Investigating the effect of pre-transplant thrombocytopenia and anemia on the engraftment and long-term survival in multiple myeloma patients.

BACKGROUND: Autologous stem cell transplantation (ASCT) following high-dose melphalan is the standard treatment for Multiple Myeloma (MM). Despite new treatments, further investigation is needed to identify prognostic factors of ASCT. This study evaluated the impact of thrombocytopenia and anemia on the engraftment of MM patients after ASCT. MATERIALS AND METHODS: This retrospective study involved 123 MM patients who underwent ASCT with high-dose Melphalan. Successful engraftment is achieved when both platelets (Plt) and white blood cells (WBC) engraft successfully. We examined the statistically significant cut-offs for the prognostic factors on the admission day. Ultimately, the association of risk factors with the Plt and WBC engraftment and long-term survival were analyzed as the outcomes of interest. RESULTS: Spearman's correlation coefficient between Plt and WBC engraftment was 0.396 (p < 0.001). The engraftment in the patients with Plt < 140,000/µL was 17.4% slower (p = 0.036) and the odds of long-term survival was 72% lower (p = 0.016) than in patients with higher Plt. Patients with Hb < 11 g/dL were 12.7% slower in engraftment. Age over 47 was a significant factor in slower engraftment (p = 0.036) which decelerated the engraftment by 15.2%. CONCLUSION: Thrombocytopenia and anemia before transplantation are related to slower Plt/WBC engraftment and as prognostic factors might predict the long-term survival of MM patients following ASCT.

Prognostic Factors for the Long-Term Survival after Hematopoietic Stem Cell Transplantation in Patients with Hodgkin Lymphoma.

OBJECTIVES: This study investigated the possible prognostic factors for the long-term survival (Cure Rate) of Hodgkin Lymphoma patients who underwent HSCT. METHODS: This retrospective cohort study analyzed 116 Patients diagnosed with Hodgkin Lymphoma who received autologous hematopoietic stem cell transplantation (Auto-HSCT) between the years 2007 and 2014 and followed up until 2017. The information regarding patients' survival had been collected using phone calls, and their pre-transplant information was available in the archived documents. Prognostic effects were investigated using long-term survival models. RESULTS: Patients with obesity had five times higher odds of long-term survival (cure) than the others (P=0.06). Also, the recurrence experience after HSCT negatively impacted the curing potential by 78% (P=0.05). Also, with 32 years as the change point, patients younger than 32 had 76% fewer odds of surviving long-term (P=0.03), and Poor transfused stem cell dose of CD34+ (<0.16 × 106 cells/ml) reduced the odds of long-term survival by 92% (P=0.01). CONCLUSION: According to the statistical models used in this study, obesity can increase the curing potential of Hodgkin lymphoma after transplantation. Meanwhile, aging, poor transfused CD34+ cells, and recurrence after HSCT were associated with lower survival following HSCT.

Defective 3-parameter Gompertz model with frailty term for estimating cure fraction in survival data.

In several survival data, a proportion of units is not susceptible to the event of interest, even if, accompanied by a sufficiently large time, which is so-called immune or cured. In this paper, the defective Gamma 3-parameter Gompertz model with a frailty term is proposed for estimating the cure fraction. This model does not require adding extra parameters for modeling the cure rate, and it accommodates unimodal hazard shapes as well as monotone hazards. A simulation study has been carried out to assess the performance of the maximum likelihood estimators. The model was applied to two real data sets.

Cause-specific hazard regression estimation for modified Weibull distribution under a class of non-informative priors.

In time to event analysis, the situation of competing risks arises when the individual (or subject) may experience p mutually exclusive causes of death (failure), where cause-specific hazard function is of great importance in this framework. For instance, in malignancy-related death, colorectal cancer is one of the leading causes of the death in the world and death due to other causes considered as competing causes. We include prognostic variables in the model through parametric Cox proportional hazards model. Mostly, in literature exponential, Weibull, etc. distributions have been used for parametric modelling of cause-specific hazard function but they are incapable to accommodate non-monotone failure rate. Therefore, in this article, we consider a modified Weibull distribution which is capable to model survival data with non-monotonic behaviour of hazard rate. For estimating the cumulative cause-specific hazard function, we utilized maximum likelihood and Bayesian methods. A class of non-informative types of prior (uniform, Jeffrey's and half-t) is introduced for Bayes estimation under squared error (symmetric) as well as LINEX (asymmetric) loss functions. A simulation study is performed for a comprehensive comparison of Bayes and maximum likelihood estimators of cumulative cause-specific hazard function. Real data on colorectal cancer is used to demonstrate the proposed model.

Evaluation of the Factors Affecting the Cure Rate of Cervical Intra-Epithelial Neoplasia Recurrence Using Defective Models.

BACKGROUND: Treatment of cervical intraepithelial neoplasia is very important since if it remains untreated, it may progress to cervical cancer. It is usually treated with excisional surgery. This study aimed to find the factors affecting the cure rate of cervical intraepithelial neoplasia recurrence after surgery using defective models. STUDY DESIGN: A retrospective cohort study. METHODS: Excisional surgery was performed on 307 patients with high-grade cervical intraepithelial neoplasia, from 2009 to 2017. The patients were followed up until recurrence based on histopathology report. Hematologic factors were measured before surgery. The cure rates were estimated using defective models with a Gamma frailty term and the results were compared. RESULTS: Neutrophil-to-lymphocyte ratio (NLR) (P<0.001) and excised mass size (P<0.001) had significant impacts on cure rates, and their cut-off values were 1.9 (P<0.001) and 15 mm2 (P<0.001), respectively. Patients with lower neutrophil-to-lymphocyte ratios and larger excised tissues had higher cure rates. Defective 3-parameter Gompertz distribution with gamma frailty term had the best fit to the data, and its estimated cure rates were 98% among patients with an excised mass size of > 15 mm2 and NLR of <1.9, 84% among patients with an excised mass size of >15 mm2 and NLR of >1.9, 79% among patients with an excised mass size of <15 mm2 and NLR of <1.9, and 30% among patients with an excised mass size of <15 mm2 and NLR of >1.9. CONCLUSION: Cervical intraepithelial neoplasia must be identified and treated before its progress. Excision of more tissues during excisional surgery, especially when the NLR of the patient is high, can help to prevent cervical intraepithelial neoplasia recurrence.

Predictive Biomarker Panel in Proliferative Lupus Nephritis- Two-Dimensional Shotgun Proteomics.

INTRODUCTION: Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematous (SLE). With no specific clinical or laboratory manifestation to predict response to treatment, this study was aimed to provide a panel of predictive biomarkers of response before initiation of treatment. METHODS: Liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis was performed on plasma and urine samples of 11 patients with biopsy proven proliferative LN at the time of biopsy. Unsupervised principal component analysis (PCA), orthogonal projection to latent structures discriminant analysis (OPLS-DA), gene ontology annotation and protein mapping were performed on 326 proteins in plasma and 1381 proteins in urine samples. RESULTS: Samples of eight patients achieved complete remission and three reached partial remission were analyzed. The mean 24-hour protein excretion was 3259 mg/day and the mean eGFR was 87.73 cc/min. OPLS-DA analysis of plasma samples showed a clear discrimination for complete and partial remission patients. Twenty plasma proteins and ten urine proteins with the highest fold changes and AUCs were selected as candidate biomarkers (IGHV1-18, PI16, IGHD, C3, FCER2, EPS8L2, CTTN, BLVRB). This plasma and urine biomarker panel is involved in oxidative stress, acute inflammation, reduction in regulatory T cells, complement pathway consumption, and proximal tubule bicarbonate reclamation. CONCLUSION: Our suggested panel of plasma and urine biomarkers can precisely discriminate patients with possibility of complete response to treatment. It seems that the higher indices of inflammation will associate with better chance of achieving complete remission.

Evaluating the effect of Coriandrum sativum syrup on being migraine-free using mixture models.

Background: Coriandrum sativum (coriander) is prescribed as a treatment for headache in traditional Persian medicine. Several investigations have been carried out to find the medicinal properties of this plant. However, no study has evaluated the effectiveness of this plant on becoming migraine-free. Methods: Sixty-eight migraineurs were randomly allocated to two equal groups of intervention and control . Each received 500 mg of sodium valproate in addition to 15 mL of coriander or placebo syrup three times a day. We followed subjects and recorded their migraine duration in the 1st, 2nd, 3rd, and 4th weeks. We applied an appropriate statistical model so as to consider special features of the data, which led to more accurate results using SAS 9.4 Results: Our findings showed that the probability of being migraine-free was not only considerably higher in final weeks of the study (p<0.001) in all patients of the intervention group than placebo group, but it was also significantly higher in patients less than 30 years of age compared to patients older than 30 years old. Migraine duration in migraineurs using coriander syrup reduced considerably during the study (p<0.001). Conclusion: The finding of this study revealed that coriander has a significant effect both on the probability of being migraine free and the duration of migraine attacks. Its effects were more significant during the final weeks of study.

Sexual Compatibility with Spouse Questionnaire: Development and Psychometric Property Evaluation.

BACKGROUND: Sexual compatibility between husband and wife is an effective factor in both sexual and marital satisfaction. However, there is limited valid and reliable questionnaire to measure the degree of sexual compatibility between the couples. METHODS: In this exploratory mixed method study, 54 individuals were interviewed in the qualitative phase and 448 persons participated in the quantitative phase. Totally 502 participants (261 woman, 241 men) took part in this study. According to 205 final codes derived from the qualitative phase, 102 initial items were developed, the number of which reached 69 items after deletion and merging performed by the research team. After face validity, content validity and construct validity, 68 items were introduced into the construct validity phase. RESULTS: Following exploratory factor analysis and promax rotation, the items were reduced to 35 in 4 factors: "Requirements of a sexual relationship", "Sexual agreement", "Contextual obstacles" and "Outcomes of sexual compatibility". The questionnaire Cronbach alpha and correlation coefficient of the test-retest method were 0.90 and 0.91, respectively. CONCLUSION: Final Questionnaire included 35 items in 4 point-Likert scale with total score of between 35-140. This valid and reliable questionnaire is brief, easily interpreted and can measure the main factors affecting sexual compatibility with the spouse in clinics and research fields.

Analyzing Survival Rate of Leukemia Patients Applying Long Term Exponential Model.

BACKGROUND: Making progressin treatment of all branches of cancers has increasedthe percent of patients that never experience the event of interest. These cases are called immune or cure and models for handling the data included cure fraction rate, are referred to as cure model or long-term survival models. METHODS: The data for this historical cohort study, were collected from leukemia patients diagnosed between 2007 to 2014 and followed up until 2016 in Taleghani hospital and received BMT (Bone Marrow Transplant). Some data had to be excluded because of incomplete information. Using recorded files mostly and phone calls rarely, were made to confirm whether the patients were still alive or not. Death due to leukemia was regarded as interested event. Analysis were performed by R version 3.4.1and Stata version 14. RESULTS: Number of recurrents after receiving BMT, pre-transplant Hb and age at diagnosis were found as significant prognostics of survival time. HD patients had the highest 5-years overall survival in category of diagnosis type with 81.3%. Cure fraction was estimated to be 64.1%. CONCLUSION: According to high percentage of censoring, using long-term model had better fit.

Multistate Models to Predict Development of Late Complications of Type 2 Diabetes in an Open Cohort Study.

BACKGROUND: Increase in the prevalence of type 2 diabetic mellitus (T2DM) as a complex disease, its complications, and spread has become a dominant global health threat in recent decades. OBJECTIVE: The aim of the current study was to investigate the impact of risk factors and transition probability on the development and progression of the late complications of T2DM. METHODS: This study was an open cohort one which was conducted at Isfahan Endocrine and Metabolism Research Center (IEMRC). The data were collected from 1993 to 2018. The sample size consisted of 2519 adults diagnosed with type 2 diabetes. We applied the homogeneous multistate models including no complication, retinopathy alone, coronary artery disease (CAD), microalbuminuria, retinopathy and CAD, and the final absorbing mortality states. RESULTS: Based on our results, time-varying hypertension strongly intensified the hazard of transition to mortality in CAD, no complication, CAD and retinopathy, and retinopathy patients by 4.99, 4.09, 3.42, and 2.65 times, respectively. Hypertension seemed to be a potential factor for the transition of microalbuminuria to no complication in diabetic patients. One-unit increase in LDL increased the hazard ratio of transition from CAD, and retinopathy and CAD to mortality by 1.8% and 2.4%, respectively. Moreover, one level increase in time-varying HbA1c increased the hazard ratio of transition to retinopathy and mortality among no complication diabetic patients by 30% and 67%, respectively. One level increase in time-varying HbA1c also intensified the hazard ratio of transition from retinopathy to mortality by 45%. The same level of increase in time-varying HbA1c also intensified the hazard ratio of transition from CAD alone to CAD and retinopathy, and microalbuminuria to retinopathy by 26% and 50%, respectively. CONCLUSION: In addition to glycemic control, our study indicates that controlling hypertension and hyperlipidemia is more effective in reducing mortality and the diabetic macro- and microvascular complications.

Survival Rate and Prognostic Factors among Iranian Breast Cancer Patients.

BACKGROUND: Survival time is one of the indicators used for evaluation of the quality of care in different types of malignancies, including breast cancer. The present study aimed to estimate the survival rate of breast cancer and its related factors among Iranian patients. METHODS: Overall, 3148 cases of breast cancer who referred to the Cancer Research Center in Shahid Beheshti University of Medical Sciences, Tehran, Iran during 1994-2017 participated in this longitudinal study. Survival estimates were calculated using the Kaplan-Meier method and the Bayesian generalized Birnbaum-Saunders model with cure rate from geometric distribution. Clinical, pathological, and biological variables as potential prognostic factors were entered in univariate and multivariate analyses.In order to identify the significant prognostic factors, 95% highest posterior density (HPD) intervals were used. RESULTS: The overall 1, 5, 10, 15, 20 and 25-year survival rate were 95%, 75%, 60%, 47%, 46% and 46%, respectively. A significant relation was observed between survival time and the variables such as age, size of tumor, number of lymph nodes, stage, histological grade, estrogen receptor, progesterone receptor, and lymphovascular invasion. CONCLUSION: The findings of this study might help the health managers to plan long-term programs considering regional determinants, public education, and screening for early detection of breast cancer cases which can eventually influence the overall survival rate of these patients.

Development and validation of 'caring ability of family caregivers of patients with cancer scale (CAFCPCS)'.

AIM: Family caregivers have limited abilities that make them vulnerable to the care needs of patients. Therefore, it seems necessary to evaluate their caring ability. The aim of this study was to design an instrument for assessing the caring ability of family caregivers of cancer patients. METHODS: This was a sequential exploratory mixed-method study, carried out in two qualitative and quantitative phases. The concept of caring ability and its dimensions were explained using conventional content analysis in the qualitative phase. The research participants included 41 family caregivers of cancer patients and professional caregivers who were selected using purposeful sampling method until reaching data saturation. The scale items were designed using the results of the qualitative phase of the study, as well as the review of relevant literature. In the quantitative phase, the scale was validated using content and face validity, construct validity, as well as internal consistency and stability. RESULTS: The primary item pool was prepared in 108 items. Content validity was determined using CVR with a cut-off point (0.62), CVI with a cut-off point (0.8) and kappa coefficient (κ) (>0.75). The validity of 72 items was confirmed. Then, the overlapping items were merged and eventually the 45-item scale entered the face validity stage and five items with an impact factor < 1.5 were omitted. Results of KMO = 0.904 and Bartlett = 6184.012 (p < 0.001) justified the need for factor analysis. Scree plot indicates five factors with eigenvalues above 1 and 67.7% of the total variance, including 'Effective role play, Fatigue and Surrender, Trust, Uncertainty, and Caring ignorance'. Reliability of the 31-item instrument indicated a Cronbach's alpha coefficient of 0.93 and ICC of 0.94. CONCLUSIONS: Caring abilities scale (CAI) of family caregivers of patients with cancer is a valid and reliable instrument that can assess caregivers' caring ability.

Bayesian approach for cure models with a change-point based on covariate threshold: application to breast cancer data.

In this study, a Bayesian approach was suggested to estimate a change-point according to a covariate threshold when some patients never experienced the event of interest. Gibbs sampler algorithm with latent binary cure indicators was used to simplify the implementation of Markov chain Monte Carlo method. Then, the accuracy of new model was demonstrated by simulation studies to compute the point and interval estimates of parameters. Finally, an effective threshold was suggested in age at surgery time to experience the metastasis when the model was applied for a data set of breast cancer patients.

Spatiality in small area estimation: A new structure with a simulation study.

In numerous practical applications, data from neighbouring small areas present spatial correlation. More recently, an extension of the Fay-Herriot model through the Simultaneously Auto- Rregressive (SAR) process has been considered. The Conditional Auto-Regressive (CAR) structure is also a popular choice. The reasons of using these structures are theoretical properties, computational advantages and relative ease of interpretation. However, the assumption of the non-singularity of matrix (Im-ρW) is a problem. We introduce here a novel structure of the covariance matrix when approaching spatiality in small area estimation (SAE) comparing that with the commonly used SAR process. As an example, we present synthetic data on grape production with spatial correlation for 274 municipalities in the region of Tuscany as base data simulating data at each area and comparing the results. The SAR process had the smallest Root Average Mean Square Error (RAMSE) for all conditions. The RAMSE also generally decreased with increasing sample size. In addition, the RAMSE valuess did not show a specific behaviour but only spatially correlation coefficient changes led to a stronger decrease of RAMSE values than the SAR model when our new structure was applied. The new approach presented here is more flexible than the SAR process without severe increasing RAMSE values.

Effects of Early Enteral Glutamine Supplementation on Intestinal Permeability in Critically Ill Patients.

BACKGROUND AND AIMS: Enteral administration of glutamine has been proposed as an effective recovery of intestinal barrier function. This amino acid has a modulating effect on the reducing bacterial translocation, which can influence immune functions of the intestine. The objective was to evaluate the effects of early enteral glutamine supplementation on intestinal permeability in critically ill patients. MATERIALS AND METHODS: A total of 80 critically ill patients older than 18 years were randomly assigned to one of two groups according to the stratified blocked randomization by age and admission category. Consecutive participants took enteral formula plus 0.3 g/kg/day glutamine powder or enteral formula plus maltodextrin during the ICU stay for a maximum of 10 days. Plasma glutamine, endotoxin, zonulin, and antiendotoxin immunoglobulin (Ig)G/IgM concentrations were measured on days 5 and 10 of intervention. RESULTS: Out of 80 participants, 36 patients in the glutamine group and 34 patients in the control group were included in the analysis of the outcomes. Enteral glutamine significantly reduced plasma zonulin concentration up to 40% during 10 days. This reduction was significantly greater compared with that of the placebo group (p<0.001). Endotoxin concentration decreased in both groups; this reduction was significantly greater in the glutamine group (p = 0.014). The antiendotoxin IgM and IgG antibody levels increased in the glutamine group but decreased in the control group (p <0.001). There were no significant differences in clinical outcomes between two groups. CONCLUSION: Early enteral glutamine supplementation led to a declined intestinal permeability in critically ill patients. HOW TO CITE THIS ARTICLE: Shariatpanahi ZV, Eslamian G, Ardehali SH, Baghestani AR. Effects of Early Enteral Glutamine Supplementation on Intestinal Permeability in Critically Ill Patients. Indian J Crit Care Med 2019;23(8):356-362.

Determination of Cut Point in the Age of Colorectal Cancer Diagnosis Using a Survival Cure Model.

Background and Objectives: Colorectal Cancer (CRC) is the fourth cancer-related cause of death worldwide. CRC is a multi-stage cancer, which is curable during the early stages of the disease. Therefore, determining the time of cut-point existence could improve treatment planning and help directly allocate resources. This study aims to determine the cut point in the age of CRC diagnosis. Methods: This study, covering the course 1985 to 2012, consisted of 345 colorectal cancer patients registered in Taleghani Hospital, Tehran, Iran and followed up to 2013. The cut-point in the age of CRC diagnosis was obtained using a mixture cure model. The data were analyzed using SPSS and R, V. 20 and 2.15.0, respectively. Results: The results showed that the cut point in the age of CRC diagnosis was 50 years. Based on our estimation, 65% of the patients diagnosed with CRC at or younger than 50 were cured, while 31% of them diagnosed older than 50 were cured, and the younger group had a better survival over the older group. Conclusion: Since access to a cut-point and analysis of created prognostic groups are important in screening and treatment planning, our results suggested that it is better to estimate the cut-point in the age of curable cancers in early stages via survival cure models, and the cure rate would increase by CRC timely screening.

Effects of early enteral bovine colostrum supplementation on intestinal permeability in critically ill patients: A randomized, double-blind, placebo-controlled study.

OBJECTIVES: In this study we sought to investigate the effect of early enteral bovine colostrum supplementation on intestinal permeability in intensive care unit (ICU)-hospitalized patients. METHODS: A total of 70 ICU-hospitalized adult patients were randomly assigned to receive a bovine colostrum supplement or placebo according to the stratified blocked randomization by age and admission category. Plasma endotoxin and zonulin concentrations were measured on days 5 and 10 of intervention. RESULTS: Out of 70 participants, 32 patients in the colostrum group and 30 patients in the control group were included in the final analysis of the outcomes. Plasma endotoxin concentration decreased significantly in the colostrum group on the 10th day (P < 0.05). Furthermore, plasma levels of zonulin reduced in the colostrum group significantly compared with the placebo group (P < 0.001).The incidence of diarrhea was significantly lower in the colostrum group than in the control group (P = 0.02). CONCLUSIONS: Our results provide evidence that bovine colostrum supplementation may have beneficial effects on intestinal permeability and gastrointestinal complications in ICU-hospitalized patients. Further studies are needed to investigate the exact mechanism of action of these effects.

DEVELOPMENT AND PSYCHOMETRIC TESTING OF AN INSTRUMENT TO MEASURE WOMEN'S PERCEPTIONS OF UNPLANNED PREGNANCY.

A woman's decision to continue or terminate an unplanned pregnancy is affected by a broad range of contextual and cognitive factors. The identification of women's perceptions of unplanned pregnancy is crucial for health care providers to be able to offer supportive care and counselling. The aim of this study was to develop an instrument to accurately measure women's perceptions of unplanned pregnancy: the Women's Perceptions of Unplanned Pregnancy Questionnaire. The instrument was developed using a methodological framework guided by Waltz et al. (2010). A conceptual model of the designed instrument emerged from the qualitative study using a content analysis approach conducted in Tabriz, Iran. Participants were recruited using convenience sampling method between June 2016 and July 2017. Participants were a sample of married Iranian women between the ages of 15 and 49 who had experienced an unplanned pregnancy, either unwanted or mistimed, within the last 3 months. Women with an established diagnosis of a psychological disorder were excluded from the study. The psychometric properties of the instrument were assessed using face, content, concurrent and construct validations. To evaluate face validity, qualitative and quantitative (item impact score) methods were used. The content validity was assessed by fifteen panel experts. In addition, concurrent validity of the designed instrument was tested using the Persian version of the Cambridge Worry Scale and the Spielberger State-Trait Anxiety Inventory. The construct validity was calculated by using the exploratory factor analysis method. Data were collected from questionnaires completed by 310 eligible women. Analysis of the data using exploratory factor analysis yielded 31 items in a unique six-factor structure. The instrument was found to have high internal consistency (Cronbach's α=0.88) and adequate reliability (Intraclass Correlation Coefficient=0.89). A clearer understanding of women's perceptions of unplanned pregnancy may enhance reproductive services and interventions.

Trend of Gastric Cancer after Bayesian Correction of Misclassification Error in Neighboring Provinces of Iran.

BACKGROUND: Some errors may occur in the disease registry system. One of them is misclassification error in cancer registration. It occurs because some of the patients from deprived provinces travel to their adjacent provinces to receive better healthcare without mentioning their permanent residence. The aim of this study was to re-estimate the incidence of gastric cancer using the Bayesian correction for misclassification across Iranian provinces. MATERIALS AND METHODS: Data of gastric cancer incidence were adapted from the Iranian national cancer registration reports from 2004 to 2008. Bayesian analysis was performed to estimate the misclassification rate with a beta prior distribution for misclassification parameter. Parameters of beta distribution were selected according to the expected coverage of new cancer cases in each medical university of the country. RESULTS: There was a remarkable misclassification with reference to the registration of cancer cases across the provinces of the country. The average estimated misclassification rate was between 15% and 68%, and higher rates were estimated for more deprived provinces. CONCLUSION: Misclassification error reduces the accuracy of the registry data, in turn causing underestimation and overestimation in the assessment of the risk of cancer in different areas. In conclusion, correcting the regional misclassification in cancer registry data is essential for discerning high-risk regions and making plans for cancer control and prevention.

A placebo-controlled clinical trial to evaluate the effectiveness of massaging on infantile colic using a random-effects joint model.

BACKGROUND: Infantile colic viewed as a non-dangerous prevalent issue could lead to stress in parents and long-term negative consequences in ex-colicky children. Researchers have not been successful in finding a certain treatment for colic symptoms. Studies suggest completely different approaches as its treatment. Massage therapy as an alternative method in reducing colic symptoms has been recommended in several studies. METHODS: A total of 100 colicky infants in a single blind study were randomly specified to two equal groups of intervention and control. Infants in the intervention group received massage for 15-20 minutes once during the day and once at night before sleep, while infants in the control group were rocked for 15-25 minutes when the symptoms of colic appeared. Parents recorded the details of the colic symptoms in a diary every day. All these outcomes were modeled simultaneously via a random-effects joint model. RESULTS: Among 100 infants included in the analysis, 48% were female; 91% of all infants were breastfed and 54% of them were born via normal vaginal delivery. In general, the effect of massage therapy on colic symptoms was assessed using the joint model. Our findings illustrated that massaging colicky infants would substantially reduce colic symptoms and increase the sleep duration in babies compared with the rocking group (P<0.001). CONCLUSION: Massage therapy could be considered as an effective method in reducing colic symptoms. Mean of the symptoms dropped significantly in the intervention group compared with that in the rocking group. Our study also represents that a relevant and correct statistical model could result in more reliable findings.