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.
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.
ObjectiveTo evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS).MethodsWe conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6–12 sessions delivered by specialised exercise- and physiotherapists. Primary outcome measure: patient's level of functioning. Secondary outcomes: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts.ResultsCompared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference − 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference − 1.93 [95% CI -3.81 to −0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference − 0.91 [95% CI -1.78 to −0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups.ConclusionWe only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study.Trial registration: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356.
MULTIFILE
