UNASSIGNED: The Berg Balance Scale (BBS) is one of the most used tools to quantify balance in Persons with Multiple Sclerosis, a population at high risk of falling.
UNASSIGNED: To evaluate the measurement characteristics of the BBS in Multiple Sclerosis through Rasch analysis.
UNASSIGNED: Retrospective study.
UNASSIGNED: Outpatients in three Italian Rehabilitation centers.
UNASSIGNED: Eight hundred and fourteen persons with Multiple Sclerosis able to stand independently for more than 3 s.
UNASSIGNED: The sample (N = 1,220) was split into one validating (B1) and three confirmatory subsamples. Following the Rasch analysis performed on B1, the item estimates were exported and anchored to the three confirmatory subsamples. After obtaining the same final solution across all samples, we studied the convergent and discriminant validity of the final BBS-MS using the EDSS, the ABC scale, and the number of falls.
UNASSIGNED: The base analysis on the B1 subsample failed the monotonicity, local independence, and unidimensionality requirements and did not fit the Rasch model. After grouping locally dependent items, the BBS-MS fitted the model (χ28 = 23.8; p = 0.003) and satisfied all requirements for adequate internal construct validity (ICV). However, it was mistargeted to the sample, given the striking prevalence of higher scores (targeting index 1.922) with a distribution-independent Person Separation Index sufficient for individual measurements (0.962). The B1 item estimates were anchored to the confirmatory samples with confirmation of adequate fit (χ2 = [19.0, 22.8], value of ps = [0.015, 0.004]) and satisfaction of all ICV requirements for all subsamples. The final BBS-MS directly correlated with the ABC scale (rho = 0.523) and inversely with EDSS (rho = -0.573). The BBS-MS estimates significantly differed across groups according to the pre-specified hypotheses (between the three EDSS groups, between the ABC cut-offs, distinguishing \'fallers\' vs. \'non-fallers\', and between the \'low\' vs. \'moderate\' vs. \'high\' levels of physical functioning; and, finally, between \'no falls\' vs. \'one or more falls\').
UNASSIGNED: This study supports the internal construct validity and reliability of the BBS-MS in an Italian multicentre sample of persons with Multiple Sclerosis. However, as the scale is slightly mistargeted to the sample, it represents a candidate tool to assess balance, mainly in more disabled people with an advanced walking disability.

OBJECTIVE: This study aimed to identify a threshold in annual surgeon volume associated with increased risk of revision (for any cause) and deep infection requiring surgery following primary elective total knee arthroplasty (TKA).
METHODS: A propensity score matched cohort study.
METHODS: Ontario, Canada.
METHODS: 169 713 persons who received a primary TKA between 2002 and 2016, with 3-year postoperative follow-up.
METHODS: Revision arthroplasty (for any cause), and the occurrence of deep surgical infection requiring surgery.
RESULTS: Based on restricted cubic spline analysis, the threshold for increased probability of revision and deep infection requiring surgery was <70 cases/year. After matching of 51 658 TKA recipients from surgeons performing <70 cases/year to TKA recipients from surgeons with greater than 70 cases/year, patients in the former group had a higher rate of revision (for any cause, 2.23% (95% Confidence Interval (CI) 1.39 to 3.07) vs 1.70% (95% CI 0.85 to 2.55); Hazard Ratio (HR) 1.33, 95% CI 1.21 to 1.47, p<0.0001) and deep infection requiring surgery (1.29% (95% CI 0.44 to 2.14) vs 1.09% (95% CI 0.24 to 1.94); HR 1.33, 95% CI 1.17 to 1.51, p<0.0001).
CONCLUSIONS: For primary TKA recipients, cases performed by surgeons who had performed fewer than 70 TKAs in the year prior to the index TKA were at 31% increased relative risk of revision (for any cause), and 18% increased relative risk for deep surgical infection requiring surgery, at 3-year follow-up.

Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.

To analyse the patient-nurse ratio and its association with health outcomes in public hospitals of the Andalusian Health Service (SAS).
Cross-sectional ecological study carried out in adult units of 26 Andalusian public hospitals. Data on structure (beds, type of unit, nursing control), management (average stay, index of use of stays, complexity index) and nursing staff were collected. They were extracted from official sources: CMBDA, SAS/Health Council (CS) publications and specific respondents to Nursing Directorates. The patient-nurse ratio was calculated and related to 19 indicators of hospital quality, safety, and mortality. Measures of central tendency and Spearman\'s correlation coefficient were used for statistical analysis.
A response was obtained from 100% of the Andalusian hospitals. The average patient-nurse ratio in the three shifts was lower in hospitals with a broader portfolio of services-regional scope (11.6), followed by those with a medium portfolio-specialties (12.7) and hospitals with a basic portfolio-county (13.5). By type of unit, the medical units were 11.8 (SD = 1.8) lower than the surgical ones 13.5 (SD = 2.7). Significant differences were only found in medical units of regional hospitals 10.5 (SD = 1.4) and district hospitals 13.03 (SD = 1.46) (p = .001). In critical care, the ratio was greater than 2 patients per nurse in the three groups. When relating the ratio to health outcomes, 5 significant associations were found: pressure ulcers (p = .005), prevalence of nosocomial infections (p = .036), postoperative sepsis (p = .022), zero bacteraemia verification (p = .045) and mortality from heart failure (p = .004).
The results indicate a high patient-nurse ratio in adult hospitalization units and that there is a positive association between the patient-nurse ratio and worse results related to nursing care.

Measurement can affect the people being measured; for example, asking people to complete a questionnaire can result in changes in behaviour (the \'question-behaviour effect\'). The usual methods of conduct and analysis of randomised controlled trials implicitly assume that the taking of measurements has no effect on research participants. Changes in measured behaviour and other outcomes due to measurement reactivity may therefore introduce bias in otherwise well-conducted randomised controlled trials, yielding incorrect estimates of intervention effects, including underestimates.
The main objectives were (1) to promote awareness of how and where taking measurements can lead to bias and (2) to provide recommendations on how best to avoid or minimise bias due to measurement reactivity in randomised controlled trials of interventions to improve health.
We conducted (1) a series of systematic and rapid reviews, (2) a Delphi study and (3) an expert workshop. A protocol paper was published [Miles LM, Elbourne D, Farmer A, Gulliford M, Locock L, McCambridge J, et al. Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance. Trials 2018;19:653]. An updated systematic review examined whether or not measuring participants had an effect on participants\' health-related behaviours relative to no-measurement controls. Three new rapid systematic reviews were conducted to identify (1) existing guidance on measurement reactivity, (2) existing systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes and (3) experimental studies that have investigated the effects of exposure to objective measurements of behaviour on health-related behaviour. The views of 40 experts defined the scope of the recommendations in two waves of data collection during the Delphi procedure. A workshop aimed to produce a set of recommendations that were formed in discussion in groups.
Systematic reviews - we identified a total of 43 studies that compared interview or questionnaire measurement with no measurement and these had an overall small effect (standardised mean difference 0.06, 95% confidence interval 0.02 to 0.09; n = 104,096, I2 = 54%). The three rapid systematic reviews identified no existing guidance on measurement reactivity, but we did identify five systematic reviews that quantified the effects of measurement on outcomes (all focused on the question-behaviour effect, with all standardised mean differences in the range of 0.09-0.28) and 16 studies that examined reactive effects of objective measurement of behaviour, with most evidence of reactivity of small effect and short duration. Delphi procedure - substantial agreement was reached on the scope of the present recommendations. Workshop - 14 recommendations and three main aims were produced. The aims were to identify whether or not bias is likely to be a problem for a trial, to decide whether or not to collect further quantitative or qualitative data to inform decisions about if bias is likely to be a problem, and to identify how to design trials to minimise the likelihood of this bias.
The main limitation was the shortage of high-quality evidence regarding the extent of measurement reactivity, with some notable exceptions, and the circumstances that are likely to bring it about.
We hope that these recommendations will be used to develop new trials that are less likely to be at risk of bias.
The greatest need is to increase the number of high-quality primary studies regarding the extent of measurement reactivity.
The first systematic review in this study is registered as PROSPERO CRD42018102511.
Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research Programme.
When people are asked to complete measures such as questionnaires in research studies this can produce changes in the behaviour or emotions of those people. For example, people who are asked to complete questionnaires about drinking alcohol have been found to drink slightly less, on average, than people who are not asked to complete questionnaires. Current established methods of research usually ignore these reactions to measurement. The present research aimed to produce recommendations for how best to deal with reactions to measurement. The scope of these recommendations was limited to ‘trials’ used to test whether or not a treatment improves health. To do this, we identified relevant research studies that have investigated various different aspects of whether or not measurement affects the people being measured. We then consulted 40 experts about what the current recommendations should consider and what was not within the scope of the current recommendations. We then gathered 23 experts together for 2 days to produce a set of recommendations. We found 43 research studies that have looked at whether or not being asked to complete questionnaires or being interviewed affects the behaviour of those people invited. In general, there were some effects of completing questionnaires, but the effects were not very consistent across research studies. There were few studies that have looked at the effects of using measures of behaviour other than questionnaires (e.g. blood pressure cuffs). We could find no existing recommendations for how best to deal with reactions to measurement in research studies that examine whether or not treatments improve health. We have produced 14 recommendations for researchers to better take account of the issue of measuring affecting the people being measured. We hope that this will help future research produce more accurate answers. We also identified that there is a need for more studies of the effects of measures other than questionnaires.

OBJECTIVE: The longer-term impact of injury is increasingly recognized, but the early phases of recovery are less well understood. The best tools to measure early recovery of mobility and physical function following traumatic injury are unclear. The purpose of this study was to assess the clinical utility, validity, reliability, and responsiveness of 4 mobility and physical function measures in patients following traumatic injury.
METHODS: In this cohort, measurement-focused study (n = 100), the modified Iowa Level of Assistance Score, Acute Care Index of Function, Activity Measure for Post-Acute Care \"6 Clicks\" short forms, and Functional Independence Measure were completed during first and last physical therapy sessions. Clinical utility and floor and ceiling effects were documented. Known-groups validity (early vs late in admission and by discharge destination), predictive validity (using 6-month postinjury outcomes data), and responsiveness were established. Interrater reliability was assessed in 30 patients with stable mobility and function.
RESULTS: Participants had a median age of 52 years (interquartile range = 33-68 years), and 68% were male. The modified Iowa Level of Assistance Score, Acute Care Index of Function, and \"6 Clicks\" short forms were quick to administer (an extra median time of 30 seconds-1 minute), but the Functional Independence Measure took much longer (extra median time of 5 minutes). At the last physical therapy session, ceiling effects were present for all measures except the Functional Independence Measure (18%-33% of participants). All had strong known-groups validity (early vs late in admission and by discharge destination). All were responsive (effect sizes >1.0) and had excellent interrater reliability (intraclass correlation coefficients = 0.79-0.94).
CONCLUSIONS: All 4 measures were reliable, valid, and responsive; however, their clinical utility varied, and ceiling effects were common at physical therapy discharge.
CONCLUSIONS: This study is an important step toward evidence-based measurement in acute trauma physical therapy care. It provides critical information to guide assessment of mobility and physical function in acute trauma physical therapy, which may facilitate benchmarking across different hospitals and trauma centers and further progress the science and practice of physical therapy following traumatic injury.

Multiple hypotheses are evolving that suggest several, potentially overlapping etiologies for olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). Understanding inflammatory cytokine profiles of the olfactory cleft (OC) and their association with olfactory function is foundational for future clinical care and research.
This cross-sectional, case-control study evaluates associations among OC mucus inflammatory proteins, psychophysical olfactory testing, and computed tomography (CT) analysis of the OC and sinuses. Normative reference intervals were determined for each protein and odds ratios (ORs) were used to compare proportions of altered expression between CRS without nasal polyposis (CRSsNP) and CRS without nasal polyposis (CRSwNP).
Case subjects with CRS (n = 151) and controls (n = 74) were evaluated. A majority of OC proteins tested were found within detectable ranges for cases and controls. The CRS cohort had significantly higher concentrations for 23 of 26 proteins. CRS cases with abnormal levels of C-C motif chemokine ligand 2 (CCL2), CCL3, interleukin 5 (IL5), IL10, and IL13 associated with greater olfactory deficits. The prevalence of elevated IL5 and IL13 in anosmic patients was 64.6% and 62.5%, respectively (p < 0.004). CRS cases with the highest odds of elevated expression in CRSwNP were IL5 (OR = 10.83) and IL13 (OR = 8.36). However, both IL5 and IL13 were still elevated in approximately 14% of CRSsNP patients. The highest magnitude of correlation between the total percent of OC opacification was found to be with IL5 (r = 0.543; p < 0.001), whereas other moderate correlations were noted with immunoglobulin E (IgE), IL10, and IL13.
This study confirmed that OC inflammatory proteins vary both by disease phenotype and in their association with OD. Type 2 inflammatory mediators are increased in CRS, especially within the CRSwNP group. However, a substantial proportion of CRSsNP also express type 2 inflammatory mediators. Further research is necessary to understand the complex roles OC mucous inflammatory proteins might play in defining endotype and in impacting CRS-related OD. ©2021 ARSAAOA, LLC.

OBJECTIVE: To analyse the patient-nurse ratio and its association with health outcomes in public hospitals of the Andalusian Health Service (SAS).
METHODS: Cross-sectional ecological study carried out in adult units of 26 Andalusian public hospitals. Data on structure (beds, type of unit, nursing control), management (average stay, index of use of stays, complexity index) and nursing staff were collected. They were extracted from official sources: CMBDA, SAS/Health Council (CS) publications and specific respondents to Nursing Directorates. The patient-nurse ratio was calculated and related to 19 indicators of hospital quality, safety, and mortality. Measures of central tendency and Spearman\'s correlation coefficient were used for statistical analysis.
RESULTS: A response was obtained from 100% of the Andalusian hospitals. The average patient-nurse ratio in the three shifts was lower in hospitals with a broader portfolio of services-regional scope (11.6), followed by those with a medium portfolio-specialties (12.7) and hospitals with a basic portfolio- county (13.5). By type of unit, the medical units were 11.8 (SD=1.8) lower than the surgical ones 13.5 (SD=2.7). Significant differences were only found in medical units of regional hospitals 10.5 (SD=1.4) and district hospitals 13.03 (SD=1.46) (p=.001). In critical care, the ratio was greater than 2 patients per nurse in the three groups. When relating the ratio to health outcomes, 5 significant associations were found: pressure ulcers (p=.005), prevalence of nosocomial infections (p=.036), postoperative sepsis (p=.022), zero bacteraemia verification (p=.045) and mortality from heart failure (p=.004).
CONCLUSIONS: The results indicate a high patient-nurse ratio in adult hospitalization units and that there is a positive association between the patient-nurse ratio and worse results related to nursing care.

OBJECTIVE: Implantable pulse generator (IPG) site pain following neuromodulation procedures is a recognized complication. The site of the IPG placement varies depending on the neuromodulation type and physician preference. The incidence of IPG site pain as a function of the site of IPG implantation has not been studied systematically.
METHODS: We performed a multicenter cross-sectional survey of the incidence, severity, and quality of IPG site pain, location of the IPG, the pain management needs, functional impairment, and cosmetic appearance related to the IPG placement. Contingency table analysis was conducted for categorical variables, and logistic regression analysis and linear regression model was used.
RESULTS: The survey response rate was 60.5% (n = 510). Overall, 31.0% of patients reported pain at the IPG site in the last 72 hours with 31.4% reporting moderate to severe pain and 7.6% reporting severe pain. Older age was inversely associated with IPG-related pain (OR = 0.97, 95% CI = 0.96-0.99, p = 0.001). IPG implantation site did not have a statistically significant interaction with IPG site pain (p > 0.05). The most important factor for IPG site-associated pain was having a spinal cord stimulator implanted as compared to a deep brain stimulator, or sacral nerve stimulator. Most subjects reported no functional impairment related to IPG site pain (91%), found the IPG site pain as expected (80%), and found IPG site cosmetic appearance as expected (96%).
CONCLUSIONS: The incidence of IPG site pain is an important complication of invasive neuromodulation. The anatomic location of the IPG placement does not appear to affect the incidence or severity of IPG site pain. However, the presence of a pre-implant chronic pain disorder does appear to affect the frequency and severity of IPG site pain.

Craniosynostosis is typically diagnosed and surgically corrected within the first year of life. The diagnosis and surgical correction of the condition can be a very stressful experience for families. Despite this, there is little research exploring the impact that craniosynostosis has on families, especially in the period immediately following diagnosis and correction. In this study, the authors aimed to qualitatively examine the psychosocial experience of families with a child diagnosed with craniosynostosis.
Qualitative study.
Tertiary care paediatric health centre.
Mothers of children newly diagnosed with single-suture, non-syndromic craniosynostosis.
Semistructured interviews regarding parental experience with the initial diagnosis, their decision on corrective surgery for their child, the operative experience, the impact of craniosynostosis on the family and the challenges they encountered throughout their journey.
Thematic analysis, a type of qualitative analysis that provides an in-depth account of participant\'s experiences, was used to analyse the interview data.
Over a 4-year period, 12 families meeting eligibility criteria completed the study. Three main themes (six subthemes) emerged from the preoperative interviews: frustration with diagnostic delays (parental intuition and advocacy, hope for improved awareness), understanding what to expect (healthcare supports, interest in connecting with other families) and justifying the need for corrective surgery (influence of the surgeon, struggle with cosmetic indications). Two main themes (four subthemes) were drawn from the postoperative interviews: overcoming fear (the role of healthcare professionals, transition home) and relief (reduction in parental anxiety, cosmetic improvements).
Overall, the diagnosis of craniosynostosis has a profound impact on families, leading them to face many struggles throughout their journey. A better understanding of these experiences will help to inform future practice, with a hope to improve this experience for other families moving forward.