Usual Clinical Care Research Articles

Workflow standardization of a novel team care model to improve chronic care: a quasi-experimental study

BackgroundTeam-based chronic care models have not been widely adopted in community settings, partly due to their varying effectiveness in randomized control trials, implementation challenges, and concerns about physician acceptance. The Palo Alto Medical Foundation designed and implemented “Champion,” a novel team-based model that includes new standard work (e.g. proactive patient outreach, pre-visit schedule grooming, depression screening, care planning, health coaching) to support patients’ self-management of hypertension and diabetes. We investigated whether Champion improved clinical outcomes.MethodsWe conducted a quasi-experimental study comparing the Champion clinic-level intervention (n = 38 physicians) with a usual care clinic (n = 37 physicians) in Northern California. The primary outcomes, blood pressure and glycohemoglobin (A1c), were analyzed using a piecewise linear growth curve model for patients exposed to a Champion physician visit (n = 3156) or usual care visit (n = 8034) in the two years prior and one year post implementation. Secondary outcomes were provider experience, compared at baseline and 12 months in both the intervention and usual care clinics using multi-level ordered logistic modeling, and electronic health record based fidelity measures.ResultsCompared to usual care, in the first 6 months after a Champion physician visit, diabetes patients aged 18-75 experienced an additional -1.13 mm Hg (95% CI: -2.23 to -0.04) decline in diastolic blood pressure and -0.47 (95% CI: -0.61 to -0.33) decline in A1c. There were no additional improvements in blood pressure or A1c 6 to 12 months post physician visit. At 12 months, Champion physicians reported improved experience with managing chronic care patients in 6 of 7 survey items (p < 0.05), but compared to usual, this difference was only statistically significant for one item (p < 0.05). Fidelity to standard work was uneven; depression screening was the most commonly documented element (85% of patients), while care plans were the least (30.8% of patients).ConclusionsChampion standard work improved glycemic control over the first 6 months and physicians’ experience with managing chronic care; changes in blood pressure were not clinically meaningful. Our results suggest the need to understand the relationship between the intervention, the contextual features of implementation, and fidelity to further improve chronic disease outcomes. This study was retrospectively registered with the ISRCTN Registry on March 15, 2017 (ISRCTN11341906).

Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial

BackgroundPrior studies in critically ill patients suggest the supra-physiologic chloride concentration of 0.9% (“normal”) saline may be associated with higher risk of renal failure and death compared to physiologically balanced crystalloids. However, the comparative effects of 0.9% saline and balanced fluids are largely unexamined among patients outside the intensive care unit, who represent the vast majority of patients treated with intravenous fluids.Methods/designThis study, entitled Saline Against Lactated Ringer’s or Plasma-Lyte in the Emergency Department (SALT-ED), is a pragmatic, cluster, multiple-crossover trial at a single institution evaluating clinical outcomes of adults treated with 0.9% saline versus balanced crystalloids for intravenous fluid resuscitation in the emergency department. All adults treated in the study emergency department receiving at least 500 mL of isotonic crystalloid solution during usual clinical care and subsequently hospitalized outside the intensive care unit are included. Treatment allocation of 0.9% saline versus balanced crystalloids is assigned by calendar month, with study patients treated during the same month assigned to the same fluid type. The first month (January 2016) was randomly assigned to balanced crystalloids, with each subsequent month alternating between 0.9% saline and balanced crystalloids. For balanced crystalloid treatment, clinicians can choose either Lactated Ringer’s or Plasma-Lyte A©. The study period is set at 16 months, which will result in an anticipated estimated sample size of 15,000 patients. The primary outcome is hospital-free days to day 28, defined as the number of days alive and out of the hospital from the index emergency department visit until 28 days later. Major secondary outcomes include proportion of patients who develop acute kidney injury by creatinine measurements; major adverse kidney events by hospital discharge or day 30 (MAKE30), which is a composite outcome of death, new renal replacement therapy, and persistent creatinine elevation >200% of baseline; and in-hospital mortality.DiscussionThis ongoing pragmatic trial will provide the most comprehensive evaluation to date of clinical outcomes associated with 0.9% saline compared to physiologically balanced fluids in patients outside the intensive care unit.Trial registrationClinicalTrials.gov, NCT02614040. Registered on 18 November 2015.

Bridging Income Generation with Group Integrated Care for cardiovascular risk reduction: Rationale and design of the BIGPIC study

Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with >80% of CVD deaths occurring in low and middle income countries (LMICs). Diabetes mellitus and pre-diabetes are risk factors for CVD, and CVD is the major cause of morbidity and mortality among individuals with DM. There is a critical period now during which reducing CVD risk among individuals with diabetes and pre-diabetes may have a major impact. Cost-effective, culturally appropriate, and context-specific approaches are required. Two promising strategies to improve health outcomes are group medical visits and microfinance. This study tests whether group medical visits integrated into microfinance groups are effective and cost-effective in reducing CVD risk among individuals with diabetes or at increased risk for diabetes in western Kenya. An initial phase of qualitative inquiry will assess contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance for CVD risk reduction. Subsequently, we will conduct a four-arm cluster randomized trial comparing: (1) usual clinical care, (2) usual clinical care plus microfinance groups only, (3) group medical visits only, and (4) group medical visits integrated into microfinance groups. The primary outcome measure will be 1-year change in systolic blood pressure, and a key secondary outcome measure is 1-year change in overall CVD risk as measured by the QRISK2 score. We will conduct mediation analysis to evaluate the influence of changes in social network characteristics on intervention outcomes, as well as moderation analysis to evaluate the influence of baseline social network characteristics on effectiveness of the interventions. Cost-effectiveness analysis will be conducted in terms of cost per unit change in systolic blood pressure, percent change in CVD risk score, and per disability-adjusted life year saved. This study will provide evidence regarding effectiveness and cost-effectiveness of interventions to reduce CVD risk. We aim to produce generalizable methods and results that can provide a model for adoption in low-resource settings worldwide.

Measures in assessment of pediatric systemic lupus erythematosus

Systemic lupus erythematosus in children is aggressive disease with an unpredictable course and a more severe phenotype compared to adults. An appropriate monitoring of disease activity, damage and effectiveness of therapy is reqired. The first part of this artcle is review of indices and scales validated by international community for assessment of disease activity, flares, damage and response to therapy in clinical research, trials and usual clinical care; their strengths, restrictions and ability to detect changes are evaluated. We characterized different versions and modifications of standard indices, their advantages and disadvantages. Conclusion: The set of indices including ECLAM, SELENA-SLEDAI, SFI and Ped-SDI can be recommended for retrospective pediatric clinical studies, as they are simple for use and validated by international community.

Neutrophil Counts and Initial Presentation of 12 Cardiovascular Diseases: A CALIBER Cohort Study

BackgroundNeutrophil counts are a ubiquitous measure of inflammation, but previous studies on their association with cardiovascular disease (CVD) were limited by small numbers of patients or a narrow range of endpoints. ObjectivesThis study investigated associations of clinically recorded neutrophil counts with initial presentation for a range of CVDs. MethodsWe used linked primary care, hospitalization, disease registry, and mortality data in England. We included people 30 years or older with complete blood counts performed in usual clinical care and no history of CVD. We used Cox models to estimate cause-specific hazard ratios (HRs) for 12 CVDs, adjusted for cardiovascular risk factors and acute conditions affecting neutrophil counts (such as infections and cancer). ResultsAmong 775,231 individuals in the cohort, 154,179 had complete blood counts performed under acute conditions and 621,052 when they were stable. Over a median 3.8 years of follow-up, 55,004 individuals developed CVD. Adjusted HRs comparing neutrophil counts 6 to 7 versus 2 to 3 × 109/l (both within the ‘normal’ range) showed strong associations with heart failure (HR: 2.04; 95% confidence interval [CI]: 1.82 to 2.29), peripheral arterial disease (HR: 1.95; 95% CI: 1.72 to 2.21), unheralded coronary death (HR: 1.78; 95% CI: 1.51 to 2.10), abdominal aortic aneurysm (HR: 1.72; 95% CI: 1.34 to 2.21), and nonfatal myocardial infarction (HR: 1.58; 95% CI: 1.42 to 1.76). These associations were linear, with greater risk even among individuals with neutrophil counts of 3 to 4 versus 2 to 3 × 109/l. There was a weak association with ischemic stroke (HR: 1.36; 95% CI: 1.17 to 1.57), but no association with stable angina or intracerebral hemorrhage. ConclusionsNeutrophil counts were strongly associated with the incidence of some CVDs, but not others, even within the normal range, consistent with underlying disease mechanisms differing across CVDs. (White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study [CALIBER]; NCT02014610)

The Herts and minds study: evaluating the effectiveness of mentalization-based treatment (MBT) as an intervention for children in foster care with emotional and/or behavioural problems: a phase II, feasibility, randomised controlled trial

BackgroundA significant proportion of children in the social care system in England present with mental health problems, with the majority experiencing some form of emotional and behavioural difficulties. The most effective treatments for these children are currently unknown, partly due to a lack of robust, controlled studies. Researchers have identified a number of obstacles to conducting well-designed research with this population, making the need to test the feasibility of a randomised controlled trial especially important.Methods/designThis protocol outlines a two-arm, randomised control feasibility trial to explore the acceptability and credibility of mentalization-based treatment (MBT) as a treatment for reducing emotional and behavioural difficulties in looked after children and to test the possibility of addressing a number of methodological challenges to conducting high-quality research with this population. MBT is a relatively new intervention which, in the adaptation of the model tested here, includes many of the features of therapy identified in NICE guidelines as necessary to support children in care. The two arms are MBT and usual clinical care (UCC). The study will take place in Hertfordshire Partnership University NHS Foundation Trust with follow-up at 12 and 24 weeks.DiscussionThis study will aim to ascertain whether it is worthwhile and feasible to progress to testing the intervention in a full-scale definitive randomised controlled trial (RCT). This study therefore has the potential to improve our understanding of the obstacles to conducting high-quality research with this very vulnerable population, and in the medium term, could help to improve the stability of foster placements and the emotional well-being of children in care.Trial registrationISRCTN90349442

Cost-effectiveness of a cascade screening program for the early detection of familial hypercholesterolemia

Although familial hypercholesterolemia (FH) confers a high risk of coronary artery disease, most patients are undiagnosed, and little is known about the efficiency of genetic cascade screening programs at national level. The aim of the study was to estimate the cost-effectiveness of a national genetic cascade screening program in Spain. An economic evaluation was performed using a decision tree analysis. The choice in the decision tree was between implementation of the national program for FH (NPFH) or keeping the usual clinical care. The NPFH detects FH patients through total cholesterol measurement at primary care level and use of genetic testing in index cases and relatives. The payer (National Health System) and social (including the productivity lost) perspectives were considered. The outcome variables were coronary events avoided, deaths avoided, and quality-adjusted life years (QALYs) gained. From the payer perspective, the application of the NPFH during 1 year prevents 847 coronary events and 203 deaths in the 9000 FH patients cohort during a 10-year follow-up, yielding an extra 767 QALYs, at a cost of €29,608 per QALY gained. From the social perspective, the NPFH is dominant over the control (the cost decreases and the effectiveness increases). The sensitivity analysis confirms the robustness of the findings. The NPFH based on molecular testing is a cost-effective diagnostic and management strategy that supports government expenditure aimed at preventing coronary artery disease in FH patients in Spain. Implementation of such a strategy is likely to be also cost-effective in countries with similar developed healthcare systems.

Telemedicine for Depression in Older People Living with HIV

Objective: The aims were to evaluate older HIV+ participant initial amenability towards telemedicine, change in amenability post-session, and clinician impressions of conducting the interview (including the Hamilton Depression Rating Scale (Ham-D)) via telemedicine. This paper focuses specifically on telemedicine as videoconferencing. Methods: This 2-phase study evaluated telemedicine in an urban setting to people living with HIV (PLWH) aged 50+ with mild-moderate depression based on the Patient Health Questionnaire (PHQ-9). Initial perception on telemedicine was collected during Phase I. Amenable participants who completed Phase I engaged in an actual home-based telemedicine (HBT) session during Phase II, after which their perception was measured again. Results: 41 subjects completed Phase I; 25 completed Phase II. Among Phase II completers, analysis using paired t-tests and chi-squared tests demonstrated a significantly improved outlook towards telemedicine after the session, including comfort with perceived privacy (p=0.001), overall satisfaction (p<0.001), and preference for telemedicine over in-person consultation (p<0.001). Those who were not amenable to scheduling a telemedicine session were more likely to be unsure about the privacy of such sessions (44% vs. 8%, p=0.011). Clinician questionnaires further supported the utility of telemedicine for clinical assessment. Conclusion: Telemedicine with use of standardized assessments is a clinically viable means to evaluate depression in HIV-positives aged ≥50 with mild-moderate depression. Systems of care in HIV psychiatry may consider use of home-based telemedicine when expanding clinical services for this growing population, particularly those with barriers to participate in usual in-person clinical care

Patient empowerment as a promising avenue towards health and social care integration: results from an overview of systematic reviews of patient empowerment interventions

Background : The ever increasing complexity of health care paired with the increasing proportion of chronic patients and other factors are clearly exacerbating the need for an all round well coordinated health (and social) system. This need for better integration of services has long sparked the interest for health system research and in the last 15 years this area has expanded and it now includes the increasingly active role of the patients, the field of patient empowerment. Although it has been strongly developed for over a decade now, it is still far from being consistent in terms of conceptualisations, categorisations and analysis. The results from the EMPATHiE project, by conducting a through review of systematic reviews analysing patient empowerment interventions targeting chronic conditions, aims to provide an overview of the field and advance in our common understanding of the role the patients as active players can have in the future developments of an integrated health (and social) systems. Objectives : To identify the effective empowerment interventions targeting chronic patients (chronic respiratory diseases (COPD or Asthma); chronic cardiovascular diseases; diabetes mellitus (type 1 and 2); severe mental illness (schizophrenia or chronic depression); complex patients (multi-morbidity) or health or social professionals working with the described chronic patients). Also we aimed to describe main contextual factors that help or hinder their implementation. Methods : Overview of systematic reviews (SR) of empowerment interventions for patients with chronic conditions from 2000 to 2013 was conducted for EMPATHIE (EU Project on Patient empowerment). Selected articles were extracted collecting intervention characteristics, outcome measures and scientific quality (AMSTAR). The effectiveness of the interventions was measured in terms of patient empowerment related measures, clinical outcomes, quality of life measures and use of health services. The success and failure factors were identified with a mixed methodology: results from meta-analysis and subgroup analysis and qualitative review of the conclusions of the SR’s authors. The interventions and identified factors are categorized by type of intervention, targeted condition, and level of evidence. Results : The search identified 101 SRs of interest (corresponding to more than 2300 individual studies) A descriptive analysis detected that most of the interventions reported in the studies were addressed to patients at micro or meso level. A predominance of interventions targeted diabetic patients (28.7% of SRs), followed at a distance by interventions targeting chronic respiratory conditions (25.7%), cardiovascular (12.9%), mental health conditions (10.9%) and just 1% specifically targeting complex patients. Within a general positive tendency (when compared to usual clinical centred care) some specific interventions emerge as the most effective: self-management support interventions across all conditions and different formats of patient education for diabetic patients. Recent innovative practices (such as virtual interactive platforms and tele-monitoring through smartphones) present a positive tendency, mainly in diabetes and cardiovascular conditions. Finally, systemic changes regarding the model of care (such as the chronic care model), seem to yield positive results. Similar interventions report different levels of effectiveness, which can be partially explained by multiple factors such as targeted condition, specific components of the intervention, patient and provider characteristics, contextual factors and outcome measures used. The study of the effect appears to indicate that, to a significant degree, success and failure factors are related to the targeted behaviour, which in turn is mediated, by the type of condition in which it is applied. Conclusion : Interventions targeting patient empowerment tend to present positive results in several types of outcomes. Self-management support interventions and some type of patient education formats presented the most conclusive evidence in their effectiveness. Recent innovative practices (as IT based platforms) present a positive tendency but still need further research particularly regarding the ideal combination between more traditional care and these innovative practices. Practical implications for policy and clinical organization will be discussed during the presentation. Stronger evaluative work on effectiveness of meso and macro level initiatives of patient empowerment is needed. Overall patient empowerment has opened a promising avenue towards healthcare (and social) integration.

The Impact of a Sleep Hygiene Intervention on Sleep Habits in Children with Attention Deficit/Hyperactivity Disorder

BackgroundAttention Deficit/Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood. Up to 50% of these children suffer from at least one comorbid sleep disorder. Considering the deleterious effects of sleep problems on all aspects of children's life, this study was designed to investigate the impact of a sleep hygiene intervention on sleep habits in children with ADHD and comorbid sleep disorders.Materials and MethodsThis randomized controlled trial, was conducted on 62 children aged 7 to13 years with diagnosis of ADHD and comorbid sleep disorders. Children's Sleep Habits Questionnaire (CSHQ) was completed by children's mothers and then the participants allocated randomly into experimental (n=28) and control (n=28) groups. Mothers of the children in experimental group received a sleep hygiene educational intervention which was delivered through a training session and a booklet followed by two telephone calls and educational text messages. Participants in the control group received usual clinical care. The post-test was performed two months after intervention.Results56 children (case and control groups) completed the survey (mean age 8.62 ± 1.57 years). Data analysis showed that, compared with control children, experimental children had a significant- reduction in mean scores of Bedtime resistance (P<0.05), Sleep onset delay (P<0.05), Sleep duration (P<0.05), Sleep anxiety (P<0.05), Daytime sleepiness (P<0.05) and total score of CSHQ (P<0.05), after controlling pre-test.ConclusionThe sleep hygiene intervention improved sleep problems in a sample of children with ADHD by parent report. The findings of this study support the design, implementation and evaluation of educational programs on good sleep-hygiene practices for children and adolescents.

Impact of Pharmacy Intervention on Prior Authorization Success and Efficiency at a University Medical Center.

Prior authorizations (PAs) may improve appropriate use of prescription medications. Despite potential savings for health insurance plans, the PA process is time consuming for the ordering provider, pharmacy, and patient. The UC Davis Health System (UCDHS) has created a centralized pharmacy-run clinic PA process. To compare the mean PA processing time between the new centralized clinic and usual care and provide secondary endpoints for PA approval rates, time to prescription fill, time to prescription pick-up, total staff time, and estimated labor costs. This is a prospective observational study comparing sequential PA requests at the UCDHS centralized clinic (intervention) and other UCDHS clinics (usual care) between January 1, 2014, and December 31, 2014. The Cochran-Mantel-Haenszel test was used to compare dichotomous outcomes (approval/denial rates) between the 2 groups, controlling for insurance type. A generalized linear model was applied for comparing the continuous outcomes (PA process time, time to first fill, time to pick-up, and cost) with insurance type as covariate. For the intervention group, 47 PAs were evaluated, and 77 PAs were evaluated in the usual care group. The average PA process time was 0.53 days for the intervention group versus 7.02 days for usual care (P < 0.001), and the PA approval rate was 93% for the intervention group versus 68% for usual care (P < 0.002). The mean time to fill was 2.49 days and 5.52 days for the intervention and usual care clinics, respectively (P = 0.02). The pick-up percentage was 75% versus 52% for intervention and usual care, respectively (P < 0.001). The intervention clinic spent a significantly lower mean time processing PAs (15 minutes vs. 64 minutes) compared with the usual care clinics (P < 0.001). It is estimated that the mean total labor cost per PA at the intervention clinic was $11.50 compared with $37.50 for the usual care clinics (P < 0.001). Pharmacy-led interventions in PA processing resulted in a statistically significant benefit in improving time to PA approval, time to first fill, and time to pick-up. No outside funding supported this study. The authors report no conflicting interests. Melnikow and Cutler contributed the study concept and design, with assistance from the other authors. Lester, Barca, and She collected the data, and Xin performed all statistical analysis. Cutler was the major contributor to manuscript preparation, with assistance from the other authors.

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

BackgroundThe benefit of an implantable cardioverter–defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT).MethodsIn a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death.ResultsAfter a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29).ConclusionsIn this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945.)

A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.

The Use of Infrared Thermometry in Confirming First Metatarsophalangeal Joint Fusion

Category: Midfoot/Forefoot Introduction/Purpose: Confirming the presence or absence of union is a critical determination in the care of individuals following attempted surgical fusion. This most commonly is done using clinical examination in conjunction with imaging. Infrared thermometry (IRT) has been used in other areas of clinical foot and ankle care, and has been shown to be a reliable method of measuring skin temperature. Given the complex morphology of the foot and ankle and the confounding clinical presentation of cases of foot and ankle fusions during the post-operative recovery, trying to determine the presence of absence of clinical union can be difficult. An adjunctive method to further inform the post-operative recovery would be helpful. In this study, IRT is investigated as an adjunctive method of confirming clinical union of attempted first metatarsophalangeal (or 1st MTP) fusion. Methods: Thirty-three individuals undergoing 1st MTP joint fusion were prospectively measured using IRT. Temperature at the 1st MTP site was recorded preoperatively, 10-14 days postoperatively, 42 days postoperatively, and 90 days postoperatively. Each case was followed post-operatively as per usual clinical care guidelines, and union was confirmed by a combination of clinical examination and radiographs. All data were collected from two testing centers, using compatible IRT devices. Results: Temperature at the 1st MTP site increased from preoperatively (82.7°F ± 4.4°) to 10-14 days postoperatively (89.2°F ± 2.7°; p &lt; .001); it declined from 10-14 days postoperatively to 42 days postoperatively (84.5°F ± 3.9°; p &lt; .001); and it declined from 42 days postoperatively to 90 days postoperatively (81.5°F ± 4.6°; p &lt; .001). The final temperature was statistically not significant from the pre-operative value, or the value measured on the opposite 1st MTP joint. Temperature data collected from one of the testing centers was significantly higher than the data collected from the other center (p &lt; .001), suggesting a potential location or climate effect. No non-unions were recorded during the study. Conclusion: Results suggest that IRT was successful in predicting and confirming union in the setting of 1st MTP joint fusion - where temperature of the 1st MTP joint returned to pre-operative and opposite side levels. For this reason, IRT presents itself as a valuable adjunct in the setting of 1st MTP joint fusion. Collecting contralateral foot temperature data may be a less biased means of tracking the progression of healing than the use of absolute foot temperatures, and a method to avoid regional ambient temperature differences.

Development of a nomogram to estimate the quality of life in asthmatic children using the Childhood Asthma Control Test.

Pediatric Asthma Quality of Life Questionnaire (PAQLQ) provides detailed information on QoL in asthmatic children, whereas Childhood Asthma Control Test (C-ACT) Questionnaire is the most validated instrument for asthma control. No study assessed the relationship between C-ACT and QoL in children by means of those instruments. The aim of this study was to determine whether a QoL estimation is possible using the C-ACT questionnaire in asthmatic children. Medical history, spirometry, C-ACT, and PAQLQ were assessed in 144 (60% male) outpatient asthmatic children from September 2011 to November 2014. A generalized linear model (GLM) for the prediction of PAQLQ was obtained through a stepwise procedure starting from a full model with all C-ACT items, and predictive nomograms were created. Fifty-five (38%) well-controlled (WC) asthma, 37 (26%) partially controlled (PC) asthma, and 52 (36%) uncontrolled asthma (UA) patients were enrolled. Persistent asthmatics (PA) were significantly more uncontrolled (p < 0.0001). A significant reduction in FEV1 , FEV1 /FVC, and FEF25-75 (p = 0.005, p < 0.0001, and p < 0.001, respectively) was found in WC vs. UA. Through a stepwise process, a reduced model showed a positive relationship between the PAQLQ and the four items of C-ACT. The regression equations for predicted PAQLQ were ln(PAQLQ) = 1.17 + 0.05*C-ACT2 + 0.03*C-ACT3 + 0.04*C-ACT6 + 0.03*C-ACT7. Thus, a nomogram was constructed. The designed nomogram provides a highly predictive assessment of QoL in individual patients, facilitating a more comprehensive assessment of asthmatic children in usual clinical care.

Do pessimists report worse outcomes after total hip arthroplasty?

BackgroundSeligman’s theory of causal attribution predicts that patients with a pessimistic explanatory style will have less favorable health outcomes. We investigated this hypothesis using self-reported hip pain and hip function 2- years after total hip arthroplasty (THA).MethodsMost THA patients had completed the Minnesota Multiphasic Personality Inventory (MMPI) during their usual clinical care long before THA (median, 14.7 to 16.6 years). Scores from the MMPI Optimism-Pessimism (PSM) scale were used to categorize patients as pessimistic (t-score >60) or non-pessimistic (t score ≤60). Outcomes were self-reported: (a) moderate-severe pain, (b) absence of “much better” improvement compared to preoperative hip function, and (c) moderate-severe activity limitation. Multivariable logistic regression was adjusted for gender, age and other covariates. Odds ratios (OR) with 95 % confidence intervals (CI) are presented.ResultsWe identified 507 patients with 565 primary THAs with an MMPI prior to primary THA, of whom 441 patients with 488 primary THAs had responded to hip pain and function follow-up surveys at 2-years post-surgery. Similarly, 202 patients with 235 revision THAs had an MMPI prior to surgery, of whom 172 patients with 196 revision THAs completed 2-year surveys. Among those with primary THA, pessimists reported (a) a non-significant trend toward more moderate-severe pain at 2-years with OR (95 % CI; p-value), 2.16 (0.90, 5.20; p = 0.08; reference, none-mild pain),; (b) no significant difference for absence of “much better” improvement in hip function at 2-years, 1.87 (0.77, 4.52; p = 0.16; reference, much better hip function); and (c) significantly higher rate of moderate-severe activity limitation at 2-years, 2.90 (1.25, 6.70; p = 0.01). Among revision THA cohort, pessimists reported no significant differences from non-pessimists in moderate-severe pain, improvement in hip function or moderate-severe functional limitation at 2-years.ConclusionsA pessimistic explanatory style was associated with moderate-severe activity limitation and a non-significant trend towards moderate-severe pain post-THA.

Changes in resting metabolic rate and body composition after bariatric surgery in two severely obese adolescent patients attending a bariatric healthy weight clinic: A clinical case report

BackgroundThe literature supports the concept that resting metabolic rate (RMR) decreases significantly after bariatric surgery and that there is a relationship between body composition changes and decline in RMR. Research also indicates that the greater the decline in RMR through weight loss, the greater the chance for weight regain. There are currently no data describing RMR changes of severely obese adolescent bariatric patients in the clinical setting.AimThis current clinical observation describes changes in RMR and body composition in two severely obese adolescents who were part of a healthy weight bariatric clinic and who underwent laparoscopic sleeve gastrectomy.MethodsPatients who were eligible for bariatric surgery were recruited as part of a nine‐ month pilot study which aimed to observe changes in RMR in adolescents pre‐ and post –surgery. Institutional Review Board (IRB) approval was obtained and patients interested in the study signed an informed consent and assent for the measurement of RMR via indirect calorimetry. Eight patients signed informed consent for RMR testing; four patients were lost to clinical follow‐up. Four patients underwent pre‐surgery RMR testing, two of those patients underwent bariatric surgery and completed post‐surgery RMR testing. Patients participated in their usual clinical care. Patients arrived at the clinic approximately 30–45 minutes before their regularly scheduled clinic appointment and were fasting. Protocol for indirect calorimetry was followed.ResultsPre‐surgery (one month before surgery) weight for Patient 1: 124.4kg, BMI 36.8; Patient 2 : 149.4kg, BMI 55.5. Both patients demonstrated a decline in RMR post‐surgery (Patient 1: 25% of baseline, 68 days post‐surgery; Patient 2: 5% of baseline, 94 days post‐surgery). Patient 1 lost 12.8% body weight with a decrease of RMR from 21.28kcal/kg body weight to 18.28kcal/kg. Patient 2 lost 14.8% body weight with change in RMR from 15.29kcal/kg body weight to 17.26 kcal/kg. Interestingly, patient 2 lost more muscle mass (14.1%) than patient 1 (9.4%) through surgery yet had less of a decline in RMR when compared to patient 1. Overall total percent body fat changes post‐surgery was quite small for both patients (Patient 1: −2.8%; Patient 2: −1.6%)ConclusionCurrently, best‐practice guidelines are used in the nutrition management of adolescent bariatric patients; however, there is no standardization of nutrition care. Further research investigating the changes in RMR and body composition in severely obese adolescents undergoing bariatric surgery in the clinical setting and what may be the clinical implications of these changes is still needed. Tracking RMR and body composition over‐time may help guide clinical practice for individualized nutrition and exercise recommendations that could help prevent weight regain post‐surgery.Support or Funding InformationGeorgia State University, Lewis School of Nursing and Health Professions Intramural Grant Program 2013–2014

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

ObjectivesWe aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI).MethodsFor this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care (n = 84), or usual clinic care only (n = 75). Online outcome data were solicited at 3, 6, and 12 months.ResultsMen were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website (n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90).ConclusionIt is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings.Trial registration number: ISRCTN18649610

Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

Initial development of a treatment adherence measure for cognitive-behavioral therapy for child anxiety.

The measurement of treatment adherence (a component of treatment integrity defined as the extent to which a treatment is delivered as intended) is a critical element in treatment evaluation research. This article presents initial psychometric data for scores on the Cognitive-Behavioral Therapy Adherence Scale for Youth Anxiety (CBAY-A), an observational measure designed to be sensitive to common practice elements found in individual cognitive-behavioral therapy (ICBT) for youth anxiety. Therapy sessions (N = 954) from 1 efficacy and 1 effectiveness study of ICBT for youth anxiety were independently rated by 2 coders. Interrater reliability (as gauged by intraclass correlation coefficients) for the item scores averaged 0.77 (SD = 0.15; range .48 to .80). The CBAY-A item and scale (skills, model, total) scores demonstrated evidence of convergent and discriminant validity with an observational measure of therapeutic interventions and an observational measure of the alliance. The CBAY-A item and scale scores also discriminated between therapists delivering ICBT in research and practice settings and therapists delivering nonmanualized usual clinical care. We discuss the importance of replicating these psychometric findings in different samples and highlight possible application of an adherence measure in testing integrity-outcome relations.