Interview results
The initial two questions relating to the “frequency” and “duration” of episodes of arrhythmia were reported by all initial interviewees as difficult to distinguish between, and the word “duration” was not well understood. Patients felt that “length” (of arrhythmia attacks) was a better option, and suggested, the words “frequency” and “length” were typed in bold capitals with a short descriptive sentence for each, i.e. “how often they occur” for frequency and “how long they last” for length [
19,
20]. Following these updates, no problems were encountered on these questions in subsequent interviews.
The two parts of question 3 (what do) “you expect to happen to your tiredness and breathlessness” were generally well understood, but several suggestions were made to improve the layout. These included making key words stand out by using uppercase or bold lettering. Some of the first patients interviewed also stated that while they expected symptoms such as tiredness and breathlessness to potentially worsen immediately after the procedure, they would expect them to improve in the longer term. This led to the subjects requesting that the phrase “after you have recovered from the procedure” be added to these and the previous questions to clarify the time frame under discussion. These changes during the initial stages of the study resolved issues with this field.
The following two questions (Questions 4 and 5) relating to past procedures did not cause any confusion to the participants, and were easily understood requiring no adaptation. Discussion of Question 6, a table of symptoms suggested that no items were redundant, but some new areas were identified for inclusion. This led to five additional items, while terms used in five existing fields were expanded to fully describe symptom variations (Table
2). This ensured that symptoms important to patients such as anxiety, tiredness and difficulty sleeping were included.
Table 2
Amended post interview question 6 table (amendments in bold)
Palpitations/fast or irregular heartbeats | 0 | 1 | 2 | 3 |
Heart flutters | 0 | 1 | 2 | 3 |
Extra heart beats/missed heart beats
| 0 | 1 | 2 | 3 |
Fatigue/no energy | 0 | 1 | 2 | 3 |
Dizziness/light-headedness/feeling faint
| 0 | 1 | 2 | 3 |
Hard to catch breath/short of breath
| 0 | 1 | 2 | 3 |
Chest pressure as heart is racing | 0 | 1 | 2 | 3 |
Headache/migraine
| 0 | 1 | 2 | 3 |
Trouble concentrating | 0 | 1 | 2 | 3 |
Neck pounding/neck pain/neck discomfort
| 0 | 1 | 2 | 3 |
Passing out/fainting/blackouts
| 0 | 1 | 2 | 3 |
Trouble sleeping
| 0 | 1 | 2 | 3 |
Tiredness/sleepiness
| 0 | 1 | 2 | 3 |
Nausea/vomiting
| 0 | 1 | 2 | 3 |
Anxiety/fear/worry
| 0 | 1 | 2 | 3 |
Feedback related to Questions 7 and 8, discussing how often episodes of palpitations occur and how long they last, suggested that patients would naturally indicate more than one answer. This was clarified by specifying that only one could be chosen. Whilst feedback suggested this would not always resolve the issue, patients felt that it would help in most circumstances. Wording was also updated to reflect that the PROM team wanted feedback relating to the “usual” frequency and length of attacks. Several participants felt that the maximum duration of palpitations of 1 hour was inadequate, and following expert clinical input, the options were updated to reflect those patients with longer lasting episodes of arrhythmia. While some patients also felt that they would like a free-text option, or wider choice for the frequency of attacks, it was considered impractical to expand the options further without impacting on the wider PROM design, while free-text would require interpretation by a third person.
Question 9 (impact on social activities in the last 30 days) was appropriate to subjects, while Question 10 (work/school/college days affected) was problematic only for those patients in voluntary work or acting as care-giver. Wording was subsequently inserted in the instruction to assert that these roles should be included. The three questions were reordered with work being placed first, and in each of the three, a “not applicable” option was added as some interviewees felt this was a more appropriate response in some instances. Several subjects felt that the time period of 30 days was too short a time period for consideration, as they noted that arrhythmia patients often have “good” and “bad” months, and a 30 day cut off may not give a full representation. However, overall, participants felt that this was a suitable time period and was not too difficult to remember, while a longer time frame could lead to recall issues.
The draft PROM (v 2.0) asked patients to specify the number of times they had needed to visit their GP/Hospital in the 30 days prior to the procedure. Several patients felt that this should be two separate questions, with some noting that the costs of the two services are very different. The question was subsequently modified in version 3.0 to reflect this feedback.
The table of questions (Q13) relating to impact on life produced numerous comments, with many suggestions for additional items. While some of these were suggested by only one patient, several themes were recurring, and four fields were subsequently added. These were: i) impact on sport and leisure activities; ii) impact on family and friends; iii) reduced confidence, and iv) financial impact (due to time off work, childcare costs etc.). All existing fields were felt to be appropriate, with the only additional change being to alter “Disagree” to “Not Applicable” as a column header.
The new fields which had been added to the PROM to gather data on arrhythmia medication and concomitant illnesses were generally well accepted, with only slight changes required to the wording to reiterate that only arrhythmia related drugs were to be listed and to clarify that the illnesses listed could be caused by their arrhythmia, but were for background purposes only. As the pre and post-procedure PROMs are very similar, issues were generally the same for the post-procedure tool as for the pre-procedure tool, with one main difference whereby Question 2 (relating to the duration of palpitations) was updated to add a “Stopped” option, as participants felt that this was clearer than asking patients to omit the question if not applicable.
Regarding complications, several patients reported that they had not been warned of the possibility that the arrhythmia could get worse following ablation. This is not classed as a clinical complication, and as symptom severity is included elsewhere in the tool, it was not added to the PROM as a separate field in the complication table.
All participants felt that the layout of the final drafts of the pre and post procedure questionnaires [
19,
20] were good, and the font size clear and easy to read. The current version of the PROMs are available online at:
http://www.cedar.wales.nhs.uk/ccap. Other than the changes discussed, the questions were correctly interpreted by patients with very few issues. Overall subjects commented that they felt the tool was highly comprehensive and covered all relevant areas, with clear instructions throughout.