CONSORT to community: translation of an RCT to a large-scale community intervention and learnings from evaluation of the upscaled program.

BACKGROUND: Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale. METHODS: The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016. RESULTS: Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project. CONCLUSIONS: Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature. TRIALS REGISTRATION: PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314).

Acupoint catgut embedding versus acupuncture for simple obesity: a systematic review and Meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the clinical effectiveness and safety of acupoint catgut embedding and acupuncture on simple obesity by Meta-analysis. METHODS: Studies on clinical randomized controlled trials of acupoint catgut embedding for simple obesity which were published from January 2015 to November 2020 were searched in Cochrane Central Register of Control Trials (Central), PubMed, China Science and Technology Journal Database, China National Knowledge Infrastructure Database and Wanfang data-bases. And those that met the inclusion criteria were screened. RevMan5.3 was used for Meta-analysis. The "Risk of Bias" tool was used to evaluate the quality of included studies. R studio software was used for the measurement of publication bias. RESULTS: A total of 33 studies were included for Meta-analysis, including 2685 patients with simple obesity. Meta-analysis results showed the comparison of effectiveness rate was relative risk () = 1.12, 95%(1.08, 1.16), body mass index (BMI) was mean difference () = -1.12, 95% (-2.09, -0.14), waist circumference was = -2.14, 95% (-4.22, -0.06), and body mass was = -2.36, 95% (-3.99, -0.73). On the basis of diet and exercise intervention, the effectiveness rate [ = 1.12, 95% (1.05, 1.19)], BMI [ = -0.88, 95% (-1.35, -0.40)], waist circumference [ = -1.10, 95%(-4.27, 2.07)], and body mass [ = -0.68, 95%(-2.90, 1.54)]. The risk of bias of included literatures was low. CONCLUSIONS: Acupoint catgut embedding therapy was slightly better than acupuncture therapy in most of the outcomes. Moreover, the treatment frequency of acupoint catgut embedding is less with larger stimulation intensity, which is more conducive to clinical promotion.

Evidence base of randomized controlled trials and guideline recommendations of patent Traditional Chinese Medicines for uncomplicated acute lower respiratory tract infections in adults.

OBJECTIVE: To compare clinical practice guideline recommendations on the use of oral patent Traditional Chinese Medicines (PTCMs) for uncomplicated acute lower respiratory tract infections (ALRTIs) in adults with the existing evidence using results of a systematic review of randomized controlled trials (RCTs). METHODS: A systematic review on RCTs and a systematic review of current guidelines on orally taken PTCMs for uncomplicated ALRTIs were performed. PubMed, Cochrane Library, EMBASE and four Chinese databases were searched from inception to September 2016 for RCTs testing orally taken PTCMs for uncomplicated ALRTIs (excluding pneumonia). Two reviewers independently screened each study, extracted study data, and assessed risk of bias. Disagreements were resolved through discussion or by consultation with a third reviewer. Clinical practice guidelines for uncomplicated ALRTIs containing PTCM recommendations were identified and quality appraised. The quality of pooled evidence of the RCTs and the guidelines was assessed with GRADE and AGREE respectively. The consistency of the evidence base in RCTs and the guideline recommendations were then compared. RESULTS: For the systematic review of RCTs, 4810 papers were identified, among which 29 RCTs (5093 patients) were included in the review. PTCMs compared to placebo increased the effective treatment rate of cough (3 trials, 949 patients, risk ratio (RR) 2.50, 1.16 to 5.43; low certainty); improved assessment of global health (3 trials, 948 patients, RR 1.70, 1.44 to 2.01; low certainty); and increased the effective rate of specific symptom relief (1 trial, 478 patients, RR 4.01, 2.76 to 5.81; moderate certainty). 21 trials (3432 patients) compared effects of different PTCMs. For the guideline evaluation, 29 PTCMs were recommended for the use of uncomplicated ALRTIs, of which27 had no supportive evidence from RCTs. CONCLUSION: The evidence base of PTCMs for uncomplicated ALRTIs is weak and the guideline recommendations were based on almost no clinical trial evidence. Rigorous clinical research is urgently needed to inform the clinical use of these herbal medicines. Further training in evidence-based medicine methods for Traditional Chinese Medicine guideline developers is essential.