Dr Mark Williams

Purpose
This review synthesised the evidence for the effect of prehabilitation interventions on biopsychosocial and service outcomes.

Materials and Methods
A systematic review was conducted. 10 databases were searched to December 2023. Prospective experimental studies exploring prehabilitation interventions in adults undergoing upper gastrointestinal surgery were included. Prehabilitation was any preoperative intervention to improve physical or psychological outcomes. Included studies required a comparator group or alternative preoperative intervention as well as baseline, presurgical and postoperative assessment points. Study quality was assessed using the Cochrane risk of bias tool (v.2). Data synthesis was narrative (SWiM guidance).

Results
6028 studies were screened, with 25 studies included. Prehabilitation interventions were: inspiratory muscle training (five studies n = 450); exercise (nine studies n = 683); psychological (one study n = 400); and nutritional (ten studies n = 487). High quality studies showed preoperative improvements in impairments directly targeted by the interventions. Generally, these did not translate into functional or postoperative improvements, but multimodal interventions were more promising.

Conclusion
Current evidence supports prehabilitation as safe to preserve or improve preoperative function. Heterogeneity in outcomes and variable study quality means definitive conclusions regarding interventions are not yet possible, limiting implementation. Agreement of clinical outcomes and cost effectiveness evaluation is required.

Osteonecrosis (ON) is a common disabling complication of treatment for patients with acute lymphoblastic
leukaemia (ALL). Reported incidence rates range from 1% to 61% and multiple possible risk factors have been identified. This review explored existing evidence to provide new perspectives and recommendations for future interdisciplinary research. PEDro, CINAHL, AMED, EMBSAE, OVID, EMCARE databases were systematically searched from their inception to March 2022. Published original research reporting the incidence rates of osteonecrosis in patients aged 10–25 with ALL were included. Study reporting quality was assessed against appropriate reporting guidelines (STROBE, CONSORT and CROSS). All relevant data reporting incidence rates and risk factors were extracted for narrative synthesis. 3146 report titles were screened, with 34 studies included (n = 12,056) (30 observational cohort studies, three randomised trials, and one questionnaire study). The median study quality reporting score was 68% (IQR 64–82%). Median overall incidence rate of ON was 51.8% (IQR 41.4–58.9%) and 15.65% (IQR 9.2–24.2%) for asymptomatic and symptomatic patient screening respectively. Five possible risk factor categories were identified: sex assigned at birth, age, ethnicity, steroid regimen, and genotype. The female sex and white ethnicity were consistently reported as risk factors independently associated with an increased risk of osteonecrosis in all studies. A heterogenous body of literature with moderate reporting quality identified a high incidence rate of osteonecrosis in patients with ALL. Future research investigating the efficacy of stratified treatments that focus on reducing the risk of osteonecrosis through modification of steroid
regimen particularly in females of white ethnicity is needed. Obtaining multidisciplinary consensus with regards to screening methodologies and intervention outcomes may also help to improve evidence synthesis in this area. This may in turn facilitate early diagnosis and improve long term patient outcomes through treatment regimen modification and possible prevention of ON progression. 

Psychological readiness following anterior cruciate ligament reconstruction (ACLR) correlates with different return to sport outcomes. However, the relationship between strength and power and psychological readiness remains unexplored. The aim of this study was to investigate the relationship between anterior cruciate ligament return to sport after injury (ACL-RSI) scores and various hamstrings and quadriceps strength and power variables. Twelve participants (20.7 ± 2.5 years old; 174.2 ± 7.5 cm; 70.2 ± 8.5 kg; 18.2 ± 8.3% of body fat) who had an ACLR nine months or more before the study completed the ACL-RSI questionnaire and isokinetic strength testing of the hamstrings and quadriceps (60°·s−1 and 180°·s−1). Based on ACL-RSI scores, they were divided into “cases” and “controls”, deemed not psychologically ready and psychologically ready to return to previous sport performance (PILOS), respectively. The main findings are that quadriceps’ and hamstrings’ rate of torque development (RTD) and time since surgery were determinants of psychological readiness following ACLR. Furthermore, compared to controls, cases showed significantly lower quadriceps torque at angles close to full knee extension (40 deg and 30 deg from extension). They also showed lower RTD than controls, but no difference in peak torque. These results suggest that physiotherapists should facilitate athletes’ return to sport (RTS) by focusing on the restoration of RTD and strength at angles close to full knee extension.

Keywords: angle-specific torque; rate of force development; time since surgery; rehabilitation

Background
Survivors of critical care are at risk of long-term disability from musculoskeletal (MSK) impairments. These can have a biopsychosocial impact on the patient and their families with a reduction in health-related quality of life, increased health care utilization, caregiving roles and associated psychological distress.

Aims
To understand the experiences of patients living with MSK impairments following critical illness, and family and health care professionals supporting them, to inform the development of a future intervention to improve MSK health following critical illness.

Study Design
A four-site qualitative case study approach will be taken, with each of the four hospital sites and associated community services representing a case site. We will conduct semi-structured interviews with 10–15 patients/family members and 10–15 health care professionals about their experiences of MSK impairment following critical illness. Interviews will be audio recorded, transcribed verbatim and analysed using reflexive thematic analysis within a descriptive phenomenological approach. Alongside interview data, analysis of publicly available policy documentation, patient-facing materials and information from service leads at the four sites will be conducted. Discourse analysis will be used for this case study documentation.

Results
This protocol describes a qualitative study exploring the experiences of patients living with MSK impairments following critical illness, and the family and health care professionals supporting them.

Relevance to Clinical Practice
Data analysis will illuminate their experiences and enable data richness to contribute to the qualitative body of evidence of intensive care unit (ICU) survivors. These findings will inform the development of a complex intervention for MSK rehabilitation after critical illness.

Purpose: This systematic review and meta-analysis aimed to evaluate the effectiveness of inspiratory
muscle training (IMT) on respiratory muscle strength, lung function and quality of life (QOL) in adults
with spinal cord injuries (SCI).
Methods: Databases were searched up to June 2022; CENTRAL, CINAHL, MEDLINE, PEDRo, and PubMed. Following PRISMA reporting guidelines, two independent reviewers selected studies and extracted data. Study quality and levels of evidence were assessed.
Results: Following selection from 624 initial search results, six randomised controlled trials were identified, comprising 124 participants. Quality of Evidence was very low to moderate. Meta-analysis showed that post intervention, IMT significantly improved maximal inspiratory pressure (MD 15.72 cmH2O, 95% CI 5.02, 26.41, p = 0.004) when compared with a control intervention. There was no significant benefit for physical QOL (SMD 0.12, 95% CI −1.01, 1.25, p = 0.84), mental QOL (SMD −0.2, 95% CI −1.72, 1.33, p = 0.80), maximal expiratory pressure (MD 5.19 cmH2O, 95% CI −4.16, 14.55, p = 0.80), or FEV1 (MD 0.26 L, 95% CI −0.19, 0.7, p = 0.26). Sensitivity analyses found larger effects for studies with 8 week interventions (MD 17.5 cmH2O (95% CI 3.36 to 31.66)) and spring loaded devices alone (MD 21.18 cmH2O, 95% CI 9.65 to 32.72).​​​​​​​
Conclusion: Moderate quality evidence suggests IMT improves respiratory strength in adults with an SCI.
The mental and physical QOL outcomes provided very low quality of evidence, with considerable heterogeneity between study results, leading to inconsistency. Further research is warranted to investigate medium and long-term impact of robust IMT protocols, accounting for patient motivation and adherence to

Background To investigate the impact of physical activity interventions, including early mobilisation, on delirium outcomes in critically ill patients.

Methods Electronic database literature searches were conducted, and studies were selected based on pre-specified eligibility criteria. Cochrane Risk of Bias-2 and Risk Of Bias In Non-randomised Studies-of Interventions quality assessment tools were utilised. Grading of Recommendations, Assessment, Development and Evaluations was used to assess levels of evidence for delirium outcomes. The study was prospectively registered on PROSPERO (CRD42020210872).

Results Twelve studies were included; ten randomised controlled trials one observational case-matched study and one before-after quality improvement study. Only five of the included randomised controlled trial studies were judged to be at low risk of bias, with all others, including both non-randomised controlled trials deemed to be at high or moderate risk. The pooled relative risk for incidence was 0.85 (0.62–1.17) which was not statistically significant in favour of physical activity interventions. Narrative synthesis for effect on duration of delirium found favour towards physical activity interventions reducing delirium duration with median differences ranging from 0 to 2 days in three comparative studies. Studies comparing varying intervention intensities showed positive outcomes in favour of greater intensity. Overall levels of evidence were low quality.

Conclusions Currently there is insufficient evidence to recommend physical activity as a stand-alone intervention to reduce delirium in Intensive Care Units. Physical activity intervention intensity may impact on delirium outcomes, but a lack of high-quality studies limits the current evidence base.

Objective: Synthesize evidence on objectively quantified lower limb strength recovery in people treated surgically or non-surgically after patellar dislocation. 

Methods: MEDLINE, EMBASE, Cochrane Library, SPORTDiscus, PEDro, AMED and CINAHL databases were last searched on July 30th 2020 for randomized controlled trials and observational studies that objectively quantified lower limb strength in people (any age or sex) treated surgically or non-surgically after patellar dislocation.

Results: 24 studies were included (877 participants, median age 20.7). All assessed knee extension strength, 11 knee flexion strength, three hip abduction strength, two hip external rotation strength, and one hip flexion, extension, adduction, and internal rotation strength. One randomized controlled trial judged at high risk of bias and two cohort studies with methodological limitations compared lower limb strength recovery
between surgically and non-surgically treated people, with conflicting findings. After surgery, median long-term (>8 months) knee extension strength was 82.5% (IQR 78.5-88.2; 13 studies) of the unaffected leg and knee flexion strength was 91.5% (IQR 90.7-96.9; five studies). After non-surgical treatment, median long-term knee extensor strength was 86% (IQR 79.3-87.4; four studies) and mean flexion strength ranged from 95.2-96.7% (two studies). Hip strength was always >90% (two studies). Two redislocations during eccentric isokinetic knee testing and knee pain during isokinetic knee extension testing were reported as adverse events. 

Conclusions: Available evidence indicates that after patellar dislocation, knee extension strength deficits in the affected limb are frequently observed and can persist long term, but this remains uncertain due to the limitations of relevant included studies. Whether lower limb strength recovery differs between people
treated surgically and those treated non-surgically after patellar dislocation also remains uncertain. 

Objectives: To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint osteoarthritis (BTOA).

Methods: A pragmatic, multi-centre parallel group randomised controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction.   We randomised participants (1:1:1) using a computer-based minimisation system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS).  Participants were blinded to group allocation, received 90 minutes therapy over 8 weeks and were followed up for 12 weeks from baseline. AUSCAN hand pain at 8 weeks was the primary outcome, using intention to treat (ITT) analysis.  We calculated costs of treatment. 

Results: We randomised 349 participants to SSM (n=116), SSM+S (n= 116) or SSM+PS (n=117) and 292 (84%) provided AUSCAN hand pain scores at the primary end point (8 weeks).  All groups improved, with no mean treatment difference between groups: SSM+S vs. SSM -0.5 (95% CI -1.4 to 0.4, p=0.255), SSM+PS vs. SSM -0.1 (95% CI -1.0 to 0.8, p = 0.829) and SSM+S vs. SSM+PS -0.4 (95% CI -1.4 to 0.5, p=0.378).  The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685.   

Conclusion:  There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists.

Background. To aid design of exercise trials for people with pelvic and lower limb fragility fractures a systematic review was conducted to identify what types of exercise and mobility outcomes have been assessed, investigate intervention reporting quality, and evaluate risk of bias in published trials. Methods. Systematic searches of electronic databases (CENTRAL, MEDLINE, EMBASE, PEDro) 1996-2019 were conducted to identify randomised controlled trials of exercise for pelvic or lower limb fragility fractures. Two reviewers independently screened titles and abstracts. One reviewer extracted data, a second verified. Two reviewers independently assessed risk of bias. Intervention reporting quality was based on TIDieR, assessed by one reviewer and verified by a second. Narrative synthesis was undertaken. Registration. PROSPERO CRD42017060905. Results. Searches identified 37 trials including 3564 participants, median sample size 81(IQR 48-124), participants aged 81 years (IQR 79-82) and 76%(2536/3356) female. All trials focussed on people with hip fracture except one on ankle fracture. Exercise types focussed on resistance exercise in 14 trials, weight bearing exercise in 5 trials, 13 varied dose of sessions with health professionals, and 2 trials each focussed on treadmill gait training, timing of weight bearing or aerobic exercise. 30/37(81%) of trials reported adequate sequence generation, 25/37(68%) sufficient allocation concealment. 10/37(27%) trials lacked outcome assessor blinding. Of 65 exercise interventions, reporting was clear for 33(51%) in terms of when started, 61(94%) for where delivered, 49(75%) for who delivered, 47(72%) for group or individual, 29(45%) for duration, 46(71%) for session frequency, 8(12%) for full prescription details to enable the exercises to be reproduced, 32(49%) clearly reported tailoring or modification, and 23(35%) reported exercise adherence. Subjectively assessed mobility was assessed in 22/37(59%) studies and 29/37(78%) used an objective measure.
Conclusions. All trials focussed on hip fracture, apart from one ankle fracture trial. Research into pelvic and other lower limb fragility fractures is indicated. A range of exercise types were investigated but to date deficiencies in intervention reporting hamper reproducibility. Adoption of TIDieR and CERT guidelines should improve intervention reporting as use increases. Trials would be improved by consistent blinded outcome assessor use and with consensus on which mobility outcomes should be assessed.

Objective. To determine research priorities for the management of broken bones of the upper limb in people over 50 which represent the shared priorities of patients, their families, carers and healthcare professionals. Design/setting. A national (UK) research priority-setting partnership. Participants. People aged 50 and over who have experienced a fracture of the upper limb; carers involved in their care; family and friends of patients; healthcare professionals involved in the treatment of these patients. Methods. Using a multiphase methodology in partnership with the James Lind Alliance over 15 months (September 2017 – December 2018), a national scoping survey asked respondents to submit their research uncertainties. These were amalgamated into a smaller number of research questions. The existing evidence was searched to ensure that the questions had not already been answered. A second national survey asked respondents to prioritise the research questions. A final shortlist of 25 questions was taken to a multistakeholder workshop where a consensus was reached on the top 10 priorities. Results. There were 1898 original uncertainties submitted by 328 respondents to the first survey. These original uncertainties were refined into 51 research questions of which 50 were judged to be true uncertainties following a review of the research evidence. There were 209 respondents to the second (interim prioritisation) survey. The top 10 priorities encompass a broad range of uncertainties in management and rehabilitation of upper limb fractures. Conclusions. The top 10 UK research priorities highlight uncertainties in how we assess outcomes, provide information, achieve pain control, rationalise surgical intervention, optimise rehabilitation and provide psychological support. The breadth of these research areas highlights the value of this methodology. This work should help to steer research in this area for the next 5-10 years and the challenge for researchers now is to refine and deliver answers to these research priorities.

Introduction. The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectivenss. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. Methods and Analysis. Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint, or a self-management programme plus a placebo thumb splint. The primary outcome is the AUSCAN hand pain scale. The study end point is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4; 8 and 12 weeks. Cost effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. Ethics and Dissemination. South Central - Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions. 

Background. The purpose of this study was to identify factors associated with limitations in function measured by patient-reported outcome measures (PROMs) 6-9 months after elbow fractures in adults from a range of demographic, injury, psychological, and social variables measured within a week and 2-4 weeks after injury.

Methods. We enrolled 191 adult patients sustaining an isolated elbow fracture and invited them to complete PROMs at their initial visit to the orthopedic outpatient clinic (within a maximum of 1 week after fracture), between 2 and 4 weeks, and between 6 and 9 months after injury; 183 patients completed the final assessment. Bivariate analysis was performed, followed by multivariable regression analysis accounting for multicollinearity. This was evaluated using partial R2, correlation matrices, and variable inflation factor assessment.

Results. There was a correlation between multiple variables within a week of injury and 2-4 weeks after injury with PROMs 6-9 months after injury in bivariate analysis. Kinesiophobia measured within a week of injury and self-efficacy measured at 2-4 weeks were the strongest predictors of limitations 6-9 months after injury in multivariable regression. Regression models accounted for substantial variance in all PROMs at both time points.

Conclusions. Developing effective coping strategies to overcome fears related to movement and reinjury and finding ways of persevering with activity despite pain within a month of injury may enhance recovery after elbow fractures. Heightened fears around movement and suboptimal coping ability are modifiable using evidence-based behavioral treatments.

Background. Ankle sprains are very common injuries. Although recovery can occur within weeks, around one-third of patients have longer-term problems. Objectives. To develop and externally validate a prognostic model for identifying people at increased risk of poor outcome after an acute ankle sprain. Design. Development of a prognostic model in a clinical trial cohort data set and external validation in a prospective cohort study. Setting. Emergency departments (EDs) in the UK. Participants.  Adults with an acute ankle sprain (within 7 days of injury). Sample size. There were 584 clinical trial participants in the development data set and 682 recruited for the external validation study. Predictors. Candidate predictor variables were chosen based on availability in the clinical data set, clinical consensus, face validity, a systematic review of the literature, data quality and plausibility of predictiveness of the outcomes. Main outcome measures. Models were developed to predict two composite outcomes representing poor outcome. Outcome 1 was the presence of at least one of the following symptoms at 9 months after injury: persistent pain, functional difficulty or lack of confidence. Outcome 2 included the same symptoms as outcome 1, with the addition of recurrence of injury. Rates of poor outcome in the external data set were lower than in the development data set, 7% versus 20% for outcome 1 and 16% versus 24% for outcome 2. Analysis. Multiple imputation was used to handle missing data. Logistic regression models, together with multivariable fractional polynomials, were used to select variables and identify transformations of continuous predictors that best predicted the outcome based on a nominal alpha of 0.157, chosen to minimise overfitting. Predictive accuracy was evaluated by assessing model discrimination (c-statistic) and calibration (flexible calibration plot). Results. (1) Performance of the prognostic models in development data set – the combined c-statistic for the outcome 1 model across the 50 imputed data sets was 0.74 [95% confidence interval (CI) 0.70 to 0.79], with good model calibration across the imputed data sets. The combined c-statistic for the outcome 2 model across the 50 imputed data sets was 0.70 (95% CI 0.65 to 0.74), with good model calibration across the imputed data sets. Updating these models, which used baseline data collected at the ED, with an additional variable at 4 weeks post injury (pain when bearing weight on the ankle) improved the discriminatory ability (c-statistic 0.77, 95% CI 0.73 to 0.82, for outcome 1 and 0.75, 95% CI 0.71 to 0.80, for outcome 2) and calibration of both models. (2) Performance of the models in the external data set – the combined c-statistic for the outcome 1 model across the 50 imputed data sets was 0.73 (95% CI 0.66 to 0.79), with a calibration plot intercept of –0.91 (95% CI –0.98 to 0.44) and slope of 1.13 (95% CI 0.76 to 1.50). The combined c-statistic for the outcome 2 model across the 50 imputed data sets was 0.63 (95% CI 0.58 to 0.69), with a calibration plot intercept of –0.25 (95% CI –0.27 to 0.11) and slope of 1.03 (95% CI 0.65 to 1.42). The updated models with the additional pain variable at 4 weeks had improved discriminatory ability over the baseline models but not better calibration. Conclusions. The SPRAINED (Synthesising a clinical Prognostic Rule for Ankle Injuries in the Emergency Department) prognostic models performed reasonably well, and showed benefit compared with not using any model; therefore, the models may assist clinical decision-making when managing and advising ankle sprain patients in the ED setting. The models use predictors that are simple to obtain. Limitations. The data used were from a randomised controlled trial and so were not originally intended to fulfil the aim of developing prognostic models. However, the data set was the best available, including data on the symptoms and clinical events of interest. Future work. Further model refinement, including recalibration or identifying additional predictors, may be required. The effect of implementing and using either model in clinical practice, in terms of acceptability and uptake by clinicians and on patient outcomes, should be investigated. Trial registration: Current Controlled Trials ISRCTN12726986. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and was published in full in Health Technology Assessment; Vol. 22, No. 64. See the NIHR Journals Library website for further project information. Funding was also recieved from the NIHR Collaboration for Leadership in Applied Health Research, Care Oxford at Oxford Health NHS Foundation Trust, NIHR Biomedical Research Centre, Oxford, and the NIHR Fellowship programme.

Objectives. To develop and externally validate a prognostic model for poor recovery after ankle sprain. Setting and participants. Model development used secondary data analysis of 584 participants from a UK multicentre randomised clinical trial. External validation used data from 682 participants recruited in 10 UK emergency departments for a prospective observational cohort. Outcome and analysis. Poor recovery was defined as presence of pain, functional difficulty or lack of confidence in the ankle at 9 months after injury. Twenty-three baseline candidate predictors were included together in a multivariable logistic regression model to identify the best predictors of poor recovery. Relationships between continuous variables and the outcome were modelled using fractional polynomials. Regression parameters were combined over 50 imputed data sets using Rubin’s rule. To minimise overfitting, regression coefficients were multiplied by a heuristic shrinkage factor and the intercept re-estimated. Incremental value of candidate predictors assessed at 4 weeks after injury was explored using decision curve analysis and the baseline model updated. The final models included predictors selected based on the Akaike information criterion (p

Background.
Rheumatoid arthritis is an inflammatory polyarthritis that frequently affects the hands and wrists. Hand exercises are prescribed to improve mobility and strength, and thereby hand function.

Objectives.
To determine the benefits and harms of hand exercise in adults with rheumatoid arthritis.

Search methods.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, Embase, CINAHL, AMED, Physiotherapy Evidence Database (PEDro), OTseeker, Web of Science, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) up to July 2017.

Selection criteria.
We considered all randomised or quasi‐randomised controlled trials that compared hand exercise with any non‐exercise therapy.

Data collection and analysis.
We used standard methodological procedures as outlined by the Cochrane Musculoskeletal Group.

Main results.
We included seven studies involving 841 people (aged 20 to 94 years) in the review. Most studies used validated diagnostic criteria and involved home programmes.

Very low‐quality evidence (due to risk of bias and imprecision) from one study indicated uncertainty about whether exercise improves hand function in the short term (

Moderate‐quality evidence (due to risk of bias) from one study indicated that exercise compared to usual care probably slightly improves hand function (mean difference (MD) 4.5, 95% confidence interval (CI) 1.58 to 7.42; n = 449) in the medium term (3 to 11 months) and in the long term (12 months or beyond) (MD 4.3, 95% CI 0.86 to 7.74; n = 438). The absolute change on a 0‐to‐100 hand function scale (higher scores mean better function) and number needed to treat for an additional beneficial outcome (NNTB) were 5% (95% CI 2% to 7%); 8 (95% CI 5 to 20) and 4% (95% CI 1% to 8%); 9 (95% CI 6 to 27), respectively. A 4% to 5% improvement indicates a minimal clinical benefit.

Very low‐quality evidence (due to risk of bias and imprecision) from two studies indicated uncertainty about whether exercise compared to no treatment improved pain (MD ‐27.98, 95% CI ‐48.93 to ‐7.03; n = 124) in the short term. The absolute change on a 0‐to‐100‐millimetre scale (higher scores mean more pain) was ‐28% (95% CI ‐49% to ‐7%) and NNTB 2 (95% CI 2 to 11).

Moderate‐quality evidence (due to risk of bias) from one study indicated that there is probably little or no difference between exercise and usual care on pain in the medium (MD ‐2.8, 95% CI ‐ 6.96 to 1.36; n = 445) and long term (MD ‐3.7, 95% CI ‐8.1 to 0.7; n = 437). On a 0‐to‐100 scale, the absolute changes were ‐3% (95% CI ‐7% to 2%) and ‐4% (95% CI ‐8% to 1%), respectively.

Very low‐quality evidence (due to risk of bias and imprecision) from three studies (n = 141) indicated uncertainty about whether exercise compared to no treatment improved grip strength in the short term. The standardised mean difference for the left hand was 0.44 (95% CI 0.11 to 0.78), re‐expressed as 3.5 kg (95% CI 0.87 to 6.1); and for the right hand 0.46 (95% CI 0.13 to 0.8), re‐expressed as 4 kg (95% CI 1.13 to 7).

High‐quality evidence from one study showed that exercise compared to usual care has little or no benefit on mean grip strength (in kg) of both hands in the medium term (MD 1.4, 95% CI ‐0.27 to 3.07; n = 400), relative change 11% (95% CI ‐2% to 13%); and in the long term (MD 1.2, 95% CI ‐0.62 to 3.02; n = 355), relative change 9% (95% CI ‐5% to 23%).

Very low‐quality evidence (due to risk of bias and imprecision) from two studies (n = 120) indicated uncertainty about whether exercise compared to no treatment improved pinch strength (in kg) in the short term. The MD and relative change for the left and right hands were 0.51 (95% CI 0.13 to 0.9) and 44% (95% CI 11% to 78%); and 0.82 (95% CI 0.43 to 1.21) and 68% (95% CI 36% to 101%).

High‐quality evidence from one study showed that exercise compared to usual care has little or no benefit on mean pinch strength of both hands in the medium (MD 0.3, 95% CI ‐0.14 to 0.74; n = 396) and long term (MD 0.4, 95% CI ‐0.08 to 0.88; n = 351). The relative changes were 8% (95% CI ‐4% to 19%) and 10% (95% CI ‐2% to 22%).

No study evaluated the American College of Rheumatology 50 criteria.

Moderate‐quality evidence (due to risk of bias) from one study indicated that people who also received exercise with strategies for adherence were probably more adherent than those who received routine care alone in the medium term (risk ratio 1.31, 95% CI 1.15 to 1.48; n = 438) and NNTB 6 (95% CI 4 to 10). In the long term, the risk ratio was 1.09 (95% CI 0.93 to 1.28; n = 422).

Moderate‐quality evidence (due to risk of bias) from one study (n = 246) indicated no adverse events with exercising. The other six studies did not report adverse events.

Authors' conclusions.
It is uncertain whether exercise improves hand function or pain in the short term. It probably slightly improves function but has little or no difference on pain in the medium and long term. It is uncertain whether exercise improves grip and pinch strength in the short term, and probably has little or no difference in the medium and long term. The ACR50 response is unknown. People who received exercise with adherence strategies were probably more adherent in the medium term than who did not receive exercise, but with little or no difference in the long term. Hand exercise probably does not lead to adverse events. Future research should consider hand and wrist function as their primary outcome, describe exercise following the TIDieR guidelines, and evaluate behavioural strategies.

Aims

Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation.

Materials and Methods

A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to “CATs”, “orthopaedics”, “trauma”, and “anatomical regions”. Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and registered (PROSPERO: CRD42016053886).

Results

A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing.

Conclusion

Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures.

Objectives. The Stretching And strengthening for Rheumatoid Arthritis of the Hand (SARAH) randomised controlled trial evaluated the effectiveness of a hand exercise programme and demonstrated it was clinically effective and cost-effective at 12 months. The aim of this extended follow-up was to evaluate the effects of the SARAH programme beyond 12 months.

Methods. Using postal questionnaires, we collected the Michigan Hand Questionnaire hand function (primary outcome), activities of daily living and work subscales, pain troublesomeness, self-efficacy and health-related quality of life. All participants were asked how often they performed hand exercises for their rheumatoid arthritis. Mean difference in hand function scores were analysed by a linear model, adjusted for baseline score.

Results. Two-thirds (n=328/490, 67%) of the original cohort provided data for the extended follow-up. The mean follow-up time was 26 months (range 19–40 months).
There was no difference in change in hand function scores between the two groups at extended follow-up (mean difference (95% CI) 1.52 (−1.71 to 4.76)). However, exercise group participants were still significantly improved compared with baseline (p=0.0014) unlike the best practice usual care group (p=0.1122). Self-reported performance of hand exercises had reduced substantially.

Conclusions. Participants undertaking the SARAH exercise programme had improved hand function compared with baseline >2 years after randomisation. This was not the case for the control group. However, scores were no longer statistically different between the groups indicating the effect of the programme had diminished over time. This reduction in hand function compared with earlier follow-up points coincided with a reduction in self-reported performance of hand exercises. Further intervention to promote long-term adherence may be warranted.
Trial registration number ISRCTN89936343.

The aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D (utility)), Short Form 12 Dimensions (SF-12), SF-6D and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand.

Methods

The empirical investigation was based upon data from a randomised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the hands and/or wrists. Participants completed the EQ-5D, SF-12 and MHQ at baseline and at 4 and 12 months follow up. Acceptability was measured using completion rates over time; construct validity using the “known groups” approach, based on pain troublesomeness; convergent validity using spearman’s rho correlation (ρ); reliability using internal consistency (Cronbach’s alpha); interpretability using minimal important differences (MID); and responsiveness using effect sizes and standardised response means (SRM) stratified by level of self-rated improvement in hand and wrist function or level of self-rated benefit and satisfaction from trial treatments.

Results

At baseline, the study population had a mean age of 62.4 years, a mean MHQ score of 52.1 and included 76% women. The EQ-5D (utility) had the highest completion rates across time points. All instruments discriminated between pre-specified groups based on pain troublesomeness. Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D (ρ = 0.65) and SF-6D (ρ = 0.63) utility scores. The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months, whilst minimal important differences varied considerably across PROMs.

Conclusions

The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the hand. The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.

BACKGROUND CONTEXT: This qualitative study was part of a larger project that evaluated the feasibility of conducting a randomised controlled trial of exercises for young people with adolescent idiopathic scoliosis (AIS) (The ACTiVATeS Study ISRCTN90480705). Current UK management for AIS includes monitoring, bracing for some and, for the most progressive and serious cases, surgery. Exercise is a promising non-surgical intervention for AIS that needs more research. Qualitative research can allow us to incorporate a patient's experience into the design and evaluation of interventions.

PURPOSE: We aimed to explore participants' perception of the trial, the issues influencing exercise adherence and the appropriateness of the chosen outcome measurement.

STUDY DESIGN/SETTING: Qualitative research embedded within a randomised feasibility study at four NHS trusts across England which recruited 58 patients with AIS.

PATIENT SAMPLE: 6 adolescents with AIS, 8 parents and 4 physiotherapists participating in the ACTiVATeS Study. This sample size is appropriate for the chosen methodology which aims to explore experience in depth.

OUTCOME MEASURES: Not applicable.

METHODS: We used semi-structured interviews to explore the experience of adolescents with AIS, parents and physiotherapists. Interviews were digitally recorded and transcribed verbatim. We used the methods of interpretive phenomenological analysis to interpret the data. This involves sorting the interview material into progressively abstracted thematic groups with the aim of developing a meaningful interpretation. We used a computerised programme to assist analysis. This study was funded by the National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 10/38/03. The authors have no conflict of interests to declare.

RESULTS: This study presents themes that help us to understand what matters to patients with AIS, their families and physiotherapists in the context of a study evaluating exercise treatments. Our findings include the following categories: (1) it won't necessarily change the bony bits; (2) I didn't realise I stood like that; (3) she doesn't mention the pain now; (4) it gives her a sense of control; (5) creating a space for concerns; (6) they talked to her like a person.

CONCLUSIONS: What matters to patients with AIS and their families may be different from what matters to clinicians. Our qualitative findings raise issues about which valued aspects of health care should drive the management and evaluation of AIS. These decisions have implications for intervention design, research and commissioning, namely, who decides what a valued outcome is, how do we measure valued outcomes and how do we decide what outcomes we should fund?

CONFLICTS OF INTEREST: None.

FUNDING SOURCES: National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 10/38/03.

To compare the characteristics of early hand involvement in rheumatoid arthritis (RA) using two matched populations, from the UK and China.

Methods

A cohort comparison study was conducted. Sixty Chinese patients recruited from Shanghai, China were matched on gender and age with 60 patients from a prospective early RA cohort from the UK (SARAH trial). The procedures of data collection in China followed the standard operating procedures employed in the SARAH trial. Outcome measures including Michigan Hand Outcomes Questionnaire (MHQ), medication history and physical assessments were used to assess functional ability and hand impairment.

Results

UK patients reported significantly more hand pain (P = 0.015), less satisfaction with dominant hand performance (P  = 0.040), more swollen and tender joints (P = 0.016 and P = 0.001) and greater dexterity of both dominant and non-dominant hands (P

Conclusion

The severity of RA is not milder in China than in the UK and the characteristics of hand involvement tend to be different. Clinicians should consider country-specific differences in managing pain and delivering treatment. It would be helpful for a future study to investigate the RA impact characteristics on a wider range of patients both from within China and from other populations.

The study aims were (1) to estimate the clinical effectiveness and cost-effectiveness of adding an optimised exercise programme for hands and upper limbs to standard care for patients with RA; and (2) to qualitatively describe the experience of participants in the trial with a particular emphasis on acceptability of the intervention, exercise behaviours and reasons for adherence/non-adherence.

Design

A pragmatic, multicentred, individually randomised controlled trial with an embedded qualitative study. Outcome assessors were blind to group assignment and independent of treatment delivery.

Setting

Seventeen NHS trusts in England comprising 21 rheumatology and therapy departments.

Participants

Adults with RA who had pain and dysfunction of the hands and/or wrists and had been on stable medication for at least 3 months. Patients were excluded if they were under 18 years old, had undergone upper limb surgery/fracture in the last 6 months, were on a waiting list for upper limb surgery or were pregnant.

Interventions

Usual care or usual care plus an individualised exercise programme. Usual care consisted of joint protection education, general exercise advice and functional splinting if required. The exercise programme consisted of six sessions of strengthening and stretching exercises with a hand therapist, daily home exercises and strategies to maximise adherence.

Main outcome measures

The primary outcome was the Michigan Hand Outcome Questionnaire (MHQ) overall hand function subscale score at 12 months. Secondary outcome measures included the full MHQ, pain, health-related quality of life (Short Form questionnaire-12 items), impairment (grip strength, dexterity and range of motion) and self-efficacy. European Quality of Life-5 Dimensions, medication and health-care use were collected for the health economics evaluation. Follow-up was at 4 and 12 months post randomisation. Analysis was performed on an intention-to-treat basis.

Results

We randomised 490 patients (244 to usual care, 246 to exercise programme). Compliance with the treatments was very good (93% of usual care participants and 75% of exercise programme participants completed treatment). Outcomes were obtained for 89% of participants at 12 months (222 for usual care, 216 for exercise programme). There was a statistically significant difference in favour of the exercise programme for the primary outcome at 4 and 12 months [mean difference 4.6 points, 95% confidence interval (CI) 2.2 to 7.0 points; and mean difference 4.4 points, 95% CI 1.6 to 7.1 points, respectively]. There were no significant differences in pain scores or adverse events. The estimated difference in mean quality-adjusted life-years (QALYs) accrued over 12 months was 0.01 greater (95% CI –0.03 to 0.05) in the exercise programme group. Imputed analysis produced incremental cost-effectiveness ratio estimates of £17,941 (0.59 probability of cost-effectiveness at willingness-to-pay threshold of £30,000 per QALY). The qualitative study found the exercise programme to be acceptable and highlighted the importance of the therapist in enabling patients to establish a routine and incorporate the exercises into their lives.

Conclusions

The results of the Strengthening And stretching for Rheumatoid Arthritis of the Hand trial suggest that the addition of an exercise programme for RA hands/wrists to usual care is clinically effective and cost-effective when compared with usual care alone. No adverse effects were associated with the exercise programme. The economic analysis suggests that the intervention is likely to be cost-effective.

The feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain.
 

Objectives

The aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS; (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise; (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites; (4) develop, document and assess acceptability and adherence of interventions; (5) assess and describe training requirements of physiotherapists; and (6) gain user input in all relevant stages of treatment and protocol design.
 

Design

Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial.
 

Setting

The randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS.
 

Participants

The randomised feasibility study recruited people aged 10–16 years with mild AIS (Cobb angle of < 50°).
 

Interventions

The randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS.
 

Main outcome measures

The main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities.
 

Results

A UK survey of orthopaedic consultants and physiotherapists indicated a wide variation in current provision of exercise therapy through physiotherapy services. It also found that clinicians from at least 15 centres would be willing to have their patients involved in a full study. A systematic review update found five new studies that were generally of low quality but showed some promise of effectiveness of SSE. The randomised study recruited 58 patients from four NHS trusts over 11 months and exceeded the pre-specified target recruitment rate of 1.4 participants per centre per month, with acceptable 6-month follow-up (currently 73%). Adherence to treatment was variable (56% of participants completed treatment offered). The qualitative study found the exercise programme to be highly acceptable. We learnt important lessons from patient and public involvement during the study in terms of study and intervention presentation, as well as practical elements such as scheduling of intervention sessions.
 

Conclusions

A definitive RCT evaluating clinical effectiveness and cost-effectiveness of SSE for idiopathic scoliosis is warranted and feasible. Such a RCT is a priority for future work in the area. There is a sufficiently large patient base, combined with willingness to be randomised within specialist UK centres. Interventions developed during the feasibility study were acceptable to patients, families and physiotherapists and can be given within the affordability envelope of current levels of physiotherapy commissioning.