Prospective Longitudinal Intervention Study Research Articles

The knowledge and skills of emergency department registered nursing staff at an academic hospital in South Africa, on endotracheal tube cuff manometry, before and after a training session

IntroductionAccurate management of endotracheal tube cuff pressure is essential to prevent patient morbidity and mortality. Due to increased length of stay of critically ill patients in emergency departments, it has become an increasingly important skill among Emergency Department nurses. MethodsThis prospective longitudinal interventional study was performed among registered nurses at the emergency departments in a Johannesburg Academic Hospital. The study aimed to determine their current knowledge and practical skills on endotracheal tube cuff manometry and assess the effectiveness of a training program. The training program was provided once, in the form of a narrated PowerPoint presentation developed by the researchers and involved theoretical and practical components. The participants' theoretical knowledge and practical skills were measured by using questionnaires and skill assessments. The theoretical and practical scores were compared pre- and post-training. ResultsOf the 63 registered nurses employed in the emergency departments, 95 % (60) participated in this study. 86 % reported having never received any formal training on endotracheal tube cuff manometry. Only 38.9 % used cuff manometry as standard practice and only 12.8 % checked it at appropriate 12-hourly intervals. The pre-training median score on theory was 4.5 (IQR=3.0) and improved to 7.0 (IQR=3.0) post-training. The maximum achievable score was 11 with a pre-training average of 41.8 % and post-training of 64.5 % (p = 0.001).The practical pre-training median score was 1.0 (IQR=8.0) and improved to 12.0 (IQR=2.0) post-training. The maximum achievable score was 12 with a pre-training average of 29.1 % and a post-training average of 93.3 % (p = 0.001). ConclusionThis study showed inadequate knowledge and skills on endotracheal cuff pressure manometry among registered nurses in the emergency department. It also correlates with other evidence that supports the need for ongoing training programs. Our training program led to significant improvement among participants in both knowledge and practical skills. This training program was well received by participants and deemed to be practice changing. The recommendation after this study will be for South African emergency units to consider using this study and training material as a guide for annual in-service training.

Effect of a person-centred goals-of-care form and clinical communication training on shared decision-making and outcomes in an acute hospital: a prospective longitudinal interventional study.

Patients with a life-limiting illness (LLI) requiring hospitalisation have a high likelihood of deterioration and 12-month mortality. To avoid non-aligned care, we need to understand our patients' goals and values. To describe the association between the implementation of a shared decision-making (SDM) programme and documentation of goals of care (GoC) for hospitalised patients with LLI. A prospective longitudinal interventional study of patients admitted to acute general medicine wards in an Australian tertiary hospital over 5 years was conducted. A SDM programme with a new GoC form, communication training and clinical support was implemented. The primary outcome was the proportion of patients with a documented person-centred GoC discussion (PCD). Clinical outcomes included hospital utilisation and 90-day mortality. 1343 patients were included. The proportion of patients with PCDs increased from 0% to 35.4% (adjusted odds ratio (aOR), 2.38; 95% confidence interval (CI), 2.01-2.82; P < 0.001). During this time, median hospital length of stay decreased from 8 days (interquartile range (IQR), 4-14) to 6 days (IQR, 3-11) (adjusted estimate effect, -0.38; 95% CI, -0.64 to -0.11; P = 0.005) and rapid response team activation from 28% to 13% (aOR, 0.87; 95% CI, 0.78-0.97; P value = 0.01). Documented treatment preference of high-dependency unit care decreased from 39.7% to 24.4% (aOR, 0.81; 95% CI, 0.73-0.89; P value < 0.001), and ward-based care increased from 31.9% to 55.1% (aOR, 1.24; 95% CI, 1.14-1.36; P value < 0.001). The implementation of a SDM programme was associated with increased documentation of person-centred GoC, changed patient treatment preference to lower intensity care and reduced hospital utilisation.

Piloting an online telecoaching community-based exercise intervention with adults living with HIV: protocol for a mixed-methods implementation science study

IntroductionOur aim is to evaluate the implementation of an online telecoaching community-based exercise (CBE) intervention with the goal of reducing disability and enhancing physical activity and health among adults living...

Effects of yogic interventions on cardiopulmonary and endothelial health at high altitude: A prospective longitudinal interventional study

High-altitude sojourn may lead to risk factors for high-altitude disorders and subsequent altitude sickness. This study was aimed to analyse the effects of sea-level yoga practices on individuals when they ascend to high altitudes (HAs). Healthy male subjects were randomly divided into two groups i) yoga group (n = 43) and ii) control group (n = 44). One month of yoga training was given to the yoga group for 30 min daily. The control group was provided daily routine for one month. Blood samples were collected when subjects were in fasting condition at sea level and at high altitude. The pulmonary function, blood pressure, cardiovascular and resting metabolic parameters and estimated markers of endothelial homeostasis were monitored at sea level and then at high altitude. The study revealed that yoga group had enhanced pulmonary functions (p < 0.001), maintained blood pressure, and increased endothelial homeostasis markers such as corin and ACE; and showed decrease in VO2resting and hypoxia-induced endothelial leak parameters such as Angptl4, sKDR. In control group, the blood pressure, VO2, VCO2, and Angptl4 increased, while ACE, corin, and sKDR decreased. Sea-level yogic intervention before ascending to high altitude was found helpful for individuals.

Visual Outcome Following Manual Small Incision Cataract Surgery at a Tertiary Center in South India.

IntroductionCataract being one of the leading causes of avertible blindness has been found to be quite prevalent in developing countries like India. The National Programme for Control of Blindness (NPCB) aims at reducing blindness due to cataract via cataract control programs. The most commonly performed surgery is the manual small incision cataract surgery (MSICS).AimThe aim of this study was to determine the visual acuity and outcome in patients who underwent MSICS in a tertiary hospital in south India.MethodologyA prospective longitudinal interventional study was conducted in a tertiary hospital in Karnataka, India, over a period of nine months. A total of 105 eyes underwent MSICS and were followed up for one month to assess their postoperative visual outcome and complications, if any. During this period, they were started on antibiotic + steroid combination eyedrops, which were tapered over four weeks.ResultsResults were assessed based on visual grading categorized by the World Health Organization (WHO). A total of 103 (98.1%) patients had good vision, i.e., visual acuity of 6/6 - 6/18, followed by two (1.9%) who had moderate vision i.e., visual acuity of <6/18 - 3/60, and none were blind or with visual acuity of <3/60. Complications seen intraoperatively in two patients (1.9%) were iris prolapse and posterior capsular rent, respectively, and postoperatively one (0.95%) patient showed hyphema with inferior haptic in the anterior chamber.ConclusionThis study proves that a good visual outcome with a low complication rate can be achieved after MSICS with posterior chamber intraocular lens implantation.

Study on functional outcome of bimalleolar ankle fractures treated by open reduction and internal fixation

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Ankle injury is the most common weight bearing orthopaedic musculoskeletal trauma encountered in emergency medicine and practice. Ankle joint is highly congruous and any disturbance of normal articular relationship may result in some progressive arthrosis of biomechanical dysfunction. As with all intra-articular fractures it necessitates accurate reduction and stable internal fixation. The objectives were to study the functional outcome of surgical treatment of bimalleolar ankle fractures and to know the complications of open reduction internal fixation of bimalleolar fractures.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 45 patients with malleolar fractures were included in this prospective longitudinal interventional study. Patients who underwent operative treatment were followed up regularly for 6 months with OPD visits and X-ray imaging at each stage. Patient parameters were recorded at immediate post op period, 6 weeks, 12 weeks and 24 weeks. Baird and Jackson scoring system for ankle were used for the functional outcome measurement.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; Most common type of injury pattern was supination-external rotation with 21 cases (47% of cases). The results are excellent to good in 65% of patients, 27% of patients had fair and 8% had poor result. Syndesmotic screw fixation was done with 4.5 mm cortical screw in 7 cases. Most common complication was surgical site infection in 3 cases (6.67%). 2 patients underwent implant removal due to unresolved infection at 3 months.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; The results of operative fixation were satisfactory in 90% of patients. Most of the complications were minor and resolved within three weeks.&lt;/p&gt;&lt;p class="abstract"&gt; &lt;/p&gt;

Effect of single intravitreal triamcinolone acetonide injection on intraocular pressure and retinal nerve fibre layer thickness

Purpose: To investigate the intraocular pressure (IOP) changes following intravitreal triamcinolone acetonide (IVTA) injection for inflammatory, proliferative and edematous diseases of posterior segment of eye. Design: Prospective longitudinal interventional study. Methods: The prospective longitudinal study included 30 with posterior uveitis (n=12), retinal vascular occlusive diseases (n=10), Eales’ disease (n=6), pseudophakic cystoid macular edema (n=1) and idiopathic cystoid macular edema (n=1). 4 mg of IVTA injection IOP increased significantly from baseline IOP of 14.27±3.53 mm Hg to mean IOP of 16.54± 4.29, 18.54± 5.50, 19.00± 5.98, 18.82± 5.00 and 22.50±0.71 mm Hg at 2, 4, 6, 8 and 12 weeks follow up respectively. In study group IOP elevation of ≥6 mm Hg from baseline was seen in 17 out of 30 eyes (64.71% males and 35.29%females). The majority of patients belonged to younger age group. An IOP elevation was seen in 58.82% and 88.24% eyes upto 4 and 6 weeks follow up respectively. In 15 out of 17 eyes, IOP was controlled with topical anti-glaucoma medications while 2 eyes required filtering glaucoma surgery. Conclusions: After 4 mg of IVTA injection 57.67% of eyes developed IOP elevation ≥6 mm Hg from baseline. In 88.24% eyes raised IOP was controlled with topical anti-glaucoma medications. There was no statistically significant change observed in retinal nerve fibre layer thickness upto 12 weeks follow up, despite elevated IOP. Besides glaucoma no other complication was observed upto 12 weeks of follow up.

Effect of testosterone replacement therapy on insulin sensitivity and body composition in congenital hypogonadism: A prospective longitudinal follow-up study.

Aims:To evaluate the prevalence of metabolic syndrome (MS) and whole-body composition in patients with congenital hypogonadism and investigate the effects of replacement therapy with testosterone undecanoate on MS, insulin resistance (IR), and whole-body composition in subset of patients.Methods:In a single arm prospective longitudinal intervention study, 33 patients with congenital hypogonadism, ages 20–39 years, were recruited and their parameters of MS, whole-body composition by DXA were compared with age and BMI matched healthy controls. In 21 patients, after 9 months we prospectively studied the effect (pre–post difference) of injection testosterone undecanoate (1,000 mg) replacement on MS, IR, and whole-body compositions.Results:The prevalence of MS was similar in patients and controls (27.3% vs. 9.1%, P = 0.05). Hypogonadism patients had higher prevalence of hypertension (33% vs. 3%, P < 0.01). Patients had decrease in lean body mass (P < 0.05) as compared to controls. After testosterone replacement, there was significant decrease in waist circumference (88.6 ± 13.1 cm vs. 83.9 ± 12.9 cm, P < 0.01), truncal fat (25.9 ± 7.3% vs. 24.0 ± 6.3%, P < 0.05), fasting C-peptide (2.1 ± 0.79 ng/ml vs. 0.68 ± 0.23 ng/ml, P < 0.01), serum proinsulin [1.43 (0.32– 13.4) vs. 0.5 (0.5–3.2) pmol/l, P < 0.001] and a significant increase in lean body mass (46,906 ± 8,876 gm vs. 50,083 ± 7,590 gm, P < 0.001). Homeostasis model assessment of insulin resistance (HOMA-IR) (4.6 ± 1.7 vs. 0.5 ± 0.2, P < 0.001) and homeostatic model for assessment of insulin sensitivity (HOMA%S) [21 (12–65) vs. 206 (125–714), P < 0.001] were improved significantly following testosterone replacement.Conclusion:In this study, 36 weeks of testosterone replacement resulted in significant decrease in waist circumference, IR, truncal fat, total body fat and improvement in lean body mass, and insulin sensitivity.

Combined assessment of 3q26 amplification and promoter methylation in patients with high grade cervical lesions show age specific differences.

A considerable proportion of high grade cervical intraepithelial lesions (CIN2/3) are known to resolve on their own especially among young women. However, since reliable prognostic markers are still lacking, the diagnosis "CIN3" is still an indication for surgery which may result in overtreatment. It is conceivable that a combination of different, ideally independent molecular markers may provide more reliable results. In the present cross-sectional study two established triage markers, 3q26 amplification and a methylation signature, were evaluated in an age-dependent manner. The patient cohort comprised 60 patients with histologically confirmed CIN2/3 in two equally sized age groups (<30 years, ≥30 years). Cervical scrapes were analyzed by interphase fluorescence in situ hybridization for 3q26 amplification and methylation specific PCR (GynTect®) for six different genome regions. Both assays showed a significantly different pattern of test outcome independent of age (P = .001). Moreover, the combination of both assays differed significantly for double positive and double negative cases when comparing the two age groups: In patients <30 years there were clearly less cases with positive methylation signature and amplification of 3q26 as in women ≥30 years (23% vs 63%, Bonferroni adjusted P = .016). Of particular interest is the finding that double negative results were exclusive for the young age group (0% vs 27%, Bonferroni adjusted P = .020). Since regression of CIN2/3 characteristically occurs among young women it is tempting to speculate that a double negative test result could be prognostic for regression of CIN2/3. This will have to be investigated further in a prospective longitudinal intervention study.

Commentary: The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study.

Commentary: The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study.

Clinical Skills Passport: A Method to Increase Participation in Clinical Skills by Medical Students During a Surgery Clerkship

To prospectively evaluate the effect of introducing a clinical skills "passport" on medical students' reporting of their experience with basic clinical skills. A prospective longitudinal intervention study was conducted. Medical students were administered a questionnaire at the conclusion of their 12-week surgery clerkship regarding their experience with 15 clinical skills, inquiring whether they had "learned on surgery clerkship", "learned before surgery clerkship", or "not learned". Preintervention baseline data were obtained for 2 consecutive academic years (n = 213 students). In the third year, students (n = 124) were given a clinical skills passport to document performance of 8 of the 15 skills under the supervision of a surgical resident or faculty member. After excluding from analysis those students who learned a skill before their surgery clerkship, the fraction of students who reported learning clinical skills during their surgery clerkship before and after the introduction of the clinical skills passport was compared using Fisher exact test and chi-squared test, where appropriate (p ≤ 0.003 was considered significant; Bonferroni correction for multiple comparisons). Washington University School of Medicine. A total of 337 medical students completing the junior surgery clerkship over a 3-year period were included in the study. All 337 students completed a survey. Considering each skill individually, survey response rate was 5045/5055 (99.8%). Combining all responses for all skills, the fraction of students reporting that skills were learned on the surgery clerkship increased after the introduction of the clinical skills passport (1498/1938 [77%] preintervention vs. 974/1109 [88%] postintervention, p < 0.0001, chi square). After the introduction of the clinical skills passport, the fraction of students reporting that a skill was "learned on surgery clerkship" significantly increased for the 8 skills listed on the passport (1026/1699 [83%] preintervention vs. 685/714 [96%] postintervention, p < 0.0001, chi square), but did not increase for the 7 skills not listed on the passport (472/695 [68%] preintervention vs. 289/395 [73%] postintervention, p = 0.08, chi square). Considering each skill individually, after the introduction of the clinical skills passport, the fraction of students reporting that a skill was "learned on surgery clerkship" significantly increased for 4/15 skills (all listed on the clinical passport) and decreased for 0/15 skills (p < 0.003, Fisher exact test, 2 tailed). Institution of a clinical skills passport system during a surgery clerkship increased medical student reporting of their performance of basic clinical skills.

The challenge of nutritional profiling of a protein-free feed module for children on low protein tube feeds with organic acidaemias.

Enteral tube feeding for children with organic acidaemias (OA) is recommended. Protein restriction, providing minimum safe levels of protein intake, is advocated. Standard paediatric tube feeding formulae provide more than the minimum safe protein requirements and are unsuitable in OA without modification. Modified paediatric enteral feeds consist of several modular ingredients. The aim of this prospective longitudinal interventional study was to assess the efficacy of a premeasured novel protein-free module developed for children aged over 12 months compared to conventional practice. In total, 15 children with OA (11.6-31 kg) needing enteral feeding were recruited. The protein-free module, from either a protein-free infant feed or modular ingredients, was replaced by the study feed. To ensure metabolic stability, energy and protein intake were unchanged. Dietary intake, anthropometry and nutritional biochemistry were recorded at baseline and week 26. Dietary intakes of magnesium (P = 0.02), sodium (P = 0.005), vitamin D (P = 0.04), docosahexaenoic acid (P = 0.01) and arachidonic acid (P = 0.001) significantly improved; plasma selenium (P = 0.002) and whole blood glutathione peroxidase (P = 0.02) significantly increased. Feed preparation accuracy as measured by composition analysis showed consistent errors both in pre- and study feeds. A protein-free module improved nutritional intake and biochemistry, although feed preparation errors remained a common finding.

Enhancement of hand hygiene compliance among health care workers from a hemodialysis unit using video-monitoring feedback

The importance of hand hygiene in the prevention of health care-associated infection is well known. Experience with hand hygiene compliance (HHC) evaluation in hemodialysis units is scarce. This study was a 3-phase, prospective longitudinal intervention study during a 5-month period in a 13-bed hemodialysis unit at a university hospital in Northern Mexico. The unit performs an average of 1,150 hemodialysis procedures per month. Compliance was evaluated by a direct observer and a video assisted observer. Feedback was given to health care workers in the form of educational sessions and confidential reports and video analysis of compliance and noncompliance. A total of 5,402 hand hygiene opportunities were registered; 5,201 during 7,820 minutes of video footage and 201 by direct observation during 1,180 minutes. Lower compliance during the baseline evaluation was observed by video monitoring compared with direct observation (P <0.05). Discrepancy between both methods was 29.2% (0.4%-59.8%); the average improvement in compliance during the study was 30.6% (range, 7.3%-75.5%). Global and Individual results for each subject revealed a statistically significant Improvement in the majority. Noncompliance according to WHO's 5 Moments for HH was greater for moment 5 (30.1%). We estimated that a health care worker in a hemodialysis unit could take 22-44.3% of working hours for proper hand hygiene compliance. Video-assisted monitoring of hand hygiene is an excellent method for the evaluation of HHC in a hemodialysis unit; enhanced HHC can be achieved through a feedback program to the hemodialysis staff that includes video examples and confidential reports.

Detecting in-hospital stroke: Assessment of results from a training programme for medical personnel

IntroductionIn-hospital stroke (IHS) is a frequent event, but its care priority level is not well established in many hospitals. IHS care at our centre has been redefined by implementing a training programme for medical personnel not usually involved in stroke management, in order to optimise IHS detection and treatment. This study evaluates results from the training programme. MethodsIt was a prospective longitudinal intervention study. Neurologists experienced in vascular diseases developed a training programme for medical personnel. We recorded incidence, epidemiological data, reason for hospitalisation, department, aetiology, severity (NIHSS), time from symptom onset to neurological assessment, use of endovascular thrombolysis, exclusion criteria for untreated patients, and 90-day outcome (mortality/disability) in 2 patient groups: patients experiencing IHS in the 6 months before (PRE) and the 6 months after the training programme (POST). ResultsSixty patients were included (19 PRE, 41 POST) with a mean age of 75.3±12.5; 41% were male. There were no differences between groups regarding assessment time, treatment administered, or morbidity/mortality. Overall, 68.3% of the patients were assessed in <4.5hours; however, only 6 patients (10%) were able to undergo endovascular therapy. This situation was mainly due to pre-existing disability (26%) and comorbidity (13%). ConclusionsMore IHS code activations were recorded after the training programme. However, that increase was not accompanied by a higher percentage of treated patients or improvements in patient prognosis during the study period, and these findings could probably be explained by the high rates of pre-existing disability and comorbidity in this series.

Response of systemic PUVA in vitiligo - experience with 25 cases in Combined Military Hospital, Dhaka

Introduction: It is a pigmentation disorder in which melanocytes (the cells that make pigment) in the skin are destroyed. As a result, white patches appear in the skin in different parts of the body. Objective: The objective of this study is to see the efficacy of systemic PUVA in the treatment of vitiligo patient. Methods: This is an prospective longitudinal interventional study, carried out in the depigmented area was assessed according to the department of Dermatology and Venereology, Combined Military Hospital, Dhaka in between the duration of April 2010 to March 2011. Total 25 vitiligo patients based on inclusion criteria like patient with vitiligo affecting more than 5% body surface area, patient having ivory- white fluorescence on Wood’s lamp, patient who was above 15 years of age, patient who had given written consent, patient was not taken any previous treatment etc. Results: This study showed the therapeutic response of study group after 04 weeks of therapy, 05 (20%) patients responsed Fair, 15 (60%) patients responsed Poor and no responsed by 05 (20%) patients. Therapeutic response of study group after 08 weeks of therapy showed that 15 (60%) patients responsed Fair and 10 (40%) patients responsed Poor. It was observed after 12 weeks of therapy that 13 (52%) patients responsed Poor followed by 10 (40%) patients responsed Fair and 02 (08%) patients responsed well. 29 JAFMC Bangladesh. Vol 10, No 1 (June) 2014 Therapeutic response of study group after 16 weeks of therapy was 15 (60%) patients responsed Fair, followed by 06 (24%) patients responsed Poor and 04 (16%) patients responsed Good. It was showed that after 20 weeks of therapy 13 (52%) patients responsed Fair, followed by 08 (32%) patients responsed Good, 03 (12%) patients responsed Poor and 01 (04%) patients responsed Excellent. It was observed that after 24 weeks of therapy 12 (48%) patients responsed Good, followed by 08 (32%) patients responsed Fair, 03 (12%) patients responsed Poor and 02 (08%) patients responsed Excellent. Conclusion: Systemic PUVA for the repigmentation of vitiligo seems to be effective. Study needs large number of patients for longer period of duration for confirmation of results. DOI: http://dx.doi.org/10.3329/jafmc.v10i1.22900 Journal of Armed Forces Medical College Bangladesh Vol.10(1) 2014

Poster #M149 ARE UHR PATIENTS WHO PRESENT WITH HALLUCINATIONS ALONE AT LOWER RISK OF TRANSITION TO PYCHOSIS?

This study assessed the effects of highly active antiretroviral therapy on the cognitive performances of HIV seropositive patients with severe immune depression.It is a prospective longitudinal interventional study of 69 anti-retroviral naïve HIV-seropositive adult patients with CD4 levels ≤ 350/μl. The cognitive assessment was done at initiation and 12 months after anti-retroviral treatment using the Community Screening Instrument for Dementia (CSID) and the computer-assisted Iron Psychology (FePsy). The impact of therapy on CD4 levels and cognitive scores of the patients before and after therapy were compared and tested for statistical significance using Student t test and one-way ANOVA.The mean age of the patients was 36.6 ± 8.8 years. There was a significant increase in CD4 levels of the patients from 144.75 ± 88.92 at baseline to 295.91 ± 148.79 after 12 months of HAART (p < 0.0001). There were significant improvements in their cognitive scores (p < 0.05) in all cognitive domains tested but the finger tapping task (motor speed) did not show any improvement (p > 0.05). Combination ARV drugs with efavirenz did not significantly improve attention and choice reaction time.Highly active antiretroviral therapy significantly improved the CD4 levels and cognitive performances of treated HIV positive patients in all tested domains with the exception of motor speed.

Intervención grupal del síndrome subacromial en atención primaria

IntroductionDue to the increase in consultations for shoulder pain in rehabilitation services, there is a need for efficient alternatives to improve the management of this disorder. ObjectivesTo evaluate the effectiveness of a supervised group exercise program to improve functionality and pain in patients with shoulder impingement syndrome and to identify the variables that are associated with a better functional outcome. MethodsA prospective longitudinal, pre and post intervention study was carried out in a sample of 211 patients. The treatment consisted of 10 individual sessions of analgesic electrotherapy, 5 sessions of group exercise therapy and an educational session: «shoulder school». One year follow-up was performed. Shoulder function and pain were assessed using Constant's test and the visual analogue scale. The statistical analysis was carried out with the chi-square test, T-test, ANOVA and multiple linear regression (P<.05). ResultsFunctionality improved significantly in all periods studied compared with baseline and stabilized at 6 months. The profile of patients who achieved greater functionality was female, older than 60 years, with no initial rest pain and occupationally inactive. Long-term pain improvement was not significant. Analgesic use was significantly reduced at 3 months. Adherence to home exercise treatment was 81% at 3 and 6 months and 70.6% at one year. ConclusionsThe application of a group rehabilitation program in patients with shoulder impingement syndrome was effective in improving long-term functionality. However, there was no significant pain improvement during the study.

Safety and predictors of adverse events during oral immunotherapy with raw egg white

Methods Prospective longitudinal epidemiological intervention study. Egg-allergic children aged 5–18 underwent a Spanish-approved egg-OIT protocol without premedication. Clinical data, skin prick test (SPT) and specific IgE (sIgE) at baseline and 9 months after OIT were registered. All dose-related reactions, treatments needed and cofactors involved were recorded. Through survival analysis, we studied the cumulative probability of reactions resolution over time and clinical/immunological risk factors of reactions persistence.

Early rehabilitation of cancer patients – a randomized controlled intervention study

BackgroundFaced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses.MethodPatients (≥ 18 years) with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis.DiscussionThis RCT will provide empirical evidence of whether an individually administered stress-management programme in two steps can decrease stress as well as maintain or enhance patients’ physical activity level, quality of life and psychological well-being. Further, this RCT, with a stepped-care approach, will provide knowledge regarding the cost-effectiveness of an individually administered stress-management programme whose aim is to help and support individual patients at the right level of care.Trial registrationClinicalTrials.gov Identifier: NCT 01588262.

Safety and predictors of adverse events during oral immunotherapy for milk allergy: severity of reaction at oral challenge, specific IgE and prick test

Strict avoidance is the only accepted management for cow's milk (CM) allergy. CM oral immunotherapy (CM-OIT) is under investigation. To evaluate long-term safety of CM-OIT. To identify clinical/immunological predictors of adverse events. Prospective longitudinal epidemiological intervention study. CM-allergic children aged 5-18 underwent a Spanish-approved CM-OIT protocol without premedication. Clinical data, skin prick test (SPT) and specific IgE (sIgE) at baseline and 1 year after OIT were registered. All dose-related reactions, treatments needed and cofactors involved were recorded. Through survival analysis, we studied the cumulative probability of reactions resolution over time and clinical/immunological risk factors of reactions persistence. 81 children were recruited. Mean follow-up was 25 months. 95% of children suffered reactions, 91% of which affected a single organ. Reactions were heterogeneously distributed: (a) 60 children (75%) had occasional symptoms which ceased over time. 86% of them reached complete desensitization (200 mL). (b) 20 children (25%) suffered frequent (78% of total reactions), more severe and unpredictable reactions, which persisted during follow-up or led to withdrawal (6 cases). Reactions persistence was associated with a higher frequency and severity. Kaplan-Meier estimate revealed a cumulative probability of reactions resolution of 25% at 3 months (95% CI: 1.9-4.1) and 50% (95% CI: 6.1-9.9) at 8 months based on all patients. Cox proportional hazards multivariate regression model identified 3 variables (CM-sIgE ≥ 50 KU L(-1) , CM-SPT ≥ 9 mm and Sampson's severity grades 2, 3 and 4 at baseline food challenge) as independent risk factors of reactions persistence. The combination of 2 or 3 of these factors involved hazard ratios to develop persistent reactions of 2.26 (95% CI: 1.14-4.46; P = 0.019) and 6.06 (95% CI: 2.7-13.7; P < 0.001), respectively. CM-OIT was insufficiently safe in 25% of children. The above-mentioned clinical and immunological parameters would help clinicians to identify highly reactive patients before CM-OIT. In them, individualized schedules and premedication should be considered.