Predictors of adherence to diabetes medicationss: multicentre study from the Eastern Province, Saudi Arabia

Background: The prevalence of diabetes mellitus disease (DM) is growing rapidly across the world, however the rate of increment is considerably high in Arab countries, which increases in them the risks of developing microvascular (e.g., retinopathy, nephropathy, and neuropathy) and macrovascular diseases (e.g., cardiovascular diseases and cerebrovascular disease). Better Adherence to diabetes medications play important role in achieving better health outcomes and preventing the complications of the disease. However, there are different factors that might affect the adherences. The aim of the study was to evaluate the predicators of the level of adherence of type 2 DM patients in the Eastern Province, KSA. Methodology: 376 participants were randomly selected from two hospitals in the Eastern Province, Saudi Arabia, and adherence towards anti-diabetic drugs was measured using the General Medication Adherence Scale (GMAS). Results: The participants included equal proportion of males and females, 79% with older than 50 years, 46% with an education of primary school or lower, and 43% with monthly income of 5000 SAR or lower. Among the participants, 22% did not have any diabetes related complications, 38% were on oral medication as well as insulin injection for diabetes and 10% had history of hospitalisation due to diabetes. Importantly, 37% (138/376) of participants were reported partial or lower adherence level, and only 42% (160/376) of participants reported high level of adherence. The degree of adherence was also lower among participants had Random blood glucose level (RBG) of 200 mg/dl or more compared to participants with RBG of 200 mg/dl or lower (p-value<0.001) (AU)

Efficacy of core stability training on upper extremity performance in collegiate athletes.

OBJECTIVE: To determine the efficacy of a five-week core stability training program for collegiate athletes on upper extremity performance measures. METHODS: Seventy healthy collegiate athletes (age 21.6±1.7years; height 175±4.63 cm; body mass 65.31±5.63 kg) were randomly allocated to experimental (n=35) and control group (n=35). The experimental group has undergone a five-week core stabilisation protocol (three days /week) and regular training, whereas the control group maintained their regular training. The upper quarter Y balance test (UQ-YBT) and Functional throwing performance index (FTPI) were assessed pre and post-training. RESULTS: The results of mixed ANOVA show that there was a significant interaction between time and group variables on YBT (p<0.001, ηp2 =0.759) and FTPI (p<0.001, ηp2 =0.411) after five weeks of core stability training. Statistically, significant improvement was shown in YBT (mean change=15.2, p<0.001) and FTPI (mean change=14.4, p<0.001) in the experimental group; however, there was no significant change observed in both outcomes in the control groups. CONCLUSION: After five weeks of core stabilisation training program, the measures of UQ-YBT and FTPI were improved, thus advocating the use of a core stabilisation training program among collegiate athletes to enhance their upper extremity performance.

Impact of Pharmacophobia and Pharmacophilia on Perception of Medication Use and Self-Medication Behaviors in Saudi Arabia.

Objectives: Pharmacophilia and pharmacophobia have positive and negative effects on treatment outcomes. There exist lacune of information on these phenomena in middle east countries. Therefore the current study aimed to determine the pattern and predictors of Pharmacophilia and pharmacophobia in Saudi Arabia. The study further explored the impact of these phenomena on the perception of medication use and self-medication behaviours. Experimental design: An online questionnaire-based cross-sectional study was conducted during March-May 2021. Saudi residents aged 15 years or older were eligible for this study. Individuals' attitude towards medication was assessed using the Drug attitude inventory classification questionnaire, and the general belief of medication was assessed using the Beliefs about Medicine Questionnaire. Observation: One-fifth (n = 101; 20%) and two-third (n = 338; 65%) participants were categorized as pharmacophobic and pharmacophilic, respectively. The mean BMQ score was not statistically significant between the pharmacophobic and pharmacophilic groups (mean difference = 0.314; p-value = 0.176). Males were more likely pharmacophilic than females [AOR: 0.34 (95% CI 0.17-0.69)]. Both groups showed nearly a similar pattern of self-medication behaviours. Conclusion: There exist a good number of pharmacophobic and pharmacophilic among the Saudi population. A detailed understanding of the attitudes towards treatment among these groups is essential for enhancing treatment outcomes.

Incidence and Risk Factors of Colistin-Induced Nephrotoxicity Associated with The International Consensus Guidelines for the Optimal Use of the Polymyxins: A Retrospective Study in a Tertiary Care Hospital, Saudi Arabia.

Background: Colistin is an effective therapy against multidrug-resistant gram-negative bacteria. However, nephrotoxicity is a major issue with its use. Objective: We aimed to evaluate the incidence and the potential risk factors of nephrotoxicity in colistin-treated patients. Methods: A retrospective cohort study was conducted. All adult patients aged 18 years and older who received colistin for ≥72 h were included in the study, while end-stage kidney disease patients requiring dialysis or had renal transplants were excluded. The incidence and severity of acute kidney injury (AKI) were assessed based on the Kidney Disease Improving Global Outcomes (KDIGO). Result: Out of 128 patients who received colistin, 51.56% of them have experienced AKI. The incidence was increased among oldest patients (above 80) and those who did not receive the appropriate dose (p-value = 0.0003). In addition, the median time until the AKI occurred was 10 days after receiving the colistin treatment. Rates of AKI in patients with previous AKI (71.7%) were three times higher than patients who did not previously experience AKI (HR = 2.97, 95% CI [1.8-4.8]). Conclusions: Nephrotoxicity is a significant issue among patients who receive colistin in the hospital, especially among older patients and those who did not receive the appropriate dose. As a result, healthcare providers should play a major role in colistin dosing, especially among the older adult population.

Short-Term Effects of Dry Needling with a Standard Exercise Program on Pain and Quality of Life in Patients with Chronic Mechanical Neck Pain.

BACKGROUND: This study aimed to determine the short-term effects of dry needling (DN) combined with a standard exercise program on pain and quality of life in patients with chronic mechanical neck pain (CMNP). METHODS: Thirty-one patients with CMNP were randomly allocated to the experimental and control groups. The experimental group received DN and underwent a standard exercise program (one DN session and six exercise sessions) for two weeks, whereas the control group underwent the same exercise program alone for two weeks. The participants' scores in the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), Short Form-36 Quality of Life Scale (SF-36 QOLS), and Beck Depression Inventory (BDI) before and after the intervention were assessed. RESULTS: The control and experimental groups' post-test NDI, NPRS, SF-36 QOLS, and BDI scores significantly differed from their baseline scores (p ≤ 0.05). The between-group comparison of the post-test scores using Wilcoxon rank-sum test revealed no significant differences between the NDI, NPRS, BDI, and SF-36 QOLS scores of both groups (p ≥ 0.05). CONCLUSIONS: One session of trigger point DN (TrP-DN) with exercise and exercise alone showed the same pain and quality-of-life outcomes after a two-week intervention. We did not recognise TrP-DN as an efficient intervention, not because we obtained evidence that it is ineffective, but because there were inadequate high-quality studies on the subject and unavailable data on the minimum quantity of injections required for better DN outcomes in CMNP patients.

Efficacy of Core Training in Swimming Performance and Neuromuscular Parameters of Young Swimmers: A Randomised Control Trial.

Background: This study aimed to investigate the efficacy of core training in the swimming performance and neuromuscular properties of young swimmers. Methods: Eighteen healthy male swimmers (age: 13 ± 2 years, height: 159.6 ± 14.5 cm, weight: 48.7 ± 12.4 kg) were recruited from the Public Authority for Sports swimming pool in Dammam and randomly assigned to the experimental and control groups. The experimental group performed a six-week core-training program consisting of seven exercises (three times/week) with regular swimming training. The control group maintained its regular training. Swimming performance and neuromuscular parameters were measured pre- and post-interventions. Results: The experimental group benefitted from the intervention in terms of the 50 m swim time (−1.4 s; 95% confidence interval −2.4 to −0.5) compared with the control group. The experimental group also showed improved swimming velocity (+0.1 m.s−1), stroke rate (−2.8 cycle.min−1), stroke length (+0.2 m.cycle−1), stroke index (+0.4 m2·s−1), total strokes (−2.9 strokes), and contraction time for erector spinae (ES; −1.5 ms), latissimus dorsi (LD; −7 ms), and external obliques (EO; −1.9 ms). Maximal displacement ES (DM-ES) (+3.3 mm), LD (0.5 mm), and EO (+2.2 mm) were compared with the baseline values for the experimental group, and TC-ES (5.8 ms), LD (3.7 ms), EO (2.5 ms), DM-ES (0.2 mm), LD (−4.1 mm), and EO (−1.0 mm) were compared with the baseline values for the control group. The intergroup comparison was statistically significant (p < 0.05; DM-ES p > 0.05). Conclusion: The results indicate that a six-week core-training program with regular swimming training improved the neuromuscular properties and the 50 m freestyle swim performance of the experimental group compared with the control group.

Exploring the perception and readiness of Pharmacists towards telepharmacy implementation; a cross sectional analysis.

Background: Amid the turbulent nature of the COVID-19 pandemic, telepharmacy has shifted the paradigm of patient care by leveraging digital medicine. Government mandated lockdowns and norms of social distancing have further underscored the need for telepharmacy. Many developed and developing countries implemented such initiatives where pharmacists have provided tele-pharmacy services via telecommunications. However, the implementation and utilization of tele-pharmacy services are quite negligible in resource limited settings due to financial and administrative constraints. This study was aimed to ascertain the perception and readiness of pharmacists working in various sectors of a resource limiting country. Methodology: A cross sectional study was carried out in all provinces of Pakistan to explore the perceptions of pharmacists towards telepharmacy implementation through a 35-items study instrument. The collected data was analyzed descriptively and scored accordingly. The chi-square test was used for inferential analysis on pharmacist's perception regarding implementation of tele-pharmacy with their demographics. Results: Of 380 pharmacists, the mean age is 27.67 ± 3.67 years with a preponderance of male pharmacists (n = 238, 62.6%). The pharmacists (n = 321, 84.5%) perceived that telepharmacy implementation improves patient's quality of life and decreases patients' visits (n = 291, 76.6%). Overall, pharmacists (n = 227, 59.7%) had negative perception towards benefits of telepharmacy implementation, but pharmacists had positive perception towards eligibility (n = 258, 67.9%), regulatory issues (n = 271, 71.3%) and telepharmacy during pandemic and beyond (n = 312, 82.1%). In chi-square testing gender (p = 0.03) and age (p = 0.03) had a significant association with perception regarding regulatory issues. Among perception regarding telepharmacy during COVID-19 pandemic and beyond age had a significant association (p = 0.03). Among perception regarding eligibility job location of pharmacists had significant association (p = 0.04). Conclusion: The majority of pharmacists had a positive perception regarding the eligibility of patients and regulatory issues/legal framework regarding the implementation of tele-pharmacy, as well as its use during the COVID-19 pandemic and beyond. The implementation of tele-pharmacy can play a major role in providing timely and better patient care to remote patient areas and may help in the prevention and treatment of different infectious diseases.

Patient satisfaction with pharmaceutical care services for chronic diseases and their medication adherence during COVID-19 in Saudi Arabia.

OBJECTIVES: During the ongoing coronavirus 2019 (COVID-19) pandemic, chronic disease management and medication adherence have become challenging; thus, health-related quality of life may have been compromised. As highly trusted healthcare providers, pharmacies in Saudi Arabia have undergone restructuring or redesign to cope with the current demands during the pandemic. The study assessed satisfaction levels of patients with chronic diseases concerning pharmaceutical care services provided during COVID-19 in addition to medication adherence and quality of life during the pandemic. METHODS: An online questionnaire-based cross-sectional study was administered. Saudi residents suffering from chronic diseases and receiving pharmaceutical care from a hospital or community pharmacy during the COVID-19 pandemic were eligible. The survey was created using Google Forms and distributed through online channels. The survey targeted 385 participants. KEY FINDINGS: A sample of 317 patients was included. More than half had missed a follow-up visit for their chronic conditions since the beginning of the pandemic. The overall mean score ± standard deviation for the satisfaction level with pharmaceutical care services was 22.0 ± 10.3 on a scale of 0-36 with different satisfaction levels for different services. In addition to a good level of medication adherence, a high percentage of these patients reported no problem in most of the dimensions of the EQ-5D scale. CONCLUSIONS: Pharmacists should take a more proactive and consultive role to deliver healthcare needs of patients with a chronic condition and be aware of patient expectations from a pharmacist in situations, such as the current pandemic.

A quasi-experimental trial of the clinical and economic impact of implementing of hepatitis B immunoglobulin policy post needle stick and sharp injuries in reducing its unnecessary use at a tertiary care hospital.

INTRODUCTION: Hepatitis B virus infection has the highest rate of transmission out of the blood-borne viruses in health care workers. Exposure to HBsAg positive source should be managed based on Hepatitis B serology results. Given that Hepatitis B immunoglobulin (HBIG) is an expensive medication with limited stock levels, it should be given more attention to make sure of its optimum use. This trial aims to evaluate the effectiveness of a policy on the use of HBIG following needle stick and sharp injuries among health care workers. METHODS: It is a quasi-experimental trial conducted at a Tertiary Care hospital in Saudi Arabia. The participants were health care workers who received HBIG following needle stick and sharp injuries from January 2018 to May 2020. Before and after implementing departmental guidelines and education on the post-exposure procedure, the trial re-evaluated the need for HBIG among the receivers. RESULTS: A total of 60 health care workers received HBIG for needle stick and sharp injuries between the trial period (pre- and post-implementation). The percentage of patients who received inappropriate HBIG was significantly lower during the post-implementation of the guideline (30%) than that among the pre-implementation period (60%). Thus, the direct cost associated with the inappropriate use was reduced from SAR 30000 to SAR 13500 post-implementation. CONCLUSION: The implementation of HBIG guidelines of use and education has led to a statistically significant decrease in its inappropriate use and led to cost reduction.

Changes in Attitude to Waterpipe Tobacco Smoking among Youngsters in Eastern Province, Saudi Arabia: A Cross-Sectional Study.

BACKGROUND: A growing number of epidemiological evidence suggests a significant increase in waterpipe tobacco smoking, and its potential to become a major public health concern in most Arabic countries, including Saudi Arabia. METHODS: A cross-sectional study was carried out to assess the prevalence of intention to quit among ever users of waterpipe and intention to start among the never users. The study also investigated the barriers that may prevent users from quitting or trigger the nonusers to start waterpipe smoking. The study consisted of 464 university students from Eastern Province, Saudi Arabia. RESULTS: One hundred and sixty-eight (36.2%) participants were responded that they had WTS at least one time in the past. Among the ever users of WTS, 120 (71.4%) participants had made an attempt or more to quit WTS in the past, 64 (38.1%) had made more than one attempt, and nearly two-third expressed the intention to quit WTS in the future. Forty (13.5%) out of 296 never-users expressed their intention to start WTS in the future. The study further showed that peer influence, social acceptance, and risk perception were significant predictors of intention to start or stop WTS among students. CONCLUSION: It is promising that substantial users have the intention to discontinue WTS, though a fraction of never users wish to try WTS in the future.
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The immediate psychological response of the general population in Saudi Arabia during COVID-19 pandemic: A cross-sectional study.

BACKGROUND: The outbreak of COVID-19 may differentially exacerbate anxiety and stress in people subjected to the real or perceived threat of the virus. METHOD: An online cross-sectional survey was carried out to assess the general population's psychological response during the initial state of the outbreak in Saudi Arabia. The study used brief screening tools PHQ-4 for anxiety-depression symptoms and IES-6 for posttraumatic stress disorder symptoms. RESULTS: Among the 584 respondents, 19.8% and 22.0% reported moderate to severe anxiety and depression symptoms respectively. According to the combined PHQ-4 score, 14.5% of participants showed moderate to severe anxiety or depression disorder. Overall, 64.8% met the level of clinical concern for posttraumatic stress disorder and 51.3% met the level of probable posttraumatic stress disorder diagnosis. Multivariate analyses showed that females, non-Saudi nationalities, and those who had a history of mental illness were more vulnerable to anxiety and depression disorders than their counterparts, whereas a higher prevalence of distress symptoms was reported among those who prefer Arabic over English for communication. It was found that people whose colleagues or family infected with the disease were more likely to report moderate to severe symptoms of anxiety or depression and distress. The study further showed that the higher the perceived threat, the higher the chances of exhibiting anxiety-depressive disorder symptoms and distress symptoms. CONCLUSION: The findings might be a matter for serious concern, and considerable attention is required from authorities and policymakers regarding early detection and treatment of these illnesses in order to reduce the burden of the pandemic related mental illness.

An observational study on adverse reactions of cosmetics: The need of practice the Cosmetovigilance system.

INTRODUCTION: Cosmetovigilance is public health surveillance on cosmetic products with a public health objective. Since the radical development in beautifying products in Saudi Arabia, the Saudi Food and Drug Authority takes the responsibility of regulating cosmetic products and issuing guidelines to ensure its safety. Despite this, there exists a lacuna of Re published reports on cosmetics-related adverse reactions in the Saudi population. We aimed to assess self-reported adverse reactions in the general public of the Eastern Province, Saudi Arabia. MATERIALS AND METHOD: A cross-sectional study was conducted for three months. The questionnaire for data collection was adopted and modified from previous studies for the cosmetic utilization behaviors and adverse reactions. RESULTS: Among the 425 participants, 50.6% reported that they had at least one adverse reaction in the past two years. Redness of the skin (19%), pimples (15%), and itching (13%) were the commonly reported adverse reactions. The majority of the adverse reactions were reported with hair care (29%) and skincare products (25%). The majority [n = 181 (84.2%)] of the participants with managed the ARs by the cessation of the product use. The univariate analysis found that gender, age, allergic to medications and food, family history of allergy, mixing cosmetics, and frequent switching of cosmetic brands were associated with adverse events. However, the adjusted analysis found that allergic to medication (adjusted OR: 3.9), family history of allergy (adjusted OR: 1.91), and mixing cosmetics (adjusted OR: 1.70) were significantly associated with cosmetics-related adverse reactions. CONCLUSION: Cosmetovigilance is a model of safety monitoring of cosmetics. It can be considered as a one of the element in public health activities. Pharmacists should be more vigil on this issue in the near future. To strengthen the findings further, a national wide prevalence study can be conducted prospectively and analyses causality and report to the pharmacovigilanvce system of the country.

Evaluation of acinetobacter baumannii pneumonia among critically ill patients in a tertiary care hospital in Saudi Arabia.

Microbiology; Bacteria; Antimicrobial; Infectious disease; Medical microbiology; Pharmacology; Pneumonia; Acinetobacter baumannii; Colistin.

Off-label Medications Use in the Eastern Province of Saudi Arabia: The Views of General Practitioners, Pediatricians, and Other Specialists.

Background: Off-label drug prescribing remains a major pediatric health concern worldwide. The lack of studies in this vulnerable population causes many practitioners to prescribe drugs outside their license. This study aims to investigate and compare the current knowledge and views of general practitioners, pediatricians, and other specialists toward off-label pediatric prescribing. Methods: A descriptive, cross-sectional-based study conducted on a random sample of physicians who work in three different hospitals in the Eastern Province of Saudi Arabia. Results: Data were obtained from three hospitals, comprising a total of 160 practitioners. Overall, more than half of the participated practitioners (54%) were familiar with the definition of off-label prescribing. Thirty percentage of participated practitioners agreed that more than 10% of their prescribed medicines to children were off-labeled. A majority of participants expressed concerns over the efficacy (83%) and safety (92%) of off-label prescribing to children. Importantly, a noticeable proportion of the responders claimed that they sometimes observed an adverse drug reaction (n = 23; 20%) or treatment failure (n = 43; 37%) following off-label prescribing medicines to children. Only 46% participants have always informed the parents or guardian about the off-label prescription of medications to their children. Conclusion: A Large number of physicians are familiar with the concept of off-label prescribing of medicines to children in the Eastern Province of Saudi Arabia. Safety and efficacy are the main concerns of prescribing such medications. Policies toward improving pediatric clinical research and supporting the safety and efficacy of the drugs should be encouraged.

Assessment of knowledge and attitude toward the new antibiotic dispensing law and its effect on antibiotic use in Saudi Arabia.

BACKGROUND: Antibiotics resistance is a serious problem around the world, which has been increasing in the last century due to misuse of antibiotics. Recently, Saudi Arabia enforced the Executive Regulations of Health Practice Law that prohibits dispensing antibiotics without prescription. AIM: (1) To assess the association between the knowledge and attitude toward the recent enforcement of the antibiotic restriction Law and the antibiotic use among Saudi population.(2) To assess the pattern of antibiotic use before and after the enforcement of the Law. METHOD: An online cross-sectional study was conducted among residents of Saudi Arabia. RESULTS: The study was carried out among 570 Saudi participants; the result shows no considerable difference before and after law enforcement in purchasing and use of antibiotics. During the six months before the law implementation, antibiotics were obtained by 42 (7%) through purchase from the pharmacy without a prescription, 23 (4%) through remains of previously used containers, and 7 (1%) through a relative or a friend; while during the six months after the law implementation it was 31 (5%), 22 (4%) and 7 (1%), respectively. Only 48% agreed that they always received advice from a doctor, nurse or pharmacist on how to use your antibiotics. 32% have no knowledge about antibiotic resistance or drug resistance or antibiotic-resistant bacteria. More than two third (75%) were aware of the recent enforcement of the law that prohibits dispensing antibiotics without prescription. Among the participants, 91 (16%), 285 (50%) and 194 (34%) were expressed negative, neutral and positive attitude towards the law, respectively. CONCLUSION: In spite of the recent enforcement of the Law, there is still misuse of antibiotics, which indicate need for educational programs and campaigns to improve the knowledge of the population.

Health-related quality of life among patients with type 2 diabetes mellitus in Eastern Province, Saudi Arabia: A cross-sectional study.

Diabetes mellitus has reached epidemic levels, and it threatens the economy and health globally and Saudi Arabia in particular. The study assessed health-related quality of life using EuroQol instrument and its predictors among patients with Type 2 diabetes mellitus in Eastern Province, Saudi Arabia. A cross-sectional study was conducted among 378 patients with Type 2 diabetes mellitus from two major health centers in Eastern Province. The study showed moderate health-related quality of life, as reported by the median index score of 0.808 with more than a quarter of patients with severe-extreme health state in some or all domains. Multiple-regression models showed that male gender, high monthly income, having no diabetes-related complications and having random blood glucose level less than 200 mg/dl were prone to have a higher index score compared to the corresponding contrary groups. The study will help in guiding the development of effective intervention programs to improve diabetes-related health-related quality of life among the Saudi population.

A causal modelling framework for reference-based imputation and tipping point analysis in clinical trials with quantitative outcome.

We consider estimation in a randomised placebo-controlled or standard-of-care-controlled drug trial with quantitative outcome, where participants who discontinue an investigational treatment are not followed up thereafter, and the estimand follows a treatment policy strategy for handling treatment discontinuation. Our approach is also useful in situations where participants take rescue medication or a subsequent line of therapy and the estimand follows a hypothetical strategy to estimate the effect of initially randomised treatment in the absence of rescue or other active treatment. Carpenter et al proposed reference-based imputation methods which use a reference arm to inform the distribution of post-discontinuation outcomes and hence to inform an imputation model. However, the reference-based imputation methods were not formally justified. We present a causal model which makes an explicit assumption in a potential outcomes framework about the maintained causal effect of treatment after discontinuation. We use mathematical argument and a simulation study to show that the "jump to reference", "copy reference" and "copy increments in reference" reference-based imputation methods, with the control arm as the reference arm, are special cases of the causal model with specific assumptions about the causal treatment effect. We also show that the causal model provides a flexible and transparent framework for a tipping point sensitivity analysis in which we vary the assumptions made about the causal effect of discontinued treatment. We illustrate the approach with data from two longitudinal clinical trials.

A Call for Effective Interventions to Curb Shisha Tobacco Smoking among University Students in Eastern Province, Saudi Arabia: Findings from a Cross-Sectional Study.

BACKGROUND: Although the number of cigarettes smoked has been declining due to major public health initiatives, shisha tobacco smoking is gaining popularity around the world, particularly among youth and university students. METHODS: A cross-sectional study was conducted among 464 university students in Eastern Province of Saudi Arabia using a structured questionnaire (i) to assess the prevalence of shisha smoking; (ii) to evaluate risk-perception, knowledge and normative belief about shisha smoking, and to compare these among users and non-users of shisha. RESULTS: The study reported a high prevalence (22.8%) of the current use of shisha among the university students with a narrow gender gap and found that STS is getting more popular than other forms of tobacco. A quarter of participants had low risk perception and 30.2% had low knowledge of shisha smoking harm. Importantly, more than two-fifth of them were current users of shisha. Low risk-perception about shisha and social acceptability were significantly contributed to the high prevalence of shisha smoking among the youth. CONCLUSION: It is important to provide exposure to education related to shisha hazards and increase the awareness of students and the public about the health effects of shisha smoking.

A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data.

OBJECTIVES: In randomized trials, the primary analysis should be consistent with the intention-to-treat (ITT) principle and should address missing data appropriately to draw valid inferences. This review focuses on current practices relating to the ITT principle and methods to handle missing data in the major musculoskeletal journals. STUDY DESIGN AND SETTING: A systematic review of randomized trials published in 2010 and 2011 in five musculoskeletal journals was performed. RESULTS: We reviewed 91 trials: 38% performed a full ITT analysis (analyzing outcome data for all randomized participants) and 31% performed a partial ITT analysis (excluding participants with no follow-up data). The overall median dropout was 12%; 60% of trials had more than 10% dropouts, and 32% of trials had more than 20% dropouts. Among those that performed an ITT analysis, the majority adopted a form of single imputation; last observation carried forward was the designated approach in most cases. Mixed models for repeated measures and/or multiple imputations were limited to eight trials. CONCLUSION: It appears that many trials reporting missing data are inappropriately analyzed and may therefore be prone to biased estimates and invalid inferences.