stem cell transplantation (HSCT). Patients analyzed were adults and pediatric populations receiving allogeneic or autologous HSCT.

Type of Resource/Evidence-Based Process

The resource was presented as an evidence-based guideline. An international group of experts from identified professional organizations reviewed and graded evidence and developed recommendations.

Phase of Care and Clinical Applications

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for pediatric populations.

Results Provided in the Reference

The volume and highly specific process were not discussed.

Guidelines & Recommendations

Recommendations were made, and possible opportunistic infections at pre-engraftment, post-engraftment, and late phases of HSCT were identified. Recommendations included

  • Antibiotic and antifungal prophylaxis.
  • Consideration of hepatitis B vaccination for those who are hepatitis B-naïve and for donors and recipients of allogeneic transplantation prior to cell collection.
  • Varicella-zoster virus (VZV) vaccination for people in close contact and healthcare providers who are seronegative at least six weeks prior to HSCT contact.
  • Measles, mumps, rubella (MMR) vaccination of those in close contact and healthcare workers.
  • MMR patient vaccination for select groups of patients.
  • Policies that prohibit visits or close contact for people with respiratory or flu-like symptoms.
  • Education to reduce exposure to potential opportunistic infections.
  • Pneumococcal vaccination, annual influenza vaccination, hepatitis B vaccination, consideration of hepatitis A vaccination for people in areas where hepatitis A is endemic, diphtheria vaccination for appropriate age children according to general immunization guidelines, and pertussis reimmunization of appropriate patients.

Timing and appropriate individuals for various immunizations are important considerations, and it is recommended that users of this information refer to the full report. Overall, use of live vaccines is contraindicated for these patients; vaccination is contraindicated in those with chronic graft-versus-host disease or when patients are still immunosuppressed.

Limitations

Some recommendations were based on expert opinion due to lack of research evidence in the area.

Nursing Implications

Specific interventions for prevention of infection among HSCT recipients is a complex field, and healthcare providers who work with these patients need to be aware of current knowledge. Evidence in this area continues to evolve as HSCT techniques change and further evidence is gained regarding the immediate and long-term effects of HSCT.

Print

Tomazevic, T., & Jazbec, J. (2013). A double blind randomised placebo controlled study of propolis (bee glue) effectiveness in the treatment of severe oral mucositis in chemotherapy treated children. Complementary Therapies in Medicine, 21, 306-312. 

Study Purpose

To assess the efficacy of propolis versus placebo for the treatment of chemotherapy-induced severe oral mucositis (OM) treatment as a complementary and alternative medicine to alleviate severe OM from cancer therapy in the pediatric population. Propolis is a resinous material collected by bees from various plant sources and mixed with the bee’s salivary enzymes and beeswax. Recent scientific evidence suggests that honeybee products include anti-inflammatory, antioxidant, and antimicrobial properties.

Intervention Characteristics/Basic Study Process

The pediatric patients randomly were assigned to two groups: propolis or placebo. The oral care protocol consisted of teeth brushing.

The propolis or placebo was applied twice a day—once in the morning and once in the evening. The patients' OM was assessed according to the modified Eilers Oral Assessment Guide (OAG) twice a week when the patients were in the hospital. Patients were followed for the period of the chemotherapy or the first six months of the chemotherapy. An average of 0.38 g of propolis or placebo was used for each application. Each patient was given an information folder to reinforce cooperation and help them remember the protocol. A protocol follow-up regarding side effects and efficacy was assessed by questionnaire.

Sample Characteristics

  • N = 40
  • AGE = 1–19 years
  • MALES: 20 (50%), FEMALES: 20 (50%)
  • KEY DISEASE CHARACTERISTICS: Variety of children’s cancer, no specific diagnosis given

Setting

  • SITE: Single site 
  • SETTING TYPE: Inpatient    
  • LOCATION: Division of Oncology and Haematology, University Children’s Hospital, Medical Centre, Ljubljana

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

  • Double-blind, randomized, placebo-controlled study

Measurement Instruments/Methods

OM was clinically assessed using a dental mirror and portable head light. OM was scored according to the modified Eilers OAG twice a week.

Results

The study assessed OM episode frequency, duration, and severity. The OM episode frequency and OM mean duration were assessed. The frequency of severe OM and duration of OM were not statistically significant between the study groups. Thus, the findings found that severe OM was of slightly shorter duration and of a lesser extent in the propolis group. The study results demonstrated that almost half of the patients enrolled in the study suffered from severe OM. Severe OM was seen in 18 (45%) patients. In the propolis group, 8 of 19 (42%) patients had OM, while in the placebo group, the corresponding number was 10 of 21 (48%). Twenty-four episodes of severe OM were recorded—10 (42%) in the propolis group and 14 (58%) in the placebo group.

Conclusions

The authors do not recommend propolis in severe OM as a treatment plan. Because of the limitations in the study design, further clinical studies are needed to verify whether the use of propolis in OM treatment truly is not justified.

Limitations

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Small sample size (50 patients and dropped 10 [20%]), key sample group differences that could influence results (the type of cancer might be important), measurement was discussed and appropriate but did not include validity/reliability of instrument used, the findings are not generalizable, less than optimal preparation of the propolis

Nursing Implications

The study was limited to the pediatric population in one hospital. Therefore, there is a need to replicate it with a different study population and multiple settings to establish regular use and guidelines.

Print

Togni, S., Maramaldi, G., Bonetta, A., Giacomelli, L., & Di Pierro, F. (2015). Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: A randomized placebo controlled trial. European Review for Medical and Pharmacological Sciences, 19, 1338–1344. Retrieved from http://www.europeanreview.org/article/8795

Study Purpose

To explore the anti-inflammatory and radiodermatitis prevention efficacy and safety of a Boswellia-based topical cream among patients with breast cancer

Intervention Characteristics/Basic Study Process

Placebo arm: Base cream
Experimental arm: 2% Boswellia serrata cream in Phytosome (R) (Bosexil [R])
The assigned cream was applied after radiotherapy and before bedtime on the days of treatment and in the morning and at night on nontreatment days.

Sample Characteristics

  • N = 114  
  • MEAN AGE = 58.5 years (32–78)
  • MALES (%): Not stated, FEMALES (%): Not stated
  • KEY DISEASE CHARACTERISTICS: Breast carcinoma
  • OTHER KEY SAMPLE CHARACTERISTICS: All participants were overweight.

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified  
  • LOCATION: Not stated; however, the researchers were from Italy.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Parallel-group
  • Randomized
  • Placebo-controlled

Measurement Instruments/Methods

  • Visual grading scale consisting of “slight (slight redness, spotty, and diffuse), moderate (moderate and uniform redness), [and] intense (intense redness)” (Togni et al., 2015, p. 1340)
  • Radiation Therapy Oncology Group (RTOG) acute skin toxicity
  • Photographs taken of nonirradiated and irradiated breast areas using an SLR camera without flash in ambient office exam room light, computer-assisted analysis using Adobe Photoshop CS2 with image reader, and digital evaluation of magenta color saturation in percent
  • Use of a steroid cream in addition to the study cream

Results

Significantly more visually intense erythema existed in the placebo group compared to the Boswellia group in general (p = 0.009) and when no concurrent chemotherapy was used (p = 0.018). However, no statistically significant difference existed when concurrent chemotherapy was used (p = 0.258). A highly significant decrease was observed in the use of supplemental steroid cream in the Boswellia group (25%) compared to the placebo group (63%, p < 0.0001). More participants in the Boswellia group had grade 1 RTOG scores, and more participants in the placebo cream group had grade 2 scores. However, the difference was not significance (p = 0.066). No significant differences in adverse effects existed between groups.

Conclusions

Further studies are needed to compare Boswellia serrata with other topical products among patients with breast cancer undergoing radiotherapy.

Limitations

The process of randomization was not well described. The first two authors are employed by and fourth author is a consultant for a company that develops botanical pharmaceuticals. Patient use of both a topical steroid cream with Boswellia serrate cream may prohibit the full pharmacologic outcome of using just one topical cream.

Nursing Implications

Boswellia serrata may be useful in reducing breast radiodermatitis. However, additional larger and independent studies are needed.

Print

Tofthagen, C., Boses, S., Healy, G., & Jooma, N. (2015). Evaluation of group acupuncture for cancer-related symptoms: A retrospective analysis. Journal of Palliative Medicine, 18, 878–880.

Study Purpose

To evaluate the effects of group acupuncture on specific cancer-related symptoms in persons with cancer receiving outpatient treatment

Intervention Characteristics/Basic Study Process

Retrospective participants completed an assessment prior to the first study and following weekly treatments; received group acupuncture at a rate of up to eight patients an hour provided in a staggered fashion by one practitioner. Meridian diagnosis established the acupoint prescription based on patient symptom complaint. Instead of standardized treatments, many factors were considered to tailor individual acupuncture treatments for the patients symptoms.

Sample Characteristics

  • N = 43  
  • AGE RANGE = 25–84 years
  • MEAN AGE = 66.1 years
  • MALES: 27.2%, FEMALES: 73.8%
  • KEY DISEASE CHARACTERISTICS: Breast cancer was the most common diagnosis.
  • OTHER KEY SAMPLE CHARACTERISTICS: Caucasian (88.1%), non-Hispanic (76.2%)

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: West Central Florida

Phase of Care and Clinical Applications

  • PHASE OF CARE: Undescribed
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Retrospective descriptive analysis

Measurement Instruments/Methods

Patients completed a pre-study and pre-treatment assessment for seven basic cancer-related symptoms (pain/numbness, dry mouth, headache, fatigue, sleep trouble, nausea, digestion) on a numeric rating scale (0–10).

Results

Patients who completed four group acupuncture treatments reported significantly less pain/numbness and problems with digestion. There were no significant changes in any of the other symptoms (sleep, fatigue, dry mouth, headache, or nausea). Comparing baseline symptom data to week 3 revealed no significant improvement for any symptom.

Conclusions

This retrospective analysis pilot study of mostly patients with breast cancer with unknown treatment/medical history were evaluated over four weeks of acupuncture treatment, revealing significantly reduced reports of pain/numbness and digestive complaints after the fourth treatment. It could not be determined if this was clinically meaningful or a durable response.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Retrospective study; study subjects not ethnically diverse; symptom data presented only for four weeks; no explanation for competencies and treatment standards as performed by acupuncture practitioner(s); same or different practitioner each week unknown; predominantly patients with breast cancer; unknown phases of care; limited data description of patient population tumor types; no data for prior/concurrent treatment or side effects of therapy; potential confounding variables—inclusion/exclusion criteria; pain/numbness measured as one symptom; incomplete symptom evaluation, no standardized measurement tool for PN used; internal and external validity limited due to study design; sample characteristics and unknown sampling technique; not mentioned if assumptions were met for paired t-test
 

 

Nursing Implications

This pilot study identified that group acupuncture may be a beneficial treatment for PN. Prospective randomized, controlled trials with validated measures and complete symptom evaluation are needed to investigate meaningful therapeutic benefits, doses, frequency, side effects, and duration of response to group acupuncture in specific populations, tumor types, and neurotoxic regimens.
Print

Tofil, N.M., Benner, K.W., Faro, S.J., & Winkler, M.K. (2006). The use of enteral naloxone to treat opioid-induced constipation in a pediatric intensive care unit. Pediatric Critical Care Medicine, 7, 252–254.

Study Purpose

To describe the effects of enteral naloxone for the treatment opioid-induced constipation.

Intervention Characteristics/Basic Study Process

Patients in the treatment group received opioids and enteral naloxone for suspected opioid-induced constipation. Patients in the control group received opioids and were randomly chosen from patients receiving opioids during the study period.

Sample Characteristics

  • The study reported on a sample of 46 pediatric patients (23 in the treatment group and 23 in the member-matched control group).
  • Mean patient age was 6.4 years (range 5 months to 18 years) in the treatment group and 6.1 years (range 4 months to 17 years) in the control group.
  • The sample comprised 14 boys (61%) in the treatment group and 14 boys (61%) in the control group.
  • The morphine equivalent was 86 mg per day (SD = 83, range 9–197) in the treatment group and 20 mg per day (SD = 17, range 1.3–59) in the control group.
  • Mean length of stay in the pediatric intensive care unit was 15 days (SD = 8, range 7–43) in the treatment group and 10 days (SD = 7, range 3–31) in the control group.
  • Mean length of stay in the pediatric intensive care unit five days before enteral naloxone initiation ranged from 0 to 13 days.

Setting

Pediatric intensive care unit of a children’s hospital in Alabama

Study Design

This was a retrospective study conducted from January 2003 to February 2004.

Measurement Instruments/Methods

  • Daily stool output and opiate usage
  • Nutrition
  • Adjuvant laxative use
  • Side effects

Results

  • In the treatment group, mean stool output before enteral naloxone was 0.14 (SD = 0.38) stools per day. After initiation, mean stool output was 1.6 (SD = 1.14) stools per day (p < 0.001).
  • In the control group, mean stool output was 0.53 (SD = 1.21) stools per day.
  • Eighteen patients in the treatment group (78%) received other bowel agents in addition to enteral naloxone (13 Miralax®, 7 bisacodyl, 4 glycerin suppositories, and 1 milk-and-molasses enema).
  • Eight patients in the control group (35%) received other bowel agents (4 Miralax, 4 bisacodyl, 1 glycerin suppository, and 1 milk-and-molasses enema).
  • A significant inverse relationship existed between opioid dose and increase in stool output after naloxone initiation (r2 = 0.17; p < 0.05).
  • Two patients experienced withdrawal symptoms. One was caused by medication error.

Conclusions

Enteral naloxone may be effective for increasing stool output in opioid-induced constipation but carries risk of withdrawal symptoms. Additional study is needed.

Limitations

  • The study was retrospective.
  • The study was not able to control several variables that could be confounders (e.g., dose, duration, and type of opioids; use of additional bowel stimulants; amount of nutrition).
  • Other patients may have had unrecognized mild withdrawal symptoms.
  • Stool size or weight would have been a more objective outcome measure, but was not available.
  • A significant difference existed in morphine equivalent per day between the treatment and control groups (p = 0.01).
Print

To, J., Goldberg, A.S., Jones, J., Zhang, J., Lowe, J., Ezzat, S., . . . Sawka, A.M. (2014). A systematic review of randomized controlled trials for management of persistent post-treatment fatigue in thyroid cancer survivors. Thyroid, 25, 198–210. 

Purpose

STUDY PURPOSE: To identify and critically appraise published randomized, controlled trials of interventions for the management of persistent post-treatment fatigue in thyroid cancer survivors
 
TYPE OF STUDY: Systematic review

Search Strategy

  • DATABASES USED: Medline (Ovid), MEDLINE In-Process, other nonindexed citations (Ovid), Embase (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials (Ovid), and CINAHL (EBSCO) 
  • KEYWORDS: Extensive search terms per database were provided
  • INCLUSION CRITERIA: One randomized, controlled trial of interventions for the management of persistent post-treatment fatigue of adult thyroid cancer survivors  
  • EXCLUSION CRITERIA: Studies primarily focusing on patients with thyroid cancer around the time of thyroid cancer treatment (e.g., first six months around first surgery or radioactive iodine treatment) or those focusing on the preparation procedures for radioactive iodine treatment or scanning were not eligible for inclusion. Pharmacologic (including hormonal) and nonpharmacologic interventions were included.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,086 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The critical appraisal of studies and data abstraction were independently performed by two reviewers (A.S.G. and A.M.S. using standardized abstraction forms). The Cochrane Risk of Bias Tool was used to appraise the quality of the studies. Each abstracted data set was checked (by the other reviewer), and a final consensus data set was created after detailed discussion.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 4 (one of these was a second report on the same population as in another study)
  • TOTAL PATIENTS INCLUDED IN REVIEW = 75 
  • SAMPLE RANGE ACROSS STUDIES: 15–36 patients
  • KEY SAMPLE CHARACTERISTICS: The target population was thyroid cancer survivors aged greater than 18 years whose disease was of any histologic subtype and who completed primary treatment (surgery with or without other treatment). To be eligible for inclusion, more than half the study population was required to consist of thyroid cancer survivors, or a thyroid cancer subgroup data analysis needed to have been reported. There was no specific requirement relating to disease stage or disease status. All patients were receiving thyrotropin suppressive therapy.

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

Two studies examined use of T3 and T4. In one study comparing the combination of T3 and T4 to T4 alone, the fatigue subscale of the Profile of Mood states showed significant improvement at five weeks. One study using T4 compared to maintenance TSH suppression showed improvement in one subscale of the multidimensional fatigue scale at six months but no change in other fatigue subscales. Two references that reported on one study examined the impact of an exercise program.

Conclusions

There is insufficient evidence to demonstrate the impact of the administration of T3 or T4 on fatigue in patients who had thyroid cancer.

Limitations

There was a small number of studies included, the number participants recruited in the identified studies was small, and some of these studies were of low quality.

Nursing Implications

There is insufficient evidence to evaluate any benefits of the administration of T3 or T4 for the management of fatigue among patients receiving TSH suppressive therapy

Print

Timsit, J.F., Schwebel, C., Bouadma, L., Geffroy, A., Garrouste-Orgeas, M., Pease, S., . . . Dressing Study Group. (2009). Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: A randomized controlled trial. JAMA, 301, 1231–1241. 

Study Purpose

To assess chlorhexidine-impregnated sponge dressings for prevention of catheter-related infections

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of four treatment groups. Groups were (a) standard dressing every three days, (b) chlorhexidine sponge dressing every three days, (c) standard dressing every seven days, and (d) chlorhexidine dressing every seven days. Insertion sites were the radial artery or subclavian vein whenever possible. Insertions were done with maximal barriers and antisepsis techniques. Semitransparent dressings were used for all. Povidone-idodine was used for skin antisepsis with each dressing change. Patients were followed for 48 hours after discharge from the ICU. A noninferiority analysis was planned with the identification of a 3% difference in catheter-related infection (CRI) rate as the comparison value. Only cultured catheters were considered to compare three- versus seven-day dressing intervals.

Sample Characteristics

  • N = 1,636 in intent to treat analysis, 28,931 catheter days   
  • MEDIAN AGE = 62 years
  • AGE RANGE = 50–74 years
  • MALES: 64.3%, FEMALES: 35.7%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: 64 patients (3.9%) had metastatic cancer and 52 (3.2%) had hematologic cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: 45% were arterial catheters and, of these, 41% were femoral; 54.3% were venous catheters and, of these, 40% were subclavian; the rest were jugular or femoral catheters.

Setting

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

Study Design

  • Four-group, single-blind randomized, controlled trial

Measurement Instruments/Methods

  • CRI defined as either catheter-related sepsis without bloodstream infection or catheter-related bloodstream infection. 
  • Catheter colonization was the major outcome for comparison of three- versus seven-day dressing intervals
  • Catheter colonization: At least 1,000 colony forming units/ml
  • CRI defined as combination of (a) body temperature ≥ 38.5 C or hypothermia, (b) catheter tip culture with at least 103 CFUs/ml, (c) pus at insertion site or resolution of clinical sepsis with catheter removal, and (d) absence of any other foci for infection.

Results

Use of chlorhexidine dressings overall were associated with a 0.6 CRI rate compared to 1.4 in the control groups per 1,000 catheter days (hazard ratio [HR] = 0.39, p = 0.03). Of those assigned to seven-day dressings, 50.6% had more frequent unplanned dressing changes. There was no significant difference in colonization rate between those having three- and seven-day dressing intervals. There was a slight but insignificant increase in skin colonization in the seven-day group at the time of catheter removal. Overall, the rate of central line–associated bloodstream infection (CLABSI) was lower (p = 0.005) with sponge dressings. 

Conclusions

Use of chlorhexidine sponge dressing reduced the incidence of catheter-related bloodstream infections. Analysis by dressing change interval did not show any significant difference in outcomes.

Limitations

  • There was no analysis of each separate group to determine which combination of dressing frequency and dressing type was most effective.  
  • Low volume of patients with cancer
  • No subgroup analysis by catheter insertion site. A rather large proportion were femoral and jugular sites.

Nursing Implications

Findings showed lower CLABSI rate and risk with use of chlorhexidine-impregnated sponge dressings. Findings also suggest no difference in infection outcomes related to catheters according to the frequency of dressing changes, although more than half of patients assigned to dressing changes every seven days needed changes more frequently for soiling or separation. Chlorhexidine-impregnated dressings can reduce CLABSI rate, and less frequent catheter dressing changes can be done with no apparent increase in infections.

Print
Subscribe to