The St. George’s Respiratory Questionnaire (SGRQ) and chronic obstructive pulmonary disease (COPD) assessment test (CAT) are the measures used to assess health status. This study aims to examine the responsiveness of these tools by severity of dyspnoea category in patients with COPD. Forty-nine COPD patients who underwent a 12-week pulmonary rehabilitation (PR) programme were assessed at baseline, 12 weeks and at 28-week follow-up. Patients were categorized into two groups by severity of dyspnoea category (i.e. mild to moderate (modified Medical Research Council (mMRC) 1–2) and severe to very severe (mMRC 3–4)) using the mMRC dyspnoea scale. Effect size (ES) was computed as estimates of responsiveness. The SGRQ demonstrated greater responsiveness by total sample (SGRQ, ES = 0.87; CAT, ES = 0.75) and for the mMRC 3–4 category (SGRQ, ES = 0.91; CAT, ES = 0.76) on completion of PR. At 28-week follow-up, overall comparable responsiveness of the CAT and SGRQ was identified by total sample (SGRQ, ES = 0.75; CAT, ES = 0.74) and by severity of dyspnoea category. The symptom, impact and activity domains of the SGRQ showed good responsiveness, with greater ESs obtained overall for the mMRC 3–4 category. On completion of PR, the SGRQ demonstrates a greater responsiveness with COPD patients, especially in relation to the mMRC 3–4 category, while both the CAT and SGRQ show comparable responsiveness on follow-up.

The development of biological therapies has had an impact on the management of several medical conditions. Their use in systemic lupus erythematosus (SLE), however, remains very limited. This review has summarized the evidence on the clinical effect of biologicals in SLE. Biological drugs with a number of targets have been studied in several phase II and III randomized controlled trials (RCTs). Positive results have been obtained in phase III RCTs with belimumab and this led to its license for active SLE. The clinical experience with belimumab has confirmed the efficacy and safety of belimumab in SLE. Promising results have been noted in phase II trials for blisibimod, sifalimumab, anifrolumab, and ustekinumab. Despite the fact that the RCTs with rituximab did not achieve their primary endpoint, clinical experience with rituximab is extensive and shows favorable clinical response in refractory renal and non-renal SLE. It is hoped that further ongoing phase III RCTs on a number of biological agents in SLE will highlight the potential role of other biologicals in the management of this challenging and heterogeneous condition.

Background In addition to the well-known role of vitamin D in calcium homeostasis and bone metabolism, vitamin D is important in the modulation of the immune system and inflammatory processes. Vitamin D deficiency is common in patients with systemic lupus erythematosus (SLE), possibly as a result of sun avoidance. The aim of this prospective open-label study was to assess the effect of the treatment of vitamin D deficiency and insufficiency in SLE patients, particularly with regards to disease activity, fatigue and interferon signature gene expression. Methods 31 SLE patients, 13 with vitamin D deficiency and 18 with vitamin D insufficiency were treated with vitamin D3. They were supplemented with vitamin D3 8000 IU daily for 8 weeks if they were vitamin D deficient, or 8000 IU daily for 4 weeks if they were insufficient. This was followed by 2000 IU daily maintenance. They were assessed at baseline, after 6 and 12 months by means of an interview, filling in questionnaires and blood tests. The expression of 12 interferon signature genes in RNA extracted from whole blood was measured by using QuantiGene Plex technology. Results An improvement in disease activity measured by systemic lupus erythematosus disease activity index-2K (SLEDAI-2K; p = 0.028) and fatigue measured by fatigue severity scale (FSS; p = 0.071) at 12 months were noted. A significant decrease in anti-double stranded deoxyribonucleic acid (dsDNA) titre (p = 0.045) was also noted. The mean interferon signature gene expression score decreased from baseline to 6 months, however statistical significance was not achieved (p = 0.165). Conclusions Improved disease activity and fatigue have been noted when Vitamin D has been supplemented in vitamin D deficient/insufficient SLE patients. One possible mechanism could be the suppression of the interferon signature gene expression. Trial registration: The study was registered with the ISRCTN registry on 12/04/2021 (Trial ID: ISRCTN59058825).

Systemic Lupus Erythematosus (SLE) is a multisystemic autoimmune disorder. The aim of this study was to characterise the SLE patients living in Malta in order to estimate the prevalence and incidence of SLE and characterise the clinical presentation as well as identify any unmet needs. 107 SLE patients who fulfilled SLICC classification criteria were identified. These were invited to participate in the study by means of an interview, blood and urine tests, and filling of the following questionnaires: Fatigue Severity Scale (FSS), visual analogue scale (VAS) for fatigue, Hospital Anxiety and Depression Scale (HADS), VAS for pain, Pittsburgh Sleep Quality Index (PSQI), and modified Health Assessment Questionnaire (mHAQ). The estimated prevalence of SLE in Malta is 29.3 patients per 100,000 and the estimated incidence is 1.48 per 100,000 per year. 93.5% of SLE patients were female, and the mean age at diagnosis was 33.1 years. 60.8% were overweight or obese and body mass index (BMI) had a significant positive correlation with daily dose of prednisolone (R=0.177, p=0.046). 20.7% and 3.3% had a moderate and high disease activity, respectively, as measured by SLEDAI-2K. Disease activity had a significant positive correlation with functional disability measured by mHAQ (R=0.417, p<0.001). 56.5% had an abnormal level of fatigue (FSS >3.7) and 57.6% had a high level of anxiety (HADS ≥8). This study has identified a number of unmet needs of SLE patients, including obesity, uncontrolled disease activity, fatigue, and anxiety.

Acute hepatitis B (AHB) is a self-limiting condition in more than 95% of cases. Treatment is however recommended in patients with severe AHB (<1% of cases), aiming to prevent liver failure and death. Various nucleos(t)ide analogues (NA) have been found to be effective in severe AHB, although NA-resistant strains causing AHB have been also recently reported. The use of tenofovir in severe AHB has only been described in 3 cases (1 adult and 1 infant with HBV mono-infection, 1 adult with HBV/HIV co-infection). We hereby report a 47-year-old treatment-naïve male, who developed severe AHB and was initially treated with lamivudine (LMV). Initial rapid biochemical response was followed by biochemical breakthrough after 9 days, suggesting LMV resistance. Rescue therapy with ‘add-on’ tenofovir brought about a sustained improvement in biochemical, serological and virological markers until HBsAg was lost after 4 months. Thus, this is the second adult HBV mono-infected patient, who responded successfully to tenofovir in severe AHB.

The assessment of fatigue, sleep quality and functional disability requires the use of validated instruments such as the Fatigue Severity Scale (FSS), the Pittsburgh Sleep Quality Index (PSQI) and the Modified Health Assessment Questionnaire (mHAQ) respectively. The aim of this study was to translate and validate these instruments into the Maltese Language. METHOD: Forward translation from the original English version into Maltese was carried out by two translators. The two versions were compiled to produce a preliminary initial Maltese translation. This was translated back into English by two other translators. This led to the development of the pre-final version of the Maltese translation, which was pilot-tested in 20 bilingual patients with systemic lupus erythematosus. RESULTS: Psychometric testing revealed good reliability of the Maltese translation of the three questionnaires. Cronbach's alpha of the Maltese versions of the FSS, PSQI and mHAQ were 0.877, 0.859 and 0.897 respectively, showing good internal consistency. Validity of the Maltese version of the FSS was shown, since it had a significant positive correlation with visual analogue scale for fatigue (r=0.809, p<0.001). CONCLUSION: The Maltese translations were thus finalised, and could be used for clinical assessment or research purposes.

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BackgroundThe Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI) and Modified Health Assessment Questionnaire (mHAQ) are validated questionnaires that measure fatigue, sleep quality and function respectively. Research in the Maltese population, on systemic lupus erythematosus (SLE) requiring the use of these questionnaires, necessitates their translation and validation into the Maltese language.ObjectivesThe aim of the study is to translate, validate and perform cross-cultural adaptation of the FSS, PSQI and mHAQ into the Maltese language, according to the recommended methodology.1MethodsThe original instruments were translated into Maltese by two translators whose mother language is Maltese. One of the translators had a medical background and was knowledgeable on the concepts being examined in the questionnaires; while the other did not. The two translated versions of the instruments were then compared and the discrepancies were resolved by reaching a consensus on the best Maltese version that reflects the underlying meaning of the original English version. The preliminary initial Maltese translations were then given to two other translators for back translation into English. English was the native language of these translators and they were totally blind to the original versions. The back translated English versions were then compared to the original English questionnaires and any discrepancies were highlighted. The equivalent statements in the Maltese translations were discussed and changes were made to reflect the original English versions more accurately. The pre-final Maltese translations were produced and pilot tested in a sample of 20 bilingual SLE patients to evaluate the clarity of the questionnaires. These 20 patients were also asked to fill in the original English version of the FSS, PSQI and mHAQ, seven days after filling in the Maltese versions. Psychometric testing was carried out to assess reliability of the translation, internal consistency and validity.ResultsReliability of the translation of the FSS, PSQI and mHAQ into Maltese was analysed by using Kendall's tau test for statements having an ordinal scale and Pearson's correlation test for variables having a metric scale. The p value for each statement in the FSS, PSQI and mHAQ was less than 0.05 showing that the reliability of the translated versions was satisfactory. Internal consistency of the Maltese translations was demonstrated using Cronbach's alpha. This was calculated to be 0.877 for the FSS, 0.859 for the PSQI, and 0.897 for the mHAQ. Validity of the Maltese translation of the FSS was assessed by its correlation with the visual analogue scale for fatigue using Pearson's Correlation test. Pearson's R value was 0.809 and the p value was <0.001 confirming a positive significant correlation.ConclusionsThis study has confirmed the reliability and internal consistency of the translated English versions of the FSS, PSQI and mHAQ into Maltese. Moreover the validity of the Maltese version of the FSS has been shown. The Maltese ...