Transcutaneous electric nerve stimulation of acupuncture points improves tolerance in adults undergoing diagnostic upper gastrointestinal endoscopy: a single-center, double-blinded, randomized controlled trial.

BACKGROUND: Oesophagogastroduodenoscopy (OGDS) is the most common diagnostic procedure for upper gastrointestinal diseases. It often causes discomfort and anxiety, which are only mitigated by systemic sedation. However, sedation poses additional risks of adverse cardiopulmonary events, increased medical costs, and prolonged recovery. Transcutaneous electrical nerve stimulation of acupuncture points (Acu-TENS) is a non-invasive and innovative approach that induces analgesic effect during endoscopy. This trial is the first to be reported in English that explores the potential of Acu-TENS to increase patient tolerance during non-sedated elective diagnostic OGDS. METHODS: A double-blinded randomized controlled trial involving 348 subjects was conducted at a tertiary hospital to evaluate the success rate of OGDS with Acu-TENS. Subjects aged 18-75 years scheduled for their first elective diagnostic OGDS were randomized into the intervention (Acu-TENS) and placebo arms. OGDS success was assessed based on subjects' satisfaction ratings on a Likert scale and procedure's technical adequacy. Secondary measures included subjects' willingness to undergo future OGDS under similar conditions, procedure duration, and the endoscopist's perceived ease of the procedure. RESULTS: OGDS success rates were significantly higher with Acu-TENS (77.8%) than with the placebo (68.0%; odds ratio [OR] 1.64, 95% confidence interval [CI] 1.01-2.66, p = 0.043). Subjects who received Acu-TENS expressed higher willingness for future OGDS (78.9%) than those who received the placebo (68.6%; OR 1.71, 95% CI 1.04-2.79, p = 0.031). Procedure duration were significantly shorter in the intervention arm (6.0 min) than in the placebo arm (10.0 min; p = 0.002). No adverse effects were reported, and endoscopists perceived similar procedure ease in both arms. CONCLUSIONS: Acu-TENS improved OGDS success and enhanced patients' experiences during non-sedated OGDS. It demonstrated safety with no side effects and reduced the procedure completion time. It could be used as an adjunct in non-sedated diagnostic OGDS.

What inhibits "speaking up" for patient safety among healthcare workers? A cross-sectional study in Malaysia.

BACKGROUND: In healthcare, "speaking up" refers to when healthcare workers raise concerns regarding patient safety through questions, sharing information, or expressing their opinion to prevent harmful incidents and ensure patient safety. Conversely, withholding voice is an act of not raising concerns, which could be beneficial in certain situations. Factors associated with speaking up and withholding voices are not fully understood, especially in strong authoritarian societies, such as Malaysia. This study aimed to examine the factors associated with speaking up and withholding the voices of healthcare workers in Malaysia, thus providing suggestions that can be used in other countries facing similar patient safety challenges. METHODS: This cross-sectional study was conducted in a tertiary hospital in Sarawak State, Malaysia. Data were collected from 474 healthcare workers from 43 departments using a self-administered questionnaire for speaking up and withholding voices measures in 4 weeks prior to data analysis as well as socio-demographic factors of healthcare workers (sex, age group, profession, department, weekly work hours for patient care, years of employment in the hospital, and the hierarchical level) and speaking up related climate of the working environment were recorded. Data were analyzed using descriptive statistics. Logistic regression was performed to find out (adjusted) odds ratio of frequent speaking up and withholding voices. RESULTS: Nurse compared to doctors and healthcare workers with short weekly working hours were more likely to speak up. Healthcare workers in emergency and intensive care department, those with short years of employment, and those who worked at low hierarchical levels were less likely to speak up. Healthcare workers in discouraging environment towards speaking up were more likely to withhold their voices. CONCLUSIONS: This study demonstrates the characteristics of healthcare workers who speak up and those who withhold their voices in Malaysia. To ensure patient safety and prevent harm, it is essential to establish an encouraging environment that promotes speaking up and prevents withholding voices among healthcare worker, especially in circumstances where multiple types of healthcare workers with different socio-demographic backgrounds work together.

Introduction of a newly created AW stereotactic frame: a phantom-based accuracy evaluation and an initial experience in clinical usage.

BACKGROUND: A new stereotactic frame was created in 2015, based on a linear algorithm. It is called Albert Wong (AW) frame. A simple AW stereo-calculator was also designed based on Excel® (Microscoft Corporation, Redmond, WA) programme for the frame. OBJECTIVE: The aim of this study is to test the accuracy of the AW frame by a direct head to head comparison with CRW® frame (Integra Life Sciences, Plainsboro, NJ) on a phantom. METHODS: This is a prospective pilot cross-sectional phantom study with a total of 42 (21 for AW and 21 for CRW®) laboratory testings performed in 2017 at our institute to compare the accuracies of both frames in a consecutive manner. A phantom (BL phantom) was newly created, where targets can be placed at different heights and positions on a platform attached under the frame for accuracy testing comparing between the AW and CRW® frames. RESULTS: A comparable accuracy testing results were observed between the AW and CRW® frames of 0.64 mm versus 1.07 mm respectively. Approval from the local ethics committee for a clinical trial was obtained. We report on three case illustrations who had the AW frame-based biopsies with definitive diagnoses and without any post-biopsy related complication. CONCLUSION: AW frame successfully demonstrated a good accuracy of 0.64 mm in phantom testing using the BL phantom by a linear algorithmic calculation. The clinical trial with three patients demonstrated definitive diagnoses and safety with its use.

Gender and Ethnic Differences in Diabetes Self Care in Malaysia: An Individual Participant Meta-Analysis of Summary of Diabetes Self Care Activities Studies.

Background: Many published studies in Malaysia have examined and assessed self care among type 2 diabetes mellitus (T2DM) patients using the Summary of Diabetes Self Care Activities (SDSCA) scale. The current paper is a meta-analysis of related studies that also examines how gender and ethnicity influence and shape T2DM self care practices in Malaysia. Methods: We undertook a bibliographic search for studies conducted and published in Malaysia on T2DM adults using the SDSCA scale. This is a two-stage individual participant meta-analysis of SDSCA which synthesised the overall and subscale score based on gender and ethnic groups as well as the correlation between SDSCA and HbA1c. Results: We examined 11 studies that utilised SDSCA to analyse 3,720 T2DM patients. The overall SDSCA score was 33.46 (47.8% of the 7-day week). The subscale score for general diet, specific diet, exercise, blood glucose self-monitoring and foot care were 4.80, 4.09, 2.87, 1.80 and 3.21, respectively. A small but statistically significant better self care in some gender or ethnic groups was noted. The SDSCA diet subscale and HbA1c showed statistically significant correlation. Conclusion: The finding suggested Malaysian T2DM patients were deficient in exercise and blood glucose self-monitoring. In fact, overall self care among Malaysian adult T2DM patients appears to be suboptimal across gender and the three main ethnic groups. Greater efforts are therefore needed to educate Malaysian adult T2DM patients to improve their self care practices.

A Step-by-Step Process on Sample Size Determination for Medical Research.

Determination of a minimum sample size required for a study is a major consideration which all researchers are confronted with at the early stage of developing a research protocol. This is because the researcher will need to have a sound prerequisite knowledge of inferential statistics in order to enable him/her to acquire a thorough understanding of the overall concept of a minimum sample size requirement and its estimation. Besides type I error and power of the study, some estimates for effect sizes will also need to be determined in the process to calculate or estimate the sample size. The appropriateness in calculating or estimating the sample size will enable the researchers to better plan their study especially pertaining to recruitment of subjects. To facilitate a researcher in estimating the appropriate sample size for their study, this article provides some recommendations for researchers on how to determine the appropriate sample size for their studies. In addition, several issues related to sample size determination were also discussed.

Ratio of Nitric Oxide Metabolite Levels in Cerebrospinal Fluid and Serum, and Their Correlation with Severity and Outcome in Patients with Subarachnoid Haemorrhage.

BACKGROUND: Nitric oxide (NO) is involved in a multitude of physiological processes in the central nervous system (CNS). Given the ubiquitous nature of NO and its involvement in various vital processes, nitric oxide metabolite (NOx) has been investigated as a biomarker in CNS diseases. This study aims to investigate the ratio of NOx levels and serum in cerebrospinal fluid (CSF) in patients with spontaneous subarachnoid haemorrhage (SAH). The associations among these markers with clinical outcomes were also studied. METHODS: A prospective cohort study was conducted over a 2-year period (May 2013-May 2015) to investigate the levels of NOx in the CSF and serum of patients with radiologically confirmed aneurysmal SAH. NOx samples and all relevant data were collected from the patients on admission and serially over 5 days. On admission, NOx levels were compared between the groups of patients, who were divided as per the World Federation Neurosurgeons Score (WFNS) grading scale, Fisher scale, occurrence of vasospasm on transcranial doppler (TCD), and Glasgow outcome scale (GOS) upon discharge and at 6 months follow-up. The ratios of CSF-to-serum were calculated and correlated with SAH severity and the outcome parameters listed above. RESULTS: The patients (N = 40) had a mean (SD) age of 58.2 (11.8) years old. The majority (65%) had a higher severity of SAH (WFNS score 3-5). On evaluation of the CT scan findings, 74% had outcomes equivalent to 4 on the Fisher scale. Vasospasm was detected via TCD in nearly half (45%) of the cohort during the study period; 80% were noted to have a poor outcome (GOS 1-3) at discharge; this persisted at 6 months follow-up. Comparison of NOx levels in the CSF/serum ratio was based on the incidence of vasospasm and severity of outcome (GOS) for day-1 and day-4. Statistically significant results were evident for patients with better outcomes, high severity grading, and the presence of vasospasm (P-values: 0.031, 0.034 and 0.043, respectively). CONCLUSION: Elevated NOx levels in CSF and serum and reductions in the ratio of NOx in CSF/serum were found to be associated with severity, occurrence of vasospasm and clinical outcome in aneurysmal SAH patients. This indicates the possible role of NOx as a biomarker to assess severity and prognosis in patients with SAH.

The Development and Validation of Job Satisfaction Questionnaire for Health Workforce.

BACKGROUND: This study aims to develop and validate a job satisfaction questionnaire (JS-Q) for health workforce who are employed by a healthcare institution. METHODS: The study consists of six phases which begins with eliciting a conceptual understanding of the subject matter which is then followed by questions development, designing the overall structure and format of the questionnaire, assessing both its content validity and face validity, conducting a pilot study and finally a field test. A sample of study respondents who were permanent hospital staff above 18 years of age had been recruited from three government hospitals in Kuching, Sarawak, Malaysia. RESULTS: The finalised JS-Q consists of a total of 34 questions that were based on 8 domains. For all these 8 domains, the minimum loading of each item on the factors was calculated to be at least 0.500, its coefficient of Cronbach's alpha was calculated to be at least 0.750 and its corrected item-total correlation was calculated to be at least 0.500. The goodness of fit of the model was determined to be satisfactory with a value of Chi-square/df < 3.0, and a value of root mean square error approximation (RMSEA) < 0.8 and finally with both Tucker Lewis index (TLI) and comparative fit index (CFI) > 0.9. CONCLUSION: This newly developed and validated questionnaire (JS-Q) is found to be a valid and reliable study instrument for assessing job satisfaction among health workforce.

An Application of the Runs Test to Test for Randomness of Observations Obtained from a Clinical Survey in an Ordered Population.

Runs test is a statistical procedure which determines whether a sequence of data within a given distribution have been derived with a random process or not. It may be applied to test the randomness of data in a survey that collect data from an ordered population. This article illustrates on method to perform a runs test and explains the rationale for performing it by providing some examples of how this test can be applied. The aim of this article was to describe on ways to use the runs test in a clinical survey from an ordered population to determine the degree of randomness in the sequence of subjects who are recruited within a sample obtained from the whole population. Clinical survey that involves an ordered population usually collects data from subjects who have been recruited by a consecutive sampling method. Therefore, this study recommends that the degree of randomness in the sequence of selected variable(s) obtained from consecutive sampling is necessary to be tested from a pilot study to ensure random data collection in the study.

A Review on Sample Size Determination for Cronbach's Alpha Test: A Simple Guide for Researchers.

BACKGROUND: Reliability studies are commonly used in questionnaire development studies and questionnaire validation studies. This study reviews the sample size guideline for Cronbach's alpha test. METHODS: Manual sample size calculation using Microsoft Excel software and sample size tables were tabulated based on a single coefficient alpha and the comparison of two coefficients alpha. RESULTS: For a single coefficient alpha test, the approach by assuming the Cronbach's alpha coefficient equals to zero in the null hypothesis will yield a smaller sample size of less than 30 to achieve a minimum desired effect size of 0.7. However, setting the coefficient of Cronbach's alpha larger than zero in the null hypothesis could be necessary and this will yield larger sample size. For comparison of two coefficients of Cronbach's alpha, a larger sample size is needed when testing for smaller effect sizes. CONCLUSIONS: In the assessment of the internal consistency of an instrument, the present study proposed the Cronbach's alpha's coefficient to be set at 0.5 in the null hypothesis and hence larger sample size is needed. For comparison of two coefficients' of Cronbach's alpha, justification is needed whether testing for extremely low and extremely large effect sizes are scientifically necessary.

Sample Size Guidelines for Logistic Regression from Observational Studies with Large Population: Emphasis on the Accuracy Between Statistics and Parameters Based on Real Life Clinical Data.

BACKGROUND: Different study designs and population size may require different sample size for logistic regression. This study aims to propose sample size guidelines for logistic regression based on observational studies with large population. METHODS: We estimated the minimum sample size required based on evaluation from real clinical data to evaluate the accuracy between statistics derived and the actual parameters. Nagelkerke r-squared and coefficients derived were compared with their respective parameters. RESULTS: With a minimum sample size of 500, results showed that the differences between the sample estimates and the population was sufficiently small. Based on an audit from a medium size of population, the differences were within ± 0.5 for coefficients and ± 0.02 for Nagelkerke r-squared. Meanwhile for large population, the differences are within ± 1.0 for coefficients and ± 0.02 for Nagelkerke r-squared. CONCLUSIONS: For observational studies with large population size that involve logistic regression in the analysis, taking a minimum sample size of 500 is necessary to derive the statistics that represent the parameters. The other recommended rules of thumb are EPV of 50 and formula; n = 100 + 50i where i refers to number of independent variables in the final model.

Validation of Malay Version of Body Self- Image Questionnaire-Short Form among Malaysian Young Adults.

BACKGROUND: Body self-image questionnaire-short form (BSIQ-SF) is developed to measure body image perceptions. Due to the cultural, language and environmental differences between western and eastern population, the validity and reliability need to be established. The aim of this study was to determine validity and reliability of Malay version BSIQ-SF. METHODS: A cross-sectional study involved web-based survey was employed. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) was performed using SPSS version 22 and Mplus 7.3. RESULTS: There were 688 young adults in Malaysia with mean age of 23.67 (SD = 0.188) and mean body mass index (BMI) of 23.34 (SD = 0.27) participated in the study. Exploratory factor analysis performed and the number domains reduced from nine to four, namely 'Negative Affect', 'Attractiveness Evaluation', 'Physical Functionality Awareness' and 'Height Dissatisfaction'. CFA further confirmed the structure of the model with adequate goodness-of-fit values [CFI = 0.927, TLI = 0.913, SRMR = 0.075, RMSEA = 0.053 (95% CI: 0.047, 0.060)]. CONCLUSION: The revised 21-item of the Malay version BSIQ-SF was a valid and reliable instrument to measure body image perceptions among Malaysian young adults.

Evaluation of creatine kinase and liver enzymes in identification of severe dengue.

BACKGROUND: Existing biomarkers such as AST, ALT and hematocrit have been associated with severe dengue but evidence are mixed. Recently, interests in creatine kinase as a dengue biomarker have risen. These biomarkers represent several underlying pathophysiological processes in dengue. Hence, we aimed to assess AST, ALT, CK and hematocrit in identification of severe dengue and to assess the correlational relationship amongst common biomarkers of dengue. METHODS: This was a retrospective cohort study of confirmed dengue patients who were warded in Kuala Lumpur Hospital between December 2014 and January 2015. CK, AST, ALT, hematocrit, platelet count, WBC and serum albumin were taken upon ward admission and repeated at timed intervals. Composite indices based on admission AST and ALT were analyzed. Correlation coefficients and coefficients of determination were computed. RESULTS: Among the 365 cases reviewed, twenty-two (6%) patients had severe dengue. AST and ALT were found to be good at identification of severe dengue. The AST2/ALT composite index was the most accurate (AUC 0.83; 95% CI 0.73 - 0.93). Optimal cutoff was 402 with a sensitivity of 59.1% (95% CI: 36.4 - 79.3%) and specificity of 92.4% (95% CI: 89.1 - 95.0%). Modified cutoff of 653 had a sensitivity of 40.9% (95% CI: 20.7 - 63.7%) and specificity of 97.4% (95% CI: 95.1 - 98.8%). Our analyses also suggested that several underlying biological processes represented by biomarkers tested were unrelated despite occurring in the same disease entity. Also, markers of plasma leakage were discordant and AST was likely hepatic in origin. CONCLUSIONS: The composite index AST2/ALT may be used as a marker for identification of severe dengue based on admission AST and ALT, with two choices of cutoff values, 402 and 653. AST is most likely of liver origin and CK does not provide additional value.

Mandarin parents' evaluation of developmental status in the detection of delays.

BACKGROUND: We examined the parental perception and accuracy of the Mandarin translation of the Parents' Evaluation of Developmental Status, a screening questionnaire for parent concerns about children's various developmental skills. METHODS: The questionnaire was translated into Mandarin. Upon enrollment, caregivers completed the Mandarin PEDS and answered four questions about its acceptability and usefulness, and its ease of understanding and completion. The Mandarin PEDS was independently evaluated by a pediatrician and a community nurse, and classified as high risk (≥two predictive concerns), medium risk (one predictive concern), low risk (any non-predictive concerns) or no risk (if no concern) for developmental delays. The caregivers repeated Mandarin PEDS at a 2 week interval for test-retest reliability, while the children underwent testing for accuracy using a developmental assessment test. RESULTS: The majority (≥85%) of the 73 caregivers perceived the Mandarin PEDS as acceptable and useful, as well as easy to understand and complete. Fifteen (20.5%) and 24 responses (33.9%) were classified as high and moderate risk, respectively. The test-retest and inter-rater reliabilities were excellent, with an intra-class correlation coefficient of 0.812 (95% CI: 0.701-0.881, P < 0.001) and a kappa value of 0.870 (P < 0.001), respectively. Mandarin PEDS was 80.0% sensitive and 83.8% specific for those in the high-risk category (adjusted OR, 64.68; 95% CI: 1.33-3,139.72; P = 0.035). CONCLUSION: Mandarin PEDS was well received by the caregivers, and was reliable and accurate in detecting developmental delays in the Mandarin-speaking subjects. We recommend it for early detection of children with developmental and behavioral problems.

Validation of the Malay version of Diabetes Quality of Life (DQOL) Questionnaire for Adult Population with Type 2 Diabetes Mellitus.

OBJECTIVE: We aimed to validate the Malay version of Diabetes Quality of Life (DQOL) questionnaire for Malaysian adult population with type 2 diabetes mellitus (DM). METHODS: This is a cross-sectional study to validate Malay version of DQOL among the adult diabetic patients. DQOL questionnaire has 46 items consist of three domains, namely Satisfaction Domain, Impact Domain and Worry Domain. Both forward and backward translations from the English version of DQOL into Malay version were performed. After the face validity of the Malay version was established, it was then pilot-tested. Finally, the validity and reliability of the final Malay version of DQOL questionnaire were evaluated. RESULTS: There were 290 patients participated in this study with a mean (SD) age of 53.1 (10.0) years. The Cronbach's alpha coefficients of the overall items and the main domains were between 0.846 and 0.941. The Pearson's correlation coefficients for the three domains were between 0.228 and 0.451. HbA1C was found to be positively correlated with Impact Domain (P = 0.006). The Worry Domain was associated with diabetic retinopathy (P = 0.014) and nephropathy (P = 0.033). CONCLUSION: The Malay version of diabetes quality of life (DQOL) questionnaire was found to be a valid and reliable survey instrument to be used for Malaysian adult patients with diabetes mellitus.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

BACKGROUND: The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. METHODS: This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. RESULTS: A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. CONTROL: 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. CONTROL: -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. CONCLUSIONS: This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. TRIAL REGISTRATION: Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Risk Factors and Prediction Models for Retinopathy of Prematurity.

OBJECTIVES: To develop a simple prediction model for the pre-screening of Retinopathy of Prematurity (ROP) among preterm babies. METHODS: This was a prospective study. The test dataset (January 2007 until December 2010) was used to construct risk prediction models, and the validation dataset (January 2011 until March 2012) was used to validate the models developed from the test dataset. Two prediction models were produced using the test dataset based on logistic regression equations in which the development of ROP was used as the outcome. RESULTS: The sensitivity and specificity for model 1 [gestational age (GA), birth weight (BW), intraventricular haemorrhage (IVH) and respiratory distress syndrome (RDS)] was 82 % and 81.7%, respectively; for model 2, (GA and BW) the sensitivity and specificity were 80.5% and 80.3%, respectively. CONCLUSION: Model 2 was preferable, as it only required two predictors (GA and BW). Our prediction model can be used for early detection of ROP to avoid poor outcomes.

Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care.

BACKGROUND: Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. METHODS/DESIGN: A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. DISCUSSION: Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia. TRIAL REGISTRATION: ClinicalTrials.gov NCT01545401.

An elaboration on sample size determination for correlations based on effect sizes and confidence interval width: a guide for researchers.

Objectives: This paper aims to serve as a useful guide for sample size determination for various correlation analyses that are based on effect sizes and confidence interval width. Materials and Methods: Sample size determinations are calculated for Pearson's correlation, Spearman's rank correlation, and Kendall's Tau-b correlation. Examples of sample size statements and their justification are also included. Results: Using the same effect sizes, there are differences between the sample size determination of the 3 statistical tests. Based on an empirical calculation, a minimum sample size of 149 is usually adequate for performing both parametric and non-parametric correlation analysis to determine at least a moderate to an excellent degree of correlation with acceptable confidence interval width. Conclusions: Determining data assumption(s) is one of the challenges to offering a valid technique to estimate the required sample size for correlation analyses. Sample size tables are provided and these will help researchers to estimate a minimum sample size requirement based on correlation analyses.

Quality of life following laparoscopic totally extraperitoneal repair of a unilateral reducible inguinal hernia.

BACKGROUND: Laparoscopic totally extraperitoneal (TEP) inguinal hernia repair has become increasingly favored over open Lichtenstein tension-free mesh repair owing to its associated benefits, including reduced postoperative pain, early return to normal activities, and a comparable recurrence rate. In recent years, emphasis has been placed on patient-reported outcomes, particularly health-related quality of life (QOL), as a critical metric for evaluating surgical success. This study aimed to evaluate the overall QOL following laparoscopic TEP repair of unilateral inguinal hernia. METHODS: This prospective study enrolled patients aged 18 years or older who underwent elective laparoscopic TEP hernia repair for unilateral inguinal hernia from April 2020 to March 2022. Data collected include demographic details, hernia characteristics, postoperative complications, and postoperative QOL assessment. The Short Form 36 Health Survey Version 2 (SF-36v2), a validated general QoL questionnaire, was administered preoperatively and at 1 month, 6 months, and 1 year postoperatively. Statistical analysis utilized paired t-tests for comparisons, with significance set at a p-value <.05. RESULTS: A cohort of 49 patients, with a mean (standard deviation) age of 56.7 (14.0) years, predominantly comprising 47 men, was available for evaluation. Complications were observed in three (6.1%) of cases, with seroma/hematoma occurring in two patients and a wound infection necessitating antibiotic treatment in one patient. Notably, there were no instances of recurrence during the study period. Postoperative assessments revealed significant improvements in both physical and mental health at 1 month, with continued improvement noted up to 12 months. CONCLUSION: Laparoscopic TEP inguinal hernia repair has been shown to improve both physical and mental health in patients with unilateral reducible inguinal hernia, with the majority of the improvement typically occurring within the initial month following surgery. It is crucial to communicate these improvement trends to patients undergoing hernia repair to help manage their expectations effectively.

Sample size determination for conducting a pilot study to assess reliability of a questionnaire.

This article is a narrative review that discusses the recommended sample size requirements to design a pilot study to assess the reliability of a questionnaire. A list of various sample size tables that are based on the kappa agreement test, intra-class correlation test and Cronbach's alpha test has been compiled together. For all calculations, type I error (alpha) was set at a maximum value of 0.05, and power was set at a minimum value of 80.0%. For the kappa agreement test, intra-class correlation test, and Cronbach's alpha test, the recommended minimum sample size requirement based on the ideal effect sizes shall be at least 15, 22, and 24 subjects respectively. By making allowances for a non-response rate of 20.0%, a minimum sample size of 30 respondents will be sufficient to assess the reliability of the questionnaire. The clear guideline of minimum sample size requirement for the pilot study to assess the reliability of a questionnaire is discussed and this will ease researchers in preparation for the pilot study. This study provides justification for a minimum requirement of a sample size of 30 respondents specifically to test the reliability of a questionnaire.