Prospective 12-month Follow-up Study Research Articles

Arthroscopic and open reconstruction of the posterolateral corner of the knee have equally good clinical results: first results of a prospective 12-month follow-up study.

Arthroscopic reconstruction techniques for higher-grade posterolateral corner (PLC) injuries (Fanelli Type B, PoLIS LI-B) have not yet been validated in clinical studies. The open reconstruction technique described by Arciero is well-established and showed good restoration of joint stability in previous studies. This study aimed to compare clinical outcomes of this established open surgery technique to a newly developed arthroscopic technique in a prospective randomized clinical trial. Between 2019 and 2021, this study focused on chronic high-grade PLC injuries (Fanelli Type B, PoLIS LI-B). Group A consisted of patients treated with conventional open surgery following Arciero's technique, while Group B included patients treated with Arciero's arthroscopic technique. All cases underwent additional PCL reconstruction. After a minimum 12-month follow-up, clinical scores and objective stability assessments were compared between the groups. In total, 26 (group A 12, group B 14) eligible patients with a mean follow-up of 14.9 ± 7.2 months were evaluated in the present study. Knee stability and patient-reported outcome scores (PROMS) were significantly improved when comparing pre- and post-operative values (p < 0.0001). No clinically relevant differences in PROMS (Lysholm: A 83.9 ± 11.4 vs. B 85.3 ± 13.8; IKDC: A 76.91 ± 12.6 vs. B 76.8 ± 15.7) were shown in both groups. Additionally, no statistically significant differences were detected between groups with respect to external rotation, range of motion and instrumental stability testing. Arthroscopic reconstruction showed significantly shorter operation time (p = 0.0109). There were no clinical failures or neurovascular complications of the surgical procedures. Both surgical techniques for isolated chronic PLC Fanelli Type B injuries significantly improved the knee stability, were equivalent with respect to PROMs and led to good clinical results. However, arthroscopic PLC reconstruction was associated with a shorter surgery time compared to open PLC reconstruction. Therefore, arthroscopic PLC reconstruction may be a viable option in the hands of an experienced surgeon. Prospective cohort study, II.

(105) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in North Africa and the Middle East

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt; 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt; 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality-of-life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

(388) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in the Middle East and North Africa

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt; 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt; 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality of life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

Angiogenic and Microvascular Status Alterations after Endovascular Revascularization of Lower Limb Arteries among Patients with Diabetic Foot Syndrome: A Prospective 12-Month Follow-Up Study.

Peripheral arterial disease (PAD)-induced ischemia is an important component of diabetic foot syndrome (DFS). The results of revascularization of the lower extremity arteries (including percutaneous transluminal angioplasty [PTA]) do not always give satisfactory long-term results, which is due to many factors. The aim of the study was to investigate the alterations in selected circulating angiogenic factors and microcirculation parameters in 41 patients with DFS following PTA and analyze their relationships with clinical outcomes during 1-year follow-up. Our study revealed a general decrease in pro-angiogenic factor levels after PTA and their subsequent stabilization during subsequent observation. The results indicated a significant association between plasma circulating FGF-2 level and poor outcomes (including the incidence of restenosis/reocclusion of treated arteries) during 12 months of observation. The perioperative changes in FGF-2 showed a significant association with LDF alterations after PTA. Follow-up 1-3 months post-intervention showed a tendency towards elevated TcpO2, VEGF-A, and VEGF-R2 levels in patients free from adverse events. These results may provide a basis for further research on the potential use of selected circulating angiogenic factors for monitoring the treatment of patients with DFS following PTA.

(472) The AM-EDITS: A New Tool for Evaluating the Arab Patient and Partner Satisfaction Following Penile Prosthesis Implantation

Abstract Introduction The Modified Erectile Dysfunction Inventory of Treatment Satisfaction (M-EDITS) is recognized as a useful tool in English language to assess post penile prosthetic implantation (PPI) satisfaction. Nevertheless, a more global questionnaire remains to be introduced for the Arab population, where malleable PPI (MPPI) remains more popular, compared to the inflatable types. Due to the sensitivity of the topic and the conservative nature of the Middle East and North Africa (MENA) region, a scarce body of related research is available. Objective Our primary goal was to develop a validated Arabic version of the M-EDITS adapted to the Arabic culture and introduce it as the AM-EDITS. Our secondary goal was to utilize it to investigate the levels of Arab patient and partner satisfaction after MPPI and its sustainability during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing MPPI at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). For our study, we developed a validated Arabic version of the M-EDITS, coined as the AM-EDITS. The first encounter covered general patient perioperative experience, beginning from preoperative counseling till early after surgery. The second and third encounters focused on patient and partner satisfaction regarding implant utilization. Results The mean ages for the men and their spouses were 54.7±8.4 and 32.9±4.6 years, respectively. Over 82% of the patients in our study showed a decreased level of anxiety after preoperative counseling. 96% of the patients reported a positive experience regarding their early PO days with above half exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied wives at 3 months, 78.5% were highly satisfied. Feeling sexually desirable by their husbands was reported in 93.4%. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt;0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt;0.001), respectively, compared to the 3 months follow up. Conclusions The AM-EDITS may expand the global application of the original M-EDITS. MPPI represents a good quality of life treatment option for middle to low-income countries. Time has a positive effect on the Arab men’s PO satisfaction as opposed to their partners’. These findings should be considered during perioperative counseling of both parties to ensure sustainable satisfaction. Extended studies are necessary to confirm our findings as well as assess long-term PO satisfaction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder

The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.

Radiation pneumonitis in relation to pulmonary function, dosimetric factors, TGFβ1 expression, and quality of life in breast cancer patients receiving post-operative radiotherapy: a prospective 6-month follow-up study.

To investigate development of radiation pneumonitis (RP) in relation to pulmonary function, dosimetric factors, and transforming growth factor beta-1 (TGFβ1) expression in irradiated breast cancer patients. A total of 49 breast cancer patients who received post-operative radiotherapy (RT) were evaluated in terms of pulmonary function tests (PFTs), quality of life (QoL), development of RP, dosimetric factors, cytokine levels, and lung high-resolution computed tomography (HRCT) before and after RT. ROC analysis was performed for performance of dosimetric factors in predicting RP, while frequencies of single nucleotide polymorphisms (SNPs) genotyped for TGFβ1 (rs11466345 and rs1800470) were also evaluated. All cases with RP (10.2%) recovered clinically at the end of third post-RT month. PFT and HRCT parameters were similar before and after RT overall, as well as by RP and the radiation field subgroups. ROC analysis revealed the significant role of the ipsilateral V5 (cutoff value of 45.9%, p = 0.039), V10 (29.4%, p = 0.015), V20 (23%, p = 0.017), and MLD (1200cGy, p = 0.030) in predicting RP. Higher post-RT TGFβ1 levels (p = 0.037) were noted overall and in patients with RP. Patient and control groups were similar in terms of frequencies of SNPs genotyped for TGFβ1 (rs11466345 and rs1800470). EORTC QLQ-C30 and QLQ-BR-23 scores were similar in patients with vs. without RP. Our findings revealed significant role of dosimetric factors including MLD, V20 as well as the low dose-volume metrics in predicting the risk of RP among breast cancer patients who received post-operative RT. Implementation of RT, extent of radiation field or the presence of RP had no significant impact on PFTs.

Effect of Oral Health Promotion on Caries Experience and Oral Cleanliness of School Children in Kerung, Nepal: A Prospective 6-month Follow-Up Study.

A longitudinal oral health promotion project on caries experience and oral cleanliness was performed in a remote village in Nepal. The aim of this 6-month prospective survey was to investigate the impact of an oral health promotion project on caries experience, oral health-related behaviour, and general knowledge about oral health in Kerung, a remote village in Nepal. A prospective study was conducted in a convenience sample of children from the local school in Kerung. At baseline and after six months, dental plaque scores and caries experience scores were measured by calibrated examiners. Validated questionnaires on oral health habits and knowledge on oral health were taken. In addition, an oral health promotion program was developed. At baseline, 359 children were included, of which 266 could be surveyed after six months. A statistically significant decrease in the mean plaque score was found at after six months with a higher reduction for boys. A significant decrease in caries prevalence, as well as a significant increase in knowledge about oral health, was observed. Furthermore, after six months there were significantly more children reporting that they brushed their teeth for at least two minutes. Dental screenings and a comprehensive educational program resulted in a significant improvement of oral health.

Neurocognitive and Quality-of-life Outcomes Following Intensive Care Admission: A Prospective 6-month Follow-up Study.

BackgroundPost-intensive care survivors have decreased quality-of-life scores and prolonged cognitive dysfunction due to baseline factors and events related to intensive care unit admission, which remain largely unrecognized.Materials and methodsA prospective observational cohort study to assess the quality of life and occurrence of cognitive dysfunction, 3 and 6 months following discharge from the intensive care unit, was carried out. We enrolled 136 adults presenting to the intensive care unit with no prior cognitive dysfunction or depression and followed up and assessed them with repeatable battery for the assessment of neuropsychological status (RBANS) and quality of life with short Form-36 (SF-36) health survey.ResultsThe incidence and prevalence of cognitive dysfunction was 100% at 3 and 6 months, respectively, as assessed by RBANS with a global cognition scores at 3 and 6 months of 71 (IQR 68.5–73) and 74 (IQR 72–86), respectively. Higher Charlson's comorbidity score, increased severity of illness, longer duration of mechanical ventilation, pain, delirium, coma, and hospital stay were associated with statistically significant lower scores at 3 months. The median SF-36 mental component score (MCS) and physical component score (PCS) at 3 months were 38.4 and 32.5 and at 6 months were 38.2 and 32.6, respectively. Poor score was associated significantly with advancing age, poor functional parameters at baseline as evidenced by clinical frailty, poor baseline Katz ADL scores, increased severity of illness, longer duration of mechanical ventilation, occurrence and duration of delirium, coma, pain, and usage of sedatives with or without analgesics.Conclusion and clinical significancePatients discharged from the intensive care unit are at high risk for persistent cognitive impairment and poor quality of life score. Poor baseline patient characteristics and events occurring in ICU are associated with worse cognition and quality of life scores. There is an urgent need to prevent, diagnose, and manage these patients by optimizing intensive care practices.How to cite this articleBalasubramanian V, Suri JC, Ish P, Gupta N, Behera D, Gupta P, et al. Neurocognitive and Quality-of-life Outcomes Following Intensive Care Admission: A Prospective 6-month Follow-up Study. Indian J Crit Care Med 2020;24(10):932–937.

Predictors of social and role outcomes in first episode psychosis: A prospective 12-month study of social cognition, neurocognition and symptoms.

Poor functioning is common in psychosis, with predictors of poor outcome including negative symptoms and deficits in neurocognition (NC) and social cognition (SC). The extent to which these variables contribute unique variance in social and role trajectories remains inconclusive. Identifying robust predictors of outcome will inform targeted interventions in early psychosis, where functional trajectories are being set. Prospective 12-month follow-up study investigating the predictive values of NC and SC on social and role functioning in individuals with first-episode psychosis (FEP), within the context of clinical variables. 98 individuals with FEP (mean age=24; male=77) were assessed within the first year of diagnosis on functioning (social and role), cognition (SC and NC) and psychosis symptoms. Negative symptoms were the only significant predictor of 12-month social (χ2 =9.59, P=.002, OR=1.12) and role (χ2 =10.86, P < .001, OR=1.16) functioning in FEP. In exploratory analyses, negative symptoms mediated the relationship between baseline social knowledge and social functioning (Z=1.92, P=.05; d=0.56), and between baseline logical memory and role functioning (Z=2.40, P=.02; d=0.80) at 12-month follow-up. Although social and role trajectories in early psychosis appear somewhat distinct, negative symptoms were the best prognostic marker of social and role outcome in FEP, and mediated the relationship between SC and social outcome, and NC and role outcome; these relationships may be important when considering interventions to improve functional outcome in early psychosis.

5-Aminolevulinic acid patch (Alacare) photodynamic therapy for actinic cheilitis: data from a prospective 12-month follow-up study on 21 patients.

BackgroundActinic cheilitis (AC) is a variant of actinic keratosis (AK) affecting the lips and caused by chronic ultraviolet exposure.ObjectiveAlacare is a self‐adhesive, skin‐coloured 5‐aminolaevulinic acid patch that has been developed for use in photodynamic therapy (PDT) of mild‐to‐moderate AK. Based on promising preliminary results in the treatment of AC with Alacare patch PDT, we decided to extend our previous investigation to gain more data on the efficacy, tolerability, safety and cosmetic outcome of Alacare patch PDT for AC.MethodsTwenty‐one patients with a clinical diagnosis of mild‐to‐moderate AC were included in the study and subjected to one single session of PDT. After occlusion with the Alacare patch for 4 h, the AC lesions were illuminated for 10 min with red light at a dose of 37 J/cm2. All patients received local anaesthesia prior to illumination. Additionally, all lesions were cooled during PDT with a cold air blower. PDT‐induced pain and skin phototoxicity were monitored during and up to 7 days after PDT. Clinical assessment of efficacy, cosmetic outcome and global patient satisfaction was performed at 3, 6 and 12 months after treatment.ResultsNineteen patients completed the study. Three months after PDT, 17 patients (89.5%) had achieved complete remission. Of these, one patient presented with recurrence of AC at the 6‐month follow‐up, whereas all other patients remained in remission until the end of the observation period. The complete clinical cure rate at 1 year after a single Alacare patch PDT thus was 84.2%. Pain during illumination and the phototoxic skin reaction were in general mild to moderate. The cosmetic outcome was excellent.ConclusionThe present prospective study on Alacare patch PDT for AC confirms its high clinical efficacy, good tolerability and favourable cosmetic effects. Alacare patch PDT should be considered as a valid treatment option for patients with AC.

A one-year prospective study on scleral lens wear success

PurposeTo report the success rate of scleral lens wear and the lens handling learning curve from the wearers perspective. MethodsNinety-five participants were consecutively screened for enrollment in a prospective study. Participants were divided into two groups: ICGroup (71 participants with irregular corneas) and RCGroup (24 participants with regular corneas). Participants attended several visits: Baseline, Lens Dispense Visit (LDV), 1-month, 3-month, 6-month and 12-month follow-ups. The number and causes of scleral lens discontinuation and the time to correctly apply the lens for the first time at the LDV were evaluated. During follow-ups, participants answered a questionnaire regarding scleral lens wear (mean number of hours/day and days/week of lens wear, methods used for handling, number of attempts to correctly apply and remove the lenses). ResultsSixty-nine participants (73 %) successfully completed the 12-month period. Twenty-six participants (27 %) discontinued scleral lens wear. None of the discontinuations were due to adverse events. The success rate (number of participants that wore the lenses for the 12 months) was 77 % in ICGroup and 58 % in RCGroup. The main reasons for scleral lens discontinuation were handling issues (35 %) and discomfort (19 %). 36 % of participants required <15 min to correctly apply the lens at the LDV, however 13 % required >60 min (participants that wore spectacles, soft lenses or had no correction method at Baseline). The mean wearing time (hours/day and days/week) increased significantly from 1-month to 12-month appointments: from 9.8–11.1 h and 5.1–5.6 days in new scleral lens wearers, while the number of attempts to correctly apply and remove the lenses decreased significantly. ConclusionsThe success rate was 73 % during this prospective 12-month follow-up study. The main reasons for drop-out were handling issues and discomfort. Participants who continued scleral lens demonstrated increased handling skills.

Intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema in patients not previously treated with any intravitreal drug: a prospective 12-month follow-up study

Objective: To evaluate the mid-long-term efficacy and safety of the dexamethasone intravitreal (DEX) implant (Ozurdex1) in naïve patients with diabetic macular edema (DME).Methods: Prospective and single-center study conducted on consecutive patients with a diagnosis of DME, who received a DEX implant and were followed up for at least 12 months. The main outcomes measurements were the mean change in best corrected visual acuity (BCVA) and in foveal thickness (FT) as compared to the baseline values.Results: Of the 84 screened patients 50 were included in the study. The BCVA significantly improved from 52.4 (20.4) letters at baseline to 62.6 (15.6), 61.2 (18.4), 61.6 (18.6), 60.6 (19.0), and 60.6 (18.8) at 2, 4, 6, 12 months and end of follow-up period, respectively (repeated measures ANOVA and the Greenhouse-Geisser correction; p = .0008). At the end of the follow-up period, a gain of BCVA of ≥5, ≥10, and ≥15 letters were observed in 26 (52.0%), 18 (36.0%), and 16 (32.0%) patients, respectively. The mean FT was significantly reduced from 446.0 (139.9) µm at baseline to 327.2 (103.6) at the end of follow-up (repeated measures ANOVA and the Greenhouse-Geisser correction; p = .0008). During the study follow-up, the patients receive a mean of 3.4 (2.9–3.9) implants. Of the 32 phakic eyes at baseline, 17 (53.1%) either developed new lens opacity or progression of an existing opacity.Conclusion: In eyes with DME not previously treated with intravitreal drugs, DEX implants provide meaningful functional and anatomical benefits, and these results are sustained mid–long-term.

Lack of clinically relevant correlation between subjective and objective cognitive function in ICU survivors: a prospective 12-month follow-up study

BackgroundCognitive impairment and psychological distress are common in intensive care unit (ICU) survivors. Early identification of affected individuals is important, so intervention and treatment can be utilized at an early stage. Cognitive Failures Questionnaire (CFQ) is commonly used to screen for subjective cognitive function, but it is unclear whether CFQ scores correlate to objective cognitive function in this population.MethodsBetween 2014 and 2018, 100 ICU survivors aged 18–70 years from the general ICU at the Karolinska University Hospital, Solna, were included in the study. Out of these, 58 patients completed follow-up at 3 months after ICU discharge, 51 at 6 months, and 45 at 12 months. Follow-up included objective cognitive function testing using the Cambridge Neuropsychological Test Automated Battery (CANTAB) and subjective cognitive function testing with the self-rating Cognitive Failures Questionnaire (CFQ), as well as psychological self-rating with the Post-Traumatic Stress Symptoms Scale-10 (PTSS-10) and Hospital Anxiety and Depression Scale (HADS).ResultsThe prevalence of cognitive impairment as measured by four selected CANTAB tests was 34% at 3 months after discharge, 18% at 6 months, and 16% at 12 months. There was a lack of significant correlation between CANTAB scores and CFQ scores at 3 months (r = − 0.134–0.207, p > 0.05), at 6 months (r = − 0.106–0.257, p > 0.05), and at 12 months after discharge (r = − 0.070–0.109, p > 0.05). Correlations between CFQ and PTSS-10 scores and HADS scores, respectively, were significant over the follow-up period (r = 0.372–0.710, p ≤ 0.001–0.023). In contrast, CANTAB test scores showed a weak correlation with PTSS-10 and HADS scores, respectively, at 3 months only (r = − 0.319–0.348, p = 0.008–0.015).ConclusionWe found no clinically relevant correlation between subjective and objective cognitive function in this cohort of ICU survivors, while subjective cognitive function correlated significantly with psychological symptoms throughout the follow-up period. Treatment and evaluation of ICU survivors’ recovery need to consider both subjective and objective aspects of cognitive impairment, and subjective reports must be interpreted with caution as an indicator of objective cognitive function.

Novel Perceived Stress and Life Events Precede Flares of Inflammatory Bowel Disease: A Prospective 12-Month Follow-Up Study.

Inflammatory bowel disease [IBD] is characterized by recurrent disease flares. The impact of psychosocial wellbeing on the occurrence of flares is unclear. In this prospective study, we aimed to evaluate the association between patient-reported psychosocial wellbeing and disease flares using continuous monitoring. Consecutive IBD patients were recruited from the myIBDcoach telemedicine study cohort. Over 12 months, participants reported on disease activity together with anxiety, depression, fatigue, perceived stress and life events every 1-3 months. Flares were defined using a combination of clinical disease activity and additional measurements. Generalized estimating equation models were used to assess associations between psychosocial wellbeing and flares over time. The influences of both the presence of psychosocial symptoms in general as well as novel psychosocial symptoms were analysed. In total, 417 patients were included. Forty-nine patients [11.8%] experienced a flare during the study period. The occurrence of life events in the preceding 3 months was positively associated with flares (odds ratio [OR] = 1.81; 95% confidence interval [CI] = 1.04-3.17), while the presence of anxiety, depression, fatigue and perceived stress in general was not. However, novel perceived stress [OR = 2.92; 95% CI = 1.44-5.90] was associated with flares. The occurrence of life events and novel perceived stress are associated with disease flares in the next 3 months, while the presence of perceived stress in general is not. These findings underline the importance of continuous personalized monitoring of IBD patients and may contribute to the prevention of disease flares.

Predictors of pain, urinary symptoms and quality of life in patients with chronic pelvic pain syndrome (CPPS): A prospective 12-month follow-up study

ObjectiveChronic pelvic pain syndrome (CPPS) can affect both men and women and often causes substantial impairment to quality of life. Although cross-sectional studies have suggested that psychosocial aspects may constitute important factors in the etiology and maintenance of CPPS, longitudinal studies are rare. Therefore, the present study examines psychosocial factors as prospective predictors of pain intensity, urinary symptoms and impediments to quality of life in men and women with CPPS. MethodsData were collected from patients during visits to a specialized, interdisciplinary outpatient clinic and after 12 months. Outcomes included pain intensity, urinary symptoms and impediments to quality of life, all of which were measured with the NIH-CPSI. Age, sex, depressive-anxious symptomatology (PHQ-ADS), pain catastrophizing (PCS), health anxiety (WI-7) and social support (FSozU) were examined as predictors in multivariate linear regressions. ResultsData from 109 patients (59.6% female; age M = 49.3, SD = 16.7) were analyzed. Pain severity (β = .30, p = .004), age (β = .22, p = .02), urinary symptoms (β = .24, p = .01) and depressive-anxious symptomatology (β = .29, p = .009) at baseline emerged as predictors of pain at follow-up. Urinary symptoms were predicted by urinary symptoms (β = .53, p < .001) and depressive-anxious symptomatology (β = .25, p = .01) at baseline; impediments to quality of life were predicted by depressive-anxious symptomatology (β = .27, p = .01). ConclusionPsychological factors, especially depressive-anxious symptomatology, predict CPPS-specific symptom severity and impediments to quality of life after 12 months and thus substantially contribute to the chronification of CPPS. It is recommended to address anxiety and depression in patients with CPPS as early as possible in biopsychosocially oriented treatment approaches.

Long-term outcome of profound hyponatremia: a prospective 12 months follow-up study.

Hyponatremia is the most common electrolyte abnormality in hospitalized patients and given its impact on mortality and morbidity, a relevant medical condition. Nevertheless, little is known about factors influencing long-term outcome. This is a prospective observational 12-month follow-up study of patients with profound hyponatremia (≤125 mmol/L) admitted to the emergency department of two tertiary care centers between 2011 and 2013. We analyzed the predictive value of clinical and laboratory parameters regarding the following outcomes: 1-year mortality, rehospitalization and recurrent profound hyponatremia. Median (IQR) initial serum sodium (s-sodium) level of 281 included patients was 120 mmol/L (116-123). During the follow-up period, 58 (20.6%) patients died. The majority (56.2%) were rehospitalized at least once. Recurrent hyponatremia was observed in 42.7%, being profound in 16%. Underlying comorbidities, assessed by the Charlson Comorbidity Index, predicted 1-year mortality (odds ratio (OR) 1.43, 95% confidence interval (CI) 1.25-1.64, P < 0.001). Furthermore, 's-sodium level at admission' (OR 1.14, 95% CI 1.01-1.29, P = 0.036) and 'correction of hyponatremia' defined as s-sodium ≥135 mmol/L at discharge were associated with mortality (OR 0.47, 95% CI 0.23-0.94, P = 0.034). Mortality rate fell with decreasing baseline s-sodium levels and was lower in the hyponatremia category ≤120 mmol/L vs >120 mmol/L (14.8% and 27.8%, P < 0.01). Patients with s-sodium level ≤120 mmol/L were more likely to have drug-induced hyponatremia, whereas hypervolemic hyponatremia was more common in patients with s-sodium >120 mmol/L. Hyponatremia is associated with a substantial 1-year mortality, recurrence and rehospitalization rate. The positive correlation of s-sodium and mortality emphasizes the importance of the underlying disease, which determines the outcome besides hyponatremia itself.

Health-related quality of life in patients with lower rectal cancer after sphincter-saving surgery: a prospective 6-month follow-up study.

This longitudinal descriptive study examined whether rectal cancer patients report changes in health-related quality of life (HRQOL) over a 6-month period after different types of sphincter-saving surgery (SSS): intersphincteric resection (ISR), ultra-low anterior resection (ULAR) and low anterior resection (LAR). It also compares HRQOL among the three groups of patients. Seventy-three patients from two hospitals in Japan completed questionnaires on HRQOL and defecation symptoms immediately before surgery and 1 and 6months afterwards. Results showed that ISR patients had significantly worse HRQOL scores than ULAR and LAR patients and more defecation symptoms that persisted during the 6months post-SSS. Thus, patients undergoing ISR require psychological and social support, including skills in competent self-management, during the early post-operative period. Furthermore, defecation problems substantially influence HRQOL. The first month post-SSS is particularly challenging. The assumption that HRQOL is better after SSS compared to living with a permanent stoma might not be valid.

Comparing the DN4 tool with the IASP grading system for chronic neuropathic pain screening after breast tumor resection with and without paravertebral blocks: a prospective 6-month validation study.

Investigating protective strategies against chronic neuropathic pain (CNP) after breast cancer surgery entails using valid screening tools. The DN4 (Douleur Neuropathique en 4 questions) is 1 tool that offers important research advantages. This prospective 6-month follow-up study seeks to validate the DN4 and assess its responsiveness in screening for CNP that satisfies the International Association for the Study of Pain (IASP) definition and fulfills its grading system criteria after breast tumor resection with and without paravertebral blocks (PVBs). We randomized 66 females to standardized general anesthesia and sham subcutaneous injections, or PVB and total intravenous anesthesia. The 6-month CNP risk was assessed using the IASP grading system and the DN4 screening tools. We evaluated the DN4 sensitivity, specificity, and responsiveness in capturing the impact of PVB on the CNP risk relative to the IASP grading system. Data from 64 patients showed similar demographic characteristics in both groups. Twenty patients in both groups met the grading system CNP criteria; among these, 18 patients also met the DN4 CNP criteria. Furthermore, 15 patients in both groups did not meet the grading system CNP criteria; among these, 9 patients also did not meet the DN4 CNP criteria. Therefore, the sensitivity and specificity of the DN4 were estimated at 90% and 60%, respectively. Both screening tools suggested that PVB reduced the 6-month CNP risk. Our results suggest that the DN4 can reliably identify CNP at 6 months after breast tumor resection and detect the preincisional PVB effect on the risk of developing such pain.

Short Berg Balance Scale, BBS-9, as a predictor of fall risk among the aged: a prospective 12-month follow-up study

The aim of this study was to assess the adequacy of the short, 9-item Berg Balance Scale (BBS-9) to predict fall risk among the community-dwelling aged. The subjects (n=519) were derived from the participants in a multifactorial fall prevention intervention conducted in Pori, Finland. Receiver operating characteristic (ROC) analysis was used to determine the cut-off score for BBS-9 (range 0-36) to classify aged people with a fall risk during a 12-month follow-up. Logistic regression was used to analyse the relationship of potential confounders with fall risk. The association between the cut-off score for BBS-9 and fall risk was tested using the Chi-square test. In determining the cut-off score of BBS-9 to classify fall risk, the highest sensitivity (0.51) and specificity (0.57) (when both presumed to be above 0.50) sum score was within the limit range 32 scores or below. The area under curve (AUC) was significantly better in the model adjusted for significant confounders (vision and the number of regularly used drugs) (AUC=0.64) than in the unadjusted model (AUC=0.57) (p=0.045). Among patients who scored 32 or below in BBS-9 the incidence of multiple falls was 20.0%, whereas among those who scored 33-36 it was 15.7%. BBS-9 with the cut-off score of 32/33 together with data on vision and the number of regularly used drugs predicted moderately the risk of falling among the community-dwelling aged.