Background: Complementary and alternative therapy is widely used to treat chronic obstructive pulmonary disease (COPD). A Chinese herbal medicine, JianPiYiFei (JPYF) II granules, have been shown to improve COPD patients' quality of life, however long-term effectiveness has not been examined. Purpose: To investigate whether long-term treatment with JPYF II granules is effective and safe for patients with stable, moderate to very severe COPD. Study design and methods: A multicentre, randomised, double-blinded, placebo-controlled trial was conducted. Eligible participants from six hospitals were randomly assigned 1:1 to receive either JPYF II granules or placebo for 52 weeks. The primary outcome was the change in St. George's Respiratory Questionnaire (SGRQ) score during treatment. Secondary outcomes included the frequency of acute exacerbations during treatment, COPD Assessment Test (CAT), 6-minute walking test (6MWT), lung function, body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index, and peripheral capillary oxygen saturation (SpO2) at the end of treatment. Results: A total of 276 patients (138 in each group) were included in the analysis. JPYF II granules led to a significantly greater reduction in SGRQ score (-7.33 points, 95% CI -10.59 to -4.07; p < 0.0001) which reflects improved quality of life. JPYF II granules improved CAT (-3.49 points, 95% CI -5.12 to -1.86; p < 0.0001) and 6MWT (45.61 metres, 95% CI 20.26 to 70.95; p = 0.0005), compared with placebo. Acute exacerbations were less frequent with JPYF II granules than with placebo (0.87 vs. 1.34 events per patient; p = 0.0043). There were no significant differences between the groups in lung function, BODE index and SpO2. JPYF II granules were well tolerated and no significant adverse effects were noted. Conclusions: Long-term treatment with JPYF II granules is effective in moderate to very severe COPD, improving quality of life and exercise capacity, decreasing the risk of acute exacerbation, and relieving symptoms.

Background: People with suspected prostate cancer are usually offered either a local anaesthetic transrectal ultrasound-guided prostate biopsy or a general anaesthetic transperineal prostate biopsy. Transperineal prostate biopsy is often carried out under general anaesthetic due to pain caused by the procedure. However, recent studies suggest that performing local anaesthetic transperineal prostate biopsy may better identify cancer in particular regions of the prostate and reduce infection rates, while being carried out in an outpatient setting. Devices to assist with freehand methods of local anaesthetic transperineal prostate may also help practitioners performing prostate biopsies. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of local anaesthetic transperineal prostate compared to local anaesthetic transrectal ultrasound-guided prostate and general anaesthetic transperineal prostate biopsy for people with suspected prostate cancer, and local anaesthetic transperineal prostate with specific freehand devices in comparison with local anaesthetic transrectal ultrasound-guided prostate and transperineal prostate biopsy conducted with a grid and stepping device conducted under local or general anaesthetic. Data sources and methods: We conducted a systematic review of studies comparing the diagnostic yield and clinical effectiveness of different methods for performing prostate biopsies. We used pairwise and network meta-analyses to pool evidence on cancer detection rates and structured narrative synthesis for other outcomes. For the economic evaluation, we reviewed published and submitted evidence and developed a model to assess the cost-effectiveness of the different biopsy methods. Results: We included 19 comparative studies (6 randomised controlled trials and 13 observational comparative studies) and 4 single-arm studies of freehand devices. There were no statistically significant differences in cancer detection rates for local anaesthetic transperineal prostate (any method) compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.00, 95% confidence interval 0.85 to 1.18) (n = 5 randomised controlled trials), as was the case for local anaesthetic transperineal prostate with a freehand device compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.40, 95% confidence interval 0.96 to 2.04) (n = 1 randomised controlled trial). Results of meta-analyses of observational studies were similar. The economic analysis indicated that local anaesthetic transperineal prostate is likely to be cost-effective compared with local anaesthetic transrectal ultrasound-guided prostate (incremental cost below £20,000 per quality-adjusted life-year gained) and less costly and no less effective than general anaesthetic transperineal prostate. local anaesthetic transperineal prostate with a freehand device is likely to be the most cost-effective strategy: incremental cost versus local anaesthetic transrectal ultrasound-guided prostate of £743 per quality-adjusted life-year for people with magnetic resonance imaging Likert score of 3 or more at first biopsy. Limitations: There is limited evidence for efficacy in detecting clinically significant prostate cancer. There is comparative evidence for the PrecisionPoint™ Transperineal Access System (BXTAccelyon Ltd, Burnham, UK) but limited or no evidence for the other freehand devices. Evidence for other outcomes is sparse. The cost-effectiveness results are sensitive to uncertainty over cancer detection rates, complication rates and the numbers of core samples taken with the different biopsy methods and the costs of processing them. Conclusions: Transperineal prostate biopsy under local anaesthetic is equally efficient at detecting prostate cancer as transrectal ultrasound-guided prostate biopsy under local anaesthetic but it may be better with a freehand device. local anaesthetic transperineal prostate is associated with urinary retention type complications, whereas local anaesthetic transrectal ultrasound-guided prostate has a higher infection rate. local anaesthetic transperineal prostate biopsy with a freehand device appears to meet conventional levels of costeffectiveness compared with local anaesthetic transrectal ultrasound-guided prostate. Study registration: This study is registered as PROSPERO CRD42021266443. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR134220) and is published in full in Health Technology Assessment Vol. 28, No. 60. See the NIHR Funding and Awards website for further award information.

OBJECTIVE: To evaluate the effectiveness of VR therapy (VRT) for symptoms related to social anxiety disorder (SAD), namely fear and avoidance of social interactions and performance situations (FASIP), fear of negative evaluation (FNE), anxiety and depression, a systematic review and meta-analysis were performed. METHODS: Medline, PubMed, Science Direct, Web of Science, CINAHL, PsychINFO and Scopus were searched to include randomised controlled trials of VRT for SAD that met the criteria. A total of 15 RCTs with 720 participants published between 1998 and 2022 were included. Hedge's g with a 95 % confidence interval (CI) was adopted to compute the effect sizes. RESULTS: Results showed no difference between the effect of VRT and CBT on FASIP, FNE, anxiety and depression and a large effect size for VRT versus the waitlist control group on FASIP (g = -1.170, 95 % CI: -2.056-0.283; p < 0.010). The moderator analysis demonstrated that VRT was superior to the controlled group in addressing FASIP, FNE and anxiety when the sample size was smaller than 50 and the number of sessions was five or fewer. LIMITATIONS: Differences in hardware, software and intervention duration for VRT across studies. CONCLUSION: This study confirmed the feasibility of VRT in alleviating the FASIP in patients with SAD, with the waitlist control group as a comparison. However, the effectiveness of VRT was not significant in FASIP, FNE, anxiety and depression compared to cognitive behavioural therapy (CBT). Additional social interaction scenarios should be developed in VRT, standardised hardware should be used and the proper length of exposure time to VR should be determined to enhance the efficacy of VRT.

OBJECTIVES: The objective of this systematic review was to identify, critically appraise and synthesise evidence for the effectiveness of communication skills training interventions in nursing practice. DESIGN: A systematic review of literature. DATA SOURCES: Randomised controlled trials published in English from 1998 to 2018, identified in five computerised databases (Medline, Cinahl, Embase, Psychinfo and Cochrane Database). Studies were included if they reported an educational intervention to enhance nurses' communication with patients and contained an objective measure of communication skills and/or patient outcome measures. REVIEW METHODS: The Preferred reporting Items for Systematic reviews and Meta-Analyses guided the review. Data were extracted regarding study design and effectiveness on nurses' communication skills. Trial quality was assessed using the Joanna Briggs Institute Critical Appraisal Checklist. The heterogeneity of the included studies prohibited meta-analysis. RESULTS: Of the 7811 papers identified, seven trials met the eligibility criteria. The quality was modest. Training programs varied significantly in duration, structure, location and use of outcome measurement tools. Five trials focused on communication with cancer patients using simulated patients. All trials found at least one statistically significant improvement for nurses' communication skills. CONCLUSIONS: Educational interventions to enhance nurses' capacity to communicate with patients show promise. The paper reports the first systematic review of randomised controlled trials concerning the effect of communication skills training on nurses' abilities to communicate with patients, inclusive of non-cancer settings. The direct impact of educational interventions on nurses' communication skills is difficult to measure arising from non-standardised outcome measurement tools. Further research is particularly needed in acute, chronic illness, aged care and community settings.

BACKGROUND: Cardiovascular disease has caused heavy health care burdens in many countries, and hypertension (HTN) is a well-known independent cardiovascular risk factor. OBJECTIVE: To assess the efficacy of empowerment strategies that affect systolic blood pressure (SBP), diastolic blood pressure (DBP), body mass index (BMI), quality of life, and self-management behaviours for patients with hypertension. METHODS: A literature search of the Cochrane Library, PubMed, MEDLINE, Embase, Web of Science, and several Chinese medical databases was performed. Study screening, quality assessment, data extraction, and meta-analysis were conducted according to Cochrane standards. RESULTS: Eleven randomised controlled trials with 988 subjects were identified. Relative to control groups, the empowerment strategies showed significant decreases in SBP (the mean difference [MD]=9.46, 95 % confidence interval [CI]=6.36-12.55, p< 0.00001) and DBP (MD = 6.68, 95 % CI = 3.07-10.29, p= 0.0003). However, no significant difference was found in BMI (p = 0.05). Subgroup analysis showed significant differences in the improvement of both SBP and DBP among the various groups, regardless of the duration and type of interventions. DISCUSSION: Empowerment strategies can decrease both SBP and DBP in hypertension patients. However, its influence on patients' BMI, quality of life, and self-management behaviour remains unclear. PRACTICAL VALUE: Empowerment strategies are useful for controlling the blood pressure of hypertension patients.

OBJECTIVES: Systematic review and meta-analysis to determine the effectiveness of interventions in reducing depressive symptoms in ethnic minority carers of people with dementia. METHODS: We systematically searched EMBASE, CINAHL, MEDLINE, PsycINFO, PsycARTICLES, Applied Social Sciences Index and Abstracts (ASSIA), The Cochrane Central Register of Controlled Trials (CENTRAL), and Sociological Abstracts and Social Policy and Practices databases from 1990 to 2015, supplemented by a grey literature search, hand searches of bibliographies, and contacting authors. Study quality was assessed independently by two researchers using The Effective Public Health Practice Project Quality Assessment Tool, with an inter-rater reliability of Cohen's kappa of 0.72 (95% CI, 0.42-1.01). Narrative synthesis and meta-analysis were used to assess intervention effectiveness. Meta-regression was used to assess whether factors such as intervention type, peer support, and ethnicity accounted for hetereogeneity. RESULTS: Thirteen studies were eligible for inclusion, with 1076 participants in control groups and 980 participants in intervention groups; 12 studies provided estimates for meta-analysis. All studies were from the United States. Interventions were associated with an overall mean reduction in depression in caregivers (SMD -0.17 (95% CI, -0.29 to -0.05; P = 0.005). Meta-regression did not indicate any potential sources of heterogeneity, although narrative synthesis suggested that interventions developed with the target ethnic minority group's preferred mode of engagement in mind alongside cultural adaptations may have enhanced effectiveness. CONCLUSIONS: Psychosocial interventions for depression in ethnic minority carers of people with dementia are effective and could be enhanced through cultural adaptations. High-quality studies targeting minority ethnic groups outside of the United States are needed.

BACKGROUND: Shared decision-making (SDM) is recommended for men facing prostate cancer (PC) screening decisions. We synthesize the evidence on the comparative effectiveness of SDM with usual care. METHODS: We searched academic and grey literature databases, and other sources for primary randomised controlled trials (RCTs) published in English comparing SDM to usual care and conducted in primary and specialised care. We assessed the individual study risk of bias, and calculated the study-specific and pooled relative risks (RR) or standardised mean differences (SMD) [with 95% confidence intervals (CI)] to perform random-effects meta-analyses for SDM-related and patient outcomes. RESULTS: Four RCTs comparing SDM to usual care, involving 1760 men, were included. SDM improved knowledge (SMD 0.23, 95%CI 0.02 to 0.43; 2 RCTs), but was not different to usual care in reducing either patient participation in prostate-specific antigen (PSA) testing (RR 1.03, 95%CI 0.90 to 1.19; 2 RCTs) or decisional conflict (SMD -0.04, 95%CI -0.23 to 0.15; SMD -0.05, 95%CI -0.24 to 0.14; 2 RCTs). Individual trial estimates (46.7%) also suggest that SDM may reduce or neutralise physicians' tendency for PSA screening, and may improve the accuracy of patients' perception of lifetime-risks and men's views towards screening. There was no evidence on the effects of SDM on health outcomes. The studies represent various interventions and outcomes and are prone to risk of bias. CONCLUSIONS: There is currently insufficient evidence to support a clear association of SDM on patient- and SDM-related outcomes for decisions about PSA testing. Further research needs to assess the clinical effectiveness of SDM using well-defined SDM interventions and outcomes. It should address the absence of evidence, particularly on health outcomes.

OBJECTIVE: To systematically review evidence for the efficacy of family-based education for heart failure (HF) patients and carers. METHOD: A systematic review was conducted. Databases CINAHL, MEDLINE Complete, Cochrane, PubMed, Web of Science, EMBASE, PsycINFO, and Scopus were searched between 1 January 2005 and 1 May 2015. Randomised controlled trials included HF patient and carer dyads or carers alone. The primary outcome was HF knowledge. Secondary outcomes included self-care behaviour, dietary and treatment adherence, quality of life, depression, perceived control, hospital readmissions, and carer burden. RESULT: Six trials reported in nine papers were included. Wide variation in the quality of the studies was found. Two studies only examined HF knowledge; a significant improvement among patients and carers was reported. Other significant findings were enhanced patient self-care, boosted dietary and treatment adherence, enriched patient quality of life, improved perceived control among patients but not carers, and reduced carer burden CONCLUSION: Modest evidence was found for family-based education among HF patients and carers. Methodological shortcomings of trials signify the need for empirically sound future research. PRACTICE IMPLICATION: Family-based HF education needs to include strategies that are tailored to the HF patient and carer, and sustainable in nature

BACKGROUND: Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. METHODS: The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. RESULTS: A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom use. Finally, one trial showed that collection of sexual health information using mobile technology was acceptable. CONCLUSIONS: The findings suggest interventions delivered by SMS interventions can increase uptake of sexual health services and STI testing. High quality trials of interventions using standardised objective measures and employing a wider range of behavioural change techniques are needed to assess if interventions delivered by mobile phone can alter safer sex behaviours carried out between couples and reduce STIs.