scholarly journals Development, validation and evaluation of an instrument for active monitoring of men with clinically localised prostate cancer: systematic review, cohort studies and qualitative study

2015 ◽  
Vol 3 (30) ◽  
pp. 1-138 ◽  
Author(s):  
Andrew J Simpkin ◽  
Leila Rooshenas ◽  
Julia Wade ◽  
Jenny L Donovan ◽  
J Athene Lane ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Decision Making ◽  
Clinical Practice ◽  
Clinical Review ◽  
Clinical Outcomes ◽  
Reference Ranges ◽  
Active Monitoring ◽  
Radical Treatment

BackgroundActive surveillance [(AS), sometimes called active monitoring (AM)],is a National Institute for Health and Care Excellence-recommended management option for men with clinically localised prostate cancer (PCa). It aims to target radical treatment only to those who would benefit most. Little consensus exists nationally or internationally about safe and effective protocols for AM/AS or triggers that indicate if or when men should move to radical treatment.ObjectiveThe aims of this project were to review how prostate-specific antigen (PSA) has been used in AM/AS programmes; to develop and test the validity of a new model for predicting future PSA levels; to develop an instrument, based on PSA, that would be acceptable and effective for men and clinicians to use in clinical practice; and to design a robust study to evaluate the cost-effectiveness of the instrument.MethodsA systematic review was conducted to investigate how PSA is currently used to monitor men in worldwide AM/AS studies. A model for PSA change with age was developed using Prostate testing for cancer and Treatment (ProtecT) data and validated using data from two PSA-era cohorts and two pre-PSA-era cohorts. The model was used to derive 95% PSA reference ranges (PSARRs) across ages. These reference ranges were used to predict the onset of metastases or death from PCa in one of the pre-PSA-era cohorts. PSARRs were incorporated into an active monitoring system (AMS) and demonstrated to 18 clinicians and 20 men with PCa from four NHS trusts. Qualitative interviews investigated patients’ and clinicians’ views about current AM/AS protocols and the acceptability of the AMS within current practice.ResultsThe systematic review found that the most commonly used triggers for clinical review of PCa were PSA doubling time (PSADT) < 3 years or PSA velocity (PSAv) > 1 ng/ml/year. The model for PSA change (developed using ProtecT study data) predicted PSA values in AM/AS cohorts within 2 ng/ml of observed PSA in up to 79% of men. Comparing the three PSA markers, there was no clear optimal approach to alerting men to worsening cancer. The PSARR and PSADT markers improved the modelc-statistic for predicting death from PCa by 0.11 (21%) and 0.13 (25%), respectively, compared with using diagnostic information alone [PSA, age, tumour stage (T-stage)]. Interviews revealed variation in clinical practice regarding eligibility and follow-up protocols. Patients and clinicians perceive current AM/AS practice to be framed by uncertainty, ranging from uncertainty about selection of eligible AM/AS candidates to uncertainty about optimum follow-up protocols and thresholds for clinical review/radical treatment. Patients and clinicians generally responded positively to the AMS. The impact of the AMS on clinicians’ decision-making was limited by a lack of data linking AMS values to long-term outcomes and by current clinical practice, which viewed PSA measures as one of several tools guiding clinical decisions in AM/AS. Patients reported that they would look to clinicians, rather than to a tool, to direct decision-making.LimitationsThe quantitative findings were severely hampered by a lack of clinical outcomes or events (such as metastases). The qualitative findings were limited through reliance on participants’ reports of practices and recollections of events rather than observations of actual interactions.ConclusionsPatients and clinicians found that the instrument provided additional, potentially helpful, information but were uncertain about the current usefulness of the risk model we developed for routine management. Comparison of the model with other monitoring strategies will require clinical outcomes from ongoing AM/AS studies.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

Between a logic of disruption and a logic of continuation: Negotiating the legitimacy of algorithms used in automated clinical decision-making

2021 ◽  
pp. 136345932199674
Author(s):  
Rikke Torenholt ◽  
Henriette Langstrup
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Patient Reported Outcomes ◽  
Patient Involvement ◽  
Clinical Decision Making ◽  
Diagnostic Procedures ◽  
Clinical Decision ◽  
Patient Reported ◽  
Pro Tools

In both popular and academic discussions of the use of algorithms in clinical practice, narratives often draw on the decisive potentialities of algorithms and come with the belief that algorithms will substantially transform healthcare. We suggest that this approach is associated with a logic of disruption. However, we argue that in clinical practice alongside this logic, another and less recognised logic exists, namely that of continuation: here the use of algorithms constitutes part of an established practice. Applying these logics as our analytical framing, we set out to explore how algorithms for clinical decision-making are enacted by political stakeholders, healthcare professionals, and patients, and in doing so, study how the legitimacy of delegating to an algorithm is negotiated and obtained. Empirically we draw on ethnographic fieldwork carried out in relation to attempts in Denmark to develop and implement Patient Reported Outcomes (PRO) tools – involving algorithmic sorting – in clinical practice. We follow the work within two disease areas: heart rehabilitation and breast cancer follow-up care. We show how at the political level, algorithms constitute tools for disrupting inefficient work and unsystematic patient involvement, whereas closer to the clinical practice, algorithms constitute a continuation of standardised and evidence-based diagnostic procedures and a continuation of the physicians’ expertise and authority. We argue that the co-existence of the two logics have implications as both provide a push towards the use of algorithms and how a logic of continuation may divert attention away from new issues introduced with automated digital decision-support systems.

scholarly journals Outcomes of Arthroscopic Capsular Release in the Beach-Chair Versus Lateral Decubitus Position: A Systematic Review

2019 ◽  
Vol 7 (12) ◽  
pp. 232596711988817 ◽  
Author(s):  
Darby A. Houck ◽  
John W. Belk ◽  
Armando F. Vidal ◽  
Eric C. McCarty ◽  
Jonathan T. Bravman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
Cochrane Library ◽  
Recurrence Rates ◽  
Capsular Release ◽  
Arthroscopic Capsular Release ◽  
Patient Reported ◽  
Lateral Decubitus ◽  
Beach Chair

Background: Arthroscopic capsular release (ACR) for the treatment of adhesive capsulitis of the shoulder can be performed in either the beach-chair (BC) or lateral decubitus (LD) position. Purpose: To determine the clinical outcomes and recurrence rates after ACR in the BC versus LD position. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines was performed by searching PubMed, Embase, and the Cochrane Library databases for studies reporting clinical outcomes of patients undergoing ACR in either the BC or LD position. All English-language literature from 1990 through 2017 reporting on clinical outcomes after ACR with a minimum 3-month follow-up were reviewed by 2 independent reviewers. Recurrence rates, range of motion (ROM) results, and patient-reported outcome (PRO) scores were collected. Study methodological quality was evaluated using the modified Coleman Methodology Score (MCMS). Results: A total of 30 studies (3 level 1 evidence, 2 level 2 evidence, 4 level 3 evidence, 21 level 4 evidence) including 665 shoulders undergoing ACR in the BC position (38.1% male; mean age, 52.0 ± 3.9 years; mean follow-up, 35.4 ± 18.4 months) and 603 shoulders in the LD position (41.8% male; mean age, 53.0 ± 2.3 years; mean follow-up, 37.2 ± 16.8 months) were included. There were no significant differences in overall mean recurrence rates between groups (BC, 2.5%; LD, 2.4%; P = .81) or in any PRO scores between groups ( P > .05). There were no significant differences in improvement in ROM between groups, including external rotation at the side (BC, 36.4°; LD, 42.8°; P = .91), forward flexion (BC, 64.4°; LD, 79.3°; P = .73), abduction (BC, 77.8°; LD, 81.5°; P = .82), or internal rotation in 90° of abduction (BC, 40.8°; LD, 45.5°; P = .70). Significantly more patients in the BC group (91.6%) underwent concomitant manipulation than in the LD group (63%) ( P < .0001). There were significantly more patients with diabetes in the LD group (22.4%) versus the BC group (9.6%) ( P < .0001). Conclusion: Low rates of recurrent shoulder stiffness and excellent improvements in ROM can be achieved after ACR in either the LD or BC position. Concomitant manipulation under anesthesia is performed more frequently in the BC position compared with the LD position.

scholarly journals Impact of metformin on clinical outcomes among men with prostate cancer: a systematic review and meta-analysis

2015 ◽  
Vol 18 (2) ◽  
pp. 110-121 ◽  
Author(s):  
A D Raval ◽  
D Thakker ◽  
A Vyas ◽  
M Salkini ◽  
S Madhavan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Clinical Outcomes ◽  
Meta Analysis

Systematic Review and Meta-analyses of Effects of Phosphate-lowering Agents in Non-dialysis Chronic Kidney Disease

2021 ◽  
pp. ASN.2021040554
Author(s):  
Nicole Lioufas ◽  
Elaine Pascoe ◽  
Carmel Hawley ◽  
Grahame Elder ◽  
Sunil Badve ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Clinical Outcomes ◽  
Serum Phosphate ◽  
Risk Of Bias ◽  
Lowering Therapy ◽  
Mean Differences ◽  
Meta Analyses

Background: Benefits of phosphate-lowering interventions on clinical outcomes in patients with chronic kidney disease (CKD) are unclear; systematic reviews have predominantly involved dialysis patients. This study aimed to summarize evidence from randomized controlled trials (RCTs) concerning benefits and risks of non-calcium-based phosphate-lowering treatment in non-dialysis CKD. Methods: We conducted a systematic review and meta-analyses of RCTs involving noncalcium-based phosphate-lowering therapy compared to placebo, calcium-based binders, or no study medication, in adults with CKD not on dialysis or post-transplant. RCTs had ≥3 months follow up and outcomes included biomarkers of mineral metabolism, cardiovascular parameters, and adverse events. Outcomes were meta-analyzed using the Sidik-Jonkman method for random effects. Unstandardized mean differences were used as effect sizes for continuous outcomes, with common measurement units and Hedge's g standardized mean differences (SMD) otherwise. Odds ratios were used for binary outcomes. Cochrane risk of bias and GRADE assessment determined the certainty of evidence. Results: Twenty trials involving 2,498 participants (median sample size 120, median follow up 9 months) were eligible for inclusion. Overall, risk of bias was low. Compared with placebo, non calcium-based phosphate binders reduced serum phosphate (12 trials, weighted mean difference -0.37, 95% CI -0.58,-0.15 mg/dL, low certainty evidence) and urinary phosphate excretion (8 trials, SMD -0.61, 95% CI -0.90,-0.31, low certainty evidence), but resulted in increased constipation (9 trials, log odds ratio [OR] 0.93, 95% CI 0.02, 1.83, low certainty evidence) and greater vascular calcification score (3 trials, SMD 0.47, 95% CI 0.17, 0.77, very low certainty evidence). Data for effects of phosphate-lowering therapy on cardiovascular events (log OR 0.51 [95% CI -0.51, 1.17]) and death were scant. Conclusions: Non-calcium-based phosphate-lowering therapy reduced serum phosphate and urinary phosphate excretion, but there was an unclear effect on clinical outcomes and intermediate cardiovascular end-points. Adequately powered RCTs are required to evaluate benefits and risks of phosphate-lowering therapy on patient-centered outcomes.

scholarly journals Mid-term Outcomes of Autologous Osteochondral Transplantation for Osteochondral Lesions of the Talus

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0044
Author(s):  
Yoshiharu Shimozono ◽  
Eoghan Hurley ◽  
John Kennedy
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
Osteochondral Transplantation ◽  
Autologous Osteochondral Transplantation ◽  
Short Term ◽  
Level Of Evidence ◽  
Quality Of Evidence ◽  
Current Systematic Review

Category: Ankle Introduction/Purpose: Autologous osteochondral transplantation (AOT) is an established treatment for large-sized OLT, typically greater than 107mm2. Several studies have demonstrated favourable outcomes following AOT at short- and mid-term follow-up. However, the majority of the literature on AOT has short-term follow-up and little evidence exists on the mid-term and longer-term follow-up. Additionally, few studies include a large number of patients or have a high level of evidence, limiting the ability to draw broad and meaningful conclusions about the effectiveness of the AOT procedure for the treatment of OLT beyond short-term follow-up. The purpose of the current systematic review was to evaluate the clinical outcomes analysing level and quality of evidence of the AOT procedure in the treatment of OLT at mid-term and long-term follow-up. Methods: A systematic search of the MEDLINE, EMBASE and Cochrane Library databases was performed in October 2017 based on the PRISMA guidelines. Included studies were evaluated with regard to level of evidence (LOE) and quality of evidence (QOE) using the Coleman Methodology Score. Clinical outcomes, and complications were also evaluated. Results: Eleven studies, with 500 ankles were included at a mean 62.8 months follow-up. There were 3 studies of LOE III, and 8 studies of LOE IV. There were 3 studies of fair quality and 8 studies of poor quality. The weighted mean preoperative AOFAS score was 55.1 ± 6.1, and the postoperative score was 86.2 ± 4.5, with 87.4% of patients being reported as excellent or good results. In total, 54 of the 500 patients (10.8%) had complications. The most common complication was donor site morbidity with 18 patients (3.6%) at final follow-up. Thirty-one patients (6.2%) underwent reoperations, and the authors deemed a total of 5 ankles (1.0%) failures. Only 5 studies (45.5%) used MRI for follow-up evaluation. Conclusion: The current systematic review demonstrated that good clinical and functional outcomes can be expected following AOT procedure for the treatment of OLT, with a failure rate of only 1.0% at 63 months follow-up. MRI and radiographs showed restoration of articular surface as well as a minimal presence of osteoarthritis at mid-term follow-up. However, there is still lack of data from high LOE and QOE studies, and further high quality studies are necessary.

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