Pain Management in End of Life Care

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Table of Contents

Background
Literature Review
Change Management
Implementation
Conclusion
Appendix 1
Appendix 2
Appendix 3
References

End of life care is among the crucial concerns in nursing all over the world because it can influence the dying persons’ quality of life. This type of care is aimed primarily at elderly people with various comorbidities, as well as those in the terminal stage of a disease. The literature review will seek to define the target population and its needs with regards to pain management, describe different types of treatment used in the UK and explore various concerns associated with pain management in end of life care. Based on the information gathered from evidence, the review will also suggest how the quality of care in this area can be enhanced.

Background

The subject of pain management in end of life care is of critical importance in the contemporary world. According to the definition provided by Schmidlin and Oliver (2015), a significant portion of palliative care, including the end of life care, is dedicated to providing relief for pain and discomfort associated with an illness. A recent ranking of countries by the Quality of Death Index showed that the United Kingdom performed better than other countries in Europe, America, and Asia (Ling 2016). This means that the country has a solid framework for providing the end of life care, well-trained staff, and high standards in terms of care quality (Ling 2016).

However, there are still some issues evident in the UK healthcare system that affect people’s access to and use of pain management services and medications (Ling 2016). To facilitate improvements in this area of palliative care, it is essential to understand the needs of the target population and evaluate the treatment types offered in the United Kingdom.

Literature Review

Based on the background analysis of the issue, two key topics were chosen for further examination in the literature review. First, the review defines the target population and their needs, and second, it discusses major treatment types. The results were found primarily through the University library, although some guidelines were accessed from databases, such as PubMed and PMC. The full information on search criteria and keywords can be found in Appendix 1.

Target Population and Needs

Older adults

Due to the aging of the global population, the share of older adults in the United Kingdom has increased over the last decade. However, as shown by a quantitative population study by Prince et al. (2015), the quality of life of many older adults is undermined by chronic disease, and their symptoms increase in severity as a person reaches the end of their life. To provide adequate pain management services to older adults living in the United Kingdom, it is essential to understand the influence of various common diseases and conditions on their life.

One of the most prominent concerns in caring for older adults is dementia. According to the literature review provided by De Witt Jansen et al. (2017a), the number of people affected by dementia globally is over 46 million, and this figure is expected to reach 74 million by 2030. A quantitative study by Sampson et al. (2018) confirms this data and applies it to the United Kingdom, where one in three older adults will develop dementia before they die.

The study also showed that those with advanced dementia have an increased risk of developing pressure sores and immobility, as well as anxiety, depression, and apathy (Sampson et al. 2018). In addition, difficulty swallowing and impaired respiratory functions were among the most common physical symptoms of advanced dementia noted by Sampson et al. (2018). These factors contribute to the need for pain management since they cause patients to experience severe discomfort and pain.

However, some studies have noted decreased access to care in older adults with dementia. In their qualitative study, Bunn et al. (2014) remarked that dementia patients are less likely to receive high-quality pain management services than those who have other impairments.

Besides dementia, older adults struggle with other conditions that can cause physical symptoms. For instance, diabetes, which is prevalent in older adults, can lead to the development of diabetic neuropathy (British Geriatrics Society 2018). A qualitative review of patients’ experiences by Margiotta et al. (2017) shows that osteoarthritis, arthritis, and other joint diseases are also common in the elderly, thus contributing to chronic pain. Based on research evidence, the notion that older adults are among the key populations requiring pain management as part of the end of life care is unchallenged.

Patients with terminal illnesses

Another group of patients requiring pain management as part of end of life care are patients with terminal cancer and other illnesses in the final stage. The number of people with cancer in the UK has increased by 400,000 between 2010 and 2015, and research shows that it will reach 4,000,000 by 2030 (Macmillan Cancer Support 2017). Cancer is particularly prevalent among older adults, but can also affect other populations of people regardless of age and gender (Macmillan Cancer Support 2017).

Cancer is the most common cause of disease-related death in the United Kingdom, with 164,000 people dying from terminal cancer each year (Macmillan Cancer Support 2017). As a result, the population of the end of life patients with cancer is large, and people suffering from this illness usually require some form of pain management.

Cancer pain is a rather complex phenomenon that has been widely studied in the United Kingdom. According to the position statement of the British Pain Society, cancer pain can derive from the illness itself, as well as from treatment and concurrent disorders, which makes it difficult to assess and treat pain in cancer patients successfully (Raphael et al. 2010a). In addition, cancer patients may feel pain in several sites at once, and it is up to care providers to determine “if the pain is nociceptive, neuropathic, visceral, or a combination of all three” (Raphael et al. 2010a, p. 743). As the disease progresses into its final stages, symptoms can become much more severe.

As a result, multiple studies show that patients nearing the end of life feel psychological distress caused by pain and require the use of multiple medications, including powerful pain relievers (Raphael et al., 2010a). Thus, providers must ensure adequate pain management to reduce distress and improve cancer patients’ quality of life while avoiding negative drug interactions and side effects.

Besides cancer, there are other life-threatening diseases that cause significant pain and discomfort in the terminal stage. Research studies suggest that these diseases include chronic heart failure, kidney failure, chronic obstructive pulmonary disease (COPD), cystic fibrosis, metabolic conditions, cerebral palsy, and other conditions (Ekström, Abernethy & Currow, 2015; Taylor et al. 2010). Although terminal conditions are usually associated with a variety of symptoms, pain is often considered to be a defining focus of palliative care (Chan, Webster & Bowers 2013).

A quantitative survey by Lowney et al. (2015) found that in patients with kidney failure awaiting transplantation, pain and immobility had an equally detrimental effect on the quality of life. Hence, research shows that it is critical to ensure adequate pain management regardless of the patient’s disease in order to decrease the suffering before death.

Treatment Types

The WHO Analgesic Ladder

Healthcare institutions, including primary care facilities and community health providers, remain the most widely used resource of pain management services in the United Kingdom. As described in the UK Core Standards for Pain Management services, the care provided by medical professionals follows the standards of pain management defined by the World Health Organisation as the Analgesic Ladder (Sharma & Lynch 2015). Consequently, there is a great variety of descriptive studies that explain the application of the framework of pain management in the United Kingdom.

The first step is when the pain is first diagnosed, and a mild, non-opioid pain relief medication is prescribed. At this stage, patients normally describe mild to moderate pain, which is why physicians and other care providers are instructed to avoid strong pain management medications (Hughes et al. 2012). Examples of medicines that can be prescribed at this stage are paracetamol or ibuprofen, which can be accompanied by adjuvant drugs. Adjuvant agents that can be prescribed to patients with chronic pain include anti-depressants and anticonvulsants, which can complement pain relief therapy by increasing the effectiveness of non-opioid analgesics (Evans, Hoggarth & Lanigan 2016).

The prescription of adjuvant agents largely depends on the patient’s condition and the type of pain they experience. For instance, a systematic review by Lunn, Hughes, and Wiffen (2014) showed that duloxetine is effective in treating pain caused by diabetic neuropathy and fibromyalgia, with moderate quality studies confirming this conclusion. Evidence in favour of amitriptyline is weaker; although it is widely recommended as a first-line treatment for neuropathic pain, a recent systematic review showed that its positive effects are overestimated (Moore et al. 2017). After an initial prescription for non-opioid analgesics or adjuvant agents is issued, the patient is scheduled for a follow-up appointment to discuss the progress.

If the pain persists or becomes worse, care providers are instructed to use medications from Step 2 of the WHO Ladder. While patients might be advised to continue taking non-opioid analgesics or adjuvant agents, this step also adds mild opioids to provide relief from moderate pain (Hughes et al. 2012). If a patient is suffering pain because of chronic wounds, a mild opioid is applied topically and complemented by ibuprofen and lidocaine (Metcalfe 2015).

If the treatment prescribed in Step 2 is inefficient, and the patient continues to experience moderate or severe pain, stronger opioids are used for pain management. These include morphine, oxycodone, and buprenorphine, which can be complemented by paracetamol or NSAIDs (Hughes et al. 2012). At this stage, providers should consider both the background pain and breakthrough pain, which occurs between two doses of pain management medications.

Breakthrough pain is especially prominent in patients nearing the end of life who are on strong pain relief medications. For instance, a recent study showed that cancer patients experience breakthrough pain in over 60% of cases (Bass 2016). Since breakthrough pain is usually managed by an increased dose of analgesics taken for background pain, this means that end of life patients should have access to extra doses of medications, such as morphine or oxycodone (Bass 2016). Overall, the WHO Analgesics Ladder provides a useful framework for care providers with regards to pain management options, and the application of the framework to end of life care in the United Kingdom helps to improve the quality of care.

Opioid prescription

The topic of opioids in pain management is widely researched and debated all over the world, including the United Kingdom. The primary reason for this is the fact that, while opioids have high efficiency in pain relief, they cause dangerous side effects and consequences that can impair patients’ life, including addiction. Since the main focus of palliative care is on the quality of patient’s life, considering the benefits and drawbacks of opioid prescription in end of life care is of critical importance.

Although the WHO guidelines and most authors cited in the previous section consider opioids as the second-line option in pain management, many research studies show that opioids have a variety of drawbacks.

The first concern regarding the use of opioids is their efficiency, which has been debated in prior studies. According to the report by Rafael et al. (2015a), opioids proved to be effective for cancer pain, but have limited effectiveness in non-cancer patients with chronic pain. This could be because cancer patients in palliative care tend to receive stronger opioids, such as diamorphine, in weeks prior to their death (Ziegler 2016).

In addition, research suggests that there are certain groups of patients who would not benefit from opioids regardless of the diagnosis. For example, tramadol will not be effective in all cases, since “some 7% of the population do not have the enzyme required to convert tramadol into its active metabolite, and so will not get any analgesic benefit” (Evans, Hoggarth & Lanigan 2016, p. 746). Similarly, 9% of the Caucasian population are not responsive to codeine, and even more patients could struggle with metabolising it effectively (Evans, Hoggarth & Lanigan 2016). The researchers do not note any strategies for predicting opioid effectiveness in specific cases, and thus care providers should monitor patients and perform regular pain assessments to determine if the treatment with opioids is effective.

There are also other considerations that have to be taken into account when prescribing opioids for pain management in end of life patients. Both mild and strong opioids are associated with a risk side effects that could put a patient’s life in danger. For instance, tramadol can increase the risk of seizures in patients with epilepsy and those who have an addiction to drugs or alcohol, while codeine is associated with a risk of respiratory depression (Evans, Hoggarth & Lanigan 2016).

Besides these side effects, opioids also pose a risk of constipation and sedation, which have a detrimental impact on patients’ quality of life (De Witt Jansen et al. 2017b; Rafael et al., 2015a). Some of these side effects can be controlled by additional medications, such as laxatives, but most patients on strong opioids will still experience at least one side effect from treatment (Ziegler 2016). It is advisable for care providers to discuss each pain management option and its possible side effects with the end of life patients or their family member to select an appropriate medication.

Since a significant share of patients at the end of life are older adults, it is also critical to define the risks of prescribing opioids to elderly patients. Several high-quality sources show that long-term opioid therapy can cause bone demineralisation and lead to an increased risk of falls (De Witt Jansen et al. 2017b; Rafael et al. 2015a). These factors are especially important in the treatment of older adults since they increase their risk of hip fracture and other injuries.

Contributing to immobility, fractures impair the quality of life and cause more pain, which means that a risk and benefit assessment should be conducted before prescribing opioids to elderly patients in palliative care. Moreover, for patients who can move without assistance, the use of patient safety strategies is required to improve the safety environment at home or in long-term care facilities.

The final considerations in using opioids for pain management are an addiction, overdosing, and drug interactions. As noted by Rafael et al. (2015a), at least 18% of patients prescribed opioids for at least one month will develop an addiction to the substance. For the end of life patients, addiction can result in reduced quality of life and the exacerbation of symptoms, as well as a high risk of medication side effects. Prescription opioid abuse is also common, and overdosing on opioids can lead to serious complications and death.

A nationwide longitudinal report by Giraudon et al. (2013) states that in 2010, over 16,000 people in the United Kingdom died as a result of taking opioids, and in most cases, death was caused by an overdose of the drug. In contrast with other studies that only consider the role of strong opioids in lethal overdosing, Giraudon et al. (2013) found that mild opioids, such as tramadol, can have lethal consequences if taken in large amounts: at least 154 deaths in the UK in 2011 were caused by overdosing on tramadol.

Based on the available research data, it is critical for care providers issuing opioid prescriptions to monitor patients’ adherence to treatment plans. In addition, it would be beneficial to provide sufficient education and support to carers, since they can control at-home drug administration and adherence (Carduff et al. 2016).

Physical therapy

Due to the multiple limitations and negative consequences of opioid treatments, various alternative methods of pain relief are available in the United Kingdom. Although the vast majority of people who use these services are not terminally ill, they could still be beneficial to some end of life patients, especially those for whom opioid therapy is ineffective or too risky. First of all, the end of life patients who suffer pain as a result of arthritis, muscle atrophy, and other musculoskeletal disorders could benefit from physical therapy tailored to their physical capacity and needs. Raphael et al. (2010b) explain that physical therapy can provide some relief from background pain if performed correctly, which is why it is often used in cancer patients in combination with other methods.

Patients with restricted mobility or those with severe cognitive impairment could engage in physical therapy through meaningful activities, such as drawing or knitting. A large quantitative trial of the Namaste Care programme, which combines these forms of physical activity with high-quality nursing care found that patients with advanced dementia experienced a decrease in pain as a result of activities, even when traditional pain relief options were not available (Stacpoole et al. 2014). Thus, physical therapy could be useful in pain management in end of life patients, regardless of whether it engages the entire body or focused on fine motor skills.

Medical marijuana and cannabis-based treatments

Cannabis-based pain medication is another viable option for pain management in end of life care. Medical marijuana was illegal in the United Kingdom until November 2018, and now specialist care providers can prescribe cannabis-based treatments for pain and other symptoms (Chambers 2018). For example, a qualitative study of European countries’ policies discovered that patients with multiple sclerosis and late-stage cancer who require palliative care are eligible for medical marijuana in the United Kingdom (Krcevski-Skvarc, Wells & Häuser 2018).

The same study confirmed that medical marijuana is effective in reducing various negative symptoms, including nausea and vomiting caused by chemotherapy (Krcevski-Skvarc, Wells & Häuser 2018). Since no other relevant studies contested this view, it appears that cannabis-based treatments can be particularly helpful for end of life patients with cancer.

The efficacy of medical marijuana in pain management was proven by numerous studies, although most of them are from the United States, where medical marijuana has been used for years. The literature review on this subject is largely based on a recent report from the European Pain Federation, which has been used to support the decision-making process in the United Kingdom. It showed that marijuana could be effective in treating chronic neuropathic pain in patients with untreatable illness (Häuser et al. 2018).

The panel also states that it should also be considered as a third-line treatment for patients who do not respond well to other pain management strategies, including opioids (Häuser et al. 2018). Therefore, cannabis can help to address the needs of the end of life patients who experience significant side effects of opioids or who cannot metabolise the drug effectively.

Nevertheless, there are some resources that discuss important concerns with regards to the use of medical marijuana in end of life patients. First of all, since the drug is relatively new to the United Kingdom, it is possible that its accessibility will remain limited until more care providers and pharmacies obtain the necessary licensing (Chambers 2018). Secondly, the use of medical marijuana or cannabis-based medications has a list of contraindications.

The position paper of the European Pain Federation advises against prescribing cannabis-based treatments to patients who have a history of substance or drug abuse, psychosis, seizures, and severe cardiac disorders (Häuser et al. 2018). Thirdly, the guidelines also state that cannabis-based treatments are incompatible with certain medications, such as high doses of opioids or benzodiazepines (Häuser et al. 2018). These sources show that the use of medicinal cannabis in end of life patients has some critical limitations and that this method of pain management is not available to all patients.

Mindfulness-based cognitive therapy

Mindfulness meditation practices have become a popular method of alternative therapy for chronic pain in the United Kingdom. Mindfulness-based cognitive therapy is a method that combines mindfulness meditations and other cognitive practices to change people’s response to certain events or conditions (Bawa et al. 2015). In palliative care, mindfulness meditations proved to be effective in improving the quality of life and reducing the need for strong opioids in pain management (Maschio 2016).

A randomized controlled trial by Dowd et al. (2015) shows that mindfulness programs resulted in decreased pain levels among the participants, as well as in improved well-being in quality of life. However, the population included in the study did not include the end of life patients with severe pain, and thus it is unclear whether or not the results can be generalised to this patient population.

A high-quality systematic review by Bawa et al. (2015) stated that, although there is some evidence that this treatment can be useful for patients with chronic musculoskeletal pain, the number of research studies available on the topic is limited, and more research is required to recommend this treatment for pain management.

Change Management

The Need for Change

Based on the review of the literature, there are two main issues that should be addressed as part of the change process. First of all, it is essential to increase the number of high-quality systematic review studies on different pain management options available in the end of life care. For example, since cannabis-based medicines have been legalised for some patients in the UK, it is critical to assess their effectiveness in end of life care and compare it to other options.

More recent research is also needed to reassess the WHO Analgesic Ladder. Although it is widely used by care providers throughout the country, research suggests that some treatments offered in this framework are either damaging or ineffective (Giraudon et al. 2013; Moore et al. 2017; Rafael et al. 2010a). Building more recent and reliable knowledge about different treatments would support evidence-based practice and help care providers to improve the quality of pain management services.

Secondly, it is essential to address disparities in the quality of pain management services provided to different populations. Studies indicate that dementia patients and those who receive the end of life treatment at home are less likely to have their pain managed successfully (Bunn et al. 2014; Ziegler 2016). In order to ensure a matching quality of pain management services for all end of life patients, it would be necessary to improve access to pain management medications and provide sufficient education to people rendering at-home care.

Lewin’s Change Theory

In order to achieve sustainable change in both areas, it would be beneficial to apply an appropriate change theory to the process. Lewin’s theory posits that change requires a positive environment and a set of measures to implement and control the outcomes (Swansea University n.d.). Lewin’s Change Model is the product of these ideas, and it includes three main stages contributing to the desired outcome.

The first stage is unfreezing, during which the need for change is established, and the plan for the change is created (Cummings, Bridgman & Brown 2016). The primary goal of this step of the process is to create and solidify the motivation for change, which should serve as a driving force throughout the implementation phase. The second phase is the change phase when the plan is realised, and the desired outcomes are achieved (Cummings, Bridgman & Brown 2016).

Depending on the results, the plan might be adjusted, or some steps in it might be repeated until the change is successful. As the desired results are achieved, the system is frozen, which is the third step of the change process (Swansea University n.d.). After the change is completed, quality outcomes should be monitored regularly to identify any gaps and address them promptly.

Involved Persons

Identifying those involved in the change process will help to identify the sources of support and resistance to change. It will also assist in planning for the unfreezing stage of the change model by defining the positions and needs of involved persons. The first group includes patients and their family members, as they will benefit most from the proposed change. Effective pain management will provide relief to patients, thus easing the end of life stage for them and their loved ones.

The second group of involved persons is care providers, such as doctors, nurses, and carers. This group will be part of the change process since they could assist in gathering research data and implementing changes in practice. Researchers also constitute a group of involved persons because they will be tasked with performing studies to support new approaches in evidence-based pain management practice. Lastly, the NHS and the government will be expected to provide institutional support and funding for the change project.

Force Field Analysis

The Force Field Analysis is an essential tool that can help to identify supporting and resisting forces to the change that should be influenced during the unfreezing stage of the model. The key drivers of change, in the present case, are the end of life care providers, patients, and their families, since these groups are interested in high-quality pain management services. To motivate these groups to support meaningful change, it would be useful to discuss how the proposed plan would benefit them. For example, updating the UK pain management guidelines based on new research evidence would assist care providers in making quick and effective decisions, whereas patients would benefit from improved pain management.

The main restraining forces that could impede the change are the government and the NHS, which would face an increase in costs associated with change implementation. For instance, providing additional training and education to at-home care providers can be costly. Moreover, improving access to strong pain relief medication could increase the incidence of overdosing or suicide among the end of life patients. To create motivation for change in these structures, it is essential to show that the benefits of change would outweigh its costs. It would be useful to connect policymakers with patients and care providers to establish a dialogue, thus helping those against the process to understand the need for change.

Leadership Theory

A particular leadership theory that would be useful to address the barriers to change identified in this section and maintain a high quality of practice is transformational leadership. The application of this leadership theory is pivotal in increasing and maintaining the motivation of those involved in a change process (Lee 2014). In transformational leadership, a leader recognises the input of all involved persons while ensuring that they work towards the same goal (Metwally, El-bishbishy & Nawar 2014). Thus, it can help to resolve potential disagreements and encourage those sceptical about change to contribute.

To use transformational leadership in this context, it would be essential to create a vision of the proposed change by defining its positive effects on the end of life patients (Alvesson & Kärreman 2016). This would help all involved persons to understand the impact of change, thus engaging them in planning and implementation processes. To maintain a high level of engagement throughout the change process, it would also be useful to apply the principles of goal-setting theory by creating a list of change milestones and celebrating their achievement. This would provide the team and other stakeholders with a sense of achievement and motivate them to work harder (Parker, Bindl & Strauss 2010).

Effects of the Change

The primary effect of the proposed change will be an improvement in the quality of pain management services available to end of life patients in the UK. As a result of the process, patients nearing the end of life will be able to receive medications that will be effective in controlling background and breakthrough pain while also avoiding negative side effects. The change will also have a beneficial impact on care providers in multidisciplinary teams due to the reduced workload and improved patient satisfaction.

One negative effect of the proposed change is that it will increase healthcare expenditures in the UK due to the need for extensive research and education. By improving access to pain relief, the change might also contribute to the problem of drug misuse in the country, and thus the team will need to plan for controlling this effect.

Implementation

First, the team should create a step-by-step plan following Lewin’s change model as a framework. The preliminary plan that was designed based on the SMART criteria can be found in Appendix 2. Secondly, it would be useful for the team to conduct research focused on the effectiveness of different pain medication options and issues concerning access to them. Based on the results, the team should revisit current pain management guidelines and amend them to improve the quality of service provided. To remove barriers in access to pain medications, the team would need to partner with the NHS and present research results to support a meaningful change in pain medication delivery.

Finally, it would be beneficial to measure the outcomes before and after the change. The two key outcomes that should be addressed as part of the change should be pain relief effectiveness and access to pain medication. The first variable can be measured using a pain assessment scale, such as Pain in Advanced Dementia (PAINAD) or the Numerical Rating Scale advised by the national guidelines (Schofield 2018). Access to pain medication should be measured using a survey completed by patients or their carers.

Conclusion

Overall, the literature review suggests that the need for improved pain management in the United Kingdom is substantial. Pain relief is particularly important for older adults and people with terminal illnesses nearing the end of life because the pain has a detrimental influence on their quality of life and death. Most medications that are currently used for pain relief in the end of life patients are either ineffective or have serious side effects, and thus it is essential to revisit the current guidelines and improve them.

Increasing access to medications will also help to ensure that people with dementia or those receiving at-home care can manage their pain successfully. Further research should also seek to evaluate the gaps in the end of life pain management access for different populations since few studies considered this topic in the UK. In addition, researchers should provide more data on the efficiency of cannabis-based medicines in pain management at the end of life to support their use in evidence-based practice.

Two particular areas for further self-development identified while completing this assignment are leadership theory knowledge and evidence search. Improved knowledge of leadership and motivation theories and their application in practice would assist me in advocating for and implementing change successfully. Enhancing the ability to search for high-quality evidence is critical to improving practice. This goal can be achieved by learning about new search tools and applying evidence evaluation frameworks consistently. While Cormack’s framework is useful for assessing research studies, it would be useful to find tools that can be used to evaluate descriptive materials, such as books or articles.

Appendix 1

Summary of Literature Search

Search engines used:

Google Scholar.
The University Library.
Elsevier.
PubMed.
PMC.

Keywords:

Pain management.
Palliative care pain management.
End of life pain.
Cancer pain.
Elderly health UK.
Opioid addiction UK.
Mindfulness palliative care.
Pain management programmes UK.
UK guidelines cancer pain.

Date ranges:

2014-today (first line).
2010-today (second line).
all-time (third line).

Inclusion criteria:

United Kingdom.
Authors’ credentials (degree in Nursing or Medicine, not undergraduate students).
Content applies to the topic.

Exclusion criteria:

Irrelevant content.
Full text unavailable.

Appendix 2

Action Plan

Unfreeze
- Prepare a research plan by 30/06/2019
- Presentation to stakeholders before 01/09/2019
- Conduct research on pain management effectiveness and accessibility by 01/05/2020
- Present study results to the NHS by 01/072020
Change
- Propose amendments to national pain management guidelines by 01/08/2020
- Create a national framework for improving access to pain management by 30/09/2020
- Present the framework to the NHS for approval and authorization by 15/10/2020
Refreeze
- Repeat research on pain management effectiveness and accessibility at 6 months and 2 years after full implementation
- Publish research results on completion to inform similar initiatives in other countries

Appendix 3

Cormack’s Framework

Study 1: De Witt Jansen et al. (2017b).

Heading	Question to be asked	Yes	No	Don’t know
Title	Is the title concise? Is the title informative? Does the title clearly indicate the content? Does the title clearly indicate the research approach used?	+ + +	+
Author(s)	Does the author(s) have appropriate academic qualifications? Does the author(s) have appropriate professional qualifications and experience?	+ +
Abstract	Is there an abstract included? Does the abstract identify the research problem? Does the abstract state the hypotheses (if appropriate)? Does the abstract outline the methodology? Does the abstract give details of the sample subjects? Does the abstract report major findings?	+ ++ + +
Introduction	Is the problem clearly identified? Is a rationale for the study stated? Are limitations of the study clearly stated?	+ +	+
Literature review	Is the literature review up-to-date? Does the literature review identify the underlying theoretical framework(s)? Does the literature review present a balanced evaluation of material both supporting and challenging the position being proposed? Does the literature clearly identify the need for the research proposed? Are important references omitted?	N/a	N/a	N/a
The hypothesis	Does the study use an experimental approach? Is the hypothesis capable of testing? Is the hypothesis unambiguous?	N/a N/a	+ N/a N/a	N/a N/a
Operational definitions	Are all terms used in the research question/ problem clearly defined?		+
Methodology	Does the methodology section clearly state the research approach to be used? Is the method appropriate to the research problem? Are the strengths and weaknesses of the approach chosen stated?	+ + +
Subjects	Are the subjects clearly identified?	+
Sample selection	Is the sample selection approach congruent with the method to be used? Is the approach to sample selection clearly stated? Is the sample size clearly stated?	+ + +
Data collection	Are any data collection procedures adequately described? Has the validity and reliability of any instruments or questionnaires been clearly stated?	+	+
Ethical considerations	If the study involves human subjects has the study of ethical committee approval? Is informed consent sought? Is confidentiality assured? Is anonymity guaranteed?	+ + +		+
Results	Are results presented clearly? Are the results internally consistent? Is sufficient detail given to enable the reader to judge how much confidence can be placed in the findings? Does graphic material enhance clarity of the results being presented?	+ ++	+
Data analysis	Is the approach appropriate to the type of data collected? Is any statistical analysis correctly performed? Is there sufficient analysis to determine whether ‘significant differences’ are not attributable to variations in other relevant variables? Is complete information (test value, df, and p) reported?	+ N/a N/a N/a	N/a N/aN/a	N/a N/aN/a
Discussion	Is the discussion balanced? Does the discussion draw upon previous research? Are the weaknesses of the study acknowledged? Are clinical implications discussed?	+ ++ +
Conclusions	Are conclusions supported by the results obtained? Are the implications of the study identified?	+ +
Recommendations	Do the recommendations suggest further areas for research? Do the recommendations identify how any weaknesses in the study design could be avoided in future research?	+	+

Study 2: Dowd et al. (2015).

Heading	Question to be asked	Yes	No	Don’t know
Title	Is the title concise? Is the title informative? Does the title clearly indicate the content? Does the title clearly indicate the research approach used?	+ + + +
Author(s)	Does the author(s) have appropriate academic qualifications? Does the author(s) have appropriate professional qualifications and experience?	+ +
Abstract	Is there an abstract included? Does the abstract identify the research problem? Does the abstract state the hypotheses (if appropriate)? Does the abstract outline the methodology? Does the abstract give details of the sample subjects? Does the abstract report major findings?	+ ++ + +	+
Introduction	Is the problem clearly identified? Is a rationale for the study stated? Are limitations of the study clearly stated?	+ +	+
Literature review	Is the literature review up-to-date? Does the literature review identify the underlying theoretical framework(s)? Does the literature review present a balanced evaluation of material both supporting and challenging the position being proposed? Does the literature clearly identify the need for the research proposed? Are important references omitted?	N/a	N/a	N/a
The hypothesis	Does the study use an experimental approach? Is the hypothesis capable of testing? Is the hypothesis unambiguous?	+ + +
Operational definitions	Are all terms used in the research question/ problem clearly defined?	+
Methodology	Does the methodology section clearly state the research approach to be used? Is the method appropriate to the research problem? Are the strengths and weaknesses of the approach chosen stated?	+ +	+
Subjects	Are the subjects clearly identified?	+
Sample selection	Is the sample selection approach congruent with the method to be used? Is the approach to sample selection clearly stated? Is the sample size clearly stated?	+ + +
Data collection	Are any data collection procedures adequately described? Has the validity and reliability of any instruments or questionnaires been clearly stated?	+ +
Ethical considerations	If the study involves human subjects has the study ethical committee approval? Is informed consent sought? Is confidentiality assured? Is anonymity guaranteed?			+ + + +
Results	Are results presented clearly? Are the results internally consistent? Is sufficient detail given to enable the reader to judge how much confidence can be placed in the findings? Does graphic material enhance clarity of the results being presented?	+ ++	+
Data analysis	Is the approach appropriate to the type of data collected? Is any statistical analysis correctly performed? Is there sufficient analysis to determine whether ‘significant differences’ are not attributable to variations in other relevant variables? Is complete information (test value, df, and p) reported?	+ + + +
Discussion	Is the discussion balanced? Does the discussion draw upon previous research? Are the weaknesses of the study acknowledged? Are clinical implications discussed?	+ + + +
Conclusions	Are conclusions supported by the results obtained? Are the implications of the study identified?	+ +
Recommendations	Do the recommendations suggest further areas for research? Do the recommendations identify how any weaknesses in the study design could be avoided in future research?	+ +

Study 3: Stacpoole et al. (2014).

Heading	Question to be asked	Yes	No	Don’t know
Title	Is the title concise? Is the title informative? Does the title clearly indicate the content? Does the title clearly indicate the research approach used?	+ + +	+
Author(s)	Does the author(s) have appropriate academic qualifications? Does the author(s) have appropriate professional qualifications and experience?	+		+
Abstract	Is there an abstract included? Does the abstract identify the research problem? Does the abstract state the hypotheses (if appropriate)? Does the abstract outline the methodology? Does the abstract give details of the sample subjects? Does the abstract report major findings?	+ + + +	+ +
Introduction	Is the problem clearly identified? Is a rationale for the study stated? Are limitations of the study clearly stated?	+ +	+
Literature review	Is the literature review up-to-date? Does the literature review identify the underlying theoretical framework(s)? Does the literature review present a balanced evaluation of material both supporting and challenging the position being proposed? Does the literature clearly identify the need for the research proposed? Are important references omitted?	N/a	N/a	N/a
The hypothesis	Does the study use an experimental approach? Is the hypothesis capable of testing? Is the hypothesis unambiguous?	N/a	N/a	N/a
Operational definitions	Are all terms used in the research question/ problem clearly defined?	+
Methodology	Does the methodology section clearly state the research approach to be used? Is the method appropriate to the research problem? Are the strengths and weaknesses of the approach chosen stated?	+ + +
Subjects	Are the subjects clearly identified?	+
Sample selection	Is the sample selection approach congruent with the method to be used? Is the approach to sample selection clearly stated? Is the sample size clearly stated?	+ +	+
Data collection	Are any data collection procedures adequately described? Has the validity and reliability of any instruments or questionnaires been clearly stated?		+ +
Ethical considerations	If the study involves human subjects has the study ethical committee approval? Is informed consent sought? Is confidentiality assured? Is anonymity guaranteed?	+ + + +
Results	Are results presented clearly? Are the results internally consistent? Is sufficient detail given to enable the reader to judge how much confidence can be placed in the findings? Does graphic material enhance clarity of the results being presented?	+ + ++
Data analysis	Is the approach appropriate to the type of data collected? Is any statistical analysis correctly performed? Is there sufficient analysis to determine whether ‘significant differences’ are not attributable to variations in other relevant variables? Is complete information (test value, df, and p) reported?	+ + +	+
Discussion	Is the discussion balanced? Does the discussion draw upon previous research? Are the weaknesses of the study acknowledged? Are clinical implications discussed?	+ + + +
Conclusions	Are conclusions supported by the results obtained? Are the implications of the study identified?	+ +
Recommendations	Do the recommendations suggest further areas for research? Do the recommendations identify how any weaknesses in the study design could be avoided in future research?	+	+

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