Current practices and challenges in adaptation of clinical guidelines: a qualitative study based on semistructured interviews

Investigación cualitativa; Calidad en la atención de la salud; Estadísticas y métodos de investigaciónQualitative research; Quality in health care; Statistics & research methodsRecerca qualitativa; Qualitat en l'atenció sanitària; Estadística i mètodes d'investigacióObjective This study aims to better understand the current practice of clinical guideline adaptation and identify challenges raised in this process, given that published adapted clinical guidelines are generally of low quality, poorly reported and not based on published frameworks. Design A qualitative study based on semistructured interviews. We conducted a framework analysis for the adaptation process, and thematic analysis for participants’ views and experiences about adaptation process. Setting Nine guideline development organisations from seven countries. Participants Guideline developers who have adapted clinical guidelines within the last 3 years. We identified potential participants through published adapted clinical guidelines, recommendations from experts, and a review of the Guideline International Network Conference attendees’ list. Results We conducted ten interviews and identified nine adaptation methodologies. The reasons for adapting clinical guidelines include developing de novo clinical guidelines, implementing source clinical guidelines, and harmonising and updating existing clinical guidelines. We identified the following core steps of the adaptation process (1) selection of scope and source guideline(s), (2) assessment of source materials (guidelines, recommendations and evidence level), (3) decision-making process and (4) external review and follow-up process. Challenges on the adaptation of clinical guidelines include limitations from source clinical guidelines (poor quality or reporting), limitations from adaptation settings (lacking resources or skills), adaptation process intensity and complexity, and implementation barriers. We also described how participants address the complexities and implementation issues of the adaptation process. Conclusions Adaptation processes have been increasingly used to develop clinical guidelines, with the emergence of different purposes. The identification of core steps and assessment levels could help guideline adaptation developers streamline their processes. More methodological research is needed to develop rigorous international standards for adapting clinical guidelines.YS is funded by China Scholarship Council (No 201707040103)

Quality assessment of clinical practice guidelines for chronic kidney disease : A systematic review

Chronic kidney disease (CKD) is a worldwide public health problem. Clinical practice guidelines (CPGs) are being developed and implemented in order to improve clinical practice related to the detection and treatment of CKD. The objective of our study was to evaluate the quality of CPGs regarding the CKD and to examine whether there are factors which influence their quality. A systematic search was conducted to identify all CPGs regarding the early diagnosis and treatment of CKD. The CPGs quality were evaluated by three reviewers using the AGREE II instrument to decide if the guidelines are recommended for their use in clinical practice. In total, 13 CPGs were identified: five from America, six from Europe, one from Asia, and one from Oceania. Five CPGs were recommended for their use in clinical practice; since all their domains achieved the medium or high category. Furthermore, six CPGs were recommended with modifications, as the stakeholders' involvement, applicability, and editorial independence domains were evaluated as low category. These domains, as well as the rigor of the development domain, reached the very low category in those CPGs that were not recommended for its use in clinical practice. In all CPGs, the domains with the lowest average were the stakeholder involvement and the applicability. When comparing the domains of the CPGs according to the origin, type of developer group, the checklist used during the development and the publication period, a significantly higher average in the domain stakeholder involvement was found in the CPGs from Asia and Oceania compared to the ones in Latin America. Additionally, a significantly higher average in the applicability domain was found in the CPGs developed by CPGs developer organizations compared to those developed by medical societies. In total, 85% of the CPGs regarding CKD were recommended or recommended with modifications. The stakeholder involvement and applicability domains are assessed in the low category, which might affect the CPGs implementation. In order to save resources in low- and middle-income countries, an adaptation of the recommended CPGs should be considered

Return to Play After Soleus Muscle Injuries

Soleus muscle injuries are common in different sports disciplines. The time required for recovery is often difficult to predict, and reinjury is common. The length of recovery time might be influenced by different variables, such as the involved part of the muscle. Injuries in the central aponeurosis have a worse prognosis than injuries of the lateral or medial aponeurosis as well as myofascial injuries. Case series; Level of evidence, 4. A total of 61 high-level or professional athletes from several sports disciplines (soccer, tennis, track and field, basketball, triathlon, and field hockey) were reviewed prospectively to determine the recovery time for soleus muscle injuries. Clinical and magnetic resonance imaging evaluation was performed on 44 soleus muscle injuries. The association between the different characteristics of the 5 typical muscle sites, including the anterior and posterior myofascial and the lateral, central, and medial aponeurosis disruption, as well as the injury recovery time, were determined. Recovery time was correlated with age, sport, extent of edema, volume, cross-sectional area, and retraction extension or gap. Of the 44 patients with muscle injuries who were analyzed, there were 32 (72.7%) strains affecting the myotendinous junction (MT) and 12 (23.7%) strains of the myofascial junction. There were 13 injuries involving the myotendinous medial (MTM), 7 affecting the MT central (MTC), 12 the MT lateral (MTL), 8 the myofascial anterior (MFA), and 4 the myofascial posterior (MFP). The median recovery time (±SD) for all injuries was 29.1 ± 18.8 days. There were no statistically significant differences between the myotendinous and myofascial injuries regarding recovery time. The site with the worst prognosis was the MTC aponeurosis, with a mean recovery time of 44.3 ± 23.0 days. The site with the best prognosis was the MTL, with a mean recovery time of 19.2 ± 13.5 days (P <.05). There was a statistically significant correlation between recovery time and age (P <.001) and between recovery time and the extent of retraction (P <.05). Wide variation exists among the different types of soleus injuries and the corresponding recovery time for return to the same level of competitive sports. Injuries in the central aponeurosis have a significantly longer recovery time than do injuries in the lateral and medial aponeurosis and myofascial sites

Long-term risks of stress and urgency urinary incontinence after different vaginal delivery modes

BACKGROUND: Although operative delivery increases the risk of immediate pelvic floor trauma, no previous studies have adequately compared directly the effects of different kinds of instrumental vaginal deliveries on stress urinary incontinence and/or urgency urinary incontinence. OBJECTIVE(S): The objectives of the study were to estimate and compare the impact of different kinds of vaginal deliveries, including spontaneous, vacuum, and forceps, on stress and urgency urinary incontinence. STUDY DESIGN: All women aged 20 years or older, living in 1 county in Norway were invited to participate in 2 surveys addressing stress and urgency urinary incontinence using validated questions, "Do you leak urine when you cough, sneeze, laugh, or lift something heavy?" and "Do you have involuntary loss of urine in connection with sudden and strong urge to void?" with response options yes or no. Incontinence data were linked to the Medical Birth Registry of Norway. For this study, we included only women who had a history of vaginal birth(s). Case definitions for stress and urgency urinary incontinence were moderate to severe based on Sandvik Severity Index (slight, moderate, severe). We adjusted analyses for age, parity, body mass index, and time since last delivery and addressed effect modification, including an age threshold of 50 years. RESULTS: The final analysis included 13,694 women of whom 12.7% reported stress urinary incontinence and 8.4% urgency urinary incontinence. Among women aged younger than 50 years, there was a statistically significant difference in the risk of stress urinary incontinence for forceps delivery (odds ratio, 1.42, 95% confidence interval, 1.09-1.86, absolute difference 5.0%) but not for vacuum (odds ratio, 0.80, 95% confidence interval, 0.59-1.09) when compared with spontaneous vaginal delivery. Among women aged younger than 50 years, forceps also had increased risk for stress urinary incontinence (odds ratio, 1.76, 95% confidence interval, 1.20-2.60) when compared with vacuum. There was no association of stress or urgency urinary incontinence with mode of delivery in women aged 50 years or older. CONCLUSION: For women aged younger than 50 years, forceps delivery is associated with significant increased long-term risk of stress urinary incontinence compared with other vaginal deliveries.Peer reviewe

Serum immunoglobulins and biomarkers of dementia:a population-based study

Background: Inflammation plays a key role in the development of dementia, but its link to early biomarkers, particularly those in plasma or neuroimaging, remains elusive. This study aimed to investigate the association between serum immunoglobulins and biomarkers of dementia. Methods: Between 1997 and 2009, serum immunoglobulins (IgA, IgG and IgM) were measured in dementia-free participants of the population-based Rotterdam Study. A random subset of participants had assessment of biomarkers in plasma (total tau (t-tau), neurofilament light chain (NfL), amyloid-β40 (Aβ-40), amyloid-β42 (Aβ-42), while another subset of participants underwent neuroimaging to quantify brain volume, white matter structural integrity and markers of cerebral small vessel disease. Linear regression models were constructed to determine cross-sectional associations between IgA, IgG, IgM and biomarkers of dementia, with adjustment for potential confounders. Multiple testing correction was applied using the false discovery rate. As a sensitivity analysis, we re-ran the models for participants within the reference range of immunoglobulins, excluding those using immunomodulating drugs, and conducted a stratified analysis by APOE-ε4 carriership and sex. Results: Of 8,768 participants with serum immunoglobulins, 3,455 participants (65.8 years [interquartile range (IQR): 61.5–72.0], 57.2% female) had plasma biomarkers available and 3,139 participants (57.4 years [IQR: 52.7–60.7], 54.4% female) had neuroimaging data. Overall, no associations between serum immunoglobulins and biomarkers of dementia remained significant after correction for multiple testing. However, several suggestive associations were noted: higher serum IgA levels concurred with lower plasma levels of Aβ-42 (standardized adjusted mean difference: -0.015 [95% confidence interval (CI): -0.029−-0.002], p = 2.8 × 10–2), and a lower total brain volume, mainly driven by less gray matter (-0.027 [-0.046−-0.008], p = 6.0 × 10–3) and more white matter hyperintensities (0.047 [0.016 – 0.077], p = 3.0 × 10–3). In sensitivity analyses, higher IgM was linked to lower t-tau, Aβ-40, and Aβ-42, but also a loss of white matter microstructural integrity. Stratified analyses indicate that these associations potentially differ between carriers and non-carriers of the APOE-ε4 allele and men and women. Conclusions: While associations between serum immunoglobulins and early markers of dementia could not be established in this population-based sample, it may be valuable to consider factors such as APOE-ε4 allele carriership and sex in future investigations.</p

Discovering Distinct Phenotypical Clusters in Heart Failure Across the Ejection Fraction Spectrum:a Systematic Review

Review Purpose: This systematic review aims to summarise clustering studies in heart failure (HF) and guide future clinical trial design and implementation in routine clinical practice. Findings: 34 studies were identified (n = 19 in HF with preserved ejection fraction (HFpEF)). There was significant heterogeneity invariables and techniques used. However, 149/165 described clusters could be assigned to one of nine phenotypes: 1) young, low comorbidity burden; 2) metabolic; 3) cardio-renal; 4) atrial fibrillation (AF); 5) elderly female AF; 6) hypertensive-comorbidity; 7) ischaemic-male; 8) valvular disease; and 9) devices. There was room for improvement on important methodological topics for all clustering studies such as external validation and transparency of the modelling process.Summary:The large overlap between the phenotypes of the clustering studies shows that clustering is a robust approach for discovering clinically distinct phenotypes. However, future studies should invest in a phenotype model that can be implemented in routine clinical practice and future clinical trial design. Graphical Abstract: HF = heart failure, EF = ejection fraction, HFpEF = heart failure with preserved ejection fraction, HFrEF = heart failure with reduced ejection fraction, CKD = chronic kidney disease, AF = atrial fibrillation, IHD = ischaemic heart disease, CAD = coronary artery disease, ICD = implantable cardioverter-defibrillator, CRT = cardiac resynchronization therapy, NT-proBNP = N-terminal pro b-type natriuretic peptide, BMI = Body Mass Index, COPD = Chronic obstructive pulmonary disease. [Figure not available: see fulltext.]</p

Quality appraisal of clinical guidelines for recurrent urinary tract infections using AGREE II:a systematic review

INTRODUCTION AND HYPOTHESIS: Recommendations for preventing and diagnosing recurrent urinary tract infection (UTI) tend to vary between clinical practice guidelines (CPGs) because of low-quality scientific evidence, potentially leading to practice variation and suboptimal care. We assessed the quality of existing CPGs for recurrent UTI. METHODS: A systematic search was performed from January 2000 to June 2021 in PubMed and EMBASE for CPGs on recurrent UTI prevention or hospital diagnostics in Dutch, English, and Spanish. Each CPG was assessed by four appraisers in a multidisciplinary review team, using the Appraisal of Guidelines, Research, and Evaluation II (AGREE II) instrument. RESULTS: We identified and assessed eight CPGs published between 2013 and 2021. The scope and purpose (mean and standard deviation: 67.3 ± 21.8) and clarity of presentation (74.8 ± 17.6) domains scored highly. However, issues with methods, patient participation, conflict of interests, and facilitators and barriers were common and resulted in lower scores for the rigour of development (56.9 ± 25.9), applicability (19.6 ± 23.4), stakeholder involvement (50.4 ± 24.6), and editorial independence (62.1 ± 23.1) domains. Overall, two CPGs were recommended, three were recommended with modifications, and three were not recommended. CONCLUSIONS: Significant room for improvement exists in the quality of CPGs for recurrent UTI, with most displaying serious limitations in the stakeholder involvement, rigour of development, and applicability domains. These aspects must be improved to decrease diagnostic and therapeutic uncertainty. Developers could benefit from using checklists and following guidelines when developing de novo CPGs