Outcome Assessment Methods Research Articles

Patient-based outcome analysis is important to determine the success of total knee arthroplasty: result of a focus group discussion.

BackgroundTotal knee replacement (TKR) results in an excellent outcome in terms of pain relief. The reporting of outcomes was traditionally focused on implant survivorship and objective outcomes such as range of motion, knee stability, and radiographic alignment. However, patients and doctors had differing perceptions of all domains of outcome, especially subjective quality of life domains such as emotions and social functioning. In this study, we tried to find out the expectations of Indian patients regarding TKR and assess the level of satisfaction among our patients from their view point using focus group discussion (FGD), and whether these expectations have an impact on outcomes and patient satisfaction.Materials and methodsThis study was conducted in the Department of Orthopedics, Government Medical College, Kozhikode, Kerala, India, in November 2014. Patients between the ages 60 and 65 years who met inclusion criteria were selected. A total of 50 patients were selected for FGDs. Among them, 42 patients participated in FGD. The remaining eight did not appear for the discussion. A total of four FGD sessions were conducted.Results and discussionIt was found that there is a discrepancy between the satisfaction levels of patient and surgeon. There is a difference in satisfaction level achieved depending on socioeconomic, geographic, and cultural characteristics.ConclusionNewer methods of TKR outcome assessment combining radiological outcome, surgeon-based assessment, and patient satisfaction based on their socioeconomic status and cultural characteristics should be developed for different populations.

Posture and fluids for preventing post-dural puncture headache.

Post-dural puncture headache (PDPH) is a common complication of lumbar punctures. Several theories have identified the leakage of cerebrospinal fluid (CSF) through the hole in the dura as a cause of this side effect. It is therefore necessary to take preventive measures to avoid this complication. Prolonged bed rest has been used to treat PDPH once it has started, but it is unknown whether prolonged bed rest can also be used to prevent it. Similarly, the value of administering fluids additional to those of normal dietary intake to restore the loss of CSF produced by the puncture is unknown. This review is an update of a previously published review in the Cochrane Database of Systematic Reviews (Issue 7, 2013) on "Posture and fluids for preventing post-dural puncture headache". To assess whether prolonged bed rest combined with different body and head positions, as well as administration of supplementary fluids after lumbar puncture, prevent the onset of PDPH in people undergoing lumbar puncture for diagnostic or therapeutic purposes. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and LILACS, as well as trial registries up to February 2015. We identified randomized controlled trials that compared the effects of bed rest versus immediate mobilization, head-down tilt versus horizontal position, prone versus supine positions during bed rest, and administration of supplementary fluids versus no/less supplementation, as prevention measures for PDPH in people who have undergone lumbar puncture. Two review authors independently assessed the studies for eligibility through the web-based software EROS (Early Review Organizing Software). Two different review authors independently assessed risk of bias using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We resolved any disagreements by consensus. We extracted data on cases of PDPH, severe PDPH, and any headache after lumbar puncture and performed intention-to-treat analyses and sensitivity analyses by risk of bias. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created a 'Summary of findings' table. We included 24 trials with 2996 participants in this updated review. The number of participants in each trial varied from 39 to 382. Most of the included studies compared bed rest versus immediate mobilization, and only two assessed the effects of supplementary fluids versus no supplementation. We judged the overall risk of bias of the included studies as low to unclear. The overall quality of evidence was low to moderate, downgraded because of the risk of bias assessment in most cases. The primary outcome in our review was the presence of PDPH.There was low quality evidence for an absence of benefits associated with bed rest compared with immediate mobilization on the incidence of severe PDPH (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.68 to 1.41; participants = 1568; studies = 9) and moderate quality evidence on the incidence of any headache after lumbar puncture (RR 1.16; 95% CI 1.02 to 1.32; participants = 2477; studies = 18). Furthermore, bed rest probably increased PDPH (RR 1.24; 95% CI 1.04 to 1.48; participants = 1519; studies = 12) compared with immediate mobilization. An analysis restricted to the most methodologically rigorous trials (i.e. those with low risk of bias in allocation method, missing data and blinding of outcome assessment) gave similar results. There was low quality evidence for an absence of benefits associated with fluid supplementation on the incidence of severe PDPH (RR 0.67; 95% CI 0.26 to 1.73; participants = 100; studies = 1) and PDPH (RR 1; 95% CI 0.59 to 1.69; participants = 100; studies = 1), and moderate quality evidence on the incidence of any headache after lumbar puncture (RR 0.94; 95% CI 0.66 to 1.34; participants = 200; studies = 2). We did not expect other adverse events and did not assess them in this review. Since the previous version of this review, we found one new study for inclusion, but the conclusion remains unchanged. We considered the quality of the evidence for most of the outcomes assessed in this review to be low to moderate. As identified studies had shortcomings on aspects related to randomization and blinding of outcome assessment, we therefore downgraded the quality of the evidence. In general, there was no evidence suggesting that routine bed rest after dural puncture is beneficial for the prevention of PDPH onset. The role of fluid supplementation in the prevention of PDPH remains unclear.

Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) - lessons learned.

BackgroundTrials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial.MethodsWe undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen’s kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial.ResultsDigital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site.ConclusionsDespite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori.Trial registrationISRCTN Registry ISRCTN18994246

Systematic comparison of study quality criteria

Approaches for the systematic review and evaluation of chemical toxicity are currently being reconsidered, with a specific focus on the evaluation of individual studies and their integration into the overall body of evidence. This renewed interest has arisen, in part, as a result of several prominent reviews of these approaches by special committees of the National Research Council (NRC), among others. We conducted a critical evaluation of several available frameworks for evaluating study quality. We assessed the criteria separately for human, animal, and in vitro studies as well as for systematic reviews. We then evaluated commonalities across disciplines. We also considered the potential implications of applying criteria frameworks and how they bear on fundamental risk assessment questions. We found that the available frameworks within each discipline differed in terms of their intended purpose and level of guidance for decision making. All the frameworks across disciplines shared common themes, however, including the adequate reporting of specific details of study conditions and design/protocol, selection and randomization of study groups (where applicable), outcome assessment methods and applicability (e.g., validity and reliability), avoidance of selective reporting, and the consideration of potential confounders or bias. We identified the most informative study quality considerations, which will enable researchers to implement more objective and standardized methods for evaluating studies and, ultimately, improve risk assessment methods.

Dietary patterns and successful ageing: a systematic review.

PurposeNutrition is a key determinant of chronic disease in later life. A systematic review was conducted of studies examining dietary patterns and quality of life, physical function, cognitive function and mental health among older adults.Methods Literature searches in MEDLINE complete, Academic Search Complete, CINAHL Complete, Ageline, Global health, PsycINFO, SCOPUS and EMBASE and hand searching from 1980 up to December 2014 yielded 1236 results. Inclusion criteria included dietary pattern assessment via dietary indices or statistical approaches, a sample of community-dwelling adults aged 45 years and over at baseline and a cross-sectional or longitudinal study design. Exclusion criteria included a single 24-h recall of diet, evaluation of single foods or nutrients, clinical or institutionalised samples and intervention studies. Risk of bias was assessed using the six-item Effective Public Health Practice Project’s Quality Assessment Tool for Quantitative Studies.ResultsThere were 34 articles (11 cross-sectional and 23 longitudinal) included with 23 studies examining dietary indices and 13 studies using empirical analysis. Most studies examined mental health (n = 10) or cognitive function (n = 18), with fewer studies examining quality of life (n = 6) and physical function (n = 8). Although dietary pattern and outcome assessment methods varied, most studies reported positive associations between a healthier diet and better health outcomes.ConclusionOverall, the number of studies using dietary patterns to investigate diet and successful ageing is small, and further investigation in longitudinal studies is needed, particularly for quality-of-life outcomes. This review provides support for the importance of a healthy diet for the ageing population globally.Electronic supplementary materialThe online version of this article (doi:10.1007/s00394-015-1123-7) contains supplementary material, which is available to authorized users.

Graduated compression stockings for the prevention of deep-vein thrombosis in postoperative surgical patients: a systematic review and economic model with a value of information analysis.

Deep-vein thrombosis (DVT) can occur in surgical patients. Routine prophylaxis can be pharmacological and/or mechanical [e.g. graduated compression stockings (GCSs)]. GCSs are available in knee length or thigh length. To establish the expected value of undertaking additional research addressing the relative effectiveness of thigh-length GCSs versus knee-length GCSs, in addition to pharmacoprophylaxis, for prevention of DVT in surgical patients. Systematic review and economic model, including value of information (VOI) analysis. Randomised controlled trials (RCTs) assessing thigh- or knee-length GCSs in surgical patients were eligible for inclusion. The primary outcome was incidence of DVT. DVT complications and GCSs adverse events were assessed. Random-effects meta-analysis was performed. To draw on a wider evidence base, a random-effects network meta-analysis (NMA) was undertaken for the outcome DVT. A review of trials and observational studies of patient adherence was also conducted. A decision-analytic model was developed to assess the cost-effectiveness of thigh- and knee-length GCSs and the VOI. Twenty-three RCTs were included in the review of effectiveness. There was substantial variation between trials in terms of the patient characteristics, interventions and methods of outcome assessment. Five trials comparing knee-length with thigh-length GCSs with or without pharmacoprophylaxis were pooled; the summary estimate of effect indicated a non-significant trend favouring thigh-length GCSs [odds ratio (OR) 1.48, 95% confidence interval (CI) 0.80 to 2.73]. Thirteen trials were included in the NMA. In the base-case analysis, thigh-length GCSs with pharmacoprophylaxis were more effective than knee-length GCSs with pharmacoprophylaxis (knee vs. thigh OR 1.76, 95% credible interval 0.82 to 3.53). Overall, thigh-length stockings with pharmacoprophylaxis was the most effective treatment, with a 0.73 probability of being the most effective treatment in a new trial of all the treatments. Patient adherence was generally higher with knee-length GCSs, and patients preferred knee-length GCSs. Thigh-length GCSs were found to be cost-effective in all but the subgroup with the lowest baseline risk, although the absolute differences in costs and effects were relatively small. The expected value of perfect information ranged from £0.2M to £178.0M depending on the scenario and subgroup. The relative effect parameters had the highest expected value of partial perfect information and ranged from £2.0M to £39.4M. The value of further research was most evident in the high-risk subgroups. There was substantial variation across the included trials in terms of patient and intervention characteristics. Many of the included trials were old and poorly reported, which reduces the reliability of the results of the review. Given that the results from both the standard meta-analysis and the NMA lacked precision (CIs were wide) owing to the heterogeneous evidence base, a new definitive trial in high-risk patients may be warranted. However, the efficiency of any further research (i.e. whether this represents value for money) is dependent on several factors, including the acquisition price of GCSs, expected compliance with thigh-length GCSs wear, and whether or not uncertainty can be resolved around possible effect modifiers, as well as the feasibility and actual cost of undertaking the proposed research. This study is registered as PROSPERO CRD42014007202. The National Institute for Health Research Health Technology Assessment programme.

Taxane-containing regimens for metastatic breast cancer.

It is generally accepted that taxanes are among the most active chemotherapy agents in the management of metastatic breast cancer. This is an update of a Cochrane review first published in 2003. The objective of this review was to compare taxane-containing chemotherapy regimens with regimens not containing a taxane in the management of women with metastatic breast cancer. In this review update, we searched the Cochrane Breast Cancer Group Specialised Register, MEDLINE, EMBASE, the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov on 14 February 2013 using keywords such as 'advanced breast cancer' and 'chemotherapy'. We searched reference lists of articles, contacted study authors, and did not apply any language restrictions. Randomised controlled trials comparing taxane-containing chemotherapy regimens to regimens without taxanes in women with metastatic breast cancer. We included published and unpublished studies. Two review authors independently assessed trial quality and extracted data. We derived hazard ratios (HRs) for overall survival, time to progression, and time to treatment failure where possible, and used a fixed-effect model for meta-analysis. We represented objective tumour response rates and toxicity as risk ratios (RRs). We extracted quality of life data where present. This review included 28 studies. The updated analysis included 6871 randomised women, while the original review had 3643 women. Of the 28 included studies, we considered 19 studies to be at low risk of bias overall; however, some studies failed to report details on allocation concealment and methods of outcome assessment for those outcomes that are more likely to be influenced by a lack of blinding (for example tumour response rate). Studies varied in the taxane-containing chemotherapy backbone, and the comparator arms and were categorised into three groups: Regimen A plus taxane versus Regimen A (2 studies); Regimen A plus taxane versus Regimen B (14 studies); and single-agent taxane versus Regimen C (13 studies). Thirteen studies used paclitaxel, 14 studies used docetaxel, and 1 study allowed the investigator to decide on the type of taxane; the majority of studies delivered a taxane every 3 weeks. Twenty studies administered taxanes as first-line treatment, and 21 studies involved anthracycline naïve women in the metastatic setting. The combined HR for overall survival and time to progression favoured the taxane-containing regimens (HR 0.93, 95% confidence interval (CI) 0.88 to 0.99, P = 0.002, deaths = 4477; and HR 0.92, 95% CI 0.87 to 0.97, P = 0.002, estimated 5122 events, respectively) with moderate to substantial heterogeneity across trials. If the analyses were restricted to studies of first-line chemotherapy, this effect persisted for overall survival (HR 0.93, 95% CI 0.87 to 0.99, P = 0.03) but not for time to progression (HR 0.96, 95% CI 0.90 to 1.02, P = 0.22). Tumour response rates appeared to be better with taxane-containing chemotherapy in assessable women (RR 1.20, 95% CI 1.14 to 1.27, P < 0.00001) with substantial heterogeneity across studies. Taxanes were associated with an increased risk of neurotoxicity (RR 4.84, 95% CI 3.18 to 7.35, P < 0.00001, 24 studies) and hair loss (RR 2.37, 95% CI 1.45 to 3.87, P = 0.0006, 11 studies) but less nausea/vomiting compared to non-taxane-containing regimens (RR 0.62, 95% CI 0.46 to 0.83, P = 0.001, 26 studies). Leukopaenia and treatment-related death did not differ between the two groups (RR 1.07, 95% CI 0.97 to 1.17, P = 0.16, 28 studies; and RR 1.00, 95% CI 0.63 to 1.57, P = 0.99, 23 studies, respectively). For quality of life measures, none of the individual studies reported a difference in overall or any of quality of life subscales between taxane-containing and non-taxane chemotherapy regimens. Taxane-containing regimens appear to improve overall survival, time to progression, and tumour response rate in women with metastatic breast cancer. Taxanes are also associated with an increased risk of neurotoxicity but less nausea and vomiting compared to non-taxane-containing regimens. The considerable heterogeneity encountered across studies probably reflects the varying efficacy of the comparator regimens used in these studies and indicates that taxane-containing regimens are more effective than some, but not all, non-taxane-containing regimens.

The role of clinical judgment in integration of indicators of outcome in psychotherapy research

AbstractBackgroundEvaluation of psychotherapy impact and effect has advanced substantially in the last half century. The development of reliable standardised measures has been especially important. However, several issues remain controversial. One such issue is the extent to which standardised measures adequately capture change and their integration with normal clinical practice. A second is how to deal with the not uncommon situation where one outcome measure indicates change and another does not. Finally, researchers are often confronted with cases where standardised measures are used, but some participants quit therapy without completing them.AimIn this study, we present and discuss an outcome assessment method developed in the context of a naturalistic, mixed‐methods study of 22 treatments of psychosomatic patients.MethodologyThis multimodal, multi‐informant method involved a thorough and individualised analysis of transcripts, questionnaires and other clinical data, the consideration of patient and therapist's opinions about outcome, and the use of clinical judgment to integrate different indicators and classify outcome, with the aid of two auditors reviewing the process.FindingsEight cases improved, six deteriorated, and eight did not change. Three case vignettes illustrate the application of the method, and some possible sources of bias of patient and therapist's opinion about outcome are identified.ImplicationsClinical judgment can help integrate results from standardised measures and other data sources into outcome assessment normally practised by clinicians. This method, besides its high cost in time and resources, can also be useful in research to rescue outcome assessment when collection of outcome measures fails.

FLiGS Score: A New Method of Outcome Assessment for Lip Carcinoma-Treated Patients.

Background:Lip cancer and its treatment have considerable functional and cosmetic effects with resultant nutritional and physical detriments. As we continue to investigate new treatment regimens, we are simultaneously required to assess postoperative outcomes to design interventions that lessen the adverse impact of this disease process. We wish to introduce Functional Lip Glasgow Scale (FLiGS) score as a new method of outcome assessment to measure the effect of lip cancer and its treatment on patients’ daily functioning.Methods:Fifty patients affected by lip squamous cell carcinoma were recruited between 2009 and 2013. Patients were asked to fill the FLiGS questionnaire before surgery, 1 month, 6 months, and 1 year after surgery. The subscores were used to calculate a total FLiGS score of global oral disability. Statistical analysis was performed to test validity and reliability.Results:FLiGS scores improved significantly from preoperative to 12 months postoperative values (P = 0.000). Statistical evidence of validity was provided through rs (Spearman correlation coefficient) that resulted >0.30 for all surveys and for which P < 0.001. FLiGS score reliability was shown through examination of internal consistency and test-retest reliability.Conclusions:FLiGS score is a simple way of assessing functional impairment related to lip cancer before and after surgery; it is sensitive, valid, reliable, and clinically relevant: it provides useful information to orient the physician in the postoperative management and in the rehabilitation program.

FLiGS Score

Background: Lip cancer and its treatment have considerable functional and cosmetic effects with resultant nutritional and physical detriments. As we continue to investigate new treatment regimens, we are simultaneously required to assess postoperative outcomes to design interventions that lessen the adverse impact of this disease process. We wish to introduce Functional Lip Glasgow Scale (FLiGS) score as a new method of outcome assessment to measure the effect of lip cancer and its treatment on patients’ daily functioning. Methods: Fifty patients affected by lip squamous cell carcinoma were recruited between 2009 and 2013. Patients were asked to fill the FLiGS questionnaire before surgery, 1 month, 6 months, and 1 year after surgery. The subscores were used to calculate a total FLiGS score of global oral disability. Statistical analysis was performed to test validity and reliability. Results: FLiGS scores improved significantly from preoperative to 12 months postoperative values (P = 0.000). Statistical evidence of validity was provided through rs (Spearman correlation coefficient) that resulted >0.30 for all surveys and for which P < 0.001. FLiGS score reliability was shown through examination of internal consistency and test-retest reliability. Conclusions: FLiGS score is a simple way of assessing functional impairment related to lip cancer before and after surgery; it is sensitive, valid, reliable, and clinically relevant: it provides useful information to orient the physician in the postoperative management and in the rehabilitation program.

Using record linkage to investigate perinatal factors and neonatal thyroid-stimulating hormone.

Studies examining the relationship between maternal and infant thyroid parameters have shown conflicting results. Record linkage provides an opportunity to examine the association between maternal and infant thyroid-stimulating hormone (TSH) levels. Our aim was to demonstrate the feasibility of record linkage of newborn screening (NBS), laboratory and birth databases for research by investigating the association between maternal and newborn TSH levels. The records of 2802 women with first trimester serum TSH concentrations were linked with population-based birth data and NBS data containing infant TSH levels. Association between moderately high neonatal TSH levels (>5 mIU/L) and maternal and infant characteristics was evaluated. The correlation and association between maternal and infant TSH levels were assessed using Pearson's correlation coefficient and multivariable linear regression, respectively. Of maternal and birth records, 99.3% linked with an NBS record. Mother's country of birth, gestational age (>41 weeks) and lower birthweight were associated with neonatal TSH levels >5 mIU/L. Neonatal and maternal first trimester TSH levels were not correlated, although statistically significant (r = 0.05, P = 0.008). The association between neonatal TSH and maternal TSH, after adjusting for maternal age, gestational age and age at NBS testing, was also small (b = 0.039, P = 0.009). Record linkage is a feasible and cost-efficient way to investigate the association between maternal factors and neonatal hormone levels. First trimester maternal thyroid levels are not correlated with neonatal TSH levels. This method of outcome assessment can be used for future research examining long-term outcomes for infants with different NBS results.

Pharmacotherapy for sleep bruxism.

Sleep bruxism is an oral activity characterized by involuntary teeth grinding or clenching during sleep. Several forms of treatment have been proposed for this disorder, including behavioural, dental and pharmacological strategies. To evaluate the effectiveness and safety of pharmacological therapy for the treatment of sleep bruxism compared with other drugs, no treatment or placebo. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2014), MEDLINE (1966 to August 2014), EMBASE (1980 to August 2013) and LILACS (1982 to August 2014). We identified additional reports from the reference lists of retrieved reports and from reviews on treatment of sleep bruxism. We applied no language restrictions. We selected randomized controlled trials (RCTs) or quasi-RCTs that compared drugs with other drugs, no treatment or placebo in people with sleep bruxism. Review authors carried out data extraction and quality assessment of the included trials independently and in duplicate. We discussed discrepancies until we reached consensus. We consulted a third review author in cases of persistent disagreement. We contacted authors of primary studies when necessary. We identified 18 potentially relevant RCTs, but only seven met the inclusion criteria. All studies had a small number of participants, ranging from seven to 16 people per study and had a cross-over design. Three studies were of low risk of bias, while four were of uncertain risk. Amitriptyline (three studies), bromocriptine (one study), clonidine (one study), propranolol (one study), levodopa (Prolopa®) (one study) and tryptophan (one study) were compared with placebo. Studies evaluating bromocriptine, clonidine, propranolol and levodopa reported our primary outcome of indices of bruxism motor activity.Results were imprecise and consistent with benefit, no difference or harm. These were the specific findings for each of the drugs according to specific outcomes: 1. Amitriptyline versus placebo for masseteric electromyography (EMG) activity per minute: standardized mean difference (SMD) -0.28 (95% confidence interval (CI) -0.91 to 0.34; P value = 0.37), 2. bromocriptine versus placebo for bruxism episodes per hour: mean difference (MD) 0.60 (95% CI -2.93 to 4.13), bruxism bursts per hour: MD -2.00 (95% CI -53.47 to 49.47), bruxism bursts per episode: MD 0.50 (95% CI -1.85 to 2.85) or number of episodes with grinding noise: MD 2.40 (95% CI -24.00 to 28.80), 3. clonidine versus placebo for number of bruxism episodes per hour: MD -2.41 (95% CI -4.84 to 0.02), 4. propranolol versus placebo for the number of bruxism episodes per hour: MD 1.16 (95% CI -1.89 to 4.21), 5. L-tryptophan versus placebo for masseteric EMG activity per second: SMD 0.08 (95% CI -0.90 to 1.06) and 6. levodopa versus placebo for bruxism episodes per hour of sleep: MD -1.47 (95% CI -3.64 to 0.70), for bruxism bursts per episode: MD 0.06 (95% CI -2.47 to 2.59).We combined several secondary outcomes (sleep duration, masseteric EMG activity per minute and pain intensity) in a meta-analysis for comparison of amitriptyline with placebo. The results for most comparisons were uncertain because of statistical imprecision. One study reported that clonidine reduced rapid eye movement (REM) sleep stage and increased the second stage of sleep. However, results for other sleep-related outcomes with clonidine were uncertain. Adverse effects were frequent in people who took amitriptyline (5/10 had drowsiness, difficulty awakening in the morning, insomnia or xerostomia compared with 0/10 in the placebo group), as well as in people who received propranolol (7/16 had moderate-to-severe xerostomia compare with 2/16 in the placebo group). Clonidine was associated with prolonged morning hypotension in three of 16 participants. The use of preventive medication avoided any adverse effects in people treated with levodopa and bromocriptine. There was insufficient evidence on the effectiveness of pharmacotherapy for the treatment of sleep bruxism. This systematic review points to the need for more, well-designed, RCTs with larger sample sizes and adequate methods of allocation, outcome assessment and duration of follow-up. Ideally, parallel RCTs should be used in future studies to avoid the bias associated with cross-over studies. There is a need to standardize the outcomes of RCTs on treatments for sleep bruxism.

Computed tomography in evaluation of revision hip arthroplasty outcomes.

Background. This study aimed to assess contact between Recon Shell reinforcement cages used in revision hip arthroplasty and the bony base. Radiographic examinations were performed with the use of multi-energy computed tomography. Material and methods. We tentatively assess the fixation of Burch-Schneider reinforcement cages (Recon Shell made by Aesculap company) implanted in 10 patients, using two methods of evaluation. An analysis of dual energy CT scans enabled us to assess contact between the reinforcement cages and the bony base. Results. The two methods of evaluation produced different results. The evaluation method based on the division of the acetabular component into a weight-bearing zone and a non-weight-bearing zone (accounting for screw fixation) showed lack of support in the weight-bearing zone in 6 out of 10 cases and direct contact with the implant bed in only one case. The assessment of contact at anchorage holes of reinforcement cages fixed at primary procedures revealed no such support in only one case and the presence of direct contact in 5 cases. There was no correlation between the radiological outcomes and clinical results based on the Harris Hip Score. Conclusions. 1. Multi-energy computed tomography (MARS) is useful in evaluating results of revision hip allo-plasty. 2. The introduction of new imaging techniques for the evaluation of revision procedures demonstrates a need for new, unified methods of outcome assessment adjusted to the characteristics of a particular procedure.

Bilateral Versus Unilateral Stenting for Malignant Hilar Obstruction: A Meta-Analysis

Introduction: Malignant hilar biliary obstruction is a dreaded complication of various types of cancers including pancreatic cancer, cholangiocarcinoma, gallbladder carcinoma, and hepatocellular carcinoma. Palliative endoscopic biliary drainage plays an important role in resolving jaundice and cholangitis. The optimal stenting techniques remain to be definitely decided and the necessity to drain both liver lobes in hilar tumors remains uncertain. We report a meta-analysis of studies comparing unilateral versus bilateral stenting for malignant hilar biliary obstruction. Methods: We searched Pubmed, Medline, Embase, and Cochrane for controlled studies that compared unilateral versus bilateral stenting for malignant hilar biliary obstruction. Studies were excluded if they were non-controlled or included patients with non-malignant and non-hilar obstruction. Studies selection and data extraction were done by 2 reviewers. Disagreement was solved by a third reviewer. The quality for each included study was assessed by Consort system. Heterogeneity of the studies was analyzed by Cochran’s Q statistics. Mantel Haenszel relative risk and mean difference were calculated with random effect for outcomes with significant heterogeneity; for all others the fixed effect method was used. Results: Seven studies met the inclusion criteria with a total of 634 patients. After the initial placement of stents, there was no significant difference in the occlusion rate between unilateral and bilateral stenting (odds ratio [OR]: 1.47; confidence interval [CI]: 0.68-3.19). There was moderate heterogeneity among results reported in the studies but the clinical characteristics of the patients and the method of outcome assessment were similar and did not change our inferences. A sensitivity analysis that sorted studies based on the use of metal versus plastic stents found no statistically significant difference in the occlusion rate. Therapeutic failure, defined as the lack of resolution of symptoms post stenting, was noted in 17% with unilateral stenting compared to 22% with bilateral stenting without a statistically significant difference (OR: 0.63; CI: 0.31-1.28). Bilateral stenting was associated with higher incidence of post-stenting cholangitis 22% compared to unilateral stenting 12% (OR 0.52; 95% CI 0.28-0.96). There was no evidence of publication bias among the reported outcomes. Conclusion: When compared to bilateral stenting, unilateral stenting performed for patients with malignant hilar strictures is associated with lower incidence of post-stenting cholangitis, similar success in symptom resolution and no difference in the post stenting occlusion rate. Therefore, in the majority of patients with malignant biliary obstruction, unilateral stenting provides similar outcome to bilateral stenting.

Doctoral Programs Outcomes Assessment: An Approach to Assessing Program Inputs, Learning Objectives, and Postgraduation Outcomes

Abstract Student learning outcomes assessment is conducted at the undergraduate level for academic departments to determine whether students are meeting learning goals. The assessments do not include course grades; rather, they include measures such as standardized tests or student coursework being rated outside the course by committees. Increasingly, there has been a movement to conduct outcomes assessment on graduate programs as well. This article presents an assessment methodology that can be applied to the special conditions of doctoral programs, which are generally structured very differently than undergraduate and masters’ level programs, and which therefore require different methods of outcomes assessment.

Doctoral Programs Outcomes Assessment: An Approach to Assessing Program Inputs, Learning Objectives, and Postgraduation Outcomes

Abstract Student learning outcomes assessment is conducted at the undergraduate level for academic departments to determine whether students are meeting learning goals. The assessments do not include course grades; rather, they include measures such as standardized tests or student coursework being rated outside the course by committees. Increasingly, there has been a movement to conduct outcomes assessment on graduate programs as well. This article presents an assessment methodology that can be applied to the special conditions of doctoral programs, which are generally structured very differently than undergraduate and masters’ level programs, and which therefore require different methods of outcomes assessment.

Methods for Assessing Single-Case School-Based Intervention Outcomes

The purpose of this article is to present various single-case outcome assessment methods for evaluating school-based intervention effectiveness. We present several outcome methods, including goal attainment scaling, visual analysis, trend analysis, percentage of non-overlapping data, single-case mean difference effect size, reliable change index, and convergent evidence scaling. The strengths and limitations of each of these methods are discussed, along with the potential practice applications. We conclude the article with a suggested display format for single-case intervention outcomes.

Development of an EMS Curriculum

Emergency medical services (EMS) became an American Board of Medical Specialties (ABMS) approved subspecialty of emergency medicine in September 2010. Achieving specialty or subspecialty recognition in an area of medical practice requires a unique body of knowledge, a scientific basis for the practice, a significant number of physicians who dedicate a portion of their practice to the area, and a sufficient number of fellowship programs. To prepare EMS fellows for successful completion of fellowship training, a lifetime of subspecialty practice, and certification examination, a formalized structured fellowship curriculum is necessary. A functional curriculum is one that takes the entire body of knowledge necessary to appropriately practice in the identified area and codifies it into a training blueprint to ensure that all of the items are covered over the prescribed training period. A curriculum can be as detailed as desired but typically all major headings and subheadings of the core content are identified and addressed. Common curricular components, specific to each area of the core content, include goals and objectives, implementation methods, evaluation, and outcomes assessment methods. Implementation methods can include simulation, observations, didactics, and experiential elements. Evaluation and outcomes assessment methods can include direct observation of patient assessment and treatment skills, structured patient simulations, 360° feedback, written and oral testing, and retrospective chart reviews. This paper describes a curriculum that is congruent with the current EMS core content, as well as providing a 12-month format to deploy the curriculum in an EMS fellowship program. Key words: curriculum; education; emergency medical services; fellowships and scholarships

Fractures of the femoral head

Femoral head fractures are rare injuries that occur most commonly from high-energy impacts, such as those seen in road traffic accidents. The traumatic nature of these injuries means that they are often associated with many other injuries, which can often be life threatening. Although a fracture of the femoral head is not often a life-threatening injury, there is a high potential for developing complications that can greatly affect the function of the joint later in life. A femoral head fracture is most commonly associated with a traumatic dislocation of the hip joint. Thus, once these injuries have been identified, they need to be reduced promptly and accurately. A number of classifications systems are used for describing femoral head fractures, and of these, the Pipkin classification system is one of the most widely used. As this injury is relatively rare, the published literature on the subject is limited and thus much debate still exists about the best methods for classification, treatment and assessment of outcomes. The aim of this article is to provide an overview of the injury and its management.

Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials

Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing difficulty in everyday activities and may also affect social, psychosexual and psychological well-being. There are no standardized measures routinely used to assess the impact of vulval disease on daily life. To report outcome measures used in clinically based randomized controlled trials (RCTs) investigating therapeutic interventions in vulval disease. The Medline, EMBASE and CENTRAL databases were searched to identify RCTs of vulval skin conditions written in English. Studies with laboratory tests or survival rates as the primary outcome, or those investigating menopausal symptoms or infections were excluded. Twenty-eight published RCTs were included. The vulval conditions represented were vulvodynia (n = 14), lichen sclerosus (n = 9), vulval intraepithelial neoplasia (n = 2), vulval pruritus (n = 2) and lichen planus (n = 1). The 28 RCTs measured 25 different outcomes, using 49 different scales. The method of outcome assessment was lacking on nine occasions. Only 21% (six of 28) of included trials had a clearly stated primary outcome. Patient-reported outcomes were more commonly reported than clinician-related outcome measures. The most commonly reported patient-rated outcome measure was a reduction in pain (measured 15 times) and an overall improvement in symptoms using a patient global assessment (measured 11 times). The most commonly reported clinician-rated outcome was an overall assessment of the appearance of affected sites (measured 13 times). There were no agreed standard scales used for the global assessments. Only nine of the recorded outcome measure tools were designed to assess vulval disease or sexual functioning, the remainder were general measures. There is heterogeneity in the outcome measures used when reporting therapeutic interventions in vulval disease. This field of dermatology would benefit from development of a vulval-specific outcome measure and the establishment of a core outcome measure set.