Ignasi Gich

The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies

Background Despite the increasing number of manuals on how to develop clinical practice guidelines (CPGs) there remain concerns about their quality. The aim of this study was to review the quality of CPGs across a wide range of healthcare topics published since 1980. Methods The authors conducted a literature search in MEDLINE to identify publications assessing the quality of CPGs with the Appraisal of Guidelines, Research and Evaluation (AGREE) instrument. For the included guidelines in each study, the authors gathered data about the year of publication, institution, country, healthcare topic, AGREE score per domain and overall assessment. Results In total, 42 reviews were selected, including a total of 626 guidelines, published between 1980 and 2007, with a median of 25 CPGs. The mean scores were acceptable for the domain ‘Scope and purpose’ (64%; 95% CI 61.9 to 66.4) and ‘Clarity and presentation’ (60%; 95% CI 57.9 to 61.9), moderate for domain ‘Rigour of development’ (43%; 95% CI 41.0 to 45.2), and low for the other domains (‘Stakeholder involvement’ 35%; 95% CI 33.9 to 37.5, ‘Editorial independence’ 30%; 95% CI 27.9 to 32.3, and ‘Applicability’ 22%; 95% CI 20.4 to 23.9). From those guidelines that included an overall assessment, 62% (168/270) were recommended or recommended with provisos. There was a significant improvement over time for all domains, except for ‘Editorial independence.’ Conclusions This review shows that despite some increase in quality of CPGs over time, the quality scores as measured with the AGREE Instrument have remained moderate to low over the last two decades. This finding urges guideline developers to continue improving the quality of their products. International collaboration could help increasing the efficiency of the process.

Values and preferences for oral antithrombotic therapy in patients with atrial fibrillation: physician and patient perspectives

Exploration of values and preferences in the context of anticoagulation therapy for atrial fibrillation (AF) remains limited. To better characterize the distribution of patient and physician values and preferences relevant to decisions regarding anticoagulation in patients with AF, we conducted interviews with patients at risk of developing AF and physicians who manage patients with AF.

Alzheimer's disease dementia guidelines for diagnostic testing: a systematic review.

Alzheimer’s disease dementia (AD dementia) is one of the most common neurodegenerative diseases worldwide, with a growing incidence during the last decades. Clinical diagnosis of cognitive impairment and presence of AD biomarkers have become important issues for early and adequate treatment. We performed a systematic literature search and quality appraisal of AD dementia guidelines, published between 2005 and 2011, which contained diagnostic recommendations on AD dementia. We also analyzed diagnostic recommendations related to the use of brief cognitive tests, neuropsychological evaluation, and AD biomarkers. Of the 537 retrieved references, 15 met the selection criteria. We found that Appraisal of Guidelines Research and Evaluation (AGREE)-II domains such as applicability and editorial independence had the lowest scores. The wide variability on assessment of quality of evidence and strength of recommendations were the main concerns identified regarding diagnostic testing. Although the appropriate methodology for clinical practice guideline development is well known, the quality of diagnostic AD dementia guidelines can be significantly improved.

Low- vs. high-pressure suction drainage after total knee arthroplasty: a double-blind randomized controlled trial

AIM The aim of this study was to assess the efficacy of continuous low-pressure suction drainage compared with closed high-pressure suction following total knee arthroplasty. BACKGROUND Closed wound drainage systems are used in surgical interventions to reduce the incidence of haematomas, promote wound healing and reduce infections. However, evidence shows that using a closed wound drainage system can increase transfusion requirements. DATA SOURCES A randomized, double-blind and parallel controlled trial was performed. Adult knee replacement patients recruited between May 2006 and March 2007 were assigned to receive low-pressure suction of 50 mmHg (experimental drainage) or high-pressure suction of 700 mmHg (comparator drainage). METHODS The primary outcome was total blood loss after surgery. Secondary outcomes were incidence of transfusion, complications and mortality. Statistical analysis was based on an intention-to-treat approach. Linear regression was performed to account for factors that could influence blood loss. RESULTS A total of 169 patients were included. Mean age was 73 (±6) years, 128 women and 41 men. A total of 84 patients were randomized to the experimental drainage and 85 to the comparator drainage. Analysis showed a total postoperative blood loss of 541·8 mL in the experimental group and 524·4 mL in the comparator group (P = 0·734). The only factor that showed an association with blood loss was the length of surgery. Linear regression did not show differences between the groups. CONCLUSION Continuous low-pressure suction of 50 mmHg is not more effective than the higher aspiration pressure system to diminish the blood loss in total knee arthroplasty. The results do not support any change in current nursing practice relating to the use of this drain system.

Efficacy and safety of urinary catheters with silver alloy coating in patients with spinal cord injury: a multicentric pragmatic randomized controlled trial. The ESCALE trial

BACKGROUND Patients with spinal cord injury (SCI) who carry indwelling urinary catheters have an increased risk of urinary tract infection (UTI). Antiseptic silver alloy-coated (SAC) silicone urinary catheters prove to be a promising intervention to reduce UTIs; however, current evidence cannot be extrapolated to patients with SCI. PURPOSE This study aimed to assess the efficacy of SAC urinary catheters for preventing catheter-associated urinary tract infections. DESIGN/SETTING This is an open-label, multicenter (developed in Spain, Portugal, Chile, Turkey, and Italy), randomized clinical trial conducted in 14 hospitals from November 2012 to December 2015. PATIENT SAMPLE Eligible patients were men or women with traumatic or medical SCI, aged ≥18 years, requiring an indwelling urinary catheter for at least 7 days. OUTCOME MEASURES The primary outcome was the incidence of symptomatic UTIs. The secondary outcome included bacteremia in the urinary tract and adverse events. MATERIALS AND METHODS Patients were randomized to receive a SAC urinary catheter (experimental group) or a standard catheter (control group) for at least 7 days. Data were compared using chi-squared test and also calculating the absolute risk difference with a 95% confidence interval. An adjusted analysis including different risk factors of UTI was performed. This study was mainly funded by La Marató de TV3 Foundation (grant number # 112210) and the European Clinical Research Infrastructures Network organization. The funders had no role in the interpretation or reporting of results. RESULTS A total of 489 patients were included in the study, aged 55 years in the experimental group and aged 57 in the control group (p=.870); 72% were men; 43% were hospitalized patients, and 57% were outpatients (p=1.0). The most frequent cause of SCI was traumatic (73.75%), and the localization was mainly the cervical spine (42.74%). Most of the patients had an A score (complete spinal injury and no motor and sensory is preserved) on the ASIA scale (62.37%). The median time of urethral catheterization was 27 days in the experimental group and 28 days in the control group (p=.202). Eighteen patients (7.41%) in the experimental group and 19 in the control (7.72%) group had a symptomatic UTI (odds ratio [OR] 0.96 [0.49-1.87]). The adjusted analysis revealed no change in the results. Only three patients in the experimental group had bacteremia within the urinary tract. The experimental group presented more adverse events related to the use of a catheter than the control group (OR 0.03 [0.00-0.06]). CONCLUSIONS The results of this study do not support the routine use of indwelling antiseptic SAC silicone urinary catheters in patients with SCI. However, UTIs associated to long-term urinary catheter use remain a challenge and further investigations are still needed.

Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).

Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research.