Research involves the use of systematic procedures to answer an inquiry. It involves data collection, synthesis and analysis in the light of the question or inquiry; and formulation of conclusions and recommendations, (Badke, 2004). General types of research include experimental studies which “are used to test the effect of a treatment or intervention”, (Peat, 2001, p. 16). Clinical trails fall under the broad category of experimental trials. Clinical trials are controlled experiments with patients, which range from “studies to prevent, detect, diagnose, control and treat health problems to studies of the psychological impact of a health problem and ways to improve people’s health, comfort, functioning, and quality of life”, (Brooten, 2006, p.86). Generally, clinical trials can be categorised into either randomised trials or non-randomised trials.
This paper will try to evaluate the scientific research conducted by Vickers and colleagues (2004), entitled: Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial, which was published on 15 March 2004 at the British Medical Journal. This particular topic was selected due to its relevance to this field of study. Numerous insights from this field of study and valuable best practice information in quantitative research methods can be gained from undertaking this critiquing task. This critique will be carried out using the research framework for critiquing health research formulated by Caldwell and co-workers (2005), which provides a comprehensive set of criteria against which the elements of the research article by Vickers and colleagues (2004) can be appropriately measured. This paper will first evaluate the overview of the study, including the abstract, literature review and the methodology used. Next, it will critically analyse issues concerning research ethics, data protection and research funding. Then, it will evaluate the reliability, validity of the research results, including the sampling methods employed. It will then identify the specific strengths and weaknesses of the research article. Finally, the concluding judgement about the research article will be presented.
Below are the definitions of selected important terms used in the research article:
- Acupuncture – pertains to the “technique of traditional Chinese medicine, in which a number of very fine metal needles are inserted into the skin at specially designated points”, (“Acupuncture”, 2007).
- ANCOVA – stands for ‘analysis of covariance’ which is a statistical treatment that combines analysis of variance (ANOVA) and regression; whereby “the predictable component of the individual differences can be removed with regression analysis”, (Anderson, 2001, p. 283).
- Chronic – “all impairments or deviations from normal that have one or more of the following characteristics: are permanent; leave residual disability; are caused by nonreversible pathological alteration; require special training of the patient for rehabilitation; or may be expected to require a long period of supervision, observation or care”, (Sidell, 1997, p. 1)
- Negative binomial regression – “is one of a class of mixed Poisson models that mix a second source of variance with the Poisson variance to account for overdispersion”, (Cohen, et al., 2003, p. 531).
- Outcome measures – “reflect patient health status at either the individual or the aggregate (population) level”, (Stommel & Wills, 2004, p. 234).
- Randomised trial – A randomised trial is a clinical trial that pertains to “an experiment in which therapies under investigation are allocated by a chance mechanism”, (Brooten, 2006, p.86).
- Sham Treatment – is the experimental treatment that “has no effect and which subjects cannot distinguish from the active treatment “(Peat, 2001, p. 20).
In March 15, 2004, the BMJ Publishing Group Ltd, a wholly owned subsidiary of the British Medical Association, published the research article in its medical journal, the British Medical Journal (BMJ). Its “print BMJ has been published continuously since 1840, and now appears in four weekly editions, varying only in their advertising content. Together, their circulation totals about 122 000 copies, of which 10 000 are distributed outside Britain”, (BMJ, undated). Its website provides “the full text of everything published in the print journal since 1994, as well as much material unique to the web”, (BMJ, undated).These make the BMJ Publishing Group Ltd. an influential and authoritative source of medical articles.
The authors are recognized medical practitioners with different fields of specialisations. Andrew Vickers is an assistant attending research methodologist at the Integrative Medicine Service, Biostatistics Service, Memorial Sloan-Kettering Cancer Center in New York; Rebecca Rees is a research officer at the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), Social Science Research Unit in London; Catherine E Zollman is a general medical practitioner from Montpelier Health Centre in Bristol; Rob McCarney is a research officer at the Department of Psychological Medicine, Imperial College in London; Nadia Ellis is lecturer Department of Health and Social Sciences, Coventry University in Coventry; and both Peter Fisher, who is the director of research and Robbert Van Haselen who works as the deputy director of research are from Royal London Homeopathic Hospital. Thus, based on their qualifications, the authors have the credibility, needed knowledge and expertise to engage in an extensive scientific study such as the article being evaluated.
The article is appropriately titled as Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial, since it essentially focussed on the effectiveness of the use of acupuncture to relieve chronic headache. Moreover, the title expressly implies that the methodology utilizes a large sample in the randomised trial. The abstract appears to be concise and complete. In a few paragraphs, the essential research components were summarised in the abstract, namely: (1) the research objective; (2) setting; (3) participants; (4) interventions; (5) main outcome measures; (6) results; and (7) conclusions. The abstract provides the complete key information that the readers need to fully understand the article. The introduction explained the health costs related to headache, which is the main topic of the article, including the need to apply other approaches in its treatment, particularly, acupuncture. The introduction also provides the main aim or rationale of the study, which was: “to estimate the effects of acupuncture in practice” in general; and “to determine the effects of a policy of ‘use acupuncture’ on headache, health status, days off sick, and use of resources in patients with chronic headache compared with a policy of “avoid acupuncture”, in particular, (Vickers et al., 2004). However, the literature review was limited to only one source of published work – the Cochrane review of 26 randomised trials. This would be very insufficient in terms of the extent of evaluating available sources of information related to the topic of the study. Moreover, it does not provide a comprehensive evaluation of scholarly work from which the rationale of the study could be based.
The study is a quantitative research, since the data obtained are represented in the form of numbers and statistical treatment was employed to interpret the data gathered (Grinnell & Unrau, 2005, p. 62). Despite the lack of implicit statement of the hypothesis, the audience or reader can obtain a general notion or idea of what is being tested (the effectiveness of acupuncture in the treatment of chronic headache). However, the variables were not clearly defined. Nevertheless, the procedures employed in the methodology were intricate and systematic. The participants were clearly identified and adequately described in the study. In the accrual of patients, several stages were established to facilitate the flow and recruitment of participants. Figure 1 in the appendix illustrates the flow of participants in the study. Moreover, ethical principles were upheld during the conduct of participant recruitment. Since most legal instruments expressly prohibit the use of human subjects for medical research, the researchers obtained written informed consent from the participants.
The researchers implemented a system to ensure randomization of the study through a ‘password protected database’, thereby eliminating the potential for bias and subsequently improving the quality of the results. As Peat (2001, p. 28), explains: “ in randomised controlled trials, the quality of the evidence is improved if measurement bias, such as observer or reporting bias, is reduced by using objective outcome measurements and if observers are blinded to the group status of the subjects. The method of data collection proves to be valid and reliable, as evidenced by the relatively high number of treatments (12 treatments) employed over a sufficient length of time (3 months). Moreover, a follow-up procedure was implemented to generate “a global estimate of current and baseline headache severity”, (Vickers, et al., 2004). This further enhanced the validity of the results. The large sample size helped ensure the reliability of the results. Additionally, the use of measurable outcomes such as the Likert scale of headache severity helped eliminate bias by extending common measurement criteria for the respondents. The article correlated its results with the findings in “prior literature on acupuncture”, (Vickers, et al., 2004), suggesting a high degree of validity of results generated.
The presentation of results was systematic and at the same time, clear and comprehensive. The results portion explained the process of participant recruitment including the flow of participants through the trial, patient compliance and dropout rate and their characteristics. It also provided a clear explanation of data that were obtained with accompanying tables and graphs. Thus, the audience can easily comprehend the results obtained. In the discussion, the results generated were translated into the main findings of the study which were stated in a clear, yet simple manner. Moreover, the strengths and the limitations were identified and discussed clearly.
The strengths of the research article are anchored on its methodology, such as in the recruitment of participants with a large sample size, the implementation of a system to conceal the randomization and the meticulous follow-up procedure one year after the experiment. Such procedures helped ensure that the research findings are reliable and valid. On the other hand, one of the limitations of the study is the absence of sham acupuncture for the participants, thereby failing to consider the potential placebo effects. Additionally, the participants were not blinded in the study; thereby raising the possibility of bias in terms of the participants’ assessments of their headache scores. In terms of the literature review, the article failed to provide an objective evaluation of a sufficient body of literature related to the topic of the research. Thus, it failed to address the gaps in knowledge related to acupuncture and chronic headache due to the lack of an extensive evaluation of available literature.
In the final analysis, the research article serves as an additional source of authoritative and credible information regarding the use of acupuncture for the relief of chronic headache. The findings of the study strongly support available scientific evidence. The weaknesses of the research article discussed above can serve as important considerations for researchers who are planning to engage in a similar undertaking – they must evaluate a substantial body of literature to gain insight into the currently available information and subsequently identify knowledge gaps. Moreover, future randomised clinical studies in acupuncture should include a sham treatment to be able to consider potential placebo effects; and blinding of participants must be observed to eliminate bias.
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- Vickers, A.J., Rees, R., Zollman, C.E., McCarney, R., Smith, C.M., Ellis, N., Fisher, P., 2004. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. Available from: http://www.bmj.com/cgi/content/full/328/7442/744. [Accessed: 15 April 2008].
Figure 1Flow of Participants Through the Trial
Source: Vickers, et al., 2004