Feasibility of conducting a cohort randomised controlled trial assessing the effectiveness of a nurse-led package of care for knee pain.

OBJECTIVE: To evaluate the feasibility of conducting a cohort randomised-controlled trial (RCT) of a nurse-led package of care for knee pain and determine treatment sequence for use in a future trial. METHODS: Open label, three-arm, single-centre, mixed-methods, feasibility cohort RCT. Adults aged ≥40 years with moderate-to-severe knee pain for ≥3 months were eligible. Participants were randomised into groups A (non-pharmacological treatment first), B (pharmacological treatment first), or group C (usual care). The intervention was delivered over 26-weeks. Outcomes were dropout rate, recruitment rate, intervention fidelity, ability to collect outcome data and treatment acceptability. RESULTS: Seventeen participants were randomised and enrolled into each of groups A and B (5.2% recruitment rate), and 174 randomised to group C. Participant characteristics at randomisation were comparable across the three arms. COVID-19 paused the study from March-November-2020. Participants enrolled in groups A and B before March-2020 were withdrawn at restart. Of the 20 participants enrolled after restart, 18 completed the study (10% dropout). The nurse reported delivering most aspects of the intervention with high fidelity. Participants viewed the package of care as structured, supportive and holistic, they learnt about self-managing knee pain, and could engage with and follow the non-pharmacological treatment. Most found the non-pharmacological treatment more useful than the pharmacological treatment, preferring to receive it before or alongside analgesia. Many self-reported questionnaires were not fully completed. CONCLUSIONS: The nurse-led package of care for knee pain was acceptable with low dropout, although the cohort RCT design may not be feasible for a definitive trial. TRIAL REGISTRATION: clinicaltrials.gov; NCT03670706.

A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection.

BACKGROUND: When conducting a randomised controlled trial, there exist many different methods to allocate participants, and a vast array of evidence-based opinions on which methods are the most effective at doing this, leading to differing use of these methods. There is also evidence that study characteristics affect the performance of these methods, but it is unknown whether the study design affects researchers' decision when choosing a method. METHODS: We conducted a review of papers published in five journals in 2019 to assess which randomisation methods are most commonly being used, as well as identifying which aspects of study design, if any, are associated with the choice of randomisation method. Randomisation methodology use was compared with a similar review conducted in 2014. RESULTS: The most used randomisation method in this review is block stratification used in 162/330 trials. A combination of simple, randomisation, block randomisation, stratification and minimisation make up 318/330 trials, with only a small number of more novel methods being used, although this number has increased marginally since 2014. More complex methods such as stratification and minimisation seem to be used in larger multicentre studies. CONCLUSIONS: Within this review, most methods used can be classified using a combination of simple, block stratification and minimisation, suggesting that there is not much if any increase in the uptake of newer more novel methods. There seems to be a noticeable polarisation of method use, with an increase in the use of simple methods, but an increase in the complexity of more complex methods, with greater numbers of variables included in the analysis, and a greater number of strata.

Motivation and willingness to increase physical activity for dementia risk reduction: Cross-Sectional UK survey with people aged 50 and over.

METHODS: Attitudes to increasing physical activity to reduce risk of dementia were assessed in a national online survey promoted via online forums and public adverts. The Motivation to Change Behaviour for Dementia Risk Reduction (MOCHAD-10) scale examined motivation for lifestyle change. Multivariable logistic regression was used to identify the predictors of willingness and motivation to increase physical activity. RESULTS: Data from 3,948 individuals showed most people were moderately/very physically active (80%). People more likely to be physically active had better health and education, were older, male, and had a partner. People willing to increase physical activity (73%) were more likely to be younger, non-White, underweight, had better health and lifestyles, and had experience caring for someone with dementia. People with higher levels of motivation to change lifestyle (MOCHAD-10 subscales) were more likely to be female, younger, in poorer physical/mental health, had lower perceived mental activity, and were a carer for someone with dementia. CONCLUSION: Men and those with better health status were more physically active. Those who exercised less and those who were more motivated to increase physical activity were not necessarily able to be physically active. Multisectoral public health strategies should seek to use the high motivation levels among this group to mitigate the barriers related to physical activity for dementia risk reduction.

The cost-effectiveness of different approaches to exercise and corticosteroid injection for subacromial pain (impingement) syndrome.

OBJECTIVES: To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome. METHODS: An incremental cost-utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves. RESULTS: The cost-utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI -0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI -59.36, 109.86) and 0.024 (95% CI -0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection. CONCLUSION: Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection. CLINICAL TRIAL REGISTRATION: ISRCTN, http://www.isrctn.com, ISRCTN42399123.

Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial.

OBJECTIVES: To compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (formerly impingement) syndrome (SAPS). METHODS: This was a single-blind 2×2 factorial randomised trial. Adults with SAPS were randomised equally to one of four treatment groups: (1) ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet. The primary outcome was the Shoulder Pain and Disability Index (SPADI), collected at 6 weeks, 6 and 12 months and compared at 6 weeks for the injection interventions and 6 months for the exercise interventions by intention to treat. RESULTS: We recruited 256 participants (64 treatment per group). Response rates for the primary outcome were 94% at 6 weeks, 88% at 6 months and 80% at 12 months. Greater improvement in total SPADI score was seen with physiotherapist-led exercise than with the exercise leaflet at 6 months (adjusted mean difference -8.23; 95% CI -14.14 to -2.32). There were no significant differences between the injection groups at 6 weeks (-2.04; -7.29 to 3.22), 6 months (-2.36; -8.16 to 3.44) or 12 months (1.59; -5.54 to 8.72). CONCLUSIONS: In patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet. Ultrasound guidance confers no additional benefit over unguided corticosteroid injection. TRIAL REGISTRATION NUMBER: ISRCTN42399123.

Factors associated with costs and health outcomes in patients with Back and leg pain in primary care: a prospective cohort analysis.

BACKGROUND: There is limited research on the economic burden of low back-related leg pain, including sciatica. The aim of this study was to describe healthcare resource utilisation and factors associated with cost and health outcomes in primary care patients consulting with symptoms of low back-related leg pain including sciatica. METHODS: This study is a prospective cohort of 609 adults visiting their family doctor with low back-related leg pain, with or without sciatica in a United Kingdom (UK) Setting. Participants completed questionnaires, underwent clinical assessments, received an MRI scan, and were followed-up for 12-months. The economic analysis outcome was the quality-adjusted life year (QALY) calculated from the EQ-5D-3 L data obtained at baseline, 4 and 12-months. Costs were measured based on patient self-reported information on resource use due to back-related leg pain and results are presented from a UK National Health Service (NHS) and Societal perspective. Factors associated with costs and outcomes were obtained using a generalised linear model. RESULTS: Base-case results showed improved health outcomes over 12-months for the whole cohort and slightly higher QALYs for patients in the sciatica group. NHS resource use was highest for physiotherapy and GP visits, and work-related productivity loss highest from a societal perspective. The sciatica group was associated with significantly higher work-related productivity costs. Cost was significantly associated with factors such as self-rated general health and care received as part of the study, while quality of life was significantly predicted by self-rated general health, and pain intensity, depression, and disability scores. CONCLUSIONS: Our results contribute to understanding the economics of low back- related leg pain and sciatica and may provide guidance for future actions on cost reduction and health care improvement strategies. TRIAL REGISTRATION: 13/09/2011 Retrospectively registered; ISRCTN62880786 .

Subgrouping patients with sciatica in primary care for matched care pathways: development of a subgrouping algorithm.

BACKGROUND: Sciatica is a painful condition managed by a stepped care approach for most patients. Currently, there are no decision-making tools to guide matching care pathways for patients with sciatica without evidence of serious pathology, early in their presentation. This study sought to develop an algorithm to subgroup primary care patients with sciatica, for initial decision-making for matched care pathways, including fast-track referral to investigations and specialist spinal opinion. METHODS: This was an analysis of existing data from a UK NHS cohort study of patients consulting in primary care with sciatica (n = 429). Factors potentially associated with referral to specialist services, were identified from the literature and clinical opinion. Percentage of patients fast-tracked to specialists, sensitivity, specificity, positive and negative predictive values for identifying this subgroup, were calculated. RESULTS: The algorithm allocates patients to 1 of 3 groups, combining information about four clinical characteristics, and risk of poor prognosis (low, medium or high risk) in terms of pain-related persistent disability. Patients at low risk of poor prognosis, irrespective of clinical characteristics, are allocated to group 1. Patients at medium risk of poor prognosis who have all four clinical characteristics, and patients at high risk of poor prognosis with any three of the clinical characteristics, are allocated to group 3. The remainder are allocated to group 2. Sensitivity, specificity and positive predictive value of the algorithm for patient allocation to fast-track group 3, were 51, 73 and 22% respectively. CONCLUSION: We developed an algorithm to support clinical decisions regarding early referral for primary care patients with sciatica. Limitations of this study include the low positive predictive value and use of data from one cohort only. On-going research is investigating whether the use of this algorithm and the linked care pathways, leads to faster resolution of sciatica symptoms.

Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial.

BACKGROUND: Exercise interventions improve clinical outcomes of pain and function in adults with knee pain due to osteoarthritis and higher levels of physical activity are associated with lower severity of pain and higher levels of physical functioning in older adults with knee osteoarthritis in cross-sectional studies. However, to date no studies have investigated if change in physical activity level during exercise interventions can explain clinical outcomes of pain and function. This study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain. METHODS: Secondary longitudinal data analyses of a three armed exercise intervention randomised controlled trial. Participants were adults with knee pain attributed to osteoarthritis, over the age of 45 years old (n = 514) from Primary Care Services in the Midlands and Northwest regions of England. Crude and adjusted associations between absolute change in physical activity from baseline to 3 months (measured by the self-report Physical Activity Scale for the Elderly (PASE)) and i) pain ii) physical function (Western Ontario and McMaster Universities Osteoarthritis Index) and iii) treatment response (OMERACT-OARSI responder criteria) at 3 and 6 months follow-up were investigated using linear and logistic regression. RESULTS: Change in physical activity level was not associated with future pain, function or treatment response outcomes in crude or adjusted models at 3 or 6 months (P > 0.05). A 10 point increase in PASE was not associated with pain ß = - 0.01 (- 0.05, 0.02), physical function ß = - 0.09 (- 0.19, 0.02) or likelihood (odds ratio) of treatment response 1.02 (0.99, 1.04) at 3 months adjusting for sociodemographics, clinical covariates and the trial intervention arm. Findings were similar for 6 month outcome models. CONCLUSIONS: Change in physical activity did not explain future clinical outcomes of pain and function in this study. Other factors may be responsible for clinical improvements following exercise interventions. However, the PASE may not be sufficiently responsive to measure change in physical activity level. We also recommend further investigation into the responsiveness of commonly used physical activity measures. TRIAL REGISTRATION: ( ISRCTN93634563 ). Registered 29th September 2011.

Significant pain variability in persons with, or at high risk of, knee osteoarthritis: preliminary investigation based on secondary analysis of cohort data.

BACKGROUND: While knee osteoarthritis (OA) is characterised as a slowly progressive disease, acute flares, episodes of severe pain, and substantial fluctuations in pain intensity appear to be part of the natural history for some patients. We sought to estimate what proportion of symptomatic community-dwelling adults might be affected, and to identify patient and problem characteristics associated with higher risk of such variability in pain. METHODS: We analysed data collected at baseline, 18, 36, 54, and 72 month follow-up of a prospective cohort of symptomatic adults aged over 50 years with current/recent knee pain. At each time point we estimated the proportion of participants reporting 'significant pain variability' (defined as worst pain intensity in the past 6 months ≥5/10 and ≥2 points higher than average pain intensity during the same 6-month period). The associations between significant pain variability and demographic, socioeconomic, lifestyle, clinical, radiographic, and healthcare utilisation factors measured at baseline were estimated by adjusted odds ratios and 95% confidence intervals (aOR; 95%CI) from multivariable discrete-time survival analysis. RESULTS: Seven hundred and nineteen participants were included in the final analysis. At each time point, 23-32% of participants were classed as reporting significant pain variability. Associated factors included: younger age (aOR (per year): 0.96; 95% CI 0.94, 0.97), higher BMI (per kg/m2:1.03; 1.01, 1.06), higher WOMAC Pain score (per unit: 1.06; 1.03, 1.10), longer time since onset (e.g. 1-5 years vs < 1 year: 1.79; 1.16, 2.75) and morning stiffness (≤30 min vs none: 1.43; 1.10, 1.85). The models accounting for multiple periods of significant symptom variability found similar associations. CONCLUSIONS: Our findings are consistent with studies showing that, for some patients OA symptoms are significantly variable over time. Future prospective studies on the nature and frequency of flare ups are needed to help determine triggers and their underlying pathophysiology in order to suggest new avenues for effective episode management of OA to complement long-term behaviour change.

The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581).

BACKGROUND: Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of 'wait and see' for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. METHODS/DESIGN: Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. DISCUSSION: This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. TRIAL REGISTRATION: ISRCTN75449581 , date: 20.11.2014.

Natural menopause among women below 50 years in India: A population-based study.

BACKGROUND & OBJECTIVES: The age at which menopause naturally occurs may reflect nutritional and environmental circumstances as well as genetic factors. In this study we examined natural menopause as a marker of women's health at the population level in India and in some major States. METHODS: Data from the Indian District Level Household Survey (DLHS) carried out during 2007-2008 covering 643,944 ever-married women aged 15-49 yr were used; women of older ages were not included in this survey. Since not all women in this age group had achieved natural menopause at the time of survey, Cox proportional hazard regression models were employed to obtain the median age of women reporting a natural menopause, excluding those who underwent hysterectomy. Hazard ratios (HRs) were estimated for key socio-economic and reproductive variables that could potentially affect the age at natural menopause <40 yr. RESULTS: Overall, menopause prior to age 40 was reported by approximately 1.5 per cent of women. In the national data set, significant associations with age at natural menopause were identified with marriage breakdown or widowhood, poverty, Muslim religious affiliation, 'scheduled caste' status, not having received schooling, rural residence, having never used contraceptive pills, not been sterilized or had an abortion, low parity and residence in the western region. Within data from five selected States examined separately, the strength of these associations varied. INTERPRETATION & CONCLUSIONS: Associations of natural menopause with sociocultural, family planning and demographic variables were noted. Most importantly, there was an association with poverty that would require further investigation as to causality. The proportion of women experiencing early menopause may represent a useful overall indicator of women's health. The data are reassuring with regard to possible late effects of sterilization on ovarian function.

Characteristics of patients with low back and leg pain seeking treatment in primary care: baseline results from the ATLAS cohort study.

BACKGROUND: Patients with back pain radiating to the leg(s) report worse symptoms and poorer recovery than those with back pain alone. Robust evidence regarding their epidemiological profile is lacking from primary care, the setting where most of these patients will present and be managed. Our objective was to describe the characteristics of patients with back and leg pain, including sciatica, seeking treatment in primary care. METHODS: Adults visiting their general practitioner with back and leg pain, of any duration and severity, were invited to participate. Participants completed questionnaires, underwent clinical assessments and received MRI scans. Characteristics of the sample are described, and differences between patients diagnosed with referred leg pain and those with sciatica are analysed. RESULTS: Six hundred nine patients participated; 62.6 % were female, mean (SD) age 50.2 (13.9). 67.5 % reported pain below the knee, 60.7 % were in paid employment with 39.7 % reporting time off work. Mean disability (RMDQ) was 12.7 (5.7) and mean pain intensity was 5.6 (2.2) and 5.2 (2.4) for back and leg respectively. Mean sciatica bothersomeness index (SBI) was 14.9 (5.1). Three quarters (74.2 %) were clinically diagnosed as having sciatica. In the sciatica group, leg pain intensity, neuropathic pain, pain below the knee, leg pain worse than back pain, SBI and positive MRI findings were significantly higher as compared to patients with referred leg pain. CONCLUSIONS: This primary care cohort reported high levels of disability and pain. This is the first epidemiological study of unselected primary care patients seeking healthcare for back and leg pain. Follow-up of this cohort will investigate the prognostic value of their baseline characteristics. This new information will contribute to our understanding of the characteristics and clinical features of this population, and will underpin future research aimed at defining prognostic subgroups to enable better targeting of health care provision.

Post-sterilization autonomy among young mothers in South India.

This study examined the post-sterilization autonomy of women in south India in the context of early sterilization and low fertility. Quantitative data were taken from the third round of the National Family Health Survey (NFHS-3) carried out in 2005-06, and qualitative data from one village each in Kerala and Tamil Nadu during 2010-11. The incident rate ratios and thematic analysis showed that among currently married women under the age of 30 years, those who had been sterilized had significantly higher autonomy in household decision-making and freedom of mobility compared with women who had never used any modern family planning method. Early age at sterilization and low fertility enables women to achieve the social status that is generally attained at later stages in the life-cycle. Policies to capitalize on women's autonomy and free time resulting from early sterilization and low fertility should be adopted in south India.

Prognosis of Patients With Neuropathic Low Back-Related Leg Pain: An Exploratory Study Using Prospective Data From UK Primary Care.

This prospective cohort study investigates the prognosis of patients with neuropathic low back-related leg pain consulting in UK primary care. Data from 511 patients were collected using standardised baseline clinical examinations (including magnetic resonance imaging scan findings), self-report questionnaires at baseline, 4 months, 12 months, and 3 years. Cases of possible neuropathic pain (NP) and persistent-NP were identified using either of 2 definitions: 1) clinical diagnosis of sciatica, 2) self-report version of leeds assessment for neurological symptoms and signs (s-LANSS). Mixed-effects models compared pain intensity (highest of mean leg or mean back pain [0-10 Numerical Rating Scale]) over 3-years between persistent-NP versus non-persistent-NP based on 1) clinical diagnosis, 2) s-LANSS. Logistic regression examined associations between potential prognostic factors and persistent-NP at 4 months based on the 2 NP definitions. At 4-months, using both definitions: 1) approximately 4 out of 10 patients had persistent-NP, 2) mean pain intensity was higher for patients with persistent-NP at all follow-up points compared to those without, 3) only pain self-efficacy was significantly associated with persistent-NP (s-LANSS: OR .98, sciatica: .98), but it did not predict cases of persistent-NP in either multivariable model. Based on factors routinely collected from self-report and clinical examination, it was not possible to predict persistent-NP in this population. PERSPECTIVE: This study provides evidence that neuropathic back-related leg pain in patients consulting in primary care is not always persistent. Patients with persistent neuropathic pain had worse outcomes than those without. Neither leg pain intensity, pain self-efficacy nor MRI scan findings predicted cases of persistent neuropathic pain in this patient population.

Choosing and evaluating randomisation methods in clinical trials: a qualitative study.

BACKGROUND: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is still a lot of variety in practice not explained. This study used qualitative methods to explore more deeply the motivations behind researchers' choice of randomisation, and which features of the method they use to evaluate the performance of these methods. METHODS: Data was collected from online focus groups with various stakeholders involved in the randomisation process. Focus groups were recorded and then transcribed verbatim. A thematic analysis was used to analyse the transcripts. RESULTS: Twenty-five participants from twenty clinical trials units across the UK were recruited to take part in one of four focus groups. Four main themes were identified: how randomisation methods are selected; researchers' opinions of the different methods; which features of the method are desirable and ways to measure method features. Most researchers agree that the randomisation method should be selected based on key trial characteristics; however, for many, a unit standard is in place. Opinions of methods were varied with some participants favouring stratified blocks and others favouring minimisation. This was generally due to researchers' perception of the effect these methods had on balance and predictability. Generally, predictability was considered more important than balance as adjustments cannot be made for it; however, most researchers felt that the importance of these two methods was dependent on the design of the study. Balance is usually evaluated by tabulating variables by treatment arm and looking for perceived imbalances, predictability was generally considered much harder to measure, partly due to differing definitions. CONCLUSION: There is a wide variety in practice on how randomisation methods are selected and researcher's opinions on methods. The difference in practice observed when looking at randomisation method selection can be explained by a difference in unit practice, and also by a difference in researchers prioritisation of balance and predictability. The findings of this study show a need for more guidance on randomisation method selection.

Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (Hand-2): study protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function. Two treatments for Dupuytren's contractures are widely used within the National Health Service (NHS) in the UK: removal of the contractures via surgery (limited fasciectomy) and division of the contractures via a needle inserted through the skin (needle fasciotomy). This study aims to establish the clinical and cost-effectiveness of needle fasciotomy (NF) versus limited fasciectomy (LF) for the treatment of DC in the NHS, in terms of patient-reported hand function and resource utilisation. METHODS/DESIGN: Hand-2 is a national multi-centre, two-arm, parallel-group randomised, non-inferiority trial. Patients will be eligible to join the trial if they are aged 18 years or older, have at least one previously untreated finger with a well-defined Dupuytren's contracture of 30° or greater that causes functional problems and is suitable for treatment with either LF or NF. Patients with a contracture of the distal interphalangeal joint only are ineligible. Eligible consenting patients will be randomised 1:1 to receive either NF or LF and will be followed up for 24 months post-treatment. A QuinteT Recruitment Intervention will be used to optimise recruitment. The primary outcome measure is the participant-reported assessment of hand function, assessed by the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 12 months post-treatment. Secondary outcomes include other patient-reported measures, loss of finger movement, and cost-effectiveness, reported over the 24-month post-treatment. Embedded qualitative research will explore patient experiences and acceptability of treatment at 2 years post-surgery. DISCUSSION: This study will determine whether treatment with needle fasciotomy is non-inferior to limited fasciectomy in terms of patient-reported hand function at 12 months post-treatment. TRIAL REGISTRATION: International Standard Registered Clinical/soCial sTudy ISRCTN12525655. Registered on 18th September 2020.

Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people.

BACKGROUND: falls disproportionately affect older people, who are at increased risk of falls and injury. This pilot study investigates shock-absorbing flooring for fall-related injuries in wards for frail older people. METHODS: we conducted a non-blinded cluster randomised trial in eight hospitals in England between April 2010 and August 2011. Each site allocated one bay as the 'study area', which was randomised via computer to intervention (8.3-mm thick Tarkett Omnisports EXCEL) or control (2-mm standard in situ flooring). Sites had an intervention period of 1 year. Anybody admitted to the study area was eligible. The primary outcome was the fall-related injury rate. Secondary outcomes were injury severity, fall rate and adverse events. RESULTS: during the intervention period, 226 participants were recruited to each group (219 and 223 were analysed in the intervention and control group, respectively). Of 35 falls (31 fallers) in the intervention group, 22.9% were injurious, compared with 42.4% of 33 falls (22 fallers) in the control group [injury incident rate ratio (IRR) = 0.58, 95% CI = 0.18-1.91]. There were no moderate or major injuries in the intervention group and six in the control group. The fall IRR was 1.07 (95% CI = 0.64-1.81). Staff at intervention sites raised concerns about pushing equipment, documenting one pulled back. CONCLUSIONS: future research should assess shock-absorbing flooring with better 'push/pull' properties and explore increased faller risk. We estimate a future trial will need 33,480-52,840 person bed-days per arm.

Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review.

BACKGROUND: Testing for group B streptococcus (GBS) requires a vaginal-rectal swab in late pregnancy. OBJECTIVE: A systematic review of the test accuracy of a self-collected swab compared with a health-care professional collected swab in the diagnosis of GBS colonisation. SEARCH STRATEGY: The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects [DARE] and the Cochrane Central Register of Controlled Trials [CENTRAL]), EMBASE, MEDLINE and Trip were searched in May 2022. SELECTION CRITERIA: Randomised trials, test accuracy studies or diagnostic yield studies that compared the accuracy of a self-collected vaginal-rectal swab, compared to that taken by a health-care professional, for the detection of GBS colonisation in the third trimester. DATA COLLECTION AND ANALYSIS: Two researchers independently screened, selected studies, extracted data and assessed study quality. MAIN RESULTS: 10 studies, with 2578 women were included. Pooled sensitivity of self-collected swabs was 0.90 (95% confidence interval [CI] 0.81 to 0.95) and pooled specificity was 0.98 (95% CI 0.96 to 0.99). CONCLUSION: This study provides reassuring evidence that self-collected swabs for maternal GBS colonisation are highly accurate relative to swabs collected by health-care professionals. Women requiring a swab for GBS colonisation can self-swab with appropriate instructions if they choose. FUNDING: Personal fellowship from the University of Nottingham for KFW.

Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study.

Background: Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance. Objective: To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean. Design: A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial. Setting: Secondary care. Participants: Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents. Results: Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable. Limitations: Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial. Conclusions: We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK. Future work: We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies. Study registration: This study is registered as Research Registry 4942. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.

Text: One-quarter of UK pregnant women have a caesarean section. Most of these procedures are straightforward, but in a small number of cases unexpected complications can make the birth difficult. One complication, an impacted fetal head, may happen when caesarean sections are done in the second 'pushing' stage of labour. If the baby's head is low and wedged in the woman's pelvis, lifting it can be difficult, which can result in damage to the mother's womb and vagina, and to her baby. Occasionally, babies die. There are different techniques doctors and midwives can use to make these births easier, but there is uncertainty around which is best. To plan a trial to test these techniques, we needed to know how often impacted head happens, what techniques are used to manage it and whether or not research is acceptable to parents and health-care professionals. We surveyed doctors and midwives to find out which techniques they use and what training they need. We surveyed parents and pregnant women and interviewed women who had experienced a second-stage caesarean. We collected information from UK hospitals to find out how common this is and the impact on women and babies. We found out the following. List: • Around 7% of caesareans take place in second stage, and impacted fetal head occurs in 16% of these births. List: • One-third of women would consent to take part in a trial, if the complication happened to them. List: • Nearly all midwives and doctors thought that this research was important and would be willing to take part. Text: Using all of the information we collected, we designed a clinical trial. We wanted to compare two techniques for managing an impacted fetal head. The first is the vaginal push technique, where the doctor or midwife puts their hand into the mother's vagina to push her baby's head up, and the second is the fetal pillow, a device inserted into the mother's vagina before the operation starts to dislodge the baby's head upwards.

Accuracy of placement of ultrasound-guided corticosteroid injection for subacromial pain (impingement) syndrome does not influence pain and function: Secondary analysis of a randomised controlled trial.

OBJECTIVES: To investigate whether the accuracy of placement of ultrasound-guided (US-guided) corticosteroid injections for subacromial pain (impingement) syndrome (SAPS) influences pain and function outcomes. METHODS: This was a secondary analysis of data collected in a previous randomised controlled trial (RCT). Video images of US-guided subacromial corticosteroid injections delivered in the RCT were reviewed to categorise injection accuracy into three groups: definitely/probably not in the subacromial bursa (Group 1); probably in the subacromial bursa (Group 2); and definitely in the subacromial bursa (Group 3). The primary outcome was the Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI pain and function subscales and participants' self-reported global impression of change. Outcomes were compared between the accuracy groups after adjusting for pre-selected baseline characteristics. RESULTS: US-guided injection accuracy data were available for 114 participants: 22 categorised into Group 1, 21 into Group 2 and 71 into Group 3. There were no significant differences in mean total SPADI scores between the three injection accuracy groups at 6 weeks (Group 2 vs. 1: 8.22 (95% CI -4.01, 20.50); Group 3 versus 1: -0.57 (95% CI -10.27, 9.13) or 6 months (Group 2 vs. 1: 12.38 (95% CI -5.34, 30.10); Group 3 versus 1: 3.10 (95% CI -11.04, 17.23). CONCLUSIONS: The accuracy of injection placement in SAPS did not influence pain and function, suggesting that improvements in patients' outcomes using subacromial corticosteroid injections can be achieved without US guidance.