Botulinum toxin skeletal muscle injection treatment is long-lasting and monitored dependent on individual effects (Mancini et al., 2005; Bakheit et al., 2010). Problems such as pain, co-contraction, spastic dystonia, flexor spasms, etc. triggered by muscle overactivity/spasticity often have a huge impact on the individual’s quality of life (QoL) (Hefter et al., 2012; Milinis et al., 2016). Accurate and detailed reporting of these effects is therefore crucial (Bakheit et al., 2010). Often, several health care professionals are involved in the patient’s treatment and important information is easily lost (Demetrios et al., 2013). A patient diary may increase the patient’s awareness of problems triggered by muscle overactivity and may help the patient to evaluate the treatment better. This should result in more appropriate treatment goals for the individual patient and ultimately lead to higher QoL. In addition, the diary may lead to a closer collaboration between physiotherapists, occupational therapists, and the physician injecting the botulinum toxin, leading to common goals and final optimization of the treatment.
Patient diaries have been used in various neurological fields, including headache (Russell et al., 1992, 1994; Allena et al., 2012; Seidel et al., 2012; Stinson et al., 2013; Larsson and Fichtel, 2014; Barmettler et al., 2015; Heyer and Rose, 2015; Pasek et al., 2015), epilepsy (Le et al., 2011; Haut et al., 2013; Cobabe et al., 2015; Fisher et al., 2015), sleep, other pain, etc. (Le et al., 2011; Jacob et al., 2012). Several of these have been in the form of electronic diaries (Haut et al., 2013; Stinson et al., 2013; Barmettler et al., 2015; Pasek et al., 2015), including on-line (Fisher et al., 2015), web-based (Le et al., 2011) through the internet (Heyer and Rose, 2015), on-palm device (Allena et al., 2012), and smartphone (Jacob et al., 2012).
The prospective paper diary has been compared with a retrospective questionnaire for headache, and the results suggested that more valid and reliable results would be obtained using the prospective diary (Larsson and Fichtel, 2014).
The aim of this pilot study was primarily to develop a diary that constantly follows the patient in treatment with botulinum toxin skeletal muscle injections for spasticity.
Methods and results
Content of the treatment diary (Appendix)
- Problems triggered by skeletal muscle overactivity.
- Agreed goals for treatment and the patient’s continuous self-evaluation of achievement of objectives on the Goal Attainment Scale (Turner-Stokes, 2009).
- Which skeletal muscles were injected and the botulinum toxin dose administered.
- Physiotherapists’ and occupational therapists’ evaluation of the patients’ achievement of objectives on the Goal Attainment Scale as well as proposals for optimization of treatment and changing goals.
Development of the treatment diary
- A focus group with physicians, a physiotherapist, a nurse, and a representative from Allergan Pharmaceuticals discussed the primary elements to be included.
- Inspiration was gained from meetings with therapists from rehabilitation centers.
- The first version was developed.
- This edition was presented to a focus group. Because of the feedback, some of the formulations were changed to make them more easily understandable.
A protocol for a Pilot study was submitted to the National Committee on Health Research Ethics and it was approved by the Danish Data Protection Agency (GLO-2014-30, I-suite 02998).
The pilot study enrolled ten patients after their oral and written informed consent was obtained. The evaluation also included the use of the Danish translations of the WHO-QoL BREF (http://www.cure4you.dk/960/WHOQoL-Bref%20-%20dansk.pdf; http://depts.washington.edu/seaqol/docs/WHOQOL-BREF%20with%20scoring%20instructions_Updated%2001–10–14.pdf) and the WHO-5 well-being score (https://www.psykiatri-regionh.dk/who-5/Documents/WHO5_Danish.pdf; Topp et al., 2015). These were to be completed before and after the use of the diary over an ~3-month period between two botulinum toxin injection cycles. The patient and the therapist were asked to fill in a questionnaire on the usefulness of the treatment diary and suggestions on how to make the diary better.
Results of pilot testing
Ten patients completed the study, but one lost the spasticity diary.
In Table 1 the patients’ responses to the Satisfaction questionnaire are shown. Among those who used the diary, 86% (6/7) found that they were more involved in their treatment and it was easier to set personal goals for treatment with this tool. In addition, all participants who used the diary found it worth the time spent using it.
Table 2 lists the scores to the answers to the WHO-QoL BREF and WHO-5 well-being.
Some patients and therapists reported that they had misunderstood how to complete the diary and needed more clear instructions.
Further developments of the treatment diary
- Feedback from the patients and therapists showed that the diary should be simplified and more clear instructions should be provided.
- The new diary was then presented during three workshops with around 70 physicians, physiotherapist, occupational therapist, and nurses.
- Translation of the diary from Danish into English included adjustments, making the diary more easily comprehensible and useable.
The translation process included both language translation and cultural adaptation (Price et al., 2009). Therefore, the translation of the Treatment Diary from the original Danish version into English was not purely made word for word, but we aimed to include conceptual equivalence. It is the meaning of the content in the original Danish version of the diary that should be translated. The translation had to similarly be concise, clear, and simple, whereas terms, jargon, and abbreviations that are not easily understood were avoided.
The initial translation was made by F.B.S., and afterwards, the translation was checked by B.B.S. and H.K.I. The ‘checkers’ did not provide another translation, but had to report whether the translation of the diary was sufficient to convey the original concepts (Biering-Sørensen et al., 2011). Where there were disagreements, the three translators came to a consensus on which translations would be the most appropriate. Finally, the translation was scrutinized by a bilingual person (English/Danish) with knowledge of the field and minor adjustments were made.
Feedback from colleagues shows that physicians and therapists find inputs from patients and all health care professionals involved helpful and important for the treatment success. The fact that the therapist and the patient/caregiver together have the opportunity to choose other relevant treatment goals and communicate these to the physician using the treatment diary was highlighted as the botulinum toxin injections or other spasticity treatment can be adjusted according to these new goals.
If the patient cannot cooperate with goal setting or evaluation of the treatment, a caregiver or a relative taking care of the patient can help to set relevant goals and evaluate whether the goals are reached.
The reason having the treatment diary in paper was to make it easier for the patient to carry around and allowed the patient and the therapist to write their evaluations of the treatment and suggestions for optimization of the treatment. An electronic version might lead to obstacles when the patient and different health care professionals require access to the same e-diary. In the future, we hope that it will be possible to develop an e-version where data security challenges can be solved.
The presented treatment diary has the potential to increase the patient’s awareness of problems triggered by skeletal muscle overactivity and may help the patient to evaluate the treatment better. It may also encourage the patient to be aware of new relevant goals, and will hopefully result in more appropriate treatment goals, increased patient empowerment, and ultimately, lead to higher QoL, although this was not reported in the pilot study. In addition, the diary may lead to a closer collaboration between physiotherapists, occupational therapists, and the physician injecting the botulinum toxin, leading to common goals and optimization of the treatment.
A study evaluating the revised treatment diary is ongoing. The publication of this English version is because of requests from physicians, caregivers, patients, and therapists in Nordic Countries to enable quick use of the diary.
The authors like to thank senior consultants Stephen W. Pedersen and Jesper Bøje Clausen for initial inspiration for this work. The patients and the therapists are thanked for their participation in the pilot project and their useful comments to improve the treatment diary.
Allergan A/S has provided unconditional grant supporting the production of the treatment diary.
Conflicts of interest
Bo Biering-Sørensen has received honoraria for lectures from IPSEN, Allergan, Abbvie, UCB Pharma, and Berlin-Chemie AG, received honoraria for participating in Advisory Boards for IPSEN, Allergan, Merz, and Abbvie, and received an unconditional grant for this study from Allergan. Helle Klingenberg Iversen, Inge Mona Schack Frederiksen, and Jeanet Roger Vilhelmsen have received honoraria for lectures from IPSEN. For the remaining author there are no conflicts of interest.
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