Secondary Outcome Scores Research Articles

Effects of a Short-time health literacy promotion program (HeLPP) on biochemical factors, self-care and quality of life among rural patients with type-2 diabetes: A field trial with Solomon four-group design.

Current evidence suggests that health literacy (HL) impacts self-care behaviors and quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM). This study aimed to evaluate the impact of a short-time health literacy promotion program (HeLPP) on self-care behaviors and QOL in rural patients with type 2 diabetes. Conducted from 2018 to 2019 in Chaldoran county, Iran, this randomized controlled trial followed the Solomon four-group design. Participants included 160 rural individuals with T2DM, who were divided into two intervention (A and C) and two control (B and D) groups. Pre-tests were conducted for intervention group A and control group B, with post-tests administered to all groups at three and six months. Interventions, consisting of five training sessions lasting 45 to 55 minutes, were planned and executed based on pre-test analyses. Primary outcomes were QOL and self-care behaviors, and secondary outcomes were glycated hemoglobin (HbA1c), HL and patients' awareness of the disease. Prior to the intervention, there was no significant difference in awareness, HL, self-care behaviors, HbA1c, and QOL between intervention group A and control group B (P>0.05). However, at three and six months after the educational program, intervention group A exhibited significantly increased average scores in awareness, HL, self-care behaviors, and QOL, along with reduced HbA1c levels (P<0.05) compared to control group B. No interaction was detected between the pre-test and the primary and secondary outcome scores after intervention. Implementing intervention programs like HeLPP focusing on enhancing practical HL and empowering T2DM patients seems to be promising in improving patients' self-care behaviors and QOL, while reducing their HbA1c levels. Identifier: IRCT20131116015422N7; https://irct.behdasht.gov.ir/trial/35569.

Quality of Patient-Centered eHealth Information on Erosive Tooth Wear: Systematic Search and Evaluation of Websites and YouTube Videos.

Due to the declining prevalence of dental caries, noncarious tooth defects such as erosive tooth wear have gained increased attention over the past decades. While patients more frequently search the internet for health-related information, the quality of patient-centered, web-based health information on erosive tooth wear is currently unknown. This study aimed to assess the quality of patient-centered, web-based health information (websites and YouTube videos) on erosive tooth wear. German-language websites were systematically identified through 3 electronic search engines (google.de, bing.de or yahoo.de, and duckduckgo.com) in September 2021. Eligible websites were independently assessed for (1) technical and functional aspects via the LIDA instrument, (2) readability via the Flesch reading-ease score, (3) comprehensiveness of information via a structured checklist, and (4) generic quality and risk of bias via the DISCERN instrument by 2 different reviewers. An overall quality score (ie, higher scores being favored) generated from all 4 domains was used as the primary outcome. Quality scores from each domain were separately analyzed as secondary outcomes and compared by the Friedman test. The effect of practice-specific variables on quality scores of websites from private dental offices was assessed using generalized linear modeling. Eligible YouTube videos were judged based on (1) the comprehensiveness of information, (2) viewers' interaction, and (3) viewing rate. The comprehensiveness of information was compared between websites and YouTube videos using the Wilcoxon rank-sum test. Overall, 231 eligible websites and 7 YouTube videos were identified and assessed. The median overall quality of the websites was 33.6% (IQR 29.8%-39.2%). Secondary outcome scores amounted to 64.3% (IQR 59.8%-69.0%) for technical and functional aspects, 40.0% (IQR 34.0%-49.0%) for readability, 11.5% (IQR 3.9%-26.9%) for comprehensiveness of information, and 16.7% (IQR 8.3%-23.3%) for generic quality. While the comprehensiveness of information and generic quality received low scores, technical and functional aspects as well as readability resulted in higher scores (both Padjusted<.001). Regarding practice-specific variables, websites from private dental offices outside Germany (P=.04; B=-6.64, 95% CI -12.85 to -0.42) or from dentists who are a dental society member (P=.049; B=-3.55, 95% CI -7.09 to -0.01) resulted in lower readability scores (ie, were more difficult to read), while a shorter time since dentists' examination resulted in higher readability scores (P=.01; B=0.24 per year, 95% CI 0.05-0.43). The comprehensiveness of information from YouTube videos was 34.6% (IQR 13.5%-38.5%). However, the comprehensiveness of information did not vary between websites and YouTube videos (P=.09). Additionally, viewers' interaction (1.7%, IQR 0.7%-3.4%) and viewing rates (101%, IQR 54.6%-112.6%) were low. The quality of German-language, patient-centered, web-based information on erosive tooth wear was limited. Especially, the comprehensiveness and trustworthiness of the available information were insufficient. Web-based information on erosive tooth wear requires improvement to inform patients comprehensively and reliably.

Clinical Study of Intraoperative Microelectrode Recordings during Awake and Asleep Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease: A Retrospective Cohort Study.

Our objective is to analyze the difference of microelectrode recording (MER) during awake and asleep subthalamic nucleus deep brain stimulation (STN-DBS) for Parkinson's disease (PD) and the necessity of MER during "Asleep DBS" under general anesthesia (GA). The differences in MER, target accuracy, and prognosis under different anesthesia methods were analyzed. Additionally, the MER length was compared with the postoperative electrode length by electrode reconstruction and measurement. The MER length of two groups was 5.48 ± 1.39 mm in the local anesthesia (LA) group and 4.38 ± 1.43 mm in the GA group, with a statistical significance between the two groups (p &lt; 0.01). The MER length of the LA group was longer than its postoperative electrode length (p &lt; 0.01), however, there was no significant difference between the MER length and postoperative electrode length in the GA group (p = 0.61). There were also no significant differences in the postoperative electrode length, target accuracy, and postoperative primary and secondary outcome scores between the two groups (p &gt; 0.05). These results demonstrate that "Asleep DBS" under GA is comparable to "Awake DBS" under LA. GA has influences on MER during surgery, but typical STN discharges can still be recorded. MER is not an unnecessary surgical procedure.

Long-Term Outcomes of Multiligament Knee Injuries.

To characterize long-term outcomes of multiligament knee injuries (MLKIs) using patient-reported outcome measures, physical examination, and knee radiographs. Retrospective clinical follow-up. Twenty knees (18 patients) were evaluated at a mean follow-up of 13.1 years (range 11-15 years). The primary outcome measure was the Internal Knee Documentation Committee score. Patients also completed secondary patient-based outcome assessments including Patient-Reported Outcomes Measurement Information System computer adaptive testing, Short Form-36, and Tegner activity score. Sixteen knees (14 patients) also had physical examination and bilateral knee radiographs assessed with the Kellgren-Lawrence score. The mean Internal Knee Documentation Committee score was 56 points, which was significantly lower than the age-matched normative value of 77 ( P = 0.004) and exceeds the minimum clinically important difference of 12 points. Most secondary outcome scores were worse than normative population values. Posttraumatic arthritis was present in 100% of MLKIs that had radiographs. Comparing operative versus nonoperative management, there were no statistical differences in patient demographics, injury characteristics, physical examination, or imaging, but surgical patients had better Short Form-36 Social Functioning (89 vs. 63, P = 0.02) and Tegner scores (4.5 vs. 2.9, P = 0.05). The long-term outcomes of MLKIs are generally poor, and posttraumatic radiographic evidence of arthritis seems to be universal . Operative management of these injuries may improve long-term outcomes. Clinicians should be aware of these results when counseling patients. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Return to match running performance after a hamstring injury in elite football: a single-centre retrospective cohort study

ObjectivesTo determine the number of matches to return to pre-injury match running performance after sustaining an acute hamstring injury.MethodsIn this retrospective cohort study, the injuries of the players of the...

Proximal hamstring tendon avulsions: comparable clinical outcomes of operative and non-operative treatment at 1-year follow-up using a shared decision-making model

ObjectiveTo prospectively evaluate 1-year clinical and radiological outcomes after operative and non-operative treatment of proximal hamstring tendon avulsions.MethodsPatients with an MRI-confirmed proximal hamstring tendon avulsion were included. Operative or non-operative...

A Simplified clinical algorithm for standardized surgical treatment of chronic pain after inguinal hernia repair: A quality assessment study.

The optimal surgical strategy for the treatment of chronic pain after inguinal hernia repair is controversial and based on relatively weak evidence. The purpose of this study was to analyze pain-related functional impairment using a simplified clinical treatment algorithm for a standardized surgical treatment. The algorithm was predefined, and the indication to operate was based on strict criteria. This was a prospective, non-controlled, explorative study. The pain operation was either open triple neurectomy with total mesh removal or laparoscopic retroperitoneal triple neurectomy. A clinically relevant postoperative change was defined as ⩾25% change from the baseline level. Primary outcome was pain-related impairment of physical function using the Activity Assessment Scale. Secondary outcomes included Individual Patient-Reported Outcome Measures, Hospital Anxiety and Depression Scale, and PainDETECT Questionnaire. A total of 240 patients were referred (2016-2019). Sixty-six patients were included for the analysis. A total of 25% of referred patients were offered a pain operation. Follow-up was a median 3 months (range: 3-13). Activity Assessment Scale scores were clinically relevant improved in 43 patients (68%), not clinically relevant different in 19 (30%), and clinically relevant worsened in one (2%). Secondary outcome scores were all significantly improved (P < 0.05) except for the risk of postoperative depression (P = 0.092). Fifty-one patients (77%) reported that chronic groin pain was reduced after the operation. Pain-related functional impairment was improved with clinical relevance in roughly 70% of patients through a simplified clinical algorithm for surgical treatment of severe chronic pain after an inguinal hernia repair.

Effectiveness of an e-health tennis-specific injury prevention programme: randomised controlled trial in adult recreational tennis players

BackgroundDespite reported injury rates of up to 3 per 1000 hours exposure, there are no evidence-based prevention programmes in tennis.PurposeTo evaluate the effectiveness of an e-health prevention programme for reducing...

Medial Patellofemoral Ligament Repair Versus Reconstruction for Recurrent Patellar Instability: Two-Year Results of an Algorithm-Based Approach.

Background:Patellar instability remains a challenging problem for both the patient and surgeon. Medial patellofemoral ligament (MPFL) repair has historically had poor results, and due to this, there is currently a trend toward reconstruction.Purpose/Hypothesis:This study was undertaken to investigate experience with repair versus reconstruction of the MPFL using a multifactorial treatment algorithm approach. Our hypothesis was that there will be no significant difference in outcome scores between patients in the MPFL repair and reconstruction groups.Study Design:Cohort study; Level of evidence, 2.Methods:A total of 24 patients with recurrent (≥2) lateral patellar dislocations were included. All had failed nonoperative treatment for more than 6 months, and all were observed for a minimum of 2 years. First, magnetic resonance imaging (MRI) was used to find the location of the MPFL tear. A tilt test was used to determine whether a lateral retinacular lengthening was required to allow the patella to have neutral tilt. If the MRI showed a tibial tubercle–trochlear groove (TT-TG) distance greater than 20 mm, a tibial tubercle osteotomy (TTO) was recommended. An MPFL reconstruction was performed if the entire ligament was inadequately visualized on MRI or if it was torn from both insertion sites. Failure was defined as recurrent lateral patellar instability after surgery. As a secondary outcome measure, Knee injury and Osteoarthritis Outcome Score (KOOS), Lysholm score, and Tegner score were calculated.Results:All patients were evaluated with a mean follow-up of 51 months (range, 25-79 months). Sixteen patients initially underwent MPFL repair, 8 underwent reconstruction, and 3 also underwent TTO. MPFL reconstructions were performed in all patients who underwent TTO. One MPFL repair was to the anatomic femoral origin and 15 were to the patellar insertion corresponding to the site of tearing on MRI. A lateral retinacular lengthening was performed in 21 patients. There was 1 failure in the repair group (6%) and none in the reconstruction group. However, the patient who failed had a TT-TG distance of 26 mm but refused a TTO. She subsequently underwent revision with a TTO and MPFL reconstruction and did not have any further instability events. There were no significant differences between groups for any of the secondary outcome scores.Conclusion:Using an algorithm-based approach, MPFL repair or reconstruction may lead to clinically acceptable results at 2-year follow-up.

Acupuncture for Primary Sj\xf6gren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial

BackgroundCurrently, feasible medical treatments are hitherto not satisfying to relieve pSS symptoms, which concerns numbers of clinical doctors. Acupuncture seems to be an alternative to treat pSS and conduces to good symptomatic results. However further research is necessary. This trial is to investigate the efficacy of acupuncture on improving the key symptoms of pSS, which are dryness, pain and fatigue (DPF).Methods & DesignThe study is designed as a randomized controlled trial of two arms with a single centre. We compare acupuncture with sham acupuncture on symptomatic improvements of pSS. A total of 120 pSS patients, aged at least 18, with DPF, will be randomly assigned to acupuncture or sham acupuncture groups, where they will have needle intervention for 8 weeks with 16 weeks of follow-up. Subjects will be assessed each time before interventions during the 8-week intervention, in week 8 after all interventions and in week 12, 16, 20 and 24 for follow-up with different measurements. The primary outcome are the proportions of subjects that have 30% or greater reduction in at least 2 out of 3 items of DPF in Numeric Analog Scale (NAS) scores (0 = the best, 10 = the severest), calculated between the baseline and the average scores of week 2 to 8. The secondary outcome are related to individual items of NAS scores, EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), Schirmer test score and unstimulated salivary flow, serum Immunoglobulin G, A and M levels, Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36), Salivary glands ultrasounds, Hospital Anxiety and Depression (HAD) scale score. The secondary outcome scores are to be collected at baseline, in week 8, 16, and 24. Besides, individual items of NAS will also be collected in week 12 and 20. Moreover, subjects’ satisfaction and the proportion of the subjects who identified their allocation will also be measured and analyzed.DiscussionThis study will be the first randomized and controlled pilot trial of acupuncture on alleviating the symptoms of pSS with relatively long-term follow-up. The result of the study might offer a new option to treat pSS and might be a clinical proof that acupuncture has beneficial effects on pSS.Trial registrationClinicalTrials.gov: NCT02691377 (February 20, 2016)

Rationale, secondary outcome scores and 1-year follow-up of a randomised trial of platelet-rich plasma injections in acute hamstring muscle injury: the Dutch Hamstring Injection Therapy study

BackgroundPlatelet-rich plasma (PRP) injections are an experimental treatment for acute muscle injuries. We examined whether PRP injections would accelerate return to play after hamstring injury. The methods and the primary...

Comparison of effectiveness of different surgical treatments for meralgia paresthetica: Results of a prospective observational study and protocol for a randomized controlled trial

IntroductionVarious surgical procedures can be applied in the treatment of meralgia paresthetica. The two main ones are neurolysis and neurectomy of the lateral femoral cutaneous nerve. To date, no prospective or randomized controlled trial has compared the effectiveness of these procedures with standardized outcome measures. In this study we present our results for two prospectively followed cohorts and we present the protocol for a double blind randomized controlled trial (RCT). Methods and analysisAll patients that had an indication for surgical treatment of idiopathic meralgia paresthetica between August 2012 and April 2014 were included in the study. The patient decided on the type of treatment (neurolysis or neurectomy) after informed consent had been given. Primary outcome was measured using the Likert scale obtained 6 weeks after the surgery. Successful pain reduction was defined as Likert 1 or 2. Secondary outcome measures were the Numeric Rating Scale (NRS) and Bothersomeness Index (BSI). In case of neurectomy the BSI for numbness was also obtained. ResultsA total of 22 consecutive patients were included: neurolysis was performed in 8 patients and neurectomy in 14 patients (one bilateral case). Successful pain reduction was observed more frequently after neurectomy (93.3%) than after neurolysis (37.5%, P<0.05). Secondary outcome scores (NRS and BSI pain) were also better after neurectomy, although not significantly (respectively P=0.07 and 0.05). Paired analysis of the scores before and after the surgery showed an improvement in both the NRS and BSI after the neurectomy procedure (both P<0.001), while scores were not significantly different before and after the neurolysis procedure. Patient's scores for the BSI numbness after the neurectomy procedure were low (mean 1.4, SD±1.0, range 0–3). DiscussionThe results of our prospective study confirm results previous studies reported in the literature in that the percentage pain relief was better after neurectomy than after neurolysis. A RCT is needed to further investigate potential differences in effectiveness. The protocol for such a trial is presented in this article.

Impact of PCA strategies on pain intensity and functional assessment measures in adults with sickle cell disease during hospitalized vaso‐occlusive episodes

Clinical trials of sickle cell disease (SCD) pain treatment usually observe only small decrements in pain intensity during the course of hospitalization. Sub-optimal analgesic management and inadequate pain assessment methods are possible explanations for these findings. In a search for better methods for assessing inpatient SCD pain in adults, we examined several pain intensity and interference measures in both arms of a randomized controlled trial comparing two different opioid PCA therapies. Based upon longitudinal analysis of pain episodes, we found that scores from daily average Visual Analogue Scales (VAS) and several other measures, especially the Brief Pain Inventory (BPI), were sensitive to change in daily improvements in pain intensity associated with resolution of vaso-occlusive pain. In this preliminary trial, the low demand, high basal infusion (LDHI) strategy demonstrated faster, larger improvements in various measures of pain than the high demand, low basal infusion (HDLI) strategy for opioid PCA dosing, however, verification in larger studies is required. The measures and statistical approaches used in this analysis may facilitate design, reduce sample size, and improve analyses of treatment response in future SCD clinical trials of vaso-occlusive episodes.

Full Kinetic Chain Manual and Manipulative Therapy Plus Exercise Compared With Targeted Manual and Manipulative Therapy Plus Exercise for Symptomatic Osteoarthritis of the Hip: A Randomized Controlled Trial

Brantingham JW, Parkin-Smith G, Cassa TK, Globe GA, Globe D, Pollard H, deLuca K, Jensen M, Mayer S, Korporaal C. Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial. ObjectiveTo determine the short-term effectiveness of full kinematic chain manual and manipulative therapy (MMT) plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip osteoarthritis (OA). DesignParallel-group randomized trial with 3-month follow-up. SettingTwo chiropractic outpatient teaching clinics. ParticipantsConvenience sample of eligible participants (N=111) with symptomatic hip OA were consented and randomly allocated to receive either the experimental or comparison treatment, respectively. InterventionsParticipants in the experimental group received full kinematic chain MMT plus exercise while those in the comparison group received targeted hip MMT plus exercise. Participants in both groups received 9 treatments over a 5-week period. Main Outcome MeasuresWestern Ontario and McMasters Osteoarthritis Index (WOMAC), Harris hip score (HHS), and Overall Therapy Effectiveness, alongside estimation of clinically meaningful outcomes. ResultsTotal dropout was 9% (n=10) with 7% of total data missing, replaced using a multiple imputation method. No statistically significant differences were found between the 2 groups for any of the outcome measures (analysis of covariance, P=.45 and P=.79 for the WOMAC and HHS, respectively). ConclusionsThere were no statistically significant differences in the primary or secondary outcome scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. Consequently, the nonsignificant findings suggest that there would also be no clinically meaningful difference between the 2 groups. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that the full kinematic chain approach does not appear to have any benefit over targeted treatment.