Effectiveness of GP access to magnetic resonance imaging of the knee: a randomised trial

Background

GPs commonly see patients with knee problems. Magnetic resonance imaging (MRI) of the knee is an accurate diagnostic test for meniscus and ligament injuries of the knee, but there is uncertainty about the appropriate use of MRI and when it should enter the diagnostic pathway for patients with these problems.

Aim

To assess the effectiveness of GP referral to early MRI and a provisional orthopaedic appointment, compared with referral to an orthopaedic specialist without prior MRI for patients with continuing knee problems.

Design of study

Pragmatic multicentre randomised trial with two parallel groups.

Setting

A total of 553 patients consulting their GP about a continuing knee problem were recruited from 163 general practices at 11 sites across the UK.

Method

Patients were randomised to MRI within 12 weeks of GP referral including a provisional orthopaedic appointment, or orthopaedic appointment without prior MRI within a maximum of 9 months from GP referral. The primary outcome measures were the Short Form 36-item (SF-36) physical functioning scale and the Knee Quality of Life 26-item Questionnaire (KQoL-26) at 6, 12, and 24 months.

Results

Patients randomised to MRI improved mean SF-36 physical functioning scores by 2.81 (95% confidence interval [CI] = −0.26 to 5.89) more than those referred to orthopaedics (P = 0.072). Patients randomised to MRI improved mean KQoL-26 physical functioning scores by 3.65 (95% CI = 1.03 to 6.28) more than controls (P = 0.007). There were no other significant differences.

Conclusion

GP access to MRI yielded small, but statistically significant, benefits in patients'' knee-related quality of life but non-significant improvements in physical functioning.     

Reducing the time before consulting with symptoms of lung cancer: a randomised controlled trial in primary care

Background

Most individuals with lung cancer have symptoms for several months before presenting to their GP. Earlier consulting may improve survival.

Aim

To evaluate whether a theory-based primary care intervention increased timely consulting of individuals with symptoms of lung cancer.

Design and setting

Open randomised controlled trial comparing intervention with usual care in two general practices in north-east Scotland.

Method

Smokers and ex-smokers aged ≥55 years were randomised to receive a behavioural intervention or usual care. The intervention comprised a single nurse consultation at participants’ general practice and a self-help manual. The main outcomes were consultations within target times for individuals with new chest symptoms (≤3 days haemoptysis, ≤3 weeks other symptoms) in the year after the intervention commenced, and intentions about consulting with chest symptoms at 1 and 6 months.

Results

Two hundred and twelve participants were randomised and 206 completed the trial. The consultation rate for new chest symptoms in the intervention group was 1.19 (95% confidence interval [CI] = 0.92 to 1.53; P = 0.18) times higher than in the usual-care group and the proportion of consultations within the target time was 1.11 (95% CI = 0.41 to 3.03; P = 0.83) times higher. One month after the intervention commenced, the intervention group reported intending to consult with chest symptoms 31 days (95% CI = 7 to 54; P = 0.012) earlier than the usual care group, and at 6 months this was 25 days (95% CI = 1.5 to 48; P = 0.037) earlier.

Conclusion

Behavioural intervention in primary care shortened the time individuals at high risk of lung disease intended to take before consulting with new chest symptoms (the secondary outcome of the study), but increases in consultation rates and the proportions of consultations within target times were not statistically significant.     

Providing general practice needs-based care for carers of people with advanced cancer: a randomised controlled trial

Background

Carers of patients with advanced cancer often have health and psychosocial needs, which are frequently overlooked.

Aim

To meet the needs of carers through a GP consultation directed by a self-completed carer needs checklist.

Design and setting

Randomised controlled trial in general practice with recruitment through specialist oncology clinics, in Brisbane, Australia.

Method

Intervention was (a) carer–GP consultations directed by a self-completed checklist of needs at baseline and 3 months; and (b) a GP-Toolkit to assist GPs to address carer-identified needs. Control group received usual care. Outcome measures were intensity of needs, anxiety and depression, and quality of life.

Results

Total recruitment 392. Overall, no significant differences were detected in the number or intensity of need between groups. Compared to controls, intervention participants with baseline clinical anxiety showed improvements in mental wellbeing (P = 0.027), and those with baseline clinical depression had slower development of anxiety (P = 0.044) at 6 months. For those not anxious, physical wellbeing improved at 1 month (P = 0.040). Carers looking after patients with poor functional status had more physical needs (P = 0.037) at 1 month and more psychological and emotional needs at 3 months (P = 0.034). Those caring for less unwell patients showed improved mental wellbeing at 3 months (P = 0.022).

Conclusion

The intervention did not influence the number or intensity of needs reported by carers of people with advanced cancer. There was limited impact in people with pre-existing clinical anxiety and depression. For the carer of those most severely affected by advanced cancer, it drew attention to the needs arising from the caregiving role.     

Effectiveness of a smartphone application to promote physical activity in primary care: the SMART MOVE randomised controlled trial

Background

Physical inactivity is a major, potentially modifiable, risk factor for cardiovascular disease, cancer, and other chronic diseases. Effective, simple, and generalisable interventions that will increase physical activity in populations are needed.

Aim

To evaluate the effectiveness of a smartphone application (app) to increase physical activity in primary care.

Design and setting

An 8-week, open-label, randomised controlled trial in rural, primary care in the west of Ireland.

Method

Android smartphone users >16 years of age were recruited. All participants were provided with similar physical activity goals and information on the benefits of exercise. The intervention group was provided with a smartphone app and detailed instructions on how to use it to achieve these goals. The primary outcome was change in physical activity, as measured by a daily step count between baseline and follow-up.

Results

A total of 139 patients were referred by their primary care health professional or self-referred. In total, 37 (27%) were screened out and 12 (9%) declined to participate, leaving 90 (65%) patients who were randomised. Of these, 78 provided baseline data (intervention = 37; control = 41) and 77 provided outcome data (intervention = 37; control = 40). The mean daily step count at baseline for intervention and control groups was 4365 and 5138 steps per day respectively. After adjusting, there was evidence of a significant treatment effect (P = 0.009); the difference in mean improvement in daily step count from week 1 to week 8 inclusive was 1029 (95% confidence interval 214 to 1843) steps per day, favouring the intervention. Improvements in physical activity in the intervention group were sustained until the end of the trial.

Conclusion

A simple smartphone app significantly increased physical activity over 8 weeks in a primary care population.     

Successful GP intervention with frequent attenders in primary care: randomised controlled trial.

BACKGROUND: Frequent attenders to GP clinics can place an unnecessary burden on primary care. Interventions to reduce frequent attendance have had mixed results. AIM: To assess the effectiveness of a GP intervention to reduce frequent-attender consultations. DESIGN OF STUDY: Randomised controlled trial with frequent attenders divided into an intervention group and two control groups (one control group was seen by GPs also providing care to patients undergoing the intervention). SETTING: A health centre in southern Spain. METHOD: Six GPs and 209 randomly-selected frequent attenders participated. Three GPs were randomly allocated to perform the new intervention: of the 137 frequent attenders registered with these three GPs, 66 were randomly allocated to receive the intervention (IG) and 71 to a usual care control group (CG2). The other three GPs offered usual care to the other 72 frequent attenders (CG1). The main outcome measure was the total number of consultations 1 year post-intervention. Baseline measurements were recorded of sociodemographic characteristics, provider-user interface, chronic illnesses, and psychosocial variables. GPs allocated to the new intervention received 15 hours' training which incorporated biopsychosocial, organisational, and relational approaches. After 1 year of follow-up frequent attenders were contacted. An intention-to-treat analysis was used. RESULTS: A multilevel model was built with three factors: time, patient, and doctor. After adjusting for covariates, the mean number of visits at 1 year in IG was 13.10 (95% confidence interval [CI]=11.39 to 14.94); in the CG1 group was 19.37 (95% CI=17.31 to 21.55); and in the CG2 group this was 16.72 (95% CI=4.84 to 18.72). CONCLUSION: The new intervention with GPs resulted in a significant and relevant reduction in frequent-attender consultations. Although further trials are needed, this intervention is recommended to GPs interested in reducing consultations by their frequent attenders.     

Effectiveness of a community intervention on malaria in rural Tanzania - a randomised controlled trial

Background

Malaria infections are a major public health problem in Africa and prompt treatment is one way of controlling the disease and saving lives.

Methods

This cluster-randomised controlled community intervention conducted in 2003–2005 aimed at improving early malaria case management in under five children. Health workers were trained to train community-based women groups in recognizing malaria symptoms, providing first-line treatment for uncomplicated malaria and referring severe cases. Evaluation was through a pre- (2004) and a post-intervention survey (2005). Anaemia prevalence was the primary outcome.

Results

1715 children aged 6–59 months were included in the pre-intervention survey and 2169 in the post-intervention survey. The prevalence of anaemia decreased significantly from 37% [95% CI 34.7–39.3] to 0.5% [95% CI 0.2–0.7] after the intervention (p<0.001); slightly more in the intervention (from 43.9% to 0.8%) than in the control (30.8% to 0.17%) group (p=0.038). Fever and reported fever decreased significantly and the mean body weight of the children increased significantly over the study period in both control and intervention groups.

Conclusion

The decrease in anaemia was significantly associated with the intervention, whereas the fever and body weight trends might be explained by other malaria control activities or seasonal/climate effects in the area. The community intervention was shown to be feasible in the study context.     

Case finding for chronic obstructive pulmonary disease in primary care: a pilot randomised controlled trial

Background

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. However, much of the disease burden remains undiagnosed.

Aim

To compare the yield and cost effectiveness of two COPD case-finding approaches in primary care.

Design and setting

Pilot randomised controlled trial in two general practices in the West Midlands, UK.

Method

A total of 1634 ever-smokers aged 35–79 years with no history of COPD or asthma were randomised into either a ‘targeted’ or ‘opportunistic’ case-finding arm. Respiratory questionnaires were posted to patients in the ‘targeted’ arm and provided to patients in the ‘opportunistic’ arm at routine GP appointments. Those reporting at least one chronic respiratory symptom were invited for spirometry. COPD was defined as pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)<0.7 and FEV1<80% of predicted. Primary outcomes were the difference in the proportion of patients diagnosed with COPD and the cost per case detected.

Results

Twenty-six per cent (212/815) in the ‘targeted’ and 13.6% (111/819) in the ‘opportunistic’ arm responded to the questionnaire and 78.3% (166/212) and 73.0% (81/111), respectively, reported symptoms; 1.2% (10/815) and 0.7% (6/819) of patients in the ‘targeted’ and ‘opportunistic’ arms were diagnosed with COPD (difference in proportions = 0.5% [95% confidence interval {CI} = –0.5% to 3.08%]). Over a 12-month period, the ‘opportunistic’ case-finding yield could be improved to 1.95% (95% CI = 1.0% to 2.9%). The cost-per case detected was £424.56 in the ‘targeted’ and £242.20 in the ‘opportunistic’ arm.

Conclusion

Opportunistic case finding may be more effective and cost effective than targeting patients with a postal questionnaire alone. A larger randomised controlled trial with adequate sample size is required to test this.     

Comparison of methadone and buprenorphine for opiate detoxification (LEEDS trial): a randomised controlled trial

Background

Many opiate users require prescribed medication to help them achieve abstinence, commonly taking the form of a detoxification regime. In UK prisons, drug users are nearly universally treated for their opiate use by primary care clinicians, and once released access GP services where 40% of practices now treat drug users. There is a paucity of evidence evaluating methadone and buprenorphine (the two most commonly prescribed agents in the UK) for opiate detoxification.

Aim

To evaluate whether buprenorphine or methadone help to achieve drug abstinence at completion of a reducing regimen for heroin users presenting to UK prison health care for detoxification.

Design

Open-label, pragmatic, randomised controlled trial in three prison primary healthcare departments in the north of England.

Method

Prisoners (n = 306) using illicit opiates were recruited and given daily sublingual buprenorphine or oral methadone, in the context of routine care, over a standard reduced regimen of not more than 20 days. The primary outcome measure was abstinence from illicit opiates at 8 days post detoxification, as indicated by urine test (self-report/clinical notes where urine sample was not feasible). Secondary outcomes were also recorded.

Results

Abstinence was ascertained for 73.7% at 8 days post detoxification (urine sample = 52.6%, self report = 15.2%, clinical notes = 5.9%). There was no statistically significant difference in the odds of achieving abstinence between methadone and buprenorphine (odds ratio [OR] = 1.69; 95% confidence interval [CI] = 0.81 to 3.51; P = 0.163). Abstinence was associated solely with whether or not the participant was still in prison at that time (15.22 times the odds; 95% CI = 4.19 to 55.28). The strongest association for lasting abstinence was abstinence at an earlier time point.

Conclusion

There is equal clinical effectiveness between methadone and buprenorphine in achieving abstinence from opiates at 8 days post detoxification within prison.     

Effectiveness of nurse-delivered cardiovascular risk management in primary care: a randomised trial

Background

A substantial part of cardiovascular disease prevention is delivered in primary care. Special attention should be paid to the assessment of cardiovascular risk factors. According to the Dutch guideline for cardiovascular risk management, the heavy workload of cardiovascular risk management for GPs could be shared with advanced practice nurses.

Aim

To investigate the clinical effectiveness of practice nurses acting as substitutes for GPs in cardiovascular risk management after 1 year of follow-up.

Design of study

Prospective pragmatic randomised trial.

Setting

Primary care in the south of the Netherlands. Six centres (25 GPs, six nurses) participated.

Method

A total of 1626 potentially eligible patients at high risk for cardiovascular disease were randomised to a practice nurse group (n = 808) or a GP group (n = 818) in 2006. In total, 701 patients were included in the trial. The Dutch guideline for cardiovascular risk management was used as the protocol, with standardised techniques for risk assessment. Changes in the following risk factors after 1 year were measured: lipids, systolic blood pressure, and body mass index. In addition, patients in the GP group received a brief questionnaire.

Results

A larger decrease in the mean level of risk factors was observed in the practice nurse group compared with the GP group. After controlling for confounders, only the larger decrease in total cholesterol in the practice nurse group was statistically significant (P = 0.01, two-sided).

Conclusion

Advanced practice nurses are achieving results, equal to or better than GPs for the management of risk factors. The findings of this study support the involvement of practice nurses in cardiovascular risk management in Dutch primary care.     

电针结合雷火灸治疗寒湿型膝骨性关节炎的临床随机对照试验

文题释义：膝骨性关节炎：又称为膝关节增生性关节炎、退行性膝关节炎,是中老年人常见的一种慢性骨关节病,主要病理特点为关节软骨退变、破坏、软骨下骨硬化、关节边缘软骨下骨增生,进而引起滑膜炎症、半月板损伤、游离体形成及关节外组织炎症等一系列病变,临床症状以膝关节的疼痛、肿胀、变形及活动受限为主。白细胞介素6：是由CD4⁺T细胞、巨噬细胞等多种细胞产生的促炎性细胞因子,它能够对多种细胞产生促炎作用,在正常健康人群的血浆中其表达水平较低,在手术、炎症、感染等情况时其表达水平会显著上升。背景：雷火灸疗法及电针疗法均能有效改善膝骨性关节炎的相关症状,同时两种疗法兼具操作简单、廉价、实用性强等优点。目的：观察电针结合雷火灸与塞来昔布胶囊治疗寒湿型膝骨性关节炎的疗效差异。方法：选择2017年6月至2018年12月在广西中医药大学附属瑞康医院就诊的寒湿型膝骨性关节炎患者72例,其中男35例,女37例,采用随机数字表法分为2组：观察组(n=35)进行雷火灸(1次/d)结合电针治疗(1次/d),对照组(n=37)口服塞来昔布胶囊(1次/d),每个疗程14 d,两组均治疗2个疗程,疗程之间休息2 d。治疗前与治疗结束后进行目测类比评分、WOMAC评分、关节液相关炎性指标检测,并评估中医证候疗效有效率,并在治疗结束后进行1个月的随访。试验获得广西中医药大学附属瑞康医院伦理委员会批准,伦理批件号：KY2017-005。结果与结论：①两组试验过程中无严重不良反应发生;②观察组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、僵硬、功能3项目评分)均较治疗前明显降低(P < 0.05);对照组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、功能2项目评分)均较治疗前明显降低(P < 0.05);观察组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、僵硬、功能3项目评分)均低于对照组(P < 0.05);③两组治疗结束后的白细胞介素6、肿瘤坏死因子α水平均较治疗前明显降低(P < 0.05),并且观察组两指标水平低于对照组(P < 0.05);④观察组的治疗总有效率高于对照组(97.1%,81.1%,P < 0.05);⑤结果表明,电针结合雷火灸治疗寒湿型膝骨性关节炎的临床效果明显且不良反应少,其与塞来昔布胶囊相比在疗效持久性方面更具优势。ORCID: 0000-0002-7859-7850(邓凯烽)中国组织工程研究杂志出版内容重点：组织构建;骨细胞;软骨细胞;细胞培养;成纤维细胞;血管内皮细胞;骨质疏松;组织工程     

关节腔内注射透明质酸与安慰剂治疗早中期膝骨关节炎的疗效差异:基于随机、双盲、对照、临床试验的Meta分析

目的:随着临床医师采用关节内注射透明质酸钠治疗早中期膝骨关节炎的广泛应用,对其疗效的争议日趋激烈,但缺乏高质量随机对照双盲临床研究的循证医学证据.文章基于关节内注射透明质酸钠治疗早中期膝骨关节炎的双盲随机对照临床研究,明确其客观疗效.方法:在中英文电子数据库(中国知网、万方、读秀学术、超星期刊、维普中文数据库和Web ...     

Predictors of persistent complaints after a knee injury in primary care

Background

Prognosis of persistent complaints after knee injury is based on secondary care populations. In a primary care setting, however, no studies have addressed this issue.

Aim

To identify possible predictors of persistent complaints 1 year after a knee injury. These predictors are important for guiding the GP’s therapeutic management, and giving advice to patients about work and/or sports-related activities.

Design and setting

Primary care prospective cohort study with a 1-year follow-up period in five municipalities in the southwest region of the Netherlands.

Method

Patients who were eligible were recruited to the study by a GP research network with around 84 000 patients and 40 participating GPs. A total of 134 patients (aged 18–65 years) who consulted their GP within 5 weeks after a knee injury entered the study. Follow-up after 1 year was conducted in 122 patients. The main outcome was persistent complaints 1 year after injury; possible predictors for these complaints were obtained with a questionnaire, a physical examination, and magnetic resonance imaging (MRI), according to a standardised protocol.

Results

After 1 year, of the 122 available patients, 21 (17%) reported persistent complaints and 101 (83%) reported full recovery or major improvement. In this study being aged >40 years had a significant association (P<0.05) with persistent complaints (odds ratio 8.0, 95% confidence interval 2.1 to 30.5). Physical examination and MRI findings revealed no predictors that were associated with these complaints.

Conclusion

Being aged >40 years was the only determinant with a significant association with persistent complaints. As physical examination and MRI had no predictive value, they are not recommended for prognosis of persistent complaints.     

A randomised controlled trial to test the feasibility of a collaborative care model for the management of depression in older people

BACKGROUND: Depression is the most common mental health disorder in people aged over 65 years. Late-life depression is associated with chronic illness and disability. AIM: To investigate the feasibility of a collaborative care model for depression in older people in a primary care setting. DESIGN OF STUDY: Randomised controlled trial with 16-weeks follow up. SETTING: A primary care trust in Manchester. METHOD: Participants were 105 people aged 60 years or older who scored 5 or more on the Geriatric Depression Scale; 53 were randomly allocated to an intervention group and 52 to a usual care group. The intervention group received care managed by a community psychiatric nurse who delivered an intervention comprising a facilitated self-help programme with close liaison with primary care professionals and old-age psychiatry according to a defined protocol. The usual care group received usual GP care. A nested qualitative study explored the views of the health professionals and patients regarding the acceptability and effectiveness of the intervention. RESULTS: The main outcome measure was recovery from depression. Patients in the intervention group were less likely to suffer from major depressive disorder at follow up compared with usual care (0.32, 95% confidence = interval = 0.11 to 0.93, P = 0.036). The qualitative component of the study demonstrated the acceptability of the intervention to patients. CONCLUSION: A model of collaborative care for older people with depression, used in a primary care setting with a facilitated self-help intervention is more effective than usual GP care. This study demonstrates that the implementation of a collaborative care model is feasible in UK primary care and that the intervention is effective and acceptable to patients.     

Motivational interviewing for modifying diabetes risk: a randomised controlled trial

BACKGROUND: Around 10-15% of adults aged over 40 years have pre-diabetes, which carries a high risk of progression to type 2 diabetes. Intensive lifestyle intervention reduces progression by as much as 58%. However, the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care. AIM: To assess the effectiveness of a low-cost intervention, delivered in primary care by non-NHS staff, to reduce the risk of diabetes through weight loss and physical activity. DESIGN OF STUDY: Pragmatic single-blind randomised controlled trial with researchers and statistician blinded to group allocation. SETTING: UK primary care. METHOD: One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more, but without diabetes or heart disease, received either information leaflets or individual behavioural counselling using motivational interviewing techniques. The intervention was delivered by five counsellors recruited from the local community. The primary outcomes were the proportions of participants meeting predefined targets for weight loss (5%) and moderate physical activity (150 minutes/week) after 6 months. RESULTS: Using intention-to-treat analysis, more people in the intervention group achieved the weight-loss target (24% versus 7% for controls; odds ratio [OR]=3.96; 95% confidence interval [Cl]=1.4 to 11.4; number needed to treat [NNT]=6.1 (95% Cl=4 to 21). The proportion achieving the physical activity target did not increase significantly (38% versus 28% for controls; OR=1.6; 95% Cl=0.7 to 3.8). CONCLUSION: Short-term weight loss, at a level which, if sustained, is clinically meaningful for reducing diabetes risk, is achievable in primary care, without excessive use of NHS monetary or personnel resources.     

Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial

Background

GPs investigate approximately half of all infertile couples with semen analysis and endocrine blood tests. For assessment of tubal status, hysterosalpingography (HSG) is recommended as a first-line investigation for women not known to have comorbidities.

Aim

To test whether providing GPs with open access to HSG results in infertile couples progressing to a diagnosis and management plan sooner than with usual management.

Design of study

A pragmatic cluster randomised controlled trial.

Setting

Seventy-one of 173 general practices in north-east England agreed to participate.

Method

A total of 670 infertile couples presented to 33 intervention practices and 25 control practices over a 2-year period. Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled predefined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan.

Results

An annual incidence of 0.8 couples per 1000 total population equated to each GP seeing an average of one or two infertile couples each year. Open access HSG was used for 9% of all infertile women who presented to the intervention practices during the study period. The time to reach a diagnosis and management plan for all infertile couples presenting was not affected by the availability of open access HSG (Cox regression hazard ratio = 0.9, 95% confidence interval [CI] = 0.7 to 1.1). For couples who reached a diagnosis and management plan, there was a non-significant difference in time to primary outcome for intervention versus control practices (32.5 weeks versus 30.5 weeks, mean difference 2.2 weeks, 95% CI = 1.6 to 6.1 weeks, P = 0.1). The intracluster correlation coefficient was 0.03 across all practices.

Conclusion

Providing GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.     

Exploring patients' reasons for declining contact in a cognitive behavioural therapy randomised controlled trial in primary care

Background

The difficulties of recruiting individuals into mental health trials are well documented. Few studies have collected information from those declining to take part in research, in order to understand the reasons behind this decision.

Aim

To explore patients'' reasons for declining to be contacted about a study of the effectiveness of cognitive behavioural therapy as a treatment for depression.

Design and setting

Questionnaire and telephone interview in general practices in England and Scotland.

Method

Patients completed a short questionnaire about their reasons for not taking part in research. Semi-structured telephone interviews were conducted with a purposive sample to further explore reasons for declining.

Results

Of 4552 patients responding to an initial invitation to participate in research involving a talking therapy, 1642 (36%) declined contact. The most commonly selected reasons for declining were that patients did not want to take part in a research study (n = 951) and/or did not want to have a talking therapy (n = 688) (more than one response was possible). Of the decliners, 451 patients agreed to an interview about why they declined. Telephone interviews were completed with 25 patients. Qualitative analysis of the interview data indicated four main themes regarding reasons for non-participation: previous counselling experiences, negative feelings about the therapeutic encounter, perceived ineligibility, and misunderstandings about the research.

Conclusion

Collecting information about those who decline to take part in research provides information on the acceptability of the treatment being studied. It can also highlight concerns and misconceptions about the intervention and research, which can be addressed by researchers or recruiting GPs. This may improve recruitment to studies and thus ultimately increase the evidence base.     

Supervised exercises for adults with acute lateral ankle sprain: a randomised controlled trial.

BACKGROUND: During the recovery period after acute ankle sprain, it is unclear whether conventional treatment should be supported by supervised exercise. AIM: To evaluate the short- and long-term effectiveness of conventional treatment combined with supervised exercises compared with conventional treatment alone in patients with an acute ankle sprain. DESIGN: Randomised controlled clinical trial. SETTING: A total of 32 Dutch general practices and the hospital emergency department. METHOD: Adults with an acute lateral ankle sprain consulting general practices or the hospital emergency department were allocated to either conventional treatment combined with supervised exercises or conventional treatment alone. Primary outcomes were subjective recovery (0-10 point scale) and the occurrence of a resprain. Measurements were carried out at intake, 4 weeks, 8 weeks, 3 months, and 1 year after injury. Data were analysed using intention-to-treat analyses. RESULTS: A total of 102 patients were enrolled and randomised to either conventional treatment alone or conventional treatment combined with supervised exercise. There was no significant difference between treatment groups concerning subjective recovery or occurrence of resprains after 3 months and 1-year of follow-up. CONCLUSION: Conventional treatment combined with supervised exercises compared to conventional treatment alone during the first year after an acute lateral ankle sprain does not lead to differences in the occurrence of resprains or in subjective recovery.     

富血小板血浆与透明质酸治疗膝骨关节炎疗效对比的Meta分析

文题释义：透明质酸：是细胞外基质的主要成分,是一种由氨基葡萄糖组成的多糖,主要分布于关节软骨、滑液、皮肤和房水中,具有调节生物化学过程、提供支持和润滑的功效,在维持关节的正常功能方面具有重要的作用。富血小板血浆：是自体外周血经离心后得到的血制品,对于自身无免疫排斥反应,含有大量生长因子,如血小板源性生长因子、血管内皮生长因子、转化生长因子等,这些因子能够刺激软骨细胞的增殖分化,诱导血管生成,对软组织损伤修复起着积极的作用。背景：透明质酸是治疗膝骨关节炎的常用药物,富血小板血浆治疗膝骨关节炎则是近年来的研究热点,对于这两者之间的有效性和安全性的比较尚存在争议。目的：系统评价富血小板血浆与透明质酸治疗膝骨关节炎的有效性及安全性。方法：按照Cochrane系统评价的方法,应用计算机检索CNKI、维普网、万方数据知识服务平台、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、Embase等数据库,检索有关富血小板血浆与透明质酸治疗膝骨关节炎的随机对照试验,文献发表时间为建库至2020年1月。对所有符合纳入标准的文献进行质量评价,采用Revman 5.3软件对其WOMAC评分、IKDC评分、目测类比评分、Lequesne指数及不良事件进行Meta分析。结果与结论：①纳入21篇文献,共1 872例患膝,其中富血小板血浆组963例,透明质酸组909例;②Meta分析结果显示,富血小板血浆组治疗后3,6,12个月的WOMAC评分明显低于透明质酸组[MD=-5.84,95%CI(-10.11,-1.57),P=0.007;MD=-9.48,95%CI(-13.02,-5.95),P < 0.000 01;MD=-10.47,95%CI(-13.95,-7.00),P < 0.000 01],治疗后6,12个月的目测类比评分低于透明质酸组[MD=-5.02,95%CI(-8.87,-1.18),P=0.01;MD=-3.33,95%CI(-4.89,-1.76),P< 0.000 1],治疗后3,6,12个月的IKDC评分高于透明质酸组[MD=7.10,95%CI(3.88,10.32),P < 0.000 1;MD=7.88,95%CI(5.12,10.65),P < 0.000 01;MD=6.85,95%CI(2.50,11.19),P=0.002],治疗后6,12个月的Lequesne指数低于透明质酸组[MD=-0.82,95%CI(-1.31,-0.32),P=0.001;MD=-2.37,95%CI(-2.93,-1.81),P < 0.000 01];两组不良事件发生率比较差异无显著性意义[OR=1.46,95%CI(0.94,2.24),P=0.09];③结果表明相较于透明质酸,富血小板血浆治疗膝骨关节炎更能缓解疼痛、改善功能、提高患者生活质量,疗效更持久。ORCID: 0000-0003-4045-0340(王养发)中国组织工程研究杂志出版内容重点：人工关节;骨植入物;脊柱;骨折;内固定;数字化骨科;组织工程     

Evaluating the transferability of a hospital-based childhood obesity clinic to primary care: a randomised controlled trial

Background

The Care Of Childhood Obesity (COCO) clinic at the Bristol Royal Hospital for Children (BRHC) uses a multidisciplinary approach comprising a consultant, dietitian, and exercise specialist. The clinic has demonstrated efficacy in managing children''s weight but similar clinics are scarce in the UK.

Aim

This pilot randomised controlled trial (RCT) aimed to examine the feasibility of undertaking a fully powered RCT and to gauge whether the COCO model could be effective as a nurse-led clinic in primary care settings.

Design and setting

Patients were randomised to a hospital-based childhood obesity clinic or a nurse-led clinic in a primary care setting in south-west England.

Method

Children aged 5–16 years with a body mass index (BMI) ≥98th centile were referred by GPs to the consultant in charge of the COCO clinic at BRHC. Referred children were clinically screened for suitability and invited into the study. Consenting families were randomised to BRHC or a primary care clinic (PCC) and offered five appointments over 12 months. Clinical effectiveness was measured by change in body mass index standard deviation score (BMI SDS) at 12 months. Other measures included: treatment adherence, quality of life (QOL), and satisfaction. Feasibility was examined by assessing referral, screening, and recruitment data.

Results

A total 152 patients were referred by GPs: 31 (20%) were screened out; 45 (30%) declined to participate. Seventy-six (50%) patients were randomised and 68 provided baseline data (PCC = 42; BRHC = 26); 52 provided outcome data (PCC = 29; BRHC = 23). Mean change in BMI SDS was PCC –0.17 (95% confidence interval [CI] = –0.27 to –0.07); BRHC –0.15 (95% CI = –0.26 to –0.05). QOL, adherence, and satisfaction data indicated similar positive patterns in both trial arms.

Conclusion

Screening and recruitment data indicate that primary care is a clinically appropriate setting and acceptable to families. The primary clinical outcome measure (reduction in BMI SDS), along with secondary outcome measures, indicate that primary care has the potential to be effective in providing weight management for children, using the COCO model.