Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study.

PURPOSE: Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT). METHODS: Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY. RESULTS: Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted. CONCLUSION: Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED. CLINICAL TRIALSGOV: NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.

The ASHA (Hope) Project: Testing an Integrated Depression Treatment and Economic Strengthening Intervention in Rural Bangladesh: A Pilot Randomized Controlled Trial.

Depression, a debilitating disorder, is highly prevalent among low-income women in low- and middle-income countries. Standard psychotherapeutic approaches may be helpful, but low treatment uptake, low retention, and transient treatment effects reduce the benefit of therapy. This pilot randomized controlled trial examined the effectiveness and feasibility of an integrated depression treatment/economic strengthening intervention. The study took place in two villages in the Sirajganj district in rural Bangladesh. Forty-eight low-income women with depressive symptoms (Patient Health Questionnaire (PHQ-9) score ≥ 10) were recruited and randomized to intervention or control arms. The intervention included a six-month group-based, fortnightly depression management and financial literacy intervention, which was followed by a cash-transfer of $186 (equivalent to the cost of two goats) at 12 months' follow-up. The cash transfer could be used to purchase a productive asset (e.g., agricultural animals). The control arm received no intervention. Findings showed significant reduction in depression scores in the intervention group. The mean PHQ-9 score decreased from 14.5 to 5.5 (B ± SE, -9.2 ± 0.8 95% CI -10.9, -7.5, p < 0.01) compared to no change in the control group. Most other psycho-social outcomes, including tension, self-esteem, hope, social-support, and participation in household economic decision-making, also improved with intervention. An integrated depression treatment and financial empowerment intervention was found to be highly effective among rural low-income women with depression. Next steps involve formal testing of the model in a larger trial.

"I Felt Like It Was God's Hands Putting the Needles In": A Qualitative Analysis of the Experience of Acupuncture for Chronic Pain in a Low-Income, Ethnically Diverse, and Medically Underserved Patient Population.

OBJECTIVES: To examine the experience of patients from a low-income, ethnically diverse medically underserved population receiving acupuncture for chronic pain. DESIGN: Qualitative analysis using inductive thematic analysis of interviews with participants from an acupuncture trial. SETTINGS/LOCATION: Four community health centers in the Bronx, New York. PARTICIPANTS: Thirty-seven adults with chronic neck or back pain or osteoarthritis who participated in a previous acupuncture trial. INTERVENTIONS: Up to 14 weekly acupuncture treatments. OUTCOME MEASURES: Pain and quality of life were examined in the original trial; this study examines qualitative outcomes. RESULTS: The themes grouped naturally into three domains of the acupuncture experience: the decision-making process, the treatment experience, and the effect of acupuncture on health. Regarding decision-making, important factors were a willingness to try something new even if you do not necessarily "believe" in it or have specifically positive expectations; a sense that medications were not working for their pain, that they also caused significant adverse effects, and that natural strategies might be preferable; and a feeling of desperation. Cost and access were significant barriers to acupuncture treatment. Regarding the process of acupuncture, the open and personal communication with the acupuncturist was an important factor, as were the sense that the process of acupuncture related to a natural process of healing or correction within the body and that part of making acupuncture successful required being open to the power of the mind to generate a positive outcome. Regarding the effect of treatment, notable aspects were the deep sense of rest and relaxation participants reported during treatment as well as the benefit they experienced for conditions other than pain. CONCLUSIONS: The themes that emerged in this ethnically diverse, low-income population were very similar to those that have emerged over the past decade of qualitative research on the acupuncture experience in other patient populations.

An integrative medicine approach to asthma: who responds?

OBJECTIVES: The objectives of this study were to develop a better understanding of which patients with chronic illness tend to respond to integrative medicine interventions, by identifying a set of characteristics or qualities that are associated with a positive outcome in a randomized clinical trial of an integrative medicine approach to asthma that incorporated journaling, yoga breathing instruction, and nutritional manipulation and supplementation. DESIGN: The study used qualitative analysis using a grounded-theory approach comparing a group of responders in the parent trial (based on the Asthma Quality of Life Scale) to a group of nonresponders. RESULTS: Twelve (12) responders and 8 nonresponders were interviewed. Responders demonstrated an attitude of "change as challenge;" a view of themselves as "independent" and "leaders;" an ability to accept one's illness while still maintaining a feeling of control over one's choices; a connection to the deeper context or meaning of complementary and alternative medicine (CAM) interventions, as opposed to just "previous experience" of CAM; and a sense of determination, commitment, and "willingness to fight" for what one needs from the health care system. Nonresponders were more often uncertain and anxious in their relationship to their asthma, tending to fall back on denial, and lacking a connection to the deeper context or philosophy of CAM interventions. CONCLUSIONS: It is possible to identify a set of characteristics that may predict a positive response to an integrative/lifestyle approach to asthma. These characteristics should be examined prospectively using both quantitative and qualitative methods in future integrative medicine clinical trials.

Providers' experiences treating chronic pain among opioid-dependent drug users.

BACKGROUND: Successful management of chronic pain with opioid medications requires balancing opioid dependence and addiction with pain relief and restoration of function. Evaluating these risks and benefits is difficult among patients with chronic pain and pre-existing addiction, and the ambiguity is increased for patients on methadone maintenance therapy for opioid dependence. Providers treating both chronic pain and addiction routinely make diagnostic and therapeutic decisions, but decision-making strategies in this context have not been well described. OBJECTIVE: Our objective was twofold. We sought first to explore providers' perceptions of ambiguity, and then to examine their strategies for making diagnostic and treatment decisions to manage chronic pain among patients on methadone maintenance therapy. DESIGN: Qualitative semi-structured interviews. SETTING AND PARTICIPANTS: We interviewed health-care providers delivering integrated medical care and substance abuse treatment to patients in a methadone maintenance program. RESULTS: Providers treating pain and co-morbid addiction described ambiguity in all diagnostic and therapeutic decisions. To cope with this inherent ambiguity, most providers adopted one of two decision-making frameworks, which determined clinical behavior. One framework prioritized addiction treatment by emphasizing the destructive consequences of abusing illicit drugs or prescription medications; the other prioritized pain management by focusing on the destructive consequences of untreated pain. Identification with a decision-making framework shaped providers' experiences, including their treatment goals, perceptions of treatment risks, pain management strategies, and tolerance of ambiguity. Adherence to one of these two frameworks led to wide variation in pain management practices, which created tension among providers. CONCLUSIONS: Providers delivering integrated medical care and substance abuse treatment to patients in a methadone maintenance program found tremendous ambiguity in the management of chronic pain. Most providers adopted one of the two divergent heuristic frameworks we identified, which resulted in significant variations in pain management. To reduce variation and determine best practices, studies should examine clinically relevant endpoints, including pain, illicit drug use, prescription drug abuse, and functional status. Until then, providers managing chronic pain in patients with co-morbid addiction should attempt to reduce tension by acknowledging ambiguity and engaging in open discourse.

An investigation of douching practices in the botánicas of the Bronx.

Douching is a common practice in women and has been associated with adverse health outcomes. In order to explore douching products and practices we conducted qualitative interviews in ten botánicas (stores that provide healing and spiritual services to immigrant communities) located in New York City. We interviewed 15 people, 14 of whom were botánica owners and employees and ten of whom were women. We found that douching was not easily separated from the more holistic concerns of botánica customers involving health, well-being and spirituality. These issues included abortion, infertility, menopause, the prevention and treatment of infections, sexuality, cleanliness, hygiene and relationship issues. The vagina was seen as a sensitive, even vulnerable part of the body, not clearly distinguished from other female organs. A variety of products were used in the vagina in the form of creams, douches, suppositories, baths and herbal steaming of the urogenital area. Alum, an astringent, was used for the purposes of vaginal tightening to enhance sexual pleasure for the partner, to make the vagina 'younger', or to hide evidence of infidelity. Botánicas are part of a complex healing system with conceptual models different from those of allopathic medicine. These models may not be unique to the botánicas.

Women's experiences of abnormal cervical cytology: illness representations, care processes, and outcomes.

BACKGROUND: We wanted to explore the conceptual representations of illness and experiences with care among women who have learned of an abnormal Papanicolaou (Pap) smear result. METHODS: The study took place in 2 primary care, family practice clinics serving low-income, multiethnic patients in the Bronx, New York City. We conducted qualitative, semistructured telephone interviews with 17 patients who had recently learned of abnormal findings on a Pap smear. After a preliminary coding phase, the investigators identified 2 important outcomes: distress and dissatisfaction with care, and factors affecting these outcomes. A model was developed on a subset of the data, which was then tested on each transcript with an explicit search for disconfirming cases. A revised coding scheme conforming to the dimensions of the model was used to recode transcripts. RESULTS: Women reported complex, syncretic models of illness that included both biomedical and folk elements. Many concerns, especially nonbiomedical concerns, were not addressed in interactions with physicians. An important source of both distress and dissatisfaction with care was the women's lack of understanding of the inherent ambiguity of Pap smear results. When perceived care needs, which included emotional support as well as information, were not met, distress and dissatisfaction were greatly increased. CONCLUSION: In this study, patients' illness models and expectations of care were not routinely addressed in their conversations with physicians about abnormal Pap smear results. When physicians can take the time to review patients' illness models carefully, distress and dissatisfaction with care can be reduced considerably.