Assessing social work effectiveness in child care practice: the contribution of randomized controlled trials

This article discusses the role of randomized controlled trials (RCTs) in evaluating the impact of social work interventions with children. While recognizing the difficulties of applying RCTs to all aspects of practice, we argue that controlled trials can provide the most convincing evidence of the impact of social work activities on the welfare of children and families. Accumulating evidence of the effectiveness of interventions, we propose, should constitute the core business of social work research. To this end, it is necessary to recognize the primacy of the randomized controlled trial in exploring the relationship between social work activities and client outcomes.     

Cluster size variability and imbalance in cluster randomized controlled trials

Cluster randomized controlled trials are increasingly used to evaluate medical interventions. Research has found that cluster size variability leads to a reduction in the overall effective sample size. Although reporting standards of cluster trials have started to evolve, a far greater degree of transparency is needed to ensure that robust evidence is presented. The use of the numbers of patients recruited to summarize recruitment rate should be avoided in favour of an improved metric that illustrates cumulative power and accounts for cluster variability. Data from four trials is included to show the link between cluster size variability and imbalance. Furthermore, using simulations it is demonstrated that by randomising using a two block randomization strategy and weighting the second by cluster size recruitment, chance imbalance can be minimized.     

临床营养研究中随机对照研究质量评价

目的评价两种主要临床营养期刊中随机对照试验（RCT）的质量。方法查阅2000～2008年《中国临床营养杂志》和《肠外与肠内营养》发表的RCT研究，按Cochrane协作网标准评价，并进行Jadad评分。结果两种期刊共发表238篇RCT研究，Jadad评分为（1．65±0．82）分。高质量RCT仅28篇（11．76％），评分为满分5分的仅5篇（2．10％）。随机分组的方法、组间可比性、纳入排除标准、盲法、撤除和退出的数量和理由、样本含量等方面存在各种问题。结论国内临床营养领域RCT研究的设计和质量控制还存在不足或欠缺，水平尚待提高。     

The use of text messaging to improve attendance in primary care: a randomized controlled trial

BACKGROUND: Non-attendance is common in primary care and previous studies have reported that reminders were useful in reducing broken appointments. OBJECTIVE: To determine the effectiveness of a text messaging reminder in improving attendance in primary care. DESIGN: Multicentre three-arm randomized controlled trial. SETTING: Seven primary care clinics in Malaysia. Participants. Patients (or their caregivers) who required follow-up at the clinics between 48 hours and 3 months from the recruitment date. Interventions. Two intervention arms consisted of text messaging and mobile phone reminders 24-48 hours prior to scheduled appointments. Control group did not receive any intervention. Outcome measures. Attendance rates and costs of interventions. RESULTS: A total of 993 participants were eligible for analysis. Attendance rates of control, text messaging and mobile phone reminder groups were 48.1, 59.0 and 59.6%, respectively. The attendance rate of the text messaging reminder group was significantly higher compared with that of the control group (odds ratio 1.59, 95% confidence interval 1.17 to 2.17, P = 0.005). There was no statistically significant difference in attendance rates between text messaging and mobile phone reminder groups. The cost of text messaging reminder (RM 0.45 per attendance) was lower than mobile phone reminder (RM 0.82 per attendance). CONCLUSIONS: Text messaging reminder system was effective in improving attendance rate in primary care. It was more cost-effective compared with the mobile phone reminder.     

In-patient interventions supported by results of randomized controlled trials in Japan.

OBJECTIVE: To determine to what extent the results of randomized controlled trials (RCTs) support medical interventions for in-patients at the department of general medicine of a university hospital in Japan. DESIGN: Retrospective analysis. By reviewing discharge summaries, two physicians first independently decided on patients' respective primary problems at admission and up to two secondary problems. Next, up to five interventions for the primary problem and one intervention for each of the secondary problems were selected. Differences of opinion (if any) between the two physicians regarding these selected interventions were resolved by discussion. MEDLINE and/or the Cochrane Library were used as data sources for literature regarding the selected interventions. SETTING: A ward of the department of general medicine of a Japanese university hospital, 1995-1997. MAIN MEASURES: The proportion of therapeutic interventions supported by RCT results and associated meta-analyses. RESULTS: For the primary problems, 103 (48.8%) of the 211 most important interventions were supported by the results of RCTs, as were 47.8% of all the interventions including the most important and the adjunctive ones. Furthermore, 56.2% of the most important interventions for the secondary problems were also supported by the RCT results. CONCLUSIONS: Approximately half of the therapeutic interventions performed at an academic medical in-patient unit in Japan were RCT-supported. This was true not only for the most important interventions for primary problems but also for the adjunct interventions for the primary problems and the interventions for secondary problems.     

Digital technologies in primary care: Implications for patient care and future research

Digital health is the convergence of digital technologies with health, healthcare, living, and society. Contrasting with the slow trend during the last decades, in the last few years, we have observed an expansion and widespread adoption and implementation. In this paper, we revisit the potential that digital health presents for the delivery of higher quality, safer and more equitable care. Focussing on three examples – patient access to health records, big data analytics, and virtual care – we discuss the emerging opportunities and challenges of digital health, and how they can change primary care. We also reflect on the implications for research to evaluate digital interventions: the need to evaluate clear outcomes in light of the six dimensions of quality of care (patient-centredness, efficiency, effectiveness, safety, timeliness, and equity); to define clear populations to understand what works and for which patients; and to involve different stakeholders in the formulation and evaluation of the research questions. Finally, we share five wishes for the future of digital care in General Practice: the involvement of primary healthcare professionals and patients in the design and maintenance of digital solutions; improving infrastructure, support, and training; development of clear regulations and best practice standards; ensuring patient safety and privacy; and working towards more equitable digital solutions, that leave no one behind.     

阶梯整群随机对照试验的样本量和功效计算方法

目的 介绍阶梯整群随机对照试验（SW-CRT）的样本量和功效计算方法。 方法 参考既往的相关方法学研究,并配合实际案例,介绍SW-CRT两种情景下的样本量和功效计算方法、具体实现步骤和实现工具。 结果 利用所介绍的公式能方便计算已知每群调查样本量或已知调查总群数的两种情景下满足样本功效要求的样本量,推荐使用Stata软件提供的steppedwedge程序进行样本功效的计算。结论 本研究能够为相关研究者的研究设计和结果检验工作提供具有实际操作意义的方法选择。     

Cluster randomized trial of a multifaceted primary care decision-support intervention for inherited breast cancer risk

BACKGROUND: GPs are increasingly expected to meet the needs of patients concerned about their risk of inherited breast cancer, but may lack skills or confidence to use complex management guidelines. We developed an evidence-based, multifaceted intervention intended to promote confidence and skills in this area. OBJECTIVE: To evaluate the effectiveness of the intervention in improving GP confidence in managing patients concerned about genetic risk of breast cancer. METHODS: DESIGN: Cluster randomized controlled trial. SETTING: General practices in the Grampian region of Scotland. SUBJECTS: GPs and the patients they referred for genetic counselling for risk of breast cancer. MAIN OUTCOME MEASURES: GPs' self-reported confidence in four activities related to genetics; rates of referral of patients at elevated genetic risk; and referred patients' understanding of cancer risk factors. RESULTS: No statistically significant differences were observed between intervention and control arms in the primary or secondary outcomes. A possible effect of the intervention on the proportion of referred patients who were at elevated risk could not be discounted. Only a small proportion of intervention GPs attended the educational session, were aware or the software, or made use of it in practice. CONCLUSIONS: No convincing evidence of the effectiveness of the intervention was found, probably reflecting barriers to its use in routine practice.     

Effect of fruits and vegetables on metabolic syndrome: a systematic review and meta-analysis of randomized controlled trials

Abstract

Evidence regarding the effect of fruit and vegetable consumption on metabolic syndrome remains inconclusive. Using MEDLINE, EMBASE, and Cochrane, we searched for relevant studies published before 10 December 2013. Of the 383 articles identified, eight randomized controlled trials with 396 participants (205 in intervention groups and 191 in control groups) were included in the final analyses. Fruit and vegetable intake was associated with a reduction in diastolic blood pressure (standardized mean difference: ?0.29; 95% confidence interval: ?0.57 to ?0.02; p?=?0.04); however, such intake did not affect waist circumference, systolic blood pressure, fasting glucose, high-density lipoprotein cholesterol, and triglyceride levels in metabolic syndrome patients. In a subgroup analysis, there were no statistically significant differences found according to the intervention period and provision type. Our results suggest an inverse association between fruit and vegetable consumption and diastolic blood pressure in metabolic syndrome patients.     

临床营养研究中随机对照研究质量评价

Objective To evaluate the quality of the randomized controlled trials (RCTs) published in two key Chineze journals on clinical nutrition.Methods The articles published in CHINESE JOURNAL OF CLIN-ICAL NUTRlTION and PARENTERAL & ENTERAL NUTRITION from 2000 to 2008 were reviewed and the RCTs were identified according to criteria of the handbook of Cochrane Collaboration.The Jadad scale was used to evalu-ate the quality of these RCTs.Results Totally 238 RCT articles were published in these two journals in this peri-od.The Jadad score of all RCT articles was 1.65±0.82.Twenty-eight articles (11.76%) were of high quality and only 5 articles (2.10%) were identified 5 points.There were some problems in the RCTs design,conduction and analyses included unclear randomization methods,poor comparison,lack of inclusion and exclusion criteria.less blinding employment,unclear withdrawals and dropouts,and improper sample size.Conclusion The design and quality control of Chinese clinical nutrition RCTs still have some problems and require further improvement.     

An alternative trial design to overcome validity and recruitment problems in primary care research

BACKGROUND: Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems. OBJECTIVE: Our aim was to present an alternative trial design to overcome internal validity and recruitment problems. METHODS: In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied. RESULTS: Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up. CONCLUSION: Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study.     

Postal surveys in primary care: the hidden burden

Objective  To investigate and analyse concerns raised by unsolicited mailing of a health survey to a community sample of older people.
Design  Observation and monitoring of all telephone calls received throughout a 6-week survey mailing period.
Setting and participants  A total sample of all those aged over 50 years registered with three general practices in North Staffordshire ( n =8995).
Main variable studied  The frequency of telephone contact following the receipt of a postal questionnaire, and the nature of any associated distress.
Results and conclusions  Individuals who receive unsolicited postal surveys may experience anxiety because of the actual receipt of the questionnaire, concerns about taking part or not taking part, personal issues, anger, worthiness or frustration with NHS services. Anxiety may also be triggered because of administrative issues, for example lost mail or overlap between mailing periods. Researchers can adopt measures both to reduce the potential anxiety and often hidden burden of postal surveys, and to facilitate individuals' positive participation in research.     

Integration of depression and hypertension treatment: a pilot, randomized controlled trial

PURPOSE We wanted to examine whether integrating depression treatment into care for hypertension improved adherence to antidepressant and antihypertensive medications, depression outcomes, and blood pressure control among older primary care patients.METHODS Older adults prescribed pharmacotherapy for depression and hypertension from physicians at a large primary care practice in West Philadelphia were randomly assigned to an integrated care intervention or usual care. Outcomes were assessed at baseline, 2, 4, and 6 weeks using the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression, an electronic monitor to measure blood pressure, and the Medication Event Monitoring System to assess adherence.RESULTS In all, 64 participants aged 50 to 80 years participated. Participants in the integrated care intervention had fewer depressive symptoms (CES-D mean scores, intervention 9.9 vs usual care 19.3; P <.01), lower systolic blood pressure (intervention 127.3 mm Hg vs usual care 141.3 mm Hg; P <.01), and lower diastolic blood pressure (intervention 75.8 mm Hg vs usual care 85.0 mm Hg; P <.01) compared with participants in the usual care group at 6 weeks. Compared with the usual care group, the proportion of participants in the intervention group who had 80% or greater adherence to an antidepressant medication (intervention 71.9% vs usual care 31.3%; P <.01) and to an antihypertensive medication (intervention 78.1% vs usual care 31.3%; P <.001) was greater at 6 weeks.CONCLUSION A pilot, randomized controlled trial integrating depression and hypertension treatment was successful in improving patient outcomes. Integrated interventions may be more feasible and effective in real-world practices, where there are competing demands for limited resources.     

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review

PURPOSE

Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients.

METHODS

We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models.

RESULTS

The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I² = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I² = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I² = 0; P >.05).

CONCLUSIONS

Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care.     

Mothers' attitudes to the randomized controlled trial (RCT): the case of acute lymphoblastic leukaemia (ALL) in children

OBJECTIVES: Survival rates for childhood cancer have improved substantially partly as a result of national and international randomized clinical trials (RCT). However, the decision for families is complex and emotional. Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to randomized controlled trials. DESIGN: Qualitative interview to explore mothers knowledge, and reasons for involving their child in RCTs. Interviews took place in mothers' homes. PARTICIPANTS: Fifty mothers of children with newly diagnosed ALL (age 4-16 years; mean = 7.4) recruited through research nurses at outpatient appointments. RESULTS: All but three families had consented for their child to be treated in the RCT, although there was wide variation in their understanding of the aims, costs and benefits. Most mothers reported the aim of the trial to compare 'old' and 'new' treatments. CONCLUSION: Despite detailed verbal and written information, mothers were poorly informed about the purpose of the trial, and possibility of side effects. Individual preferences for either standard or new treatment were routinely reported. The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT.