The Importance of Early Phase Research

Aickin, Mikel

doi:10.1089/acm.2007.6370

Cited by 32 publications

(29 citation statements)

References 7 publications

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“…Since this study represents an early-phase trial with a small sample size, we also used the separation test described by Aickin [36,37]. Data from this approach can be used to determine whether further research on TENS for pain control in patients undergoing a VATS procedure appears reasonable.…”

Section: Discussionmentioning

confidence: 99%

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial

Engen

Carns

Allen

et al. 2016

Complementary Therapies in Clinical Practice

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Section: Discussionmentioning

confidence: 99%

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial

Engen

Carns

Allen

et al. 2016

Complementary Therapies in Clinical Practice

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“…In particular, a focused line of research is recommended that employs the early phase research model (including ecologic validity). 53 For example, a small (n = 6) outcomes-based study assessed the effects of Japanese-style acupuncture treatments to reduce pain caused by acute appendicitis. 33 The positive trends and feasibility led the authors to call for a future trial with a larger sample and include a comparator group (usual care).…”

Section: Discussionmentioning

confidence: 99%

Acupuncture for Pediatric Conditions: A Narrative Review

Milley

Davis

Kong

et al. 2015

Medical Acupuncture

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Background: The use of acupuncture for common pediatric conditions continues to grow. Three previous overviews have summarized the research literature. Objective: The aim of this article is to provide an updated narrative review of the literature on the use of acupuncture within the pediatric population. Methods: A systematic search was performed to identify clinical trials and reviews published through July 2015. Trials were excluded if they were not: (1) acupuncture-specific; (2) limited to pediatric patients; (3) published in English. The literature was assessed and synthesized into a narrative review and commentary. Results: Seventy-one publications were identified (59 clinical trials and 12 reviews) that represented 20 conditions. Since the prior overviews, 36 new publications (33 clinical trials) were identified and represented nine countries; the top three were China, Norway, and the United States. The top five areas of research at that timepoint were autism spectrum disorder, cerebral palsy, colic, pain, and nausea and vomiting. Conclusions: Clinical trials in pediatric acupuncture (n = 59) represent a small subset of acupuncture research. Data are promising for conditions such as pain and amblyopia; however, conclusions cannot be made due to limited number of trials and heterogeneity of treatment approaches. Specifically, caution is warranted, as acupuncture needling of a single acupoint in clinical research may not be equivalent to acupuncture treatment in clinical practice. Further research on the use of acupuncture for pediatric conditions is warranted. The current authors posit that the early phase research model, with pragmatic treatment approaches, should be employed to all areas of study. The conditions with promising evidence may represent key areas of focus for future research.

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“…There was a strong consensus that both qualitative and quantitative methods are valuable and should be combined in the CAM research agenda, e.g., qualitative methods to formulate hypothesis on mechanisms (which might be tested by quantitative methods) as well as in specific clinical studies, e.g., to assess reasons for dropouts, identification of the most relevant outcomes or to generally improve interventions [2,14,16,18,22,25,26,28,42,71,98,100,102,[107][108][109][110]. The use of qualitative methods has been particularly discussed as a preliminary basis for preparation of clinical trials [25,28,29,79,97,101].…”

Section: Quantitative Research Methodsmentioning

confidence: 99%

“…Integration of diverse research methods [2,12,27,38,61,71], preference trials [3,72,73] or the use of different outcome measures [74,75] could help overcome these shortcomings. Feasibility studies are a vital preliminary phase in the design of high-quality RCTs with adequate power [3,4,10,[76][77][78][79]. When individualised and standardised treatments are to be compared [3], or if specific and non-specific effects need to be separated [80], RCTs can be extended to more than 2 treatment arms to account for preference towards a specific treatment in preference trials [20,28,72,73].…”

Section: Full-text Analysis and Data Extractionmentioning

confidence: 99%

Key Issues in Clinical and Epidemiological Research in Complementary and Alternative Medicine – a Systematic Literature Review

Fischer

Junne²,

Witt

et al. 2012

Complement Med Res

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Background: In the last 2 decades there has been a large increase in publications on complementary and alternative medicine (CAM). However, CAM research methodology was heterogeneous and often of low quality. The aim of this systematic review was to investigate scientific publications with regards to general issues, concepts and strategies. We also looked at research priorities and methods employed to evaluate the clinical and epidemiological research of CAM in the past to identify the basis for consensus-based research strategies. Methods: We performed a systematic literature search for papers published between 1990 and 2010 in 7 electronic databases (Medline, Web of Science, PsychArticles, PsycInfo, CINAHL, EMBASE and Cochrane Library) on December 16 and 17, 2010. In addition, experts were asked to nominate relevant papers. Inclusion criteria were publications dealing with research methodology, priorities or complexities in the scientific evaluation of CAM. All references were assessed in a multistage process to identify relevant papers. Results: From the 3,279 references derived from the search and 98 references contributed by CAM experts, 170 papers fulfilled the criteria and were included in the analysis. The following key issues were identified: difficulties in past CAM research (e.g., randomisation, blinding), utility of quantitative and qualitative research methods in CAM, priority setting in CAM research and specific issues regarding various CAM modalities. Conclusions: Most authors vote for the use of commonly accepted research methods to evaluate CAM. There was broad consensus that a mixed methods approach is the most suitable for gathering conclusive knowledge about CAM.

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The Importance of Early Phase Research

Cited by 32 publications

References 7 publications

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial

Acupuncture for Pediatric Conditions: A Narrative Review

Key Issues in Clinical and Epidemiological Research in Complementary and Alternative Medicine – a Systematic Literature Review

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