Categories
Nevin Manimala Statistics

Does the Application of Topical Vancomycin Reduce Surgical Site Infections in Spine Surgery? A Meta-analysis of Randomized Controlled Trials

Clin Orthop Relat Res. 2024 Jul 12. doi: 10.1097/CORR.0000000000003179. Online ahead of print.

ABSTRACT

BACKGROUND: Surgical site infections (SSIs) represent a major challenge in spine surgery, leading to severe morbidity, mortality, and increased costs. The local application of antibiotics, particularly vancomycin, has emerged as a potential strategy. Individual randomized controlled trials (RCTs) have disagreed about the efficacy of topical vancomycin in preventing SSIs after spine surgery, and so a meta-analysis that pools data from those RCTs might be helpful to inform clinicians’ decisions on the topic.

QUESTIONS/PURPOSES: This meta-analysis of RCTs asked: Does intrawound topical vancomycin reduce the risk of (1) SSIs, (2) deep SSIs, and (3) superficial SSIs in patients undergoing spine surgery?

METHODS: PubMed, Cochrane, and Google Scholar (pages 1-20) were searched up through March 13, 2024 (search performed on March 13, 2024). Inclusion criteria consisted of English or non-English-language RCTs comparing the implementation of topical vancomycin in spine surgery to its nonuse and assessing its efficacy in preventing SSI, while exclusion criteria consisted of nonrandomized comparative studies, single-arm noncomparative studies, comparative studies based on national databases or from the same center as other included studies, studies posted to preprint servers, studies reporting incomplete/nonrelevant outcomes, and studies adding another SSI preventive measure. The studies were assessed using the Cochrane Risk of Bias tool. Heterogeneity was evaluated by Q tests and I2 statistics. We used a random-effects model when considerable heterogeneity was observed (all SSIs, deep SSIs); otherwise, a fixed-effects model was used (all SSIs subanalysis, superficial SSIs). Furthermore, the fragility index was calculated for each of the assessed outcomes when there was no difference between the two groups to assess how many patients were needed to experience the outcomes for a difference to become present. The studied outcomes were the risks of SSIs, deep SSIs, and superficial SSIs. Deep SSIs were defined by the included trials as SSIs underneath the fascia, otherwise they were considered superficial. Six RCTs representing a total of 2140 patients were included, with 1053 patients in the vancomycin group and 1087 in the control group. Using an alpha of 0.05, our meta-analysis had 80% power to detect a risk difference of 1.5% for the primary outcome between patients who did and did not receive vancomycin. The age of the patients in the vancomycin group ranged from 37 to 52 years, while the age in the control group ranged from 34 to 52 years. The surgical procedures consisted of both instrumented and noninstrumented spinal procedures. Overall, the risk of bias in the included studies was either low or unclear, with none of the studies having a high risk of bias in any of the assessed categories (selection bias, performance bias, detection bias, attrition bias, and reporting bias).

RESULTS: We found no difference in the risk of SSI between the vancomycin and control groups (3.0% [32 of 1053] versus 3.9% [42 of 1087], relative risk 0.74 [95% CI 0.35 to 1.57]; p = 0.43). Ten additional patients (4.8% infection risk) in the control group would need to experience an SSI for a difference to be observed between the two groups. We found no difference in the risk of deep SSI between the vancomycin and control groups (1.8% [15 of 812] versus 2.7% [23 of 860], relative risk 0.69 [95% CI 0.24 to 2.00]; p = 0.50). Seven additional patients (3.5% infection risk) in the control group would need to experience a deep SSI for a difference to be observed between the two groups. We found no difference in the risk of superficial SSI between the vancomycin and control groups (1.0% [6 of 620] versus 1.4% [9 of 662], relative risk 0.68 [95% CI 0.25 to 1.89]; p = 0.46). Seven additional patients (2.4% infection risk) in the control group would need to experience a superficial SSI for a difference to be observed between the two groups.

CONCLUSION: This meta-analysis of randomized trials examining use of topical vancomycin in spine surgery failed to show efficacy in reducing infection, and thus we do not recommend routine use of topical vancomycin for this indication. Future large-scale trials would be needed if surgeons believe that between-group differences smaller than those for which we were powered here (this meta-analysis had 80% power to detect a between-group difference of 1.5% in infection risk) are clinically important, and large database surveys may be informative in terms of assessing for postoperative adverse events associated with the use of vancomycin powder.

LEVEL OF EVIDENCE: Level I, therapeutic study.

PMID:38996386 | DOI:10.1097/CORR.0000000000003179

Categories
Nevin Manimala Statistics

What Are the Sex-Based Differences of Acetabular Coverage Features in Hip Dysplasia?

Clin Orthop Relat Res. 2024 Jul 12. doi: 10.1097/CORR.0000000000003126. Online ahead of print.

ABSTRACT

BACKGROUND: Eccentric rotational acetabular osteotomy is performed to prevent osteoarthritis caused by developmental dysplasia of the hip (DDH). To achieve sufficient acetabular coverage, understanding the characteristics of acetabular coverage in DDH is necessary. However, the features of acetabular coverage in males with DDH remain unclear. We thought that the differences in acetabular coverage between females and males might be associated with the differences in pelvic morphology between the sexes.

QUESTIONS/PURPOSES: (1) What are the differences in the acetabular coverage between females and males with DDH? (2) What are the differences in the rotations of the ilium and ischium between females and males with DDH? (3) What is the relationship between the rotation of the ilium and ischium and the acetabular coverage at each height in females and males with DDH?

METHODS: Between 2016 and 2023, 114 patients (138 hips) underwent eccentric rotational acetabular osteotomy at our hospital. We excluded patients with Tönnis Grade 2 or higher, a lateral center-edge angle of 25º or more, and deformities of the pelvis or femur, resulting in 100 patients (122 hips) being included. For female patients (98 hips), the median (range) age was 40 years (10 to 58), and for the male patients (24 hips), it was 31 years (14 to 53). We used all patients’ preoperative AP radiographs and CT data. The crossover sign, posterior wall sign, and pelvic width index were evaluated in AP radiographs. The rotation of the innominate bone in the axial plane was evaluated at two different heights, specifically at the slice passing through the anterior superior iliac spine and the slice through the pubic symphysis and ischial spine in CT data. Furthermore, we evaluated the anterior and posterior acetabular sector angles. Comparisons of variables related to innominate bone measurements and acetabular coverage measurements between females and males in each patient were performed. The correlations between pelvic morphology measurements and acetabular coverage were evaluated separately for females and males, and the results were subsequently compared to identify any sex-specific differences. For continuous variables, we used the Student t-test; for binary variables, we used the Fisher exact test. A p value less than 0.05 was considered statistically significant.

RESULTS: In the evaluation of AP radiographs, an indicator of acetabular retroversion-the crossover sign-showed no differences between the sexes, whereas the posterior wall sign (females 46% [45 of 98] hips versus males 75% [18 of 24] hips, OR 3.50 [95% confidence interval (CI) 1.20 to 11.71]; p = 0.01) and pelvic width index less than 56% (females 1% [1 of 98] versus males 17% [4 of 24], OR 18.71 [95% CI 1.74 to 958.90]; p = 0.005) occurred more frequently in males than in females. There were no differences in the iliac rotation parameters, but the ischium showed more external rotation in males (females 30° ± 2° versus males 24° ± 1°; p < 0.001). Regarding acetabular coverage, no differences between females and males were observed in the anterior acetabular sector angles. In contrast, males showed smaller values than females for the posterior acetabular sector angles (85° ± 9° versus 91° ± 7°; p = 0.002). In females, a correlation was observed between iliac rotation and acetabular sector angles (anterior acetabular sector angles: r = -0.35 [95% CI -0.05 to 0.16]; p < 0.001, posterior acetabular sector angles: r = 0.42 [95% CI 0.24 to 0.57]; p < 0.001). Similarly, ischial rotation showed a correlation with both acetabular sector angles (anterior acetabular sector angles: r = -0.34 [95% CI -0.51 to -0.15]; p < 0.001 and posterior acetabular sector angles: r = 0.45 [95% CI 0.27 to 0.59]; p < 0.001). Thus, in females, we observed that external iliac rotation and ischial internal rotation correlated with increased anterior acetabular coverage and reduced posterior coverage. In contrast, although acetabular coverage in males showed a correlation with iliac rotation (anterior acetabular sector angles: r = -0.55 [95% CI -0.78 to -0.18]; p = 0.006 and posterior acetabular sector angles: r = 0.74 [95% CI 0.48 to 0.88]; p < 0.001), no correlation was observed with ischial rotation.

CONCLUSION: In males, acetabular retroversion occurs more commonly than in females and is attributed to their reduced posterior acetabular coverage. In females, an increase in the posterior acetabular coverage was correlated with the external rotation angle of the ischium, whereas in males, no correlation was found between ischial rotation and posterior acetabular coverage. In treating males with DDH via eccentric rotational acetabular osteotomy, it is essential to adjust bone fragments to prevent inadequate posterior acetabular coverage. Future studies might need to investigate the differences in acetabular coverage between males and females in various limb positions and consider the direction of bone fragment rotation.

CLINICAL RELEVANCE: Our findings suggest that males with DDH exhibit acetabular retroversion more frequently than females, which is attributed to the reduced posterior acetabular coverage observed in males. The smaller posterior acetabular coverage in males might be related to differences in ischial morphology between sexes. During eccentric rotational acetabular osteotomy for males with DDH, adequately rotating acetabular bone fragments might be beneficial to compensate for deficient posterior acetabular coverage.

PMID:38996383 | DOI:10.1097/CORR.0000000000003126

Categories
Nevin Manimala Statistics

Efficacy of first-line ART regimens based on tenofovir in HIV-infected patients with pre-existing A62V mutation in reverse transcriptase

Vopr Virusol. 2024 Jul 5;69(3):231-240. doi: 10.36233/0507-4088-232.

ABSTRACT

INTRODUCTION: The amino acid substitution A62V in reverse transcriptase was identified as a mutation correlated with virologic failure in patients on first-line therapy including tenofovir (TDF) and tenofovir alafenamide (TAF). A62V is a typically polymorphic mutation in HIV-1 sub-subtype A6, which is the most widespread virus variant in Russia.

MATERIALS AND METHODS: The European EuResist (EIDB) database was queried to form two equivalent groups of patients: group 1 ‒ patients with A62V at baseline treated with TDF or TAF on the first-line therapy, group 2 ‒ patients without A62V at baseline treated with TDF or TAF on the first-line therapy. Each group included 23 patients.

RESULTS: There was no statistical difference between the two groups in virologic efficacy in 4, 12, and 24 weeks after the start of antiretroviral therapy (ART) and in the frequency of virologic failures.

CONCLUSION: This study has some limitations, and the exact role of A62V in the efficacy of the first-line ART based on tenofovir deserves further investigation.

PMID:38996372 | DOI:10.36233/0507-4088-232

Categories
Nevin Manimala Statistics

The Diagnostic Value of Conventional MRI Combined With Diffusion-Weighted Imaging in Microprolactinomas

J Magn Reson Imaging. 2024 Jul 12. doi: 10.1002/jmri.29531. Online ahead of print.

ABSTRACT

BACKGROUND: Turbo spin-echo (TSE) diffusion-weighted imaging (DWI) sequences may reduce susceptibility artifacts and image distortion in sellar region, allowing better visualization of small pituitary lesions, and may be used to assist in the diagnosis of pituitary microadenomas.

PURPOSE: To explore the application value of conventional MRI combined with DWI sequences in the diagnosis of microprolactinomas.

STUDY TYPE: Prospective.

POPULATION: Thirty-four patients in microprolactinomas with high signal on T2WI (HT2-PRL) group (34 females, 34 ± 7 years), 26 patients in microprolactinomas with equal or low signal on T2WI (ELT2-PRL) group (21 females, 34 ± 7 years), 35 patients with hyperprolactinemia (33 females, 32 ± 8 years), and 30 normal controls (25 females, 31 ± 7 years).

FIELD STRENGTH/SEQUENCE: TSE sequence at 3 T.

ASSESSMENT: Pituitary morphological parameters (such as length and volume), dynamic contrast-enhanced parameters (such as time to peak) and the apparent diffusion coefficients (ADCs) were measured in each group.

STATISTICAL TESTS: ANOVA and Mann-Whitney U test were used to compare parameters among groups. Spearman’s coefficient was used to evaluate the correlation between variables. ROC analysis was used to assess the performance of the parameters. A P-value <0.05 was considered statistically significant.

RESULTS: The pituitary volume of patients in HT2-PRL, ELT2-PRL, and hyperprolactinemia group were 831.00 (747.60, 887.60), 923.63 ± 219.34, and 737.20 (606.40, 836.80) mm3. The pituitary maximum height in these three groups were 7.03 (6.43, 8.63), 8.03 ± 1.41, and 6.63 ± 1.28 mm, respectively. The lesion ADC value was significantly correlated with T2 relative signal intensity (the ratio of signal intensity of microprolactinoma or anterior pituitary to left temporal cortex) (r = 0.821). Compared with patients with hyperprolactinemia, the diagnostic efficacy of T2 relative signal intensity was higher in HT2-PRL group, with an AUC of 0.954, whereas the ADC value was the highest in ELT2-PRL group, with an AUC of 0.924.

CONCLUSION: DWI sequences can be used to assist in the diagnosis of pituitary microadenomas.

EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 2.

PMID:38996369 | DOI:10.1002/jmri.29531

Categories
Nevin Manimala Statistics

Development and Validation of the Oxford Skin Cancer Treatment Scale, a Patient-Reported Outcome Measure for Health-Related Quality of Life and Treatment Satisfaction After Skin Cancer Treatment

Dermatol Surg. 2024 Jul 12. doi: 10.1097/DSS.0000000000004305. Online ahead of print.

ABSTRACT

BACKGROUND: Patient-reported outcome measures (PROMs) are necessary to assess the value of skin cancer treatment and to better compare therapeutic options.

OBJECTIVE: To develop and validate the Oxford Skin Cancer Treatment (OxSCanTr) scale, evaluating health-related quality of life and satisfaction after skin cancer treatment.

MATERIALS AND METHODS: After qualitative patient interviews, international expert consultation, and item reduction, 2 separate patient samples were used to assess the factor structure of the scale. Exploratory factor analysis with categorical variables and a polychoric correlation matrix followed by promax oblique rotation was performed to establish a factor structure on Group A. Confirmatory factor analysis with a Satorra-Bentler scaled test statistic evaluating the root mean squared error of approximation (RMSEA), standardized root mean squared residual (SRMR), and comparative fit index (CFI) was conducted on Group B. Reliability as internal consistency was assessed using McDonald omega. Convergent and discriminant validity were assessed using the Pearson correlation coefficient.

RESULTS: A total of 480 subjects returned completed surveys (completion rate 96%). A 12-item scale was developed encompassing 4 domains: aesthetic satisfaction, treatment choice satisfaction, treatment experience, and future concerns regarding recurrence/spread. Confirmatory factor analysis showed excellent goodness-of-fit characteristics, with RMSEA = 0.048, SRMR = 0.051, and CFI = 0.962 using the 4-factor model. Reliability was very good (McDonald omega 0.81-0.82), as was convergent validity with the FACE-Q skin cancer module appraisal of scars subscale (r = 0.55). Discriminant validity with a single question regarding being conservative was similarly excellent (r = -0.02).

CONCLUSION: The OxSCanTr scale is a parsimonious, feasible, and valid PROM for the holistic assessment of the experience of patients who have undergone skin cancer treatment.

PMID:38996368 | DOI:10.1097/DSS.0000000000004305

Categories
Nevin Manimala Statistics

Expanding Access to Contraceptive Services in a Family Medicine Residency Clinic: The Rapid Access to Contraception Clinic Model

Fam Med. 2024 Jul;56(7):442-446. doi: 10.22454/FamMed.2024.562790.

ABSTRACT

BACKGROUND AND OBJECTIVES: Learning to provide long-acting reversible contraception (LARC) during family medicine residency is an important step in building capacity for the primary care workforce to meet the reproductive health care needs of communities. We aimed to measure the impact of adding a contraceptive visit type (CVT) allowing for rapid access to contraception (RAC) on family medicine resident LARC procedure numbers.

METHODS: Our program created a CVT in which patients were seen only for contraceptive services. We added the CVT to third-year family medicine resident continuity clinic schedules and a block of CVTs (the RAC clinic) to the third-year gynecology rotation. Residents self-reported LARC procedure numbers performed throughout residency, and the totals were compared for graduating residents from 2023 (post-RAC cohort) to 2022 graduates and 2018-2022 graduates (pre-RAC cohort).

RESULTS: Post-RAC cohort residents reported a statistically significant increase in intrauterine device (IUD; P=.015) and contraceptive implant (P=.010) removals compared to the 2022 pre-RAC cohort. Insertions of IUDs and contraceptive implants were unchanged when compared to the pre-RAC cohort. IUD removals (P=.004) and insertions (P=.034), and contraceptive implant removals (P=.028) were significantly increased for post-RAC compared to 2022 graduates, with no difference in contraceptive implant insertions (P=.211).

CONCLUSIONS: The addition of the CVT and RAC clinic contributed to an increase in LARC removals in both comparisons, and IUD insertions between 2022 and 2023. This clinic model offers an opportunity for other family medicine residency programs to improve access to contraceptive services and increase resident training in LARC management.

PMID:38996355 | DOI:10.22454/FamMed.2024.562790

Categories
Nevin Manimala Statistics

Efficacy of 0.25% Lidocaine Versus 0.5% Lidocaine in Dermatologic Surgery: A Double-Blind, Randomized Controlled Trial

Dermatol Surg. 2024 Jul 12. doi: 10.1097/DSS.0000000000004319. Online ahead of print.

ABSTRACT

BACKGROUND: Although lidocaine is widely used in dermatologic surgery, no formal standard concentration is established. Previous research indicates that more dilute concentrations may offer equally effective anesthesia while potentially reducing toxicity risks. In addition, diluting commercially available lidocaine conserves supplies-a significant benefit during periods of lidocaine shortage.

OBJECTIVE: To evaluate the efficacy of 0.25% lidocaine compared with that of 0.5% lidocaine in achieving anesthesia in cutaneous surgery.

MATERIALS AND METHODS: A prospective, double-blind study with 100 patients undergoing cutaneous surgery (Mohs surgery or excision) randomized to receive either 0.25% or 0.5% lidocaine for their percutaneous anesthesia. Patients completed a postoperative survey assessing pain level, satisfaction, and willingness to undergo future dermatologic surgery.

RESULTS: This study revealed no statistically significant differences between the 0.25% and 0.5% lidocaine groups regarding pain scores, patient satisfaction, total lidocaine volume, rescue lidocaine volume, or willingness to undergo the procedure again.

CONCLUSION: 0.25% lidocaine is a safe and effective option for achieving anesthesia during Mohs surgery and standard excisions. The results suggest that 0.25% lidocaine can be used to optimize high-value care and enhance patient safety in dermatologic surgery.

PMID:38996348 | DOI:10.1097/DSS.0000000000004319

Categories
Nevin Manimala Statistics

High-Throughput Single-Molecule Surface-Enhanced Raman Spectroscopic Profiling of Single-Amino Acid Substitutions in Peptides by a Gold Plasmonic Nanopore

ACS Nano. 2024 Jul 12. doi: 10.1021/acsnano.4c04775. Online ahead of print.

ABSTRACT

Simultaneous detection and structural characterization of protein variants on a single platform are highly desirable but technically challenging. Herein, we present a single-molecule spectral system based on a gold plasmonic nanopore for analyzing two peptides and their single-point mutated variants. The gold plasmonic nanopore enabled the high-throughput acquisition of surface-enhanced Raman scattering (SERS) spectra at the single-molecule level by electrically driving analytes into hot spots. Furthermore, a statistical method based on Boolean operations was developed to extract prominent features from fluctuated single-molecule SERS spectra. The effects of the single-amino acid substitutions on both the intramolecular interactions and the peptide conformations were directly characterized by the nanopore system, and the results agreed with the predictions by AlphaFold2. This study highlights the mutual benefits of spectroscopy and nanopore technology, whereby the gold plasmonic nanopore offers a powerful tool for the structural analysis of single-molecule proteins.

PMID:38996344 | DOI:10.1021/acsnano.4c04775

Categories
Nevin Manimala Statistics

Is Quantitative Radiographic Measurement of Acetabular Version Reliable in Anteverted and Retroverted Hips?

Clin Orthop Relat Res. 2024 Jul 12. doi: 10.1097/CORR.0000000000003159. Online ahead of print.

ABSTRACT

BACKGROUND: The acetabular version is crucial for hip function, and its accurate assessment is necessary for treating patients with hip disorders. Current studies reveal discrepancies in the precision of quantitative radiographic measurements versus CT measurements, but there is a lack of focused analysis on anteverted versus retroverted hips. This study aims to fill this gap by directly comparing the reliability of these two methods in assessing varied hip configurations.

QUESTIONS/PURPOSES: (1) How reliable are quantitative radiographic and CT methods in measuring the acetabular version angle? (2) Is there any difference in the reliability of acetabular version angle measurements using radiography compared with CT in anteverted and retroverted hips? (3) What is the extent of variation in acetabular version measurements when quantitative radiographic and CT methods are compared in anteverted and retroverted hips?

METHODS: We searched our image archives for patients who had received both radiographs and CT scans between January 2020 and June 2022 and found 84 patients who met the criteria. From these patients, we selected those who presented with hip pain of different causes and who had no previous elective and/or hip trauma surgery, no hip dysplasia, and results from adequate radiographic examinations. Accordingly, 73% (61 of 84) of the patients were included in this study, and angle measurements were performed on both hips of these patients (122 hips). Standardized positioning was meticulously verified for all plain radiographs and CT scans utilized in the measurement process. We measured quantitative angles and assessed qualitative signs of retroversion, including crossover, posterior wall, and ischial spine findings. We considered a hip with at least one of these findings a retroverted hip, and the hips without these findings were included in the anteverted hip group. Three clinicians took measurements independently. Measurement reliability and agreement were examined using intraobserver and interobserver intraclass correlation coefficients (ICCs), with statistical analyses including paired and independent t-tests. To investigate the reliability of quantitative radiographic and CT methods, we assessed both intraobserver and interobserver agreements. To explore the reliability disparities in measuring the acetabular version via radiography and CT in anteverted and retroverted hips, we analyzed the agreement between measurements from both modalities in the hip groups. Furthermore, to evaluate the degree of variation in acetabular version measurements when comparing quantitative radiographic and CT methods in anteverted and retroverted hips, we utilized paired and independent t-tests to examine the measurement differences within these hip categories. The difference between radiographic and CT measurements was also evaluated by Bland-Altman analysis.

RESULTS: Quantitative radiographic measurements showed intraobserver and interobserver reliabilities with ICCs of 0.87 (95% CI 0.84 to 0.91) and 0.78 (95% CI 0.75 to 0.82), respectively, and CT measurements demonstrated higher reliabilities with ICCs of 0.92 (95% CI 0.90 to 0.93) and 0.91 (95% CI 0.89 to 0.92), respectively. The reliability of measuring the acetabular version in anteverted hips was moderate, with an ICC of 0.59 (95% CI 0.49 to 0.68). In contrast, retroverted hips showed an ICC of -0.41 (95% CI -1.17 to 0.08), indicating a lack of consistency between quantitative radiographic and CT measurements. Variation in measurement on plain radiographs in anteverted hips was less than that of retroverted hips (mean ± SD absolute difference between anteverted hips and retroverted hips 3° ± 3° versus 6° ± 4°; p = 0.0001), indicating greater variability in the radiographic measurement of retroverted hips. According to Bland-Altman analysis, we observed that the difference between radiographic and CT measurements was well outside the CI, especially in retroverted hips.

CONCLUSION: Although quantitative radiographic measurement demonstrates acceptable intraobserver and interobserver reliabilities, its precision is lower than that of CT-based measurements. Specifically, quantitative radiographic methods are prone to a larger margin of error in retroverted hips. For more precise assessments of acetabular version, especially in retroverted hips, we recommend using CT measurement instead of the radiographic method.

LEVEL OF EVIDENCE: Level III, diagnostic study.

PMID:38996337 | DOI:10.1097/CORR.0000000000003159

Categories
Nevin Manimala Statistics

Deconstructing Fitbit to Specify the Effective Features in Promoting Physical Activity Among Inactive Adults: Pilot Randomized Controlled Trial

JMIR Mhealth Uhealth. 2024 Jul 12;12:e51216. doi: 10.2196/51216.

ABSTRACT

BACKGROUND: Wearable activity trackers have become key players in mobile health practice as they offer various behavior change techniques (BCTs) to help improve physical activity (PA). Typically, multiple BCTs are implemented simultaneously in a device, making it difficult to identify which BCTs specifically improve PA.

OBJECTIVE: We investigated the effects of BCTs implemented on a smartwatch, the Fitbit, to determine how each technique promoted PA.

METHODS: This study was a single-blind, pilot randomized controlled trial, in which 70 adults (n=44, 63% women; mean age 40.5, SD 12.56 years; closed user group) were allocated to 1 of 3 BCT conditions: self-monitoring (feedback on participants’ own steps), goal setting (providing daily step goals), and social comparison (displaying daily steps achieved by peers). Each intervention lasted for 4 weeks (fully automated), during which participants wore a Fitbit and responded to day-to-day questionnaires regarding motivation. At pre- and postintervention time points (in-person sessions), levels and readiness for PA as well as different aspects of motivation were assessed.

RESULTS: Participants showed excellent adherence (mean valid-wear time of Fitbit=26.43/28 days, 94%), and no dropout was recorded. No significant changes were found in self-reported total PA (dz<0.28, P=.40 for the self-monitoring group, P=.58 for the goal setting group, and P=.19 for the social comparison group). Fitbit-assessed step count during the intervention period was slightly higher in the goal setting and social comparison groups than in the self-monitoring group, although the effects did not reach statistical significance (P=.052 and P=.06). However, more than half (27/46, 59%) of the participants in the precontemplation stage reported progress to a higher stage across the 3 conditions. Additionally, significant increases were detected for several aspects of motivation (ie, integrated and external regulation), and significant group differences were identified for the day-to-day changes in external regulation; that is, the self-monitoring group showed a significantly larger increase in the sense of pressure and tension (as part of external regulation) than the goal setting group (P=.04).

CONCLUSIONS: Fitbit-implemented BCTs promote readiness and motivation for PA, although their effects on PA levels are marginal. The BCT-specific effects were unclear, but preliminary evidence showed that self-monitoring alone may be perceived demanding. Combining self-monitoring with another BCT (or goal setting, at least) may be important for enhancing continuous engagement in PA.

TRIAL REGISTRATION: Open Science Framework; https://osf.io/87qnb/?view_only=f7b72d48bb5044eca4b8ce729f6b403b.

PMID:38996332 | DOI:10.2196/51216