Using Conjoint Analysis to Measure the Acceptability of Rectal Microbicides Among Men Who Have Sex with Men in Four South American Cities

Conjoint Analysis (CJA), a statistical market-based technique that assesses the value consumers place on product characteristics, may be used to predict acceptability of hypothetical products. Rectal Microbicides (RM)-substances that would prevent HIV infection during receptive anal intercourse-will require acceptability data from potential users in multiple settings to inform the development process by providing valuable information on desirable product characteristics and issues surrounding potential barriers to product use. This study applied CJA to explore the acceptability of eight different hypothetical RM among 128 MSM in Lima and Iquitos, Peru; Guayaquil, Ecuador; and Rio de Janeiro, Brazil. Overall RM acceptability was highest in Guayaquil and lowest in Rio. Product effectiveness had the greatest impact on acceptability in all four cities, but the impact of other product characteristics varied by city. This study demonstrates that MSM from the same region but from different cities place different values on RM characteristics that could impact uptake of an actual RM. Understanding specific consumer preferences is crucial during RM product development, clinical trials and eventual product dissemination.     

A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery

Introduction

This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator.

Methods

A randomized crossover study among 115 women in South Africa, using both methods during five sex acts.

Results

We found no significant differences in acceptability between the two products. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%).

Conclusions

A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.

     

Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial

A randomized, placebo-controlled, efficacy trial of Carraguard was unable to demonstrate a reduction in women’s risk of HIV infection, which may have been due, in part, to low adherence (gel used in 42 % of vaginal sex acts, on average). A secondary analysis was undertaken to understand baseline factors associated with high adherence (gel used in ≥85 % of sex acts). Women who reported ≥1 vaginal sex act, returned ≥1 opened applicator, and had ≥1 conclusive post-enrollment HIV test (N = 5990) were included. Adherence was estimated as the ratio of average weekly applicator insertions (based on a dye stain assay indicating vaginal insertion)/average weekly sex acts (by self-report). Multivariate logistic regression modeling indicated that coital frequency, site, contraception, and partner age difference had a significant impact on adherence. Women reporting >1 and ≤2 vaginal sex acts per week, on average, were half as likely to be adherent as those reporting 1 vaginal sex act per week or less [adjusted odds ratio (AOR): 0.48; 95 % CI 0.38–0.61]; women from the Western Cape had one-third the odds of being adherent compared to women from KZN (AOR: 0.31; 95 % CI 0.23–0.41); compared to women using injectable contraception, women using any other or no method were more likely to be adherent (AOR: 1.30; 95 % CI 1.04–1.63); and women who had a larger age gap from their partners were more likely to be adherent (AOR: 1.03; 95 % CI 1.01–1.05; p = 0.001). Despite low adherence, overall, 13 % of participants achieved nearly perfect adherence, indicating a potential niche for a coitally dependent microbicide. More research is needed on the impact of sexual patterns and HIV risk perception on product acceptability and adherence to improve counseling in ongoing trials and when products are eventually introduced.     

A Novel Breath Test to Directly Measure Use of Vaginal Gel and Condoms

We assessed the feasibility of a breath test to detect women’s single or concurrent use of vaginal products by adding ester taggants to vaginal gel and condom lubricant. Healthy non-pregnant women were enrolled into a two-day cohort (N = 13) and a single-day cohort (N = 12) in San Francisco. Within each cohort, women were randomized (5:1) to tagged or untagged products, and inserted in a clinical setting: 4 mL of tenofovir placebo gel (ten tagged with 15 mg 2-pentyl acetate; three untagged), and an artificial phallus with a lubricated condom (11 tagged with 15 mg 2-butyl acetate; two untagged), on two separate days (two-day cohort) or concurrently (single-day cohort). Using a portable mini-gas chromatograph, the presence/absence of taggants was determined in breath specimens collected prior to, and at timed intervals following product exposure. Demographic, clinical and product use experience data were collected by structured interview. All participants completed all visits and inserted their assigned products. At 5 min post-insertion, the breath test was 100 % accurate in identifying insertion of the tagged (or untagged) gel and/or condom. The half-life in breath of the two esters tested was <1 h with large variability between individuals, taggants and cohorts. Overall, among those receiving tagged product, six mild and two moderate product-related AEs were reported. All were transient and resolved spontaneously. Additional sensations included taste in mouth (N = 4) and scent (N = 5). The tagged products were well tolerated. This breath test has the potential to accurately and objectively monitor adherence to vaginal gel and condom used separately or concurrently.     

Economic impact of remote monitoring on ordinary follow-up of implantable cardioverter defibrillators as compared with conventional in-hospital visits. A single-center prospective and randomized study

Introduction

Few data are available on actual follow-up costs of remote monitoring (RM) of implantable defibrillators (ICD). Our study aimed at assessing current direct costs of 1-year ICD follow-up based on RM compared with conventional quarterly in-hospital follow-ups.

Methods and results

Patients (N?=?233) with indications for ICD were consecutively recruited and randomized at implant to be followed up for 1 year with standard quarterly in-hospital visits or by RM with one in-hospital visit at 12 months, unless additional in-hospital visits were required due to specific patient conditions or RM alarms. Costs were calculated distinguishing between provider and patient costs, excluding RM device and service cost. The frequency of scheduled in-hospital visits was lower in the RM group than in the control arm. Follow-up required 47 min per patient/year in the RM arm versus 86 min in the control arm (p?=?0.03) for involved physicians, generating cost estimates for the provider of USD 45 and USD 83 per patient/year, respectively. Costs for nurses were comparable. Overall, the costs associated with RM and standard follow-up were USD 103?±?27 and 154?±?21 per patient/year, respectively (p?=?0.01). RM was cost-saving for the patients: USD 97?±?121 per patient/year in the RM group versus 287?±?160 per patient/year (p?=?0.0001).

Conclusion

The time spent by the hospital staff was significantly reduced in the RM group. If the costs for the device and service are not charged to patients or the provider, patients could save about USD 190 per patient/year while the hospital could save USD 51 per patient/year.     

Enhancing Acceptability and Use of Sexual Barrier Products Among HIV Concordant and Discordant Couples

Strategies to prevent HIV transmission may benefit from addressing both individual and dyadic factors. This study compared the impact of group and individual interventions on the acceptability of sexual barrier products among HIV sero-concordant and discordant couples, and evaluated the contribution of couple members’ perceived product acceptability to their sexual barrier use. Participants (n = 216 couples) were multicultural couples in Miami, Florida. Longitudinal multilevel modeling and the actor–partner interdependence model were used for analyses. Product acceptability increased more among female group participants, and acceptability of male condoms increased more among sero-discordant couples in the group. Additionally, acceptability of products associated with prevention of STDS/HIV and pregnancy increased more among sero-concordant couples in the group condition. Both actor and partner product acceptability predicted use. Results support the use of group interventions targeting both partners in relationships in prevention programs designed to enhance sexual barrier use.     

End-Users’ Product Preference Across Three Multipurpose Prevention Technology Delivery Forms: Baseline Results from Young Women in Kenya and South Africa

A multipurpose prevention technology (MPT) that combines HIV and pregnancy prevention is a promising women’s health intervention, particularly for young women. However, little is known about the drivers of acceptability and product choice for MPTs in this population. This paper explores approval ratings and stated choice across three different MPT delivery forms among potential end-users. The Trio Study was a mixed-methods study in women ages 18–30 that examined acceptability of three MPT delivery forms: oral tablets, injections, and vaginal ring. Approval ratings and stated choice among the products was collected at baseline. Factors influencing stated product choice were explored using multivariable multinomial logistic regression. The majority (62%) of women in Trio stated they would choose injections, 27% would choose tablets and 11% would choose the ring. Significant predictors of choice included past experience with similar contraceptive delivery forms, age, and citing frequency of use as important. Ring choice was higher for older (25–30) women than for younger (18–24) women (aRR = 3.1; p < 0.05). These results highlight the importance of familiarity in MPT product choice of potential for variations in MPT preference by age.     

Rapid Colonoscopy Preparation Using Bolus Lukewarm Saline Combined with Sequential Posture Changes: A Randomized Controlled Trial

Objective

In this randomized clinical trial, we have compared the Shudh? colon cleanse (SCC) with HalfLytely^® colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability.

Methods

Patients were randomized to receive either SCC (n = 65) or HCP (n = 68). All colonoscopies were performed by a single, blinded endoscopist. Colon prep was evaluated on a 5 point grading scale. Statistical non-inferiority was pre-defined as a difference of <15 % in the lower limit of the 95.5 % confidence interval for the treatment difference. Data that were collected include bowel prep score, BPT, adverse events, electrolyte abnormalities and patient acceptability.

Results

Bowel preparation efficacy was rated as “successful” for 59/65 (90.7 %) in SCC versus 66/68 (97.1 %) in HCP. This gave a success difference of ?6.4 % with a 1-sided 95 % lower confidence limit (LCI) for the difference = ?13.3 % (non-inferiority p = 0.25). This difference fell within the predefined limit for non-inferiority. The average BPT for SCC was 1.9 h versus 10.9 in HCP (p < 0.001). No serious adverse events were reported in either group. None of the patients in either group had any clinically significant electrolyte imbalance. Patient ratings for palatability and willingness to repeat were significantly better for SCC (p < 0.05).

Conclusion

SCC was found to not be inferior to PEG with regards to the quality of bowel preparation. It is worth highlighting that a major advantage of SCC is shorter BPT. (Clinical trial registration number: NCT01547130).     

Awareness and Acceptability of Female Condoms Among Monogamous Hong Kong Chinese Female Sexually Transmitted Infection Patients

Female condom is an effective means of HIV prevention. Monogamous female sexually transmitted infection (STI) patients are exposed indirectly to high risk of contracting HIV/STI via their sole male sex partners. There are few interventions to protect such women whilst female condom use is a potential means of self-protection. With informed consent, this cross-sectional study investigated the prevalence of awareness and acceptability of female condoms among 335 Chinese monogamous female STI patients attending a government STI clinic in Hong Kong. Among those who were aware of female condoms (66.9 % of the sample), 68.3 % were willing to use free female condoms. Awareness was associated with having the sex partner being a boyfriend (OR = 3.76, P < 0.001), knowledge about asymptomatic property of HIV (OR = 2.14, P = 0.006) and no immunity for STI (OR = 2.14, P = 0.011), experience of HIV antibody testing (OR = 2.21, P = 0.004) and unemployment (OR = 0.50, P = 0.011). Among those who had heard of female condoms, acceptability was associated with knowledge about possibility to contracting two STI concomitantly (OR = 2.26, P = 0.03) and perceived chance of contracting STI from the sex partner in the coming 6 months (OR = 2.27, P = 0.04). Awareness is relatively low but the prevalence of acceptability is encouraging. Female condoms have been underused and should be promoted among monogamous female STI patients as a means of empowerment as an option for sex protection.     

Measures to Reduce Mother-to-Child Transmission of Hepatitis B Virus in China: A Meta-Analysis

Background

Mother-to-child transmission (MTCT) is the main mode of spread of hepatitis B virus (HBV) in China. We performed a meta-analysis to compare the effects of three measures for prevention of MTCT.

Methods

A meta-analysis was performed on randomized controlled trials and non-randomized studies comparing the index of MTCT among five groups of pregnant women: hepatitis B immunoglobulin (HBIG) administration, antiviral treatment, placebo, elective caesarean section, and vaginal delivery.

Results

Compared with the control group, the incidence of HBV intrauterine infection (RR = 0.42, 95 % CI 0.27–0.64, P < 0.0001) and the number of chronic hepatitis B (CHB) infants (RR = 0.44, 95 % CI 0.32–0.61, P < 0.00001) were lower in the HBIG administration group. In the antiviral treatment group, serum HBV DNA levels were lower (MD = ?4.01, 95 % CI ?5.07 to ?2.94, P < 0.00001) at the time of delivery, and normalization of ALT levels was better (RR = 1.11, 95 % CI 1.06–1.17, P < 0.0001). Infant serum HBsAg positivity (RR = 0.45, 95 % CI 0.22–0.91, P = 0.03) and incidence of infant HBV transmission RR = 0.06, 95 % CI 0.01–0.24, P < 0.0001) were reduced in antiviral the treatment group. Infant serum anti-HBs positivity at birth (RR = 1.24, 95 % CI 0.89–1.74, P = 0.2) or at 6–7 months (RR = 0.98, 95 % CI 0.86–1.11, P = 0.73) was not significantly different between the caesarean section and vaginal delivery groups. The incidence of infant CHB infection may have been higher in the vaginal delivery group (RR = 2.20, 95 % CI 1.02–4.74, P = 0.04).

Conclusions

Administration of HBIG or antiviral therapy to HBV carrier mothers during pregnancy is effective in reducing MTCT.     

Curcumin-supplemented diets increase superoxide dismutase activity and mean lifespan in Drosophila

Curcumin is a polyphenolic bioactive compound in turmeric. We examined if antioxidant effects of curcumin are associated with lifespan extension in Drosophila. In this experiment, females and males of Drosophila were fed diets either containing no curcumin (C0) or supplemented with curcumin at 0.5 (C1) and 1.0 (C2) mg/g of diet. The levels of malondialdehyde (MDA), enzyme activity of superoxide dismutase (SOD), and expression of seven age-related genes in females and males were analyzed. We found that C1 and C2 increased mean lifespan by 6.2 % and 25.8 % in females, and by 15.5 % and 12.6 % in males, respectively. Meanwhile, C1 and C2 significantly decreased MDA levels and increased SOD activity in both genders. Diets C1 in females and C2 in males are effective in extending mean lifespan and improving levels of two physiological and biochemical measures related to aging in Drosophila. Lifespan extension of curcumin in Drosophila was associated with the up-regulation of Mn-SOD and CuZn-SOD genes, and the down-regulation of dInR, ATTD, Def, CecB, and DptB genes. The present results suggest that curcumin increases mean lifespan of Drosophila via regulating gene expression of the key enzyme SOD and reducing accumulation of MDA and lipid peroxidation. This study provided new insights for understanding the anti-aging mechanism of curcumin in Drosophila.     

A Validated Bowel-Preparation Tolerability Questionnaire and Assessment of Three Commonly Used Bowel-Cleansing Agents

Background and Study Aims

Bowel-cleansing studies are frequently underpowered, poorly designed, and with subjective assessments. Consensus on tolerability of the bowel-cleansing agents is thus lacking. This study developed and validated a bowel-preparation tolerability questionnaire and used it to assess the tolerability of three bowel-cleansing agents, sodium phosphate (NaP), polyethylene glycol (PEG), and sodium picosulphate (Pico), in a prospective randomized single-blinded trial of ambulatory patients.

Patients and Methods

The bowel-preparation tolerability questionnaire was validated in 125 consecutive patients and then bowel-preparation agent tolerability was assessed in 634 patients in a prospective randomized single-blinded trial.

Results

The questionnaire’s internal consistency was satisfactory with good to excellent “test–retest” reliability for aggregate tolerability and visual analogue scores. Validity assessment confirmed it as reliable and accurate. Of 634 patients, 97.8 % took >75 % of the allocated preparation and 98.9 % completed the questionnaire. Overall, Pico was better tolerated than PEG (p < 0.001) and NaP (p < 0.001). NaP was better tolerated than PEG (p < 0.001). Regardless of the bowel-preparation agent used, males tolerated them better than females (p = 0.009) as did patients having their procedure in the AM. Older patients, however, tolerated all preparations better than younger patients (p = 0.006).

Conclusions

This study used the first validated bowel-preparation tolerability questionnaire and identified that age, sex, and procedure time all impacted tolerability. Overall, Pico was best tolerated, but PEG’s tolerability in patients ≥60 years was equal to that of Pico and NaP, suggesting that PEG can be recommended for older patients to avoid the electrolyte disturbances associated with the osmotic preparations.     

Patterns of simultaneous and concurrent alcohol and marijuana use among adolescents

Background: Alcohol and marijuana are the most commonly used substances among adolescents but little is known about patterns of co-use. Objectives: This study examined patterns of concurrent (not overlapping) and simultaneous (overlapping) use of alcohol and marijuana among adolescents. Methods: Data from US-national samples of 12th graders (N = 84,805, 48.4% female) who participated in the Monitoring the Future study from 1976 to 2016 and who used alcohol and/or marijuana in the past 12 months were used to identify latent classes of alcohol use, marijuana use, and simultaneous alcohol and marijuana (SAM) use. Results: A four-class solution indicated four patterns of use among adolescents: (1) Simultaneous alcohol and marijuana (SAM) use with binge drinking and recent marijuana use (SAM-Heavier Use; 11.2%); (2) SAM use without binge drinking and with recent marijuana use (SAM-Lighter Use; 21.6%); (3) Marijuana use and alcohol use but no SAM use (Concurrent Use; 10.7%); and (4) Alcohol use but no marijuana or SAM use (Alcohol-Only Use; 56.4%). Membership in either SAM use class was associated with a higher likelihood of truancy, evenings out, and use of illicit drugs other than marijuana. SAM-Heavier Use, compared to SAM-Lighter Use, class members were more likely to report these behaviors and be male, and less likely to have college plans. Conclusions: Among 12th graders who use both alcohol and marijuana, the majority use simultaneously, although not all use heavily. Given the recognized increased public health risks associated with simultaneous use, adolescent prevention programming should include focus on particular risks of simultaneous use.     

Effect of Intracoronary and Intravenous Melatonin on Myocardial Salvage Index in Patients with ST-Elevation Myocardial Infarction: a Randomized Placebo Controlled Trial

Melatonin has attenuated myocardial ischemia reperfusion injury in experimental studies. We hypothesized that the administration of melatonin during acute myocardial reperfusion improves myocardial salvage index in patients with ST-elevation myocardial infarction. Patients (n = 48) were randomized in a 1:1 ratio to intracoronary and intravenous melatonin (total 50 mg) or placebo. The myocardial salvage index assessed by cardiac magnetic resonance imaging at day 4 (± 1 day) after primary percutaneous coronary intervention was similar in the melatonin group (n = 22) at 55.3% (95% CI 47.0–63.6) and the placebo group (n = 19) at 61.5% (95% CI 57.5–65.5), p = 0.21. The levels of high-sensitive troponin T, creatinine kinase myocardial band, and oxidative biomarkers (advanced oxidation protein products, malondialdehyde, myeloperoxidase) were similar in the groups. The frequency of clinical events at 90 days did not differ between the groups. In conclusion, melatonin did not improve the myocardial salvage index after primary percutaneous coronary intervention in patients with ST elevation myocardial infarction compared with placebo.     

Effectiveness of Mindfulness-Based Cognitive Therapy on the Quality of Life,Emotional Status,and CD4 Cell Count of Patients Aging with HIV Infection

Long-term diagnosed and treated HIV-infected patients have to cope with a wide range of challenges that threaten their ability to age successfully. We report the results of a randomized controlled trial testing the effects of a mindfulness-based cognitive therapy (MBCT) program on quality of life (QoL), emotional status, and immune status over a 3-month period. Forty HIV-infected patients diagnosed prior to 1996 and on cART for a minimum of 5 years were randomized to follow an MBCT program (n = 20) or remain as controls (routine follow-up) (n = 20). A regression analysis was performed, and the measurement of effect size was estimated using Cohen’s d. QoL, psychological stress, depressive symptoms, and anxiety symptoms improved in the MBCT group compared with the control group. During follow-up, patients in the MBCT group had a significantly increased CD4 cell count. Effect sizes for MBCT on the variables assessed were large (d = 0.8). The findings suggest that this program may help to promote successful aging in these patients.     

Comparison of human insulin and insulin analogues on hypoglycaemia and metabolic variability in type 1 diabetes using standardized measurements (HYPO score and Lability Index)

To evaluate whether treatment with insulin analogues is associated with a lower risk of hypoglycaemia (HYPO score) and less glycaemic variability (Lability Index) than treatment with human insulin in patients with type 1 diabetes. In a 6-month prospective, open-labelled trial, we randomized 47 patients treated with human insulin to receive treatment with human insulin (n = 21) or insulin analogues (n = 26). HYPO score, Lability Index (LI), and hypoglycaemic episode characteristics were assessed at baseline and at the end of follow-up. A 72-h, continuous glucose monitoring was performed at the end in a subgroup of patients. Groups were compared with nonparametric tests. Significance was defined as P < 0.05. HYPO score (71.5 [36.0–162] vs. 260 [52.0–676], P < 0.05), nocturnal hypoglycaemia (0.4 vs. 1.4 events/patient/4-week, P < 0.05), and <2.5 mmol/l hypoglycaemic events were lower in insulin analogue group after 6 months. There was a trend towards a lower LI in insulin analogue group (74.3 [51.3–133] vs. 123 [76.4–171] mmol/l²/h week^?1, P = 0.064). HbA_1c and insulin dose were comparable between groups. In type 1 diabetes, insulin analogues were associated with a lower hypoglycaemic risk and a trend towards reduced glycaemic variability compared with human insulin. These effects occurred despite comparable metabolic control.     

Association of Interleukin-18 Gene Polymorphisms with Hepatitis B Virus Clearance

The outcome of hepatitis B virus (HBV) infection can be affected by host immune factors. Interleukin-18 (IL-18) was originally discovered as an interferon-γ-inducing factor and plays a critical role in immune response. We assessed the association between the clearance of HBV infection and single-nucleotide polymorphisms (SNPs) in the IL-18 gene. Between March 2002 and December 2004, a total of 1,050 Korean subjects were enrolled in the study and divided into two groups: (1) the HBV spontaneous recovery group (n = 320) and (2) the chronic HBV carrier group (n = 730). We analyzed SNPs at four polymorphic sites in the IL-18 gene at positions ?667G>T, ?148G>C, +8925C>G, and +13925A>C. We observed that the subjects bearing the IL-18 ?148C allele [odds ratio (OR), 0.25; confidence interval (CI), 0.09–0.68; P = 0.01], the +8925G allele (OR, 0.36; CI, 0.15–0.88; P = 0.02), and the +13925C allele (OR, 0.25; CI, 0.13–0.82; P = 0.01) were significantly associated with HBV clearance in a recessive model. This study indicates that the ?148C, +8925G, and +13925C alleles of the IL-18 gene are likely associated with HBV clearance in a Korean population.     

Biologic therapy response and drug survival for females compared to males with rheumatoid arthritis: a cohort study

Prior research has identified differences between sexes in rheumatoid arthritis (RA) disease characteristics and treatment response, but not how these differences affect therapeutic decision making to switch therapy. Our objective was to assess for sex differences in RA disease activity during the course of biologic therapy and how these differences impact drug survival and therapeutic switching. Data from the Alberta Biologics Pharmacosurveillance Program, a population-based observational cohort of patients receiving biologic therapy for RA, were used for a sex-stratified analysis of disease activity. Linear mixed-model analysis was applied to compare continuous effectiveness outcomes (DAS28, HAQ scores, visual analogue scales of patient-reported outcomes). Chi-squared tests and log-rank tests were used to determine differences in the frequency of switching and drug survival between females and males. At biologic initiation, females (n = 419) and males (n = 148) had similar disease activity (DAS28 in females 5.83, males 5.72), but females reported worse function (HAQ 1.64 vs 1.51, p = 0.037) and more fatigue (6.7 vs 5.9/10, p = 0.013), but the same global score as males (6.9 vs 6.8/10). During biologic therapy, females reported more fatigue (β = ?0.454, 95 % CI ?0.852, ?0.056, p = 0.0252), worse function (β = ?0.183, 95 % CI ?0.291, ?0.074, p = 0.0010) and higher DAS28 scores (β = ?0.401, 95 % CI ?0.617, ?0.184, p = 0.0003). A new composite disease activity index, the HUPI, eliminated the observed differences in disease activity scores between females and males. Median survival for biologic-naïve patients was similar between sexes (3.7 years males, 3.3 years females, log-rank test p = 0.25). The frequency of switching and survival on subsequent biologics were the same between females and males. Guided by traditional outcome measurement tools, worse disease activity and patient-reported outcomes through the course of therapy did not translate into differences in drug survival or more frequent switching for females on biologic therapy for RA.     

Is low-level laser therapy in relieving neck pain effective? Systematic review and meta-analysis

The aim of this study is to determine the efficacy of low-level laser therapy (LLLT) in reducing acute and chronic neck pain as measured by the visual analog scale (VAS). A systematic search of nine electronic databases was conducted to identify original articles. For study selection, two reviewers independently assessed titles, abstracts, and full text for eligibility. Methodological quality was assessed using the Detsky scale. Data were analyzed using random-effects model in the presence of heterogeneity and fixed-effect model in its absence. Heterogeneity was assessed using Cochran’s Q statistic and quantifying I ². Risk ratios (RR) with 95 % confidence intervals (CI) were reported. Eight randomized controlled trials involving 443 patients met the strict inclusion criteria. Inter-rater reliability for study selection was 92.8 % (95 % CIs 80.9–100 %) and for methodological quality assessment was 83.9 % (95 % CIs 19.4–96.8 %). Five trials included patients with cervical myofascial pain syndrome (CMPS), and three trials included different patient populations. A meta-analysis of five CMPS trials revealed a mean improvement of VAS score of 10.54 with LLLT (95 % CI 0.37–20.71; Heterogeneity I ² = 65 %, P = 0.02). This systematic review provides inconclusive evidence because of significant between-study heterogeneity and potential risk of bias. The benefit seen in the use of LLLT, although statistically significant, does not constitute the threshold of minimally important clinical difference.     

Adherence to Antiretroviral Therapy and Acceptability of Planned Treatment Interruptions in HIV-Infected Children

There have been no paediatric randomised trials describing the effect of planned treatment interruptions (PTIs) of antiretroviral therapy (ART) on adherence, or evaluating acceptability of such a strategy. In PENTA 11, HIV-infected children were randomised to CD4-guided PTIs (n = 53) or continuous therapy (CT, n = 56). Carers, and children if appropriate, completed questionnaires on adherence to ART and acceptability of PTIs. There was no difference in reported adherence on ART between CT and PTI groups; non-adherence (reporting missed doses over the last 3 days or marking <100 % adherence since the last clinical visit on a visual analogue scale) was 18 % (20/111) and 14 % (12/83) on carer questionnaires in the CT and PTI groups respectively (odds ratios, OR (95 % CI) = 1.04 (0.20, 5.41), χ² (1) = 0.003, p = 0.96). Carers in Europe/USA reported non-adherence more often (31/121, 26 %) than in Thailand (1/73, 1 %; OR (95 % CI) = 54.65 (3.68, 810.55), χ² (1) = 8.45, p = 0.004). The majority of families indicated they were happy to have further PTIs (carer: 23/36, 64 %; children: 8/13, 62 %), however many reported more clinic visits during PTI were a problem (carer: 15/36, 42 %; children: 6/12, 50 %).