Evaluating Osteoarthritis Management Programs: outcome domain recommendations from the OARSI Joint Effort Initiative.

OBJECTIVE: To develop sets of core and optional recommended domains for describing and evaluating Osteoarthritis Management Programs (OAMPs), with a focus on hip and knee Osteoarthritis (OA). DESIGN: We conducted a 3-round modified Delphi survey involving an international group of researchers, health professionals, health administrators and people with OA. In Round 1, participants ranked the importance of 75 outcome and descriptive domains in five categories: patient impacts, implementation outcomes, and characteristics of the OAMP and its participants and clinicians. Domains ranked as "important" or "essential" by ≥80% of participants were retained, and participants could suggest additional domains. In Round 2, participants rated their level of agreement that each domain was essential for evaluating OAMPs: 0 = strongly disagree to 10 = strongly agree. A domain was retained if ≥80% rated it ≥6. In Round 3, participants rated remaining domains using same scale as in Round 2; a domain was recommended as "core" if ≥80% of participants rated it ≥9 and as "optional" if ≥80% rated it ≥7. RESULTS: A total of 178 individuals from 26 countries participated; 85 completed all survey rounds. Only one domain, "ability to participate in daily activities", met criteria for a core domain; 25 domains met criteria for an optional recommendation: 8 Patient Impacts, 5 Implementation Outcomes, 5 Participant Characteristics, 3 OAMP Characteristics and 4 Clinician Characteristics. CONCLUSION: The ability of patients with OA to participate in daily activities should be evaluated in all OAMPs. Teams evaluating OAMPs should consider including domains from the optional recommended set, with representation from all five categories and based on stakeholder priorities in their local context.

Correction to: Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: Protocol for THE PARTNER STUDY.

After the publication of this protocol [1], our collaborator Prima Health solutions advised us of their intent to withdraw from the study.

Strength training for partially paralysed muscles in people with recent spinal cord injury: a within-participant randomised controlled trial.

STUDY DESIGN: Within-participant randomised controlled trial. OBJECTIVES: To determine whether strength training combined with usual care increases strength in partially paralysed muscles of people with recent spinal cord injury (SCI) more than usual care alone. SETTINGS: SCI units in Australia and India. METHODS: Thirty people with recent SCI undergoing inpatient rehabilitation participated in this 12-week trial. One of the following muscle groups was selected as the target muscle group for each participant: the elbow flexors, elbow extensors, knee flexors or knee extensors. The target muscle on one side of the body was randomly allocated to the experimental group and the same muscle on the other side of the body was allocated to the control group. Strength training was administered to the experimental muscle but not to the control muscle. Participants were assessed at baseline and 12 weeks later. The primary outcome was maximal isometric muscle strength, and the secondary outcomes were spasticity, fatigue and participants' perception of function and strength. RESULTS: There were no dropouts, and participants received 98% of the training sessions. The mean (95% confidence interval (CI)) between-group difference for isometric strength was 4.3 Nm (1.9-6.8) with a clinically meaningful treatment effect of 2.7 Nm. The mean (95% CI) between-group difference for spasticity was 0.03/5 points (-0.25 to 0.32). CONCLUSION: Strength training increases strength in partially paralysed muscles of people with recent SCI, although it is not clear whether the size of the treatment effect is clinically meaningful. Strength training has no deleterious effects on spasticity.

A pilot randomised trial of community-based care following discharge from hospital with a recent spinal cord injury in Bangladesh.

OBJECTIVES: To explore the feasibility of conducting a full trial designed to determine the effectiveness of a model of community-based care for people with spinal cord injury in Bangladesh. STUDY DESIGN: A pilot randomised trial. SETTING: Community, Bangladesh. SUBJECTS: Participants were 30 people with recent spinal cord injury who were wheelchair-dependent and soon to be discharged from hospital. INTERVENTION: Participants randomised to the intervention group received a package of care involving regular telephone contact and three home visits over two years. Participants randomised to the control group received usual care consisting of a telephone call and an optional home visit. MAIN MEASURES: Participants were assessed at baseline and two years after randomization. The primary outcome was mortality and secondary outcomes were measures of complications, depression, participation and quality of life. RESULTS: A total of 24 participants had a complete spinal cord injury and six participants had an incomplete spinal cord injury. Median (interquartile) age and time since injury at baseline were 31 years (24 to 36) and 7 months (4 to 13), respectively. Two participants, one in each group, died. Five participants had pressure ulcers at two years. There were no notable impediments to the conduct of the trial and no significant protocol violations. The phone calls and home visits were delivered according to the protocol 87% and 100% of the time, respectively. Follow-up data were 99% complete. CONCLUSION: This pilot trial demonstrates the feasibility of a full clinical trial of 410 participants, which has recently commenced. SPONSORSHIP: University of Sydney, Australia.

The effectiveness of 22 commonly administered physiotherapy interventions for people with spinal cord injury: a systematic review.

STUDY DESIGN: A systematic review of randomised controlled trials. OBJECTIVES: To determine the effectiveness of 22 commonly administered physiotherapy interventions for people with spinal cord injuries (SCIs). METHODS: The inclusion criteria contained 22 pairs of key interventions and outcomes. Each intervention and outcome was considered independently such that 22 brief reviews were conducted and summarised in this one paper. The interventions included hand, wheelchair, seated mobility, fitness, strength and gait training, as well as electrical stimulation, passive movements, stretch, cycling, exercise and transcutaneous electrical nerve stimulation (TENS). Interventions were compared with no or sham treatment, usual care or another physiotherapy intervention. The primary outcome for each review was one of the following: seated mobility, wheelchair mobility, hand function, gait, voluntary strength, joint mobility, fitness and pain. Data were extracted to determine mean between-group differences or risk ratios (95% confidence interval). Where possible, results were pooled in meta-analyses and the strength of evidence rated using Grading of Recommendations Assessment, Development and Evaluation. RESULTS: Thirty-eight randomised controlled trials met the inclusion criteria and were relevant to 15 of the brief reviews. The following four interventions were clearly effective: fitness, hand and wheelchair training as well as TENS; however, the strength of evidence was not high for any of these interventions. None of the other interventions were clearly effective. CONCLUSION: There is initial evidence to support four physiotherapy interventions, but there is still a long way to go to put a strong evidence base to the range of physiotherapy interventions commonly used to manage people with SCI.

Psychological and socioeconomic status, complications and quality of life in people with spinal cord injuries after discharge from hospital in Bangladesh: a cohort study.

STUDY DESIGN: Mixed retrospective-prospective cohort study. OBJECTIVES: To determine psychological and socioeconomic status, complications and quality of life in people with spinal cord injuries (SCI) after discharge from a hospital in Bangladesh. SETTING: Bangladesh. METHODS: All patients admitted in 2011 with a recent SCI to a hospital in Bangladesh were identified. Patients were interviewed by telephone in 2014 using translated versions of the SF12, the SCI Secondary Conditions Scale, the Centre for Epidemiologic Studies Depression Scale (CESDS) and the Participation Component of the WHODAS. Questions were also asked about employment, living and financial situation, and opportunities to get out of bed and out of the house. Data were stratified by ability to walk on discharge. RESULTS: A total of 350 people were discharged with a recent SCI in 2011. By 2014, 55 had died. Of those still living, 283 were interviewed (96% follow-up rate). At the time of interview, 47% of participants were employed. One-quarter (26%) of those who were wheelchair-dependent had a pressure ulcer. The mean (s.d.) scores for the Mental and Physical Component of the SF12 were 32.0 points (5.5) and 35.8 points (3.9), respectively. The median (interquartile range) scores for the SCI Secondary Conditions Scale, CESDS and WHODAS for those who were wheelchair-dependent were 15% (10 to 19), 11 points (9 to 18) and 26 points (23 to 26), respectively. CONCLUSION: Many people with SCI in Bangladesh are house-bound, unemployed, living in poverty and have pressure ulcers. They experience moderate rates of depression and report limited quality of life.

A telephone-based version of the spinal cord injury-secondary conditions scale: a reliability and validity study.

OBJECTIVE: The objective of this study was to determine the inter-rater reliability and validity of using a telephone-based version of the spinal cord injury-secondary conditions scale (SCI-SCS). TRIAL DESIGN: A psychometric study was conducted. SETTING: The study was conducted in Royal North Shore Hospital, Sydney, Australia. PARTICIPANTS: Forty people with a complete or an incomplete spinal cord injury. METHODS: Inter-rater reliability was tested by comparing the telephone-based version of the SCI-SCS administered on two different days by two different telephone assessors. Validity was tested by comparing the telephone-based version of the SCI-SCS with the paper-based version of the SCI-SCS. RESULTS: The median (interquartile range) age and time since injury were 54 (48-63) years and 28 (14-35) years, respectively. The intraclass correlation coefficient (95% confidence interval) reflecting the agreement between the telephone-based version of the SCI-SCS administered on two different days by two different assessors was 0.96 (0.93-0.98). The corresponding value reflecting agreement between the telephone-based assessment and the paper-based assessment was 0.90 (0.83-0.95). CONCLUSION: The telephone-based version of the SCI-SCS is a simple and a quick questionnaire to administer that has both inter-rater reliability and validity. It may be useful as a way to screen for secondary health conditions in low- and middle-income countries where it is not always feasible to provide routine face-to-face follow-ups and where literacy may be a problem.

Two-year survival following discharge from hospital after spinal cord injury in Bangladesh.

STUDY DESIGN: Mixed retrospective-prospective cohort study. OBJECTIVES: To determine 2-year survival following discharge from hospital after spinal cord injury in Bangladesh. SETTING: Bangladesh. METHODS: Medical records were used to identify all patients admitted in 2011 with a recent spinal cord injury to the Centre for Rehabilitation of the Paralysed, a large Bangladeshi hospital that specialises in care of people with spinal cord injury. Patients or their families were subsequently visited or contacted by telephone in 2014. Vital status and, where relevant, date and cause of death were determined by verbal autopsy. RESULTS: 350 of 371 people admitted with a recent spinal cord injury in 2011 were discharged alive from hospital. All but eleven were accounted for two years after discharge (97% follow-up). Two-year survival was 87% (95% CI 83% to 90%). Two-year survival of those who were wheelchair-dependent was 81% (95% CI 76% to 86%). The most common cause of death was sepsis due to pressure ulcers. CONCLUSION: In Bangladesh, approximately one in five people with spinal cord injury who are wheelchair-dependent die within two years of discharge from hospital. Most deaths are due to sepsis from potentially preventable pressure ulcers.

Does regular standing improve bowel function in people with spinal cord injury? A randomised crossover trial.

STUDY DESIGN: A randomised crossover trial. OBJECTIVES: To determine the effects of a 6-week standing programme on bowel function in people with spinal cord injury. SETTING: Community, Australia and the United Kingdom. METHODS: Twenty community-dwelling people with motor complete spinal cord injury above T8 participated in a 16-week trial. The trial consisted of a 6-week stand phase and a 6-week no-stand phase separated by a 4-week washout period. Participants were randomised to one of two treatment sequences. Participants allocated to the Treatment First group stood on a tilt table for 30 min per session, five times per week for 6 weeks and then did not stand for the next 10 weeks. Participants allocated to the Control First group did the opposite: they did not stand for 10 weeks and then stood for 6 weeks. Participants in both groups received routine bowel care throughout the 16-week trial. Assessments occurred at weeks 0, 7, 10 and 17 corresponding with pre and post stand and no-stand phases. The primary outcome was Time to First Stool. There were seven secondary outcomes reflecting other aspects of bowel function and spasticity. RESULTS: There were three dropouts leaving complete data sets on 17 participants. The mean (95% confidence interval) between-intervention difference for Time to First Stool was 0 min (-7 to 7) indicating no effect of regular standing on Time to First Stool. CONCLUSION: Regular standing does not reduce Time to First Stool. Further trials are required to test the veracity of some commonly held assumptions about the benefits of regular standing for bowel function.

How well do randomised controlled trials of physical interventions for people with spinal cord injury adhere to the CONSORT guidelines? An analysis of trials published over a 10-year period.

STUDY DESIGN: Cross-sectional descriptive study of randomised controlled trials involving physical interventions for people with spinal cord injury (SCI) published between 2003 and 2013. OBJECTIVES: To determine how well randomised controlled trials of physical interventions for people with SCI adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. SETTING: University of Sydney, Sydney, NSW, Australia. METHODS: A search was conducted for randomised controlled trials designed to determine the effectiveness of physical interventions for people with SCI published between 2003 and 2013. The CONSORT checklist for the reporting of randomised controlled trials was used to determine how well each trial adhered to the guidelines. Two independent reviewers rated each trial on each of the 37 items on the CONSORT checklist using the following criteria: 'fully reported', 'partially reported', 'not reported', 'not relevant' or 'not reported but unable to determine if relevant/done'. RESULTS: Fifty-three trials were retrieved. None of the trials 'fully reported' all items of the CONSORT guidelines. The median (IQR) number of items that was 'fully reported' was 11/37 (7-20). The median (IQR) number of items that was either 'fully reported' or 'not relevant' or 'not reported but unable to determine if relevant' was 20/37 items (17-27). CONCLUSION: The reporting of randomised controlled trials in SCI is only partially adhering to the CONSORT guidelines. Journals can help lift standards by encouraging authors of randomised controlled trials to adhere to the CONSORT guidelines.

How much equipment is prescribed for people with spinal cord injury in Australia, do they use it and are they satisfied 1 year later?

BACKGROUND AND PURPOSE: The purpose of this study was to determine the amount and type of equipment prescribed to aid mobility and self-care for patients with spinal cord injuries (SCI) in Australia and to determine how frequently the equipment is used 1 year later and whether patients are satisfied with it. METHODS: A consecutive series of 61 patients admitted for rehabilitation to two Sydney SCI units were recruited. All mobility and self-care equipment worth more than $AU50 prescribed by therapists before patients' discharge was recorded. This included wheelchairs, commodes, shower chairs, hoists, electric beds, pressure-relieving cushions, bed mattresses, slideboards, walking aids, orthoses, electrical stimulation systems and other pieces of notable exercise equipment. Patients were interviewed 1 year later and asked about each piece of equipment they had been prescribed. Specifically, they were asked about how frequently they had used each piece of equipment and whether they were satisfied with it. Data were analysed using descriptive statistics. RESULTS: Three hundred and fourteen pieces of equipment, including 68 wheelchairs, were prescribed for the 61 patients. Most of the equipment (226/314) was used more than 20 times in the 2 months preceding the 1-year review. Most patients were satisfied or highly satisfied with the majority of equipment prescribed, although patients were very dissatisfied or only partly dissatisfied with 18/314 pieces of equipment. DISCUSSION: Patients were generally satisfied with the equipment they were prescribed. There was a small amount of equipment prescribed that was not used 1 year later or with which patients were dissatisfied.

The diagnostic accuracy of self-report for determining S4-5 sensory and motor function in people with spinal cord injury.

STUDY DESIGN: A diagnostic accuracy study. OBJECTIVES: The objective was to determine the ability of people with SCI to accurately self-report S4-5 sensory and motor function. SETTING: Outpatient clinic, Sydney, Australia. METHODS: A consecutive series of thirty-four people who had sustained a SCI more than 1 year before the study, and who were attending an outpatient medical clinic were recruited. They were assessed on two occasions. On the first occasion, ability to self-report S4-5 sensory and motor function was assessed with four questions. On the second occasion, a rehabilitation physician performed a physical examination to determine participants' S4-5 sensory and motor function. The rehabilitation physician was unaware of the results of participants' self-report. Participants' self-reports were compared with results from the physical examination using likelihood ratios. RESULTS: The likelihood ratios (95% CI) associated with a positive response to the sensory and motor questions were 1.92 (1.0-3.6) and 2.4 (1.2-4.9), respectively. The likelihood ratios associated with a negative response to the sensory and motor questions were 0.1 (0.0-0.6) and 0.4 (0.1-1.2), respectively. CONCLUSION: People with SCI are reasonably accurate at self-reporting S4-5 sensory and motor function, although there is a high rate of false positives for S4-5 motor in those with motor levels below T10. In some situations it may be appropriate to use self-report rather than a physical examination to determine S4-5 sensory and motor function.

Mapping the motor point in the human tibialis anterior muscle.

OBJECTIVE: Percutaneous electrical stimulation of the motor point permits selective activation of a muscle. However, the definition and number of motor points reported for a given muscle varies. Our goal was to address these problems. METHODS: The area, location and number of motor points in human tibialis anterior were examined, using isometric dorsiflexion torque responses to electrical stimuli. Three methods were used: lowest electrical threshold, maximum muscle response, and approximate motor point. RESULTS: A single motor point was identified in 39/40 subjects regardless of method. The area of the site of lowest electrical threshold was smaller (median, 35 mm(2)) than those using the maximum muscle response (144 mm(2)) and approximate motor point (132 mm(2)). There was substantial, but not significant, between-subject variation in motor point location. Fifty three percent of motor points would have been missed if located only by reference to anatomical landmarks. CONCLUSIONS: These results suggested that the motor point's location cannot be determined a priori and that the identification method will affect both area and location. SIGNIFICANCE: If it is important to maximally activate a single muscle in isolation, the motor point is best represented by the site producing a maximal but isolated muscle response at the lowest stimulation intensity.

Electrical stimulation plus progressive resistance training for leg strength in spinal cord injury: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To determine the effectiveness of electrical stimulation (ES)-evoked muscle contractions superimposed on progressive resistance training (PRT) for increasing voluntary strength in the quadriceps muscles of people with spinal cord injuries (SCI). SETTING: Sydney, Australia. METHODS: A total of 20 people with established SCI and neurologically induced weakness of the quadriceps muscles participated in the trial. Participants were randomized between experimental and control groups. Volunteers in the experimental group received ES superimposed on PRT to the quadriceps muscles of one leg thrice weekly for 8 weeks. Participants in the control group received no intervention. Assessments occurred at the beginning and at the end of the 8-week period. The four primary outcomes were voluntary strength (Nm) and endurance (fatigue ratio) as well as the performance and satisfaction items of the Canadian Occupational Performance Measure (COPM; points). RESULTS: The between-group mean differences (95% confidence interval (CI)) for voluntary strength and endurance were 14 Nm (1-27; P=0.034) and 0.1 (-0.1 to 0.3; P=0.221), respectively. The between-group median differences (95% CI) for the performance and satisfaction items of the COPM were 1.7 points (-0.2 to 3.2; P=0.103) and 1.4 points (-0.1 to 4.6; P=0.058), respectively. CONCLUSION: ES superimposed on PRT improves voluntary strength, although there is uncertainty about whether the size of the treatment effect is clinically important. The relative effectiveness of ES and PRT is yet to be determined.