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"Ghai, S."
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Task shifting of cardiovascular risk assessment and communication by nurses for primary and secondary prevention of cardiovascular diseases in a tertiary health care setting of Northern India
2020
Background
Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality in India. CVDs are to a large extent preventable with the availability of wide range of interventions focusing on primary and secondary prevention. However human resource deficit is the biggest challenge for implementing these prevention programs. Task shifting of the cardiovascular risk assessment and communication to nurses can be one of the most viable and sustainable option to run prevention programs.
Methods
The study was quasi experimental in nature with 1 year follow up to determine the effect of CVD risk assessment and communication by nurses with the help of risk communication package on primary and secondary prevention of CVDs. The study was done in the outpatient departments of a tertiary health care center of Northern India. All the nurses (
n
= 16) working in selected OPDs were trained in CVD risk assessment and communication of risk to the patients. A total of 402 patients aged 40 years and above with hypertension (HTN) were recruited for primary prevention of CVDs from medicine and allied OPDs, whereas 500 patients who had undergone CABG/PTCA were recruited from cardiology OPDs for secondary prevention of CVDs and were randomized to intervention (
n
= 250) and comparison group (
n
= 250) by using block randomization. CVD risk modification and medication adherence were the outcomes of interest for primary and secondary prevention of CVDs respectively.
Results
The results revealed high level of agreement (k = 0.84) between the risk scores generated by nurses with that of investigator. In the primary prevention group, there were significantly higher proportion of participants in the low risk category (70%) as compared to baseline assessment (60.6%) at 1 year follow up. Whereas in secondary prevention group the mean medication adherence score among intervention group participants (7.60) was significantly higher than that of the comparison group (5.96) with a large effect size of 1.1.(
p
< 0.01).
Conclusion
Nurse led intervention was effective in risk modification and improving medication adherence among subjects for primary and secondary prevention of CVDs respectively.
Trial registration
Trial registration no
CTRI/2018/01/011372
[Registered on: 16/01/2018] Trial Registered Retrospectively.
Journal Article
Follow-up modalities in focal therapy for prostate cancer: results from a Delphi consensus project
by
Scionti, S.
,
Wijkstra, H.
,
Brausi, M.
in
Biopsy, Large-Core Needle
,
Consensus
,
Follow-Up Studies
2015
Introduction
Focal therapy can offer the middle ground for treatment between active surveillance and radical therapy in patients with low- and intermediate-risk prostate cancer. Factors that prohibit focal therapy from being standard of care are numerous. Several consensus projects have been conducted to position the utilization of imaging and trial design in focal therapy. However, the literature is still scarce on patient follow-up after focal therapy. For these reasons, an international multidisciplinary consensus project was established in order to reach consensus about a uniform follow-up protocol after focal therapy.
Objective
To standardize patient follow-up after focal therapy.
Materials and methods
A literature study was performed, and a questionnaire was constructed. The questionnaire was sent out to 76 participants (70 % urologists, 28 % radiologists and 2 % biomedical engineers) in three consecutive rounds according to the Delphi method. In each round, the panelists were presented with the results of the previous round. Participants each had the opportunity to adapt, delete or add questions. The topics discussed pertaining to follow-up after focal therapy were as follows: (1) general,(2) biopsies, (3) PSA, (4) digital rectal examination (DRE), (5) imaging, (6) quality of life (QoL) and (7) registration and pooling of data. The project was concluded with a face-to-face meeting in which final conclusions were formulated.
Results
The follow-up after focal therapy should be a minimum of 5 years. The following modalities should be included in assessing post-treatment outcomes: multiparametric MRI (mpMRI), biopsies, assessment of erectile function, QoL, urinary symptoms and incontinence. A systematic 12-core TRUS biopsy combined with 4–6 targeted biopsy cores of the treated area and any suspicious lesion(s) should be performed after 1 year, and thereafter only when there is suspicion on imaging. The ideal way to perform targeted biopsies is to use TRUS–MRI fusion technology. PSA should be performed for research purposes, in the first year, every 3 months, and after the first year, every 6 months. mpMRI is the optimal imaging modality for follow-up after focal therapy. On a 1.5T scanner, an endorectal coil is strongly advised by the panel, whereas on a 3T machine, it is optional, however, it will improve image quality. The following sequences should be included: T2WI, DWI including high
b
values of >1,000 and ADC maps of DWI, DCE and T1WI. Imaging should be performed at 6 months and at 1 year following treatment; after the first year post-treatment, it should be performed every year until 5 years following treatment. All data should ideally be pooled in a common global database.
Conclusion
Focal therapy is a relatively new form of treatment for prostate cancer. In order to include focal therapy as a standard of care treatment, consistent follow-up is necessary. By implementing the results of this consensus study, focal therapy users will be able to provide important and standardized outcome data.
Journal Article
Patient selection for prostate focal therapy in the era of active surveillance: an International Delphi Consensus Project
by
Tay, K J
,
Jones, J S
,
Scheltema, M J
in
692/699/67/1059
,
692/699/67/589/466
,
Biomedical and Life Sciences
2017
Background:
Whole-gland extirpation or irradiation is considered the gold standard for curative oncological treatment for localized prostate cancer, but is often associated with sexual and urinary impairment that adversely affects quality of life. This has led to increased interest in developing therapies with effective cancer control but less morbidity. We aimed to provide details of physician consensus on patient selection for prostate focal therapy (FT) in the era of contemporary prostate cancer management.
Methods:
We undertook a four-stage Delphi consensus project among a panel of 47 international experts in prostate FT. Data on three main domains (role of biopsy/imaging, disease and patient factors) were collected in three iterative rounds of online questionnaires and feedback. Consensus was defined as agreement in ⩾80% of physicians. Finally, an in-person meeting was attended by a core group of 16 experts to review the data and formulate the consensus statement.
Results:
Consensus was obtained in 16 of 18 subdomains. Multiparametric magnetic resonance imaging (mpMRI) is a standard imaging tool for patient selection for FT. In the presence of an mpMRI-suspicious lesion, histological confirmation is necessary prior to FT. In addition, systematic biopsy remains necessary to assess mpMRI-negative areas. However, adequate criteria for systematic biopsy remains indeterminate. FT can be recommended in D’Amico low-/intermediate-risk cancer including Gleason 4+3. Gleason 3+4 cancer, where localized, discrete and of favorable size represents the ideal case for FT. Tumor foci <1.5 ml on mpMRI or <20% of the prostate are suitable for FT, or up to 3 ml or 25% if localized to one hemi-gland. Gleason 3+3 at one core 1mm is acceptable in the untreated area. Preservation of sexual function is an important goal, but lack of erectile function should not exclude a patient from FT.
Conclusions:
This consensus provides a contemporary insight into expert opinion of patient selection for FT of clinically localized prostate cancer.
Journal Article
A multi‐institutional randomized controlled trial comparing first‐generation transrectal high‐resolution micro‐ultrasound with conventional frequency transrectal ultrasound for prostate biopsy
2021
Objectives To study high‐frequency 29 MHz transrectal side‐fire micro‐ultrasound (micro‐US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro‐US imaging of the prostate. Materials and methods A prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro‐US vs conventional end‐fire ultrasound (conv‐US) transrectal‐guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro‐US image interpretation protocol that was developed during the trial using data from the pre‐training micro‐US arm. Investigators received a standardized training program mid‐trial, and the post‐training micro‐US data were used to examine the training effect. Results Detection of csPCa (the primary outcome) was no better with the first‐generation micro‐US system than with conv‐US in the overall population (34.6% vs 36.6%, respectively, P = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI‐MUS in order to address the lack of understanding of the appearance of cancer under micro‐US. Micro‐US sensitivity in the post‐training group improved to 60.8% from 24.6% (P < .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro‐US arm increased by 7% after training (32% to 39%, P < .03), but training instituted mid‐trial did not affect the overall results of the comparison between arms. Conclusion Micro‐US provided no clear benefit over conv‐US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first‐generation system. In this work high‐frequency 29 MHz transrectal side‐fire micro‐ultrasound (US) for the detection of clinically significant prostate cancer on prostate biopsy is studied, and an image interpretation protocol for micro‐US imaging of the prostate is validated. The YouTube link is here: https://youtu.be/U2Svj-4Ae_k
Journal Article
Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project
by
Sedelaar, J P M
,
Choyke, P L
,
J J M C H de la Rosette
in
Biopsy
,
Clinical trials
,
Laser ablation
2019
PurposeTo define the role of focal laser ablation (FLA) as clinical treatment of prostate cancer (PCa) using the Delphi consensus method.MethodsA panel of international experts in the field of focal therapy (FT) in PCa conducted a collaborative consensus project using the Delphi method. Experts were invited to online questionnaires focusing on patient selection and treatment of PCa with FLA during four subsequent rounds. After each round, outcomes were displayed, and questionnaires were modified based on the comments provided by panelists. Results were finalized and discussed during face-to-face meetings.ResultsThirty-seven experts agreed to participate, and consensus was achieved on 39/43 topics. Clinically significant PCa (csPCa) was defined as any volume Grade Group 2 [Gleason score (GS) 3+4]. Focal therapy was specified as treatment of all csPCa and can be considered primary treatment as an alternative to radical treatment in carefully selected patients. In patients with intermediate-risk PCa (GS 3+4) as well as patients with MRI-visible and biopsy-confirmed local recurrence, FLA is optimal for targeted ablation of a specific magnetic resonance imaging (MRI)-visible focus. However, FLA should not be applied to candidates for active surveillance and close follow-up is required. Suitability for FLA is based on tumor volume, location to vital structures, GS, MRI-visibility, and biopsy confirmation.ConclusionFocal laser ablation is a promising technique for treatment of clinically localized PCa and should ideally be performed within approved clinical trials. So far, only few studies have reported on FLA and further validation with longer follow-up is mandatory before widespread clinical implementation is justified.
Journal Article
Understanding antibiotic resistance via outer membrane permeability
2018
Collective antibiotic drug resistance is a global threat, especially with respect to Gram-negative bacteria. The low permeability of the bacterial outer cell wall has been identified as a challenging barrier that prevents a sufficient antibiotic effect to be attained at low doses of the antibiotic. The Gram-negative bacterial cell envelope comprises an outer membrane that delimits the periplasm from the exterior milieu. The crucial mechanisms of antibiotic entry via outer membrane includes general diffusion porins (Omps) responsible for hydrophilic antibiotics and lipid-mediated pathway for hydrophobic antibiotics. The protein and lipid arrangements of the outer membrane have had a strong impact on the understanding of bacteria and their resistance to many types of antibiotics. Thus, one of the current challenges is effective interpretation at the molecular basis of the outer membrane permeability. This review attempts to develop a state of knowledge pertinent to Omps and their effective role in solute influx. Moreover, it aims toward further understanding and exploration of prospects to improve our knowledge of physicochemical limitations that direct the translocation of antibiotics via bacterial outer membrane.
Journal Article
Effectiveness of a breathing training program on quality of life in patients with predialysis chronic kidney disease: A randomized controlled trial
by
Kharbteng, Lasara
,
Kaur, Sukhpal
,
Kumar, Vivek
in
Breathing exercises
,
Chronic kidney failure
,
Clinical outcomes
2020
Context: Chronic kidney disease (CKD) patients have suboptimal quality of life (QOL). Various studies/researches have revealed that breathing exercises have a positive and favorable impact on different systems of the body. Aims: This study aims to assess the effect of a breathing training program on QOL in patients with predialysis CKD. Settings: The study was a single-center study conducted at PGIMER, Chandigarh. Design: Randomized controlled trial. Methods: Sixty individuals were enrolled and randomized using lottery method. QOL was assessed or evaluated by Kidney Disease and QOL questionnaire (KDQOL™-36). Breathing exercises were taught to the intervention group. Patients included in control group continued with the routine care. Assessment of QOL was done after 4 weeks in both the groups. Results: Change in KDQOL™-36 scores showed significant difference between control and the intervention group. The mean scores of control group in the subscale effects of kidney disease, SF-12 Physical functioning (Physical Health Composite) and SF-12 Mental functioning (Mental Health Composite) were 84.79, 39.16 and 37.40, respectively, whereas in intervention group, the respective mean scores were 91.88, 43.92, and 44.16. The difference was statistically significant (P = 0.04, P = 0.01, and P = 0.003, respectively). Conclusions: Breathing training program improves QOL in patients with predialysis CKD.
Journal Article
Standardization of definitions in focal therapy of prostate cancer: report from a Delphi consensus project
by
Jones, J. S.
,
Ghai, S.
,
Hohenfellner, M.
in
Combined Modality Therapy - standards
,
Delphi Technique
,
Humans
2016
Purpose
To reach standardized terminology in focal therapy (FT) for prostate cancer (PCa).
Methods
A four-stage modified Delphi consensus project was undertaken among a panel of international experts in the field of FT for PCa. Data on terminology in FT was collected from the panel by three rounds of online questionnaires. During a face-to-face meeting on June 21, 2015, attended by 38 experts, all data from the online rounds were reviewed and recommendations for definitions were formulated.
Results
Consensus was attained on 23 of 27 topics;
Targeted
FT
was defined as a lesion-based treatment strategy, treating all identified significant cancer foci;
FT
was generically defined as an anatomy-based (zonal) treatment strategy. Treatment failure due to the ablative energy inadequately destroying treated tissue is defined as
ablation failure.
In
targeting failure
the energy is not adequately applied to the tumor spatially and
selection failure
occurs when a patient was wrongfully selected for FT. No definition of biochemical recurrence can be recommended based on the current data. Important definitions for outcome measures are potency (minimum IIEF-5 score of 21), incontinence (new need for pads or leakage) and deterioration in urinary function (increase in IPSS >5 points). No agreement on the best quality of life tool was established, but UCLA-EPIC and EORTC-QLQ-30 were most commonly supported by the experts. A complete overview of statements is presented in the text.
Conclusion
Focal therapy is an emerging field of PCa therapeutics. Standardization of definitions helps to create comparable research results and facilitate clear communication in clinical practice.
Journal Article
Effects of dual tasks and dual-task training on postural stability: a systematic review and meta-analysis
2017
The use of dual-task training paradigm to enhance postural stability in patients with balance impairments is an emerging area of interest. The differential effects of dual tasks and dual-task training on postural stability still remain unclear. A systematic review and meta-analysis were conducted to analyze the effects of dual task and training application on static and dynamic postural stability among various population groups. Systematic identification of published literature was performed adhering to Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines, from inception until June 2016, on the online databases Scopus, PEDro, MEDLINE, EMBASE, and SportDiscus. Experimental studies analyzing the effects of dual task and dual-task training on postural stability were extracted, critically appraised using PEDro scale, and then summarized according to modified PEDro level of evidence. Of 1,284 records, 42 studies involving 1,480 participants met the review's inclusion criteria. Of the studies evaluating the effects of dual-task training on postural stability, 87.5% of the studies reported significant enhancements, whereas 30% of the studies evaluating acute effects of dual tasks on posture reported significant enhancements, 50% reported significant decrements, and 20% reported no effects. Meta-analysis of the pooled studies revealed moderate but significant enhancements of dual-task training in elderly participants (95% CI: 1.16-2.10) and in patients suffering from chronic stroke (-0.22 to 0.86). The adverse effects of complexity of dual tasks on postural stability were also revealed among patients with multiple sclerosis (-0.74 to 0.05). The review also discusses the significance of verbalization in a dual-task setting for increasing cognitive-motor interference. Clinical implications are discussed with respect to practical applications in rehabilitation settings.
Journal Article
Long-term use of 5-alpha-reductase inhibitors is safe and effective in men on active surveillance for prostate cancer
2021
BackgroundAlthough 5-alpha-reductase inhibitors (5ARIs) have been shown to benefit men with prostate cancer (PCa) on active surveillance (AS), their long-term safety remains controversial. Our objective is to describe the long-term association of 5ARI use with PCa progression in men on AS.Materials/subjects and methodsThe cohort of men with low-risk PCa was derived from a prospectively maintained AS database at the Princess Margaret (1995–2016). Pathologic, grade, and volume progression were the primary end points. Kaplan–Meier time-to-event analysis was performed and Cox proportional hazards regression was used to determine predictors of progression where 5ARI exposure was analyzed as a time-dependent variable. Patients who came off AS prior to any progression events were censored at that time.ResultsThe cohort included 288 men with median follow-up of 82 months (interquartile range: 37–120 months). Among non-5ARI users (n = 203); 114 men (56.2%) experienced pathologic progression compared with 24 men (28.2%) in the 5ARI group (n = 85), (p < 0.001). Grade and volume progression were higher in the non-5ARI group compared with the 5ARI group (n = 82; 40.4% vs. n = 19; 22.4% respectively, p = 0.003 for grade progression; n = 87; 43.1% and n = 15; 17.7%, respectively for volume progression p < 0.001). Lack of 5ARI use was independently positively associated with pathologic progression (HR: 2.65; CI: 1.65–4.24), grade progression (HR: 2.75; CI: 1.49–5.06), and volume progression (HR: 3.15; CI: 1.78–5.56). The frequency of progression to high-grade (Grade Group 4–5) tumors was not significantly different between the groups.ConclusionsUse of 5ARIs diminished both grade and volume progression without an increased risk of developing Grade Groups 4–5 disease.
Journal Article