The relative efficacy of nine osteoporosis medications for reducing the rate of fractures in post-menopausal women

Background

Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups.

Methods/Design

A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles, using linear mixed models for continuous outcomes, Mann Whitney U tests for ordinal outcomes, and Chi-square, risk ratios and risk differences for dichotomous outcomes.

Discussion

This trial will determine the difference in outcomes between specific physiotherapy treatment tailored to each of the five subgroups versus advice which is recommended in guidelines as a suitable treatment for most people with a low back disorder.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000834257.     

Multicenter evaluation of the use of venous thromboembolism prophylaxis in acutely ill medical patients in Canada

BACKGROUND: Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients has been shown to be safe and effective. Underutilization of this patient safety practice may result in avoidable mortality and morbidity. OBJECTIVES: We aimed to determine the proportion of hospitalized, acutely ill medical patients across Canada who were eligible to receive thromboprophylaxis and to evaluate the frequency, determinants and appropriateness of its use. PATIENTS/METHODS: CURVE is a national, multicenter chart audit of 29 Canadian hospitals. Data were collected on consecutive patients admitted to hospital for an acute medical illness during a defined 3-week study period. Information on demographic and clinical characteristics, risk factors for VTE and bleeding and use of VTE prophylaxis were recorded. The indications for and appropriateness of VTE prophylaxis were assessed using pre-specified criteria based on international consensus guidelines. Multivariable analyses were performed to identify determinants of prophylaxis use. RESULTS: Of the 4124 medical admissions screened over the study period, 1894 patients (46%) were eligible for study inclusion. The most common specified admitting diagnoses were severe infection (28%), COPD exacerbation or respiratory failure (12%), malignancy (9%) and congestive heart failure (8%). Thromboprophylaxis was indicated in 1702 (90%) study patients. Overall, some form of prophylaxis was administered to 23% of all patients. However, only 16% received appropriate thromboprophylaxis. Factors independently associated with greater use of prophylaxis included internist (vs. other specialty) as attending physician (OR 1.33, 95% confidence interval (CI) [1.03, 1.71]), university-associated (vs. community) hospital (OR 1.46, 95% CI [1.03, 2.07]), immobilization (per day) (OR 1.60, 95% CI [1.45, 1.77]), presence of >or=1 VTE risk factors (OR=1.78, 95% CI [1.35, 2.34]) and duration of hospitalization (per day of stay) (OR 1.05, 95% CI [1.03, 1.07]), however, use of prophylaxis was unacceptably low in all groups. Patients with cancer had a significantly reduced likelihood of receiving prophylaxis (OR=0.40, 95% CI [0.24, 0.68]). Presence of risk factors for bleeding did not influence the use or choice of prophylaxis. CONCLUSION: Most patients hospitalized for medical illness had indications for thromboprophylaxis, yet only 16% received appropriate prophylaxis. Efforts should be made to elucidate the reasons that underlie the very low rate of thromboprophylaxis in medical patients and to develop and test strategies to improve implementation of this patient safety practice.     

Cost analysis of monitoring asthma treatment using sputum cell counts

BACKGROUND:

In a four-centre trial, the use of sputum cell counts (sputum strategy [SS]) to guide treatment had resulted in fewer and less severe exacerbations without the need for a higher corticosteroid dose, compared with the use of symptoms and spirometry (clinical strategy [CS]).

OBJECTIVE:

To compare the cost of the SS with the CS in the treatment of patients with moderate to severe asthma.

METHODS:

In 39 patients (19 in the SS, 20 in the CS) from one of the centres, the cost (third-party payer) of the two treatment strategies was compared. Resource use data were collected using a structured questionnaire. Corresponding unit costs in 2006 Canadian dollars were obtained.

RESULTS:

The clinical characteristics of the patients were similar to the study population at the four centres. In the SS, the number of visits to a family physician for health disorders indirectly related to asthma (P=0.003) and the amount of inhaled long-acting beta-agonists (P=0.007) were less than that of the CS. While the total estimated median cost per patient for spirometry ($393; range $299 to $487) was less than that for sputum induction ($1,008; range $907 to $1,411), the total cost of the SS ($2,265; range $1,466 to $4,347) was less than that of the CS ($3369; range $2208 to $3927) (P=0.216). This cost difference was due to lower costs of physician and hospital visits and services (P=0.078), of inhaled short-acting bronchodilators (P=0.067), of long-acting beta-agonists (P=0.002) and of inhaled corticosteroids (P=0.064) in the SS.

CONCLUSION:

In patients with moderate to severe asthma, the use of sputum cell counts to guide treatment is more effective and is likely to be less costly than management using symptoms and spirometry.     

Clinical review 170: A systematic review and metaanalysis of the effectiveness of radioactive iodine remnant ablation for well-differentiated thyroid cancer

Radioactive iodine remnant ablation destroys residual thyroid tissue after surgical resection of papillary or follicular thyroid cancer. We systematically reviewed 1543 English references to determine whether remnant ablation decreases the risk of thyroid cancer-related death or recurrence after bilateral thyroidectomy for papillary or follicular thyroid cancer. In 13 cohort studies in which the analysis of thyroid cancer-related outcomes was statistically adjusted to a variable degree for prognostic factors or cointerventions, rates of recurrences of thyroid cancer-related outcomes were significantly decreased in the following: one of seven studies examining thyroid cancer-related mortality, three of six studies examining any tumor recurrence, three of three studies examining locoregional recurrence, and two of three studies examining distant metastases. Thyroid hormone suppressive therapy was not adjusted for in the majority of these analyses. In 18 cohort studies not adjusted for prognostic factors or interventions, the benefit of radioactive iodine ablation in decreasing the thyroid cancer-related mortality and any recurrence at 10 yr was inconsistent among centers. However, pooled analyses were suggestive of a statistically significant treatment effect of ablation for the following 10-yr outcomes: locoregional recurrence (relative risk of 0.31, 95% confidence interval, 0.2, 0.49) and distant metastases (absolute decrease in risk 3%, 95% confidence interval, risk decreases 1-4%). In conclusion, radioactive iodine ablation may be beneficial in decreasing recurrence of well-differentiated thyroid cancer; however, results are inconsistent among centers for some outcomes, and the incremental benefit of remnant ablation in low-risk patients treated with bilateral thyroidectomy and thyroid hormone suppressive therapy is unclear.     

Regional differences in opinions on adjuvant radioactive iodine treatment of thyroid carcinoma within Canada and the United States.

OBJECTIVE: To identify regional differences in recommendations for radioactive iodine remnant ablation (RRA) in early stage well-differentiated thyroid carcinoma (WDTC) within Canada and the United States. DESIGN: A cross-sectional written survey of a sample of physicians in specialties potentially involved in thyroid cancer care was performed in 2006. Participants were asked if they recommended RRA for a hypothetical 38-year-old woman with a solitary, 1.6-cm papillary carcinoma resected by total thyroidectomy. Exploratory regional comparisons were performed using Student t tests or analysis of variance. The regions studied were western Canada, eastern Canada (Ontario, the Maritimes), Quebec, the northeastern United States, the western and midwestern United States, and the southern United States. In a secondary multivariable logistic regression analysis, we explored potential relationships between individual respondent characteristics RRA recommendations. MAIN OUTCOME: Agreement with case-based RRA recommendations was measured on a Likert scale of 1 to 7 (7 = strongest agreement). RESULTS: The effective response rate was 56.3% (486/864). There were significant differences in RRA recommendations among the regions studied (F = 11.99, 5 df, p < 0.001); national boundaries did not explain regional variations. For the sample case, the strongest support for RRA was in Quebec and the southern United States, intermediate support in eastern Canada and the northeastern United States, and the least support in western Canada and the western and midwestern United States. Academic affiliation and surgical specialty were independently inversely associated with strong RRA recommendations. CONCLUSIONS: There are significant regional differences in physician-based RRA recommendations in early stage WDTC within Canada and the United States. Physician specialty and practice characteristics may influence RRA recommendations.     

The health competence measurement tool (HCMT): Developing a new scale to measure self-rated “health competence”

Objectives

To develop and test a tool for measuring health competence.

Methods

In order to measure this attribute, we used a sequential exploratory mixed methods design in rural and urban communities in Cameroon. In the qualitative phase, 67 clients constituted 10 focus groups to elicit themes related to health competence. In the quantitative phase, self-rated items were tested on 300 participants and on a random selection of 25 participants 2 weeks later.

Results

The internal consistency for the subscales derived varied from 0.61-0.81. Older (F[45, 339.1] = 1.2; p = 0.031) and more educated (F[3, 22.6] = 2.1; p = 0.004) people were more likely to score higher on the scale. Interviewers also contributed to the variance (F[5, 37.6] = 3.6; p < 0.001). Test–retest reliability was 0.66. The final scale with 15 items is made up of three subscales: knowledge of disease, how to stay in good health and health information.

Conclusion

We present a new self-rated scale for health competence with good psychometric properties. It circumvents the need to be literate, but requires well trained interviewers. We recommend that it be tested in other settings.

Practice implications

This tool should be used to appraise individual and community health education needs with minor context specific modifications.     

Community Program Improves Quality of Life and Self‐Management in Older Adults with Diabetes Mellitus and Comorbidity

Objectives

To compare the effect of a 6‐month community‐based intervention with that of usual care on quality of life, depressive symptoms, anxiety, self‐efficacy, self‐management, and healthcare costs in older adults with type 2 diabetes mellitus (T2DM ) and 2 or more comorbidities.

Design

Multisite, single‐blind, parallel, pragmatic, randomized controlled trial.

Setting

Four communities in Ontario, Canada.

Participants

Community‐dwelling older adults (≥65) with T2DM and 2 or more comorbidities randomized into intervention (n = 80) and control (n = 79) groups (N = 159).

Intervention

Client‐driven, customized self‐management program with up to 3 in‐home visits from a registered nurse or registered dietitian, a monthly group wellness program, monthly provider team case conferences, and care coordination and system navigation.

Measurements

Quality‐of‐life measures included the Physical Component Summary (PCS , primary outcome) and Mental Component Summary (MCS , secondary outcome) scores of the Medical Outcomes Study 12‐item Short‐Form Health Survey (SF ‐12). Other secondary outcome measures were the Generalized Anxiety Disorder Scale, Center for Epidemiologic Studies Depression Scale (CES ‐D‐10), Summary of Diabetes Self‐Care Activities (SDSCA ), Self‐Efficacy for Managing Chronic Disease, and healthcare costs.

Results

Morbidity burden was high (average of eight comorbidities). Intention‐to‐treat analyses using analysis of covariance showed a group difference favoring the intervention for the MCS (mean difference = 2.68, 95% confidence interval (CI ) = 0.28–5.09, P  = .03), SDSCA (mean difference = 3.79, 95% CI  = 1.02–6.56, P  = .01), and CES ‐D‐10 (mean difference = ?1.45, 95% CI  = ?0.13 to ?2.76, P  = .03). No group differences were seen in PCS score, anxiety, self‐efficacy, or total healthcare costs.

Conclusion

Participation in a 6‐month community‐based intervention improved quality of life and self‐management and reduced depressive symptoms in older adults with T2DM and comorbidity without increasing total healthcare costs.

     

Network Meta-analysis: Users’ Guide for Surgeons: Part I – Credibility

Conventional meta-analyses quantify the relative effectiveness of two interventions based on direct (that is, head-to-head) evidence typically derived from randomized controlled trials (RCTs). For many medical conditions, however, multiple treatment options exist and not all have been compared directly. This issue limits the utility of traditional synthetic techniques such as meta-analyses, since these approaches can only pool and compare evidence across interventions that have been compared directly by source studies. Network meta-analyses (NMA) use direct and indirect comparisons to quantify the relative effectiveness of three or more treatment options. Interpreting the methodologic quality and results of NMAs may be challenging, as they use complex methods that may be unfamiliar to surgeons; yet for these surgeons to use these studies in their practices, they need to be able to determine whether they can trust the results of NMAs. The first judgment of trust requires an assessment of the credibility of the NMA methodology; the second judgment of trust requires a determination of certainty in effect sizes and directions. In this Users’ Guide for Surgeons, Part I, we show the application of evaluation criteria for determining the credibility of a NMA through an example pertinent to clinical orthopaedics. In the subsequent article (Part II), we help readers evaluate the level of certainty NMAs can provide in terms of treatment effect sizes and directions.