Outcomes reported in randomised trials of surgical prehabilitation: a scoping review.

BACKGROUND: Heterogeneity of reported outcomes can impact the certainty of evidence for prehabilitation. The objective of this scoping review was to systematically map outcomes and assessment tools used in trials of surgical prehabilitation. METHODS: MEDLINE, EMBASE, PsychInfo, Web of Science, CINAHL, and Cochrane were searched in February 2023. Randomised controlled trials of unimodal or multimodal prehabilitation interventions (nutrition, exercise, psychological support) lasting at least 7 days in adults undergoing elective surgery were included. Reported outcomes were classified according to the International Society for Pharmacoeconomics and Outcomes Research framework. RESULTS: We included 76 trials, mostly focused on abdominal or orthopaedic surgeries. A total of 50 different outcomes were identified, measured using 184 outcome assessment tools. Observer-reported outcomes were collected in 86% of trials (n=65), with hospital length of stay being most common. Performance outcomes were reported in 80% of trials (n=61), most commonly as exercise capacity assessed by cardiopulmonary exercise testing. Clinician-reported outcomes were included in 78% (n=59) of trials and most frequently included postoperative complications with Clavien-Dindo classification. Patient-reported outcomes were reported in 76% (n=58) of trials, with health-related quality of life using the 36- or 12-Item Short Form Survey being most prevalent. Biomarker outcomes were reported in 16% of trials (n=12) most commonly using inflammatory markers assessed with C-reactive protein. CONCLUSIONS: There is substantial heterogeneity in the reporting of outcomes and assessment tools across surgical prehabilitation trials. Identification of meaningful outcomes, and agreement on appropriate assessment tools, could inform the development of a prehabilitation core outcomes set to harmonise outcome reporting and facilitate meta-analyses.

Cost-effectiveness analysis of home-based rehabilitation compared to usual care for people with inoperable lung cancer.

OBJECTIVE: Few economic evaluations of lung cancer rehabilitation exist. The aim of this study was to assess the cost-effectiveness of providing home-based rehabilitation for inoperable lung cancer. METHODS: A cost-utility analysis alongside a randomised controlled trial (RCT) of rehabilitation compared with usual care. The primary outcome was quality-adjusted life years (QALYs) gained. The incremental cost-effectiveness ratio [ICER (95% CI)] and the net monetary benefit are reported. Value of information (VOI) analysis assessed the need/value of more research. RESULTS: Seventy participants (34 intervention and 36 usual care), average (SD) age 63.0 (12.0) years, 32 (45.7%) stage IV. The average intervention cost was AU$3421 (AU$5352 usual care), and effect (QALY) was 0.30 (0.31 usual care). The ICER was AU$228,197 (-1,173,194 to 1,101,450) per QALY gained. The net monetary benefit was AU$1508, favouring the intervention. The probability that the intervention was more cost-effective than usual care, at a willingness to pay threshold of AU$50,000, was 75%. VOI analysis showed that additional research to resolve decision uncertainty is potentially worthwhile. CONCLUSION: A high degree of uncertainty exists regarding the cost-effectiveness of lung cancer rehabilitation. Further RCTs, powered for economic evaluations and utilising rehabilitation sensitive outcomes, are required to support translation of evidence into clinical practice.

Feasibility of establishing a rehabilitation programme in a Vietnamese intensive care unit.

Increasing numbers of people are surviving critical illness throughout the world, but survivorship is associated with long-term disability. In high-income settings physical rehabilitation is commonly employed to counter this and improve outcomes. These utilize highly-trained multidisciplinary teams and are unavailable and unaffordable in most low and middle income countries (LMICs). We aimed to design a sustainable intensive care unit (ICU) rehabilitation program and to evaluate its feasibility in a LMIC setting. In this project patients, care-givers and experts co-designed an innovative rehabilitation programme that can be delivered by non-expert ICU staff and family care-givers in a LMIC. We implemented this programme in adult patient with patients with tetanus at the Hospital for Tropical Diseases, Ho Chi Minh City over a 5-month period, evaluating the programme's acceptability, enablers and barriers. A 6-phase programme was designed, supported by written and video material. The programme was piloted in total of 30 patients. Rehabilitation was commenced a median 14 (inter quartile range (IQR) 10-18) days after admission. Each patient received a median of 25.5 (IQR 22.8-34.8) rehabilitation sessions out of a median 27 (22.8-35) intended (prescribed) sessions. There were no associated adverse events. Patients and staff found rehabilitation to be beneficial, enhanced relationships between carers, patients and staff and was deemed to be a positive step towards recovery and return to work. The main barrier was staff time. The programme was feasible for patients with tetanus and viewed positively by staff and participants. Staff time was identified as the major barrier to ongoing implementation.

Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.

QUESTION: Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery? DESIGN: Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand. INTERVENTIONS: The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only. OUTCOME MEASURES: The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months. RESULTS: Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention. CONCLUSIONS: Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation. TRIAL REGISTRATION: ACTRN12613000664741.

The Cost of Bottling It Up: Emotion Suppression as a Mediator in the Relationship Between Anger and Depression Among Men with Prostate Cancer.

BACKGROUND: Prostate cancer is a risk factor for major depressive disorder. Recent psycho-oncology research suggests a potential role for male-specific mood-related symptoms in this relationship. Gender socialisation experiences may reinforce men's anger and emotion suppression responses in times of distress, and anger and emotion suppression may be implicated in pathways to, and maintenance of depression in prostate cancer. PATIENTS AND METHODS: Data were collected online from men with a self-reported diagnosis of prostate cancer (N=100; mean age 64.8 years). Respondents provided information regarding diagnosis and treatment, in addition to current experience of major depression and male-specific externalising symptoms. RESULTS: Prostate cancer diagnosis in the last 12 months occurred for 35.4% of the sample. Elevated major depression symptoms were observed for 49% of respondents, with 14% endorsing past 2-week suicide ideation. Parallel mediation analysis (99% CIs) controlling for prostatectomy and active surveillance indicated men's emotion suppression mediated the relationship between anger and depression symptoms (R 2=0.580). Trichotimised emotion suppression scores with control variables yielded a large multivariate effect (p<0.001, partial η 2=0.199). Univariate moderate-sized effects were observed for emotion suppression comparisons for symptoms of depressed mood and sleep disturbance, and a large effect observed for guilt-proneness. CONCLUSION: Findings highlight the salience of anger in the experience of depression symptoms for men with prostate cancer. The mediating role of emotion suppression, which in turn was strongly linked to men's feelings of guilt, suggests potential assessment and intervention targets. Future work should examine the role of androgen deprivation therapy and other treatments including active surveillance on the relationship between anger and depression in men with prostate cancer. Consideration of interventions focused on emotion processing skills in psycho-oncology settings may help reduce men's reliance on emotion suppression as a strategy for coping with feelings of anger or guilt in the context of prostate cancer.

Socioeconomic Position and Health Outcomes Following Critical Illness: A Systematic Review.

OBJECTIVES: Systematically review evidence examining association between preadmission socioeconomic position and physical function, health-related quality of life and survival following critical illness. DATA SOURCES: Four electronic databases (MEDLINE, Embase, CINAHL, CENTRAL) and personal libraries were searched. Reference lists of eligible articles were cross-checked. STUDY SELECTION: Primary quantitative studies reporting association between socioeconomic position and physical function, health-related quality of life, or survival of adults admitted to the ICU were included. DATA EXTRACTION: Performed by two reviewers independently in duplicate using a prepiloted data extraction form. Quality appraisal was completed by two reviewers independently in duplicate using standardized algorithms and checklists. The Preferred Reporting Items for Systematic Reviews guidelines were followed. DATA SYNTHESIS: From 1,799 records, 10 studies were included, one examining association of socioeconomic position with health-related quality of life and five with survival. Four studies accounted for socioeconomic position in survival analyses. Patients with lower socioeconomic position were found to have higher ICU, in-hospital, 30-day, and long-term mortality and lower 6-month Short Form-12 Mental Component Summary scores. No articles examined socioeconomic position and performance-based physical function. Notable variability in methods of socioeconomic position assessment was observed. CONCLUSIONS: Lower socioeconomic position is associated with higher mortality and lower 6-month Short Form-12 Mental Component Summary scores following critical illness. Effect on performance-based physical function is unknown. We make recommendations for consistent socioeconomic position measurement in future ICU studies.

Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): protocol for a single-centre, pilot, randomised controlled trial.

INTRODUCTION: Postoperative pulmonary complications (PPCs) are a common serious complication following upper abdominal surgery leading to significant consequences including increased mortality, hospital costs and prolonged hospitalisation. The primary objective of this study is to detect whether there is a possible signal towards PPC reduction with the use of additional intermittent non-invasive ventilation (NIV) compared with continuous high-flow nasal oxygen therapy alone following high-risk elective upper abdominal surgery. Secondary objectives are to measure feasibility of: (1) trial conduct and design and (2) physiotherapy-led NIV and a high-flow nasal oxygen therapy protocol, safety of NIV and to provide preliminary costs of care information of NIV and high-flow nasal oxygen therapy. METHODS AND ANALYSIS: This is a single-centre, parallel group, assessor blinded, pilot, randomised trial, with 130 high-risk upper abdominal surgery patients randomly assigned via concealed allocation to either (1) usual care of continuous high-flow nasal oxygen therapy for 48 hours following extubation or (2) usual care plus five additional 30 min physiotherapy-led NIV sessions within the first two postoperative days. Both groups receive standardised preoperative physiotherapy and postoperative early ambulation. No additional respiratory physiotherapy is provided to either group. Outcome measures will assess incidence of PPC within the first 14 postoperative days, recruitment ability, physiotherapy-led NIV and high-flow nasal oxygen therapy protocol adherence, adverse events relating to NIV delivery and costs of providing a physiotherapy-led NIV and a high-flow nasal oxygen therapy service following upper abdominal surgery. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the relevant institution and results will be published to inform future multicentre trials. TRIAL REGISTRATION NUMBER: ACTRN12617000269336; Pre-results.

A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol.

INTRODUCTION: Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. METHODS AND ANALYSIS: The primary question is what effect regular ER morphine has on worst breathlessness, measured daily on a 0-10 numerical rating scale. Uniquely, the coprimary outcome will use a FitBit to measure habitual physical activity. Secondary questions include safety and, whether upward titration after initial benefit delivers greater net symptom reduction. Substudies include longitudinal driving simulation, sleep, caregiver, health economic and pharmacogenetic studies. Seventeen centres will recruit 171 participants from respiratory and palliative care. The study has five phases including three randomisation phases to increasing doses of ER morphine. All participants will receive placebo or active laxatives as appropriate. Appropriate statistical analysis of primary and secondary outcomes will be used. ETHICS AND DISSEMINATION: Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness. TRIAL REGISTRATION NUMBER: NCT02720822; Pre-results.

Survey of neurodevelopmental allied health teams in Australian and New Zealand neonatal nurseries: Staff profile and standardised neurobehavioural/neurological assessment.

AIMS: The primary aim of this study was to establish how many neonatal nurseries in Australia and New Zealand had a neurodevelopmental allied health team, to ascertain the disciplines involved, their qualifications and experience. The secondary aim was to evaluate which standardised neurobehavioural/neurological assessments were currently being implemented, and the existing practice in relation to their use. METHODS: A descriptive cross-sectional survey, sampling 179 eligible public and private hospital neonatal intensive care units (NICUs) and special care nurseries (SCNs) throughout Australia and New Zealand, was purpose-developed and administered electronically from the 5th April to 23rd July 2013. RESULTS: A total of 117 units (65%) overall, and 26 of 26 (100%) NICUs responded to the survey. NICUs had more neurodevelopmental allied health staff than SCNs, with physiotherapists and speech pathologists the most common disciplines. Physiotherapists were more likely to administer standardised neurobehavioural/neurological assessments in NICUs, while medical staff were more likely to do so in SCNs. A wide variety of standardised neurobehavioural/neurological assessment tools were used, with Prechtl's General Movements Assessment the most common in the NICUs (50%) and the Hammersmith Neonatal Neurological Examination the most common in the special care units (25%). Standardised neurobehavioural assessments were not administered in 22% of SCNs. CONCLUSIONS: Although neurodevelopmental allied health teams and standardised neurobehavioural/neurological assessments are valued by many, there was little consistency across Australian and New Zealand neonatal nurseries.

The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. METHODS/DESIGN: The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. DISCUSSION: The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and physiotherapy, measures many known confounders, and includes a post-discharge follow-up of complication rates, functional capacity, and health-related quality of life. This trial is currently recruiting. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.

Functional outcomes in ICU ­ what should we be using? ­ an observational study.

INTRODUCTION: With growing awareness of the importance of rehabilitation, new measures are being developed specifically for use in the intensive care unit (ICU). There are currently 26 measures reported to assess function in ICU survivors. The Physical Function in Intensive care Test scored (PFIT-s) has established clinimetric properties. It is unknown how other functional measures perform in comparison to the PFIT-s or which functional measure may be the most clinically applicable for use within the ICU. The aims of this study were to determine (1) the criterion validity of the Functional Status Score for the ICU (FSS-ICU), ICU Mobility Scale (IMS) and Short Physical Performance Battery (SPPB) against the PFIT-s; (2) the construct validity of these tests against muscle strength; (3) predictive utility of these tests to predict discharge to home; and (4) the clinical applicability. This was a nested study within an ongoing controlled study and an observational study. METHODS: Sixty-six individuals were assessed at awakening and ICU discharge. Measures included: PFIT-s, FSS-ICU, IMS and SPPB. Bivariate relationships (Spearman's rank correlation coefficient) and predictive validity (logistic regression) were determined. Responsiveness (effect sizes); floor and ceiling effects; and minimal important differences were calculated. RESULTS: Mean ± SD PFIT-s at awakening was 4.7 ± 2.3 out of 10. On awakening a large positive relationship existed between PFIT-s and the other functional measures: FSS-ICU (rho = 0.87, p < 0.005), IMS (rho = 0.81, p < 0.005) and SPPB (rho = 0.70, p < 0.005). The PFIT-s had excellent construct validity (rho = 0.8, p < 0.005) and FSS-ICU (rho = 0.69, p < 0.005) and IMS (rho = 0.57, p < 0.005) had moderate construct validity with muscle strength. The PFIT-s and FSS-ICU had small floor/ceiling effects <11% at awakening and ICU discharge. The SPPB had a large floor effect at awakening (78%) and ICU discharge (56%). All tests demonstrated responsiveness; however highest effect size was seen in the PFIT-s (Cohen's d = 0.71). CONCLUSIONS: There is high criterion validity for other functional measures against the PFIT-s. The PFIT-s and FSS-ICU are promising functional measures and are recommended to measure function within the ICU. TRIAL REGISTRATION: Clinicaltrials.gov NCT02214823. Registered 7 August 2014).

A new two-tier strength assessment approach to the diagnosis of weakness in intensive care: an observational study.

INTRODUCTION: Intensive care unit-acquired weakness (ICU-AW) is a significant problem. There is currently widespread variability in the methods used for manual muscle testing and handgrip dynamometry (HGD) to diagnose ICU-AW. This study was conducted in two parts. The aims of this study were: to determine the inter-rater reliability and agreement of manual muscle strength testing using both isometric and through-range techniques using the Medical Research Council sum score and a new four-point scale, and to examine the validity of HGD and determine a cutoff score for the diagnosis of ICU-AW for the new four-point scale. METHODS: Part one involved evaluation of muscle strength by two physical therapists in 29 patients ventilated >48 hours. Manual strength testing was performed by both physical therapists using two techniques: isometric and through range; and two scoring systems: traditional six-point Medical Research Council scale and a new collapsed four-point scale. Part two involved assessment of handgrip strength conducted on 60 patients. A cutoff score for ICU-AW was identified for the new four-point scoring system. RESULTS: The incidence of ICU-AW was 42% (n = 25/60) in this study (based on HGD). In part one the highest reliability and agreement was observed for the isometric technique using the four-point scale (intraclass correlation coefficient = 0.90: kappa = 0.72 respectively). Differences existed between isometric and through-range scores (mean difference = 1.76 points, P = 0.005). In part two, HGD had a sensitivity of 0.88 and specificity of 0.80 for diagnosing ICU-AW. A cutoff score of 24 out of 36 points was identified for the four-point scale. CONCLUSIONS: The isometric technique is recommended with reporting on a collapsed four-point scale. Because HGD is easy to perform and sensitive, we recommend a new two-tier approach to diagnosing ICU-AW that first tests handgrip strength with follow-up strength assessment using the isometric technique for muscle strength testing if handgrip strength falls below cutoff scores. Whilst our results for the four-point scale are encouraging, further research is required to confirm the findings of this study and determine the validity of the four-point scoring system and cutoff score developed of less than 24 out of 36 before recommending adoption into clinical practice.

Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties.

PURPOSE: To identify measures used to evaluate the broad constructs of functional impairment and limitations in the critically ill across the continuum of recovery, and to evaluate, synthesise and compare the clinimetric properties of the measures identified. METHODS: A systematic review of articles was carried out using the databases Medline (1950-2014), CINAHL (1982-2014), EMBASE (1980-2014), Cochrane Library (2014) and Scopus (1960-2014). Additional studies were identified by searching personal files. Eligibility criteria for selection: Search 1: studies which assessed muscle mass, strength or function using objective non-laboratory measures; Search 2: studies which evaluated a clinimetric property (reliability, measurement error, validity or responsiveness) for one of the measures identified in search one. Two independent reviewers assessed articles for inclusion and assessed risk of bias using the consensus-based standards for selection of health status measurement instruments checklist. RESULTS: Thirty-three measures were identified; however, only 20 had established clinimetric properties. Ultrasonography, dynamometry, physical function in intensive care test scored and the Chelsea critical care physical assessment tool performed the strongest for the measurement of impairment of body systems (muscle mass and strength) and activity limitations (physical function), respectively. CONCLUSIONS: There is considerable variability in the type of measures utilized to measure physical impairments and limitations in survivors of critical illness. Future work should identify a core set of standardized measures, which can be utilized across the continuum of critical illness recovery embedded within the International Classification of Functioning framework. This will enable improved comparisons between future studies, which in turn will assist in identifying the most effective treatment strategies to ameliorate the devastating longer-term outcomes of a critical illness.

Outcome measures report different aspects of patient function three months following critical care.

BACKGROUND: Previous investigation of the relationship between physical performance and patient self-report physical function (PF) measures in intensive care unit (ICU) survivors have not been performed. OBJECTIVES: To (1) analyze the extent to which other activity-based measures of physical performance may serve as proxies for the 6-min walk test (6 MWT); (2) determine the extent to which the Short Form (SF) 36 domain of PF and physical component summary (PCS) score, reflect components of physical performance and (3) examine the relationship between demographic and ICU variables and the 6 MWT. DESIGN: Cross-sectional data from two clinical trials. SETTING: Two acute care hospitals (Melbourne, Australia and Denver, USA). PATIENTS: A total of 177 survivors of ICU. MEASUREMENTS: Were evaluated at 3 months. Performance-based measures were: 6 MWT, timed up and go test (TUG), the five times sit to stand test (5 × STS), the Berg balance scale (BBS) and two self-report measures: the SF-36 PF domain and the PCS score. MAIN RESULTS: 6 MWT showed excellent correlation with the TUG (rho = -0.79) and BBS (rho = 0.80); and good correlation with 5 × STS (rho = -0.69) and SF-36 PF scores (rho = 0.69). 6 MWT explained 54 and 33% of variance in SF-36 PF and PCS scores respectively. No variables were clinically important in predicting 6 MWT. CONCLUSIONS: The 6 MWT and TUG may both be acceptable measures of PF performance 3 months after ICU. Performance-based tests measure different constructs than self-report measures and choice of outcome variables should be aligned with study aims to ensure the most appropriate measure is used.

Postural control and fear of falling assessment in people with chronic obstructive pulmonary disease: a systematic review of instruments, international classification of functioning, disability and health linkage, and measurement properties.

OBJECTIVES: To systematically review the instruments used to assess postural control and fear of falling in people with chronic obstructive pulmonary disease (COPD), and to synthesize and evaluate their breadth of content and measurement properties. DATA SOURCES: MEDLINE, EMBASE, Web of Science, CINAHL, CENTRAL, PsycINFO, PEDro, and OTSeeker databases searched in September 2012. STUDY SELECTION: Two independent reviewers performed the selection of articles, the ICF linking process and quality assessment. Only quantitative studies were included, irrespective of language or publication date. DATA EXTRACTION: This systematic review comprised two phases. Phase 1 aimed to identify the commonly used instruments to assess postural control and fear of falling in the COPD literature. The breadth of content of each instrument was examined based on the International Classification of Functioning, Disability and Health (ICF). In phase 2, a measurement property search filter was adopted and used in four electronic databases to retrieve properties reported in the COPD population. The COSMIN checklist was used to assess the methodological quality of each measurement property reported. DATA SYNTHESIS: Seventeen out of 401 publications were eligible in phase 1. Seventeen instruments were identified including 15 for postural control and 2 for fear of falling assessment. The Berg Balance Scale, the Short Physical Performance Battery, and the Activities-specific Balance Confidence (ABC) scale were the most frequently used instruments to assess postural control and fear of falling respectively. The ICF categories covered varied considerably among instruments. The Balance Evaluation Systems test and ABC presented the greatest breadth of content. Measurement properties reported included criterion predictive validity (4 instruments), construct validity (11 instruments) and responsiveness (1 instrument), with inconsistent findings based on 'fair' and 'poor' quality studies. CONCLUSIONS: Different instruments with heterogeneous content have been used to assess postural control and fear of falling outcomes. Standardized assessment methods and best evidence on measurement properties is required in the COPD literature.

Functional capacity, physical activity and muscle strength assessment of individuals with non-small cell lung cancer: a systematic review of instruments and their measurement properties.

BACKGROUND: The measurement properties of instruments used to assess functional capacity, physical activity and muscle strength in participants with non-small cell lung cancer (NSCLC) have not been systematically reviewed. OBJECTIVES: To identify outcome measures used to assess these outcomes in participants with NSCLC; and to evaluate, synthesise and compare the measurement properties of the outcome measures identified. DATA SOURCES: A systematic review of articles using electronic databases MEDLINE (1950-2012), CINAHL (1982-2012), EMBASE (1980-2012), Cochrane Library (2012), Expanded Academic ASAP (1994-2012), Health Collection Informit (1995-2012) and PEDRO (1999-2012). Additional studies were identified by searching personal files and cross referencing. Eligibility Criteria for Study Selection: Search one: studies which assessed functional capacity, physical activity or muscle strength in participants with NSCLC using non-laboratory objective tests were included. Search two: studies which evaluated a measurement property (inter- or intra-rater reliability; measurement error; criterion or construct validity; or responsiveness) in NSCLC for one of the outcome measures identified in search one. Studies published in English from 1980 were eligible. Data Extraction and Methodological Quality Assessment: data collection form was developed and data extracted. Methodological quality of studies was assessed by two independent reviewers using the 4-point COSMIN checklist. RESULTS: Thirteen outcome measures were identified. Thirty-one studies evaluating measurement properties of the outcome measures in participants with NSCLC were included. Functional capacity was assessed using the six- and twelve-minute walk tests; incremental- and endurance-shuttle walk tests; and the stair-climbing test. Criterion validity for three of these measures was established in NSCLC but not the reliability or responsiveness. Physical activity was measured using accelerometers and pedometers. Only the construct validity for accelerometers and pedometers was reported. Muscle strength was measured using hand-held dynamometry, hand-grip dynamometry, manual muscle test, one-repetition maximum and the chair-stand test, however only two studies reported reliability and measurement error and one study reported construct validity. CONCLUSION: Currently there is a gap in the literature regarding the measurement properties of commonly used outcome measures in NSCLC participants, particularly reliability, measurement error and responsiveness. Further research needs to be conducted to determine the most suitable outcome measures for use in trials involving NSCLC participants.

Validity of the Microsoft Kinect for assessment of postural control.

Clinically feasible methods of assessing postural control such as timed standing balance and functional reach tests provide important information, however, they cannot accurately quantify specific postural control mechanisms. The Microsoft Kinect™ system provides real-time anatomical landmark position data in three dimensions (3D), and given that it is inexpensive, portable and simple to setup it may bridge this gap. This study assessed the concurrent validity of the Microsoft Kinect™ against a benchmark reference, a multiple-camera 3D motion analysis system, in 20 healthy subjects during three postural control tests: (i) forward reach, (ii) lateral reach, and (iii) single-leg eyes-closed standing balance. For the reach tests, the outcome measures consisted of distance reached and trunk flexion angle in the sagittal (forward reach) and coronal (lateral reach) planes. For the standing balance test the range and deviation of movement in the anatomical landmark positions for the sternum, pelvis, knee and ankle and the lateral and anterior trunk flexion angle were assessed. The Microsoft Kinect™ and 3D motion analysis systems had comparable inter-trial reliability (ICC difference=0.06±0.05; range, 0.00-0.16) and excellent concurrent validity, with Pearson's r-values >0.90 for the majority of measurements (r=0.96±0.04; range, 0.84-0.99). However, ordinary least products analyses demonstrated proportional biases for some outcome measures associated with the pelvis and sternum. These findings suggest that the Microsoft Kinect™ can validly assess kinematic strategies of postural control. Given the potential benefits it could therefore become a useful tool for assessing postural control in the clinical setting.

Assessing physical function and activity for survivors of a critical illness: a review of instruments.

BACKGROUND: Functional outcomes and health-related quality of life are important measures for survivors of a critical illness. Studies have demonstrated debilitating physical effects for a significant proportion of surviving patients, particularly those with intensive care unit-acquired weakness. Contemporary practice changes include a focus on the continuum of critical illness, with less sedation and more physical activity including mobility while in ICU, and post-ICU and post-hospitalisation activities to support optimal recovery. How to best assess the physical function of patients at different phases of their recovery and rehabilitation is therefore important. PURPOSE: This narrative review paper examined observational and functional assessment instruments used for assessing patients across the in-ICU, post-ICU and post-hospital continuum of critical illness. METHODS: Relevant papers were identified from a search of bibliographic databases and a review of the reference list of selected articles. The clinimetric properties of physical function and HRQOL measures and their relevance and utility in ICU were reported in narrative format. FINDINGS: The review highlighted many different instruments used to measure function in survivors of ICU including muscle strength testing, functional tests and walk tests, and patient centred outcomes such as health related quality of life. In general, the sensitivity and validity of these instruments for use with survivors of a critical illness has not yet been established. CONCLUSION: Based on findings from the review, screening of patients using reliable and valid instruments for ICU patients is recommended to inform both practice and future studies of interventions aimed at improving recovery and rehabilitation.

An assessment of early tracheostomy after anterior cervical stabilization in patients with acute cervical spine trauma.

BACKGROUND: The optimal timing of tracheostomy after anterior cervical spine surgery remains controversial because of the potential for deep infection. The aims of this study were to compare the infection rates in patients requiring tracheostomy who underwent anterior versus posterior cervical spine surgery, and to report the timing of tracheostomy tube placement in such patients. METHOD: All patients admitted to a referral Intensive Care Unit for spinal trauma from January 1998 until May 2005, who underwent surgical stabilization with instrumentation and also received a tracheostomy, were retrospectively evaluated for demographic data, severity of neurologic injury, and complications including infection to a surgical site and timing and type of tracheostomy procedure. RESULTS: We identified 71 patients, all who had a diagnosis of acute cervical spine injury. Thirty-two (45%) underwent anterior stabilization, 15 (21%) had posterior stabilizations, and 24 (34%) required both anterior and posterior approaches. The mean time from stabilization to tracheostomy for an anterior approach was 3.8 +/- 2.6 days. There was no significant difference in the timing of tracheostomy for different surgical approaches. Seventeen patients (25%) had a positive culture of their cervical and or tracheostomy incision site. Only one patient, however, had infection with the same organism at both the tracheostomy site and the anterior stabilization site. Suspected infection was managed with antibiotics and no further surgical intervention was required. CONCLUSIONS: Early tracheostomy after spinal stabilization is associated with a low risk of infection even after the anterior approach.