The pharmacological and clinical aspects behind dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs): rationale and systematic narrative review of clinical evidence.

BACKGROUND: Dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs) is performed to achieve steady state drug concentrations earlier after treatment start compared to dosing regimens without loading. Although loading inherently results in increased costs, treatment targets in terms of reduced disease activity may be achieved at an earlier state. It is an interesting topic that, surprisingly, has not received much attention in literature. METHODS: In this review, we aimed at providing a theoretical description of the pharmacodynamic / -kinetic rationale for dose loading of bDMARDs in AIRDs and to systematically review the clinical evidence on the effectiveness of dose loading on disease activity in AIRDs. RESULTS: Only a small number of studies (n = 5) has been published comparing the effectiveness of dose loading versus a regimen without dose loading of bDMARDs in AIRDs, addressing abatacept (n = 2), certolizumab pegol (n = 1), and secukinumab (n = 2). These studies provide insufficient evidence on superiority of dose loading in terms of disease activity compared to a dosing regimen without loading, while safety issues might be comparable. CONCLUSIONS: Although dose loading is commonly adopted for several bDMARDs in AIRDs, scientific evidence on its effectiveness and safety is surprisingly scarce and does not suggest superiority compared to a regimen without dose loading. More research in this field, also with regard to the pharmaco-economic consequences of dose loading, is urgently needed.

Case-mix adjustment for diabetes indicators: a systematic review.

OBJECTIVES: Case-mix adjustment is generally considered indispensable for fair comparison of healthcare performance. Inaccurate results are also unfair to patients as they are ineffective for improving quality. However, little is known about what factors should be adjusted for. We reviewed case-mix factors included in adjustment models for key diabetes indicators, the rationale for their inclusion, and their impact on performance. STUDY DESIGN: Systematic review. METHODS: This systematic review included studies published up to June 2013 addressing case-mix factors for 6 key diabetes indicators: 2 outcomes and 2 process indicators for glycated hemoglobin (A1C), low-density lipoprotein cholesterol, and blood pressure. Factors were categorized as demographic, diabetes-related, comorbidity, generic health, geographic, or care-seeking, and were evaluated on the rationale for inclusion in the adjustment models, as well as their impact on indicator scores and ranking. RESULTS: Thirteen studies were included, mainly addressing A1C value and measurement. Twenty-three different case-mix factors, mostly demographic and diabetes-related, were identified, and varied from 1 to 14 per adjustment model. Six studies provided selection motives for the inclusion of case-mix factors. Marital status and body mass index showed a significant impact on A1C value. For the other factors, either no or conflicting associations were reported, or too few studies (n ≤ 2) investigated this association. CONCLUSIONS: Scientific knowledge about the relative importance of case-mix factors for diabetes indicators is emerging, especially for demographic and diabetes-related factors and indicators on A1C, but is still limited. Because arbitrary adjustment potentially results in inaccurate quality information, meaningful stratification that demonstrates inequity in care might be a better guide, as it can be a driver for quality improvement.

A systematic approach towards the development of a set of quality indicators for public reporting in community-based maternity care.

OBJECTIVE: to demonstrate the process and outcome of a systematic approach towards the development of a set of quality indicators for public reporting on quality of community-based maternity care. DESIGN AND SETTING: a four-stepped approach was adopted. Firstly, we defined key elements of community-based maternity care, by performing a systematic search on care guidelines/ standards. Secondly, the literature was searched for existing indicators for maternity care, which were subsequently categorised according to the key elements and systematically selected on suitability of public presentation. The emerging set of indicators suitable for public reporting was presented to five health-care professionals using a Delphi technique (step 3). Based on the comments of the professionals, the set was adjusted and subsequently presented to the health-care consumers (a sample of pregnant women) in step four to test its validity, after which the final set was composed. PARTICIPANTS: health-care professionals in the field of maternity care and pregnant women. FINDINGS: key elements of community-based maternity care were extracted from eight guidelines and care standards. We then extracted 10 documents with 223 indicators in total, from which 19 indicators covering the key elements were included in the first set and presented to experts. Based on their comments three indicators were deleted and four indicators were added to the set or slightly rephrased. These were subsequently judged by 13 pregnant women. Seventy-five per cent of the indicators were judged positively by them; no indicator was judged negatively. The set of indicators was thus left unchanged after this final step. KEY CONCLUSIONS AND IMPLICATIONS FOR CLINICAL PRACTICE: the systematic approach adopted in this study resulted in an indicator set that was considered valid by both maternity care professionals and pregnant women, and is likely to satisfy the essential requirements on clinimetric properties. The next step will be to pilot test the indicator set on feasibility in daily clinical practice and to refine the set when necessary. In the future, maternity care professionals may use the set to present the quality of care they provide and to define issues of improvement. Pregnant women may use the information to make a founded choice between maternity care professionals, which ultimately should result in improved safety and quality of maternity care as well as patient satisfaction. Although we focused on the Dutch, community-based maternity care system, the approach used may be extrapolated to other care processes and health-care systems. Extrapolation of the results itself (i.e. the indicator set) may need to be limited to systems with an emphasis on community-based maternity care.

Quality and coordination of care for patients with multiple conditions: results from an international survey of patient experience.

Previous studies using clinical performance measures suggest that quality of care for patients with multiple chronic conditions is not worse than that for others. This article presents patient-reported experiences of health care among 8,973 of chronically ill adults from eight countries, using telephone survey data. We designed a ''morbidity score'' combining the number of conditions and reported health status. Respondents with high morbidity scores reported less favorable experience with coordination of care compared to those with low morbidity scores. They also reported lower ratings of overall quality of care. There were no differences in reported experience with the individual physicians. Comparing type of comorbidity, chronic lung, and mental health problems were associated with lower ratings than hypertension, heart disease, diabetes, arthritis, and cancer. The implications and limitations of this study are discussed in the context of health care reform. Pay-for-performance programs need to account for chronic conditions to avoid penalizing physicians who care for larger shares of such patients.

Perceived spasticity in chronic spinal cord injured patients: associations with psychological factors.

PURPOSE: To explore the association between perceived spasticity and psychological factors (pain sensations, coping strategies, and illness cognitions) in chronic spinal cord injured (SCI) patients. METHODS: Cross-sectional study using a set of questionnaires was designed for chronic complete patients with SCI and with self-reported leg spasticity. Outcome measures were Visual Analogue Scale for average perceived leg spasticity (VAS(Spasticity)), VAS(Pain) for average perceived pain sensations in the leg, Utrecht Coping List (UCL) including its seven subscales, and Illness Cognition Questionnaire (ICQ) with its three subscales. Psychological factors with a bivariate correlation with VAS(Spasticity) of p < 0.2 were selected for regression analyses. RESULTS: Nineteen patients with SCI (response rate 86%) participated. Bivariate correlations of p < 0.2 were found between VAS(Spasticity) and VAS(Pain), UCL(Active approach), UCL(Seeking social support), UCL(Reassuring thoughts), ICQ(Acceptation), and ICQ(Helplessness). Only UCL(Reassuring) (thoughts) (Beta -0.59, p = 0.01) and ICQ(Helplessness) (Beta 0.50, p = 0.02) were retained in the multivariate model, explaining 44% of the variance in VAS(Spasticity) (R(2)(adjusted)). CONCLUSIONS: Perceived spasticity appeared associated with psychological factors in complete patients with SCI: Those with higher levels of reassuring thoughts and lower levels of helplessness reported relatively lower levels of perceived spasticity. Large prospective cohort studies are recommended.

Review article: Effectiveness of patient care teams and the role of clinical expertise and coordination: a literature review.

Health care is increasingly provided by teams of health professionals rather than by individual doctors. For decision makers, it is imperative to identify the critical elements for effective teams to transform health care workplaces into effective team-based environments. The authors reviewed the research literature published between 1990 and February 2008. The available research indicated that teams with enhanced clinical expertise improved professional performance and had mixed effects on patient outcomes. Teams with improved coordination had some positive effects on patient outcomes and limited effects on costs and resource utilization. The combination of enhanced expertise and coordination only showed some limited effect on patient outcomes. The authors conclude that enhancement of the clinical expertise is a potentially effective component of improving the impact of patient care teams. The added value of coordination functions remained unclear. Overall, current studies provide little insight into the underlying mechanisms of teamwork.

Short-term effects and long-term use of a hybrid orthosis for neuromuscular electrical stimulation of the upper extremity in patients after chronic stroke.

OBJECTIVE: To associate the short-term effects of the Handmaster orthosis on disabling symptoms of the affected upper extremity with long-term Handmaster orthosis use after stroke. DESIGN: Historic cohort study. PATIENTS: Patients with chronic stroke. METHODS: The Modified Ashworth Scale (0-5) for wrist (primary outcome) and elbow flexor hypertonia, visual analogue scale (0-10) for pain, oedema score (0-3), and passive range of wrist flexion and extension (pROM, degrees) were assessed prior to Handmaster orthosis prescription (T0), after 6 weeks try-out (T1) and a subsequent 4 weeks withhold period (T2). Long-term use was evaluated using a questionnaire. Non-parametric analyses and predictive values were used for statistical analyses. RESULTS: Of the 110 included patients 78.2% were long-term Handmaster orthosis users. Long-term users showed significant short-term (T0-T1) improvements on all impairment scores and a significant relapse of wrist and elbow Modified Ashworth Scale (T1-T2). Non-users showed significant short-term effects on elbow Modified Ashworth Scale and visual analogue scale only. Positive predictive values of short-term effects for long-term use varied between 75% and 100%, with 85% (95% confidence interval (CI) 0.72-0.93) for wrist Modified Ashworth Scale. Negative predictive values were low (11-27%). CONCLUSION: Short-term Handmaster orthosis effects were generally beneficial for hypertonia, pain, oedema, and pROM, especially in long-term users. Short-term beneficial effects were highly predictive for long-term use, but not for non-use.

Prognostic factors for the effects of two interventions for work-related neck-shoulder complaints: myofeedback training and ergonomic counselling.

AIM: To explore prognostic factors for the effects of two interventions (myofeedback training in combination with ergonomic counselling (Mfb/EC) and ergonomic counselling alone (EC)) on discomfort and disability in work-related neck-shoulder complaints. METHODS: Thirty-six females completed the interventions. Discomfort and disability were assessed at baseline, immediately after the intervention, and at 3-month follow-up. Potential sociodemographic and psychological prognostic factors were assessed using questionnaires. Data were analysed using multiple regression and general linear modelling. RESULTS: Changes in discomfort were best predicted by baseline discomfort levels. Changes in disability were predicted by baseline disability levels, patient profile, and coping strategy 'ignoring sensations'. A significant difference between the Mfb/EC and EC group was found for coping strategy 'ignoring sensations', which appeared to be a predictor for changes in disability at 3-month follow-up in the Mfb/EC group only. CONCLUSIONS: Subjects with high levels of initial discomfort and disability and specific psychological patient profiles benefit most from interventions. Myofeedback training contributes a specific quality to those who ignore pain sensations.

Changes in cognitive-behavioral factors and muscle activation patterns after interventions for work-related neck-shoulder complaints: relations with discomfort and disability.

OBJECTIVES: Knowledge regarding the working mechanism of an intervention is essential for obtaining a better understanding of the intervention and contributes to optimize its outcome. This study aimed at investigating whether changes in cognitive-behavioral factors and muscle activation patterns after myofeedback training and ergonomic counseling were associated with outcome, in subjects with work-related musculoskeletal neck-shoulder complaints. METHODS: Seventy-nine symptomatic subjects received either myofeedback with ergonomic counseling (Mfb/EC) or ergonomic counseling alone (EC). Outcome measures discomfort and disability, and process factors catastrophizing, pain control, fear-avoidance beliefs, and muscle activation patterns were assessed at baseline, after the interventions (T0), and at 3 months follow-up (T3). Mixed modeling techniques were used for analysis. RESULTS: Outcome in terms of discomfort and disability was generally comparable between both interventions. Catastrophizing was significantly reduced and fear-avoidance beliefs about work slightly increased after the interventions, but no consistent changes in muscle activation patterns were observed. Changes in discomfort were especially associated with changes in catastrophizing at T0 and T3, but R(2) was low (<0.14). Reduced catastrophizing at T0 and T3, and also reduced fear-avoidance beliefs about work at T3, were related to reduced disability (R(2) between 0.30 and 0.40). No differences between the two intervention groups were observed. CONCLUSIONS: Intervention effects were generally non-specific and findings suggested that cognitive-behavioral factors underlie the outcome of these interventions rather than changes in muscle activation patterns. Emphasizing these factors during therapy may increase the beneficial outcome of occupational interventions.

Effects of ambulant myofeedback training and ergonomic counselling in female computer workers with work-related neck-shoulder complaints: a randomized controlled trial.

OBJECTIVE: To investigate the effects of ambulant myofeedback training including ergonomic counselling (Mfb) and ergonomic counselling alone (EC), on work-related neck-shoulder pain and disability. METHODS: Seventy-nine female computer workers reporting neck-shoulder complaints were randomly assigned to Mfb or EC and received four weeks of intervention. Pain intensity in neck, shoulders, and upper back, and pain disability, were measured at baseline, immediately after intervention, and at three and six months follow-up. RESULTS: Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC, and the effects remained at follow up. No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability. CONCLUSIONS: Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up. No differences were observed between the two intervention groups.

Changes in pain, disability, and muscle activation patterns in chronic whiplash patients after ambulant myofeedback training.

OBJECTIVE: The aim of this exploratory study was to investigate changes in pain, disability, and muscle activation patterns in patients with chronic whiplash-associated disorder (WAD) after 4 weeks of myofeedback training. METHODS: Eleven WAD patients received ambulatory myofeedback training, during which upper trapezius muscle activation and relaxation were continuously recorded and processed for 4 weeks. Feedback was provided when muscle relaxation was insufficient. Pain in neck, shoulders, and upper back (Visual Analogue Scale), disability (Neck Disability Index), and muscle activation patterns during rest, typing, and stress tasks (surface electromyography) were assessed before and after the 4 weeks of training. RESULTS: Pain intensity decreased after 4 weeks of training. Clinically relevant changes were found with regard to pain in the neck and upper back region (55% of the patients), right shoulder (64%), and left shoulder (18%). A trend for decreased disability was found which was clinically relevant in 36% of the patients. A remarkable reduction was found in the Neck Disability Index items concerning headache and lifting weights. Overall, muscle activation was lower and muscle relaxation was higher after the training period with the largest differences during rest. Clinically relevant changes in surface electromyography parameters were found in a minority of patients. CONCLUSION: Four weeks of ambulant training may be beneficial in reducing pain and disability levels and normalizing muscle activation patterns in chronic WAD patients. A randomized-controlled study is recommended to further explore the effects of myofeedback training.