Concomitant Unstable and Stable Gravity Stress Tests on Weight-Bearing Stable Weber B Ankle Fractures Treated Nonoperatively: A 2-Year Outcome Study.

BACKGROUND: Replacing gravity stress tests with weight-bearing radiographs to evaluate the stability of Weber B (also called Lauge-Hansen supination-external rotation [SER]) ankle fractures results in a lower surgery rate, thus avoiding associated risks and complications. Still, nonoperative treatment of weight-bearing stable fractures is controversial because of the scarcity of strong evidence. We investigated the influence of a concomitant unstable gravity stress test compared with a stable gravity stress test on outcomes after nonoperative treatment of weight-bearing stable fractures. METHODS: We performed a prospective, noninferiority study on 149 patients with Weber B ankle fractures and stable weight-bearing radiographs. Gravity stress radiographs classified fractures as stable (SER2 [n = 88]) or partially unstable (SER4a [n = 61]). All were treated with a functional orthosis and weight-bearing was allowed; patients were followed for 2 years. The primary outcome was the Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ), with a range from 0 to 100, in which lower scores indicate fewer symptoms. A noninferiority margin was prospectively defined as 7.5 points. The secondary outcomes included the Olerud-Molander Ankle Score, assessment of ankle congruence, and treatment-related adverse events. RESULTS: The primary outcome data were available for 144 (96.6%) of 149 participants at 2 years. The between-group difference in the MOXFQ score was 1.0 point (95% confidence interval, -1.4 to 3.4 points; p = 0.397) in favor of the SER2 group, consistent with noninferiority. We found no appreciable between-group differences for any other outcome. CONCLUSIONS: In Weber B/SER ankle fractures that are stable on weight-bearing radiographs, are treated with removable orthoses, and are allowed to bear weight, a concomitant unstable gravity stress test (SER4a) was not associated with worse patient-reported or radiographic outcomes compared with a stable gravity stress test (SER2) at the 2-year follow-up. Thus, the identification of stress instability seems redundant, which questions the applicability of stress instability for surgical decision-making. LEVEL OF EVIDENCE: Diagnostic Level II . See Instructions for Authors for a complete description of levels of evidence.

Has growth mixture modeling improved our understanding of how early change predicts psychotherapy outcome?

OBJECTIVE: Early change in psychotherapy predicts outcome. Seven studies have used growth mixture modeling [GMM; Muthén, B. (2001). Second-generation structural equation modeling with a combination of categorical and continuous latent variables: New opportunities for latent class-latent growth modeling. In L. M. Collins & A. G. Sawyers (Eds.), New methods for the analysis of change (pp. 291-322). Washington, DC: American Psychological Association] to identify patient classes based on early change but have yielded conflicting results. Here, we review the earlier studies and apply GMM to a new data set. METHOD: In a university-based training clinic, 251 patients were administered the Outcome Questionnaire-45 [Lambert, M. J., Hansen, N. B., Umphress, V., Lunnen, K., Okiishi, J., Burlingame, G., … Reisinger, C. W. (1996). Administration and scoring manual for the Outcome Questionnaire (OQ 45.2). Wilmington, DE: American Professional Credentialing Services] at each psychotherapy session. We used GMM to identify class structure based on change in the first six sessions and examined trajectories as predictors of outcome. RESULTS: The sample was best described as a single class. There was no evidence of autoregressive trends in the data. We achieved better fit to the data by permitting latent variables some degree of kurtosis, rather than to assume multivariate normality. Treatment outcome was predicted by the amount of early improvement, regardless of initial level of distress. The presence of sudden early gains or losses did not further improve outcome prediction. CONCLUSIONS: Early improvement is an easily computed, powerful predictor of psychotherapy outcome. The use of GMM to investigate the relationship between change and outcome is technically complex and computationally intensive. To date, it has not been particularly informative.

Evaluation of the Bifactor Nominal Response Model Analysis of a Health Efficacy Measure.

The bifactor nominal response item response theory (IRT) model, proposed by Cai, Yang and Hansen (2011), provides an extension of Bock's (1972, 1997) unidimensional nominal response model to multidimensional IRT. This model has not been utilized in any published studies since its original development. In this study, the model was applied to data from a sample of college students (N = 799) to evaluate the psychometric properties of a health efficacy measure. The nominal response model has the unique capability to estimate the functioning of each single response category, and higher response categories were found to have better functioning in this study. Poor-functioning categories were identified and combined into their adjacent categories. Items with revised response format showed improved functioning. The bifactor nominal response model is a useful tool for evaluation of bifactor scales with ordered while non-equivalently functioning categories.

Network or regression-based methods for disease discrimination: a comparison study.

BACKGROUND: In stark contrast to network-centric view for complex disease, regression-based methods are preferred in disease prediction, especially for epidemiologists and clinical professionals. It remains a controversy whether the network-based methods have advantageous performance than regression-based methods, and to what extent do they outperform. METHODS: Simulations under different scenarios (the input variables are independent or in network relationship) as well as an application were conducted to assess the prediction performance of four typical methods including Bayesian network, neural network, logistic regression and regression splines. RESULTS: The simulation results reveal that Bayesian network showed a better performance when the variables were in a network relationship or in a chain structure. For the special wheel network structure, logistic regression had a considerable performance compared to others. Further application on GWAS of leprosy show Bayesian network still outperforms other methods. CONCLUSION: Although regression-based methods are still popular and widely used, network-based approaches should be paid more attention, since they capture the complex relationship between variables.

[SHORT-TERM EFFECTIVENESS OF TightRope SYSTEM FOR TREATMENT OF SYNDESMOTIC TIBIOFIBULAR DIASTASIS].

OBJECTIVE: To summarize the short-term effectiveness of TightRope system for the treatment of syndesmotic tibiofibular diastasis. METHODS: Between June 2013 and June 2015, 23 patients with syndesmotic tibiofibular diastasis were treated by TightRope system, including 15 males and 8 females with an average age of 32.3 years (range, 16-63 years). Injury was caused by sports in 13 cases, by traffic accident in 6 cases, and by falling from height in 4 cases. The locations were the left side in 13 cases and the right side in 10 cases. The time from injury to operation was 6 hours to 12 days (mean, 3.8 days). According to Lauge-Hansen classification, 13 cases were rated as supination-external rotation type, 7 cases as pronation-abduction type, and 3 cases as pronation-external rotation type; according to Weber classification, 5 cases were rated as type A, 11 cases as type B, and 7 cases as type C. RESULTS: The mean operative time was 68.1 minutes (range, 48-93 minutes); the mean intraoperative blood loss was 70.3 mL (range, 20-150 mL); and the mean hospitalization days were 7 days (range, 5-13 days). Superficial local skin necrosis occurred in 6 cases, and primary healing of incision was obtained in the others. All patients were followed up 8-30 months (mean, 16.4 months). X-ray films showed bone union was achieved within 6-12 weeks (mean, 9.4 weeks). No related complications of reduction failure and re-fracture occurred. The internal fixators were removed at 10-18 months postoperatively (mean, 13.3 months). According to American Orthopaedic Foot and Ankle Society (AOFAS) score for ankle function evaluation, the results were excellent in 19 cases and good in 4 cases at last follow-up. CONCLUSIONS: TightRope system is a good method to treat syndesmotic tibiofibular diastasis, because of safety, convenient operation, and satisfactory short-term effectiveness.

Assessing and improving adherence with multidrug therapy.

INTRODUCTION: Adherence with multidrug therapy (MDT) in the treatment of leprosy is important to minimise the risk of relapse and avoid the emergence of drug resistance. Adherence is defined as the extent to which the patient's behaviour matches recommendations from the prescriber. This paper reviews the methods for assessing adherence with MDT in leprosy, and community approaches to improving adherence based on evidence from the treatment of tuberculosis (TB) and HIV, as well as leprosy. METHODS: To identify and summarise the available literature regarding the assessment of treatment regularity in leprosy, a literature search of MEDLINE was conducted using the following search terms: 'leprosy' AND ('adherence' OR 'compliance' OR 'concordance'). To identify evidence for interventions that have involved community members in HIV, TB or leprosy adherence support, a literature search was conducted using the key terms and medical subject headings 'treatment or adherence' 'community,' 'HIV, TB or Leprosy' and 'low and middle income countries' combined using Boolean operators. RESULTS: Leprosy programmes routinely use defaulting and treatment completion as proxy measures of adherence as recommended by the WHO global strategy. However, a number of other methods have been used to assess adherence including questionnaires, pill counts, as well as direct measures based on testing urine for the presence of dapsone. Direct methods were extensively used during the dapsone mono-therapy era but there is little evidence of their use in MDT. Use of multiple methods of assessing adherence improves the accuracy and reliability of the results. Community activities in TB and HIV such as variants of treatment observation, and/or wider programmes of counselling or direct support to the patient or their family or to increase community or social support were shown to improve treatment outcomes. Outcomes evaluated included treatment default and completion, clinical indicators, and adherence (pill-count, self report). CONCLUSIONS: Adherence is very important in leprosy and regular assessment of medication adherence together with constructive feedback and counselling of patients is likely to be beneficial. Leprosy programme can learn from adherence support interventions developed by both TB and HIV programmes.

A comparison of the Screening Activity Limitation and Safety Awareness (SALSA) scale to objective hand function assessments.

PURPOSE: The purpose of this study was to demonstrate construct validity of the Screening of Activity Limitation and Safety Awareness (SALSA) scale by comparing the measurement outcomes to objective hand function assessments. The SALSA questionnaire was developed to measure self-reported activity limitation in persons affected by peripheral neuropathy. METHOD: In 25 persons affected by leprosy impairment scores were determined via sensory and manual motor testing of the hands. The SALSA was administered as well as the Functional Dexterity Test (FDT), the Nine Hole Peg Test (NHPT) and daily living tasks from the Smith Hand Function Evaluation (SHFE). RESULTS: The SALSA score varied from 16 to 64 (mean 29.16, SD 12.43). Twelve persons had no activity limitation while the others had increasing levels of activity limitation. Performance on the hand function tests was slower than established norms for these tests. The SALSA score correlated significantly with the NHPT (r = 0.77), the SHFE (r = 0.66) and the fdt (r = 0.54). Impairment scores correlated with both SALSA and functional tests results. CONCLUSION: The credibility of the SALSA scale was enhanced by this validation study and showed that the SALSA is a useful assessment tool to measure level of function and activity limitation.

Leprosy elimination campaign in Qazvin province, Islamic Republic of Iran (2006-07).

Multi-drug therapy (MDT) and Leprosy Elimination Campaigns (LEC) are the major strategies for eliminating leprosy. We report the results of a LEC conducted in 2006 in Qazvin. A total of 1987 individuals (1379 household contacts of 319 registered leprosy patients and 608 people from 3 endemic villages with a high prevalence of leprosy) were examined for detection of new cases of leprosy. All new cases were given MDT and were reviewed after a year. There were 256 suspected cases of leprosy, 13 of whom were confirmed as new cases (7 were classified as multibacillary leprosy). None had visible deformity nor was < 20 years old. All patients completed the recommended MDT course. The few cases detected suggest that in low prevalence areas, a long-term approach of integrated leprosy services and disability management may be more appropriate than LEC as a leprosy elimination strategy.

Evaluation of counseling outcomes at a university counseling center: the impact of clinically significant change on problem resolution and academic functioning.

The main purpose of this study was to investigate how receiving personal counseling at a university counseling center helps students deal with their personal problems and facilitates academic functioning. To that end, this study used both clinical and academic outcome measures that are relevant to the practice of counseling provided at a counseling center and its unique function in an institution of higher education. In addition, this study used the clinical significance methodology (N. S. Jacobson & P. Truax, 1991) that takes into account clients' differences in making clinically reliable and significant change. Pre-intake and post-termination surveys, including the Outcome Questionnaire (M. J. Lambert, K. Lunnen, V. Umphress, N. Hansen, & G. Burlingame, 1994), were completed by 78 clients, and the responses were analyzed using clinical significance methodology. The results revealed that those who made clinically reliable and significant change (i.e., the recovered group) reported the highest level of improvement in academic commitment to their educational goals and problem resolution, compared with those who did not make clinically significant change. The implications of the findings on practice for counseling at university counseling centers and for administrators in higher education institutions are discussed.

Long term sustainability and efficacy of self-care education on knowledge and practice of wound prevention and management among leprosy patients.

In a chronic disease like leprosy, assessment of self-care education of long duration is necessary to find out its effectiveness and to bring out sustainability both in the point of view of the provider and of the recipient. Self-care education was imparted to patients for 8 years in the Katpadi Block as part of 'prevention of impairment and disability' programme from the year 2000 onwards. The patients were provided with knowledge regarding 'inspection' for pre-disposing factors of wound development and about external causes (trauma) or dangerous environments for wound development. Additionally, they were given practice on self-care techniques for prevention and management of wounds. Staff as part of their routine work has been doing this. An evaluation, done by independent assessor, compared the effect of this programme with a control area where no such programme was going on. This showed that the self-care education resulted in very high level of knowledge and practice compared to the control area, even up to 100% practice in some aspects. Self-care education is effective, can be sustained for a long time and also can be carried out as part of routine work.

Community based rehabilitation programmes: monitoring and evaluation in order to measure results.

Although Community Based Rehabilitation has now formally existed for almost 30 years, few papers have been written about the results of this approach. The authors hope to contribute with this paper towards methodologies that will help to measure results of Community Based Rehabilitation programmes. The importance of establishing--prior to the development of Community Based Rehabilitation--an extensive baseline has not been extensively covered as the importance of it is almost self-evident; yet the lack of baseline data often severely hampers the possibility of being able to measure the effects of Community Based Rehabilitation. The article places considerable importance on management information systems and monitoring, since it is believed that evaluation will greatly benefit from both the existence of baseline data as well as a well-developed and well-implemented information system. The present article emphasises the need for participatory processes in the development of baseline data and information systems. Four key areas for measuring CBR are highlighted: people, power, public society and partnerships. Finally, a tool is presented in order to evaluate (or monitoring and evaluation) systematically. What gets measured gets done; If you don't measure results, you can't tell success from failure; If you can't see success, you can't reward it; If you can't reward success, you're probably rewarding failure; If you can't see success, you can't learn from it; If you can't recognize failure, you can't correct it; If you can demonstrate results, you can win public support.

Evidence for the effectiveness of rehabilitation-in-the-community programmes.

The present literature review identified 29 reports from 22 countries in Asia, Africa and Central America reporting on the outcomes of rehabilitation-in-the-community programmes in low and middle income countries published between 1987 and 2007. Interventions included home visits by trained community workers who taught disabled persons skills to carry out activities of daily living, encouraged disabled children to go to school, helped find employment or an income generating activity, often involving vocational training and/or micro-credit. Many programmes had a component of influencing community attitudes towards disabled persons. The information collected shows that such programmes were effective in that they increased independence, mobility and communication skills of disabled persons, helped parents of disabled children to cope better and increased the number of disabled children attending schools. Economic interventions effectively increased the income of disabled persons although they rarely made them financially independent. CBR activities result in social processes that change the way community members view persons with disabilities, increase their level of acceptance and social inclusion and mobilise resources to meet their needs. In most countries, coverage of CBR programmes is inadequate. CBR initiatives appear most beneficial to those who have mild physical disability and can communicate verbally. There is a need to invest in the generation of quality evidence about the outcome and impact of rehabilitation-in-the-community programmes to ensure its continued support.

Current situation of leprosy colonies/leprosaria and their future in P.R. China.

OBJECTIVE: To identify the current situation of leprosy colonies/leprosaria and make some recommendations for improving the quality of life of people affected by leprosy in China. METHODS: A national survey using designed forms was carried out in 2004. The forms were filled in by local heads responsible for the management of leprosy colonies/leprosaria and sent to Provincial and National Centres for analysis. RESULTS: China had 605 leprosy colonies/leprosaria with 555 active leprosy patients (on treatment) and 18,175 ex-patients (people affected by leprosy) living in them at the end of 2004. Among 18,730 patients and people affected by leprosy, 13,430 (71.7%) had grade 2 disabilities. Among those with visible disability, 6392 (47.6%) lost the ability to take care of themselves due to serious deformity. Because of a decrease in health workers working at leprosy colonies and a shortage of medical materials, the health care quality of these people was neglected. Most colonies/leprosaria were located at remote and isolateS places with difficult transportation, and most buildings/houses were in danger of collapse because the colonies/leprosaria were built in the 1950's. Those affected by leprosy were in great need of help. CONCLUSION: The authors recommend that small, remote and isolated leprosy colonies should be closed. New leprosaria at District, Provincial or National levels should be established or some old leprosaria with good transportation should be reconstructed to house those affected by leprosy from closed leprosy colonies/leprosaria. The newly established or reconstructed leprosaria could act as centres for reference, training, rehabilitation and research on leprosy.

Monitoring impairment in leprosy: choosing the appropriate tool.

OBJECTIVE: To assess to what extent the Maximum WHO Impairment Grade, the EHF Score and Impairment Summary Form (ISF) reflect changes in impairment, both in number(s) and severity. DESIGN: The impairment data at registration and at release from treatment of 444 persons affected by leprosy registered for MDT from 1994-2003 in Federal Capital Territory, Nigeria were analysed using three monitoring tools. RESULTS: Of the 444 patients, 92 people had a change (10 deteriorated, 70 improved while 12 had improvement in some parts of their body and deterioration in other parts) in their impairment between Registration and Release from Treatment. Of the 10 people whose impairment status deteriorated, the WHO Grade missed 7 and the EHF score missed 4. The ISF missed none. Of the 70 whose impairment status improved, the WHO grade missed 27; the EHF score missed 20 and the ISF missed 9. The WHO Grade had a sensitivity of 50%, the EHF Score 61% and the ISF 90%. Negative predictive values were 88%, 91% and 98% respectively. CONCLUSIONS: The Maximum WHO Impairment Grade use should be limited to an indicator of late case detection. The EHF score is better used at programme level than individual patient level. The ISF is a sensitive tool for monitoring impairments at patient level to aid clinical decision making.

Clinical utility of a stability-based ankle fracture classification system.

OBJECTIVE: Neither of the ankle fracture classification systems (Lauge-Hansen or Weber) in widespread use today is prognostic. To test the hypothesis that ankle fracture prognosis is dependent on initial biomechanical stability, an alternative classification system created using stability-based treatment criteria was developed on the basis of a structured analysis of the ankle fracture literature. DATA SOURCES: All English-language papers reporting on ankle fractures (searched using the terms "ankle + fracture") published between 1966 and 2005 with available online abstracts via PubMed were screened. STUDY SELECTION: Abstracts were manually screened for inclusion using the following criteria: (1) there were at least 2 groups of patients categorized on the basis of either fracture configuration or treatment and (2) data was reported in sufficient detail to permit interstudy comparisons. DATA EXTRACTION: Each included paper was abstracted into a computerized database for consistent data capture. Data elements included the following: fracture classification, stability definitions, surgical indications, patient follow-up parameters, and outcome measures. Ankle fractures were also stratified into stable and unstable groups using predefined stability criteria, and the outcome measures were re-analyzed. DATA SYNTHESIS: Wilcoxon matched-pairs signed-rank test was used for statistical comparisons, assigning statistical significance to 2-tailed tests with P < 0.05. CONCLUSIONS: The results support the hypothesis that a stability-based ankle fracture classification system can be prognostic. For unstable ankle fractures, the radiographic outcomes were better after surgery, when the decision for surgery was made on the basis of stability (P = 0.0173). Overall, non-operative treatment results were also better with stability-based treatment (P = 0.0299).

Sustainable leprosy related disability care within integrated general health services: findings from Salem District, India.

The main focus of leprosy control has been case detection and treatment delivery with relative neglect of prevention of disability. Absence of reliable data and lack of research have added to the problem. This raised concerns about the capacity of the general health system to address the needs of people living with leprosy-related disabilities. In this prospective study appropriate services for people living with leprosy-related disabilities were introduced in the form of self-care training, guidance and monitoring by the general health staff facilitated by a non-governmental organisation leprosy centre in a district in south India with a population of 3.1 million (estimated in 2005). The staff identified 1232 people with leprosy-related disabilities and trained them in self-care. Follow-up assessments indicated that 86% were found to be practising self-care regularly and all the 239 general health workers were found to be actively involved. The most heartening outcome was the healing of plantar ulcers in 70% of people at the 1-year follow up. This intervention is sustainable because of the simplicity of the procedures and the involvement of all health staff including supervisors.

A note on testing for intervention effects on binary responses.

OBJECTIVES: In some circumstances controlled trials are not feasible and treatments can only be evaluated using clinical databases. Here we consider the situation where treatment is introduced at a particular calendar time and can only be evaluated by comparison with historical controls. In these circumstances Heuer and Abel recommended using change-point methods to search for change in characteristics over the whole study period rather than simply comparing treated and untreated patients. Their recommendation is to only conclude that the intervention had an effect if a change-point could be demonstrated close in time to the introduction of the new treatment. This reduces the risk of false positives caused by confounding changes in population characteristics or changes in patient management. For binary data we develop a method that follows their philosophy and apply it to an observational study in the treatment of pin sites after orthopaedic surgery. METHODS: Tests for change in binomial probabilities based on Brownian bridge and Hansen's approximation for maximally selected chi(2) statistics are compared to an exact test by Worsley. The approximate method is generalized to logistic regression models allowing for covariates. RESULTS: The agreement of the exact and approximate method is good for sample sizes of 100 or more. The actual test size of the Hansen approximate test allowing for covariates is close to the nominal level, whereas the Brownian bridge approximation is slightly conservative. The change in pin site treatment significantly reduces the risk of infection for both adults and children. CONCLUSIONS: We consider the Hansen approximation to provide a very good and very simple method for obtaining the p-value when testing for a change in binary data event probabilities, with or without covariates.

Contribution of mini-LECS to cluster approach case finding in Kaduna State, Nigeria.

Mini-leprosy elimination campaigns (Mini-LECs) were carried out over a period of 5 years (2000-2004) in Kaduna State, Nigeria. After careful preparation, the campaign team visited areas with a high suspicion of hidden cases in 12 selected Local Government Areas (LGAs). During the years of the 12 campaigns, 156 new cases of leprosy were detected against an expected number of 70 within the same LGAs. The results of the mini-LECs were analysed to find out if this cluster approach contributed significantly to the overall leprosy case finding and change in the proportion of the multi-bacillary (MB) forms of leprosy among new cases in the State. The analysis shows that, at LGA level, the number of cases detected during the year of mini-LEC is statistically higher then the expected number of cases. The MB proportion at LGA level did not change due to the mini-LEC exercises. Due to the limited number of exercises, the impact at state level is insignificant. However, the experience at LGA level suggests that with an increase in number of mini-LEC campaigns per state per annum an impact at the state indicators can be expected. In addition the campaigns should be repeated for further yield of new leprosy cases.

A Delphi consensus on criteria for contraindications, assessment indicators and expected outcomes related to tibialis posterior transfer surgery.

A team of experts in the field of reconstructive surgery for leprosy-affected people was identified. Using the Delphi method, an exercise was undertaken to ascertain whether a consensus on essential criteria and indicators for Tibialis Posterior Transfer (TPT) could be reached among the team. This paper describes the Delphi Exercise, giving results at each stage of consensus development. The final outcome was that essential criteria, including contraindications for surgery, pre- and post- operative assessments and expected outcomes, were agreed. The criteria are presented with recommendations.