Background: Hypothyroidism is a common endocrine disorder and the standard treatment is replacement therapy with levothyroxine (LT4). Although many hypothyroid patients improve upon treatment with LT4, a proportion seems to experience residual hypothyroid complaints despite treatment, even when plasma TSH and FT4 are within reference ranges. Methods: Using an on-line survey we investigated 1. the health-related quality of life (QoL) (ThyPRO), 2. the activities of daily living (SF-36), 3. hypothyroid-related symptoms (ThySHI) in diagnosed, treated hypothyroid patients (>18 years, treated >6 months) and control persons (without thyroid disease, >18 years). In patients, the time course of symptoms from diagnosis until 3 years was asked (retrospectively, ThySHI). Patients and control persons were recruited by e-mails from patient organizations, posters in pharmacies and health centers and Twitter/Facebook. For data analysis (ThyPRO, 0-100 scale, t-test; daily functioning, 1-5 scale and ThySHI 0-3 scale, Mann-Whitney; time course symptoms, Friedmann-Dunnett; confounding factors, ANCOVA) IBM SPSS 24 was used. Results: In this cohort consisted of 1667 patients (mean duration of illness 12.2 ± SD 9.9 years) and 275 controls. Treated hypothyroid patients had 1. a significant decrease in health-related QoL and all domains (fatigue, vitality, cognition, anxiety, depressivity, emotional susceptibility, social life, daily life), as compared to controls (mean total QoL 39.9 vs 19.1 resp. and all domains p<0.001), 2. Significantly more impairment with activities of daily living (p<0.001), and 3. significantly higher scores for symptoms related to hypothyroidism, as compared to control persons (all p<0.01). Symptoms generally decreased after 3 years of treatment, with fatigue, reduce daily functioning, coldness, muscle pain/cramps and being overweight as the most intense residual complaints. Many patients (78.5%) reported having complaints despite taking thyroid medication and reported not feeling well (77.8%) while their blood values were within range. TSH level, age, gender and duration of illness did not significantly affect total QoL, whereas the M3 comorbidity index did. Desiccated thyroid hormone users (9.4%) had a significantly better mean total QoL than LT4 users (90.5%) (36,0 vs 40.6, p=0.003). Conclusions: Persistent complaints, such as reduced health-related quality of life, reduced daily functioning, and residual hypothyroid related symptoms, are common in this group of hypothyroid patients despite replacement therapy. Caregivers should be aware that persistent complaints can be present in treated hypothyroid patients, despite following current guidelines, and that these remaining symptoms may affect their quality of life and daily functioning.
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Background: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient’s risk of persistent disabling pain. Mode of care delivery can be matched to the patient’s suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. Methods: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient’s risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient’s suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. Discussion: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints.
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Background Providing individualized care based on the context and preferences of the patient is important. Knowledge on both prognostic risk stratification and blended eHealth care in musculoskeletal conditions is increasing and seems promising. Stratification can be used to match patients to the most optimal content and intensity of treatment as well as mode of treatment delivery (i.e. face-to-face or blended with eHealth). However, research on the integration of stratified and blended eHealth care with corresponding matched treatment options for patients with neck and/or shoulder complaints is lacking. Methods This study was a mixed methods study comprising the development of matched treatment options, followed by an evaluation of the feasibility of the developed Stratified Blended Physiotherapy approach. In the first phase, three focus groups with physiotherapists and physiotherapy experts were conducted. The second phase investigated the feasibility (i.e. satisfaction, usability and experiences) of the Stratified Blended Physiotherapy approach for both physiotherapists and patients in a multicenter single-arm convergent parallel mixed methods feasibility study. Results In the first phase, matched treatment options were developed for six patient subgroups. Recommendations for content and intensity of physiotherapy were matched to the patient’s risk of persistent disabling pain (using the Keele STarT MSK Tool: low/medium/high risk). In addition, selection of mode of treatment delivery was matched to the patient’s suitability for blended care (using the Dutch Blended Physiotherapy Checklist: yes/no). A paperbased workbook and e-Exercise app modules were developed as two different mode of treatment delivery options, to support physiotherapists. Feasibility was evaluated in the second phase. Physiotherapists and patients were mildly satisfied with the new approach. Usability of the physiotherapist dashboard to set up the e-Exercise app was considered ‘OK’ by physiotherapists. Patients considered the e-Exercise app to be of ‘best imaginable’ usability. The paper-based workbook was not used. Conclusion Results of the focus groups led to the development of matched treatment options. Results of the feasibility study showed experiences with integrating stratified and blended eHealth care and have informed amendments to the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints ready to use within a future cluster randomized trial.
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