A comparison of the stages at which cancer is diagnosed in physicians and in the general population in Taiwan

Background:Previous investigations have reported that physicians tend to neglect their own health care; however, they may also use their professional knowledge and networks to engage in healthier lifestyles or seek prompt health services. We sought to determine whether the stage at which cancer is diagnosed differs between physicians and nonphysicians.Methods:We conducted a nationwide matched cohort study over a period of 14 years in Taiwan. We accessed data from two national databases: the National Health Insurance Research Database and the Taiwan Cancer Registry File. We collected data on all patients with the 6 most common cancers in Taiwan (hepatoma, lung, colorectal, oral, female breast and cervical cancer) from 1999 to 2012. We excluded patients less than 25 years of age, as well as those with a history of organ transplantation, cancer or AIDS. We used propensity score matching for age, sex, residence and income to select members for the control (nonphysicians) and experimental (physicians) groups at a 5:1 ratio. We used χ² tests to analyze the distribution of incident cancer stages among physicians and nonphysicians. We compared these associations using multinomial logistic regression. We performed sensitivity analyses for subgroups of doctors and cancers.Results:We identified 274 003 patients with cancer, 542 of whom were physicians. After propensity score matching, we assigned 536 physicians to the experimental group and 2680 nonphysicians to the control group. We found no significant differences in cancer stage distributions between physicians and controls. Multinomial logistic regression and sensitivity analyses showed similar cancer stages in most scenarios; however, physicians had 2.64-fold higher risk of having stage IV cancer at diagnosis in cases of female breast and cervical cancer.Interpretation:In this cohort of physicians in Taiwan, cancer was not diagnosed at earlier stages than in nonphysicians, with the exception of stage IV cancer of the cervix and female breast.The health of physicians is vital to health care systems. Physicians who are unwell mentally or physically are prone to providing suboptimal patient care.¹ Several studies have investigated the risk of cancer for doctors with inconclusive findings;^1–4 few investigations have addressed whether cancer is diagnosed at earlier stages in physicians.Previous investigations have reported that physicians tend to neglect their own physical examinations and, once sick, procrastinate seeking medical treatment.^5–8 However, doctors may use their own professional knowledge and network to engage in healthy lifestyles or seek prompt health services in ways that reduce their risk of illness.^9–11Factors protecting people from advanced cancer stages include attending screening services^12–14 and access to physicians.^15,16 Delayed cancer diagnoses lead to poorer outcomes. We sought to compare the incident cancer stages of the 6 most common cancers between physicians and nonphysicians in Taiwan to determine whether physicians’ cancers were diagnosed at earlier or later stages than nonphysicians’ cancers.     

Determinants of variations in initial treatment strategies for stable ischemic heart disease

Background:

The ratio of revascularization to medical therapy (referred to herein as the revascularization ratio) for the initial treatment of stable ischemic heart disease varies considerably across hospitals. We conducted a comprehensive study to identify patient, physician and hospital factors associated with variations in the revascularization ratio across 18 cardiac centres in the province of Ontario. We also explored whether clinical outcomes differed between hospitals with high, medium and low ratios.

Methods:

We identified all patients in Ontario who had stable ischemic heart disease documented by index angiography performed between Oct. 1, 2008, and Sept. 30, 2011, at any of the 18 cardiac centres in the province. We classified patients by initial treatment strategy (medical therapy or revascularization). Hospitals were classified into equal tertiles based on their revascularization ratio. The primary outcome was all-cause mortality. Patient follow-up was until Dec. 31, 2012. Hierarchical logistic regression models identified predictors of revascularization. Multivariable Cox proportional hazards models, with a time-varying covariate for actual treatment received, were used to evaluate the impact of the revascularization ratio on clinical outcomes.

Results:

Variation in revascularization ratios was twofold across the hospitals. Patient factors accounted for 67.4% of the variation in revascularization ratios. Physician and hospital factors were not significantly associated with the variation. Significant patient-level predictors of revascularization were history of smoking, multivessel disease, high-risk findings on noninvasive stress testing and more severe symptoms of angina (v. no symptoms). Treatment at hospitals with a high revascularization ratio was associated with increased mortality compared with treatment at hospitals with a low ratio (hazard ratio 1.12, 95% confidence interval 1.03–1.21).

Interpretation:

Most of the variation in revascularization ratios across hospitals was warranted, in that it was driven by patient factors. Nonetheless, the variation was associated with potentially important differences in mortality.Stable ischemic heart disease is a common manifestation of cardiovascular disease, the leading cause of death in the world.^1,2 The treatment strategies for stable ischemic heart disease include medical therapy alone or in combination with revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).A tremendous amount of research has examined the best initial treatment strategy for stable ischemic heart disease.^3–5 Randomized controlled trials have not shown a difference in major adverse events between optimal medical therapy and revascularization.⁶ Some argue that revascularization should be reserved only for symptom relief.^5,7,8 Criteria for the appropriate use of revascularization have been developed to aid in clinical decision-making; however, a substantial proportion of revascularization procedures for stable ischemic heart disease are performed under clinical circumstances deemed as “uncertain.”^9,10 Reflecting this uncertainty, there is wide regional variation in the rate of coronary revascularization,^11–13 which suggests different thresholds for invasive therapy for stable ischemic heart disease.Studies have predominantly examined the determinants of variations in the type of revascularization modality used.^13,14 There is a paucity of data exploring the determinants of variations in the earlier decision to treat with medical therapy alone or with revascularization. A study published nearly a decade ago did not examine outcomes.⁷ Accordingly, our primary research objective was to determine whether the variations in initial treatment strategies for stable ischemic heart disease are warranted. We conducted a comprehensive population-based study to identify patient, physician and hospital factors associated with variations in treatment strategies within 90 days after angiography. We also explored whether clinical outcomes differed between hospitals with high, medium and low ratios of revascularization to medical therapy (hereafter referred to as the revascularization ratio).     

Effect of lung-protective ventilation with lower tidal volumes on clinical outcomes among patients undergoing surgery: a meta-analysis of randomized controlled trials

Background:In anesthetized patients undergoing surgery, the role of lung-protective ventilation with lower tidal volumes is unclear. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of this ventilation strategy on postoperative outcomes.Methods:We searched electronic databases from inception through September 2014. We included RCTs that compared protective ventilation with lower tidal volumes and conventional ventilation with higher tidal volumes in anesthetized adults undergoing surgery. We pooled outcomes using a random-effects model. The primary outcome measures were lung injury and pulmonary infection.Results:We included 19 trials (n = 1348). Compared with patients in the control group, those who received lung-protective ventilation had a decreased risk of lung injury (risk ratio [RR] 0.36, 95% confidence interval [CI] 0.17 to 0.78; I² = 0%) and pulmonary infection (RR 0.46, 95% CI 0.26 to 0.83; I² = 8%), and higher levels of arterial partial pressure of carbon dioxide (standardized mean difference 0.47, 95% CI 0.18 to 0.75; I² = 65%). No significant differences were observed between the patient groups in atelectasis, mortality, length of hospital stay, length of stay in the intensive care unit or the ratio of arterial partial pressure of oxygen to fraction of inspired oxygen.Interpretation:Anesthetized patients who received ventilation with lower tidal volumes during surgery had a lower risk of lung injury and pulmonary infection than those given conventional ventilation with higher tidal volumes. Implementation of a lung-protective ventilation strategy with lower tidal volumes may lower the incidence of these outcomes.Estimates suggest that more than 230 million patients undergo major surgical procedures worldwide each year.¹ Postoperative pulmonary complications, including lung injury, pneumonia and atelectasis, are common and a major cause of morbidity and death.^2–5 Thus, prevention of these complications has become a high priority of perioperative care.Mechanical ventilation is mandatory in patients undergoing surgical procedures during general anesthesia. Conventional mechanical ventilation with tidal volumes of 10 to 15 mL/kg has been advocated to prevent hypoxemia and atelectasis in anesthetized patients undergoing surgery.⁶ However, unequivocal evidence from experimental and clinical studies suggests that mechanical ventilation, especially the use of high tidal volumes, may cause or aggravate lung injury.^7–9 Mechanical ventilation using high tidal volumes can result in overdistention of alveoli that mainly causes ventilator-associated lung injury.¹⁰Lung-protective ventilation refers to the use of low tidal volumes and moderate to high levels of positive end-expiratory pressure, with or without a recruitment manoeuvre.¹¹ Lung-protective ventilation has been found to reduce morbidity and mortality among patients with acute lung injury and acute respiratory distress syndrome.^11,12 However, in anesthetized patients without the syndrome, the role of lung-protective ventilation remains unclear. Two previous meta-analyses addressing similar research questions have been published,^13,14 but the inclusion of observational studies compromised the reliability of the results. Recently, randomized controlled trials (RCTs) on the topic have reported conflicting results. We performed a meta-analysis of RCTs to evaluate the effect of lung-protective ventilation with lower tidal volumes on clinical outcomes in patients undergoing surgery.     

Imaging for distant metastases in women with early-stage breast cancer: a population-based cohort study

Background:

Practice guidelines recommend that imaging to detect metastatic disease not be performed in the majority of patients with early-stage breast cancer who are asymptomatic. We aimed to determine whether practice patterns in Ontario conform with these recommendations.

Methods:

We used provincial registry data to identify a population-based cohort of Ontario women in whom early-stage, operable breast cancer was diagnosed between 2007 and 2012. We then determined whether imaging of the skeleton, thorax, and abdomen or pelvis had been performed within 3 months of tissue diagnosis. We calculated rates of confirmatory imaging of the same body site.

Results:

Of 26 547 patients with early-stage disease, 22 811 (85.9%) had at least one imaging test, and a total of 83 249 imaging tests were performed (mean of 3.7 imaging tests per patient imaged). Among patients with pathologic stage I and II disease, imaging was performed in 79.6% (10 921/13 724) and 92.7% (11 882/12 823) of cases, respectively. Of all imaging tests, 19 784 (23.8%) were classified as confirmatory investigations. Imaging was more likely for patients who were younger, had greater comorbidity, had tumours of higher grade or stage or had undergone preoperative breast ultrasonography, mastectomy or surgery in the community setting.

Interpretation:

Despite recommendations from multiple international guidelines, most Ontario women with early-stage breast cancer underwent imaging to detect distant metastases. Inappropriate imaging in asymptomatic patients with early-stage disease is costly and may lead to harm. The use of population datasets will allow investigators to evaluate whether or not strategies to implement practice guidelines lead to meaningful and sustained change in physician practice.Most women with newly diagnosed breast cancer present with early-stage, potentially curable disease.¹ Among patients whose disease is restricted to the breast and axillary lymph nodes, without signs or symptoms of metastatic disease, the likelihood of having radiologically evident metastases in pathologic stage I and II disease is about 0.2% and 1.2%, respectively.² This low frequency has not changed significantly, even with the increasing use of magnetic resonance imaging (MRI) and positron emission tomography.^2,3 For this reason, most provincial, national and international guidelines do not recommend imaging for all patients with early-stage breast cancer who are asymptomatic.^4–8Despite these evidence-based guidelines, imaging for distant metastases in patients with a new diagnosis of breast cancer remains common.^2,9–12 In response to the Choosing Wisely campaign of the American Board of Internal Medicine Foundation,¹³ the American Society of Clinical Oncology (ASCO) published its inaugural “top 5” list for choosing wisely in oncology.¹⁴ It recommended against routine imaging for staging purposes in women with early breast cancer, because “such imaging adds little benefit to patient care and has the potential to cause harm.”¹⁴ In 2014, Choosing Wisely Canada was launched in an effort to encourage physicians and patients to engage in conversations about unnecessary tests, treatments and procedures, to help ensure that patients receive the highest-quality care.¹⁵The ASCO Choosing Wisely recommendation¹⁴ is similar to the Cancer Care Ontario guideline,⁴ which has been in existence for over a decade. Whereas ASCO in its Choosing Wisely campaign recommends no imaging for patients with stage I or II disease, the Cancer Care Ontario guideline recommends no imaging for patients with stage I disease and a bone scan for those with stage II disease. A recent study at a large Canadian academic cancer centre showed that, despite publication of both a provincial guideline and the ASCO recommendations, most patients with primary operable (early-stage) breast cancer undergo imaging for distant metastases.¹⁰ We hypothesized that despite the provincial guideline, this practice may be more widespread. We undertook this population-based study to determine whether physician practice patterns in Ontario regarding imaging of patients with early-stage breast cancer are in keeping with the published Cancer Care Ontario guideline.     

Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay

Background:We aimed to prospectively validate a novel 1-hour algorithm using high-sensitivity cardiac troponin T measurement for early rule-out and rule-in of acute myocardial infarction (MI).Methods:In a multicentre study, we enrolled 1320 patients presenting to the emergency department with suspected acute MI. The high-sensitivity cardiac troponin T 1-hour algorithm, incorporating baseline values as well as absolute changes within the first hour, was validated against the final diagnosis. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, echocardiography, follow-up data and serial measurements of high-sensitivity cardiac troponin T levels.Results:Acute MI was the final diagnosis in 17.3% of patients. With application of the high-sensitivity cardiac troponin T 1-hour algorithm, 786 (59.5%) patients were classified as “rule-out,” 216 (16.4%) were classified as “rule-in” and 318 (24.1%) were classified to the “observational zone.” The sensitivity and the negative predictive value for acute MI in the rule-out zone were 99.6% (95% confidence interval [CI] 97.6%–99.9%) and 99.9% (95% CI 99.3%–100%), respectively. The specificity and the positive predictive value for acute MI in the rule-in zone were 95.7% (95% CI 94.3%–96.8%) and 78.2% (95% CI 72.1%–83.6%), respectively. The 1-hour algorithm provided higher negative and positive predictive values than the standard interpretation of highsensitivity cardiac troponin T using a single cut-off level (both p < 0.05). Cumulative 30-day mortality was 0.0%, 1.6% and 1.9% in patients classified in the rule-out, observational and rule-in groups, respectively (p = 0.001).Interpretation:This rapid strategy incorporating high-sensitivity cardiac troponin T baseline values and absolute changes within the first hour substantially accelerated the management of suspected acute MI by allowing safe rule-out as well as accurate rule-in of acute MI in 3 out of 4 patients. Trial registration: ClinicalTrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT00470587","term_id":"NCT00470587"}}NCT00470587Acute myocardial infarction (MI) is a major cause of death and disability worldwide. As highly effective treatments are available, early and accurate detection of acute MI is crucial.^1–5 Clinical assessment, 12-lead electrocardiography (ECG) and measurement of cardiac troponin levels form the pillars for the early diagnosis of acute MI in the emergency department. Major advances have recently been achieved by the development of more sensitive cardiac troponin assays.^6–15 High-sensitivity cardiac troponin assays, which allow measurement of even low concentrations of cardiac troponin with high precision, have been shown to largely overcome the sensitivity deficit of conventional cardiac troponin assays within the first hours of presentation in the diagnosis of acute MI.^6–15 These studies have consistently shown that the classic diagnostic interpretation of cardiac troponin as a dichotomous variable (troponin-negative and troponin-positive) no longer seems appropriate, because the positive predictive value for acute MI of being troponin-positive was only about 50%.^6–15 The best way to interpret and clinically use high-sensitivity cardiac troponin levels in the early diagnosis of acute MI is still debated.^3,5,7In a pilot study, a novel high-sensitivity cardiac troponin T 1-hour algorithm was shown to allow accurate rule-out and rule-in of acute MI within 1 hour in up to 75% of patients.¹¹ This algorithm is based on 2 concepts. First, high-sensitivity cardiac troponin T is interpreted as a quantitative variable where the proportion of patients who have acute MI increases with increasing concentrations of cardiac troponin T.^6–15 Second, early absolute changes in the concentrations within 1 hour provide incremental diagnostic information when added to baseline levels, with the combination acting as a reliable surrogate for late concentrations at 3 or 6 hours.^6–15 However, many experts remained skeptical regarding the safety of the high-sensitivity cardiac troponin T 1-hour algorithm and its wider applicability.¹⁶ Accordingly, this novel diagnostic concept has not been adopted clinically to date. Because the clinical application of this algorithm would represent a profound change in clinical practice, prospective validation in a large cohort is mandatory before it can be considered for routine clinical use. The aim of this multicentre study was to prospectively validate the high-sensitivity cardiac troponin T 1-hour algorithm in a large independent cohort.     

Risk of vascular events in patients with polymyalgia rheumatica

Background:

Polymyalgia rheumatica is one of the most common inflammatory rheumatologic conditions in older adults. Other inflammatory rheumatologic disorders are associated with an excess risk of vascular disease. We investigated whether polymyalgia rheumatica is associated with an increased risk of vascular events.

Methods:

We used the General Practice Research Database to identify patients with a diagnosis of incident polymyalgia rheumatica between Jan. 1, 1987, and Dec. 31, 1999. Patients were matched by age, sex and practice with up to 5 patients without polymyalgia rheumatica. Patients were followed until their first vascular event (cardiovascular, cerebrovascular, peripheral vascular) or the end of available records (May 2011). All participants were free of vascular disease before the diagnosis of polymyalgia rheumatica (or matched date). We used Cox regression models to compare time to first vascular event in patients with and without polymyalgia rheumatica.

Results:

A total of 3249 patients with polymyalgia rheumatica and 12 735 patients without were included in the final sample. Over a median follow-up period of 7.8 (interquartile range 3.3–12.4) years, the rate of vascular events was higher among patients with polymyalgia rheumatica than among those without (36.1 v. 12.2 per 1000 person-years; adjusted hazard ratio 2.6, 95% confidence interval 2.4–2.9). The increased risk of a vascular event was similar for each vascular disease end point. The magnitude of risk was higher in early disease and in patients younger than 60 years at diagnosis.

Interpretation:

Patients with polymyalgia rheumatica have an increased risk of vascular events. This risk is greatest in the youngest age groups. As with other forms of inflammatory arthritis, patients with polymyalgia rheumatica should have their vascular risk factors identified and actively managed to reduce this excess risk.Inflammatory rheumatologic disorders such as rheumatoid arthritis,^1,2 systemic lupus erythematosus,^2,3 gout,⁴ psoriatic arthritis^2,5 and ankylosing spondylitis^2,6 are associated with an increased risk of vascular disease, especially cardiovascular disease, leading to substantial morbidity and premature death.^2–6 Recognition of this excess vascular risk has led to management guidelines advocating screening for and management of vascular risk factors.^7–9Polymyalgia rheumatica is one of the most common inflammatory rheumatologic conditions in older adults,¹⁰ with a lifetime risk of 2.4% for women and 1.7% for men.¹¹ To date, evidence regarding the risk of vascular disease in patients with polymyalgia rheumatica is unclear. There are a number of biologically plausible mechanisms between polymyalgia rheumatica and vascular disease. These include the inflammatory burden of the disease,^12,13 the association of the disease with giant cell arteritis (causing an inflammatory vasculopathy, which may lead to subclinical arteritis, stenosis or aneurysms),¹⁴ and the adverse effects of long-term corticosteroid treatment (e.g., diabetes, hypertension and dyslipidemia).^15,16 Paradoxically, however, use of corticosteroids in patients with polymyalgia rheumatica may actually decrease vascular risk by controlling inflammation.¹⁷ A recent systematic review concluded that although some evidence exists to support an association between vascular disease and polymyalgia rheumatica,¹⁸ the existing literature presents conflicting results, with some studies reporting an excess risk of vascular disease^19,20 and vascular death,^21,22 and others reporting no association.^23–26 Most current studies are limited by poor methodologic quality and small samples, and are based on secondary care cohorts, who may have more severe disease, yet most patients with polymyalgia rheumatica receive treatment exclusively in primary care.²⁷The General Practice Research Database (GPRD), based in the United Kingdom, is a large electronic system for primary care records. It has been used as a data source for previous studies,²⁸ including studies on the association of inflammatory conditions with vascular disease²⁹ and on the epidemiology of polymyalgia rheumatica in the UK.³⁰ The aim of the current study was to examine the association between polymyalgia rheumatica and vascular disease in a primary care population.     

Incidence of psychotic disorders among first-generation immigrants and refugees in Ontario

Background:

Evidence suggests that migrant groups have an increased risk of psychotic disorders and that the level of risk varies by country of origin and host country. Canadian evidence is lacking on the incidence of psychotic disorders among migrants. We sought to examine the incidence of schizophrenia and schizoaffective disorders in first-generation immigrants and refugees in the province of Ontario, relative to the general population.

Methods:

We constructed a retrospective cohort that included people aged 14–40 years residing in Ontario as of Apr. 1, 1999. Population-based administrative data from physician billings and hospital admissions were linked to data from Citizenship and Immigration Canada. We used Poisson regression models to calculate age- and sex-adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for immigrant and refugee groups over a 10-year period.

Results:

In our cohort (n = 4 284 694), we found higher rates of psychotic disorders among immigrants from the Caribbean and Bermuda (IRR 1.60, 95% CI 1.29–1.98). Lower rates were found among immigrants from northern Europe (IRR 0.50, 95% CI 0.28–0.91), southern Europe (IRR 0.60, 95% CI 0.41–0.90) and East Asia (IRR 0.56, 95% CI 0.41–0.78). Refugee status was an independent predictor of risk among all migrants (IRR 1.27, 95% CI 1.04–1.56), and higher rates were found specifically for refugees from East Africa (IRR 1.95, 95% CI 1.44–2.65) and South Asia (IRR 1.51, 95% CI 1.08–2.12).

Interpretation:

The differential pattern of risk across ethnic subgroups in Ontario suggests that psychosocial and cultural factors associated with migration may contribute to the risk of psychotic disorders. Some groups may be more at risk, whereas others are protected.Meta-analytic reviews suggest that international migrants have a two- to threefold increased risk of psychosis compared with the host population, and the level of risk varies by country of origin and host country.^1,2 This increased risk may persist into the second and third generations.^2,3 Incidence rates are not typically found to be elevated in the country of origin;^4–7 therefore, it is believed that the migratory or postmigration experience may play a role in the etiology.The migration-related emergence of psychotic disorders is a potential concern in Canada, which receives about 250 000 new immigrants and refugees each year.⁸ However, there is a notable lack of current epidemiological information on the incidence of psychosis among these groups.⁹ Hospital admission data from the early 1900s suggest that European migrants to British Columbia had a higher incidence of schizophrenia than the general population,¹⁰ and more recent data from Ontario suggest higher rates of hospital admission for psychotic disorders in areas with a large proportion of first-generation migrants.¹¹ The fact that a large and increasing proportion of Canada’s population are migrants has been cited as a potential explanation for the higher prevalence of schizophrenia compared with international estimates.¹²The province of Ontario is home to the largest number of migrants in Canada, with first-generation migrants constituting nearly 30% of the population. Canada operates on a human capital model of immigration, using a points-based system that favours younger age, higher education, and proficiency in English or French. Nearly 60% of all newcomers to Canada are economic migrants, 27% are sponsored by a relative living in Canada, and 13% are refugees or temporary workers.⁸ Canada also requires a prearrival medical examination, but less than 0.001% of all applications are denied on the basis of medical grounds, and exemptions may be granted for refugees and some family-reunification applicants.¹³The Canadian migration process differs from that of many countries where the association between migration and psychotic disorders has been previously investigated.^1,2 In most of these countries, migrants generally originate from a smaller number of countries that have historic ties to the host country, and there tends to be a low proportion of refugees, although these processes have changed in recent years. In Canada, migrants come from a wide array of countries, admission policies focus on migrants with professional skills and there is a larger proportion of refugees. Few studies to date have examined the role of refugee status in the risk of psychotic disorders¹⁴ or have assessed all of the migrant groups within a country, because most studies focus on particular groups considered to be at high risk.¹ An examination of migrants to Canada offers a unique opportunity to investigate the risk of psychotic disorders in a group with diverse geographical origins, and the larger proportion of refugees also allows us to investigate their risk separately from immigrant groups. Thus, the breadth, scope and scale of migration to Canada over time offers a diverse and deep population for advancing our understanding of why some groups may have a higher risk of psychotic disorders.Our primary objective was to examine the incidence of schizophrenia and schizoaffective disorders over a 10-year period in first-generation immigrants and refugees in Ontario, relative to the general population. We also compared the incidence among specific migrant groups, stratified by country of birth and refugee status, because research suggests differences in the degree and direction of risk.^1,2 We restricted the sample to first-generation migrants to estimate the extent to which sociodemographic factors had an impact on the risk of schizophrenia and schizoaffective disorders among all migrants.     

Effect of ambient air pollution on the incidence of appendicitis

Background

The pathogenesis of appendicitis is unclear. We evaluated whether exposure to air pollution was associated with an increased incidence of appendicitis.

Methods

We identified 5191 adults who had been admitted to hospital with appendicitis between Apr. 1, 1999, and Dec. 31, 2006. The air pollutants studied were ozone, nitrogen dioxide, sulfur dioxide, carbon monoxide, and suspended particulate matter of less than 10 μ and less than 2.5 μ in diameter. We estimated the odds of appendicitis relative to short-term increases in concentrations of selected pollutants, alone and in combination, after controlling for temperature and relative humidity as well as the effects of age, sex and season.

Results

An increase in the interquartile range of the 5-day average of ozone was associated with appendicitis (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.03–1.25). In summer (July–August), the effects were most pronounced for ozone (OR 1.32, 95% CI 1.10–1.57), sulfur dioxide (OR 1.30, 95% CI 1.03–1.63), nitrogen dioxide (OR 1.76, 95% CI 1.20–2.58), carbon monoxide (OR 1.35, 95% CI 1.01–1.80) and particulate matter less than 10 μ in diameter (OR 1.20, 95% CI 1.05–1.38). We observed a significant effect of the air pollutants in the summer months among men but not among women (e.g., OR for increase in the 5-day average of nitrogen dioxide 2.05, 95% CI 1.21–3.47, among men and 1.48, 95% CI 0.85–2.59, among women). The double-pollutant model of exposure to ozone and nitrogen dioxide in the summer months was associated with attenuation of the effects of ozone (OR 1.22, 95% CI 1.01–1.48) and nitrogen dioxide (OR 1.48, 95% CI 0.97–2.24).

Interpretation

Our findings suggest that some cases of appendicitis may be triggered by short-term exposure to air pollution. If these findings are confirmed, measures to improve air quality may help to decrease rates of appendicitis.Appendicitis was introduced into the medical vernacular in 1886.¹ Since then, the prevailing theory of its pathogenesis implicated an obstruction of the appendiceal orifice by a fecalith or lymphoid hyperplasia.² However, this notion does not completely account for variations in incidence observed by age,^3,4 sex,^3,4 ethnic background,^3,4 family history,⁵ temporal–spatial clustering⁶ and seasonality,^3,4 nor does it completely explain the trends in incidence of appendicitis in developed and developing nations.^3,7,8The incidence of appendicitis increased dramatically in industrialized nations in the 19th century and in the early part of the 20th century.¹ Without explanation, it decreased in the middle and latter part of the 20th century.³ The decrease coincided with legislation to improve air quality. For example, after the United States Clean Air Act was passed in 1970,⁹ the incidence of appendicitis decreased by 14.6% from 1970 to 1984.³ Likewise, a 36% drop in incidence was reported in the United Kingdom between 1975 and 1994¹⁰ after legislation was passed in 1956 and 1968 to improve air quality and in the 1970s to control industrial sources of air pollution. Furthermore, appendicitis is less common in developing nations; however, as these countries become more industrialized, the incidence of appendicitis has been increasing.⁷Air pollution is known to be a risk factor for multiple conditions, to exacerbate disease states and to increase all-cause mortality.¹¹ It has a direct effect on pulmonary diseases such as asthma¹¹ and on nonpulmonary diseases including myocardial infarction, stroke and cancer.^11–13 Inflammation induced by exposure to air pollution contributes to some adverse health effects.^14–17 Similar to the effects of air pollution, a proinflammatory response has been associated with appendicitis.^18–20We conducted a case–crossover study involving a population-based cohort of patients admitted to hospital with appendicitis to determine whether short-term increases in concentrations of selected air pollutants were associated with hospital admission because of appendicitis.     

Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial

Background:

Little evidence exists on the effect of an energy-unrestricted healthy diet on metabolic syndrome. We evaluated the long-term effect of Mediterranean diets ad libitum on the incidence or reversion of metabolic syndrome.

Methods:

We performed a secondary analysis of the PREDIMED trial — a multicentre, randomized trial done between October 2003 and December 2010 that involved men and women (age 55–80 yr) at high risk for cardiovascular disease. Participants were randomly assigned to 1 of 3 dietary interventions: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts or advice on following a low-fat diet (the control group). The interventions did not include increased physical activity or weight loss as a goal. We analyzed available data from 5801 participants. We determined the effect of diet on incidence and reversion of metabolic syndrome using Cox regression analysis to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).

Results:

Over 4.8 years of follow-up, metabolic syndrome developed in 960 (50.0%) of the 1919 participants who did not have the condition at baseline. The risk of developing metabolic syndrome did not differ between participants assigned to the control diet and those assigned to either of the Mediterranean diets (control v. olive oil HR 1.10, 95% CI 0.94–1.30, p = 0.231; control v. nuts HR 1.08, 95% CI 0.92–1.27, p = 0.3). Reversion occurred in 958 (28.2%) of the 3392 participants who had metabolic syndrome at baseline. Compared with the control group, participants on either Mediterranean diet were more likely to undergo reversion (control v. olive oil HR 1.35, 95% CI 1.15–1.58, p < 0.001; control v. nuts HR 1.28, 95% CI 1.08–1.51, p < 0.001). Participants in the group receiving olive oil supplementation showed significant decreases in both central obesity and high fasting glucose (p = 0.02); participants in the group supplemented with nuts showed a significant decrease in central obesity.

Interpretation:

A Mediterranean diet supplemented with either extra virgin olive oil or nuts is not associated with the onset of metabolic syndrome, but such diets are more likely to cause reversion of the condition. An energy-unrestricted Mediterranean diet may be useful in reducing the risks of central obesity and hyperglycemia in people at high risk of cardiovascular disease. Trial registration: ClinicalTrials.gov, no. ISRCTN35739639.Metabolic syndrome is a cluster of 3 or more related cardiometabolic risk factors: central obesity (determined by waist circumference), hypertension, hypertriglyceridemia, low plasma high-density lipoprotein (HDL) cholesterol levels and hyperglycemia. Having the syndrome increases a person’s risk for type 2 diabetes and cardiovascular disease.^1,2 In addition, the condition is associated with increased morbidity and all-cause mortality.^1,3–5 The worldwide prevalence of metabolic syndrome in adults approaches 25%^6–8 and increases with age,⁷ especially among women,^8,9 making it an important public health issue.Several studies have shown that lifestyle modifications,¹⁰ such as increased physical activity,¹¹ adherence to a healthy diet^12,13 or weight loss,^14–16 are associated with reversion of the metabolic syndrome and its components. However, little information exists as to whether changes in the overall dietary pattern without weight loss might also be effective in preventing and managing the condition.The Mediterranean diet is recognized as one of the healthiest dietary patterns. It has shown benefits in patients with cardiovascular disease^17,18 and in the prevention and treatment of related conditions, such as diabetes,^19–21 hypertension^22,23 and metabolic syndrome.²⁴Several cross-sectional^25–29 and prospective^30–32 epidemiologic studies have suggested an inverse association between adherence to the Mediterranean diet and the prevalence or incidence of metabolic syndrome. Evidence from clinical trials has shown that an energy-restricted Mediterranean diet³³ or adopting a Mediterranean diet after weight loss³⁴ has a beneficial effect on metabolic syndrome. However, these studies did not determine whether the effect could be attributed to the weight loss or to the diets themselves.Seminal data from the PREDIMED (PREvención con DIeta MEDiterránea) study suggested that adherence to a Mediterranean diet supplemented with nuts reversed metabolic syndrome more so than advice to follow a low-fat diet.³⁵ However, the report was based on data from only 1224 participants followed for 1 year. We have analyzed the data from the final PREDIMED cohort after a median follow-up of 4.8 years to determine the long-term effects of a Mediterranean diet on metabolic syndrome.     

Longitudinal evaluation of physician payment reform and team-based care for chronic disease management and prevention

Background:

We evaluated a large-scale transition of primary care physicians to blended capitation models and team-based care in Ontario, Canada, to understand the effect of each type of reform on the management and prevention of chronic disease.

Methods:

We used population-based administrative data to assess monitoring of diabetes mellitus and screening for cervical, breast and colorectal cancer among patients belonging to team-based capitation, non–team-based capitation or enhanced fee-for-service medical homes as of Mar. 31, 2011 (n = 10 675 480). We used Poisson regression models to examine these associations for 2011. We then used a fitted nonlinear model to compare changes in outcomes between 2001 and 2011 by type of medical home.

Results:

In 2011, patients in a team-based capitation setting were more likely than those in an enhanced fee-for-service setting to receive diabetes monitoring (39.7% v. 31.6%, adjusted relative risk [RR] 1.22, 95% confidence interval [CI] 1.18 to 1.25), mammography (76.6% v. 71.5%, adjusted RR 1.06, 95% CI 1.06 to 1.07) and colorectal cancer screening (63.0% v. 60.9%, adjusted RR 1.03, 95% CI 1.02 to 1.04). Over time, patients in medical homes with team-based capitation experienced the greatest improvement in diabetes monitoring (absolute difference in improvement 10.6% [95% CI 7.9% to 13.2%] compared with enhanced fee for service; 6.4% [95% CI 3.8% to 9.1%] compared with non–team-based capitation) and cervical cancer screening (absolute difference in improvement 7.0% [95% CI 5.5% to 8.5%] compared with enhanced fee for service; 5.3% [95% CI 3.8% to 6.8%] compared with non–team-based capitation). For breast and colorectal cancer screening, there were no significant differences in change over time between different types of medical homes.

Interpretation:

The shift to capitation payment and the addition of team-based care in Ontario were associated with moderate improvements in processes related to diabetes care, but the effects on cancer screening were less clear.Health care systems with a strong primary care orientation have better health outcomes, lower costs and fewer disparities across population subgroups.¹ Countries around the world have been experimenting with reforms to improve the delivery of primary care, changing the way physicians are organized and paid. In the United States, several national organizations^2,3 and policy experts^4,5 have advocated a shift away from fee for service toward capitation or blended payments, and in 2015, the Centers for Medicare and Medicaid Services brought in blended payment in primary care, introducing a non–visit-based payment for chronic care management.⁶Patient-centred medical homes have provided an opportunity to transition physicians to new payment models, but they also necessitate changes in care delivery, including incorporation of team-based care, enhancement of access for patients, coordination of care and a focus on quality and safety.^7–9 Evidence suggests that team-based care is a particularly important element in improving the management and prevention of chronic disease and reducing related costs.¹⁰ Early evaluations of patient-centred medical home pilots were promising,^11,12 but a recent study of large-scale implementation showed limited improvements in the quality of chronic disease care and no reduction in health care utilization or total costs over 3 years.¹³Before 2002, primary care physicians in Ontario, Canada, were almost universally paid through a fee-for-service system. Over the past decade, more than three-quarters have transitioned to patient-centred medical homes.^14,15 About half of Ontario physicians working in patient-centred medical homes have shifted to blended capitation payments, with a portion of these physicians working in groups that also receive government funding for nonphysician health professionals to enable team-based care. However, about 40% of physicians in patient-centred medical homes still receive most of their income through fee-for-service payments. This natural health policy experiment offers a unique opportunity to compare the effectiveness of different payment models and team-based care. Early studies have shown small differences in the quality of cardiovascular¹⁶ and diabetes mellitus¹⁷ care between physicians receiving capitation payments and those receiving fee-for-service payments, but no studies have assessed changes in quality of care over time.We evaluated a large-scale transition of primary care physicians to blended capitation models and team-based care to understand the effect of each type of reform on chronic disease management and prevention over time.     

Prevalence of and risk factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year prospective multicentre study

Background:

Persistent postoperative pain continues to be an underrecognized complication. We examined the prevalence of and risk factors for this type of pain after cardiac surgery.

Methods:

We enrolled patients scheduled for coronary artery bypass grafting or valve replacement, or both, from Feb. 8, 2005, to Sept. 1, 2009. Validated measures were used to assess (a) preoperative anxiety and depression, tendency to catastrophize in the face of pain, health-related quality of life and presence of persistent pain; (b) pain intensity and interference in the first postoperative week; and (c) presence and intensity of persistent postoperative pain at 3, 6, 12 and 24 months after surgery. The primary outcome was the presence of persistent postoperative pain during 24 months of follow-up.

Results:

A total of 1247 patients completed the preoperative assessment. Follow-up retention rates at 3 and 24 months were 84% and 78%, respectively. The prevalence of persistent postoperative pain decreased significantly over time, from 40.1% at 3 months to 22.1% at 6 months, 16.5% at 12 months and 9.5% at 24 months; the pain was rated as moderate to severe in 3.6% at 24 months. Acute postoperative pain predicted both the presence and severity of persistent postoperative pain. The more intense the pain during the first week after surgery and the more it interfered with functioning, the more likely the patients were to report persistent postoperative pain. Pre-existing persistent pain and increased preoperative anxiety also predicted the presence of persistent postoperative pain.

Interpretation:

Persistent postoperative pain of nonanginal origin after cardiac surgery affected a substantial proportion of the study population. Future research is needed to determine whether interventions to modify certain risk factors, such as preoperative anxiety and the severity of pain before and immediately after surgery, may help to minimize or prevent persistent postoperative pain.Postoperative pain that persists beyond the normal time for tissue healing (> 3 mo) is increasingly recognized as an important complication after various types of surgery and can have serious consequences on patients’ daily living.^1–3 Cardiac surgeries, such as coronary artery bypass grafting (CABG) and valve replacement, rank among the most frequently performed interventions worldwide.⁴ They aim to improve survival and quality of life by reducing symptoms, including anginal pain. However, persistent postoperative pain of nonanginal origin has been reported in 7% to 60% of patients following these surgeries.^5–23 Such variability is common in other types of major surgery and is due mainly to differences in the definition of persistent postoperative pain, study design, data collection methods and duration of follow-up.^1–3,24Few prospective cohort studies have examined the exact time course of persistent postoperative pain after cardiac surgery, and follow-up has always been limited to a year or less.^9,14,25 Factors that put patients at risk of this type of problem are poorly understood.²⁶ Studies have reported inconsistent results regarding the contribution of age, sex, body mass index, preoperative angina, surgical technique, grafting site, postoperative complications or level of opioid consumption after surgery.^{5–7,9,13,14,16–19,21–23,25,27} Only 1 study investigated the role of chronic nonanginal pain before surgery as a contributing factor;²¹ 5 others prospectively assessed the association between persistent postoperative pain and acute pain intensity in the first postoperative week but reported conflicting results.^{13,14,21,22,25} All of the above studies were carried out in a single hospital and included relatively small samples. None of the studies examined the contribution of psychological factors such as levels of anxiety and depression before cardiac surgery, although these factors have been shown to influence acute or persistent postoperative pain in other types of surgery.^1,24,28,29We conducted a prospective multicentre cohort study (the CARD-PAIN study) to determine the prevalence of persistent postoperative pain of nonanginal origin up to 24 months after cardiac surgery and to identify risk factors for the presence and severity of the condition.     

Effectiveness of interventions designed to reduce the use of imaging for low-back pain: a systematic review

Background:Rates of imaging for low-back pain are high and are associated with increased health care costs and radiation exposure as well as potentially poorer patient outcomes. We conducted a systematic review to investigate the effectiveness of interventions aimed at reducing the use of imaging for low-back pain.Methods:We searched MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials from the earliest records to June 23, 2014. We included randomized controlled trials, controlled clinical trials and interrupted time series studies that assessed interventions designed to reduce the use of imaging in any clinical setting, including primary, emergency and specialist care. Two independent reviewers extracted data and assessed risk of bias. We used raw data on imaging rates to calculate summary statistics. Study heterogeneity prevented meta-analysis.Results:A total of 8500 records were identified through the literature search. Of the 54 potentially eligible studies reviewed in full, 7 were included in our review. Clinical decision support involving a modified referral form in a hospital setting reduced imaging by 36.8% (95% confidence interval [CI] 33.2% to 40.5%). Targeted reminders to primary care physicians of appropriate indications for imaging reduced referrals for imaging by 22.5% (95% CI 8.4% to 36.8%). Interventions that used practitioner audits and feedback, practitioner education or guideline dissemination did not significantly reduce imaging rates. Lack of power within some of the included studies resulted in lack of statistical significance despite potentially clinically important effects.Interpretation:Clinical decision support in a hospital setting and targeted reminders to primary care doctors were effective interventions in reducing the use of imaging for low-back pain. These are potentially low-cost interventions that would substantially decrease medical expenditures associated with the management of low-back pain.Current evidence-based clinical practice guidelines recommend against the routine use of imaging in patients presenting with low-back pain.^1–3 Despite this, imaging rates remain high,^4,5 which indicates poor concordance with these guidelines.^6,7Unnecessary imaging for low-back pain has been associated with poorer patient outcomes, increased radiation exposure and higher health care costs.⁸ No short- or long-term clinical benefits have been shown with routine imaging of the low back, and the diagnostic value of incidental imaging findings remains uncertain.^9–12 A 2008 systematic review found that imaging accounted for 7% of direct costs associated with low-back pain, which in 1998 translated to more than US$6 billion in the United States and £114 million in the United Kingdom.¹³ Current costs are likely to be substantially higher, with an estimated 65% increase in spine-related expenditures between 1997 and 2005.¹⁴Various interventions have been tried for reducing imaging rates among people with low-back pain. These include strategies targeted at the practitioner such as guideline dissemination,^15–17 education workshops,^18,19 audit and feedback of imaging use,^7,20,21 ongoing reminders⁷ and clinical decision support.^22–24 It is unclear which, if any, of these strategies are effective.²⁵ We conducted a systematic review to investigate the effectiveness of interventions designed to reduce imaging rates for the management of low-back pain.     

Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial

Background:

Brief interventions delivered by family physicians to address excessive alcohol use among adult patients are effective. We conducted a study to determine whether such an intervention would be similarly effective in reducing binge drinking and excessive cannabis use among young people.

Methods:

We conducted a cluster randomized controlled trial involving 33 family physicians in Switzerland. Physicians in the intervention group received training in delivering a brief intervention to young people during the consultation in addition to usual care. Physicians in the control group delivered usual care only. Consecutive patients aged 15–24 years were recruited from each practice and, before the consultation, completed a confidential questionnaire about their general health and substance use. Patients were followed up at 3, 6 and 12 months after the consultation. The primary outcome measure was self-reported excessive substance use (≥ 1 episode of binge drinking, or ≥ 1 joint of cannabis per week, or both) in the past 30 days.

Results:

Of the 33 participating physicians, 17 were randomly allocated to the intervention group and 16 to the control group. Of the 594 participating patients, 279 (47.0%) identified themselves as binge drinkers or excessive cannabis users, or both, at baseline. Excessive substance use did not differ significantly between patients whose physicians were in the intervention group and those whose physicians were in the control group at any of the follow-up points (odds ratio [OR] and 95% confidence interval [CI] at 3 months: 0.9 [0.6–1.4]; at 6 mo: 1.0 [0.6–1.6]; and at 12 mo: 1.1 [0.7–1.8]). The differences between groups were also nonsignificant after we re stricted the analysis to patients who reported excessive substance use at baseline (OR 1.6, 95% CI 0.9–2.8, at 3 mo; OR 1.7, 95% CI 0.9–3.2, at 6 mo; and OR 1.9, 95% CI 0.9–4.0, at 12 mo).

Interpretation:

Training family physicians to use a brief intervention to address excessive substance use among young people was not effective in reducing binge drinking and excessive cannabis use in this patient population. Trial registration: Australian New Zealand Clinical Trials Registry, no. ACTRN12608000432314.Most health-compromising behaviours begin in adolescence.¹ Interventions to address these behaviours early are likely to bring long-lasting benefits.² Harmful use of alcohol is a leading factor associated with premature death and disability worldwide, with a disproportionally high impact on young people (aged 10–24 yr).^3,4 Similarly, early cannabis use can have adverse consequences that extend into adulthood.^5–8In adolescence and early adulthood, binge drinking on at least a monthly basis is associated with an increased risk of adverse outcomes later in life.^9–12 Although any cannabis use is potentially harmful, weekly use represents a threshold in adolescence related to an increased risk of cannabis (and tobacco) dependence in adulthood.¹³ Binge drinking affects 30%–50% and excessive cannabis use about 10% of the adolescent and young adult population in Europe and the United States.^10,14,15Reducing substance-related harm involves multisectoral approaches, including promotion of healthy child and adolescent development, regulatory policies and early treatment interventions.¹⁶ Family physicians can add to the public health messages by personalizing their content within brief interventions.^17,18 There is evidence that brief interventions can encourage young people to reduce substance use, yet most studies have been conducted in community settings (mainly educational), emergency services or specialized addiction clinics.^1,16 Studies aimed at adult populations have shown favourable effects of brief alcohol interventions, and to some extent brief cannabis interventions, in primary care.^19–22 These interventions have been recommended for adolescent populations.^4,5,16 Yet young people have different modes of substance use and communication styles that may limit the extent to which evidence from adult studies can apply to them.Recently, a systematic review of brief interventions to reduce alcohol use in adolescents identified only 1 randomized controlled trial in primary care.²³ The tested intervention, not provided by family physicians but involving audio self-assessment, was ineffective in reducing alcohol use in exposed adolescents.²⁴ Sanci and colleagues showed that training family physicians to address health-risk behaviours among adolescents was effective in improving provider performance, but the extent to which this translates into improved outcomes remains unknown.^25,26 Two nonrandomized studies suggested screening for substance use and brief advice by family physicians could favour reduced alcohol and cannabis use among adolescents,^27,28 but evidence from randomized trials is lacking.²⁹We conducted the PRISM-Ado (Primary care Intervention Addressing Substance Misuse in Adolescents) trial, a cluster randomized controlled trial of the effectiveness of training family physicians to deliver a brief intervention to address binge drinking and excessive cannabis use among young people.     

Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial

Background:Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting.Methods:We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4–11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1–3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation.Results:Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in ear-related quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score −0.42, 95% CI −0.63 to −0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups.Interpretation:Autoinflation in children aged 4–11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life. Trial registration: ISRCTN, No. 55208702.Otitis media with effusion, also known as glue ear, is an accumulation of fluid in the middle ear, without symptoms or signs of an acute ear infection. It is often associated with viral infection.^1–3 The prevalence rises to 46% in children aged 4–5 years,⁴ when hearing difficulty, other ear-related symptoms and broader developmental concerns often bring the condition to medical attention.^3,5,6 Middle-ear fluid is associated with conductive hearing losses of about 15–45 dB HL.⁷ Resolution is clinically unpredictable,^8–10 with about a third of cases showing recurrence.¹¹ In the United Kingdom, about 200 000 children with the condition are seen annually in primary care.^12,13 Research suggests some children seen in primary care are as badly affected as those seen in hospital.^7,9,14,15 In the United States, there were 2.2 million diagnosed episodes in 2004, costing an estimated $4.0 billion.¹⁶ Rates of ventilation tube surgery show variability between countries,^17–19 with a declining trend in the UK.²⁰Initial clinical management consists of reasonable temporizing or delay before considering surgery.¹³ Unfortunately, all available medical treatments for otitis media with effusion such as antibiotics, antihistamines, decongestants and intranasal steroids are ineffective and have unwanted effects, and therefore cannot be recommended.^21–23 Not only are antibiotics ineffective, but resistance to them poses a major threat to public health.^24,25 Although surgery is effective for a carefully selected minority,^13,26,27 a simple low-cost, nonsurgical treatment option could benefit a much larger group of symptomatic children, with the purpose of addressing legitimate clinical concerns without incurring excessive delays.Autoinflation using a nasal balloon device is a low-cost intervention with the potential to be used more widely in primary care, but current evidence of its effectiveness is limited to several small hospital-based trials²⁸ that found a higher rate of tympanometric resolution of ear fluid at 1 month.^29–31 Evidence of feasibility and effectiveness of autoinflation to inform wider clinical use is lacking.^13,28 Thus we report here the findings of a large pragmatic trial of the clinical effectiveness of nasal balloon autoinflation in a spectrum of children with clinically confirmed otitis media with effusion identified from primary care.     

A qualitative investigation of smoke-free policies on hospital property

Background:

Many hospitals have adopted smoke-free policies on their property. We examined the consequences of such polices at two Canadian tertiary acute-care hospitals.

Methods:

We conducted a qualitative study using ethnographic techniques over a six-month period. Participants (n = 186) shared their perspectives on and experiences with tobacco dependence and managing the use of tobacco, as well as their impressions of the smoke-free policy. We interviewed inpatients individually from eight wards (n = 82), key policy-makers (n = 9) and support staff (n = 14) and held 16 focus groups with health care providers and ward staff (n = 81). We also reviewed ward documents relating to tobacco dependence and looked at smoking-related activities on hospital property.

Results:

Noncompliance with the policy and exposure to secondhand smoke were ongoing concerns. Peoples’ impressions of the use of tobacco varied, including divergent opinions as to whether such use was a bad habit or an addiction. Treatment for tobacco dependence and the management of symptoms of withdrawal were offered inconsistently. Participants voiced concerns over patient safety and leaving the ward to smoke.

Interpretation:

Policies mandating smoke-free hospital property have important consequences beyond noncompliance, including concerns over patient safety and disruptions to care. Without adequately available and accessible support for withdrawal from tobacco, patients will continue to face personal risk when they leave hospital property to smoke.Canadian cities and provinces have passed smoking bans with the goal of reducing people’s exposure to secondhand smoke in workplaces, public spaces and on the property adjacent to public buildings.^1,2 In response, Canadian health authorities and hospitals began implementing policies mandating smoke-free hospital property, with the goals of reducing the exposure of workers, patients and visitors to tobacco smoke while delivering a public health message about the dangers of smoking.^2–5 An additional anticipated outcome was the reduced use of tobacco among patients and staff. The impetuses for adopting smoke-free policies include public support for such legislation and the potential for litigation for exposure to second-hand smoke.^2,4Tobacco use is a modifiable risk factor associated with a variety of cancers, cardiovascular diseases and respiratory conditions.^6–11 Patients in hospital who use tobacco tend to have more surgical complications and exacerbations of acute and chronic health conditions than patients who do not use tobacco.^6–11 Any policy aimed at reducing exposure to tobacco in hospitals is well supported by evidence, as is the integration of interventions targetting tobacco dependence.¹² Unfortunately, most of the nearly five million Canadians who smoke will receive suboptimal treatment,¹³ as the routine provision of interventions for tobacco dependence in hospital settings is not a practice norm.^14–16 In smoke-free hospitals, two studies suggest minimal support is offered for withdrawal, ^17,18 and one reports an increased use of nicotine-replacement therapy after the implementation of the smoke-free policy.¹⁹Assessments of the effectiveness of smoke-free policies for hospital property tend to focus on noncompliance and related issues of enforcement.^17,20,21 Although evidence of noncompliance and litter on hospital property^2,17,20 implies ongoing exposure to tobacco smoke, half of the participating hospital sites in one study reported less exposure to tobacco smoke within hospital buildings and on the property.¹⁸ In addition, there is evidence to suggest some decline in smoking among staff.^18,19,21,22We sought to determine the consequences of policies mandating smoke-free hospital property in two Canadian acute-care hospitals by eliciting lived experiences of the people faced with enacting the policies: patients and health care providers. In addition, we elicited stories from hospital support staff and administrators regarding the policies.     

Smoked cannabis for chronic neuropathic pain: a randomized controlled trial

Background

Chronic neuropathic pain affects 1%–2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood.

Methods

Adults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events.

Results

We recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02–1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p < 0.001; more drowsy, p = 0.003) and improved quality of sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough.

Conclusion

A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long-term safety and efficacy studies are indicated. (International Standard Randomised Controlled Trial Register no. ISRCTN68314063)Chronic neuropathic pain has a prevalence of 1%–2%,¹ and treatment options are limited.² Pharmacotherapy includes anticonvulsants, antidepressants, opioids and local anesthetics,^3,4 but responses vary and side effects limit compliance.Cannabis sativa has been used to treat pain since the third millennium BC.⁵ An endogenous pain-processing system has been identified, mediated by endogenous cannabinoid ligands acting on specific cannabinoid receptors.⁶ These findings, coupled with anecdotal evidence of the analgesic effects of smoked cannabis,⁷ support a reconsideration of cannabinoid agents as analgesics.Oral cannabinoids such as tetrahydrocannabinol, cannabidiol and nabilone have, alone and in combination, shown efficacy in central^8,9 and peripheral¹⁰ neuropathic pain, rheumatoid arthritis¹¹ and fibromyalgia.¹²The analgesic effects of smoked cannabis remain controversial, although it is used by 10%–15% of patients with chronic noncancer pain¹³ and multiple sclerosis.¹⁴ Clinical trials are needed to evaluate these effects, given that the risks and benefits of inhaled cannabinoids may differ from oral agents. To date, three small clinical trials of the analgesic efficacy of smoked cannabis have been reported.^15–17 All studies were conducted in residential laboratories, and participants smoked multiple doses of the drug at each time point. No study adequately reported data related to adverse events.We conducted a clinical trial using a standardized single-dose delivery system to explore further the safety and efficacy of smoked cannabis in outpatients with chronic neuropathic pain.