Title and Abstract
Describe about the Evidence Based Health Practice for Adjuvant Chemotherapy.
A critique of “Jeffs, E., & Wiseman, T. (2013). Randomised controlled trial to determine the benefit of daily home-based exercise in addition to self-care in the management of breast cancer-related lymphoedema: a feasibility study.Supportive Care in Cancer, 21(4), 1013-1023.”
Breast cancer related lymphoedema (BCRL) has long been identified as an additional repercussion to women cancer survivors impeding their normal lives. Therapeutic interventions to address their conditions by means of suitable exercise and self care strategies have been proposed to result in positive outcomes for the patients. However, dearth of evidences to support the hypothesis was found in the context of BCRL that may create a gap in practice and clinical research. Therefore, to procure insight into this matter, other literatures need to be reviewed thoroughly to obtain better understanding. CONSORT 2010 checklist helps to critically appraise the published trial reports. A critical appraisal of this article published in 2013 will be done in accordance with the CONSORT 2010 checklist utilizing RCT to evaluate the feasibility of daily home based exercise interventions before undertaking a larger RCT to treat stable BCRL in women.
The article (Jeffs & Wiseman, 2013) under consideration clearly states the research study conducted as the randomized controlled trial in the name of the title itself. Further in the structured abstract portion, the research design, methodology adopted, important findings and relevant conclusions that can be extrapolated from the results have been mentioned in a comprehensive manner.
- Background and Objectives
Breast cancer have thwarted the lives of a large proportion of women worldwide and reports of the chronic condition of lymphoedema in the breast cancer survivors following treatment have been found to negatively impact their quality of living to a great extent and the number is surging. Evidence based studies pertinent to breast cancer related lymphoedema (BCRL) have highlighted on the symptoms, diagnosis, reduction of risks and management strategy to tackle this debilitating problem (Fu, 2014). Evidences contraindicates that manual lymphatic drainage (MLD) is not suitable for preventing or managing BCRL (Huang et al., 2013). Other studies have provided alternative, superior and cost-effective tool such as measurement of tissue dielectric constant (TDC) to estimate the changes in the water content of the tissues thereby acting as an indicator of early onset of BCRL (Haen, 2012). Upper body resistance exercises have borne positive implications for cancer survivors with BCRL fostering improved physical functionality and overall health status in some studies (Cormie et al., 2013). Similar findings support the view that high intensity resistance exercise training (RET) has the potential to influence the muscular strength in the breast cancer survivors with BCRL (Nelson, 2016). Thus, the efficacy of the proposed exercise regime as a treatment modality to tackle BCRL in the chosen article can be very well corroborated with other studies of similar kind.
The primary objective set up by the investigators emphasizes in differentiating the declined levels of the excess limb volume (ELV) among both the studied groups, with the control group subjected to only self care phase and the interventional group experiencing self care in addition to daily home-based exercise program. In this context, the findings from relevant research may be cited which states that prescription for and adherence to BCRL self care techniques are not optimized but variable for the breast cancer survivors (Brown et al., 2014). The secondary objectives in the given study accounted for vital considerations concerning the impacts of the exercise in quality of life, range of movement (ROM) of the shoulder and operation of the arms associated to BCRL. Recent investigations have also thrown light upon these paraphernalia of BCRL, determining the changes in arm volume following sessions of low and heavy load resistance exercise and prepare prescription guidelines accordingly (Bloomquist, 2016). Therefore, the projected objectives in the given study offer scope for further probe into the matter.
RCT in the chosen study aimed to generate reproducible, authentic results by virtue of eliminating the selection bias. The pilot mode of experiment predicted the feasibility of the research undertaken in terms of time, cost, and adverse consequences if any. Study utilizing the therapeutic effects of Yogic interventions to manage BCRL have also adopted randomized controlled pilot for their research work (Loudon et al., 2014). Hence, the choice of the trial design is found to be appropriate.
Careful examination of the medical records for the BCRL patients identified 532 patients to be suitable. The inclusion criterion was the BCRL in unilateral arm with stable swelling for at least 3 months and ≥ 10% ELV. Exclusion criteria included previous history for bilateral breast cancer treatment, factors contributing to alteration in limb volumes and documented non-conformity with agreed self care practices. Abiding by the criteria 85 was found to be suitable and invitation along with the Patient information sheet was sent to these potential candidates seeking their approval to participate in the study. Out of the 85, 39 consented to participate. Thereafter by means of rigorous telephonic screening and screening appointments, a handful of 23 participants were finally chosen to be included. 11 out of 23 formed the interventional group, while the remaining 12 comprised the control group. Thus, selection of the subjects was carried out in a stepwise methodical fashion minimizing the negative factors as far as practicable.
The interventional strategy improvised and implemented was in accordance with the standard guidelines and protocols followed to ensure MLD. The exercise recommended for the interventional group (IG) was an amalgamation of breathing, hand pumping as well as gravity resistive isotonic arm exercises. The IG participants were trained and instructed to do the prescribed exercises through demonstrations and necessary follow up was conducted at every encounter to allay any sort of apprehension. Thus the interventions were completely justified.
As per the predefined primary and secondary measurement outcomes, the measurements and estimations were undertaken. Clinical measurements comprised limb volume assessment through standard optoelectric device, weight and height to calculate the body mass index (BMI), range of movement of the shoulder during each visit in the study tenure at weeks 0, 4, 12 and 26. Functional status and self study report regarding the quality of life (QOL) of the participants were procured as well from relevant questionnaire.
The population of 23 respondents adds to the sample size in the givens study. All 23 participants out of the originally screened 532 records expressed their willingness to volunteer in the study and fulfilled all the inclusion criteria to be eligible. No breach of participation or any sort of interim analysis was applicable in this particular studied case that favored the reliability of the research.
Subjects were randomly assigned by virtue of applying sequentially numbered sealed envelopes to either CG or IG. Randomisation was conducted in blocks of six and eight in order to justify the balanced nature of allocation for the respective groups in case the recruitment was not sufficient.
- Allocation concealment mechanism
Allocation of groups was carried out in blocks of six and eight through sequentially numbered sealed envelopes as a measure to maintain balance if subject recruitment was inadequate.
The random allocation scheme was conceptualized by the researchers themselves to suit their research setting. Participants were enrolled under the supervision of two nurses specializing in lymphoedema treatment, three experienced physiotherapists to treat BCRL and two patient users. The interventional approaches and the familiarization trials for all concerned were moderated under the trained care of these healthcare professionals.
In the chosen study, the researcher was blinded to the allocation process and the resulting interventional outcomes. The probability of the ensuing bias and flaws are thus checked due to such blinding on the part of the researcher.
All the statistical analysis was done through the SPSS version 19 software packages setting the level of significance at p<0.05. To maintain homogeneity baseline data were evaluated. Distribution of data was noted with the help of histogram as well as calculation encompassing 95% of the population and the non-normal distributed data were presented as median, lower quartile and upper quartile. Non-parametric tests were adopted and for median calculation 95% confidence interval (CI) was considered.
The Figure 1 of the article provided necessary information related to the number of participants allocated to each of the groups of IG and CG, the subjects undergoing approved intended treatments with the outcomes briefed clearly in due course of the weekly follow up trials. Training procedures and the clinical assessment knowledge is also represented diagrammatically in the Figure 1.
The given study extended for 6 months with the follow up regime fixed for both the IG and CG participants to be at the end of 4th, 12th and 26th weeks. Baseline data for all the participants irrespective of their groups was noted at week 0. For the IG only, exercise technique and sequence followed was monitored at every week of follow up. The outcome variables were constantly assessed in every week for both the groups.
Baseline data comprising the demographic and clinical characteristics for each of the participating groups are depicted in Table 1 and Table 2 respectively. However, at the week 0 level of the baseline data, no significant differences among the parameters measured were observed for both the CG and IG. Demographic information includes age, ethnicity, occupation in which the participant is involved and the type of work accustomed to. Clinical parameters encompass a wide range of variables from basic height, weight data to data concerning various treatment modalities and experience encountered due to BCRL (Kwan, 2016).
The number of participants for each of the two analyses carried in case of week 12 and 26 when compared to week 0 varied as depicted in Table 3 and Table 4 of the studied article. In Table 3, the number of total participants is 23 only with 11 belonging to IG and 12 comprising CG. Contrarily, In Table 4, total participants are 22 with the IG having 10 and CG accounting for 12 subjects. One data in case of Table 4 was omitted on the ground of deviating hugely from the mean value, thus posing as an outlier. The final data analysis was thus based upon data retrieved from Table 4 and the implications of such exclusion reflected on the calculated values of the results through the statistical tools.
The changes in swollen limb volume over the 6 months data period have been reported as the primary change outcomes. Decline in absolute volume and relative volume has been recorded as a negative value and the increase as positive amount. The Wilcoxon signed rank test exposed significant reduction in terms of relative ELV at week 12 for both the IG and CG. However at week 26, similar investigation for both the groups revealed no statistical significance (p<0.05). Exclusion of the ID6 data due to overriding revealed significant difference at week 26 for both groups, although Mann Whitney test provided no statistical significance among the two groups regarding relative ELV change. Further intriguing into the secondary objectives brought to the forefront no significant improvements in the QOL or ROM. The report of the insignificant improvement in the functioning and neurological symptoms as perceived by the IG during week 12 was not continued till week 26 although they reported of having less severe pain in the forearms. Thus, the effects as indicated in the 95% CI is of relevance to extrapolate the findings and the values obtained through proper statistical analysis to a larger fraction of the population in real life (DiSipio, 2013, Dominick, 2013).
The chosen article was found to have certain limitations, the prime being the sample size considered for the study. The less number of participants taking part in the study stands on the way of concretely defining the positive implications of such effects. Chances of bias due to less sample size remains that cannot be undone with and serve as an obstacle to extrapolate the results to future studies and research. Exclusion of one of the participant’s data due to overriding effect may also account for omitting and overlooking some vital underpinning that might have contributed to the desired result.
The hypothesis as opined in the pilot RCT study has the scope of being carried forwarded and to be utilized in the population context. The idea and concept of the chosen study can then only achieve far reaching consequences and harbor positive outcomes to provide respite patients with similar clinical conditions.
The pivotal theme of the research considers the positive outcomes due to exercise interventions for the BCRL patients. The findings corroborate with other relevant studies as well that suggest exercise as mode of treatment modality to remedy BCRL (Singh, 2015, Cormie, 2015, Bloomquist, 2014, Singh, 2016, Chang, 2013). Exercise regime for cure of BCRL should essentially comprise of resistance exercise in conjunction with compression therapy and surgical interventions wherever applicable.
Practically, evidence based practice is vital to nursing profession to encourage better patient outcomes in patients through following of suitable treatment modalities. Thus researches contribute to provision of necessary information regarding particular clinical condition as in the article’s case of BCRL, to favor the evidence based practice in real life cases.
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