Essay: Critically appraise two pieces of evidence relevant to the area of general practice nursing

Introduction
This paper aims to critically appraise two pieces of evidence relevant to the area of general practice nursing. The CASP framework (Critical Appraisal Skill Programme 2018) was used to aid the critiquing and analysis of a systematic review and case-control study which focus on the effectiveness of yoga practice on the reduction of blood glucose in patients with type 2 diabetes mellitus (T2DM). Diabetes is steadily rising in low- middle income families (W.H.O. 2017), and responsible for an estimated for a 34.5% increase in premature death, with the greatest risk being amongst the younger population and females (HSCIC 2012). Good diabetes management (which includes reducing and maintain blood glucose levels), has been shown to reduce the risk of complications. If diabetes is not well managed, it is associated with serious complications including stroke, heart disease, kidney failure, blindness and amputations leading to disability and premature mortality (Stratton et al 2000). Obesity is the most potent risk factor for Type 2 diabetes and accounts for 80–85 per cent of the overall risk of developing Type 2 diabetes (Hauner, 2010). Exercise is not only a key factor in reducing and maintaining blood glucose levels but also may help tackle cardiovascular risk factors (Diabetes UK 2017). As a practice nurse responsible for lifestyle advice for patients with T2DM it is important to review the evidence to see if yoga practice is an option as a low cost, form of exercise, suitable for most people that is effective in reducing blood glucose levels.
An answerable question related to the area of practice needed to be formulated, yoga practice and diabetes were the subjects of interest. Time was spent to break down, re-structure and refine the question using the PICO framework (Schardt et al., 2007). The structure of the PICO pneumonic helped to identify the key concepts which can be clearly defined and applied into search terms.
P I C O
Adults with type 2
diabetes
Yoga, with or
without standard care and treatment Standard Care and
Treatment Reduce blood glucose
Levels (HbA1c, FBG,
PPBG).
The framework provided clarity in formulating the question “Is yoga effective in reducing blood glucose levels in adults with type 2 diabetes?”
When identifying the evidence, it was necessary to determine the most appropriate study design to answer the question which would detect associations between an intervention and outcome. The nature of the question posed for this assignment could be answered by a systematic review and meta- analyses, randomized control study, quasi-controlled design or case-control study.
Critical Appraisal of the evidence
The two pieces of evidence were found by entering key words* into the following databases of The Cochrane library, Medline, Embase and CINHAHL, Google Scholar, Bestevidence.info and TRIP database, that compared yoga practice with standard treatment versus standard care and treatment alone, in patients with T2DM. A total of 8 studies met the review criteria, of these, 3 were meta-analysis, 2 systematic reviews, 1 Cochrane systematic review protocol, a feasibility study and case-control study. The most recent systematic review was chosen along with a prospective case-control study which didn’t meet the inclusion criteria for the systematic review due to the nature of the study design.
“The effects of yoga among adults with type 2 diabetes: A systematic review and meta- analysis”. Thind et al (2017).
The primary purpose of the systematic review and meta-analysis was to examine the effect of yoga on glycaemic control among adults with T2DM. The authors acknowledge previous, recent, systematic reviews undertaken. Their study is justified by increasing the scope of the literature search and databases and assessing a wider range of outcomes related to T2DM such as blood pressure, lipid profile and fasting cortisol. In addition, they purport to examine possible influences of the intervention effect such as geographical location, sample characteristics and length and duration of yoga practice.
The eligibility criteria for studies included, was both randomized control trials (RCT) and quasi-experimental design. The quasi design may be subject to increased bias due to the non-random methods applied (Harris 2006). Each study included a control group, to measure the intervention, (yoga) against the outcome (reported measure of glycaemic control), with a minimum follow-up/post-test at 8 weeks from baseline. The population studied were adults (18 years or over) with a diagnosis of T2DM. Although the diagnosis criteria for diabetes is not mentioned in any of the studies and may vary from country to country. The primary outcome for the study was measure of glycaemic control (HbA1c, FBG, and PPBG). Studies excluded were Type 1 diabetes, gestational diabetes and if yoga was not the primary intervention.
The authors used Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). However, PRISMA provides guidelines to conduct systematic reviews but does not assess the quality of a systematic review. An extensive search of relevant electronic databases, ProQuest dissertations and Theses and search-terms were described using BOOLEAN search strategy. The authors included reference lists of manuscripts (including published reviews and included studies) and searched tables of contents of relevant journals. Missing data and additional information was sought from the original authors of these studies. Non-English studies were included in the systematic review to reduce publication bias.
*Key words: Diabetes Mellitus (DM), Type 2 Diabetes Mellitus (T2DM), Fasting Blood Glucose (FBG), glycaemic control. haemoglobin (HbA1c), postprandial blood glucose (PPBG), Yoga.
Assessing reliability of the data collection process involved two independent coders, recruited to extract specific study information for each study. Cohen’s kappa was reported as the assessment tool for inter-related reliability for all studies. Disagreement amongst coders was resolved by a third-party investigator.
A total of 23 studies were included with 2473 participants, comparing yoga practice to usual care for adults with T2DM. Forest plots presented each study outcome, weighted mean differences, degrees of freedom, confidence intervals, p values and overall homogeneity. The overall summary effect size represented by a diamond in favour for yoga intervention for each primary outcome.
This paper’s findings report Yoga intervention was moderately effective in reducing HbA1c (p<0,001, 95% CI 0.48-0.81), FBG (p<0,001, 95% CI 0.41-0.77), PPBG (p 0.025, 95% CI 0.40-72
Most of the studies in the systematic review were undertaken in India with the authors reporting that geographical location was not found to have any effect of the measured outcomes. This study could be beneficial and transferable to the diverse UK population. However, Cramer et al (2015), suggest yoga is very much steeped within the Indian culture and such familiarity may have favourable results on the outcome measured. There were no reported incidents of harm in any of the studies, one could assume no harm occurred or that it was not reported. The systematic review was comprehensive in its search and selection of appropriate data available. Studies included and excluded were clearly identified as were the results. Yoga practice uses various methods, some of which are more aerobic in practice where others are more meditative these differing styles may impact on blood glucose level outcomes. The authors conclude more rigorous studies are required with improved methodological design, over a longer time- period to determine the long-term efficacy of yoga in patients with T2DM.
Effect of Yoga on Blood Glucose Levels in Patients with Type 2 Diabetes Mellitus
Chimkode et al., (2015).
This prospective case- control study asks a clearly focused question ‘Effect of Yoga on Blood Glucose Levels in Patients with Type 2 Diabetes Mellitus”.
The population studied are males only, between the ages of 36yrs – 55 yrs., with a diagnosis of T2DM for a least one year on diabetic diet and oral hypo-glycaemic medication. Controls were matched for gender and age, and weight. Recruitment of cases was from a diabetic clinic in a tertiary teaching hospital only, which may suggest their diabetes care required more intervention. Although the cases were selected from this clinic there is no mention of how they were selected. The locality of the cases is not stated, one could assume they are local to travel to the hospital, but this cannot be verified. Consent and ethics approval were sought.
As with the cases, the controls were recruited as ‘coming to join the yoga clinic for yoga practice’, but no clear statement is provided whether they were already practicing yoga or had been specifically selected as controls for the study. Their age, height and weight were comparable with the cases (demonstrated on a table), but there was no mention (as with the cases) of smoking status, education, socio-economic status or whether they were a true representation of the population.
The time frame of the study was over 2 years, and yoga practice was implemented daily over 6 months during a 2-year period. This would be sufficient to see the effect of yoga on blood glucose levels. The study was small in numbers (30 cases and 30 controls) and men only. The findings may be useful for generalisability, although the numbers are relatively small.
Baseline measurements of blood glucose were recorded from both cases and controls before yoga practice was initiated, at 3 months and 6 months of yoga training. There is no report that independent assessment of the results occurred when collecting the results.
During the trial 5 cases and 3 controls dropped out of the study. No further mention of follow-up or reason for discontinuing is mentioned. They were not included in the final analysis.
Results were presented as percentages, mean and standard deviation. A paired t-test was used to estimate the difference in the means calculated before and after yoga in the same training group. A statistically significant p-value was considered <0.05. The reduction in the mean values of FBG and PPBG in both groups was highly significant at 6 months (p <0,001), at 3 months the reduction, FBG and PPBG was highly significant in T2DM group (p<0.001) but not in the control group (p <0.05).
The authors interpretation is yoga is effective in reducing blood glucose levels in patients with T2DM, this study is considered open to bias, with lack of transparency in the recruitment and confounding variables for cases and controls. A further study with more rigorous selection, recording and comparison of individuals not exposed may be more beneficial.
Evidence – In context of practice
Improving overall glycaemic control is fundamental in the management of T2DM and good blood glucose control in people with type 2 diabetes is important for reducing the risk of microvascular and macro-vascular complications. Whilst reducing glycaemic levels is associated with a significant decrease in long-term complications, Skyler et al. (2009) report that lifestyle changes can be difficult for patients to adhere to and pharmacological treatment without exercise modification and dietary changes is not enough alone. It is estimated that approximately one third of people with diabetes use some form of complimentary or alternative medicine (CAM) therapy, with 3-20% using CAM solely for the treatment of their diabetes (Nahin et al., 2012).
Diet, medication, exercise and education are instrumental in standard diabetes management (NICE 2015). In view of an increasing rise in obesity and individuals adopting a more sedentary lifestyle and long-term treatment becoming less effective the role of regular, low cost exercise, especially yoga appears to be a beneficial adjunctive in the management of T2DM and is effective in reducing FBG and PPBG levels (Chimkode et al 2015). Yoga practice incorporates psychological, physical and spiritual well-being and seeks to unite the individual self with the transcendental self. Over recent years It has become increasing popular (Cramer et al 2015) with many studies reporting its usefulness in mental health, anxiety, depression, hypertension, cardiovascular disease, asthma and diabetes.
Sreedevi et al (2017) found in their study of yoga and support, both helped FBG and the longer yoga was practiced, the more the individual experienced self-awareness and suggest a positive impact on body image and eating habits. Whilst (Dasappa et al 2016), reported a significant reduction in FBG levels, but no significant difference in HbA1C between the intervention and control group. A meta-analysis undertaken by (Kumer el al 2016) support yoga to be considered as an effective complementary treatment for patients with T2DM in the short-term but call for further rigorous methodological studies to establish if yoga is effective in the long-term. This is reinforced by (Ciu et all 2017) and (Alisjasir et al 2017), with their findings supporting yoga practice as effective in significantly reducing FBG but no significant reduction in HbA1c. In view of providing rigorous research methods (Alisjasir et al 2017) included only randomized control trials with many pre-post trials excluded. The trials included in their study were deemed not to be of high quality acknowledging that studies are limited in methodology with the potential for heterogeneity. Finally, (Thind et al 2017) systematic review reveal yoga is effective in reducing short-term glycaemic outcomes in patients with type 2 diabetes mellitus, with longer-term, rigorous studies needed.
The most recent systematic reviews and meta-analysis mentioned acknowledge there is some benefit of yoga practice in patients with T2DM. This is more evident in fasting blood glucose levels as opposed to longer-term glycaemic control such as HbA1c. It is clear there is a need for longer-term study with rigorous methodology. At present the evidence does suggest yoga is effective in reducing fasting blood sugar but is not strong enough to support yoga either as a therapy alone or with oral hypo-glycaemic medication for long-term glycaemic reduction in patients with T2DM.
NHS (2017) advocate 150 minutes of exercise a week and state that most forms of yoga are not strenuous enough to count towards these, but do acknowledge other benefits such as increasing strength, stamina and flexibility. Whilst (Chu et al 2014) and (Rioux et al 2014) found yoga to be effective for weight reduction. Yoga practice has also been reported to have some impact on reducing stress, anxiety and depression (Smith et al 2007, Cramer et al 2013), which may have an impact on appetite control. Whether it is more successful in terms of long-term weight loss and reduction of blood glucose levels than other forms of exercise, is unclear from the evidence. It is also unclear if individuals are more likely to adhere to a yoga program (supervised or home-based) (Picorelli et al 2014) than other forms of exercise.
In view of the current evidence, yoga practice could not be presented to patients as an effective long-term method of reducing blood glucose levels. Although it may be presented as a form of exercise to increase strength, flexibility and stamina and in those patients, who are reluctant to participate in any other form of exercise. Practitioners are required to address the complexity of diabetes management and acknowledge patients require an individualised approach to their care. Standard diabetic care should be provided by practitioners who are knowledgeable, empathetic and have the clinical skills to manage their care or refer onto specialist care when appropriate.
Practice leadership
The review of the evidence highlights the complexity of diabetes mellitus and reinforces the notion that reducing and maintain blood glucose levels is not a straightforward task. Yoga alone cannot be recommended to patients to reduce their blood glucose levels but may be used in conjunction with standard diabetes care and management which will be now be discussed in relation to leadership in practice.
The management of diabetes and adherence to modifying lifestyles continues to be a major challenge in healthcare. It is estimated 25-40 per cent of the population have low levels of activation, characterised by low confidence in managing their health, with a passivity and desire not to think about health and reveal poor self-care behaviour in terms of diabetes management, including avoidance of healthy eating and compliance with medication and exercise (Alcott 2017).
Primary care is recognised as the gateway to health services and is often the first point of contact patients have with the health services. It is instrumental to identify individuals, both at risk and those with long-term conditions, acting promptly to prevent complications. Practice nurses are often at the forefront of the delivery and management, of the provision of long-term conditions in general practice and play an important part in diabetes care. This can be a challenge not only to motivate patients to become more involved in their health, but also involving colleagues to take a more pro-active approach to improve the quality of care given to these patients. The King’s Fund
(2018) acknowledge the importance of engaging clinicians in understanding the need for change and to be the leaders, with effort to achieve that change. Developing evidence-based practice and involving those who are willing to help can help to build systems that grow outwards to improve long-term conditions. Care must be efficient, effective and have an impact. Involving patients and their families in their long-term health care is essential for partnerships of trust to develop and transparency between health care provider and patient. Healthcare is a constant spiral of change and health care professionals and organisations must be willing and adaptable to meet such changes. A flexible but consistent approach is required to deliver and lead on long-term conditions such as diabetes. Leadership is a collective process, which means everyone in an organisation taking responsibility.
Sustainability and transformation partnerships (STP’s) are now an integral part of primary healthcare, providing locally acquired, cost effective services designed to meet the needs of the local population. More recently included in our practice is the Integrated Network Teams (INC) which have formed to meet the health needs of patients with long-term needs. INC is a relatively new concept in primary care where a core team of GP/Nurse, Social Worker, Mental Health Practitioner, Integrated Care Matron, Health Navigator and Administrator meet fortnightly in a GP clinic to discuss and manage complex individual needs. Liaising across various specialist areas helps to bring about cohesive care and share expert knowledge and opinion to support patients.
In addition to INC, the Year of Care (YoC) program was introduced to our practice and is about improving care for people with long-term conditions and supporting them to manage their own conditions. YoC places importance on individualised care planning and support for self-management. A pilot study in Tower Hamlets saw patient-involvement increase from 52% -82%, with improved clinical outcomes, including blood glucose levels and blood pressure and clinicians reporting greater job satisfaction. The YoC has been recognised by NICE (2016) in the Quality standard statement pertaining to care planning.
On a practical level nurses must adopt a systematic approach in diabetes management, utilising a ‘team approach’ with shared responsibility delivery of evidence base health care for improved health outcomes. Nurses must drive initiatives in their practice such as INC and YoC, chair meetings, invite expert speakers to educate and motivate both GPs, registrars, junior nurses, health care assistants and administrators to improve health outcomes for patients. Nurses may act as a role model for junior members of the team, encourage learning through, action research, reflection, sharing of experiences and goal setting with feedback from team members and patients. They may develop and encourage a culture of sharing knowledge from experience, evidence and continuing professional development. With a patient centred, team approach that is well managed, encouraging patients to be proactive in making decisions about their own healthcare, it is possible to improve health outcomes and reduce long-term glycaemic levels to reduce further complications in patients with T2DM.