Respiratory infections reduce the growth response to vitamin A supplementation in a randomized controlled trial

BACKGROUND: Studies on the effect of vitamin A supplementation on growth have yielded various results. It is possible that such growth is dependent on the burden of infectious diseases in the population. METHODS: We analysed data from a randomized, double-masked, placebo-controled trial to examine the role of respiratory infections and diarrhoea in modifying the growth response to vitamin A supplementation. A single high dose of vitamin A or placebo was given every 4 months to 1405 children aged 6-48 months, and 4430 child treatment cycles were used in this analysis. RESULTS: Vitamin A supplementation modestly improved linear but not ponderal growth of children who experienced little respiratory infection and especially of those who had vitamin A intake below the normative requirement (<400 RE/day). Children who received vitamin A and were free of respiratory infection grew 0.22 cm/4 months (95% CI: 0.08, 0.37) more in height than the placebo group, but those with > or =21.5% of days of respiratory infection did not show a significant growth response to vitamin A supplementation. Children who experienced no respiratory infection and had vitamin A intake <400 RE/day benefited most, gaining 0.31 cm/4 months (95% CI: 0.10, 0.52) more in height compared to the placebo group. Diarrhoea was associated with poorer growth, but did not significantly modify the effect of vitamin A supplementation on growth. CONCLUSIONS: Vitamin A supplementation improves the linear growth of children who have a low intake of vitamin A but this impact is muted with increasing levels of respiratory infections.     

Feasibility of the randomized response technique in rural Ethiopia.

A multiple answer model of Randomized Response Technique (known as Hopkins RRT Model II) was tried in a rural area (Nekempte) in Ethiopia to estimate the incidence of induced abortion among currently married women of childbearing age. In the RRT adopted here, the question on abortion--sensitive as it is--was preceded by two innocuous "practice questions". Despite the very low literacy level of the women, nearly all of them cooperated. The RRT estimates in regard to the two innocuous "practice questions" were fairly reasonable, while the RRT estimate of the rate of induced abortion (35 per cent) was far higher than that derived from direct reporting. The differentials in abortion rates by age and parity were consistent with expectation. A post RRT survey indicated that more than one-half (58 per cent) of the women found RRT "easy" or "moderately easy" to understand, while nearly 80 per cent of them thought that there was no "trick" involved in it.     

A randomized controlled trial of home telecare

We have established a randomized controlled trial of home telecare. The intervention aims to address a growing problem in the National Health Service (NHS), that is, high admission rates of patients with exacerbations of chronic obstructive pulmonary disease (COPD). Equipment procurement for the trial has been difficult, as no single supplier was able to meet the project s full requirements. The fact that the service is provided by existing clinical NHS staff has advantages when considering the generalizability of the results within the NHS. However, there are also disadvantages, since existing staff have little research experience. Considerable time has been required to help staff familiarize themselves with the equipment and become comfortable with its use. This has posed a barrier to the implementation of the service.     

A comparison of response rate and time according to the survey methods used: A randomized controlled trial

The purpose of this study was to evaluate the effects of recorded and standard deliveries, and stamped and franked return envelopes in a postal survey of Korean–Vietnam veterans. Nine hundred veterans were randomly divided into four subgroups. A randomized controlled trial was conducted for two mailing strategies. The 52 study subjects to whom mail was undeliverable and 36 additional study subjects found not to be residing at the listed addresses were excluded from the study. The 699 (86%) surveys were returned within 39 business days after the first mailing. The response rate for the recorded delivery (88%) was significantly higher than that of the standard delivery (82%)(p = 0.03), and the response rate of the stamped return envelops (88%) was higher than that of the franked return envelops (85%)(p = 0.27). The replies for the recorded and standard deliveries arrived an average of 10.2 and 9.9 business days, respectively, after the first mailing (p = 0.60). The average times of the responses for the stamped and franked return envelopes were 9.8 and 10.4 business days, respectively (p = 0.25). Recorded deliveries significantly increased the response rate compared to standard deliveries, and stamped return envelops slightly increased the response rate a little compared to franked return envelops. The timing of response of recorded deliveries was similar to that of standard deliveries but the volume of response of recorded deliveries was higher than that of standard deliveries.This revised was published online in April 2005. In the previous version the article category was missing.     

Registered post achieved a higher response rate than normal mail--a randomized controlled trial

OBJECTIVE: The aim was to study the most effective method for increasing response rates to postal questionnaires by comparing normal post with registered mail and to assess the cost implications of the two mailing methods. STUDY DESIGN AND SETTING: General Practitioners in Victoria (n=1,550) were randomized to receive a research questionnaire via either normal post or registered mail. RESULTS: The overall response rate for the study after two reminders was 76.1% (1,179/1,550). After the initial mail out the response rate for the registered mail arm was 55.9% (n=433) compared to the normal post arm, 40.1% (n=311, P-value <0.001). After the first and second reminders the response rates dropped, registered mail obtained a response rate of 47.4% (n=162) and 37.8% (n=68), respectively, compared to a response rate of 28.0% (n=130) and 22.5% (n=75) for normal post. Overall, the cumulative response rate for the registered mail was greater, 85.6% (n=663) compared to 66.6% (n=516) for the normal post arm (P-value <0.001) There was a total cost difference between the registered and normal method of AUD $1,531.50. CONCLUSION: Registered post when used for mail out of the initial questionnaire and all subsequent reminders is a more effective yet more expensive method for achieving a high response rate.     

Electronic reminders did not improve postal questionnaire response rates or response times: a randomized controlled trial

Objective

We aim to evaluate the effectiveness of electronic reminders (ERs) to improve the response rates and time to response of postal questionnaires in a health research setting.

Study Design and Setting

This pragmatic randomized controlled trial (RCT) was nested within a multicenter RCT of yoga for lower back pain. Participants who provided an electronic mail address and/or mobile phone number were randomized to receive an ER or no reminder (controls) on the day they were due to receive a follow-up questionnaire.

Results

One hundred twenty-five participants (32 males and 93 females) mean age 46 (standard deviation: 11, range: 20-65) were randomized to ER (n = 62) or controls (n = 63). Overall 85.6% of participants returned postal questionnaires (87.1% ER group and 84.1% from controls). No significant differences were found between the two groups for response rate (difference between groups = 3.0%, 95% confidence interval [CI] = −10, 16; P = 0.64) or time to response after adjusting for age, gender, and treatment allocation (χ² _[3df] = 7.10; P = 0.07).

Conclusion

In the present RCT, we found little evidence for the effectiveness of ERs to increase response rates or time to respond for the return of questionnaires in this study population group.     

A randomized controlled trial of an online immunization curriculum

IntroductionImmunization education for physicians-in-training is crucial to address vaccine concerns in clinical practice. Vaccine education is not standardized across residency programs. The Collaboration for Vaccination Education and Research (CoVER) team developed an online curriculum for pediatric (Peds) and family medicine (FM) residents.MethodsA cluster randomized controlled trial (RCT) was performed during the 2017–2018 academic year to evaluate the CoVER curriculum. A convenience sample of residency institutions were randomly allocated to the intervention or control group, with stratification by residency type. The intervention, the CoVER curriculum, consisted of four online modules and an in-person training guide. Control sites continued with their standard vaccine education. Pre-intervention and post-intervention surveys were emailed to residents in both groups. The primary outcomes compared between groups were changes in “vaccine knowledge,” “vaccine attitudes/hesitancy,” and “self-confidence” in immunization communication. The team assessing outcomes was unblinded to assignments. Hierarchical general linear model was used to adjust for residency type and residency year; residency site was modeled as a random effect.ResultsOverall, 1444 residents from 31 residency programs were eligible to participate (734 intervention, 710 control). The pre-intervention response rate was 730 (51%) and post-intervention was 526 (36%). Average knowledge scores increased from pre-intervention (control 53%; CoVER 53%) to post-intervention (control 58%; CoVER 60%). Increases in vaccine knowledge among FM residents were greater for CoVER compared to controls (p = 0.041). Vaccine hesitancy was more common among FM (23%) than Peds (10%) residents. In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.ConclusionThe CoVER curriculum is an effective model to standardize immunization education of physicians-in-training. This RCT demonstrated the effectiveness of the CoVER curriculum to improve resident confidence in their ability to discuss vaccines with parents and patients.     

A randomized controlled trial of hypnotherapy for smoking cessation

A randomized controlled study in a family practice setting was conducted on the use of hypnosis in helping people quit smoking. In the hypnosis group 21 percent of patients quit smoking by the three month follow-up compared with 6 percent in the control group. By six months there were no significant differences between the two groups, and at one year 22 percent in the hypnosis group and 20 percent in the control group had quit. The only significant predictor of success with quitting was having a college education.     

A randomized controlled trial comparing quantitative informed consent formats

Informed consent has been indirectly studied only in settings that do not replicate the actual consent process. We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment". Patients randomized to Consent A were more likely to consent than those randomized to Consent B (consent rate A = 67%, consent rate B = 42%, p less than 0.01). Among patients who cited quantitative information, the difference in consent rate was even more marked (95% vs 36%, p less than 0.001); patients who did not cite quantitative information had equivalent consent rates. Patients who perceived minimal or severe symptoms had lower consent rates than those with mid-range symptom scores (chi 2(2) = 8.35, p = 0.015). Patients who recognize quantitative information will use it to make informed consent decisions.     

The one-person randomized controlled trial

Currently, the gold standard for collection of clinical evidence is the randomized controlled trial (RCT), preferably with large, multicenter samples of subjects. Although this approach provides valuable information, many clinicians find it difficult to translate RCT results to the individual patient level. In this report, a statistical approach called Design of Experiments (DOE) is described as a method of applying the principles of RCTs one person at a time. An overview of the method, with a simple clinical example, is presented. As shown, DOE is a more efficient method than the sequential approach often taken by clinicians and their patients when evaluating various treatment choices. Further, the effect of multiple interventions can be assessed, alone or in combination with each other. In this way, DOE can be an important addition to the field of evidence-based medicine, although further studies are needed.     

Analysis of randomized controlled trials

Although the sophistication and flexibility of the statistical technology available to the data analyst have increased, some durable, simple principles remain valid. Hypothesis-driven analyses, which were anticipated and specified in the protocol, must still be kept separate and privileged relative to the important, but risky data mining made possible by modern computers. Analyses that have a firm basis in the randomization are interpreted more easily than those that rely heavily on statistical models. Outcomes--such as quality of life, symptoms, and behaviors--that require the cooperation of subjects to be measured will come to be more and more important as trials move away from mortality as the main outcome. Inevitably, such trials will have to deal with more missing data, especially because of dropout and noncompliance. There are fundamental limits on the ability of statistical methods to compensate for such problems, so they must be considered when studies are designed. Finally, it must be emphasized that the availability of software is not a substitute for experience and statistical expertise.     

POWERSforID: Personalized online weight and exercise response system for individuals with intellectual disability: A randomized controlled trial

BackgroundObesity is associated with early mortality and chronic disease among adults with intellectual disability (ID), yet there is a paucity of effective weight management interventions for this population.Objective/hypothesisThis pilot study examined a tailored intervention on weight loss, waist circumference, A1c, and lipid profile among adults with ID.MethodsObese adults (BMI ≥ 30 kg/m²) with mild to moderate ID were randomized to an intervention (n = 17) or comparison group (n = 18) for a 24-week trial. All participants completed health-related questionnaires and clinic visits. Participants in the intervention group received access to an online weight management platform that assisted them in monitoring their diet and physical activity along with weekly coaching calls (weeks 1–12) that were tapered off to calls every other week (weeks 12–24). The comparison group completed questionnaires and clinic visits, but did not receive access to the online platform or calls. Differences in weight, waist circumference, percent body fat, A1c, lipid profile were assessed at baseline and at week 24.ResultsThe intervention group reduced body weight by an average of 2.7% (−2.6 kg; p = 0.02) and waist circumference by 3.4% (−3.89 cm; p = 0.02) versus the comparison. There were no statistically significant group by time interactions observed among other variables.ConclusionAdults with ID who received the intervention were able to maintain or slightly reduce their body weight and waist circumference after the 24-week intervention. Despite not achieving the targeted sample size, the pilot study findings serve as a basis for developing accessible weight management interventions for people with ID.     

Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial,Karachi, Pakistan

BackgroundOutbreaks of circulating vaccine derived polioviruses type 2 (cVDPV2) remain a risk to poliovirus eradication in an era without live poliovirus vaccine containing type 2 in routine immunization. We evaluated existing outbreak response strategies recommended by the World Health Organization (WHO) for control of cVDPV2 outbreaks.MethodsSeronegative children for poliovirus type 2 (PV2) at 22 weeks of life were assigned to one of four study groups and received respectively (1) one dose of trivalent oral poliovirus vaccine (tOPV); (2) monovalent OPV 2 (mOPV2); (3) tOPV together with a dose of inactivated poliovirus vaccine (IPV); or (4) mOPV2 with monovalent high-potency IPV type 2. Stool and blood samples were collected and assessed for presence of PV2 (stool) and anti-polio antibodies (sera).ResultsWe analyzed data from 265 children seronegative for PV2. Seroconversion to PV2 was achieved in 48, 76, 98 and 100% in Groups 1–4 respectively. mOPV2 was more immunogenic than tOPV alone (p < 0.001); and OPV in combination with IPV was more immunogenic than OPV alone (p < 0.001). There were 33%, 67%, 20% and 43% PV2 excretors in Groups 1–4 respectively. mOPV2 resulted in more prevalent shedding of PV2 than when tOPV was used (p < 0.001); and tOPV together with IPV resulted in lower excretion of PV2 than tOPV alone (p = 0.046).ConclusionmOPV2 was a more potent vaccine than tOPV. Adding IPV to OPV improved immunological response; adding IPV also seemed to have shortened the duration of PV2 shedding. mIPV2 did not provide measurable improvement of immune response when compared to conventional IPV. WHO recommendation to use mOPV2 as a vaccine of first choice in cVDPV2 outbreak response was supported by our findings.Clinical Trial registry number: NCT02189811.     

A randomized controlled trial of analgesia during vaccination in adults

Although immunization injections are the most common painful medical procedures, pain-relieving interventions are not routinely used. In this randomized controlled trial, we compared the effectiveness of topical anesthesia using liposomal lidocaine to: (1) vapocoolant spray using a proprietary blend of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane; (2) nurse-administered tactile stimulation; or (3) self-directed distraction by means of reading a magazine. Liposomal lidocaine was more effective (p ≤ 0.05) than distraction, as assessed by self-reported pain using the visual analog scale and global report, but did not differ from either vapocoolant spray or tactile stimulation. This information can be incorporated in immunization programs.     

A randomized controlled trial of home telerehabilitation for post-knee arthroplasty

We compared the effectiveness of home telerehabilitation with conventional rehabilitation following knee replacement surgery (total knee arthroplasty, TKA). Forty-eight patients (mean age 66 years) who received TKA were recruited prior to discharge from hospital after surgery and were randomly assigned to telerehabilitation or usual care. Telerehabilitation sessions (16 per participant over two months) were conducted by trained physiotherapists using videoconferencing to the patient's home via an Internet connection (512 kbit/s upload speed). Disability and function were measured using standardized outcome measures in face-to-face evaluations at three times (prior to and at the end of treatment, and four months after the end of treatment). Clinical outcomes improved significantly for all subjects in both groups between endpoints. Some variables showed larger improvements in the usual care group two months post-discharge from therapy than in the telerehabilitation group. Home telerehabilitation is at least as effective as usual care, and has the potential to increase access to therapy in areas with high speed Internet services.     

A randomized controlled trial of direct access for laparoscopic sterilization

OBJECTIVES: The aim of this study was to establish and evaluate a direct access service for laparoscopic sterilization. METHODS: A pragmatic randomized controlled trial was carried out on a total of 232 women referred to Aberdeen Royal Infirmary for sterilization between 1 June 1996 and 31 March 1997, from 57 general practices around Aberdeen, Scotland, comprising 75 from general practices that had received criteria for direct access, and 157 from control practices. The main outcome measures were: patients' waiting times to appointments and operation, satisfaction, short-term regret, operative complications and costs; conjoint analysis of patient preferences; GPs' adherence to referral criteria; GP and gynaecologist satisfaction; and NHS costs. RESULTS: Analysis was by intention to treat. There were no inappropriate direct referrals. Waiting time was lower in the intervention group, but there were more visits post-operatively to the GP. Patient and doctor satisfaction was equally high in both groups. There was no difference in operative complication rate, nor in total cost to patients or to the NHS. GPs and gynaecologists strongly supported direct access, but women preferred to meet both a gynaecologist and a GP before sterilization (routine referral). Other attributes of care important to patients included written information, although waiting time was not important. Of all women referred for sterilization during the study period, only 31% were suitable for direct referral. CONCLUSIONS: Patients preferred routine referral, and there were no differences in patient costs or satisfaction. There was, however, strong medical support for direct referral. Restrictive direct referral criteria may limit the uptake. These findings are important for future planning of direct referral services. Important methodological lessons were also learnt about the conduct of trials involving the primary-secondary care interface.