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The Functional Difficulties Questionnaire: A New Tool for Assessing Physical Function of the Thoracic Region in a Cardiac Surgery Population

Sturgess, Tamica R., MPhysio1,2; Denehy, Linda, PhD2; Tully, Elizabeth A., PhD2; McManus, Margaret, Grad Dip Advanced Nursing Practice3; Katijjahbe, Mohd Ali, MPhysio2; El-Ansary, Doa, PhD2

Cardiopulmonary Physical Therapy Journal: July 2018 - Volume 29 - Issue 3 - p 110–123
doi: 10.1097/CPT.0000000000000074
Research Report
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Purpose: There is a paucity of functional outcome measures that specifically target the thoracic region and none that are specific for use in people following cardiac surgery. The aim of this study was to develop a functional questionnaire for this purpose and investigate its psychometric properties.

Methods: Participants who underwent cardiac surgery were included in this single-site, observational study (part A, n = 38 and part B, n = 25). The investigators developed a 13-item Functional Difficulties Questionnaire (FDQ) informed by the literature, theory, and clinical practice. The questionnaire and measures of physical function, pain, and health-related quality of life (HRQOL) were completed at 4 time points by 38 participants to investigate internal consistency, convergent validity, and responsiveness to change of the FDQ (part A). A different group of 25 participants completed the questionnaire twice within a single day to investigate test–retest reliability, and minimal detectable change (MDC) was calculated (part B).

Results: The questionnaire showed good internal consistency (Cronbach alpha coefficient = 0.971); moderate to good correlation with assessments for HRQOL 3 months postoperatively (rho = 0.54–0.65 for 5 36-Item Short Form Health Survey subscales) and total pain at all postoperative time points (rho = 0.55–0.69); a responsiveness to change with significant differences in scores across time (Χ2 [3, n = 38] = 41.37, P ≤ 0.0001); and excellent test–retest reliability (intraclass correlation 0.918). The MDC was 16.35 cm out 130 cm.

Conclusions: The FDQ is an appropriate functional outcome measure specific to the thoracic region for people after cardiac surgery. It may also be suitable for use by clinicians and researchers assessing the thoracic region within other surgical or medical populations, and this warrants further investigation.

1Department of Physiotherapy, Monash Health, Monash Medical Centre, Victoria, Australia

2Department of Physiotherapy, The University of Melbourne, Victoria, Australia

3Cardiology, Rehabilitation and Outpatients, Canberra Hospital, Australian Capital Territory, Australia

Correspondence: Tamica R. Sturgess, MPhysio, Physiotherapy Department, Monash Health, Monash Medical Centre, 246 Clayton Road, Clayton 3138, Victoria, Australia (tamica.sturgess@monashhealth.org).

The authors declare no conflicts of interest.

Clinical trial registration number: This trial received ethics approval from the Southern Health Human Research and Ethics Committee (project number 06071B) and is registered with the Australian Clinical Trials Register (ACTRN012606000430538).

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INTRODUCTION AND PURPOSE

Cardiac surgery procedures performed through sternotomy incisions are well-established surgical treatment options for coronary heart disease.1 Despite improvements in survival with advances in cardiac surgery, people requiring cardiac surgery present with increasing age and comorbidities.2 As a result, there is a growing interest in quantifying patient-reported outcomes such as quality of life3 and functional performance that impact recovery after cardiac surgery.1 It is widely accepted that the mechanical and physiological demands of cardiac surgery result in musculoskeletal problems that impact function in a significant number of these people postoperatively.4–7 It has been reported that overall surgery-specific symptoms may remain beyond 12 months, impacting recovery and resumption of the role within the community.8–10 Chronic poststernotomy pain is a well-recognized phenomenon.8 Research has found that 56% of people after cardiac surgery experience new onset, nonanginal chest wall pain at least 3 months postoperatively, and 72% of these people report that this pain interferes with daily activities.11 Chronic poststernotomy pain has also been found to be associated with a poor quality of life.12

A validated outcome measure, suitable for a population after cardiac surgery performed through a sternotomy incision, and which addresses the thoracic region and assesses global physical function, currently does not exist. However, numerous specific functional difficulties reported by people in the early postoperative period have been described in the literature.13–15 These activities are representative of everyday tasks that challenge the thoracic cage such as changes in position when supine, lying on the side, getting in and out of bed/chair, coughing, sneezing, bending, and reaching.13–15

The aim of this study was to develop a Functional Difficulties Questionnaire (FDQ) specific to the thoracic region for patients after cardiac surgery and to evaluate its psychometric properties, including internal consistency, convergent validity, responsiveness to change, test–retest reliability, and minimal detectable change (MDC).

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METHODS

Development of the Functional Difficulties Questionnaire

The FDQ was developed based on literature findings, clinical practice, and kinematics. The FDQ comprised 13 separate functional tasks, selected by the investigators, which are necessary in everyday life and involve movements associated with the thoracic region. These tasks included upright sitting, walking with arms swinging freely, coughing/sneezing, rolling over in bed, getting out of bed, washing hair, scratching the back, picking up an object off the ground, turning to reach backward, doing the clasp of a bra or tucking in a shirt at the back of pants, putting on a dressing gown/cardigan/jacket, drying the back with a towel, and pushing a set of drawers shut.

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Administering and Scoring the Functional Difficulties Questionnaire

The FDQ is a paper-based questionnaire that contains generic instructions for completion. After reading these, participants rated the 13 separate tasks on unmarked 10-cm visual analog scales (VAS) according to the level of difficulty experienced when completing each task. The VAS end points were “no difficulty” and “maximal difficulty”; refer to Appendix 1. The therapist was present to assist in completion of the questionnaire, in accordance with a standardized administration protocol (Appendix 2). Individual VAS scores, measured to the nearest millimeter, were then aggregated to form a total of a possible 130, with higher scores representing greater difficulty experienced during functional activities. If the participant was unable to complete a particular task, it was automatically scored as a 10 to indicate maximal difficulty.

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Psychometric Properties of the Functional Difficulties Questionnaire

Participants from a single hospital who underwent cardiac surgery through a sternotomy incision were included in this study. They were eligible for inclusion if they underwent any cardiac surgery procedure performed through a sternotomy incision and were able to provide consent. Exclusion criteria included an inability to comprehend written and spoken English, a physical limitation preventing assessment/exercises, or a length of stay in the intensive care unit for 5 days or more due to medical reasons (part A). Withdrawal criteria (part A) included postoperative wound infections or sternal instability as diagnosed by medical staff.

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Part A: Internal Consistency, Convergent Validity, and Responsiveness to Change

Data were collected from 38 participants enrolled as part of a previously published, assessor-blinded, parallel group pilot randomized controlled trial that investigated the effect of thoracic mobilization exercises after cardiac surgery performed through a sternotomy incision.16 Sturgess et al16 conducted this trial over a 10-month period at a large tertiary public hospital in Australia with a well-established cardiothoracic surgery unit. As part of this pilot study, the newly developed FDQ and measures of health-related quality of life (HRQOL) (assessed using the 36-Item Short Form Health Survey [SF36] version 2), pain (assessed using VAS), functional mobility (assessed using the timed up and go [TUG] test), and range of movement (ROM) (assessed using digital image analysis) were collected at 4 time points. These were preoperatively, postoperatively before discharge from the hospital, 4 weeks after discharge, and 3 months postoperatively.

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Part B: Test–Retest Reliability and Minimal Detectable Change

Data were collected for reliability analyses from a single-site, prospective observational study. Test–retest reliability was assessed over 8.5 months in 25 participants within the same tertiary institution in part A; however, they were not involved in part A. The FDQ was administered twice between 2 and 4 hours apart, and at least 30 minutes after analgesia, by a physical therapist who had received a 1-hour training session regarding safety elements and administration of the FDQ, as per a protocol (Appendix 2). Sample size calculations for test–retest reliability were based on an expected intraclass correlation coefficient range of 0.700 to 0.900. A minimum of 19 participants were required to achieve a power of β = 0.20, with a significance level of α = 0.05.17

Studies were approved by the hospital's Human Research Ethics Committees and were registered with the ACTR (Registration number ACTRN012606000430538).

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Data Analysis

Data were analyzed using the SPSS Graduate Pack version 16.0 for Windows and SPSS Windows Version 23.0 (SPSS Inc., Chicago, IL). Normality of the FDQ data was assessed using visual examination, obtaining skewness and kurtosis values and the Kolmogorov–Smirnov statistic, and was considered skewed if the Kolmogorov–Smirnov statistic was <0.05.

For part A, the FDQ's internal consistency (Cronbach α) was assessed using test scores from all repeated tests over time. Convergent validity was assessed by examining the relationship between FDQ scores and results of the SF36, pain, TUG, and ROM using Spearman rank-order correlation testing for results for the 3 postoperative time points. The FDQ's responsiveness to change was investigated using a repeated measures design and all 4 time points. As the FDQ data were not normally distributed, the Friedman test was used and post hoc testing was conducted using the Wilcoxon signed-rank test to assess which time points were significantly different from each another.

Within part B, test–retest reliability was assessed. Intraclass correlation model (2,1) for single raters and similar raters were used. A Bland–Altman plot was also developed to investigate the limits of agreement and identify any systemic error in the mean of the overall FDQ between tests.18 A “clinical applicability” index, the MDC, was also calculated. The MDC represents the smallest change in score needed to reflect a clinically meaningful change in function19 and derived using the following formula MDC95 = 1.96 × √2 × SEM.20 The SEM was estimated by taking the square root of the within-subject variance (from test–retest result).

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RESULTS

The mean age ± SD of the overall study sample was 62 ± 11 years and comprised 64 (69%) men. Sixty-six participants (71%) underwent a coronary artery bypass grafting procedure, 21 (23%) a cardiac valve repair/replacement surgery, and 5 (5%) a combination of these. The remaining participant underwent a ventricular septal defect repair. In part A, there were missing data for one participant at the final time point, and another participant for the final 2 data collection time points. There were no adverse events resulting from the study. The flow of participants through part A and part B is given in Figures 1 and 2, respectively.

Fig. 1

Fig. 1

Fig. 2

Fig. 2

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Part A

Internal Consistency

The Cronbach alpha coefficient of the FDQ was 0.971; refer to Appendix 3 for full FDQ individual item and overall questionnaire results for each participant.

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Convergent Validity

Before discharge postoperatively, there was a moderate to good correlation17 between FDQ scores and SF36 vitality, SF36 mental health, sternal pain, and total pain. There was moderate to good correlation with thoracic pain, total pain, and SF36 bodily pain at 4 weeks after discharge and with total pain, SF36 role physical, SF36 bodily pain, SF36 general health, SF36 vitality, and SF36 social function at 3 months after discharge; refer to Table 1.

TABLE 1

TABLE 1

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Responsiveness to Change

There were significant differences in the FDQ scores across time for all participants (Χ2 [3, n = 38] = 41.37, P ≤ 0.0001), as given in Figure 3. Post hoc tests revealed a significant increase in FDQ score from preoperative assessment to postoperative assessment, followed by a significant decrease postoperatively to 4 weeks after discharge and again from 4 weeks after discharge to 3 months after operation. Three months postoperative FDQ scores were not significantly different from baseline scores. Results are summarized in Table 2, and Appendix 3 includes full FDQ data.

Fig. 3

Fig. 3

TABLE 2

TABLE 2

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Part B

Test–Retest Reliability

The test–retest reliability of the mean of overall FDQ score was intraclass correlation (2,1) 0.918 and SEM 5.9 points of a possible total score of 130 on the FDQ. This indicates excellent reliability.21 The Bland–Altman plot revealed that there was little difference between tests. Specifically, all the plot's points fell within 1.96 SD of the mean FDQ scores, except for 1; refer to Figure 4.

Fig. 4

Fig. 4

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Minimal Detectable Change

The MDC for the FDQ score was 16.35 of 130 (in cm), which represents the threshold to detect change beyond that of random error.

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DISCUSSION

This study investigated the development of a new questionnaire, the FDQ, which is specific to the thoracic cage and assesses functional outcomes after cardiac surgery. Our findings demonstrate that the FDQ is an appropriate tool for this purpose, and that those undergoing cardiac surgery procedures can safely and effectively complete it preoperatively and postoperatively. The FDQ is adaptable in nature, making it particularly suitable in the acute postoperative phase. Each of the component tasks is based on tasks that are completed on a daily basis, and so if individuals are unable to complete the task at the time of assessment (e.g. secondary to fatigue), they can base their response on the last time they completed it.

The FDQ was developed as literature has highlighted that people experience difficulties with functional tasks that challenge the thoracic cage and upper limbs after cardiac surgery. Its content was devised based on these scientific publications1,4,22 and clinical practice within this population. It was also informed by kinematics of the thoracic region, resulting in the identification of 13 items for inclusion within the tool. This study demonstrated that the FDQ has good internal consistency,23 with a Cronbach alpha coefficient of 0.971. If component tasks were deleted from the questionnaire, Cronbach alpha values were assessed, but no single item yielded a value greater than 0.971, thus indicating that each item of the questionnaire related to every other item and to the instrument as a whole.21

The FDQ displayed moderate to good correlations with measures of pain and HRQOL. After operation, before hospital discharge assessment, there were moderate to good correlations between SF36 vitality and mental health domains, in addition to shoulder pain, sternal pain, and total pain. All other aspects of HRQOL and pain variables displayed a fair relationship. The strongest correlations at this time point were found between the FDQ and sternal pain and total pain scores (r = 0.60, r = 0.69 respectively). Arguably, sternal pain and total pain are 2 of the most significant symptoms after cardiac surgery. Both display proportionally larger changes in scores across time after cardiac surgery compared with other assessments. Furthermore, thoracic mobilization exercises have been shown to significantly decrease sternal pain at the 4-week postdischarge review.16

Correlations with HRQOL early after operation were stronger with vitality, mental health, and role emotion domains compared with the physical SF36 domains of role physical and physical function. This may be accounted for by the more general nature of the SF36 physical components, which may be less relevant in the early postoperative phase. Alternately, this discrepancy may indicate the holistic approach of the FDQ, whereby functional difficulty is not only dependent on physical capabilities, but also on emotional and mental aspects at this time point. This is an important finding, as up to half of people after cardiac surgery report depressive symptoms,24 which are associated with a slow recovery and worse functional status.24–26 Furthermore, researchers have found an interdependence between physical and psychological wellbeing,26 and so although each of the FDQ tasks is physical in nature, the subjective rating scale may be influenced by these factors.

Assessments conducted 4 weeks after discharge demonstrated the strongest associations between various measures of pain (SF36 bodily pain r = 0.51, thoracic pain r = 0.52, and total pain = 0.68). Interestingly, although there was ongoing moderate to good correlations between the FDQ score and total pain (r = 0.55) when assessed 3 months after operation, other measures of pain demonstrated only a fair degree of relationship20 and were much stronger with SF36 items role physical, bodily pain, vitality, and social function (r = −0.63 to −0.65). General health (r = −0.54) also showed a moderate to good correlation. This supports that the FDQ not only measures pain, and after people recover from the early effects of surgery it also assesses HRQOL.

The weaker correlations between the FDQ and ROM/TUG across all assessments indicate that people's functional status after cardiac surgery is more closely associated with pain and HRQOL aspects as opposed to ROM or functional mobility. Although these correlations do not contribute substantially to the convergent validity, they do perhaps highlight the notion that the FDQ is measuring a domain of function that is not currently measured by the existing tools. The investigators reviewed upper extremity questionnaires and tools before developing the FDQ because of the close relationship between pain and range of movement of the thoracic spine and shoulder.27–29 Although these questionnaires contain elements that would be applicable to patients having cardiac surgery through a sternotomy incision, no single tool provided a comprehensive assessment for the thoracic region. For example, tasks such as coughing/sneezing and getting in/out of bed are more specific to the thoracic region and are not found in upper extremity–based tools.30,31 Furthermore, some tasks within the upper extremity tools (e.g. writing, recreational activities which require little effort, such as knitting)30 are unlikely to be relevant for people after cardiac surgery.

The FDQ displayed a responsiveness to change, with significant changes in scores over time. The responsiveness was highest between preoperation to the time of discharge postoperation and the time of discharge from hospital postoperatively to 4 weeks postoperatively, which co-relates with the time where most people report sternal pain and difficulty performing functional tasks during recovery from the surgical procedure.16

The FDQ has excellent test–retest reliability (ICC 0.918),21 and so this inexpensive tool can be effectively completed and easily administered in the clinical setting with little training required. The Bland–Altman plot revealed little variability between tests. The MDC of 16.35 cm indicates that the difference in FDQ scores from preoperatively to before hospital discharge postoperatively and before hospital discharge to 4 weeks postdischarge are not only statistically significant but also clinically meaningful.

Functional assessments after cardiac surgery are of importance to comprehensively evaluate outcomes, and so this tool has an important purpose both clinically and in research. The FDQ may be of use to evaluate effectiveness of other research and interventions in people undergoing cardiac surgery, as well as other groups, such as those after thoracic surgery.

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Study Limitations

A major limitation in establishing validity of the FDQ is that there is no true gold standard for function of the thoracic region to act as a comparison for concurrent validity. Furthermore, there was a lack of any tool specific to the thoracic region and suitable for use in people having cardiac surgery through a sternotomy incision. This includes upper extremity questionnaires and tools. Future research comparing the FDQ with other upper extremity tools may be of interest.

The FDQ was developed in Australia, and so there are cultural differences in language between Australia and the United States, for example dressing gown versus robe, cardigan versus sweater, which are component tasks within the FDQ. As such, the tool may require modifications to accommodate cultural and linguistic variations.

Functional Difficulties Questionnaire assessments for test–retest reliability were separated by as little as 2 hours. This was a necessary compromise between research and practicality requirements, as some assessments occurred within a busy acute hospital and often on the day of discharge. This is the time when patients have reviews by a number of health professionals (e.g. pharmacist, nursing, medical, and allied health), in addition to getting themselves ready for home. A longer time separation between assessments posed a risk to delaying patient flow within the hospital by delaying discharges, or missing assessments altogether. However, there was the possibility that individuals may have remembered how they initially scored the FDQ, and this could impact on the test–retest reliability results. Intuitively, it would seem that markings made on a VAS would be less likely to be remembered than other forms of scoring, such as Likert scales, and the volume of activity before discharge may have minimized this likelihood.

It is possible that pain may have had an impact on FDQ scores between tests for the test–retest reliability study. Therapists ensured individuals had received charted analgesia, and that this had occurred at least 30 minutes before commencement of the FDQ; however, it is still possible that variations in pain levels may have occurred and this is a limitation of the study.

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CONCLUSION

The FDQ is a reliable, responsive, and valid tool and it has demonstrated good internal consistency in the cardiac surgery population. It may be suitable for use by clinicians and researchers investigating the thoracic region, as there is no alternative tool that specifically evaluates physical function or the effectiveness of interventions in this area. As such, the FDQ warrants further investigation in varied surgical and medical populations.

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ACKNOWLEDGMENTS

The authors acknowledge Alexandra Cain, who assisted with data collection for part B.

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Functional Difficulties Postcardiac Surgery Questionnaire

Please mark on each of the lines below the level of difficulty that you experience when completing each of the following tasks. Make sure you read each question fully, as it will explain to you the exact way in which the task has to be completed.

Feel free to try any of the activities (where appropriate) while you are completing the questionnaire. For those activities you cannot trial whilst filling out the questionnaire, think back to the last time you did them.

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Functional Difficulties Questionnaire Postcardiac Surgery Outcome Measure Protocol Equipment:

  1. Desk/table
  2. Pen
  3. Chair
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Set up:

  1. Subject sits at a desk/table to complete the survey
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Procedure:

  1. Questionnaire is given to subject
  2. Subject reads questionnaire
  3. Verbal instructions given by clinician/researcher on how to complete the questionnaire
  4. Subjects can ask any questions
  5. Subject completes questionnaire
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Instructions to Subject:

  1. For each activity listed, you need to place a mark on the line which corresponds to how much difficulty you experience when completing the task
  2. (Demonstrate to subject)
    1. If you experience no difficulty at all, your mark will be at the far left hand side of the line
    2. If you experience maximal difficulty, your mark will be at the far right hand side
    3. You can place the mark anywhere along the line, which you feel represents how much difficulty you experience
  3. Feel free to try any of the activities, where possible, to help you fill out the questionnaire
  4. For the activities that you cannot try now, think back to the last time you did them
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Clinician/Researcher Feedback:

  1. The clinician/researcher will redirect the subject if they do not place a single, vertical mark on the line. The following redirection will be provided:
    1. In the event a mark is not placed on the line, the clinician/researcher will direct as follows, “You need to place your mark somewhere along this line. At this end (demonstrating) it means you experience no difficulty at all, and it gradually increases as you move along the line, so that at this end (demonstrating) it means you experience maximal difficulty.”
    2. In the event the mark is not vertical, the clinician/researcher will direct as follows, “You need to place your mark as a line running top to bottom, like this (drawn demonstration).”
    3. In the event, several marks are placed on the line for a single task, the clinician/researcher will direct as follows, “You can only place a single mark somewhere along this line. Choose how much discomfort you experience when you complete the task now/when you last completed the task (dependent on the task).”
  2. If the subject reports they cannot complete the task the researcher will score the task as a 10, to indicate maximal difficulty.
  3. Verbal feedback otherwise:
    1. Just place the mark where you feel is appropriate
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Participant FDQ Full Results, Across All 4 Time Points, Used for Determining Internal Consistency and Responsiveness to Change

Table

Table

Table

Table

Table

Table

Table

Table

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Keywords:

cardiac surgery; sternotomy; physical therapy; outcome measure; function; thoracic region

© 2018 Cardiovascular and Pulmonary Section, APTA