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PERSPECTIVE PAPER

The Search for a Functional Outcome Measure for Physical Therapy in Specialist Palliative Care: An Ongoing Journey

Looney, Finola PT, BSc Physiotherapy1; Cobbe, Sinead PT, MSc Clinical Therapies, BSc Physiotherapy2; Ryan, Angela PT, MSc Clinical Therapies, BSc Physiotherapy3; Barriscale, Isabel PT, BSc Physiotherapy4; McMahon, Ailbhe PT, BSc Physiotherapy5; Real, Shirley PT, MA Healthcare Management, BSc Physiotherapy6

Author Information
doi: 10.1097/01.REO.0000000000000194
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Abstract

Most palliative care (PC) patients express a desire to remain physically independent during the course of their disease.1 Indeed, physical function is intertwined with a person's sense of self and spiritual well-being.2 Reduction in physical capacity impacts on quality of life in PC patients and consequently the concept of palliative rehabilitation is gaining more attention in recent years.3 One of the primary goals of palliative rehabilitation is to maximize function and reduce physical dependency for as long as possible.

Devising a program of therapy to maximize limited functional potential in PC patients is extremely challenging, with fluctuating functional status, competition with other therapies for priority, frequently changing goals, and patients in a cohort who are in functional decline.4 Choosing an outcome measure to objectively assess the effectiveness of physical therapy (PT) in this population has also proved a significant challenge, one that has contributed to a marked lack of evidence for PT interventions in PC patients. This has important implications for service provision. In some countries, the funding of PT programs is dependent on the ability to prove benefit of treatment. It is likely that the lack of concrete evidence for PT, particularly in low-functioning PC patients, proves to be a barrier for referrals to PT programs.

To prove efficacy of PT interventions in PC, the outcome measure must be sensitive enough to show small treatment effects on frail patients who are on a deteriorating trajectory. The twin tasks of treating patients effectively, while also measuring treatment outcomes without adding to patient burden, are a challenging act for clinicians to balance. The authors started searching for an outcome measure in 2008 while evaluating the PT service. The resultant activities allowed the team to pragmatically evaluate the clinical usefulness of different measurement tools. It is hoped that this documented journey will assist other PT teams in deciding on a tool that best suits their individual PC service.

DESCRIPTION OF SERVICE

Palliative care in Ireland may be different from other international models of care. It is not defined by length of prognosis but rather by the needs of either patients or their family. The goal of PC is to improve the quality of life of patients and their families who are facing problems associated with a life-limiting or life-threatening illness.5 The scope of PC has extended over the last number of years, with focus on care earlier in the disease trajectory rather than solely in the last stages of life or time of death. With this change in focus, PC can often coexist with curative treatment. In Ireland, there is no distinction between PC and hospice care so that services provide a spectrum of care ranging from symptom control to end-of-life care. Another significant change in recent years is the inclusion of nonmalignant diseases in PC,5 such as neurological or cardiac disease, whereas previously it was exclusive to those with a cancer diagnosis. In Ireland, PC is organized into specialist and non-specialist services, identifying 3 levels of care provision and 3 levels of competence by health care professionals.6,7 See Table 1 for description of levels of PC specialization.

TABLE 1 - Levels of Palliative Care Specialization (NACPC, 2001:32)a
Level 1—Palliative care approach Palliative care principles should be practiced by all health care professionals. The palliative care approach should be a core skill of every clinician at the hospital and community levels. Many individuals with progressive and advanced disease will have their care needs met comprehensively and satisfactorily without referral to specialist palliative care units or personnel.
Level 2—General palliative care At an intermediate level, a portion of individuals and families will benefit from the expertise of health care professionals who, although not engaged full time in palliative care, have had some additional training and experience in palliative care. Such intermediate-level expertise may be available in hospital or community settings.
Level 3—Specialist palliative care Specialist palliative care services are those services whose core activity is limited to the provision of palliative care. These services are involved in the care of individuals with more complex and demanding needs and, consequently, require a greater degree of training, staff, and resources.
a
Adapted from Collin et al.7

Milford Care Centre is a level 3 specialist PC service in Ireland. As a level 3 service, the core activity is limited to the provision of PC. Such services are involved in the care of individuals with more complex and demanding needs and, consequently, require a greater degree of training, staff, and resources. The service is staffed by a full interdisciplinary team of highly trained professionals, with a 30-bed inpatient unit, a day unit, an outpatient department, and community-based service for a population of 361 028. The service is led by 4 consultant doctors in palliative medicine, and the team consists of physical therapists, occupational therapists, nurses, social workers, pastoral care, dietetics, speech and language therapists, complementary therapists, social and therapeutic horticulturalist, pharmacists, and music and art therapists. Physical therapy is administered to patients with rehabilitation needs, including those whose decline is expected. Supportive interventions include respiratory, lymphedema, and pain interventions, among others.4,8 Physical therapists treat patients in the inpatient unit, the day unit, as outpatients, and in their homes. Since 2008, the PT team has consisted of 7 specialist PC PT positions, involving 15 individuals who were engaged in the audit and research activities.

Field testing outcome measures were part of internal quality improvement projects and did not require ethical approval. Ethical approval was sought and granted for any published work that manipulated patient data.

OUTCOME MEASURES IN SPECIALIST PC INPATIENT UNIT

In 2008, the authors started looking for an outcome measure to assess function in PC patients before and after PT. While there were a number of functional tools in widespread medical use at the time, such as the Eastern Cooperative Oncology Group Performance Status9 and the Australian Karnofsky Performance Scale (AKPS),10 these were designed as medical prognostic tools and did not adequately reflect functional change in a PT setting. For example, the AKPS measures patient participation in daily life in increments of 10%. At 50%, a patient “requires considerable assistance and frequent medical care” and at 60% “requires occasional assistance but is able to take care of most of his or her personal needs.” A successful PT program could potentially improve a patient's mobility from requiring physical assistance of 2 to walking independently with a walker but without changing from the 50% category.

A non-systematic but widespread search was conducted for articles on PT in PC11 to search for a measurement tool. At a time when most articles were descriptive or perspective, just 3 research studies investigating PC PT were found.12–14 Of interest was the scale used by Laakso et al,14 an adjusted version of the Functional Independence Measure (FIM),15 as this had been specifically designed to measure PT input in PC patients. It measured 10 different transfers/mobility tasks but included lower-level functional tasks than the FIM to reduce the floor effect encountered. It therefore captured smaller increments of functional change observed in PC patients but had not been validated. One further measurement tool was identified in the search, the Edmonton Function Assessment Tool, Second Version (EFAT-2),16–18 a global functional tool, which was devised specifically for occupational therapists or physical therapists to use with patients in PC. It measures 10 domains, including mood, transfers/mobility, and symptoms.

After a 3-month trial using both scales, it was noted that both tools responded to clinical changes in function. Since the EFAT-2 had been validated for PC patients,16–18 it was decided to use this routinely in the inpatient unit and community services. In 2010, we conducted a 6-month retrospective evaluation of our inpatient service, using EFAT-2 to measure physical function,4 and 2 years later a similar retrospective study of our specialist PC community service.8 Results indicated that inpatients had large functional fluctuations during their inpatient admission, that mobility could improve or decline rapidly,4 and that community-based patients were generally at a higher functional level than the inpatients.8 Results also demonstrated that mobility and transfer training was almost 70% of the work carried out in both settings, although other symptoms were addressed, namely, breathlessness, respiratory function, lymphedema, pain, and psychological distress.4,8 However, while EFAT-2 captured general functional change, daily use over the 3-year period convinced the team that it was not sensitive to small functional change and the outcome of PT interventions. This was based on experienced clinical judgment rather than formal assessment, and all team members agreed. For example, providing a walking aid to enable a person to walk independently instead of requiring physical assistance of one only gains 1 point on the 30-point EFAT-2 scale. However, if a person's mobility improved because he or she received pain relief, which also reduced fatigue and improved motivation, he or she might change 6 to 7 points despite no PT intervention. Clearly, another tool was required.

OUTCOME MEASURES IN SPECIALIST PC DAY UNIT

Other functional tools were trialed in the specialist PC day unit. In 2014, a retrospective medical chart review was conducted over 6 months of community-dwelling patients attending PT in the day unit.19 The program involved weekly PT for an 8-week period. Interventions included individually tailored strength and balance exercises. Patients were evaluated before and after their program using 4 functional tools: EFAT-2,16–18 Five Times Sit to Stand (FTSTS) test,20–22 Timed Up and Go (TUG) test,23–25 and a self-devised Mobility Measure (see Table 2). The latter was devised to capture the level of independence/supervision/physical assistance patients required. Attrition occurred because of clinical deterioration of 5 patients; therefore, 54.6% of participants (n = 6) had complete data. Five of the 6 patients who completed the program showed improved function and balance, and 1 remained unchanged. All the tools recorded changes corresponding with observed functional change, with individual biases toward measuring balance, strength, or general mobility. However, this was a cohort of medium- to high-functioning patients, where it was appropriate and easy to formally test specific functional tasks, which some of the tools demanded. The researchers found clinically that the TUG and FTSTS tests, despite excellent psychometric properties, were burdensome to administer in other settings, namely, lower-functioning inpatients or in certain patients' homes. Advantages and disadvantages of all tools are outlined in Table 3.

TABLE 2 - Mobility Measure Used for Specialist Palliative Day Unit
Score Descriptor of Mobility
1 Independent
2 Supervision, no aid
3 Supervision with a cane
4 Assistance of 1 with a cane
5 Independent with a walker
6 Supervision with a walker
7 Assistance of 1 with a walker
8 Transfers only, no walking

TABLE 3 - Evaluation of Tools Used by Physical Therapists on Palliative Care Patients
Tool Description Type of Tool Purpose Advantages Disadvantages
Edmonton Functional Assessment Tool, Second Version (EFAT-2)16–18 (30 points) Measures 10 various domains, including mood, symptoms, and mobility Generic clinical rated assessment Evaluate degrees of functional performance of patients throughout the phase of illness Designed and validated for physical therapists in palliative care
Useful for low-functioning patients
Minimal burden on patients
Measures general change well
Too generic to assess small changes in function in a PT setting
Sometimes changes were independent of PT interventions
Not useful for neurological patients or those with dyspnea
Adjusted Functional Independence Measure (FIM)15 (30 points) Measures 10 functional items that the patient performs Generic functional performance based Evaluating independence in activities of daily living Designed for physical therapists in palliative care
Responded to treatment effect
Too lengthy to use on a daily basis.
Equipment required for some items a barrier to use
Too long for fatigued patients
Distress thermometer26 (10 points) NRS, measuring distress around symptoms before and after treatment Patient-reported outcome measure NRS Assessing psychological distress to assess patients' emotional and physical needs Short and quick
For patients who understood concept, it was easy to use
Difficult for those with cognitive issues or cognitive fatigue
Burdensome if more than 1 symptom involved
Awkward if using repeatedly
Patient-Specific Functional Scale27(30-50 points) Patient measures 1-10 on VAS for 3-5 different things that they are finding hard to do Patient-reported outcome measure To quantify activity limitation and measure functional outcome for patients Patient specific
Previously used for research in palliative care PT
Measures aspects of function most relevant to the patient
Cognitive task involved, so not suitable for confused or cognitively fatigued patients
Significant explanation needed
Goals and clinical issues changed too quickly to be useful when following up at next treatment
European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire (EORTC-QLQ C30)28 (30 points) 30 item self-report scale on QOL Patient-reported outcome measure Health QOL of symptoms and function Validated for palliative care patients
Easy to use
Clear instructions
Probing questions a barrier to use; some questions felt out of context
Score did not always change with obvious treatment effects
Timed Up and Go (TUG)23–25 (measurement in seconds) Time taken to rise from a chair, walk 3 m, turn around, walk back to the chair, and sit down Functional performance measure Assess a person's mobility (requires both static and dynamic balance) Quick
Easy to administer and explain
Well validated albeit not for palliative care patients
Stopwatch required a barrier to use in some settings
Repeated use can be a distressing indicator of decline
Floor effect for low-functioning patients
Five Times Sit-to-Stand (FTSTS)20–22 (in seconds) Test of an individual's ability to transition between sitting and standing 5 times in a row Functional performance measure Assesses functional lower extremity strength and transitional movements Quick
Easy to administer and explain
Well validated albeit not for palliative care
Not useful for low-functioning patients
Repeated use distressing for deteriorating patients
Resource Utilisation Group Activities of Daily Living (RUG-ADL)29 (18 points) 4-item scale measuring motor function with activities of daily living Generic clinical rated assessment Assesses dependency level; scored out of 4 domains; total score 18
Assists prognostication.
Quick
Easy to use
Part of PCOC30 battery of palliative care tools
Does not record changes with treatment unless very large
Australian modified Karnofsky Performance Status (AKPS)10 (10 points, in increments of 10%) Measure of the patient's overall performance status or ability to perform activities of daily living; single score between 10% and 100% Generic clinical rated assessment Performance as a % in 3 dimensions: activity, work, and self-care
Functional status of patients
Assists prognostication
Specifically designed for palliative care
Easy to use
Part of PCOC30 battery of palliative care tools
Not sensitive enough to record treatment effect
Mobility Measure19 (8 points) 8-point scale scored by the therapist recording levels of assistance/independence/supervision with 1 independent and 8 only able to transfer Condition-specific scale Measures mobility of patients and assistance required for the same Easy to use
No burden to patients
Can be used retrospectively
Too few items on the scale to have adequate responsiveness to change
Self-devised, not validated
One-dimensional: just assesses 1 item
A
bbreviations: NRS, numerical rating scale; PCOC, Palliative Care Outcome Collaboration; PT, physical therapy; QOL, quality of life; VAS, visual analog scale.

The Mobility Measure, while simplistic, was the easiest to administer and the least burden to the patient and the therapeutic relationship because it could be filled out retrospectively and did not require the patient to do extra tasks during the treatment.

OUTCOME MEASURES IN SPECIALIST PC COMMUNITY SERVICES

To investigate options other than functional tools, in 2015, the physical therapists in the specialist PC community services (n = 4) trialed a variety of outcome measures on their patients, each tool for a period of 1 month. These included EFAT-216–18; the aforementioned adjusted FIM15; European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire (EORTC-QLQ C30)28; the distress thermometer,26 where patients rate their distress (0-10) due to an identified symptom, for example, fatigue, breathlessness, and immobility; and the Patient-Specific Functional Scale,27 where patients rate the difficulty of doing certain self-identified activities. The latter had been used in a study on community-based PC PT.31 Questionnaires on the use of the tools were completed by the physical therapists, using a 5-point Likert scale to measure agreement with the following 3 statements:

  • The tool is easy to use.
  • It measures the effect of my treatment.
  • It does not burden the patients.

Results are presented in Table 4. Advantages and disadvantages reported by physical therapists are summarized in Table 3. The scale deemed most favorable to use was the adjusted FIM,15 previously trialed by us but discarded because of lack of validity studies. This was a functional scale in the traditional sense; however, it had too many items to be administered daily and was hard to administer to poorly functioning patients or in some patients' homes.

TABLE 4 - Evaluation of Tools Trialed in Community Services
Tool Number of Physical Therapists Assessing Max Scorea for Each Section Tool Was Easy to Use (% Agreement With Statement) It Measured Treatment Effect (% Agreement With Statement) Does Not Burden Patient (% Agreement With Statement) Total Score (% of Full Score)
Edmonton Functional Assessment Tool, Second Version (EFAT-2)16–18 4 20 19 (95%) 7 (35%) 19 (95%) 45 (75%)
European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire (EORTC-QLQ C30)28 3 15 11 (73%) 5 (33%) 11 (73%) 27 (60%)
Adjusted Functional Independence Measure (FIM)15 3 15 13 (86%) 12 (80%) 12 (80%) 37 (82%)
Distress thermometer26 3 15 15 (100%) 8 (53%) 10 (66%) 33 (73%)
Patient-Specific Functional Scale27 3 15 5 (33%) 2 (13%) 5 (33%) 12 (26%)
a
Likert scale: 5 = totally agree; 4= somewhat agree; 3 = neither agree or disagree; 2 = somewhat disagree; 1 = totally disagree.

TREATMENT VERSUS MEASUREMENT

These findings highlight a fundamental issue of working with PC patients. The duty of care of clinicians is to conduct an appropriate intervention, while the measurement of that intervention may be just as important for service providers. These 2 aspects of care are often in direct conflict during a care episode. For example, an extremely fearful patient has been referred to the PC team. He finally agrees reluctantly to attend only PT, as he has mobility problems and it has perceived links with rehabilitation and provides hope. The physical therapist is aware that they have one chance of providing a positive experience of PC or that the client may not return. Do they then run a battery of tests, known to carry some patient burden, to objectively measure the treatment effect, thereby risking further patient anxiety and the patient-therapist relationship? Or, do they provide the intervention, including psychological support, with measurement as a secondary aspiration, perhaps at a later time? In addition, using defined tasks, for example, the FTSTS test,20,22 and measuring repeatedly over time brings ethical dilemmas, as once terminal progression starts, measurement is simply highlighting deterioration to the patient, which can be unnecessarily distressing. Another problem area encountered is cognitive fatigue and cognitive impairment. Performance-based measures under specific conditions with participants who may not have the cognitive ability to follow the directions required can affect the reliability and validity of such measures.32

In the authors' opinions, the burden to patients and/or the therapeutic relationship is one of the most important factors in determining the clinical utility of an outcome measure in PC PT, alongside its responsiveness to change. Furthermore, considering high rates of attrition for formal research projects, the authors argue that a user-friendly tool in daily use may well further the evidence base for PC PT just as much as using one with excellent psychometric properties, which is only suitable for use in research trials. An ideal outcome measure should satisfy both clinical and research requirements for measuring the evolving field of PC PT.32

INITIAL DEVELOPMENT OF A FUNCTIONAL MEASUREMENT SCALE

Limitations to the currently available outcome measures led the authors to conclude that the tool required to measure function in PC patients does not, in fact, exist and needs to be developed. Based on the findings outlined earlier, our aim is to devise a measure that has the following properties:

  1. Measures traditional functional tasks and is sensitive to small functional changes.
  2. Is easy to use for physical therapists to reduce barriers to its routine utilization on a daily basis.
  3. Is short, as fatigue levels are a frequent limiting factor.
  4. Does not ask the patients to perform any extra tasks during a PT assessment, apart from routine items.
  5. Does not impact on the patient-therapist interaction.
  6. Can be used retrospectively. The chance to measure function is frequently opportunistic, unexpected, and not always at a convenient time (eg, a patient in bed requests to go to toilet). Therefore, the need for equipment, such as a stopwatch or a step, has to be negated.
  7. Can be used in different service settings: inpatient, outpatient, and in a patient's home.
  8. Is able to capture a wide range of functional capacity, ranging from fully functional patients to those almost bedbound.
  9. Can respond within 1 treatment session to changes in function, for example, giving a walking frame to increase independence.
  10. Does not require lengthy explanations or cognitive tasks.

The team has started the process of developing a functional tool that fulfills all the aforementioned criteria. The next step is to marry this process with input from content experts to ensure adequate psychometric properties so that it can be used for research purposes.

THE FUTURE OF OUTCOME MEASUREMENT IN PC PT

Internationally, there is a drive toward the use of multidisciplinary outcome measures that can be compared between services and countries. Murtagh et al33 describe such a collaboration using the Integrate Palliative Care Outcome Scale. In Ireland, the authors' workplace uses the Palliative Care Outcome Collaboration (PCOC)30 battery of tests to measure clinical changes in the physical, spiritual, and psychosocial domains of patients during the evolving phases of disease (stable, unstable, deteriorating). However, the functional elements of the PCOC, namely, the AKPS10 and the Resource Utilisation Group Activities of Daily Living (RUG-ADL) score,29 do not adequately measure treatment effect of PT. Therefore, these multidisciplinary developments do not negate the need for a PT-specific functional measure.

We believe that a functional measurement will be useful as the primary outcome measure of PT interventions on PC patients or as an adjunct to symptom-specific scales, for example, balance, breathlessness, and lymphedema scales. In addition, for patients who can cognitively engage with goal setting, the development of the Goal Attainment Scale–Light (GAS-Light) scale34 is an exciting development for PC physical therapists. It is a method of scoring the extent to which PC patients achieve their goals and evaluates the meaningful benefit from rehabilitation services in PC.34 Furthermore, the development of a satisfaction scale specific for PC PT would be welcome.

Having a usable functional scale will empower PC physical therapists, both generalist and specialist, to evaluate the effectiveness of their treatments and to determine which cohorts benefit from intervention or not. It may also allow researchers to examine the complex relationship between declining physical function and movement between phases of illness (stable, unstable, deteriorating) while still attaining certain rehabilitation goals.

LIMITATIONS

As our PT team conducts research alongside a full patient caseload, our assessment of tools was, at times, not based on formal research methods but rather on experienced clinical judgment. Since clinical judgment guides us in our ethical decision-making regarding burden to patient and treatment choices, the authors argue that this is still valuable information until more robust methods are employed. Similarly, our efforts to evaluate tools have been based on the urgent need to find an outcome measure, rather than to conduct strong research; therefore, the number of physical therapists evaluating the scales was too small (varying from 3 to 12) for our findings to be accepted globally. However, since our service is a specialist service, with expert and experienced staff members, the authors still consider the findings to be extremely relevant.

CONCLUSION

Physical therapy for PC patients, including palliative rehabilitation, can involve complex interventions that result in incrementally small but important benefits for patients. The measurement of these benefits remains challenging due to lack of clinically usable outcome measures. This review article details research and quality assurance projects undertaken by an Irish specialist PC PT service over the past decade, which resulted in trialing a number of currently available outcome measures. All of these were found to lack important qualities, including ease of use and responsiveness to change for PC settings. Work has now started on devising a new functional tool to address these shortcomings. We are optimistic that PC physical therapists will have a choice of measures to use in the coming years in order to evaluate their input in both specialist and generalist PC PT.

ACKNOWLEDGEMENT

The authors thank all the physical therapists who have been working in Milford Care Centre that has piloted various tools and their contribution to the development of an outcome measure in specialist PC. The authors also thank their patients, past and present, who provide them with this opportunity to learn.

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Keywords:

clinician research; physical therapy effectiveness

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