Conservative management equally effective to new suture anchor technique for acute mallet finger deformity: A prospective randomized clinical trial

Study Design

Prospective randomized controlled trial.

A prospective randomized trial of external fixation and plaster cast immobilization in the treatment of distal radial fractures

Distal radial fractures are common, and many methods of treatment have been reported but there are no studies that compare the different treatment methods. This randomized prospective study demonstrated no advantage in using an external fixator to immobilize reduced distal radial fractures over closed reduction and plaster cast immobilization in patients less than 60 years of age. The external fixator group had a significant complication rate.     

Application of behavioral economic strategies to enhance recruitment into a pediatric randomized clinical trial for postoperative pain relief: A randomized clinical trial

Introduction

A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk.

Methods

This single-center, prospective, randomized trial recruited patients 12-18 years old undergoing surgery requiring postoperative admission and narcotic administration. Patient-parent dyads were randomized to watch a behavioral economics-informed (n = 64) or standard biological (n = 66) recruitment video about a study designed to assess impact of a virtual reality pain management intervention.

Results

There was no difference in rates of intention to enroll in the study between groups (behavioral economics: 75%, control: 79%, p = 0.744) or in median response scores to questions regarding intention to adhere to therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.084), acceptability of therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p = 0.376), perceptions of treatment burden (3.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.251), and efficacy (3.0 [3.0, 4.0] vs. 3.0 [3.0, 4.0], p = 0.914). Patients in the behavioral economics group were less likely to perceive risk associated with virtual reality versus the control group (behavioral economics: 2.0 [1.0, 2.0], control: 2.0 [2.0, 3.0], p = 0.023).

Discussion

A behavioral economics-informed video did not increase patients’ intentions to enroll into a clinical trial assessing the impact of virtual reality intervention for postoperative pain management.

Conclusion

Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77%.     

益精方治疗弱精子症的临床随机对照研究

目的:观察益精方治疗弱精子症的临床疗效。方法:450例患者以信封法随机分为治疗组(益精方组)300例和对照组(五子衍宗丸+左卡尼汀口服液组)150例,经精液常规检查诊为弱精子症,治疗组服用益精方,每天1剂,温水冲服,分2次服用,对照组服用五子衍宗丸+左卡尼汀口服液,五子衍宗丸9 g,口服,每日2次,左卡尼汀口服液,10 ml,口服,每日2次,均治疗3个月,于治疗前及治疗后的第1个月(第27~33天)、2个月(第57~63天)和3个月(第87~93天)分别检测患者的精液常规,比较治疗前后精子浓度、前向运动精子百分率(PR)、精子总活力(PR+NP)等精液参数的变化。结果:两组患者治疗前精液常规检查结果无显著差异(P0.05)。治疗组治疗1、2、3个月时,精子浓度分别为49.66±10.91、55.21±11.46、74.90±13.07(×10~6/ml),PR分别为23.81±2.56、26.12±2.34、32.17±1.62(%),PR+NP分别为34.17±3.43、36.59±3.36、47.08±2.97(%),精液体积分别为3.15±1.06、3.12±0.90、3.27±0.78(ml),液化时间分别为31.68±3.14、30.38±3.44、30.86±2.42(min),组内比较显示,治疗后精子浓度、PR、PR+NP较治疗前差异显著(P0.001),精液体积、液化时间差异不明显(P0.05)。对照组治疗1、2、3个月时,精子浓度分别为40.53±8.32、47.51±12.73、56.14±11.98(×10~6/ml),PR分别为25.17±2.64、27.23±2.25、31.89±2.27(%),PR+NP分别为33.89±2.26、37.38±4.79、40.35±3.06(%),精液体积分别为3.16±1.78、3.15±0.96、3.12±0.65(ml),液化时间分别为29.36±4.25、28.21±3.26、28.33±3.59(min),组内比较显示,治疗后精子浓度、PR、PR+NP较治疗前差异显著(P0.001),精液体积、液化时间差异不明显(P0.05)。组间比较显示,治疗组精子浓度及PR+NP增长率较对照组有显著差异(P0.001),PR增长率两组间差异不明显(P0.05)。结论:益精方可在生精周期多个阶段调控精子的发生,提高弱精子症患者的PR及PR+NP比例,是一种有效的治疗弱精子症的方剂。     

Effectiveness of pulmonary artery catheters in aortic surgery: A randomized trial

Purpose: To evaluate the routine use of pulmonary artery catheters (PAC) in patients who undergo aortic surgery. Methods: One hundred twenty patients were randomized to placement of PACs for perioperative monitoring and hemodynamic optimization (tune up) in the intensive care unit on the night before aortic operation, or to intravenous hydration in the ward and perioperative monitoring without PACs. Before randomization, all patients underwent routine adenosine thallium-201 scintigraphy. Results: To meet predetermined endpoints, 30 PAC patients (50%) received nitrates, inotropic agents, or both. PAC patients received more fluid in the preoperative period (p < 0.001) and in the first 24 hours after operation (p = 0.002) than control subjects. Eleven PAC patients (18%) and three control subjects (5%) had adverse intraoperative events (p = 0.02). There were 20 adverse postoperative events in 15 PAC patients (25%; nine cardiac, seven pulmonary, four acute tubular necrosis), which was not different compared with 11 postoperative events in 10 control subjects (17%; five cardiac, five pulmonary, one acute tubular necrosis). There were also no differences in duration of mechanical ventilation, intensive care unit stay, or hospital stay between groups. Postoperative cardiac complications were more common among patients who had a history of congestive heart failure (p = 0.02; odds ratio, 3.75; confidence interval, 1.3 to 11) or reperfusion defects on adenosine thallium scintigraphy (p = 0.01; odds ratio, 3.4; confidence interval, 1.2 to 9.4), regardless of group. Conclusions: Routine use of PACs for perioperative monitoring with the above protocol during aortic surgery is not beneficial and may be associated with a higher rate of intraoperative complications. Preoperative tune up does not prevent postoperative cardiac, renal, and other complications. Variables such as cardiac risk factors and adenosine thallium scintigraphy may be more important predictors of cardiac events in patients who undergo aortic operations. (J Vasc Surg 1998;27:203-12.)     

A postdeployment expressive writing intervention for military couples: a randomized controlled trial

The current study tested the effectiveness of a brief expressive writing intervention on the marital adjustment of 102 military couples recently reunited following a deployment to Iraq or Afghanistan. Active duty soldiers and their spouses were randomly assigned to write about either their relationship or a nonemotional topic on 3 occasions on a single day. The resulting design included 4 couple-level writing topic conditions: soldier-expressive/spouse-expressive, soldier-expressive/spouse-control, soldier-control/spouse-expressive, and soldier-control/spouse-control. Participants completed marital adjustment measures before writing, 1 month, and 6 months after writing. When soldiers, but not spouses, did expressive writing, couples increased in marital satisfaction over the next month, particularly if the soldier had had high combat exposure.     

A prospective, randomized trial of cognitive intervention for postoperative pain

A single-blind, randomized prospective trial was performed at a university hospital to determine if preoperative relaxation training will decrease pain and narcotic demand postoperatively. A convenience sample of 49 patients undergoing lumbar and cervical spine surgery was randomized to receive instruction on relaxation techniques or routine preoperative information before surgery. Pain score and narcotic demand in the first 48 hours after surgery were the primary outcomes. Pain scores were higher in the relaxation (4.8 +/- 1.7) versus the standard preparation group (3.9 +/- 1.7) on postoperative day one (POD) 1, but lower on POD 2 (3.9 +/- 1.9 vs 4.1 +/- 1.9), whereas narcotic use (milligrams of IV morphine per hour) was higher in the relaxation group on POD 1 (1.14 +/- 0.94 vs 0.54 +/- 0.55) and POD 2 (0.86 +/- 0.73 vs 0.50 +/- 0.61). The differences were significant for narcotic demand (P = 0.01) but not for pain (P = 0.94). In conclusion, our results could not support the use of relaxation training for reducing postoperative pain and narcotic demand in this selected surgical population.     

Exercise handout and one-on-one hand therapy for management of stiffness after plaster cast immobilization of simple phalangeal and metacarpal fractures in children: A randomized,noninferiority trial

Study DesignThis is a noninferior, single-blind, randomized controlled trial.IntroductionJoint stiffness is common after plaster cast immobilization for simple phalanx and metacarpal fractures in children. The limited literature suggests this joint stiffness in children resolves without one-on-one therapy; however, without robust studies confirming that there is no detrimental effect from withdrawing treatment, many children are still referred.Purpose of the StudyThe purpose of this study was to determine if an educational handout for self-management of stiffness is noninferior to one-on-one hand therapy for achieving full range of motion (ROM).MethodsParticipants were randomly assigned to group one who received the handout or group two who received hand therapy in addition to the handout. The ROM was measured by composite flexion and total active motion (TAM). The noninferiority margin was 10% difference between the two groups in the proportion of participants who achieved full ROM at two weeks after cast removal.ResultsSixty participants in each group completed the study. Group difference for composite flexion was 1.7% (95% CI: −3.9% to 7.2%), demonstrating noninferiority. Group difference for TAM was inconclusive at 8.3% (95% CI: −2.1% to 18.7%). Sensitivity analysis adjusting for participants with full composite flexion at the baseline resulted in the group difference for composite flexion of 3.1% (95% CI: −3.6% to 9.8%), maintaining noninferiority, but group difference for TAM at 10.4% (95% CI: 0.0% to 20.9%), was inconclusive with the handout group significantly worse.ConclusionAn educational handout is noninferior to hand therapy for achieving full ROM in composite flexion but not TAM. This needs to be taken into consideration for changing clinical practise.     

Open versus closed management of the abdomen in the surgical treatment of severe secondary peritonitis: a randomized clinical trial

BACKGROUND: Despite recent advances in diagnosis, antimicrobial therapy, and intensive care support, operative treatment remains the foundation of the management of patients with severe secondary peritonitis (SSP). This management is based on three fundamental principles: (1) Elimination of the source of infection; (2) reduction of bacterial contamination of the peritoneal cavity; and (3) prevention of persistent or recurrent intra-abdominal infection. Although recent studies have emphasized the role of open management of the abdomen and planned re-laparotomies to fulfill these principles, controversy surrounds the optimal approach because no randomized studies exist. METHODS: Patients with SSP, documented clinically, with calculated Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation (APACHE II) scores and appropriate ancillary studies, were allocated randomly to two groups for the management of the abdomen after operation for SSP (group A: open; group B: closed). Both surgical strategies were standardized, and patients were followed up until cure or death. RESULTS: During a 24-month period, 40 patients with SSP were admitted for treatment. Patients in group A (n = 20) and group B (n = 20) did not differ in sex, age, site of origin (etiology), APACHE II score (24 vs. 22), SOFA score (15 vs. 15), or previous operative treatment (< or =1: 20 vs. 20). Postoperatively, there were no differences in the likelihood of acute renal failure (25% vs. 40%), duration of mechanical ventilatory support (10 vs. 12 days), need for total parenteral nutrition (80% vs. 75%), or rate of residual infection or need for reoperation because of the latter (15% vs. 10%). Although the difference in the mortality rate (55% vs. 30%) did not reach statistical significance (p < 0.05; chi-square and Fisher exact test), the relative risk and odds ratio for death were 1.83 and 2.85 times higher in group A. This clinical finding, as evidenced by the clear tendency toward a more favorable outcome for patients in group B, led to termination of the study at the first interim analysis. CONCLUSION: This randomized study from a single institution demonstrates that closed management of the abdomen may be a more rational approach after operative treatment of SSP and questions the recent enthusiasm for the open alternative, which has been based on observational studies.     

Effects of a dynamic progressive orthotic intervention for chronic hemiplegia: A case series

Study designCase series design on a single subgroup of participants.IntroductionManagement of hypertonicity and resistance to passive movement (RTPM) in the upper extremity is an intractable problem for persons with stroke and the therapists who provide their care. Therapists have limited options for assessment and treatment of this condition which can profoundly limit functional performance and quality of life.Purpose of the studyTo evaluate the effect of a 12-week dynamic progressive orthotic intervention in persons with chronic stroke exhibiting wrist flexion contracture who are residents of a long-term skilled nursing facility.MethodsA custom-fitted dynamic progressive wrist extension orthotic was applied to 6 residents with chronic stroke. The orthotic was worn for 4 h daily, 4×/week for 12 weeks. Wrist passive range of motion (PROM) and RTPM were measured weekly and after discontinuation of the orthotics using the Modified Ashworth Scale and the Tardieu Scale of Spasticity. Signal analysis of electromyographical (EMG) flexor response to extensor stretching was also measured before and after orthotic intervention using maximal root mean square (RMS) values and EMG burst onset time.ResultsA moderate effect was found for changes in PROM with the orthotic intervention. Progress made diminished following discontinuation. Moderate effects were also seen in EMG measures which indicated increases in amount of resistive-free movement following intervention.ConclusionA dynamic progressive orthotic intervention can be an effective option for increasing wrist PROM and reducing RTPM in persons with chronic stroke.Level of evidence4.     

A comparison of the effectiveness of splinting,exercise and electrotherapy in women patients with hallux valgus: A randomized clinical trial

BackgroundHallux valgus (HV) is a very common foot deformity involving lateral deviation of the hallux and medial deviation of the first metatarsal head.ObjectivesTo investigate the effects of HV night splinting, exercise and electrotherapy on the HV angle, and foot-specific health-related quality of life.MethodsSixty women (120 feet) with bilateral HV deformity were randomly assigned to one of three groups — an HV night splint (SP) group, an exercise (EX) group, and a high-voltage galvanic stimulation (HVPGS) (EL) group. The patients in SP group used the HV night splints while resting or sleeping for at least 8 h a day and the patients in the EX group performed exercises 3–4 times a day with 10 repetitions for the duration of the one-month treatment period. Twenty-minute HVPGS was applied in total over three weekly sessions for four weeks in EL group. Angular degrees (hallux interphalangeal angle (HIPA), HV angle (HVA), and intermetatarsal angle (IMA)) were determined before (t0) and three months after treatment (t2). Foot-specific quality of life was assessed using the Manchester-Oxford Foot Questionnaire (MOFQ) at t0, after one month (t1), and at t2.ResultsAll groups exhibited significant changes in the HIPA, HVA, and IMA angles and outcome measures (p ≤ 0.001). Decreases in the HIPA and IMA angles, and MOFQ-Pain subscale scores, were higher in the SP group than in the other two groups (p < 0.05). IMA angle at t2, MOFQ-Walking score at t1 and t2 and MOFQ-Pain subscale score at t1 were lower in the SP group (p < 0.05).ConclusionThe SP group exhibited more positive effects in the parameters measured than the other two groups. A combination of these conservative treatment approaches may be more beneficial to improve HV symptoms with longer follow-up periods.ClinicalTrials.gov IdentifierNCT04393545.