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1.  Patients’ values and preferences of the expected efficacy of hip arthroscopy for osteoarthritis: a protocol for a multinational structured interview-based study combined with a randomised survey on the optimal amount of information to elicit preferences 
BMJ Open  2014;4(10):e005536.
Introduction
Symptomatic hip osteoarthritis (OA) is a disabling condition with up to a 25% cumulative lifetime risk. Total hip arthroplasty (THA) is effective in relieving patients’ symptoms and improving function. It is, however, associated with substantial risk of complications, pain and major functional limitation before patients can return to full function. In contrast, hip arthroscopy (HA) is less invasive and can postpone THA. However, there is no evidence regarding the delay in the need for THA that patients would find acceptable to undergoing HA. Knowing patients’ values and preferences (VP) on this expected delay is critical when making recommendations regarding the advisability of HA. Furthermore, little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients’ VP.
Methods and analysis
We will perform a multinational, structured interview-based survey of preference in delay time for THA among patients with non-advanced OA who failed to respond to conservative therapy. We will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences. Eligible patients will be randomly assigned (1 : 1) to either a short or a long format of health scenarios of THA and HA. We will determine each patient's VP using a trade-off and anticipated regret exercises. Our primary outcomes for the combined surveys will be: (1) the minimal delay time in the need for THA surgery that patients would find acceptable to undertaking HA, (2) patients’ satisfaction with the amount of information provided in the health scenarios used to elicit their VPs.
Ethics and dissemination
The protocol has been approved by the Hamilton Integrated Research Ethics Board (HIREB13-506). We will disseminate our study findings through peer-reviewed publications and conference presentations, and make them available to guideline makers issuing recommendations addressing HA and THA.
doi:10.1136/bmjopen-2014-005536
PMCID: PMC4202002  PMID: 25326208
Patients' values and preference; Total Hip Arthroplasty; Hip Arthroscopy; Patient Written Information; Decision Making
3.  Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology 
Systematic Reviews  2014;3(1):150.
Background
Pharmacological thromboprophylaxis in the peri-operative period involves a trade-off between reduction in venous thromboembolism (VTE) and an increase in bleeding. Baseline risks, in the absence of prophylaxis, for VTE and bleeding are known to vary widely between urological procedures, but their magnitude is highly uncertain. Systematic reviews and meta-analyses addressing baseline risks are uncommon, needed, and require methodological innovation. In this article, we describe the rationale and methods for a series of systematic reviews of the risks of symptomatic VTE and bleeding requiring reoperation in urological surgery.
Methods/design
We searched MEDLINE from January 1, 2000 until April 10, 2014 for observational studies reporting on symptomatic VTE or bleeding after urological procedures. Additional studies known to experts and studies cited in relevant review articles were added. Teams of two reviewers, independently assessed articles for eligibility, evaluated risk of bias, and abstracted data. We derived best estimates of risk from the median estimates among studies rated at the lowest risk of bias. The primary endpoints were 30-day post-operative risk estimates of symptomatic VTE and bleeding requiring reoperation, stratified by procedure and patient risk factors.
Discussion
This series of systematic reviews will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding. Our work advances standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at best estimates of risk (including modeling of timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate certainty in estimates of risk. The results will be incorporated in the upcoming European Association Urology Guideline on Thromboprophylaxis.
Systematic review registration
PROSPERO CRD42014010342.
Electronic supplementary material
The online version of this article (doi:10.1186/2046-4053-3-150) contains supplementary material, which is available to authorized users.
doi:10.1186/2046-4053-3-150
PMCID: PMC4307154  PMID: 25540016
Baseline risk; Bleeding; Hemorrhage; Modeling; Risk of bias; Surgical complications; Thromboprophylaxis; Thrombosis; Urology
4.  Management of chronic neuropathic pain: a protocol for a multiple treatment comparison meta-analysis of randomised controlled trials 
BMJ Open  2014;4(11):e006112.
Introduction
Chronic neuropathic pain is associated with reduced health-related quality of life and substantial socioeconomic costs. Current research addressing management of chronic neuropathic pain is limited. No review has evaluated all interventional studies for chronic neuropathic pain, which limits attempts to make inferences regarding the relative effectiveness of treatments.
Methods and analysis
We will conduct a systematic review of all randomised controlled trials evaluating therapies for chronic neuropathic pain. We will identify eligible trials, in any language, by a systematic search of CINAHL, EMBASE, MEDLINE, AMED, HealthSTAR, DARE, PsychINFO and the Cochrane Central Registry of Controlled Trials. Eligible trials will be: (1) enrol patients presenting with chronic neuropathic pain, and (2) randomise patients to alternative interventions (pharmacological or non-pharmacological) or an intervention and a control arm. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible trials and extract information from eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias of eligible studies, recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes we will collect, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate our confidence in treatment effects. When possible, we will conduct: (1) in direct comparisons, a random-effects meta-analysis to establish the effect of reported therapies on patient-important outcomes; and (2) a multiple treatment comparison meta-analysis within a Bayesian framework to assess the relative effects of treatments. We will define a priori hypotheses to explain heterogeneity between studies, and conduct meta-regression and subgroup analyses consistent with the current best practices.
Ethics and Dissemination
We do not require ethics approval for our proposed review. We will disseminate our findings through peer-reviewed publications and conference presentations.
Trial registration number
PROSPERO (CRD42014009212).
doi:10.1136/bmjopen-2014-006112
PMCID: PMC4244486  PMID: 25412864
EPIDEMIOLOGY; STATISTICS & RESEARCH METHODS
5.  Evaluating the Individualized Treatment of Traditional Chinese Medicine: A Pilot Study of N-of-1 Trials 
Purpose. To compare the efficacy of individualized herbal decoction with controlled decoction for individual patients with stable bronchiectasis. Methods. We conducted N-of-1 RCTs (single-patient, double-blind, randomized, multiple crossover design) in 3 patients with stable bronchiectasis. The primary outcome was patient self-rated symptom scores on visual analogue scales. Secondary outcome was 24-hour sputum volume. A clinical efficacy criterion which combined symptoms score and medication preference was also formulated. Results. All three patients showed various degrees of improvement on their symptoms and one patient's (Case 3) 24 h sputum volume decreased from 70 mL to 30 mL. However, no significant differences were found between individualized herbal decoction and control decoction on symptoms score, or on 24-hour sputum volume. One patient (Case 2) had clear preference for the individualized herbal decoction over the standard one with the confirmation after unblinding. We therefore considered this case as clinically important. Discussion. N-of-1 trials comply with individualized philosophy of TCM clinical practice and had good compliance. It is necessary to set up clinical efficacy criteria and to consider the interference of acute exacerbation.
doi:10.1155/2014/148730
PMCID: PMC4244929  PMID: 25477988
6.  Activity-Based Funding of Hospitals and Its Impact on Mortality, Readmission, Discharge Destination, Severity of Illness, and Volume of Care: A Systematic Review and Meta-Analysis 
PLoS ONE  2014;9(10):e109975.
Background
Activity-based funding (ABF) of hospitals is a policy intervention intended to re-shape incentives across health systems through the use of diagnosis-related groups. Many countries are adopting or actively promoting ABF. We assessed the effect of ABF on key measures potentially affecting patients and health care systems: mortality (acute and post-acute care); readmission rates; discharge rate to post-acute care following hospitalization; severity of illness; volume of care.
Methods
We undertook a systematic review and meta-analysis of the worldwide evidence produced since 1980. We included all studies reporting original quantitative data comparing the impact of ABF versus alternative funding systems in acute care settings, regardless of language. We searched 9 electronic databases (OVID MEDLINE, EMBASE, OVID Healthstar, CINAHL, Cochrane CENTRAL, Health Technology Assessment, NHS Economic Evaluation Database, Cochrane Database of Systematic Reviews, and Business Source), hand-searched reference lists, and consulted with experts. Paired reviewers independently screened for eligibility, abstracted data, and assessed study credibility according to a pre-defined scoring system, resolving conflicts by discussion or adjudication.
Results
Of 16,565 unique citations, 50 US studies and 15 studies from 9 other countries proved eligible (i.e. Australia, Austria, England, Germany, Israel, Italy, Scotland, Sweden, Switzerland). We found consistent and robust differences between ABF and no-ABF in discharge to post-acute care, showing a 24% increase with ABF (pooled relative risk  = 1.24, 95% CI 1.18–1.31). Results also suggested a possible increase in readmission with ABF, and an apparent increase in severity of illness, perhaps reflecting differences in diagnostic coding. Although we found no consistent, systematic differences in mortality rates and volume of care, results varied widely across studies, some suggesting appreciable benefits from ABF, and others suggesting deleterious consequences.
Conclusions
Transitioning to ABF is associated with important policy- and clinically-relevant changes. Evidence suggests substantial increases in admissions to post-acute care following hospitalization, with implications for system capacity and equitable access to care. High variability in results of other outcomes leaves the impact in particular settings uncertain, and may not allow a jurisdiction to predict if ABF would be harmless. Decision-makers considering ABF should plan for likely increases in post-acute care admissions, and be aware of the large uncertainty around impacts on other critical outcomes.
doi:10.1371/journal.pone.0109975
PMCID: PMC4210200  PMID: 25347697
7.  Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study 
Trials  2014;15:206.
Background
The role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively.
Methods
We conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device. All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery. The goals of our pilot study were to determine recruitment rates in individual centers, investigators’ ability to adhere to study protocol and data collection procedures, our ability to achieve close to 100% follow-up rates, and the degree to which patients were compliant with treatment. Patients were followed for one year and a committee (blinded to allocation) adjudicated all outcomes. The committee adjudicators were experienced (10 or more years in practice) orthopedic surgeons with formal research training, specializing in trauma surgery.
Results
Our overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures. Our rate of follow-up at one year was 84%. Patient compliance, measured by an internal timer in the study devices, revealed that 39 (76%) of the patients were fully compliant and 12 (24%) demonstrated a greater than 50% compliance. Based on patient feedback regarding excessive questionnaire burden, we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment (SMFA) dysfunction index offered no important advantages over the SF-36 Physical Component Summary (PCS) score. No device-related adverse events were reported.
Conclusions
Our pilot study identified key issues that might have rendered a definitive trial unfeasible. By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing.
Trial registration
The TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 (identifier: NCT00667849).
doi:10.1186/1745-6215-15-206
PMCID: PMC4060850  PMID: 24898987
Ultrasound; Fracture healing; Randomized controlled trial
8.  What Is the Most Bothersome Lower Urinary Tract Symptom? Individual- and Population-level Perspectives for Both Men and Women 
European Urology  2014;65(6):1211-1217.
Background
No study has compared the bothersomeness of all lower urinary tract symptoms (LUTS) using a population-based sample of adults. Despite this lack of evidence, investigators have often cited their LUTS of interest as the “most bothersome” or “one of the most bothersome.”
Objective
To compare the population- and individual-level burden of LUTS in men and women.
Design, setting, and participants
In this population-based cross-sectional study, questionnaires were mailed to 6000 individuals (18–79 yr of age) randomly identified from the Finnish Population Register.
Outcome measurements and statistical analysis
The validated Danish Prostatic Symptom Score questionnaire was used for assessment of bother of 12 different LUTS. The age-standardized prevalence of at least moderate bother was calculated for each symptom (population-level burden). Among symptomatic individuals, the proportion of affected individuals with at least moderate bother was calculated for each symptom (individual-level bother).
Results and limitations
A total of 3727 individuals (62.4%) participated (53.7% female). The LUTS with the greatest population-level burden were urgency (7.9% with at least moderate bother), stress urinary incontinence (SUI) (6.5%), nocturia (6.0%), postmicturition dribble (5.8%), and urgency urinary incontinence (UUI) (5.0%). Burden from incontinence symptoms was higher in women than men, and the opposite was true for voiding and postmicturition symptoms. At the individual level, UUI was the most bothersome for both genders. Although the response proportion was high, approximately a third did not participate.
Conclusions
Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS. At the population level, the most prevalent bothersome symptoms are urgency, SUI, and nocturia.
Patient summary
Urinary urgency was the most common troubling symptom in a large population-based study; however, for individuals, urgency incontinence was the most likely to be rated as bothersome.
Take Home Message
Population-based study assessing bother of individual lower urinary tract symptoms (LUTS) found the highest age-standardized prevalence for bothersome urgency. However, among individuals affected by LUTS, urgency incontinence was the most likely to cause significant bother. LUTS were generally well tolerated across ages and genders.
doi:10.1016/j.eururo.2014.01.019
PMCID: PMC4018666  PMID: 24486308
Age factors; Bothersomeness; Definition; Lower urinary tract symptoms; Overactive bladder; Prevalence; Sex; Urinary incontinence; Urination disorders; Voiding dysfunction
9.  Methodological survey of designed uneven randomization trials (DU-RANDOM): a protocol 
Trials  2014;15:33.
Background
Although even randomization (that is, approximately 1:1 randomization ratio in study arms) provides the greatest statistical power, designed uneven randomization (DUR), (for example, 1:2 or 1:3) is used to increase participation rates. Until now, no convincing data exists addressing the impact of DUR on participation rates in trials. The objective of this study is to evaluate the epidemiology and to explore factors associated with DUR.
Methods
We will search for reports of RCTs published within two years in 25 general medical journals with the highest impact factor according to the Journal Citation Report (JCR)-2010. Teams of two reviewers will determine eligibility and extract relevant information from eligible RCTs in duplicate and using standardized forms. We will report the prevalence of DUR trials, the reported reasons for using DUR, and perform a linear regression analysis to estimate the association between the randomization ratio and the associated factors, including participation rate, type of informed consent, clinical area, and so on.
Discussion
A clearer understanding of RCTs with DUR and its association with factors in trials, for example, participation rate, can optimize trial design and may have important implications for both researchers and users of the medical literature.
doi:10.1186/1745-6215-15-33
PMCID: PMC3902027  PMID: 24456965
Participation rate; Designed uneven randomization trials; Trial participation
10.  Correction: Association of Psychotherapy with Disability Benefit Claim Closure among Patients Disabled Due to Depression 
PLoS ONE  2014;9(1):10.1371/annotation/fd8ade2b-e9ed-4f75-8e32-5b327535306c.
doi:10.1371/annotation/fd8ade2b-e9ed-4f75-8e32-5b327535306c
PMCID: PMC3880342
11.  Patient-reported outcomes in meta-analyses --Part 2: methods for improving interpretability for decision-makers 
Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes (PROs) often provide crucial information for patients, clinicians and policy-makers facing challenging health care decisions. Based on emerging methods, guidance on improving the interpretability of meta-analysis of patient-reported outcomes, typically continuous in nature, is likely to enhance decision-making. The objective of this paper is to summarize approaches to enhancing the interpretability of pooled estimates of PROs in meta-analyses. When differences in PROs between groups are statistically significant, decision-makers must be able to interpret the magnitude of effect. This is challenging when, as is often the case, clinical trial investigators use different measurement instruments for the same construct within and between individual randomized trials. For such cases, in addition to pooling results as a standardized mean difference, we recommend that systematic review authors use other methods to present results such as relative (relative risk, odds ratio) or absolute (risk difference) dichotomized treatment effects, complimented by presentation in either: natural units (e.g. overall depression reduced by 2.4 points when measured on a 50-point Hamilton Rating Scale for Depression); minimal important difference units (e.g. where 1.0 unit represents the smallest difference in depression that patients, on average, perceive as important the depression score was 0.38 (95% CI 0.30 to 0.47) units less than the control group); or a ratio of means (e.g. where the mean in the treatment group is divided by the mean in the control group, the ratio of means is 1.27, representing a 27% relative reduction in the mean depression score).
doi:10.1186/1477-7525-11-211
PMCID: PMC3984637  PMID: 24359184
12.  A methodological survey of the analysis, reporting and interpretation of Absolute Risk ReductiOn in systematic revieWs (ARROW): a study protocol 
Systematic Reviews  2013;2:113.
Background
Clinicians, providers and guideline panels use absolute effects to weigh the advantages and downsides of treatment alternatives. Relative measures have the potential to mislead readers. However, little is known about the reporting of absolute measures in systematic reviews. The objectives of our study are to determine the proportion of systematic reviews that report absolute measures of effect for the most important outcomes, and ascertain how they are analyzed, reported and interpreted.
Methods/design
We will conduct a methodological survey of systematic reviews published in 2010. We will conduct a 1:1 stratified random sampling of Cochrane vs. non-Cochrane systematic reviews. We will calculate the proportion of systematic reviews reporting at least one absolute estimate of effect for the most patient-important outcome for the comparison of interest. We will conduct multivariable logistic regression analyses with the reporting of an absolute estimate of effect as the dependent variable and pre-specified study characteristics as the independent variables. For systematic reviews reporting an absolute estimate of effect, we will document the methods used for the analysis, reporting and interpretation of the absolute estimate.
Discussion
Our methodological survey will inform current practices regarding reporting of absolute estimates in systematic reviews. Our findings may influence recommendations on reporting, conduct and interpretation of absolute estimates. Our results are likely to be of interest to systematic review authors, funding agencies, clinicians, guideline developers and journal editors.
doi:10.1186/2046-4053-2-113
PMCID: PMC3867670  PMID: 24330779
Systematic reviews; Meta-analysis; Statistical data; Evidence-based medicine; Numbers needed to treat; Data reporting; Absolute effect measures
13.  Determinants of knowledge gain in evidence-based medicine short courses: an international assessment 
Open Medicine  2010;4(1):e3-e10.
Background
Health care professionals worldwide attend courses and workshops to learn evidence-based medicine (EBM), but evidence regarding the impact of these educational interventions is conflicting and of low methodologic quality and lacks generalizability. Furthermore, little is known about determinants of success. We sought to measure the effect of EBM short courses and workshops on knowledge and to identify course and learner characteristics associated with knowledge acquisition.
Methods
Health care professionals with varying expertise in EBM participated in an international, multicentre before–after study. The intervention consisted of short courses and workshops on EBM offered in diverse settings, formats and intensities. The primary outcome measure was the score on the Berlin Questionnaire, a validated instrument measuring EBM knowledge that the participants completed before and after the course.
Results
A total of 15 centres participated in the study and 420 learners from North America and Europe completed the study. The baseline score across courses was 7.49 points (range 3.97–10.42 points) out of a possible 15 points. The average increase in score was 1.40 points (95% confidence interval 0.48–2.31 points), which corresponded with an effect size of 0.44 standard deviation units. Greater improvement in scores was associated (in order of greatest to least magnitude) with active participation required of the learners, a separate statistics session, fewer topics, less teaching time, fewer learners per tutor, larger overall course size and smaller group size. Clinicians and learners involved in medical publishing improved their score more than other types of learners; administrators and public health professionals improved their score less. Learners who perceived themselves to have an advanced knowledge of EBM and had prior experience as an EBM tutor also showed greater improvement than those who did not.
Interpretation
EBM course organizers who wish to optimize knowledge gain should require learners to actively participate in the course and should consider focusing on a small number of topics, giving particular attention to statistical concepts.
PMCID: PMC3116678  PMID: 21686291
14.  Opioids for chronic non-cancer pain: a protocol for a systematic review of randomized controlled trials 
Systematic Reviews  2013;2:66.
Background
Opioids are prescribed frequently and increasingly for the management of chronic non-cancer pain (CNCP). Current systematic reviews have a number of limitations, leaving uncertainty with regard to the benefits and harms associated with opioid therapy for CNCP. We propose to conduct a systematic review and meta-analysis to summarize the evidence for using opioids in the treatment of CNCP and the risk of associated adverse events.
Methods and design
Eligible trials will include those that randomly allocate patients with CNCP to treatment with any opioid or any non-opioid control group. We will use the guidelines published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes that we collect and present. We will use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to evaluate confidence in the evidence on an outcome-by-outcome basis. Teams of reviewers will independently and in duplicate assess trial eligibility, abstract data, and assess risk of bias among eligible trials. To ensure interpretability of our results, we will present risk differences and measures of relative effect for all outcomes reported and these will be based on anchor-based minimally important clinical differences, when available. We will conduct a priori defined subgroup analyses consistent with current best practices.
Discussion
Our review will evaluate both the effectiveness and the adverse events associated with opioid use for CNCP, evaluate confidence in the evidence using the GRADE approach, and prioritize patient-important outcomes with a focus on functional gains guided by IMMPACT recommendations. Our results will facilitate evidence-based management of patients with CNCP and identify key areas for future research.
Trial registration
Our protocol is registered on PROSPERO (CRD42012003023), http://www.crd.york.ac.uk/PROSPERO.
doi:10.1186/2046-4053-2-66
PMCID: PMC3765127  PMID: 23965223
Chronic pain; Opioid analgesics; Systematic review; Meta-analysis; Randomized controlled trials; Quality of life; Adverse effects
15.  Patient-reported outcomes in meta-analyses – Part 1: assessing risk of bias and combining outcomes 
Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes (PROs) often provide crucial information for patients and clinicians facing challenging health care decisions. Based on emerging methods, guidance on combining PROs in meta-analysis is likely to enhance their usefulness.
The objectives of this paper are: i) to describe PROs and why they are important for health care decision-making, ii) illustrate the key risk of bias issues that systematic reviewers should consider and, iii) address outcome characteristics of PROs and provide guidance for combining outcomes.
We suggest a step-by-step approach to addressing issues of PROs in meta-analyses. Systematic reviewers should begin by asking themselves if trials have addressed all the important effects of treatment on patients’ quality of life. If the trials have addressed PROs, have investigators chosen the appropriate instruments? In particular, does evidence suggest the PROs used are valid and responsive, and is the review free of outcome reporting bias? Systematic reviewers must then decide how to categorize PROs and when to pool results.
doi:10.1186/1477-7525-11-109
PMCID: PMC3708764  PMID: 23815754
Patient-reported outcomes; Health-related quality of life; Meta-analysis; Systematic review; Health care decision-making
16.  Association of Psychotherapy with Disability Benefit Claim Closure among Patients Disabled Due to Depression 
PLoS ONE  2013;8(6):e67162.
Background
Depression is the most frequent reason for receiving disability benefits in North America, and treatment with psychotherapy is often funded by private insurers. No studies have explored the association between the provision of psychotherapy for depression and time to claim closure.
Methods
Using administrative data from a Canadian disability insurer, we evaluated the association between the provision of psychotherapy and short-term disability (STD) and long-term disability (LTD) claim closure by performing Cox proportional hazards regression.
Results
We analyzed 10,508 STD and 10,338 LTD claims for depression. In our adjusted analyses, receipt of psychotherapy was associated with longer time to STD closure (HR [99% CI] = 0.81 [0.68 to 0.97]) and faster LTD claim closure (1.42 [1.33 to 1.52]). In both STD and LTD, older age (0.90 [0.88 to 0.92] and 0.83 [0.80 to 0.85]), per decade), a primary diagnosis of recurrent depression versus non-recurrent major depression (0.78 [0.69 to 0.87] and 0.80 [0.72 to 0.89]), a psychological secondary diagnosis (0.90 [0.84 to 0.97] and 0.66 [0.61 to 0.71]), or a non-psychological secondary diagnosis (0.81 [0.73 to 0.90] and 0.77 [0.71 to 0.83]) versus no secondary diagnosis, and an administrative services only policy ([0.94 [0.88 to 1.00] and 0.87 [0.75 to 0.996]) or refund policy (0.86 [0.80 to 0.92] and 0.73 [0.68 to 0.78]) compared to non-refund policy claims were independently associated with longer time to STD claim closure.
Conclusions
We found, paradoxically, that receipt of psychotherapy was independently associated with longer time to STD claim closure and faster LTD claim closure in patients with depression. We also found multiple factors that were predictive of time to both STD and LTD claim closure. Our study has limitations, and well-designed prospective studies are needed to establish the effect of psychotherapy on disabling depression.
doi:10.1371/journal.pone.0067162
PMCID: PMC3696037  PMID: 23840614
19.  Development and Validation of an Instrument to Predict Functional Recovery in Tibial Fracture Patients: The Somatic Pre-Occupation and Coping (SPOC) Questionnaire 
Journal of Orthopaedic Trauma  2012;26(6):370-378.
Objective
To explore the role of patients’ beliefs in their likelihood of recovery from severe physical trauma.
Methods
We developed and validated an instrument designed to capture the impact of patients’ beliefs on functional recovery from injury; the Somatic Pre-occupation and Coping (SPOC) questionnaire. At 6-weeks post-surgical fixation, we administered the SPOC questionnaire to 359 consecutive patients with operatively managed tibial shaft fractures. We constructed multivariable regression models to explore the association between SPOC scores and functional outcome at 1-year, as measured by return to work and short form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) scores.
Results
In our adjusted multivariable regression models that included pre-injury SF-36 scores, SPOC scores at 6-weeks post-surgery accounted for 18% of the variation in SF-36 PCS scores and 18% of SF-36 MCS scores at 1-year. In both models, 6-week SPOC scores were a far more powerful predictor of functional recovery than age, gender, fracture type, smoking status, or the presence of multi-trauma. Our adjusted analysis found that for each 14 point increment in SPOC score at 6-weeks (14 chosen on the basis of half a standard deviation of the mean SPOC score) the odds of returning to work at 1-year decreased by 40% (odds ratio = 0.60; 95% CI = 0.50 to 0.73).
Conclusion
The SPOC questionnaire is a valid measurement of illness beliefs in tibial fracture patients and is highly predictive of their long-term functional recovery. Future research should explore if these results extend to other trauma populations and if modification of unhelpful illness beliefs is feasible and would result in improved functional outcomes.
doi:10.1097/BOT.0b013e31822421e2
PMCID: PMC3263327  PMID: 22011635
20.  A systematic review of studies comparing health outcomes in Canada and the United States 
Open Medicine  2007;1(1):e27-e36.
Background
Differences in medical care in the United States compared with Canada, including greater reliance on private funding and for-profit delivery, as well as markedly higher expenditures, may result in different health outcomes.
Objectives
To systematically review studies comparing health outcomes in the United States and Canada among patients treated for similar underlying medical conditions.
Methods
We identified studies comparing health outcomes of patients in Canada and the United States by searching multiple bibliographic databases and resources. We masked study results before determining study eligibility. We abstracted study characteristics, including methodological quality and generalizability.
Results
We identified 38 studies comparing populations of patients in Canada and the United States. Studies addressed diverse problems, including cancer, coronary artery disease, chronic medical illnesses and surgical procedures. Of 10 studies that included extensive statistical adjustment and enrolled broad populations, 5 favoured Canada, 2 favoured the United States, and 3 showed equivalent or mixed results. Of 28 studies that failed one of these criteria, 9 favoured Canada, 3 favoured the United States, and 16 showed equivalent or mixed results. Overall, results for mortality favoured Canada (relative risk 0.95, 95% confidence interval 0.92-0.98, p= 0.002) but were very heterogeneous, and we failed to find convincing explanations for this heterogeneity. The only condition in which results consistently favoured one country was end-stage renal disease, in which Canadian patients fared better.
Interpretation
Available studies suggest that health outcomes may be superior in patients cared for in Canada versus the United States, but differences are not consistent.
PMCID: PMC2801918  PMID: 20101287
21.  Commentary—Goodbye M(C)ID! Hello MID, Where Do You Come From? 
Health Services Research  2005;40(2):593-597.
doi:10.1111/j.1475-6773.2005.00374.x
PMCID: PMC1361157  PMID: 15762909
22.  Systematic review and network meta-analysis of interventions for fibromyalgia: a protocol 
Systematic Reviews  2013;2:18.
Background
Fibromyalgia is associated with substantial socioeconomic loss and, despite considerable research including numerous randomized controlled trials (RCTs) and systematic reviews, there exists uncertainty regarding what treatments are effective. No review has evaluated all interventional studies for fibromyalgia, which limits attempts to make inferences regarding the relative effectiveness of treatments.
Methods/design
We will conduct a network meta-analysis of all RCTs evaluating therapies for fibromyalgia to determine which therapies show evidence of effectiveness, and the relative effectiveness of these treatments. We will acquire eligible studies through a systematic search of CINAHL, EMBASE, MEDLINE, AMED, HealthSTAR, PsychINFO, PapersFirst, ProceedingsFirst, and the Cochrane Central Registry of Controlled Trials. Eligible studies will randomly allocate patients presenting with fibromyalgia or a related condition to an intervention or a control. Teams of reviewers will, independently and in duplicate, screen titles and abstracts and complete full text reviews to determine eligibility, and subsequently perform data abstraction and assess risk of bias of eligible trials. We will conduct meta-analyses to establish the effect of all reported therapies on patient-important outcomes when possible. To assess relative effects of treatments, we will construct a random effects model within the Bayesian framework using Markov chain Monte Carlo methods.
Discussion
Our review will be the first to evaluate all treatments for fibromyalgia, provide relative effectiveness of treatments, and prioritize patient-important outcomes with a focus on functional gains. Our review will facilitate evidence-based management of patients with fibromyalgia, identify key areas for future research, and provide a framework for conducting large systematic reviews involving indirect comparisons.
doi:10.1186/2046-4053-2-18
PMCID: PMC3610251  PMID: 23497523
Fibromyalgia; Systematic review; Network meta-analysis; Multiple treatment comparison; Randomized controlled trials
23.  Addressing Dichotomous Data for Participants Excluded from Trial Analysis: A Guide for Systematic Reviewers 
PLoS ONE  2013;8(2):e57132.
Introduction
Systematic reviewer authors intending to include all randomized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data.
Objective
The objective of this paper is to provide systematic reviewer authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of randomized trials.
Methods
This guide is based on a review of the Cochrane handbook and published methodological research. The guide deals with participants excluded from the analysis who were considered ‘non-adherent to the protocol’ but for whom data are available, and participants with missing data.
Results
Systematic reviewer authors should include data from ‘non-adherent’ participants excluded from the primary study authors' analysis but for whom data are available. For missing, unavailable participant data, authors may conduct a complete case analysis (excluding those with missing data) as the primary analysis. Alternatively, they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data. When the primary analysis suggests important benefit, sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis. The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta-analysis. The proposed guide does not take into account the uncertainty associated with assumed events.
Conclusions
This guide proposes methods for handling participants excluded from analyses of randomized trials. These methods can help in establishing the extent to which risk of bias impacts meta-analysis results.
doi:10.1371/journal.pone.0057132
PMCID: PMC3581575  PMID: 23451162
24.  Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening 
Trials  2013;14:40.
Background
Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment.
Methods
Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse.
Results
After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01).
Conclusions
Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging.
Trial registration
Clinicaltrials.gov NCT00865527
doi:10.1186/1745-6215-14-40
PMCID: PMC3599938  PMID: 23399518
Randomized controlled trial; Recruitment; Telephone; Mail; Colorectal cancer screening
25.  Predictors of Seizure Outcomes in Children with Tuberous Sclerosis Complex and Intractable Epilepsy Undergoing Resective Epilepsy Surgery: An Individual Participant Data Meta-Analysis 
PLoS ONE  2013;8(2):e53565.
Objective
To perform a systematic review and individual participant data meta-analysis to identify preoperative factors associated with a good seizure outcome in children with Tuberous Sclerosis Complex undergoing resective epilepsy surgery.
Data Sources
Electronic databases (MEDLINE, EMBASE, CINAHL and Web of Science), archives of major epilepsy and neurosurgery meetings, and bibliographies of relevant articles, with no language or date restrictions.
Study Selection
We included case-control or cohort studies of consecutive participants undergoing resective epilepsy surgery that reported seizure outcomes. We performed title and abstract and full text screening independently and in duplicate. We resolved disagreements through discussion.
Data Extraction
One author performed data extraction which was verified by a second author using predefined data fields including study quality assessment using a risk of bias instrument we developed. We recorded all preoperative factors that may plausibly predict seizure outcomes.
Data Synthesis
To identify predictors of a good seizure outcome (i.e. Engel Class I or II) we used logistic regression adjusting for length of follow-up for each preoperative variable.
Results
Of 9863 citations, 20 articles reporting on 181 participants were eligible. Good seizure outcomes were observed in 126 (69%) participants (Engel Class I: 102(56%); Engel class II: 24(13%)). In univariable analyses, absence of generalized seizure semiology (OR = 3.1, 95%CI = 1.2–8.2, p = 0.022), no or mild developmental delay (OR = 7.3, 95%CI = 2.1–24.7, p = 0.001), unifocal ictal scalp electroencephalographic (EEG) abnormality (OR = 3.2, 95%CI = 1.4–7.6, p = 0.008) and EEG/Magnetic resonance imaging concordance (OR = 4.9, 95%CI = 1.8–13.5, p = 0.002) were associated with a good postoperative seizure outcome.
Conclusions
Small retrospective cohort studies are inherently prone to bias, some of which are overcome using individual participant data. The best available evidence suggests four preoperative factors predictive of good seizure outcomes following resective epilepsy surgery. Large long-term prospective multicenter observational studies are required to further evaluate the risk factors identified in this review.
doi:10.1371/journal.pone.0053565
PMCID: PMC3566144  PMID: 23405072

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