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foundation of research

foundation of research
Assessment details
Step: 1 – Select a research paper
Amer M, Woodward M, Appel L 2014, ‘Effects of dietary sodium and the DASH diet on the occurrences of headaches: results from randomised multicentre DASH-Sodium clinical trial’, BMJ Open, vol. 4 e006671.doi:10.1136/bmjopen-2014-006671.
Step 2 – Download and complete the adapted “Caldwell” tool template available in the assessment folder on the course homepage
Using the template provided, work through and answer each section. When providing your answers you should support your statements with evidence from the chosen research paper and /or other research journal articles, textbooks, credible online sources etc
Note the weighing of each section on the marking rubric will guide you regarding the word count for each section e.g. 30% is approximately 500 words, 50% equals 850 words and 20% weighting is approximately 350 words.
Mudge, E, Price, P, Neal, W & Harding, KG 2014, ‘A randomized controlled trial of larval therapy for the debridement of leg ulcers: Results of a multicenter, randomized, controlled, open, observer blind, parallel group study’, Wound Repair and Regeneration, vol. 22, no.1, pp. 43-51.
Briefly state a rationale for your answers
‘A randomized controlled trial of larval therapy for the debridement of leg ulcers: Results of a multicenter, randomized, controlled, open, observer blind, parallel group study’
The title states the study design (randomised controlled trial), what it is looking at (larval therapy for the debridement of leg ulcers), and then it states it is carried out in multiple areas, again states it is randomised and controlled, that the observer is blind and that there is a parallel group study.
Three of the four authors are attached to a wound healing research unit at a university school of medicine whereas the fourth was attached to a student section of the university. The authors are credible and reputable because they are associated to a university as well as a research centre (Columbia College nd).
The abstract of an article is generally the first section that the person will read and if this is not clear it can deter people from continuing to read the article (Ezeala & Ezeala 2012). The abstract for this article has introduced the study well with a short overview of the study which has given the reader a clear understanding of what to expect in the article. The abstract presentation is written well as supported by Vintzileos, and Ananth (2010) who state that providing an abstract which is structured well helps to focus the reader as  well as the writer to present the information in a logical manner.
There is limited data from RCTs to support the claim that larvae therapy is
successful in clinical practice (p.43 paragraph 5).  To improve the efficiency of
this treatment, a new approach to larval therapy was  developed, which
required evaluation within a RCT frame-work and was investigated in this
study (p. 44 paragraph 3).
Of the 29 articles used in the introduction/background only 13 were 5 years or less, the others ranged from 6 years to 82 years of age. They were all related to larval therapy and identified what has been done in this field previously. To be identified as current evidence generally the literature should be mostly published in the last five years, only unknown topics or topics that have been minimally researched recently should go back any older (Johnson & Hengstberger-Sims 2011), which reflects some of the articles used in this study.
The aim is stated as: ‘to compare the clinical effectiveness of a larval therapy dressing with a standard debridement using hydrogel in terms of time to debridement of venous or mixed arterial/venous leg ulcers’.
The aim itself is clear and derived from the issues/information put forth in the introduction. It describes the comparison of an intervention (larvae therapy) against routine/standard practice (hydrogel), what is the outcome of interest (time of debridement) and the problem of interest (venous or mixed arterial/venous leg ulcers).
For a paper to be identified as credible the aim needs to be clearly defined, a clearly written aim will also help the reader to identify what the goal of the research was and to evaluate if it is relevant to them (Davidson & Delbridge 2011; McGaghie, Bordage & Shea 2001)
Are the authors reputable?
Does the abstract summarise the key components of the study?
Is the rationale for undertaking the research clearly outlined?
Literature Review:
Is the literature review comprehensive and up-to-date?
Is the aim of the research clearly stated?
Are all the ethical issues identified and addressed?
No    Briefly state a rationale for your answer including what ethical issues were identified or not identified
Ethics approval is stated. States that ‘participation was voluntary and
patient care was not influenced by non-participation. Participants provided
fully informed written consent. If the study met the ethics committee
requirements, one wonders why the statement about conducting the study
in accordance with the Declaration of Helsinki, the good clinical practice
guidelines and any applicable national and local laws and regulations was
necessary? Interestingly there have been a number of updates to the
document refereed to with the most recent occurring in 2013 (WMA 2014)
and despite this the 2002 document has been used.
Ethical considerations when undertaking research is that it does not impact adversely on the participants and when writing up the findings for publication
that the participant’s privacy has not been breached (Johnson &
Hengstberger-Sims 2011).
Some countries have national committees that direct the ‘ethical conduct of human research’ with these committees directing organisational ethics committees processes therefore in receiving approval from Research Ethics Committee and local research and development departments, they have met the requirements for this study (Chater 2011).
Is the methodology identified and justified?
State the methodology used and the evidence based reasons why it was a suitable choice
Quantitative studies are proven to be the best design for evaluating the effectiveness of an intervention with the purpose of confirming or falsifying a pre-stated comparative research hypothesis (Burls 2009 p.3). This study focuses on comparing the effectiveness of one treatment against another, which involves the research of randomized controlled trials and is appropriate for a quantitative study (Stolberg, Norman, & Trop 2004, p. 1539).
Study Design:
Is the study design identified ?
Is the rationale for choice of design evident?
State the study design used and give evidence based reasons why it was a suitable choice
Randomised control trials are used with the aim of achieving comparability between an intervention group and control group (Jirojwong & Pepper 2011). As a quantitative analytical study, randomised controlled trials are proven to be the best design for evaluating the effectiveness of an intervention with the purpose of confirming or falsifying a pre-stated comparative research hypothesis (Burls 2009 p.3).
Yes, as randomised controlled trials involve large samples, random allocation and blinding, all of which were included in this study (Jirojwong & Pepper 2011). This study focuses on comparing the effectiveness of one treatment against another, which involves the research of randomized controlled trials (Johnson &
Hengstberger-Sims 2011; Stolberg, Norman, & Trop 2004, p. 1539).
Justification of the study is clear and provides support for the research.
There is limited data from RCTs to support the claim that larvae therapy is
successful in clinical practice (p.43 paragraph 5).  To improve the efficiency of
this treatment, a new approach to larval therapy was developed, which
required evaluation within a RCT frame-work and was investigated in this
study (p. 44 paragraph 3).
Research Hypothesis:
Is the research hypothesis clearly stated and variables (outcomes) defined?
No      Describe (in your own words) what problem the researchers identified and how they set out to answer their question?
A hypothesis is used by the researcher to provide a possible answer to a problem or question that they will then investigate to either confirm or refute (Nieswiadomy 2008).
The aim itself is clear and derived from the issues/information put forth in the introduction. It describes the comparison of an intervention (larvae therapy) against routine/standard practice (hydrogel), what is the outcome of interest (time of debridement) and the problem of interest (venous or mixed arterial/venous leg ulcers).
There is a pseudo hypothesis in the last section of the Introduction section, of: ‘It was postulated that this method of delivery (ie: of containing the larvae within a bag) may also increase ease of use and reassure patients that all the larvae are contained within the dressing’ – this was not the aim of the actual study.
Is the population identified?
No    State the population that was studied and how they were identified
88 recruited with 64 completing the study. People with venous or mixed arterial/venous leg ulcers were recruited as subjects.
Describes some of the inclusion criteria, ie: ‘people with either venous leg ulcers or mixed aetiology leg ulcer quantified by brachial pressure index > 0.5mmHg which contained over 25% slough/ necrotic material’.
Describes some of the inclusion criteria however they:
Do not define age range (ulcers generally affect older people, this should be reflected in the selection criteria).
Do not define duration of the ulcer (venous or mixed ulcers are generally chronic – a timeframe for this should be stated).
Do not describe how ‘over 25% slough/necrotic material’ was determined – was a particular criteria used to determine this, if so, what was it?
Did not provide/describe an exclusion criteria
Significant issues in terms of the inclusion/exclusion criteria is missing from the article.
Recruitment /Sampling
Is recruitment of subjects  described ?
No    In your own words outline how the subjects were recruited and what sampling strategy/s were used
Describes the settings from which participants were recruited – these are the type of settings where one would expect to find patients with leg ulcers (need a reference here).
Did undertake a power calculation to determine the numbers that needed to be recruited (allowing for attrition) and to achieve the defined power (alpha set at 0.05 with a power of 80%). To be able to ensure that the results are statistically significant the optimal amount of participants needs to be identified, if this is not done correctly the results could end up statistically inconclusive (Suresh & Chandrashekara 2012).
The paper does not provide exact details about the how the approach to recruit participants unfolded other than the participants were enlisted after full informed consent was undertaken.
Data Collection:
Is the method of data collection well described?
Describe in your own words how data were collected
Participants were measured at the start of the study in order to establish a baseline for comparability. After initial randomisation and application of either larvae or hydrogel the participants were reviewed every 3 – 4 days until debridement was complete OR up to a maximum of 21 days. A final evaluation was scheduled for 7 – 14 days after the completion of the intervention (p. 44).
It did not identify if they were actually measured at these reviews only that the wound bed and surrounding skin was assessed.
Nieswiadomy (2008, p. 214) states that the data collection process should involve the researcher asking ‘What? How? Who? Where? When?’ and although some of this was considered in the article not all of these aspects are obvious. Not all aspects of the data collection are clear such as how infection was assessed in this study.
Data Analysis
Was the data analysis rigorously conducted?
Give reasons for your answer using evidence to support your statement?
The achieve the results shown on pages 45-49 the researchers used the t-test to assess whether there was any statistical difference between the two groups in the study. The researchers identified the p-value during the analysis to provide a statistical probability to ascertain if the results are statistically significant which reduces the chance they occurred by accident (Forbes 2012).
Both of these data analysis tools are generally used for quantitative research and appropriate for this study (Buettner, Muller & Buhrer-Skinner 2011).
Are the results presented in a way that is appropriate and clear?
Briefly discuss the implications of these results for nursing/midwifery practice and/or patient care? Include a discussion about generalizability of the results
Larvae therapy was shown to improve debridement and reduce the number of dressing changes and treatment visits BUT it also increased wound malodour, heavy exudate and the slough returned within a fortnight of treatment cessation. In addition, a number of people were withdrawn from the study due to pain and participants who remained in the study rated the therapy as uncomfortable. Based upon this, it is questionable whether this type of therapy is appropriate for application in clinical practice.
If you attempted to replicate this study based upon the information presented, you couldn’t.
Demographic and other baseline characteristics
Demographic details are clearly presented in Table 1. However, as p values are
not presented, it cannot be determined whether there are statistically
significant differences between the groups.
Ulcer characteristics at baseline
States median duration of the ulcer for each group but this is not presented in
table 3. Table 3. location + aspect of the ulcer should have been combined to
reflect what would be encountered + recorded  in clinical practice, ie: ‘medial
ankle’ or ‘lateral calf’.
Appearance of wound bed at baseline
P values should be presented in the table 4. in relation to wound appearance.
States that a ‘moderate’ amount of exudate was present but does not define
what ‘moderate’ equates too.
Appearance of wound at final evaluation
No significant difference by the end of the study, ie: larvae therapy not shown
to be superior. NB. Look at the data presented in table 4. In the Larvae group, malodour, heavy exudate and skin maceration had actually increased by trial
end. However, the researchers claim in this section that ‘exudate noted at the
final evaluation was generally lower’ – this is not a true reflection of all of the
Ulcer related pain
States that this was measured via the visual analog scale – this should be
discussed in the Methods section (which it isn’t), not the Results section.
Does not address the validity of the VAS. States that overall (ie: in both groups combined) pain experience was lower at final evaluation. The whole point of
An  RCT is to compare the new intervention against standard care, therefore,
an analysis should be undertaken that compares the VAS of the larvae group
against the VAS of the hydrogel group to see if the new intervention (Larvae)
is superior to standard care (Hydrogel) in reducing ulcer related pain.
States that analysis was undertaken looking at the impact of ulcer duration
and ulcer etiology on pain, although these things can influence pain, the aim of
this study was not how ulcer duration or etiology impact upon pain experience,
therefore, why did they perform this analysis?
Dressing changes and number of treatment visits
How number of dressing changes & visits was recorded is not addressed.
Larvae therapy resulted in significantly (p < 0.001) less dressing changes and treatment visits. Significantly more (p < 0.001)  larvae treated ulcers had re-sloughed within a fortnight of treatment cessation. Patient adherence to & level of comfort of study intervention Does not address the validity of the Likert-Scale nor the validity of the questions that participants were asked to  answer. Higher proportion (number or % not stated ) of subjects in larvae group rated the treatment as ‘uncomfortable’ or ‘ very uncomfortable’. Nurse rating of experience of study intervention Does not address the validity of the Likert-Scale nor the validity of the questions that Nurses were asked to answer. States that nurses rated the ease of application and removal of the study treatment as ‘very easy’ or ‘easy’ – which study ‘treatment’ are they referring to? Larvae? Hydrogrel? Or both? NB. Number of dressing changes + treatment visits, patient adherence + comfort and nurses rating of experience  were not originally stated as primary or secondary measurement outcomes of this study. Discussion Is the discussion comprehensive? Yes No In your own words briefly summarise the discussion The discussion section does not compare or contrast the study results with existing literature in the field, for example how do the results from this study compare with similar studies, how are the study results better or worse and why?. They state at the end of paragraph 2 that ‘These results imply that if pain relief, patient education and treatment concordance are appropriately managed the potential for larvae therapy to be effective & efficient at debridement of tissue would be enhanced’ – they cannot make this statement as they did not measure these things in the study! The researchers do discuss the fact that slough returned post treatment cessation and that in clinical practice the normal procedure would be to apply a follow up application of larvae therapy (paragraph 5). The researchers state that arterial ulcers were excluded from the study and give an explanation as to why (paragraph 6), however, this should have been stated in the ‘Sample’ section of the article. The researchers state that ‘incidence of infection during the study was higher in the hydrogel v’s the larvae group however ‘bacterial load was not investigated in this study and criteria for infection were not confirmed’ (Discussion paragraph 9) – so what exactly was the infection incidence based upon? Why is their statement about infection incidence legitimate? They stated in the discussion paragraph 10 that ‘the majority of subjects rated the treatment as comfortable’ – this is not true of the larvae  group who rated the treatment as ‘uncomfortable’ and ‘very uncomfortable’, therefore this statement  Contradicts the study results as presented in the Results section. The discussion should provide a concise report of the main findings and any new knowledge that was identified, it should discuss any weaknesses or strengths of the study, it should compare the findings to any previous studies and present any reason for differences found (Vintzileos and Ananth 2010). Limitations Are the limitations discussed? Yes No Briefly discuss the limitations of this study both those identified by the authors and any other that you consider important The source of funding for this study was BioMonde Ltd. BioMonde Ltd is a European wound care company specialising in manufacturing and distributing larval debridement therapy. This could be interpreted as funding bias leading to biased positive results (Acknowledgements p. 50). Possible intervention bias was also noted. Subjects were aware of the treatment they were receiving, potentially impacting on their participation and results. The various settings had the ability to impact on results with certain criteria having to be met or excluded ie. Hospital policy that all inpatients receive anticoagulation therapy; anticoagulation therapy was a study exclusion criterion. It is stated under the acknowledgements section (p. 50 paragraph 4) that conflict of interest was avoided, meaning that the authors individual responsibilities did not have the potential to influence their roles in the research (National Health and Medical Research Council 2014). The adoption of the good clinical practice guidelines impeded the recruitment of participants from nurse led treatment settings – therefore, why did the researchers adopt this framework?? All inpatients in the UK are given anti-coagulation therapy, impeding the recruitment of participants from this setting, as anti-coagulation therapy was an exclusion criteria – the exclusion of this was not explicitly stated in the Sample section. ‘Fewer ulcers than anticipated were covered in greater than 25% of slough or necrotic tissue’ – wasn’t this a selection criteria? – are they implying that some ulcers in the study did not meet this criteria? ‘No evaluation of side effects or complications was conducted’ – why? – as larvae therapy could potentially be a new treatment option for leg ulcers, it is important to know the side effects & complications. Some studies will identify what they perceive their limitations are, are there any others that you feel are also limitations? For example did the authors receive funding from a source that may impact on the desired results? Conclusion Is the conclusion comprehensive? Yes No Briefly summarise what the authors’ concluded There is no specific conclusion as the article ends with the discussion, however it does identify areas lacking and future research ideas. Vintzileos and Ananth (2010) state that there should be a clear and succinct to conclusion to a research study with recommendations for future research, and some of these aspects are missing. REFLECTION Briefly discuss the overall quality of the research based upon this appraisal You need to consider if it was a good or poor quality study, is there some supporting evidence that can support your statement? Very average – given the significant issues outlined above. Discuss how the appraisal process has broadened your understanding of assessing the quality of published research. This can be written in the first person as it is a personal reflection of how the activity has helped your understanding

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