Lubna A. Al-Ansary

Point-of-Care Testing for Hb A1c in the Management of Diabetes: A Systematic Review and Metaanalysis

BACKGROUND The measurement of hemoglobin A(1c) (Hb A(1c)) is employed in monitoring of patients with diabetes. Use of point-of-care testing (POCT) for Hb A(1c) results at the time of the patient consultation potentially provides an opportunity for greater interaction between patient and caregiver, and more effective care. OBJECTIVE To perform a systematic review of current trials to determine whether POCT for Hb A(1c), compared with conventional laboratory testing, improves outcomes for patients with diabetes. METHODS Searches were undertaken on 4 electronic databases and bibliographies from, and hand searches of, relevant journal papers. Only randomized controlled trials were included. The primary outcome measures were change in Hb A(1c) and treatment intensification. Metaanalyses were performed on the data obtained. RESULTS Seven trials were found. There was a nonsignificant reduction of 0.09% (95% CI -0.21 to 0.02) in the Hb A(1c) in the POCT compared to the standard group. Although data were collected on the change in proportion of patients reaching a target Hb A(1c) of <7.0%, treatment intensification and heterogeneity in the populations studied and how measures were reported precluded pooling of data and metaanalysis. Positive patient satisfaction was also reported in the studies, as well as limited assessments of costs. CONCLUSIONS There is an absence of evidence in clinical trial data to date for the effectiveness of POCT for Hb A(1c) in the management of diabetes. In future studies attention to trial design is needed to ensure appropriate selection and stratification of patients, collection of outcome measures, and action taken upon Hb A(1c) results when produced.

Risk Factors for Spontaneous Abortion: A Preliminary Study on Saudi Women

A preliminary case-control study was conducted on Saudi women to detect possible risk factors for spontaneous abortion (SA). Two hundred and twenty six consecutive women hospitalised for SA and 226 women admitted for normal delivery and used as controls, were studied. Women with SA were significantly older at menarche (Relative Risk (RR) = 3.2), more frequently married to blood-related husbands (RR = 2.1) and husbands older than 50 years (RR = 2.4). Number of previous abortions related linearly to the risk of aborting spontaneously in the next pregnancy. Compared to primigravidas, the RR was 3.2 if the outcome of the most recent pregnancy was SA, and 0.8 if it was a livebirth. A family history of SA was more common among cases (RR = 4.6). Spontaneous abortion was also associated with daily consumption of more than 150 mg of caffeine, abdominal trauma, infection and fever during pregnancy. No significant association, however, emerged with mater nal age, social class, education, exposure to video display terminals, parity, use of contraception, diabetes or obesity. The application of these data in clinical practice and future research needs are discussed.

Guidance for modifying the definition of diseases: a checklist

Importance No guidelines exist currently for guideline panels and others considering changes to disease definitions. Panels frequently widen disease definitions, increasing the proportion of the population labeled as unwell and potentially causing harm to patients. We set out to develop a checklist of issues, with guidance, for panels to consider prior to modifying a disease definition. Observations We assembled a multidisciplinary, multicontinent working group of 13 members, including members from the Guidelines International Network, Grading of Recommendations Assessment, Development and Evaluation working group, and the World Health Organisation. We used a 5-step process to develop the checklist: (1) a literature review of issues, (2) a draft outline document, (3) a Delphi process of feedback on the list of issues, (4) a 1-day face-to-face meeting, and (5) further refinement of the checklist. The literature review identified 12 potential issues. From these, the group developed an 8-item checklist that consisted of definition changes, number of people affected, trigger, prognostic ability, disease definition precision and accuracy, potential benefits, potential harms, and the balance between potential harms and benefits. The checklist is accompanied by an explanation of each item and the types of evidence to assess each one. We used a panel’s recent consideration of a proposed change in the definition of gestational diabetes mellitus (GDM) to illustrate use of the checklist. Conclusions and Relevance We propose that the checklist be piloted and validated by groups developing new guidelines. We anticipate that the use of the checklist will be a first step to guidance and better documentation of definition changes prior to introducing modified disease definitions.

Risk factors for spontaneous abortion among Saudi women.

The objective of this study was to identify important risk factors for spontaneous abortion (SA) among Saudi women. It was a casecontrol study conducted at King Khalid University Hospital, Riyadh, Saudi Arabia. The cases were 226 consecutive women hospitalized for SA between October 1992 and January 1993. The controls were 226 consecutive women who had normal delivery in the same hospital during the same period. Bivariate analysis using chi-square tests and estimates of relative risks indicated a positive association of age at menarche with risk of SA (P<0.01). Also, there was a significant higher risk of SA when a woman was married to a blood related husband than if married to a non relative (RR=2.1). The number of previous abortions was also positively related to the risk of SA in the current pregnancy (P<0.01). Compared to primigravidas, the risk of SA was 3.2 times greater than if the outcome of the most recent pregnancy was also an SA. Other factors that had significant bivariate association with SA were a family history of SA, abdominal trauma, and infection during pregnancy. When multiple logistic regression was used to adjust for the effects of confounding variables, all the factors that showed significant bivariate association with SA (except outcome of the last pregnancy) remained significant. Early menarche may be protective, but further study is needed to confirm this. Greater attention should be given to pregnant women who had personal or family history of SA and those who had trauma and/or infection during pregnancy. Premarital counselling concerning consanguineous marriages is recommended.

Management of convulsive status epilepticus in children: an adapted clinical practice guideline for pediatricians in Saudi Arabia

Objective: To increase the use of evidence-based approaches in the diagnosis, investigations and treatment of Convulsive Status Epilepticus (CSE) in children in relevant care settings. Method: A Clinical Practice Guideline (CPG) adaptation group was formulated at a university hospital in Riyadh. The group utilized 2 CPG validated tools including the ADAPTE method and the AGREE II instrument. Results: The group adapted 3 main categories of recommendations from one Source CPG. The recommendations cover; (i)first-line treatment of CSE in the community; (ii)treatment of CSE in the hospital; and (iii)refractory CSE. Implementation tools were built to enhance knowledge translation of these recommendations including a clinical algorithm, audit criteria, and a computerized provider order entry. Conclusion: A clinical practice guideline for the Saudi healthcare context was formulated using a guideline adaptation process to support relevant clinicians managing CSE in children.

Adapting evidence-based clinical practice guidelines at university teaching hospitals: A model for the Eastern Mediterranean Region

RATIONALE, AIMS, AND OBJECTIVES Clinical practice guidelines (CPGs) are significant tools for evidence-based health care quality improvement. The CPG program at King Saud University was launched as a quality improvement program to fulfil the international accreditation standards. This program was a collaboration between the Research Chair for Evidence-Based Healthcare and Knowledge Translation and the Quality Management Department. This study aims to develop a fast-track method for adaptation of evidence-based CPGs and describe results of the program. METHODS Twenty-two clinical departments participated in the program. Following a CPGs awareness week directed to all health care professionals (HCPs), 22 teams were trained to set priorities, search, screen, assess, select, and customize the best available CPGs. The teams were technically supported by the programs CPG advisors. To address the local health care context, a modified version of the ADAPTE was used where recommendations were either accepted or rejected but not changed. A strict peer-review process for clinical content and methodology was employed. RESULTS In addition to raising awareness and building capacity, 35 CPGs were approved for implementation by March 2018. These CPGs were integrated with other existing projects such as accreditation, electronic medical records, performance management, and training and education. Preliminary implementation audits suggest a positive impact on patient outcomes. Leadership commitment was a strength, but the high turnover of the team members required frequent and extensive training for HCPs. CONCLUSION This model for CPG adaptation represents a quick, practical, economical method with a sense of ownership by staff. Using this modified version can be replicated in other countries to assess its validity.

007 Partnering To Transform Clinical Research Into Evidence-Based Health Care Guidelines

Background Despite the availability of clinical practice guidelines (CPGs) on the management of diabetes mellitus type 2 (DMT2), optimal control is not achieved in many parts of the world. Objectives To assess whether recent nationally-endorsed DMT2 CPGs refer to Cochrane reviews that relate to the recommendations of these CPGs. Methods MEDLINE, EMBASE, guideline agency websites and Google were searched for CPGs written in English on the management of DMT2 in any practice setting published between Jan 2008 – Jan 2013. Four raters independently appraised each CPG using the AGREE-II instrument. The Cochrane Library (CL) was searched for published reviews using ‘Diabetes mellitus, Type 2’ [MeSH]. Reviews published one year prior to the CPG’s publication date were considered ‘available’ reviews. Two reviewers independently assessed their relevance for the CPGs’ recommendations. Results Five CPGs were identified. The highest scores were for ‘clarity-of-presentation’ and the lowest were for ‘applicability’. The CL search retrieved 45 reviews; 7 of them were assessed as irrelevant. The Canadian-2008, the Australian-2009 and the UK-NICE-2008/2009 guidance referred respectively to 80%, 85.7% and 93.8% of “potential” Cochrane reviews. The American-Diabetes-Association Standards of Medical Care in Diabetes 2013 cited 9/38 and the Malaysian 1/18 recent review. This variation in the uptake of relevant Cochrane reviews was not directly related to the rigour-of-development domain score. Implications for Guideline Developers, Adaptors, Implementers, and/or Users Despite the increased production of Cochrane reviews, guidelines developers do not consistently refer to them. This needs to be explored and the practical means for maximising their uptake should be entertained.

A validation study comparing the sensitivity and specificity of the new Dr. KSU H1N1 RT- PCR kit with real-time RT-PCR for diagnosing influenza A (H1N1)

Background and Objectives: A new test (Dr. KSU H1N1 RT-PCR kit) was recently developed to provide a less expensive alternative to real-time reverse transcriptase-polymerase chain reaction (RT-PCR). We report the findings of a validation study designed to assess the diagnostic accuracy, including sensitivity and specificity, of the new kit, as compared to real-time RT-PCR. Design and Setting: Cross-sectional validation study conducted from 18-22 November 2009 at a primary care clinic for H1N1 at a tertiary care teaching hospital in Riyadh. Patients and Methods: Nasopharyngeal swab samples and data on socio-demographic characteristics and symptoms were collected from 186 patients. Swab samples were sent to the laboratory for testing with both real-time RT-PCR and the new Dr. KSU H1N1 RT-PCR kit. We measured the sensitivity and specificity of the new test across the entire sample size and investigated how these values were affected by patient socio-demographic characteristics and symptoms. Results: The outcomes of the two tests were highly correlated (kappa=0.85; P<.0001). The sensitivity and specificity of the new test were 99.11% and 83.78%, respectively. The sensitivity of the new test was affected only minimally (96%-100%) by patient characteristics and number of symptoms. On the other hand, the specificity of the new test varied depending on how soon patients were tested after onset of symptoms (100% specificity when swabs were taken on the first day of the symptoms, decreasing to 75% when swabs were taken on or after the third day). The specificity of the new test also increased with increasing body temperature. Conclusion: The new test seems to provide a cost-effective alternative to real-time RT-PCR for diagnosing H1N1 influenza. However, further testing may be needed to verify the efficacy of the test in different settings and communities.

Vacunas para la prevención de la gripe en personas de edad avanzada

Resumen Antecedentes Durante las ultimas cuatro decadas, las vacunas han sido la principal arma global para disminuir la repercusion de la gripe en las personas de edad avanzada, y a nivel mundial se recomiendan para los individuos de 65 anos o mas de edad. El objetivo principal de la vacunacion contra la gripe en las personas de edad avanzada es reducir el riesgo de complicaciones en quienes son mas vulnerables. Objetivos Evaluar la efectividad de las vacunas sobre la prevencion de la gripe, la enfermedad similar a la gripe, los ingresos hospitalarios, las complicaciones y la mortalidad en las personas de edad avanzada. Identificar y evaluar los estudios comparativos que evaluan los efectos de las vacunas para la gripe en las personas de edad avanzada. Documentar los tipos y la frecuencia de los efectos adversos asociados con las vacunas contra la gripe en las personas de edad avanzada. Estrategia de busqueda Se realizaron busquedas en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials, CENTRAL), que contiene el Registro Especializado de Ensayos Controlados del Grupo Cochrane de Infecciones Respiratorias Agudas (Cochrane Acute Respiratory Infections [ARI]) (The Cochrane Library numero 4 de 2009), MEDLINE (enero de 1966 hasta la primera semana de octubre de 2009); EMBASE (1974 hasta octubre de 2009) y Web of Science (1974 hasta octubre de 2009). Criterios de seleccion Ensayos controlados aleatorios (ECAs), ensayos controlados cuasialeatorios, estudios de cohortes y estudios de casos y controles que evaluan la eficacia contra la gripe (casos confirmados por laboratorio), la efectividad contra la enfermedad similar a la gripe (ESG) o la seguridad. Se considero cualquier vacuna administrada de forma independiente, en cualquier dosis, preparacion o cronograma de administracion, comparada con placebo o ninguna intervencion. Obtencion y analisis de los datos Los informes se agruparon en primer lugar segun el contexto del estudio (comunidad o establecimientos de atencion a largo plazo) y luego por el nivel de circulacion virica y de pareamiento de la vacuna. Se estratifico adicionalmente por la administracion concomitante de la vacuna de polisacarido antineumococico (PPV) y por diferentes tipos de vacunas contra la gripe. Se analizaron los siguientes resultados: gripe, enfermedad similar a la gripe, ingresos hospitalarios, complicaciones y muertes. Resultados principales Se incluyeron 75 estudios. En general se identificaron 100 conjuntos de datos. Se identifico un ECA que evaluo la eficacia y la efectividad. Aunque el mismo parecio mostrar un efecto contra los sintomas de la gripe no tuvo poder estadistico suficiente para detectar efectos sobre las complicaciones (1348 participantes). La base de pruebas restante incluyo ensayos controlados no aleatorios. Debido a la baja calidad general de los ensayos controlados no aleatorios y la probable presencia de sesgos, que dificultan la interpretacion de estos datos y hacen que cualquier conclusion solida se torne potencialmente enganosa, no fue posible establecer conclusiones claras acerca de los efectos de las vacunas en las personas de edad avanzada. Conclusiones de los autores Las pruebas disponibles son de calidad deficiente y no proporcionan orientacion con respecto a la seguridad, la eficacia o la efectividad de las vacunas contra la gripe en las personas de 65 anos de edad o mas. Para resolver la incertidumbre se debe realizar un ensayo aleatorio controlado con placebo, con financiamiento publico y con poder estadistico adecuado, durante varias estaciones.