ObjectivesTo assess the feasibility of delivering a culturally tailored pulmonary rehabilitation (PR) programme and conducting a definitive randomised controlled trial (RCT).DesignA two-arm, randomised feasibility trial with a mixed-methods process evaluation.SettingSecondary care setting in Georgia, Europe.ParticipantsPeople with symptomatic spirometry-confirmed chronic obstructive pulmonary disease recruited from primary and secondary care.InterventionsParticipants were randomised in a 1:1 ratio to a control group or intervention comprising 16 twice-weekly group PR sessions tailored to the Georgian setting.Primary and secondary outcome measuresFeasibility of the intervention and RCT were assessed according to: study recruitment, consent and follow-up, intervention fidelity, adherence and acceptability, using questionnaires and measurements at baseline, programme end and 6 months, and through qualitative interviews.ResultsThe study recruited 60 participants (as planned): 54 (90%) were male, 10 (17%) had a forced expiratory volume in 1 second of ≤50% predicted. The mean MRC Dyspnoea Score was 3.3 (SD 0.5), and mean St George’s Respiratory Questionnaire (SGRQ) 50.9 (SD 17.6). The rehabilitation specialists delivered the PR with fidelity. Thirteen (43.0%) participants attended at least 75% of the 16 planned sessions. Participants and rehabilitation specialists in the qualitative interviews reported that the programme was acceptable, but dropout rates were high in participants who lived outside Tbilisi and had to travel large distances. Outcome data were collected on 63.3% participants at 8 weeks and 88.0% participants at 6 months. Mean change in SGRQ total was −24.9 (95% CI −40.3 to –9.6) at programme end and −4.4 (95% CI −12.3 to 3.4) at 6 months follow-up for the intervention group and −0.5 (95% CI −8.1 to 7.0) and −8.1 (95% CI −16.5 to 0.3) for the usual care group at programme end and 6 months, respectively.ConclusionsIt was feasible to deliver the tailored PR intervention. Approaches to improve uptake and adherence warrant further research.Trial registration numberISRCTN16184185.
Background and Aims
Kidney biopsy registry has been established in Georgia in 2011 by Dialysis, Nephrology and Kidney Transplantation Union of Georgia (DNT Union) to address the natural history of kidney disease, describe the clinical features, improve disease understanding and tracking, healthcare planning, patient care and outcomes. This report is the first review of histological data over a period of 10 years (2011-2020) covering the entire population of 3.7 million inhabitants and demonstrates the current data on trends of kidney disease in Georgia.
Method
1267 ultrasound-guided kidney biopsies were performed during the 10 years. Data were extracted from the DNT Union kidney biopsy registry as of 1st of December 2020. Data on kidney function, urinalysis, treatment options and outcomes were also included in biopsy registry database. After exclusion of transplant and re-biopsies, kidney biopsies were analyzed for evaluation main trends in kidney biopsy rates and diagnosis of glomerular and non-glomerular diseases in two groups divided in 5-year time frames: the first group 2011-2015 and the second group 2016-2020. The overall treatment outcome was evaluated as complete remission (CR), partial remission (PR) and progression to ESRD.
Results
Final cohort consisted of 1089 patients. Mean age was 39 years [SD 13 years]. Fifty five percent of the cohort were male. The average annual biopsy incidence was 455 biopsies in the first group and 634 cases in the second group. The most common indication as clinical syndrome for performing the kidney biopsy was a decrease of glomerular filtration rate GFR (35%), followed by nephrotic syndrome (30%) and nephritic syndrome (21 %) and in lesser degree asymptomatic urinary abnormalities (14 %).
The frequency of kidney biopsies increased significantly over the years (Fig.1). The distribution of major histological groups of kidney disease in both groups is shown in the Table 1. As for comparison of the major trends among various histological patterns, there was 3,6 times more heredity kidney diseases diagnosed in the second group, followed by tubulointerstitial nephritis with 3.3 times increase, acute tubular necrosis 1.5 times increase and glomerulonephritis (primary and secondary) with 1.3 times increase. There was found statistically no changes in the incidence of vascular kidney disease between two groups (p=0.005).
Overall outcome demonstrates some changes during the time. PR was the most prevalent outcome in both time groups. However, proportion of PR cases increased (45%vs.64%) and proportion of CR (25% vs.17%) and ESRD (30% vs.18%) cases decreased. This change is statistically significant at p<0.0001. There were no data obtained from 15% (173) of patients.
The distribution of overall outcome among patients with primary glomerulonephritis (PGN) repeated the same trend. Out of total PGN patients (481 cases) 61% showed PR, 24% reached CR and 15% progressed to ESRD. The proportion of patients with PR was higher (69%) among patients diagnosed with PGN in the second group compared with the first (48%). Proportion of patients, who developed ESRD, was lower in the second group (12% vs.19%).
( Fig. 2).
Conclusion
The present data are an important contribution to the epidemiology of kidney disease in Georgia. The incidence of glomerulonephritis generally increased between 2011 and 2020, that may be related to changes in kidney biopsy policy. Substantial decrease in numbers of kidney biopsies were registered in 2020 due to pandemic issues. Membranous nephropathy was the most common primary glomerular disease according to the registry database. The prognosis regarding progression to ESRD has improved.
The review discusses literature data on the clinical relevance of functional assessment of magno- (M), parvo- (P), and koniocellular (K) pathways. It also covers the differential contribution of the M, P, and K channels to visual impairments and how it determines the prognosis, early diagnosis, and treatment choice in patients with neurodegenerative diseases of the retina and brain. Selective changes in the performance of the visual channels are investigated by the example of glaucoma and optic neuritis in multiple sclerosis (MS) patients. A detailed analysis of pattern electroretinogram and visual evoked potentials in response to pattern stimuli of varying luminance and chromatic contrast in glaucoma and MS and characteristic functional alterations (objective markers of pathology of the visual pathways) are presented.
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