Deborah Kennedy

The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study

Objective  Ondansetron (Zofran) is a drug used for the treatment of nausea and vomiting caused by cancer chemotherapy. Despite the fact that it is not indicated, women are being prescribed this drug for the treatment of nausea and vomiting of pregnancy (NVP). There is a paucity of information on fetal safety for this indication. The objective of this study is to determine whether this drug increases the baseline rate of major malformations.

Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review

Background Soy and red clover isoflavones are controversial due to purported estrogenic activity and possible effects on breast cancer. We conducted a systematic review of soy and red clover for efficacy in improving menopausal symptoms in women with breast cancer, and for potential impact on risk of breast cancer incidence or recurrence. Methods We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to March 2013 for human interventional or observational data pertaining to the safety and efficacy of soy and red clover isoflavones in patients with or at risk of breast cancer. Results Of 4179 records, we included a total of 131 articles: 40 RCTs, 11 uncontrolled trials, and 80 observational studies. Five RCTs reported on the efficacy of soy for hot flashes, showing no significant reductions in hot flashes compared to placebo. There is lack of evidence showing harm from use of soy with respect to risk of breast cancer or recurrence, based on long term observational data. Soy intake consistent with that of a traditional Japanese diet (2-3 servings daily, containing 25-50mg isoflavones) may be protective against breast cancer and recurrence. Human trials show that soy does not increase circulating estradiol or affect estrogen-responsive target tissues. Prospective data of soy use in women taking tamoxifen does not indicate increased risk of recurrence. Evidence on red clover is limited, however existing studies suggest that it may not possess breast cancer-promoting effects. Conclusion Soy consumption may be associated with reduced risk of breast cancer incidence, recurrence, and mortality. Soy does not have estrogenic effects in humans. Soy intake consistent with a traditional Japanese diet appears safe for breast cancer survivors. While there is no clear evidence of harm, better evidence confirming safety is required before use of high dose (≥100mg) isoflavones can be recommended for breast cancer patients.

Selenium and Lung Cancer: A Systematic Review and Meta Analysis

Background Selenium is a natural health product widely used in the treatment and prevention of lung cancers, but large chemoprevention trials have yielded conflicting results. We conducted a systematic review of selenium for lung cancers, and assessed potential interactions with conventional therapies. Methods and Findings Two independent reviewers searched six databases from inception to March 2009 for evidence pertaining to the safety and efficacy of selenium for lung cancers. Pubmed and EMBASE were searched to October 2009 for evidence on interactions with chemo- or radiation-therapy. In the efficacy analysis there were nine reports of five RCTs and two biomarker-based studies, 29 reports of 26 observational studies, and 41 preclinical studies. Fifteen human studies, one case report, and 36 preclinical studies were included in the interactions analysis. Based on available evidence, there appears to be a different chemopreventive effect dependent on baseline selenium status, such that selenium supplementation may reduce risk of lung cancers in populations with lower baseline selenium status (serum<106 ng/mL), but increase risk of lung cancers in those with higher selenium (≥121.6 ng/mL). Pooling data from two trials yielded no impact to odds of lung cancer, OR 0.93 (95% confidence interval 0.61–1.43); other cancers that were the primary endpoints of these trials, OR 1.51 (95%CI 0.70–3.24); and all-cause-death, OR 0.93 (95%CI 0.79–1.10). In the treatment of lung cancers, selenium may reduce cisplatin-induced nephrotoxicity and side effects associated with radiation therapy. Conclusions Selenium may be effective for lung cancer prevention among individuals with lower selenium status, but at present should not be used as a general strategy for lung cancer prevention. Although promising, more evidence on the ability of selenium to reduce cisplatin and radiation therapy toxicity is required to ensure that therapeutic efficacy is maintained before any broad clinical recommendations can be made in this context.

Herbal medicine use in pregnancy: results of a multinational study

BackgroundThe use of complementary and alternative medicines (CAM) is growing in the general population. Herbal medicines are used in all countries of the world and are included in the top CAM therapies used.MethodsA multinational study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North and South America and Australia. In this study, the primary aim was to determine the prevalence of herbal medicine use in pregnancy and factors related to such use across participating countries and regions. The secondary aim was to investigate who recommended the use of herbal medication in pregnancy.ResultsThere were 9,459 women from 23 countries participating in the study. Of these, 28.9% reported the use of herbal medicines in pregnancy. Most herbal medicines were used for pregnancy-related health ailments such as cold and nausea. Ginger, cranberry, valerian and raspberry were the most commonly used herbs in pregnancy. The highest reported rate of herbal use medicines was in Russia (69%). Women from Eastern Europe (51.8%) and Australia (43.8%) were twice as likely to use an herbal medicine versus other regions. Women using herbal medicines were characteristically having their first child, non-smokers, using folic acid and consuming some alcohol in pregnancy. Also, women who were currently students and women with an education other than a high school degree were more likely to use herbal medicines than other women. Although 1 out of 5 women stated that a physician had recommended the herbal use, most women used herbal medicine in pregnancy on their own initiative.ConclusionsIn this multinational study herbal medicine use in pregnancy was high although there were distinct differences in the herbs and users of herbal medicines across regions. Most commonly the women self-medicated with herbal medicine to treat pregnancy-related health ailments. More knowledge regarding the efficacy and safety of herbal medicines in pregnancy is warranted.

Quantifying Self-Report Measures' Overestimation of Mobility Scores Postarthroplasty

Background Self-reports of function may systematically overestimate the ability of patients to move around postarthroplasty. Objective The purpose of this study was to estimate the magnitude of systematic differences in Lower Extremity Functional Scale (LEFS) and Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale (WOMAC-PF) scores before and after primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) by referencing the values to Six-Minute Walk Test (6MWT) distances and Timed “Up & Go” Test (TUG) times. Design This study was a secondary analysis of data from a prospective cohort study. Methods The LEFS, WOMAC, 6MWT, and TUG were administered to 85 patients prearthroplasty and once at 9 to 13 weeks postarthroplasty. Regression analysis was applied using a robust error term for clustered data. With the self-report measures as dependent variables and performance measures, occasion (prearthroplasty or postarthroplasty), and performance measure-by-occasion as independent variables, 3 propositions were examined: (1) the relationship between self-report and performance measures is identical prearthroplasty and postarthroplasty (ie, regression lines are coincident); (2) the relationship differs between occasions, but is consistent (ie, regression lines are parallel); (3) the relationship is not consistent (ie, the regression lines are not parallel). Results For all analyses, the results supported the second proposition (ie, the relationship differed between occasions, but was consistent). The systematic differences varied by location of arthroplasty, but were similar for both performance tests. For the LEFS, the difference was approximately 11 points for patients who received TKA and 13 points for patients who received THA. For the WOMAC-PF, the difference was approximately 12 points for patients who received TKA and 19 points for patients who received THA. These differences exceed the minimal clinically important change for an individual patient. Limitations The findings are specific to 9 to 13 weeks postarthroplasty. Conclusion Dependence on scores of self-report measures alone, without knowledge of the magnitude of the identified systematic differences, will result in overestimating the ability of patients to move around postarthroplasty.

Vitamin A and Retinoid Derivatives for Lung Cancer: A Systematic Review and Meta Analysis

Background Despite reported antiproliferative activity of vitamin A and its common use for cancer, there is no comprehensive synthesis of its safety and efficacy in lung cancers. To address this issue we conducted a systematic review of the safety and efficacy of vitamin A for the treatment and prevention of lung cancers. Methods and Findings Two independent reviewers searched six electronic databases from inception to July 2009 for clinical, observational, and preclinical evidence pertaining to the safety and efficacy of vitamin A and related retinoids for lung cancers. 248 studies were included for full review and analysis. Five RCTs assessed treatment of lung cancers, three assessed primary prevention, and three looked at secondary prevention of lung cancers. Five surrogate studies, 26 phase I/II, 32 observational, and 67 preclinical studies were also included. 107 studies were included for interactions between vitamin A and chemo- or radiation- therapy. Although some studies demonstrated benefits, there was insufficient evidence overall to support the use of vitamin A or related retinoids for the treatment or prevention of lung cancers. Retinyl palmitate combined with beta carotene increased risk of lung cancer in smokers in the large CARET trial. Pooling of three studies pertaining to treatment and three studies on secondary prevention revealed no significant effects on response rate, second primary tumor, recurrence, 5-year survival, and mortality. There was a small improvement in event free survival associated with vitamin A compared to controls, RR 1.24 (95% CI 1.13–1.35). The synthetic rexinoid bexarotene increased survival significantly among a subset of patients in two RCTs (p<0.014, <0.087). Conclusions There is a lack of evidence to support the use of naturally occuring retinoids for the treatment and prevention of lung cancers. The rexinoid bexarotene may hold promise for use among a subset of patients, and deserves further study.

Using outcome measure results to facilitate clinical decisions the first year after total hip arthroplasty.

STUDY DESIGN Variable-occasion, repeated-measures design. OBJECTIVES To model change in lower extremity functional status of patients 1 year after total hip arthroplasty (THA), using the Lower Extremity Functional Scale (LEFS) and the 6-minute walk test (6MWT), and, secondarily, to provide clinicians with useful data to guide practice. BACKGROUND Given the prevalence of THA and current resource pressures, standardized outcome measures play an important role in providing physical therapists with objective knowledge about postoperative recovery and prognosis. METHODS Seventy-five patients, with a mean age of 61 years and a diagnosis of hip osteoarthritis, consented to participate in the study. Assessments were conducted preoperatively and at multiple time points for up to 65 weeks postoperatively. Recovery was modeled using a nonlinear robust regression analysis for clustered data. The predictive ability of age, body mass index, and preoperative score was explored. RESULTS Gender-based recovery curves were generated to depict the rate and amount of change in LEFS scores and 6MWT distances over the first year. Preoperative baseline 6MWT distance was the only covariate predictive of postarthroplasty 6MWT distances for both males and females. None of the covariates examined were significantly associated with postarthroplasty LEFS scores. CONCLUSION Although there were variations in the recovery curves by measure, general patterns were noted. There was a rapid increase in both self-reported and physical performance measure scores for 12 to 15 weeks. Thereafter, we observed a slowing of recovery, with a plateau at 30 to 35 weeks for the 6MWT and later for the LEFS. These data can be used to make evidence-based decisions regarding prognosis and to guide the setting of measurable treatment goals. LEVEL OF EVIDENCE Prognosis, level 1b.

Patients Are Satisfied with Advanced Practice Physiotherapists in a Role Traditionally Performed by Orthopaedic Surgeons

PURPOSE To measure and compare patient satisfaction with follow-up care in advanced practice physiotherapist (APP) and orthopaedic surgeon clinics for patients following total hip or knee replacement. METHOD Consecutive patients attending either an APP-led or a surgeon-led review clinic were surveyed using a modified nine-item satisfaction questionnaire based on the Visit-Specific Satisfaction Instrument (VSQ-9). Chi-square analyses were used to examine differences in patient characteristics and type of visit. Independent t-tests were used to examine potential differences in patient satisfaction. RESULTS Of the 123 participants, more than half were aged 65 years or older. Chi-squared analyses revealed no significant difference in participant characteristics (gender, age, and overall health status) between the two different types of clinics. There was a significant difference (χ(2) (4)=12.49, p=0.014) in the distribution of the timing of follow-up appointments. There was no significant difference between the groups in mean overall patient satisfaction scores on the modified VSQ-9 (p=0.34) nor in the mean of the sum of the seven items related to the service provider (p=0.85). Satisfaction scores for most of the service-provider items were above 90/100. CONCLUSION Patients are highly satisfied with the care provided by APPs in follow-up clinics after joint replacement. Evaluation of the patient perspective is essential to any new role involving a shift in traditional practice boundaries.

Evaluation of an Advanced-Practice Physical Therapist in a Specialty Shoulder Clinic: Diagnostic Agreement and Effect on Wait Times

PURPOSE To examine the role of an advanced-practice physiotherapist (APP) with respect to (1) agreement with an orthopaedic surgeon on diagnosis and management of patients with shoulder problems; (2) wait times; and (3) satisfaction with care. METHODS This prospective study involved patients with shoulder complaints who were referred to a shoulder specialist in a tertiary care centre. Agreement was examined on seven major diagnostic categories, need for further examination and surgery, and type of surgical procedure. Wait times were compared between the APP- and surgeon-led clinics from referral date to date of initial consultation, date of final diagnostic test, and date of confirmed diagnosis and planned treatment. A modified and validated version of the Visit-Specific Satisfaction Instrument assessed satisfaction in seven domains. Kappa (κ) coefficients and bias- and prevalence-adjusted kappa (PABAK) values were calculated, and strength of agreement was categorized. Wait time and satisfaction data were examined using non-parametric statistics. RESULTS Agreement on major diagnostic categories varied from 0.68 (good) to 0.96 (excellent). Agreement with respect to indication for surgery was κ=0.75, p<0.001; 95% CI, 0.62-0.88 (good). Wait time for APP assessment was significantly shorter than wait time for surgeon consultation at all time points (p<0.001); the surgeons wait time was significantly reduced over 3 years. High satisfaction was reported in all components of care received from both health care providers. CONCLUSIONS Using experienced physiotherapists in an extended role reduces wait times without compromising patient clinical management and overall satisfaction.

Strategies Aimed at Preventing Chronic Post-surgical Pain: Comprehensive Perioperative Pain Management after Total Joint Replacement Surgery.

PURPOSE Chronic post-surgical pain (CPSP) is a frequent outcome of musculoskeletal surgery. Physiotherapists often treat patients with pain before and after musculoskeletal surgery. The purposes of this paper are (1) to raise awareness of the nature, mechanisms, and significance of CPSP; and (2) to highlight the necessity for an inter-professional team to understand and address its complexity. Using total joint replacement surgeries as a model, we provide a review of pain mechanisms and pain management strategies. SUMMARY OF KEY POINTS By understanding the mechanisms by which pain alters the bodys normal physiological responses to surgery, clinicians selectively target pain in post-surgical patients through the use of multi-modal management strategies. Clinicians should not assume that patients receiving multiple medications have a problem with pain. Rather, the modern-day approach is to manage pain using preventive strategies, with the aims of reducing the intensity of acute postoperative pain and minimizing the development of CPSP. CONCLUSIONS The roles of biological, surgical, psychosocial, and patient-related risk factors in the transition to pain chronicity require further investigation if we are to better understand their relationships with pain. Measuring pain intensity and analgesic use is not sufficient. Proper evaluation and management of risk factors for CPSP require inter-professional teams to characterize a patients experience of postoperative pain and to examine pain arising during functional activities.