Methodological Issues Relevant to Blinding in Physical Medicine and Rehabilitation Research.

ABSTRACT: Blinding in research is important, and the field of physical medicine and rehabilitation poses special consideration owing to the patient populations and treatment methodologies used. Historically, blinding has been increasingly relevant to conducting good-quality research. The main reason to blind is to reduce bias. There are several strategies to blinding. At times, when blinding is not possible, alternatives to blinding include sham control and description of study and control groups. Illustrative examples of blinding used in physical medicine and rehabilitation research are described in this article, along with how to assess success and fidelity of blinding.

Effect of integrated exercise therapy and psychosocial interventions on self-efficacy in patients with chronic low back pain: A systematic review.

OBJECTIVE: Investigate if integrated exercise and psychosocial (EP) interventions effect self-efficacy to manage pain and self-efficacy for physical functioning compared to alternate interventions, usual care, waitlists and attention controls for individuals with chronic low back pain (CLBP). METHODS: MEDLINE, Embase, CINAHL, Web of Science, PsychINFO, PEDro, and Cochrane Library were searched. Included randomized controlled trials utilized an EP intervention for CLBP and measured self-efficacy. Independent reviewers screened abstracts, reviewed full-texts, extracted data, and assessed risk of bias. GRADE, synthesis without meta-analysis, and ranges of effects (Hedges' g) were used. RESULTS: 2207 Participants were included (22-studies). EP interventions positively effected self-efficacy to manage pain short-term compared to usual care (range of effects: -0.02, 0.94) and controls (range of effects: 0.69, 0.80) and intermediately compared to usual care (range of effects: 0.11, 0.29); however, no differences were found when compared to alternate interventions. EP interventions positively effected self-efficacy for physical functioning short-term compared to alternate interventions (range of effects: 0.57, 0.71), usual care (range of effects: -0.15, 0.94), and controls (range of effects: 0.31, 0.56), and intermediately compared to alternate interventions (1-study, effect: 0.57) and controls (1-study, effect: 0.56). Conclusions were limited by low to very low-quality-evidence often from risk of bias, imprecision, and clinical/statistical heterogeneity. CONCLUSIONS: EP interventions may be more effective short-term for self-efficacy to manage pain than usual care and waitlists, but not alternate interventions. EP interventions may be effective for self-efficacy for physical functioning at short- and intermediate-term compared to alternate interventions, usual care, waitlist and attention controls. Considerations for future research include methods for blinding and measurement of self-efficacy for physical functioning.

Interventions to improve adherence to pharmacological therapy for chronic obstructive pulmonary disease (COPD).

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a chronic lung condition characterised by persistent respiratory symptoms and limited lung airflow, dyspnoea and recurrent exacerbations. Suboptimal therapy or non-adherence may result in limited effectiveness of pharmacological treatments and subsequently poor health outcomes. OBJECTIVES: To determine the efficacy and safety of interventions intended to improve adherence to single or combined pharmacological treatments compared with usual care or interventions that are not intended to improve adherence in people with COPD. SEARCH METHODS: We identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register, CENTRAL, MEDLINE and Embase (search date 1 May 2020). We also searched web-based clinical trial registers. SELECTION CRITERIA: RCTs included adults with COPD diagnosed by established criteria (e.g. Global Initiative for Obstructive Lung Disease). Interventions included change to pharmacological treatment regimens, adherence aids, education, behavioural or psychological interventions (e.g. cognitive behavioural therapy), communication or follow-up by a health professional (e.g. telephone, text message or face-to-face), multi-component interventions, and interventions to improve inhaler technique. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Working in pairs, four review authors independently selected trials for inclusion, extracted data and assessed risk of bias. We assessed confidence in the evidence for each primary outcome using GRADE. Primary outcomes were adherence, quality of life and hospital service utilisation. Adherence measures included the Adherence among Patients with Chronic Disease questionnaire (APCD). Quality of life measures included the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ). MAIN RESULTS: We included 14 trials (2191 participants) in the analysis with follow-up ranging from six to 52 weeks. Age ranged from 54 to 75 years, and COPD severity ranged from mild to very severe. Trials were conducted in the USA, Spain, Germany, Japan, Jordan, Northern Ireland, Iran, South Korea, China and Belgium. Risk of bias was high due to lack of blinding. Evidence certainty was downgraded due to imprecision and small participant numbers. Single component interventions Six studies (55 to 212 participants) reported single component interventions including changes to pharmacological treatment (different roflumilast doses or different inhaler types), adherence aids (Bluetooth inhaler reminder device), educational (comprehensive verbal instruction), behavioural or psychological (motivational interview). Change in dose of roflumilast may result in little to no difference in adherence (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.22 to 1.99; studies = 1, participants = 55; low certainty). A Bluetooth inhaler reminder device did not improve adherence, but comprehensive verbal instruction from a health professional did improve mean adherence (prescription refills) (mean difference (MD) 1.00, 95% CI 0.46 to 1.54). Motivational interview improved mean adherence scores on the APCD scale (MD 22.22, 95% CI 8.42 to 36.02). Use of a single inhaler compared to two separate inhalers may have little to no impact on quality of life (SGRQ; MD 0.80, 95% CI -3.12 to 4.72; very low certainty). A Bluetooth inhaler monitoring device may provide a small improvement in quality of life on the CCQ (MD 0.40, 95% CI 0.07 to 0.73; very low certainty). Single inhaler use may have little to no impact on the number of people admitted to hospital compared to two separate inhalers (OR 1.47, 95% CI 0.75 to 2.90; very low certainty). Single component interventions may have little to no impact on the number of people expereincing adverse events (very low certainty evidence from studies of a change in pharmacotherapy or use of adherence aids). A change in pharmacotherapy may have little to no impact on exacerbations or deaths (very low certainty). Multi-component interventions Eight studies (30 to 734 participants) reported multi-component interventions including tailored care package that included adherence support as a key component or included inhaler technique as a component. A multi-component intervention may result in more people adhering to pharmacotherapy compared to control at 40.5 weeks (risk ratio (RR) 1.37, 95% CI 1.18 to 1.59; studies = 4, participants = 446; I2 = 0%; low certainty). There may be little to no impact on quality of life (SGRQ, Chronic Respiratory Disease Questionnaire, CAT) (studies = 3; low to very low certainty). Multi-component interventions may help to reduce the number of people admitted to hospital for any cause (OR 0.37, 95% CI 0.22 to 0.63; studies = 2, participants = 877; low certainty), or COPD-related hospitalisations (OR 0.15, 95% CI 0.07 to 0.34; studies = 2, participants = 220; moderate certainty). There may be a small benefit on people experiencing severe exacerbations. There may be little to no effect on adverse events, serious adverse events or deaths, but events were infrequently reported and were rare (low to very certainty). AUTHORS' CONCLUSIONS: Single component interventions (e.g. education or motivational interviewing provided by a health professional) can help to improve adherence to pharmacotherapy (low to very low certainty). There were slight improvements in quality of life with a Bluetooth inhaler device, but evidence is from one study and very low certainty. Change to pharmacotherapy (e.g. single inhaler instead of two, or different doses of roflumilast) has little impact on hospitalisations or exacerbations (very low certainty). There is no difference in people experiencing adverse events (all-cause or COPD-related), or deaths (very low certainty). Multi-component interventions may improve adherence with education, motivational or behavioural components delivered by health professionals (low certainty). There is little to no impact on quality of life (low to very low certainty). They may help reduce the number of people admitted to hospital overall (specifically pharmacist-led approaches) (low certainty), and fewer people may have COPD-related hospital admissions (moderately certainty). There may be a small reduction in people experiencing severe exacerbations, but evidence is from one study (low certainty). Limited evidence found no difference in people experiencing adverse events, serious adverse events or deaths (low to very low certainty). The evidence presented should be interpreted with caution. Larger studies with more intervention types, especially single interventions, are needed. It is unclear which specific COPD subgroups would benefit, therefore discussions between health professionals and patients may help to determine whether they will help to improve health outcomes.

Joint movements associated with minimum toe clearance variability in older adults during level overground walking.

BACKGROUND: Approximately one-third of falls are caused by the swing foot contacting an object or the ground, resulting in a trip. The increased incidence of trip-related falls among older adults may be explained by greater within-person minimum toe clearance (MTC) variability. RESEARCH QUESTION: Will kinematic variability at any of the 6 major joints in the lower limbs, individually or in combination, be associated with MTC variability? METHODS: This cross-sectional study investigated whether single or multiple joint movements best explained MTC variability in older adults. Twenty healthy older adults (7 males, 13 females; mean age = 71.3 ±â€¯7.2 years) were recruited. Participants were fitted with a modified Cleveland Clinic marker set and walked for 50 trials at self-selected speeds over a 7-meter walkway (with a rest at 25 trials) while 6 infrared cameras recorded kinematics. RESULTS: Seven joint movements were evaluated, and swing hip flexion-extension variability was the only joint movement significantly associated with MTC variability (r = 0.577, p = 0.008) and explained 29.6% (adjusted R2) of the variance of MTC variability in older adults (F (1, 18) = 8.897, p = 0.008). SIGNIFICANCE: Identifying the joint movement/s associated with inconsistencies in toe clearance will improve our understanding of endpoint control in older adults and may lead to the development of effective trip prevention strategies.

Randomized Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke.

OBJECTIVE: To compare the long-term effects of external focus (EF) and internal focus (IF) of attention after 4 weeks of arm training. DESIGN: Randomized, repeated-measures, mixed analysis of variance. SETTING: Outpatient clinic. PARTICIPANTS: Individuals with stroke and moderate-to-severe arm impairment living in the community (N=33; withdrawals: n=3). INTERVENTIONS: Four-week arm training protocol on a robotic device (12 sessions). MAIN OUTCOME MEASURES: Joint independence, Fugl-Meyer Assessment, and Wolf Motor Function Test measured at baseline, discharge, and 4-week follow-up. RESULTS: There were no between-group effects for attentional focus. Participants in both groups improved significantly on all outcome measures from baseline to discharge and maintained those changes at 4-week follow-up regardless of group assignment (joint independence EF condition: F1.6,45.4=17.74; P<.0005; partial η2=.39; joint independence IF condition: F2,56=18.66; P<.0005; partial η2=.40; Fugl-Meyer Assessment: F2,56=27.83; P<.0005; partial η2=.50; Wolf Motor Function Test: F2,56=14.05; P<.0005; partial η2=.35). CONCLUSIONS: There were no differences in retention of motor skills between EF and IF participants 4 weeks after arm training, suggesting that individuals with moderate-to-severe arm impairment may not experience the advantages of an EF found in healthy individuals. Attentional focus is most likely not an active ingredient for retention of trained motor skills for individuals with moderate-to-severe arm impairment, whereas dosage and intensity of practice appear to be pivotal. Future studies should investigate the long-term effects of attentional focus for individuals with mild arm impairment.

Test-retest reliability of the seated Functional Rotation Test in people with Parkinson's disease: a preliminary study.

This study established the test-retest reliability of a seated Functional Rotation Test monitoring hand-pointing, together with head and trunk-rotation performance, in people with Parkinson's disease. An ancillary purpose was to establish the concurrent validity between the Functional Rotation Test and an electrogoniometer. 10 males with Parkinson's disease (M age=70.5 yr.; Hoehn and Yahr staging severity ranging from II to IV) were recruited. Subjects were fitted with laser-pointing devices, sat in the Functional Rotation room, and were instructed to turn actively and point to their right (or left) as far as they could comfortably manage. Tagged projections were scored (in degrees). Testing was repeated after a brief interval. Electrogoniometer projected locations were compared with Functional Rotation Test scores. Intraclass correlation coefficients (.91 to .97) indicated excellent test-retest reliability. There was also excellent agreement between electrogoniometric and Functional Rotation Test values (Intraclass correlation coefficients=.99). Thus the Functional Rotation Test provides a replicable measure of axial rotation of head, trunk, and hand-pointing in seated subjects with Parkinson's disease.

Contraindications for superficial heat and therapeutic ultrasound: do sources agree?

OBJECTIVES: To determine the amount of agreement among general rehabilitation sources for both superficial heating and therapeutic ultrasound contraindications. DATA SOURCES: English-language textbook and peer-reviewed journal sources, from January 1992 to July 2002. Searches of computerized databases (HealthSTAR, CINAHL, MEDLINE, Embase) as well as Library of Congress Online Catalogs, Books in Print, and AcqWeb's Directory of Publishers and Venders. DATA SELECTION: Sources were excluded if they (1) were published before 1992, (2) failed to address general rehabilitation audiences, or (3) were identified as a researcher's related publication with similar information on the topic. DATA EXTRACTION: Type and number of contraindications, type of audience, year of publication, number of references, rationales, and alternative treatment strategies. DATA SYNTHESIS: Eighteen superficial heat and 20 ultrasound sources identified anywhere from 5 to 22 and 9 to 36 contraindications/precautions, respectively. Agreement among sources was generally high but ranged from 11% to 95%, with lower agreement noted for pregnancy, metal implants, edema, skin integrity, and cognitive/communicative concerns. Seventy-two percent of superficial heat sources and 25% of ultrasound sources failed to reference at least 1 contraindication claim. CONCLUSIONS: Agreement among contraindication sources was generally good for both superficial heat and therapeutic ultrasound. Sources varied with regard to the number of contraindications, references, and rationales cited. Greater reliance on objective data and standardized classification systems may serve to develop more uniform guidelines for superficial heat and therapeutic ultrasound.

Test-retest reliability in performance of persons with hemiparesis tracking by means of compatibly displayed myoelectric feedback derived from upper limb muscles.

The aim of this study was to assess whether persons with hemiparesis will yield statistically reliable test-retest tracking performance on a procedure using limb-generated, compatibly displayed, myoelectric video feedback. A convenience sample of 50 inpatients and outpatients with upper extremity involvement of at least six months were recruited. 30 had hemiparesis and had both upper extremities tested. 20 had hemiplegia and had the nonparetic upper extremity tested. Tracking skill was measured as mean tracking error. Repeated measures analysis of variance yielded statistically significant effects of main factors: Response mode, Cursor Feedback, and Session. Extremity tested was not significant. Performance with involved limb, uninvolved limb, isometric mode, and isotonic mode all yielded positive rest-retest correlations. The reliable range of tracking error obtained from subjects with hemiparesis performing a task requiring modulation of compatibly displayed myoelectric output supports the therapeutic rationale for employing compatibly displayed video feedback in the rehabilitation of motor control.

Dynamic stability during walking following unilateral total hip arthroplasty.

The purpose of this study was to examine dynamic stability, defined as the vertical projection of the center of mass (COM) to the base of support (BOS) mediolaterally during walking in 16 healthy and 16 unilateral total hip arthroplasty (THA) persons. There was a significant effect of side for double limb support (DLS) for the healthy group and between groups but not significant for single limb support. The dynamic stability pattern for the THA group was to hold the COM in the midline during a longer DLS phase demonstrating a different motor control strategy compared to healthy adults.

Disability, chronic condition, and iatrogenic illness.

People with disabilities and chronic conditions are disadvantaged by the US health care system. Some people receive too few of the services they need; others receive too many services from practitioners who do not understand their disability-related needs and thus subject them to iatrogenic illnesses (health problems arising from the health care process). We explore this deprivation and excess and focus on 3 categories of iatrogenic illness that can harm this patient population and impede their ability to live independently. Empirical studies of iatrogenic illness in people with disabilities and chronic illnesses are needed. Physiatrists must play a central role in conducting such studies and in helping these persons access needed care while avoiding potential health problems associated with such care.

Test-retest reliability of the functional rotation test in healthy adults.

Test-retest reliability and concurrent validity for a Functional Rotation Test, developed as a clinical tool for quantifying the extent of body rotation while sitting or standing, were evaluated with healthy adults in this study. Participants, ages 20 to 72 years (n = 36) donned laser-pointing devices, stood or sat in the center of a room calibrated for the test, and actively turned and pointed to the right (or left) as far as they could comfortably. The locations of the lasers were recorded and subsequently scored. Testing was repeated after a brief rest. Concurrent measurements between a clinical goniometer and the Functional Rotation Test were also compared. Intraclass correlation coefficients (ICCs) indicated good to excellent test-retest reliability indices, ranging from .89 to .96 for standing and .87 to .95 for sitting tests. Agreement between the Functional Rotation Test and the goniometer was excellent (ICC = 1.0). The relevance and possible applications of the Functional Rotation Test are discussed.